AMENDMENT #3 (FEBRUARY 2005 LICENSE AGREEMENT)
Exhibit
10.11
AMENDMENT
#3
(FEBRUARY
2005 LICENSE AGREEMENT)
This
amendment #3, effective as of the 31st day of
January 2007 (“Third Amendment Effective Date”), amends the February 1, 2005
License Agreement entered into and between The Trustees of Columbia University
in the City of New York, a New York corporation located at 000xx xxxxxx
xxx Xxxxxxxx, Xxx Xxxx, Xxx Xxxx, 00000 (“Columbia”), and Omnimmune Corp., a
Texas corporation located at 0000 Xxxx Xxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxx
00000 (“Company”), as amended on March 29, 2005 and June 10, 2005 (collectively,
the “Agreement”) according to the following terms and conditions:
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1)
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Section
3a(ii)(a) is amended by replacing the entirety of this section with the
following:
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“$25,000
by May 1, 2007, and”
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2)
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Section
3e is hereby amended by replacing the entirety of this section with the
following:
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“e. License
Maintenance Fees – Company shall pay annual license maintenance fees according
to the schedule below:
$10,000
on or before May 1, 2007;
$20,000
on or before May 1, 2008;
$35,000
on or before May 1, 2009;
$50,000
on or before May 1, 2010; and $40,000 each first of May
thereafter.”
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3)
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Section
6a(i) is amended by replacing the entirety of this section with the
following:
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“Before
February 1, 2008, Company and/or its Sublicensees or Affiliates shall have spent
at least four hundred thousand dollars ($400,000) on the direct research and
development of Licensed Product(s) in the Field.”
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4)
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Section
6a(iii) is amended by replacing the entirety of this section with the
following:
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“Before
February 1, 2010, Company and/or its Sublicensees or Affiliates shall have spent
at least $2,500,000 on the direct research and development of Licensed
Product(s) in the Field.”
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5)
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Section
6a(iv) is amended by replacing the entirety of this section with the
following:
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“(iv) Diagnosis
(a) Company
and/or its Sublicensees or Affiliates shall file an application with the FDA for
at least one (1) Licensed Product for diagnosis of a human disease before
February 1, 2008.
(b) Company
and/or its Sublicensees or Affiliates shall have received FDA approval for at
least one (1) Licensed Product for diagnosis of a human disease before February
1, 2010.
(c) Company
and/or its Sublicensees or Affiliates shall file develop and market at least one
(1) Licensed Product for diagnosis of a human disease somewhere in the world
before February 1, 2011.”
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6)
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Section
6a(v) is amended by replacing the entirety of this section with the
following:
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“(v) Therapy
(a) Company
and/or its Sublicensees or Affiliates shall begin the first animal efficacy
study of a murine or humanized MAb or fragment or any other variation thereof
leading to a Licensed Product for therapy of a human disease before February 1,
2008, and shall complete said animal study before February 1, 2010.
(b) Company
and/or its Sublicensees or Affiliates shall begin the first human clinical trial
of at least one (1) Licensed Product for therapy of a human disease before
February 1, 2010.
(c) Company
and/or its Sublicensees or Affiliates shall begin the first phase II human
clinical trial of at least one (1) Licensed Product for therapy of a human
disease before February 1, 2011.
(d) Company
and/or its Sublicensees or Affiliates shall have filed an NDA with the FDA for
at least one (1) Licensed Product for therapy of a human disease before February
1, 2013.”
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7)
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In
consideration for the execution and delivery of this Amendment #3 by
Columbia, the Company will, upon such execution and delivery, (i) enter
into an Amended and Restated Stockholders Agreement of the Company, in
form and substances satisfactory to Columbia, and cause the stockholders
of the Company to enter into such agreement at such time, (ii) issue to
Columbia a number of additional shares of the common stock of the Company
equal to 1% of the fully-diluted equity of the Company after giving effect
to such issuance, and (iii) enter into a Stock Purchase Agreement, in form
and substance satisfactory to Columbia, with respect to such additional
shares.
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8)
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Except
as expressly set forth in this Amendment #3, the Agreement shall remain in
full force and effect. If there is any inconsistency or
conflict between this Amendment #3 and the Agreement, the provisions of
this Amendment #3 shall govern and control. This Amendment #3
may be executed in any number of counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the
same instrument. This Amendment #3 shall be binding upon, and
shall inure to the benefit of, the parties hereto and their respective
successors and assigns.
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IN WITNESS WHEREOF, the parties have executed
this Amendment #3 in multiple originals as of the date set out below next to
their signatures.
| OMNIMMUNE CORP. | THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK | |
| /s/ Xxxxxx X. Xxxxxxxxxxxx | /s/ Xxxxxxx X. Xxxxxx | |
| Xxxxxx X. Xxxxxxxxxxxx, Ph.D. | Xxxxxxx X. Xxxxxx, Ph.D. | |
| President | Executive Director, Columbia Innovation Enterprise | |
| Date:4/30/07 | Date:5/2/07 tts# 33227 |
