EXHIBIT
10.49
XXXX Confidential treatment has been requested for this information
pursuant to Rule 24B-2.
AMENDMENT NO. 1 TO LICENSE AGREEMENT
THIS AMENDMENT NO. 1 TO LICENSE AGREEMENT (the "First
Amendment") is
made as o the 23d day of March, 1995 by and between XOMA
Corporation, a Delaware
corporation ("XOMA"), and Xxxxxxxxx Wellcome Co., a North Carolina
corporation
(as more fully described below, "BWCo").
W I T N E S S E T H:
WHEREAS, XOMA and Sterling Drug Inc., a Delaware
corporation
("Sterling"), entered into a License Agreement as of June 11, 1991
(the
"Agreement") pursuant to which XOMA granted to Sterling (i) an
exclusive
worldwide license to develop and market products utilizing the
Engineered
Antibody (as defined in the Agreement) designated ING-1 ("ING-1"),
and (ii) a
non-exclusive license to develop and market products utilizing
certain genetic
engineering technology, information and know-how for uses in the in
vivo
localization (imaging) and/or treatment of human cancers;
WHEREAS, on January 21, 1994, with the prior written
approval of XOMA,
Sterling sold, granted, assigned and conveyed to BWCo all of
Sterling's right,
title and interest in and to the Agreement, and BWCo assumed and
agreed to
perform all of the obligations of Sterling that arise on or after
January 21,
1994 under and pursuant to the Agreement;
WHEREAS, BWCo and XOMA desire to amend the Agreement in
certain
respects, which amendment shall govern the parties' rights and
obligations
under and pursuant to the Agreement from and after the date hereof;
NOW, THEREFORE, in consideration of the premises and the
mutual
covenants and agreements herein contained, and for other good and
valuable
consideration, the receipt and sufficiency of which is hereby
acknowledged by
both BWCo and XOMA, the parties hereto, intending to be legally
bound hereby,
do thereby agree as follows:
1. Definitions.
a. The following definitions contained in the Agreement
are hereby
amended as follows:
(1) "Engineered Antibody" set forth in Section 1.7
of the
Agreement is amended by adding the following sentence after the end
of the
current text:
"Engineered Antibody" shall also include any
humanized antibody derived from DNA encoding such an
Engineered Antibody.
(2) "ING-1" set forth in Section 1.13 of the
Agreement is
amended to read, in its entirety, as follows:
"ING-1" means the Engineered Antibody derived from
the BA-Br1 hybridoma described in Schedule 1.17
hereto.
b. A new Section 1.30 is added to the Agreement
which shall
read, in its entirety, as follows:
1.30 "BWCo" means Xxxxxxxxx Wellcome Co., a North
Carolina corporation and the successor to all of
Sterling's right, title and interest in and to the
Agreement, and to all of Sterling's obligations that
arise on or after January 21, 1994 under and
pursuant to the Agreement.
2. Grant. The final clause of Section 2.1 of the
Agreement is
hereby amended to read as follows:
. . . and the related XOMA Patent Rights and XOMA
Technology and Know-How to make, have made, use and
sell ING-1 Products in the Field of Use.
3. License Fees. Section 4.1(c) is hereby amended to
read, in its
entirety, as follows:
$200,000 payable within five (5) Business Days after
the execution of the First Amendment.
4. Royalties.
a. Section 4.2(c) of the Agreement is amended as
follows: The
words "or non-exclusive" are hereby added after the word
"exclusive"
appearing in the heading of
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Section 4.2(c), the ninth line of the first paragraph of Section
4.2(c), the
denominator of the fraction appearing in the first paragraph of
Section 4.2(c),
and the fifth line of the second paragraph of Section 4.2(c).
b. Section 4.2(d) of the Agreement is amended to
read, in its
entirety, as follows:
(d) Non-exclusive License or Lack of Valid Claim.
If (i) for any reason the license granted in Section 2.1 above
is made non-exclusive, or (ii) at any time prior to the end of
time for paying royalties as determined pursuant to Section
4.2(f) below (the "Royalty Period") all of the claims
contained in the XOMA Patent Rights that read on BWCo's
exercise of the license granted by Section 2.1 hereof (the
"ING-1 Claims") expire or are declared invalid by the patent
office or court of competent jurisdiction in any country in
the Territory, or (iii) for so long prior to the end of the
Royalty Period as none of the ING-1 Claims has been issued or
granted by the U.S. Patent office or its counterpart in any
foreign country, then the Basic Royalty Rate described in
Section 4.2(a) above in respect of the applicable country or
countries shall equal XXXX, and shall be subject to
further downward adjustments, if applicable, as described in
Section 4.2(b) above and/or Section 4.2(c) above. XOMA shall
have the right to make the license granted in Section 2.1 a
non-exclusive license pursuant to a breach of the royalty
payment obligations or the ING-1 Product development
obligations as described in Section 10.1(a).
c. Subsection (ii) of the second sentence of
Section 4.2(h) is revised to read as follows:
(ii) possess and use the then current technology
developed and owned by BWCo to the extent reasonably
necessary for the production and purification of
ING-1, such use to be restricted to the production
and purification of ING-1.
