FIRST AMENDMENT TO LICENSE AGREEMENT
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment and have been filed separately with the
Commission
pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit
10.9
FIRST
AMENDMENT TO LICENSE AGREEMENT
THIS
FIRST AMENDMENT TO LICENSE AGREEMENT (hereinafter referred to as "FIRST
Amendment") is made and entered into this 2nd day of June, 2004 (hereinafter
the
"Effective Date") by and between:
Emory
University,
a
non-profit Georgia corporation with offices located at Office of Technology
Transfer, Xxxxx Xxxxxxx Xxxx., Xxxxx 000, 0000 X. Xxxxxxx Xxxx, Xxxxxxx, Xxxxxxx
00000 (hereinafter referred to as "EMORY");
AND
Cougar
Biotechnology, Inc., a
for-profit Delaware corporation with offices at
00000
Xxxxxxxx Xxxx., Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000 XXX (hereinafter
referred to as "CBT").
RECITALS:
WHEREAS,
EMORY
and CBT entered into a License Agreement, dated the 23rd
day of
February, 2004, for inventions which are owned by EMORY (hereinafter referred
to
as "License Agreement") and incorporated herein by reference; and
WHEREAS,
the
parties have agreed to modify the terms of the License Agreement;
NOW,
THEREFORE,
in
consideration of the premises and mutual covenants contained herein, and
intending to be legally bound hereby, the parties hereto agree to the statements
and representations made above and do hereby mutually agree to amend the License
Agreement as follows:
1. The
second (2nd)
WHEREAS
under
WITNESSETH,
which
reads as:
WHEREAS,
Drs. Xxxxxx Xxxxx, Xxxxxx Xxxx, Xxxx Ke, Xxxxxxx Xxx, Xxxxx Xxxxxx, Xxxxxx
Xxxxxxxxx, Xxxxx Xxxxxx and Keqiang Ye are employees of EMORY and are named
as
inventors on Emory invention disclosures: (i) no. 97012, titled: "The Antitissue
Drug Noscapine is a Tubulin Binding Anti-Tumor Drug",
(ii) no. 98056, titled: "Use of the Anti-Cancer Agent, Noscapine, as an
Immunological Adjuvant for Tumor Therapy", (iii) no. 01028, titled: "Noscapine
and Noscapine Derivatives, Useful as Anticancer Agents", and (iv) no. 02040,
titled: "Delivery Systems and Methods for Nocapine and Noscapine Derivatives,
Useful as Anticancer Agents", which are the subject of those issued patents
and
pending patent applications listed in Appendix "A" herein (hereinafter
"Inventions");
is
hereby
amended and shall read as:
WHEREAS,
Drs.
Xxxxxx Xxxxx, Xxxxxx Xxxx, Xxxx Ke, Xxxxxxx Xxx, Xxxxx Xxxxxx, Xxxxxx Xxxxxxxxx,
Xxxxx Xxxxxx and Keqiang Ye are employees of EMORY and are named
as
inventors on Emory invention disclosures: (i) no. 97012, titled: "The Antitissue
Drug Noscapine is a Tubulin Binding Anti-Tumor Drug"; (ii) no. 98056, titled:
"Use of the Anticancer Agent, Noscapine, as an Immunological Adjuvant for Tumor
Therapy"; (iii) no. 01028, titled: "Noscapine and Noscapine Derivatives, Useful
as Anticancer Agents"; (iv) no.
02040,
titled: "Delivery Systems and Methods for Nocapine and Noscapine Derivatives,
Useful as Anticancer Agents"; and (v) no. 04053, titled: "Novel Alkaloids for
Cancer Therapy", which are the subject of those issued patents and pending
patent applications listed in Appendix "A" herein (hereinafter
"Inventions");
2. Appendix A,
which
reads as:
LICENSED
PATENTS
Licensed
Patents shall include, but not be limited to, the following issued patents
and
pending patent applications:
|
1.
