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EXHIBIT 10.1
Portions of 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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LICENSE AGREEMENT
AGREEMENT made this 3rd day of January, 2000 (the "Effective Date") by
and between OSI Pharmaceuticals, Inc. ("OSI"), a Delaware corporation with
principal offices at 106 Charles Lindbergh Boulevard, Uniondale, New York
11553-3649, American Home Products Corporation ("AHPC"), a Delaware corporation
with principal offices at Five Giralda Farms, Madison, New Jersey 07940, and
American Cyanamid Company ("ACC"), a Maine corporation and wholly-owned
subsidiary of AHPC with principal offices at One Campus Drive, Parsippany, New
Jersey 07054.
W I T N E S S E T H:
WHEREAS, OSI is the owner of certain gene transcription patents and is
willing to grant a license under such patents to AHPC and its Affiliates,
including ACC; and
WHEREAS, AHPC and its Affiliates, including ACC, are the owners of
certain patents relating to yeast screening assays and AHPC and its Affiliates,
including ACC, are willing to grant a license under such patents to OSI; and
WHEREAS, OSI and AHPC desire to cross license their respective
patents, according to the terms contained herein.
NOW, THEREFORE, in consideration of the covenants and premises
contained herein, the Parties agree as follows:
1. DEFINITIONS
1.1 "Affiliate" means any corporation, company, partnership, joint
venture and/or firm which controls, is controlled by or is under
common control with a Party. For purposes of this Section 1.1,
"control" means (a) in the case of corporate entities, direct or
indirect ownership of at least 50% of the stock or shares entitled
to vote for the election of directors; and (b) in the case of
non-corporate entities, direct or indirect ownership of at least
50% of the equity interest with the power to direct the management
and policies of such non-corporate entities.
1.2 "AHPC Field of Use" means (a) the research and development of
products for human therapeutic purposes, other than the discovery
or development of Cosmeceuticals, and (b) the research and
development of products for agricultural purposes. Following April
23, 2002, the discovery or development of Cosmeceuticals shall be
included in the "AHPC Field of Use".
1.3 "AHPC Licensed Compound" means any compounds or other molecules,
and any compounds or other molecules derived therefrom, the
identification, development, manufacture, use, importation or sale
of which in a specific
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country would, in the absence of this Agreement, infringe an
issued or granted claim in an AHPC Licensed Patent.
1.4 "AHPC Licensed Patents" means the U.S. patents and patent
applications listed on Exhibit A hereto, any patent applications
filed prior or subsequent to the Effective Date that claim the
benefit of the filing date of any patent application listed on
Exhibit A and any reissues, extensions, substitutions,
confirmations, re-registrations, re-examinations, continuations,
divisionals or continuations-in-part of the foregoing patents and
patent applications, as well as all foreign counterparts thereof.
1.5 "AHPC Licensed Product" means any product for sale by OSI or its
Affiliates to a Third Party in the OSI Field of Use which contains
an AHPC Licensed Compound.
1.6 "Confidential Information" means all information received by a
Party from another Party pursuant to this Agreement, which is
deemed confidential by the disclosing Party and is designated
confidential at the time the information is disclosed, subject to
the exceptions set forth in Section 6.
1.7 "Cosmeceuticals" means compounds, or assays for discovering
compounds, useful for (a) stimulation or control of hair growth,
(b) prevention or reversal of wrinkling of the skin, and (c)
alteration of skin or hair pigmentation.
1.8 "Licensed Patent" means an AHPC Licensed Patent or an OSI Licensed
Patent.
1.9 "Licensed Product" means an AHPC Licensed Product or an OSI
Licensed Product.
1.10 "OSI Field of Use" means the internal research and development by
OSI and its Third Party collaborators, without the right to
sublicense, of products for human therapeutic purposes.
1.11 "OSI Licensed Compound" means any compounds or other molecules,
and any compounds or other molecules derived therefrom, the
identification, development, manufacture, use, importation or sale
of which in a specific country would, in the absence of this
Agreement, infringe an issued or granted claim in an OSI Licensed
Patent.
1.12 "OSI Licensed Patents" means the U.S. patents and patent
applications listed on Exhibit B hereto, any patent applications
filed prior or subsequent to the Effective Date that claim the
benefit of the filing date of any patent application listed on
Exhibit B and any reissues, extensions, substitutions,
confirmations, re-registrations, re-examinations, continuations,
divisionals or continuations-in-part of the foregoing patents and
patent applications, as well as all foreign counterparts thereof.
