EXHIBIT 10.4
FIRST AMENDMENT TO LICENSE AGREEMENT
This First Amendment to License Agreement ("First Amendment") is
entered into as of May 6, 1999, and effective as of the Effective Date (as
defined in the GW License Agreement) by and between Triangle Pharmaceuticals,
Inc., a for-profit Delaware corporation with principal offices located at 0
Xxxxxxxxxx Xxxxx, 0000 Xxxxxxxxxx Xxxxx, Xxxxxx, Xxxxx Xxxxxxxx 00000
("COMPANY") and Emory University, a not-for-profit Georgia corporation with
offices at 0000 Xxxxx Xxxxxx Xxxx, X.X., Xxxxxxx, Xxxxxxx 00000 ("LICENSOR"),
and amends certain terms of that certain License Agreement, dated as of April
17, 1996 between LICENSOR and COMPANY (the "Agreement").
RECITALS:
A. LICENSOR and COMPANY have previously entered into the Agreement,
pursuant to which LICENSOR has licensed certain patent rights and know-how to
COMPANY with respect to FTC.
B. LICENSOR has acquired certain rights from a third party which
LICENSOR and COMPANY desired to be included within the Agreement.
C. LICENSOR and COMPANY desire to amend certain terms of the
Agreement as set forth in this First Amendment.
NOW, THEREFORE, for good and valuable consideration, COMPANY and
LICENSOR hereby agree as follows:
1. DEFINITIONS. As used in this First Amendment, the following
terms shall have the following meanings:
(a) "GW Agreements" shall mean the GW License Agreement and the
Settlement Agreement.
(b) "GW License Agreement" shall mean the Exclusive License
Agreement by and among Glaxo Group Limited, The Wellcome Foundation
Limited, Glaxo Wellcome, Inc. (collectively "GW"), LICENSOR and
COMPANY, dated as of even date herewith, pursuant to which GW has,
among other things, granted LICENSOR certain rights under patents
and patent applications relating to FTC.
(c) "Settlement Agreement" shall mean the Settlement Agreement,
dated as of even date herewith, by and among Glaxo Wellcome plc and
GW on the one hand, and LICENSOR, COMPANY and Xx. Xxxxx X. Xxxxx on
the other hand, providing for the settlement, release and dismissal
of the FTC litigation and related claims (including but not limited
to Civil Action 1:96-CV-1754-GET), and certain claims of Xx. Xxxxx X.
Xxxxx against Glaxo Wellcome, plc, GW and their Affiliates.
(d) All other terms used in this First Amendment and not
otherwise defined herein shall have the same meanings ascribed to
them in the Agreement.
2. AMENDMENTS. The Agreement is hereby amended as follows:
(a) The patents and patent applications to which LICENSOR
acquires title under the GW Agreements shall be deemed to be
"Licensed Patents" under the Agreement.
(b) The patents and patent applications under which LICENSOR
obtains an exclusive license or a covenant not to xxx under the GW
Agreements shall be deemed to be the "GW Patents" referred to in the
Agreement.
(c) APPENDIX "A" to the Agreement is deleted and replaced with
APPENDIX "A" attached to this First Amendment.
(d) The data package, regulatory filings and any other
know-how, information or technology to which LICENSOR acquires any
right, title, license or other interest under the GW Agreements
shall be deemed to be the "GW Know How" referred to in the Agreement.
(e) The GW Know How shall be deemed to constitute "Licensed
Technology" under the Agreement and shall be subject to all
applicable provisions thereunder including, but not limited to,
COMPANY's obligations under Section 11.7 of the Agreement.
(f) Pursuant to Subsection 2.6(b) of the Agreement, COMPANY
acknowledges that LICENSOR has given COMPANY the required notice of
and information concerning the licenses and covenants not to xxx
under the GW Patents and the title and licenses under the GW Know
How that LICENSOR is obtaining under the GW Agreements. Pursuant to
Section 2.6 of the Agreement, COMPANY hereby elects to obtain from
LICENSOR a sublicense under the GW Patents and the GW Know How and
LICENSOR hereby grants to COMPANY a sublicense and a sub-immunity
from suit under the GW Patents and the GW Know How, each of which is
exclusive in accordance with and coterminous with the provisions of
Sections 2.1, 2.2, 2.3, 2.4 and 2.5 of the Agreement.
(g) COMPANY shall have the right to grant sublicenses and
sub-immunities from suit under the GW Patents and GW Know How, to
the same extent and under the same conditions provided in Sections
2.4 and 3.7 of the Agreement.
