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EXHIBIT 10.1
Portions of this Exhibit 10.1 have been redacted and are the subject of a
confidential treatment request filed with the Secretary of the Securities and
Exchange Commission.
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NON-EXCLUSIVE CROSS LICENSE AGREEMENT
THIS NONEXCLUSIVE CROSS LICENSE AGREEMENT (the "Agreement") among MERCK
& CO., INC., a New Jersey corporation ("Merck"), Merck and Company,
Incorporated, a Delaware corporation ("MACI") and OSI Pharmaceuticals, Inc. a
Delaware corporation ("OSI"), is effective on the date of signature by the last
of the parties to sign (the "Effective Date").
WHEREAS, Merck and MACI are the owners of certain patents and related
foreign counterparts claiming methods for identifying compounds that modulate
cell surface protein activity via a transcription-based assay; and
WHEREAS, OSI is the owner of certain patents and related foreign
counterparts as described herein claiming methods of discovering compounds which
modulate gene transcription using reporter gene technology and methods of
determining whether chemicals are specific transcriptional modulators of gene
expression; and
WHEREAS, OSI has agreed to grant to Merck (as to the United States) and
to MACI (outside the United States) a non-exclusive license for research
purposes under OSI Patents (as defined below), and Merck and MACI have agreed to
grant to OSI a non-exclusive license for research purposes under Merck Patents
(as defined below), all on the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the mutual covenants and agreements
set forth herein and for other good and valuable consideration the receipt and
sufficiency is hereby acknowledged, the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
1.1. "Affiliates" means (i) any corporation or business entity of which at least
fifty percent (50%) of the securities or other ownership interests
representing the equity, the voting stock or general partnership interests
are owned, controlled or held, directly or indirectly, by Merck, MACI or
OSI; or (ii) any corporation or business entity which directly or
indirectly, owns, controls or holds at least fifty percent (50%) of the
securities or other ownership interests representing the equity, the voting
stock or, if applicable, the general partnership interests, of Merck, MACI
or OSI.
1.2. "Confidential Information" means all information received by a party hereto
from the other party hereto pursuant to this Agreement which is deemed
confidential and is designated confidential at the time the information is
disclosed, subject to the exceptions set forth in Section 4.3.
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1.3. "Cosmeceuticals" means compounds, or assays for discovering compounds,
useful to (a) stimulation or control of hair growth, (b) prevention or
reversal of wrinkling of the skin, and (c) alteration of skin or hair
pigmentation.
1.4. "OSI Patents" means the U.S. patents and parent applications listed on the
attached Exhibit A and any reissues, extensions, substitutions,
re-registrations, re-examinations, continuations, divisionals, or
continuations-in-part of such patents and patent applications, and foreign
equivalents thereof.
1.5. "Merck Patents" means U.S. Patent No. 5,401,629 and any reissues,
extensions, substitutions, re-registrations, re-examinations,
continuations, divisionals or continuations-in-part of such patent and
foreign counterparts of such patent.
1.6. "Research" means research drug discovery and development. "Research" does
not include performance of testing services or other services for, or on
behalf of, a third party.
1.7. "Territory" means all of the countries in the world.
ARTICLE II
GRANT OF RIGHTS
2.1. License Grant to OSI. Upon the terms and conditions set forth herein, (i)
Merck, as to the United States, its territories and possessions, and (ii)
MACI, as to the rest of the world, together granting rights as to the
entire Territory, hereby grant to OSI an irrevocable, non-exclusive,
royalty-free, paid-up license in the Territory to practice under Merck
Patents including without limitation the right to make, have made and use
all inventions claimed in Merck Patents for Research purposes and to
perform all Research activities which activities would, but for the license
granted herein, infringe Merck Patents. OSI may sublicense its rights under
this Section 2.1 to (i) OSI's Affiliates and (ii) OSI's agents and third
party collaborators solely for the purpose and to the extent necessary to
enable such agents and third parties to conduct Research for, or on behalf
of, OSI or its Affiliates.