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1.13 "OSI Licensed Product" means any product for sale by AHPC or its
Affiliates to a Third Party in the AHPC Field of Use which
contains an OSI Licensed Compound.
1.14 "Party" means any of AHPC, ACC or OSI and "Parties" means AHPC,
ACC and OSI, collectively.
1.15 "Person" means any individual, corporation, limited liability
company, cooperative, partnership, trust, unincorporated
association or any other entity which possesses a juridical
personality, including any governmental authorities or body of
competent jurisdiction; pronouns, when referring to a Person,
shall have a similar extended meaning.
1.16 "Third Party" means any entity other than AHPC or its Affiliates,
including ACC, or OSI or its Affiliates.
2. LICENSE GRANT
2.1 By OSI.
2.1.1 OSI hereby grants to AHPC and its Affiliates, including
ACC, for the AHPC Field of Use, a nonexclusive,
nontransferable (other than as permitted by Section 8.1),
worldwide, ** license under the OSI Licensed Patents to
make, have made, use, sell, offer for sale, import, export,
or otherwise exploit OSI Licensed Products.
2.1.2 OSI agrees that commencing April 24, 2002 (or on such
earlier date if the field of Cosmeceuticals ceases to be
the subject of an exclusive license grant by OSI to the
Third Party as of the Effective Date), the scope of the
nonexclusive license under Section 2.1 shall be expanded to
include Cosmeceuticals.
2.2 By AHPC. Each of AHPC and ACC hereby grants to OSI and its
Affiliates, for the OSI Field of Use, a nonexclusive,
nontransferable, world-wide, ** license under the AHPC License
Patents owned by it to make, have made, use, sell, offer for sale,
import, export or otherwise exploit AHPC Licensed Products,
provided that the foregoing license shall not include the right
for OSI to sell any compositions or methodologies used in the
discovery or development of such AHPC Licensed Products, such as
screens, to a Third Party or otherwise provide Third Parties
(other than OSI's collaborators) with access to same.
3. PATENT RIGHTS AND INFRINGEMENT
3.1 OSI shall have complete control, at its expense and within its
sole discretion, over the prosecution, maintenance and enforcement
of the OSI Licensed Patents.
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** This portion has been redacted pursuant to a request for confidential
treatment.
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When information comes to the attention of AHPC or its Affiliates,
including ACC, that an OSI Licensed Patent has been or is
threatened to be infringed by a Third Party, AHPC shall promptly
bring such infringement or threatened infringement to the
attention of OSI. OSI shall have the right (but not the
obligation), in its sole discretion, at its own risk and expense,
and using counsel of its choice, to take such action as it may
deem necessary to prosecute or prevent such infringement.
3.2 AHPC shall have complete control, at its expense and within its
sole discretion, over the prosecution, maintenance and enforcement
of the AHPC Licensed Patents. When information comes to the
attention of OSI that an AHPC Licensed Patent has been or is
threatened to be infringed by a Third Party, OSI shall promptly
bring such infringement or threatened infringement to the
attention of AHPC. AHPC shall have the right (but not the
obligation), in its sole discretion, at its own risk and expense,
and using counsel of its choice, to take such action as it may
deem necessary to prosecute or prevent such infringement.
3.3 If AHPC or any of its customers shall be sued by a Third Party for
infringement of a patent because of the research, development,
manufacture, use or sale of OSI Licensed Products, AHPC shall
promptly notify OSI in writing of the institution of such suit.
OSI shall have all authority over such suit (including the right
to exclusive control of the defense of any such suit, action, or
proceeding and the exclusive right to compromise, litigate,
settle, or otherwise dispose of any such suit, action, or
proceeding). AHPC and its Affiliates shall provide information and
assistance necessary to defend or settle any such suit, action or
proceeding at OSI's expense. If OSI does not elect to manage the
defense against such infringement action or fails to take
appropriate and diligent action with respect to such defense, then
AHPC shall have the right to assume such defense, at its own cost
and expense.
3.4 If OSI or any of its customers shall be sued by a Third Party for
infringement of a patent because of the research, development,
manufacture, use or sale of AHPC Licensed Products, OSI shall
promptly notify AHPC in writing of the institution of such suit.
AHPC shall have all authority over such suit (including the right
to exclusive control of the defense of any such suit, action, or
proceeding and the exclusive right to compromise, litigate,
settle, or otherwise dispose of any such suit, action, or
proceeding). OSI shall provide information and assistance
necessary to defend or settle any such suit, action or proceeding
at AHPC's expense. If AHPC does not elect to manage the defense
against such infringement action or fails to take appropriate and
diligent action with respect to such defense, then OSI shall have
the right to assume such defense, at its own cost and expense.
