Unassociated Document


    Exhibit
10.54

      Donawa

      Lifescience

      Consulting

      


      CONFIDENTIAL

      AGREEMENT FOR

      AUTHORIZED REPRESENTATIVE
SERVICES

      


      TO: Nephros Inc. (USA)

      


      FROM: Donawa Lifescience Consulting Sri1
(Italy)

      


      INITIAL PERIOD

      OF AGREEMENT: From 1 June 2009 to 21
March 2010

      


      
        	
                1.

              	
                This document describes an
      agreement for Authorized Representative services to be provided by Donawa
      Lifescience Consulting Sri for the devices identified in Annex
      1.

              


      

      


      
        	
                2.

              	
                On the basis of this agreement,
      Donawa Lifescience Consulting Sri1 will serve as the Authorized
      Representative established in the European Union (EU) for Nephros,
      Inc. of 41 Grand Avenue, River Edge, NJ
      07661, USA. In accordance with the European Directive for Medical Devices
      (93/42/EEC),
      "authorised
      representative"
      means any natural or
      legal person established in the Community who, explicitly designated by
      the manufacturer, acts and may be addressed by authorities and bodies in
      the Community instead of the manufacturer with regard to the latter's
      obligations under this Directive.

              


      

      


      
        	
                3.

              	
                For the remainder of this
      agreement,
      Nephros,
      Inc. will be referred to as the
      "Manufacturer" and Donawa
      Lifescience Consulting Sri1, as the "Authorized
      Representative."

              


      

      


      
        	
                4.

              	
                The Manufacturer agrees to meet
      the requirements of all applicable national laws and
      regulations,
      which transpose the
      European Directives for medical devices, and any other relevant European
      Directives.

              


      

      


      
        	
                5.

              	
                The responsibility for ensuring
      that the Manufacturer's product(s) meets the requirements of the European
      Directives for medical devices and any other relevant European Directives
      lies with the Manufacturer and not with the Authorized
      Representative.

              


      

      


      
        	
                6.

              	
                The Manufacturer agrees that the
      Authorized Representative is not liable or responsible in any way for any
      incomplete or inaccurate statements or information concerning or placed on
      the products affixed with the CE mark and marketed within the EU for which
      the Authorized Representative has been designated by the
      Manufacturer.

              


      

      


      
        	
                7.

              	
                The Manufacturer agrees that the
      Authorized Representative is not liable or responsible in any way for the
      safety, performance or failure of the devices for which the Authorized
      Representative has been designated caused by the design, manufacture, packaging, labeling, distribution, or use of the devices, or any other characteristics or
      attributes of the devices.

              


      

      


      
        	
                8.

              	
                The Manufacturer agrees to
      maintain product liability insurance in the minimum amount of €1 ,000,000
      (one million euros) per incident. It is agreed by the Manufacturer that
      under no circumstances shall the Authorized Representative be liable for
      any damages, costs or other expenses, direct or consequential, related to
      any product liability or intellectual property suit, and shall indemnify
      the Authorized Representative in this
  respect.

              


      

      


      
        	
                9.

              	
                The Manufacturer agrees that the
      Authorized Representative is not liable or responsible in any way for the
      costs incurred by voluntary product withdrawal from the market by the
      Manufacturer or as a result of actions taken by any Competent Authority
      with regard to the medical devices placed on the EU market by the
      manufacturer.

              


      


      
        
           


        

        
           


          
            

          

        

        
           


        

      

      


      
        	
                10.

