Document:

Exhibit 10.2

 

GENAISSANCE PHARMACEUTICALS, INC. INCENTIVE PLAN

2000 AMENDED AND RESTATED EQUITY

 

Incentive Stock Option Terms And Conditions

 

Genaissance
Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, hereby grants to
the person named on the Certificate of Stock Option Grant available from the
AST Stockplan website (the “certificate”) an option to purchase shares of
Common Stock, $0.001 par value, of the Company (the “Option”) under and subject
to the Company’s 2000 Amended and Restated Equity Incentive Plan (the “Plan”)
exercisable on the terms and conditions set forth below and those attached
hereto and in the Plan.

 

This Option is intended to be treated as an
Incentive Stock Option under section 422 of the Internal Revenue Code of 1986,
as amended (the “Code”).

 

1.     Plan Incorporated by
Reference.  This Option is issued
pursuant to the terms of the Plan and may be amended as provided in the Plan.
Capitalized terms used and not otherwise defined in the Certificate have the
meanings given to them in the Plan.  The
Certificate does not set forth all of the terms and conditions of the Plan,
which are incorporated herein by reference. 
The Committee administers the Plan and its determinations regarding the
operation of the Plan are final and binding. 
Copies of the Plan may be obtained upon written request without charge
from the Finance or Human Resources Department of the Company.

 

2.     Option Price.  The price to be paid for each share of Common
Stock issued upon exercise of the whole or any part of this Option is the
Option Price set forth on the Certificate.

 

3.     Exercisability Schedule.  This Option may be exercised at any time and
from time to time for the number of shares and in accordance with the
exercisability schedule set forth on the Certificate, but only for the purchase
of whole shares.  This Option may not be
exercised as to any shares after the Expiration Date.  This Option may be terminated by the Company
before the Expiration Date as permitted by the Plan.

 

4.     Method of Exercise.  To exercise this Option, the Optionholder
shall deliver to the Company a Cash Letter of Authorization which is a written
notice of exercise available from the AST Stockplan website specifying the
number of shares with respect to which the Option is being exercised
accompanied by payment of the Option Price for such shares in cash, by
certified check or in such other form, including, to the extent then permitted
by the Committee, shares of Common Stock of

 

 

the Company
valued at their Fair Market Value on the date of delivery or a payment
commitment of a financial or brokerage institution, as the Committee may
approve. Promptly following such notice, the Company will deliver to the
Optionholder a certificate representing the number of shares with respect to which
the Option is being exercised.

 

5.     No Right To Employment.  No
person shall have any claim or right to be granted an Option.  Each employee of the Company or any of its
Affiliates is an employee-at-will (that is to say that either the Participant
or the Company or any Affiliate may terminate the employment relationship at
any time for any reason or no reason at all) unless, and only to the extent,
provided in a written employment agreement for a specified term executed by the
chief executive officer of the Company or his duly authorized designee or the
authorized signatory of any Affiliate. 
Neither the adoption, maintenance, nor operation of the Plan nor any
Option hereunder shall confer upon any employee of the Company or of any
Affiliate any right with respect to the continuance of his/her employment by
the Company or any such Affiliate nor shall they interfere with the right of
the Company or Affiliate to terminate any employee at any time or otherwise
change the terms of employment, including, without limitation, the right to
promote, demote or otherwise re-assign any employee from one position to
another within the Company or any Affiliate.

 

6.     Effect of Grant.  Optionholder shall not earn any Options
granted hereunder until such time as all the conditions set forth herein and in
the Plan which are required to be met in order to
exercise the Option have been fully satisfied.

 

7.     Change of Control.   In order to preserve the Optionholder’s
rights under the Option in the event of a change in control of the Company as
defined by the Committee, the Committee in its discretion may at any time take
one or more of the following actions: (i) provide for the acceleration of any
time period relating to the exercise of the Option, (ii) provide for payment to
the Optionholder of cash or other property with a Fair Market Value equal to
the amount that would have been received upon the exercise or payment of the
Option had the Option been exercised or paid upon the change in control, (iii)
adjust the terms of the Option in a manner determined by the Committee to
reflect the change in control, (iv) cause the Option to be assumed, or new
rights substituted therefor, by another entity, or (v) make such other
provision as the Committee may consider equitable to Optionholder and in the
best interests of the Company.

 

8.     Option Not Transferable.  This Option is not transferable by the
Optionholder other than by will or the laws of descent and distribution, and is
exercisable, during the Optionholder’s lifetime, only by the Optionholder.  The naming of a Designated Beneficiary does
not constitute a transfer.

 

9.     Termination of
Employment or Engagement.  If the
Optionholder’s status as an employee or consultant of (a) the Company, (b) an
Affiliate, or (c) a corporation (or parent or subsidiary corporation of such
corporation) issuing or assuming a stock

 

 

option in a transaction to which section
424(a) of the Code applies, is terminated for any reason (voluntary or
involuntary), (i) this Option shall not thereafter become exercisable as to any
additional shares and (ii) if the period of exercisability for this Option
following such termination has not been specified by the Board, the vested
portion of this Option shall remain exercisable (to the extent not previously
exercised) for three (3) months after the day on which the Participant’s
employment or engagement is terminated, whereupon this Option shall terminate; except
that -

 

(a)       If
the Participant is on military, sick leave or other leave of absence approved
by the Company, his or her employment or engagement with the Company will be
treated as continuing intact if the period of such leave does not exceed ninety
(90) days, or, if longer, so long as the Participant’s right to reemployment or
the survival of his or her service arrangement with the Company is guaranteed
either by statute or by contract; otherwise, the Participant’s employment or
engagement will be deemed to have terminated on the 91st day of such leave.

 

(b)      If
the Participant’s employment is terminated by reason of his or her retirement
from the Company at normal retirement age, each Option then held by the
Participant, to the extent exercisable at retirement, may be exercised by the
Participant at any time within three (3) months after such retirement unless terminated
earlier by its terms.

 

(c)       If
the Participant’s employment or engagement is terminated by reason of his or
her death, each Option then held by the Participant, to the extent exercisable
at the date of death, may be exercised at any time within one year after that
date (unless terminated earlier by its terms) by the person(s) to whom the
Participant’s option rights pass by will or by the applicable laws of descent
and distribution.

 

(d)      If
the Participant’s employment or engagement is terminated by reason of his or
her becoming permanently and totally disabled, each Option then held by the
Participant, to the extent exercisable upon the occurrence of permanent and
total disability, may be exercised by the Participant at any time within one
(1) year after such occurrence unless terminated earlier by its terms.  For purposes hereof, an individual shall be
deemed to be “permanently and totally disabled” if he or she is unable to
engage in any substantial gainful activity by reason of any medically determinable
physical or mental impairment which can be expected to result in death or which
has lasted or can be expected to last for a continuous period of not less than
twelve (12) months.  Any determination of
permanent and total disability shall be made in good faith by the Company on
the basis of a report signed by a qualified physician.

 

10.   Compliance with
Securities Laws.  It shall be a
condition to the Optionholder’s right to purchase shares of Common Stock
hereunder that the Company may, in its discretion, require (a) that the shares
of Common Stock reserved for issuance upon the exercise of this Option shall
have been duly listed, upon official notice of issuance, upon any national
securities exchange or automated quotation system on

 

 

which the Company’s Common Stock may then be
listed or quoted, (b) that either (i) a registration statement under the
Securities Act of 1933 with respect to the shares shall be in effect, or (ii)
in the opinion of counsel for the Company, the proposed purchase shall be
exempt from registration under that Act and the Optionholder shall have made
such undertakings and agreements with the Company as the Company may reasonably
require, and (c) that such other steps, if any, as counsel for the Company
shall consider necessary to comply with any law applicable to the issue of such
shares by the Company shall have been taken by the Company or the Optionholder,
or both.  The certificates representing
the shares purchased under this Option may contain such legends as counsel for the
Company shall consider necessary to comply with any applicable law.

 

11.   Payment of Taxes. The
Optionholder shall pay to the Company, or make provision satisfactory to the
Committee for payment of, any taxes required by law to be withheld with respect
to the exercise of the Option no later than the date of the event creating the
tax liability.  The Company and its
Affiliates may, to the extent permitted by law, deduct any such tax obligations
from any payment of any kind due to the Optionholder.  In the Committee’s discretion, the minimum
tax obligations required by law to be withheld with respect to the exercise of
the Option may be paid in whole or in part in shares of Common Stock, including
shares retained from the exercise of the Option, valued at their Fair Market
Value on the date of retention.

 

12.   Notice of Sale of Shares
Required.  The Optionholder agrees to
notify the Company in writing within 30 days of the disposition of any shares
purchased upon exercise of this Option if such disposition occurs within two
years of the date of the grant of this Option or within one year after such
purchase.

 

Optionee acknowledges receipt
of a copy of the Plan, a copy of which is available from the AST Stockplan
website, and represents that he or she is familiar with the terms and
provisions thereof, and hereby accepts this option subject to all of the terms
and provisions thereof.  Optionee hereby
agrees to accept as binding, conclusive and final all decisions or interpretations
of the Board or of the Committee upon any questions arising under the Plan.

 

 

Adopted:
September 20, 2000

 

 

By acceptance of this Option,
the Optionholder agrees to the terms and conditions set forth above and those
attached hereto and in the Plan.

 

 

GENAISSANCE PHARMACEUTICALS,
INC.

 

 

 

	
  Granted
  to:

  Social Security Number:

  Employee ID:

  Option to Purchase:

  Type of Stock Option: ISO

  	
  This
  stock option was granted to you

  on <<date>> by your company. The

  stock option price is the FMV on the

  date of grant, which was $<<price>>.

  
	
   

  	
   

  
	
  Grant Number:

  Grant Date:

  Grant Expiration Date:

  Grant Price: $

  	
  

  

 

Vesting
Schedule

Vesting
Start Date:

 

 

	
  Date of

  Vest

  	
   

  	
  Shares
  Vesting Over

  the Period

  	
   

  	
  Vesting
  in Period

  Occurs

  	
   

  	
  Last
  Date to

  Exercise

  	
   

  	
  

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

 

Authorized by:

Genaissance Pharmaceuticals,
Inc.Exhibit
10.21

 

	
  Master Purchasing Agreement

  	
   

  	
  

  
	
   

  	
   

  
	
  Philips Medical Systems

  	
   

  

 

Master
Purchasing Agreement

 

(Agreement
No. P01-000132)

 

between

 

Fischer Imaging

12300 North Grant
Street

Denver, Colorado
80241

 

(Hereinafter
referred to as “Fischer Imaging”)

 

and

 

Philips Medical
Systems

DMC GmbH

Röntgenstrasse 24

22335 Hamburg

 

(hereinafter
referred to as “PMS”)

 

Purchasing
Frame Agreement

 

	
  PMS DMC:
  Einkauf PST

  	
   

  
	
   

  	
  PMS

  	
  Fischer imaging

  
			

 

 

Contents:

 

	
  1

  	
   

  	
  PREAMBLE

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  OBJECT
  OF THE AGREEMENT

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  SUBCONTRACT

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  PRODUCT
  DEVELOPMENT AND PRODUCT UPDATING

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  4.1

  	
   

  	
  DEVELOPMENT

  	
   

  
	
  4.2

  	
   

  	
  PRODUCT UPDATING
  / PRODUCT MODIFICATION

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  PLANNING
  AND ORDERING

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  5.1

  	
   

  	
  REQUIREMENTS
  PLAN

  	
   

  
	
  5.2

  	
   

  	
  PURCHASE ORDERS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  6

  	
   

  	
  MANUFACTURE

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  6.1

  	
   

  	
  SPECIFICATION

  	
   

  
	
  6.2

  	
   

  	
  TRACEABILITY

  	
   

  
	
  6.3

  	
   

  	
  DRAWINGS
  AND TOOLS

  	
   

  
	
  6.4

  	
   

  	
  DOCUMENTATION

  	
   

  
	
  6.5

  	
   

  	
  DOWN PAYMENTS AND SUPPLIES
  (ITEMS PROVIDED BY THE CLIENT)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  DELIVERY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  7.1

  	
   

  	
  MODE OF
  DELIVERY

  	
   

  
	
  7.2

  	
   

  	
  TAKING
  RECEIPT OF GOODS

  	
   

  
	
  7.3

  	
   

  	
  DELIVERY
  IN GOOD TIME

  	
   

  
	
  7.4

  	
   

  	
  PACKAGING

  	
   

  
	
  7.5

  	
   

  	
  INCOMING GOODS INSPECTION

  	
   

  
	
  7.6

  	
   

  	
  COMPLAINTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

  	
  PRICES

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  8.1

  	
   

  	
  PRICE
  CALCULATION

  	
   

  
	
  8.2

  	
   

  	
  PRICE CHANGE, PRICE
  REVIEW

  	
   

  
	
  8.3

  	
   

  	
  COST
  PRICE REDUCTION

  	
   

  
	
  8.4

  	
   

  	
  RESULTS OF PRICE
  CALCULATION

  	
   

  
	
  8.5

  	
   

  	
  MOST-FAVORED-NATION CLAUSE

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  9

  	
   

  	
  INVOICING
  AND PAYMENT

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  9.1

  	
   

  	
  INVOICING

  	
   

  
	
  9.2

  	
   

  	
  PAYMENT

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  10

  	
   

  	
  SERVICING SUPPORT
  AND SERVICING PARTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  10.1

  	
   

  	
  SERVICING
  SUPPORT

  	
   

  
	
  10.2

  	
   

  	
  COMMITMENT TO DELIVER
  SPARE PARTS

  	
   

  
	
  10.3

  	
   

  	
  TRAINING

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  11

  	
   

  	
  QUALITY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  11.1

  	
   

  	
  QS-AGREEMENT

  	
   

  
	
  11.2

  	
   

  	
  INDUSTRIAL
  STANDARDS AND COMPANY STANDARDS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  12

  	
   

  	
  COMPLIANCE
  WITH THE REGULATIONS REGARDING THE ENVIRONMENT AND

  	
   

  
	
  ECOLOGICAL
  ASPECTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  12.1

  	
   

  	
  LEGAL
  REGULATIONS

  	
   

  

 

 

	
  12.2

  	
   

  	
  BANNED
  SUBSTANCES AND SUBSTANCES RELEVANT FOR THE ENVIRONMENT

  	
   

  
	
  12.3

  	
   

  	
  OTHER
  REGULATIONS REGARDING THE ENVIRONMENT AND ECOLOGICAL ASPECTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  13

  	
   

  	
  WARRANTY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  13.1

  	
   

  	
  WARRANTY

  	
   

  
	
  13.2

  	
   

  	
  SCOPE OF
  WARRANTY

  	
   

  
	
  13.3

  	
   

  	
  TERM OF
  WARRANTY

  	
   

  
	
  13.4

  	
   

  	
  EPIDEMIC
  DEFECTS

  	
   

  
	
  13.5

  	
   

  	
  REMEDYING EPIDEMIC DEFECTS

  	
   

  
	
  13.6

  	
   

  	
  INTERRUPTION
  IN THE PERIOD OF LIMITATION

  	
   

  
	
  13.7

  	
   

  	
  RECALLS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  14

  	
   

  	
  LIABILITY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  15

  	
   

  	
  LIABILITY
  INSURANCE

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  16

  	
   

  	
  RIGHTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  16.1

  	
   

  	
  THIRD-PARTY PROPERTY RIGHTS

  	
   

  
	
  16.2

  	
   

  	
  RIGHTS OF USE

  	
   

  
	
  16.3

  	
   

  	
  RIGHTS IN NAMES AND
  TRADEMARKS

  	
   

  
	
  16.4

  	
   

  	
  SAFE-KEEPING OF SPARE PARTS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  17

  	
   

  	
  SECRECY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  17.1

  	
   

  	
  SECRECY

  	
   

  
	
  17.2

  	
   

  	
  EXCEPTIONS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  18

  	
   

  	
  TERM OF
  AGREEMENT

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  19

  	
   

  	
  TERMINATION

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  19.1

  	
   

  	
  TERMINATION
  BECAUSE OF VIOLATION OF AN IMPORTANT OBLIGATION

  	
   

  
	
  19.2

  	
   

  	
  TERMINATION BECAUSE
  OF MAJOR CHANGES

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  20

  	
   

  	
  GENERAL
  PROVISIONS

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  20.1

  	
   

  	
  ENTIRE
  AGREEMENT / WRITTEN FORM

  	
   

  
	
  20.2

  	
   

  	
  ASSIGNMENT

  	
   

  
	
  20.3

  	
   

  	
  EXPORT CONTROL

  	
   

  
	
  20.4

  	
   

  	
  STANDARD TERMS AND
  CONDITIONS

  	
   

  
	
  20.5

  	
   

  	
  AUTHORITATIVE
  PROVISIONS

  	
   

  
	
  20.6

  	
   

  	
  SAVING CLAUSE

  	
   

  
	
  20.7

  	
   

  	
  FORCE MAJEURE

  	
   

  
	
  20.8

  	
   

  	
  APPLICABLE LAW

  	
   

  
	
  20.9

  	
   

  	
  PLACE
  OF JURISDICTION

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  21

  	
   

  	
  LIST OF ANNEXES

  	
   

  

 

 

1              Preamble

 

Fischer
Imaging produces and develops a digital mammography system,
the specification for which is set forth on Annex E1 (the “Specification”)

 

PMS
manufactures medical equipment for worldwide distribution.