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4. REPRESENTATIONS AND WARRANTIES
4.1 Representations and Warranties of AHPC, ACC and OSI. As of the
Effective Date, each Party hereby represents and warrants that:
4.1.1 Corporate Power. Such Party is duly organized and validly
existing and in good standing under the laws of the state
of its incorporation and has all requisite corporate power
and authority to enter into this Agreement and to carry out
the provisions hereof.
4.1.2 Due Authorization. Such Party is duly authorized to execute
and deliver this Agreement and to perform its obligations
hereunder.
4.1.3 Binding Agreement. This Agreement is a legal and valid
obligation binding upon it and enforceable in accordance
with its terms. The execution, delivery and performance of
this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor
violate any law or regulation of any court, governmental
body or administrative or other agency having jurisdiction
over it.
4.1.4 Patents. Such Party acknowledges and agrees that nothing in
this Agreement shall be construed as a warranty or
representation that any Licensed Product is, or will be,
free from infringement of patents of Third Parties.
4.1.5 Right to License. Such Party owns all right, title and
interest in and to the Licensed Patents licensed by it
hereunder.
4.1.6 Patents. There are no pending or, to its knowledge,
threatened suits, claims, or proceedings including
interferences or opposition proceedings relating to the
Licensed Patents licensed by it hereunder, other than
normal patent prosecution proceedings.
5. INDEMNITY
5.1 AHPC shall indemnify and hold harmless OSI, its Affiliates
and all directors, officers, employees and agents of OSI
and its Affiliates from and against any and all claims,
demands, actions, liabilities, judgments, costs and
expenses of whatever kind, whether based on contract,
negligence, strict liability or statutory liability,
including, without limitation, attorneys' fees and costs of
defense, arising out of or related in any way to the
clinical testing or use, production, sale, offer to sell,
import, export or other exploitation of OSI Licensed
Products by AHPC or its Affiliates under this Agreement,
other than such as arise out of or are related to OSI's
gross negligence or intentional misconduct.
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5.2 OSI shall indemnify and hold harmless AHPC, its Affiliates
and all directors, officers, employees and agents of AHPC
and its Affiliates from and against any and all claims,
demands, actions, liabilities, judgments, costs and
expenses of whatever kind, whether based on contract,
negligence, strict liability or statutory liability,
including, without limitation, attorneys' fees and costs of
defense, arising out of or related in any way to the
clinical testing or use, production, sale, offer to sell,
import, export or other exploitation of AHPC Licensed
Products by OSI or its Affiliates under this Agreement,
other than such as arise out of or are related to AHPC's
gross negligence or intentional misconduct.
5.3 Each of AHPC and OSI shall indemnify and hold the other and
the other's Affiliates harmless with respect to any injury,
loss or cost resulting from the breach of any
representation or warranty provided pursuant to Section 4
hereof.
6. CONFIDENTIALITY
6.1 Confidential Information. Except as expressly provided
herein, the Parties agree that the receiving Party shall
keep completely confidential and shall not publish or
otherwise disclose to another Party and shall not use for
any purpose other than to perform the purposes contemplated
by this Agreement any Confidential Information furnished to
it by the disclosing Party hereto 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 time 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 Party; (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 person other
than a Party hereto; or (e) was independently developed by
the receiving Party.
6.2 Permitted Use and Disclosures. Each Party hereto may use or
disclose Confidential Information disclosed to it by
another Parry to the extent such use or disclosure is
reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation,
complying with applicable law, governmental regulation or
court order, submitting information to tax or other
governmental authorities, or otherwise exercising its
rights hereunder, provided that if a Party is required to
make any such disclosure of another Party's Confidential
Information, it will give reasonable advance notice to the
latter Party of such disclosure and, save to the extent
inappropriate in the case of patent applications, will use
reasonable efforts to secure confidential treatment of such
information prior to its disclosure (whether through
protective orders or otherwise).
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6.3 Confidential Terms. Except as expressly provided herein,
each Party agrees not to disclose any terms of this
Agreement to a Third Party without the consent of the other
Parties; provided, however, that each Party reserves the
right to make reasonable disclosures as required by
securities or other applicable laws, or to actual or
prospective investors or corporate partners, or to
accountants, attorneys and other professional advisors on a
need-to-know basis under circumstances that reasonably
ensure the confidentiality thereof, or to the extent
required by law. If such Confidential Information is to
become public information by such disclosure the disclosing
Party must obtain the written consent of the non-disclosing
Parties in order to obtain protection of the Confidential
Information if necessary.
