1
Portions of this Exhibit 10.3 have been redacted and are the subject of
a confidential treatment request filed with the Secretary of the Securities and
Exchange Commission.
2
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This RESEARCH COLLABORATION AND LICENSE AGREEMENT, dated as of
April 1st 1998, is entered by and between FUJIREBIO, INC., a company duly
organized and existing under the laws of Japan with its principal place of
business at 2-62-5, Nihonbashi, Hamacho, Chuo-ku, Tokyo 103, Japan ("FRI"), and
ONCOGENE SCIENCE DIAGNOSTICS, INC., a company duly organized and existing under
the laws of Delaware with its principal place of business at 80 Rogers Street,
Cambridge, Massachusetts 02142 ("OSD") and OSI PHARMACEUTICALS INC., a company
duly organized and existing under the laws of Delaware with its principal place
of business at 106 Charles Lindbergh Boulevard, Uniondale, NY 11553-3649
("OSIP", together with OSD, collectively "OSI".)
WHEREAS, OSI was organized to develop, produce and market
diagnostic products for, among other things, the early detection, monitoring and
treatment of human disease, particularly cancer;
WHEREAS, OSD is a wholly owned subsidiary (and a former
division) of OSIP engaged principally in the development of novel cancer
diagnostic assays;
WHEREAS, FRI has the capability to develop, format,
manufacture, attain regulatory approvals for, market and distribute diagnostic
products and instrumentation systems in Japan;
WHEREAS, FRI desires to commercialize certain of OSI's
proprietary cancer assays for use in connection with the Clinical Diagnostic
Product (as defined herein) for sales and marketing in Japan;
WHEREAS, FRI wishes to provide funding in support of OSI's
research and further development of certain proprietary cancer assays; and
WHEREAS, OSI and FRI understand that, pursuant to OSI's
research and development agreement with Bayer Corporation ("Bayer"), OSI shall
collaborate with Bayer in the research and further development of such
proprietary cancer assays.
NOW, THEREFORE, in consideration of the premises and promises
contained herein, the parties agree as follows:
1. Definitions
Whenever used in this Agreement, the terms defined in this Section 1
shall have the meanings specified.
1.1. "Affiliates" of a party means any corporation, partnership or
other entity directly or indirectly owned by, owning, or under
common ownership with such party of
3
at least fifty percent (50%) of its stock and having the power
to vote for the election of directors, such corporation,
partnership or other entity to be deemed an Affiliate only so
long as such ownership of voting stock continues.
1.2. "Clinical Diagnostic Product" means any version, successor or
application of FRI's Lumipulse system now in existence or
hereafter devised, which is sold to medical centers, reference
laboratories, cancer centers, clinicians, pathologists,
oncologists and others that typically utilize diagnostic kits
and automated systems to provide clinical information to
assist in the diagnosis, prognosis, monitoring or screening of
cancer or potential cancer patients.
1.3. "FRI Technology" means all Technology that was:
(a) developed by employees of, or consultants to, FRI
alone or jointly with Third Persons on or prior to
the Effective Date.
(b) acquired by purchase, license, assignment or other
means from Third Persons by FRI on or prior to the
Effective Date.
FRI Technology shall be owned by FRI.
1.4. "Licensed Product" means any Clinical Diagnostic Product that
incorporates the Proprietary Assays and/or that employs OSI
Technology in its manufacture, use or sale.
1.5. "Net Sales" means the gross amount received by FRI for arm's
lengths sales to a Third Person of Licensed Products,
respectively, after deducting, where applicable the following:
(a) normal and customary trade discounts actually allowed
and taken;
(b) returns and credits;
(c) taxes (the legal incidence of which is on the
purchaser and separately shown on the shipping
invoice); and,
(d) transportation, insurance and postage charges (if
prepaid and invoiced as a separate item).
1.6. "OSI Patent Rights" means all Patent Rights comprised in OSI
Technology. OSI Patent Rights shall be owned by OSI subject to
the rights granted to FRI under this Agreement and shall
include the ones attached hereto as Exhibit C.
1.7. "OSI Product" means ELISA kits for certain cancer markers
developed and manufactured by OSI and listed in Exhibit B.
