Exhibit 10. 4

 

Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.  Asterisks denote omissions.

 

FIRST AMENDMENT TO DISTRIBUTION AGREEMENT

 

This FIRST AMENDMENT TO DISTRIBUTION AGREEMENT, is made and entered into as of
February 24, 2004 (this “Amendment”), by and among Edwards Lifesciences LLC, a
Delaware limited liability company (“Edwards”), PLC Systems Inc., a Yukon
Territory corporation (“PLC Parent”), and PLC Medical Systems, Inc., a Delaware
corporation (“PLC”).  Certain capitalized terms used herein have the meanings
ascribed to them in the Agreement (defined below).

 

RECITALS

 

WHEREAS, the parties hereto have previously entered into a Distribution
Agreement, dated as of January 9, 2001, by and among Edwards, PLC Parent and PLC
(the “Agreement”); and

 

WHEREAS, the parties hereto desire to amend certain provisions of the Agreement
pursuant to Section 11.11 thereof.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing and the respective covenants
and agreements set forth herein, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties hereto
agree as follows:

 

1.                                       AMENDMENT OF AGREEMENT.  The Agreement
is hereby amended as follows:

 

1.1.                              Section 7.1(a) of the Agreement is hereby
amended and restated in its entirety to read as follows:

 

“Edwards shall purchase the TMR Disposable Kits from PLC at 36.5% of the Average
End User Price.  The “Average End User Price” shall mean the average of the
actual sales price for each TMR Disposable Kit sold during a calendar quarter. 
Edwards shall calculate the Average End User Price and deliver such calculation
to PLC within 15 days after the end of each quarter.”

 

1.2.                              The first sentence of Section 7.1(b) of the
Agreement is hereby amended and restated in its entirety to read as follows:

 

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“PLC shall bill TMR Disposable Kits to Edwards on a preliminary basis at 36.5%
of the Estimated End User Price.”

 

1.3                                 Section 8.1 of the Agreement is hereby
deleted in its entirety and restated to read as follows:

 

“Term and Renewal.  This Agreement shall commence on the date hereof (the
“Effective Date”) and shall continue for the enforceable life of the last to
expire of the United States patents held by PLC related to the Products.”

 

2.                                       PAYMENT OF CONSIDERATION FOR
AMENDMENT.  In consideration of the amendments to the Agreement contained in
Section 1 above, concurrently with execution of this Amendment, Edwards will pay
to PLC the sum of four million five hundred thirty-three thousand three hundred
thirty-three dollars ($4,533,333) by wire transfer of immediately available and
non-refundable funds.

 

3.                                       MISCELLANEOUS.

 

3.1                                 Governing Law.  This Amendment shall be
governed by, interpreted under, and construed in accordance with the internal
laws of the State of New York, including, without limitation, Sections 5-1401,
5-1402 of the New York General Obligations Law and New York Civil Practice Laws
and Rules 327(b).

 

3.2                                 Counterparts.  This Amendment may be
executed in two or more counterparts, each of which shall be deemed an original
and all of which shall, taken together, be considered one and the same
amendment, it being understood that the parties need not sign the same
counterpart.

 

3.3                                 Severability.  In the event that any one or
more of the provisions contained herein, or the application thereof in any
circumstances, is held invalid, illegal or unenforceable in any respect for any
reason, the parties shall negotiate in good faith with a view to the
substitution therefore of a suitable and equitable solution in order to carry
out, so far as may be valid and enforceable, the intent and purpose of such
invalid provision; provided, however, that the validity, legality and
enforceability of any such provision in every other respect and of the remaining
provisions contained herein shall not be in any way impaired thereby, it being
intended that all of the rights and privileges of the parties hereto shall be
enforceable to the fullest extent permitted by law.

 

3.4                                 Ratification and Reaffirmation.  Except as
otherwise expressly provided herein, the Agreement remains in full force and
effect unamended, and all of the terms and provisions of the Agreement, as
modified by this Amendment, are hereby ratified and reaffirmed by Edwards, PLC
Parent and PLC.  All references to the Agreement contained in the Agreement
shall mean the Agreement as modified hereby.

 

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IN WITNESS WHEREOF, the parties have caused this Amendment to be duly executed
and delivered, all as of the date first set forth above.

 

 

EDWARDS LIFESCIENCES LLC

 

 

 

 

 

 

 

By:

 

/s/John H. Kehl, Jr.

 

 

Name:

John H. Kehl, Jr.

 

Title:

Corporate Vice President,
Strategy and Business Development

 

 

 

 

 

 

 

PLC SYSTEMS INC.

 

 

 

 

 

 

 

By:

 

/s/James G. Thomasch

 

 

Name:

James G. Thomasch

 

Title:

Senior Vice President &
Chief Financial Officer

 

 

 

 

 

 

 

PLC MEDICAL SYSTEMS INC.

 

 

 

 

 

 

 

By:

 

/s/James G. Thomasch

 

 

Name:

James G. Thomasch

 

Title:

Senior Vice President &
Chief Financial Officer

 

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