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.
2
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND LICENSE AGREEMENT is entered by and between
BAYER CORPORATION, an Indiana corporation acting through its Business Group
Diagnostics, having an office at 000 Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxx 00000
("Bayer"), and ONCOGENE SCIENCE, INC., a Delaware corporation, having an office
at 000 Xxxxxxx Xxxxxxxxx Xxxx., Xxxxxxxxx, Xxx Xxxx 00000 ("OSI").
WHEREAS, OSI was organized to develop, produce and market research,
diagnostic and therapeutic products for, among other things, the early
detection, monitoring and treatment of human disease, particularly cancer;
WHEREAS, Bayer has the capability to develop, format, manufacture, attain
regulatory approvals for, market and distribute diagnostic products and
instrumentation systems throughout the world; and
WHEREAS, Bayer desires to commercialize proprietary cancer assays in the
Clinical Diagnostic Market (as defined herein) and OSI desires to establish
proprietary cancer assays for the Clinical Research Market (as defined herein);
and
WHEREAS, Bayer and OSI wish to collaborate in research to identify and
develop proprietary cancer diagnostic assays.
NOW, THEREFORE, in consideration of the premises and promises contained
herein, the parties agree as follows:
3
1. Definitions
Whenever used in this Agreement, the terms defined in this Section 1 shall
have the meanings specified.
1.1 "Affiliate" means any corporation or other legal entity controlled by,
controlling, or under common control with the affected party, wherein control
means direct or indirect ownership of a least forty percent (40%) of the voting
stock, or at least forty percent (40%) interest in the income, of such
corporation or other business entity or in either case the maximum amount
allowed by local law.
1.2 "Allocated Costs" means the amount of costs, determined in accordance
with generally accepted accounting principles, incurred by OSI and allocated to
the Research Program.
1.3 "Annual Commitment" means the maximum amount agreed upon by the Joint
Management Committee to fund the OSI/Bayer Annual Operating Plan and Budget for
any Commitment Year.
1.4 "Bayer" means Bayer Corporation and its Affiliates.
1.5 "Bayer Confidential Matter" means all information, material or other
matter encompassed within Bayer Technology which is disclosed or provided by
Bayer to OSI, orally or in writing, and is designated by Bayer, in writing,
"Confidential", or words to the same effect, no later than thirty (30) days
after the time of first disclosure or provision to OSI, but excluding any such
information, material or matter that is (i) already known to OSI at the time of
disclosure or provision to it, other than by virtue of a prior confidential
disclosure or provision to OSI by Bayer, (ii) at any time disclosed in the
published literature or
- 2 -
4
otherwise generally known or available to the public, or (iii) at any time
obtained from a Third Person free from any obligation of secrecy.
1.6 "Bayer Patent Rights" shall mean all Patent Rights comprised in Bayer
Technology. Bayer Patent Rights shall be owned by Bayer subject to the rights
granted to OSI under this Agreement.
1.7 "Bayer Technology" means all Technology that was:
(a) developed by employees of, or consultants to, Bayer alone or
jointly with Third Persons on or prior to the Effective Date which Bayer
determines in its sole discretion to contribute to the Research Program; or
(b) acquired by purchase, license, assignment or other means from
Third Persons by Bayer on or prior to the Effective Date which Bayer
determines in its sole discretion to contribute to the Research Program.
Bayer Technology shall be owned by Bayer subject to the rights granted
to OSI under this Agreement.
1.8 "Bayer/OSI Patent Rights" means all Patent Rights comprised in
Bayer/OSI Technology.
1.9 "Bayer/OSI Technology" means Technology that is:
(a) developed by employees of, or consultants to, OSI alone or jointly
with Bayer during the term hereof in the Field; or
(b) acquired by purchase, license, assignment or other means from
Third Persons by OSI, Bayer or both Bayer and OSI
- 3 -
5
after the Effective Date in the Field in accordance with Paragraph 2.1.1(a)
hereof.
Bayer/OSI Technology shall be owned by Bayer subject to the rights
granted to OSI under this Agreement.
1.10 "Clinical Diagnostic Market" means those medical centers,
laboratories, cancer centers, clinicians, pathologists, oncologists and others
that typically utilize regulatory approved diagnostic kits and systems to
provide clinical information to assist in the diagnosis, prognosis, monitoring
or screening of cancer or potential cancer patients.