 

PMS is
interested in forming a strategic partnership with Fischer
Imaging to integrate the Fischer Imaging Subsystem into a
PMS-branded digital imaging system that PMS will market, sell and support.   In addition, the parties will investigate
avenues to broaden the relationship to develop, market and sell additional valuable
medical products and services.  In
addition, both PMS and Fischer Imaging will leave the opportunity open for the
mutual development of future technology.

 

To
regulate their co-operation, the parties have resolved to conclude a master
agreement with the following provisions:

 

2              Object of the agreement

 

According to this
master agreement Fischer Imaging shall deliver, in
accordance with the purchase order, products and (servicing) spare parts
(hereinafter referred to as “the products”) to PMS,
which have been developed and/or manufactured by it.

 

PMS
will process the products, integrate them into systems manufactured by it
and/or deliver them to its customers directly. Fischer
Imaging shall sell and deliver the Philips branded products
exclusively to PMS unless otherwise expressly
stated in writing by PMS.

 

3              Subcontract

 

N.A.

 

4              Product development and product updating

 

4.1          Development

 

If Fischer
Imaging develops products according to a specification authorized by
PMS at its own expense on its own
account, a separate agreement shall be concluded regarding such co-operation on
development. See Annex E3: “Development of Systems,
....”.

 

4.2          Product
updating /
product modification

 

Fischer
Imaging undertakes, after commencing batch production, to
work on the further development and technical improvement of the products and
submit to PMS suitable suggestions for the
further development/adjustment. PMS shall be entitled
to suggest product improvements itself or, if necessary, demand them from Fischer Imaging if this relates to the special requirements for Philips
branding. Suggestions for product improvements will be presented and
negotiated in good faith on a regular base between both parties. In order to
ensure that the products have a consistent, reproducible quality, Fischer Imaging shall not perform any modifications to its
product without written consent from PMS. The
product delivered by Fischer Imaging
shall conform to that at the time of release by PMS
upon assignment of the PMS code no.
The procedure described in Annex E2 shall
apply (XMW – 11517).

 

If Fischer
Imaging is not in a position to perform a product modification
requested by PMS which has a major influence on
the competitiveness of the product, PMS may, after
definitive refusal by Fischer Imaging

 

 

or after a reasonable period
of time after the request to modify the product has elapsed, serve notice to
terminate the agreement.

 

In the event of extensive
modifications, Fischer Imaging and PMS shall conclude a separate Development agreement. In such
a case details shall be regulated in Annex E3: “Development of systems”

 

5              Planning and ordering

 

5.1          Requirements
plan

 

To be
able to correctly plan the quantity of products required by PMS, PMS shall inform
Fischer Imaging once a year of its market estimate with regard to sales potential
for the coming calendar year. Fischer Imaging and PMS shall, by means of a
logistics agreement (Annex O1), agree on the parameters of requirement planning
for each product delivered by Fischer Imaging and covered by this agreement.

 

PMS
shall inform Fischer Imaging of the changed
planning figures for the coming year in good time prior to expiry of a calendar
year.

 

Quarterly
meetings between both parties shall be targeted to control the business.

 

5.2          Purchase orders

 

Purchase
orders (Details in Annex O1) are only valid if they have been made in writing.
Inasmuch as written purchase orders or order changes are generated
automatically by data processing equipment, the statements shall be valid even
if they have not been signed by PMS.

 

6              Manufacture

 

6.1          Specification

 

The manufacture of the
products shall be based on the specification or drawings released by PMS in writing. (Annex E1).
The intellectual property and patents of the product specified in E1 is the
exclusive property of Fischer Imaging.

 

6.2          Traceability

 

For reasons of
quality assurance and product traceability PMS may request
Fischer Imaging to give the products a
serial number by means of which Fischer Imaging
can document and evaluate/trace the production and supply data and by which PMS can document and evaluate/trace the utilization and
quality data. The items will usually be safety-relevant parts/Products. The
serial numbers, which are defined by PMS, shall be
recorded on all documents accompanying the goods.

 

In the
specification /parts list (Annex E1)  Fischer Imaging is informed which data are necessary to identify
the products, e.g.: product number, name, manufacturer, production date, serial
number, technical parameters etc.

 

6.3          Drawings and
tools

 

All the drawings,
patterns and calculations lent for the purpose of executing orders shall remain
the property of PMS. They shall be kept secret,
must not be reproduced or used for other purposes and shall be returned if
requested by PMS. Tools, patterns, drawings and
other aids which are made in order to execute orders and which will be charged
separately by Fischer Imaging shall become PMS’ property at the time they are made. The transfer of
possession is replaced by Fischer Imaging
keeping them on behalf of PMS free of
charge; they may only be used to execute the orders and shall be handed over to
PMS immediately free of charge if
requested to do so after the contract has been processed or in the event of
supply difficulties. 

 

 

Fischer
Imaging shall clearly mark the aforementioned items as the
property of PMS and draw the attention of any
third parties who wish to establish rights in them to PMS’
title. It shall inform PMS of any such
event immediately. The cost of intervention shall be borne by Fischer Imaging.

 

Fischer
Imaging shall look after the aforementioned items, maintain
them and minimize any normal wear and tear; Fischer
Imaging shall have actual copies of drawings for manufacturing these
items in safe-keeping (e.g. from fire and flood damage); the necessary cost is
compensated for by the purchase price of the items.

 

To execute PMS orders, Fischer Imaging
shall only commission a subcontractor to make products, parts, tools, and
patterns, if permission has been obtained from PMS
in writing. Fischer Imaging shall subject the
subcontractor to his duties arising under this agreement. Fischer
Imaging hereby assigns its claims vis-à-vis the subcontractor with
regard to transfer of title in the tools and patterns to PMS
in accordance with the obligations of this contract.

 

6.4          Documentation

 

Fischer
Imaging shall make use of a device master record which
contains all relevant documents, for instance, drawings, specifications, test
protocols, calculations, engineering changes and software programming. The
device master record shall be maintained systematically and in a clear order so
that all relevant information and every delivery can be tracked and easily inspected.

 

Fischer
Imaging shall have the device master record in safe-keeping for at least 13 years after the last manufacture of the
product unless PMS requires the handing over. Fischer Imaging agrees that PMS
can inspect and copy the device master record at all times.

 

After
13 years Fischer Imaging shall offer the device
master record to PMS for safe-keeping before annihilation.

 

6.5          Down
payments and supplies (items provided by the client)

 

Fischer
Imaging undertakes to use any down payment (deposits) and
supplies (items provided by the client) supplied by PMS
solely for executing the orders.

 

PMS
will supply Fischer with loaner equipment that will allow for testing of PMS
systems in a simulated environment to their customer installations.

 

Fischer
Imaging shall keep the supplies provided by PMS separately and mark the property of PMS
on the supplies themselves and in its business records. It is agreed that the
goods manufactured on the basis of the purchase orders from PMS, for which PMS has
affected a down payment or supply, shall become its property. The transfer of
possession shall be replaced by Fischer Imaging
keeping the goods safely on behalf of PMS, with due
commercial diligence and free of charge. For this purpose Fischer Imaging
shall keep the manufactured goods separately from other stocks and indicate PMS’s ownership on the goods themselves and in the business
records. Fischer Imaging shall give PMS confirmation of this in writing. Moreover, PMS shall be entitled at any time to convince itself of
separate safe-keeping and proper identification of the goods/supplies on the
spot. If the supplies of PMS are
processed to make a new item, Fischer Imaging
shall not acquire ownership of the same. Any processing shall take place by Fischer Imaging on behalf of PMS.
If Fischer Imaging acquires co-ownership
by combining or mixing the goods, it hereby assigns its portion of co-ownership
to PMS. The transfer of possession shall
be replaced by the fact that Fischer Imaging
holds the item in safe-keeping on behalf of PMS
free of charge.

 

Fischer
Imaging shall notify to PMS any access
by third parties to the goods belonging to PMS without
delay and shall assist PMS in
intervening in any manner, the cost of which shall be borne by Fischer Imaging. The duty to notify shall apply by analogy
if composition or bankruptcy proceedings are initiated. Under no circumstances
shall Fischer Imaging have a right of
retention.

 

 

7              Delivery

 

7.1          Mode of
delivery

 

Delivery shall be done FCA (free carrier, loading at sellers premises,
Incoterms 2000), including packaging. Title, risk of loss and insurance
risk related to the product shall pass to PMS at delivery to a qualified
carrier.

 

7.2          Taking
receipt of goods

 

PMS
takes receipt of the products only under reservation with regard to quality,
condition and quantity. An inspection of the products at the factory or
warehouse of Fischer Imaging shall constitute
neither delivery nor receipt.

 

PMS is
under no obligation to accept incomplete Subsystems, but it will take receipt
of and pay for the complete systems that may be less than the total number
ordered.  Notwithstanding any other legal
or contractual entitlements PMS shall, in
the event that Fischer Imaging violates the duty
to deliver, be entitled to withhold payment related to incomplete products on
the order until the delivery has been received in full.

 

PMS
will not accept additional quantities or shortages.

 

If there are shortages in
deliveries, Fischer Imaging shall inform PMS in good time and compensate PMS
for the damage or loss due to the shortage.

 

Notwithstanding any other
legal or contractual entitlements PMS shall, in
the event that Fischer Imaging violates the duty
to deliver, be entitled to withhold payment of the respective order until the
delivery has been received in full. In any case the condition of payment are
related to date of delivery of products received in full.

 

If the products arrive at
PMS in damaged packaging, PMS shall be entitled to reject the delivery without
examining the contents. The goods will be returned for the account and at the
risk of Fischer Imaging.

 

7.3          Delivery in
good time

 

Fischer
Imaging is obliged to adhere to the agreed delivery dates
under all circumstances. Otherwise PMS shall be
entitled to refuse to take receipt of the delivery.

 

If the loading day varies
by more than two days from the delivery date agreed between the two parties to
the agreement, a penalty clause shall be agreed for every additional week by
which delivery takes place before or after the agreed delivery date. PMS shall charge 2% of the price of delinquent product for
each week or part of a week by which delivery takes place after the agreed
delivery date. The penalty amount shall be limited to a maximum of 10% of the
order sum. The order sum shall be calculated as the price multiplied by the
quantity for each delivery batch.

 

Independent of
penalty clause PMS can fix an extension for delivery. PMS
may terminate the agreement with immediate effect if the period of grace (one
week) is not observed and, if it is Fischer Imaging’s
fault, demand compensation for non-performance. This applies mutatis mutandis
to orders.

 

As soon as Fischer Imaging has reason to believe that it cannot provide
the delivery or part of the delivery in good time, it shall inform PMS of this without delay. The additional expense incurred
by PMS due to the delay shall be borne by Fischer Imaging. If PMS should
declare itself willing to take receipt of the delivery despite the delay in
delivery, Fischer Imaging shall bear the resulting
additional cost, e.g. airfreight charges, express freight charges.

 

If the deadline
agreed for delivery is not met and delivery carried out too early, for whatever
reason, e.g. works holidays of Fischer
Imaging - PMS may to
refuse to take receipt of the delivery and insist on delivery later in good
time.

 

If Fischer Imaging plans to carry out the
delivery too early, it shall inform PMS as soon as possible. If PMS decides to
take receipt of the delivery, Fischer Imaging shall bear the resulting
additional costs, e.g. freight charges, cost of stock keeping.

 

In any case the
condition of payment are related to the date of delivery originally planned.

 

 

7.4          Packaging

 

Fischer
Imaging shall effect delivery in packaging suitable for the
product, taking into consideration the relevant rules and legal regulations,
particularly the environmental protection regulations. The packaging and the
delivery documents shall bear the necessary information such as

 

•
Type number (Philips article no.)

•
Description

•
Number of packages

•
Serial number

 

In addition, information
shall be provided in accordance with the specification.

 

7.5          Incoming
goods inspection

 

The parties have agreed
that Fischer Imaging shall perform an
incoming goods inspection on behalf of PMS. The scope
shall be according to the test specifications defined by PMS
in accordance with Annex O2. The
cost of this inspection is included in the price of the products ordered.

 

The transfer of the
inspection duty to Fischer Imaging
and the waiving of the duty to file a complaint in accordance with §§ 377 f. of
the German Commercial Code (“HGB”) shall not constitute the waiving of
contractual or legal guarantee and compensation rights.

 

7.6          Complaints

 

PMS
will check the products delivered by Fischer Imaging
for external intactness and completeness within a reasonable period, but not
later than 30 days following delivery at the designated PMS or customer
destination. PMS will normally report any
apparent defects within six (6) weeks after receipt of goods and report any
concealed defects without delay after they have been discovered. Payment of the
goods shall not constitute their acceptance by PMS
as conforming to the agreement and being devoid of defects.

 

 

8              Prices

 

8.1          Price
calculation

 

The parties shall
negotiate the prices to be paid by PMS for the
products taking their respective interests into account and shall define them
in the price calculation sheet in accordance with Annex P1
with regard to amount and term of validity.

 

8.2          Price change, price review

 

Changes in price shall be
reviewed and negotiated on a quarterly basis in good time prior immediately
following the expiry of each calendar quarter.

 

If after price
calculation in accordance with para. 8.1 (price calculation) circumstances
should arise which exert a considerable influence on the cost situation, e.g.
product change, change in demand, change in the cost of labor and materials, currency
movements, etc., the parties shall commence negotiations even within a price
period, and agree to what extent the prices must be adjusted to take account of
the new situation. The change shall be laid down in writing. Currency moves
have to be taken into account as follows: Should the EUR fluctuate more than
3.5% from the set rate as per contract date for a minimum period of 30 days,
than Fischer Imaging and PMS each will incur 50% of the total difference in the
fluctuation above 3.5% of the contracted rates. Starting date and starting rate
will be fixed in Annex P1 (Prices)

 

This adjusted price shall
be effective with the first firm PO received by FIC following the adjustment.

