Amendment No. 1 to OTT License Agreement Number L-086-2000/0
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*Certain
confidential information contained in this document, marked by brackets,
has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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Amendment
No. 1
to
XXX License Agreement Number L-086-2000/0
This
is
the First Amendment to the XXX License Agreement Number L-086-2000/0 dated
May
21, 2004 by and between the United States Public Health Service as represented
by the Office of Technology Transfer, National Institutes of Health having
offices at 0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxxxxx, XX 00000-0000
(“PHS”)
and
Targeted Genetics Corporation (“TGC”),
a
corporation of Washington having a principal place of business at 0000 Xxxxx
Xxx, Xxxxx 000, Xxxxxxx, XX 98101(hereinafter, First Amendment).
WHEREAS,
the parties would like to amend the License Agreement having XXX License
Agreement Number L-086-2000/0 (hereinafter, “License Agreement”)
in
connection with the development and commercialization of HIV vaccine
Licensed Products
by the
International Aids Vaccine Initiative (“IAVI”),
in
collaboration with Licensee,
for use
and sale in the Developing World.
WHEREAS,
the parties are also amending the License Agreement
to
improve the administration of the License Agreement.
In
consideration of the value of the availability of vaccines in the Developing
World to accomplishing the public health mission of the National Institutes
of
Health the parties agree to amend the License Agreement
as
follows:
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1.
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The
Recitations on the Cover Page of the “Agreement”
are amended to add a Reference to Appendix G - Royalty Payment
Options which is also being added by this First Amendment
The amended text of the recitations reads as
follows:
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This
Patent License Agreement, hereinafter referred to as the “Agreement”,
consists of this Cover Page, an attached Agreement,
a
Signature Page, Appendix A (List of Patent(s) and/or Patent
Application(s)), Appendix B (Fields of Use and Territory),
Appendix C (Royalties), Appendix D (Modifications),
Appendix E (Benchmarks),
Appendix F (Commercial Development Plan) and
Appendix G (Royalty Payment Options). The Parties to this Agreement
are:
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1)
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The
National Institutes of Health (“NIH”), the Centers for Disease Control and
Prevention (“CDC”), or the Food and Drug Administration (“FDA”),
hereinafter singly or collectively referred to as “PHS”,
agencies of the United States Public Health Service within the
Department of Health and Human Services (“DHHS”);
and
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2)
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The
person, corporation, or institution identified above and/or on the
Signature Page, having offices at the address indicated on the
Signature Page, and its Affiliates
as
defined in Appendix D, Paragraph 2.14, hereinafter referred
to as “Licensee”.
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2.
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Appendix C,
Section C Earned Royalties
is
amended to read as follows:
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C.
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Earned Royalty(ies)
pursuant to Paragraph 6.03, as amended and set forth in
Appendix D, of this Agreement:
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Licensee
agrees
to pay to PHS,
according to schedule as set forth in Paragraph 9.04 of this Agreement,
an
Earned Royalty
amount
calculated on the basis of Net Sales
according to percentage set forth below:
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1.
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[*]
Percent ([*]%)
of Net Sales
of
Licensee
and its sublicensees of all Licensed Products
manufactured and sold in the Licensed Territory.
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Notwithstanding
the foregoing, Licensee
shall be
entitled to a One Percent (1.0%) credit against the earned royalty
rate set forth in Paragraph C.1. above for each percent of royalty in
excess of [*]
Percent ([*]%)
Licensee
must pay
to other unaffiliated licensors for the manufacture and sale of Licensed Products.
Said
reduction, however, shall not reduce the earned royalty rate for Licensed Products
below
[*]
provided
for in Paragraph C.1. above.
Notwithstanding
the foregoing, Earned
Royalty(ies)
will be
waived by PHS
related
to sales of any HIV vaccine Licensed Products
in the
Developing World,
for use
in the Developing World,
which
have been specifically developed through a collaboration between the
Licensee
and the
International AIDS Vaccine Initiative (IAVI),
an IRS
certified 501(c)3 tax exempt organization, with principal offices at 000 Xxxxxxx
Xxxxxx, Xxxxx 00, Xxx Xxxx, XX 00000-0000. Should Licensee
receive
any sales royalty from sales of Licensed Products
by
IAVI
or its
designee in the Developing World,
TGC
and
PHS
shall
mutually agree on compensation from Licensee
to
PHS.