-2-
4
1.8. "OSI Technology" means all Technology relating to the
Proprietary Assays used in connection with the development of
a Clinical Diagnostic Product that was:
(a) developed by employees of, or consultants to, OSI
alone or jointly with third persons (including Bayer)
on or prior to the Effective Date, which OSI
determines in its discretion to contribute to the
research program as outlined in the OSI/FRI Annual
Operating Plan; or
(b) acquired by purchase, license, assignment or other
means from third persons (including Bayer) by OSI on
or prior to the Effective Date, which OSI determines
in its discretion to contribute to the research
program; or,
(c) developed by employees of, or consultants to, OSI
alone or jointly with third persons (including Bayer)
on or after the Effective Date pursuant to, or in
connection with, the OSI/FRI Annual Operating Plan
OSI Technology shall be owned by OSI subject to the
rights granted to FRI under this Agreement.
1.9. "OSI/FRI Annual Operating Plan" means the written plan
describing the research to be carried out on the Proprietary
Assays for each Research Year excluding FRI's activity on the
development of Licensed Products.
1.10. "Patent Rights" means all patentable inventions, including all
applications for patents, whether domestic or foreign,
disclosing or claiming such inventions, all continuations,
continuations-in-part, divisions, renewals and patents of
addition thereof, all patents granted thereon, whether
domestic or foreign, and all reissued or reexamined patents
based thereon.
1.11. "Proprietary Assays" mean the nine (9) proprietary cancer
assays owned by OSI set forth in Exhibit A and
attached hereto.
1.12. "Research Year" means each twelve (12) month period outlined
in Exhibit A attached hereto.
1.13. "Technology" means Patent Rights and all know-how, trade
secrets and confidential technical information and material,
including, without limitation, all laboratory notebooks,
research plans, inventions, genes and gene fragments and other
sequences, cell lines, hybridomas, monoclonal and polyclonal
antibodies, proteins and protein fragments, assay methodology,
processes, materials and methods for production, formulae,
plans, specifications, characteristics, marketing surveys and
plans and business plans.
-3-
5
1.14. "Third Person" means a person other than OSI or FRI, or other
than any employee of, or consultant to OSI or FRI.
1.15. "Materials" mean antibodies, antigens, and other substances
relating to Proprietary Assays, which are in use of FRI for
the development and manufacturing of Licensed Products.
2. Licenses.
2.1. License granted to FRI. During the term of this Agreement and
subject to the terms and conditions herein appearing, OSI
hereby grants to FRI a non-exclusive right and license under
the OSI Patents Rights and the OSI Technology to develop,
manufacture, and sell Licensed Products in Japan. FRI shall
use its best efforts to commercialize the Proprietary Assays
set forth in the OSI/FRI Annual Operating Plan and should FRI
fail to commercialize any such Proprietary Assay within the
five (5) years immediately following the effective date of the
OSI/FRI Annual Operating Plan in which such Proprietary Assay
appears, FRI shall forfeit to OSI all rights in and to such
Proprietary Assay licensed in this Section;
2.2. Up-front Payment. In consideration of the right granted
pursuant to Section 2.1 above, FRI shall pay to OSI a
non-refundable sum of ** on a date not later than fifteen (15)
days prior to June 15 in each applicable Research Year,
provided that the first such payment shall be paid on or
before May 30, 1998.
2.3. Royalties. FRI shall pay to OSI a royalty of ** percent ** of
Net Sales of any Licensed Product hereunder from the first
sale of a Licensed Product until the event with the later to
occur of (i) the date ten (10) years after the date of such
first sale or (ii) the expiration of the last to expire of any
OSI Patent Rights underlying any Licensed Product sold by FRI
hereunder.
2.4. Payment Dates. Within sixty (60) days following the close of
each calendar quarter (or any part in the first or last
calendar quarter) of this Agreement, FRI shall deliver to OSI
a true and accurate report, stating for each Licensed Product,
for said calendar quarter (a) Net Sales, (b) the royalties
payable thereon, and (c) the amount of any credit taken
against royalties payable pursuant hereto. Except as otherwise
provided, simultaneously with the delivery of each report, FRI
shall pay to OSI the amount, if any, due for the period of
such report.
