[ENDO LOGO]
000 Xxxxxxxx Xx.
Xxxxxx Xxxx, XX 00000
000-000-0000
xxx.xxxx.xxx
Exhibit 10.43.2
March 2, 2004
BY FACSIMILE & OVERNIGHT MAIL
Xxxxxxx Xxxxxx
SkyePharma, Inc.
000 Xxxxxxxxxx
Xxxxxx X0X 0XX
Xxxxxxx
Dear Xxxxxxx:
Reference is hereby made to that certain Development and Marketing
Strategic Alliance Agreement, dated as of December 31, 2002 (as amended, the
"Agreement"), among Endo Pharmaceuticals Inc. ("Endo"), SkyePharma, Inc. and
SkyePharma Canada Inc. (collectively, "Skye"). Defined terms used but not
defined herein shall have the meanings set forth in the Agreement.
The purpose of this letter is to amend and restate the fifth milestone
on the chart set forth in Section 4.2 of the Agreement which milestone relates
to the FDA's written approval and acceptance of the protocol of the first of the
Phase III clinical trials for Propofol IDD-D in the United States (the "Propofol
Protocol Milestone"). Now for good and valuable consideration, the sufficiency
and receipt of which is hereby acknowledged, the Parties agree that the Propofol
Protocol Milestone is amended and restated as follows:
With respect to Propofol IDD-D, upon the earlier of (a) the JEC's Two (2) days following $5,000,000
approval of the FDA protocol submission package, which shall occurrence of Milestone
follow Endo's receipt of both the FDA end-of-Phase II (EOPII) Event
meeting minutes and the timeline for the Phase III clinical plan,
or (b) 30 days following Endo's receipt of the FDA EOPII meeting
minutes and the timeline for the Phase III clinical plan.
Xxxxxxx Xxxxxx
SkyePharma, Inc.
March 2, 2004
Page Two
Other than as set forth in this letter agreement, all other terms and
conditions of the Agreement remain the same and in full force and effect.
If Skye is in agreement with the above, please have a duly authorized,
appropriate officer countersign this letter below.
Very truly yours,
/S/ XXXXX X. XXXXX
Xxxxx X. Xxxxx
ACCEPTED AND AGREED THIS 2nd DAY OF MARCH 2004:
SKYEPHARMA, INC.
By /s/ XXXXXXX XXXXXX
----------------------
Name: Xxxxxxx Xxxxxx
Title: CEO
SKYEPHARMA CANADA INC.
By /s/ XXXXXXX XXXXXX
-------------------------
Name: Xxxxxxx Xxxxxx
Title: Director