2.2. License Grant to Merck and MACI. Upon the terms and conditions set forth
herein, OSI hereby grants to Merck (as to the United States, its
territories and possessions) and to MACI (as to the rest of the world), an
irrevocable, non-exclusive, royalty-free, paid-up license in the Territory
to practice under OSI Parents including without limitation the right to
make, have made and use all inventions claimed in OSI Patents for Research
purposes and to perform all Research activities which activities would, but
for the license granted herein, infringe OSI Patents; provided, however,
that prior to April 24, 2002 such license shall not include Research in the
field of Cosmeceuticals. Commencing on April 24,2002 (or on such earlier
date if the field of Cosmeceuticals ceases to the subject of an exclusive
license granted by OSI to a third party) the scope of the license shall
automatically be expanded to include Cosmeceuticals. Merck and MACI may
further sublicense their rights under this Section 2.2 to (i) Merck's
Affiliates and (ii) Merck's agents and third party collaborators solely for
the purpose and to the extent necessary to enable such agents and third
parties to conduct Research for, or on behalf of, Merck or MACI or their
Affiliates.
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2.3. No Implied Licenses. Except as specifically set forth herein, no license or
right is granted, by implication or otherwise, under any patent, patent
application or other intellectual property right owned or controlled by
Merck, MACI or OSI. During the term of this Agreement, and at all times
after its termination or expiration, Merck and MACI shall retain all
rights, without any restriction, to practice under the Merck Patents.
During the term of this Agreement, and at all times after its termination
or expiration, OSI shall retain all rights to practice under the OSI
Patents.
2.4. No Additional Obligations. Neither Merck nor MACI shall have any obligation
to transfer any know-how, materials, technology or information to OSI or to
perform any research, manufacturing or other services under, or in
connection with, this Agreement. OSI shall have no obligation to transfer
any know-how, materials, technology or information to Merck or MACI, or to
perform any research, manufacturing or other services under, or in
connection with, this Agreement.
2.5. Release and Covenant Not to Sue.
(a) If and to the extent that Merck and/or MACI and/or any of their
respective Affiliates have practiced or used in any country of the
world any invention claimed under OSI Patents following issuance of
any patent included within OSI Patents in any such country prior to
the Effective Date of this Agreement, OSI, on behalf of itself and its
Affiliates, hereby releases, waives and discharges all claims, rights,
and causes of action of any nature whatsoever that it or its
Affiliates may have against Merck and any of its Affiliates with
respect to any such infringement or other misuse of the OSI Patents
prior to the Effective Date.
(b) If and to the extent that OSI and/or any of its Affiliates have
practiced or used in any country of the world any invention claimed
under Merck Patents following issuance of any patent included within
Merck Patents in any such country prior to the Effective Date of this
Agreement, Merck. on behalf of itself and its Affiliates, hereby
releases, waives and discharges all claims, rights, and causes of
action of any nature whatsoever that it or its Affiliates may have
against OSI and any of its Affiliates with respect to any such
infringement or other misuse of the Merck Patents prior to the
Effective Date.
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ARTICLE III
PATENTS AND INVENTIONS
3.1. Merck Patents.
(a) Merck and MACI shall be solely responsible for the prosecution and
maintenance of the Merck Patents, and Merck and MACI may cease
prosecution and maintenance of any or all of such Merck Patents at any
time without obligation to OSI. Merck and MACI shall have the sole
right (but not obligation) to bring and control, at their own expense,
any infringement action against any person or entity infringing the
Merck Patents, and any recovery realized as a result of such action
shall belong to Merck and/or MACI.
(b) * *
3.2. OSI Patents. OSI shall be solely responsible for the prosecution and
maintenance of the OSI Patents, and OSI may cease prosecution and
maintenance of any or all of such OSI Patents at any time without
obligation to Merck or MACI. OSI shall have the sole right (but not the
obligation) to bring and control, at its own expense, any infringement
action against any person or entity infringing the OSI Patents, and any
recovery realized as a result of such action shall belong to OSI.
3.3. Inventions. OSI shall own any and all inventions resulting from its
exercise of its rights under Section 2.1 hereof. Merck and/or MACI shall
own any and all inventions resulting from the exercise of their respective
rights under Section 2.2 hereof.
ARTICLE IV
PUBLICATIONS AND PUBLICITY
4.1. Publications. Each party shall be entitled to publish the results of its
Research performed while exercising the rights granted hereunder without
restriction and without obligation to provide a copy of any such
publication to any other party for review and/or approval.