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-4-
6
2.5. Accounting. All amounts payable hereunder shall be payable in
US Dollars (to OSD or OSIP as designated by notice to FRI);
provided, however, that if any payment of Net sales by FRI or
its Affiliates is received in Japanese yen, such amount shall
be converted into US dollars at the bank selling rate for
Japanese yen into US dollars on the last day of quarterly
reporting period (as outlined in Section 2.4), quoted by
authorized foreign exchange bank in Tokyo.
2.6. Records. During term of this Agreement, FRI shall keep
complete and accurate records of Net Sales in sufficient
detail to enable OSI to determine payments owed to it under
this Agreement for a period of three (3) years after such
payments are due. FRI shall permit an independent certified
public account, acceptable to FRI (a list of independent
public accountants selected by OSI and acceptable to FRI is
attached as Exhibit E hereto) and appointed by OSI and at
OSI's expense, to examine its books, ledgers and records
covering Net Sales during regular business hours for the
purpose of verifying, and only to the extent necessary to
verify, the amount of royalties due and payable but in no
event more than once per calendar year. The accountant shall
maintain all information received during such examination in
confidence, and shall report to OSI only with respect to the
accuracy of any report. Any report not examined within three
(3) years of its having been made shall be deemed true and
accurate. In the event the records examined reveal that FRI
has paid less than ninety-five percent (95%) of the amount due
to OSI, FRI shall pay the costs of the audit and shall pay the
additional amount due plus accrued interest at the rate of ten
percent (10%) per annum.
2.7. Tax. In the event that withholding taxes or other similar
taxes be levied by any taxing authority in connection with
accrual or payment to OSI pursuant to this Article 2, FRI
shall pay such taxes to the local authorities on behalf of
OSI, and the payment to OSI of the net amount due after
reduction by the amount of such taxes shall fully satisfy OSI'
obligations under this Agreement.
2.8. Option. OSI hereby agrees to negotiate with FRI or its
Affiliates in respect of a non-exclusive right to market and
commercialize OSI Products in Japan without additional upfront
payments. The term for the marketing agreement shall be
negotiated and agreed separately between parties.
2.9. Patentable Technology. In the event that FRI develops any
patentable Technology based upon OSI Technology for the
Proprietary Assays in connection with development of Licensed
Products, OSI agrees that FRI has the right to apply for
patents in any countries with its own name and at its expense.
FRI and OSI further agrees that FRI license a world-wide
non-exclusive right for such patents to OSI (with sublicensing
right) with the condition of royalty from OSI
-5-
7
and its sublicensees to FRI, at a pre-agree royalty rate equal
to ** of net sales or in the event that OSI sublicensees such
rights, the lesser of ** and ** of the royalty rate received
by OSI from its sublicensee.
2.10. Supply of Materials.
(a) For research and development efforts as well as for
FRI's commercialization of Proprietary Assays, OSI
shall supply the Materials to FRI at OSI's
manufacturing cost (including overhead cost directly
related to manufacturing, which overhead cost shall
include general and administrative charges
customarily and consistently applied by OSIP to OSD's
manufacturing) plus ** mark-up thereon.
(b) OSI and FRI hereby agree to negotiate and execute in
good faith a mutually satisfactory supply agreement
of Materials for FRI's manufacturing of Licensed
Product based on the above condition. OSI shall
represents and warrants to FRI that all of Materials
delivered pursuant to this Agreement or supply
agreement, shall confirm to the specifications to be
agreed in the supply agreement between OSI and FRI in
accordance with applicable regulatory requirements.
(c) OSI shall use its commercially reasonable efforts to
supply for the Materials to FRI during the term of
this Agreement in accordance with the terms of the
supply agreement to be negotiated by the parties.
(d) OSI agrees to defend, protect, indemnify, and hold
harmless FRI from and against any liability, claim,
loss, cost or expense arising from any claim for
product liability based on OSI's quality of the
Materials to be used in the Licensed Product except
to the extent such liability, claim, loss or expense
also results from the negligence or willful
misconduct of FRI, its employees and agents.
3. Collaborative Research
3.1. Research Projects. FRI and OSI hereby agree, subject to the
terms and conditions of this Agreement, to undertake four (4)
collaborative research projects stated in Exhibit A attached
hereto in respect of the Proprietary Assays for four Research
Years as set forth in four (4) OSI/FRI Annual Operating Plans.
OSI shall provide technical information related to the
Proprietary Assays in accordance with agreed upon objectives
set forth in an OSI/FRI Annual Operating Plan.