1.11 "Clinical Diagnostic Product" means test kits or systems, other than
manual or semi-automated microtiter plate-based test kits and systems, which are
developed pursuant hereto for use in the Field, it being understood that such
product format is typically targeted for the Clinical Diagnostic Market;
provided, however, that such products shall exclude any products that are
subject to any exclusive rights held by any of the Other Companies pursuant to
agreements with OSI in effect prior to the Effective Date.
1.12 "Clinical Research Market" means those medical centers, laboratories,
cancer centers, clinical researchers, pathologists, oncologists and others that
typically utilize test kits and systems which do not require approval by the
United States Food and Drug Administration (the "FDA") to establish clinical
utility and correlation and that often publish the results in academic or
research journals, but shall specifically exclude any utilization of research
products in life science research typically performed
- 4 -
6
with non-human specimens that is the subject of the sublicense granted by OSI to
Calbiochem-Novabiochem Corporation under the Sublicense Agreement dated as of
August 2, 1995.
1.13 "Clinical Research Product" means manual or semi-automated microtiter
plate-based test kits or systems which are developed pursuant hereto for use in
the Field, it being understood that such product format is typically targeted
for the Clinical Research Market; provided, however, that such products shall
exclude any products that are subject to any exclusive rights held by any of the
Other Companies pursuant to agreements with OSI prior to the Effective Date.
1.14 "Commitment Year" means a twelve-month period commencing each January
1.
1.15 "Contract Period" means the period beginning on the Effective Date and
ending on the date on which this Agreement terminates.
1.16 "Effective Date" shall mean January 1, 1997.
1.17 "Event(s) of Termination" has the meaning set forth in Section 10.3.
1.18 "Field" means methods and reagents, test compositions, test devices
and other products useful in the diagnosis of cancer. To the extent that a
method or product is first discovered to be useful in the diagnosis of cancer
and subsequently is discovered to be useful in the diagnosis of one or more
other conditions, all such uses of such method or product shall be included in
"Field"; whereas to the extent that a method or product is first discovered to
be useful in the diagnosis of at least one condition other than
- 5 -
7
cancer and subsequently is discovered to be useful in the diagnosis of cancer,
only such use in cancer diagnosis shall be included in "Field".
1.19 "Fully absorbed costs" means all direct expenses of OSI, as well as
OSI's proportional allocation of overhead consistent with OSI's usual practice.
1.20 "Joint Management Committee" has the meaning specified in Section 2.2.
1.21 "Licensed Diagnostic Product" means a Clinical Diagnostic Product that
employs Bayer, OSI and/or Bayer/OSI Technology in its manufacture, use or sale.
1.22 "Licensed Research Product" means a Clinical Research Product that
employs Bayer, OSI and/or Bayer/OSI Technology in its manufacture, use or sale.
1.23 "Licensed Product" means a Clinical Diagnostic Product or a Clinical
Research Product, as the case may be.
1.24 "Net Sales" means the gross amount received by Bayer (and its
sublicensee) or OSI (and its permitted sublicensees, if any), as the case may be
for arm's length 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
- 6 -
8
(d) transportation, insurance and postage charges (if prepaid and
invoiced as a separate item).
In the event that a Licensed Product sold by Bayer can be identified
as having been sold (a) at a price which is increased to include an amount
or amounts to cover instrument systems, service, interest and/or other
costs, such as under a Reagent Agreement or Reagent Rental Plan (herein
referred to as "RAP"), (b) as part of an arrangement in which the customer
pays a comprehensive monthly or other periodic charge for a fixed total
volume of assays from a product list that may include both Licensed
Products as well as assays which are not Licensed Products, and the
customer then selects the quantity of each different assay to be delivered,
such as under a Cost Management Plan (herein referred to as "CMP"), or (c)
some other reagent plan, the Net Sales of such reagent Licensed Product
sold under a RAP, CMP or other reagent plan ("Reagent Plans") shall be
calculated by (i) multiplying the total number of reagent Licensed Product
units sold under Reagent Plans by the fraction E/F where E is the total net
revenue invoiced for sales of Licensed Product when sold (i.e., independent
of a Reagent Plan) in the United States and F is the total number of units
of Licensed Product sold (i.e., independent of a Reagent Plan) in the
United States, and (ii) then multiplying the result of (i) by the
adjustment factor 0.55, which is estimated (subject to audit) by Bayer to
reflect the portion of net revenue invoiced that is attributable to the
sale of such reagent Licensed Product. Such adjustment factor shall be
recalculated by Bayer in accordance with generally
- 7 -
9
accepted accounting principles at the close of each calendar year after the
first commercial sale of the first Licensed Product to be sold, and a
retroactive correction made to the royalties paid during such prior
calendar year, with settlement of any overpayment or underpayment of
royalties being made in the payment for the first quarter royalties for the
new calendar year and with the new adjustment factor being applied to
royalties to be paid on sales during the new calendar year. Bayer hereby
represents and warrants that the adjustment factor set forth herein is
equal to the adjustment factor used by Bayer in those of its agreements
with Third Persons which contain the foregoing formula. In the event that
Bayer changes the adjustment factor in any of those agreements or provides
for a different adjustment factor in agreements it enters into with Third
Persons during the Term hereof, resulting in either case in the adjustment
factor being more favorable to any such Third Person than the adjustment
factor set forth herein, then this Agreement shall be deemed to be amended
to provide for the more favorable adjustment factor.