4.2. Publicity. No public announcements or similar publicity with respect to
this Agreement, the existence of or the terms hereof or the transaction
contemplated herein, including the fact that the parties hereto have
entered into this Agreement, shall be made or shall take place unless
mutually agreed upon in writing by the parties; provided, however, that
nothing herein shall prevent a party from, upon reasonable prior notice to
and opportunity to revise by the other parties, making such public
announcements as such party's legal obligations require.
-----------------------
** This portion has been redacted pursuant to a confidential treatment request
4
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4.3. Confidentiality. Except as expressly provided herein, the parties hereto
agree that the receiving party shall keep confidential and shall not
publish or otherwise disclose to any third party and shall not use for any
purpose other than to perform the activities contemplated by this Agreement
any Confidential Information furnished to it by the disclosing party
pursuant to this Agreement, except to the extent that it can be
established by the receiving party by competent proof that such
Confidential Information (a) was already known to the receiving party,
other than under an obligation of confidentiality, at the tune of
disclosure; (b) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving parry;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement; (d) was
lawfully disclosed to the receiving party by a third party, provided that
such third party is not under a confidentiality obligation to the
disclosing party; (e) was independently developed by the receiving party;
(I) is required to be disclosed by a party (i) to any governmental or
other regulatory agency, including, without limitation, the U.S. Food and
Drug Administration, as necessary to file or prosecute patent
applications, or to obtain approval to conduct clinical investigations or
to market products to the extent necessary to obtain such authorization,
or (ii)to its permitted sublicensees in order to practice under the
sublicense granted thereto, provided that such sublicensees agree to be
bound by equivalent confidentiality obligations as are contained in this
Agreement; or (g) is required to be disclosed by either party to comply
with applicable law, governmental regulation or court order, provided that
if a party is required to make any such disclosure of the other party's
Confidential Information, it will give reasonable advance notice to the
latter party of such disclosure and will use reasonable efforts to secure
confidential treatment of such information prior to this disclosure
(whether through protective orders or otherwise).
ARTICLE V
WARRANTIES AND INDEMNIFICATION
5.1. Representations and Warranties. Each of Merck, MACI and OSI hereby
represents and warrants that it has the right, power and authority to enter
into this Agreement and to grant the license rights set forth herein.
Neither Merck nor MACI makes any representation or warranty regarding the
scope, validity or enforceability of Merck Patents. OSI makes no
representation or warranty regarding the scope, validity or enforceability
of OSI Patents. None of Merck, MACI or OSI makes any warranty or
representation that the exercise by the other party of the rights granted
hereunder will not infringe patents or other intellectual property rights
owned by third parties. Neither Merck nor MACI shall have liability to OSI
or to any third party arising from the infringement by OSI of any patent or
other intellectual property right owned by a third party in the course of
OSI's exercise of its rights granted hereunder. OSI shall have no liability
to Merck or to MACI or to any third party arising from the infringement by
Merck of any patent or other intellectual property right owned by a third
party in the course of Merck's and MACI's exercise of their respective
rights granted hereunder.
5.2. Disclaimer. EXCEPT AS SPECIFICALLY SET FORTH HEREIN, NONE OF MERCK, MACI OR
OSI MAKES ANY REPRESENTATION OR WARRANTY EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, OF ANY ASSAY, ANIMAL, PRODUCT OR PROCESS COVERED IN THE
CLAIMS OF MERCK PATENTS OR OSI PATENTS.
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5.3. OSI Indemnity. OSI agrees to indemnify and hold Merck and MACI and their
Affiliates, employees, directors, agents, and consultants harmless from and
against all liability, claims, damages, expenses (including reasonable
attorneys' fees), and losses, including but not limited to death, personal
injury, illness, or property damage arising from the exercise by OSI or its
permitted sublicensees of any rights granted to OSI hereunder, or the
making, use or sale by OSI or its permitted sublicensees of any products or
processes developed through the exercise of the rights panted to OSI
hereunder, except to the extent that such liability, claims, damages,
expenses and losses arise directly from (i) infringement of third party
intellectual property rights by Merck or MACI or (ii) the gross negligence
or willful misconduct of Merck or MACI.
