EXHIBIT 10.6.1
natus(R)
[LETTERHEAD OF NATUS]
ADDENDUM TO THE DISTRIBUTOR AGREEMENT BETWEEN
NATUS MEDICAL INC. AND NIPPON EUROTEC CO., LTD.,
EFFECTIVE JUNE 11, 1997
AGREEMENT PERTAINING TO NEW JAPANESE REGULATION
"GMP-I"
MANUFACTURER'S ADDRESS: 0000 Xxxxxxxxxx Xxxx, Xxx Xxxxxx,
Xxxxxxxxxx 00000-0000, Xxxxxx Xxxxxx xx Xxxxxxx
(Natus Medical Inc.)
DISTRIBUTOR'S ADDRESS: Akasaka Daiichi Building, 0-00,
Xxxxxxx 0-xxxxx,Xxxxxx-xx, Xxxxx, 000-0000, Xxxxx
(Nippon EUROTEC Co., Ltd.)
EFFECTIVE DATE: January 1, 2000
GMP-I AGREEMENT
This GMP-I Agreement ("Agreement"), effective as of January 1, 2000 (the
"Effective Date") is entered into by and between Natus Medical Inc., a
California corporation having offices at 0000 Xxxxxxxxxx Xxxx, Xxx Xxxxxx,
Xxxxxxxxxx 00000-0000, Xxxxxx Xxxxxx xx Xxxxxxx ("Natus"), and Nippon Eurotec
Co., Ltd. a corporation organized under the laws of Japan, having offices at
Akasaka Daiichi Building, 0-00, Xxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx 107-0052 Japan
("Nippon Eurotec")
BACKGROUND
Nippon Eurotec desires to smoothly communicate with Natus in order to obtain
such information from Natus as is required by the new Japanese Regulations for
Quality Assurance of Imported Medical Device, or Good Manufacturing Practice -
Import regulations ("GMP-I").
GMP-I Addendum to Distribution Agreement
Natus desires to disclose necessary information required for the GMP-I to Nippon
Eurotec periodically and when need arises, on the terms and conditions set forth
below:
Article 1. CONTROL OF MANUFACTURE FROM GMP-I REGULATIONS
1.1 Nippon Eurotec shall periodically get confirmation from Natus that the
medical devices to be imported to Japan are manufactured under appropriate
manufacturing and quality control in accordance with DIN EN ISO 9001/08.94, DIN
EN 46001/09.96 and EC Directive 93/42/EEC Annex II, Article 3 applicable for
specific devices.
Nippon Eurotec shall send every year, at Nippon EUROTEC's expense, an inspector
to Natus' manufacturing site for GMP-I inspection. An annual inspection report
shall be established with the person responsible for GMP at Natus (Natus'
Management Representative).
3.2 Natus shall send each year at fixed period to Nippon Eurotec the latest
CERTIFICATE TO FOREIGN GOVERNMENT (if available), issued by the Food and
Drug Administration ("FDA") or an equivalent document, such as a copy of EN
46001 and/or ISO 9001 certificate, as well as the latest technical
specifications, latest user manual and latest test manual of the medical
devices to be imported to Japan, within the framework of GMP-I provisions.
Article 2. CHANGE OF SPECIFICATIONS AND/OR TEST METHOD
3.2 Nippon Eurotec shall request from Natus prompt transmission of information
regarding changes to be made to future manufacturing methods, testing
methods or other related issues which may have possible effects on the
quality of the medical devices, as defined in the GMP-I Article 4,
Paragraph 1, Number 2.
3.3 Natus shall send in due course to Nippon Eurotec pre-advice pertaining to
all significant changes of technical specifications, test standards and
others of the medical devices, and information on related measures which
will be taken in this regard.
Article 3. DEFICIENCY REPORT
3.1 Nippon Eurotec shall request of Natus prompt transmission of information on
the following matters related to the medical devices:
A. Information on suspension of manufacture, export or marketing, recall,
disposal, and actions taken to prevent the occurrence or spread of public
health hazards caused by the medical devices.
B. Other information on the quality of the medical devices, as defined in the
GMP-I Article 4, Paragraph 1, Number 3.