|
United
States Patent No.: 6,376,516, titled: "Noscapine
Derivatives, Useful as Anticancer Agents";
|
|
| 2. |
International
Patent Application No.: PCT/US98/14979, titled: "Noscapine Derivatives,
Useful as Anticancer Agents";
|
|
| 3. |
United
States Patent Application No.: 09/558,042, titled: "Noscapine Derivatives
as
Adjuvant Compositions and Methods of Use Thereof';
|
|
| 4. | United States Patent Application No.: 10/288,442, titled: “Noscapine Derivatives as Adjuvant Compositions and Methods of Use Thereof”; | |
|
5.
|
International Patent Application No.: PCT/US00/11082, titled: "Noscapine Derivatives as Adjuvant Compositions and Methods of Use Thereof'; | |
| 6. | Canadian Patent Application No.: 2,370,643, titled: “Noscapine Derivatives as Adjuvant Compositions and Methods of Use Thereof'; | |
| 7. | European Patent Application No.: 00928370.6, titled: “Noscapine Derivatives as Adjuvant Compositions and Methods of Use Thereof'; and | |
| 8. | United States Patent No.: 6,673,814, titled: "Delivery Systems and Methods for Noscapine and Noscapine Derivatives, Useful as Anticancer Agents". |
is
hereby
amended and shall read as:
LICENSED
PATENTS
Licensed
Patents shall include, but not be limited to, the following issued patents
and
pending patent applications:
A. Licensed
Patents Group I.
|
1.
|
United
States Patent No.: 6,376,516, titled: "Noscapine Derivatives, Useful
as
Anticancer Agents";
|
|
| 2. |
International
Patent Application No.: PCT/US98/14979, titled: "Noscapine Derivatives,
Useful as Anticancer Agents";
|
|
| 3. |
United
States Patent Application No.: 09/558,042, titled: "Noscapine Derivatives
as Adjuvant Compositions and Methods of Use Thereof';
|
|
| 4. |
United
States Patent Application No.: 10/288,442, titled: "Noscapine Derivatives
as Adjuvant Compositions and Methods of Use
Thereof';
|
|
5.
|
International
Patent Application No.: PCT/US00/11082, titled: "Noscapine Derivatives
as
Adjuvant Compositions and Methods of Use Thereof';
|
|
| 6. |
Canadian
Patent Application No.: 2,370,643, titled: "Noscapine Derivatives
as
Adjuvant Compositions and Methods of Use Thereof';
|
|
| 7. |
European
Patent Application No.: 00928370.6, titled: "Noscapine Derivatives
as
Adjuvant Compositions and Methods of Use Thereof'; and
|
|
| 8. |
United
States Patent No.: 6,673,814, titled: "Delivery Systems and Methods
for
Noscapine and Noscapine Derivatives, Useful as Anticancer Agents";
and
|
B. Licensed
Patents Group II.
1.
United
States Patent Application No.: 60/557,266, titled: "Novel Alkaloids for Cancer
Therapy".
3. Paragraph
3.3.1, which reads as:
3.3.1 CBT,
its
Affiliates or its sublicensee shall pay EMORY a milestone payment (the
"Milestone Payment") in the amount specified below no later than thirty (30)
days after the occurrence of the corresponding event designated below for the
First Licensed Product:
|
Event
|
Milestone
Payment
|
|
|
(i)
|
The
date of commencement of the first Phase I trial by CBT,
its Affiliates, or sublicensees for the First Licensed
Product
|
$[***]
|
|
|
||
|
(ii)
|
The
date of commencement of the first Phase III Clinical Trial
for the First Licensed Product
|
$[***]
|
|
|
||
|
(iii)
|
The
date of Regulatory Approval or Authorization of the First
Licensed Product.
|
$[***]
|
|
|
||
|
(iv)
|
The
date of Regulatory Approval or Authorization of the First Licensed
Product
or Consecutive Licensed Product in
an additional new
indication (limit 3 )
|
$[***]
for each new approval
(limit 3)
|
Should
the First Licensed Product be abandoned by CBT, its Affiliate or sublicensee
for
any reason following the filing of an IND or its equivalent in a Major Market
and prior to the First Commercial Sale and should another Licensed Product
commence Phase III Clinical Trials, then such Licensed Product shall become
the
replacement First Licensed Product and CBT, its Affiliate or sublicensee shall
resume the Milestone Payments, starting at the event subsequent to the event
for
which a Milestone Payment had already been paid. No Milestone Payment shall
be
paid more than once for the First Licensed Product.