Any
other
Licensed Product
which is
not the direct result of the above-mentioned collaboration and is not intended
solely for use and sale in the Developing World
will be
subject to all applicable Earned Royalty obligations.
First
Amendment Continues on Next Page
*Confidential
Treatment
Requested.
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3.
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Appendix C,
Section D shall be amended to read as
follows.
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D.
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Benchmark Royalty(ies)
pursuant to Paragraph 6.04, as amended and set forth in
Appendix D, of this Agreement:
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Licensee
agrees
to pay to PHS Benchmark Royalties
in the
amounts set forth herein:
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Benchmark
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Benchmark Royalty
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For
each [*]
up
to a total of [*],
at the time of [*]
of
a [*]
or
equivalent clinical trial for a particular [*]
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[*]
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For
each [*],
up to a total of [*],
at the time of [*]
of
a [*]
or
equivalent clinical trial for a particular [*]
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[*]
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For
each [*],
up to a total of [*],
at the time of [*]
for a particular [*]
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[*]
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Each
Benchmark Royalty
payment
as set forth herein is due to PHS
upon
Licensee,
its
sublicensees, or other Person,
as set
forth in Appendix D, Paragraph 2.14 of this Agreement,
acting
by or on behalf of Licensee,
achieving the Benchmark
and is
payable to PHS
within
thirty (30) days thereof or in the event that a sublicensee achieves
the benchmark and sublicensee is responsible for making a benchmark/milestone
payment to Licensee
upon
achieving the benchmark/milestone the Benchmark Royalty
is
payable to PHS
by
Licensee
within
thirty (30) days of receipt by Licensee
from
sublicensee of the benchmark/milestone payment due from
sublicensee.
Notwithstanding
the foregoing, Benchmark Royalty(ies)
will be
waived by PHS,
as set
forth in Appendix D, Paragraph 2.14 of this Agreement
if and
only if the Benchmark
is
achieved during the course of development of an HIV vaccine Licensed Product
which is
specific for use and sale in the Developing World
and is
the direct result of a collaboration between the Licensee
and
IAVI.
Any
other
Licensed Product
which is
not the direct result of the above-mentioned collaboration and is not intended
solely for use and sale in the developing world will be subject to all
applicable Benchmark Royalties.
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4.
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Appendix
D - Modifications is amended to add the following Paragraph 2.18 to
Article 2 - Definitions:
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2.18.
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“Developing World”
means those countries defined from time to time by the World Bank
as
having “low-income economies” or “middle-income economies” (whether
lower-middle or upper-middle).
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*Confidential
Treatment
Requested.
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5.
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Appendix
D - Modifications is changed to amend Paragraph 9.06 to reflect that
Appendix G has been added to the Agreement.
Paragraph 9.06 as amended reads as
follows:
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9.06
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Royalties
due under Article 6 shall be paid in U.S. dollars and payment
options are listed in Appendix G. For conversion of foreign currency
to U.S. dollars, the conversion rate shall be the average New York
foreign exchange rate quoted in The
Wall Street Journal
for the previous thirty (30) trading days prior to the date the
payment is due. All checks and bank drafts shall be drawn on
United States banks and shall be payable, as appropriate, to
“NIH/Patent Licensing”. Any loss of exchange, value, taxes, or other
expenses incurred in the transfer or conversion to U.S. dollars shall
be paid entirely by Licensee.
The royalty report required by Paragraph 9.04 of this Agreement
shall accompany each such payment, and a copy of such report shall
also be
mailed to PHS
at
its address for Agreement Notices indicated on the Signature Page of
this First Amendment.
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First
Amendment Continues on Next Page
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6.