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-6-
8
3.2. Research Funding. FRI shall pay to OSI a sum of** (** as last
payment) as the research funding fee on a date not later than
fifteen (15) days prior to June 15 in each applicable Research
Year, provided that the first such payment shall be paid on or
before May 30, 1998.
3.3. Termination of Research Projects by FRI. FRI may terminate
further collaborative research pursuant to the terms hereof
only (i) upon not less than twelve (12) months advance written
notice provided to OSI on or prior to the first day (June 15)
of any applicable Research Year (provided, however, that FRI
shall have no such termination right in respect of research to
be conducted in the second Research Year), and (ii) upon
payment of all sums due pursuant to Section 2.2 and 3.2 hereof
in respect of the upcoming Research Year (for example, FRI
must (i) provide notice on or before June 15, 1999 and (ii)
pay the ** , when due, in respect of the Second Research Year
(1999-2000) in order to terminate research to be conducted in
the Third Research Year(2000-2001)). In the event that FRI
terminate further collaborative research pursuant hereto, the
license to commercialize the Proprietary Assays granted to
FRI hereunder shall be limited to those assays listed in
Exhibit A attached hereto under Research Years in respect of
which FRI provided both an up-front fee and research funding
under Sections 2.2 and 3.2 hereof. Upon termination of further
collaborative research in accordance with the terms of further
collaborative research in accordance with the terms of this
Section 3.3, FRI shall not be required to make additional or
further payments to OSI pursuant to Sections 2.2 and 3.2
hereof.
3.4. CSI/FRI Annual Operating Plan. The OSI/FRI Annual Operating
Plan for the initial Research Year is set forth in Exhibit D
attached hereto. For each year after the initial Research
Year, the CSI/FRI Annual Operating Plan shall be prepared by
the Research Committee no later than ninety (90) days before
the end of the prior Research Year and approved by FRI and OSI
no later than thirty (30) days before the end of the prior
Research Year. The OSI/FRI Annual Operating Plan for each
Research Year shall be appended to and made part of this
Agreement.
3.5. Research Committee.
3.5.1. Purpose. The Research Committee shall:
(a) Prepare the OSI/FRI Annual Operating Plan for each
year;
(b) Review, evaluate progress under and modify the
OSI/FRI Annual Operating Plan for each year;
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-7-
9
(c) With respect to each Licensed Product prior to
commercialization, whether (a) license(s) need(s) to
be obtained from a third person(s) in order to make,
use or sell such Licensed Product; and,
(d) Determine priority of the Proprietary Assays to be
commercialized by FRI.
3.5.2. Membership. FRI and OSI each shall appoint, in its
sole discretion, two (2) members to the Research
Committee. Substitutes may be appointed at any time
upon written notice .
The members initially shall be:
Appointees:
For FRI: For OSI:
** **
3.5.3. Chairman. The Research Committee shall be chaired by
** . Should the Chairman of the Research Committee
need to be changed for any reason, OSI shall
recommend a person with a comparable knowledge and
experience in the cancer diagnostic field as the
predecessor and shall obtain consent from FRI within
30 days before the change is planned to be
implemented, which such acceptance shall not be
unreasonably withheld.
3.5.4. Meetings. The Research Committee shall meet at least
one time per calendar year at mutually agreeable
dates and places. Representatives of FRI may visit
OSI on an as needed basis to obtain technical help
with its commercialization of Proprietary Assays.
3.5.5. Minutes. The Research Committee shall keep accurate
minutes which record all proposed decisions and all
actions recommended or taken. The minutes shall be
delivered to all Research Committee members within
ten (10) business days after each meeting. OSI shall
be responsible for the preparation of the minutes.
3.5.6. Expenses. FRI and OSI shall each bear all expenses of
their respective members related to the participation
of the Research Committee.
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-8-
10
3.6. Reports.
OSI shall submit to FRI a report indicating the final results
for each of the research projects within thirty (30) days
after the end of each Research Year describing in detail the
work accomplished by it under the OSI/FRI Annual Operating
Plan. OSI further shall submit to FRI summary reports within
thirty (30) days after the end of each four-month period,
commencing with the period ending 15th of October, 1998,
describing its progress under the OSI/FRI Annual Operating
Plan.
