<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MAY 28, 1996
REGISTRATION NO. 333-2924
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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AMENDMENT NO. 3
TO
FORM S-1
REGISTRATION STATEMENT
UNDER THE
SECURITIES ACT OF 1933
---------------
TREX MEDICAL CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
---------------
DELAWARE 3844 06-1439632
(STATE OR OTHER (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER
JURISDICTION OF CLASSIFICATION CODE NUMBER) IDENTIFICATION NUMBER)
INCORPORATION OR
ORGANIZATION)
---------------
36 APPLE RIDGE ROAD, DANBURY, CONNECTICUT 06810
(203)-790-1188
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING
AREA CODE, OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
---------------
SANDRA L. LAMBERT, SECRETARY
TREX MEDICAL CORPORATION
C/O THERMO ELECTRON CORPORATION
81 WYMAN STREET
POST OFFICE BOX 9046
WALTHAM, MASSACHUSETTS 02254-9046
(617) 622-1000
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF AGENT FOR SERVICE)
COPIES TO:
SETH H. HOOGASIAN, DAVID E. REDLICK, ESQUIRE EDWIN L. MILLER, JR.,
ESQUIRE HALE AND DORR ESQUIRE
GENERAL COUNSEL 60 STATE STREET TESTA, HURWITZ & THIBEAULT, LLP
TREX MEDICAL CORPORATION BOSTON, MASSACHUSETTS 02109 125 HIGH STREET
C/O THERMO ELECTRON (617) 526-6000 BOSTON, MASSACHUSETTS
CORPORATION 02110
81 WYMAN STREET (617) 248-7000
POST OFFICE BOX 9046
WALTHAM, MASSACHUSETTS
02254-9046
(617) 622-1000
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the Registration Statement has become effective.
---------------
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [X]
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act of 1933, check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [_]
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act of 1933, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
check the following box. [_]
---------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS
REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION
STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING
PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
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<PAGE>
TREX MEDICAL CORPORATION
CROSS REFERENCE SHEET
BETWEEN ITEMS OF FORM S-1 AND PROSPECTUS
<TABLE>
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ITEM LOCATION IN PROSPECTUS
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<C> <S> <C>
1. Forepart of Registration Statement and
Outside Front Cover Page of
Prospectus............................ Outside Front Cover Page
2. Inside Front and Outside Back Cover
Pages of Prospectus................... Inside Front Cover Page; Outside
Back Cover Page; Additional
Information; Reports to Security
Holders
3. Summary Information, Risk Factors and
Ratio of Earnings to Fixed Charges.... Prospectus Summary; Risk Factors;
The Company
4. Use of Proceeds........................ Prospectus Summary; Use of
Proceeds
5. Determination of Offering Price........ Outside Front Cover Page; The
Rights Offering
6. Dilution............................... Dilution
7. Selling Security Holders............... Not Applicable
8. Plan of Distribution................... Outside Front Cover Page; The
Rights Offering
9. Description of Securities to be
Registered............................ Outside Front Cover Page;
Capitalization; Description of
Capital Stock
10. Interests of Named Experts and
Counsel............................... Experts; Legal Opinions
11. Information With Respect to the
Registrant:
(a) Description of Business............ Business; Management's Discussion
and Analysis of Financial
Condition and Results of
Operations
(b) Description of Property............ Business--Facilities
(c) Legal Proceedings.................. Risk Factors--Risks Associated
With Pending and Threatened
Patent Litigation; Business--
Patents and Proprietary
Technology; Business--Legal
Proceedings
(d) Market Price of and Dividends on
the Registrant's Common Equity and
Related Stockholder Matters........ Outside Front Cover Page;
Dividend Policy; Executive
Compensation; Description of
Capital Stock; Shares Eligible
for Future Sale
(e) Financial Statements............... Consolidated Financial
Statements; Capitalization
(f) Selected Financial Data............ Selected Financial Information
(g) Supplementary Financial
Information........................ Not Applicable
</TABLE>
<PAGE>
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<CAPTION>
ITEM LOCATION IN PROSPECTUS
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<C> <S> <C>
(h) Management's Discussion and
Analysis of Financial Condition
and Results of Operations........ Management's Discussion and
Analysis of Financial Condition
and Results of Operations
(i) Changes in and Disagreements with
Accountants on Accounting and
Financial Disclosure............. Not Applicable
(j) Directors, Executive Officers,
Promoters and Control Persons.... Relationship and Potential
Conflicts of Interest with Thermo
Electron and ThermoTrex;
Management
(k) Executive Compensation........... Executive Compensation
(l) Security Ownership of Certain
Beneficial Owners and
Management....................... Security Ownership of Certain
Beneficial Owners and Management
Relationship and Potential
(m) Certain Relationships and Related
Transactions..................... Conflicts of Interest with Thermo
Electron and ThermoTrex;
Management--Certain Transactions
12. Disclosure of Commission Position on
Indemnification for Securities Act
Liabilities......................... Not Applicable
</TABLE>
<PAGE>
EXPLANATORY NOTE
This Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-
2924) of Trex Medical Corporation is filed solely to file copies of the
exhibits listed in Item 16 hereto.
<PAGE>
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULE
(A) EXHIBITS
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EXHIBIT NO. DESCRIPTION OF EXHIBIT
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*3.1 Certificate of Incorporation, as amended, of the Registrant.
*3.2 By-Laws of the Registrant.
*4.1 Specimen Common Stock Certificate.
*4.2 $42,000,000 Subordinated Convertible Note due 2000 of the
Registrant issued to ThermoTrex.
*4.3 Specimen Rights Certificate.
*5 Opinion of Seth H. Hoogasian, Esq. with respect to the validity of
the securities being offered.
*10.1 Corporate Services Agreement dated as of September 27, 1995
between Thermo Electron Corporation ("Thermo Electron") and the
Registrant.
10.2 Thermo Electron Corporate Charter, as amended and restated
effective January 3, 1993 (incorporated by reference herein form
Exhibit 10.1 to Thermo Electron's Annual Report on form 10-K for
the fiscal year ended January 2, 1993 (File No. 1-8002)).
*10.3 Tax Allocation Agreement dated as of September 27, 1995 between
Thermo Electron and the Registrant.
*10.4 Master Repurchase Agreement dated as of September 27, 1995 between
Thermo Electron and the Registrant.
*10.5 Master Guarantee Reimbursement Agreement dated as of September 27,
1995 between Thermo Electron and the Registrant.
*10.6 Master Guarantee Reimbursement Agreement dated as of September 27,
1995 between ThermoTrex and the Registrant.
+10.7 OEM Agreement between Philips Medical Systems North American
Company and Lorad dated as of November 2, 1993.
+10.8 OEM Agreement between Philips Medical Systems North American
Company and Lorad dated November 17, 1993.
*+10.9 Purchase Agreement between General Electric Company and Bennett
dated November 17, 1994.
*+10.10 Agreement between Philips Medizin Systeme Unternehmensbereich der
Philips GmbH and Bennett dated February 12, 1992.
*+10.11 Distributor Agreement between ThermoTrex and US Surgical
Corporation dated October 20, 1995, as amended.
*10.12 Note Purchase and Sale Agreement dated as of October 2, 1995
between ThermoTrex and the Registrant.
10.13 Lease dated as of September 15, 1995, by and among ThermoTrex and
BK Realty Associates, L.P. and Calrob Realty Associates (filed as
Exhibit 10.26 to ThermoTrex's Annual Report on Form
10-K for the fiscal year ended September 30, 1995 [File No. 1-
10791] and incorporated herein by reference).
*10.14 Lease dated as of December 20, 1995, between Melvyn J. Powers and
Mary P. Powers D/B/A M&M Realty and Lorad, as amended.
*10.15 Equity Incentive Plan of the Registrant.
*10.16 Deferred Compensation Plan for Directors of the Registrant.
*10.17 Directors Stock Option Plan of the Registrant.
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EXHIBIT NO. DESCRIPTION OF EXHIBIT
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*10.18 Form of Indemnification Agreement for Officers and Directors.
In addition to the stock-based compensation plans of the
Registrant, the executive officers of the Registrant may be
granted awards under stock-based compensation plans of the
Registrant's parent, Thermo Electron Corporation, and its
subsidiaries, for services rendered to the Registrant or to such
affiliated corporations. Such plans are listed under Exhibits
10.19-10.74.
10.19 Thermo Electron Corporation Incentive Stock Option Plan (filed as
Exhibit 4(d) to Thermo Electron's Registration Statement on Form
S-8 [Reg. No. 33-8993] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under this
plan and the Thermo Electron Nonqualified Stock Option Plan is
9,035,156 shares, after adjustment to reflect share increases
approved in 1984 and 1986, share decrease approved in 1989, and 3-
for-2 stock splits effected in October 1986, October 1993 and May
1995).
10.20 Thermo Electron Corporation Nonqualified Stock Option Plan (filed
as Exhibit 4(e) to Thermo Electron's Registration Statement on
Form S-8 [Reg. No. 33-8993] and incorporated herein by reference).
(Plan amended in 1984 to extend expiration date to December 14,
1994; maximum number of shares issuable in the aggregate under
this plan and the Thermo Electron Incentive Stock Option Plan is
9,035,156 shares, after adjustment to reflect share increases
approved in 1984 and 1986, share decrease approved in 1989, and 3-
for-2 stock splits effected in October 1986, October 1993 and May
1995).
10.21 Thermo Electron Corporation Equity Incentive Plan (filed as
Exhibit 10.1 to Thermo Electron's Quarterly Report on Form 10-Q
for the quarter ended July 2, 1994 [File No. 1-8002] and
incorporated herein by reference). (Plan amended in 1989 to
restrict exercise price for SEC reporting persons to not less than
50% of fair market value or par value; maximum number of shares
issuable is 7,050,000 shares, after adjustment to reflect 3-for-2
stock splits effected in October 1993 and May 1995 and share
increase approved in 1994).
10.22 Thermo Electron Corporation--Thermedics Inc. Nonqualified Stock
Option Plan (filed as Exhibit 4 to a Registration Statement on
Form S-8 of Thermedics [Reg. No. 2-93747] and incorporated herein
by reference). (Maximum number of shares issuable is 450,000
shares, after adjustment to reflect share increase approved in
1988, 5-for-4 stock split effected in January 1985, 4-for-3 stock
split effected in September 1985, and 3-for-2 stock splits
effected in October 1986 and November 1993).
10.23 Thermo Electron Corporation--Thermo Instrument Systems Inc.
(formerly Thermo Environmental Corporation) Nonqualified Stock
Option Plan (filed as Exhibit 4(c) to a Registration Statement on
Form S-8 of Thermo Instrument [Reg. No. 33-8034] and incorporated
herein by reference). (Maximum number of shares issuable is
421,875 shares, after adjustment to reflect 3-for-2 stock splits
effected in July 1993 and April 1995 and a 5-for-4 stock split
effected in December 1995).
10.24 Thermo Electron Corporation--Thermo Instrument Systems Inc.
(formerly Thermo Environmental Corporation) Nonqualified Stock
Option Plan (filed as Exhibit 10.12 to Thermo Electron's Annual
Report on Form 10-K for the fiscal year ended January 3, 1987
[File No. 1-8002] and incorporated herein by reference). (Maximum
number of shares issuable is 600,285 shares, after adjustment to
reflect share increase approved in 1988 and 3-for-2 stock splits
effected in January 1988, July 1993 and April 1995 and a 5-for-4
stock split effected in December 1995).
10.25 Thermo Electron Corporation--Thermo Terra Tech Inc. (formerly
Thermo Process Systems Inc.) Nonqualified Stock Option Plan (filed
as Exhibit 10.13 to Thermo Electron's Annual Report on Form 10-K
for the fiscal year ended January 3, 1987 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of shares
issuable is 108,000 shares, after adjustment to reflect 6-for-5
stock splits effected in July 1988 and March 1989, and 3-for-2
stock split effected in September 1989).
10.26 Thermo Electron Corporation--Thermo Power Corporation (formerly
Tecogen Inc.) Nonqualified Stock Option Plan (filed as Exhibit
10.14 to Thermo Electron's Annual Report on Form 10-K for the
fiscal year ended January 3, 1987 [File No. 1-8002] and
incorporated herein by reference). (Amended in September 1995 to
extend the plan expiration date to December 31, 2005).
</TABLE>
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<CAPTION>
EXHIBIT NO. DESCRIPTION OF EXHIBIT
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10.27 Thermo Electron Corporation--Thermo Cardiosystems Inc.
Nonqualified Stock Option Plan (filed as Exhibit 10.11 to Thermo
Electron's Annual Report on Form 10-K for the fiscal year ended
December 29, 1990 [File No. 1-8002] and incorporated herein by
reference). (Maximum number of shares issuable is 130,500 shares,
after adjustment to reflect share increases approved in 1990 and
1992, 3-for-2 stock split effected in January 1990, 5-for-4 stock
split effected in May 1990 and 2-for-1 stock split effected in
November 1993).
10.28 Thermo Electron Corporation--Thermo Ecotek Corporation (formerly
Thermo Energy Systems Corporation) Nonqualified Stock Option Plan
(filed as Exhibit 10.12 to Thermo Electron's Annual Report on Form
10-K for the fiscal year ended December 29, 1990 [File No. 1-8002]
and incorporated hereby by reference).
10.29 Thermo Electron Corporation--ThermoTrex Corporation (formerly
Thermo Electron Technologies Corporation) Nonqualified Stock
Option Plan (filed as Exhibit 10.13 to Thermo Electron's Annual
Report on Form 10-K for the fiscal year ended December 29, 1990
[File No. 1-8002] and incorporated herein by reference). (Maximum
number of shares issuable is 180,000 shares, after adjustment to
reflect 3-for-2 stock split effected in October 1993).
10.30 Thermo Electron Corporation--Thermo Fibertek Inc. Nonqualified
Stock Option Plan (filed as Exhibit 10.14 to Thermo Electron's
Annual Report on Form 10-K for the fiscal year ended December 28,
1991 [File No. 1-8002] and incorporated herein by reference).
(Maximum number of shares issuable is 600,000 shares, after
adjustment to reflect 2-for-1 stock split effected in September
1992 and 3-for-2 stock split effected in September 1995).
10.31 Thermo Electron Corporation--Thermo Voltek Corp. (formerly
Universal Voltronics Corp.) Nonqualified Stock Option Plan (filed
as Exhibit 10.17 to Thermo Electron's Annual Report on Form 10-K
for the fiscal year ended January 2, 1993 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of shares
issuable is 57,500 shares after adjustment to reflect 3-for-2
stock split effected in November 1993 and share increase approved
in September 1995).
10.32 Thermo Electron Corporation--Thermo BioAnalysis Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.31 to Thermo
Power's Annual Report on Form 10-K for the fiscal year ended
September 30, 1995 [File No. 1-10573] incorporated herein by
reference).
10.33 Thermo Electron Corporation--ThermoLyte Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.32 to Thermo Power's Annual
Report on Form 10-K for the fiscal year ended September 30, 1995
[File No. 1-10573] and incorporated herein by reference).
10.34 Thermo Electron Corporation--Thermo Remediation Inc. Nonqualified
Stock Option Plan (filed as Exhibit 10.33 to Thermo Power's Annual
Report on Form 10-K for the fiscal year ended September 30, 1995
[File No. 1-10573] and incorporated herein by reference).
10.35 Thermo Electron Corporation--ThermoSpectra Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.34 to Thermo
Power's Annual Report on Form 10-K for the fiscal year ended
September 30, 1995 [File No. 1-10573] and incorporated herein by
reference).
10.36 Thermo Electron Corporation--ThermoLase Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.35 to Thermo Power's Annual
Report on Form 10-K for the fiscal year ended September 30, 1995
[File No. 1-10573] and incorporated herein by reference).
10.37 Thermo Electron Corporation--ThermoQuest Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.41 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
10.38 Thermo Electron Corporation--Thermo Optek Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.42 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
</TABLE>
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<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION OF EXHIBIT
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<C> <S>
10.39 Thermo Electron Corporation--Thermo Sentron Inc. Nonqualified
Stock Option Plan (filed as Exhibit 10.43 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
10.40 Thermo Electron Corporation--Trex Medical Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.44 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
10.41 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Incentive Stock Option Plan (filed as Exhibit 10.18
to Thermo Electron's Annual Report on Form 10-K for the fiscal
year ended January 2, 1993 [File No. 1-8002] and incorporated
herein by reference). (Maximum number of shares issuable in the
aggregate under this plan and the Thermo Ecotek Nonqualified Stock
Option Plan is 900,000 shares, after adjustment to reflect share
increase approved in December 1993).
10.42 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Nonqualified Stock Option Plan (filed as Exhibit
10.19 to Thermo Electron's Annual Report on Form 10-K for the
fiscal year ended January 2, 1993 [File No. 1-8001] and
incorporated herein by reference). (Maximum number of shares
issuable in the aggregate under this plan and the Thermo Ecotek
Incentive Stock Option Plan is 900,000 shares, after adjustment to
reflect share increase approved in December 1993).
10.43 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Equity Incentive Plan (filed as Exhibit 10.39 to
Thermo Instrument's Annual Report on Form 10-K for the fiscal year
ended December 31, 1994 [File No. 1-9786] and incorporated herein
by reference).
10.44 Thermedics Inc. Incentive Stock Option Plan (filed as Exhibit
10(d) to Thermedics' Registration Statement on Form S-1 [Reg. No.
33-84380) and incorporated herein by reference). (Maximum number
of shares issuable in the aggregate under this plan and the
Thermedics Nonqualified Stock Option Plan is 1,931,923 shares,
after adjustment to reflect share increases approved in 1986 and
1992, 5-for-4 stock split effected in January 1985, 4-for-3 stock
split effected in September 1985, and 3-for-2 stock splits
effected in October 1986 and November 1993).
10.45 Thermedics Inc. Nonqualified Stock Option Plan (filed as Exhibit
10(e) to Thermedics' Registration Statement on Form S-1 [Reg. No.
33-84380) and incorporated herein by reference). (Maximum number
of shares issuable in the aggregate under this plan and the
Thermedics Incentive Stock Option Plan is 1,931,923 shares, after
adjustment to reflect share increases approved in 1986 and 1992,
5-for-4 stock split effected in January 1985, 4-for-3 stock split
effected in September 1985, and 3-for-2 stock splits effected in
October 1986 and November 1993).
10.46 Thermedics Inc. Equity Incentive Plan (filed as Appendix A to the
Proxy Statement dated May 10, 1993 of Thermedics [File No. 1-9567]
and incorporated herein by reference). (Maximum number of shares
issuable is 1,500,000, after adjustment to reflect 3-for-2 stock
split effected in November 1993).
10.47 Thermedics Inc.--Thermo Sentron Inc. Nonqualified Stock Option
Plan (filed as Exhibit 10.51 to Thermo Cardiosystems Annual Report
on Form 10-K for the fiscal year ended December 30, 1995 [File No.
1-10114] and incorporated herein by reference).
10.48 Thermedics Inc.--Thermedics Detection Inc. Nonqualified Stock
Option Plan (filed as Exhibit 10.20 to Thermo Electron's Annual
Report on Form 10-K for the fiscal year ended January 2, 1993
[File No. 1-8002] and incorporated herein by reference).
10.49 Thermedics Detection Inc.--Equity Incentive Plan (fiuled as
Exhibit 10.69 to Thermo Instrument's Annual Report on Form 10-K
for the fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference).
</TABLE>
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<CAPTION>
EXHIBIT NO. DESCRIPTION OF EXHIBIT
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10.50 Thermo Cardiosystems Inc. Incentive Stock Option Plan (filed as
Exhibit 10(f) to Thermo Cardiosystems' Registration Statement on
Form S-1 [Reg. No. 33-25144] and incorporated herein by
reference). (Maximum number of shares issuable in the aggregate
under this plan and the Thermo Cardiosystems Nonqualified Stock
Option Plan is 1,143,750 shares, after adjustment to reflect share
increase approved in 1992, 3-for-2 stock split effected in January
1990, 5-for-4 stock split effected in May 1990 and 2-for-1 stock
split effected in November 1993).
10.51 Thermo Cardiosystems Inc. Nonqualified Stock Option Plan (filed as
Exhibit 10(g) to Thermo Cardiosystems' Registration Statement on
Form S-1 [Reg. No. 33-25144] and incorporated herein by
reference). (Maximum number of shares issuable in the aggregate
under this plan and the Thermo Cardiosystems Incentive Stock
Option Plan is 1,143,750 shares, after adjustment to reflect share
increase approved in 1992, 3-for-2 stock split effected in January
1990, 5-for-4 stock split effected in May 1990 and 2-for-1 stock
split effected in November 1993).
10.52 Thermo Cardiosystems Inc. Equity Incentive Plan (filed as Exhibit
10.46 to Thermo Instrument's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference).
10.53 Thermo Voltek Corp. (formerly Universal Voltronics Corp.) 1985
Stock Option Plan (filed as Exhibit 10.14 to Thermo Voltek's
Annual Report on Form 10-K for the fiscal year ended June 30, 1985
[File No. 0-8245] and incorporated herein by reference). (Maximum
number of shares issuable is 200,000 shares, after adjustment to
reflect 1-for-3 reverse stock split effected in November 1992 and
3-for-2 stock split effected in November 1993).
10.54 Thermo Voltek Corp. (formerly Universal Voltronics Corp.) 1990
Stock Option Plan (filed as Exhibit 10.2 to Thermo Voltek's Annual
Report on Form 10-K for the fiscal year ended June 30, 1990 [File
No. 1-10574] and incorporated herein by reference). (Maximum
number of shares issuable is 400,000 shares, after adjustment to
reflect share increases in 1993 and 1994. 1-for-3 reverse stock
split effected in November 1992, and 3-for-2 stock split effected
in November 1993).
10.55 Thermo Voltek Corp. Equity Incentive Plan (filed as Exhibit 10.49
to Thermo Instrument's Annual Report on Form 10-K for the fiscal
year ended December 31, 1994 [File No. 1-9786] and incorporated
herein by reference).
10.56 Thermo Instrument Systems Inc. Incentive Stock Option Plan (filed
as Exhibit 10(c) to Thermo Instrument's Registration Statement on
Form S-1 [Reg. No. 33-6762] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under this
plan and the Thermo Instrument Nonqualified Stock Option Plan is
2,812,500 shares, after adjustment to reflect share increase
approved in 1990 and 3-for-2 stock splits effected in January
1988, July 1993 and April 1995 and 5-for-4 stock split effected in
December 1995).
10.57 Thermo Instrument Systems Inc. Nonqualified Stock Option Plan
(filed as Exhibit 10(d) to Thermo Instrument's Registration
Statement on Form S-1 [Reg. No. 33-6762] and incorporated herein
by reference). (Maximum number of shares issuable in the aggregate
under this plan and the Thermo Instrument Incentive Stock Option
Plan is 2,812,500 shares, after adjustment to reflect share
increase approved in 1990 and 3-for-2 stock splits effected in
January 1988, July 1993 and April 1995 and 5-for-4 stock split
effected in December 1995).
10.58 Thermo Instrument Systems Inc. Equity Incentive Plan (filed as
Appendix A to the Proxy Statement dated April 27, 1993 of Thermo
Instrument [File No. 1-9786] and incorporated herein by
reference). (Maximum number of shares issuable is 4,031,250
shares, after adjustment to reflect share increase approved in
December 1993 and 3-for-2 stock split effected in July 1993 and
April 1995 and 5-for-4 stock split effected in December 1995).
</TABLE>
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EXHIBIT NO. DESCRIPTION OF EXHIBIT
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10.59 Thermo Instrument Systems Inc. (formerly Thermo Environmental
Corporation) Incentive Stock Option Plan (filed as Exhibit 10(d)
to Thermo Environmental's Registration Statement on Form S-1 [Reg.
No. 33-329] and incorporated herein by reference). (Maximum number
of shares issuable in the aggregate under this plan and the Thermo
Instrument (formerly Thermo Environmental Corporation)
Nonqualified Stock Option Plan is 1,160,156 shares, after
adjustment to reflect share increase approved in 1987 and 3-for-2
stock splits effected in July 1993 and April 1995 and 5-for-4
stock split effected in December 1995).
10.60 Thermo Instrument Systems Inc. (formerly Thermo Environmental
Corporation) Nonqualified Stock Option Plan (filed as Exhibit
10(e) to Thermo Environmental's Registration Statement on Form S-1
[Reg. No. 33-329] and incorporated herein by reference). (Maximum
number of shares issuable in the aggregate under this plan and the
Thermo Instrument (formerly Thermo Environmental Corporation)
Incentive Stock Option Plan is 1,160,156 shares, after adjustment
to reflect share increase approved in 1987 and 3-for-2 splits
effected in July 1993 and April 1995 and 5-for-4 stock split
effected in December 1995).
10.61 Thermo Instrument Systems Inc.--ThermoSpectra Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.51 to Thermo
Instrument's Annual Report on Form 10-K for the fiscal year ended
December 31, 1994 [File No. 1-9786] and incorporated herein by
reference).
10.62 Thermo Instrument Systems Inc.--Thermo BioAnalysis Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.64 to Thermo
Cardiosystems' Annual Report on Form 10-K for the fiscal year
ended December 30, 1995 [File No. 1-10114] and incorporated herein
by reference).
10.63 Thermo Instrument Systems Inc.--ThermoQuest Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.65 to Thermo
Cardiosystems' Annual Report on Form 10-K for the fiscal year
ended December 30, 1995 [File No. 1-10114] and incorporated herein
by reference).
10.64 ThermoSpectra Corporation Equity Incentive Plan (filed as Exhibit
10.52 to Thermo Instrument's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference).
10.65 Thermo BioAnalysis Corporation Equity Incentive Plan (filed as
Exhibit 10.67 to Thermo Cardiosystems' Annual Report on Form 10-K
for the fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference).
10.66 Thermo Optek Corporation Equity Incentive Plan (filed as Exhibit
10.68 to Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference).
10.67 ThermoQuest Corporation Equity Incentive Plan (filed as Exhibit
10.69 to Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference).
10.68 ThermoTrex Corporation (formerly Thermo Electron Technologies
Corporation) Incentive Stock Option Plan (filed as Exhibit 10(h)
to ThermoTrex's Registration Statement on Form S-1 [Reg. No. 33-
40972] and incorporated herein by reference) (Maximum number of
shares issuable in the aggregate under this plan and the
ThermoTrex Nonqualified Stock Option Plan is 1,945,000 shares,
after adjustment to reflect share increases approved in 1992 and
1993 and 3-for-2 stock split effected in October 1993).
10.69 ThermoTrex Corporation (formerly Thermo Electron Technologies
Corporation) Nonqualified Stock Option Plan (filed as Exhibit
10(i) to ThermoTrex's Registration Statement on Form S-1 [Reg. No.
33-40972] and incorporated herein by reference) (Maximum number of
shares issuable in the aggregate under this plan and the
ThermoTrex Nonqualified Stock Option Plan is 1,945,000 shares,
after adjustment to reflect share increases approved in 1992 and
1993 and 3-for-2 stock split effected in October 1993).
</TABLE>
II-6
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<C> <S>
10.70 ThermoTrex Corporation-ThermoLase Corporation (formerly ThermoLase
Inc.) Nonqualified Stock Option Plan (filed on Exhibit 10.53 to
ThermoTrex Corporation's Annual Report on Form 10-K for the fiscal
year ended January 1, 1994 [File No. 1-10791] and incorporated
herein by reference.
10.71 ThermoTrex Corporation--Trex Medical Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.73 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
10.72 ThermoLase Corporation (formerly ThermoLase Inc.) Nonqualified
Stock Option Plan (filed as Exhibit 10.54 to ThermoTrex's Annual
Report on Form 10-K for the fiscal year ended January 1, 1994
[File No. 1-10791] and incorporated herein by reference). (Maximum
number of shares issuable in the aggregate under this plan and the
ThermoLase Incentive Stock Option Plan is 2,800,000 shares, after
adjustment to reflect share increase approved in 1993 and 2-for-1
stock splits effected in March 1994 and June 1995).
10.73 ThermoLase Corporation (formerly ThermoLase Inc.) Incentive Stock
Option Plan (filed as Exhibit 10.55 to ThermoTrex Corporation's
Annual Report on Form 10-K for the fiscal year ended January 1,
1994 [File No. 1-10791] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under this
plan and the ThermoLase Nonqualified Stock Option Plan is
2,800,000 shares, after adjustment to reflect share increase
approved in 1993 and 2-for-1 stock splits effected in March 1994
and June 1995).
10.74 ThermoLase Corporation Equity Incentive Plan (filed as Exhibit
10.81 to Thermo TerraTech's Annual Report on Form 10-K for the
fiscal year ended April 1, 1995 [File No. 1-9549] and incorporated
herein by reference).
10.75 Thermo Fibertek Inc. Incentive Stock Option Plan (filed as Exhibit
10(k) to Thermo Fibertek's Registration Statement on Form S-1
[Reg. No. 33-51172] and incorporated herein by reference.
10.76 Thermo Fibertek Inc. Nonqualified Stock Option Plan (filed as
Exhibit 10(l) to Thermo Fibertek's Registration Statement on Form
S-1 [Reg. No. 33-51172] and incorporated herein by reference.
10.77 Thermo Fibertek Inc. Equity Incentive Plan (filed as Exhibit 10.60
to Thermo Instrument's Annual Report on Form 10-K for the fiscal
year ended December 31, 1994 [File No. 1-9786] and incorporated
herein by reference.
10.78 Thermo Power Corporation (formerly Tecogen Inc.) Incentive Stock
Option Plan (filed as Exhibit 10(h) to Thermo Power's Quarterly
Report on Form 10-Q for the quarter ended April 3, 1993 [Reg. No.
33-10573] and incorporated herein by reference). (Maximum number
of shares issuable in the aggregate under this plan and the Thermo
Power Nonqualified Stock Option Plan is 950,000 shares, after
adjustment to reflect share increases approved in 1990, 1992 and
1993).
10.79 Thermo Power Corporation (formerly Tecogen Inc.) Nonqualified
Stock Option Plan (filed as Exhibit 10(i) to Thermo Power's
Quarterly Report on Form 10-Q for the quarter ended April 3, 1993
[Reg. No. 33-10573] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under this
plan and the Thermo Power Incentive Stock Option Plan is 950,000
shares, after adjustment to reflect share increases approved in
1990, 1992 and 1993).
10.80 Thermo Power Corporation Equity Incentive Plan (filed as Exhibit
10.63 to Thermo Instrument's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference).
10.81 Thermo Power Corporation--ThermoLyte Corporation Nonqualified
Stock Option Plan (filed as Exhibit 10.84 to Thermo Cardiosystems'
Annual Report on Form 10-K for the fiscal year ended December 30,
1995 [File No. 1-10114] and incorporated herein by reference).
</TABLE>
II-7
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10.82 ThermoLyte Corporation Equity Incentive Plan (filed as Exhibit
10.71 to Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573] and incorporated
herein by reference).
10.83 Thermo TerraTech Inc. (formerly Thermo Process Systems Inc.)
Incentive Stock Option Plan (filed as Exhibit 10(h) to Thermo
Process' Registration Statement on Form S-1 [Reg. No. 33-6763] and
incorporated herein by reference). (Maximum number of shares
issuable in the aggregate under this plan and the Thermo TerraTech
Nonqualified Stock Option Plan is 1,850,000 shares, after
adjustment to reflect share increases approved in 1987, 1989 and
1992, 6-for-5 stock splits effected in July 1988 and March 1989
and 3-for-2 stock split effected in September 1989).
10.84 Thermo TerraTech Inc. (formerly Thermo Process Systems Inc.)
Nonqualified Stock Option Plan (filed as Exhibit 10(i) to Thermo
Process' Registration Statement on Form S-1 [Reg. No. 33-6763] and
incorporated herein by reference). (Maximum number of shares
issuable in the aggregate under this plan and the Thermo TerraTech
Incentive Stock Option Plan is 1,850,000 shares, after adjustment
to reflect share increases approved in 1987, 1989 and 1992, 6-for-
5 stock splits effected in July 1988 and March 1989 and 3-for-2
stock split effected in September 1989).
10.85 Thermo TerraTech Inc. (formerly Thermo Process Systems Inc.)
Equity Incentive Plan (filed as Exhibit 10.63 to Thermedics'
Annual Report on Form 10-K for the fiscal year ended January 1,
1994 [File No. 1-9567] and incorporated herein by reference).
(Maximum number of shares issuable is 1,750,000 shares, after
adjustment to reflect share increase approved in 1994).
10.86 Thermo TerraTech Inc. (formerly Thermo Process Systems Inc.)--
Thermo Remediation Inc. Nonqualified Stock Option Plan (filed as
Exhibit 10(l) to Thermo Process' Quarterly Report on Form 10-Q for
the fiscal quarter ended January 1, 1994 [File No. 1-9549] and
incorporated herein by reference).
10.87 Thermo Remediation Inc. Equity Incentive Plan (filed as Exhibit
10.7 to Thermo Remediation's Registration Statement on Form S-1
[Reg. No. 33-70544] and incorporated herein by reference).
*10.88 License Agreement between the Registrant and ThermoTrex dated as
of October 16, 1995.
*11 Computation of Earnings per Share
*21 Subsidiaries of the Registrant
*23.1 Consent of Arthur Andersen LLP
*23.2 Consent of Arthur Andersen LLP
*23.3 Consent of Arthur Andersen LLP
*23.4 Consent of Topel Forman L.L.C.
*23.5 Consent of Seth H. Hoogasian, Esq. (included in Exhibit 5)
*24 Power of Attorney
*27 Financial Data Schedule
*99.1 Form of Subscription Agency Agreement.
*99.2 Instructions as to use of Trex Medical Corporation Subscription
Certificates and International Holder Subscription Forms.
*99.3 International Holder Subscription Form.
*99.4 Form of Letter to Trex Medical stockholders.
*99.5 Form of Letter to ThermoTrex stockholders.
</TABLE>
- --------
* Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commission.
(B) FINANCIAL STATEMENT SCHEDULE
The financial Statement Schedule as of September 30, 1995 and the Report of
Independent Public Accountants on such schedule are included in this
Registration Statement. All other schedules are omitted because they are not
applicable or are not required under Regulation S-X.
II-8
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this Amendment No. 3 to Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of
Danbury, Connecticut, on this 24th day of May, 1996.
TREX MEDICAL CORPORATION
/s/ Jonathan W. Painter
By:________________________________
Jonathan W. Painter
Treasurer
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, this Amendment
No. 3 to Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
SIGNATURE TITLE DATE
Chief Executive
* Officer, President May 24, 1996
_____________________________________ and Director
HAL KIRSHNER (Principal
Executive Officer)
* Vice President, Chief
_____________________________________ Accounting Officer May 24, 1996
JOHN N. HATSOPOULOS and Director
(Principal
Financial Officer)
* Chief Accounting
_____________________________________ Officer (Principal May 24, 1996
PAUL F. KELLEHER Accounting Officer)
* Director
_____________________________________ May 24, 1996
DR. ELIAS P. GYFTOPOULOS
* Director
_____________________________________ May 24, 1996
ROBERT C. HOWARD
II-9
<PAGE>
SIGNATURE TITLE DATE
* Director
_____________________________________ May 24, 1996
EARL R. LEWIS
* Director
_____________________________________ May 24, 1996
DR. JAMES W. MAY JR.
