Document:

Unassociated Document

    Exhibit 10.53

     

    CONSULTING
AGREEMENT

    between

    

    John
Shallman

    3601 West
Thirteen Mile Road

    Royal
Oak, MI 48073

    and

    

    Nephros,
Inc.

    

    This
Consulting Agreement is made and entered into as of the 2nd
day of January, 2009, (the "Effective Date"), between Nephros, Inc., a Delaware corporation
(the "Company") and Mr. John Shallman (the "Consultant").

    

    WHEREAS,
the Company desires to engage Consultant to provide consulting services to it in
connection with its business; and

    

    WHEREAS,
Consultant desires to provide consulting services to the Company;

    

    In
consideration of and for the mutual promises and covenants contained herein,
and for
other good and valuable consideration, the receipt of which is hereby
acknowledged, the parties hereto agree as follows:

    

    1.           Consulting
Services.

    

    (a)
Subject to the terms and conditions hereinafter set forth, the Company retains
Consultant,
and Consultant hereby accepts such retention by the Company,

    

    
      	  	
              (i) 

            	
              As
      Marketing Executive to market and sell DSU Water Filtration
      products into
      healthcare facilities and other market segments as directed by
      the President
      &
      CEO.

            

    

     

    
      	  	
              (ii) 

            	
              To work
      closely with Sales and other Nephros employees to aid in
      sales support,
      by developing marketing materials and programs, and
      other business
      development activities.

            

    

    

    (b) The
Company and Consultant hereby acknowledge and agree that Consultant shall
perform the services specified in paragraphs (a) and (b) above (collectively,
the "Consulting Services") as an independent contractor and not as an employee
of the Company. Consultant agrees that he will file his own tax returns on the
basis of his status as an independent contractor for the reporting of all
income, social security, employment and other taxes due and owing on the
consideration received by him under this Agreement and that she is responsible
for the payment of such taxes. Similarly, Consultant shall not be
entitled to receive additional benefits specifically
associated with employment status, such as medical, dental and life
insurance, stock or stock options
of the Company and shall not be entitled to participate in any other
employee benefit programs. As
an independent contractor, Consultant acknowledges, understands and
agrees that she is not, and shall not
represent himself to third parties as being, the agent or representative of the
Company nor does she have, and shall not represent himself to third parties as
having, power or authority to do or take any action for or on behalf of the
Company, as its agent, representative or otherwise, except as specifically
herein set forth.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    (d) The
Consultant will work from his home office and have the necessary infrastructure
conducive to good selling principles and his role as Business Development
Executive. From time to time it will be necessary for the Consultant to attend
meetings and work from the Nephros office in New York.

    

    2.           Consideration for Consulting
Services.

    

    In
consideration of Consultant's performance of the Consulting Services, during the
Term (as defined below in Section 4 below) the Company shall pay Consultant a
consulting fee (the"Consulting Fee") at the rate of one hundred dollars
($100.00) per hour not to exceed 40 hours per month, to be paid to Consultant on
a monthly basis, on receipt of invoice net 10.

    

    3.           Reimbursement of
Expenses.

    

    The
Company shall reimburse Consultant for all normal, usual and necessary expenses
in excess of twenty-five dollars ($25.00) in the aggregate incurred by
Consultant in furtherance of the business and affairs of the Company against
receipt by the Company of appropriate vouchers or other proof of the Company's
expenditures and otherwise in accordance with such expense-reimbursement policy
as may from time to time be adopted by the Company.

    

    4.           Term and
Termination.

    

    (a) The
term of This Agreement shall commence on the Effective Date and shall expire on
December 31, 2009.

    

    (b) This
Agreement may be terminated by either party upon fourteen (14) days written
notice to the other party and may be terminated by either party at any time for
any reason. Said termination will be effective after either party sends to the
other by Certified Mail, Return Receipt Requested, a written notice of intent to
terminate at the expiration of fourteen (14) days from the date upon which such
notice is mailed to the other. Such termination will then occur at the end of
the fourteen (14) day notice period. Notwithstanding the foregoing, the Company
shall be able to terminate this Agreement immediately, without the sending of
the aforesaid written fourteen (14) day notice, upon your death, bankruptcy, or
in the event the Consultant breaches any of the material terms in this
Agreement.

