Exhibit 10.42.2
January 28, 2004
BY FACSIMILE AND EXPRESS MAIL
CONFIDENTIAL
Peter A. Lankau
President
Endo Pharmaceuticals Inc.
100 Painters Drive
Chadds Ford, PA 19317
Re: Amendment to Development, Commercialization and Supply License Agreement
Dear Peter:
Reference is made to the Development, Commercialization and Supply License
Agreement between Endo Pharmaceuticals Inc. ("Endo") and DURECT Corporation
("DURECT") effective November 8, 2002 ("Agreement"). Effective on the date
written above, Endo and DURECT hereby agree as follows:
1. Amendment to Section 4.6(a). Section 4.6(a) of the Agreement
shall be amended to change "June 30, 2004" to "January 1,
2005".
2. Restatement of Section 4.6(c). Section 4.6(c) of the Agreement
shall be deleted in its entirety, and in lieu thereof, the
following shall be inserted:
"(c) Notwithstanding anything to the contrary in Sections
4.6(a) and (b) and except as set forth in this Section 4.6(c),
Endo shall have no obligations under Sections 4.6(a) and (b)
to make any payments to DURECT for any Developments Costs
incurred up to and including the date on which the first
patient is dosed with the Product in the first clinical trial
of at least that number of patients necessary to satisfy the
FDA which occurs after the Effective Date (such date, the
"Trial Commencement Date" and such trial, the "First Trial").
Notwithstanding the foregoing: (i) in the event the Trial
Commencement Date has not occurred by December 31, 2003, then
during the period commencing on January 1, 2004 until the
earlier of the Trial Commencement Date or January 1, 2005,
Endo shall be responsible for 25% of the Development Costs
incurred in each such calendar month, up to an aggregate
payment by Endo to DURECT of $250,000 of Development Costs for
such period; and (ii) in the event the
Trial Commencement Date has not occurred on or before January
1, 2005, then Endo shall be responsible for such portion of
the Development Costs incurred after January 1, 2005 in
accordance with Section 4.6(a). Furthermore, until the Trial
Commencement Date, DURECT hereby agrees to initiate any human
trial only if such trial and the initiation thereof is
consistent with a reasonable pharmaceutical company's overall
global strategic development plan for a product similarly
situated to the Product. Finally, in no event shall Endo be
liable for any costs associated with any human pharmacokinetic
(PK) study undertaken by DURECT prior to the earlier of the
Trial Commencement Date or January 1, 2005."
3. Restatement of Section 13.3(d). Section 13.3(d) of the
Agreement shall be deleted in its entirety, and in lieu
thereof, the following shall be inserted:
"(d) [INTENTIONALLY OMITTED.]"
4. Restatement of Section 13.3(e). Section 13.3(e) of the
Agreement shall be deleted in its entirety, and in lieu
thereof, the following shall be inserted:
"(e) In the event that the Trial Commencement Date shall not
have occurred on or before January 1, 2005, Endo shall have
the right to terminate this Agreement effective upon 10 days'
written notice with no further rights or obligations hereunder
(other than those rights or obligations which are expressly
indicated herein to survive termination or expiration of this
Agreement); provided that such written notice is delivered to
DURECT no later than January 31, 2005."
5. New Section 4.10. A new Section 4.10 shall be added to the
Agreement as follows:
"4.10 Retention of Key Personnel. DURECT shall use its
reasonable efforts to retain key personnel involved with the
development of the Product. Such key personnel shall be those
individuals identified as such by the JEC. In the event that a
member of the key personnel leaves the employ of DURECT
(either on his/her own volition or otherwise), DURECT shall,
within three (3) business days of such departure, inform
Endo of (1) such fact and (2) DURECT's plan as to how it
intends to address the departure of such key personnel to
ensure the smooth continuance of the Development Program."
Except as set forth above, all other terms of the Agreement shall remain the
same. Please sign below to indicate Endo's agreement to the foregoing.
Very truly yours,
/s/ JAMES E. BROWN
James E. Brown
President and CEO
AGREED TO BY ENDO:
By: /s/ PETER A. LANKAU
----------------------
Peter A. Lankau
President
Date: January 28, 2004