* Director
_____________________________________ May 24, 1996
HUTHAM S. OLAYAN
* Director
_____________________________________ May 24, 1996
ANTHONY J. PELLEGRINO
* Director
_____________________________________ May 24, 1996
FIROOZ RUFEH
* Director
_____________________________________ May 24, 1996
KENNETH Y. TANG
* Director and
_____________________________________ Chairman of the May 24, 1996
GARY S. WEINSTEIN Board
/s/ Jonathan W. Painter
*By:_________________________________
Jonathan W. Painter
Attorney-in-Fact
II-10
<PAGE>
EXHIBIT INDEX
<TABLE>
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*3.1 Certificate of Incorporation, as amended, of the
Registrant.................................................
*3.2 By-Laws of the Registrant..................................
*4.1 Specimen Common Stock Certificate..........................
*4.2 $42,000,000 Subordinated Convertible Note due 2000 of the
Registrant issued to ThermoTrex............................
*4.3 Specimen Rights Certificate................................
*5 Opinion of Seth H. Hoogasian, Esq. with respect to the
validity of the securities being offered...................
*10.1 Corporate Services Agreement dated as of September 27, 1995
between Thermo Electron Corporation ("Thermo Electron") and
the Registrant.............................................
10.2 Thermo Electron Corporate Charter, as amended and restated
effective January 3, 1993 (incorporated by reference herein
form Exhibit 10.1 to Thermo Electron's Annual Report on
form 10-K for the fiscal year ended January 2, 1993 (File
No. 1-8002))...............................................
*10.3 Tax Allocation Agreement dated as of September 27, 1995
between Thermo Electron and the Registrant.................
*10.4 Master Repurchase Agreement dated as of September 27, 1995
between Thermo Electron and the Registrant.................
*10.5 Master Guarantee Reimbursement Agreement dated as of
September 27, 1995 between Thermo Electron and the
Registrant.................................................
*10.6 Master Guarantee Reimbursement Agreement dated as of
September 27, 1995 between ThermoTrex and the Registrant...
+10.7 OEM Agreement between Philips Medical Systems North
American Company and Lorad dated as of November 2, 1993....
+10.8 OEM Agreement between Philips Medical Systems North
American Company and Lorad dated November 17, 1993.........
*+10.9 Purchase Agreement between General Electric Company and
Bennett dated November 17, 1994............................
*+10.10 Agreement between Philips Medizin Systeme
Unternehmensbereich der Philips GmbH and Bennett dated
February 12, 1992..........................................
*+10.11 Distributor Agreement between ThermoTrex and US Surgical
Corporation dated October 20, 1995, as amended.............
*10.12 Note Purchase and Sale Agreement dated as of October 2,
1995 between ThermoTrex and the Registrant.................
10.13 Lease dated as of September 15, 1995, by and among
ThermoTrex and BK Realty Associates, L.P. and Calrob Realty
Associates (filed as Exhibit 10.26 to ThermoTrex's Annual
Report on Form 10-K for the fiscal year ended September 30,
1995 [File No. 1-10791] and incorporated herein by
reference).................................................
*10.14 Lease dated as of December 20, 1995, between Melvyn J.
Powers and Mary P. Powers D/B/A M&M Realty and Lorad, as
amended....................................................
*10.15 Equity Incentive Plan of the Registrant....................
*10.16 Deferred Compensation Plan for Directors of the
Registrant.................................................
*10.17 Directors Stock Option Plan of the Registrant..............
</TABLE>
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*10.18 Form of Indemnification Agreement for Officers and
Directors.
In addition to the stock-based compensation plans of the
Registrant, the executive officers of the Registrant may be
granted awards under stock-based compensation plans of the
Registrant's parent, Thermo Electron Corporation, and its
subsidiaries, for services rendered to the Registrant or to
such affiliated corporations. Such plans are listed under
Exhibits 10.19-10.74 ......................................
10.19 Thermo Electron Corporation Incentive Stock Option Plan
(filed as Exhibit 4(d) to Thermo Electron's Registration
Statement on Form S-8 [Reg. No. 33-8993] and incorporated
herein by reference). (Maximum number of shares issuable in
the aggregate under this plan and the Thermo Electron
Nonqualified Stock Option Plan is 9,035,156 shares, after
adjustment to reflect share increases approved in 1984 and
1986, share decrease approved in 1989, and 3-for-2 stock
splits effected in October 1986, October 1993 and May
1995) .....................................................
10.20 Thermo Electron Corporation Nonqualified Stock Option Plan
(filed as Exhibit 4(e) to Thermo Electron's Registration
Statement on Form S-8 [Reg. No. 33-8993] and incorporated
herein by reference). (Plan amended in 1984 to extend
expiration date to December 14, 1994; maximum number of
shares issuable in the aggregate under this plan and the
Thermo Electron Incentive Stock Option Plan is 9,035,156
shares, after adjustment to reflect share increases
approved in 1984 and 1986, share decrease approved in 1989,
and 3-for-2 stock splits effected in October 1986, October
1993 and May 1995) ........................................
10.21 Thermo Electron Corporation Equity Incentive Plan (filed as
Exhibit 10.1 to Thermo Electron's Quarterly Report on Form
10-Q for the quarter ended July 2, 1994 [File No. 1-8002]
and incorporated herein by reference). (Plan amended in
1989 to restrict exercise price for SEC reporting persons
to not less than 50% of fair market value or par value;
maximum number of shares issuable is 7,050,000 shares,
after adjustment to reflect 3-for-2 stock splits effected
in October 1993 and May 1995 and share increase approved in
1994) .....................................................
10.22 Thermo Electron Corporation--Thermedics Inc. Nonqualified
Stock Option Plan (filed as Exhibit 4 to a Registration
Statement on Form S-8 of Thermedics [Reg. No. 2-93747] and
incorporated herein by reference). (Maximum number of
shares issuable is 450,000 shares, after adjustment to
reflect share increase approved in 1988, 5-for-4 stock
split effected in January 1985, 4-for-3 stock split
effected in September 1985, and 3-for-2 stock splits
effected in October 1986 and November 1993) ...............
10.23 Thermo Electron Corporation--Thermo Instrument Systems Inc.
(formerly Thermo Environmental Corporation) Nonqualified
Stock Option Plan (filed as Exhibit 4(c) to a Registration
Statement on Form S-8 of Thermo Instrument [Reg. No. 33-
8034] and incorporated herein by reference). (Maximum
number of shares issuable is 421,875 shares, after
adjustment to reflect 3-for-2 stock splits effected in July
1993 and April 1995 and a 5-for-4 stock split effected in
December 1995) ............................................
10.24 Thermo Electron Corporation--Thermo Instrument Systems Inc.
(formerly Thermo Environmental Corporation) Nonqualified
Stock Option Plan (filed as Exhibit 10.12 to Thermo
Electron's Annual Report on Form 10-K for the fiscal year
ended January 3, 1987 [File No. 1-8002] and incorporated
herein by reference). (Maximum number of shares issuable is
600,285 shares, after adjustment to reflect share increase
approved in 1988 and -for-2 stock splits effected in
January 1988, July 1993 and April 1995 and a 5-for-4 stock
split effected in December 1995)...........................
10.25 Thermo Electron Corporation--Thermo Terra Tech Inc.
(formerly Thermo Process Systems Inc.) Nonqualified Stock
Option Plan (filed as Exhibit 10.13 to Thermo Electron's
Annual Report on Form 10-K for the fiscal year ended
January 3, 1987 [File No. 1-8002] and incorporated herein
by reference). (Maximum number of shares issuable is
108,000 shares, after adjustment to reflect 6-for-5 stock
splits effected in July 1988 and March 1989, and 3-for-2
stock split effected in September 1989) ...................
</TABLE>
<PAGE>
<TABLE>
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10.26 Thermo Electron Corporation--Thermo Power Corporation
(formerly Tecogen Inc.) Nonqualified Stock Option Plan
(filed as Exhibit 10.14 to Thermo Electron's Annual Report
on Form 10-K for the fiscal year ended January 3, 1987
[File No. 1-8002] and incorporated herein by reference).
(Amended in September 1995 to extend the plan expiration
date to December 31, 2005) ................................
10.27 Thermo Electron Corporation--Thermo Cardiosystems Inc.
Nonqualified Stock Option Plan (filed as Exhibit 10.11 to
Thermo Electron's Annual Report on Form 10-K for the fiscal
year ended December 29, 1990 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of
shares issuable is 130,500 shares, after adjustment to
reflect share increases approved in 1990 and 1992, 3-for-2
stock split effected in January 1990, 5-for-4 stock split
effected in May 1990 and 2-for-1 stock split effected in
November 1993).............................................
10.28 Thermo Electron Corporation--Thermo Ecotek Corporation
(formerly Thermo Energy Systems Corporation) Nonqualified
Stock Option Plan (filed as Exhibit 10.12 to Thermo
Electron's Annual Report on Form 10-K for the fiscal year
ended December 29, 1990 [File No. 1-8002] and incorporated
hereby by reference) ......................................
10.29 Thermo Electron Corporation--ThermoTrex Corporation
(formerly Thermo Electron Technologies Corporation)
Nonqualified Stock Option Plan (filed as Exhibit 10.13 to
Thermo Electron's Annual Report on Form 10-K for the fiscal
year ended December 29, 1990 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of
shares issuable is 180,000 shares, after adjustment to
reflect 3-for-2 stock split effected in October 1993) .....
10.30 Thermo Electron Corporation--Thermo Fibertek Inc.
Nonqualified Stock Option Plan (filed as Exhibit 10.14 to
Thermo Electron's Annual Report on Form 10-K for the fiscal
year ended December 28, 1991 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of
shares issuable is 600,000 shares, after adjustment to
reflect 2-for-1 stock split effected in September 1992 and
3-for-2 stock split effected in September 1995) ...........
10.31 Thermo Electron Corporation--Thermo Voltek Corp. (formerly
Universal Voltronics Corp.) Nonqualified Stock Option Plan
(filed as Exhibit 10.17 to Thermo Electron's Annual Report
on Form 10-K for the fiscal year ended January 2, 1993
[File No. 1-8002] and incorporated herein by reference).
(Maximum number of shares issuable is 57,500 shares after
adjustment to reflect 3-for-2 stock split effected in
November 1993 and share increase approved in September
1995) .....................................................
10.32 Thermo Electron Corporation--Thermo BioAnalysis Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.31 to
Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573]
incorporated herein by reference) .........................
10.33 Thermo Electron Corporation--ThermoLyte Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.32 to
Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573] and
incorporated herein by reference) .........................
10.34 Thermo Electron Corporation--Thermo Remediation Inc.
Nonqualified Stock Option Plan (filed as Exhibit 10.33 to
Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573] and
incorporated herein by reference) .........................
10.35 Thermo Electron Corporation--ThermoSpectra Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.34 to
Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573] and
incorporated herein by reference) .........................
10.36 Thermo Electron Corporation--ThermoLase Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.35 to
Thermo Power's Annual Report on Form 10-K for the fiscal
year ended September 30, 1995 [File No. 1-10573] and
incorporated herein by reference) .........................
10.37 Thermo Electron Corporation--ThermoQuest Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.41 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
</TABLE>
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10.38 Thermo Electron Corporation--Thermo Optek Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.42 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.39 Thermo Electron Corporation--Thermo Sentron Inc.
Nonqualified Stock Option Plan (filed as Exhibit 10.43 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.40 Thermo Electron Corporation--Trex Medical Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.44 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.41 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Incentive Stock Option Plan (filed as Exhibit
10.18 to Thermo Electron's Annual Report on Form 10-K for
the fiscal year ended January 2, 1993 [File No. 1-8002] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Ecotek Nonqualified Stock Option Plan is 900,000
shares, after adjustment to reflect share increase approved
in December 1993) .........................................
10.42 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Nonqualified Stock Option Plan (filed as
Exhibit 10.19 to Thermo Electron's Annual Report on Form
10-K for the fiscal year ended January 2, 1993 [File No. 1-
8001] and incorporated herein by reference). (Maximum
number of shares issuable in the aggregate under this plan
and the Thermo Ecotek Incentive Stock Option Plan is
900,000 shares, after adjustment to reflect share increase
approved in December 1993) ................................
10.43 Thermo Ecotek Corporation (formerly Thermo Energy Systems
Corporation) Equity Incentive Plan (filed as Exhibit 10.39
to Thermo Instrument's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference) .........................
10.44 Thermedics Inc. Incentive Stock Option Plan (filed as
Exhibit 10(d) to Thermedics' Registration Statement on Form
S-1 [Reg. No. 33-84380) and incorporated herein by
reference). (Maximum number of shares issuable in the
aggregate under this plan and the Thermedics Nonqualified
Stock Option Plan is 1,931,923 shares, after adjustment to
reflect share increases approved in 1986 and 1992, 5-for-4
stock split effected in January 1985, 4-for-3 stock split
effected in September 1985, and 3-for-2 stock splits
effected in October 1986 and November 1993) ...............
10.45 Thermedics Inc. Nonqualified Stock Option Plan (filed as
Exhibit 10(e) to Thermedics' Registration Statement on Form
S-1 [Reg. No. 33-84380) and incorporated herein by
reference). (Maximum number of shares issuable in the
aggregate under this plan and the Thermedics Incentive
Stock Option Plan is 1,931,923 shares, after adjustment to
reflect share increases approved in 1986 and 1992, 5-for-4
stock split effected in January 1985, 4-for-3 stock split
effected in September 1985, and 3-for-2 stock splits
effected in October 1986 and November 1993) ...............
10.46 Thermedics Inc. Equity Incentive Plan (filed as Appendix A
to the Proxy Statement dated May 10, 1993 of Thermedics
[File No. 1-9567] and incorporated herein by reference).
(Maximum number of shares issuable is 1,500,000, after
adjustment to reflect 3-for-2 stock split effected in
November 1993) ............................................
10.47 Thermedics Inc.--Thermo Sentron Inc. Nonqualified Stock
Option Plan (filed as Exhibit 10.51 to Thermo Cardiosystems
Annual Report on Form 10-K for the fiscal year ended
December 30, 1995 [File No. 1-10114] and incorporated
herein by reference) ......................................
</TABLE>
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10.48 Thermedics Inc.--Thermedics Detection Inc. Nonqualified
Stock Option Plan (filed as Exhibit 10.20 to Thermo
Electron's Annual Report on Form 10-K for the fiscal year
ended January 2, 1993 [File No. 1-8002] and incorporated
herein by reference) ......................................
10.49 Thermedics Detection Inc.--Equity Incentive Plan (fiuled as
Exhibit 10.69 to Thermo Instrument's Annual Report on Form
10-K for the fiscal year ended December 31, 1994 [File No.
1-9786] and incorporated herein by reference) .............
10.50 Thermo Cardiosystems Inc. Incentive Stock Option Plan
(filed as Exhibit 10(f) to Thermo Cardiosystems'
Registration Statement on Form S-1 [Reg. No. 33-25144] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Cardiosystems Nonqualified Stock Option Plan is
1,143,750 shares, after adjustment to reflect share
increase approved in 1992, 3-for-2 stock split effected in
January 1990, 5-for-4 stock split effected in May 1990 and
2-for-1 stock split effected in November 1993) ............
10.51 Thermo Cardiosystems Inc. Nonqualified Stock Option Plan
(filed as Exhibit 10(g) to Thermo Cardiosystems'
Registration Statement on Form S-1 [Reg. No. 33-25144] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Cardiosystems Incentive Stock Option Plan is
1,143,750 shares, after adjustment to reflect share
increase approved in 1992, 3-for-2 stock split effected in
January 1990, 5-for-4 stock split effected in May 1990 and
2-for-1 stock split effected in November 1993) ............
10.52 Thermo Cardiosystems Inc. Equity Incentive Plan (filed as
Exhibit 10.46 to Thermo Instrument's Annual Report on Form
10-K for the fiscal year ended December 31, 1994 [File No.
1-9786] and incorporated herein by reference) .............
10.53 Thermo Voltek Corp. (formerly Universal Voltronics Corp.)
1985 Stock Option Plan (filed as Exhibit 10.14 to Thermo
Voltek's Annual Report on Form 10-K for the fiscal year
ended June 30, 1985 [File No. 0-8245] and incorporated
herein by reference). (Maximum number of shares issuable is
200,000 shares, after adjustment to reflect 1-for-3 reverse
stock split effected in November 1992 and 3-for-2 stock
split effected in November 1993) ..........................
10.54 Thermo Voltek Corp. (formerly Universal Voltronics Corp.)
1990 Stock Option Plan (filed as Exhibit 10.2 to Thermo
Voltek's Annual Report on Form 10-K for the fiscal year
ended June 30, 1990 [File No. 1-10574] and incorporated
herein by reference). (Maximum number of shares issuable is
400,000 shares, after adjustment to reflect share increases
in 1993 and 1994. 1-for-3 reverse stock split effected in
November 1992, and 3-for-2 stock split effected in November
1993) .....................................................
10.55 Thermo Voltek Corp. Equity Incentive Plan (filed as Exhibit
10.49 to Thermo Instrument's Annual Report on Form 10-K for
the fiscal year ended December 31, 1994 [File No. 1-9786]
and incorporated herein by reference) .....................
10.56 Thermo Instrument Systems Inc. Incentive Stock Option Plan
(filed as Exhibit 10(c) to Thermo Instrument's Registration
Statement on Form S-1 [Reg. No. 33-6762] and incorporated
herein by reference). (Maximum number of shares issuable in
the aggregate under this plan and the Thermo Instrument
Nonqualified Stock Option Plan is 2,812,500 shares, after
adjustment to reflect share increase approved in 1990 and
3-for-2 stock splits effected in January 1988, July 1993
and April 1995 and 5-for-4 stock split effected in December
1995) .....................................................
</TABLE>
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<TABLE>
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10.57 Thermo Instrument Systems Inc. Nonqualified Stock Option
Plan (filed as Exhibit 10(d) to Thermo Instrument's
Registration Statement on Form S-1 [Reg. No. 33-6762] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Instrument Incentive Stock Option Plan is 2,812,500
shares, after adjustment to reflect share increase approved
in 1990 and 3-for-2 stock splits effected in January 1988,
July 1993 and April 1995 and 5-for-4 stock split effected
in December 1995) .........................................
10.58 Thermo Instrument Systems Inc. Equity Incentive Plan (filed
as Appendix A to the Proxy Statement dated April 27, 1993
of Thermo Instrument [File No. 1-9786] and incorporated
herein by reference). (Maximum number of shares issuable is
4,031,250 shares, after adjustment to reflect share
increase approved in December 1993 and 3-for-2 stock split
effected in July 1993 and April 1995 and 5-for-4 stock
split effected in December 1995) ..........................
10.59 Thermo Instrument Systems Inc. (formerly Thermo
Environmental Corporation) Incentive Stock Option Plan
(filed as Exhibit 10(d) to Thermo Environmental's
Registration Statement on Form S-1 [Reg. No. 33-329] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Instrument (formerly Thermo Environmental
Corporation) Nonqualified Stock Option Plan is 1,160,156
shares, after adjustment to reflect share increase approved
in 1987 and 3-for-2 stock splits effected in July 1993 and
April 1995 and 5-for-4 stock split effected in December
1995) .....................................................
10.60 Thermo Instrument Systems Inc. (formerly Thermo
Environmental Corporation) Nonqualified Stock Option Plan
(filed as Exhibit 10(e) to Thermo Environmental's
Registration Statement on Form S-1 [Reg. No. 33-329] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Instrument (formerly Thermo Environmental
Corporation) Incentive Stock Option Plan is 1,160,156
shares, after adjustment to reflect share increase approved
in 1987 and 3-for-2 splits effected in July 1993 and April
1995 and 5-for-4 stock split effected in December 1995) ...
10.61 Thermo Instrument Systems Inc.--ThermoSpectra Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.51 to
Thermo Instrument's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994 [File No. 1-9786] and
incorporated herein by reference) .........................
10.62 Thermo Instrument Systems Inc.--Thermo BioAnalysis
Corporation Nonqualified Stock Option Plan (filed as
Exhibit 10.64 to Thermo Cardiosystems' Annual Report on
Form 10-K for the fiscal year ended December 30, 1995 [File
No. 1-10114] and incorporated herein by reference) ........
10.63 Thermo Instrument Systems Inc.--ThermoQuest Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.65 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.64 ThermoSpectra Corporation Equity Incentive Plan (filed as
Exhibit 10.52 to Thermo Instrument's Annual Report on Form
10-K for the fiscal year ended December 31, 1994 [File No.
1-9786] and incorporated herein by reference) .............
10.65 Thermo BioAnalysis Corporation Equity Incentive Plan (filed
as Exhibit 10.67 to Thermo Cardiosystems' Annual Report on
Form 10-K for the fiscal year ended December 30, 1995 [File
No. 1-10114] and incorporated herein by reference) ........
10.66 Thermo Optek Corporation Equity Incentive Plan (filed as
Exhibit 10.68 to Thermo Cardiosystems' Annual Report on
Form 10-K for the fiscal year ended December 30, 1995 [File
No. 1-10114] and incorporated herein by reference) ........
</TABLE>
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10.67 ThermoQuest Corporation Equity Incentive Plan (filed as
Exhibit 10.69 to Thermo Cardiosystems' Annual Report on
Form 10-K for the fiscal year ended December 30, 1995 [File
No. 1-10114] and incorporated herein by reference) ........
10.68 ThermoTrex Corporation (formerly Thermo Electron
Technologies Corporation) Incentive Stock Option Plan
(filed as Exhibit 10(h) to ThermoTrex's Registration
Statement on Form S-1 [Reg. No. 33-40972] and incorporated
herein by reference) (Maximum number of shares issuable in
the aggregate under this plan and the ThermoTrex
Nonqualified Stock Option Plan is 1,945,000 shares, after
adjustment to reflect share increases approved in 1992 and
1993 and 3-for-2 stock split effected in October 1993) ....
10.69 ThermoTrex Corporation (formerly Thermo Electron
Technologies Corporation) Nonqualified Stock Option Plan
(filed as Exhibit 10(i) to ThermoTrex's Registration
Statement on Form S-1 [Reg. No. 33-40972] and incorporated
herein by reference) (Maximum number of shares issuable in
the aggregate under this plan and the ThermoTrex
Nonqualified Stock Option Plan is 1,945,000 shares, after
adjustment to reflect share increases approved in 1992 and
1993 and 3-for-2 stock split effected in October 1993) ....
10.70 ThermoTrex Corporation-ThermoLase Corporation (formerly
ThermoLase Inc.) Nonqualified Stock Option Plan (filed on
Exhibit 10.53 to ThermoTrex Corporation's Annual Report on
Form 10-K for the fiscal year ended January 1, 1994 [File
No. 1-10791] and incorporated herein by reference .........
10.71 ThermoTrex Corporation--Trex Medical Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.73 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.72 ThermoLase Corporation (formerly ThermoLase Inc.)
Nonqualified Stock Option Plan (filed as Exhibit 10.54 to
ThermoTrex's Annual Report on Form 10-K for the fiscal year
ended January 1, 1994 [File No. 1-10791] and incorporated
herein by reference). (Maximum number of shares issuable in
the aggregate under this plan and the ThermoLase Incentive
Stock Option Plan is 2,800,000 shares, after adjustment to
reflect share increase approved in 1993 and 2-for-1 stock
splits effected in March 1994 and June 1995) ..............
10.73 ThermoLase Corporation (formerly ThermoLase Inc.) Incentive
Stock Option Plan (filed as Exhibit 10.55 to ThermoTrex
Corporation's Annual Report on Form 10-K for the fiscal
year ended January 1, 1994 [File No. 1-10791] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
ThermoLase Nonqualified Stock Option Plan is 2,800,000
shares, after adjustment to reflect share increase approved
in 1993 and 2-for-1 stock splits effected in March 1994 and
June 1995) ................................................
10.74 ThermoLase Corporation Equity Incentive Plan (filed as
Exhibit 10.81 to Thermo TerraTech's Annual Report on Form
10-K for the fiscal year ended April 1, 1995 [File No. 1-
9549] and incorporated herein by reference) ...............
10.75 Thermo Fibertek Inc. Incentive Stock Option Plan (filed as
Exhibit 10(k) to Thermo Fibertek's Registration Statement
on Form S-1 [Reg. No. 33-51172] and incorporated herein by
reference .................................................
10.76 Thermo Fibertek Inc. Nonqualified Stock Option Plan (filed
as Exhibit 10(l) to Thermo Fibertek's Registration
Statement on Form S-1 [Reg. No. 33-51172] and incorporated
herein by reference .......................................
10.77 Thermo Fibertek Inc. Equity Incentive Plan (filed as
Exhibit 10.60 to Thermo Instrument's Annual Report on Form
10-K for the fiscal year ended December 31, 1994 [File No.
1-9786] and incorporated herein by reference ..............
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10.78 Thermo Power Corporation (formerly Tecogen Inc.) Incentive
Stock Option Plan (filed as Exhibit 10(h) to Thermo Power's
Quarterly Report on Form 10-Q for the quarter ended April
3, 1993 [Reg. No. 33-10573] and incorporated herein by
reference). (Maximum number of shares issuable in the
aggregate under this plan and the Thermo Power Nonqualified
Stock Option Plan is 950,000 shares, after adjustment to
reflect share increases approved in 1990, 1992 and 1993) ..
10.79 Thermo Power Corporation (formerly Tecogen Inc.)
Nonqualified Stock Option Plan (filed as Exhibit 10(i) to
Thermo Power's Quarterly Report on Form 10-Q for the
quarter ended April 3, 1993 [Reg. No. 33-10573] and
incorporated herein by reference). (Maximum number of
shares issuable in the aggregate under this plan and the
Thermo Power Incentive Stock Option Plan is 950,000 shares,
after adjustment to reflect share increases approved in
1990, 1992 and 1993) ......................................
10.80 Thermo Power Corporation Equity Incentive Plan (filed as
Exhibit 10.63 to Thermo Instrument's Annual Report on Form
10-K for the fiscal year ended December 31, 1994 [File No.
1-9786] and incorporated herein by reference) .............
10.81 Thermo Power Corporation--ThermoLyte Corporation
Nonqualified Stock Option Plan (filed as Exhibit 10.84 to
Thermo Cardiosystems' Annual Report on Form 10-K for the
fiscal year ended December 30, 1995 [File No. 1-10114] and
incorporated herein by reference) .........................
10.82 ThermoLyte Corporation Equity Incentive Plan (filed as
Exhibit 10.71 to Thermo Power's Annual Report on Form 10-K
for the fiscal year ended September 30, 1995 [File No. 1-
10573] and incorporated herein by reference) ..............
10.83 Thermo TerraTech Inc. (formerly Thermo Process Systems
Inc.) Incentive Stock Option Plan (filed as Exhibit 10(h)
to Thermo Process' Registration Statement on Form S-1 [Reg.
No. 33-6763] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under
this plan and the Thermo TerraTech Nonqualified Stock
Option Plan is 1,850,000 shares, after adjustment to
reflect share increases approved in 1987, 1989 and 1992, 6-
for-5 stock splits effected in July 1988 and March 1989 and
3-for-2 stock split effected in September 1989) ...........
10.84 Thermo TerraTech Inc. (formerly Thermo Process Systems
Inc.) Nonqualified Stock Option Plan (filed as Exhibit
10(i) to Thermo Process' Registration Statement on Form S-1
[Reg. No. 33-6763] and incorporated herein by reference).
(Maximum number of shares issuable in the aggregate under
this plan and the Thermo TerraTech Incentive Stock Option
Plan is 1,850,000 shares, after adjustment to reflect share
increases approved in 1987, 1989 and 1992, 6-for-5 stock
splits effected in July 1988 and March 1989 and 3-for-2
stock split effected in September 1989) ...................
10.85 Thermo TerraTech Inc. (formerly Thermo Process Systems
Inc.) Equity Incentive Plan (filed as Exhibit 10.63 to
Thermedics' Annual Report on Form 10-K for the fiscal year
ended January 1, 1994 [File No. 1-9567] and incorporated
herein by reference). (Maximum number of shares issuable is
1,750,000 shares, after adjustment to reflect share
increase approved in 1994) ................................
10.86 Thermo TerraTech Inc. (formerly Thermo Process Systems
Inc.)--Thermo Remediation Inc. Nonqualified Stock Option
Plan (filed as Exhibit 10(l) to Thermo Process' Quarterly
Report on Form 10-Q for the fiscal quarter ended January 1,
1994 [File No. 1-9549] and incorporated herein by
reference) ................................................
10.87 Thermo Remediation Inc. Equity Incentive Plan (filed as
Exhibit 10.7 to Thermo Remediation's Registration Statement
on Form S-1 [Reg. No. 33-70544] and incorporated herein by
reference) ................................................
*10.88 License Agreement between the Registrant and ThermoTrex
dated as of October 16, 1995...............................
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*11 Computation of Earnings per Share.............................................................
*21 Subsidiaries of the Registrant................................................................
*23.1 Consent of Arthur Andersen LLP................................................................
*23.2 Consent of Arthur Andersen LLP................................................................
*23.3 Consent of Arthur Andersen LLP................................................................
*23.4 Consent of Topel Forman L.L.C. ...............................................................
*23.5 Consent of Seth H. Hoogasian, Esq. (included in Exhibit 5)....................................
*24 Power of Attorney.............................................................................
*27 Financial Data Schedule.......................................................................
*99.1 Form of Subscription Agency Agreement.........................................................
*99.2 Instructions as to use of Trex Medical Corporation Subscription Certificates and International
Holder Subscription Forms.....................................................................
*99.3 International Holder Subscription Form........................................................
*99.4 Form of Letter to Trex Medical stockholders...................................................
*99.5 Form of Letter to ThermoTrex stockholders.....................................................
</TABLE>
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* Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commission.
<PAGE>
CONFIDENTIAL TREATMENT
TREX MEDICAL CORPORATION HAS
REQUESTED THAT THE MARKED PORTIONS OF
THIS DOCUMENT BE ACCORDED CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER
THE SECURITIES ACT OF 1933, AS AMENDED.
OEM AGREEMENT
between
LORAD Corporation,
A subsidiary of Thermo Trex Corporation
36 Apple Ridge Road
Danbury, Connecticut 06810
hereinafter referred to as "LORAD"
and
Philips Medical Systems North America Company
Division of Philips Electronics North America Corporation
P. O. Box 860
710 Bridgeport Avenue
Shelton, Connecticut 06484
hereinafter referred to as "PMSNA"
Subject:
Supply of Mobile Radiographic X-Ray Systems
1. Introduction and Definitions
1.1 Introduction
Whereas, LORAD is a company engaged in the marketing and
distribution of, among other things, mobile radiographic x-ray systems;
Whereas, LORAD has designed and developed a mobile radiographic x-
ray system, its Model RT 125 Mobile Radiographic Unit, is willing to
modify it according to legal requirements and certain PMSNA
specifications and is interested meeting PMSNA's requirements for such
modified product as an OEM for PMSNA, on an exclusive and long-term
basis;
Whereas, PMSNA desires to purchase from LORAD a minimum quantity
of said product, modified for PMSNA as further specified in this OEM
Agreement and the Exhibits hereto, for resale either directly and/or
through any of the Philips Associated Companies, its/their distributors,
agents and dealers;
Whereas, LORAD and PMSNA want to establish the terms and conditions
under which during the term of this Agreement LORAD shall supply the
modified Model RT 125 Mobile Radiographic Unit to PMSNA for
subsequent resale.
<PAGE>
NOW THEREFORE, IN CONSIDERATION OF THE MUTUAL PROMISES
AND PREMISES HEREINAFTER SET FORTH, THE PARTIES HERETO
HAVE AGREED AS FOLLOWS:
1.2 Definitions
1.2.1 "Agreement"
means this present document and all the Exhibits and other
documents incorporated by reference herein or attached hereto and
signed or initialed by the parties hereto, all of which Exhibits or other
documents are an integral part hereof.
1.2.2 "Batteries"
means the batteries which power the Product, the battery
charging system and associated housings, containers, etc. as more fully
described in Exhibit I hereto.
1.2.3 "Confidential Information"
means any and all information whether obtained or given
orally or in writing concerning either party not generally known to
persons not associated with the disclosing party, including, without
limitation, information about product discovery and development,
manufacturing processes and techniques, samples, drawings, customer
marketing and new product data, trade secrets, computer programming
techniques and business strategy, financial data and all other
proprietary or trade secret information of whatever description.
1.2.4 "Documentation"
shall mean the technical documentation by type or subpart
for Product(s) including, without limitation, electrical diagrams and parts
lists, necessary to incorporate the Product in or connect to other PMSNA
systems, respectively to service and sustain the Product in the field, all
as further specified in Article 3, and Exhibits I and II hereto.
1.2.5 "First Commercial Delivery"
means the earliest date on which Product which conforms to the
Specifications and which has successfully completed testing as set forth in
Section 3.2 below, for which a Release for Delivery Certificate is issued and
for which all legal and regulatory requirements for distribution and marketing
in ****************************have been met, is delivered to a customer of
PMSNA in the ordinary course of PMSNA's business. Delivery of Product to a
clinical site as an investigational device or for evaluation for marketing
purposes or to serve as a "show" or "seed" site for demonstration of the Product
to prospective customers shall not be considered to be a delivery in the
ordinary course of PMSNA's business.
1.2.6 "Form, Fit or Function"
means items, components, or processes that are sufficient to
enable physical and functional interchangeability, in particular as to
source, size, configuration, mating, and attachment characteristics,
functional characteristics, and performance requirements.
2
<PAGE>
1.2.7 "OEM"
means original equipment manufacturer.
1.2.8 "Option(s)"
means all those parts or accessories for Product(s) which can
be ordered from LORAD and be shipped on request. They will be specified,
as necessary, in close consultation between LORAD and PMSNA. They
are listed or may later be added to Exhibit I hereto and identified by a
special PMSNA code number.
1.2.9 "Philips Associated Companies"
shall mean any and all companies, firms and legal entities
with respect to which now or hereafter Philips Electronics N.V. directly or
indirectly holds 50% or more of the nominal value of the issued share
capital or has 50% or more of the voting power at general meetings or
has the power to appoint a majority of the directors or otherwise directs
the activities of such company, firm or legal entity but any such company
firm or legal entity shall be deemed a Philips Associated Company only as
long as such liaison exists.
1.2.10 "Product(s)"
jointly and severally shall mean the PMSNA versions of
LORAD's Model RT 125 Mobile Radiographic Unit including Options and
Accessories, as further set forth in the Specifications, including any
changes thereto, as well as such new models and options and
accessories as the parties hereto may agree to include under this
Agreement by amendment to this Agreement and Exhibits I and III
hereto.
1.2.11 "Purchase Order(s)"
shall mean the purchase order(s) for Products which will be
placed by the Purchasing Department of PMSNA with reference to this
Agreement.
1.2.12 "Software/Firmware"
shall mean all computer programs either on disk, diskettes
or embedded in other carriers (e.g. PROMS etc.) consisting of the set of
logical instructions and tables of the information which guide the
functioning of the processors, such programs include all necessary
operating system software, application software, related documentation
useful with Software/Firmware such as functional descriptions, design
documentation, program description and listings as well as the source
code versions itself on disk, all as specified in Exhibits I and II hereto.