3.7. Laboratory Facilities and Personnel. OSI shall provide
suitable laboratory facilities, equipment and personnel for
the work to be done in carrying out the OSI/FRI Annual
Operating Plan.
3.8. Diligent Efforts. FRI and OSI each shall use reasonably
diligent efforts to achieve the objectives of the OSI/FRI
Annual Operating Plan. Specifically, OSI and FRI shall use
diligent efforts to allocate those resources necessary (i.e.,
manpower, facilities, equipment) to meet the objectives of the
OSI/FRI Annual Operating Plan. FRI shall use its best efforts
to commercialize the Proprietary Assays.
3.9. Extension. OSI (in advance of the expiration of the last
Research Year hereunder) agrees to negotiate in good faith
with FRI, on a non-exclusive basis and subject to the prior
commitments of OSI, to extend the collaborative research
program, upon mutually agreeable terms and conditions, upon
nine (9) months' prior written notice from FRI to OSI of FRI's
intent to negotiate therefore. The foregoing commitment to
negotiate shall terminate sixty (60) days after the date on
which FRI provides to CSI of its intent to negotiate pursuant
to this Section 3.9.
3.10. For avoidance of doubt, OSI and FRI acknowledge and agree that
any result, data and technical knowledge resulting from the
collaborative research projects shall be included in OSI
Technology. If OSI applies for the patent under certain
technical knowledge resulting from the research projects in
any countries with its own name and at its own expense, OSI
agrees to add such patents or patent applications to OSI
Patent Rights in this Agreement upon the Research Committee's
conclusion .
3.11. Further Collaboration. During the period of Research Years,
OSI may disclose to FRI, subject to OSI's obligations to Third
Parson (including, but not limited to, confidentiality
obligations), information concerning technical progress made
by OSI in connection with new assay development. If, upon such
disclosure by OSI, FRI wishes to enter into a similar research
collaboration and license agreement in respect of such now
assays, OSI may propose to FRI the terms of such an agreement.
-9-
11
4. Treatment of Confidential Matter.
4.1. Confidentiality.
During the term of this Agreement and for a period of five
years following the termination of this Agreement, each party
shall continue to keep all information disclosed to the other
pursuant hereto strictly confidential and neither party shall
disclose such information to any third party (including Bayer)
nor use such information for any purposes other than the
purpose specified herein. The confidentiality obligations of
this Agreement shall not apply to:
(a) information and materials which at the time of
disclosure are in the public domain; or
(b) information which after disclosure becomes part of
public domain by publication or otherwise, except by
breach of this Agreement; or
(c) information which the receiving party can demonstrate
it independently developed prior to the disclosure;
or
(d) information disclosed to the receiving party by a
third party who has the right to make such
disclosure.
4.2. Restrictions on Transferring Materials. FRI and OSI recognize
that the biological, chemical and biochemical materials which
are part of the OSI Technology and FRI Technology represent
valuable commercial assets. Accordingly, nothing containing
herein shall be construed to permit either party to transfer
to any third person (including Bayer) any such material which
constitutes Technology owned by the other party. Additionally,
subject to FRI's rights as set forth herein, throughout the
term hereof and thereafter, FRI agrees not to transfer to any
third person any biological, chemical or biochemical materials
which are part of OSI Technology and which comprise, consist
of or are useful in the manufacture of any Licensed Product or
OSI Product, unless prior consent for any such transfer is
obtained from OSI.
4.3. Notwithstanding Sections 4.1 and 4.2 above, OSI may disclose
the Technology not related to the Clinical Diagnostic Product
and /or a Licensed Product, (which do not include the FRI
Technology), to Bayer based on OSI's agreement with Bayer.
5. Patent Infringement and Hold Harmless.
5.1. Actual or Threatened Infringement by Third Persons. If
information comes to the attention of FRI or OSI to the effect
that any OSI Patent Rights relating to a Licensed Product have
been or are threatened or infringed, OSI shall have
-10-
12
the right, at its expense, to take such action as it may deem
necessary to prosecute or prevent such infringement, including
the right to bring or defend any suit, action or proceeding
involving any such infringement. FRI or OSI shall notify the
other promptly of the receipt of any such information and OSI
shall notify FRI promptly of its commencement of any such
suit, action or proceeding. If OSI determines, and FRI agrees
that it is necessary or desirable for FRI to join any such
suit, action or proceeding, FRI shall execute all papers and
perform such other acts as may be reasonably required to
permit OSI to act in FRI's name, In the event that OSI brings
a suit, it shall be entitled to all sums recovered in such
suit or in its settlement. FRI always have the right to be
represented by counsel of its own selection and at its own
expense in any suit instituted by OSI for infringement, under
the terms of this Section. If OSI lacks standing to bring any
such suit, action or proceeding, then FRI shall have a right
to do so at the request of OSI and, with respect to expenses
approved in advance by OSI, at OSI's expense.
