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EXHIBIT
10.5
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. 5
TO
LICENSE
AGREEMENT
DATED AS OF APRIL 13,
2002
BY AND
BETWEEN
UNIGENE LABORATORIES,
INC.
AND
SMITHKLINE BEECHAM
CORPORATION
This Amendment No. 5
(“Amendment No. 5”) dated as of January 24,
2007 (the “Amendment Date”) to the License Agreement
dated as of April 13, 2002, as amended on January 16,
2003, October 14, 2003, May 27, 2004 and
September 23, 2004 (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 to discover,
develop, make, have made, market, sell and import certain Licensed
Products throughout the world under the Unigene Patent Rights (as
defined in the Agreement) and Unigene Know-How; 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. Article I of the Agreement is hereby
amended by adding a new Section 1.0 which shall read as
follows:
“1.0. “ ***
PTH ” means all formulations of PTH *** including, but
not limited to fusion proteins, muteins and chemical modifications
of any or all of the aforementioned
PTH ***.” For the
avoidance of doubt, “*** PTH shall not include any other
formulations of PTH *** or any other formulations of
PTH.
2. The Agreement shall be deemed to be
modified to include the following provisions:
(A) GSK hereby consents and
agrees that Unigene may enter into one or more agreement(s) with
*** (or its Affiliates) providing for the development,
manufacturing, marketing or sale of *** PTH into a drug product in
the Field in finished pharmaceutical form in an oral formulation
containing or incorporating *** PTH, alone or in combination with a
peptide or a small molecule that is not proprietary to GSK (or its
Affiliates), and which such oral formulation of *** PTH product
incorporates Unigene Know-How or is covered by Unigene Patent
Rights (a “ *** PTH Product ”). The foregoing
agreement(s) shall be referred to herein as the (“ ***
Agreement ”).
(B) Subject to the terms and
conditions of the Agreement, GSK hereby grants back to Unigene, but
only to the extent necessary to effectuate the *** Agreement, an
exclusive license (even as to GSK) under the Licensed Technology
that relates solely to the manufacturing of *** PTH API for use
solely in a *** PTH Product for Unigene to make and sell to ***
(and for *** as Unigene’s licensee to subsequently sell, have
sold, make, have made and import) *** PTH API for use solely in a
*** PTH Product in the Territory in the Field. For the avoidance of
doubt, the foregoing license back to Unigene shall only apply to
Licensed Technology that is solely related to the manufacturing of
*** PTH API for use solely in a *** PTH Product and not any other
aspects of Licensed Technology such as (but not limited to)
Licensed Technology as to the oral delivery
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