1.2.13 "Spare Part(s)"
shall mean those items listed as such in Exhibit II (Spare
Parts, Prices and other Service Aspects) hereto and any and all other
components or items necessary to allow PMSNA or its customers to keep
the Product in good repair throughout its useful life.
1.2.14 "Specification(s)"
shall mean the final functional requirements, technical
specifications, drawings, documentation and other requirements of the
Product(s) all as set forth in this Agreement and in Exhibit I hereto and
3
<PAGE>
such amendments thereto as the parties hereto may agree upon from
time to time, in writing.
1.2.15 "Term"
means the time period set forth in Section 13.1 below and
any extensions thereof.
1.2.16 "Territory"
shall mean **************************.
1.2.17 "Time Schedule"
shall mean the time schedule attached hereto as Exhibit IV.
2. Scope of Agreement
2.1 Delivery and Purchases
Subject to the terms of this Agreement, LORAD agrees to manufacture
and to supply and deliver Product(s) and Spare Parts (such manufacture,
supply and delivery of Product(s) in PMSNA's trade dress and of any
Option(s) and Spare Parts which are unique to Product(s), being
exclusively to PMSNA) and
PMSNA agrees to purchase and take delivery of Product(s), Option(s) and
Spare Parts from LORAD for marketing, subsequent resale, installation,
service and maintenance in the Territory.
2.2 Branding and Trademark
The Product will be sold under trademarks or trade names designated
(and solely owned) by PMSNA and will be branded with the Philips logo
and shield emblem and/or any other trademark or trade or brand name
that may be specified by PMSNA from time to time, in writing. The
trademark or trade name that PMSNA is considering for assignment to
the Product(s) as of the date of this Agreement is "PMX-2000." The
trademarks or trade names to be applied will either be in the form of
labeling provided by PMSNA or printed on the product, packaging,
manuals or other documentation in accordance with written instructions
provided by PMSNA.
2.3 Marketing Rights/License
2.3.1 Marketing
LORAD herewith grants to PMSNA the ***************************** to
sell, install, maintain and/or repair the Product(s)) and/or the individual
items thereof, within the Territory.
LORAD further agrees that, for a period of two years from the date of the
First Commercial Delivery of Product(s) under this Agreement, *****
*********************************** LORAD sells mobile radiographic
systems ******************************************, under a trademark
or trade name *************************************************
4
<PAGE>
Model RT 125 Mobile Radiographic Unit *******************************
********************** manufactured or distributed by LORAD.
************************************************************************
**********************:
- *************************************************
- *********************************************************************
*********************************************************************
*************************************************.
2.3.2 Regulatory Requirements
LORAD agrees to obtain for PMSNA all regulatory approvals and clearances
necessary for distribution and marketing of the Product(s), Option(s), Spare
Parts, upgrades or enhancements in ********************and also to provide to
PMSNA all documentation and assistance which is reasonably necessary for PMSNA
or a Philips Associated Company to complete all submittals for the regulatory or
other governmental approvals and clearances necessary for marketing and
distribution of Product(s), Option(s), Spare Parts, or upgrades or enhancements
to them, elsewhere in the Territory, in addition to assuring, that the
Product(s) meets all the requirements and standards listed in the Specification,
including labeling and certifications of compliance as set forth in the
Specification.
Furthermore, LORAD agrees to provide PMSNA with all current
information of the kind which is generally made available by
manufacturers of medical devices to their sales and service personnel
made concerning hardware and Software/Firmware modifications or
upgrades to the Product.
2.3.3 Marketing of Other Products
If LORAD, during the Term, offers a new mobile radiographic system and
sells such system directly or to LORAD's dealers under LORAD's own
name, this system shall, at PMSNA's option, be distributed by PMSNA in
place of the PMSNA version of the Model RT 125 Mobile Radiographic
Unit.
Such new mobile radiographic x-ray system or accessory or option for
such new mobile radiographic x-ray system or for LORAD's Model RT 125
Mobile Radiographic Unit, which is developed by LORAD for sale under
its own name shall also be made available to PMSNA for distribution in a
special version in PMSNA's trade dress. If PMSNA is interested in such
new product of LORAD, the parties shall in good faith negotiate the terms
for its distribution by PMSNA. PMSNA shall be the only reseller
supported by LORAD as original equipment supplier, of any new LORAD
mobile radiographic x-ray system, as set forth in section 2.3.1 above,
during the rest of the two year term specified in section 2.3.1 for
********* OEM distribution.
5
<PAGE>
LORAD agrees to make available to PMSNA all minor updates and
improvements which it develops for its LORAD's Model RT 125 Mobile
Radiographic Unit product, at no additional charge.
3. Product
3.1 Product Definition
3.1.1 Specification
The Specifications of the Product are incorporated and made a part of this
Agreement as Exhibit I and Exhibit V hereto.
LORAD agrees to adapt the Specifications of the Product as a result of
tests performed together by LORAD and PMSNA or according to further
requirements of PMSNA (subject to acceptance of such additional
requirements by LORAD) and will update the Specifications and provide
PMSNA with the revised version thereof. Upon written agreement of
LORAD and PMSNA such revised Specifications will be added to this
Agreement and replace the earlier version thereof.
3.1.2 Operator's Manuals
Part of the Product will also be the Operator's Manual, written in English
and French. Such Operator's Manual shall comply with the legal
requirements of ******************************* and be made in
accordance with the Philips house-style manual, an example of which
shall be supplied by PMSNA. LORAD shall be solely responsible for the
content of these manuals, even though they are in Philips' standard
format and even though parts of them may not be identical to the
manuals LORAD has prepared for its own version of the mobile x-ray
systems. PMSNA shall be responsible for the preparation and cost of
translation into all other languages as may be required and for the
expense of any arrangements made with LORAD for distribution of
Operator's Manuals in such other languages and for compliance of the
Operator's Manual with the legal requirements of all other jurisdictions.
3.2 Testing, Type-Approval, Release for Delivery
Prior to execution of this Agreement LORAD has consigned to PMSNA --
free of charge -- a test unit prototype ("Test Unit"). As a result of initial
tests PMSNA may require that certain additions, alterations or
modifications in the said Product are incorporated in order to reach full
compliance with PMSNA's requirements.
LORAD will provide PMSNA with a second test unit (collectively, with the
Test Unit, "Test Units") to comply with the Specifications and with such
changes as may be agreed upon by LORAD and PMSNA. LORAD will
provide PMSNA with the results and supporting data of all tests
performed within its development department, all in accordance with the
Time Schedule in Exhibit IV hereto.
Together with the Test Units LORAD shall provide PMSNA with
preliminary Documentation and technical service information.
6
<PAGE>
The Test Unit(s) shall be delivered "F.O.B." (as that term is defined in the
Connecticut Uniform Commercial Code, C.G.S. sec. 42a-2-319), at
LORAD's facility in Danbury, Connecticut.
PMSNA will execute such type-approval tests as PMSNA may reasonably
require to satisfy PMSNA that the Test Units conform to the
Specifications and PMSNA shall keep LORAD informed of the results of
the tests and will give LORAD a reasonable opportunity to be present at
said tests.
a. If, as a result of these tests, PMSNA is of the reasonable opinion to
be confirmed in writing that certain additions, alterations or
modifications in the Test Unit(s) are required in order that the Test
Unit(s) comply with the Specifications or to eliminate faulty or
substandard workmanship and/or material, LORAD undertakes to
modify and to make same in the Test Unit(s) and to supply to
PMSNA all at LORAD's cost and expense, the changed Test Unit(s).
b. If, as a result of these tests, PMSNA desires modifications or
enhancements of the Test Unit(s) in excess of the Specifications
and which were not earlier agreed upon, then, if both parties
hereto so agree, LORAD will provide a quotation and a revised Time
Schedule for PMSNA approval and the execution by LORAD of any
such modification or enhancements shall be the subject of a
separate Purchase Order by PMSNA.
Upon the finalization of the tests and changes requested by PMSNA and
agreed upon by LORAD and if PMSNA is reasonably satisfied that the
second test unit complies with its Specifications, PMSNA shall provide
LORAD with a written Release for Delivery Certificate signed by an officer
of PMSNA.
Upon PMSNA's satisfaction that the Test Units conform to the
Specifications or should the Test Units fail to comply with the
Specifications after the tests described above, the Test Units shall either
(i) be returned to LORAD in the same manner delivered to PMSNA or (ii)
be purchased by PMSNA at a price to be agreed upon between the
parties.
Any new or replacement version of the Product and Option(s) for PMSNA,
shall require a similar procedure for testing and releasing as described
above.
3.3 Modifications, Engineering Change Control
Once PMSNA has released the Product(s) for delivery LORAD shall not,
except as may be required by law, make any changes or modifications in
the Product(s), Spare Parts, Option(s) and/or Specifications which affect
Form, Fit or Function, intended use, labeling, listing or other certification
by standards agencies (as set forth in Exhibit I hereto), or which affect
government approvals or clearances of the Product(s) or Option(s) or
which affect the Spare Part stock, without the prior, written consent of
PMSNA. PMSNA's consent shall not be unreasonably withheld.
7
<PAGE>
The foregoing provision is intended, in particular, to assure continuing
conformity with the Specifications.
This requirement, however, does not preclude LORAD from using
equivalent components and parts that do not affect Form, Fit or Function
of the Product and/or interchangeability of Spare Parts and/or
compliance with the Specifications, Standards, Approval or
Certifications.
In the event LORAD uses such equivalent components and/or parts
LORAD shall provide PMSNA with an updated version of the
Documentation as soon as possible without additional charge to PMSNA.
If LORAD wishes to make a modification requiring PMSNA's consent,
LORAD shall, with sufficient lead time for PMSNA to process the request
before the modification is scheduled to be implemented, notify PMSNA in
writing of the proposed modification. The documentation and Philips
terminology used for the approval process for such modifications is:
ECR (Engineering Change Request): a standard form sheet, to be used
for all engineering and design data regarding such proposed
modifications.
ECC (engineering change committee): the PMSNA committee
responsible for discussing and deciding about such proposals
ECO (Engineering Change Order): the form sheet on which
decision of the ECC will be documented and released.
for a sample of form sheets see Exhibit VI.
In order to assist PMSNA in expediting these approvals, LORAD agrees to
submit ECR's and ECO in the format prescribed.
3.4 Proposals
During production of the Test Unit(s) PMSNA's technical, quality and
service experts are entitled to make suggestions and proposals, but such
suggestions and proposals shall be binding on LORAD and PMSNA only
if confirmed in a document signed by authorized representatives of both
parties.
3.5 New Type of Product Under this Agreement
If the parties hereto wish to introduce a new type of Product under this
Agreement, LORAD shall -- before the start of commercial deliveries of
such new type of Product -- execute such type approval tests as are
approved by PMSNA in order to ascertain that the new Product conforms
to its Specifications. LORAD shall promptly provide PMSNA with the
evidence thereof whereupon the Agreement shall be amended to reflect
any such change to the Specification.
8
<PAGE>
3.6 Continuity of Production, Supply of Products
In the event LORAD wishes to stop production of Product(s) LORAD shall
inform PMSNA thereof as early as possible but, in any event, at least
****************** prior to the date that production would be
discontinued. PMSNA shall then have the opportunity to place a final
Purchase Order in such quantities as PMSNA may require and LORAD
shall accept such Purchase Orders at a reasonable price (not exceeding
that set forth in Exhibit III if such production is discontinued during the
time schedule set forth in Exhibit III) to be agreed upon by the parties in
good faith. *************************************************************
*******************************************************************
************************************************************************
*************************, special attention to be given
to the Spare Part(s) supply as set forth in Exhibit II hereto, paragraphs 7
and 10 thereof.
Moreover, when LORAD gives notice that such production is to be
discontinued, ***********************************************************
*********************************************************************
************************************************************************
******************************************************************
*********************************************************************
*************************************************************************
*********************************************************************
**********************************************************************
***************************.
4. Planning and Ordering
4.1 Minimum Purchases
PMSNA agrees to purchase a minimum of three hundred (300) units of
Product(s) during the Term of this Agreement. The schedule for these
deliveries shall be as set forth in Exhibit III hereto.
4.2 General Planning
PMSNA and LORAD expect an increase in manufacturing and sales
activity for the Product(s) as indicated in Exhibit III hereto in response to
customer demand during the first years of the Term. The figures in
Exhibit III hereto and in later PMSNA forecasts, are not intended as
Purchase Orders, but rather as an indication, for planning purposes, of
expected market activity. Delivery dates, quantities, options included
and configuration of each unit of Product shall be specified by PMSNA
only by Purchase Order using the procedure described in Section 4.3
below.********************************************************************
************************************************************************
************************************************************
***************** minimum purchase commitment in Section 4.1
above.
9
<PAGE>
4.3 Forecast
4.3.1 Rolling Forecast, "Just in Time" Deliveries
A mutually satisfactory procedure will be established in which
production and shipment of Product and Spare Parts is matched as
closely as possible with the related demand set by orders from PMSNA's
customers.
The demand will be transmitted to LORAD by fax or telex as rolling
forecast with the following information:
Rolling Forecast:
********************** for ********************** will be renewed and
issued to LORAD on or about *******************************************
******************** according to the following *********************,
*********************forecast, during:
- months 1-3: ***************** indicated on an issue
************************* for *****************
*******************.
*****************************************************************
**************************************************************
*************************************************
*************************************
***************************************rolling forecast
*****************************************************************
************************************************
- ************ **********************************************
*******************************************
*************************rolling forecast)
*******************************************
***************************************
LORAD will use this planning to assure delivery of Product(s) and
Option(s) "just in time" within the requested delivery dates.
In order for PMSNA to minimize shipping and handling expenses, *****
***************************************************************************
******************** *.
4.3.2 Additional Quantities
Although it is the intention of the parties to assure a smooth delivery
schedule in accordance with *****************************, PMSNA may
require additional deliveries ********************* as indicated.
Then, LORAD shall use its best efforts to supply such additional
quantities.
10
<PAGE>
4.3.3 Shortage or Lack of Parts
Subject to Article 14 hereof, if LORAD can no longer or expects that it
will not (on short notice) be able to supply Product(s) to PMSNA because
of a shortage or lack of components and/or Spare Parts, LORAD shall
immediately inform PMSNA thereof and, at its own expense, take all
steps which are reasonable in the circumstances, including a redesign of
the Product(s), to obtain an additional supplier or suppliers for such
component or Spare Part.
The redesigned product shall be subject to the procedure set forth in
Article 3 of this Agreement.
4.4 Order and Delivery
4.4.1 Purchase Orders
At the beginning of each month PMSNA shall issue separate Purchase
Orders containing the consolidated figures as agreed upon.
Each Purchase Order shall specify at a minimum:
PMSNA-12-digit-code number
Price
Quantities and
Requested delivery day/week,
to cover at least the period of the commitment of the rolling forecast as
mentioned above.
The "requested delivery" specified for each shipment will be the date for
"receipt by PMSNA at the address stated on the Purchase Order form."
All Purchase Orders shall be deemed to incorporate and be subject to the
terms and conditions of this Agreement, as well as any supplemental
terms and conditions agreed to in writing by authorized representatives
of the parties. No other terms and conditions contained on any Purchase
Order form or any other form, agreement or correspondence originated
by either party, shall apply.
4.4.2 Confirmation, Delivery Dates
Purchase Orders will be confirmed by LORAD within one (1) week after
receipt by mail or telefax. They shall then be binding on LORAD and
PMSNA as set forth in Section 4.3.1 above and may be canceled only if
LORAD or PMSNA materially defaults in its execution thereof or if
otherwise agreed upon between the parties hereto.
LORAD shall take adequate delivery and transportation times into
account and shall meet the agreed upon delivery dates for each Purchase
Order. Any deviation from the delivery date specified which can be
foreseen during execution of a Purchase Order will be communicated to
PMSNA immediately. The delivery date for a unit of Product will normally
11
<PAGE>
be ***************** after receipt of PMSNA's Purchase Order, but may
be earlier or later if the parties so agree.
5. Pricing
5.1 Prices
During the term of this Agreement PMSNA will purchase and accept from
LORAD Product(s) at prices which, including their period of validity, are
specified in Exhibit III hereto. The lower pricing listed in Exhibit III
hereto for the second and subsequent years after the First Commercial
Delivery shall apply as soon as the total quantity purchased by PMSNA
during the Term is at the level shown for the prior year, even though that
prior year may not have ended at the time that level of purchases is
reached.
All agreed modifications at PMSNA's request as listed in Exhibit I hereto
are included in the price of the Product.
It is expressly understood that PMSNA's going prices in the market must
be competitive with similar products. In the event of unforeseen
circumstances affecting LORAD or PMSNA or both and/or in the event
the price/performance ratio of Products deteriorates as compared to
competitive products, the parties hereto will jointly review the situation
and attempt to find a solution reasonably acceptable to both parties.
Prices include adequate packing and any royalties or fees for licenses of
Software/Firmware for each Product.
All prices will be expressed in United States dollars ($).
5.2 Price Changes, Binding Prices
The prices of the Products set forth in Exhibit III hereto shall remain
valid for the time specified therein.
When price negotiations referred to in this Article 5 extend beyond the
price validity period the prices valid for the previous period will continue
to remain in effect until such time as the parties have reached mutual
agreement on the new prices.
5.3 Most Favored Treatment
In the event, that during the Term, LORAD would normally ***********
***** it supplies on an OEM basis or LORAD's distributors/dealers
********************************************************************************
**********************************************************RT125**************
**********************************************************************
*************************************************************************
********************************************************************************
****************
12
<PAGE>
5.4 Delivery Conditions, Transportation
Products and Spare Parts shall be delivered "F.O.B." (as that term is
defined in the Connecticut Uniform Commercial Code, C.G.S. sec. 42a-2-
319), at LORAD's facility in Danbury, Connecticut.
PMSNA shall be responsible for shipping arrangements.
5.5 Payment Conditions
Payment from PMSNA to LORAD shall be made within *********************
***, after date of invoice and delivery. A finance charge not to exceed the
lesser of *************************** or the maximum rate allowed by
law may be assessed by LORAD against any balance due LORAD which
is not paid when due.
5.6 Advance or Excess Deliveries
Unless mutually agreed upon by the parties hereto, LORAD shall not
deliver Products in excess of the quantities ordered nor in advance of the
agreed delivery date. Absent such agreement, if such advance or excess
deliveries occur, PMSNA shall be entitled - at its option - to refuse those
Products or keep them at its warehouse. Payment under any invoice
related to those deliveries shall not be due until the date originally set for
such delivery.
5.7 Invoices
All invoices shall contain at least the following information:
Purchase Order Number
Type-Number of Product (PMSNA's 12-digit ID-number)
Name of the Product
Serial Number(s) thereof
Indication of "certifiable items," contained in the Product
Unit price and total price
Bill of lading number
Invoices shall be submitted (an original and three copies) separately for each
shipment.
6. Production, Packing and Shipping
6.1 Production
The Products will be manufactured and tested by LORAD in accordance with the
Specification.
6.2 Product Identification and Labeling
LORAD shall mark the Products in accordance with PMSNA's marking
specifications, set forth in Exhibit I hereto and - if applicable - with
electrical current and frequency data.
13
<PAGE>
The S/N-number shall be listed and used on all documents, such as test
protocols, delivery papers and invoices for easy evaluation and cross
reference.
6.3 Packing, Delivery
The prices referred to include all appropriate and safe packing of
Product(s), Option(s), Spare Parts and all other items supplied for air
and ocean transport, unless otherwise specified in Exhibit I hereto.
The Packing shall be tested by PMSNA and approved in accordance with
the relevant sections of Philips Packing Standard UN-D 1400, Publication
no. UN-D 1400 (69), 1990-08-31. LORAD will use only this approved
packing method of shipment of the Product(s). Changes in approved
packing may be introduced only on PMSNA's written request or after
PMSNA's prior written approval.
The Products will be packed in a neutral box. There will be no other logo
or trademark inside or outside the packing. LORAD will, however, place
promotional stickers on the packing as PMSNA may require. Such
stickers will be supplied by PMSNA at no charge.
6.4 Labeling and Marking for Shipment, Trademarks
LORAD shall mark all packages and shipping papers (if applicable) with:
Type-Number of Product (PMSNA's 12-digit ID-number)
Name of the Product
Serial Number thereof
Indication of "certifiable items," contained in the Product,
Number of packages, if the shipment contains more than one
package per product.
Products shall only bear trademarks, trade names or other indications as
detailed in Exhibit I hereto.
Either party hereto acknowledges the other party's rights in and to said
other party's trademarks and trade names. Except as expressly set forth
in this Agreement, the manufacture and supply of Product(s), Option(s),
Spare Parts and packing with said trademarks and trade names shall not
be considered as giving either party any right to the other party's
trademarks and trade names or similar trademarks and trade names.
6.5 Execution of Logistic Procedures
PMSNA may have the Graner Company division of Philips Electronics
North America Corporation or Philips GmbH execute logistic procedures,
such as, without limitation, placing Purchase Orders for any shipments
of Product(s) sent *************************, payment of invoices,
transport arrangements, shipping instructions and handling of return
shipments for repair or replacement on behalf of PMSNA. LORAD agrees
to accept Purchase Orders from Graner Company or Philips GmbH and
deal directly with them or their authorized agents with regard to
14
<PAGE>
scheduling, invoicing, warranty claims and all matters relating to
Purchase Orders issued by Graner Company or Philips GmbH.
6.6 Export and Import Documentation
PMSNA shall obtain, at its own expense, any export or other official
authorization and carry out any other formalities necessary for the
transportation, exportation and importation of Product(s), Options and
Spare Parts to all jurisdictions in the Territory. LORAD shall provide all
documentation (including test reports) reasonably necessary for PMSNA
to prepare and submit the required documentation and to obtain any
authorization necessary for such export and import.
Except as to compliance with the standards and legal requirements set
forth in the Specification and in Exhibit V, PMSNA shall be responsible
for ensuring that the Product(s) comply with all local laws, standards and
regulations in the jurisdictions in the Territory, other than **********
******************. LORAD shall be solely responsible for such
compliance including labeling or listing Product(s), Option(s) or Spare
Part(s) as may be required by the electrical codes, ordinances or
regulations of ****************************.
7. Quality
7.1 Design Requirement, Compliance
All obligations for testing of Product, Option(s) or Spare Parts to confirm
that they comply with the Specification shall be the responsibility of
LORAD. Should it become evident that any Product(s), Option(s), Spare
Part(s) or parts thereof are not in compliance with the applicable
requirements of this Agreement and Exhibits I, II and V hereto, LORAD
shall make all necessary corrections at its own expense.
7.2 Change in Requirements, Regulations or Standards
If any of the requirements, safety regulations and/or standards listed in
the Specifications or in Exhibit V hereto change, LORAD shall, at its
costs, make all the necessary modifications in and to the Product,
Option(s) and/or parts thereof, including any Product(s) to which the
change applies which have not then been accepted by the end-user.
Subject to the provisions of this Section 7.2, implementation of
modifications or changes to Product(s) and Option(s) to comply with the
safety requirements of any and all applicable statutes, rules and
regulations, shall be mandatory.
If a revision or modification to any applicable standard or regulation
results in extraordinary cost or expense to LORAD, the parties shall
review and evaluate the change and make all reasonable efforts to find
an acceptable solution. Notwithstanding the foregoing, any revision or
modification to any applicable regulation or standard which is listed in
the Specification, which cannot be incorporated in the Product(s) at
a reasonable expense in LORAD's sole discretion (to be absorbed by
15
<PAGE>
LORAD) will be considered an event of force majeure as set forth in
Article 14 below.
7.3 Quality System, Quality Control/Audits
LORAD agrees that its quality system shall comply with the regulations
pertaining to the United States Food and Drug Administration ("FDA"),
Good Manufacturing Practices ("GMP") and shall also use its best efforts
to comply prior to the end of 1995 with the International Organization for
Standardization ("ISO") standards entitled ISO 9001 "Quality systems --
Model for quality assurance in design/development, production,
installation and servicing" and "Quality Systems -- Model for quality
assurance in production and installation" ISO 9002 (a copy of the ISO
certification shall be attached to this Agreement as Exhibit VII when
received).
Upon request and at least two (2) weeks - advance written notice to
LORAD, PMSNA's representative(s) or an independent notified body
acceptable under GMP or ISO, may visit, at their expense, the facilities of
LORAD at reasonable times to inspect the storage and quality of parts for
Product in LORAD's facilities, and audit the quality control procedures
and methods applied by LORAD in its facilities in the development and
manufacturing and assembling of Products in accordance with GMP and,
after LORAD obtains such certification, with ISO-9001.
With regard to the CE Mark, a certification which is to become
mandatory in the European Community, the parties have agreed that
LORAD will be responsible for this approval/certification by December
31, 1995, but that PMSNA or one of the Philips Associated Companies
will support LORAD in its contacts with the concerned European notified
body. Cost consequences of design changes, if any, caused by changes
relating to CE Mark certification are for the account of LORAD.
7.4 Outgoing Inspection and Record Keeping
It is understood between the parties that under normal circumstances
Product(s) may be shipped directly by LORAD to customers in **********
**************** or to Philips Associated Companies for any sales in
*********************, or, preferably, to their final destination. Hence,
PMSNA shall not be obligated to execute any incoming inspection or
other inspection of Product(s), Option(s) or Spare Part(s) delivered
hereunder by LORAD, for non-compliance with the Specifications.
Therefore, LORAD shall inspect all outgoing Product(s), Option(s) and/or
parts thereof to be supplied to PMSNA strictly in accordance with
Specifications and with the Acceptance Procedure as specified in Exhibit
VIII hereto. This Acceptance Procedure will be set up or adapted --
if necessary -- in close cooperation between the quality officers of both
companies.
LORAD will archive in a safe manner all records of the Product(s), or
Option(s) e.g. the Product master file and especially all records/test
protocols, for a period as required by law, but at least ************** after
16
<PAGE>
delivery of each Product or Option. These records will be made available
if necessary and upon specified request of PMSNA.
7.5 Incoming Inspection
PMSNA may inspect the delivered Product(s), Option(s) and Spare Part(s)
at PMSNA's factory or at PMSNA's customer's site, following the
Acceptance Procedures set forth in this Agreement and the Exhibits
hereto. PMSNA shall have the right to reject all or any of the Product(s),
Option(s) or Spare Parts which are proven, upon inspection and testing
by PMSNA, not to meet the applicable Specifications, provided that such
claim shall be submitted to LORAD with the supporting evidence within
thirty (30) days after arrival date at the destination. LORAD shall ship a
replacement within thirty (30) days of receipt of notice that a Product,
Option or Spare Part is to be returned for such reason.
8. Warranty
8.1 Extent of Warranty
LORAD warrants to PMSNA, Graner Company and Philips GmbH that
the Product(s), Option(s) and Spare Parts including the Software/
Firmware incorporated therein, comply in all material respects with the
Specifications for such Product(s), Option(s) and Spare Parts, are new
and are free from defects in material and workmanship. Except as
provided in Article 10 below, LORAD's sole obligation under the foregoing
warranty shall be to replace or repair, at its sole discretion and at its sole
cost and expense, any defective Product(s), Option(s) or Spare Parts
returned to LORAD by or on behalf of PMSNA or a Philips Associated
Company; provided, however, that (i) LORAD's sole obligation to replace
or repair Product(s), Options(s) or Spare Parts shall not exceed the lesser
of the lesser of ******************** from the date of delivery of such
Product(s), Option(s) or Spare Parts by LORAD to PMSNA or a Philips
Associated Company or ****************** from the date of completion of
its installation at a customer's site, (ii) PMSNA or its Associated Company
shall have notified LORAD, prior to the expiration of such period, with
respect to each claim that the Product(s), Option(s) or Spare Parts are
defective, and (iii) LORAD shall have no obligation to repair or replace the
defective Product(s), Option(s) or Spare Parts in the event that the
Product(s), Option(s) or Spare Parts have been transported, handled,
stored or operated in an improper or other manner which adversely
affects the Product(s), Option(s) or Spare Parts.
In addition, LORAD warrants that the Batteries incorporated in each unit
of Product(s) shall be free of defects in material or workmanship and
operate satisfactorily, provided such Batteries are maintained in
accordance with the instructions in the Operator's Manual, for a period
of *************** from the date of shipment by LORAD to PMSNA or
Graner Company. LORAD shall replace without charge, including
charges for packing (and shipment to PMSNA in Shelton, Connecticut or
to Graner Company in Port Chester, New York), Batteries which fail,
during this ************************, to be free from defects in material
and workmanship or to operate satisfactorily, provided such Batteries
are maintained in accordance with the instructions in the Operator's
17
<PAGE>
Manual. The battery manufacturer's standard warranty shall apply to
replacement Batteries provided under this warranty, except that the
duration of the warranty shall not be less than the unexpired part of the
original three year term.
LORAD shall use its reasonable best efforts to replace or repair Products,
parts of Products, Options and Spare Parts, if required by this Section, at
LORAD's cost within the shortest possible time.
8.2 Cost of Warranty Replacement or Repair
During the time LORAD's warranty is in effect for each unit of Product,
each Option and each Spare Part, LORAD shall provide without charge to
PMSNA all replacement parts necessary to correct any such Product,
Option or Spare Part which proves to be defective and shall pay all
shipping expenses (including reasonable return shipping expenses)
associated with such replacement.
8.3 Limited Warranty
EXCEPT AS EXPRESSED OR SET FORTH IN THIS AGREEMENT AND
THE EXHIBITS HERETO, PRODUCT(S), OPTION(S) AND SPARE PART(S)
SHALL BE SUPPLIED BY LORAD TO PMSNA, GRANER COMPANY OR
PHILIPS GMBH, "AS IS." LORAD HEREBY DISCLAIMS ANY AND ALL
REPRESENTATIONS AND WARRANTIES (OTHER THAN THOSE SET
FORTH IN THIS AGREEMENT) EXPRESS OR IMPLIED, WITH RESPECT
TO THE PRODUCT(S), OPTION(S) AND SPARE PARTS, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. PMSNA ACKNOWLEDGES
AND AGREES THAT IT HAS NOT RELIED ON ANY REPRESENTATIONS
OR WARRANTIES MADE BY LORAD, EXCEPT AS SET FORTH IN THIS
ARTICLE.
8.4 Epidemic Faults
Products, Options and Spare Parts shall be free of Epidemic Faults.
Epidemic Faults are, for the purpose of this Agreement, defined as
defects which
- either are the same or have the same origin and occur over a
period of ****************** during the ************* expected
lifetime of the product with a class failure quantity of at least
************************ sequentially delivered Products,
Options or Spare Parts, from the delivery date of the last
sequentially delivered Product, Option or Spare Part, and
- are such that they create an "unreasonable risk of
substantial harm" as that term is defined by the United
States Food, Drug and Cosmetic Act and the regulations
and guidelines issued thereunder.
In the event of the existence of an Epidemic Fault, the parties shall
consult with and cooperate fully with each other in a timely way to
determine if a safety concern exists and to take the appropriate actions
18
<PAGE>
and to allocate the resulting costs of such actions between them in
accordance with the terms hereof.
LORAD shall within ***************** after receipt of same respond to any
question and provide all necessary information to the PMSNA Service
Department arising out of a recall or corrective action program or related
program.
Furthermore LORAD shall inform PMSNA of all relevant details of
substantially similar incidents that occur with LORAD's products similar
to or part of Products.
In case of such Epidemic Fault(s), in any part or parts of Products or any
required recall program, LORAD shall, at its expense (including shipment
to each customer's site), provide sufficient parts to replace all such parts
in installed Products and Products purchased by PMSNA.
Spare Parts in stock which become obsolete due to Epidemic Fault(s)
may be returned to LORAD and will be credited at the original invoice
price or upgraded to the desired level at the expense of LORAD.
LORAD shall repair or replace uninstalled Products, Options and Spare
Parts which are subject to Epidemic Faults. LORAD warrants the
Products, Options and Spare Parts not yet delivered will be so upgraded.
For Products and Options in the installed base, upgraded components or
parts will be made available from LORAD at no charge and PMSNA will
be responsible for removing the old components or parts and installing
the new ones.
The remedies contained in this Section 8.4 shall be the sole remedies
available to PMSNA in the event of an Epidemic Fault as defined herein,
subject to the limitations set forth in Section 10.3 hereof.
9. Service and Spare Parts
The Spare Parts supply, maintenance and repair of Product and general
product and service support for the Product to be provided by each of
the parties shall be as set forth in Exhibit II hereto.
10. Claims
10.1 Personal Injury and Property Damage
LORAD agrees to defend, indemnify and hold harmless PMSNA and
Philips GmbH from and against any and all loss, cost and expense,
including counsel fees and all expenses of investigation, litigation,
judgment and/or settlement, arising through or out of personal injury or
death to person(s) or damage to property alleged or proven to have arisen
out of failure of a Product(s), Option(s) or Spare Parts to meet the
Specification or as a result of a defect in its workmanship or materials,
provided, that in any such case where indemnification is sought
hereunder (i) PMSNA or Philips GmbH shall have given prompt written
notice to LORAD of such claim and the facts and circumstances relating
thereto, (ii) PMSNA shall fully cooperate with LORAD in connection with
19
<PAGE>
any such claim by any governmental authority or third party, (iii) LORAD
shall have the sole right to defend, settle and compromise any such
claim, and (iv) LORAD shall have no obligation to indemnify and hold
harmless PMSNA for any negligent conduct of PMSNA or any action or
omission by PMSNA in violation of this Agreement.
PMSNA agrees to defend, indemnify and hold harmless LORAD from and
against any and all loss, cost and expense, including counsel fees and all
expenses of investigation, litigation, judgment and/or settlement, arising
through or out of personal injury or death of person(s) or damage to
property which is alleged or proven to have arisen out of the negligent act
or omission of PMSNA, its officers, directors, employees or agents,
provided, that in any such case where indemnification is sought
hereunder (i) LORAD shall have given prompt written notice to PMSNA of
such claim and the facts and circumstances relating thereto, (ii) LORAD
shall fully cooperate with PMSNA in connection with any such claim by
any governmental authority or third party, (iii) PMSNA shall have the sole
right to defend, settle and compromise any such claim, and (iv) PMSNA
shall have no obligation to indemnify and hold harmless LORAD for any
negligent conduct of LORAD or any action or omission by LORAD in
violation of this Agreement.
LORAD shall obtain and maintain current, at all times during the Term
of this Agreement and any extensions hereof, Commercial General
Liability insurance (including products and contractual coverage) with an
insurance company rated by Best "A" or better, in amounts not less than
***********single limit and ***********combined single limit. Such
insurance shall cover, among other things, product liability claims
relating to the Product. LORAD shall provide PMSNA with a certificate of
such insurance from LORAD's insurer, updated upon expiration thereof.
Such certificate shall designate PMSNA as a certificate holder. PMSNA
shall receive no less than thirty (30) days prior written notice of
cancellation or termination of such insurance.