5.2. Infringement Claims Against the Parties. OSI hereby warrants
that the use of OSI Patent Rights or OSI Technology in the
manufacture, use or sale of a Licensed Product by FRI in Japan
will not constitute any infringement of any patent owned by
any third party. If FRI or OSI is sued by a Third Party for
infringement of a patent based upon the research, development,
manufacture, sale or use of a Licensed Product, the party sued
shall notify the other promptly of the commencement of any
such suit.
(a) If the alleged infringement is due to the use of OSI
Technology or OSI Patent Rights, FRI shall give OSI
all authority (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), information and
assistance necessary to defend or settle any such
suit, action or proceeding OSI shall bear all of the
expenses incurred in connection with such suit,
action or proceeding, and OSI shall indemnify and
hold FRI harmless from and against all liabilities,
losses, expenses (including reasonable legal
expenses) and damages arising from such patent
infringement.
(b) If the alleged infringement is due to the use of FRI
Technology, OSI shall give FRI all authority
(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), information and assistance necessary to
defend or settle any such suit, action or proceeding,
FRI shall bear all of the expenses incurred in
connection with such suit, action or proceeding, and
FRI shall indemnify and hold OSI harmless from and
against liabilities, losses, expenses (including
reasonable legal expenses) and damages arising from
such patent infringement.
-11-
13
5.3. Hold Harmless for Product Liability. FRI agrees to defend,
protect, indemnify, and hold harmless OSI from and against any
liability, claim, loss, cost or expense arising from any claim
for product liability based upon FRI's manufacture, use, or
sale of any Licensed Product except to the extent such
liability, claim, loss or expense also results from the
negligence or willful misconduct of OSI, its employees and
agents.
6. Term and Termination.
6.1. Term. Subject to Section 6.4 hereof, this Agreement shall come
into force on the date first above written and shall, unless
sooner terminated pursuant to any provision of this Agreement,
be in full force until the expiration date of the last
to-expire OSI Patent Rights in Japan or for a period of ten
(10) years counting from the date of the first commercial sale
by FRI of a Licensed Product, whichever is longer.
6.2. Event(s) of Termination. The following events shall constitute
Events of Termination under this agreement.
(a) Any representation or warranty by FRI or OSI, or any
of their officers, under or in connection with this
Agreement shall prove to have been incorrect in any
material respect when made; or
(b) FRI or OSI shall fail in any material respect to
perform or observe any term, covenant or
understanding contained in this Agreement (including
OSI's inability to perform the collaborative research
in accordance with the terms of the Agreement due to
the departure of Walter P. Carney, Ph.D. from OSI) or
in any of the other documents or instruments
delivered pursuant to, or concurrently with, this
Agreement, and any such failure shall remain
unremediated for thirty (30) days after FRI's or
OSI's written notice to the other thereof.
(c) Either party hereto shall have become insolvent or
bankrupt, or shall have made an assignment for the
benefit of its creditors, or that there shall have
been an appointed trustee or receiver of the other
party hereto for all or a substantial part of its
property, or that any case or proceeding shall have
been commenced or other action taken by or against
the other party in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up,
arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, or that
there shall have been issued a warrant of attachment,
execution, distraint or similar process against any
substantial part of the property of the other party
hereto, and
-12-
14
any such event shall have continued for sixty (60)
days undismissed, unbounded and undischarged.
6.3. Termination. Upon the occurrence of any of such Events of
Termination as specified in (a) through (c) of Section 6.2
hereof, FRI or OSI shall have the right, by written notice to
the other, to immediately terminate this Agreement. Upon any
such termination, OSI shall not be obligated to return to FRI
any amounts then previously paid to OSI hereunder. Upon any
such termination, the licenses granted to FRI hereunder shall
remain in effect only in respect of those Proprietary Assays
for which FRI has provided Research Funding pursuant to
Section 3.2 and only to the extent that FRI meets its
obligations to pay royalties in respect thereof throughout the
period specified in Section 6.1.
