Exclusive License Agreement [Amendment No. 1] - University of Missouri and Santarus Inc.
AMENDMENT NO. 1 TO
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF MISSOURI AND
SANTARUS, INC.
This Amendment No. 1 (the "Amendment") to the Exclusive License
Agreement dated January 26, 2001 (the "License") between The Curators of the
University of Missouri (the "University") and Santarus, Inc. ("Santarus") is
made as of February 21, 2003 (the "Effective Date").
RECITALS
WHEREAS, the University and Santarus desire to amend certain terms of
the License as set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the covenants set forth herein, and
for other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the parties agree as follows:
1. AMENDMENT OF ARTICLE 15. Article 15 (including Sections 15.1
and 15.2) of the License is hereby amended in its entirety to read as follows:
"15. Project Status Reports. ***
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progress report shall also include any material deviations
from the Schedule of Events attached as Exhibit C."
2. AMENDMENT OF EXHIBIT C. Exhibit C to the License is hereby
replaced in its entirety with the revised Schedule of Events set forth on
Exhibit A hereto.
3. ACKNOWLEDGMENT. The University acknowledges and agrees that,
as of the Effective Date, Santarus has used commercially reasonable efforts to
develop and manufacture Licensed Products in accordance with Exhibit C of the
License and has to date otherwise satisfied all of the requirements of Section
5.1 of the License. In addition, the University waives any obligation on the
part of Santarus arising prior to the Effective Date to
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Confidential Treatment and filed separately with the Commission.
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adhere to, or notify the University of any material deviations from, the
Schedule of Events in the original Exhibit C to the License.
4. MISCELLANEOUS.
a. Except for the amendments set forth herein, all other
terms and conditions of the License shall remain in full force and effect.
b. Capitalized terms used but not otherwise defined
herein shall have the meanings assigned to them in the License.
c. This Amendment will be interpreted and construed in
accordance with the laws of the State of *** , excluding any choice of law rules
that would direct the application of the laws of another jurisdiction.
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Confidential Treatment and filed separately with the Commission.
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IN WITNESS WHEREOF, both the University and Santarus have executed this
Amendment as of the date set forth above.
SANTARUS, INC.
By: /s/ Gerald T. Proehl
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Name: Gerald T. Proehl
Title: President and CEO
THE CURATORS OF THE UNIVERSITY OF MISSOURI
By: /s/ Thomas R. Sharpe
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Name: Thomas R. Sharpe, Ph.D.
Title: Executive Director Office of Technology & Special Projects
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Exhibit A
Exhibit C
Schedule of Events
January 26, 2001 Sign definitive licensing agreement
Qtr 1 2001 Transfer IND
Qtr 2 2001 Develop formulation alternatives, place on stability
Begin sublicense negotiations with other PPI company(ies)
Qtr 3 2001 Identify and select contract manufacturing organization
for omeprazole active pharmaceutical ingredient (API)
Identify and select contract manufacturing organization
for drug product
Qtr 4 2001 Prototype formulation placed on feasibility stability
Establish analytical lab for quality control
Qtr 1 2002 Determine optimal formulation
Qtr 2 2002 Sign sublicense agreement
Begin discussions with various pharmaceutical companies on
co-development/co-promotion agreement
Qtr 3 2002 ***
Qtr 4 2002 ***
Qtr 1 2003 ***
Qtr 2 2003 ***
Qtr 3 2003 ***
Qtr 4 2003 ***
Qtr 1 2004 ***
Qtr 2 2004 ***
Qtr 3 2005 ***
Qtr 4 2005 ***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.