6.4 Press Release. Notwithstanding the foregoing, the Parties
shall agree upon a press release to announce the execution
of this Agreement. Thereafter, OSI, AHPC and ACC may each
disclose to Third Parties the information contained in such
press release without the need for further approval by the
other.
7. TERM AND TERMINATION
7.1 This Agreement is effective as of the Effective Date and
shall continue in full force and effect, with respect to a
Party, on a country by country basis until the last
expiration date of all patents encompassed within the
Licensed Patents licensed to such Party hereunder.
7.2 If a Party shall fail in any material respect to perform or
observe any term, covenant or understanding contained in
this Agreement or in any of the other documents or
instruments delivered pursuant to, or concurrently with,
this Agreement, and any such failure shall remain
unremedied for 90 days after written notice to the
defaulting Party, the Party not responsible may, by notice
to the defaulting Party, terminate the license granted by
such Party to the defaulting Party.
7.3 OSI shall have the right to terminate the Agreement if
either AHPC or ACC makes an assignment for the benefit of
its creditors, becomes insolvent, files a petition in
bankruptcy, petitions or applies to any tribunal for the
appointment of a custodian, receiver or any trustee for it
or a substantial part of its assets, or commences any
proceeding under any bankruptcy, reorganization,
arrangement, readjustment of debt, dissolution or
liquidation law or statute of any jurisdiction, whether now
or hereafter in effect; or if there has been filed any such
petition or application against either AHPC or ACC, or any
such proceeding has been commenced against it, in which an
order for relief is entered or which remains
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undismissed for a period of 60 days or more; or if either
AHPC or ACC, by any act or omission, indicates its consent
to, approval of or acquiescence in, any such petition,
application or proceeding or order for relief or the
appointment of a custodian, receiver or any trustee for it
or any substantial part of any of its properties, or is the
subject of any such custodianship, receivership or
trusteeship that continues undischarged for a period of 60
days or more.
7.4 AHPC and ACC shall have the right to terminate the
Agreement if OSI makes an assignment for the benefit of its
creditors, becomes insolvent, files a petition in
bankruptcy, petitions or applies to any tribunal for the
appointment of a custodian, receiver or any trustee for it
or a substantial part of its assets, or commences any
proceeding under any bankruptcy, reorganization,
arrangement, readjustment of debt, dissolution or
liquidation law or statute of any jurisdiction, whether now
or hereafter in effect; or if there has been filed any such
petition or application against OSI, or any such proceeding
has been commenced against it, in which an order for relief
is entered or which remains undismissed for a period of 60
days or more; or if OSI, by any act or omission, indicates
its consent to, approval of or acquiescence in, any such
petition, application or proceeding or order for relief or
the appointment of a custodian, receiver or any trustee for
it or any substantial part of any of its properties, or is
the subject of any such custodianship, receivership or
trusteeship that continues undischarged for a period of 60
days or more.
8. MISCELLANEOUS
8.1 Binding Effect; Assignment. This Agreement shall be binding
upon the Parties' respective successors and permitted
assigns. Neither Party may assign this Agreement or any of
its rights or obligations hereunder without the prior
written consent of the other Party (not to be unreasonably
withheld) except that either Party may assign this
Agreement as part of a merger or consolidation in which the
surviving entity assumes all of the Party's rights and
obligations hereunder or a sale of substantially all of the
assets of such Party to which this Agreement relates. In
addition, if AHPC sells to a Third Party all of the stock
of ACC or if ACC sells all or substantially all of its
assets to a Third Party, AHPC or ACC, as the case may be,
may assign the license granted by OSI in Section 2.1 to
such Third Party purchaser, without the consent of OSI,
only to the extent that such license is for the research
and development of products for agricultural purposes
(i.e., subsection (b) of Section 1.1), provided that such
Third Party purchaser assumes the obligations of AHPC or
ACC, as the case
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may be, to grant the license set forth in Section 2.2. In
the event of such a sale, the license granted in Section
2.1 to AHPC shall remain in effect as to AHPC and its
Affiliates only with respect to the research and
development of products for human therapeutic purposes
(i.e., subsection (a) of Section 1.1).
8.2 Effect of Waiver. No waiver of any default, condition,
provisions or breach of this Agreement shall be deemed to
imply or constitute a waiver of any other default,
condition, provision or breach of this Agreement.
