Document:

a6130392ex10-2.htm

    Exhibit
10.2

     

     

     

     

     

     

     

     

     

     

    
      
        	
                FIDIA
      FARMACEUTICI S.PA.

                 

                and

                 

                FIDIA
      ADVANCED BIOPOLYMERS S.R.L.

                 

                 

                 

                 

              
	 	 	 
	 
      	
                 

                 

                LEASE
      AGREEMENT

                 

                 

              	 
      

      

       

      
         

         

         

         

         

         

         

         

         

      

      
 

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

         

      

      This Lease
Agreement (“Agreement”)
is entered into on December 30, 2009,

      

      between

      

      Fidia
Farmaceutici S.p.A., an Italian limited liability company with registered office
in Via Ponte della Fabbrica 3A, Abano Terme (PD), Italy (“Fidia” or the “Lessor”)

      

      and

      

      Fidia
Advanced Biopolymers S.r.l., located at Via Ponte
della Fabbrica 3B, Abano Terme (PD), Italy ("FAB" or the "Lessee")

       

      (hereinafter
jointly referred to as the “Parties” and each one as a
“Party”)

       

      WHEREAS

      

      
        	
                (A)

              	
                Fidia
      and Anika Therapeutics, Inc. a company incorporated in the Commonwealth of
      Massachusetts, U.S.A. with its main office at 32 Wiggins Avenue, Bedford,
      MA 01730, U.S.A. (“Anika”) entered into a
      share purchase agreement (the “Purchase Agreement”) dated the date hereof,
      pursuant to which Fidia sold the entire quota capital of the Lessee to
      Anika, all as more fully set forth in the Purchase
    Agreement;

              

      

       

      
        	
                (B)

              	
                the
      Parties wish to enter into an agreement setting forth the terms pursuant
      to which the Lessor will grant certain leases to the Lessee effective from
      the Closing Date (as defined in the Purchase
  Agreement);

              

      

       

      
        	
                (C)

              	
                the
      Lessor is the owner of the premises located at Abano Terme (PD), Via Ponte
      della Fabbrica 3/A and 3/B, registered with the NCT F. 10 mapp. 632 and NCEU F.10
      mapp. 632, as
      described by the extract from the Land Registry and maps as per Annex A
      hereto and identified as follows (the "Property”):

              

      

       

      
        	
                 
      

              	
                (1)

              	
                portion
      of the building named F2 (“Building F2 – Maps 0008_59 and 0008_02”) per mq
      380 for warehouse use;

              

      

       

      
        	
                 
      

              	
                (2)

              	
                portion
      of the building named “Istituto di Ricerca” (LR1 - Maps 0005 e 006) for mq
      1,055 for laboratories and production facility Tissue Tech and per mq 982
      for office (ground floor and first
floor);

              

      

       

      
        	
                (D

              	
                the
      Property, as identified above, is a portion of a bigger real estate
      complex (the “Complex”) owned by the
      Lessor and used by the Lessor for other commercial activities already
      known to the Lessee;

              

      

       

      
        	
                (E)

              	
                the
      Parties agree that the previous lease agreement in force between Fidia and
      FAB has been terminated by mutual consent on the occasion of the signature
      of the Purchase Agreement.

              

      

       

      In
consideration of the mutual covenants contained herein, the Parties covenant and
agree as follows:

      

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

       

      
        	
                1.

              	
                OBJECT OF THE
      LEASE

              

      

       

      
        	
                1.1        
      

              	
                Description of the
      Property

              

      

       

      
        	
                 
      

              	
                1.1.1

              	
                The
      Lessor grants on lease to the Lessee, who accepts, the Property of which
      the Lessor is full owner.

              

      

       

      
        	
                 
      

              	
                1.1.2

              	
                The
      Property will be destined for the following permitted uses: research
      laboratories, production facilities, warehouse and
  offices.

              

      

       

      
        	
                1.2

              	
                Availability of the Property
      and Lessor and Lessee
Warranties

              

      

       

      
        	
                 
      

              	
                1.2.1

              	
                The
      Property shall be made available to the Lessee and this Agreement shall be
      effective as of the Closing Date.

              

      

       

      
        	
                 
      

              	
                1.2.2

              	
                The
      Lessee accepts the Property in its current condition (stato di fatto e di
      diritto) as of the time of delivery to the
  Lessee.

              

      

       

      
        	
                 
      

              	
                1.2.3

              	
                The
      Lessor represents and warrants (i) to be the legitimate owner of the
      Property, to have the free and unconditional right to lease the Property
      according to this Agreement; (ii) that the Property was duly built in all
      material aspects based on valid building licenses and concessions and
      according to all applicable, material and relevant administrative,
      national and local regulations; (iii) that the use of Property according
      to the above Section 1.1.2 is compliant with all applicable, material and
      relevant administrative, national and local regulations; (iv) there are no
      third parties’ rights which could adversely affect the right of the Lessee
      on the Property under this Agreement in all material
    aspects.

              

      

       

      
        	
                 
      

              	
                1.2.4

              	
                The
      Lessee undertakes to vacate the Property in its current condition (stato di fatto e di
      diritto) as of the time of delivery to the Lessee, except for
      the  normal deterioration caused by use of the Property. To this
      end, the Parties shall enter into an initial and a final minute of
      delivery of the Property (verbale di consegna).
      Without prejudice to the provisions under Article 10 below, any
      discrepancy between the final conditions of the Property and the initial
      conditions of the Property shall cause the Lessee to pay to the Lessor any
      related costs and expenses.

              

      

       

      
        	
                 
      

              	
                1.2.5

              	
                Fidia
      and FAB expressly agree that any and all existing lease agreements between
      them having as object the Property, are terminated with immediate effect
      by mutual consent and notwithstanding anything contained in such
      agreements to the contrary, no rights or obligations thereunder shall
      survive such termination.  Fidia and FAB expressly acknowledge
      to each other that there are no outstanding rights arising from such
      terminated agreements and that, in case, any right or obligations, credit,
      liability or obligation, that exists or shall arise on the basis of the
      terminated lease agreement, it is hereby waived by both Fidia and
      FAB.

              

      

       

      
        	
                2.

              	
                DURATION, EXTENSION AND
      WITHDRAWAL

              

      

       

      
        	
                2.1

              	
                Duration and extension of the
      Agreement

              

      

       

      
        	
                 
      

              	
                2.1.1

              	
                This
      Agreement will be effective for 6 years starting from the date indicated
      in Section 1.2.1.

              

      

       

      
        	
                 
      

              	
                2.1.2

              	
                After
      the second year of this Agreement and with effects from the first day of
      the third year, the Lessee may, at any time and for any reason at its sole
      discretion, withdraw from this Agreement by giving at least six months'
      previous notice to the Lessor by registered mail. Such withdrawal shall
      take effect on the date set out in the notice (which need not necessarily
      coincide with the anniversary of this
  Agreement).

              

      

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

       

      
        	
                 
      

              	
                2.1.3

              	
                At
      the expiry of the validity of this Agreement, the Lessee may refuse to
      renew the same by notifying this via registered mail addressed to the
      Lessor, at least 6 months prior to the date of expiration. If the Lessee
      does not exercise the right to refuse the renewal of the Agreement, the
      period of validity of this Agreement will be extended automatically for 6
      year period.

              

      

       

      
        	
                 
      

              	
                2.1.4

              	
                The
      Lessor is not entitled to deny an extension of this Agreement at the end
      of the initial 6-year term. To such purpose, the Lessor expressly waives
      its rights under article 29 of Law No.
392/1978.

              

      

       

      
        	
                3.

              	
                RENT

              

      

       

      
        	
                3.1

              	
                Determination of the
      rent

              

      

       

      Subject to
any agreed adjustment on the basis of the number of square metres leased as set
out in this Section, the total rent for the Property has been agreed to be Euro
34,026 monthly (the “Amount”) starting from the
date of the delivery of the Property pursuant to Section 1.2.1 above, with the
exclusion of the additional charges indicated in Article 6, plus VAT as set by
the law.

       

      The Amount
shall be calculated as follows:

       

      
        	
                Area

              	
                Mq.

              	
                Monthly
      rent/mq

                 

                (Euro)

              	
                Monthly
      rent

                 

                (Euro)

              
	
                Istituto
      di Ricerca 

                (LR1
      - Maps 0005 e 

                006)
      - Offices

                 

              	
                982

              	
                14.29

              	
                14,033

              
	
                Warehouse

                (“Building
      F2 – Map

                0008_59”)

                 

              	
                373

              	
                5.11

              	
                1,906

              
	
                Warehouse

                (“Building
      F2 – Map

                0008_02”)

                 

              	
                7

              	
                14.29

              	
                100

              
	
                Istituto
      di Ricerca

                (LR1
      - Map 0005)-

                Research

                Laboratories

                 

              	
                536

              	
                17.05

              	
                9,138

              
	
                Istituto
      di Ricerca

                (LR1
      - Map 006)-

                Production
      facility

                Tissue
      Tech

                 

              	
                519

              	
                17.05

              	
                8,849

              
	
                Amount

                 

              	
                2,417

              	 
      	
                34,026

              

      

      

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

       

      In the
event that the Lessee, at any time and for any reason, needs either to reduce or
to extend the occupancy of the above listed areas of the Property, the Lessor
and Lessee expressly undertake to discuss in good faith terms and conditions of
such extension/reduction, which shall not be unreasonably denied by the
Lessor.

       

      The
Parties acknowledge that the Amount already include consumption of electricity,
drinking and industrial water, gas, heating, air-conditioning and cleaning (in
the latter case, with the exclusion of the cleaning of the production facility
Tissue Tech whose costs shall be paid directly by FAB).