 

8.3          Cost price
reduction

 

Fischer
Imaging undertakes to perform cost price reduction of his
products and procedures continuously to maintain the competitiveness of the
products of PMS. Fischer Imaging
shall make proposals during the price change and price review meeting (acc.
Para 8.2 Price change, price re-view), take actions by itself and together with
PMS to find reasonable measures of cost price reduction and realize them in a
coordinated manner. Fischer Imaging
shall reduce the prices of its deliveries to PMS according these cost reduction
measures in a share of 50%.

 

The annual
savings realized will at least meet the annual price erosion of the PMS
products, of which the products of Fischer
Imaging are part of. PMS and Fischer
Imaging agree upon transparency of cost calculation as precondition
to realize the targets of this cost price reduction.

 

8.4          Results
of price calculation

 

If the parties do
not reach an agreement on the prices during the negotiations according para 8.1
(Price calculation), Either party can give extraordinary notice of withdrawal
of the master purchasing agreement and the orders of products concerned with a
time limit of 12 months. Until the last delivery those prices are in force,
which were paid finally. Para 16.4 (Safe-keeping) is not applicable.

 

8.5          Most-favored-nation
clause

 

Fischer
Imaging shall offer PMS the most
advantageous prices and conditions compared to other customers of the same or
similar products and the same or similar terms. These prices and conditions are
also in force if the concerned products are ordered but not yet delivered.

 

 

9              Invoicing and payment

 

9.1          Invoicing

 

Fischer
Imaging undertakes to perform the invoicing of PMS only when the order has been properly and completely executed.
Invoicing shall take place according to Annex O1.

 

9.2          Payment

 

In as much as the above
prerequisites are fulfilled, payment by PMS will be
effected within sixty (60) days End of Month after receipt of invoice.

 

Vis-à-vis Fischer Imaging  PMS shall be
entitled to set off amounts against credit notes issued by Fischer
Imaging or accounts receivable from companies related to PMS which have all authorized PMS
to set off amounts.

 

Fischer
Imaging may assign its claims vis-à-vis PMS
only with the latter’s prior consent in writing; this shall also apply to factoring.
With regard to any debt assignments, which take place on the basis of an
extended reservation of title, agreed by Fischer Imaging
with subcontractors, PMS now hereby
gives its consent with the proviso that it is also allowed to set off the
amount against the counterclaim acquired after notification of assignment.

 

10           Servicing support and servicing parts

 

10.1        Servicing
support

 

In as much as it is
necessary, Fischer Imaging shall provide PMS with servicing support in accordance with Annex S1 (Servicing Agreement) of this agreement so that PMS can meet its commitments to its customers.

 

10.2        Commitment
to deliver spare parts

 

Fischer
Imaging shall supply PMS with all
servicing parts for the products delivered under this agreement for at least
ten (10) years after delivery of the product concerned. This shall also apply
beyond the term of the agreement. Fischer Imaging
guarantees PMS reasonable prices for the
servicing parts in accordance with Annex S1  (Servicing Agreement).

 

A sufficient stock
of spare parts is to be kept by Fischer
Imaging shall be delivered within 24h. Different agreements to be
made Annex S1  (Servicing
Agreement)

 

For
repairable assemblies or the complete unit, an exchange procedure with prices
not exceeding 60% of the part-/unit price shall be agreed upon.

 

10.3        Training

 

Fischer
Imaging shall train the staff of PMS with regard to
installation, commissioning and maintenance of the products in accordance with
Annex S1 (Servicing Agreement). For complex systems, a free training for PMS
employees (reasonable group) before delivery of the serial models shall be
supplied by Fischer Imaging. Tuition
will not be charged and it is assumed that PMS will pay all expenses associated
with travel and lodging.  Fischer will
provide a service-training specialist to support at least 1 training session at
the PMS training facility in Europe.

 

Fischer European based
service engineers will support the first PMS installations (reasonable number)
in Europe by assisting in the installations with the PMS engineers.

 

 

11           Quality

 

11.1        QS-Agreement

 

Within
its quality improvement program PMS follows a zero-fault strategy for the
products.

 

PMS
expects Fischer Imaging to commit itself to a
zero-fault strategy for its products. Fischer
Imaging is obliged to establish the conditions for the delivery of
faultless products by continuously improving, supervising and assessing its
work procedures.

 

Fischer
Imaging shall receive a quality fault report and an advice of
debit for any product that are faulty. The respective procedure is described in
Annex O3.

 

Upon request Fischer Imaging shall hand over a detailed
action list with scheduled improvement measures to PMS.

 

Fischer
Imaging agrees to set in agreement with PMS
for each product QS targets and to pursue these targets if requested by PMS. Fischer Imaging
agrees to let PMS examine the respective
documents verifying the achievement of the QS targets.

 

11.2        Industrial standards and company standards

 

Fischer
Imaging shall be responsible for ensuring that the products
delivered by it conform to the requirements of the relevant legal regulations,
industrial standards and company standards.

 

Particularly the Medical
Products Law, environmental protection regulations, accident prevention and
safety-at-work regulations, the generally recognized rules of engineering and
the state of the art shall be observed.

 

In addition, the
following standards and specifications shall apply: ISO 13485, FDA / DHH S, UL
/ CSA, CE labeling and IEC standards. For fulfillment of American standards
(FDA /DHH, VL / CSA) Fischer Imaging
shall, on request, make the necessary documents available to PMS in English.

 

Fischer
Imaging gives an assurance that in development and
manufacture it has taken the monitoring measures necessary to meet these
requirements. It undertakes to provide evidence upon request by PMS on this by supplying written documents or by taking
other suitable measures such as local inspection, spot checks, audits etc.

 

12           Compliance with the regulations regarding the
environment and ecological aspects

 

12.1        Legal
regulations

 

In addition to the
compliance with legal regulations, decrees and standards regarding the
environment and ecological aspects, the respective state of the art shall be
employed to keep the pollution of environment and resources as low as possible.
Compliance with regulation EWG 1836/93 is complied with by Fischer Imaging or  being worked
at.

 

12.2        Banned substances and substances relevant for the environment

 

A list of the banned
substances and the relevant substances is attached to this agreement as Annex U.

 

Fischer
Imaging confirms that the products and their packaging do not
contain any of the banned substances and agrees to declare any relevant
substances to PMS according to the attachment.

 

12.3        Other regulations regarding the environment and ecological aspects

 

Fischer
Imaging agrees to support PMS
in realizing the Philips environmental program.

 

This program
comprises:

 

•      The reduction
of packaging material

•      The
construction according to ecological principles (Eco-design)

 

 

•      The elimination
of banned substances as well as dangerous or toxic materials

•      The recycling
of the products or parts of them

•        Fischer
Imaging assures PMS of the fact that the disposal of the products and their
packaging can take place without any special safety measures needed.

 

13           Warranty

 

13.1        Warranty

 

Fischer
Imaging guarantees that the products are devoid of faults
that they do not have any defect affecting their value or their suitability and
that no guaranteed property is missing. Fischer Imaging
also guarantees that the products delivered are devoid of defects in design,
materials and manufacture.

 

13.2        Scope of
warranty

 

If there are any defects
in the products delivered, PMS can at its
discretion demand free replacement or elimination of defects. In urgent cases PMS may also eliminate the defects itself at Fischer Imaging’s expense after informing Fischer Imaging in advance. If an
elimination of defects requested by PMS is to no
avail even after expiry of a reasonable period of grace, PMS
may demand a reduction in the agreed price, serve notice to terminate the
agreement with immediate effect and demand compensation for non-performance.
Any further warranty and compensation rights, including consequential damage,
shall not be affected thereby. In particular, PMS
may demand reimbursement of the costs it has incurred due to the examination,
if PMS is forced, on account of
above-average occurrence of defects, to perform an incoming goods inspection
itself in contradiction to the provision contained in Paragraph 7.6 or have it
performed by commissioned third parties. PMS may either
hold any goods about which a complaint has been filed in safe-keeping or return
them to Fischer Imaging for the account and at
the risk of Fischer Imaging. On the date when PMS sends the notice regarding the returned goods, the title
in the goods shall return to Fischer Imaging.
The transfer is replaced by the fact that PMS holds the
goods in safe-keeping for Fischer Imaging.

 

Any defects which are
only found during processing of the products by integration or during operation
shall entitle PMS to also demand reimbursement
of the costs expended to no avail.

 

Reporting of defects is
done by “Quality Fault Report for Purchased Parts” and “List of costs” as now
are or hereafter may be in force. Details are described in Annex O3.

 

13.3        Term of
warranty

 

The term of the warranty
shall be twelve (12) months from date of installation (end of installation) or
fifteen (15) months from date of shipment, whatever comes first.

 

Replacement or
elimination of defects will prolong the term of warranty of the replaced or
repaired product for another twelve (12) months, as the case may be. The term
of warranty for service and spare parts shall be eighteen (18) months from date
of shipment.

 

13.4        Epidemic
defects

 

Epidemic defects are
defects, of the same nature or with the same cause, which in relation to a
continuous period of 3 calendar months or more, occur in more than 5% of the
products delivered. The basis of this shall be the statistics kept up to date
by PMS. If an epidemic defect is found, PMS will notify Fischer Imaging
in writing without delay. Epidemic defects must relate to failures of the
product to comply with the Specifications, and must relate to a set of products
that exceeds five (5) in number.  PMS will
provide Fischer Imaging with all documentation necessary to verify the epidemic
defect.  In response to the notice
received from PMS, Fischer Imaging shall create a corrective action plan that
shall be reviewed and approved by PMS.

 

 

13.5        Remedying
epidemic defects

 

In the case of epidemic
defects PMS shall be entitled to free
replacement of the product (including any exchange necessary locally) and to
payment of an all-in handling charge by PMS (see Annex O3). Fischer Imaging shall bear all the costs incurred as a
result of the occurrence of the epidemic defect and shall hold PMS harmless from all third-party rights in this respect.

 

If any epidemic defects
cannot be remedied or cannot be remedied within a short space of time by
replacement deliveries, PMS shall, in
addition to the rights regulated by Para. 13.2, also be entitled to postpone
the scheduled acceptance dates until the epidemic defect can be proved to have
been remedied.

 

13.6        Interruption in the period of limitation

 

Limitation of the aforementioned
warranty shall be interrupted as soon as PMS has sent Fischer Imaging a written notice regarding the existence of
a defect.

 

13.7        Recalls

 

If, owing to the
occurrence of a defect, the safety of the product is jeopardized or affected so
that PMS decides, as a responsible
manufacturer, to hold a recall campaign, PMS shall
inform Fischer Imaging of it without delay.
The parties shall endeavor to work out an inexpensive procedure jointly without
the safety interests of the end-user being neglected and without risking
causing damage to the reputation of the parties. Fischer
Imaging shall be liable to PMS for any
resulting damage in accordance with para. 14 (liability).

 

14           Liability

 

Fischer
Imaging shall be liable to PMS for all damage incurred by PMS
and shall indemnify PMS with respect to all third-party compensation claims for
damage which is due to defects in its production area or in that of its agents.
This shall also apply to the compensation (including any other costs which have
become necessary to assert legal rights according to the purpose), which PMS
declared itself willing to provide out of court, taking due consideration of
the interests of Fischer Imaging.

 

Fischer
Imaging’s liability is limited to damages resulting from Fischer Imaging product defects, and Fischer Imaging will have no liability to PMS or any third party related to products
or services not provided by Fischer Imaging
nor its subcontractors.  To the extent PMS has negotiated limitations of liability
in customer or partner agreements, Fischer
Imaging’s liability to PMS
will be equivalently limited.  Prior to
settling any potential claims for which PMS
will seek indemnification, PMS
must obtain the consent of Fischer Imaging,
which will not be unreasonably withheld.

 

15           Liability insurance

 

Fischer
Imaging gives an assurance that it has taken out adequate
employer’s liability insurance cover and is willing to provide evidence of this
upon request from PMS by
presenting the policy.

 

16           Rights

 

16.1        Third-party
property rights

 

Fischer
Imaging gives an assurance that the products are free of
third-party property rights. If nevertheless third parties file any justified
claim resulting from property rights, Fischer Imaging shall
in agreement with PMS endeavor to
find a technical solution as a remedy or at its expense acquire a license on
behalf of PMS. Fischer
Imaging undertakes to release PMS from any
claims resulting from the violation of property rights and provide compensation
for the resulting loss.

 

 

16.2        Rights of use

 

Fischer
Imaging grants PMS a
cost-free, worldwide, unrestricted, irrevocable, unlimited, non-exclusive,
transferable right of use in the industrial property rights belonging to the
product along with authorization to be able to transfer this right as a
non-transferable right to the customers of PMS.

 

The companies affiliated
to the PMS Group shall have the same rights

 

16.3        Rights
in names and trademarks

 

Fischer
Imaging is allowed to use the brand name, the protected
trademark of “Philips” and the Philips logo only with explicit written consent
from PMS. Fischer
Imaging acknowledges the rights of PMS
in the trademarks/brand names and declares that it derives no rights of use
whatsoever, either for its own products or for advertising purposes, from the
permission to use under this agreement. The rights and obligations of the
parties under this Section shall be mutual.

 

16.4        Safe-keeping
of spare parts

 

After completion of a
prototype of the product, Fischer Imaging
shall deposit with PMS all the
available documents, data and other information media, which are necessary for
manufacturing the agreed spare parts for the product. The depositing is
intended to enable PMS to
independently continue manufacturing the product if Fischer Imaging
discontinues the production activity or if notice is served by PMS in accordance with Para. 19.

 

This is conditional upon PMS itself abiding by the agreement.

 

Fischer
Imaging undertakes to grant PMS,
for the aforementioned cases, a cost-free, worldwide, unrestricted,
irrevocable, unlimited, non-exclusive right of use of the documents, data and
other information media belonging to the product, including the right to
process.

 

Fischer
Imaging shall deposit such materials with a third-party
escrow agent for the benefit of PMS.  PMS
shall be entitled to the release of such materials if the following conditions
are met: (i) PMS sells 50 or more
units of the product; and (ii) Fischer
Imaging is unable or unwilling to meet its contractual requirements
to supply spare parts for any reason.

 

17           Secrecy

 

17.1        Secrecy

 

Each party shall treat
confidentially the embodied information which is marked as being confidential
and all other information which is transmitted confidentially and has been
marked in writing as being confidential within thirty (30) days after
transmission, which it has received from the other party, and must not
reproduce, disclose, copy or use it. This shall not apply if under this
agreement a disclosure is necessary or the disclosing party has given prior
written consent.

 

This arrangement shall
not apply to the exchange of information within the companies affiliated to the
PMS Group. The commitment to secrecy shall also remain valid after termination
of this agreement.

 

This Section is
superseded by the Confidentiality Agreement between the parties dated August,
31st, 2001, which shall continue in full force and effect.

 

17.2        Exceptions

 

The commitment to secrecy
shall not apply to information which:

•      Is
known or which was already in the receiving party’s possession before transmission
by the disclosing party;

•      Has been made
available to the receiving party by a source other than the disclosing party or
which has become public domain in a manner other than by violation of this
commitment;

•      Has been
prepared independently by the receiving party;

•      Has been
disclosed by law.

 

 

18           Term of agreement

 

This agreement shall come
into effect as soon as both parties have signed it and shall apply for a period
of 3 years. After that the term will be
automatically extended by another year unless PMS
serves 3 months notice in writing to take effect at the end of a calendar month
or notice is served in accordance with Para. 19. Either party may elect not to
renew this agreement beyond its initial three-year term by serving written
notice on the other party nine (9) months prior to the end of the initial term
or any renewal thereof.