is
hereby
amended and shall read as:
3.3.1 CBT,
its
Affiliates or its sublicensee shall pay EMORY
a
milestone payment (the "Milestone Payment") in the amount specified below no
later than thirty (30) days after the occurrence of the corresponding event
designated below for the First Licensed Product from
Licensed
Patents Group I and for the First Licensed Product from Licensed Patents Group
II of Appendix A.
|
Event
|
Milestone
Payment
|
|
|
(i)
|
The
date of commencement of the first Phase I trial by CBT,
its Affiliates, or sublicensees for the First Licensed
Product
|
$[***]
|
|
|
||
|
(ii)
|
The
date of commencement of the first Phase III Clinical Trial
for the First Licensed Product
|
$[***]
|
|
|
||
|
(iii)
|
The
date of Regulatory Approval or Authorization of the First
Licensed Product.
|
$[***]
|
|
|
||
|
(iv)
|
The
date of Regulatory Approval or Authorization of the First Licensed
Product
or Consecutive Licensed Product in
an additional new
indication (limit 3 )
|
$[***]
for each new approval
(limit 3)
|
Should the First Licensed Product of Licensed Patent Group I or of Licensed Patents Group II be abandoned by CBT, its Affiliate or sublicensee for any reason following the filing of an IND or its equivalent in a Major Market and prior to the First Commercial Sale and should another Licensed Product of the same Licensed Patents Group commence Phase III Clinical Trials, then such Licensed Product shall become the replacement First Licensed Product for that Licensed Patents Group and CBT, its Affiliate or sublicensee shall resume the Milestone Payments, starting at the event subsequent to the event for which a Milestone Payment had already been paid. No Milestone Payment shall be paid more than once for the First Licensed Product of Licensed Patents Group I or for the First Licensed Product of Licensed Patent Group II.
4. That
part
of Paragraph 3.6, which reads as:
3.6 Research
Agreement. CBT
and
EMORY agree to enter into and execute a Research Agreement with a term of 2
year(s), within ninety (90) days of the last date of signing below, regarding
work by the Inventors, led by Xx. Xxxxxx Xxxx, in accordance with a mutually
agreed upon project plan. Such Research Agreement shall be consistent with
the
terms of this Agreement, including but not limited to, terms of this Section
3.6
and shall be in the form attached to this License Agreement as Appendix "C".
Such Research Agreement shall require CBT to commit [***] of direct
research funds plus [***] percent [***] for EMORY's benefits and overhead
in the amount [***] in unrestricted indirect funding to EMORY.
is
hereby
amended and shall read as:
3.6 Research
Agreement.
CBT and
EMORY agree to enter into and execute a Research Agreement with a term of 2
year(s), within ninety (90) days of the last date of signing below,
regarding
work by the Inventors, led by
Xx.
Xxxxxx Xxxxx, in accordance with a mutually agreed upon project plan. Such
Research Agreement shall be consistent with the terms of this Agreement,
including but not limited to, terms of this Section 3.6 and shall be in the
form
attached to this License Agreement as Appendix "C". Such Research Agreement
shall require CBT to commit [***] of direct research funds plus [***]
percent [***] for EMORY's benefits and overhead in the amount [***] in
unrestricted indirect funding to EMORY.
5. Except
as
amended by this FIRST Amendment, all of the terms and conditions of the License
Agreement, as originally drafted, shall remain in full force and
effect.
IN
WITNESS WHEREOF, the
parties have caused this FIRST Amendment to the License Agreement to be executed
by their duly authorized officers on the day and year first written
above.
|
EMORY
UNIVERSITY
|
COUGAR BIOTECHNOLOGY, INC. | ||||
| /s/ Xxxx X. Xxxxxx | /s/ Xxxx X. Xxxxxxxx | ||||
|
Name: Xxxx X. Xxxxxx, Ph.D.
Title: Assistant Vice President and Director
Office of Technology Transfer
|
Name: Xxxx X. Xxxxxxxx Title: Chief Executive Officer |
||||
| Date: | Date: | ||||
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