       

      
        	
                3.2

              	
                Updating and review of the
      rent

              

      

       

      
        	
                 
      

              	
                3.2.1

              	
                Under
      the law currently in force, the Amount will be updated after the second
      anniversary of this Agreement by applying an increase equal to 75% of the
      ISTAT index relating to the consumer prices for workers' and employees'
      families (the “ISTAT
      index”) recorded in the previous
year.

              

      

       

      
        	
                 
      

              	
                3.2.2

              	
                The
      Amount shall be updated following the publication of the ISTAT index. In
      case the ISTAT index is published after the payments due for the first
      quarter following the second anniversary of this Agreement, the balance of
      the updated Amount (i.e. the difference between (i) the updated Amount due
      for the first quarter and (ii) the Amount not updated as actually paid for
      the first quarter before the publication of the ISTAT index) shall be paid
      upon the payments of the Amount payable in the next
    quarter.

              

      

       

      
        	
                4.

              	
                AUTHORISATIONS AND
      TAXES

              

      

       

      
        	
                4.1

              	
                Authorisations

              

      

       

      Any
authorisation applied for in connection with business activities, the
environment, security and any administrative permits required for the regular
performance of the commercial activities of the Lessee will be at the Lessee’s
expense. Any charge required to obtain the relevant authorisations and their
maintenance cost shall be at the Lessee’s expense. All material authorizations
required to be obtained by the Lessor or by the lessee prior to the Closing Date
and needed to operate the business are currently in effect.

       

      
        	
                4.2

              	
                Taxes

              

      

       

      During
each taxable period falling within the whole duration of the Agreement, any
taxes relating to the use of the Property, including the waste collection tax,
shall be borne by the Lessee. For sake of clarity, the Local Tax on Immovable
Property (Imposta Comunale
sugli Immobili) shall be borne solely by the Lessor.

       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

       

      
        	
                5.

              	
                PAYMENT OF RENTS AND ADDITIONAL
      CHARGES

              

      

       

      
        	
                5.1

              	
                Payment
      deadline

              

      

       

      The Amount
payable by the Lessee shall be invoiced monthly on the first day of each month.
The payment date shall be 60 days after the date of each invoice.

       

      
        	
                6.

              	
                ORDINARY AND EXTRAORDINARY
      MAINTENANCE

              

      

       

      
        	
                6.1

              	
                Ordinary
      maintenance

              

      

       

      
        	
                 
      

              	
                6.1.1

              	
                The
      Lessee undertakes to keep the Property in good maintenance and working
      conditions, subject to normal wear and
tear.

              

      

       

      
        	
                 
      

              	
                6.1.2

              	
                Any
      expenses and the relevant ordinary maintenance costs shall be borne by the
      Lessor, being such costs included in the base rate.  In any
      case, out-of-pocket expenses regarding materials used to carry out such
      ordinary maintenance shall be borne by the
  Lessee.

              

      

       

      
        	
                 
      

              	
                6.1.3

              	
                It
      is understood that ordinary maintenance means any work required by the
      normal deterioration caused by use and that shall be periodically carried
      out.

              

      

       

      
        	
                 
      

              	
                6.1.4

              	
                It
      is understood that any work required to have the Property in compliance
      with new regulations applicable to the Lessee and irrespective of the
      Property itself or to be carried out upon Lessee’s instructions shall be
      borne exclusively by the Lessee, save for what is provided under Section
      6.2.1 below.

              

      

       

      
        	
                6.2

              	
                Extraordinary
      maintenance

              

      

       

      
        	
                 
      

              	
                6.2.1

              	
                Extraordinary
      maintenance is at the Lessor’s expense. Extraordinary maintenance includes
      activities that are necessary to maintain the facility’s condition for its
      intended use, however beyond the scope of routine
      maintenance.  Examples of extraordinary maintenance include but
      not limited to replacement of floorings and roofs, replacement of heating
      and cooling equipment, maintenance and replacement of standby and
      emergency power equipment, replacement of windows, resurfacing of parking
      lots, and upgrade of security
infrastructures.

              

      

       

      
        	
                 
      

              	
                6.2.2

              	
                In
      case of need or emergency and
      delay to act of the Lessor, the Lessee, upon notice to the Lessor,
      is expressly authorised to carry out extraordinary maintenance works. In
      that event, any amount paid by the Lessee for such works shall be deducted
      from the rent following the submission of the relevant invoices stating
      the kind of works done and their
cost.

              

      

       

      
        	
                6.3

              	
                Works to comply with the
      regulations in force

              

      

       

      
        	
                 
      

              	
                6.3.1

              	
                Extraordinary
      maintenance works also include any work required by the enforcement of new
      provisions, laws or regulations issued by the relevant authorities where
      such works affect in general the Property irrespective of the
      Lessee.

              

      

       

      

      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

       

      
        	
                7.

              	
                IMPROVEMENTS

              

      

       

      
        	
                7.1

              	
                Improvements

              

      

       

      
        	
                 
      

              	
                7.1.1

              	
                In
      the event of the Lessor and the Lessee agreeing that improvements shall be
      carried out to the Property, the parties shall agree at such time as to
      how the costs of such improvements shall be
  covered.

              

      

       

      
        	
                 
      

              	
                7.1.2

              	
                The
      agreement in respect of such improvements shall be reached on each
      occasion and stated in writing by the Parties depending on the kind of
      improvement.

              

      

       

      
        	
                8.

              	
                ALTERATIONS TO THE
      PROPERTY

              

      

       

      
        	
                8.1

              	
                Alterations

              

      

       

      
        	
                 
      

              	
                8.1.1

              	
                Any
      internal and external alteration to the Property can be carried out by the
      Lessee at its own expense subject to the prior written authorisation from
      the Lessor, who can not unreasonably deny or delay it. The Lessor shall
      also provide the Lessee with all the necessary executed documents required
      by the law in order to file the proper and required request of
      authorizations and/or permits with the competent
    Authorities.

              

      

       

      
        	
                 
      

              	
                8.1.2

              	
                Except
      as may be otherwise agreed, upon approval of alterations, if it is
      determined that the Lessor desires restoration to the original condition,
      the Lessee shall bear all costs and expenses for such restoration and the
      Lessor and the Lessee shall agree on a mutually satisfactory term within
      which such restoration shall be completed. The Parties acknowledge that in
      the event the Parties mutually agree that the alterations improve the
      value of the Property the Lessee shall not be required to carry out any
      restoration at its own costs and
expenses.

              

      

       

      
        	
                9.

              	
                DESTINATION AND USE OF THE
      PROPERTY

              

      

       

      
        	
                9.1

              	
                Destination of the
      Property

              

      

       

      
        	
                 
      

              	
                9.1.1

              	
                The
      Lessee shall not have the right to perform any activity that might modify
      the nature and use of the Property.

              

      

       

      
        	
                9.2

              	
                Use of the
      Property

              

      

       

      
        	
                 
      

              	
                9.2.1

              	
                For
      the entire term of the Agreement, the Lessee undertakes to keep the leased
      Property with care and diligence and to surrender it upon the expiration
      of the term hereof, in a good state and condition, wear and tear
      excluded.

              

      

       

      
        	
                 
      

              	
                9.2.2

              	
                The
      Lessee undertakes to employ all necessary precautions to avoid and prevent
      any damage to the interior of the
Property.

              

      

       

      
        	
                 
      

              	
                9.2.3

              	
                The
      costs related to any safety measures mandated by the law and relating to
      the structure of the Property are the responsibility of and shall be borne
      by the Lessor, while those relating to the use of the Property shall be
      borne by the Lessee.

              

      

       

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

       

      
        	
                10.

              	
                CUSTODY

              

      

       

      
        	
                10.1

              	
                Lessee’s
      liability

              

      

       

      The Lessee
is responsible for the custody of the leased Property and will be liable for any
damage that may occur to it under article 1588 of the Italian Civil
Code.

       

      
        	
                11.

              	
                ACCESS TO THE
      PROPERTY

              

      

       

      
        	
                11.1

              	
                Lessor’s
      access

              

      

       

      The Lessor
and its designated representatives will at any time have full access to the
Property by giving at least 48 hours’ written notice to the Lessee prior to his
visit except in emergency cases, for the purpose to check the state and
condition of the leased premises and to carry out any relevant intervention and
repair work.

       

      
        	
                12.

              	
                SIGNS

              

      

       

      
        	
                12.1

              	
                Installation and maintenance of
      signs

              

      

       

      
        	
                 
      

              	
                12.1.1

              	
                Under
      this Agreement, the Lessee shall have the right to place, maintain and
      replace, throughout the whole duration of the lease, commercial signs only
      with the prior written consent of the Lessor to their positioning, such
      consent not to be unreasonably withheld. The Lessor shall also provide the
      Lessee with all the necessary executed documents required by the law in
      order to file the proper and required request of authorizations and/or
      permits with the competent
Authorities.

              

      

       

      
        	
                 
      

              	
                12.1.2

              	
                All
      signs shall be placed and maintained by the Lessee at its own expense and
      the Lessee shall take care to secure all the required authorisations,
      permits and approvals by the relevant
  authorities.

              

      

       

      
        	
                13.

              	
                INSURANCE

              

      

       

      
        	
                13.1

              	
                Insurance

              

      

       

      The Lessee
undertakes to subscribe, at its own expense, appropriate insurance policies with
a major insurance company to cover any risks concerning the activity exercised
in the Property and the movable assets, owned by the Lessee, located in the
Property and to deliver to the Lessor a certificate of insurance naming the
Lessor as additional insured (including, without limitation, fire, hazard and
civil liability).

       

      The Lessor
undertakes to subscribe, at its own expense, appropriate insurance policies with
a major insurance company to cover any risks relating to ownership of the
Property, including, without limitation, risk of fire, storm damage and other
natural disasters and to deliver the Lessee a certificate of insurance naming
the Lessee as additional insured.

      

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

       

      
        	
                14.