              	
                As
      agreed with the Manufacturer and, when necessary, as specified in the
      Manufacturer's standard operating procedures (see parapgraph 11), the
      following services, subject to paragraphs 19 and 22 of this agreement,
      can
      be provided by
      the Authorized
Representative:

              


      

       

      
        	  	
                a) 

              	
                contacting
      Notified Bodies to carry out activities related to the CE marking
      process

              


      

       

      
        	  	
                b) 

              	
                serving
      as the official contact with European authorities if a Member State takes
      measures to withdraw the Manufacturer's medical device from the market or
      prohibits or restricts its being put into
      service

              


      

       

      
        	 	
                c)  

              	
                if
      European clinical investigations are planned, where required by Member
      States, being designated as the Authorized Representative in the clinical
      investigation notification, and serving as the official contact with
      Member States during the conduct of the clinical investigation. This
      service is not related to clinical investigation services that may be
      provided by the Donawa Lifescience Consulting
      CRO

              


      

       

      
        	  	
                d) 

              	
                receiving
      and transmitting to the Manufacturer information on adverse events
      concerning the Manufacturer's
      products

              


      

       

      
        	 	
                e) 

              	
                if
      the Manufacturer's products are intended for clinical investigations,
      notifying European authorities of the Member States in which clinical
      investigations are to be carried
      out

              


      

       

      
        	 	
                f) 

              	
                maintaining
      all required clinical evaluation
      reports

              


      

       

      
        	 	
                g) 

              	
                maintaining
      all required technical documentation for a period ending at least five
      years after the last product has been
      manufactured

              


      

       

      In
addition, the following ancillary regulatory affairs services can be provided
upon request:

       

      
        	  	
                h) 

              	
                providing
      information on the CE marking
      process

              


      

       

      
        	  	
                i) 

              	
                assisting
      in development of technical
      documentation

              


      

       

      
        	  	
                j) 

              	
                assessing
      the costs of and / or providing translation
      services

              


      

       

      
        	  	
                k) 

              	
                assisting with
      registration of devices marketed in Italy into the Ministry of Health
      on-line databank (mandatory from August 1,2007, with payment of a €100
      'repertorio' fee if sales to the national health system are planned). This
      service will be subject to a separate proposal and not covered by the
      representation fee for Authorized Representative
      services

              


      

      


      
        	
              	
                I) 

              	
                other regulatory services, as
      requested and agreed by both parties of the
    agreement

              


      

      


      
        	
                11.

              	
                The Authorized Representative will
      comply with the Nephros EU Authorized Representative procedure. Each
      version will need to be agreed by both
  parties.

              


      

      


      
        	
                12.

              	
                The Manufacturer agrees to provide
      the following information on the product(s) to be marketed in the European
      Union for which the Authorized Representative has been designated to act
      as Authorized Representative, to provide the same information on any new
      products as they are added to the portfolio, and to maintain the current
      status of this information in the event of any
    change:

              


      

      


      
        	 	
                a)

              	
                a
      list of the relevant
product(s)

              


      

       

      
        	 	
                b)

              	
                a
      copy of the Manufacturer's Declaration(s) of
      Conformity

              


      


      
        
           


        

        
           


          
            

          

        

        
           


        

      

      
 

      
        
          	  	
                  c) 

                	
                  a
      list of contents of the technical file(s) and a copy of the technical
      file(s) for the product(s) in part or in its (their) entirety, as agreed
      by the Authorized Representative and
      Manufacturer

                


        

      

       

      
        	  	
                d) 

              	
                a
      copy of product labeling including primary labeling, instruction
      leaflet/user manual, in English or another language to be agreed by the
      Manufacturer and Authorized
  Representative

              


      

       

      
        	  	
                e) 

              	
                a
      list of countries where the product(s) is (are)
      marketed

              


      

       

      
        	  	
                f) 

              	
                a
      list of importers and distributors of the relevant product(s), including
      addresses (including e-mail, if available), telephone and fax numbers, and
      the name(s) of contact
person(s)

              


      

       

      
        	  	
                g) 

              	
                the
      regulatory status (for example, classification, approval status) of the
      product(s) under the requirements of the country of origin of the
      product(s)

              


      

       

      
        	  	
                h) 

              	
                if
      any other information required by the medical devices Directives is
      requested by a European Competent Authority from the Authorized
      Representative, the Manufacturer shall provide the requested information
      to the Authorized Representative within 72 hours for transmission to the
      Competent Authority. The Manufacturer is responsible for arranging any
      translations that may be needed within an agreed
      timescale