1.25 "OSI" means Oncogene Science, Inc. and its Affiliates.
1.26 "OSI Confidential Matter" means all information, material or other
matter encompassed within OSI Technology which is disclosed or provided by OSI
to Bayer, orally or in writing, and is designated by OSI, in writing,
"Confidential", or words to the same effect, no later than thirty (30) days
after the time of first disclosure or provision to Bayer, but excluding any such
information, material or matter that is (i) already known to Bayer at the time
of disclosure or provision to it, other than by virtue
- 8 -
10
of prior confidential disclosure or provision to Bayer by OSI, (ii) at any time
disclosed in the published literature or otherwise generally known or available
to the public, or (iii) at any time obtained from a Third Person free from any
obligation of secrecy.
1.27 "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 Bayer under this Agreement. The OSI Patent Rights existing on the
Effective Date are listed on Exhibit C, attached hereto.
1.28 "OSI Technology" means all Technology relating to the Field that was:
(a) developed by employees of, or consultants to, OSI alone or jointly
with Third Persons on or prior to the Effective Date, but specifically
excludes any Technology that is subject to any exclusive rights held by any
of the Other Companies pursuant to agreements with OSI in effect prior to
the Effective Date; or
(b) acquired by purchase, license, assignment or other means from
Third Persons by OSI on or prior to the Effective Date, but specifically
excludes any Technology transferred, assigned or sold to any of the Other
Companies with respect to which OSI does not retain a co-exclusive license
as set forth in Exhibit A attached hereto.
OSI Technology shall be owned by OSI subject to the rights granted to
Bayer under this Agreement.
- 9 -
11
1.29 "OSI/Bayer Annual Operating Plan and Budget" means the written plan
describing the research, projects, contemplated products, clinical trials,
timetables, technical goals, manufacturing, regulatory approvals and marketing
to be carried out during each Commitment Year by Bayer and OSI.
1.30 "Other Companies" shall mean each of Becton, Xxxxxxxxx and Company and
Calbiochem-Novabiochem International, Inc. The essential terms and conditions of
the agreements between OSI and the respective Other Companies affecting the
rights of Bayer in OSI Technology are set forth in Exhibit A attached hereto and
forming a part hereof.
1.31 "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.
1.32 "Person" means any individual, estate, trust, partnership, joint
venture, association, firm, corporation, company or other entity.
1.33 "Product" means any Clinical Diagnostic Product, Licensed Diagnostic
Product, Clinical Research Product or Licensed Research Product.
1.34 "Research Program" means the research conducted pursuant to the terms
and conditions of this Agreement.
- 10 -
12
1.35 "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, cultures, strains,
vectors, 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, recovery and
purification of natural products, formulae, plans, specifications,
characteristics, marketing surveys and plans and business plans.
1.36 "Third Person" means a Person other than OSI or Bayer, or other than
any employee of, or consultant to, OSI or Bayer.
1.37 "Valid Claim" means a claim in an active, unexpired patent within
Patent Rights, so long as such claim shall not have been disclaimed or held
invalid in a final decision rendered by a tribunal of competent jurisdiction
from which no appeal has been or can be taken.
2. Collaborative Research Program
2.1 OSI/Bayer Annual Operating Plan and Budget. The OSI/Bayer Annual
Operating Plan and Budget for the initial Commitment Year is set forth in
Exhibit B and attached hereto. For each Commitment Year after the initial
Commitment Year, the OSI/Bayer Annual Operating Plan and Budget shall be
prepared by the Joint Management Committee no later than ninety (90) days before
the end of the prior Commitment Year. The OSI/Bayer Annual Operating Plan and
Budget for each Commitment Year shall be appended to and made part of this
Agreement.
