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.

 
 

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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

 
 

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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:

 
 

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"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.

 
 

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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_

 
 
 

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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

 
 
 
 

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