              


      

      


      Because Donawa Lifescience Consulting is
located in Italy, its Authorized Representative service and file may be subject
to audit by the Italian Competent Authority. If the Manufacturer's medical
devices are marketed in Italy, it will also be necessary for the Manufacturer to
provide:

      


      
        	 	
                i) 

              	
                a
      copy of the instructions for use and product /package labeling in the
      Italian language

              


      

       

      
        	 	
                j) 

              	
                confirmation
      of registration (e.g. device registration number) into the Italian
      Ministry of Health on-line
  databank.

              


      

       

      
        	
                13.

              	
                The
      Manufacturer agrees to provide the following information in relation to
      the Manufacturer's quality system, and to maintain the current status of
      the information provided either at the time of any change or on at least
      an annual basis:

              


      

       

      
        	 	
                a) 

              	
                a
      copy of certificates issued by the Notified Bodies, if applicable to the
      conformity assessment procedure (e.g. EC Certificate, quality system
      certificate to EN ISO
13485)

              


      

       

      
        	 	
                b) 

              	
                notification
      in writing if any certificate referred to in paragraph 12(a) has been
      withdrawn

              


      

       

      
        	 	
                c) 

              	
                a
      Standard Operating Procedure or other documented means (e.g. checklist),
      which indicates the existence of a Declaration of Conformity before
      release of product in
Europe

              


      

       

      
        	 	
                d) 

              	
                a
      copy of the quality system procedure(s) that describes the steps that will
      be taken to report adverse incidents concerning the Manufacturer's
      product(s) under the vigilance requirements of the European Directives for
      medical devices. This procedure should include:


                -
      specification of the role of the distributor(s) to transmit adequate and
      accurate information on adverse incidents directly to the Manufacturer
      

                -
      as agreed between the Manufacturer and Authorized Representative, the role
      of the Authorized Representative in helping the company comply with the
      vigilance
requirements

              


      

       

      
        	
                14.

              	
                The Manufacturer recognizes the
      requirements of Article 14 (2), Registration
      of persons responsible for placing devices on the market, of the Medical Devices Directive
      (93/42/EEC), which applies to distributors and importers and not to the
      Authorized Representative. However, the manufacturer can request that the
      Authorized Representative perform or assist in the performance of services
      related to these requirements. Article 14 (2)
    states:

              


      


      
        
           


        

        
           


          
            

          

        

        
           


        

      

      
 

      "Where a manufacturer who places devices
referred to in paragraph 1 on the market under his own name does not have a
registered place of business in a Member State, he shall designate the person(s)
responsible for marketing them who is (are) established in the Community. These
persons shall inform the competent authorities of the Member State in which they
have their registered place of business of the address of the registered place
of business and the category of devices concerned."

      


      
        	
                15.

              	
                Unless otherwise specified in
      writing, the following documents are considered to be privileged and
      confidential: 

                - this agreement and fee
      arrangement 

                - correspondence between the
      Manufacturer, Authorized Representative or other party as requested by the
      Manufacturer 

                - technical documentation, other
      than releasable commercial information 

                - information and correspondence
      to official European bodies, such as the relevant Notified Body(ies) or
      Competent Authorities, to comply with the laws and regulations of the
      European Union or of individual European Member States and
      countries.

              


      

      


      
        	
                16.

              	
                After the expiration of the
      Initial Period of Agreement, the Agreement shall automatically renew for
      successive one-year renewal periods (each a "Renewal Period") unless
      either party notifies the other party in writing in accordance with
      paragraph 17.

              


      

      


      
        	
                17.

              	
                Upon sixty (60) days' written
      notice, the Manufacturer or Authorized Representative may terminate this
      agreement; however, any services provided by the Authorized Representative
      during the period of the agreement, not covered by the representation fee,
      must be paid in full within thirty (30) days of the termination of the
      agreement. 