5.4. Merck Indemnity. Merck and MACI agree to indemnify and hold OSI and its
Affiliates, employees, directors, agents, and consultants harmless from and
against all liability, claims, damages, expenses (including reasonable
attorneys' fees), and losses, including but not limited to death, personal
injury, illness, or property damage arising from the exercise by Merck or
MACI or their permitted sublicensees of any rights granted to Merck or MACI
hereunder, or the making, use or sale by Merck or MACI or their permitted
sublicensees of any products or processes developed through the exercise of
the rights granted to Merck and to MACI hereunder, except to the extent
that such liability, claims, damages, expenses and losses arise directly
from (i) infringement of third party intellectual property rights by OSI or
(ii) the gross negligence or willful misconduct of OSI.
ARTICLE VI
TERM, TERMINATION AND SURVIVAL
6.1. Term. The term of this Agreement shall commence on the Effective Date and
shall continue, unless earlier terminated in accordance with the terms of
this Agreement, until the expiration of the last to expire of the Merck
Patents and the OSI Patents.
6.2. Termination by One Party. Each of Merck, MACI and OSI may, at any time,
terminate the rights granted to it hereunder by notice to the other
parties, but any such termination shall not terminate the rights granted to
the other parties hereunder.
6.3. Termination for Breach or Bankruptcy. This Agreement may be terminated by
Merck, MACI or OSI upon sixty (60) days' written notice to the other party
(i) upon or after the breath of any material term of this Agreement by the
other party if such breach has not been cured within the sixty (60) day
period following written notice of termination or (ii) upon the bankruptcy,
insolvency, dissolution or winding up of the other party (other than
dissolution or winding up for the purposes of reconstruction or
amalgamation).
6.4. Rights Upon Termination for Breach. Upon termination of this Agreement by a
party under Section 6.3 due to the reasons set forth in 6.3(i), all rights
granted hereunder to the breaching party shall terminate and the license
granted to the non-breaching party under Article II hereof shall be a
fully-paid up, perpetual license.
6.5. Rights Upon Termination for Bankruptcy. In the event this Agreement is
terminated due to the rejection of this Agreement by a party under Section
365 of the United States Bankruptcy Code (the "Code") all licenses and
rights to licenses granted under or pursuant
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to this Agreement by the rejecting party to the other party are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the
Code, licenses of rights to "intellectual property" as defined under
Section 101 (35A) of the Code. The parties agree that the non-rejecting
party, as licensee of such rights under this Agreement, shall retain and
may fully exercise all of its rights and elections under the Code. The
parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against a party under the Code, the other party
shall be entitled to receive a complete duplicate of (or complete access
to, as appropriate) any such intellectual property and all embodiments of
such intellectual property upon written request therefore by such
non-bankrupt party. Such intellectual property and all embodiments thereof
shall be promptly delivered to the non-bankrupt party (i) upon any such
commencement of a bankruptcy proceeding upon written request therefore by
the non-bankrupt parry, unless the party in bankruptcy elects to continue
to perform all of its obligations under this Agreement or (ii) if not
delivered under (i) above, upon the rejection of this Agreement by or on
behalf of the bankrupt party in the event of written request therefore by
the other party. The foregoing is without prejudice to any rights the
non-bankrupt party may have arising under the Code or other applicable law.
6.6. Survival. Termination or expiration of this Agreement shall not
relieve the parties of any rights or obligations accruing prior to such
termination or expiration. The terms and conditions of Section 2.3, Section
2.4, 2.5, Article III, Article IV, Article V and Section 7.5 shall survive
the expiration or any earlier termination of this Agreement.
ARTICLE VII
GENERAL PROVISIONS
7.1. Force Majeure. No party shall be held liable or responsible to the other
party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of the Agreement when
such failure or delay is caused by or results from causes beyond the
reasonable control of the affected parry including, but not limited to,
fire, floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omission or delays in acting by any
governmental authority or the other party.
7.2. Binding Effect; Assignment. This Agreement shall be binding upon the
parties' respective successors and permitted assigns. This Agreement may
not be assigned or otherwise transferred, nor, except as expressly provided
hereunder, may any right or obligation hereunder be assigned or
transferred, by any of the parties without the consent of the other party;
provided, however, that a party may, without such consent (a) assign the
Agreement and its rights and obligations hereunder to an Affiliate or (b)
assign its rights and obligations under this Agreement to any other party
to whom it sells, transfers or assigns all or substantially all of the
assets related to its Research or business. Any permitted assignee shall
assume all the rights and obligations of its assignor under the Agreement.