    

     (c)
In the
event that the Consultant sends the Company written notice of intent to
terminate
this Agreement pursuant to Paragraph (b) above, the Consultant shall continue to
solicit orders for the Company during the aforesaid fourteen (14) day period.
Notwithstanding the foregoing, if the Company sends the Consultant written
notice of its intent to terminate this Agreement pursuant to Paragraph (b)
above, the Consultant shall cease soliciting orders for the Company immediately
on the day the said notice of termination is received by the
Consultant.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    (d) At
the termination of this Agreement, the Consultant shall cease using any sales
materials and product samples in his possession or under his control and shall
return same, including all computer equipment, software, catalogs, brochures,
advertising, literature and other property of the Company, immediately upon
Company request. Final compensation due, if any, shall not be paid until such
property is received by the Company and has been returned in reasonably good
condition, together with a Termination Certification, exhibit A.

    

    (e) The
provisions of Sections 5 through 18 hereof shall survive any termination
of this
Agreement at the expiration of the Term or prior thereto.

     

    5.    Ownership Of Proprietary
Information. Consultant agrees that all information that has been
created, discovered or developed by the Company, its subsidiaries, affiliates,
licensors, licensees, successors or assigns (collectively, the "Affiliates"),
including, without limitation, information relating to the development of the
Device created, discovered, developed or made known to the Company or any of the
Affiliates by Consultant during the Consulting Term and information relating to
the Company's customers, suppliers, consultants, and licensees, and/or in which
property rights have been assigned or otherwise conveyed to the Company or the
Affiliates, shall be the sole property of the Company or the Affiliates, as
applicable, and the Company or the Affiliates, as the case may be, shall be the
sole owner of all patents, copyrights and other rights in connection therewith,
including without limitation the right to make application for statutory
protection. All of the aforementioned information is hereinafter called
"Proprietary Information." By way of illustration, but not limitation,
Proprietary Information includes trade secrets, processes, discoveries,
structures, inventions, designs, ideas, works of authorship, copyrightable
works, trademarks, copyrights, formulas, data, know-how, show-how, improvements,
inventions, product concepts, techniques, information or statistics contained
in, or relating to, marketing plans, strategies, forecasts, blueprints,
sketches, records, notes, devices, drawings, customer lists, patent
applications, continuation applications, continuation-in-part applications, file
wrapper continuation applications and divisional applications and information
about the Company's or the Affiliates' employees and/or consultants (including,
without limitation, the compensation, job responsibility and job performance of
such employees and/or consultants).

    

    6.           Delivery of Documents and
Data. On the expiration of the Term or the earlier termination of this
Agreement pursuant to Section 4 hereof, Consultant agrees that Consultant will
deliver to the Company all documents and data of any nature and embodied in any
media pertaining to his work with the Company or the Affiliates, Consultant will
not take with him or deliver to anyone else any documents or data of any
description and embodied in any media or any reproduction, abstract or summary
of any description containing or pertaining to any Proprietary Information and
Consultant will sign and deliver the "Termination Certification" attached hereto
as Exhibit A.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    
      	
               
      

            	
              7.

            	
              Disclosure of
      Inventions.

            

    

    During
the Term, Consultant agrees that she will promptly disclose to the Company, or
any persons designated by it, all improvements, inventions, designs, ideas,
works of authorship, copyrightable works, discoveries, trademarks, copyrights,
trade secrets, formulas, processes, structures, product concepts, marketing
plans, strategies, customer lists, information about the Company's employees
and/or consultants (including, without limitation, job performance of such
employees and/or consultants), techniques, blueprints, sketches, records, notes,
devices, drawings, know-how, data, whether or not patentable, patent
applications, continuation applications, continuation-in-part applications, file
wrapper continuation applications and divisional applications, made or conceived
or reduced to practice or learned by him, either alone or jointly with others,
which result from use of premises or equipment owned, leased or contracted for
by the Company or the Affiliates (all said improvements, inventions, designs,
ideas, works of authorship, copyrightable works, discoveries, trademarks,
copyrights, trade secrets, formulas, processes, structures, product concepts,
marketing plans, strategies, customer lists, information about the Company's or
the Affiliates' employees and/or consultants, techniques, blueprints, sketches,
records, notes, devices, drawings, know-how, data, patent applications,
continuation applications, continuation-in-part applications, file wrapper
continuation applications and divisional applications shall be collectively
hereinafter called "Inventions"). Notwithstanding any provisions to the contrary
herein, however, Consultant agrees that Consultant shall not disclose to the
Company any improvements, inventions, designs, ideas, works of authorship,
copyrightable works, discoveries, trademarks, copyrights, trade secrets,
formulas, processes, structures, product concepts, marketing plans, strategies,
customer lists, blueprints, sketches, records, notes, devices, drawings,
techniques, know-how, data, patent applications, continuation applications,
continuation-in-part applications, file wrapper continuation applications and
divisional applications which Consultant possesses under the obligation of
secrecy or confidentiality to a third party.