 

19           Termination

 

19.1        Termination because of violation of an important obligation

 

In the event of any
violation of an important obligation under this agreement by either party, the
other party shall be entitled to serve notice with immediate effect if the
violation of the agreement has not been discontinued within thirty (30) days
after receipt of a written warning. The party entitled to serve notice may
decide whether an order placed but not yet executed is to be cancelled or
delivered. In the event of culpable violation compensation claims may be filed.
Para. 16.4 shall apply.

 

19.2        Termination
because of major changes

 

Fischer
Imaging shall inform PMS without delay
about any major circumstances which threaten to jeopardize delivery not just
temporarily. This shall particularly apply in the case of Fischer
Imaging’s insolvency or initiation of composition or bankruptcy
proceedings against it.

 

If any of these circumstances
should apply, PMS shall be entitled to serve
notice with immediate effect and file compensation claims. Para. 15.5 shall
apply.

 

20           General provisions

 

20.1        Entire
agreement /
written form

 

This agreement is the
result of all preceding negotiations between the parties. It regulates the
supply relationship entirely and definitively. Amendments and additions to this
agreement shall be made in writing. This shall also apply to the waiving of the
requirement for written form.

 

20.2        Assignment

 

PMS
is entitled to assign its rights under this agreement and transfer performance
of obligations to third parties.

 

20.3        Export control

 

If the products are
subject to export control, Fischer Imaging shall
inform PMS of this in writing and announce the
applicable export control number (“ECCN”).

 

20.4        Standard
Terms and Conditions

 

During the term of this
agreement the Parties waive application of their respective Standard Terms and
Conditions.

 

20.5        Authoritative
provisions

 

In the event of any
contradiction between a provision in this agreement and a provision in an
Annex, the provisions of this agreement shall be authoritative.

 

 

20.6        Saving clause

 

If any provision in this
agreement shall be or become invalid, it shall not affect the validity of the
remaining agreement. The Parties shall replace the invalid provision by one,
which commercially fulfils the object of the agreement.

 

20.7        Force Majeure

 

Should one of the parties
to the agreement be prevented from fulfilling in good time his obligations
arising out of this agreement by the occurrence of unforeseen circumstances
which despite the exercise of reasonable care according to the circumstances of
the case he has not been able to circumvent (Force Majeure, in particular war,
blockade, industrial disputes, sabotage, civil commotion and administrative
order), the deadline for supplies and services shall be extended accordingly.

 

In such a case, he
shall advise the other party to the agreement without delay of the type and
consequences of the incidence of Force Majeure or other exceptional
circumstances. The parties to the agreement shall thereupon without delay, on
the basis of the principle of equity and good faith, make joint arrangements to
deal with the business affected by the aforementioned circumstances.

 

Should
the incidence of Force Majeure last for more than three months; the party to
the agreement who has thereby been prejudiced shall be entitled to terminate
the agreement with immediate effect.

 

 

20.8        Applicable law

 

The laws of the Federal
Republic of Germany shall apply.

 

The provisions of the
Vienna Uncitral Treaty on international sale-of-goods contracts, issued on 11th
April 1980, shall not apply.

 

20.9        Place of
jurisdiction

 

The place of jurisdiction
for all disputes resulting from this agreement shall be Hamburg, Germany.

 

20.10      Dispute Resolution.

 

In the event that there
is a dispute between the parties related to this transaction, the parties will
seek to resolve the dispute as follows:

 

•      The responsible
managers for each party will meet and discuss the difference for no less than
five (5) days;

•      If no
resolution is reached, the dispute will then be referred to the chief executive
officers of each party, who will meet and discuss the difference for no less
than five (5) days;

•      If the dispute
is not resolved at this point, either party may seek a remedy to the dispute
before a court that has jurisdiction over the matter as fixed in § 20.9.

 

	
  Hamburg dated

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Philips Medical Systems
  DMC GmbH

  	
   

  	
  Fischer Imaging

  	
   

  

 

21           List of Annexes

 

For each product which is
included in this master agreement (place a cross as applicable):

 

Fischer Imaging
and PMS shall keep the following List of
Annexes up to date. It shall always be the latest List of Annexes signed by
both parties, which shall apply:

 

 

	
  ID. of the

  Annex

  	
   

  	
  Description

  	
   

  	
  Applicable

  YES

  	
   

  	
  NO

  	
   

  	
  Date of

  signing

  	
   

  
	
  Product-related Annexes:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  E1

  	
   

  	
  Specification

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  E3

  	
   

  	
  Development Contract

  	
   

  	
  o

  	
   

  	
  ý

  	
   

  	
   

  	
   

  
	
  E4

  	
   

  	
  Declaration of Exclusiveness

  	
   

  	
  o

  	
   

  	
  ý

  	
   

  	
   

  	
   

  
	
  O1

  	
   

  	
  Logistics Agreement

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  O2

  	
   

  	
  Incoming Goods Inspection

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  O3

  	
   

  	
  Zero-defect-strategy

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  O4

  	
   

  	
  Quality

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  P1

  	
   

  	
  Price List (products and servicing parts)

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  S1

  	
   

  	
  Servicing Agreement: 

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  

 

 

	
   

  	
   

  	
  Servicing support, servicing parts, repair,
  servicing training

  	
   

  	
  o

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  S2

  	
   

  	
  Field Problem Reports

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  General Annexes

  	
   

  	
   

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  E2

  	
   

  	
  Change procedure incl. change application and
  resolution forms

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
  P2

  	
   

  	
  Price calculation sheet

  	
   

  	
  o

  	
   

  	
  ý

  	
   

  	
   

  	
   

  
	
  H1

  	
   

  	
  Environmental protection agreement: forbidden and
  notifiable substances Sustainability

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Contacts and
  Organigram

  	
   

  	
  ý

  	
   

  	
  o

  	
   

  	
   

  	
   

  

 

 

	
  Philips Medical Systems - FIC

  	
  PMS - FIC

  
	
  Annex O3: Service Agreement

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

ANNEX S 1

 

SERVICE

 

1.             Definitions

 

Capitalised
terms without definition shall have the same meaning as defined in the
Agreement.

 

1.1           “DOA”
means Dead on Arrival, a situation when a Product does not function within the
Product acceptance period as defined in Article 9.6 (Acceptance) of the
Agreement:

 

1.2           “FCO”
means Field Change Order;

 

1.3           “FRU”
means Field Replaceable Unit;

 

1.5           “Service
Documentation” means the accurate technical, installation, operation and
maintenance documentation relevant for the Product, including the operators
manual;

 

2.             Responsibilities

 

Unless agreed to
otherwise in writing, PMS is responsible for:

•    Installation and commissioning of
the Product;

•    Training of the user;

•    Maintenance and repair at the end
user’s site;

•    Regular training of the
PMS-engineers;

•    FCO implementation;

•    Delivery of Service Parts to end
users;

•    Delivery of repairable Service Parts
to FISCHER IMAGING;

•    Registration and supervision of
follow-up by FISCHER IMAGING of field problem reports;

 

and  FISCHER
IMAGING  is responsible for:

•    Delivery (free of charge) of Service
Documentation;

•    Delivery (free of charge) of any
possible software/ hardware updates/ upgrades (excluding additional features)

•    Service Parts supply to PMS;

•    Repair of Products or Service Parts thereof;

•    Support of PMS-service-staff;

•    Provision of FCO modification kits,
including technical, installation, operation and maintenance documentation (if
applicable).

•    Initial training (free of charge) of
PMS service personnel (train-the-trainer- concept)

 

3.             Product delivery

 

3.1.         Service Documentation

 

FISCHER IMAGING together
with PMS shall mutually agree upon the content of the Service Documentation,
that shall be in conformity with applicable laws and regulations as specified
in the Agreement especially FDA regulation e.g. “0-level” documentation.

 

When Service Parts are
defined FISCHER IMAGING shall, as part of the Service Documentation, provide
PMS with the complete proforma per Service Part as specified in the service parts list of the Agreement.

 

FISCHER IMAGING shall
provide PMS, free of charge, with Service Documentation in electronic format,
or, upon PMS’s request, in hardcopy, for PMS’s approval.  PMS is entitled to process and integrate the
Service Documentation into its overall system documentation.

 

Service Documentation
will be made available to PMS in the English language. FISCHER IMAGING herewith
grants PMS the unconditional right to translate the Service Documentation in
other languages as such is required by law or regulation.

 

The Service Documentation
shall contain at a minimum the following sections:

 

	
  PMS DMC:
  Einkauf

  	
   

  
	
   

  	
  PMS 

  	
  FIC

  
			

 

1

 

•      Technical Data;

•      Installation
(if applicable);

•      Setting-to-work
(if applicable);

•      Acceptance: Specification
checks and data applicable for field service;

•      Planned
maintenance data (if applicable);

•      Corrective
maintenance data (diagnostic procedures for fault identification; adjustment
procedures; instructions for (dis) assembly, removal and replacement;
procedures after repair or replacement and simplified drawings to facilitate
fault findings);

•      Service Parts
list including PMS’s 12 digit code numbers (“12 NC” numbers);

•      Specification
of required tools (if any), to be classified for (pre-) installation,
setting-to-work, acceptance and maintenance.

 

Unless the Agreement
provides otherwise, FISCHER IMAGING shall be solely responsible for the cost
and expense of the development and provision of the Service Documentation.
Exception: Additional requirements from PMS.

 

The Service Documentation
will be timely updated and maintained by FISCHER IMAGING during the lifetime of
the Product to include all implemented changes and modifications pertaining to
the Product. Corrections will be furnished to PMS without additional charges.

 

FISCHER IMAGING shall
forward to PMS the revised Service Documentation at least forty (40) days prior
to the first shipment of new/changed Products, so as to enable PMS to review,
edit, and approve such new documents before regular shipments will take place.

 

3.2.         Data carrier

 

All information,
including but not limited to Service Documentation will be available on one of
the following data carriers, the version to be agreed between PMS and FISCHER
IMAGING:

•    MS-EXCEL

•    MS-WORD

•    GIF for photo’s & drawings

 

3.3.         Software

 

The test- and diagnostic
software, if any, used by field service personnel will be made available in
source, documentation and object code by FISCHER IMAGING on a carrier suitable
for the Product.

 

If PMS requires other
than regular -advanced-test- and diagnostic software, both in source and object
code, FISCHER IMAGING will supply them at a reasonable price to be agreed upon.

 

The test- and diagnostic
software will be updated by FISCHER IMAGING during the lifetime of the Product
to include all implemented changes and modifications pertaining to the Product.
Corrections will be furnished to PMS without additional charges. FISCHER
IMAGING will supply new test- and diagnostic software at least thirty (30) days
before the first delivery of Products changed.

 

3.4.         Product delivery for
Service

 

Each Service Part (if
applicable) shall be delivered by  FISCHER
IMAGING  with:

•      Spare fuses in
case of power supplies;

•      An up-to-date
configuration record showing all FRU’s containing PMS part numbers and revision
levels;

•      Service key
stickers showing the location of each component inside the unit.

•      Configuration
of ie jumper settings

 

4.             Support

 

FISCHER IMAGING agrees to
respond to PMS’s request for technical support within one business day. FISCHER
IMAGING agrees to provide on-site support at PMS or PMS’s end user sites to
resolve technical issues that can not be resolved by other means. The decision
to go on-site will be by mutual agreement and ultimately within 5 business days
of PMS’s request to visit PMS or the end user site.

 

Support costs for in
warranty technical issues are borne by FISCHER IMAGING. Issues resolved to be
non-FISCHER IMAGING problems and out of warranty support costs are reimbursable
to FISCHER IMAGING including reasonable

 

2

 

material and travel expenses
and labor cost up to an amount to be agreed in writing between the parties.
Travel and waiting time shall not be billable to PMS.

 

5.             Maintenance

 

5.1.         Repair Policy

 

Repair will be made by
replacing FRU’s including but not limited to PCB’s, keyboards, power supplies,
motors, and disc drives. The amount and the level of the FRU’s may change over
the lifetime of the Product.

 

5.2.         Reporting by FISCHER
IMAGING about Reliability

 

FISCHER IMAGING and PMS
will exchange free of charge, all such relevant data regarding reliability of
the Product and Service Parts, such as, but not limited to:

•    mean time between failure- and mean
time to repair figures (if applicable);

•    problem reports at Product and
Service Part level;

•    field failures;

•    Spare part consumption for PM/ CM.

•    Call rate

 

FISCHER IMAGING will
issue free of charge on a monthly basis a repair report to PMS, which should
include all relevant data such as (but not limited to):

•    Service Part name;

•    FISCHER IMAGING code / PMS code;

•    in / out of warranty;

•    manufacturing data;

•    serial number;

•    repair activity description.

 

6.             Field Change Order
(FCO), Problem Reporting and Service Information

 

6.1.         Field Change Orders

 

6.1.1.       Modification kits

 

Field modifications, if
any, will be made available to PMS in a form of individual modification kits
and in the required amount / lead time as decided by PMS after consultation
with FISCHER IMAGING.

 

In case of software
modifications  FISCHER IMAGING  shall work together with PMS to establish the medium on
which the kit is being released.

 

These kits will at a
minimum contain:

•    List of applicable Products and
their serial numbers

•    Implementation instructions

•    Material and Service Parts

•    Special tools (if any)

•    updates of Service Documentation

 

Kits for the field
modifications in the categories of “mandatory action” and “action for
performance” will be provided by FISCHER IMAGING to PMS without charge, unless
agreed in writing otherwise.

 

6.1.2.       Categories and implementation of FCOs

 

Four (4) categories are
distinguished:

•    Mandatory action

•    Action for performance

•    Proactive

•    Retrofit on failure

•    Service recommendation

•    Documentation change

 

These categories are defined
as follows:

 

3

 

1.     Mandatory
action

 

Corrective actions
required to eliminate potential or materialized unsafe situations. They must be
given the highest priority and must be performed within the indicated time
limit.

 

2.     Action
for performance

 

Corrective actions
required to eliminate potential major deficiencies in functional performance
that might affect the satisfaction of the end user and by consequence influence
our brand image. They must be given high priority.

 

3.     Service
recommendation

 

A “Service recommendation”
is an action being neither a “Mandatory action” nor an “Action for performance”
which the Sales and Service Districts are recommended to perform. This action
may involve updating, upgrading or correcting the functioning of installed
products.

 

4.     Documentation
change

 

This kind of corrective
actions does not affect the technical state of a Product. It gives instructions
and it delivers material to update the Service Documentation.

 

Classification into any
of these categories and terms and conditions of any action will be decided by
PMS upon consultation with FISCHER IMAGING. Classification will take into
account applicable law and regulations.

 

6.2.         Field Problem Reporting
by PMS

 

PMS will report all
problems using a Field Problem Report Form sheet (see Annex 1 to this
Attachment). In order to shorten turnaround times, PMS may report by telephone,
fax or e-mail. Telephone reports must be promptly confirmed by a written Field
Problem Report.

 

The categories of
Problems are defined as very urgent problems, urgent problems, routine problems
and production stop:

VERY URGENT
PROBLEMS

•    Disables the use
of the Product or causes an abnormal end of the application program.

•    Causes danger for
the patient being examined or personnel operating the Product.

 

URGENT PROBLEMS

•    Disables the use
of the Product under certain conditions

•    Disables the use
of certain function(s) of the Product

 

ROUTINE PROBLEMS

•    Problems other
than VERY URGENT or URGENT

 

PRODUCTION
STOP

•      The
Production at PMS or any of PMS’s Affiliated Companies is stopped, caused by a
Product delivered by FISCHER IMAGING.