10.2 Intellectual Property Indemnification
10.2.1 Indemnification by LORAD
LORAD shall defend PMSNA and its respective distributor, agent, dealer
or customer against any claim by a third party that manufacture, sale or
use of a Product(s), Option(s) or Spare Part infringes *******************
**************************************************************************
************** and LORAD will pay any resulting penalties, judgments or
awards finally determined by a court or other tribunal of competent
jurisdiction to be payable in connection therewith, or amounts payable in
settlement thereof, provided that in any such case where indemnification
is sought by PMSNA hereunder (i) PMSNA shall have given prompt
written notice to LORAD of such claim and the facts and circumstances
relating thereto, (ii) PMSNA shall fully cooperate with LORAD in
connection with any such claim, (iii) LORAD shall have the sole right to
defend, settle and compromise any such claim and (iv) LORAD shall have
no obligation to indemnify and hold harmless PMSNA for any negligent
conduct of PMSNA or for any action or omission by PMSNA in violation
of this Agreement. LORAD's obligations under this Article are
20
<PAGE>
conditioned on PMSNA's agreement that, if the Product(s), Option(s)
or Spare Part or the manufacture, sale or use thereof becomes or in
LORAD's reasonable opinion is likely to become, the subject of such a
claim, PMSNA will permit LORAD, at any time thereafter, at LORAD's
expense, either to procure the right for PMSNA to continue selling the
Product(s), Option(s) or Spare Part or to replace or modify the Product(s),
Option(s) or Spare Part so that it becomes non-infringing, and if neither
of the foregoing alternatives is available on terms which are acceptable to
LORAD in its reasonable judgment, LORAD may terminate this
Agreement immediately as to that part of the Territory in which
manufacture, sale or use of the Product(s), Option(s) or Spare Part may
be infringing and/or terminate this Agreement in its entirety with notice
as set forth in Section 3.6 above and LORAD shall reimburse PMSNA for
the purchase price actually paid by PMSNA, less an allowance for
depreciation, for Product(s) and Option(s) which can no longer be sold by
PMSNA or a Philips Associated Company or used by their customers.
The foregoing states the entire liability of LORAD with respect to
infringement of rights in intellectual property.
Notwithstanding the foregoing, LORAD shall have no liability to PMSNA
to the extent that any such claim is based upon or arises out of: (i)
alterations of the Product(s), Option(s) or Spare Part by PMSNA or any
third party, (ii) failure of PMSNA to use updated Product(s), Option(s) or
Spare Parts provided by LORAD to avoid such infringement, (iii) use of
the Product(s), Option(s) or Spare Parts in combination with apparatus or
software not furnished by LORAD, (iv) use of the Product(s), Option(s) or
Spare Parts in a manner for which such Product(s), Option(s) or Spare
Parts were neither designed nor contemplated or (v) a patent or
trademark owned by PMSNA or for which PMSNA has a royalty-free
license which precludes it from being held responsible for such claim of
infringement.
10.2.2 Indemnification by PMSNA
PMSNA shall defend LORAD and its respective distributor, agent, dealer
or customer against any claim by a third party that manufacture, sale or
use of any material(s) supplied by PMSNA hereunder infringes a********
********************patent, copyright, trade secret, mask work or other
intellectual property right and PMSNA will pay any resulting penalties,
judgments or awards finally determined by a court or other tribunal of
competent jurisdiction to be payable in connection therewith, or amounts
payable in settlement thereof, provided that in any such case where
indemnification is sought by LORAD hereunder (i) LORAD or shall have
given prompt written notice to PMSNA of such claim and the facts and
circumstances relating thereto, (ii) LORAD shall fully cooperate with
PMSNA in connection with any such claim, (iii) PMSNA shall have the
sole right to defend, settle and compromise any such claim and (iv)
PMSNA shall have no obligation to indemnify and hold harmless LORAD
for any negligent conduct of LORAD or for any action or omission by
LORAD in violation of this Agreement. PMSNA's obligations under this
Article are conditioned on LORAD's agreement that, if such material(s) or
the manufacture, sale or use thereof becomes or in PMSNA's reasonable
opinion is likely to become, the subject of such a claim, LORAD will
permit PMSNA, at any time thereafter, at PMSNA's expense, either to
21
<PAGE>
procure the right for LORAD to continue reselling such material(s) or to
replace or modify such material(s) so that it becomes non-infringing, and
if neither of the foregoing alternatives is available on terms which are
acceptable to PMSNA in its reasonable judgment, PMSNA may terminate
this Agreement immediately as to that part of the Territory in which
manufacture, sale or use of such material(s) may be infringing and/or
terminate this Agreement in its entirety with notice as set forth in
Section 3.6 above and PMSNA shall reimburse LORAD for the purchase
price actually paid by LORAD, less an allowance for depreciation, for
such material(s) which can no longer be sold by LORAD or used by its
customers. The foregoing states the entire liability of PMSNA with
respect to infringement of rights in intellectual property.
Notwithstanding the foregoing, PMSNA shall have no liability to LORAD
to the extent that any such claim is based upon or arises out of: (i)
alterations of such material(s) by LORAD or any third party, (ii) failure of
LORAD to use updated material(s) provided by PMSNA to avoid such
infringement, (iii) use of such material(s) in combination with apparatus
or software not furnished by PMSNA, (iv) use of such material(s) in a
manner for which such material(s) were neither designed nor
contemplated or (v) a patent or trademark owned by LORAD or for which
LORAD has a royalty-free license which precludes it from being held
responsible for such claim of infringement.
10.3 Limitation
In no event shall either party be liable to the other for special, indirect or
consequential damages of any kind including, but not limited to, loss of
other business opportunity, profit or revenue or loss of goodwill, arising
from any failure or matter arising under this Agreement. No claim or
recovery by one party against the other shall be greater in amount than
the purchase price of the individual unit of Product(s), Option(s) or Spare
Part with respect to which such claim or recovery arose.
Notwithstanding the foregoing, any obligation of the parties under
Section 10.1 above with respect to personal injury or death to persons or
damage to property shall not exceed ************************* and
*********************************, and any obligation under Section
10.2 above with respect to intellectual property shall not exceed the
aggregate purchase price to PMSNA of the Product(s) involved.
11. ********************
11.1 ********************************
Without limiting LORAD's liability to PMSNA thereunder in any way
whatsoever, it has been agreed that if LORAD;
a) intends to enter or actually enters liquidation procedures
(either voluntarily or forced); or
b) has entered bankruptcy procedures (either voluntarily or
forced); or
22
<PAGE>
c) within ninety days of written notification by PMSNA has not
remedied any material breach of this Agreement,
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
***********************************, if and to the extent required by PMSNA,
in exchange for compensation by PMSNA for LORAD's purchase price
therefor.
********** as used in this Article 11 shall mean *******************
relating to the ************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
************************************************************.
11.2 Right to Produce
Accordingly, ******************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
******************************
12. Confidentiality
The parties shall not use, employ or disclose Confidential Information
received from the other whether orally, in writing, by demonstration
or otherwise except as is necessary to implement this Agreement, unless
and to the extent the receiving party can prove by written record that it:
a. was already in the public domain or becomes available to the
public through no breach of this Agreement by the receiving
party;
b. was in the receiving party's possession prior to receipt from
the disclosing party as proven by its written records; or
c. was received independently from third party free to disclose
such information to the receiving party or
23
<PAGE>
d. was independently developed by the receiving party without
use of the Confidential Information as proven by its written
records; or
e. became available by inspection or analysis of other products
or techniques in the market.
In protecting Confidential Information, the receiving party will take all
necessary precautions and Confidential Information will be treated in the
same manner and with the same degree of care as the receiving party
applies with respect to its own confidential information.
Nothing contained in this Article shall be construed as a grant of license
to the other party, to make, use or sell any Products using Confidential
Information or as a license under any patents or claims covering same.
The first disclosure to the media or other first publication of data
concerning the cooperation envisaged under this Agreement, including
the existence of the Agreement itself, shall not be effected unless the
nondisclosing party has given its written approval for such disclosure,
which approval shall not be unreasonably withheld and which shall be
given in a prompt manner.
LORAD may, however file a copy of this Agreement Securities and
Exchange Commission pursuant to the requirements of the Securities
Act of 1933, as amended or the Securities Exchange Act of 1934, as
amended, provided that LORAD files a confidentiality request with the
Securities and Exchange Commission seeking to protect the
confidentiality of the pricing and forecasts in Exhibit III.
The provisions of this Article shall be in full force and effect retroactively
from March 18, 1992 and shall remain in full force and effect during the
duration of this Agreement and five (5) years thereafter.
13. Term and Termination
13.1 Term
This Agreement shall enter into force upon the date of signature by both
parties and shall initially continue until the earlier of two years from the
date of the First Commercial Delivery of Product(s) under this Agreement
or fulfillment of the minimum purchase commitment set forth in Section
4.1 above.
********************************************************************************
*****************, unless and until ********************************************
***************************************************prior written notice to
the receiving party, such notice being given as set forth in 15.10 below.
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*****************************************. Any such notice(s) shall be
24
<PAGE>
effective as of the date received (certified mail return receipt requested)
by the other party.
13.2 Termination for Cause
This Agreement may also be terminated as follows:
a. if a party (the failing party) has not remedied any material
breach of this Agreement within ninety (90) days of receipt of
written notice (sent in accordance with Section 15.10 hereof)
of such breach, said other party is entitled to terminate this
Agreement and or any outstanding Purchase Orders placed
hereunder immediately by notice to the failing party, such
without prejudice to any other rights accruing under this
Agreement or in law.
b. by the other party in the event that either party shall cease
to carry on business in the normal course, becomes
insolvent, makes a general assignment for the benefit of its
creditors, suffers or permits the appointment of a receiver or
a manager for its business assets or avails itself or becomes
subject to any proceeding under bankruptcy laws or any
other statute or laws relating to the insolvency or protection
of the rights of creditors,
c. by PMSNA by written notice to LORAD in the event the
control of LORAD would pass to other(s) than those now
exercising control.
13.3 Continuing Commitments
The termination of this Agreement shall not relieve or release either party
from fulfilling any undertaking or commitment including, without
limitation, those affecting payments, work and deliveries which arise by
reason of any event other than termination, such as, for example, those
arising from Purchase Orders placed pursuant to this Agreement prior to
its termination.
14. Force Majeure
In the event of Force Majeure the party being delayed or damaged
thereby shall inform the other party as soon as possible but in any event
within fourteen (14) calendar days after the start of such Force Majeure
specifying the nature of the Force Majeure as well as the length of the
delay which is expected.
In the event the Force Majeure situation continues for more than sixty
days (60) days or is expected to last longer than sixty (60) days then
either party is entitled to terminate this Agreement by simple notice in
writing and without either party being entitled to any claim for damages.
Otherwise both parties' rights and obligations will be suspended and new
time schedules and supply dates shall be agreed upon between the
parties hereto.
25
<PAGE>
Force Majeure shall be understood to mean and to include damage or
delay by acts of God, acts of regulations or decrees of any Government
(de facto or de jure), natural phenomena, such as earthquakes or floods,
fires, riots, wars, shipwrecks, freight embargoes, labor disputes, defaults
by suppliers or other causes, whether similar or dissimilar to those
enumerated above, unforeseeable and beyond the reasonable control of
the parties and which prevent the total or partial carrying out of any
obligation under this Agreement.
PMSNA's purchase commitments under this Agreement are based on
present market information and estimates shared by both parties and
market growth figures extrapolated from that information. In the event
of unforeseen circumstances, major shifts in the market for radiographic
equipment (such as the rapid development of significant new ultrasound
technology similar to that being developed by other subsidiaries of
Thermo Trex Corporation which renders the Product obsolete) or other
occurrences which make distribution and sale not only of Product, but
also of substantially similar products by other firms in the industry,
impracticable at the levels contemplated by this Agreement, the parties
shall negotiate in good faith and agree upon alternative quantities which
are acceptable to both and reasonable given the then-current nature of
the market for radiographic equipment.
15. General Terms and Conditions
15.1 Applicable Law
This Agreement shall be deemed to have been made in the State of
Connecticut, shall be construed in accordance with, and the rights and
liabilities of the parties hereunder shall be governed by the laws of such
State, without regard to its conflicts of law doctrine, and this Agreement
shall be deemed in all respects to be a contract of such State.
15.2 Attorney's Fees
In the event of any claim or controversy arising regarding the
enforceability, interpretation or intent of this Agreement, the prevailing
party or parties (to the extent prevailing) shall be entitled to its
reasonable attorney's fee and expenses in addition to whatever other
relief said party would otherwise be entitled.
15.3 Entire Agreement
This Agreement sets forth the entire intent and understanding among the
parties relating to the subject matter hereof and merge all prior
negotiations and discussions between them and no party shall be bound
by any conditions, representations or warranty other than as expressly
set forth herein or subsequently set forth in writing executed by both
parties hereto.
Neither PMSNA's general conditions of purchase nor LORAD's general
conditions of sales are applicable to this Agreement or to any order and
order confirmations for Products or parts thereof in whole or in part.
26
<PAGE>
15.4 Waiver
No waiver by any of the parties hereto of any breach of any condition,
covenant or term thereof shall be effective unless it is in writing and it
shall not constitute a waiver of such condition, covenant or term.
15.5 Severability
If any of the terms or provisions of this Agreement are determined to be
invalid or unenforceable by any court of competent jurisdiction, it shall
not invalidate the rest of this Agreement which shall remain in full force
and effect as if such terms and provisions had not been a part of this
Agreement.
The parties shall, however, be obliged to immediately replace this term or
provision by an effective one, covering in so far as possible the original
intentions of the parties as to its legal and economic contents.
15.6 Non-Assignment
This Agreement shall be binding upon and accrue to the benefit of the
parties hereto, their respective successors and permitted assigns. This
Agreement may not be assigned, transferred or hypothecated in whole or
in part by either party except prior written consent of the other party. No
consent is required, however, to an assignment or transfer in whole or in
part by PMSNA to any of the Philips Associated Companies. PMSNA shall
notify LORAD of such assignment or transfer in writing.
15.7 Advertisements
LORAD shall not without PMSNA's prior written consent use PMSNA's or
any other of the Philips Associated Companies' name or trademark as
such and/or use name in connection with any advertisement or sale
literature nor advertise that it is a supplier of PMSNA and/or the Philips
Associated Companies and/or that this Agreement between LORAD and
PMSNA has been concluded.
15.8 Sales and Applications Support
LORAD agrees to provide four applications training courses at its facility
at Danbury, Connecticut for PMSNA personnel who will be responsible
for training PMSNA customers in the use of Product(s) and Option(s).
There shall be no charge by LORAD for these four initial training
courses which shall be of no more than two days, duration or for any
updates in training which may be necessary because of modifications or
improvements to the System. All travel and living expenses for PMSNA's
and LORAD's employees shall be at PMSNA's and LORAD's expense,
respectively. LORAD agrees to provide additional applications training to
support the Systems and any new accessories or System features, at
PMSNA's request and at such reasonable rates as LORAD and PMSNA
may agree upon. These rates when quoted by LORAD shall include all
incidental expenses, including those of travel and living expenses of
LORAD's employees.
27
<PAGE>
LORAD agrees to provide training in Shelton, Connecticut or Danbury,
Connecticut for PMSNA service engineers or PMSNA personnel
responsible for training its service engineers on the terms set out in
Exhibit II hereto.
15.9 Project Leaders
Upon the signature of this Agreement either party shall appoint, by
written notice, a Project Leader who shall represent his party in all
communication, contacts, meetings, negotiations and reports, of
technical nature as necessary for the performance of this Agreement. An
eventual subsequent change of the Project Leader shall be notified in
writing to the other party.
15.10 Notices
Notices will be addressed as follows:
If to PMSNA: Philips Medical Systems North
America Company.
710 Bridgeport Avenue
Shelton, Connecticut 06484
Attn: Vice President,
Marketing
cc: Vice President and
General Counsel
If to LORAD: LORAD Corporation,
36 Apple Ridge Road
Danbury, Connecticut 06810
Attn: Mr. A. Pellegrino
cc: Mr. H. Kirshner
or to such other address as the pertaining party will have previously
notified to the other party.
All notices will be deemed given ten (10) working days after they have
been mailed by registered mail or so much earlier as the receiving party
appears to have received the same.
15.11 Compliance with Law
Except to the extent it is precluded from doing so by the law of its
principal place of business, each party agrees that the performance of its
obligations, exercise of its rights and fulfillment of its duties under this
Agreement shall comply with applicable laws and ordinances of each
government having jurisdiction over such activity and all lawful orders,
rules and regulations issued thereunder. The Product(s), Option(s) and
Spare Part(s) in the form they are provided by LORAD to PMSNA shall
comply with all lawful orders, rules and regulations applicable in the
************************ to their shipment, installation and use.
28
<PAGE>
15.12 Surviving Articles
Articles 8, 9, 10, 11, 12, 15 and, as to Purchase Orders which have not
been filled as of the date of termination or cancellation, Articles 4, 5, 6
and 7 and such other terms and conditions of this Agreement which are
expressly intended to survive the expiration, termination or cancellation
of this Agreement shall so survive.
IN WITNESS WHEREOF authorized representatives of the parties hereto
have signed this document.
LORAD CORPORATION PHILIPS MEDICAL SYSTEMS
NORTH AMERICA COMPANY
By: /s/ Hal Kirshner By: /s/ William E Curran
------------------- ------------------------
Hal Kirshner William E. Curran
President Chief Operating &
Financial Officer
Date: November 2, 1993 Date: 11/2/95
------------------ ----------------------
29
<PAGE>
List of Exhibits
Exhibit I Specification
Exhibit II Service Arrangements
Appendix 1 Field Problem Report
Appendix 2 List of Spare Parts
Exhibit III Planning and Prices
Exhibit IV Time Schedule
Exhibit V Declaration
Exhibit VI Standard Form for Change Request
Exhibit VII ISO9000 Certificate
(to be added when obtained by LORAD)
30
<PAGE>
Exhibit 1
SPECIFICATIONS
PMX 2000 Mobile Radiographic System
Description:
The PMX 2000************************************************
***********************************************************
*********************************************************
* *************
* *******************
* ************************************************
* ***********
* ****************************
* ******************************
Subsystem Description:
***********
-----------
***** **************************************************
******* **************************************************
*******
**************************************************************
**********
************************************************************
**************************
***********
-----------
*************************************************************
*******************************
**************************************************************
*******************************************
************************************************
************************************************************
**********************
*********************
***************
***********************
************************
*************************
*******************************Increments
*********************increments down 20% increments
***************
<PAGE>
************************
**************************************************************
***************************************************
********************************
***********************************************
****************
*********************************
---------------------------------
********* ********
**** ************
********** ******
************ ***
************* *********
************* ******
*************** ***********************
******************* *******
*********************
*************** ********
****************
**********************************
**********
----------
**** *******************************************
***************************************
*********** *******************************************
***********
************************
------------------------
******* **
***** **************
******* ***************
*********** ***********************************
********************************** *****************
******************
**********
******* *********
******************************
------------------------------
**************************************************
**************************************************
********************************************************
******************************************************
******************
*************************
2
<PAGE>
***********************
-----------------------
**************************************
**************************************************
********
********************************
******************************
***************************************
************************
*********************************
************************ *****************
******************
*****************************************
**************** ********************
**************** ******************
******************
************ ***********************
************* ******************************
********* *******
*************************
************************************************************
********************************************************
***********************************************************
******************************************
**************************
*************************** **************************
*************************** *************************
**************** ********
******************* ********
**************** ************ *****
**************** **** *****
*********************
---------------------
****************
*********************
************************************************************
****************************
***************
*****************************************************
**************************
3
<PAGE>
October 19, 1993
Exhibit II
Service Arrangements
Exhibit II to the OEM Agreement between Lorad Corporation ("LORAD")
and Philips Medical Systems North America Company ("PMSNA") for
supply of portable radiographic x-ray systems.
1. Responsibilities for Product Service
Unless agreed to otherwise,
PMSNA is responsible for:
- installing and commissioning,
- training of the user
- maintenance and repair at customers' sites
- regular training of the PMSNA field engineers
LORAD is responsible for:
- provision and accuracy of documentation
- spare parts supply
- provision of special tools as required for repair of
Product(s),
Option(s) or Spare Parts
- initial training and support of PMSNA service staff and
regular training upon request
2. Product Delivery
The requirements for delivery of Product(s), Option(s) and Spare Parts
are
as set forth in the Agreement and in the other Exhibits to it.
2.1 Service Documentation
2.1.1 Preparation of Service Documentation
PMSNA will supply, at no cost to LORAD, binders with PMSNA's standard
register into which the service documentation enumerated below shall
be
inserted by LORAD (hereinafter, the "Service Documentation" or, as
assembled, the "Service Manual"). The binders will be ordered by
LORAD
from the PMSNA service organization with at least two months lead time
before the date they will be needed by LORAD for assembly of the
Service
Manuals.
The address for PMSNA's service organization is:
<PAGE>
Philips Medical Systems North America Co.
P.O. Box 860
710 Bridgeport Avenue
Shelton, Connecticut 06484
LORAD shall furnish to PMSNA ninety (90) days before the First
Commercial Delivery of Product, free of charge, two sets of Service
Documentation. If the Service Documentation complies with Philips'
standards, PMSNA will approve it for delivery and use by Philips'
service
organization.
The Service Documentation labeling shall carry only the "Philips" name,
trademark and Product or Option name (rather than LORAD's trademark
or tradename for that product).
PMSNA will assist LORAD in producing the said Service Documentation,
but each party will bear its own costs with respect to preparing the
Service Documentation.
The Service Documentation will be updated by LORAD during the lifetime
of the Product(s) or Option(s) to include all implemented changes and
modifications pertaining to Product(s) or Option(s). Corrections
(complete updated versions) will be furnished to PMSNA without
additional charge. LORAD will supply new documents at least thirty
(30)
days before the first delivery of Product which has been modified or
updated as provided in the Agreement.
2.1.2 Service Manual
For each Product or Option the following information shall be provided
by LORAD as part of the Service Documentation and the Service Manual
shall
be organized in the following format:
- Introduction and Technical Data
- Installation
- Setting to work
- Acceptance: specification checks and data applicable
or field service
- Corrective Maintenance
- Diagnostic procedures for fault identification
- Adjustment procedures
- Instructions for assembly and disassembly
- Instructions for removal and replacement
- Procedures after repair or replacement
- Simplified drawings to facilitate fault finding
- Theory of operation and explanation
- Diagrams and drawings
- Repair procedures
- Spare Parts lists with identification numbers
- Sorted by PMSNA ID code (a set of PMSNA ID codes
will be provided to LORAD)
- Sorted by LORAD ID code
- Specification of repairable/replaceable items
- Specification of required tools for:
2
<PAGE>
- Installation, setting to work and acceptance
- Maintenance
all non-metric tools required shall be listed
separately
The test and diagnostic software, if any, used by field service
personnel
will be made available by LORAD on a carrier suitable for the Product
or
Option and will be supplied with each Product or Option. ************
*****************************************************************
*********************************************************************
*******.
If PMSNA requires additional Service Manuals, LORAD will supply them
at a price of **** for each set.
2.1.3 Planned Maintenance Service Manual
Planned Maintenance is defined as pre-planned actions performed to
assure by means of systematic inspection that the Product or Option is
working in a specified manner.
The Planned Maintenance Service Manual is to be supplied directly to
Philips' service organization, not packed in shipments of Product(s)
or
Option(s) to PMSNA.
Initially, five (5) sets will be provided free of charge. Thereafter,
PMSNA,
may, free of charge, reproduce them for PMSNA's use or distribution to
Philips Associated Companies, dealers, manufacturer's representatives
and customers. PMSNA shall also have the right to revise, reorganize,
translate or otherwise modify them for distribution to and use by
Philips'
service organization.
The Planned Maintenance Service Manual will contain:
- Schedule(s)
- Instructions
- List of Spare Parts to be replaced
- List of required lubrication
- Specification of tools required (including non-
metric tools)
- Specification of other materials
2.2 Language
All Service Documentation will be made available in the English
language.
2.3 Additional Information on Data Carrier
All service-related information provided by LORAD hereunder,
including,
in particular, Spare Parts lists and prices, will be made available to
Philips' service organization on a data carrier, such as 3.5 inch
floppy
disk, and updated annually as necessary.
3
<PAGE>
3. Support on Site
If necessary and if requested by Philips' service organization,LORAD
will
provide support at customers' sites. Travel expenses and
accommodation and all other costs will be borne by PMSNA. All other
costs will be covered by an all-inclusive fee of ************. If,
however,
the problem or functional defect is a result of a design defect, the
per
diem fee will not be payable to Lorad for the time spent correcting
the
defect and travel and living expenses will also be born by LORAD.
4. Maintenance
4.1 Repair Policy
Repair will be done by replacing field exchangeable Spare Parts,
either
new or refurbished. LORAD will propose those parts in consultation
with
the PMSNA service organization. A list of these Spare Parts is
attached
(or is to be added when agreed upon) as Appendix 2 to this Exhibit.
4.2 Reporting by LORAD about Reliability
LORAD and PMSNA will exchange free of charge, all relevant data
regarding reliability of the Product, including, but not limited to:
- MTBF and MTTR-figures
- Problem reports
- Field failures
- Parts usage and approx. costs
at Product and Spare Part level.
4.3 Storage Conditions and Handling Procedures
LORAD will specify the storage conditions for Spare Part(s), such as
(but
not limited to) temperature, humidity, shelf life and air pressure,
for any
Spare Part(s) for which there are special requirements in this regard.
5. Field Change Order ("FCO"), Problem Reporting and
Service Information
5.1 Field Change Orders
5.1.1 Modification Kits
Field modifications, if any, will be made available to PMSNA in form
of individual modification kits in the quantity required to update the
entire
installed base of Product(s) or Option(s) to which each field
modification
applies.
These kits shall contain:
- List of applicable Products and their
serial numbers
- Implementation instructions
4
<PAGE>
- Material and Spare Parts
- Special tools (if any)
- Service Documentation and Operator's Manual
updates
Kits for field modifications in the categories of "mandatory for
safety" and
"action for performance" will be provided by LORAD to PMSNA without
charge.
5.1.2 Categories and Implementation of FCO's
Three (3) categories of FCO's are distinguished:
- Mandatory for Safety
- Action for Performance
- Service Recommendation
Classification into any of these categories and the terms and
conditions
of any action will be determined by PMSNA, based upon applicable law
and regulations, after consultation with LORAD.
5.2 Field Problem Reporting by PMSNA
PMSNA will report all problems using a Field Problem Report formsheet
(an example is attached as an annex to this Exhibit). In order to
shorten
turnaround times, PMSNA may report problems to LORAD by telephone
or fax. Telephone reports must be confirmed by a written Field
Problem
Report.
The categories of Problems are defined as "very urgent problems,"
"urgent
problems," "routine problems":
VERY URGENT PROBLEMS
- Disable product or cause an abnormal termination of
an application program.
- Cause danger for the patient being examined or for
personnel operating the product.
URGENT PROBLEMS
- Disable a product under certain conditions
- Disable certain function(s) of a product
ROUTINE PROBLEMS
- Problems other than VERY URGENT or URGENT
As soon as possible, but ultimately within two (2) working days after
a
problem has been reported, LORAD will confirm receipt of a Field
Problem Report and start reproducing and analyzing the Problem. In
its
confirmation LORAD will indicate the manner and time frame in which
LORAD expects to have a preliminary and/or definite solution
available,
and it will use its best efforts to meet or exceed the following
schedule:
5
<PAGE>
Time allowance:
Category Definite Solution
VERY URGENT *****************
URGENT *****************
ROUTINE *****************
6. Configuration Management
6.1 Identification/Labeling of Spare Parts
The packing as well as shipping documents for all Spare Parts,
assemblies and sub-assemblies will be clearly coded and marked.
6.2 Registration
LORAD will maintain a Configuration Record for each Product delivered
indicating:
- Product name,
- Serial number,
- Code number of each printed circuit board
("PCB"), including Hardware and
Software/Firmware level (if any), and
- Identification of assemblies and subassemblies
contained in the product by part numbers
and serial number.
The same procedure will apply for delivery of Field Change Order kits.
With each FCO kit LORAD will provide PMSNA with the valid
Configuration Record for the modified Product or Option.
7. Spare Parts
7.1 Spare Parts List
LORAD will provide to PMSNA a list of Spare Parts in Product(s) or
Option(s) as built, containing the following information,
- Spare Part numbers (to include the PMSNA- and
LORAD Spare Part numbers for reference)
- Description of the Spare Parts, including an illustrated
explosion drawing, whenever applicable
- Price of the Spare Parts
- Repair Exchange Prices
- Guaranteed delivery time per Spare Part or group of
Spare Parts
- Supplier name and address
- Restrictions on export from the United States (if
applicable)
6
<PAGE>
7.2 Availability, Delivery
LORAD will assure availability (F.O.B., Danbury, Connecticut) of Spare
Parts no less than **************** before the First Commercial
Delivery
of Product(s) or Option(s) or of each new version of a Product or
Option.
Delivery time for Spare Parts will be ************************* after
receipt
of order. For some Spare Parts LORAD may require a forecast in order
to meet this delivery time. LORAD will advise PMSNA which Spare Parts
are in this category.
LORAD guarantees the availability of Spare Parts for Product(s) and
Option(s) during a period of ************** after the last delivery of
a
Product or Option by LORAD to PMSNA under the Agreement. During
the seventh year after the last dispatch of Product(s) or Option(s)
PMSNA
and LORAD will consult each other about the expected demand for Spare
Parts over the remaining service life of the Product(s) or Option(s)
and
how this demand can best be met in a cost effective way.
7.3 Upgrade of Spare Parts
Stocks of Spare Parts in PMSNA's stores which have become obsolete due
to Field Change Orders will be returned to LORAD. The shipping costs
will be borne by PMSNA. LORAD will credit to PMSNA the actual
purchase value or modify the Spare Part to the highest configuration
level, if applicable.
7.4 Ordering of Spare Parts
7.4.1 Stock Recommendations and Planning
LORAD will provide PMSNA with recommendations for the stocking of
Spare Parts required to support and maintain the Products and update
such information as required.
LORAD will recommend and allow PMSNA to initiate an end-of-life order
after the agreed period.
PMSNA will - in so far as possible - provide LORAD with a forecast of
its expected demand for Spare Parts.
7.4.2 Priority 1 Orders (P1)
Spare Parts to be delivered under a "Priority 1 order" (breakdown or
out
of stock situation) will be shipped by LORAD, using courier service to
the
shipping address indicated on PMSNA's notification or order, within 24
hours after notification in writing (e.g. by fax).
LORAD will make all the necessary and appropriate shipping
arrangements. PMSNA will reimburse the freight costs. LORAD will
immediately inform PMSNA of the relevant shipping information and
expected time of arrival.
7
<PAGE>
*****************************************************************
*************************************************************
7.4.3 Priority 2 Orders (P2)
Spare Parts to be delivered under "Priority 2 orders" (replenishment
orders) may be placed by PMSNA during the term of this Agreement or
thereafter during the **************** set forth in the third
paragraph of
7.3 above. These Spare Parts will - in so far as they were forecasted
-
have a delivery time of *********************. In any case LORAD will
use its best efforts to meet delivery requirements.
LORAD will accept orders irrespective of value and will not impose
surcharges on any order (except as may be agreed upon with PMSNA for
Priority 1 orders).
7.5 Repair
7.5.1 Repair Services and Support
Those Spare Parts which are identified as repairable items may be
returned by PMSNA to LORAD for repair and will be repaired to their
highest configuration level within six (6) ********************** or be
replaced
within *************.
LORAD will provide repair services for a period of at least **********
after delivery of the last Product or Option under the Agreement.
Repairs will not affect Form, Fit, Function, interchangeability or
certification of the Spare Part(s).
For warranty repairs, LORAD shall be responsible for arranging and
paying for transportation and insurance for shipments of replacement
parts to and from LORAD.
For non-warranty repairs transportation charges to and from LORAD
are the responsibility of PMSNA.
LORAD will also provide Technical Assistance as required. A "help
desk"
will be available during regular working hours from 8:30 A.M. to 5:00
P.M. Eastern Standard Time.
7.5.2 Warranty on Repaired Items
Repaired parts will carry the same warranty as for primary delivered
parts (as set forth in Article 8 of the Agreement).
7.5.3 Repair at PMSNA
If PMSNA decides in the future to start repair of exchangeable Spare
Parts in its own workshops, then LORAD agrees to transfer to PMSNA all
relevant information concerning, for example but not limited to:
8
<PAGE>
- Troubleshooting
- Component specifications (names and addresses
of vendors included)
- Adjustment procedures
- Tools and repair aids (specifications and prices)
- Initial training (if applicable)
- Schematics and wiring diagrams
- Test software and firmware
The conditions (prices, reimbursement for work involved, etc.) for
transfer will be negotiated at the time of such transfer.
7.6 Packing
Each Spare Part will be packed in such a way that it can be held in
PMSNA's inventory without repacking for storage or shipment.
Electrostatic discharge packing is to be used where required.
If applicable, Spare Parts shall be marked as subject or not subject
to
United States export restrictions. Each item shall also be marked
with
the country of origin.
7.7 Prices
Prices for any additional Spare Parts required for the Product(s) or
Option(s) will be agreed upon between the parties when each new
Product or Option is added to the scope of this Agreement and is
incorporated in Appendix 2 at that time.
The prices will be based on **************************************
***************.
******************************************************************
*******************************************************************
*************************************************************
******************************************************************
***************************************************************
***************************************************************
**************************.
7.8 Modifications to Spare Parts (Because of FCO's)
For modifications to Spare Parts, or at the introduction of Product(s)
or
Option(s) for the Products, LORAD will make its best efforts to supply
new Spare Parts and price lists at least **************** before the
First
Commercial Delivery of that Option, Product or new version of a
Product
or Option which incorporates modified Spare Parts, takes place.
7.9 Second Sourcing
LORAD will Provide PMSNA with the manufacturer's name and part
numbers(s) for generic Spare Parts, to enable PMSNA, if LORAD is
unable
to supply Spare Parts, to directly source these generic Spare Parts
from
LORAD's suppliers.
9
<PAGE>
LORAD shall, however, remain responsible, as set forth herein, in the
event certain Spare Parts are no longer available from such vendors.
LORAD will then take all necessary actions to find, as soon as
possible,
substitutes for Spare Part(s) which are no longer available, including
undertaking the necessary engineering and test work connected with
such a substitution.
8. Training, Exchange of Experiences
LORAD will provide adequate initial training for the Philips' service
organization (a "train the trainer" program), to take place,
preferably, in
Danbury, Connecticut. This training will be done at least *******
******
in advance of the First Commercial Delivery of the Product, and be in
sufficient depth to enable PMSNA personnel to conduct the training of
other PMSNA technical personnel. LORAD will assist PMSNA in
preparing all documents and other training aids necessary for
successful
secondary training classes held by PMSNA. During instructor training
classes, a complete set of Service Manuals will be made available free
of
charge by LORAD to the participants.
If significant improvements are made to Products or new contract items
are added to the scope of the Agreement, LORAD will provide training
and documentation for those improvements or items on the conditions
stated above.
Once a year an exchange of experiences between PMSNA and LORAD will
the planned.
For all of the above activities, each party will bear its own costs.
The schedule for the initial training will be set by mutual consent.
Additional training will be scheduled on *************** notice from
PMSNA.
9. Software Support and Maintenance
9.1 General
LORAD will provide support, preventive and corrective maintenance for
Software/Firmware for a minimum of ************** following the last
shipment of Product(s) or Option(s) to PMSNA under this Agreement.