    

    Consultant
understands and acknowledges that all original works of authorship which
are made
by him (solely or jointly with others) while performing the Consulting Services
and which are protectable by copyright are being created at the instance of the
Company and are "works made for hire," as that term is defined in the United
States Copyright Act (17 USCA, Section 101).

    

    
      	
               
      

            	
              8.

            	
              No Prior Employer
      Property.

            

    

    

    Consultant
undertakes that, in the performance of the Consulting Services, Consultant
will not
use any materials or documents of a former or current employer which are not
generally available to the public, unless Consultant or the Company has obtained
written authorization from the current or former employer for their possession
and use.

    

    
      	
               
      

            	
              9.

            	
              Non-Solicitation.

            

    

    

    During
the Term, and for a period of two (2) years thereafter, Consultant shall not,
directly or indirectly, without the prior written consent of the
Company:

    

    (a)
solicit or induce any employee of the Company or any Affiliate to leave the
employ of the Company or any Affiliate or hire for any purpose any employee of
the Company or any Affiliate or any employee who has left the employment of the
Company or any Affiliate within six months of the termination of said employee's
employment with the Company; or

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    (b)
solicit or accept the business of any customer or supplier of the Company or any
Affiliate
with respect to products similar to those supplied by the
Company.

     

    
      	
               
      

            	
              10.

            	
              Insider
      Trading, Etc.

            

    

     

    Consultant
recognizes that in the course of his duties hereunder, Consultant may receive
from the Company or others information which may be considered "material,
non-public information" concerning a public company that is subject to the
reporting requirements of the Securities and Exchange Act of 1934, as amended.
Consultant agrees that she will not, without the prior written consent of the
Company, perform any of the following:

     

    (a)
purchase, trade, offer, pledge, sell, contract to sell or to purchase or sell
"short" or "short
against the box" (as such terms are generally understood in the securities
markets), or otherwise dispose of or acquire any securities of the Company or
options or other derivative securities
in respect of such securities while in possession of relevant material,
non-public information
received from the Company or others in connection herewith;

     

    (b)
provide the Company with information with respect to any public company that
may be
considered material, non-public information; and

     

    (c)
provide any person with material, non-public information, received from the
Company,
including any relative, associate, or other individual who intends to, or may,
(i) trade securities with respect to the Company which is the subject of such
information or (ii) otherwise directly or indirectly benefit from such
information.

     

    
      11.    Non-disparagement.
During and after the Term, Consultant agrees not to make any
disparaging comment or statement about the Company, whether or not true,
including but not limited to comments which could adversely affect the conduct
of the Company's business, any of its plans or prospects, or the business name
or reputation of the Company.

    

      

    
      12.    Non-Competition.
The Consults agrees that during the term of this Agreement, she will
not sell, promote, or offer for sale, directly or indirectly, any product which
might in any way be deemed competitive to the Company's DSU Water Filtration or
ESRD Therapy lines and that she presently is representing no competing company.
The Consultant understands and recognizes that his services to the Company are
special and unique and agrees that, during the Consulting Term and for a period
of two (2) years from the date of termination of his retention hereunder, she
shall not in any manner, directly or indirectly, on behalf of himself or any
person, firm, partnership, joint venture, corporation or other business entity
("Person"), enter into or any business which manufactures or distributes any
product directly or indirectly competitive with an existing (as of the
"Effective Date") technology of, or equivalent (as of the "Effective Date")
product manufactured or distributed by, the Company ("Conflicting Product"),
either as an individual for his own account, or as a proprietor, partner,
member, joint venturer, employee, consultant, agent, salesperson, officer,
director or shareholder of a Person operating or intending to operate within the
area that the Company is, during
the term hereof and as of the date of termination, conducting or planning
to conduct its business (the"Restricted Businesses"); provided, however, that
nothing herein will preclude Consultant from holding one percent (1
%) or less of the stock of any publicly traded company; or from holding a
position with a Person which engages in a business directly or indirectly
competitive with a Conflicting Product or a Restricted Business so long as
Consultant works solely in a division of such Person which carries on a bona
fide business which is not directly or indirectly competitive with a Conflicting
Product or a Restricted Business.