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Appendix G
- Royalty Payment Information is added to the Agreement
in
order to facilitate the administration of the Agreement
in
the future. New Appendix G reads as
follows:
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APPENDIX
G - ROYALTY PAYMENT OPTIONS
NIH/PHS
License Agreements
*In
order to process payment via Electronic Funds Transfer sender MUST supply the
following information:
Procedure
for Transfer of Electronic Funds to NIH for Royalty
Payments
Bank
Name: Federal Reserve Bank
[*]
TREAS
NYC
[*]
OBI=Licensee
Name and XXX Reference Number
Dollar
Amount Wired=$$
NOTE:
Only U.S. banks can wire directly to the Federal Reserve Bank. Foreign banks
cannot wire directly to the Federal Reserve Bank, but must go through an
intermediary U.S. bank. Foreign banks may send the wire transfer to the U.S.
bank of their choice, who, in turn forwards the wire transfer to the Federal
Reserve Bank.
Mailing
Address for Royalty Payments:
National
Institutes of Health
X.X.
Xxx
000000
Xxxxxxxxxx,
XX 00000-0000 XXX
Overnight
Mail for Royalty Payments only
National
Institutes of Health
360120
Mellon
Client Service Center
Room
670
000
Xxxx
Xxxxxx
Xxxxxxxxxx,
XX 00000-0000
(000)
000-0000 (Customer Service)
Please
make checks payable to:
NIH/Patent Licensing
The
XXX Reference Number MUST
appear
on checks, reports and correspondence
*Confidential
Treatment
Requested.
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6.
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This
First Amendment
is
effective on the date on which the last party executes this First Amendment.
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7.
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Unless
expressly modified by this First Amendment
the terms and conditions of the License Agreement
are incorporated in their entirety into the terms and conditions
of this
First Amendment
and this First Amendment
together with the License Agreement
constitute the entire agreement between the parties and all prior
negotiations, representations, agreements, and understandings are
merged
into, extinguished by, and completely expressed by this First Amendment.
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SIGNATURES
BEGIN ON NEXT PAGE
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SIGNATURE
PAGE
For
PHS:
| /s/ Xxxxxx X. Xxxxxxxx | 8/14/06 | |
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Xxxxxx
X. Xxxxxxxx, MBA
Director,
Division of Technology Development and Transfer
Office
of Technology Transfer
National
Institutes of Health
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Date | |
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Mailing
Address for Agreement Notices:
Chief,
Monitoring and Enforcement Branch
Office
of Technology Transfer
National
Institutes of Health
0000
Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxxxxx,
Xxxxxxxx 00000-0000 X.X.X.
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For
Licensee
(Upon,
information and belief, the undersigned expressly certifies or affirms that
the
contents of any statements of Licensee
made or
referred to in this document are truthful and accurate):
By:
Targeted
Genetics Corporation
Licensee
| /s/ B.G. Xxxxx Xxxxxxxx | 08-18-06 | |
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Signature
of Authorized Official
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Date | |
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B.G.
Xxxxx Xxxxxxxx
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| Printed Name | ||
| VP, Business Development | ||
| Title |
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I.
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Official
and Mailing Address for Agreement
Notices:
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Targeted
Genetics Corporation
0000
Xxxxx Xxx, Xxxxx 000
Xxxxxxx,
XX 00000
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II.
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Official
and Mailing Address for Financial Notices (Licensee’s
contact person for royalty
payments)
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| Xxxxx Xxxxxxxx | ||
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Name | |
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Vice President, Business Development | |
| Title | ||
| Mailing Address: | ||
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0000
Xxxxx Xxx, Xxxxx 000
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Xxxxxxx,
XX 00000
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| Email Address: | xxxxx.xxxxxxxx@xxxxxx.xxx | |
| Phone: | 000-000-0000 | |
| Fax: | 000-000-0000 |
Any
false
or misleading statements made, presented, or submitted to the Government,
including any relevant omissions, under this Agreement
and
during the course of negotiation of this Agreement
are
subject to all applicable civil and criminal statutes including Federal statutes
31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001
(criminal liability including fine(s) or imprisonment).
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