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EXHIBIT
10.3
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.3
TO
LICENSE
AGREEMENT
DATED AS OF APRIL 13,
2002
BY AND
BETWEEN
UNIGENE LABORATORIES,
INC.
AND
SMITHKLINE BEECHAM
CORPORATION
This Amendment No. 3
(“Amendment No. 3”) dated as of 23 Sept., 2004
(“Amendment Date”), to the License Agreement, entered
into as of the 13th of April, 2002, and amended on January 16,
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.
RECITALS:
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. Exhibit C to the Phase I
Agreement (Cost of Goods) is hereby amended to add the 2004 and
2005 Cost of Goods set forth in Appendix A to this Amendment
No. 3.
2. Exhibit A to the Phase I
Agreement (Current Manufacturing Process) is hereby amended by
replacing the existing Process Flow Diagram-PTH with the Process
Flow Diagram-PTH set forth in Appendix B to this Amendment
No. 3.
3. Appendix B to the
Agreement (the WorkPlan) is hereby amended to add the activities
regarding API set forth in Appendix C to this Amendment No. 3
at the FTE costs set forth in Appendix C to this Amendment
No. 3.
4. Article 1 of the Phase I
Agreement is hereby amended to add the following new
section:
1.25. Commercially
Reasonable Efforts means, with respect to a Party, the efforts
and resources which would be used (including without limitation the
promptness in which such efforts and resources would be applied) by
that Party consistent with its normal business practices, which in
no event shall be less than the level of efforts and resources
standard in the pharmaceutical industry for a company similar in
size and scope to such Party, with respect to a product or
potential product at a similar stage in its development or product
life taking into account efficacy, safety, commercial value, the
competitiveness of alternative products of third parties that are
in the marketplace or under development, and the patent and other
proprietary position of such product.
5. Section 2.3 of the
Phase I Agreement is hereby amended by replacing the current
language with the following language in lieu thereof:
Unigene shall supply GSK at
least four (4) batches of API (two (2) batches shall be
cGMP grade and two (2) shall be process development batches).
Unigene shall use its Commercially Reasonable Efforts to achieve a
fermentation batch yield of ***. The Parties agree and acknowledge
that one Changeover shall be required before supply of the first
batch. Any batches in excess of four (4) shall be supplied
pursuant to the terms of this Agreement, including but not limited
to, Article 4.6(b).
6. Article 2 of the Phase I
Agreement is hereby amended to add the follow
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