(b) COMPANY shall be responsible for paying the royalties due
to GW under the GW License Agreement resulting from sale of Licensed
Products (as defined in the GW License Agreement) by COMPANY, its
Affiliates and
2
sublicensees. COMPANY hereby indemnifies LICENSOR, its trustees,
directors, employees, students and their respective successors and
assigns and holds them harmless against all claims by GW of non-payment
or underpayment of such royalties. COMPANY will pay such royalties
directly to GW, as prescribed by the GW License Agreement, with notice
to LICENSOR. COMPANY's obligation under this paragraph (g) shall
terminate in respect of a given country upon the expiration or
termination of the GW License Agreement in such country.
(i) COMPANY will pay LICENSOR the Additional Milestone payment as
provided by Subsection 3.3(b) of the Agreement, but COMPANY will be
relieved of its obligation to pay the Additional Milestone payment
provided by Subsection 3.3(a) of the Agreement. Subsection 3.3(a) of the
Agreement is hereby deleted.
(j) The royalties actually paid by COMPANY, its Affiliates and
sublicensees under the GW License Agreement shall be deemed to be "Third
Party Royalties" under Subsection 3.9(a) of the Agreement and COMPANY,
its Affiliates and sublicensees shall have the right of deduction
defined by that Subsection 3.9(a) with respect to the royalties paid
thereunder to GW. This right of deduction shall apply irrespective of
whether GW has a patent in a country where any Licensed Product is made,
used, sold or offered for sale and irrespective or whether any such
patent is infringed by the activities of COMPANY, its Affiliates,
sublicensees or any party in a co-promotion or co-marketing relationship
with COMPANY in such country. Notwithstanding Section 3.9 of the
Agreement, COMPANY's payment of royalties to GW and the offset of a
portion of those royalties against COMPANY's royalty obligations to
LICENSOR shall not be an acknowledgment by either COMPANY or LICENSOR
that any GW Patents would be infringed but for the license or immunity
from suit granted by GW under the GW License Agreement.
(k) Pursuant to Section 4.2 of the GW License Agreement, COMPANY
agrees to keep and maintain records of sales of Licensed Products made
pursuant to this sublicense granted hereby and to grant to GW's
independent certified accountant in the same manner and to the same
extent as prescribed in the GW License Agreement.
(l) LICENSOR agrees not to assume responsibility for any GW Patent
Prosecution Activities (as defined in the GW License Agreement) without
first consulting with COMPANY to discuss the commercial importance of the
patents and patent applications with respect to which LICENSOR is
contemplating assuming GW Patent Prosecution Activities.
(m) Any right which LICENSOR acquires to pursue third party
infringers in respect of the GW Patents shall be immediately exercisable
by COMPANY in accordance with the applicable terms and provisions set
forth in the GW License Agreement and Article 8 of the Agreement.
3
(n) LICENSOR and COMPANY each covenant that, during the term of
the Agreement, it will:
(i) fulfill all of its obligations under the GW Agreements,
including, but not limited to, any royalty obligations set forth
therein;
(ii) take no action or omit to take any action which would
cause it to be in breach of any provision of the GW Agreements; and
(iii) immediately notify the other party in the event it
receives notice from GW that it is in default under the GW
Agreements or that GW has terminated or intends to terminate the GW
Agreements. In the event of any default of the type described in
this clause (iii), LICENSOR or COMPANY, as applicable, agrees that
if it fails or does not intend to cure such default, the other
party may, at such other party's option, do so and may offset (in
the case of COMPANY) or invoice (in the case of LICENSOR) any
reasonable expenses such other party incurs in curing such default.
(o) Notwithstanding any provision to the contrary in the GW
Agreements, COMPANY may not assign to GW or any Affiliate of GW any
rights transferred, license or sublicensed to COMPANY under the GW
Agreements.
3. GENERAL TERMS.
(a) Except as expressly amended hereby, the remaining terms of the
Agreement shall remain in full force and effect.
(b) The Agreement, as amended by this First Amendment, constitutes
the entire agreement between LICENSOR and COMPANY or regarding the
subject matters contained therein and herein.
(c) In the event of any conflict between the provisions of the
Agreement and this First Amendment, the provisions of this First
Amendment shall govern and control.
(d) This First Amendment shall be governed by, and construed in
accordance with, the laws of the Georgia without regard to its conflicts
of laws principles.
(e) This First Amendment may be executed in any number of
counterparts, each of which shall be deemed an original and all of which
shall constitute one and the same instrument.