7.3. Severability. If any one or more of the provisions contained in this
Agreement is held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless the
absence of the invalidated provision(s) adversely affects the substantive
rights of the parties. The parties shall in such an instance use their best
efforts to replace the invalid,
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illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which, insofar as practical, implement the
purposes of this Agreement.
7.4. Notices. Notices under this Agreement shall be in writing and sufficient if
delivered personally, sent by fax (and promptly confirmed by personal
delivery, registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified
mail, postage prepaid, return receipt requested, addressed as follows:
If to OSI, to:
OSI Pharmaceuticals, Inc.
106 Charles Lindbergh Blvd.
Uniondale, NY 11553
Attn: Chief Executive Officer
Fax: 516-745-6429
With a copy to:
Squadron, Ellenoff, Plesent and Sheinfeld, LLP
551 5th Avenue
New York, NY 10176
Attn: Barbara A. Wood, Esq.
Fax: 212-697-6686
If to Merck, to:
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100
Attention: Office of the Secretary
Fax: 908-735-1246
With a copy to:
Attention: Office of Assistant General Counsel,
Licensing/MRL
Fax: 908-735-1226
If to Merck and Company, Incorporated to:
Merck and Company, Incorporated
The Delaware Trust Bldg., Suite 1269
902 North Market Street
Wilmington, Delaware 19801
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With a copy to:
Merck & Co., Inc. at the address set forth above
or to such other address as the party to whom notice is to be given may
have furnished to the other parties in writing in accordance herewith.
Any such communication shall be deemed to have been given when
delivered if personally delivered or sent by fax on a business day, on
the business day after dispatch if sent by nationally-recognized
overnight courier and on the third business day following the date of
mailing if sent by registered or certified mail.
7.5. Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New Jersey and the patent laws of
the United States without reference to any rules of conflict of laws.
7.6. Entire Agreement. This Agreement contains the entire understanding of the
parties with respect to the Merck Patents and the OSI Patents. All express
or implied agreements and understandings with respect to the Merck Patents
and the OSI Patents, either oral or written, are expressly merged in and
made a part of this Agreement. This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by the parties
hereto.
7.7. Headings. The captions to the several Articles and Sections hereof are not
a part of the Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
7.8. Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original and all of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
MERCK & CO., INC. OSI PHARMACEUTICALS, INC.
BY: /s/ROGER M. PERLMUTTER BY: /s/GEOFFREY COOPER
------------------------- --------------------
Name: Dr. Roger M. Perlmutter Name: Geoffrey Cooper
----------------------- --------------------
Title: Ex. V.P., WW Basic Res. and Title: Vice President, Business
Preclinical Dev. Business Development
Date: 6/8/00 May 17th, 2000
MERCK AND COMPANY, INCORPORATED
BY: /s/JUDY C. LEWENT
----------------------
Name: Judy C. Lewent
--------------------
Title: Vice President - Finance
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EXHIBIT A
OSI LICENSED PATENTS
--------------------------------------------------------------------------------
COUNTRY APPLICATION NO. FILING DATE PATENT NO. ISSUE DATE
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 08/458,691 6/02/95 5,776,502 7/07/98
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--------------------------------------------------------------------------------
US 08/267,834 6/28/94 5,665,543 9/09/97
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 07/832,905 2/07/92 5,580,722 12/3/96
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134C3A 7/18/96 allowed 11/2/99
5,976,793
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134C3B l/06/97 5,863,733 1/26/99
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134C3C 1/06/97
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134HA 8/15/96 5,846,720 12/8/98
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134H2 6/05/95
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US 26134122 3/25/98
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US 26134G1 6/07/94
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 26134G1Z 6/05/95
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
US 2613412Y 6/05/95
--------------------------------------------------------------------------------
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US 26134C3AA 7/28/98
--------------------------------------------------------------------------------
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EPO 90911558.6 7/18/90
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Japan 02-511061 7/18/90 4506902
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Canada 2,063,822-2 7/18/90
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S. Korea 700119/1992 7/18/90 allowed
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Australia 660405 7/18/90 660405 10/16/95
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Australia 61400 7/18/90 61400
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