3.2 Natus shall inform Nippon Eurotec of the above information immediately
after
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GMP-I Addendum to Distribution Agreement
this information is known to Natus, via fax, e-mail etc, and thereafter in
writing, in full detail.
Article 4. PERSONS RESPONSIBLE FOR INFORMATION
4.1 Natus and Nippon Eurotec shall set up the method of transmitting
information and designate the person responsible for the transmission of
information as mentioned in above articles 2 and 3.
4.2 Persons responsible for the transmission of information as above are:
Natus Medical Inc.
Xx. Xxx Xxxxx, Vice President, Operations
Tel: 0-000-000-0000, Fax: 0-000-000-0000, E-mail: xxxxxx@xxxxx.xxx
----------------
Nippon Eurotec Co., Ltd.
Xx. Xxxxxxx Xxxxxxx, General Manager, Marketing Division
Tel: 00-(0)0-0000-0000, Fax: 00-(0)0-0000-0000, E-mail: xx00-xxx@xx.xxx.xx.xx
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Article 5. QUALITY CONTROL DURING TRANSPORT AND UPON RECEIPT
5.1 Nippon Eurotec shall request to Natus information on the methods of
management and quality control during transport and receipt of the medical
devices, as defined in the GMP-I Article 4, Paragraph 1, Numbers 4 and 5.
5.2 Natus shall assure that the medical devices are packed in following manner:
Double-corrugated cardboard external box, unglued foam inserts,
Corrugated cardboard internal box, unglued foam inserts,
Accessories and cables wrapped and boxed separately from device
Natus shall attach within the external packaging, three (3) complete sets of
delivery inspection sheets (incoming inspection instructions). In cases of
rejection of the medical devices by Nippon Eurotec on in-coming test, due to any
defect, Nippon Eurotec shall return to Natus the defective medical devices in
conformity with related provisions in the DISTRIBUTOR AGREEMENT.
Article 6. COMPLAINT FROM CUSTOMERS AND MEASURE TO BE TAKEN
In case of complaint from customers in Japan, Nippon Eurotec shall follow Natus'
Complaint Handling Procedures, analyze the cases, and shall request that Natus
investigate these cases, to take appropriate measures promptly and to respond to
Nippon Eurotec with a written result of the investigation and necessary measures
taken.
Article 7. MEASURES TO BE TAKEN IN CASE OF RECALL
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Natus shall respond to Nippon Eurotec with the highest priority when Nippon
Eurotec requests Natus to investigate causes of health hazard cases incurred in
Japan which might have been due to deficiencies of medical devices. And
thereafter Natus shall send to Nippon Eurotec a written report clarifying its
investigation and conclusions, as per Natus' procedure for Adverse Event
Reporting. Likewise, Nippon EUROTEC shall cooperate with Natus, when and if
Nippon EUROTEC is requested by Natus to participate in investigations concerning
Natus medical devices in Japan.
Nippon Eurotec shall return all medical devices which have been recalled by
Natus, according to Xxxxx Xxxxxxxxx, due to deficiency during manufacture
control and transportation.
Article 8. TERM
This ADDENDUM to the DISTRIBUTOR AGREEMENT shall commence upon the Effective
Date and continue in full force, and shall terminate in accordance with the
provisions of DISTRIBUTOR AGREEMENT.
Article 9. INDEMINTY
Nippon EUROTEC warrants that the procedures herein comply with GMP-I
regulations, and indemnifies and holds Natus harmless from any liability arising
from any action by Nippon EUROTEC with respect to such GMP-I laws, regulations,
or procedures, it being expressly understood that such GMP-I laws, regulations,
or procedures are Japanese domestic laws, the responsibility for compliance of
which rests with Nippon EUROTEC, as Natus' exclusive distributor.
IN WITNESS WHEREOF, the parties hereto have duly executed this ADDENDUM
effective as of the effective Date.
NIPPON EUROTEC Co., Ltd. NATUS MEDICAL INC.
By: /s/ Xxxxxxx Xxxxxxx By: /s/ Xxxxxx X. Xxxxx
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Name: Xxxxxxx Xxxxxxx Name: Xxxxxx X. Xxxxx
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(Typed or Printed) (Typed or Printed)
Title: General Manager Title: V. P. Operations
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Marketing Division
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