4
(f) If any provision of this First Amendment is for any reason
held to be ineffective, unenforceable or illegal, such condition shall
not affect the validity or enforceability of any of the remaining
portions hereof; provided, further, that the parties shall negotiate in
good faith to replace any ineffective, unenforceable or illegal provision
with an effective replacement as soon as is practical.
(g) In the event the Effective Date shall not have occurred on or
before ninety (90) days from the date first set forth above, this First
Amendment shall become null and void.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
5
IN WITNESS WHEREOF, LICENSOR and COMPANY have each executed this
First Amendment through an authorized officer as of the date first written
above.
EMORY UNIVERSITY
By: /s/ Xxxx X. Xxxxxx
------------------------------
Xxxx X. Xxxxxx
Its: Executive Vice President
TRIANGLE PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxx
-----------------------------
Xxxxx X. Xxxxx
Its: Chairman and Chief Executive
Officer
[SIGNATURE PAGE TO FIRST AMENDMENT]
6
APPENDIX "A"
FTC APPLICATIONS AND PATENTS
-------------------------------------------------------------------------------------------------
DOCKET NO. COUNTRY SERIAL NO. FILED PATENT NO. GRANT DATE
-------------------------------------------------------------------------------------------------
EMU104 U.S. 08/472,345 06/07/95 (allowed)
CON (2)
-------------------------------------------------------------------------------------------------
EMU104 U.S. 08/476,414 06/07/95 Abandoned
CON (3)
-------------------------------------------------------------------------------------------------
EMU105CIP U.S. 07/659,760 02/22/91 5,210,085 05/11/93
-------------------------------------------------------------------------------------------------
EMU105CIP U.S. 08/017,820 02/16/93 5,814,639 09/29/98
DIV
-------------------------------------------------------------------------------------------------
EMU105CIP U.S. 08/412,730 03/13/95 Suspended for
(2) CON (2) Interference
-------------------------------------------------------------------------------------------------
EMU180 U.S. 07/831,153 02/12/92 Pending
-------------------------------------------------------------------------------------------------
EMU108 U.S. 08/488,097 06/07/95 (allowed)
CON (1)
-------------------------------------------------------------------------------------------------
EMU108 U.S. 08/482,875 06/07/95 Pending
CON (2)
-------------------------------------------------------------------------------------------------
EMU108 U.S. 08/475,339 06/07/95 Interference
CON (3) No. 103,906
-------------------------------------------------------------------------------------------------
EMU122 U.S. 08/487,187 06/07/95 Interference
FWCDIV No. 104,019
-------------------------------------------------------------------------------------------------
EMU134 U.S. 08/483,653 06/07/95 5,827,727 10/27/98
-------------------------------------------------------------------------------------------------
EMU134 U.S. 08/474,406 06/07/95 Pending
DIV (1)
-------------------------------------------------------------------------------------------------
EMU134 U.S. 08/482,233 06/07/95 Pending
DIV (2)
-------------------------------------------------------------------------------------------------
EMU135 U.S. 08/485,318 06/07/95 5,728,575 03/17/98
-------------------------------------------------------------------------------------------------
EMU136 U.S. 08/481,556 06/07/95 5,700,937 12/23/97
-------------------------------------------------------------------------------------------------
EMU105 U.S. 08/775,572 12/31/96 Suspended for
CIP (2) Interference
CON (3)
-------------------------------------------------------------------------------------------------
EMU148 U.S. 08/773,580 12/27/96 Pending
-------------------------------------------------------------------------------------------------
EMU134 U.S. 09/115,780 07/14/98 5,892,075 04/06/99
CON
-------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------
FTC APPLICATIONS AND PATENTS
FOREIGN
-------------------------------------------------------------------------------------
DOCKET NO. COUNTRY SERIAL NO. FILING DATE PATENT NO. ISSUE DATE
-------------------------------------------------------------------------------------
EMU104 PCT PCT/ US91/ 07/31/91 Pub. No. Pub. Date
00685 WO 08/08/91
91/11186
-------------------------------------------------------------------------------------
Australia 73004/91 07/31/91 658136
-------------------------------------------------------------------------------------
Barbados 81/219 07/31/91 81/219
-------------------------------------------------------------------------------------
Bulgaria 96717 07/31/91
-------------------------------------------------------------------------------------
Canada 2,075,189 07/31/91
-------------------------------------------------------------------------------------
Europe 91904454.5 07/31/91 0513200 09/09/98
-------------------------------------------------------------------------------------
provisional protection under Article 67(3) in Germany,
Belgium, Austria, France, Luxembourg, Spain, Greece,
Sweden, Denmark, Switzerland, Italy and the Netherlands
-------------------------------------------------------------------------------------
Finland 923446 07/31/91
-------------------------------------------------------------------------------------
Hungary P9202496 07/31/91
-------------------------------------------------------------------------------------
Hungary P/P00581 07/31/91 211.300
-------------------------------------------------------------------------------------
Japan 3-504897 07/31/91 618/1995
-------------------------------------------------------------------------------------
Korea 92-701845 07/31/91 188357 01/12/99
-------------------------------------------------------------------------------------