                 

                If either party is in material
      breach of this Agreement, the non-breaching party may serve the breaching
      party with a written notice of the material breach and request that the
      breaching party cure such breach within 30 days of receipt of the notice.
      If the breaching party fails to cure the material breach within 30 days
      after its receipt of the notice, the non-breaching party may terminate
      this Agreement by sending written notice of termination to the breaching
      party. The termination of this Agreement shall take effect immediately
      upon receipt of such notice by the breaching
  party.

              


      

      


      All notices under this paragraph shall
be sent by courier with tracking numbers and shall be deemed received on the 3rd
business day following dispatch.

      


      
        	
                18.

              	
                 As long as the Authorized
      Representative does not exceed his powers to act on behalf of the
      Manufacturer, the responsibility for actions by the Authorized
      Representative lies with the Manufacturer and not with the Authorized
      Representative.

              


      

      


      
        	
                19.

              	
                The fee to establish and maintain
      Donawa Lifescience Consulting Sri1 as Authorized Representative is Euro
      2200 per year.

              


      

      


      
        	
                20.

              	
                The fee referred to in paragraph
      19 is not refundable in any part if this agreement is terminated at any
      time after the initiation of the period of
  agreement

              


      

      


      
        	
                21.

              	
                The fee referred to in paragraph
      19 covers a one-year period and up to two hours of work (see paragraph 10)
      and travel time related to Authorized Representative services, not
      including services related to the notification or conduct of clinical
      investigations, nor reimbursable and reasonable expenses (telephone calls,
      faxes, copying, postal,
travel).

              


      

      


      
        	
                22.

              	
                 The fee for performing work beyond
      the initial two hours covered by the representation fee is Euro 195 per
      hour for work performed by senior company management, Euro 175 per hour
      for work performed by senior regulatory staff and Euro 130 for work
      performed by regulatory assistants, plus expenses. Travel time, as agreed
      by the Manufacturer, is charged at 50 % of the hourly work
      rate.

              


      


      
        
           


        

        
           


          
            

          

        

        
           


        

      

      


      
        	
                23.

              	
                The Manufacturer will be notified
      in writing if services that are required or requested by the Manufacturer
      and provided by the Authorized Representative will exceed the two hours
      covered by the representation
fee.

              


      

      


      
        	
                24.

              	
                The Manufacturer will receive an
      invoice for charges for any work conducted beyond the two hours covered by
      the representation fee.

              


      

      


      
        	
                25.

              	
                The Manufacturer agrees to pay
      invoices upon receipt or no later than 30 days after the receipt of the
      invoice.

              


      

       

      
        
          
            	
                    AGREED
      AND ACCEPTED:

                  	 
      
	
                    Nephros,
      Inc.

                  	
                    Donawa
      Lifescience Consulting Srl

                  
	
                    41
      Grand Avenue

                  	
                    Piazza
      Albania, 10

                  
	
                    River
      Edge, NJ 07661

                  	
                    00153
      Rome

                  
	
                    USA

                  	
                    Italy

                  
	 
      	 
      
	
                  	
                    By:

                  
	 	      
                    
                      Maria
      E. Donawa, M.D

                      
                        President

                        
                          On
      this __ day of ___
20_

                        

                      

                    

                  


          

        

        


        
          	
                  Gerald J. Kochanksi

                	
                
	
                  Chief Executive Officer

                	
                
	
                  On
      this __ day of ____ 20_

                	
                


        

      

       

      
        
           


        

        
           


          
            

          

        

        
           


        

      

      
 

      ANNEX 1

      


      DEVICES COVERED BY THIS
AGREEMENT

      
      

       

      
        
          
            
              
                	      
                        Device name
      

                      	
                        Model ref
      

                      	
                        Catalog
      no

                      
	      
                        Nephros
      OIPur
      Filter 

                      	
                        MD
      190

                      	
                        70-0190

                      
	      
                        Nephros
      OIPur
      Filter 

                      	
                        MD220
    

                      	
                        70-0220