8.3 Force Majeure. No Party shall lose any rights hereunder or
be liable to the other Parties for damages or losses
(except for payment obligations) on account of failure of
performance by the defaulting Party if the failure is
occasioned by war, strike, fire, acts of God, earthquake,
flood, lockout, embargo, governmental acts or orders or
restrictions, failure of suppliers, or any other reason
where failure to perform is beyond the reasonable control
and not caused by the negligence or intentional conduct or
misconduct of the nonperforming Party, and such Party has
exerted all reasonable efforts to avoid or remedy such
force majeure; provided, however, that in no event shall a
Party be required to settle any labor dispute or
disturbance.
8.4 Amendment. No modification, supplement to or waiver of this
Agreement or any of the provisions hereof or any Exhibit
hereto shall be binding upon a Party hereto unless made in
writing and duly signed by an authorized representative of
OSI, AHPC or ACC.
8.5 Entire Agreement. This Agreement, including the Exhibits
attached hereto, sets forth the entire understanding and
agreement of the Parties as to the subject matter hereof,
and there are no other understandings, representations or
promises, written or verbal, not set forth herein on which
a Party has relied.
8.6 Notices. All notices under this Agreement shall be given in
writing and shall be addressed to the Parties at the
following addresses:
For OSI: OSI Pharmaceuticals, Inc.
106 Charles Lindbergh Blvd.
Uniondale, NY 11553
Attn: Chief Executive Officer
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For AHPC: American Home Products
c/o Wyeth-Ayerst Research
87 Cambridge Park Drive
Cambridge, MA 02140
Attn: Vice President, Law
For ACC: American Cyanamid Corporation
One Campus Drive
Parsippany, NJ 07054
Attn: Director, Technology Assessment and
Acquisition
Notices shall be in writing and shall be deemed delivered
when received, if delivered by hand, courier or overnight
delivery service, or on the second business day following
mailing, if sent by first-class certified or registered
mail, postage prepaid, and return receipt requested.
8.7 Governing Law; Jurisdiction. This Agreement shall be
governed by and construed in accordance with the laws of
the State of New York, applicable to agreements made in New
York except that the federal laws of the United States
shall apply to questions regarding the validity or
infringement or enforceability of United States federal
patents. The parties hereto agree that the state and
federal courts sitting in the state and city of New York
shall be the proper forums for any legal controversy
arising in connection with this Agreement and the parties
irrevocably and unconditionally consent to the
non-exclusive jurisdiction of such courts for such
purposes.
8.8 Severability. This Agreement is intended to be severable.
If any provision of this Agreement is or becomes invalid,
is ruled illegal by a court of competent jurisdiction or is
deemed unenforceable under the current applicable law from
time to time in effect during the term hereof, it is the
intention of the Parties that the remainder of this
Agreement shall not be affected thereby and shall continue
to be construed to the maximum extent permitted by law at
such time. It is further the intention of the Parties that
in lieu of each such provision which is invalid, illegal,
or unenforceable, there shall be substituted or added as
part of this Agreement by such court of competent
jurisdiction a provision which shall be as similar as
possible in terms of the economic and business objectives
intended by the Parties, to such invalid, illegal or
unenforceable provision, but shall be valid, legal and
enforceable.
8.9 Independent Contractors. The Parties hereto are acting as
independent contractors and shall not be considered
partners, joint venturers or agents of the other. Except as
expressly provided herein, no Party shall have the right to
act on behalf of, or to bind, the other.
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8.10 Headings; Counterparts. Captions and paragraph headings are
for convenience only and shall not form an interpretative
part of this Agreement. This Agreement may be executed in
two or more counterparts, each of which will be deemed an
original.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first above written.
OSI PHARMACEUTICALS, INC.
By: /s/ Colin Goddard
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Name: Colin Goddard, Ph.D.
Title: President and Chief Executive
Officer
AMERICAN HOME PRODUCTS CORPORATION
By: /s/ Gerald A. Jibilian
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Name: Gerald A. Jibilian
Title: Vice President and Associate
General Counsel
AMERICAN CYANAMID COMPANY
By: /s/ Gerald A. Jibilian
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Name: Gerald A. Jibilian
Title: Vice President and Associate
General Counsel
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EXHIBIT A
**
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** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT B
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
US 08/267,834 6/28/94 5,665,543 9/09/97
**
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** This portion has been redacted pursuant to a request for confidential
treatment.