Exhibit 10.41

 

January 20, 2006

 

BY FACSIMILE AND EXPRESS MAIL

CONFIDENTIAL

Peter A. Lankau

President and CEO

Endo Pharmaceuticals Inc.

100 Endo Boulevard

Chadds Ford, PA 19317

 

Re: Amendment 3 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, as last amended November 22, 2004 (the
“Agreement”). Effective on the date written above, Endo and DURECT hereby agree
to amend the Agreement as follows:

 

  1. Amendment to Section 4.6(a). Section 4.6(a) of the Agreement shall be
amended to replace each instance of “January 1, 2006” with “May 1, 2007”.

 

  2. Amendment to Section 4.6(c). Section 4.6(c) of the Agreement shall be
replaced in its entirety to read as follows:

 

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 sixty (60) days following the
delivery to Endo of written notice that a human pharmacokinetic trial has been
completed with the Product together with a full study report of the results of
such trial (such date, the “Trial Results Review Date”, such notice, the “Trial
Completion Notice” and such trial, the “First Trial”). Notwithstanding the
foregoing, in the event Endo has not delivered notice of its intent to terminate
this Agreement pursuant to Section 13.3(e), then Endo shall be responsible for
such portion of the Development Costs incurred after May 1, 2007 in accordance
with Section 4.6(a). Furthermore, until the Trial Results Review 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 Results Review Date or March 31, 2007.”

 

  3. Amendment to Section 13.3(e). Section 13.3(e) of the Agreement shall be
replaced in its entirety to read as follows:

 

In the event that (i) the Trial Results Review Date shall not have occurred on
or before March 31, 2007, or (ii) Endo determines, in its sole discretion, to
terminate the Agreement during the sixty-day period beginning on the Trial
Results Review Date, 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 April 30, 2007.

 

  4. The term “Trial Results Review Date” shall be substituted in lieu of “Trial
Commencement Date” throughout the Agreement.

 

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/

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James E. Brown President and CEO

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AGREED TO BY ENDO: By:  

/s/

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    Peter A. Lankau     President and CEO Date: 1/23/06