For this purpose, LORAD will keep available a software maintenance and
support group with adequate know-how regarding the various versions of
the software. This support will be in addition to that set forth in
Article 8
of the Agreement. For modifications to Software/Firmware the
procedure
set forth in section 3.3 of the Agreement will be followed.
9.2 Definitions
The following definitions will apply in addition to the other
definitions in
the Agreement:
10
<PAGE>
"Compatibility"
will mean that a new Release or a new Level can replace the former
Release(s) or Level(s) of the Software without degrading the
functionality
and/or affecting the interfacing of the Product or Software.
"Release(s)"
will mean a specified set of functions. A new Release of the Software
will
be made as a result of changed functional specifications and will also
contain the solutions to problems of previous Levels. A Release may
comprise a number of Versions.
"Version(3)"
will mean a distinction between various software programs which fulfil
essentially the same class of functions, but which are different for
alternative hardware choices and/or slightly different Software
configurations and/or differences in performance and/or for commercial
reasons.
"Level(s)"
will mean improved Software having the same functional specifications
as before, but originating from changed (corrected) source code.
9.3 General Support
While maintaining compatibility LORAD will actively:
search the Software/Firmware for errors and offer corrections therefor,
investigate, produce and offer enhancements to the Software/Firmware
which improve and optimize the user friendliness of the
Software/Firmware,
on request, provide advice with regard to the capabilities of the
Software/Firmware in order to fully exploit its potential, and
investigate advanced software diagnostics to aid the repair of
equipment
and maintain service efficiency and a low MTTR.
9.4 Corrective Maintenance
While maintaining compatibility and without prejudice to the
procedures
of Section 5.3 of this Exhibit, LORAD will provide Corrective
Maintenance
by:
delivering as soon as possible solutions for VERY URGENT and
URGENT PROBLEMS in the form of preliminary solutions
(temporary fixes only, no corrections to the Software/Firmware)
and
definite solutions (corrections to the Software/Firmware) if
necessary in an unscheduled Level of the Software/Firmware.
delivering solutions for ROUTINE PROBLEMS in the form of
definite solutions as part of the next Level of the
Sofware/Firmware.
11
<PAGE>
If LORAD cannot provide a definite solution without violating the
compatibility of the Sofware/Firmware with the Product(s) or Option(s)
hardware or the Specifications, then LORAD will promptly so inform
PMSNA in writing, with a comprehensive explanation of the reasons and
consequences. LORAD will not undertake any implementation of such
definite solution unless PMSNA has accepted the consequences of such
action in writing.
Both preliminary and definite solutions will be released to PMSNA as
soon as possible, but only after LORAD has produced and tested each
solution, in clinical application as well as in LORAD's product
development laboratory. Definite solutions shall be included in the
next
available Level of any Release. The solutions will be documented and
made available to PMSNA by the fastest means of communication and/or
transportation.
10. Duration of Service Arrangements
Unless explicitly agreed to the contrary in this Exhibit or in the
Agreement itself, the arrangements of this Exhibit will come into
effect on
the same day as the Agreement and continue until ************* after
delivery of the last Product or Option by LORAD pursuant to the
Agreement.
11. Survival
Should any of the provisions of this Agreement become invalid or be
ruled invalid by a court of competent jurisdiction, this shall not
impair
the legal effectiveness of the others, the parties shall, however,
immediately replace the invalid provision by one which, in so far as
possible, has the same legal and economic effect as the former.
Appendices:
Appendix 1: Field Problem Report
Appendix 2: List of Spare Parts
lrdptbsv.816
12
<PAGE>
APPENDIX 1
FIELD PROBLEM REPORT
SUPPLIER LICENSED PARTICIPANT
Form of Problem Report
1. Required urgency
2. Reporting date
3. Name
Address of participant
4. Reference to Philips International Agreement no. ...
5. Equipment (hardware) and Software configuration.
6. Problem description
7. Conditions under which the problem occurs.
Problem reports to be sent to: Name of Supplier
Address
Contact Person
Supplier will inform requesting Participant about:
- Problem acceptance/rejection for further treatment
- Status of solution such as: temporary solution, to
be solved in next
release, problem
solved etc.
<PAGE>
Exhibit II
Appendix 2
Recommended Spare Parts List for PMX 2000
(Preliminary)
- --------------------------------------------------------------------------------
P/N DESCRIPTION COMMENTS
- --------------------------------------------------------------------------------
*********** Assy L.V. Feedback Board
- --------------------------------------------------------------------------------
********** Nut, Axle Locking
- --------------------------------------------------------------------------------
********** Washer, Axle Lock
- --------------------------------------------------------------------------------
********** Wheel 10x2wx3/4 bore
- --------------------------------------------------------------------------------
********** Drive Motor
- --------------------------------------------------------------------------------
********** Gear Belt 1/2Pxl. Wx330Lg
- --------------------------------------------------------------------------------
********** Assy, Handle
- --------------------------------------------------------------------------------
********** Assy, Cable Counterweight
- --------------------------------------------------------------------------------
********** Assy, Cable Shock Absorbing
- --------------------------------------------------------------------------------
********** Switch, Micro
- --------------------------------------------------------------------------------
********** Switch, Micro
- --------------------------------------------------------------------------------
********** Fan Cooling
- --------------------------------------------------------------------------------
********** X-Ray Tube
- --------------------------------------------------------------------------------
********** Bearing Trunion
- --------------------------------------------------------------------------------
********** Assy, Collimator
- --------------------------------------------------------------------------------
********** Assy, Battery Pack
- --------------------------------------------------------------------------------
********** Assy, H.V. Tank
- --------------------------------------------------------------------------------
********** Assy, Panel (Control)
- --------------------------------------------------------------------------------
********** Switch Panel Mount
- --------------------------------------------------------------------------------
********** Label, Rotation TubeHd-RT
- --------------------------------------------------------------------------------
********** Label, Rotation TubeHd-LFT
- --------------------------------------------------------------------------------
********** Label, Rotation Housing
- --------------------------------------------------------------------------------
********** Label, Rotation TubeHd-RT
- --------------------------------------------------------------------------------
********** Label, Rotation TubeHd-LFT
- --------------------------------------------------------------------------------
********** Label, Rotation Housing
- --------------------------------------------------------------------------------
<PAGE>
Exhibit II
Appendix 2 - (cont'd)
Recommended Spare Parts List for PMX 2000
(Preliminary)
- --------------------------------------------------------------------------------
P/N DESCRIPTION COMMENTS
- --------------------------------------------------------------------------------
********** Assy Collimator
- --------------------------------------------------------------------------------
********** H.V. Cables
- --------------------------------------------------------------------------------
********** Assy Harness
- --------------------------------------------------------------------------------
********** Assy Harness
- --------------------------------------------------------------------------------
********** Assy Ribbon Cable
- --------------------------------------------------------------------------------
********** Assy Ribbon Cable
- --------------------------------------------------------------------------------
********** Assy Display Board
- --------------------------------------------------------------------------------
********** Assy L.C.D. Display
- --------------------------------------------------------------------------------
********** Assy, Pre-Regulator
- --------------------------------------------------------------------------------
********** Assy, H.V. Inverter
- --------------------------------------------------------------------------------
********** Assy Ribbon Cable
- --------------------------------------------------------------------------------
********** Assy Rotor Transformer
- --------------------------------------------------------------------------------
********** Assy Fuse Board
- --------------------------------------------------------------------------------
********** LG. Fuses D.C. Power
- --------------------------------------------------------------------------------
********** Battery Charger
- --------------------------------------------------------------------------------
********** Mobile Interconnect Board
- --------------------------------------------------------------------------------
********** Assy H.V. Control Board
- --------------------------------------------------------------------------------
********** Assy H.V. Drive Board
- --------------------------------------------------------------------------------
********** Assy Filament Supply Board
- --------------------------------------------------------------------------------
********** Assy Rotor Board
- --------------------------------------------------------------------------------
********** Assy DC Motor Drive Control
- --------------------------------------------------------------------------------
********** Assy Microprocessor Board
- --------------------------------------------------------------------------------
********** Assy Power Supply
- --------------------------------------------------------------------------------
********** Arm Interface PCB
- --------------------------------------------------------------------------------
********** Motor Interface PCB
- --------------------------------------------------------------------------------
<PAGE>
Exhibit II
Appendix 2 - (cont'd)
- --------------------------------------------------------------------------------
P/N DESCRIPTION COMMENTS
- --------------------------------------------------------------------------------
********** Pivot Brake, Arm
- --------------------------------------------------------------------------------
********** Extension Brake, Arm
- --------------------------------------------------------------------------------
********** Clevis Brake, Arm
- --------------------------------------------------------------------------------
********** Mast Brake
- --------------------------------------------------------------------------------
********** Caster 8"
- --------------------------------------------------------------------------------
********** Cable Reel
- --------------------------------------------------------------------------------
********** Input Circuit Breaker
- --------------------------------------------------------------------------------
********** Input Contactor
- --------------------------------------------------------------------------------
********** Hand Switch Assy
- --------------------------------------------------------------------------------
********** Fuse, 2A SB 2AG
- --------------------------------------------------------------------------------
********** Fuse, 1A 2AG
- --------------------------------------------------------------------------------
********** Fuse, 5A SB 2AG
- --------------------------------------------------------------------------------
********** Fuse, 3A 2AG
- --------------------------------------------------------------------------------
********** Fuse, 7A 2AG
- --------------------------------------------------------------------------------
********** Fuse, 7A SB 2AG
- --------------------------------------------------------------------------------
********** Fuse, 2A SB 3AG
- --------------------------------------------------------------------------------
********** Fuse, 7A SB 3AG
- --------------------------------------------------------------------------------
********** Fuse, 10A MDL 3AG
- --------------------------------------------------------------------------------
********** Fuse, 10A MDA 3AG
- --------------------------------------------------------------------------------
********** Fuse, 15A MDA 3AG
- --------------------------------------------------------------------------------
********** Fuse, 20A MDA
- --------------------------------------------------------------------------------
********** Fuse, 20A KTK
- --------------------------------------------------------------------------------
********** Fuse, 40A NON
- --------------------------------------------------------------------------------
********** Fuse, 60A FRN
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
Exhibit III
Planning and Prices
Year* Price Quantity Cumulative
* ******* *** *** ** ***
* ******* *** *** **** ***
* ******* *** *** **** ***
* ******* *** *** **** ***
From the date of the First Commercial Delivery under this
Agreement.
***********************************************************
*********************************************************
****************************************************
***********************************************************
************************************************************
********************************************************
************************************************************
***********************************************************
********************************************************
**************************
<PAGE>
Exhibit IV
PMX 2000 Program Time Schedule
Delivery
**************** ***************************
****************************************
***************
***********************
***************** ***************************
**************** ***************************
**************** ***************
****************
****************
****************
Product Requirements
* ****************************************
* ****************************************************************
*****
* **************************************************************
**************************
* **************************************************************
************
* **************************************
* *******************************************
Service Requirements
************ ************************
************ ********************
************ *************************
************ *************************
<PAGE>
Exhibit V
DECLARATION
SUBJECT: PMX 2000
1. Herewith Lorad Corp. confirms that PMX 2000 (LORAD RT-125) fully
complies with the following standards:
*****************
*********
********
****************************************
***************
******************
2. Furthermore, Lorad Corp. confirms that the serial number of the
tube
inserted in the tube housing of PMS 2000 (LORAD RT-125) is
indicated on
the tube. This number is identical with the serial number
indicated on
the label located on the tube housing.
3. Packing of PMX 2000 complies with *****************.
4. PMX 2000 fully complies with *************************************
*************.
LORAD Corporation
Date: _____________________
Signature: _____________________
<PAGE>
Exhibit VI
Standard Form for Change Request
Standard Form for Change Request
1. Change Request number: (date and sequence number)
2. Description of change:
Change of:
3. Reason of the change:
4. Change proposed for series:
5. Change proposed for serial number:
6. Reference to drawings:
7. Reference to reports and/or telexes:
8. Consequences for safety standards:
9. Consequences for service documentation and/or spare parts:
10. Consequences for delivery time:
11. Consequences for price:
12. Consequences for interfaces:
13. Consequences for stocks:
14. Initiated by:
<PAGE>
Exhibit VII
LORAD's ISO 9000 Certificate
[To be added Later.]
<PAGE>
CONFIDENTIAL TREATMENT
TREX MEDICAL CORPORATION HAS REQUESTED THAT THE
MARKED PORTIONS OF THIS DOCUMENT BE ACCORDED
CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 UNDER
THE SECURITIES ACT OF 1933, AS AMENDED.
DUPLICATE ORIGINAL
OEM-Agreement
between
LORAD Corporation
A subsidiary of Thermo Trex Corporation
36 Apple Ridge Road
Danbury, Connecticut 06810
USA
hereinafter referred to as "LORAD"
and
Philips Medical Systems North America Company,
Division of Philips Electronics North America Corporation
P. O. Box 860
710 Bridgeport Avenue
Shelton, Connecticut 06484
hereinafter referred to as "PMSNA"
Subject: Supply of Mammography Systems
1. Introduction and Definition
1.1 Introduction
Whereas, LORAD is a company engaged in development, production and
supply of, among other products, mammography systems;
Whereas, LORAD has designed and developed a mammography system
LORAD's ************* is willing to modify it according to legal requirements
and certain PMSNA specifications and is interested in meeting PMSNA's
requirements for such modified product on an exclusive and long-term, original
equipment manufacturer basis;
Whereas, PMSNA desires to purchase from LORAD a minimum quantity of said
product, modified for PMSNA as further specified in this OEM Agreement and
the Exhibits hereto, for resale either directly and/or through PMSNA or its
associated company Philips GmbH, its/their distributors, agents and dealers;
Whereas, LORAD and PMSNA want to establish the terms and conditions
under which during the term of this Agreement LORAD shall supply the
modified **** system to PMSNA for subsequent resale throughout the world.
NOW THEREFORE, IN CONSIDERATION OF THE MUTUAL PROMISES AND
PREMISES HEREINAFTER SET FORTH, THE PARTIES HERETO HAVE
AGREED AS FOLLOWS:
1
<PAGE>
1.2 Definitions
1.2.1 "Agreement"
shall mean this present document and all the Exhibits and other
documents incorporated by reference herein or attached hereto and signed or
initialed by the parties hereto, all of which Exhibits or other documents are an
integral part hereof.
1.2.2 "Component(s)"
shall mean all parts to be supplied by PMSNA as further defined
in Section 4.5.1.
1.2.3 "Confidential Information"
means any and all information whether obtained or given orally or
in writing concerning either party not generally known to persons not
associated with the disclosing party, including, without limitation, information
about product research and development, manufacturing processes and
techniques, samples, drawings, customer marketing and new product data,
trade secrets, computer programming techniques and business strategy,
financial data and all other proprietary or trade secret information of whatever
description.
1.2.4 "Documentation"
shall mean the technical documentation by type or subpart for
Product(s) including, without limitation, electrical diagrams and parts lists,
necessary to incorporate the Product in or connect to other PMSNA systems,
respectively to service and sustain the Product in the field, all as further
specified in Exhibit 3, Exhibit 4 and Section 3.1.2 hereto.
1.2.5 *********************
shall mean that part of the Territory in which ****************
***********************************************************************.
The ******************************** at the beginning of the Term of
***************************************************************************
**************** in Exhibit 9 hereto. ************************ will, in any
event, ****************** throughout the Term.
The extent of *********************** will be reviewed by the parties
on an on-going basis in order to ******************************** given LORAD's
other, present contractual commitments, taking into account *****************
*****************************************************************************
*****************************************************************************
********************************************************.
LORAD agrees to use all reasonable efforts to *********************
****************************.
1.2.6 "First Commercial Delivery"
means the earliest date on which Product which conforms to the
Specifications and which has successfully completed testing as set forth in
Section 3.2 below, for which a Release for Delivery Certificate is issued and
for
which all legal and regulatory requirements for distribution and marketing in
**************************** have been met, is delivered to a customer of
2
<PAGE>
PMSNA ******************** in the ordinary course of PMSNA's business.
Delivery of Product to a clinical site as an investigational device or for
evaluation for marketing purposes or to serve as a "show" or "seed" site for
demonstration of the Product to prospective customers shall not be considered
to be a delivery in the ordinary course of PMSNA's business.
1.2.7 "Form, Fit or Function"
means items, components, or processes that are sufficient to
enable physical and functional interchangeability, in particular as to source,
size, configuration, mating, and attachment characteristics, functional
characteristics, and performance requirements.
1.2.8 "Know-How"
shall mean all the information relating to the design, development,
production, testing, and servicing of Products as manufactured by or for
LORAD, which is in its possession or under its control and as will be
sufficient
to enable PMSNA or a Philips Associated Company to manufacture or have
manufactured and service Products. All such Know-How shall be in a legible
and reproducible form.
1.2.9 "OEM"
means original equipment manufacturer.
1.2.10 "Option(s)"
means all those parts or accessories for Product(s) which can be
ordered from LORAD and be shipped on request. They will be specified, as
necessary, in close consultation between LORAD and PMSNA. They are listed
or may later be added to Exhibit 1 or Exhibit 2 hereto and identified by a
special PMSNA code number.
1.2.11 "Philips Associated Companies"
shall mean any and all companies, firms and legal entities with
respect to which now or hereafter Philips Electronics N.V. directly or
indirectly
holds 50% or more of the nominal value of the issued share capital or has 50%
or more of the voting power at general meetings or has the power to appoint a
majority of the directors or otherwise directs the activities of such company,
firm or legal entity but any such company firm or legal entity shall be deemed
a
Philips Associated Company only as long as such holding or power exists.
1.2.12 "Product(s)"
jointly and severally shall mean the PMSNA versions of LORAD's
********** mammography systems including Options and accessories, as
further set forth in the Specifications, including any changes thereto, as well
as
such new models and options and accessories as the parties hereto may agree
to include under this Agreement by amendment to this Agreement and Exhibits
1 and 2 hereto.
LORAD will manufacture the PMSNA version of LORAD's ****
mammography system in two configurations, for resale in, *******************
**************************************. The differences in specifications and
pricing for each configuration shall be as set forth in Exhibits 1 and 2. The
term "Product(s)" as used in this Agreement means either or both of these
configurations.
3
<PAGE>
1.2.13 "Purchase Order(s)"
shall mean the purchase order(s) for Products which will be placed
by the Purchasing Department of PMSNA or of Graner Company under this
Agreement.
1.2.14 "Software/Firmware"
shall mean all computer programs either on disk, diskettes or
embedded in other carriers (e.g. PROMS etc.) consisting of the set of logical
instructions and tables of the information which guide the functioning of the
processors, such programs include all necessary operating system software,
application software, related documentation useful with Software/Firmware
such as functional descriptions, design documentation, program description
and listings as well as the source code versions thereof on disk, all as
specified
in Exhibit 1 and Exhibit 2 hereto.
1.2.15 "Spare Part(s)"
shall mean those items listed as such in Exhibit 1 and Exhibit 3
(Spare Parts, Prices and other Service Aspects) hereto and any and all other
components or items necessary to allow PMSNA or its customers to keep the
Product in good repair throughout its useful life.
1.2.16 "Specification(s)"
shall mean the final functional requirements, technical
specifications, drawings, documentation and other requirements of the
Product(s) all as set forth in this Agreement and in Exhibit 1 and in Exhibit 4
hereto and such amendments thereto as the parties hereto may agree upon
from time to time, in writing.
1.2.17 "Term"
means the time period set forth in Section 13.1 below and any
extensions thereof.
1.2.18 "Territory"
shall mean **************************.
1.2.19 "Time Schedule"
shall mean the time schedule attached hereto as Exhibit 6.
2. Scope of Agreement
2.1 Delivery and Purchases
Subject to the terms of this Agreement, LORAD agrees to manufacture and to
supply and deliver Product(s), Option(s) and Spare Parts (such manufacture,
supply and delivery of Product(s) in PMSNA's trade dress and of any Option(s)
and Spare Parts which are unique to Product(s), being exclusively to PMSNA)
and
PMSNA agrees to purchase and take delivery of Product(s), Option(s) and Spare
Parts from LORAD for marketing, subsequent resale, installation, service and
maintenance in the Territory.
4
<PAGE>
2.2 Branding and Trademark
The Product will be sold under PMSNA's trademark "mammo DIAGNOST
3000" or "MD 3000" and will be branded with the "Philips" logo and shield
emblem and/or any other trademark or brandname as may be specified by
PMSNA from time to time in writing. The trademarks or trade names to be
applied will either be in the form of labeling provided by PMSNA or be printed
on the products, packaging, manuals or other documentation in accordance
with written instructions provided by PMSNA.
2.3 Marketing Rights/License
2.3.1 Marketing
LORAD herewith grants to PMSNA the ***************************** to sell,
install, maintain and/or repair the Product(s) and/or the individual items
thereof, within the Territory. **********************************************
**********************************************:
* **************************************************
* **********************************************************************
**********************************************************************
***************************.
****************** in or for use in the Territory.
LORAD further agrees that certain parts of the Territory shall be the Exclusive
Territory of PMSNA in that LORAD's **** product will not be offered for sale
there in any form other than as the Product(s) as set forth in Section 1.2.6 of
this Agreement. **************************************************************
******************************************************************************
*************************************************************************
*************************************************.
With regard to distribution ************************************************
***************************************************************************
*****************************.
2.3.2 Regulatory Requirements
LORAD agrees to obtain for PMSNA all regulatory approvals and clearances
necessary for distribution and marketing of the Product(s), Option(s), Spare
Parts, upgrades or enhancements in **************************** (and shall
notify PMSNA when such are obtained), to indemnify and hold harmless
PMSNA from and against any and all civil penalties assessed against PMSNA
under the United States Food, Drug and Cosmetic Act as a result of LORAD's
not having obtained such approvals and clearances before distribution and
marketing begins, and also to provide to PMSNA all documentation and
assistance which is reasonably necessary for PMSNA or a Philips Associated
Company to complete all submittals for the regulatory or other governmental
approvals and clearances necessary for marketing and distribution of
Product(s), Option(s), Spare Parts, or upgrades or enhancements to them,
elsewhere in the Territory, in addition to assuring, that the Product(s) meets
all
5
<PAGE>
the requirements and standards listed in the Specification, including
labeling
and certifications of compliance as set forth in the Specification.
Furthermore, LORAD agrees to provide PMSNA with all current information of
the kind which is generally made available by manufacturers of medical devices
to their sales and service personnel concerning hardware and
Software/Firmware modifications or upgrades to the Product.
2.3.3 Marketing of Other Products/Right of First Refusal
If LORAD wishes to commercially exploit other products in the field of
mammography, similar to or derived from the Product with any equipment
manufacturer other than PMSNA, LORAD shall first give PMSNA an
opportunity to investigate whether such new product or application may be of
interest to PMSNA. LORAD shall give PMSNA timely notice and provide PMSNA
with all relevant information concerning the product or application to enable
PMSNA to perform its investigation in a reasonable time period not exceeding
**************, or such longer period as the parties may agree upon. Subject
to the confidentiality obligations in Article 12 below, LORAD also agrees to
keep
PMSNA advised of LORAD's progress in the development of LORAD's *********
and other new product developments, upgrades and/or technological
advancements with respect to LORAD's mammography product line.
If LORAD offers *************************************************************
*******, the cost to PMSNA thereof shall not be higher than the PMSNA
version of LORAD's ****.
If PMSNA is interested, the parties shall in good faith negotiate the terms for
PMSNA's or Philips Associated Company, Philips GmbH's purchase of such a
new product or application.
If the parties do not agree in principle within that time to reasonable terms
and
conditions, LORAD shall be free to market such product or application in any
manner it deems fit provided distributorship is not offered to anyone else on
terms equal or better than those offered to PMSNA.
LORAD agrees to make available to PMSNA all minor updates and
improvements which it develops for LORAD's **** product, at no additional
charge.
3. Product
3.1 Product Definition
3.1.1 Specification
The Specifications for the Product to be called the mammoDIAGNOST3000 or
MD3000 are incorporated and made a part of this Agreement as Exhibit 1 and
Exhibit 4.
The implementation of the biopsy unit "CYTOGUIDE" is essential for the
execution of this Agreement. A material deviation from the Time Schedule
(Exhibit 6) may be considered a material breach and a cause for termination of
this Agreement as set forth in Section 13.2 hereof.
6
<PAGE>
LORAD agrees to adapt the Specifications of the Product as a result of tests
performed together by LORAD and PMSNA or according to further
requirements of PMSNA (subject to acceptance of such additional requirements
by LORAD) and will update the Specifications and provide PMSNA with the
revised version thereof. Upon written agreement of LORAD and PMSNA such
revised Specifications will be added to this Agreement and replace the earlier
version thereof.
3.1.2 Operator's Manuals
Part of the Product will also be the Operator's Manual, written in English,
German, Spanish and French, as set forth in Exhibit 6. Such Operator's
Manual shall comply with the legal requirements of *************************
*** and be made in accordance with the Philips house-style manual, an
example of which shall be supplied by PMSNA. LORAD shall be solely
responsible for the content of these manuals, even though they are in Philips'
standard format and even though parts of them may not be identical to the
manuals LORAD has prepared for its own version of the ****. PMSNA shall be
responsible for the preparation and cost of translation into all languages
other
than those listed in Exhibit 6, as may be required and for the expense of any
arrangements made with LORAD for distribution of Operator's Manuals in such
other languages. Except for ****************************, PMSNA shall be
responsible for compliance of the Operator's Manual with the legal
requirements of all jurisdictions if such requirements are not set forth in the
Specification.
3.2 Testing, Type-Approval, Release for Delivery
Prior to execution of this Agreement LORAD has consigned to PMSNA and
Philips Associated Company Philips GmbH - free of charge - certain Test Unit
prototypes. As a result of initial tests PMSNA may require that certain
additions, alterations or modifications in the Product are incorporated in order
to reach full compliance with PMSNA's requirements.
LORAD will provide PMSNA with a second Test Unit for the version of the ****
to be sold ************************************************** and a third Test
Unit for the version of the **** to be sold **********************************
********************** (or, collectively with the Test Units LORAD consigned to
PMSNA or Philips GmbH earlier, the "Test Units") both of which will fully
comply with the Specification and with such changes as may be agreed upon
by LORAD and PMSNA. LORAD will provide PMSNA with the results and
supporting data of all tests performed within its development department, all in
substantial compliance with the Time Schedule in Exhibit 6 hereto.
Together with the Test Units LORAD shall provide PMSNA with the preliminary
Documentation and technical service information.
The parties shall decide by the mutual consent by their respective project
teams whether the tests should be performed in Hamburg or in Danbury at
LORAD's facility. If the Test Unit(s) will be evaluated in Hamburg they shall
be
delivered F.O.B. at LORAD's facility in Danbury, Connecticut ("F.O.B." as used
in this Agreement is that term as defined in the Connecticut Uniform
Commercial Code, C.G.S. sec. 42a-2-319). If the tests are to be performed at
7
<PAGE>
LORAD's site, adequate space, tools/test-equipment and support will be given
to PMSNA's personnel at no additional charge.
PMSNA will execute such type-approval tests as PMSNA may reasonably
require to satisfy PMSNA that the Test Units conform to the latest version of
the Specifications and PMSNA shall keep LORAD informed of the results of the
tests and will give LORAD a reasonable opportunity to be present at said tests.
a. If, as a result of these tests, PMSNA is of the reasonable opinion, to be
confirmed in writing, that certain additions, alterations or modifications
in the Test Unit(s) are required in order that the Test Unit(s) comply with
the latest version of the Specification(s) or to eliminate faulty or
substandard workmanship and/or material, LORAD undertakes to
modify and to make same in the Test Unit(s) and to supply to PMSNA all
at LORAD's cost and expense, the changed Test Unit(s).
b. If, as a result of these tests, PMSNA desires modifications or
enhancements of the Test Unit(s) in excess of the latest version of the
Specification(s) and which were not earlier agreed upon, then, if both
parties hereto so agree, LORAD will provide a quotation and a revised
Time Schedule for PMSNA's approval and the execution by LORAD of any
such modifications or enhancements shall be the subject of a separate
Purchase Order by PMSNA.
Upon the finalization of the tests and changes requested by PMSNA and agreed
upon by LORAD and if PMSNA is reasonably satisfied, that the second and
third Test Unit comply with their Specifications, PMSNA shall provide LORAD
with a written Release for Delivery Certificate signed by an officer of PMSNA.
The version of the Product including the CYTOGUIDE will require a similar
procedure for testing and release for distribution as described above, all in
substantial compliance with the Time Schedule.
Upon PMSNA's satisfaction that the Test Units conform to the Specification(s) or
should the Test Units fail to comply with the Specification(s) after the tests
described above, the Test Units shall either (i) be returned to LORAD in the
same manner delivered to PMSNA or (ii) be purchased by PMSNA at a price to
be agreed upon between the parties.
Any new or replacement version of the Product(s) and Option(s) for PMSNA, shall
require a similar procedure for testing and release for distribution as
described
above.
3.3 Modifications, Engineering Change Control
Once PMSNA has released the Product for delivery LORAD shall not, except as
may be required by law, make any changes or modifications in the Product(s),
Spare Part(s) or Option(s) and/or the Specification(s) which affect Form, Fit or
Function, intended use, labeling, listing or other certification by standards
agencies (as set forth in this Agreement and the Specification(s) or which
affect
government approvals or clearances of the Product(s) or Option(s) or which
affect the Spare Part(s) stock, without the prior written consent of PMSNA.
PMSNA's consent shall not be unreasonably withheld.
8
<PAGE>
The foregoing provision is intended, in particular, to assure continuing
conformity with the Specification(s).
This requirement, however, does not preclude LORAD from using equivalent
components and parts that do not affect Form, Fit or Function of the Product(s)
and/or interchangeability of Spare Part(s) and/or compliance with the
Specifications, Standards, Approval or Certifications.
In the event LORAD uses such equivalent components and/or parts LORAD
shall provide PMSNA with an updated version of the Documentation as soon as
possible without additional charge to PMSNA.
PMSNA shall advise LORAD of any changes or modifications to the
Components which may effect Form, Fit and Function of the Component(s) in
Product(s), work with LORAD to incorporate the changed or modified
Component(s) into Product(s) and be responsible for any incremental expense
caused by changes or modifications in Component(s).
If LORAD wishes to make a modification requiring PMSNA's consent, LORAD
shall, with sufficient lead time for PMSNA to process the request before the
modification is scheduled to be implemented, notify PMSNA in writing of the
proposed modification. The documentation and Philips terminology used for
the approval process for such modifications is:
ECR (Engineering Change Request): a standard form sheet, to be used for all
engineering and design data regarding such proposed modifications.
ECC (Engineering Change Committee): the PMSNA committee responsible
for discussing and deciding about such proposals.
ECO (Engineering Change Order): the form sheet on which decision of the
ECC will be documented and released.
For a sample of form sheets see Exhibit 5.
In order to assist PMSNA in expediting these approvals, LORAD agrees to
submit ECR's and ECO in the format prescribed.
3.4 Proposals
During production of the Test Unit(s) PMSNA's technical, quality and service
experts are entitled to make suggestions and proposals, but such suggestions
and proposals shall be binding on LORAD and PMSNA only if confirmed in a
document signed by authorized representatives of both parties.
3.5 New Type of Product under this Agreement
If the parties hereto wish to introduce a new type of Product under this
Agreement, LORAD shall - before the start of commercial deliveries of such new
type of Product - execute such type approval tests as are approved by PMSNA
in order to ascertain that the new Product conforms to its Specifications.
LORAD shall promptly provide PMSNA with the evidence thereof whereupon
the Agreement shall be amended to reflect any such change to the
Specification.
9
<PAGE>
3.6 Continuity of Production, Supply of Products
In the event LORAD wishes to stop production of Product(s) LORAD shall
inform PMSNA thereof as early as possible but, in any event, at least *********
********* prior to the date that production would be discontinued. PMSNA
shall then have the opportunity to place a final Purchase Order in such
quantities as PMSNA may require and LORAD shall accept such Purchase
Order(s) at a reasonable price (not exceeding that set forth in Exhibit 2 if
such
production is discontinued during the time schedule set forth in Exhibit 2) to
be agreed upon by the parties in good faith. *******************************
******************************************************************************
***************************************************** from the date of the
First Commercial Delivery under this Agreement, special attention to be given
to the Spare Part(s) supply as set forth in Exhibit 3 hereto, paragraphs 7 and
10 thereof.
********************************************************************************
*******************************************************************************
*******************************************************************************
******************************************************************************
******************************************************************************
*******************************************************************************
********************** as set forth in Section 11.2 which LORAD
********************************************************************************
******************** ******************************** production of which
LORAD has also decided ******************************************************
********************************************** *****************
********. Such approval shall not be unreasonably withheld by LORAD.
4. Planning and Ordering
4. 1 Minimum Purchases
PMSNA agrees to purchase a minimum of eight hundred (800) units of Product(s)
during the Term. Purchases on an annual basis shall be:
Year 1 Year 2 Year 3 Year 4 Year 5
------ ------ ------ ------ ------
******** ********** *********** ********** ***********
* *****************************************************************
*************************************** *************************
******** by PMSNA shall be**************************************************
minimum purchase quantity of eight hundred units (800), ********************
*************************** *************. PMSNA's ********* may be ******
**************************************************************************
*****************************************************************************
******************************************************************************
********************************.
********************************************************************************
******************** ********. The start of a year for the purposes of the
********************************************************************************
******************** **************************************************.
10
<PAGE>
4.2 General Planning
PMSNA and LORAD expect an increase in manufacturing and sales activity for the
Product(s) as indicated in Section 4.1 and Exhibit 2 hereto in response to
customer demand during the first years of the Term. The figures in Section 4.1
and Exhibit 2 hereto and in later PMSNA forecasts, are not intended as
Purchase Orders, but rather as an indication, for planning purposes, of
expected market activity. Delivery dates, quantities, options included and
configuration of each unit of Product shall be specified by PMSNA only by
Purchase Order using the procedure described in Section 4.3 below. **********
**********************************************************************
**************************************************************************
**************** minimum purchase volume above) ************** minimum
purchase commitment of eight hundred (800) units******************************
******************* as set forth in Section 4.1 hereof.
4.3 Forecast
4.3.1 Rolling Forecast, "Just in Time" Deliveries
A mutually satisfactory procedure will be established in which production and
shipment of Product(s) and Spare Part(s) is matched as closely as possible with
the
related demand set by orders from PMSNA's customers.
The demand will be transmitted to LORAD by fax or telex as a rolling forecast
with the following information:
Rolling Forecast:
- - ********************** for ********************** will be renewed and
issued to LORAD on or about the *****************************************
************** according to the following schedule for delivery***********
******************** forecast, during:
- months 1-3 ***************** indicated on an issue of
********************** for **************************
**********.
********************************************************************
******************************************************************************
*******************************************************************************
********************************** rolling forecast *****************
***************************************************************
************ **************.
- ***********: *****************************************************
**************************************************
**** rolling forecast) ***************************
*************************************************
********.
LORAD will use this planning to assure delivery of Product(s) and Option(s)
"just in time" within the requested delivery dates.
11
<PAGE>
In order for PMSNA to minimize shipping and handling expenses, **********
**********************************************************************
*******************.
4.3.2 Additional Quantities
Although it is the intention of the parties to assure a smooth delivery schedule
in accordance with *****************************, PMSNA may require
additional deliveries *********************** as indicated. Then, LORAD
shall use its best efforts to supply such additional quantities.
