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EXHIBIT
10.4
Portions of this Exhibit were omitted
and filed separately with the Secretary of the Commission pursuant
to an application for confidential treatment filed with the
Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934. Such omissions are designated as ***.
AMENDMENT NO. 4
TO
LICENSE
AGREEMENT
DATED AS OF APRIL 13,
2002
BY AND
BETWEEN
UNIGENE LABORATORIES,
INC.
AND
SMITHKLINE BEECHAM
CORPORATION
This Amendment No. 4
(“Amendment No. 4”) dated as of May 27, 2004
(“Amendment Date”), to the License Agreement, entered
into as of the 13th of April, 2002 and amended on January 14,
2003 and October 14, 2003 (referred to hereinafter as the
“Agreement”), by and between Unigene Laboratories, Inc.
(“Unigene”), a Delaware corporation, and SmithKline
Beecham Corporation, a GlaxoSmithKline company (“GSK”),
a Pennsylvania corporation.
WHEREAS, GSK and Unigene
entered into the Agreement to provide for the license grant by
Unigene to GSK of certain Licensed Technology (as defined in the
Agreement) to discover, develop, make, have made, market, sell and
import certain Licensed Products (as defined in the Agreement)
throughout the world under the Unigene Patent Rights (as defined in
the Agreement) and Unigene Know-How (as defined in the Agreement);
and
WHEREAS, GSK and Unigene have
also entered into a Phase I Clinical Manufacture and Supply
Agreement dated November 20, 2002 (the “Phase I
Agreement”); and
WHEREAS, pursuant to
Section 11.10 of the Agreement, the Parties to the Agreement
may, by written instruments specifically referring to and executed
in the same manner as the Agreement, amend the Agreement;
and
WHEREAS, the Parties hereto
desire to amend the Agreement as provided herein, and any
capitalized terms used herein shall have the meaning set forth in
the Agreement;
NOW THEREFORE, for and in
consideration of the premises and the mutual promises and benefits
contained herein, GSK and Unigene hereby agree as
follows:
1. Appendix B to the Agreement (the Work
Plan) is hereby amended to add the activities regarding PTH*** set
forth in Appendix A to this Amendment No. 4 at the FTE cost
set forth in Appendix A to this Amendment No. 4.
2. Appendix C to the Agreement (Unigene
Know-How and Technology Transfer) is hereby amended to add the
technology and know-how regarding PTH*** set forth in Appendix B to
this Amendment No. 4.
3. Section 4.5 of the Agreement
shall be amended and restated in its entirety to read:
Unigene Data Transfer
. Immediately after the Effective Date (or with respect to PTH
*** Unigene Know-How, immediately after the Amendment Date of
Amendment No. 4 to this Agreement, as applicable) ,
Unigene shall use its reasonable best efforts to promptly transfer,
or cause to be transferred to GSK, a copy of Unigene Know-How
relating to PTH and the Licensed Product, including manufacture of
API, to enable GSK to carry out its responsibilities under this
Agreement. Such data shall include, at a minimum, the information
set forth in Appendix C to this Agreement, attached hereto and
incorporated herein.
4. Appendix A to Amendment No. 2 to
the Agreement, dated October 14, 2003, is hereby amended to
include:
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Type
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Designation
(Designator)
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*** Cell Bank
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***
(Unigene) |
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*** Cell Bank
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***
(Unigene) |
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***
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***
(Unigene) |
5. Except as specifically provided
herein, all other terms and conditions of the Agreement shall
remain in full force and effect, and this Amendment No. 4 to
the Agreement shall not be construed to amend or waive any
provisions of the Agreement except as specifically set forth
above.
6. This Amendment No. 4 to the
Agreement, and the rights and obligations o
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