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5. Examination of Existing Antibodies.
a. The first sentence of Section 9.1(b) of the
Agreement is
hereby amended to read, in its entirety, as follows:
Until January 21, 1996, XOMA shall permit BWCo
to examine samples of the Engineered Antibodies and
murine antibodies/cell lines described in Schedules
1.7 and 1.17, respectively; provided, that if one or
more XOMA scientists is reasonably required to
perform services to permit BWCo to conduct its
examination or, thereafter, to ensure that adequate
samples are created and preserved for BWCo's future
use, BWCo shall pay XOMA XXXX per
man-day reasonably expended by such XOMA scientists.
b. Section 9.1(b) is further amended by adding a
new sentence
after the end of the currrent text, as modified by Section 5.a of
this
First Amendment, which sentence shall read, in its entirety, as
follows:
For so long as the license granted by
Section 2.1 of this Agreement remains exclusive,
however, nothing in this section or any other
provision of this Agreement shall be construed to
permit XOMA to grant any party other than BWCo,
whether or not such person is an Affiliate to XOMA,
any license or transfer of any rights related to
ING-1 Antibody or the ING-1 Antibody in the Field of
Use.
6. Patent Maintenance and Applications. Section 9.2 is
revised to
include a new Subsection 9.2(e) reading as follows:
(e) XOMA undertakes to keep BWCo reasonably
informed throughout the term of this Agreement
concerning the status and progress of the XOMA
Patent Rights. Without limiting the foregoing, BWCo
or
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its representatives shall have the right during
normal business hours and on reasonable prior notice
to inspect and have copied correspondence and other
records of XOMA pertaining to the XOMA Patent
Rights. To the extent XOMA has not previously done
so, XOMA shall provide BWCo with such additional
relevant documentation as BWCo may reasonably
request to permit BWCo to propose suitable
amendments to such XOMA Patent Rights; provided,
that BWCo shall reimburse XOMA for one-half (1/2)
the
outside counsel fees and other out-of-pocket costs
reasonably incurred by XOMA in considering,
addressing and/or implementing BWCo's requests and
proposed amendments.
7. Diligence Obligations.
a. Section 10.1(a)(i) is amended in its entirety to
read as
follows:
(i) undertake reasonably diligent efforts
to file an IND in any of the United States,
Japan, the United Kingdom, or Germany for an
ING-1 Product by December 31, 1996; provided,
that BWCo, at its sole option exercised anytime
prior to December 31, 1996, may elect to extend
the filing of such an IND until no later than
June 11, 1997, by providing XOMA with written
notice thereof, which notice shall be
accompanied by an additional fee of XXXX.
b. Section 10.1(a)(ii) is amended revising the
words
"XXXX per year" to read "XXXX per year during calendar 1995
and each year thereafter."
c. Section 10.1(a)(iv) is amended in its entirety
to read as
follows:
(iv) in the event BWCo, an Affiliate or
authorized sublicensee
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has not commenced a pivotal, FDA fileable Phase
III
efficacy study or equivalent study for an ING-1
Product
in any of the United States, the United
Kingdom,
Germany or Japan by June 30, 1999, then BWCo
will pay XOMA XXXX, per year, for every
year until such trial is commenced; provided,
that BWCo at its sole option exercised anytime
prior to June 30, 1999, may elect to extend the
commencement of such trial until no later than
December 31, 1999, by providing XOMA with
written notice thereof, which notice shall be
accompanied by an additional fee of XXXX;
and
d. Section 10.1(a)(v) is amended to delete the
words "within
nine (9) years after the date of this Agreement" and insert, in
their
place, the words "by June 11, 2002."
8. Failure to Satisfy Diligence Requirements.
a. The first sentence of Section 10.1(b) is hereby
amended to
read as follows:
BWCo shall be deemed to have failed to meet its
diligence obligations under this Agreement if (A) it
has failed to satisfy any of the diligence
requirements imposed by Section 10.1(a) above, or
(B) prior to filing a PLA as contemplated by
Section 10.1(a)(v), BWCo and its Affiliates and
sublicensees have failed for a period of twelve (12)
or more consecutive months to conduct, either
themselves or through some third party, development,
testing, regulatory or manufacturing activity
reasonably necessary in order to prepare and file
such a PLA, unless such failure was due to (x) valid
safety or efficacy reasons as reasonably determined
by BWCo, (y) a circumstance described in
Section 14.8 hereof, or (z) the failure by XOMA to
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perform its obligations hereunder. If XOMA notifies
BWCo in writing that it has failed under the
standard established by the preceding sentence to
meet its diligence obligations, then BWCo shall have
ninety (90) days after such written notice to cure
such failure without penalty.
b. Subsection (ii) of the sixth sentence of Section
10.1(b) (as
modified by this Paragraph 8) is revised to read as follows:
(ii) possess and use the then current
technology developed and owned by BWCo to the extent
reasonably necessary for the production and
purification of ING-1, such use to be restricted to
the production and purification of ING-1.