4.3.3 Shortage or Lack of Parts
Subject to Article 14 hereof, if LORAD can no longer or expects that it will not
(on short notice) be able to supply Product(s) to PMSNA because of a shortage
or lack of components and/or Spare Part(s), LORAD shall immediately inform
PMSNA thereof and, at its own expense, take all steps which are reasonable in
the circumstances, including a redesign of the Product(s), to obtain an
additional supplier or suppliers for such component or Spare Part.
The redesigned product shall be subject to the procedure set forth in Article 3
of this Agreement.
4.4 Order and Delivery
4.4.1 Purchase Orders
At the beginning of each month PMSNA shall issue separate Purchase Orders
containing the consolidated figures as agreed upon.
Each Purchase Order shall specify at a minimum:
PMSNA-12-digit-code number
Price
Quantities and
Requested delivery day/week,
to cover at least the period of the commitment of the rolling forecast as
mentioned above.
The "requested delivery" specified for each shipment will be the date for
"receipt
by PMSNA at the address stated on the Purchase Order form."
All Purchase Orders shall be deemed to incorporate and be subject to the terms
and conditions of this Agreement, as well as any supplemental terms and
conditions agreed to in writing by authorized representatives of the parties.
No
other terms and conditions contained on any Purchase Order form or any other
form, agreement or correspondence originated by either party, shall apply.
4.4.2 Confirmation, Delivery Dates
Purchase Orders will be confirmed by LORAD within one (1) week after receipt
by mail or telefax. They shall then be binding on LORAD and PMSNA as set
forth in Section 4.3.1 above and may be canceled only if LORAD or PMSNA
12
<PAGE>
materially defaults in its execution thereof or if otherwise agreed upon between
the parties hereto.
LORAD shall take adequate delivery and transportation times into account and
shall meet the agreed upon delivery dates for each Purchase Order. Any
deviation from the delivery date specified which can be foreseen during
execution of a Purchase Order will be communicated to PMSNA immediately.
The delivery date for a unit of Product will normally be **************** after
receipt of PMSNA's Purchase Order, but may be earlier or later if the parties so
agree.
LORAD shall take adequate delivery and transportation times into account and
shall meet the agreed upon delivery dates. Any deviation which can be
foreseen during execution of a Purchase Order will be communicated to PMSNA
immediately.
4.4.3 Late Deliveries, Compensation
If LORAD fails to meet an agreed delivery date and the delay is not caused by
Component(s), the invoice price of the respective Product shall be **********
******************************************** for each week delivery is delayed,
****************************************************, as compensation to
PMSNA for such late delivery. Subject to Article 14 hereof, if a delay extends
beyond three months, PMSNA shall be entitled to cancel or terminate the
pertaining Purchase Order(s) and/or demand compensation for non-fulfillment,
without prejudice to any other rights accruing under this Agreement, in law or
in equity and subsequently the minimum purchase commitment pursuant to
Section 4.1 will be reduced. In no event, however, shall a minor delay in
delivery of a single unit of Product or any infrequent, unrelated delays in
deliveries of Product(s) or any delay by LORAD in meeting a disproportionately
large demand for Product(s) made by PMSNA outside the planning procedure in
Section 4.3.1 hereof be deemed sufficient to allow PMSNA to cancel or termi-
nate this Agreement or effect a reduction in the minimum quantity in Section
4.1 above.
The compensation described above shall be PMSNA's sole remedy for any delay
in the delivery of a unit of Product which is less than three (3) months.
4.5 Components Specific to the PMSNA Version
4.5.1 General
LORAD agrees - upon request of PMSNA - to build into and/or ship with the
Product(s) the following Components, which shall be furnished by PMSNA at no
charge to be used for the Product(s):
************************************
*******************
******************
**********************
Provision will be made by LORAD to integrate these Components into the
Product(s) as specified in Exhibit 1. LORAD shall be responsible for the overall
design and performance of the Product(s) not only as regards the Product(s)
13
<PAGE>
meeting the Specifications (except as to the specifications for Component(s)),
but also as to their achieving the quality normally expected of products in the
medical x-ray industry and of LORAD's own products.
The technical responsibility for the Components themselves, however, will
remain with PMSNA.
The Components will be used solely for the Products and shipments to PMSNA
or to Philips Associated Companies. They shall not be used for other products
or applications nor for shipments to any third party, unless specifically agreed
to by PMSNA in writing.
All parts left over will be returned to PMSNA upon termination or expiration of
this Agreement.
4.5.2 Logistic Procedure
PMSNA will keep adequate stocks of Components at the warehouse of the
Graner Company in Port Chester, New York, to enable "just in time" supply to
LORAD. LORAD's monthly demand should be transmitted to Graner and
shipment requested, giving adequate advance notice. The stock of Components
at LORAD shall not exceed the quantity needed for the next month's
production of Product(s).
LORAD will handle these Component(s) like any other parts contained in the
Product (i.e. planning, ordering, incoming inspection, stock keeping, technical
supervision) at no extra cost to PMSNA and will use the same degree of
attention and care that it uses for its own property and inventory control.
The details of Component(s), leadtimes, addresses and procedures shall be as
set out in this Section, in Section 6.5 of this Agreement and in Exhibits 1 and
7
hereto.
4.5.3 Spare Parts, Replacement, Repair
Any Spare Part(s) required for repair or replacement of Component(s) will be
provided directly (by Philips GmbH) to PMSNA and Philips Associated
Companies.
4.5.4 Invoicing for Components
PMSNA and LORAD shall establish a "no charge" consignment invoice
procedure to track shipments of Components to LORAD.
4.5.5 Components Consigned to LORAD
Components will be shipped by PMSNA to LORAD F.O.B. Danbury,
Connecticut. LORAD shall be responsible for all risk of loss or damage to
Components consigned to LORAD while they are in LORAD's custody.
14
<PAGE>
5. Pricing
5.1 Prices
During the term of this Agreement PMSNA will purchase and accept from
LORAD Products at the prices specified in Exhibit 2 hereto.
All agreed modifications made at PMSNA's request and listed in Exhibit 1
hereto as well as the engineering work for the CYTOGUIDE adaptation are
included in the price of the Product.
It is expressly understood that PMSNA's going prices in the market have to be
competitive with similar products. In the event of unforeseen circumstances
affecting LORAD or PMSNA or both and/or in the event the price/performance
ratio of Products deteriorates as compared to competitive products, the parties
hereto will jointly review the situation and attempt to find a solution
reasonably
acceptable to both parties.
Prices include adequate packing and royalties for licenses, if any, for
Software/Firmware for each Product.
All prices are expressed in United States dollars ($).
5.2 Price Changes, Binding Prices
The prices of the Products set forth in Exhibit 2 hereto shall remain valid for
**** ***** from the date of the First Commercial Delivery under this Agreement.
Should any future price negotiations extend beyond the price validity period
the prices valid for the previous period will continue in effect until such time
as
the parties have reached mutual agreement on the new prices.
5.3 Most Favored Treatment
In the event, that during the Term, LORAD would normally ***************** it
supplies on an OEM basis or LORAD's distributors/dealers *****************
***************************************************************
******************************************************************************
******************************************
********************************************************************************
*******************************************************************************
***********************************.
5.4 Delivery Conditions, Transportation
Products and Spare Parts shall be delivered F.O.B. at LORAD's facility in
Danbury, Connecticut.
PMSNA shall be responsible for shipping arrangements.
5.5 Payment Conditions
Payment from PMSNA to LORAD shall be made within ************************,
after date of invoice and delivery. A finance charge not to exceed the lesser of
15
<PAGE>
*************************** or the maximum rate allowed by law, may be
assessed by LORAD against any balance due LORAD which is not paid when
due.
5.6 Advance or Excess Deliveries
Unless mutually agreed upon by the parties hereto, LORAD shall not deliver
Product(s) in excess of the quantities ordered nor in advance of the agreed
delivery date. Absent such agreement, if such advance or excess deliveries
occur, PMSNA shall be entitled - at its option - to refuse those Products or
keep
them at its warehouse. Payment under any invoice related to those deliveries
shall not be due until the date originally set for such delivery.
5.7 Invoices
All invoices shall contain at least the following information:
Purchase Order Number
Type-Number of Product (PMSNA's 12-digit ID-number)
Name of the Product
Serial Number(s) thereof
Indication of "certifiable items", contained in the Product
Unit price and total price
Bill of lading number
Invoices shall be submitted (an original and three copies) separately for each
shipment.
6. Production, Packing and Shipping
6.1 Production
The Product(s) shall be manufactured and tested by LORAD in accordance with
the Specification.
6.2 Product Identification and Labelling
LORAD shall mark the Product(s) in accordance with PMSNA's marking
specifications, set forth in Exhibit 1 hereto and - if applicable - with
electrical
current and frequency data.
The serial number shall be listed and used on all documents, such as test
protocols, delivery papers and invoices for easy evaluation and cross reference.
6.3 Packing, Delivery
The prices referred to include all appropriate and safe packing of Product(s),
Option(s), Spare Part(s) and all other items supplied for air and ocean
transport, unless otherwise specified in Exhibit 1 hereto.
The Packing shall be tested by PMSNA and approved in accordance with the
relevant sections of Philips Packing Standard UN-D 1400, Publication no. UN-D
1400 (69), 1990-08-31. LORAD will use only this approved packing method of
16
<PAGE>
shipment of the Product(s). Changes in approved packing may be introduced
only on PMSNA's written request or after PMSNA's prior written approval.
The Products will be packed in a neutral box. There will be no other logo or
trademark inside or outside the packing. LORAD will, however, place
promotional stickers on the packing as PMSNA may require. Such stickers will
be supplied by PMSNA at no charge.
6.4 Labelling and Marking for Shipment, Trademarks
LORAD shall mark all packages and shipping papers (if applicable) with:
Type-Number of Product (PMSNA's 12-digit ID-number)
Name of the Product
Serial Number thereof
Indication of "certifiable items", contained in the Product
Number of packages, if the shipment contains more than one package
per product.
Products shall only bear trademarks, trade names or other indications as
detailed in Exhibit 1 hereto.
Each party hereto acknowledges the other party's rights in and to said other
party's trademarks and tradenames. Except as expressly set forth in this
Agreement, the manufacture and supply of Product(s), Option(s), Spare Part(s)
and packing with said trademarks and tradenames shall not be considered as
giving either party any right to the other party's trademarks and tradenames or
similar trademarks and tradenames.
6.5 Execution of Logistic Procedures
PMSNA may have the Graner Company division of Philips Electronics North
America Corporation or Philips GmbH execute logistic procedures, such as,
without limitation, placing Purchase Orders for any shipments of Product(s)
sent ************************************, payment of invoices, transport
arrangements, shipping instructions and handling of return shipments for
repair or replacement on behalf of PMSNA. LORAD agrees to accept Purchase
Orders from Graner Company or Philips GmbH and deal directly with them or
their authorized agents with regard to scheduling, invoicing, warranty claims
and all matters relating to such Purchase Orders issued by Graner Company or
Philips GmbH.
The address and contact information for Graner Company is:
Graner Company
Philips Electronics North America Corporation
21 Grace Church Street
Port Chester, N.Y. 10573
Phone: (914) 935-8014
Fax: (914) 935-8019
Until further written notice Graner Company shall perform the services listed
above in the first paragraph of this Section 6.5 for all Purchase Orders for
Product(s), Option(s) or Spare Part(s) shipped to addresses ***************
*********************.
17
<PAGE>
6.6 Export and Import Documentation
PMSNA shall obtain, at its own expense, any export or other official
authorization and carry out any other formalities necessary for the
transportation, exportation and importation of Product(s), Option(s) and Spare
Part(s) to all jurisdictions in the Territory. LORAD shall provide all
documentation (including test reports) reasonably necessary for PMSNA to
prepare and submit the required documentation and to obtain any
authorization necessary for such export and import.
Except as to compliance with the standards and legal requirements set forth in
the Specification, Exhibit 4 and Exhibit 8, PMSNA shall be responsible for
ensuring that the Product(s) comply with all local laws, standards and
regulations in the jurisdictions in the Territory, other than ***************
*************. LORAD shall be solely responsible for such compliance including
labeling or listing Product(s), Option(s) or Spare Part(s) as may be required by
the electrical codes, ordinances or regulations of *******************
*********.
7. Quality
7.1 Design Requirement, Compliance
All obligations for testing of Product(s), Option(s) or Spare Part(s) to confirm
that
they comply with the Specification shall be the responsibility of LORAD.
Should it become evident that any Product(s), Option(s), Spare Part(s) or parts
thereof are not in compliance with the applicable requirements of this
Agreement and Exhibits 1, 3 and 4 hereto, LORAD shall, subject to Section 7.2,
make all necessary corrections at its own expense.
7.2 Change in Requirements, Regulations or Standards
If any of the requirements, safety regulations and/or standards listed in the
Specifications or in Exhibits 4 and 8 hereto change, LORAD shall, at its cost,
make all the necessary modifications in and to the Product, Option(s) and/or
parts thereof, including any Product(s) to which the change applies which have
not then been accepted by the end-user.
Subject to the provisions of this Section 7.2, implementation of modifications
or changes to Product(s) and Option(s) to comply with the safety requirements
of any and all applicable statutes, rules and regulations, shall be mandatory.
As of the date the parties entered into this Agreement, changes to the
specifications for all mammography systems sold and installed in the United
States are under consideration by certain government agencies as a result, in
particular, of the Mammography Quality Standards Act of November, 1992 (the
"MQSA"). The final regulation implementing the MQSA is expected to be
published at the beginning of 1994. The parties agree that any such changes
affecting the design and/or performance of the Product(s), Option(s), Spare
Part(s) and/or Component(s) will be incorporated therein in due time, in
accordance with such legal and regulatory requirements. Each party shall bear
its own costs and expenses related to these changes. The responsibilities of the
parties with respect to any Product(s) and Option(s) installed at PMSNA's
customers sites which may be subject to modification as a result of retroactive
18
<PAGE>
application of any such requirements shall be as set forth for warranty
obligations in Article 8 of this Agreement, notwithstanding the fact that
LORAD's warranty on such Product(s) and Option(s) may have expired.
If a revision or modification to any applicable standard or regulation results
in extraordinary cost or expense to LORAD, the parties shall review and evaluate
the change and make all reasonable efforts to find an acceptable solution.
Notwithstanding the foregoing, any revision or modification to any applicable
regulation or standard which is listed in the Specification, which cannot be
incorporated in the Product(s) at a reasonable expense in LORAD's sole
discretion (to be absorbed by LORAD) will be considered an event of force
majeure as set forth in Article 14 below.
Any redesign of Component(s) which might be necessary as a result of new or
revised industry standards or government regulations which affect the design
or manufacture of such Component(s) shall be performed by PMSNA (or the
Philips Associated Company which manufactures such Component(s)) at its
own expense.
7.3 Quality System, Quality Control/Audits
LORAD agrees that its quality system shall comply with the regulations
pertaining to the United States' Food and Drug Administration ("FDA"), Good
Manufacturing Practices ("GMP") and shall also use its best efforts to comply
prior to the end of 1994 with the International Organization for Standardization
("ISO") standards entitled ISO 9001 "Quality systems - Model for quality
assurance in design/development, production, installation and servicing" and
"Quality Systems - Model for quality assurance in production and installation"
ISO 9002 (a copy of the ISO certification shall be attached to this Agreement as
Exhibit 8 when received).
Upon request and at least two (2) weeks advance written notice to LORAD,
PMSNA's representative(s) or an independent notified body acceptable under
GMP or ISO, may visit, at their expense, the facilities of LORAD at reasonable
times to inspect the storage and quality of parts for Product in LORAD's
facilities, and audit the quality control procedures and methods applied by
LORAD in its facilities in the development and manufacturing and assembling
of Products in accordance with GMP and, after LORAD obtains such
certification, with ISO-9001.
With regard to the CE Mark, a certification which is to become mandatory in
the European Community, LORAD will use its best efforts to obtain this
approval/certification by December 31, 1994. PMSNA or one of the Philips
Associated Companies will support LORAD in its contacts with the concerned
European notified body. Cost consequences of design changes, if any, caused
by changes relating to CE Mark certification are for the account of LORAD.
If LORAD does not comply with the ISO standards listed above and/or obtain
CE Mark certification by the date set forth in this Section 7.3 and if, as a
result of such non-compliance or absence of CE Mark certification, PMSNA is
prevented or prohibited by the statutes, regulations, ordnances or other legal
requirements of one or more jurisdictions in the Territory, from importing and
selling Product(s) or customers would be prevented or prohibited from
operating Product(s) in such jurisdictions of the Territory and if PMSNA
19
<PAGE>
provides LORAD with a written statement or notice to that affect from an
appropriate regulatory or standards agency, then LORAD and PMSNA shall
negotiate an extension of the time allowed to PMSNA to purchase the minimum
quantity set out in Section 4.1 of this Agreement. Neither party shall, in these
circumstances, be obligated to bring the Product(s) into compliance with any
alternate standards or certifications that may be acceptable in jurisdictions
where sale, installation or use of Product(s) is prevented or prohibited by any
lack of ISO compliance or CE Mark certification, after January 1, 1995.
7.4 Outgoing Inspection and Record Keeping
It is understood between the parties that under normal circumstances
Product(s) may be shipped directly by LORAD to customers in ***************
************* or to Philips Associated Companies for sales in **************
*******, or, preferably, to their final destination. Hence, PMSNA shall not be
obligated to execute any incoming inspection or other inspection of Product(s),
Option(s) or Spare Part(s) delivered hereunder by LORAD, for non-compliance
with the Specifications.
Therefore, LORAD shall inspect all outgoing Products and/or parts thereof to
be supplied to PMSNA strictly in accordance with Specifications and with the
Acceptance Procedure as specified in Exhibit 4. This Acceptance Procedure will
be set up or adapted - if necessary - in close cooperation between the quality
officers of both companies.
LORAD will archive in a safe manner all records of the Product(s), or Option(s)
e.g. the Product master file and especially all records/test protocols, for a
period as required by law, but at least ************** after delivery of each
Product or Option. These records will be made available if necessary and upon
specified request of PMSNA.
7.5 Incoming Inspection
PMSNA may inspect the delivered Product(s), Option(s) and Spare Part(s) at
PMSNA's factory or at PMSNA's customer's site, following the Acceptance
Procedures set forth in this Agreement and the Exhibits hereto. PMSNA shall
have the right to reject all or any of the Product(s), Option(s) or Spare
Part(s)
which are proven, upon inspection and testing by PMSNA, not to meet the
applicable Specification(s), provided that such claim shall be submitted to
LORAD with the supporting evidence within thirty (30) days after arrival date at
the destination. LORAD shall ship a replacement within thirty (30) days of
receipt of notice that a Product(s), Option(s) or Spare Part(s) is to be
returned for such
reason.
LORAD may inspect the delivered Component(s) at LORAD's factory, following
such test protocols as have been agreed upon for them by LORAD and PMSNA.
LORAD shall have the right to reject all or any of the Component(s) which are
proven, upon inspection and testing by PMSNA, not to meet the applicable
specifications, provided that such claim shall be submitted to PMSNA with the
supporting evidence within thirty (30) days after arrival date at the
destination.
PMSNA shall ship a replacement within thirty (30) days of receipt of notice that
a Component(s) is to be returned for such reason.
20
<PAGE>
The parties agree that in the event of rejections of Product(s), Spare Part(s)
or Option(s) by PMSNA and rejections of Component(s) by LORAD, that concern
minor defects, each party will bear its own costs and expenses associated with
testing, rejection, minor rework, retesting, return of materials etc. and not
claim against the other for such costs and expenses.
Nevertheless, if such rejections exceed an acceptable level for either party,
that party's costs and expenses of such rejection shall be subject to
negotiation with the other party. In extraordinary cases, in which there is
clearly an unacceptable level of rejection, LORAD and PMSNA shall decide in
joint consultation:
a. which corrections and repairs can be made by the rejecting party against
reimbursement by the other party for labor and other expenses incurred
by the rejecting party in correction and repairing Products and/or parts
thereof.
b. which Product(s) or Component(s) respectively, or parts thereof shall be
replaced free of charge by the other party and within which period of time
such replacement shall be effected, it being understood that all costs
connected with forwarding of such replacement to the rejecting party and
removing the defective part and installing the new one shall be for the
account of the other party.
c. which replaced Product(s) or part thereof shall be returned to LORAD at
LORAD's risk and expense or which replaced Component(s) or part
thereof shall be returned to PMSNA at PMSNA's risk and expense.
In all cases the rejecting party shall advise the other party of the expected
costs and receive the other party's approval thereof prior to taking action.
8. Warranty
8.1 Extent of Warranty
LORAD warrants to PMSNA, Graner Company and Philips GmbH that the Product(s),
Option(s) and Spare Part(s) including the Software/Firmware incorporated
therein, comply in all material respects with the Specifications for such
Product(s), Option(s) and Spare Part(s), are new and are free from defects in
material and workmanship. Except as provided in Section 8.4 below, LORAD's sole
obligation under the foregoing warranty shall be to replace or repair, at its
sole discretion and at its sole cost and expense, any defective Product(s),
Option(s) or Spare Part(s) returned to LORAD by or on behalf of PMSNA or a
Philips Associated Company; provided, however, that (i) LORAD's sole obligation
to replace or repair Product(s), Options(s) or Spare Part(s) shall not extend
past the earlier of ******************** from the date of delivery of such
Product(s), Option(s) or Spare Part(s) by LORAD to PMSNA or a Philips Associated
Company or ****************** from the date of completion of its installation at
a customer's site, (ii) PMSNA or its Associated Company shall have notified
LORAD, prior to the expiration of such period, with respect to each claim that
the Product(s), Option(s) or Spare Part(s) are defective, and (iii) LORAD shall
have no obligation to repair or replace the defective Product(s), Option(s) or
Spare Part(s) in the event that the Product(s), Option(s) or Spare
21
<PAGE>
Part(s) have been transported, handled, stored or operated in an improper or
other manner which adversely affects the Product(s), Option(s) or Spare Part(s).
LORAD shall use its reasonable best efforts to replace or repair Product(s),
parts
of Product(s), Option(s) and Spare Part(s), if required by this Section, at
LORAD's
cost within the shortest possible time.
8.2 Cost of Warranty Replacement or Repair
During the time LORAD's warranty is in effect for each unit of Product, each
Option and each Spare Part, LORAD shall provide without charge to PMSNA all
replacement parts necessary to correct any such Product, Option or Spare Part
which proves to be defective and shall pay all shipping expenses (including
reasonable return shipping expenses) associated with such replacement.
8.3 Limited Warranty
EXCEPT AS EXPRESSED OR SET FORTH IN THIS AGREEMENT AND THE
EXHIBITS HERETO, PRODUCT(S), OPTION(S) AND SPARE PART(S) SHALL BE
SUPPLIED BY LORAD TO PMSNA, GRANER COMPANY OR PHILIPS GMBH,
"AS IS." LORAD HEREBY DISCLAIMS ANY AND ALL REPRESENTATIONS AND
WARRANTIES (OTHER THAN THOSE SET FORTH IN THIS AGREEMENT)
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT(S), OPTION(S) AND
SPARE PART(S), INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PMSNA
ACKNOWLEDGES AND AGREES THAT IT HAS NOT RELIED ON ANY
REPRESENTATIONS OR WARRANTIES MADE BY LORAD, EXCEPT AS SET
FORTH IN THIS ARTICLE.
PMSNA shall be responsible for warranty claims for Component(s) and all costs
related thereto.
8.4 Epidemic Faults
Product(s), Option(s) and Spare Part(s) shall be free of Epidemic
Faults. Epidemic Faults are, for the purpose of this Agreement, defined as
defects which
- either are the same or have the same origin and occur over a
period of ****************** during the ************* expected lifetime of the
product with a class failure quantity of at least ************************
sequentially delivered Product(s), Option(s) or Spare Part(s), from the delivery
date
of the last sequentially delivered Product, Option or Spare Part, and
- are such that they create an "unreasonable risk of substantial
harm" as that term is defined by the United States, Food, Drug and Cosmetic
Act and the regulations and guidelines issued thereunder.
In the event of the existence of an Epidemic Fault, the parties shall consult
with and cooperate fully with each other in a timely way to determine if a
safety
concern exists and to take the appropriate actions and to allocate the
resulting
costs of such actions between them in accordance with the terms hereof.
LORAD shall within **************** after receipt of same respond to any
question and provide all necessary information to the PMSNA Service
22
<PAGE>
Department arising out of a recall or corrective action program or related
program.
Furthermore LORAD shall inform PMSNA of all relevant details of substantially
similar incidents that occur with LORAD's products similar to or part of
Product(s).
In case of such Epidemic Fault(s), in any part or parts of Product(s) or any
required recall program, LORAD shall, at its expense (including shipment to
each customer's site), provide sufficient parts to replace all such parts in
installed Product(s) and Product(s) purchased by PMSNA.
Spare Part(s) in stock which become obsolete due to Epidemic Fault(s) may be
returned to LORAD and will be credited at the original invoice price or
upgraded to the desired level at the expense of LORAD.
LORAD shall repair or replace uninstalled Product(s), Option(s) and Spare Parts
which are subject to Epidemic Faults. LORAD warrants the Products, Options
and Spare Part(s) not yet delivered will be so upgraded. For Products and
Option(s) in the installed base, upgraded components or parts will be made
available from LORAD at no charge and PMSNA will be responsible for
removing the old components or parts and installing the new ones.
The remedies contained in this Section 8.4 shall be the sole remedies available
to PMSNA in the event of an Epidemic Fault as defined herein, subject to the
limitations set forth in Section 10.3 hereof.
9. Service and Spare Parts
The Spare Part(s) supply, maintenance and repair of Product and general
product and service support for the Product, to be provided by each of the
parties shall be as set forth in Exhibit 3 hereto.
10. Claims
10.1 Personal Injury and Property Damage
LORAD agrees to defend, indemnify and hold harmless PMSNA and Philips
GmbH from and against any and all loss, cost and expense, including counsel
fees and all expenses of investigation, litigation, judgment and/or settlement,
arising through or out of personal injury or death to person(s) or damage to
property alleged or proven to have arisen out of failure of a Product(s),
Option(s) or Spare Part(s) to meet the Specification or as a result of a defect
in
its workmanship or materials, provided, that in any such case where
indemnification is sought hereunder (i) PMSNA or Philips GmbH shall have
given prompt written notice to LORAD of such claim and the facts and
circumstances relating thereto, (ii) PMSNA shall fully cooperate with LORAD in
connection with any such claim by any governmental authority or third party,
(iii) LORAD shall have the sole right to defend, settle and compromise any such
claim, and (iv) LORAD shall have no obligation to indemnify and hold harmless
PMSNA for any negligent conduct of PMSNA or any action or omission by
PMSNA in violation of this Agreement.
23
<PAGE>
PMSNA agrees to defend, indemnify and hold harmless LORAD from and
against any and all loss, cost and expense, including counsel fees and all
expenses of investigation, litigation, judgment and/or settlement, arising
through or out of personal injury or death of person(s) or damage to property
which is alleged or proven to have arisen out of the negligent act or omission
of
PMSNA, its officers, directors, employees or agents, provided, that in any such
case where indemnification is sought hereunder (i) LORAD shall have given
prompt written notice to PMSNA of such claim and the facts and circumstances
relating thereto, (ii) LORAD shall fully cooperate with PMSNA in connection
with any such claim by any governmental authority or third party, (iii) PMSNA
shall have the sole right to defend, settle and compromise any such claim, and
(iv) PMSNA shall have no obligation to indemnify and hold harmless LORAD for
any negligent conduct of LORAD or any action or omission by LORAD in
violation of this Agreement.
LORAD shall obtain and maintain current, at all times during the Term of this
Agreement and any extensions hereof, Commercial General Liability insurance
(including products and contractual coverage) with an insurance company
rated by Best "A" or better, in amounts not less than ********** single limit
and ********** combined single limit. Such insurance shall cover, among
other things, product liability claims relating to the Product. LORAD shall
provide PMSNA with a certificate of such insurance from LORAD's insurer,
updated upon expiration thereof. Such certificate shall designate PMSNA as a
certificate holder. PMSNA shall receive no less than thirty (30) days prior
written notice of cancellation or termination of such insurance.
10.2 Intellectual Property Indemnification
10.2.1 Indemnification by LORAD
LORAD shall defend PMSNA and its respective distributor, agent, dealer or
customer against any claim by a third party that the manufacture, sale or use
of a Product(s), Option(s) or Spare Part(s) supplied by LORAD infringes******
************************************************************************** and
LORAD will pay any resulting penalties, judgments or awards finally
determined by a court or other tribunal of competent jurisdiction to be payable
in connection therewith, or amounts payable in settlement thereof, provided
that in any such case where indemnification is sought by PMSNA hereunder (i)
PMSNA shall have given prompt written notice to LORAD of such claim and
the facts and circumstances relating thereto, (ii) PMSNA shall fully cooperate
with LORAD in connection with any such claim, (iii) LORAD shall have the sole
right to defend, settle and compromise any such claim and (iv) LORAD shall
have no obligation to indemnify and hold harmless PMSNA for any negligent
conduct of PMSNA or for any action or omission by PMSNA in violation of this
Agreement. LORAD's obligations under this Section 10.2.1 are conditioned on
PMSNA's agreement that, if the Product(s), Option(s) or Spare Part(s) or the
manufacture, sale or use thereof becomes or in LORAD's reasonable opinion is
likely to become, the subject of such a claim, PMSNA will permit LORAD, at
any time thereafter, at LORAD's expense, either to procure the right for PMSNA
to continue selling the Product(s), Option(s) or Spare Part(s) or to replace or
modify, in a manner such that its performance is not degraded, the Product(s),
Option(s) or Spare Part(s) so that it becomes non-infringing, and if neither of
the
foregoing alternatives is available on terms which are acceptable to LORAD in
its reasonable judgment, LORAD may terminate this Agreement immediately as
24
<PAGE>
to that part of the Territory in which manufacture, sale or use of the
Product(s),
Option(s) or Spare Part(s) may be infringing and LORAD shall reimburse PMSNA
for the purchase price actually paid by PMSNA, less an allowance for
depreciation, for Product(s), Option(s) and Spare Part(s) which can no longer be
sold by PMSNA or a Philips Associated Company or used by their customers.
The foregoing states the entire liability of LORAD with respect to infringement
of rights in intellectual property.
Notwithstanding the foregoing, LORAD shall have no liability under this
Section 10.2.1 for a claim by a third party that the manufacture, sale or use of
a Product(s), Option(s) or Spare Part(s) infringes a patent, copyright, trade
secret, mask work or other intellectual property right in any of the following
circumstances: (i) The Product(s), Option(s) or Spare Part(s) was altered or
modified by PMSNA or any third party and such alteration or modification
resulted in or is the basis for the claim of infringement. (ii) PMSNA or its
customers failed to use updated Product(s), Option(s) or Spare Part(s) provided
by LORAD which would have avoided the claim of infringement. (iii) PMSNA or
any third party used the Product(s), Option(s) or Spare Part(s) in combination
with apparatus or software not furnished by LORAD; this combination resulted
in or is the basis for the claim of infringement; and the claim of infringement
would not have occurred if the Product(s), Option(s) or Spare Part(s) had been
used in combination with the usual apparatus or software (if any) specified by
LORAD for that use in or with the Product(s), Option(s) or Spare Part(s). In
particular, LORAD shall be responsible for a claim of infringement by a
Product(s), Option(s) or Spare Part(s) in combination with Component(s) if and
only if that claim can also be stated in the same terms against the item which
LORAD itself has specified for that use. (iv) The Product(s), Option(s) or Spare
Part(s) was used in a manner for which it was not designed, specified or
otherwise contemplated by LORAD and that use resulted in or is the basis for
the claim of infringement. (v) PMSNA owns an intellectual property right or has
a license which precludes it from being held responsible for the claim of
infringement.
10.2.2 Indemnification by PMSNA
PMSNA shall defend LORAD and its respective distributor, agent, dealer or
customer against any claim by a third party that the manufacture, sale or use
of Component(s) supplied by PMSNA hereunder infringes a patent, copyright,
trade secret, mask work or other intellectual property right and PMSNA will pay
any resulting penalties, judgments or awards finally determined by a court or
other tribunal of competent jurisdiction to be payable in connection therewith,
or amounts payable in settlement thereof, provided that in any such case
where indemnification is sought by LORAD hereunder (i) LORAD shall have
given prompt written notice to PMSNA of such claim and the facts and
circumstances relating thereto, (ii) LORAD shall fully cooperate with PMSNA in
connection with any such claim, (iii) PMSNA shall have the sole right to defend,
settle and compromise any such claim and (iv) PMSNA shall have no obligation
to indemnify and hold harmless LORAD for any negligent conduct of LORAD or
for any action or omission by LORAD in violation of this Agreement. PMSNA's
obligations under this Section 10.2.2 are conditioned on LORAD's agreement
that, if such Component(s) or the manufacture, sale or use thereof becomes or
in PMSNA's reasonable opinion is likely to become, the subject of such a claim,
LORAD will permit PMSNA, at any time thereafter, at PMSNA's expense, either
to procure the right for LORAD to continue using such Component(s) or to
25
<PAGE>
replace or modify, in a manner such that its performance is not degraded, such
Component(s) so that it becomes non-infringing, and if neither of the foregoing
alternatives is available on terms which are acceptable to PMSNA in its
reasonable judgment, PMSNA may terminate this Agreement immediately as to
that part of the Territory in which manufacture, sale or use of such
Component(s) may be infringing and PMSNA shall reimburse LORAD for the
purchase price actually paid by LORAD, less an allowance for depreciation, for
such Component(s) which can no longer be sold by LORAD or used by its
customers. The foregoing states the entire liability of PMSNA with respect to
infringement of rights in intellectual property.
Notwithstanding the foregoing, PMSNA shall have no liability under this
Section 10.2.2 for a claim by a third party that the manufacture, sale or use of
a Component(s) infringes a patent, copyright, trade secret, mask work or other
intellectual property right in any of the following circumstances: (i) The
Component(s) was altered or modified by LORAD or any third party and such
alteration or modification resulted in or is the basis for the claim of
infringement. (ii) LORAD failed to use updated Component(s) provided by
PMSNA which would have avoided the claim of infringement. (iii) LORAD or
any third party used the Component(s) in combination with apparatus or
software not furnished by PMSNA; this combination resulted in or is the basis
for the claim of infringement; and the claim of infringement would not have
occurred if the Component(s) had been used in combination with the usual
apparatus or software (if any) specified by PMSNA for that use in or with the
Product(s), Option(s) or Spare Part(s). In particular, PMSNA shall be
responsible for a claim of infringement by a Product(s), Option(s) or Spare
Part(s) in combination with Component(s) if and only if that claim can not also
be stated in the same terms against the item which LORAD itself has specified
for that use. (iv) The Component(s) was used in a manner for which it was not
designed, specified or otherwise contemplated by PMSNA and that use resulted
in or is the basis for the claim of infringement. (v) LORAD owns an intellectual
property right or has a license trademark which precludes it from being held
responsible for the claim of infringement.