              	
                TERMINATION

              

      

       

      
        	
                14.1

              	
                Termination

              

      

       

      
        	
                 
      

              	
                14.1.1

              	
                In
      the event the Property is destroyed as a result of a flood, war,
      earthquake or any other independent event beyond the control of the
      Lessor, and without there having been any prejudice to the rights of the
      Lessee and of the Lessor, this Agreement shall automatically terminate
      with immediate effect.

              

      

       

      
        	
                 
      

              	
                14.1.2

              	
                In
      the event the Property is only partially destroyed as a result of one of
      the events set out in Section 14.1.1 above, the Lessee shall have the
      right to terminate this Agreement or to continue with the Agreement
      reducing the Amount proportionally up to the date of the complete
      restoration of the Property.

              

      

       

      
        	
                15.

              	
                TRANSFER OF THE
      AGREEMENT

              

      

       

      
        	
                15.1

              	
                Transfer of the
      agreement

              

      

       

      
        	
                 
      

              	
                15.1.1

              	
                The
      rights and obligations provided for in this Agreement may not be assigned,
      delegated or transferred by either Party without the prior written consent
      of the other Party (which consent shall not be unreasonably withheld,
      conditioned or delayed), except that this Agreement may be assigned or
      transferred in full to an Affiliate or to a successor in ownership of all
      or substantially all of the business or assets of the assigning party
      (whether by merger, sale or otherwise) without the prior consent of the
      other Party; provided that such assigning party provides written notice to
      the other Party of such assignment and the assignee of this Agreement
      agrees in writing to be bound as such Party hereunder, and provided
      further that (x) this Agreement must be assigned to a successor in
      ownership of all or substantially all of the business or assets of the
      assigning party and (y) the assigning Party, in case of assignment to an
      Affiliate, shall be jointly liable with such Affiliate for breach, no
      further assignment shall be allowed without consent and if such Affiliate
      ceases at any time to be an Affiliate of the assigning Party, the
      Agreement shall be automatically assigned back to the assigning Party.
      Notwithstanding anything to the contrary in this Agreement, any
      assignment, delegation or transfer, or any such assignment or transfer, in
      violation of this Section 15.1.1 shall be void. This Agreement shall inure
      to the benefit of, and be binding upon, the legal representatives,
      successors and permitted assigns of each of the
  Parties.

              

      

       

      For
purposes of this Agreement:

       

      (i)           Control: shall mean (i) the
possession, directly or indirectly, of the power to direct the management or
policies of a person or to veto any material decision relating to the management
or policies of a person or a majority of the composition of the board of
directors (or similar governing body), in each case, whether through the
ownership of voting securities or a Affiliates, by contract or otherwise, or
(ii) the beneficial ownership, directly or indirectly, of at least 50% of the
voting securities of a person.

       

      (ii)           Affiliates: means, with
respect to a person, means any company or entity which Controls, is Controlled
by or is under common Control with such person.

       

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

         

      

      
        	
                15.1.2

              	
                The
      Lessee is allowed to transfer this Agreement or sub-let or give in
      gratuitous loan for use (comodato), whether in
      full or in part and whether temporarily or not, the Property without the
      Lessor’s prior written agreement, provided the transfer takes place with
      entities belonging to or controlled by the Anika group of
      companies.

              

      

       

      
        	
                15.1.3

              	
                The
      Parties acknowledge that the provisions of law No. 392 of 27 July 1978
      apply to transfers of the Property.

              

      

       

      
        	
                16.

              	
                MISCELLANEOUS

              

      

       

      
        	
                16.1

              	
                Expenses

              

      

       

      The
registration fee related to this Agreement shall be borne on a 50/50 basis by
the Parties.

       

      
        	
                16.2

              	
                Amendments

              

      

       

      Any
amendments to this Agreement will be effective as long as it is done in writing
and signed by both Parties.

       

      
        	
                16.3

              	
                Penalties

              

      

       

      At the
expiry of this Agreement for any reasons whatsoever, the Lessee shall release
the Property free of people and items and in the full availability to the Lessor
on the 10th day
subsequent to the expiry of this Agreement. In case of delay, a penalty shall
apply equal to Euro 1,000 for any day of delay, without prejudice to the
reimbursement of any greater damages.

       

      
        	
                16.4

              	
                Jurisdiction

              

      

       

      The Court
of Padua shall have jurisdiction to hear any dispute arising out of the
interpretation and performance of this Agreement.

       

      
        	
                16.5

              	
                Communications

              

      

       

      Any
communication between the Parties under this Agreement shall be in writing to
the addresses set out at the heading of this Agreement and will be not
considered valid unless they are delivered personally or sent via registered
mail to such addresses.

       

      
        	
                16.6

              	
                Language

              

      

       

      This
Agreement is drawn up and executed in the English language. In addition, a
translation of this Agreement into Italian will be executed for the purposes of
registration purposes in Italy. In case of any dispute, the English language
text prevails.

       

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

       

      
        	
                16.7

              	
                Confidentiality

              

      

       

      Each Party
(the “Receiving Party”)
receiving Confidential Information of the other Party (the “Disclosing Party”) (or that
has received any such Confidential Information from the other Party prior to the
date hereof) shall (i) maintain in confidence such Confidential Information
using not less than the efforts such Receiving Party uses to maintain in
confidence its own proprietary industrial information of similar kind and value
(but in no event less than reasonable efforts), (ii) not disclose such
Confidential Information to any third party without the prior written consent of
the Disclosing Party, except for disclosures expressly permitted below, and
(iii) not use such Confidential Information for any purpose except those
permitted by this Agreement; provided, that the obligations in this Section 16.7
shall not apply with respect to any portion of the Confidential Information that
the Receiving Party can show by competent written proof (i) is publicly
disclosed by the Disclosing Party, either before or after it is disclosed to the
Receiving Party hereunder; or (ii) was known to the Receiving Party or any of
its Affiliates, without any obligation to keep it confidential or any
restriction on its use, prior to disclosure by the Disclosing Party; or (iii) is
subsequently disclosed to the Receiving Party or any of its Affiliates by a
third party lawfully in possession thereof and without any obligation to keep it
confidential or any restriction on its use; provided, further that the Receiving
Party may disclose Confidential Information belonging to the Disclosing Party
only to the extent such disclosure is reasonably necessary in the following
instances: (i) regulatory filings; (ii) prosecuting or defending litigation;
(iii) complying with applicable laws (including, without limitation, the rules
and regulations of any national securities exchange and the Securities and
Exchange Commission) and with judicial process, if in the reasonable opinion of
the Receiving Party’s counsel, such disclosure is necessary for such compliance;
and (iv) disclosure, solely on a “need to know basis”, to Affiliates,
subcontractors, and each of the parties’ respective directors, employees,
contractors and agents, each of whom prior to disclosure must be bound by
written obligations of confidentiality and non-use no less restrictive than the
obligations set forth in this Section 16.7; provided, however, that the
Receiving Party shall remain responsible for any failure by any person who
receives Confidential Information pursuant to this Section 16.7 to treat such
Confidential Information as required under this Section 16.7. If and whenever
any Confidential Information is disclosed in accordance with this Section 16.7,
such disclosure shall not cause any such information to cease to be Confidential
Information except to the extent that such disclosure results in a public
disclosure of such information (otherwise than by breach of this Agreement).
Where reasonably possible except in the case of paragraph (iii) above, the
Receiving Party shall notify the Disclosing Party of the Receiving Party’s
intent to make such disclosure pursuant to this Section 16.7 sufficiently prior
to making such disclosure so as to allow the Disclosing Party adequate time to
take whatever action it may deem appropriate to protect the confidentiality of
the information. Upon expiration or earlier termination of this Agreement, the
Receiving Party shall, as the Disclosing Party may direct in writing, either
destroy or return to the Disclosing Party all tangible forms of Confidential
Information previously disclosed by the Disclosing Party together with all
copies thereof; provided, however, the Receiving Party may retain one archival
copy thereof for the purpose of determining any continuing obligations of
confidentiality.

       

      For the
purposes of this Section 16.7, “Confidential Information”
shall mean all materials and other information that are disclosed or provided by
such party or its Affiliates to the other party or its Affiliates in relation to
the subject of this Agreement, regardless of whether any of the foregoing are
marked “confidential” or “proprietary” or communicated to the other by the
Disclosing Party or its Affiliates in oral, written, graphic, or electronic
form.

       

      
        	
                17.

              	
                FORCE
      MAJEURE

              

      

       

      No Party
hereunder shall be liable to the other for its failure to perform hereunder
caused by contingencies due to the impossibility to perform for a cause not
attributable (“imputabile”) directly or
indirectly to such Party that may include, without limitation, acts of God,
fire, flood, wars, acts of terrorism, sabotage, strike, government actions;
provided that financial inability in and of itself shall not be deemed an
inability to perform any obligation hereunder. Any Party asserting its inability
to perform any obligation hereunder for any such contingency shall promptly
notify the other Party of the existence of any such contingency, and shall use
its reasonably diligent efforts to re-commence its performance of such
obligation as soon as commercially practicable.

       

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

       

      
        	
                18.

              	
                APPLICABLE
      LAW

              

      

       

      
        	
                18.1

              	
                This
      Agreement is governed by the Italian law. Unless otherwise provided for
      explicitly in this Agreement, the provisions of law No. 392/1978 will
      apply and, unless they have been expressly derogated, the Civil Code
      provisions on lease agreements will also
apply.

              

      

       

      
        	
                IN
      WITNESS WHEREOF, the Parties have duly executed this Agreement as of the
      day and year first above written.

                 

                 

                 

                 

                FIDIA
      FARMACEUTICI S.P.A.

              
	
                 

                /s/
      Antonio Germani

                 

                Name:
      Antonio Germani

                Title:
      [President] Managing Director

              
	
                 

                 

                 

                FIDIA
      ADVANCED BIOPOLYMERS S.R.L.