9. Termination.
a. Section 13.1 of the Agreement is amended by
designating the
current text as Subsection (a) and adding a new Section 13.1(b) to
read as
follows:
(b) Notwithstanding any other provision of
this Agreement, on thirty (30) days prior written
notice, from time to time, BWCo may teminate this
Agreement either in its entirety or with respect to
all, but not less than all, of the countries in any
of the following regions of the world: (i) the
countries forming the European Economic Union,
(ii) the countries comprising the continent of North
America, or (iii) the rest of the world.
b. Section 13.2 of the Agreement is amended to
read, in its
entirety, as follows:
13.2 Effect of Termination. Upon termination
of this Agreement, in whole or part, by XOMA where
permitted by this Agreement, all of the rights and
licenses so terminated shall revert to
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XOMA and XOMA shall have the rights set forth in
Section
4.2(h) or 10.1(b), as applicable. If, prior to the
filing of
a PLA for an ING-1 Product, BWCo terminates this
Agreement in its entirety pursuant to
Section 13.1(b) hereof, BWCo shall pay XOMA a
termination fee of XXXX. Upon
termination of this Agreement in whole or part by
BWCo pursuant to Section 13.1 hereof, all of the
rights so terminated shall revert to XOMA.
10. Notices. Section 14.4 of the Agreement is hereby
amended by
adding the following language immediately prior to the last two
lines of
such section:
To BWCo:
BY FACSIMILE: (000) 000-0000
BY COURIER OR U.S. MAIL:
Xxxxxxxxx Wellcome Co.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Attn: Company Secretary
With a copy to:
Xxxxxxxxx Wellcome Co.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Attn: Vice President - Business Development
BY FACSIMILE: (000) 000-0000
11. Each party represents and warrants to the other that
(i) the
Agreement is in full force and effect and such party is not in
default
thereunder, (ii) it has the requsite power and authority to enter
into this
First Amendment, (iii) that this First Amendment has been duly
authorized,
executed and delivered by such party, (iv) that this First
Amendment
constitutes the legal, valid and binding obligation of such party,
enforceable in accordance with its terms, except as
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such enforcement may be limited by applicable bankruptcy,
insolvency,
reorganization, moratorium, or other similar laws affecting
generally the
enforcement of creditors' rights and by general principles of
equity, and (v)
that the execution and delivery of this First Amendment by such
party, and the
performance by such party of its obligations hereunder, will not
(A) violate
or conflict with any provision of the charter or by-laws of such
party, or (B)
violate or conflict with, or result in a breach of any provision
of, or
constitute a default (or an event which with notice or passage of
time, or
both, would constitute a default) under, or give any party any
right to
terminate, modify, cancel or accelerate the performance required
by, any of the
provisions of, or require the consent of any other party to, any
material
note, bond, mortgage, indenture, deed of trust, license, loan
agreement,
lease or sublease with respect to real property, or other agreement
or
obligation to which such party is bound. Without limiting the
foregoing,
XOMA further represents and warrants that (x) it has sufficient
right,
title and interest in the XOMA Patent Rights and XOMA Technology
and Know-
How to grant the rights contemplated by the Agreement as modified
by this
First Amendment, (y) to the extent XOMA obtained such right, title
and
interest by license from a third party, such license is in full
force and
effect as of the date of this First Amendment and neither XOMA nor,
to the
best of XOMA's knowledge, any such third party has committed any
act or
omission that constitutes, or with the passage of time will likely
constitute, a breach or default under the terms of the license, and
(z) during the term of the Agreement, it shall pay such fees and
royalties
and take such other actions as may be required to keep the licenses
referenced by subsection (y) in full force and effect.
12. Except as expressly set forth herein, the Agreement
remains in
full force and effect as originally executed on June 11, 1991.
13. This First Amendment shall be governed by and
construed in
accordance with the laws of the State of California, without regard
to its
principles of conflicts of laws.
14. This First Amendment may be executed in two or more
counterparts,
each of which shall be deemed an original, but all of which
together shall
constitute but one and the same instrument.
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IN WITNESS WHEREOF, the undersigned have caused this
First
Amendment to be duly executed and delivered as of the date and year
first
above written.
XOMA CORPORATION
By: /s/ Xxxxxxxxxxx X. Xxxxxxxx
-------------------------------
Title: Vice President,
General Counsel and
Secretary
XXXXXXXXX WELLCOME CO.
By: /s/ Xxxxx X. Xxxxxx
-------------------------------
Title: Vice President,
Planning and
Business Development