10.3 Limitation
In no event shall either party be liable to the other for special, indirect or
consequential damages of any kind including, but not limited to, loss of other
business opportunity, profit or revenue or loss of goodwill, arising from any
failure or matter arising under this Agreement. No claim or recovery by one
party against the other shall be greater in amount than the purchase price of
the individual unit of Product(s), Option(s) or Spare Part with respect to which
such claim or recovery arose. Notwithstanding the foregoing, any obligation of
the parties under Section 10.1 above with respect to personal injury or death to
persons or damage to property shall not exceed ************************* and
*********************************, and any obligation under Section 10.2
above with respect to intellectual property shall not exceed the aggregate
purchase price to PMSNA of the Product(s) involved.
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<PAGE>
11. ********************
11.1 ********************************
Without limiting LORAD's liability to PMSNA thereunder in any way
whatsoever, it has been agreed that if LORAD;
a) intends to enter or actually enters liquidation procedures (either
voluntarily or forced); or
b) has entered bankruptcy procedures (either voluntarily or forced);
or
c) within ninety (90) days of written notification by PMSNA has not
remedied any material breach of this Agreement,
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*******************************************************************************
******************** ************************************, if and to the extent
required by PMSNA, in exchange for compensation by PMSNA for LORAD's
purchase price for such components and Spare Part(s).
11.2 Right to Produce
Accordingly,*******************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
***************************************************************************
********************************************************************************
*******************************************************************************
***************************************** *******.
11.3 *****************
If, during the Term of this Agreement or any extensions hereof, there is a
********************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************
************************* ******PMSNA shall be solely responsible for
the fees and expenses of setting up and maintaining the **************.
LORAD shall be responsible for its own costs and expenses of assembling,
checking and keeping current the ********************************************
***********************************. The terms for the escrow
*********shall be as agreed upon by the parties, consistent with those terms
which are customary and reasonable for *************************** in the
computer industry.
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<PAGE>
12. Confidentiality
The parties shall not use, employ or disclose Confidential Information received
from the other whether orally, in writing, by demonstration or otherwise except
as is necessary to implement this Agreement, unless and to the extent the
receiving party can prove by written record that it:
a. was already in the public domain or becomes available to the
public through no breach of this Agreement by the receiving party;
b. was in the receiving party's possession prior to receipt from the
disclosing party as proven by its written records; or
c. was received independently from third party free to disclose such
information to the receiving party; or
d. was independently developed by the receiving party without use of
the Confidential Information as proven by its written records; or
e. became available by inspection or analysis of other products or
techniques in the market.
In protecting Confidential Information, the receiving party will take all
necessary precautions and Confidential Information will be treated in the same
manner and with the same degree of care as the receiving party applies with
respect to its own confidential information.
Nothing contained in this Article shall be construed as a grant of license to
the
other party, to make, use or sell any Product(s) using Confidential Information
or as a license under any patents or claims covering same.
LORAD may, however, file a copy of this Agreement with the Securities and
Exchange Commission pursuant to the requirements of the Securities Act of
1933, as amended or the Securities Exchange Act of 1934, as amended,
provided that LORAD files a confidentiality request with the Securities and
Exchange Commission seeking to protect the confidentiality of the pricing and
forecasts herein and in Exhibit 2.
The provisions of this Article shall be in full force and effect retroactively
from
March 18, 1992 and shall remain in full force and effect during the duration of
this Agreement and five (5) years thereafter.
13. Term and Termination
13.1 Term
This Agreement shall enter into force upon the date of signature by both
parties and shall initially continue until the earlier of five (5) years from
the
date of the First Commercial Delivery of Product(s) under this Agreement or
fulfillment of the minimum purchase commitment set forth in Section 4.1
above.
********************************************************************************
****************, unless and until ************************************
28
<PAGE>
******************************** prior written notice to the other party, such
notice being given as set forth in Section 15.10 hereof.
13.2 Termination for Cause
This Agreement may also be terminated as follows:
a. if a party (the failing party) has not remedied any material breach
of this Agreement within ninety (90) days of receipt of written
notice (sent in accordance with Section 15.10 hereof) of such
breach, said other party is entitled to terminate this Agreement
and or any outstanding Purchase Order(s) placed hereunder
immediately by notice to the failing party, such without prejudice
to any other rights accruing under this Agreement or in law,
b. by the other party in the event that either party shall cease to carry
on business in the normal course, becomes insolvent, makes a
general assignment for the benefit of its creditors, suffers or
permits the appointment of a receiver or a manager for its business
assets or avails itself or becomes subject to any proceeding under
bankruptcy laws or any other statute or laws relating to the
insolvency or protection of the rights of creditors, or
c. by PMSNA by written notice to LORAD in the event the control of
LORAD would pass to other(s) than those now exercising control.
13.3 Continuing Commitments
The termination of this Agreement shall not relieve or release either party from
fulfilling any undertaking or commitment including, without limitation, those
affecting payments, work and deliveries which arise by reason of any event
other than termination, such as those arising from Purchase Order(s) placed
pursuant to this Agreement prior to its termination.
14. Force Majeure
In the event of Force Majeure the party being delayed or damaged thereby shall
inform the other party as soon as possible but in any event within fourteen (14)
calendar days after the start of such Force Majeure specifying the nature of the
Force Majeure as well as the length of the delay which is expected.
In the event the Force Majeure situation continues for more than sixty days
(60) days or is expected to last longer than sixty (60) days then either party
is
entitled to terminate this Agreement by simple notice in writing and without
either party being entitled to any claim for damages. Otherwise both parties'
rights and obligations will be suspended and new time schedules and supply
dates shall be agreed upon between the parties hereto.
Force Majeure shall be understood to mean and to include damage or delay by
acts of God, acts of regulations or decrees of any Government (de facto or de
jure), natural phenomena, such as earthquakes or floods, fires, riots, wars,
shipwrecks, freight embargoes, labor disputes, defaults by suppliers or other
causes, whether similar or dissimilar to those enumerated above,
29
<PAGE>
unforeseeable and beyond the reasonable control of the parties and which
prevent the total or partial carrying out of any obligation under this
Agreement.
PMSNA's purchase commitments under this Agreement are based on present
market information and estimates shared by both parties and market growth
figures extrapolated from that information. In the event of unforeseen
circumstances, major shifts in the market for mammography equipment (such
as the rapid development of significant new ultrasound technology similar to
that being developed by other subsidiaries of Thermo Trex Corporation) which
renders the Product obsolete or other occurrences which make distribution and
sale not only of Product, but also of substantially similar products by other
firms in the industry, impracticable at the levels contemplated by this
Agreement, the parties shall negotiate in good faith and agree upon alternative
quantities which are acceptable to both and reasonable given the then-current
nature of the market for mammography equipment.
15. General Terms and Conditions
15.1 Applicable Law
This Agreement shall be deemed to have been made in the State of
Connecticut, shall be construed in accordance with, and the rights and
liabilities of the parties hereunder shall be governed by the laws of such
State,
without regard to its conflicts of law doctrine, and this Agreement shall be
deemed in all respects to be a contract of such State.
15.2 Attorney's Fees
In the event of any claim or controversy arising regarding the enforceability,
interpretation or intent of this Agreement, the prevailing party or parties (to
the
extent prevailing) shall be entitled to its reasonable attorney's fee and
expenses
in addition to whatever other relief said party would otherwise be entitled.
15.3 Entire Agreement
This Agreement sets forth the entire intent and understanding among the
parties relating to the subject matter hereof and merges all prior negotiations
and discussions between them. No party shall be bound by any conditions,
representations or warranty other than as expressly set forth herein or subse-
quently set forth in writing executed by both parties hereto.
Neither PMSNA's general conditions of purchase nor LORAD's general
conditions of sales are applicable to this Agreement or to any order and order
confirmations for Product(s) or parts thereof in whole or in part.
15.4 Waiver
No waiver by any of the parties hereto of any breach of any condition, covenant
or term thereof shall be effective unless it is in writing and it shall not
constitute a waiver of such condition, covenant or term.
30
<PAGE>
15.5 Severability
If any of the terms or provisions of this Agreement are determined to be invalid
or unenforceable by any court of competent jurisdiction, it shall not invalidate
the rest of this Agreement which shall remain in full force and effect as if
such
terms and provisions had not been a part of this Agreement.
Parties are, however, obliged to immediately replace this term or provision by
an effective one, covering in so far as possible the original intentions of the
parties as to its legal and economic contents.
15.6 Non-Assignment
This Agreement shall be binding upon and accrue to the benefit of the parties
hereto, their respective successors and permitted assigns. This Agreement may
not be assigned, transferred or hypothecated in whole or in part by either party
without the prior written consent of the other party. No consent is required,
however, to an assignment or transfer in whole or in part by PMSNA to any of
the Philips Associated Companies. PMSNA shall notify LORAD of such
assignment or transfer in writing. The references to Graner Company, Philips
GmbH, and a Philips Associated Company or Companies in this Agreement are
intended only as notice to LORAD that certain functions, rights and duties
hereunder have been assigned to those entities as of the date of this
Agreement.
15.7 Advertisements
LORAD shall not without PMSNA's prior written consent use PMSNA's or any
other of the Philips Associated Companies' name or trademark as such and/or
use name in connection with any advertisement or sale literature nor advertise
that it is a supplier of PMSNA and/or the Philips Associated Companies and/or
that this Agreement between LORAD and PMSNA has been concluded.
15.8 Sales and Applications Support
LORAD shall also provide materials, documentation and training for sales and
applications training personnel of PMSNA or Philips Associated Companies and
assistance in preparation of sales materials for Product(s) and Option(s), as
reasonably required by PMSNA.
LORAD shall provide sales, applications and service training to support the
introduction of the Product(s) to the market consisting of: (i) five sessions of
sales training of no more than one day each, (ii) five sessions of applications
training of no more than one day each, and (iii) five sessions of service
training
each of no more than five days duration. The sales and applications training
and one of the service training sessions shall be held no later than four (4)
weeks before the First Commercial Delivery of Product(s) under this Agreement.
Each party shall bear its own expenses associated with training. The training
shall be conducted by LORAD personnel at PMSNA's Shelton, Connecticut
facility or at LORAD's facility in Danbury, Connecticut.
LORAD may charge PMSNA at LORAD's usual rate for additional training and
documentation services.
31
<PAGE>
LORAD's pricing for any new Product(s) or Option(s) added to the scope of this
Agreement shall include sales, service and applications training as set forth
above.
15.9 Project Leaders
Upon the signature of this Agreement either party shall appoint, by written
notice, a Project Leader who shall represent his party in all communication,
contacts, meetings, negotiations and reports, of technical nature as necessary
for the performance of this Agreement. Any subsequent change of the Project
Leader shall be notified in writing to the other party.
15.10 Notices
Notices will be addressed as follows:
If to PMSNA: Philips Medical Systems North
America Company.
710 Bridgeport Avenue
Shelton, Connecticut 06484
Attn: Vice President,
Marketing
cc: Vice President and
General Counsel
If to LORAD: LORAD Corporation,
36 Apple Ridge Road
Danbury, Connecticut 06810
Attn: Mr. A. Pellegrino
cc: Mr. H. Kirshner
or to such other address as the pertaining party will have previously notified
to
the other party.
All notices will be deemed given ten (10) working days after they have been
mailed by registered mail or so much earlier as the receiving party can be
proven to have received such notice.
15.11 Compliance with Law
Except to the extent it is precluded from doing so by the law of its principal
place of business, each party agrees that the performance of its obligations,
exercise of its rights and fulfillment of its duties under this Agreement shall
comply with applicable laws and ordinances of each government having
jurisdiction over such activity and all lawful orders, rules and regulations
issued thereunder. The Product(s), Option(s) and Spare Part(s) in the form they
are provided by LORAD to PMSNA shall comply with all lawful orders, rules
and regulations applicable in the************************** to their shipment,
installation and use therein (including any such statutes and regulations
relating to hazardous substances or environmental concerns), as well as all
legal requirements relating to their export from the United States.
32
<PAGE>
15.12 Surviving Articles
Articles 8, 9, 10, 11, 12, 15 and, as to Purchase Order(s) which have not been
filled as of the date of termination or cancellation, Articles 4, 5, 6 and 7 and
such other terms and conditions of this Agreement which are expressly
intended to survive the expiration, termination or cancellation of this
Agreement shall so survive.
IN WITNESS WHEREOF authorized representatives of the parties hereto have
signed this document.
LORAD CORPORATION PHILIPS MEDICAL SYSTEMS
NORTH AMERICA COMPANY
By: /s/ Hal Kirshner By: /s/ Michael P. Moakley
-------------------- ----------------------
Hal Kirshner Michael P. Moakley
President President
Date: DATE APPEARS HERE Date: NOV. 17, 1993
------------------ ----------------------
33
<PAGE>
List of Exhibits
The following Exhibits and Appendices are incorporated in this OEM
Agreement between LORAD Corporation and Philips Medical Systems North
America Company and are made a part hereof:
Exhibit 1 Specification
Exhibit 2 Planning and Prices
Exhibit 3 Service Arrangements
Appendix 1 Field Problem Report
Appendix 2 List of Spare Parts
Exhibit 4 Final Test Report
Exhibit 5 Standard Form of Change Request
Exhibit 6 Time Schedule
Exhibit 7 Components from PMS\Logistic Procedures
Exhibit 8 Lorad's ISO 9000 Certificate
Exhibit 9 Exclusive Territory
34
<PAGE>
Exhibit 1
SYSTEMS SPECIFICATIONS FOR PHILIPS MAMMO DIAGNOST
1.0 SCOPE AND PURPOSE
This document is intended to define the requirements of a
group of products called the "Mammo DIAGNOST 3000". The
product is to be designed and manufactured for Philips
Medical Systems by Lorad Corporation.
2.0 APPLICABLE DOCUMENTS STANDARDS
The following documents are incorporated into this document
to the extent described in this specification.
2.1 Philips Documents
**************************************************
**************************************************
***********************************
**************************************************
**************************************
2.2 Lorad Documents
*********************************************
****************************
***********
***********
***********
***********
***********
2.3 Other Documents
2.3.1 IEC 601-1 [Medical electrical equipment]
2.3.2 IEC 601-2-7 [Particular requirements for the
safety of high-voltage generators of
diagnostic x-ray generators]
2.3.3 IEC 601-1-1 [Collateral standard: Safety
requirements for medical electrical
systems]
- --------------------------------------------------------------------------------
Philips MD3000 Page - 1 15/October/93
<PAGE>
2.3.4 IEC 601-1-2 [Collateral standard:
Electromagnetic compatibility -
Requirements and tests]
2.3.5 IEC 788 Publication
[Medical radiology - Terminology]
2.3.6 IEC-4l7G [Graphical symbols for use on
equipment]
2.3.7 IEC-80l-2 [Electromagnetic compatibility for
industrial-process measurement and
control equipment. Part 2:
Electrostatic discharge requirements]
2.3.8 EC Medical Device Directive
2.3.9 U/L 187 [Standard for safety x-ray
equipment]
2.3.10 CSA C22.2 No. 601.1-M90
[Medical Electrical Equipment Part
1: General Requirements for Safety]
2.3.11 2lCFR U.S. Code of Federal Regulations
3.0 FUNCTIONAL AND DESIGN REQUIREMENTS
3.1 General System Requirements
3.1.1 ELECTRICAL INPUT
3.1.1.1 *************************
************************************
3.1.1.2 ******************************
******************************
3.1.1.3 ***********************
3.1.1.4 ***************************
3.1.1.5 ***********************************
***********************************
3.1.1.6 *****************************
3.1.2 DIMENSIONS
All dimensions are preliminary based on design
for September 1993 unit.
3.1.2.1 Height
- --------------------------------------------------------------------------------
Philips MD3000 Page - 2 15/October/93
<PAGE>
*******************
*******************
3.1.2.2 Width
*****************************
*******************
3.1.2.3 Length
****************************
3.1.2.4 Weight
***********************
***********************
3.1.3 USE ENVIRONMENT
3.1.3.1 ***************************
3.1.3.2 **********************************
3.1.3.3 **********************************
**********************************
********************
******************************
3.1.3.4 ************************************
**********************
3.1.3.5 ************************************
************************************
3.1.4 NOT IN USE ENVIRONMENT
**********************************************
3.2 Mechanical and Geometric Requirements
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 3 15/October/93
<PAGE>
3.2.1 ROTATION BRAKE
*****************************************
3.2.2 C-ARM ANGULATION
*****************************
3.2.3 VERTICAL TRAVEL
**********************************************
***********
3.2.4 ALIGNMENT OF FOCAL SPOT, COMPRESSION DEVICE
AND IMAGE RECEPTOR
**********************************************
**********************************************
************************************
3.2.5 SOURCE TO IMAGE RECEPTOR DISTANCE (SID)
**********************************************
**********************************************
**********************************************
********************
********************
***************
3.2.6 COMPRESSION
3.2.6.1
**********************************************
*********************
***********************
*******************************
*******************************
*******************************
***********************
*****************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 4 15/October/93
<PAGE>
3.2.6.2 ********************************
*********
****************************************
***********************************
*****************
****************************************
*****************
****************************************
****************************************
*****************
****************************************
************************************
************************************
******
3.2.6.3 ******************
*****************************************
*****************************************
3.2.6.4 *********************
*****************************************
**************
3.2.6.5 ***************
*****************************************
***********************************
3.2.7 MAGNIFICATION
3.2.7.1 ***************
************************************
3.2.7.2 *******************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 5 15/October/93
<PAGE>
*******************
3.2.7.3 ****************
**********
3.2.7.4 ************************************
3.2.7.5 ************************************
3.2.8 STEREOTACTIC CAPABILITY
**********************************************
*************
**********************************************
**********************************************
********
3.3 X-Ray Source Filtration and Collimation Requirements
3.3.1 X-RAY TUBE
3.3.1.1 Tube Type
*********************
3.3.1.2 Focal spot size
*********************
3.3.1.3 Tube loading
***********************
3.3.1.4 Tube voltage
**********
3.3.1.5 Heat Capacity
*************************
3.3.1.6 Maximum continuous heat dissipation
******
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 6 15/October/93
<PAGE>
3.3.1.7 Anode rotation speed
************************
3.3.1.8 Anode material
***************************
3.3.1.9 Anode angle
******
3.3.1.10 Anode disc diameter
*****
3.3.1.11 X-ray window
*****
3.3.2 X-RAY TUBE ASSEMBLY
3.3.2.1 Continuous heat dissipation
***************
3.3.2.2 Maximum temperature of housing
surface
*******
3.3.2.3 Filtration
****************
3.3.2.4 Safety class of IEC 601/88
*******
3.3.2.5 Over-temperature protection sensor
3.3.3 X-RAY COLLIMATION
**********************************************
**********************************************
**********************************************
**********************************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 7 15/October/93
<PAGE>
**********************************************
*********
3.3.4 LIGHT FIELD INDICATOR
3.3.4.1 ************************************
************
3.3.4.2 ************************************
************************************
*************
3.4 High Voltage Generator Requirements
3.4.1 MAXIMUM RIPPLE
*****
3.4.2 RATING AND DUTY CYCLE
3.4.2.1 Maximum voltage
**********
3.4.2.2 Maximum power consumption (at 30kV,
0.5 seconds)
**********
3.4.2.3 Regulation type
********************
3.4.2.4 Continuous duty rating
*****
3.4.2.5 Duty cycle
***************
3.4.3 RANGE KV,MAS
3.4.3.1 Tube voltage
*******
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 8 15/October/93
<PAGE>
3.4.3.2 Tube current
**************************************
*****************************************
****************************************
*************************************
***************
*************************************
*************************************
**************************
3.4.3.3 Exposure time
******************
*************************************
*********
3.4.4 ACCURACY
3.4.4.1 Reproducibility of radiation output
******************************
3.4.4.2 Linearity of radiation output versus
mAs product
************************************
**********
3.4.4.3 Accuracy of tube voltage
*****
3.4.4.4 Accuracy of mAs product
******************
3.4.4.5 Accuracy of mA
*****
3.4.4.6 Accuracy of mAs post-exposure
display
************************************
************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 9 15/October/93
<PAGE>
3.5 Image Receptors
**********
**********
*****************************************************
****************************************
3.6 AEC
3.6.1 DETECTOR DESIGN
**********************************************
******
3.6.2 AEC POSITIONING
**********************************************
**********************************************
**********************************************
************
3.6.3 ACCURACY
************************************
3.6.4 REPRODUCIBILITY
**********************************
3.6.5 AEC EXPOSURE TERMINATION
**********************************************
************
3.7 Control and Display Requirements
*************************************************
4.0 SAFETY REQUIREMENTS
4.1 Electrical Safety
********************************************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 10 15/October/93
<PAGE>
***************
4.1.1 CLASSIFICATION
**********************************************
***************************************
4.1.2 LEAKAGE CURRENTS
4.1.2.1 ***************
4.1.2.2 ***************
4.1.2.3 ***************
Phillips has not confirmed these values
4.1.3 PROTECTIVE EARTH IMPEDANCE
**********************************************
******************
4.1.4 EMERGENCY POWER OFF
**********************************************
******************
4.2 Mechanical Safety
**********************************************
************************
4.2.1 ******************************
4.2.2 **********************************************
4.2.3 ***********************************
4.3 Radiation Safety
**********************************************
************
4.3.1 Interlocks
**********************************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 11 15/October/93
<PAGE>
***************
**************
4.3.2 X-ray Switch
**********************************************
***********************
4.3.3 Exposure Duration
*******************************
****************************
**********************************************
**********************************************
*******
****************************
4.3.4 Radiation shield
**********************************************
**********************************************
*******
**********************************************
**********************************************
********
5.0 TEST AND COMPLIANCE REQUIREMENTS
5.1 Test Requirements
5.1.1 **********************************************
**************************
5.1.2 **********************************************
*******************************************
5.1.3 **********************************************
******************
**********************************************
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 12 15/October/93
<PAGE>
*******
**********************************************
*************************
6.0 DOCUMENTATION REQUIREMENTS
6.1 Deliverables
6.1.1 Operator's Manual - Mammographic System
6.1.2 Operator's Manual - Cytoguide Option
6.1.3 Technical Service Manual
6.1.4 Planned Maintenance Booklet
6.1.5 Site Planning Guide (with seismic mounting
data)
6.2 Relevant Document Specifications
6.2.1 Operator's Manual - Mammographic System: in
lieu of a formal spec from Philips,
Operator's Manual 4512 109 0734l/7l4H -1990-03
"mammo DIAGNOST UC" will be used
as a content and format guide.
6.2.2 Operator's Manual - Cytoguide System: Operator's
Manual 4512 109 0955l/7l4H -1992-05,
Cytoguide Rel. 2 will be used as a content and
format standard.
6.2.3 Service Manual: unnumbered document entitled
"Service Documentation" (received from
PMSNA Tech. Pub. Mgr) will be used as a content
guide. Supplied "Technical Service
Manual" for the mammo DIAGNOST UC (9885 291 40001)
will be used as a format guide.
6.2.4 Planned Maintenance Booklet: PMSNA document
entitled "SERVICE MANUAL
GUIDELINES, System Manual - Planned Maintenance"
will be used as a standard.
6.3 Language Requirements
6.3.1 Operator's Manuals (described in 6.1.1 and
6.1.2, above) will be produced in English,
French,
German and Spanish versions.
6.3.2 Technical Service Manual and Planned
Maintenance Booklet (described in 6.1.3 and
6.1.4)
will be supplied only in the English language.
6.4 Production
6.4.1 Lorad will print manuals.
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 13 15/October/93
<PAGE>
6.4.2 Production Manuals will be produced and bound
in the manner exhibited by the mammo
DIAGNOST UC package. Philips will supply service
manual binder and indexes.
- --------------------------------------------------------------------------------
PhilipsMD3000 Page - 14 15/October/93
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 1 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
ISSUED REVISED APP'D.
C 10/15/93 ROGERS/WEICHERS 10/15/93
- --------------------------------------------------------------------------------
Exhibit 1 (cont'd)
SOFTWARE SPECIFICATIONS FOR PHILIPS MD 3000
1.0 INTRODUCTION
This document describes the functional requirements of the
Operating Software for the Philips Mammo Diagnost 3000. The
reader will find some text printed plain, and some in italics.
Plain text is a general specification for the topic being
discussed, while italic text represents a more technical software
requirement.
The designer may use different designations for labels denoting
active low signals. The following text will consistently use a
preceding slash (/) to the label name (i.e. /RESET), to imply that
a logic low will activate the function.
2.0 GENERAL DESCRIPTION
The Philips MD 3000 mammography system********************************
************.
****************
**********************************************
**********************************************.
**********************************************
**********************************************
**********************************************
**********************************************
***********
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 2 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.0 SPECIFIC REQUIREMENTS
---------------------
3.1 DESIGN CONSTRAINTS
------------------
3.1.1 Hardware
A.) **********************************************
**********************************************
B.) **********************************************
**********************************************
**********************************************
C.) Complete code will be sized to fit any 32K by 8
bit PROM.
3.1.2 Software
A.) **********************************************
**********************************************
B.) **********************************************
**********************************************
C.) **********************************************
D.) *********************************************
3.2 FUNCTIONAL REQUIREMENTS FOR POWER-ON DIAGNOSTIC TEST
----------------------------------------------------
Upon power-on the software will automatically test the following
conditions:
3.2.1 Check Sum
**********************************************
**********************************************
****************
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 3 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.2.2 ************************************
**********************************************
**********************************************
**********************************************
**********************************
3.2.3 ******************************
**********************************************
**********************************************
**********************************************
*******************************************
3.3 Functional Requirements For Power On MACHINE SETUP
SCREEN
The User Option Menu sets up default settings used in the normal Main
Menu. It will be
selectable following power up diagnostics, when the operator is queried
as to which menu is
desired. Selecting 'Change' will bring up the User Option Menu, which
will present the
following menu display:
1. SET DATE
2. SET TIME
3. SET START UP DEFAULTS
4. SET MAGNIFICATION DEFAULTS
5. SET BACK-UP TIME
6. SELECT AUTO-KV WINDOW
7. SET PRE-COMPRESSION FORCE
By pressing the number key corresponding to the desired item, the
operator may edit any of
the defaults.
3.3.1 Set Date
This option will allow the operator to modify the time and to
select among two
methods of display. These will be MM/DD/YY or DD/MM/YY.
3.3.2 Set Time
This selection will allow the operator to modify the time as
well as to select a 12 or
24 hour clock.
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 4 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.3.3 *****************************
Making this selection, will cause the following menu
with one of the listed options to be displayed.
********
************* *******************************
************* *******************************
************* *******************************
************* *******************************
************* *******************************
************* *******************************
************* *******************************
******** *******************************
************* *******************************
************* *******************************
The user will be able to modify the default by using the
Up/Down cursor keys to
select the item, and then pressing the Change button to cycle
through the available
options. The option will be selected by pressing another
character key other than the
"Change" key. "Return" will return the operator to the User
Option Menu.
3.3.4 **************************
Selecting this menu item, will present the operator with
the following menu along with one of the listed options:
*******************************
************* *******************************
************* *******************************
************* *******************************
*******************************
************* *******************************
************* *******************************
The operator will be able to select an item using the
'Up' and 'Down' cursor keys.
_______________________________________________________________
1. Film type available only if DSM Receptor is not selected
2. Available only if Manual or Auto Time exposure mode is
selected.
3. Available only if Manual exposure mode is selected.
4. Available only if Manual or Auto Time exposure mode is
selected.
5. Available only if Manual exposure mode is selected.
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 5 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
Options will be cycled through by pressing the Change key,
and selected by selecting the next item, or pressing Return.
which will return the operator to the main User Option Menu.
3.3.5 ***************
***************************************************
***************************************************
***************************************************
*************************************
See also section 3.8.4.2
3.3.6. ****************************
***************************************************
*************************
************************
***********************************
***********************************
3.3.7 ********************* Force
Selecting this option will offer the operator two options, either
***************Force ********************Force. Whichever one was
previously selected, will be displayed. The operator will be
instructed to press the 'Change' key to cycle through the
displayed forces or 'Clear' to select the opposite option (*****
****************). As the operator cycles through the displayed
forces, the force will be video highlighted. The operator will be
instructed to press 'Return' to select the highlighted force which
will return the operator to the User Option Menu.
*****************Force will offer the following display, with
larger numbers representing increasing force:
***************************
******* *********
***************************
***************************
*******force*************************************************
***********************force*********************************
************force***************
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 6 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 7 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
***************Force*********************************:
**************************************************
*************************
**********************
**********************
**********forces*********************************************:
*********
*********
*********
3.4 ****************************************************
*******************
3.4.1 Summary of C-Arm Switches
A. ********************************************************
********************************************************
****************
****************
******************
*************
***************
*********
***********
B. ********************************************************
********************************************************
***********
******************
*************
***************
C. *******************************************
********************
********************
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 8 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
D. ******************** An additional switch will be
provided for
*******************
When any of the above **************** are actuated, the
following actions will be initiated:
3.4.2 **********************
********************************************************
********************************************************
************************
********************************************************
********************************************************
********************************************************
********************************************************
*********
3.4.3 **************************
********************************************************
***********************************
********************************************************
********************************************************
********************************************************
********************************************************
*************************************************
3.4.4 ***********************
********************************************************
*************************************
********************************************************
********************************************************
*************************************
3.4.5 ****************
********************************************************
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 9 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
********************************************************
********************************************************
********************************************************
**************
3.4.6 **************************
********************************************************
********************************************************
********************************************************
********************************************************
********
********************************************************
********************
********************************************************
********************************************************
************************************
********************************************************
********************************************************
**************
********************************************************
********************************************************
******************************************
********************************************************
********************************************************
********
- --------------------------------------------------------------------------------
[FOOTNOTE APPEARS HERE]
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 10 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
[FORM APPEARS HERE]
- --------------------------------------------------------------------------------
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 11 OF 35 NO. ************ C
----------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.4.7. *****************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
***************************************
** *********************************************
*****
** ******************************
*****************************************************
*****************************************************
**********
*****************************************************
*****************************************************
********************************
*****************************************************
*****************************************************
*****************************************************
**********************************************
*****************************************************
*****************************************************
**********************************
*****************************************************
*****************************
3.4.8 ****************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************
- --------------------------------------------------------------------------------
[FOOTNOTE APPEARS HERE]
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 12 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*****************************************************
*****************************************************
************
*********************************************
************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
**********************************************
3.5. *****************************************************
****************
3.5.1 ************
*****************************************************
******************
*****************************************************
*********************************************
*****************************************************
*****************************************************
*****************************************************
*****************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
3.5.2 ************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 13 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
3.5.3 ************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
3.5.4 **************
*****************************************************
*****************************************************
*****************************************************
***********************************
*****************************************************
*****************************************************
********************************
3.5.5. ******************
*****************************************************
*****************************************************
***********************************************
*****************************************************
*****************************************************
***********************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 14 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.5.6 *************
*****************************************************
****************
****************
****************
****************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*******************************
*******************************
*****************************************************
*****************************************************
3.5.7. ************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 15 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.5.8 ******************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
3.6 *****************************************************
********************************************
3.6.1 ***************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
3.6.1.1 ************************
********************************************
********************************************
********************************************
********************************************
********************************************
****************************
*** *** *** ***
******* ** ***** **
****** ** ***** **
****** ** ****** **
****** ** ****** **
****** ** ****** **
******* ** ****** **
******* ** ***** **
******* ** ****** **
******* ** ****** **
******* ** ***** **
****** ** ****** **
******* ** ****** **
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 16 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*********************************
3.6.1.2 ************************
*****************************************************
*****************************************************
*****************************************************
****************
*****************************************************
*****************************************************
******
3.6.1.3 *******************
Refer to section 3.4.8
3.6.2 ******************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
****************************************************
*****************************************************
*******************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 17 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
Figure 2 - Main Menu
********************************
*************** ***************
************** ***************
********** *****************
********************
******************** *******
********************* ************* ************ *****
********************** ******** ******* ******
*********************** ******
*********************** **** **************
***************** **********************************
***************** **********************************
***************** **********************************
***************** **********************************
***************
***************
***************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 18 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*****************************************************
*****************************************************
*****************************************************
*************
***************************
********************************
***************************
*****************************
*****************************
*****************************
*******************************
*******************************
***************************
*******************************
*******************************
*****************************
**********************************************
********************************
************************************************
**********************************
************************************************
************************************************
*********************
*****
********************
************
****************
**************
********************
*******************
3.6.3 *************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
***************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 19 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*****************************************************
*****************************************************
*****************************************************
************************
**********************************
*****************************
**********************************
**********************************
*****************************************************
*********
3.7 *****************************************************
***********
*****************************************************
*****************************************************
**************
3.7.1 *********************
*****************************************************
*****************************************************
*********
*****************************************************
*************************************************
3.7.2 ******************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
******************
*****************************************************
*****************************************************
**********
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 20 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.7.3 ***************
*****************************************************
*****************************************************
*****************************************************
********
*****************************************************
*****************************************************
***********************
3.8 *****************************************************
******************
3.8.1 ********
************************
************************************************
*******************
************************************************
************************************************
************************************************
************************************************
***********
*****************************************************
*****************************************************
**********
**************************
*******************************************
************************************************
************************************************
**********************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 21 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
TABLE 2
*************************
***********
********************************
****************************
***********
********************************
***************************
***********
*********************************
****************************
3.8.2 ********************
***************
*****************************************************
*****************************************************
*****************************************************
************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*****************************************************
*********************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 22 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
***************************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
***********
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
3.8.2.2 ***********************
*******************************************************
***********************************
**************
***************
*******************************************************
*******************************************************
*******************************************************
***************
*******************************************************
*******************************************************
*******************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 23 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.8.3 ****************
3.8.3.1 *********************
*********************************************
*********************************************
*********************************************
*********************************************
*********************************************
**********************************
*********************************************
*********************************************
*********************************************
*********************************************
***************
**************************************************
**************************************************
**************************************************
3.8.3.2 **************************
**************************************************
**************************************************
**************************************************
***********************
**************************************************
**************************************************
**************************************************
*******
**************************************************
**************************************************
**************************************************
**************************************************
***********************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 24 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.8.3.3 ****************
**************************************************
*************************
****************************************
****************************************
****************************************************
****************************
***********************************************
***************************
**********
**********
**********
***********************************************
***********************************************
3.8.3.4 ***************
****************************************************
**************
*************************
*************************
*************************
***************************************
**********************************
3.8.3.5 ***************
***************************************************
***************************************************
***************************************************
******
************************************
************** ************
********* ***** ******* ******
--------- ----- ------- ------
***************************************************
***************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 25 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.8.3.6 ***************
**************************************************
**************************************************
**************************************************
**************************************************
******
3.8.3.7 ****************
**************************************************
**************************************************
**************************************************
**************************************************
**************************************************
*********************
*****************************************
*************************************************
******
* * *
- - -
********** *** *** *** ***
********** ** ** ** ***
**********************************************
3.8.5 ********************
*******************************************************
*******************************************************
*******************************************************
****************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 26 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*******************************************************
*******************************************************
******************************
3.9 *******************************************************
-------------------------------------------------------
***********
-----------
3.9.1 ******
*******************************************************
***************************
*******************************************************
*********************
****************************************
****************************************
****************************************
****************************************
****************************************
****************************************
******************************************
3.9.2 ***********
*******************************************************
*******************************************************
*******************************************************
***********
*******************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 27 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
************************************
**************************************************
**************************************************
**********************************
**********************************
*************************************
*************************************
*************************************
****************************************
*************
**************************************************
**************
**********
***************
************
*********************
*********************
3.9.3 **********
*******************************************
3.9.4 *******
*******************************************************
*******************************************************
*******************************************************
*******************
***********************************
3.9.5 ************
*******************************************************
*******************************************************
*************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 28 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
3.10 ***********
-----------
*******************************************************
*******************************************************
*******************************************************
**********
*******************************************************
*******************************************************
****************************************
*******************************************************
*******************************************************
****************************************
3.10.1 ************
*******************************************************
*******************************************************
*******************************************************
***************
*******************************************************
*******************************************************
********************************
3.10.2 ***********
*******************************************************
*******************************************************
*******************************************************
**********
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******
3.10.3 ***********
*******************************************************
*******************************************************
*******************************************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 29 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*******************************************************
********************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
**********************
3.10.4 ***********
*******************************************************
*******************************************************
**********************
*******************************************************
*******************************************************
*******************************************************
************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*********
3.10.5 ***********
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 30 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
********************
***************************************************
************ ******
------------ ------
********************** *****************
********************** *****************************
********************** ***********************
********************** ******************************
**********
**
******************************
*******************
********************** ****************
***************** ***********************
********** *****************************
********** *******************************
********************* ********************************
*********************** ***************************
***************** ***************************
**************** *********************************
******
******************** **********************************
**********
*********** *************
**************** ******************
************** ******************
*************** *********
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 31 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*************** ***********************************
*******
********************** **************************
************* *********************
********************** ***********************************
*****************************
******************** **********************************
***********************
*********************** ***********************************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 32 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
*********************
***************
********* *******
--------- -------
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**** ******* *********************
**************** ********
**** ****** *********** ***** *******
**** ****** *********** ****** ************
**** ****** *********** ****** ************
**** ****** *********** ****** ***********
**** ****** *********** ****** ***********
**** ****** *********** ***** **********
**** ****** *********** ***** **********
**** ****** *********** ******************
*******
**************
** ******* *********** **************** *******************
* ******* *********** **************** ********************
* ******* *********** ************
* ******* *********** **************** ***
* ******* *********** **************** ********************
* ******* *********** **************** ********************
* ******* *********** **************** ********************
* ******* *********** **************** ********************
* ******* *********** **************** *******************
-- ---------------
** ***************
** ***************
** *****************************************************
****************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 33 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
***********
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*******************************************************
*****************************************
****** ************ *******
------ ------------ -------
*********************************
*********************************
*****************************----
**************
*********************************
*********************************
*********************************
*************
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 34 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
APPENDIX A3 LORAD SERIAL COMMUNICATION PROTOCOL
*********************************************************
**********
**********
**********
**********
**********
**********
**********
*******************************************************
**********************
**********************
********************************************************
**********
**********
**********
**********************************************
**********
**********
**********
**********
**********
**********
**********
****************************
**********
**********
**********
**********
**********
**********
**********
**********
**********
<PAGE>
- --------------------------------------------------------------------------------
LORAD Corporation DATA SHEET DWG. REV.