              
	
                 

                /s/
      Charles H. Sherwood

                 

                Name:
      Charles Sherwood

                Title:
      President

              

      

       

       

       

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

       

      ANNEX
A

      DESCRIPTION
OF THE PROPERTYa6130392ex10-3.htm

    Exhibit
10.3

    
       

       

       

       

      
        
          	
                   

                   

                   

                   

                  FIDIA
      FARMACEUTICI S.P.A.

                   

                  AND

                   

                  FIDIA
      ADVANCED BIOPOLYMERS S.R.L.

                   

                   

                   

                   

                
	 
      	 
      	 
      
	 	 	 
	 
      	
                   

                   

                  TOLLING
      AGREEMENT

                   

                   

                	 
      

        

         

        

         

      

       

       

       

       

       

       

       

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

    

    
       

    

    
       

      THIS AGREEMENT is made on
December 30, 2009 (the “Commencement
Date”)

      

      BETWEEN:

      

      
        	
                
                  (1)

                

              	
                FIDIA FARMACEUTICI
      S.p.A., a company duly registered in Italy with its main office at
      via Ponte della Fabbrica 3/A, 35031 Abano Terme, Italy (the "Manufacturer");
      and

              

      

       

      
        	
                (2)

              	
                FIDIA ADVANCED BIOPOLYMERS
      S.r.l., an
      Italian limited liability company with registered office in Via Ponte
      della Fabbrica 3B, Abano Terme (PD), Italy (the "Customer").

              

      

       

      WHEREAS

      

      The
Manufacturer is in the business of manufacturing pharmaceutical and medical
device products, and the Manufacturer represents that it has the necessary
expertise, experience, authorizations, personnel and facilities to manufacture
such products;

      

      The
Customer desires to have the Manufacturer manufacture certain Products (as
defined below) for the Customer, and the Manufacturer desires to manufacture
such Products for the Customer;

      

      The
Parties are willing to carry out the foregoing pursuant to the terms and
conditions set forth in this Agreement.

      

      THE PARTIES AGREE as
follows:

       

      
        	
                1.

              	
                INTERPRETATION

              

      

       

      
        	
                1.1

              	
                In
      this Agreement:

              

      

       

      “Affiliate” means, with respect
to a person, any company or entity which controls, is controlled by or is under
common control with such person, where control, for purposes of this definition,
means (i) the possession, directly or indirectly, of the power to direct the
management or policies of a person or to veto any material decision relating to
the management or policies of a person or a majority of the composition of the
board of directors (or similar governing body), in each case, whether through
the ownership of voting securities, by contract or otherwise, or (ii) the
beneficial ownership, directly or indirectly, of at least 50% of the voting
securities of a person;

       

      “Calendar Quarter” means each
of the respective periods of three consecutive calendar months ending on 31
March, 30 June, 30 September and 31 December; provided that the first Calendar
Quarter of this Agreement shall begin on the Commencement Date and end on 31
March 2010;

       

      “Calendar Year” means the period from 1
January to 31 December of each year;

       

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

        
           

           

        

      

      “cGMP” means the current good
manufacturing practice regulations promulgated by FDA pursuant to the FDC
Act;

       

      “Certificate of Analysis” means
a certificate issued by Manufacturer stating that a batch of Product and/or
Intermediate has been manufactured, packaged and supplied in accordance with the
Master Batch Record and stating the final release test results;

       

      “Certificate of Compliance”
means a written document, signed by an authorized representative of
Manufacturer, certifying that a specific lot or batch of Product and/or
Intermediate was manufactured in accordance with the Master Batch Record, cGMP,
other applicable laws, and the requirements set forth in this Agreement and the
Quality Agreement;

       

      “Confidential Information”
means information about a Party’s marketing plans, business plans, business
methodologies, strategies, technology, development plans, customers, prospective
customers, billing records, and products or services, and other non-public
information that is disclosed or provided by a Party or its Affiliates to the
other Party or its Affiliates, regardless of whether any of the foregoing is
marked “confidential” or “proprietary” or communicated to the other by the
disclosing Party or its Affiliates in oral, written, graphic, or electronic
form;

       

      “Disclosing Party” shall have
the meaning set forth in clause 16.1 of this Agreement;

       

      “Existing Product Agreements”
means the agreements between Manufacturer and Customer listed in Annex F;

       

      “Existing Purchase Orders”
means the purchase orders between Customer and Manufacturer that are attached
hereto as Annex
G, which purchase orders were placed by FAB and accepted by Manufacturer
prior to the Commencement Date;

       

      “FAB
Specific Know-How” meansall
know-how, technical information, documents, manufacturing processes,
specifications, sourcing information, and quality control and testing procedures
that are reasonably necessary for the manufacture of Products and/or
Intermediates by a party that is generally experienced in the field of medical
device manufacturing;  

       

      “Facility” mean the
Manufacturers' facility located at Abano Terme, Italy;

       

      “FDA” means the Food and Drug
Administration of the United States of America and/or any other governmental or
regulatory agencies as may regulate or control the sale of drugs in the American
territory;

       

      “FDC Act” means the U.S.
Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et. seq.) as amended from
time to time, and all regulations promulgated pursuant thereto;

       

      “FOB” has the meaning ascribed
to it in INCOTERMS (2000 version);

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

        
           

        

      

       

      “Initial Term” shall have the
meaning set forth in clause 3.1 of this Agreement;

       

      “Intermediate” means a
chemically modified derivative of hyaluronic acid used to manufacture
Products;

       

      “LCA Rules” shall have the meaning
set forth in clause 22.1 of this Agreement;

       

      “Manufacturing Process” shall
mean the processes and procedures used to manufacture the Product and/or Intermediates
in accordance with the Master Batch Record, including all protocols and
standard operating procedure documents referenced therein and the other
requirements set forth in this Agreement;

       

      “Master Batch Record” shall
mean the document containing the formula (listing intermediate and raw
materials), procedures for the manufacturing (listing components and
containers), quality assurance of the Product and/or Intermediates and
in-process and finished product specifications for the Product and/or
Intermediates;

       

      “Product Fee” shall mean the
manufacturing fee to be charged by Manufacturer for the Products to be provided
to Customer hereunder, which fee shall include the costs of materials,
manufacturing, standard quality control and quality assurance, testing,
documentation and packaging, which fee is set forth in Annex E;

       

      “Parties” means, collectively,
the Manufacturer and the Customer, and “Party” means any of
them;

       

      “Product” means any of the
products listed in Annex A;

       

      “Purchase Agreement” means the
share purchase agreement dated the date hereof agreed between Manufacturer and
Anika Therapeutics Inc. in respect of the purchase and sale of the
Customer;

       

      “Quality Agreement” means the quality
agreement attached hereto as Annex D, as the same
may be amended or modified from time to time by mutual written agreement of the
Parties;

       

      “Receiving Party” shall have
the meaning set forth in clause 16.1 of this Agreement;

       

      “Regulatory Authority” means
any applicable supranational, federal, national, regional, state or local
regulatory agency, department, bureau, commission, council or other government
entity with authority over the development, manufacture, use, marketing and/or
sale of a pharmaceutical product or medical device in any regulatory
jurisdiction throughout the world, including the FDA in the United States, the
EMEA in the Europe.

       

      “Renewal Term” shall have the
meaning set forth in clause 3.1 of this Agreement;

       

      “Specifications” means the
specifications for each Product and/or Intermediate
set out in Annex
B;

       

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

        
           

           

        

      

      “Territory” means all of the
countries of the world; and

       

      “Year” or means each successive
period of twelve (12) months commencing on the Commencement Date.

       

      
        	
                
                  1.2

                

              	
                In
      this Agreement, a reference to:

              

      

       

      
        	
                 
      

              	
                1.2.1

              	
                a
      document is a reference to that document as modified or replaced from time
      to time;

              

      

       

      
        	
                 
      

              	
                1.2.2

              	
                a
      person includes a reference to a corporation, body corporate, association,
      partnership or other legal entity;

              

      

       

      
        	
                 
      

              	
                1.2.3

              	
                a
      person includes a reference to that person’s legal personal
      representatives, successors and permitted
  assigns;

              

      

       

      
        	
                 
      

              	
                1.2.4

              	
                the
      singular includes the plural and vice versa;
and

              

      

       

      
        	
                 
      

              	
                1.2.5

              	
                a
      clause or Annex, unless the context otherwise requires, is a reference to
      a clause of or Annex to this
Agreement.

              

      

       

      
        	
                1.3 
      

              	
                The
      headings in this Agreement do not affect its
    interpretation.

              

      

       

      
        	
                2.

              	
                PRODUCTS

              

      

       

      
        	
                2.1

              	
                The
      Manufacturer shall manufacture and supply Products and/or Intermediates
      for the Customer pursuant to the provisions of this
    Agreement.

              

      

       

      
        	
                2.2

              	
                The
      Parties agree and acknowledge that it is the Customer’s intent to
      manufacture and supply its own requirements for certain Products and/or
      Intermediates, by itself and/or through suitable affiliated or third party
      manufacturers, as soon as commercially practicable following the
      Commencement Date. The Parties therefore
      agree that Customer shall not be under any obligation to purchase (i)
      Products and/or Intermediates exclusively from
      the Manufacturer, or (ii) any minimum quantities of Products and/or
      Intermediates
      from the Manufacturer, except as expressly set forth in clause
      4.2.

              

      

       

      
        	
                2.3

              	
                The
      Manufacturer shall provide the Products exclusively to the Customer, and
      shall not manufacture for or supply Product to any person other than
      Customer, except with respect to Manufacturer’s own brand-label products
      manufactured pursuant to the Existing Product Agreements in the form
      provided to Anika Therapeutics, Inc. prior to the Commencement Date as
      amended pursuant to Purchase
Agreement.

              

      

       

      
        	
                2.4

              	
                The
      Parties agree to comply with the requirements and provisions set forth in
      the Quality Agreement attached hereto as Annex D and
      made a part hereof. In the event of a conflict between the terms of the
      Quality Agreement and the terms of this Agreement, the terms of this
      Agreement shall prevail.