- 11 -
13
2.1.1 Exclusivity as to Research Activities.
(a) OSI agrees that, during the Contract Period, OSI shall not conduct
research itself, sponsor any research with a Third Person, engage in any
research sponsored by any Third Person, or acquire (by license, purchase or
otherwise) Technology from a Third Person, in the Field. If OSI becomes
aware, during the Contract Period, of an opportunity to conduct or sponsor
research relating to the Field or to engage in such research sponsored by a
Third Person in the Field, it shall promptly notify the Joint Management
Committee of such opportunity. The Joint Management Committee then shall
determine whether the opportunity is worth pursuing. If it is determined
that the opportunity is worth pursuing, Bayer and OSI shall negotiate, in
good faith, for a period not to exceed one hundred eighty (180) days, an
agreement by which such opportunity can be incorporated into this Agreement
or otherwise used to their mutual advantage. If the Joint Management
Committee cannot agree concerning the incorporation of such opportunity as
part of this Agreement, OSI shall be free to pursue such opportunity with
such Third Person without further obligation to Bayer, provided that the
opportunity shall not detract from or delay the work to be performed by OSI
under the OSI/Bayer Annual Operating Plan and Budget or make use of Bayer
or Bayer/OSI Technology.
(b) Bayer agrees that during the Contract Period, Bayer shall not
conduct research itself, sponsor any research with a Third Person, engage
in any research sponsored by any Third Person, or acquire (by license,
purchase or otherwise) Technology
- 12 -
14
from a Third Person in the Field if the objectives of such research are in
conflict with the Research Program. In all other respects, Bayer shall be free
to conduct research itself, sponsor any research with a Third Person, engage in
any research sponsored by any Third Person or acquire (by license, purchase or
otherwise) Technology from a Third Person, in the Field.
2.2 Joint Management Committee.
2.2.1 Purpose. The Joint Management Committee shall:
(a) prepare the OSI/Bayer Annual Operating Plan and Budget (including
the Annual Commitment) for each Commitment Year;
(b) review, evaluate progress under and modify the OSI/Bayer Annual
Operating Plan and Budget for each Commitment Year;
(c) coordinate and monitor publications of research results obtained
from, and the exchange of information and materials that relate to,
Bayer/OSI Technology;
(d) discuss matters relating to the activities set forth in Section 7
hereof;
(e) with respect to each Licensed Diagnostic Product or Licensed
Research Product prior to commercialization, discuss whether a license(s)
need be obtained from a Third Person(s) in order to make, use or sell such
Licensed Diagnostic Product or Licensed Product;
(f) determine priority of assays for the Clinical Diagnostic Market to
be commercialized by Bayer;
(g) determine priority of assays for the Clinical Research Market to
be established by OSI;
- 13 -
15
(h) determine funding breakdown of the Research Program pursuant to
this Agreement;
(i) discuss in-licensing of technology or products that have the
potential to benefit the objectives of Bayer and OSI under this Agreement;
and
(j) discuss the patent/intellectual property strategy and
implementation plan for internal development and external
commercialization.
2.2.2 Membership. Bayer and OSI each shall appoint, in its sole
discretion, three members to the Joint Management Committee. Substitutes
may be appointed at any time upon written notice.
The members initially shall be:
Appointees:
-----------
For Bayer: For OSI:
* *
* *
* *
2.2.3 Chair. The Joint Management Committee shall be chaired by one
member appointed by Bayer.
2.2.4 Meetings. The Joint Management Committee shall meet at least
quarterly at mutually agreeable dates and places. Representatives of Bayer
or OSI or both, in addition to members of
--------
* This portion redacted pursuant to a request for confidential treatment.
- 14 -
16
the Joint Management Committee, may attend such meetings at the invitation
of either party.
2.2.5 Minutes. The Joint Management Committee shall keep accurate
minutes which record all proposed decisions and all actions recommended or
taken. The minutes shall be delivered to all Joint Management Committee
members within five (5) business days after each meeting. The party hosting
the meeting shall be responsible for the preparation of the minutes.
2.2.6 Decisions. Subject to the provisions of 2.1.1, decisions of the
Joint Management Committee shall be made by majority vote of the members.
In the case of a tie vote, the vote of the chair shall control.
2.2.7 Expenses. Bayer and OSI shall each bear all expenses of their
respective members related to the participation of the Joint Management
Committee.
