Attached files
| file | filename |
|---|---|
| 10-K - NEPHROS INC | v179691_10k.htm |
| EX-31.1 - NEPHROS INC | v179691_ex31-1.htm |
| EX-31.2 - NEPHROS INC | v179691_ex31-2.htm |
| EX-32.2 - NEPHROS INC | v179691_ex32-2.htm |
| EX-32.1 - NEPHROS INC | v179691_ex32-1.htm |
| EX-10.55 - NEPHROS INC | v179691_ex10-55.htm |
| EX-10.53 - NEPHROS INC | v179691_ex10-53.htm |
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
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1.
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This document describes an
agreement for Authorized Representative services to be provided by Donawa
Lifescience Consulting Sri for the devices identified in Annex
1.
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2.
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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.
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3.
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For the remainder of this
agreement,
Nephros,
Inc. will be referred to as the
"Manufacturer" and Donawa
Lifescience Consulting Sri1, as the "Authorized
Representative."
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4.
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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.
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5.
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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.
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6.
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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.
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7.
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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.
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8.
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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.
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9.
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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.
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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:
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a)
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contacting
Notified Bodies to carry out activities related to the CE marking
process
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b)
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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
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c)
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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
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d)
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receiving
and transmitting to the Manufacturer information on adverse events
concerning the Manufacturer's
products
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e)
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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
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f)
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maintaining
all required clinical evaluation
reports
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g)
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maintaining
all required technical documentation for a period ending at least five
years after the last product has been
manufactured
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In
addition, the following ancillary regulatory affairs services can be provided
upon request:
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h)
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providing
information on the CE marking
process
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i)
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assisting
in development of technical
documentation
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j)
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assessing
the costs of and / or providing translation
services
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k)
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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
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I)
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other regulatory services, as
requested and agreed by both parties of the
agreement
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11.
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The Authorized Representative will
comply with the Nephros EU Authorized Representative procedure. Each
version will need to be agreed by both
parties.
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12.
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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:
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a)
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a
list of the relevant
product(s)
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b)
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a
copy of the Manufacturer's Declaration(s) of
Conformity
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c)
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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
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d)
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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
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e)
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a
list of countries where the product(s) is (are)
marketed
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f)
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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)
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g)
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the
regulatory status (for example, classification, approval status) of the
product(s) under the requirements of the country of origin of the
product(s)
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h)
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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
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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:
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i)
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a
copy of the instructions for use and product /package labeling in the
Italian language
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j)
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confirmation
of registration (e.g. device registration number) into the Italian
Ministry of Health on-line
databank.
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13.
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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:
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a)
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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)
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b)
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notification
in writing if any certificate referred to in paragraph 12(a) has been
withdrawn
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c)
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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
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d)
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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
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14.
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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."
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15.
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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.
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16.
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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.
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17.
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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.
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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.
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18.
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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.
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19.
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The fee to establish and maintain
Donawa Lifescience Consulting Sri1 as Authorized Representative is Euro
2200 per year.
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20.
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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
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21.
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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).
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22.
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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.
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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.
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24.
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The Manufacturer will receive an
invoice for charges for any work conducted beyond the two hours covered by
the representation fee.
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25.
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The Manufacturer agrees to pay
invoices upon receipt or no later than 30 days after the receipt of the
invoice.
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AGREED
AND ACCEPTED:
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Nephros,
Inc.
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Donawa
Lifescience Consulting Srl
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41
Grand Avenue
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Piazza
Albania, 10
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River
Edge, NJ 07661
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00153
Rome
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USA
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Italy
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By:
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Maria
E. Donawa, M.D
President
On
this __ day of ___
20_
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On
this __ day of ____ 20_
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ANNEX 1
DEVICES COVERED BY THIS
AGREEMENT
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Device name
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Model ref
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Catalog
no
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Nephros
OIPur
Filter
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MD
190
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70-0190
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Nephros
OIPur
Filter
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MD220
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70-0220
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