 

The Corrective Maintenance shall be provided by
FISCHER IMAGING by:

 

1.     Delivering
as soon as possible solutions for VERY URGENT, URGENT DEFECTS and PRODUCTION
STOP in the form of preliminary solutions (temporary fixes only, no corrections
to the Product) and definite solutions (corrections to the Product) if
necessary in an unscheduled revision Level of the Software. Component failures
to be resolved by mutual agreement.

 

2.     Delivering
solutions for routine defects in the form of definite solutions as part of the
next Level of the Product delivery.

 

The
time schedule for response to PMS and solution delivered to PMS, are given in
below diagram.

 

4

 

	 
	
  Error/Defect

  classification

  	
   

  	
  initial

  response solution

  	
   

  	
  preliminary

  solution

  	
   

  	
  definite

  	 

	 
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	 

	 
	
  VERY URGENT

  	
   

  	
  12 hours

  	
   

  	
  2 weeks

  	
   

  	
  6 weeks

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  URGENT

  	
   

  	
  24 hours

  	
   

  	
  4 weeks

  	
   

  	
  16 weeks

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ROUTINE

  	
   

  	
  48 hours

  	
   

  	
  N.A.

  	
   

  	
  next level

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PRODUCTION STOP

  	
   

  	
  8 working hrs

  	
   

  	
   

  	
   

  	
  2 working days

  
											

 

Note:      The
hours mentioned in initial response are meant to be business hours. The other
mentioned timeframes are referring to calendar days/weeks.

 

If FISCHER IMAGING cannot
provide a definite solution without violating the Specifications of the
Product, then FISCHER IMAGING shall timely inform PMS in writing, together with
a comprehensive explanation of the reasons and consequences. FISCHER IMAGING
shall refrain from any activity to implement such a definite solution unless
PMS has accepted the proposed solution in writing.

 

Both preliminary and
definite solutions will be made available to PMS as soon as possible after
FISCHER IMAGING has produced and tested these solutions. The solutions shall be
documented and made available to PMS by fastest means of communication and/or
transportation.

 

For all categories,
FISCHER IMAGING will work continuously during regular business hours and with
first priority on such problem until it is solved.

 

Outline of Maintenance
and Support Services:

 

To streamline customer
support and accelerate resolution of issues, the following escalation process
will be followed. PMS will employ this escalation process and all reasonable
efforts will be applied to resolving the issues at the lowest possible level,
before escalating to the next.

 

Philips will provide
Level 1 and Level 2 support to its customers. Fischer Imaging will provide
Level 3 and Level 4 support to Philips Technical Support Group. Fischer Imaging
will not be required or expected to provide support directly to Philip’s
customers or field service engineers.

 

Level 1 Support: Direct
Customer Support – This covers on site as well as phone support of the end user
in addressing issues concerning applications, workflow, functions, features or
failures.

 

Level 2 Support:
Technical Support – This applies to technical support of field engineers and
end users. Examples would be in collecting data or error logs remotely for the
purpose of diagnosing issues or replicating problems.

 

Level 3 Support: Factory
Technical Support – This applies to issues that remain unresolved and Philips
field and technical support have replicated the problem and exhausted all other
courses of action.

 

Level 4 Support:
Engineering Support – This covers software and hardware engineering to correct
design defects.

 

6.3.         Service information

 

FISCHER IMAGING shall
include PMS in the distribution list for technical information bulletins via
FISCHER IMAGING’s Extranet.

 

7.             Configuration
Management

 

FISCHER IMAGING will
maintain a Configuration Record for each Product and Service Part delivered
(Excel-file), indicating:

•    Product and Service Part serial
number

•    Hardware configuration and firmware
level (if any)

•    Identification of assemblies and
sub-assemblies contained in the Product by Service Part numbers and serial
number.

 

5

 

8.             Service Parts

 

8.1.         Service Parts List

 

FISCHER IMAGING shall
provide PMS  with a list of Service Parts
containing the following information:

•      Part number
with revision level where applicable;

•      Description of
the Service Part;

•      Identification
of critical items in close co-operation with PMS;

•      Identification
of strategic parts ECCN (Export Control Classification Number);

•      Repair or
replacement cost per Service Part;

•      Identification
of repairable and exchangeable items and delivery time.

 

8.2.         Stock Recommendations

 

FISCHER IMAGING will
provide PMS with recommendations for the stocking of Service Parts required to
support and maintain the Products and update such information as required.

 

PMS shall inform Fischer Imaging once a year of its estimate with regard to
Service parts potential for the coming calendar year.

 

FISCHER IMAGING will
ensure availability of Service Parts prior to the first dispatch of Products.

 

8.3.         Ordering and Delivery
Time for Service Parts

 

8.3.1.       Priority 1 orders (P1)

 

Service Parts to be
delivered under “priority 1 order” (breakdown and out of stock situation) will
be shipped by FISCHER IMAGING within a period of twenty-four (24) hours after
notification using courier service (or within longer period as agreed in
writing).

 

8.3.2.       Priority 2 orders (P2)

 

Service Parts to be
delivered under “priority 2 orders” may be placed by PMS during the term of
this Agreement. These Service Parts will have a Delivery Time of three (3)
days.

 

8.3.3.       Normal (replenishment) orders (P3)

 

Delivery time for Service
Parts will be 30 days after receipt of the Purchase Order.

 

8.4.         Repair

 

8.4.1.      Repair
Services

 

Service Parts which are
identified as repairable items, may be returned “as is” by PMS to FISCHER
IMAGING for repair, and will be -if allowed by applicable law and regulations-
repaired to the highest configuration level within 6 (six) calendar weeks or,
at PMS’s option, be replaced within 1 (one) week.

 

PMS may return a broken
Service Part within a reasonable time, irrespective of the supply by FISCHER
IMAGING of the replacing Service Parts.

 

Service Parts returned
already two times to FISCHER IMAGING will be taken out of circulation. The
Service Part will be replaced by a new one.

 

PMS will receive a full
refund for unused obsolete Service Parts, meaning Service Parts in its original
package, if those Service Parts are returned as a result of a mandatory FCO,
within 90 days of receipt of FCO.

 

DOA Service Parts will be
returned to FISCHER IMAGING for functional check. Those items found to be
acceptable will be returned to PMS at no charge. If an item is returned a
second time as DOA, PMS will receive a new replacement item free of charge. The
DOA Service Part will be discarded upon the second return.

 

A Service Part returned
by FISCHER IMAGING to PMS will be replenished by FISCHER IMAGING with all parts  necessary to complete the original delivery. (e.g. spare
fuses for power supply)

 

Hard Disc Assemblies (HDA) returned for repair and still containing data
shall not be read by FISCHER IMAGING. When the HDA is reused, the contents on
disc will be erased by FISCHER IMAGING before re-shipping.

 

6

 

8.4.2.      Repair at PMS

 

If PMS would elect to
start repair of exchangeable Service Parts in its own workshops, then FISCHER
IMAGING will transfer free of charge to PMS, all relevant information
concerning:

•    Trouble shooting

•    Component specifications (names and
addresses of vendors included)

•    Adjustment procedures

•    Tools and repair aids
(specifications and prices)

•    Initial training (if applicable)

•    Test equipment

•    Test and diagnostic software (both
in source and object code)

 

To maintain warranty on
Products and Service Parts, PMS must acquire prior approval to start repair of
exchangeable Service Parts in its own workshop or an approved third party.

 

8.5.         Restocking fees

 

PMS is entitled to return
all up to date Service Parts in their original package which Service Parts
shall be accepted by FISCHER IMAGING, for a
restocking fee of 90% of original purchase price to PMS.

 

8.6.         Packing and storage

 

In addition to the
conditions as stated in article 9 of the Agreement, each Service Part will be
packed in such a way, that it can be reused and stored without re-packing (if
necessary, electrostatic discharge-packing is to be used).

 

FISCHER IMAGING will
specify the storage conditions for Service Part(s), such as but not limited to
temperature, humidity, shelf life and air pressure, for any Service Part(s) for
which there are special requirements in this regard.

 

8.7.         Affiliated companies and subcontractors
involved

 

The service logistics
branch of Affiliated Companies if they so desire, or the subcontractors
appointed by PMS, are entitled to deal directly with FISCHER IMAGING in the
areas of ordering Service Parts and returning Service Parts for repair to
FISCHER IMAGING. PMS will provide prior notice of those subcontractors.

 

 

	
  Hamburg, 

  	
   

  	
   

  	
   

  	
  Denver,

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Philips Medical Systems

  	
   

  	
  FISCHER
  Imaging

  
	
  DMC GmbH

  	
   

  	
   

  

 

7

 

	
  Philips Medical Systems - FIC

  	
  PMS - FIC

  
	
  Annex S1: Service

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

Annex 1 to ATTACHMENT G

 

For the purpose of this Annex, PMS is refered to as “PMS”.

 

	
  PMS

  Reference number:

  	
   

  	
   

  	
   

  	
  FISCHER IMAGING
  

  Reference number:

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
   

  	
  Name:

  
	
  Phone:

  	
   

  	
   

  	
   

  	
  Phone:

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
   

  	
   

  
	
  Product:

  	
   

  	
   

  	
   

  	
   

  
	
  Serial number:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Problem area:

  	
   

  	
  Application Software

  	
   

  	
   

  
	
   

  	
   

  	
  Diagnostic software

  	
   

  	
   

  
	
   

  	
   

  	
  Hardware

  	
   

  	
   

  
	
   

  	
   

  	
  Documentation

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Problem description:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Solution:

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  

 

8

 

	
  Incoming Goods Inspection

  (Annex O2 of Master Purchasing Agreement)

  	
   

  	
  

  
	
   

  	
   

  
	
  Philips Medical Systems

  	
   

  

 

Annex to
the Master Purchasing Agreement

(Agreement
No. P01-000132)

regarding

 

Service
Comprising Incoming Goods Inspections 

in accordance with §§ 377 - 378 of the German commercial code (“HGB”)

 

between

 

Fischer Imaging

12300 North Grant
Street

Denver, Colorado
80421

(hereinafter
referred to as “FIC”)

 

and

 

Philips Medical
Systems

DMC GmbH

Röntgenstrasse 24

22335 Hamburg

 

(hereinafter
referred to as “PMS”)

 

Subject
of the agreement

 

	
  PMS DMC:
  Einkauf PST

  	
   

  
	
   

  	
  PMS

  	
  FIC

  
			

 

1

 

Performance
of the incoming goods inspection in accordance with §§ 377 - 378 of the German
commercial code (“HGB”)

 

The contracting parties
agree on an incoming goods inspection (GRI) on behalf of PMS.

 

The incoming goods
inspection shall be explicitly commissioned for each purchase order; the cost
of the inspection shall be included in the price of the articles ordered.

 

The scope of the
inspection shall be based on the test specifications prescribed by PMS or agreed with it, which are an integral part of the
Specification.

 

The contracting parties waive in agreement PMS’s
duty to inspect and file a complaint in accordance with §§ 377 – 378 of the German
commercial code although the contractual and statutory entitlement to
compensation shall remain. The obligation shall be replaced by the detached,
explicitly agreed incoming goods inspection at the contractor’s premises.

 

If defects occur at PMS earlier or later, which are due to an inadequate
incoming goods inspection, PMS may take
recourse to the contractor. The scope of the warranty and the periods thereof
shall be based on the purchasing conditions of PMS.
In the event of any faults occurring, the contractor shall without delay adept
the incoming goods inspection to the new requirements and ensures that the
sources of error are eliminated.

 

Notwithstanding the above
agreements, PMS shall identify the goods,
establish the quantity and check the consignment with regard to apparent damage
in transit.

 

The contractor shall
perform the specified inspections as a routine inspection, document them
individually and file the documents for at least 10 years. The documents filed
shall be made available to PMS on request.

 

Place
of jurisdiction

 

The place of jurisdiction for any
disputes resulting from the contract shall be Hamburg, Germany.

 

 

	
  Hamburg,

  	
   

  	
   

  	
  Denver,

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Philips Medical Systems

  	
   

  	
  FISCHER Imaging

  
	
  DMC GmbH

  	
   

  	
   

  
							

 

2

	
  Philips Medical Systems - FIC

  	
  PMS -
  FIC

  
	
  Annex O3: Quality Cost Agreement

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

 

Annex
of Master Purchasing Agreement

(Agreement
No. P01-000132)

concerning

 

Quality
Cost Agreement

 

 

between

 

Fischer
Imaging

12300
North Grant Street

Denver,
Colorado 80241

 

(hereinafter
referred to as “FIC”)

 

 

and

 

 

Philips
Medical Systems

DMC
GmbH

Röntgenstrasse
24

22335
Hamburg

Germany

 

(hereinafter
referred to as “PMS”)

 

	
  PMS DMC: Einkauf

  	
   

  
	
   

  	
  PMS 

  	
  FIC

  
			

 

1

 

Object
of the Agreement

 

1      Quality Cost
Agreement

 

The goods delivered shall be inspected by PMS
for apparent undamaged condition and completeness within an appropriate time.
Notification of evident defects shall as a rule be effected within 6 weeks from
receipt of the goods. Notification of hidden defects shall be effected
immediately after their discovery. Payment for the goods shall not signify
their approval as complying with the contract and free of defects.

 

PMS has established the zero defect strategy within its Quality
Management Program. PMS expects
from FIC to support the PMS
strategy and observe the zero defect strategy for all the products and services
of FIC, too. FIC
shall support the delivery of products without any defect by continuous
improvement, supervision, and analysis of all of its production and working
processes.

 

For each purchased product FIC shall, on
request of PMS, list and follow up quality
assurance targets reconciled with PMS. The proof
of reaching these targets shall be transparent and proved to PMS by giving PMS access to
the respective documents.

 

The Supplier warrants that the goods delivered comply with the agreed
specification, that they have no defects which impair their value or their
suitability, and that they do not lack any promised characteristics. The
Supplier also warrants that the goods supplied are free of design, material and
manufacturing faults and are in accordance with the latest state of the art.

 

In the event of defects in the goods supplied FIC receives a Quality
Faults Report of Purchased Products and a List of Costs (see below).

 

In the event of defects in the goods supplied, we shall be entitled at
our option to demand replacement free of charge or correction of such defect.
In urgent cases, we shall be entitled to remedy such defects ourselves at the
cost of the Supplier. If we have requested correction of a defect and such
correction is still not successfully effected after expiry of a reasonable
period of grace, we shall be entitled to demand a reduction of the agreed
price, or to rescind the contract in whole or in part, and to claim damages for
non-fulfilment. Any further rights that we have to warranty or the payment of
damages - including for consequential damage - 
shall remain unaffected thereby. In particular, we shall be entitled to
claim reimbursement of the costs incurred by us for inspection if the
above-average occurrence of faults compels us to conduct incoming inspections
over and above the usual level of random sample inspections (Master Purchasing
Agreement, par. 7.6).

 

We shall be
entitled to place nonconforming goods in storage or to return them to the
Supplier at the latter’s cost and risk. Title to such goods shall revert to the
Supplier on the date of sending of the notification of the return shipment of
the nonconforming

 

2

 

goods.
Transfer of possession of the goods shall be replaced by our safekeeping of the
goods for the Supplier.

 

In the event
of defects, which are not noticed until the goods are machined or processed, we
shall also be entitled to claim reimbursement of any cost incurred by us to no
avail.