Engineering Standard STORAGE 35 OF 35 NO. ************ C
------------------------------------------------
TITLE: Software Specifications for
Philips MD 3000
- --------------------------------------------------------------------------------
******************************************************************
*******************************
******************************************************************
****************************
*********************************************
*****************************
****************************************
<PAGE>
Agreement between Philips Medical Systems and LORAD Exhibit 2
Planning and Prices
Date: 1, October 1993 Page 1
**********
**************
- --------------------------------------------------------------------------------
***** ***** ***** ***** *****
- --------------------------------------------------------------------------------
***** ***** ***** ***** *****
- --------------------------------------------------------------------------------
******************************
**********************
================================================================================
***** ***** *****
================================================================================
***** ***** ***** ***** ***** ***** *****
***** ***** ***** ***** *****
***** *****
***** ******** ***** ***** ***** ***** *****
================================================================================
***** ******** ***** ***** ***** ***** *****
***** ******** ***** ***** ***** ***** *****
***** ******** ***** ***** ***** ***** *****
***** ******** ***** ***** ***** ***** *****
*******
- --------------------------------------------------------------------------------
***** ******** ****** *****
***** ***** ***** *****
***** ***** ***** *****
================================================================================
***** ******** ***** ****** ***** *****
******
================================================================================
*****
********** ****
********
********* ******
================================================================================
****** ***
*******
****** *******
******* *******
================================================================================
<PAGE>
November 11, 1993
Exhibit 3
Service Arrangements
Exhibit 3 to the OEM Agreement (the "Agreement") between LORAD
Corporation ("LORAD") and Philips Medical Systems North America
Company ("PMSNA") for supply of mammography x-ray systems.
1. Responsibilities for Product Service
Unless agreed to otherwise,
PMSNA is responsible for:
- installing and commissioning
- training of the user
- maintenance and repair at customers' sites
- regular training of the PMSNA field engineers
LORAD is responsible for:
- provision and accuracy of documentation
- spare parts supply
- provision of special tools as required for repair of
Product(s)
(except for Component(s)), Option(s) or Spare
Parts
- initial training and support of PMSNA service staff and
regular training upon request
2. Product Delivery
The requirements for delivery of Product(s), Option(s) and Spare
Parts are
as set forth in the Agreement and in the other Exhibits to it.
2.1 Service Documentation
2.1.1 Preparation of Service Documentation
PMSNA will supply, at no cost to LORAD, binders with PMSNA's
standard
register into which the service documentation enumerated
below shall be
inserted by LORAD (hereinafter, the "Service Documentation" or, as
assembled, the "Service Manual"). The binders will be ordered by
LORAD
from the PMSNA service organization with at least two months lead time
before the date they will be needed by LORAD for assembly of the
Service
Manuals.
The address for PMSNA's service organization is:
Philips Medical Systems North America Co.
P.O. Box 860
710 Bridgeport Avenue
Shelton, Connecticut 06484
<PAGE>
(1) Pricing for the Cytoguide adaptation and upgrade shall be *****
for a design using plastic bearings and ****** for a design
using
steel bearings. These prices are based on LORAD's preliminary
estimate of its cost of producing the Cytoguide adaptation and
upgrade. ****************************************************
**************************************************************
*********.
<PAGE>
LORAD shall furnish to PMSNA ninety (90) days before the First
Commercial Delivery of Product, free of charge, two sets of
Service
Documentation. If the Service Documentation complies with
Philips'
standards, PMSNA will approve it for delivery and use by Philips'
service
organization.
The Service Documentation labeling shall carry only the "Philips" name,
trademark and Product or Option name (rather than LORAD's trademark
or tradename for that product).
PMSNA will assist LORAD in producing the said Service Documentation,
but each party will bear its own costs with respect to preparing the
Service Documentation.
The Service Documentation will be updated by LORAD during the lifetime
of the Product(s) or Option(s) to include all implemented changes and
modifications pertaining to Product(s) or Option(s). Corrections
(complete updated versions) will be furnished to PMSNA without
additional charge. LORAD will supply new documents at least thirty
(30)
days before the first delivery of Product which has been modified or
updated as provided in the Agreement.
2.1.2 Service Manual
For each Product or Option the following information shall be provided
by LORAD as part of the Service Documentation and the Service Manual
be organized in the following format:
- Introduction and Technical Data
- Installation
- Setting to work
- Acceptance: specification checks and data applicable
or field service
- Corrective Maintenance
- Diagnostic procedures for fault identification
- Adjustment procedures
- Instructions for assembly and disassembly
- Instructions for removal and replacement
- Procedures after repair or replacement
- Simplified drawings to facilitate fault finding
- Theory of operation and explanation
- Diagrams and drawings
- Repair procedures
- Spare Parts lists with identification numbers
- Sorted by PMSNA ID code (a set of PMSNA ID codes
will be provided to LORAD)
- Sorted by LORAD ID code
- Specification of repairable/replaceable items
- Specification of required tools for:
- Installation, setting to work and acceptance
- Maintenance, all non-metric tools required shall
be listed separately
2
<PAGE>
The test and diagnostic software, if any, used by field service
personnel
will be made available by LORAD on a carrier suitable for the Product
or
Option and will be supplied with each Product or Option. **********
****************************************
**************************************************************
***************
If PMSNA requires additional Service Manuals, LORAD will supply them
at a price of ********************** for each set.
2.1.3 Planned Maintenance Service Manual
Planned Maintenance is defined as pre-planned actions performed to
assure by means of systematic inspection that the Product or Option is
working in a specified manner.
The Planned Maintenance Service Manual is to be supplied directly to
Philips' service organization, not packed in shipments of
Product(s) or Option(s) to PMSNA.
Initially, five (5) sets will be provided free of charge. Thereafter,
PMSNA,
may, free of charge, reproduce them for PMSNA's use or distribution to
Philips Associated Companies, dealers, manufacturer's representatives
and customers. PMSNA shall also have the right to revise, reorganize,
translate or otherwise modify them for distribution to and use by
Philips'
service organization.
The Planned Maintenance Service Manual will contain:
- Schedule(s)
- Instructions
- List of Spare Part(s) to be replaced
- List of required lubrication
- Specification of tools required (including non-
metric tools)
- Specification of other materials
2.2 Language
All Service Documentation will be made available in the English
language.
2.3 Additional Information on Data Carrier
All service-related information provided by LORAD hereunder, including,
in particular, Spare Part(s) lists and prices, will be made available
to
Philips' service organization on a data carrier, such as 3.5 inch
floppy
disk, and updated annually as necessary.
3. Support on Site
If necessary and if requested by Philips' service organization, LORAD
will
provide support at customers' sites. Travel expenses, accommodations
3
<PAGE>
and all other travel and living expenses of LORAD's personnel at the site
will be borne by PMSNA. All other costs will be covered by an all-
inclusive fee of *****************************. If, however,
the problem or functional defect is a result of a design defect, the per
diem fee will not be payable to LORAD for the time spent correcting the
defect and travel and living expenses will also be born by LORAD.
4. Maintenance
4.1 Repair Policy
Repair will be done by replacing field exchangeable Spare Part(s), either
new or refurbished. LORAD will propose those parts in consultation with
the PMSNA service organization. A list of these Spare Part(s) is attached
(or is to be added when agreed upon) as Appendix 2 to this Exhibit.
4.2 Reporting by LORAD about Reliability
LORAD and PMSNA will exchange free of charge, all relevant data
regarding reliability of the Product, including, but not limited to:
- MTBF and MTTR-figures
- Problem reports
- Field failures
- Parts usage and approx. costs
at the Product and Spare Part level.
4.3 Storage Conditions and Handling Procedures
LORAD will specify the storage conditions for Spare Part(s), such as (but
not limited to) temperature, humidity, shelf life and air pressure, for any
Spare Part(s) for which there are special requirements in this regard.
5. Field Change Order ("FCO"), Problem Reporting and
Service Information
5.1 Field Change Orders
5.1.1 Modification Kits
Field modifications (referred to in this Exhibit as "Field Change Orders"
or "FCO's"), if any, will be made available to PMSNA in form of individual
modification kits in the quantity required to update the entire installed
base of Product(s) or Option(s) to which each field modification applies.
These kits shall contain:
- List of applicable Products and their serial
numbers
- Implementation instructions
- Material and Spare Parts
- Special tools (if any)
4
<PAGE>
- Service Documentation and Operator's Manual
updates
Kits for field modifications in the categories of "mandatory for
safety" and
"action for performance" will be provided by LORAD to PMSNA without
charge.
5.1.2 Categories and Implementation of FCO's
Three (3) categories of FCO's are distinguished:
- Mandatory for Safety
- Action for Performance
- Service Recommendation
Classification into any of these categories and the terms and
conditions
of any action will be determined by PMSNA, based upon applicable law
and regulations, after consultation with LORAD.
5.2 Field Problem Reporting by PMSNA
PMSNA will report all problems using a Field Problem Report formsheet
(an example is attached as an annex to this Exhibit). In order to
shorten
turnaround times, PMSNA may report problems to LORAD by telephone or
fax. Telephone reports must be confirmed by a written Field Problem
Report.
The categories of Problems are defined as "very urgent problems,"
"urgent
problems," "routine problems":
VERY URGENT PROBLEMS
- Disable product or cause an abnormal termination of
an application program.
- Cause danger for the patient being examined or for
personnel operating the product.
URGENT PROBLEMS
- Disable a product under certain conditions
- Disable certain function(s) of a product
ROUTINE PROBLEMS
- Problems other than VERY URGENT or URGENT
As soon as possible, but ultimately within two (2) working days after
a
problem has been reported, LORAD will confirm receipt of a Field
Problem Report and start reproducing and analyzing the Problem. In
its
confirmation LORAD will indicate the manner and time frame in which
LORAD expects to have a preliminary and/or definite solution available,
and it will use its best efforts to meet or exceed the following
schedule:
5
<PAGE>
Time allowance:
Category Definite Solution
VERY URGENT *****************
URGENT *****************
ROUTINE *****************
6. Configuration Management
6.1 Identification / Labeling of Spare Part(s)
The packing as well as shipping documents for all Spare Part(s),
assemblies and sub-assemblies will be clearly coded and marked.
6.2 Registration
LORAD will maintain a Configuration Record for each Product delivered
indicating:
- Product name,
- Serial number,
- Code number of each printed circuit board
("PCB"), including Hardware and
Software/Firmware level (if any), and
- Identification of assemblies and subassemblies
contained in the product by part numbers and
serial number.
The same procedure will apply for delivery of Field Change Order kits.
With each FCO kit LORAD will provide PMSNA with the valid
Configuration Record for the modified Product or Option.
7. Spare Part(s)
7.1 Spare Part(s) List
LORAD will provide to PMSNA a list of Spare Part(s) in Product(s) or
Option(s) as built, containing the following information,
- Spare Part numbers (to include the PMSNA- and
LORAD Spare Part numbers for reference)
- Description of the Spare Part(s), including an
illustrated
explosion drawing, whenever applicable
- Price of the Spare Part(s)
- Repair and Exchange Prices
- Guaranteed delivery time per Spare Part or group
of Spare Part(s)
- Supplier name and address
- Restrictions on export from the United States (if
applicable)
6
<PAGE>
7.2 Availability, Delivery
LORAD will assure availability (F.O.B., Danbury, Connecticut) of Spare
Part(s) no less than ***************** before the First Commercial
Delivery
of Product(s) or Option(s) or of each new version of a Product or
Option.
Delivery time for Spare Part(s) will be ********************** after
receipt
of order. For some Spare Part(s) LORAD may require a forecast in order
to meet this delivery time. LORAD will advise PMSNA which Spare Part
(s)
are in this category.
LORAD guarantees the availability of Spare Part(s) for Product(s) and
Option(s) during a period of *************** after the last delivery
of a
Product or Option by LORAD to PMSNA under the Agreement. During
the seventh year after the last dispatch of Product(s) or Option(s)
PMSNA
and LORAD will consult each other about the expected demand for Spare
Part(s) over the remaining service life of the Product(s) or Option(s)
and
how this demand can best met in a cost effective way.
7.3 Upgrade of Spare Part(s)
Stocks of Spare Part(s) in PMSNA's stores which have become obsolete
due
to Field Change Orders will be returned to LORAD. The shipping costs
will be borne by PMSNA. LORAD will credit to PMSNA the actual
purchase value or modify the Spare Part to the highest configuration
level, if applicable.
7.4 Ordering of Spare Part(s)
7.4.1 Stock Recommendations and Planning
LORAD will provide PMSNA with recommendations for the stocking of
Spare Part(s) required to support and maintain the Products and update
such information as required.
LORAD will recommend and allow PMSNA to initiate an end-of-life order
after the agreed period.
PMSNA will - in so far as possible - provide LORAD with a forecast of
its
expected demand for Spare Part(s).
7.4.2 Priority 1 Orders (P1)
Spare Part(s) to be delivered under a "Priority 1 order" (breakdown or
out
of stock situation) will be shipped by LORAD, using courier service to
the
shipping address indicated on PMSNA's notification or order, within 24
hours after notification in writing (e.g. by fax).
LORAD will make all the necessary and appropriate shipping
arrangements. PMSNA will reimburse the freight costs. LORAD will
immediately inform PMSNA of the relevant shipping information and
expected time of arrival.
7
<PAGE>
*****************************************************************
***********************************************
7.4.3 Priority 2 Orders (P2)
Spare Part(s) to be delivered under "Priority 2 orders" (replenishment
orders) may be placed by PMSNA during the term of this Agreement or
thereafter during the **************** set forth in the third paragraph of
7.3 above. These Spare Part(s) will - in so far as they were forecasted -
have a delivery time of ********* *********. In any case LORAD will
use its best efforts to meet delivery requirements.
LORAD will accept orders irrespective of value and will not impose
surcharges on any order (except as may be agreed upon with PMSNA for
Priority 1 orders).
7.5 Repair
7.5.1 Repair Services and Support
Those Spare Part(s) which are identified as repairable items may be
returned by PMSNA to LORAD for repair and will be repaired to their
highest configuration level within six (6) ***************** or be replaced
within ***************.
LORAD will provide repair services for a period of at least ***********
after delivery of the last Product or Option under the Agreement.
Repairs will not affect Form, Fit, Function, interchangeability or
certification of the Spare Part(s).
For warranty repairs, LORAD shall be responsible for arranging and
paying for transportation and insurance for shipments of replacement
parts to and from LORAD.
For non-warranty repairs transportation charges to and from LORAD
are the responsibility of PMSNA.
LORAD will also provide Technical Assistance as required. A "help desk"
will be available during regular working hours from 8:30 A.M. to 5:00
P.M. Eastern Standard Time.
7.5.2 Warranty on Repaired Items
Repaired parts will carry the same warranty as for primary delivered
parts (as set forth in Article 8 of the Agreement).
7.5.3 Repair at PMSNA
If PMSNA decides in the future to start repair of exchangeable Spare
Part(s) in its own workshops, then LORAD agrees to transfer to PMSNA all
relevant information concerning, for example but not limited to:
8
<PAGE>
- Troubleshooting
- Component specifications (names and addresses
of vendors included)
- Adjustment procedures
- Tools and repair aids (specifications and prices)
- Initial training (if applicable)
- Schematics and wiring diagrams
- Test software and firmware
The conditions (prices, reimbursement for work involved, etc.) for
transfer will be negotiated at the time of such transfer.
7.6 Packing
Each Spare Part will be packed in such a way that it can be held in
PMSNA'S inventory without repacking for storage or shipment.
Electrostatic discharge packing is to be used where required.
If applicable, Spare Part(s) shall be marked as subject or not subject to
United States export restrictions. Each item shall also be marked with
the country of origin.
7.7 Prices
Prices for any additional Spare Part(s) required for the Product(s) or
Option(s) will be agreed upon between the parties when each new
Product or Option is added to the scope of this Agreement and is
incorporated in Appendix 2 at that time.
The prices will be based on ************************************
******************.
****************************************************************
****************************************************************
****************************************************************
****************************************************************
****************************************************************
****************************************************************
**********************************
7.8 Modifications to Spare Part(s) (Because of FCO's)
For modifications to Spare Part(s), or at the introduction of Product(s) or
Option(s) for the Products, LORAD will make its best efforts to supply
new Spare Part(s) and price lists at least ****************** before the First
Commercial Delivery of that Option, Product or new version of a Product
or Option which incorporates modified Spare Part(s), takes place.
7.9 Second Sourcing
LORAD will Provide PMSNA with the manufacturer's name and part
numbers(s) for generic Spare Part(s), to enable PMSNA, if LORAD is unable
to supply Spare Part(s), to directly source these generic Spare Part(s) from
LORAD's suppliers.
9
<PAGE>
LORAD shall, however, remain responsible, as set forth herein, in the
event certain Spare Parts are no longer available from such vendors.
LORAD will then take all necessary actions to find, as soon as
possible, substitutes for Spare Part(s) which are no longer
available, including undertaking the necessary engineering and
test work connected with such a substitution.
8. Training, Exchange of Experiences
LORAD will provide adequate initial training for the Philips' service
organization (a "train the trainer" program), to take place,
preferably, in Danbury, Connecticut, as set forth in Section 15.8 of
the Agreement. One training session will be held at least
***************** in advance of the First Commercial Delivery of the
Product, and be in sufficient depth to enable PMSNA personnel to
conduct the training of other PMSNA technical personnel. LORAD will
assist PMSNA in preparing all documents and other training aids
necessary for successful secondary training classes held by PMSNA.
During instructor training classes, a complete set of Service Manuals
will be made available free of charge by LORAD to the participants.
If significant improvements are made to Products or new contract
items are added to the scope of the Agreement, LORAD will provide
training and documentation for those improvements or items on the
conditions stated above.
Once a year an exchange of experiences between PMSNA and LORAD
will the planned.
For all of the above activities, each party will bear its own
costs.
The schedule for the initial training will be set by mutual
consent. Additional training will be scheduled on *************
notice from PMSNA.
9. Software Support and Maintenance
9.1 General
LORAD will provide support, preventive and corrective maintenance
for Software/Firmware for a minimum of *************** following
the last shipment of Product(s) or Option(s) to PMSNA under this
Agreement.
For this purpose, LORAD will keep available a software maintenance
and support group with adequate know-how regarding the various
versions of the software. This support will be in addition to
that set forth in Article 8 of the Agreement. For modifications
to Software/Firmware the procedure set forth in Section 3.3 of the
Agreement will be followed.
10
<PAGE>
9.2 Definitions
The following definitions will apply in addition to the other
definitions in the Agreement:
"Compatibility"
will mean that a new Release or a new Level can replace the former
Release(s) or Level(s) of the Software without degrading the
functionality and/or affecting the interfacing of the Product or
Software.
"Release(s)"
will mean a specified set of functions. A new Release of the Software
will be made as a result of changed functional specifications and will
also contain the solutions to problems of previous Levels. A Release
may comprise a number of Versions.
"Version(3)"
will mean a distinction between various software programs which fulfil
essentially the same class of functions, but which are different for
alternative hardware choices and/or slightly different Software
configurations and/or differences in performance and/or for commercial
reasons.
"Level(s)"
will mean improved Software having the same functional specifications
as before, but originating from changed (corrected) source code.
9.3 General Support
While maintaining compatibility LORAD will actively:
search the Software/Firmware for errors and offer corrections therefor,
investigate, produce and offer enhancements to the Software/Firmware
which improve and optimize the user friendliness of the
Software/Firmware,
on request, provide advice with regard to the capabilities of the
Software/Firmware in order to fully exploit its potential, and
investigate advanced software diagnostics to aid the repair of
equipment and maintain service efficiency and a low MTTR.
9.4 Corrective Maintenance
While maintaining compatibility and without prejudice to the procedures
of Section 5.3 of this Exhibit LORAD will provide Corrective
Maintenance by:
delivering as soon as possible solutions for VERY URGENT and
URGENT PROBLEMS in the form of preliminary solutions
(temporary fixes only, no corrections to the Software/
Firmware) and definite solutions (corrections to the Software/
Firmware) if necessary in an unscheduled Level of the
Software/Firmware.
11
<PAGE>
delivering solutions for ROUTINE PROBLEMS in the form of
definite solutions as part of the next Level of the
Software/Firmware.
If LORAD cannot provide a definite solution without violating the
compatibility of the Software/Firmware with the Product(s) or
Option(s)'
hardware or the Specifications, then LORAD will promptly so inform
PMSNA in writing, with a comprehensive explanation of the reasons and
consequences. LORAD will not undertake any implementation of such
definite solution unless PMSNA has accepted the consequences of such
action in writing.
Both preliminary and definite solutions will be released to PMSNA as
soon as possible, but only after LORAD has produced and tested each
solution, in clinical application as well as in LORAD's product
development laboratory. Definite solutions shall be included in the
next available Level of any Release. The solutions will be documented
and made available to PMSNA by the fastest means of communication
and/or transportation.
10. Duration of Service Arrangements
Unless explicitly agreed to the contrary in this Exhibit or in the
Agreement itself, the arrangements of this Exhibit will come into
effect on the same day as the Agreement and continue until
*************** after delivery of the last Product or Option by LORAD
pursuant to the Agreement.
11. Survival
Should any of the provisions of this Agreement become invalid or be
ruled invalid by a court of competent jurisdiction, this shall not
impair the legal effectiveness of the others, the parties shall,
however, immediately replace the invalid provision by one which, in so
far as possible, has the same legal and economic effect as the former.
Appendices:
Appendix 1: Field Problem Report
Appendix 2: List of Spare Part(s)
12
<PAGE>
ACCEPTANCE TEST
CONTENT:
1. Valid papers
hardware specification version ****************
software specification version ****************
******** list date ****************
SUMMARY OF ACTION ITEMS date ******************
Mentioned open test are done in the meantime.
time schedule (EXHIBIT 6 OF CONTRACT)
2. First Target: ******************************
Open major problems:
*********
- *********************************
- ****************
- ***************************
- *********** **********
- *********** **********
******** *****************************************
*********
- *********************************
- *****************************************************
***********
- ***********************************************
- ********************
3. Second Target: *************
all points mentioned in the ***************
all points listed in "SUMMARY OF ACTION ITEMS"
all jobs listed in the time schedule
(EXHIBIT 6 of contract)
Regarding the lower requirements for application this release
is only valid for application and not for series.
<PAGE>
WHAT KIND OF ACTIONS ARE NECESSARY
TO GET A RELEASE FOR APPLICATION
The release for application will be done by Quality department in
Hamburg. For a decision the
following parts/information must be available before in Hamburg.
* ***************************************************
**************
* ********************************
* ***********************************
* ****************************************
****************************************
Requirements regarding software will be done by quality department
in Hamburg a.s.a.p.
[/s/ Signature Appears Here]
------------------------------
John Rogers, LORAD
[/s/ Signature Appears Here]
------------------------------
Judy Haynie, Philips
[/s/ Signature Appears Here]
------------------------------
Juergen Wiechers, Philips
<PAGE>
Exhibit 3
Appendix 1
----------
Field Problem Report
--------------------
SUPPLIER LICENSED PARTICIPANT
FORM OF PROBLEM REPORT
----------------------
1. Required urgency
2. Reporting date
3 Name
Address of participant
4. Reference to Philips International Agreement no. ...
5. Equipment (hardware) and Software configuration.
6. Problem description
7. Conditions under which the problem occurs.
Problem reports to be sent to: Name of Supplier
Address
Contact Person
Supplier will inform requesting Participant about:
- Problem acceptance/rejection for further treatment
- Status of Solution such as: temporary solution, to
be solved in next
release, problem
solved etc.
<PAGE>
Exhibit 3
Appendix 2
PHILIPS MD3000 SPARE PARTS LIST 10/13/93 PAGE 1
DOMESTIC VERSION
* To assure latest software revision, these parts will be shipped
direct from LORAD.
-----------------------------------------------------------------
# PHILIPS P/N LORAD P/N DESCRIPTION QTY
-----------------------------------------------------------------
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
* ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
---------------------------------------------------------------
<PAGE>
PHILIPS MD3000 SPARE PARTS LIST 10/13/93 PAGE 2
DOMESTIC VERSION
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* **
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
** ************** ********** ********************* *
<PAGE>
Exhibit 4
mammo DIAGNOST 3000 Final Production Test Page 1
------------------- --------------------------------- ----------
Distribution:
Original: Archive at LORAD
Copy: PMS-Hamburg, attn. Incoming Inspection
Philips ID-Number
*********************************** S/N .....................
*********************************** S/N .....................
*********************************** S/N .....................
*********************************** S/N .....................
*********************************** S/N .....................
*********************************** S/N .....................
*********************************** S/N .....................
Name:..........................
Department:..........................
Date:..........................
Signature:..........................
Check OK
or
Insert Value
------------
1. Production-Line Test
Earth Resistance ***** .......
Earth leakage Current ***** MA
Touch voltage .......
High voltage test ***** .......
High voltage test ***** .......
2. C-Arm Controls
C-Arm up-movement .......
C-Arm down-movement .......
C-Arm rotation release .......
Compression Up .......
Compression down .......
Compression release .......
Light field - illuminate the image field
for approximately 30 seconds .......
Compression handwheel .......
Footswitches .......
Front panel release key .......
<PAGE>
mammo DIAGNOST 3000 Final Production Test Page 2
------------------- --------------------------------- ----------
Check OK
or
Insert Value
3. C-Arm Movements
C-Arm vertical movement
*********** from floor (breast tray height) cm
C-Arm down movement motorized 1b
C-Arm up movement motorized 1b
C-Arm rotation
*************************************** 1b
C-Arm rotation locked min...N N
4. Compression
Compression plate selection
********************** .....
********************** .....
********************** .....
********************** .....
********************** .....
********************** .....
Compression motorized up ********** 1B
Compression motorized down ********** 1B
Compression manual up ********** 1B
Compression manual down ********** 1b
Compression release ********** cm
(switch is located on the C-Arm 7 key
switchpad and on the front panel)
Compression release strength N
tolerance
5. C-Arm Pivot Tube
Gradient of C-Arm pivot tube mm
6. Filter and mirror
.....
Artefact free exposure .....
7. Resolution
Fokus 0.1 > ..... lp/mm vertical x = lo/mm
horizontal y = lo/mm
8. Labels
Main identification plate
X-ray tube compliance label
HV-generator compliance label
Beam limiting device compliance label
X-ray control compliance label
Image receptor support device compliance label
<PAGE>
mammo DIAGNOST 3000 Final Production Test Page 3
------------------- --------------------------------- ----------
Check OK
or
Insert Value
9. Evaluation Sheet for Text Exposure
type ............
**********
Symetric Radiaton (left/right)
Symmetry a1 (left) ...... mm
Symmetry a2 (right) ...... mm
Symmetry deviation: [a1-a2] mm
Excess radiation or overradiation to the front: not less than 1 mm
overradiation b1 (left) ...... mm
overradiation b2 (right) ...... mm
Max excess radiation ...... mm
Straight forward: deviation [b1 - b2] mm
**********
Symetric Radiation (left/right)
Symmetry a1 (left) ...... mm
Symmetry a2 (right) ...... mm
Symmetry deviation: [a1-a2] mm
Excess radiation or overradiation to the front: not less than 1 mm
overradiation b1 (left) ...... mm
overradiation b2 (right) ...... mm
Max excess radiation ...... mm
Straight forward: deviation
[b1-b2] mm
10. Illuminance of Light Field
Light field consistancy lux
(The difference between background lux and
light field lux >= 200 lux)
Light field alignment
(The light field borders must be less than ****
away from the x-ray field borders)
11. Exposure
Auto-kV mode begin at ***** .....
Auto-kV mode keeps the exposure mAs within the
preset "windows" .....
Small focus ********** .....
Large focus ********** .....
12. Image Receptor Selection
Cassette holder .....
Cassette type
********* .....
Bucky .....
<PAGE>
mammoDIAGNOST 3000 Final Production Test page 4
------------------ --------------------------------- ----------
Check OK
or
Insert Value
------------
13. Aperture
Auto-aperture .....
Fixed aperture .....
14. x-ray prevention
Patient shields
Abdomen shield .....
Face shield .....
The official authorisation for the x-ray tube has
been granted
15. Biopsy
Couple the biopsy unit: a lamp in the frame must
be light up. .....
The locking brakes for traverse and longitudinal
carriage are applied a lamp must light up. .....
Switch off the system. The locking brakes for
traverse and longitudi-
nal carriage remain to
be applied. .....
Use the non-locking switch.
The brakes are released. .....
Bring the radiography unit into the upright position.
Exposure release must not
be possible. .....
Correction values for the position of the biopsy unit
are entered. .....
Checking adjustment of the biopsy cone. .....
Adjustment of the Z-axis of the needle. .....
Checking the radiation going beyond the film.
Symetric Radiaton (left/right)
Symmetry a1 (left) ...... mm
Symmetry a2 (right) ...... mm
Symmetry deviation: [a1 - a2] **
Excess radiation or overradiation to the front: not less than 1 mm
overradiation b1 (left) ...... mm
overradiation b2 (right) ...... mm
Max excess radiation ...... mm
Straight forward: deviation
[b1 - b2] **
16. Printer ......
17. Keyboards ......
18. Monitor ......
<PAGE>
Exhibit 5
Standard Form for Change Request
Standard Form for Change Request
1. Change request number: (date and sequence number)
2. Description of change:
Change of:
3. Reason of the change:
4. Change proposed for series:
5. Change proposed for Serial Number:
6. Reference to Drawings:
7. Reference to Reports and/or telexes:
8. Consequences for Safety standards:
9. Consequences for Service documentation and/or spare parts:
10. Consequences for Delivery Time:
11. Consequences for Price:
12. Consequences for Interfaces:
13. Consequences for Stock:
14. Initiated by:
<PAGE>
Exhibit 6
Time Schedule
Date: 1 October 1993
(drawing omitted)
<PAGE>
Agreement between Philips Medical Systems and LORAD Exhibit 7
Components from PMS, Logistic Procedures
Date: 30 September 1993 Page 1
1. Components
The following Components are to be supplied to LORAD
Philips Code Number Name
*********** ****************
*********** ****************
*********** ****************
*********** ****************
2. Logistic Procedure
(Drawing Omitted)
Graner: actions, responsibilities
- import activities, custom clearance
- stock keeping and reporting to PMS on incoming and outgoing
material
- handle LORAD's request and provide components to LORAD
without charge, CIP, on an "just in time" procedure
- transport arrangement to LORAD
- handle return procedure if necessary
Lorad: actions, responsibilities
- Request from GRANER Components in due time
(average 1 week lead time or as found practical during daily
operation)
- stockkeeping (stock for manufacturing) not to exceed 1 months
demand
- inventory control and reporting if required
- returnshipment of Components, which found to be of not
sufficient quality
- build in and test, shipment with Product
<PAGE>
Agreement between Philips Medical Systems and LORAD Exhibit 7
Components from PMS, Logistic Procedures
Date: 30 September 1993 Page 2
-----------------------------------------------------------------
3 Name and Addresses
Graner Company
Philips Electronics North American Corporation
21 Grace Church Street
Port Chester, N.Y. 10573
NAME TITLE PHONE FAX
Al Singleton President 001-914-935-8003 001-914-935-8019
Gina Knox Sr. Buyer 001-914-935-8070 001-914-935-8099
Dianne DiBiello Purch. Mgr 001-914-935-8040 001-914-935-8099
Steven Holic Log. Manager 001-914-935-8014 001-914-935-8019
LORAD Corporation
A subsidiary of Thermo Trex Corporation
36 Apple Ridge Road
Danbury, Connecticut 06810
NAME TITLE PHONE FAX
Hal Kirshner President 001-203-790-1188 001-203-792-8220
John Rodgers VP Research&E 001-203-790-1189 001-203-743-3370
Barry Wrenn VP Operations 001-203-790-1188 001-203-743-3370
Jack DeMorro Traffic Man. 001-203-731-8412 001-203-731-8440
Bill Smith Prod. Control 001-203-731-8417 001-203-731-8441
<PAGE>
Exhibit 8
LORAD's ISO 9000 Certificate
[To be added later as received].
<PAGE>
Exhibit 9
***********************************Page 1
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<PAGE>
Exhibit 9
******************************** *****
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<PAGE>
Exhibit 9
Page 3
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<PAGE>
Exhibit 9
************** Page 4
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