Malawi 49/92 07/31/91 MW 49/92 12/12/94
-------------------------------------------------------------------------------------
Monaco PV 07/31/91 93 2233 02/23/93
PCT/US91/
00685
-------------------------------------------------------------------------------------
Norway P923014
-------------------------------------------------------------------------------------
Romania 1256/310792 108564
-------------------------------------------------------------------------------------
Russia 92016627.04 07/31/91
-------------------------------------------------------------------------------------
Xxx Xxxxx 00000 01/29/93
-------------------------------------------------------------------------------------
FTC APPLICATIONS AND PATENTS
FOREIGN
-----------------------------------------------------------------------------------
DOCKET NO. COUNTRY SERIAL NO. FILING DATE PATENT NO. ISSUE DATE
-----------------------------------------------------------------------------------
EMU108 PCT PCT/US92/ 02/20/92 WO 09/03/92
01339 92/14743
-----------------------------------------------------------------------------------
Australia 15617/92 02/20/92 665187 04/10/96
-----------------------------------------------------------------------------------
Xxxxxxxxx X0 37943/95 11/20/95 679649
-----------------------------------------------------------------------------------
Australia D2 80773/98 02/20/92
-----------------------------------------------------------------------------------
Brazil 9205661 02/20/92
-----------------------------------------------------------------------------------
Bulgaria 980621 02/20/92
-----------------------------------------------------------------------------------
Canada 2,104,399 02/20/92
-----------------------------------------------------------------------------------
China 92101981.5 02/20/92
-----------------------------------------------------------------------------------
China D1 95109814.4 02/20/92
-----------------------------------------------------------------------------------
China D2 98108905.4 02/20/92
-----------------------------------------------------------------------------------
Czechoslovakia PV-0497-92 02/20/92
-----------------------------------------------------------------------------------
Europe 92908027.3 02/20/92
-----------------------------------------------------------------------------------
Finland 933684 02/20/92
-----------------------------------------------------------------------------------
Hungary P93-02377 02/20/92
-----------------------------------------------------------------------------------
Hungary P/P00510 06/30/95 211344
-----------------------------------------------------------------------------------
Indonesia P-002339 02/22/92 0001489 04/17/97
-----------------------------------------------------------------------------------
Ireland 920545 02/21/92
-----------------------------------------------------------------------------------
Israel 100965 02/17/92
-----------------------------------------------------------------------------------
Japan 4-507549 02/20/92 2901160 03/19/99
-----------------------------------------------------------------------------------
Japan D1 340469/1997 11/06/97
-----------------------------------------------------------------------------------
Xxxxxxxx XX 0000000 02/21/92
-----------------------------------------------------------------------------------
Mexico 9200747 02/21/92
-----------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 02/17/92 241625 07/09/96
-----------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 02/17/92
-----------------------------------------------------------------------------------
Nigeria RP 48/92 02/21/92 11,263
-----------------------------------------------------------------------------------
Norway P932980 02/20/92
-----------------------------------------------------------------------------------
-------------------------------------------------------------------------------
EMIJ108 Pakistan 79/92 02/25/92 79/92 03/28/94
-------------------------------------------------------------------------------
Philippines 43955 02/20/92
----------------------------------------------------------------
Philippines D1 1-55191 02/20/92
----------------------------------------------------------------
Philippines D2 1-55192 02/20/92
----------------------------------------------------------------
Philippines D3 1-55193 02/20/92
----------------------------------------------------------------
Philippines D4 1-55194 02/20/92
----------------------------------------------------------------
Poland P300471 02/20/92 169842 03/06/96
----------------------------------------------------------------
Xxxxxx 000000 08/01/95 171150 03/29/96
----------------------------------------------------------------
Portugal 100151 02/21/92
----------------------------------------------------------------
Republic of 93-702516 02/20/92 172590 10/24/98
Korea
----------------------------------------------------------------
Romania 93-01137 02/20/92
----------------------------------------------------------------
Russia 93058540.04 02/20/92
----------------------------------------------------------------
South Africa 92/1251 07/20/92 92/1251 10/27/93
----------------------------------------------------------------
Taiwan 81101183 02/18/92
----------------------------------------------------------------
Thailand 015518 02/18/92
----------------------------------------------------------------
APPENDIX A
CASE NO. PB1225
------------------------------------------------------------------------------
Country Application No. Status
------------------------------------------------------------------------------
Australia 1367692 Granted
------------------------------------------------------------------------------
Canada 2105486 Pending
------------------------------------------------------------------------------
Czechoslovakia PV183593 Granted