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      13.    Remedies
for Breach. Consultant understands and agrees that any breach of
Sections
within this Agreement by the Consultant could cause irreparable damage to the
Company and to the Affiliates and that monetary damages alone would not be
adequate and, the event of such breach, the Company shall have, in addition to
any and all remedies of law, the right to an injunction, specific performance or
other equitable relief to prevent or redress the violation of Consultant's
obligations under such Sections.

    

     

    
      14.    Severability.
Every provision of this Agreement is intended to be severable. If
any term
or provision hereof is deemed unlawful or invalid in any jurisdiction for any
reason whatsoever, such unlawfulness or invalidity shall not affect the validity
of the remainder of this Agreement or the enforceability of such term or
provision in any other jurisdiction. To the extent that any such term or
provision is held to be unlawful or invalid, the parties agree to reform such
term or provision in such a way which will be enforceable in the jurisdiction to
which such holding applies, and which will reflect, as nearly as permissible,
the intention of the parties.

    

     

    18.           Representation
of Consultant; Use of Name. Consultant represents that there are no
binding agreements to which she is a party or by which she is bound, forbidding
or restricting his activities herein. In addition,
Consultant consents to the use of his name in various reports, brochures or
other documents produced by or on behalf of the Company, including any and all
documents filed with the Securities and Exchange Commission.

     

    19.           Miscellaneous
Any notice or other communication between parties shall be sufficiently given if
sent by certified or registered mail, postage prepaid, if to the Company,
addressed to it at Nephros, Inc., 41 Grand Avenue, River Edge NJ, 07661,
Attention: President &
CEO, or if to Consultant, addressed to Consultant at the address set
forth below Consultant's name on the signature page hereof, or to such address
as may hereafter be designated in writing by one party to the other. Such notice
or other communication shall be deemed to be given on the date of
receipt.

     

    This
Agreement embodies the entire agreement and understanding between the Company
and Consultant regarding the subject matter hereof and supersedes any and all
negotiations, prior discussions and preliminary and prior agreements and
understandings related to the central subject matter thereof.

     

    This
Agreement shall in all respects be governed by, and contained and enforced in
accordance
with the internal substantive laws of the State of New Jersey and not the law of
conflict of laws.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    This
Agreement may be executed in one or more counterparts, each of which, when so
executed shall be deemed to be an original and all of which counterparts, taken
together, shall constitute one and the same instrument.

    

    Neither
this Agreement nor any term hereof may be amended, modified, supplemented or
waived save in a written instrument executed by each of the parties
hereto.

     

    IN
WITNESS WHEREOF, the parties have hereto set their hand on the date first above
wirtten.

    

    CONSULTANT:

    

    By:

    Name:
John Shallman

    Address:
3601 West Thirteen Mile Road,

    Royal
Oak, MI 48073

    

    NEPHROS,
INC.

    By:

    

    Name:
Ernest Elgin, President &
CEO

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    EXHIBIT
A

    

    NEPHROS,
INC.

    

    TERMINATION
CERTIFICATION

    

    This is
to certify that, except as permitted by the Consulting Agreement (as defined
below) I do not have in my possession, nor have I failed to return, any
structures, inventions, designs, works of authorship, copyrightable works,
formulas, data, marketing plans, forecasts, product concepts, marketing plans,
strategies, forecasts, devices, records, data, notes, reports, proposals,
customer lists, correspondence, specifications, drawings, blueprints, sketches,
materials, patent applications, continuation applications, continuation-in-part
applications, divisional applications, other documents or property, or
reproductions of any aforementioned items belonging to Nephros, Inc., its
subsidiaries, affiliates, successors or assigns (together, the "Company").

     

    I further
certify that I have complied with all the terms of the Consulting Agreement,
dated July 7, 2008 between the Company and me (the "Consulting Agreement"),
relating to the reporting of any Inventions (as defined therein), conceived or
made by me (solely or jointly with others) covered by the Consulting Agreement.

     

    I further
acknowledge that the provisions of the Consulting Agreement relating to
Proprietary Information, as defined in the Consulting Agreement, continue in
effect beyond the termination of the Consulting Agreement, as set forth
therein.

     

    
      
        	
                Date: 1/29/09          
      

              	
                Signature:

              	      
                /s/
      John Shallman

              
	 
      	 
      	
                John
      ShallmanUnassociated 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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00171-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00171-of-00352.parquet"}]]