              

      

       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                3.

              	
                TERM

              

      

       

      
        	
                3.1

              	
                This
      Agreement has an initial term beginning on the Commencement Date and
      ending on 31 December 2014 (the “Initial Term”), unless
      terminated earlier pursuant to clause 14. At the end of the Initial Term,
      this Agreement shall expire unless Customer provides Notice of its intent
      to renew this Agreement for an additional two (2) year term (“Renewal Term”), giving
      to the Manufacturer not less than six (6) months Notice of renewal prior
      the expiration of the Initial Term.  At the end of each Renewal
      Term, this Agreement shall expire unless Customer provides Notice of its
      intent to renew this Agreement for an additional two (2) year Renewal
      Term, given to the Manufacturer not less than six (6) months Notice of
      renewal prior the expiration of the then-current Renewal
    Term.

              

      

       

      
        	
                4.

              	
                FORECASTS AND
      ORDERS

              

      

       

      
        	
                4.1

              	
                For
      the period up to 30 June 2010, the non-binding forecast attached as Annex I
      will apply. Beginning with the twelve (12) month period starting on 1 July
      2010, and for each consecutive twelve (12) month period thereafter,
      Customer shall provide Manufacturer with a written twelve (12) month
      forecast of its estimated orders for Product and/or Intermediates, if any
      (each a “Forecast”). Each
      Forecast shall be delivered to Manufacturer at least sixty (60) days prior
      to the beginning of the applicable twelve (12) month
      period.  Each Forecast is a non-binding estimate and shall not
      obligate Customer to purchase the volume of Product and/or Intermediates
      set forth in it; provided, however, that eighty percent
      (80%) of the aggregate volume forecasted in such Forecast shall be binding
      upon Customer and Customer shall deliver Orders to Manufacturer
      pursuant to clauses 4.3 and 4.4 (each, an “Order”) during
      such twelve (12) month period for quantities of
      Product and/or Intermediates which, in the
      aggregate, amount to at least the binding portion of such
      Forecast.

              

      

       

      
        	
                4.2

              	
                For
      the Forecast covering the period from 1 July 2010 to 30
      June 2011, although the aggregate quantities actually ordered
      during such twelve (12) month period may exceed one hundred fifty percent
      (150%) of the aggregate amounts set forth in the Forecast, the supply
      obligations of Manufacturer shall not exceed one hundred twenty percent
      (120%) of the aggregate amounts forecast for such twelve (12) month
      period. The Manufacturer shall use its reasonable endeavours to supply any
      Product and/or Intermediate that is in excess of one hundred twenty
      percent (120%) but less than one hundred fifty percent (150%) of the
      aggregate amount set forth in the Forecast, and if it is unable to do so,
      the Manufacturer’s only obligation with respect to such excess portion
      over one hundred twenty percent (120%) is to inform the Customer as soon
      as reasonably practicable, but in any event within ten (10) days of
      receipt of the applicable Order, of Manufacturer’s inability to supply,
      and the Customer may at its option agree an alternative delivery date for
      such excess.

              

      

       

      
        	
                4.3

              	
                For
      each Forecast covering  the period from 1 July 2011 to 30 June 2012,
      and each subsequent consecutive twelve (12) month period
      thereafter, although the
      aggregate quantities actually ordered may exceed one hundred twenty
      percent (120%) of the aggregate amounts set forth in such Forecast, the
      supply obligations of Manufacturer shall not exceed one hundred twenty
      percent (120%) of the aggregate amount forecast for such twelve (12) month
      period. The Manufacturer shall use its reasonable endeavours to supply any
      Product and/or Intermediate set forth in an Order that is in excess of one
      hundred twenty percent (120%) of the amount set forth in the Forecast for
      such month, but if it is unable to do so, the Manufacturer’s only
      obligation with respect to such excess portion is to inform the Customer
      as soon as reasonably practicable, but in any event within ten (10) days
      of receipt of the applicable Order, of Manufacturer’s inability to supply,
      and the Customer may at its option agree an alternative delivery date for
      such excess.

              

      

       

      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

       

       

      
        	
                4.4

              	
                Customer
      shall order Product and/or Intermediate by submitting either written
      purchase orders, in such form as the Parties shall agree from time to time
      or the order placement function of Customer, and each electronic
      submission of such an order shall constitute an Order placed by Customer
      with Manufacturer. Each Order shall specify the quantities of Product
      and/or Intermediates ordered, and the desired delivery date for such
      Product and/or Intermediate in accordance with the terms of this
      Agreement. Unless otherwise agreed by the Parties, Customer shall order
      Product and/or Intermediate in lots of a defined number of units/lot
      pursuant to each Order in not less than the minimum batch size or its
      multiples, of each Product and/or Intermediate set out in Annex C. Except
      as set forth in clause 4.8, or as otherwise agreed by the Parties, any
      Order for less than the minimum batch size shall be deemed to be for the
      minimum batch size.

              

      

       

      
        	
                4.5

              	
                Manufacturer
      shall make each delivery of Product and/or Intermediate in the quantity
      and on the delivery date specified for it on Customer’s Order to the Party
      specified on such Order.  Manufacturer shall address each
      delivery with the delivery point set forth in the applicable
      Order.  Any Order for Product and/or Intermediate submitted by
      Customer to Manufacturer shall reference this Agreement and shall be
      governed exclusively by the terms contained herein. The Parties hereby
      agree that the terms and conditions of this Agreement shall supersede any
      term or condition in any Order, confirmation or other document furnished
      by either Party to the other Party that is in any way in addition to or
      inconsistent with these terms and
conditions.

              

      

       

      
        	
                4.6

              	
                Once
      a firm Order for Products and/or
      Intermediates has been received and accepted by the Manufacturer
      from the Customer, it shall be irrevocable and may be modified only as
      mutually agreed to by both Parties.

              

      

       

      
        	
                4.7

              	
                The
      Customer shall order Products and/or Intermediates from the Manufacturer
      on the basis of firm Orders to be placed at least ninety (90) days in
      advance of required delivery dates, provided however that any such days
      falling within the months of August or December shall not be counted when
      calculating such ninety (90) day period.

              

      

       

      
        	
                4.8

              	
                To
      support the Customer’s efforts to transfer production of certain products
      to the Customer’s facility, if agreed to by the Parties, the Manufacturer
      will supply Intermediates to the Customer in quantities less than the
      minimum batch size at the prices listed in Annex E.
      

              

      

       

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

      
         

         

      

      
        	
                4.9

              	
                Subject
      to clause 4.2 and 4.3, Manufacturer shall deliver 100% of the Product
      and/or Intermediates set forth in an Order with a range of tolerance equal
      to +/- 5% within five days following, or one day prior to, the date
      specified on the applicable Order.  Should the Manufacturer more
      than once during rolling twelve (12) month period fail to provide any
      quantity of the Product and/or Intermediates ordered with an Order placed
      for forecasted quantity and not cure such default within ninety (90) days
      after the date of such failure, then the Customer reserves the right to
      take any or all of the following
actions:.

              

      

       

      
        	
                a)

              	
                arrange
      for direct expedited routing of the Product and/or Intermediates (with the
      entire cost of such expedited routing to be borne by Manufacturer);
      or

              

      

       

      
        	
                b)

              	
                terminate
      the Order upon Notice to Manufacturer and purchase substitute Product
      and/or Intermediate from another supplier.  Such Product and/or
      Intermediate purchased from another supplier shall count towards the total
      quantity with respect to the binding forecast requirements of clause
      4.1.

              

      

       

      
        	
                5.

              	
                DELIVERY
      TERM

              

      

       

      
        	
                5.1

              	
                Delivery
      shall be FOB to the Customer’s facility in Abano Terme, Italy, or to the
      nearest airport to the Customer’s facility in Abano Terme, Italy, unless
      otherwise agreed by the Parties. All Product and/or
      Intermediate shall be properly packed, marked and delivered by
      Manufacturer in accordance with the Specifications and instructions
      included in the Order in a format previously agreed upon by the
      Parties.

              

      

       

      
        	
                6.
      

              	
                ACCEPTANCE AND
      CLAIMS

              

      

       

      
        	
                6.1

              	
                The Manufacturer
      will be responsible for providing the Products and/or Intermediates to the
      Customer in accordance with the Specifications, in strict compliance with
      cGMP and with any applicable regulations of any applicable
      Regulatory Authorities, and
      Manufacturer shall not provide any Products and/or
      Intermediates that do not comply in all respects with the
      Specifications, cGMP and the requirements of any applicable Regulatory
      Authorities.

              

      

       

      
        	
                6.2

              	
                For
      each delivery of Product and/or Intermediate, the Manufacturer shall
      provide the Customer with a duly drafted and signed Certificate of
      Analysis and Certificate of
Compliance.

              

      

       

      
        	
                6.3

              	
                Neither the
      Specifications, nor the current manufacturing processes will be changed or
      amended without the prior written consent of the Customer. Customer
      may request changes to the Specifications
      and/or the current manufacturing processes, and following any such
      request, Customer and Manufacturer shall in discuss in good faith such
      requested changes. Manufacturer shall, to the extent technologically
      feasible, accommodate Customer's requested changes, provided that Customer
      shall reimburse Manufacturer for any one-time, reasonable, documented,
      out-of-pocket incremental costs associated exclusively with the
      implementation of such changes which are agreed upon by Manufacturer and
      Customer, provided that such costs and any related Product Fee change are
      pre-agreed in advance by Customer and
      Manufacturer.    