------------------------------------------------------------------------------
Europe 92906520.9 Pending
------------------------------------------------------------------------------
Hungary P9302493 Pending
------------------------------------------------------------------------------
Ireland 920701 Pending
------------------------------------------------------------------------------
Israel 101144 Granted
------------------------------------------------------------------------------
Japan 50582592 Pending
------------------------------------------------------------------------------
Xxxxxxxx xx Xxxxx 00000000 Pending
------------------------------------------------------------------------------
Xxxxxx 000000 Pending
------------------------------------------------------------------------------
Malaysia PI9200358 Pending
------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 Dead
264621 Granted
------------------------------------------------------------------------------
Philippines 44011 Pending
------------------------------------------------------------------------------
Portugal 100198 Pending
------------------------------------------------------------------------------
Russia 93043875.04 Granted
------------------------------------------------------------------------------
Saudi Arabia 92120445 Pending
------------------------------------------------------------------------------
Xxxxxx Xxxxxxxx XX00000 Granted
------------------------------------------------------------------------------
Thailand 015608 Pending
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Taiwan 81101693 Granted
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Ukraine 94051484 Pending
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United States 09.007502 Pending
------------------------------------------------------------------------------
South Africa 921658 Granted
------------------------------------------------------------------------------
APPENDIX A
LICENSED PATENTS
CASE NO. PB1226
------------------------------------------------------------------------------
Country Application No. Status
------------------------------------------------------------------------------
Australia 1351292 Granted
------------------------------------------------------------------------------
Canada 2105487 Pending
------------------------------------------------------------------------------
Czechoslovakia PV1836.93 Granted
------------------------------------------------------------------------------
Europe 92905707.3 Pending/Allowed
------------------------------------------------------------------------------
Hong Kong 98103372.5 Pending
------------------------------------------------------------------------------
Hungary P9302496 Pending
------------------------------------------------------------------------------
Ireland 920702 Pending
------------------------------------------------------------------------------
Israel 101145 Granted
------------------------------------------------------------------------------
Japan 50556492 Pending
------------------------------------------------------------------------------
Republic of Korea 93702626 Pending
------------------------------------------------------------------------------
Malaysia XX0000000 Granted
------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 Granted
------------------------------------------------------------------------------
Philippines 44010 Granted
------------------------------------------------------------------------------
Portugal 100199 Pending
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Russia 93045710.14 Granted
------------------------------------------------------------------------------
Slovak Republic PV0951.93 Granted
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Taiwan 81101695 Granted
------------------------------------------------------------------------------
Ukraine 94051479 Pending
------------------------------------------------------------------------------
Xxxxxx Xxxxxx 000000 Granted
------------------------------------------------------------------------------
Xxxxxx Xxxxxx 0000000 Pending
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South Africa 921660 Granted
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-1-
CASE NO. PA1344
------------------------------------------------------------------------------
Country Application No. Status
------------------------------------------------------------------------------
Europe 93910190.3 Pending/Allowed
------------------------------------------------------------------------------
Japan 51999693 Pending
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Xxxxxx Xxxxxx 000000 Pending
------------------------------------------------------------------------------
United States 08.825674 Pending
------------------------------------------------------------------------------
CASE NO. PB1614
------------------------------------------------------------------------------
Country Application No. Status
------------------------------------------------------------------------------
Brazil PI9607850.2 Pending
------------------------------------------------------------------------------
China 96193016.0 Pending
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Europe 96911954.4 Pending
------------------------------------------------------------------------------
Hong Kong 98110455.0 Pending
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Hungary P9801576 Pending
------------------------------------------------------------------------------
Japan 528932.96 Pending
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Norway 97.4512 Pending
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Pakistan 172.96 Granted
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Poland P322503 Pending
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United States 08.930224 Pending
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