2.3 Reports and Materials.
2.3.1 Reports. During the Contract Period, Bayer and OSI each shall
furnish to the Joint Management Committee:
(a) summary reports within fifteen (15) days after the end of each
three-month period, commencing with the period ending March 31, 1997,
describing its progress under the OSI/Bayer Annual Operating Plan and
Budget; and
(b) comprehensive written reports within thirty (30) days after the
end of each Commitment Year describing in detail the work accomplished by
it under the OSI/Bayer Annual Operating Plan and Budget during the
Commitment Year and discussing and evaluating the results of such work.
- 15 -
17
2.3.2 Materials. OSI and Bayer shall, during the Contract Period as a
matter of course as described in the OSI/Bayer Annual Operating Plan and
Budget, or upon each other's written request, furnish to each other samples
of biochemical, biological or chemical materials which are part of the OSI,
Bayer or Bayer/OSI Technology and which are necessary for each party to
perform in accordance with the OSI/Bayer Annual Operating Plan and Budget.
To the extent that the quantities of materials requested by either party
exceed the quantities set forth in the OSI/Bayer Annual Operating Plan and
Budget, the requesting party shall reimburse the other party for the
reasonable costs of such materials if they are furnished.
2.4 Laboratory Facilities and Personnel. OSI and Bayer shall each provide
suitable laboratory facilities, equipment and personnel for the work to be done
in carrying out the OSI/Bayer Annual Operating Plan and Budget.
2.5 Clinical Diagnostic Products and Clinical Research Products.
2.5.1 Bayer shall have the exclusive right to commercialize Clinical
Diagnostic Products. It is understood that Bayer also has rights to
immunohistochemical and flow cytometric assays for certain analytes
otherwise not included in the definition of Clinical Diagnostic Products
which are not exclusive, but rather co-exclusive (as a minimum right), in
view of prior rights of Becton (as defined elsewhere herein).
- 16 -
18
2.5.2 OSI shall have the exclusive right to commercialize, itself or
through a Third Person, Clinical Research Products.
2.6 Diligent Efforts. Bayer and OSI each shall use reasonably diligent
efforts to achieve the objectives of the OSI/Bayer Annual Operating Plan and
Budget. Specifically, OSI shall use diligent efforts to allocate those resources
necessary (i.e., manpower, facilities, equipment) to meet the objectives of
OSI/Bayer Annual Operating Plan and Budget at the funding levels set forth
therein. Bayer shall use diligent efforts consistent with products of like
potential and consistent with reasonable commercial judgment to commercialize
Clinical Diagnostic Products.
3. Funding of the OSI/Bayer Annual Operating Plan and Budget.
3.1 Amount. The Annual Commitment for each of the first two (2) Commitment
Years shall be $1,500,000, and for each subsequent Commitment Year shall be at
least $1,000,000 to be determined by Bayer, which such Annual Commitments shall
be adjusted annually for inflation as determined by the Joint Management
Committee.
3.2 Funding Payments. So long as this Agreement is in effect, Bayer shall
provide to OSI the Annual Commitment. In no event shall Bayer be obligated to
fund more than the Annual Commitment if expenses in any Commitment Year exceed
the Annual Commitment for that year.
3.2.1 The Annual Commitment shall be paid in equal quarterly
installments in advance. Each quarterly payment shall be paid within five
(5) business days of the first day of the
- 17 -
19
applicable quarter. The first quarterly payment due under this Agreement
shall be paid within two (2) business days of the Effective Date.
3.2.2 In addition to the Annual Commitment provided by Bayer and
commencing with the third Commitment Year, the research conducted or
managed by OSI pursuant to this Agreement shall also be funded with a
maximum amount of $500,000 per such third or subsequent Commitment Year by
any "net revenue" that is received by OSI during the first two (2)
Commitment Years from the following:
(a) out-licensing of the OSI Technology in the Field;
(b) profit margins (determined in accordance with generally accepted
accounting principles) of Clinical Research Products sold by OSI; and
(c) royalties received by OSI from the sale of Clinical Diagnostic
Products by Bayer.
Any "net revenue" from the aforementioned sources that exceeds in the
aggregate $500,000 per Commitment Year shall not be used to fund the OSI
research conducted pursuant to this Agreement and shall belong to OSI
exclusively. For purposes of this Section 3.2.2 and for Section 3.2.3
below, "net revenue" shall mean the net income received by OSI from the
enumerated sources, determined in accordance with generally accepted
accounting principles.