 

In the event of rework or replacement
delivery, the warranty period shall start again for the reworked part or for
the replaced goods. (See Master Purchase Agreement)

 

For retention
of our warranty claims beyond the warranty period, it shall suffice if we have
notified the Supplier of the defect within the warranty period.

 

Our rights as
set out above shall not be affected by a quality agreement (e.g. ppm, zero
defects).

 

2      Place of
jurisdiction

 

The place of
jurisdiction for all disputes resulting from this Agreement shall be Hamburg,
Germany.

 

 

	
  Hamburg,

  	
   

  	
   

  	
  Denver,

  	
   

  	
   

  
	
   

  
	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Philips
  Medical Systems

  	
  FISCHER
  Imaging

  
	
  DMC GmbH

  
								

 

 

Annex:   Qualitätsmängelbericht (Quality
Fault Report for Purchased Parts)

Kostenaufstellung (List of costs)

 

3

 

	
  Quality Fault Report for Purchased Parts

  	
   

  	
   

  	
  TPAI

  
	
  (Qualitätsmängelbericht)

  	
   

  	
   

  	
   

  
	
  PMG

  	
  Copy:

  	
  Accounting
  Dpt.

  	
  PK
  152

  
	
   

  	
   

  	
   

  	
   

  
	
  Report-No.: 

  	
   

  	
  Initial
  Purchasing Dpt.

  	
  PK 145

  

 

 Philips Medical Systems • D-22331 Hamburg/ Germany

 

	
   

  	
  Philips Medical Systems

  
	
   An die Geschäftsleitung

  	
  DMC GmbH

  
	
   

  	
  Röntgenstraße 24

  
	
   

  	
   

  
	
   

  	
  D-22335 Hamburg/ Germany

  
	
   

  	
   

  
	
   

  	
  Tel.:        + 49 40 50 78 {Quality manager}

  

 

	
  Your order No.

  	
  of

  	
  Our Ref.

  	
  Extension

  	
  Hamburg

  
	
   

  	
   

  	
  Name:

  	
   

  	
   

  

 

Defects have been
detected on the product manufactured by you:

	
  PMS-12 NC:

  	
  Designation:

  
	
   

  	
   

  
	
  Amount:

  	
  Series number:

  
	
   

  	
   

  
	
  Date of
  delivery:

  	
  Delivery note
  No.:

  
	
   

  	
   

  
	
  Our order No.:

  	
  Buyer:

  

 

Date:

 

Description of the
defect: See attachment {Fault Report}

 

 

o  Production shutdown

Due to the defects
described PMS proposes the following measures:

 

	
  o    PMS
  eliminates the defect

  	
  o    Scrapping
  by PMS with request for replacement delivery free of charge

  
	
   

  	
   

  
	
  o    Immediate
  return with the request for replacement delivery of the product or repair by
  you until

  

 

	
  To be
  filled out by the supplier:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Supplier agrees

  	
  o    yes

  	
  o    no

  
	
   

  	
   

  	
   

  
	
  Supplier repairs
  at PMS

  	
  o    yes

  	
  o    no

  
	
   

  	
   

  	
   

  
	
  Return delivery
  No.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Commission No.

  	
   

  	
   

  

 

4

 

Quality Fault Report   
page I

 

	
  Quality Fault Report for Purchased Parts

  	
   

  	
   

  	
  TPAI

  
	
   

  	
   

  	
   

  	
   

  
	
  Report-No.: 

  	
   

  	
   

  	
   

  

 

We are
asking you to inform PMS in written form (within no later than five work days)
what measures have been taken by you to avoid such defects in the future.

 

We are also asking you to
inform PMS in written form whether any other products might be affected.

 

Please send this form
sheet to PMS to the above fax number within 24 hours.

 

Elimination of the error:
(see attachment) {answer of supplier}

 

 

 

The accounting department
will send you a debit note over the amount of             
EUR for any costs incurred for PMS .

 

Any costs that
cannot be foreseen at the moment will later on be debited by PMS.

 

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  First name, name

  	
   

  	
  First name, name

  	
   

  	
  First name, name

  
	
  Philips Medical Systems

  	
   

  	
  Philips Medical Systems

  	
   

  	
  Philips Medical Systems

  
	
  DMC GmbH

  	
   

  	
  DMC GmbH

  	
   

  	
  DMC GmbH

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date

  	
   

  	
  Date

  	
   

  	
  Date

  

 

Quality Fault Report   
page II

 

5

 

	
  Philips Medical Systems - (NN)

  	
  PMS - (NN)

  
	
  Anhang O3: Quality Cost Agreement

  	
   

  
	
  zum Rahmenvertrag zwischen PMS
  and (NN)

  	
   

  

 

List of costs:

(Kostenaufstellung)

 

1.     Fixed charges for return shipments

 

•      Fault report internal

 

•      Fault report external

 

•      Administration, shipment, transport

 

•      Incoming/outgoing goods, administration,

 

•      Final check & completion of comlaint

 

	
  Subtotal

  	
   

  	
  200.- EUR

  	
   

  	
  200.- EUR

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.     Extra work costs

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Fault report of defective product

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Disassembly of defective product

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Assembly of a new product

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Test of a new product

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Process disturbances

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Additional requirements for a new test as a result of the
  insufficient quality

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Refinishing work

  	
   

  	
   (hours)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Material costs incl. cost for scrapping

  	
   

  	
  EUR

  	
   

  	
   EUR

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total of                      hours
  x 50.- EUR/h

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Subtotal work costs

  	
   

  	
  EUR

  	
   

  	
   EUR

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.     Fixed
  charges for shipments that are not returned

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Fault report internal

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Fault report external

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  •      Administration, final test completion of complaint

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Subtotal

  	
   

  	
  100.- EUR

  	
   

  	
  100.- EUR

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total costs:

  	
   

  	
   

  	
  EUR

  	
   

  
							

 

	
  First name, name
  (Operationsmanager)

  	
  First name, name
  (PMS employee)

  
	
  (signature)

  	
  (signature)

  

 

Quality
Fault Report    page III

 

	
  PMS DMC: Einkauf GEN

  	
   

  
	
   

  	
  PMS 

  	
  FIC

  
			

 

6

 

	
  Philips Medical Systems - FIC

  	
  PMS -
  FIC

  
	
  Annex O1: Logistic Procedure

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

Logistic
Procedure

Annex
O1 to Master Purchasing Agreement (Agreement No. P01-000132)

between

Philips
Medical Systems and Fischer Imaging

 

1.  Planning & forecasting

•      PMS will
provide a rolling 4-quarter, non-binding forecast. Regular delivery of the
product will start in Q3 2005.

•      The forecast will be updated every
quarter for the upcoming 4 quarters on the first day of the month prior to the
beginning of that quarter. It will be PMS’s most accurate expectations for
shipment requirements.

•      The
forecast for the most current quarter will not exceed current in house orders
with confirmed shipping dates within that quarter plus an additional 30% for
forecasts units, where orders are not yet confirmed, but are expected with
delivery required in that quarter.

•      Fischer
will inform Philips about general slot planning.

 

2.  Delivery times

•      Lead-time
for the product is 21 calendar days from receipt of purchase order until day of
shipment.

•      For volumes
higher than forecasted (more than additional 30%) every reasonable effort will
be made to meet the lead-time for additional volumes.

•      If
reasonable volumes are reached (approximately 100 units per year) both parties
agree to establish a consignment stock at PMS premises.

•      All orders
shall be considered firm and non-cancelable 21 days prior to the requested
shipping date

•      In case of
move outs PMS will inform Fisher and vice versa. Fischer will send a new
confirmation within 2 days

•      Fischer
will take express costs for transportation in case of late deliveries.

 

3.  Tender Business

•      Any single
order for more than 5 systems will be considered a “Tender Order”.

•      Tender
business shall be regarded as additional business to the forecast.

•      Every
reasonable effort will be made to meet the shipping requirements, but the
orders will not be subject to the 21-day shipping requirement for forecasted
orders. Both parties will agree on a delivery schedule for every individual
tender that meets the tender requirements.

 

4.  Shipment procedures

•      PMS
preferred carriers are Panalpina or Menlo. (Contact addresses/phone number are
listed at the end of this annex) Fischer will deliver all systems through these
carriers to a Uni_Data Depot in Frankfurt. Uni_Data will consolidate goods from
Hamburg and USA (Fischer) and will deliver as one lot shipment to final
customer in Europe.

•      Shipments
procedures to destinations outside Europe will be described in a separate annex
to be added, when such deliveries will start.

•      Packing
will be in heat-treated wood. This standard packing is included in the system
price.

•      Packing
will only bear Philips name and logo.

•      In case
special packing is required (e.g. water proof, etc.) PMS will bear the cost.

•      Fischer
will hand over the goods to the carrier at the committed delivery date with
company neutral paperwork ( no Fisher labels, signs or Fisher invoices are to
be attached to the shipment) . On all paperwork the customer order number and
the Philips code numbers have to be visible.

 

5.  Order procedures

PMS will send a call off to Fischer preferably by
Email or by fax with following contents:

•      Customer
order number

•      Type number

•      Required
delivery date (ex works)

•      Quantity

 

	
  PMS DMC: Einkauf

  	
   

  
	
   

  	
  PMS 

  	
  FIC

  
			

 

1

 

PMS will receive an order confirmation within 2 days
by Fischer preferably by EMAIL or fax with following contents:

•      Customer
order number

•      Type number

•      Confirmed
delivery date

•      Quantity

PMS will send a delivery advise to Uni_Data and to
Panalpina / Menlo with following contents:

•      Customer
order numbers

•      Date and
time of arrival at destination

•      Address of
final destination

 

Fischer
will advise the carrier (Menlo, Panalpina) when the goods shall be picked up at
Fischer Imaging. Reference is the customer order number.

 

Latest
the day when the carrier picks up the material, Fischer will send a delivery
note to Philips with following contents:

•      Final
customer order number

•      Philips
code numbers

•      Philips
description

•      Serial
number

•      Amount of
parcels, sizes and weight

 

6.
Addresses:

 

	
  Panalpina
  Inc.

  	
  Unidata
  - Frankfurt

  
	
  Global
  Account Division

  	
  UPS
  SCS GmbH & Co OHG

  
	
  American
  Region

  	
  Hessenring
  23

  
	
  800
  Arthur Avenue

  	
  64546
  Moorfelden-Waldorf

  
	
  Elk Groove Village, IL 60007 – USA

  	
  Germany

  
	
   

  	
   

  
	
  Menlo
  Worldwide

  	
   

  
	
  4790
  Paris Street

  	
   

  
	
  Denver,
  CO 80239

  	
   

  
	
  Tel.
  303 375-1457

  	
   

  
	
  Fax.
  303 375-1470

  	
   

  

 

2

 

	
  Philips Medical Systems - FIC

  	
  PMS -
  FIC

  
	
  Annex H1: Sustainability

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

ATTACHMENT
H1

 

SUSTAINABILITY
REQUIREMENTS

 

For the purpose of this Attachment, BUYER is also referred to as “PMS”
or “Philips Medical Systems”.

 

SECTION A:        APPLICABILITY AND SCOPE

 

1.0.          This Attachment incorporates the Royal
Philips Supply Standard on Sustainability and as such establishes minimum
requirements of behavior expected of Philips Medical Systems’ (PMS) suppliers
of Products, as well as components, parts, including Service Parts (altogether “Parts”)
and packaging (“Packaging”) with regard to sustainability and sustainable
development.

 

1.1           This Attachment establishes Royal Philips
and PMS’ specific environmental requirements for purchased Parts, Products and
Packaging that are incorporated into or part of PMS Products.

 

1.2           This Attachment is not intended to be a
listing of all product content limitations or restrictions that may be
established as a matter of law. SUPPLIER’s compliance with this Attachment does
not relieve or diminish SUPPLIER’s obligation to comply with all applicable
laws.

 

1.2.1        Precedence:  Except as noted below, if a conflict should
occur between this Attachment and any identified standard or regulation, this
Attachment shall prevail.  Should a
conflict occur between this Attachment and a PMS Product or Part
Specifications, the PMS Product or Part Specifications shall prevail.

 

1.2.2        Exception:  Legal and/or regulatory requirements for the
countries where these purchased Parts and Products are to be used take
precedence over of this Attachment.

 

1.3           This Attachment is
an addition to and does not in any way limit or supersede any Product
Specifications that may be established by PMS.

 

	
  Jens Homfeld

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  PMS

  	
  FIC

  

 

1

 

SECTION B: 
PHILIPS SUPPLY STANDARD ON SUSTAINABILITY

 

SUPPLIER represents and warrants full compliance with Philips Supply
Standard on Sustainability as follows:

 

GENERAL

SUPPLIER is committed to act fairly and with
integrity toward its stakeholders and is expected to comply with all applicable
local rules and regulations.

 

ENVIRONMENT

SUPPLIER shall
have ISO14001 certification or a plan to become certified.  Alternatively SUPPLIER must provide
documented objective evidence of an operational environmental management system
for ISO14001 or demonstrate equivalency, which shows continual environmental
improvement. SUPPLIER must comply with requirements of the respective Product
Division, including banned/hazardous substances content.

 

HEALTH AND SAFETY

SUPPLIER shall
do all that is reasonable and practicable to:

•      Protect the health and safety of employees and contract labor and
minimize any adverse work conditions;

•      Implement safe and healthful work practices to prevent injury,
illness and property damage;

•      Minimize occupational exposures to potentially hazardous materials
and unsafe work conditions by maintaining appropriate safety systems and
effective controls;

•      Implement an emergency response program that addresses the most
likely anticipated emergencies;

•      Train managers and employees to assure their continued commitment to
their own health and safety and that of their co-workers;

•      Involve employees at all levels in the health and safety program;
assure their accountability for injury and illness prevention.

 

CHILD LABOR

SUPPLIER shall not employ children in violation of convention 138 and 182 of the
International Labor Organization.  In case of child labor, SUPPLIER shall take
immediate remedial action in consultation with Philips, considering the
interests of the children employed. This action will include:

•      Minimally
acceptable employment conditions for the children employed (such as education,
working hours, wages, medical facilities etc.)

•      The
obligation of SUPPLIER not to employ any more children

•      A time period within which SUPPLIER will comply with the mentioned
ILO norms.

 

FORCED LABOR

Employment should be
freely chosen. Under no circumstances will SUPPLIER make use of forced or
bonded labor – such as forced labor performed by persons placed in an
institution, or compulsory labor including labor as a means of political
coercion or education – to design, manufacture or assemble products and
services for Philips.

 

RIGHT TO ORGANIZE

SUPPLIER shall recognize
and respect the freedom of its employees to choose whether or not to establish
or to associate with any organization of their own choosing (including labor
unions) without SUPPLIER’s prior authorization. The employment of a worker
shall not be contingent upon the condition that he/she not join a union or be
forced to relinquish trade union membership.  
Furthermore, union membership shall not be the cause for the dismissal
of – or otherwise prejudice against – a worker. . SUPPLIER will not interfere
with or finance labor organizations or take other actions with the intent of
placing such organization under the control of SUPPLIER.

 

COLLECTIVE BARGAINING

SUPPLIER shall respect –
within the framework of law, regulations and prevailing labor relations and
employment practices – the right of its employees to be represented by labor
unions and other employee organizations. SUPPLIER will engage in negotiations,
either on its own behalf or through employers’ associations, with a view toward
reaching agreement on employment conditions.

 

DISCRIMINATION

SUPPLIER shall treat its
employees equally in employment and occupation, and will ensure that each has
equal opportunities. SUPPLIER shall offer equal pay for equal work performed at
equal levels. No form of harassment or discrimination in respect of employment
and occupation will be tolerated, such as discrimination based on race, color,
sex, age, language, religion, political or other opinion, national or social
origin, property, birth or other status.