              

      

       

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

      
         

         

      

      
        	
                6.4

              	
                Customer
      shall have the right to amend the Specifications for labeling or packaging
      for Product and/or Intermediate.  In the event that Customer
      provides Notice to Manufacturer with respect to any changes to the
      Specifications for labeling or packaging, Manufacturer shall implement
      such changes and Customer agrees to pay all reasonable, out-of-pocket
      additional costs actually incurred with the implementing of such changes,
      including costs associated with up to six months (determined by reference
      to the Forecast then in effect for the Product and/or Intermediate at
      issue) of labeling or inventory rendered obsolete by such change.
      Notwithstanding the foregoing, if any changes are required to be made to
      the Specifications for packaging or labeling as a result of changes
      requested by Manufacturer, Manufacturer shall bear the expenses
      thereof.

              

      

       

      
        	
                7.

              	
                ADDITIONAL
      OBLIGATIONS

              

      

       

      
        	
                7.1

              	
                Upon
      the arrival of each delivery of Products and/or
      Intermediates at the Customer’s premises, the Customer may make a
      preliminary visual inspection (label check, customary transport packaging
      check, customary quantity check) as to determine any defects or missing
      quantities as far as reasonably practical.  The Customer may
      also perform analytical testing of the Products and/or
      Intermediates according to the Specifications. The Customer may
      also perform analytical testing of the Products and/or
      Intermediates according to the
  Specifications.

              

      

       

      
        	
                7.2

              	
                If
      a shipment
      of Products and/or
      Intermediates upon delivery does not contain those
      Products and/or Intermediates
      actually ordered by Customer pursuant to the applicable Order, or does
      not comply with, or has not been manufactured in strict accordance
      with the Specifications, cGMP and/or the other terms and conditions of
      this Agreement, including those set forth in clause 6.1, the Products
      and/or
      Intermediates shall be deemed non-conforming. The warranties set
      forth in clause 13.1, which are given solely at the delivery date, shall
      not be invalidated by any inspection or acceptance by Customer, provided
      that nothing herein shall expand the scope of the warranties set forth
      herein.

              

      

       

      
        	
                7.3

              	
                Any
      claim by the Customer for defects to the delivered Products and/or
      Intermediates according to this Agreement shall be made by Notice
      and with a preliminary description of the nature of the defect, and sent
      to the Manufacturer no later than ten (10) business days after their
      discovery by the Customer.

              

      

       

      
        	
                7.4

              	
                The
      Customer shall not send back to the Manufacturer the Products and/or
      Intermediates without the written consent of the Manufacturer. The
      Manufacturer shall retain samples of the Products and/or
      Intermediates supplied under this Agreement for at least two (2)
      Calendar Years after the expiration
date.

              

      

       

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

      
         

         

      

      
        	
                7.5

              	
                If
      the Customer notifies to the Manufacturer of a claim pursuant to this
      clause, the Manufacturer shall analyse a sample of the same batch of
      Products and/or
      Intermediates taken from its in-house retained
      quantity.

                 

                Should the
      Manufacturer agree with the complaint, then as the sole remedy of the
      Customer under this Agreement with regard to the non-conforming Product
      and/or Intermediates:

              

      

       

      
        	
                 
      

              	
                a)

              	
                the
      Customer shall not pay for the non-conforming Product and shall send the
      same back to the Manufacturer; and

              

      

       

      
        	
                 
      

              	
                b)

              	
                the
      Manufacturer shall promptly replace the non-conforming quantity of
      delivered Product with an equal quantity of the Product and/or
      Intermediates that meets the Specifications and is in compliance with
      cGMP; and

              

      

       

      
        	
                 
      

              	
                c)

              	
                the
      Manufacturer shall pay for all costs for transporting the non-conforming
      Products and/or Intermediates to and from its Facility;
  and

              

      

       

      
        	
                 
      

              	
                d)

              	
                the
      non-conforming Products and/or Intermediates shall
      count towards the binding forecast requirements of clause
    4.1.

              

      

       

      
        	
                7.6

              	
                In
      the event that the Manufacturer does not agree with the Customer’s
      complaint the matter shall, at the request of either Party, be submitted
      to an independent analytical laboratory acceptable to both Parties, which
      will resolve the discrepancy in the analysis taking into consideration the
      rejected Products and/or Intermediates and the counter-sample of the
      rejected Products and/or
      Intermediates, kept by the Manufacturer.

                 

                The
      decision of said laboratory shall be final, not subject to appeal and
      neither Party shall unreasonably withhold its approval of an independent
      laboratory proposed by the other.

                
                   

                  Should
      the independent laboratory agree with the complaint,
      then:

                

              

      

       

      
        	
                 
      

              	
                a)

              	
                clause
      7.5 shall apply, and

              

      

       

      
        	
                 
      

              	
                b)

              	
                the
      cost of the analytical testing and any other services performed by the
      independent laboratory shall be borne by the Party whose opinion was not
      supported by the independent
laboratory.

              

      

       

      
        	
                7.7

              	
                The
      provisions of clause 7.5 shall not apply if the Parties agree or the
      independent laboratory declares that (a) the Products and/or
      Intermediates fully complied with the Specifications upon delivery
      or (b) that the failure of such non–conforming quantity of the Products
      and/or
      Intermediates to meet the Specifications results from the
      Customer’s negligent or defective transportation or handling of the
      Products and/or
      Intermediates, following the delivery by the
      Manufacturer.

              

      

       

      
        	
                7.8
      

              	
                The
      Manufacturer agrees that the Customer may send representatives to the
      Manufacturer’s manufacturing Facility for audit inspection for the
      supplied Product and/or Intermediate, and the Manufacturer will allow the
      Customer’s representatives reasonable access to the necessary
      manufacturing records for the supplied Product and/or Intermediate so as
      to ensure that the Manufacturer is in compliance with cGMP provided that
      the Customer shall give the Manufacturer at least one (1) month prior
      Notice and provide for any such audit the names of the representatives and
      the audit agenda before audit inspection. Any audit inspection of
      Manufacturer by Customer shall be scheduled during normal working hours,
      at the sole expense of Customer, shall be subject to the obligations of
      confidentiality set forth in clause 16 of this Agreement, and shall not
      last more than three days, provided that if the inspection discloses
      problems that will require more than three days to review, such two-day
      period shall be extended as reasonably necessary to complete a customary
      and reasonable inspection under the circumstances. The Manufacturer
      furthermore undertakes to accept, and to procure that all approved
      sub-contractors accept audit inspections from all applicable governmental
      and Regulatory Authorities and to handle and respond to any inspection
      with respect to the manufacture of the Products and/or
      Intermediates
      and to promptly advise and inform the Customer of the results of such
      audit inspections which can negatively impact the supply of the Products
      and/or Intermediates.

              

      

       

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                7.9

              	
                It
      is the Customer’s intent to transfer the manufacturing of certain Products
      and Intermediates to its facilities during the term of this
      Agreement.  Customer may thereafter undertake such manufacturing
      itself or under contract with a third party.  In order to
      facilitate an orderly transition with respect to the transfer of
      manufacturing responsibility to Customer, Manufacturer shall fully
      cooperate in the transfer of (i) certain manufacturing equipment owned by
      Customer and listed in Annex
      H
      (“Customer
      Owned Equipment”) and (ii)
      FAB Specific Know-How to Customer.  Manufacturer shall also make
      available to Customer, in writing, electronically or other accessible
      tangible form to the extent reasonably convertible, all FAB Specific
      Know-How then in Manufacturer’s possession or at its free disposal and
      shall provide reasonable assistance to Customer in the establishment of a
      manufacturing facility.  Manufacturer shall also reasonably
      assist Customer, at Customer’s request and expense, in connection with all
      regulatory activities required in order to effect the transfer of
      manufacturing in accordance with this clause 7.9.  Costs of
      relocating and installing the Customer Owned
      Equipment shall be the responsibility of Customer.  All
      reasonable costs and expenses incurred by Manufacturer that have been
      pre-approved by Customer in advance for travel and time required by
      Manufacturer’s personnel to assist in the transfer and the establishment
      of a manufacturing facility shall be borne by Customer.  In
      order to have been successfully completed, Customer, with the assistance
      of Manufacturer, shall have produced three successive lots of Products
      meeting the then-current Specifications. The Manufacturer will support the
      Customer’s requests for planning and reasonable inventory builds to
      maintain continuity of supply during the transfer. Any inventory build
      will be delivered to Customer and invoiced when the relevant equipment is
      removed from operation at the
Facility.

              

      

       

       

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

      
         

         

      

      
        	
                7.10

              	
                Product
      Recalls. In the event Customer, after notification to and
      consultation with Manufacturer, makes a recall because the Products and/or
      Intermediates were not manufactured and supplied in conformance
      with Manufacturer’s warranties and covenants herein, Manufacturer shall
      bear all reasonable and actual out of pocket costs and expenses in
      connection with such recall to the extent caused by such breach. However,
      if it is established that the Products and/or Intermediates became
      nonconforming as a result of actions or omissions on the part of Customer,
      then Customer shall bear all reasonable and actual out of pocket costs and
      expenses in connection with such
recall.

              

      

       

      
        	
                7.11

              	
                Products
      and Intermediates will have the following minimum shelf life when
      delivered to the Customer:

              

      

       

      
        	
                a)

              	
                Products
      and/or Intermediates with 24 month expiration dating will have a
      minimum of 20 months remaining when
delivered;

              

      

       

      
        	
                b)

              	
                Products
      and/or Intermediates with 36 month expiration dating will have a
      minimum of 24 months remaining when delivered;
  and

              

      

       

      
        	
                c)

              	
                Products
      and/or Intermediates with 48 month expiration dating will have a minimum
      of 36 months remaining when
delivered.

              

      

       

      
        	
                7.12

              	
                Manufacturer
      shall keep complete and accurate records pertaining to the manufacture,
      including quality control, of the Product and
      Intermediates.   Records shall be kept for at least two (2)
      years after expiration date of the
material.

              

      

       

      
        	
                7.13

              	
                The
      Manufacturer will support the Customer in the investigation of complaints
      in accordance with the attached Quality
  Agreement.