6.4. Survival. Without limitation, the rights and obligations
arising from the following provisions shall survive any
expiration or termination of this Agreement: Articles 1, 2,4,
5, 6, 7 and 9-12.
7. Representations and Warranties. OSI and FRI each represent and warrant
as follows:
7.1. It is a corporation duly organized, validly existing and in
good standing (if applicable) under the laws of the
jurisdiction of its incorporation. It is qualified to do
business and is in good standing (if applicable) as a foreign
corporation in each jurisdiction in which the conduct of its
business or the ownership of its properties requires such
qualification. It has all requisite power and authority,
corporate or otherwise, to conduct its business as now being
conducted, to own, lease and operate its properties and to
execute, deliver and perform this Agreement.
7.2. The execution, delivery and performance by it of this
Agreement has been fully authorized by all necessary corporate
action and does not and will not (a) require the consent or
approval of its stockholders, (b) violate any provision of any
law, rule, regulation, order, write, judgment, injunction,
decree, determination or award presently in effect having
applicability to it or any provision of its charter or by-laws
or (c) result in a breach of or constitute a default under any
material agreement, mortgage, lease, license, permit or other
instrument or obligation to which it is a party or by which it
or its properties may be bound or affected.
7.3. This Agreement is a legal, valid and binding obligation of it
enforceable against it in accordance with its terms and
conditions, except as such enforceability may be limited by
applicable bankruptcy, insolvency, moratorium, reorganization
or similar laws, from time to time in effect, affecting
creditors' rights generally.
7.4. It is not under any obligation to any person, contractual or
otherwise, that is conflicting or inconsistent in any respect
with the terms of this Agreement or that would impede the
diligent and complete fulfillment of its obligations
hereunder.
-13-
15
OSI further represents and warrants to FRI that OSI's
relationship with Bayer does not prohibit OSI's diligent and
complete fulfillment of its obligations hereunder.
7.5. It has good and marketable title to or valid leases or
licenses for, all of its properties, rights and assets
necessary for the fulfillment of its responsibilities under
this Agreement, subject to no claim of any third person other
than the relevant lessors or licensers.
8. Covenants of OSI and FRI. Throughout the term of the Agreement, each of
OSI and FRI shall:
(a) Maintain and preserve its corporate existence,
rights, franchises and privileges in the jurisdiction
of its incorporation, and qualify and remain
qualified as a foreign corporation in good standing
(if applicable) in each jurisdiction in which such
qualification is from time to time necessary or
desirable in view of its business and operations or
the ownership of its properties; and
(b) Comply in all material respects with the requirements
of all applicable laws, rules, regulations and orders
of any government authority to the extent necessary
to conduct the OSI/FRI Annual Operating Plan.
9. Dispute Resolution. Any disputes, controversies, or difficulties which
may arise out of or in relation to this Agreement shall be settled
amicably between the parties. In the event the parties fail to do so,
such dispute, controversy or difficulty shall be finally settled by
arbitration at the place of the defendant's principal place of business
(as set forth herein) by the International Chamber of Commerce ("ICC")
pursuant to the arbitration rules of the ICC and by arbitrators of be
appointed according to said rules. The award in the said arbitration
shall be final and binding, and may include the reasonable legal fees
of the prevailing party.
10. Notices. All notices shall be mailed via certified mail, return receipt
requested, or courier, addressed as follows, or to such other address
as may be designated from time to time:
For FRI: To FRI at its address as set forth at
the beginning of this Agreement,
Attention: CEO of Fujirebio Inc. (Koichiro FUJITA, M.D.)
with a copy to: Manager of Legal Department, Fujirebio Inc.
For OSI: To OSD and OSIP at its address as set forth at
the beginning of this Agreement,
Attention(OSD): Walter P. Carney, Ph.D., President
Attention(OSIP): Robert L. Van Nostrand, CFO
-14-
16
Notices shall be deemed given as of the date of receipt.
11. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, without regard to
its conflicts of laws principles.