 

	
   

  	
  Declaration to be signed by Fischer Imaging:

  
	
   

  	
   

  
	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
  (Company
  stamp)

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Function:

  	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Date:

  	
   

  	
   

  
	
   

  	
  Signature:

  	
   

  	
   

  
									

 

2

 

	
  Philips & Fischer Imaging

  	
  Umbrella
  Purchasing Agreement No tbd

  

 

SECTION C:            PHILIPS MEDICAL SYSTEMS’ ENVIRONMENTAL
SPECIFICATIONS FOR PRODUCTS, PARTS AND PACKAGING

 

1.0          ENVIRONMENTAL DECLARATION, BANNED AND RELEVANT SUBSTANCES AND
SPECIFIC ADDITIONAL LEGISLATION

 

1.1           SUPPLIER
represents and warrants that on the Effective Date, the Products, Parts and
Packaging do not contain Banned Substances and comply with the Additional Environmental
Legislation as specified in Annex 1 of this Attachment, except for certain
Products specifically identified. For these identification purposes, SUPPLIER
agrees to complete and sign the “Environmental Declaration For Products, Parts
And Packaging” (Form A) of this Attachment and indicate whether or not
Products, Parts and Packaging delivered to PMS contain Banned Substances and
comply with the Additional Environmental Legislation identified in Annex 1. In
case some Products contain Banned Substances or do not comply with the
Additional Environmental Legislation identified in Annex 1, either as from the
Effective Date or otherwise during the Term of the Agreement, SUPPLER shall, on
the Effective Date or prior to the first delivery of such Products, Parts and
Packaging, submit a “Request for Dispensation” (Form B) of this Attachment to
BUYER.  Without prejudice to the
provisions of Section A, 1.2 and the provisions below, BUYER may, at its sole
discretion, provide in writing such a dispensation per Product and for a
defined period of time.

 

1.2           SUPPLIER
is responsible to inform BUYER on the Effective Date onward and prior to the
first delivery, of the presence of Relevant Substances that are contained in
Products, Parts and Packaging in excess of the thresholds listed in Form C of
this Attachment, by using the “Declaration of Relevant Substances”, Form C of
this Attachment.

 

1.3           SUPPLIER
agrees to actively search for alternatives to eliminate Banned Substances and
reduce and/or eliminate Relevant Substances contained in Products, Parts and
Packaging.

 

1.4           SUPPLIER
agrees to eliminate any non compliance with Additional Environmental
Legislation related to Products, Parts and Packaging.

 

2.0          GENERAL ENVIRONMENTAL REQUIREMENTS

 

2.1           SUPPLIER
shall comply with all applicable environmental laws, rules, regulations,
ordinances, covenants, standards and the like, and BUYER’s implementation
thereof (collectively herein referred to as “Environmental Regulations”)
concerning the Products, Parts and Packaging thereof (including correct
labeling) as well as plant operations and shipments in connection therewith,
enabling BUYER to distribute on a world-wide basis Products, Parts and
Packaging without restrictions.

 

2.2           Without
prejudice to the representation and warranty of SUPPLIER as described in
paragraph 2.1, in the event any new Environmental Regulation is promulgated
after the date of signing of this Attachment, the parties hereto will negotiate
to establish within a reasonable period of time equitable terms to prevent or
remedy any non-compliance by SUPPLIER of said warranty and representation as a
consequence of such promulgation.

 

2.3           To
ensure continuous compliance with Environmental Regulations, the BUYER shall
have the right to audit the implementation and adherence to this Attachment.

 

2.4           SUPPLIER
agrees to control the environmental aspects of the design and manufacture of
Products, Parts and Packaging through an adequate and effective environmental
management system that complies with ISO 14001 referenced in the Philips Supply
Standard on Sustainability.

 

2.5           Where
SUPPLIER is not certified to ISO 14001 nor has an equivalent environmental
management system in place, SUPPLIER shall provide to and agree on with BUYER a
plan and time schedule to achieve an operational environmental management
system or equivalent.

 

	
  Jens Homfeld

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  BUYER

  	
  SUPPLIER

  

 

3

 

3.0          DESIGN AND MANUFACTURING

 

3.1           SUPPLIER
undertakes that Products, Parts and Packaging are designed and manufactured to
comply with the objectives of the Waste Electrical and Electronic Equipment
Directive (WEEE) (2002/96/EC).

 

3.2           Upon
request, SUPPLIER will provide PMS with environmentally-related information
regarding all materials included in the Products, Parts and Packaging including
as a minimum:

 

3.2.1        Necessary
information for disassembling, recycling, reusing and treating Products, Parts
and Packaging at end of life;

 

3.2.2        The
location of dangerous substances and preparations in Products, Parts and
Packaging;

 

3.2.3        Appropriate
markings in accordance with the WEEE Directive requirements.

 

3.3           On the
basis of best effort, SUPPLIER undertakes to participate in Philips’ and/or
BUYER’s environmental programs, such as

 

3.3.1        Reduction
of the weight and volume of Packaging and Packaging materials to as low as
possible and to the technically necessary minimum, while maintaining basic
Packaging functions including transportability, protection and communication of
information;

 

3.3.2        Environmentally
Conscious Design (EcoDesign), i.e., reducing the integral environmental impact
of the product over its entire life cycle;

 

3.3.3        Reusability
of Products, Parts and Packaging.

 

4.0          CHEMICAL SUBSTANCES

 

4.1           Chemical Registration Requirements

4.1.1        SUPPLIER
represents and warrants that each chemical substance, as defined in Toxic
Substances Control Act, contained in Products, Parts and components sold to PMS
is on the inventory of chemical substances compiled and published by the United
States Environmental Protection Agency pursuant to the Toxic Substances Control
Act (TSCA) and complies with chemical registration and pre-manufacture
notification requirements in other countries that have enacted chemical
registration requirements including but not limited to Australia, Canada,
China, Japan, South Korea, Switzerland and the countries of the European Union.

 

4.2           Chemical Labeling and Materials Safety Data Sheet
Requirements

4.2.1        SUPPLIER
represents and warrants that each hazardous chemical, as defined by the United
States Occupational Safety and Health Administration Hazard Communication
Standard, contained as a chemical in Products, Parts and components complies
with the labeling and Material Safety Data Sheet (MSDS) provisions of 29 CFR
1910.1200, ISO 11014-1 and 91/155/EC in that:

 

4.2.1.1     All hazardous chemicals are appropriately labeled;

 

4.2.1.2     An MSDS is provided to BUYER prior to and with the first delivery of
the hazardous chemical, and whenever changes are made to the MSDS.

 

4.3           Carcinogen and Reproductive Toxicant Labeling
Requirements

 

4.3.1        As
determined by the State of California- 
Safe Drinking Water and Toxic Enforcement Act or 1986, List of Chemicals
Known to Cause Cancer or Reproductive Toxicity, California Code of Regulations,
Title 22, Division 2, Part 2, Subdivisions 1, Chapter 3, Section 12000
–Chemicals Known to Cause Cancer or Reproductive Toxicity, products,
accessories, parts, components or cables that contain chemical substances that
exceed their

 

4

 

•      No Significant Risk Levels (NSRLs) to
cause cancer, or

 

•      No Observable Effect Levels (NOELs) to
cause reproductive harm

 

must be labeled with a
clear and reasonable content warning.

 

5.0          OZONE DEPLETING SUBSTANCES

 

5.1           SUPPLIER represents and warrants that neither any
of the Products, Parts or Packaging, nor any component thereof contain or have
been “manufactured with a process that uses” any ozone depleting substances as
specified in the U.S. Clean Air Act, 40 CFR 82.

 

5.2           In case SUPPLIER cannot meet the above
requirements, BUYER’s written approval is required prior to delivery and
SUPPLIER must submit notification of non- conformance via the Request for
Dispensation (Form B), and label the Products, Parts and Packaging in
accordance with applicable regulatory requirements.

 

6.0          PACKAGING

 

6.1           Content restrictions that apply to Packaging
refer to all Packaging materials purchased by PMS including those used to
package PMS products for sale as well as those used to transport Products,
Parts and components to the factory to be incorporated into PMS products, after
which time, the Packaging would be discarded as waste.

 

6.2           Packaging
must comply with the objectives of the European Directive 94/62/EC on Packaging
and Packaging waste.   European
Commission Decision 97/129/EC establishes a Packaging identification system.

 

6.3           All
packaging materials, including pallets, shall be free of pests and comply with
regulations regarding Solid Wood Packaging Materials (SWPM) where applicable.
Wood originating in Canada, China, Japan and the United States must comply with
European Legislation 1999/355/EC and 2001/219/EC with respect to treating and
marking coniferous wood.

 

6.4           Timber
used as crates, pallets and in containers as lining, flooring and skids, and
any other articles described as Packaging and dunnage being exported to
Australia must satisfy Australian Quarantine and Inspection Service (AQIS)
requirements prior to entry.

 

 

	
  Signature:

  	
  Signature:

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
  Date:

  	
   

  	
   

  
	
   

  	
   

  
	
  Initials:

  	
   

  	
   

  	
  Initials:

  	
   

  	
   

  
	
   

  	
   

  
	
  Philips Medical Systems

  	
  Fischer Imaging

  
												

 

5

 

	
  Philips & Fischer Imaging

  	
  Umbrella
  Purchasing Agreement No tbd

  

 

ANNEX 1 To Section C of Attachment H1

 

Royal Philips Electronics
List of Banned Substances (CSO -BP01-2004-1)

Revision date: 2004-07-15

 

Articles (i.e. materials,
components, subassemblies, products) delivered to Royal Philips must be free of
the “Banned substances” as mentioned in this list.

 

	
  Substances

  	
   

  	
  Declaration threshold

  ppm (mg/kg) (1)

  	
   

  	
  Legal date entry

  into force

  	
   

  
	
  Cadmium
  and –compounds

  	
   

  	
  20

  	
   

  	
  Immediately

  	
   

  
	
  Mercury
  and –compounds

  	
   

  	
  2

  	
   

  	
  Immediately

  	
   

  
	
  Lead
  and – compounds

  	
   

  	
  1000

  	
   

  	
  1 July 2006

  	
   

  
	
  Lead
  and – compounds in outer sleeves of cables, according to proposition 65  legislation, USA 

  	
   

  	
  300

  	
   

  	
  Immediately

  	
   

  
	
  Hexavalent
  Chromium (Cr 6+) and compounds

  	
   

  	
  1000

  	
   

  	
  1 July 2006

  	
   

  
	
  Asbestos
  (all types)

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  CFCs,
  Chlorofluorocarbons

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  HCFCs,
  Hydrogenated chlorofluorocarbons

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Halons

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  CHCs,
  Chlorinated hydrocarbons,

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Methyl
  Bromide

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  HBFCs,
  Hydrobromofluorocarbons

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  1,1,1-Trichloroethane

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Carbon
  tetrachloride

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Dichloromethane
  (CH2Cl2)

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Trichloroethylene
  (C2HCl3)

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  Perchloroethylene
  (C2Cl4)

  	
   

  	
  1

  	
   

  	
  Immediately

  	
   

  
	
  PCBs,
  polychlorinated biphenyls

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  PCTs,
  polychlorinated terphenyls

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  PCP,
  Pentachlorophenol and its salts and esters

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  Polybrominated
  diphenyl ethers (2) (PBDEs)

  	
   

  	
  1000

  	
   

  	
  Immediately

  	
   

  
	
  Polybrominated
  biphenyls (PBBs)

  	
   

  	
  1000

  	
   

  	
  Immediately

  	
   

  
	
  Ugilec
  141 (mono methyl tetrachlorodiphenyl methane)

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  Ugilec
  121 (or Ugilec 21) (monomethyl dichlorodiphenyl methane)

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  
	
  DBBT
  (monomethyl dibromodiphenyl methane)

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  

 

Product packaging must be free from the
above-mentioned substances AND the
following:

 

	
  Substances

  	
   

  	
  Declaration threshold

  ppm (mg/kg)

  	
   

  	
  Legal date entry

  into force

  	
   

  
	
  PVC
  and PVC blends

  	
   

  	
  1000

  	
   

  	
  Immediately

  	
   

  
	
  Sum
  of Heavy metals (Cd, Hg, Cr(6+) and Pb)

  	
   

  	
  100

  	
   

  	
  Immediately

  	
   

  

 

 

Note:

For Product Division (PD) additional
banned substances and specific exemptions on above list, see appendix to this
Royal Philips Electronics list of Banned Substances.

 

(1)    In fact, banned substances are not
to be intentionally used, that is, Royal Philips Electronics accepts that
certain materials contain a certain amount of naturally occurring banned
substances. Thresholds can represent legal limits, or refer to currently
accepted analysing thresholds.

Furthermore these thresholds should be declared on
component level. Substances are measured in homogeneous materials.

(2)    Poly Brominated Biphenyl Ether are
same as Poly Brominated Diphenyl Ether (PBDE) and Poly Brominated Diphenyl
oxides (PBDO) and Poly Brominated Biphenyl oxides (PBBO)

 

 

	
   

  	
   

  
	
  BUYER

  	
  SUPPLIER

  

 

6

 

	
  Philips Medical Systems - FIC

  	
  PMS -
  FIC

  
	
  Annex H1: Sustainability

  	
   

  
	
  Master Purchasing Agreement PMS
  and FIC

  	
   

  

 

Appendix in addition to
Royal Philips Electronics list of Banned Substances CSO-BP01-2004-1

Additional
Banned Substances and specific exemption per Product Division (PD)

 

Philips Consumer Electronics (CE)

 

	
  Additional Substance(s)
  and

  different legal dates

  	
   

  	
  Declaration

  threshold

  ppm (mg/kg)

  	
   

  	
  Entry into

  force

  	
   

  	
  Remark

  
	
  Short-chain chlorinated paraffins

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  (C10-C13) used in paints
  and as flame retardant in PVC

  
	
  Organostannic compounds

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  Organic Tin compounds (TBT,
  TPT and TBTO compounds)

  
	
  TBBA (tetrabromobisphenol-A)

  	
   

  	
  10

  	
   

  	
  1 Jan 2006

  	
   

  	
  Applied as FR in Laminates
  of printed wiring boards (PWBs) also in plastics

  
	
  Azocolourants

  	
   

  	
  30

  	
   

  	
  Immediately

  	
   

  	
  Applied in leather and textiles
  in prolonged skin contact 

  
	
  Nickel and nickel alloys

  	
   

  	
  0,5μg/cm2/week

  	
   

  	
  Immediately

  	
   

  	
  Only in prolonged skin
  contact,

  
	
  Tris-(1-aziridinyl) phosphinoxide

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  Applied in leather and
  textiles in prolonged skin contact

  
	
  Tris-(2,3-dibromo-propyl) phosphate

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  Applied in leather and
  textiles in prolonged skin contact

  
	
  Lead and - compounds

  	
   

  	
  1000

  	
   

  	
  1 Jan 2005

  	
   

  	
  This is before the legal
  date (EU Directive RoHS 2002/95/EC)

  
	
  Hexavalent Chromium (Cr 6+) and compounds

  	
   

  	
  1000

  	
   

  	
  1 Jan 2005

  	
   

  	
  This is before the legal
  date (EU Directive RoHS 2002/95/EC)

  

 

CE
Requirements to phenol in laminates of printed wiring boards:

1. Smell
Emission : <200 odor unit/m2/day

Test method: Measured in duplo according to NVN2820
(or NEN-EN 13725:2003) by TNO Apeldoorn, the Netherlands, with 10 dm2 of single
sided copper cladded laminate after 3 days at room temperature in a PTFE bag of
approximately 40 l.