              

      

       

      
        	
                7.14

              	
                Manufacturer
      shall have the right to use Customer Owned Equipment for the manufacture
      of Customer’s products.  Manufacturer
  shall:

              

      

       

      
        	
                a)

              	
                be
      responsible for any damage (normal wear and tear excepted) to the Customer
      Owned Equipment caused by
Manufacturer;

              

      

       

      
        	
                b)

              	
                not
      subject the Customer Owned Equipment to any liens or
      encumbrances;

              

      

       

      
        	
                c)

              	
                not
      modify the Customer Owned Equipment without the consent of the Customer;
      and

              

      

       

      
        	
                d)

              	
                service,
      maintain and repair the Customer Owned Equipment as may be necessary to
      keep the equipment is good working
order.

              

      

       

      
        	
                8.

              	
                IMPORT AND EXPORT
      LICENSES

              

      

       

      
        	
                8.1

              	
                The
      Customer is responsible for obtaining at its cost such import licenses and
      other consents in relation to the Products
      and/or Intermediates as are
      from time to time required including, without limitation, those required
      by an applicable Regulatory Authority and, if reasonably requested by the
      Manufacturer, will make copies of those licenses and consents available to
      the Manufacturer prior to the relevant
delivery.

              

      

       

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                8.2

              	
                The
      Manufacturer is responsible for obtaining such export licenses in relation
      to the manufacture and supply of Products
      and/or Intermediates to the
      Customer as are from time to time required including, without limitation,
      those required by an applicable Regulatory Authority, and if reasonably
      requested by Customer, will make copies of those licenses and consents
      available to the Customer prior to the relevant
  delivery.

              

      

       

      
        	
                9.

              	
                RISK

              

      

       

      
        	
                9.1

              	
                The
      risk of loss in connection with Products and/or
      Intermediates shall pass to the Customer upon delivery in
      accordance with FOB.

              

      

       

      
        	
                10.

              	
                TITLE

              

      

       

      
        	
                10.1

              	
                Title
      to the Products and/or
      Intermediates will pass upon delivery to the Customer in accordance
      with FOB.

              

      

       

      
        	
                11.

              	
                PRODUCT
    FEES

              

      

       

      
        	
                11.1

              	
                The
      Customer shall purchase the Products and/or
      Intermediates from the Manufacturer at the applicable Product Fee
      set forth in Annex E and in
      accordance with the terms of this Agreement. The Product Fee shall include
      all costs associated with the manufacturing and delivery of the Products
      and/or
      Intermediates in accordance with this Agreement, and the costs of
      the approved sub-contractors.

              

      

       

      
        	
                11.2

              	
                During
      the first Year, the Manufacturer shall use commercially reasonable and
      diligent efforts to identify ways in which to reduce the costs associated
      with the manufacture and supply of Products and Intermediates hereunder,
      and the Parties shall meet in July 2010 to discuss Manufacturer’s
      efforts taken pursuant to this clause 11.2.  Prior to
      such meeting, Manufacturer shall provide Customer with a written summary
      of its efforts taken pursuant to this clause 11.2.  Once the
      Parties agree to any such cost reduction measures to be undertaken by
      Manufacturer, the Product Fees shall be adjusted accordingly and Annex E will be
      amended accordingly.

              

      

       

      
        	
                12.

              	
                PAYMENT

              

      

       

      
        	
                12.1

              	
                The
      Manufacturer shall, on delivery, invoice the Customer for all Products
      and/or
      Intermediates delivered and shall include in such invoice such
      information as may reasonably be requested by the Customer, including, but
      not limited to, details of quantities of each Product and/or
      Intermediate so ordered. The date of such invoice shall not precede
      the date of delivery.

              

      

       

      
        	
                12.2

              	
                The
      Manufacturer shall invoice the Customer upon delivery and Customer shall,
      unless otherwise agreed to by the Parties, pay each invoice received
      during the first Year of this Agreement in Euro in full within 270 days of
      the invoice date in cleared funds to the bank nominated by the
      Manufacturer. The Customer shall, unless otherwise agreed to by the
      Parties, pay each invoice received during each subsequent Year of this
      Agreement in Euro in full within 60 days of the invoice date in cleared
      funds to the bank nominated by the
Manufacturer.

              

      

       

      
        
          
          

        

        
          13

          
            

          

        

        
          
          

        

      

       

      
        	
                12.3

              	
                The
      Customer shall pay interest on all overdue amounts at the rate of 0.5% per
      month from the due date for payment until receipt by the Manufacturer of
      the full amount.

              

      

       

      
        	
                13.

              	
                WARRANTY AND
      LIABILITY

              

      

       

      
        	
                13.1

              	
                The
      Manufacturer warrants to the Customer that the Products and/or
      Intermediates  supplied to the Customer pursuant to this
      Agreement, on delivery:

              

      

       

      
        	
                13.1.1

              	
                will
      be manufactured in manufacturing facility duly authorized under Italian
      regulations in strict accordance with ISO 13485, all applicable cGMP’s and
      with all applicable laws, rules and regulations, including any applicable
      regulations of any applicable Regulatory
  Authorities;

              

      

       

      
        	
                13.1.2

              	
                will
      comply in all respects with the Specifications;
  and

              

      

       

      
        	
                13.1.3

              	
                will
      be free from defects in manufacturing and
  materials.

              

      

       

      
        	
                13.2

              	
                Manufacturer
      further represents, warrants and covenants that as of the date hereof and
      during the term of this Agreement (a) Manufacturer is and will be in full
      compliance with all applicable laws and regulations with respect to the
      performance of its obligations hereunder, including the manufacturing and
      storage of Products and/or Intermediates  and the maintenance of
      its facilities used in the manufacture of Products and/or Intermediates
      hereunder; and (b) Manufacturer holds and will hold all licenses, permits
      and similar governmental authorizations, including as required by any
      Regulatory Authority, necessary or required for Manufacturer to perform
      its obligations hereunder, including the manufacture and storage of
      Products and/or Intermediates.

              

      

       

      
        	
                13.3

              	
                Each
      Party (the “Indemnifying
      Party”) agrees that it shall protect, indemnify and save the other
      Party (the “Indemnified
      Party”) harmless from and against all liabilities, actions,
      damages, claims, demands, judgments, losses, expenses, suits or actions
      and reasonable attorneys fees, and shall defend such Party in any suit for
      injuries to or death of any person or persons arising out of the
      Indemnifying Party’s breach of its representations, warranties or
      covenants hereunder. The Indemnified Party shall give the Indemnifying
      Party prompt Notice of any claim, action or suit asserted against it and
      the Indemnifying Party shall have the sole right to defend and settle such
      action or suit.

              

      

       

      
        	
                13.4

              	
                Except for willful
      misconduct, gross negligence or fraud or as provided in clause 13.3 with
      respect to the death or bodily injury of any person, neither Party shall
      be liable to the other Party, whether for negligence, breach of
      contract, misrepresentation or otherwise, for indirect
      or consequential loss, loss of business, loss of profit, goodwill,
      business opportunity or anticipated saving suffered by such other
      Party.

              

      

       

      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                13.5

              	
                The
      invalidity, illegality or unenforceability of the whole or part of clause
      13.4 does not affect or impair the continuation in force of the remainder
      of this clause.

              

      

       

      
        	
                14.

              	
                TERMINATION

              

      

       

      
        	
                14.1

              	
                Except
      as otherwise stated herein, this Agreement may be terminated by either
      Party in the case of a material or persistent breach by the other Party or
      its Affiliates of any one or more of the terms of this Agreement which is
      not remedied within sixty (60) days after receipt of Notice of the breach
      by the terminating Party, or if such breach cannot reasonably be cured
      with such sixty (60) day period, the breaching Party has failed to
      commence such cure within such period and diligently prosecute such cure
      to completion within a reasonable time
  thereafter.

              

      

       

      
        	
                14.2

              	
                On
      termination, upon written request of the Manufacturer, the Customer shall
      purchase from the Manufacturer all Products
      and/or Intermediates already ordered by the Manufacturer as at that
      date subject to the terms of this Agreement. Unless this Agreement is
      terminated by Customer for Manufacturer’s breach or otherwise agreed by
      the Parties, the Manufacturer shall complete all work in process on Orders
      received prior to termination.

              

      

       

      
        	
                14.3

              	
                The
      following clauses shall survive any expiration or termination of this
      Agreement: 1, 7.10, 7.12, 7.13, 13, 14, 16, 17, 18, 19, 21 and
      22.

              

      

       

      
        	
                15.

              	
                FORCE
      MAJEURE. No Party
      hereunder shall be liable to the other for its failure to perform
      hereunder caused by contingencies beyond its control which may include
      acts of God, fire, flood, wars, acts of terrorism, sabotage, strike,
      government actions and any other similar occurrence beyond the
      non-performing Party’s control; provided that financial inability in and
      of itself shall not be deemed an inability to perform any obligation
      hereunder. Any Party asserting its inability to perform any obligation
      hereunder for any such contingency shall promptly notify the other Party
      of the existence of any such contingency, and shall use its reasonably
      diligent efforts to re-commence its performance of such obligation as soon
      as commercially practicable.

              

      

       

      
        	
                16.

              	
                CONFIDENTIALITY

              

      

       

      
        	
                16.1

              	
                Each
      Party (the “Receiving
      Party”) receiving Confidential Information of the other Party (the
      “Disclosing
      Party”) (or that has received any such Confidential Information
      from the other Party prior to the Effective Date) shall (i) maintain in
      confidence such Confidential Information using not less than the efforts
      such Receiving Party uses to maintain in confidence its own proprietary
      industrial information of similar kind and value (but in no event less
      than reasonable efforts), (ii) not disclose such Confidential Information
      to any Third Party without the prior written consent of the Disclosing
      Party, except for disclosures expressly permitted below, and (iii) not use
      such Confidential Information for any purpose except those permitted by
      this Agreement.  