12. Miscellaneous.
12.1. Binding Effect. This Agreement shall be binding upon and inure
to the benefit of the parties and their respective legal
representatives, successors and permitted assigns.
12.2. Headings. Paragraph headings are inserted for convenience of
reference only and do not form part of this Agreement.
12.3. Counterparts. This Agreement may be executed simultaneously in
two or more counterparts, each of which shall be deemed an
original.
12.4. Amendment, Waiver, etc. This Agreement may be amended,
modified, superseded or canceled, and any of the terms may be
waived, only by a written instrument executed by each party
or, in the case of waiver, by the party or parties waving
compliance. The delay or failure of any party at any time or
times to require performance of any provision shall in no
manner affect the rights at a later time to enforce the same.
12.5. No Third Party Beneficiaries. No Person not a party to this
Agreement, including any employee of any party to this
Agreement, shall have or acquire any right s by reason of this
Agreement. Neither party shall enter in to or incur, or hold
itself out to third parties as having authority to enter into
or incur on behalf of the other party, any contractual
obligation, expense, or liability whatsoever. The performance
of each party hereunder is undertaken as an independent
contractor, and nothing contained in this Agreement shall be
deemed to constitute the parties partners with each other or
any Person.
12.6. Assignment and Successors. This Agreement may not be assigned
by either party, except that either party may assign this
Agreement and the rights and interests of such party to an
Affiliate, or a purchaser of substantially all of the assets
of such party's business to which this Agreement pertains,
upon notice to the other party.
12.7. Severability. If performance of this Agreement or any part
hereof by either party shall be rendered unenforceable or
impossible under, or in conflict with any law, regulation, or
official action by any government agency having jurisdiction
over such party, then such party shall not be considered in
default by reason of failure to perform and the validity of
all remaining provisions hereof shall not be affected by such
result.
-15-
17
12.8. Unforeseen Circumstances. Neither party shall be liable in
damages for, nor shall the Contract Period be terminated by
reason of, any delay or default in any such party's
performance hereunder if such default or delay is caused by
events beyond such party's reasonable control including,
without limitations, acts of God, regulation or law or other
action of any government or agency thereof, war or
insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm,
labor disturbances, epidemic, or failure of suppliers, public
utilities or common carriers. Each party agrees to endeavor to
resume its performance hereunder if such performance is
delayed or interrupted by reason of such forces majeure as
listed above.
12.9. Integration. This writing constitutes the entire agreement
between the parties relating to the subject matter hereof.
There are no understandings, representations, or warranties of
any kind except as expressly set forth herein.
-16-
18
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
FUJIREBIO INC.
By: /s/ Koichiro FUJITA, M.D.
--------------------------------
Koichiro FUJITA, M.D.
Title: President and CEO
ONCOGENE SCIENCE DIAGNOSTICS, INC.
By: /s/ Walter P. Carney, Ph.D.
--------------------------------
Walter P. Carney, Ph.D.
Title: President
OSI PHARMACEUTICALS, INC.
By: /s/ Robert L. Van Nostrand
--------------------------------
Robert L. Van Nostrand
Title: CFO
-17-
19
Exhibit A: Proprietary Assays and Collaborative Research Projects
Research Year(Period) Proprietary Assays Projects
1st Year: 15 JUN 1998 - 14 JUN 1999 ** (i)
2nd Year: 15 JUN 1999 - 14 JUN 2000 ** (ii)
3rd Year: 15 JUN 2000 - 14 JUN 2001 ** (iii)
4th Year: 15 JUN 2001 - 14 JUN 2002 ** (iv)
(Collaborative Research Projects)
(i) **
(ii) **
(iii) **
(iv) **
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-18-
20
Exhibit B: OSI Products(ELISA format)
OSD Product #
** **
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-19-
21
Exhibit C: OSI Patent Lists
**
1 **
2. **
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-20-
22
Exhibit D: OSI/FRI Annual Operating Plan
**
- ------------------
** This portion has been redacted pursuant to a request for confidential
treatment.
-21-
23
Exhibit-E. A list of independent public accountants
1. KPMG Peat Marwick (in Japan)
Address:
Tel No.:
Fax No:
FRI will confirm to OSI that the above one is acceptable or not by the
launch of Licensed Products, which such acceptance shall not be
unreasonably withheld.
-22-