 

2.
Phenol monomer : <50 mg/l phenolics

Test method : Phenolics content in water (according
to ISO 6439) after shaking for 23 hours a mixture of 75 g of milled (to 3 mm)

laminate in 1.5 l of
demineralized water at pH 4).

 

Philips Domestic Appliance and
Personal Care (DAP)

 

	
  Additional Substance(s)
  and

  different legal dates

  	
   

  	
  Declaration

  threshold

  ppm (mg/kg)

  	
   

  	
  Entry into

  force

  	
   

  	
  Remark

  
	
  EPS (Expanded Polystyrene)

  	
   

  	
  1000

  	
   

  	
  Immediately

  	
   

  	
  Banned for Product
  Packaging (with a product weight of less than 20 kg)

  

 

Exemption
information:

DAP is re-enforcing its limit for the
cadmium-threshold from 100 ppm to 20 ppm. Final entry into force of this new
more stringent value is January 1st, 2006.

 

Philips Lighting

 

	
  Additional Substance(s)
  and

  different legal dates

  	
   

  	
  Declaration

  threshold

  ppm (mg/kg)

  	
   

  	
  Entry into

  force

  	
   

  	
  Remark

  
	
  Antimony in soda lime glass

  	
   

  	
  1000

  	
   

  	
  Immediately

  	
   

  	
  The antimony is present as
  an impurity, not intentionally added to the glass.

  
	
  Polycyclic aromatic
  hydrocarbons (PAHs)

  	
   

  	
  5

  	
   

  	
  Immediately

  	
   

  	
  All applications. (like
  potting material for electronic ballast)

  
	
  TBBA
  (tetrabromobisphenol-A)

  	
   

  	
  10

  	
   

  	
  1 Jan 2006

  	
   

  	
  Applied as FR in Laminates
  of printed wiring boards (PWBs) also in plastics.

  

 

Exemption information:

Mercury is allowed only in gas discharge lamps with
certain conditions referred in European Directive RoHS 2002/95/EC. This
restriction applies only for lamps placed on the European market since 1st
July, 2006.

 

Philips Medical Systems (PMS)

 

	
  Additional Substance(s)
  and

  different legal dates

  	
   

  	
  Declaration

  threshold

  ppm (mg/kg)

  	
   

  	
  Entry into

  force

  	
   

  	
  Remark

  
	
  Arsenic compounds

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  Banned for wood Packaging

  

 

Exemption information:

Lead and compounds, and Hexavalent Chromium (Cr 6+)
and compounds are only mentioned in the new European Directive RoHS

2002/95/EC and not in any other legislation.
Presently Medical equipment is exempt from this RoHS Directive. Therefore these

substances are not Banned for
PMS and no  Request for
Dispensation is required.

This exemption does not include Lead
in outer sleeves of cables in accordance with proposition 65 .

 

Philips Semiconductors

 

	
  Additional Substance(s)
  and

  different legal dates

  	
   

  	
  Declaration

  threshold

  ppm (mg/kg)

  	
   

  	
  Entry into

  force

  	
   

  	
  Remark

  
	
  Short-chain chlorinated paraffins

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  (C10-C13) used in paints
  and as flame retardant in PVC

  
	
  Organostannic compounds

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  Organic Tin compounds (TBT,
  TPT and TBTO compounds)

  
	
  Polychloronaphtalenes

  	
   

  	
  10

  	
   

  	
  Immediately

  	
   

  	
  > 3 Cl atoms  as
  stabilizer and flame retardant in plastics

  
	
  Benzene

  	
   

  	
  100

  	
   

  	
  Immediately

  	
   

  	
  As residual solvent in
  materials

  
	
  Formaldehyde

  	
   

  	
  0.1

  	
   

  	
  Immediately

  	
   

  	
  As residue in plastics,
  resins

  
	
  Lead and - compounds

  	
   

  	
  1000

  	
   

  	
  1 Jan 2005

  	
   

  	
  This is before the legal
  date (EU Directive RoHS 2002/95/EC)

  
	
  Hexavalent Chromium (Cr 6+)
  and compounds

  	
   

  	
  1000

  	
   

  	
  1 Jan 2005

  	
   

  	
  This is before the legal
  date (EU Directive RoHS 2002/95/EC)

  

 

	
   

  	
  PMS 

  	
  FIC

  

 

7

 

Additional Environmental
Legislation Applicable to PMS Products, Parts and Packaging (Based on
international legislation)

 

Additional Legislation
Applicable to PMS Products, Parts and Packaging

 

	
  Batteries

  	
   

  	
  -

  	
   

  	
  European
  Council Directive 91/157/EEC, 93/86/ EEC and the U.S. Regulation H.R. 2024 on
  Batteries (if product contains batteries)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Packaging

  	
   

  	
  -

  	
   

  	
  European
  Legislation 1999/355/EC and 2001/299/EC with respect to treating and marking
  coniferous wood originating in Canada, China, Japan and the United States

  
	
   

  	
   

  	
  -

  	
   

  	
  European
  Council Directive 94/62/EC on Packaging

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Electric &
  Electronic  Equipment

  	
   

  	
  -

  	
   

  	
  European
  Council Directive 2002/96/EC on Waste Electric and Electronic Equipment
  (WEEE)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Chemicals

  	
   

  	
  -

  	
   

  	
  United States
  (State of California) – Safe Drinking Water and Toxic Enforcement Act of 1986
  List of Chemicals Known to Cause Cancer or Reproductive Toxicity - California Code of Regulations, Title 22, Division 2, Part 2,
  Subdivisions 1, Chapter 3, Section 120000 – Chemicals Known to Cause Cancer
  or Reproductive Toxicity 

  

  120000 – Chemicals Known to the State to Cause Cancer or Reproductive
  Toxicity

  

  arcinogen and Reproductive Toxicant Requirements as determined by State of
  California

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ozone Depleting
  Chemicals

  	
   

  	
  -

  	
   

  	
  U.S. Clean Air
  Act and Amendments (CAAA) and U.S. Significant New Alternative Policy
  (SNAP-rule); 40 CFR 82

  

 

8

 

Instructions to Complete Forms A, B and C

 

Form A: Environmental Declaration For Products, Parts And
Packaging Sold To Philips Medical Systems (PMS)

SUPPLIER shall
complete, sign and return Form A to BUYER.  
To complete Form A, SUPPLIER shall check Box 1 or 2 under each section “Banned Substances
Applicable to Products, Parts and Packaging” and “Additional Environmental
Legislation Applicable to PMS Products, Parts and Packaging” to
indicate whether Products, Parts and Packaging sold to BUYER comply with the
Philips environmental requirements.

 

Form B: Request for Dispensation

If SUPPLIER
has indicated a non compliance on Form A, SUPPLIER shall additionally complete,
sign and return Form B.

One Form B must be completed for each Product, Part
and Packaging that does not comply with Philips environmental requirements. To
complete Form B, SUPPLIER shall indicate the Part, Product or Packaging and
corresponding Banned Substance(s) and/or Additional Environmental Legislation
to which it does not comply.

 

Form C:  Declaration of Relevant Substances

This Form must
be completed, signed and returned by SUPPLIER only if Products, Parts or
Packaging delivered to PMS contain any of the Relevant Substances listed on
Form C.

 

9

 

FORM A

 

ENVIRONMENTAL DECLARATION
FOR PRODUCTS, PARTS AND

PACKAGING SOLD TO PHILIPS MEDICAL SYSTEMS (PMS)

 

	
  To be filled out by Supplier

  	
  For PMS use only

  Supplier number : 

  
	
   

  	
   

  
	
  Supplier:

  	
   

  
	
   

  	
   

  
	
  Supplier Address:

  	
   

  
	
   

  	
   

  
	
  Supplier Phone:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Banned Substances Applicable to Products,
  Parts and Packaging (Based on international legislation and Philips

  Directives)           Please check box #1 or #2 below that applies.

  
	
   

  	
   

  
	
  (1)

  	
  SUPPLIER warrants that on the execution date of this
  Declaration, the Products, Parts and Packaging supplied to PMS do not contain Banned Substances in excess of the
  thresholds listed in Annex 1 of Attachment H1 of the Umbrella Purchasing
  Agreement as numbered above.

  
	
  (2)

  	
  SUPPLIER warrants that on the execution date of this
  Declaration, the Products, Parts and Packaging supplied to PMS do not contain Banned Substances in excess of the
  thresholds listed in Annex 1 of Attachment H1 of the Umbrella Purchasing
  Agreement as numbered above, except those Products, Parts, Packaging for
  which dispensation is requested.   Any
  deviation is specified on the “Request for Dispensation” (Form B) for each
  Product, Part and Packaging delivered to PMS that contains one or more Banned
  Substance. 

  
	
   

  	
   

  
	
  Additional Environmental Legislation
  Applicable to PMS Products, Parts and Packaging (Based on
  international legislation) Please check
  box #1 or #2 below that applies.

  
	
   

  	
   

  
	
  (1)

  	
  SUPPLIER herewith declares that the Products, Parts
  and Packaging supplied to PMS are in compliance with the Additional
  Environmental Legislation listed in Annex 1 of Attachment H1 of the Umbrella
  Purchasing Agreement as numbered above.

  
	
  (2)

  	
  SUPPLIER herewith declares that the Products, Parts
  and Packaging supplied to PMS are in compliance with the Additional
  Environmental Legislation listed in Annex 1 of Attachment H1 of the Umbrella
  Purchasing Agreement as numbered above, except those Products, Parts, Packaging
  for which dispensation is requested. 
  Any deviation is specified on the “ Request for Dispensation” (Form B)
  for each Product, Part and Packaging delivered to PMS that does not fully
  comply with the Additional Environmental Legislation.

  
	
   

  	
   

  
	
  Supplier must complete a Request for Dispensation (Form B)
  for any non compliance with the
  Banned Substances or Additional Environmental Legislation listed specified in
  Annex 1  of
  Attachment H1 of the Umbrella Purchasing Agreement as numbered above.   A separate Form B must be completed for
  each Product, Part and Packaging that deviates from any of these
  requirements. 

  
	
   

  	
   

  
	
  For future deliveries, Supplier warrants to
  implement effective controls to assure continuous compliance with the above
  requirements and agrees to accept PMS compliance audits on these
  requirements.

  
	
   

  	
   

  
	
  Responsible Manager:

  (Print name)

  	
   

  	
  Signature:

  
						

 

10

 

	
  Function:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  

 

FORM B

 

REQUEST FOR DISPENSATION

(To be filled out by supplier for each applicable Product, Part and Packaging)

 

	
  Product Number

  (Philips Numbering Code): 

  	
   

  	
  For Philips Medical

  Systems (PMS) only

  SUPPLIER Number:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Check all that apply: 

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Royal Philips Electronics Banned Substances
  for Products, Parts and Packaging:

  
	
   

  	
   

  	
   

  	
   

  
	
  With respect to the “ Environmental Declaration of
  Products, Parts and Packaging sold to Philips Medical Systems”, dispensation
  is requested to use Banned Substance(s) in excess of the thresholds listed in
  Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered
  above.

  

  Please list the Banned Substance(s) and concentration for which dispensation
  is requested in the space below:

  

  
	
   

  	
   

  	
   

  	
   

  
	
  Additional Legislation:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Dispensation is requested
  for non compliance(s) to Additional Environmental Legislation listed in Annex
  1 of Attachment H1 of the Umbrella Purchasing
  Agreement as numbered above.

  
Please list applicable legislation in
  the space below:

  

  
	
   

  	
   

  	
   

  	
   

  
	
  Additional Information: Please
  indicate below the amount of time for which dispensation is requested, and
  describe the deviation, reason for it and possible alternatives.  

  
	
   

  	
   

  	
   

  	
   

  
	
  Product, Part,

  Packaging:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Dispensation requested for the period:

  	
  From: 

  	
  To:

  
	
   

  	
   

  	
   

  	
   

  
	
  Description of application:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Reason for use:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
						

 

11

 

	
  Possible alternatives:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Responsible Manager:

  (Print name)

  	
   

  	
   

  	
  Signature:

  
	
   

  	
   

  	
   

  	
   

  
	
  Function:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  	
   

  

 

12

 

FORM C

 

DECLARATION OF RELEVANT
SUBSTANCES

( To be filled out by supplier for each applicable product, part and packaging)

 

	
  SUPPLIER:

  	
   

  	
  Supplier Number:

  For Philips
  Medical

  Systems (PMS) only

  
	
   

  	
   

  	
   

  	
   

  
	
  Relevant Substances: (Request for dispensation is not
  required)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  SUPPLIER confirms that, on the execution date of
  this Declaration, the Product, Part or Packaging indicated below as supplied
  to PMS contains Relevant Substance(s) in
  excess of the thresholds identified in the List of Relevant Substances for
  Product, Parts and Packaging below.

  
	
  •

  	
  For environmental improvements, end of life and
  customer information, a relevant substance in excess of the threshold must be declared. 

  
	
  •

  	
  Only
  declare relevant substances in the Product, Part or Packaging when the
  concentration is above the threshold levels as indicated in the List of
  Relevant Substances for Products, Parts, Packaging below.

  
	
  Product (Philips Numbering Code):

  	
   

  	
  SUPPLIER code:

  	
   

  
	
  Product weight:

  	
  kg  /  gr:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Please check all that apply

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Relevant Substances for Products, Parts and
  Packaging

  	
   

  	
  Threshold
  value

  in ppm (mg / kg)

  	
   

  	
  Amount

  present in grams

  
	
  Aromatic Hydrocarbons, Halogenated

  	
   

  	
  10

  	
   

  	
   

  
	
  Antimony and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Arsenic and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Beryllium and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Chromium(VI) 
  -compounds

  	
   

  	
  1000

  	
   

  	
   

  
	
  Cobalt and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Lead and -compounds (Cables
  and Printed Circuit Boards excepted)

  	
   

  	
  1000

  	
   

  	
   

  
	
  Selenium and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Tellurium and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Thallium and -compounds

  	
   

  	
  10

  	
   

  	
   

  
	
  Organic Tin and -compounds

  	
   

  	
  100

  	
   

  	
   

  
	
  Tungsten and -compounds

  	
   

  	
  100

  	
   

  	
   

  
	
  Cyanides

  	
   

  	
  10

  	
   

  	
   

  
	
  Formaldehyde

  	
   

  	
  100

  	
   

  	
   

  
	
  PAHs   (Polycyclic
  aromatic hydrocarbons)

  	
   

  	
  10

  	
   

  	
   

  
	
  PAHs,
  oxidized (Polycyclic aromatic hydrocarbons)

  	
   

  	
  100

  	
   

  	
   

  
	
  Phenol and
  phenolic compounds

  	
   

  	
  100

  	
   

  	
   

  
	
  Phthalate   (All)

  	
   

  	
  100

  	
   

  	
   

  
	
  PFCs
  (Perfluorocarbons)      (All)

  	
   

  	
  10

  	
   

  	
   

  
	
  Toluene

  	
   

  	
  10

  	
   

  	
   

  
	
  Xylenes

  	
   

  	
  10

  	
   

  	
   

  
	
  Epichlorohydrin  (Monomer)

  	
   

  	
  10

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Responsible Manager:

  (Print name)

  	
   

  	
  Signature:

  
	
   

  	
   

  	
   

  
	
  Function:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date:

  	
   

  	
   

  
													

 

13

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00074-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00074-of-00352.parquet"}]]