              

      

       

      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                16.2

              	
                The
      obligations in clause 16.1 shall not apply with respect to any portion of
      the Confidential Information that the Receiving Party can show by
      competent written proof:

              

      

       

      
        	
                16.2.1

              	
                is
      publicly disclosed by the Disclosing Party, either before or after it is
      disclosed to the Receiving Party hereunder;
or

              

      

       

      
        	
                16.2.2

              	
                was
      known to the Receiving Party or any of its Affiliates, without any
      obligation to keep it confidential or any restriction on its use, prior to
      disclosure by the Disclosing Party;
or

              

      

       

      
        	
                16.2.3

              	
                is
      subsequently disclosed to the Receiving Party or any of its Affiliates by
      a Third Party lawfully in possession thereof and without any obligation to
      keep it confidential or any restriction on its
  use.

              

      

       

      
        	
                16.3

              	
                The
      Receiving Party may disclose Confidential Information belonging to the
      Disclosing Party only to the extent such disclosure is reasonably
      necessary in the following
instances:

              

      

       

      
        	
                16.3.1

              	
                regulatory
      filings;

              

      

       

      
        	
                16.3.2

              	
                prosecuting
      or defending litigation;

              

      

       

      
        	
                16.3.3

              	
                complying
      with applicable laws (including, without limitation, the rules and
      regulations of any national securities exchange or the Securities and
      Exchange Commission) and with judicial process, if in the reasonable
      opinion of the Receiving Party’s counsel, such disclosure is necessary for
      such compliance; and

              

      

       

      
        	
                16.3.4

              	
                disclosure,
      solely on a “need to know basis”, to Affiliates, potential and future
      collaborators (including permitted sublicensees), permitted acquirers or
      assignees under clause 19.4 research collaborators, subcontractors,
      investment bankers, investors, lenders, and each of the Parties’
      respective directors, employees, contractors and agents, each of whom
      prior to disclosure must be bound by written obligations of
      confidentiality and non-use no less restrictive than the obligations set
      forth in this clause 16; provided, however, that the Receiving Party shall
      remain responsible for any failure by any Person who receives Confidential
      Information pursuant to this clause 16.3 to treat such Confidential
      Information as required under this clause
16.

              

      

       

      If and
whenever any Confidential Information is disclosed in accordance with this
clause 16.3, such disclosure shall not cause any such information to cease to be
Confidential Information except to the extent that such disclosure results in a
public disclosure of such information (otherwise than by breach of this
Agreement).  Other than with respect to a disclosure made pursuant to
clause 16.3.3, where reasonably possible the Receiving Party shall notify the
Disclosing Party of the Receiving Party’s intent to make such disclosure
pursuant to this clause 16.3 sufficiently prior to making such disclosure so as
to allow the Disclosing Party adequate time to take whatever action it may deem
appropriate to protect the confidentiality of the information.

       

      
        
          
          

        

        
          16

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                16.4

              	
                The
      Parties acknowledge that the terms of this Agreement shall be treated as
      Confidential Information of both
Parties.

              

      

       

      
        	
                17.

              	
                COSTS

              

      

       

      
        	
                17.1

              	
                Except
      where this Agreement provides otherwise, each Party shall pay its own
      costs relating to the negotiation, preparation, execution and
      implementation by it of this Agreement and of each document referred to in
      it.

              

      

       

      
        	
                18.

              	
                ENTIRE
      AGREEMENT

              

      

       

      
        	
                18.1

              	
                This
      Agreement constitutes the entire agreement, and supersedes any previous
      agreements, between the Parties relating to the subject matter of this
      Agreement.

              

      

       

      
        	
                18.2

              	
                Each
      Party acknowledges that it has not relied on or been induced to enter this
      Agreement by a representation other than those expressly set out in this
      Agreement.

              

      

       

      
        	
                18.3

              	
                A
      Party is not liable to the other Party for a representation that is not
      set out in this Agreement.

              

      

       

      
        	
                19.

              	
                GENERAL

              

      

       

      
        	
                19.1

              	
                A
      variation of this Agreement is valid only if it is in writing and signed
      on behalf of each Party.

              

      

       

      
        	
                19.2

              	
                A
      failure to exercise or delay in exercising a right or remedy provided by
      this Agreement does not constitute a waiver of the right or remedy or a
      waiver of other rights or remedies under this Agreement. No single or
      partial exercise of a right or remedy provided by this Agreement prevents
      further exercise of the right or remedy or the exercise of another right
      or remedy under this Agreement.

              

      

       

      
        	
                19.3

              	
                The
      rights and obligations provided for in this Agreement may not be assigned,
      delegated or transferred by either Party without the prior written consent
      of the other Party (which consent shall not be unreasonably withheld,
      conditioned or delayed), except that this Agreement may be assigned or
      transferred in full to an Affiliate or to a successor in ownership of all
      or substantially all of the business or assets of the assigning Party
      (whether by merger, sale or otherwise) without the prior consent of the
      other Party provided that such assigning Party provides Notice to the
      other Party of such assignment and the assignee of this Agreement agrees
      in writing to be bound as such Party hereunder, and provided further that (x)
      this Agreement must be assigned to a successor in ownership of all
      or substantially all of the business or assets of the assigning Party and
      (y) in connection with an assignment to an Affiliate, the assigning
      Party shall be
      jointly liable with such Affiliate for breach, no further assignment shall
      be allowed without consent and if such Affiliate ceases at any time to be
      an Affiliate of the assigning Party, the Agreement shall be automatically
      assigned back to the assigning Party.
      Notwithstanding anything to the contrary in this Agreement, any
      assignment, delegation or transfer, or any such assignment or transfer, in
      violation of this clause 20.1 shall be void.  This Agreement
      shall inure to the benefit of, and be binding upon successors and
      permitted assigns of each of the Parties. Manufacturer shall
      not sub-contract any of its obligations hereunder, provided that nothing
      herein shall prevent the Manufacturer from using Manufacturers and
      sub-contractors (i) that have been pre-approved by Customer, or (ii) that
      are specifically identified in the
  Specifications.

              

      

       

      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                20.

              	
                NOTICES

              

      

       

      
        	
                20.1

              	
                A
      notice under or in connection with this Agreement (a “Notice”):

              

      

       

      
        	
                 
      

              	
                20.1.1

              	
                shall
      be in writing; and

              

      

       

      
        	
                 
      

              	
                20.1.2

              	
                shall
      be sent by (i) reputable international mail courier service with
      confirmation of delivery, (ii) registered return letter, or (iii) fax, in
      each case to the Party due to receive the Notice at its address set out in
      this Agreement or to another address or fax number specified by that Party
      by not less than 7 days’ written notice to the other Party received before
      the Notice was dispatched.

              

      

       

      
        	
                21.

              	
                GOVERNING
      LAW

              

      

       

      
        	
                21.1

              	
                This
      Agreement and all matters arising from or connected with it are governed
      by Italian law.

              

      

       

      
        	
                22.

              	
                ARBITRATION

              

      

       

      
        	
                22.1

              	
                The
      Parties shall use their best endeavours to settle any dispute arising out
      or in connection with the performance of any obligation undertaken
      hereunder. To this effect, the Parties shall consult and negotiate with
      each other in good faith in order to reach a just and equitable solution
      satisfactory to both Parties. If the Parties do not reach such amicable
      solution within sixty (60) days from the Notice sent by one Party
      expressly stating that such Notice triggers the starting of the
      negotiation period hereunder, then the dispute shall be finally settled by
      arbitration in London in accordance with the then applicable London Court
      of Arbitration Rules (“LCA Rules”).
      

              

      

       

      
        	
                22.2

              	
                There
      shall be one arbitrator that is mutually agreeable to the Parties,
      appointed in accordance with the LCA Rules. If the appointment of the
      arbitrator is not effected within the terms provided for by the LCA Rules,
      the arbitrator shall be appointed by the LCA Court. The arbitrator must be
      fluent in Italian and English. 

              

      

       

      
        	
                22.3

              	
                Unless
      otherwise agreed in writing by the Parties, the arbitration will take
      place in London, England, in the English language. It is understood,
      however, that no translations shall be made of documents in the Italian or
      in the English language.

              

      

       

      
        	
                22.4

              	
                The
      cost of the arbitration, including attorneys fees, will be assessed by the
      arbitrators who will be required to make such cost allocation with respect
      to any award issued, provided, however, that the arbitrator shall not have
      the ability to assess damages against either Party which are expressly
      disclaimed in this Agreement. 

              

      

       

      
        
          
          

        

        
          18

          
            

          

        

        
          
          

        

      

      
         

      

       

      
        	
                22.5

              	
                The
      arbitrator shall decide the dispute according to Italian substantive and
      procedural law (“arbitrato rituale secondo
      diritto”) and the arbitral award may appealed for reasons of law
      according to article 829 paragraph 3 of the Italian Civil Procedure
      Code.

              

      

       

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          19

          
            

          

        

        
          
          

        

      

      
         

         

      

      IN WITNESS
WHEREOF, the Parties hereto have executed this Agreement in multiple originals,
all of which shall for all purposes be deemed an original.

       

      
        
          	
                  Signed
      by:

                	 	 
      
	
                  For
      and on behalf of

                	 	 
      
	
                  Fidia
      Farmaceutici S.p.A.

                	 	 
      
	 
      	 	 
      
	
                  /s/ Antonio Germani

                	 	
                  Signature

                
	 
      	 	 
      
	 
      	 	 
      
	 
      	 	 
      
	
                  Signed
      by:

                	 	 
      
	
                  For
      and on behalf of

                	 	 
      
	
                  Fidia
      Advanced Biopolymers S.r.l.

                	 	 
      
	 
      	 	 
      
	
                  /s/ Charles H. Sherwood

                	 	
                  Signature

                

        

      

      
 

      

20

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