3.2.3 In addition to the Annual Commitment provided by Bayer and
commencing with the third Commitment Year, the difference, if any, between
(i) the actual amount of funding
- 18 -
20
provided by OSI per such Commitment Year pursuant to Section 3.2.2 and (ii)
the maximum amount of funding by OSI of $500,000 per such Commitment Year,
shall be funded by any revenue, net of costs and expenses, that is received
by OSI, commencing with the third Commitment Year, from the following:
(a) out-licensing of the OSI Technology in the Field;
(b) profit margins (determined in accordance with generally accepted
accounting principles) of Clinical Research Products sold by OSI; and
(c) royalties received by OSI from the sale of Clinical Diagnostic
Products by Bayer.
Any "net revenue" from the aforementioned sources that exceeds in the
aggregate $500,000 per Commitment Year shall not be used to fund the OSI
research conducted pursuant to this Agreement and shall belong to OSI
exclusively.
3.2.4 Bayer shall fund any assay clinical trials conducted in
connection with its commercialization of Clinical Diagnostic Products. Any
reagent components, products or materials supplied by OSI to Bayer for such
trials shall be paid for by Bayer at OSI's actual fully absorbed cost plus
10%.
3.2.5 In the event of early termination of this Agreement, any portion
of a Funding Payment advanced to OSI and not spent shall be returned to
Bayer.
3.2.6 For three (3) years after each Commitment Year, OSI shall keep
complete and accurate records of its expenditures of Funding Payments under
the OSI/Bayer Annual Operating Plan and
- 19 -
21
Budget for such Commitment Year. Bayer shall have the right, at its own
expense, during the term of this Agreement and during the subsequent
three-year period, to appoint an independent certified public accountant to
examine such records, during regular business hours at the place or places
where such records are customarily kept, upon reasonable notice from Bayer,
to the extent reasonably necessary to verify the accuracy of the
expenditures and required reports. This right of inspection shall not be
exercised more than once in any calendar year and not more than once with
respect to records covering any specific period of time. Bayer agrees to
hold in confidence all information concerning such expenditures, other than
their total amounts, and all information learned in the course of any audit
or inspection, except to the extent that it is necessary for Bayer to
reveal the information in order to enforce any rights it may have pursuant
to this Agreement or if disclosure is required by law. Failure by Bayer to
request verification of any expenditures after the three-year period shall
be considered acceptance of the accuracy of such expenditures, and OSI
shall have no obligation to maintain any records pertaining to such report
or statement beyond the three-year period.
4. Treatment of Confidential Matter.
4.1 Confidentiality.
4.1.1 Bayer and OSI each recognize that the other's Confidential
Matter constitutes highly valuable proprietary information. Subject to the
terms and conditions of the License Agreement, the disclosure obligations
set forth in Sections 4.3 and 4.4 and publication rights set forth in
Section 4.2, Bayer and
- 20 -
22
OSI agree that for five (5) years from the termination of this Agreement,
they will keep confidential, and will cause their Affiliates to keep
confidential, all Confidential Matter that is disclosed or provided to them
or to any of their Affiliates pursuant to this Agreement. Neither Bayer nor
OSI nor any of their Affiliates shall use the other's Confidential Matter
except as expressly permitted in this Agreement or the License Agreement.
4.1.2 Bayer and OSI agree that any disclosure or provision of
Confidential Matter to any officer, employee or agent of the other or of
any of the other's Affiliates shall be made only to the extent necessary to
carry out its responsibilities under this Agreement. The receiving party
agrees not to disclose the other's Confidential Matter to any Third Persons
under any circumstance without written permission. Both Bayer and OSI shall
take such action to preserve the confidentiality of each other's
Confidential Matter as they would customarily take to preserve the
confidentiality of their own Confidential Matter. Each party, upon the
other's request, will return all the Confidential Matter disclosed or
provided pursuant to this Agreement, including all copies and extracts of
documents, within sixty (60) days of the request after the termination of
this Agreement, except for one (1) copy, which shall be retained for
archival purposes only.
4.2 Publication. Notwithstanding Section 4.1, any results obtained in the
course of this Agreement may be submitted for publication following scientific
review by the Joint Management Committee and subsequent approval by OSI's and
Bayer's managements. After receipt of the proposed publications by both
- 21 -
23
Bayer's and OSI's managements, written approval or disapproval shall be provided
within thirty (30) days for a manuscript or within fourteen (14) days for a
transcript of an oral presentation to be given at a scientific meeting. Bayer
and OSI agree to delay any publication if the Joint Management Committee
determines that Patent Rights are involved and additional time is needed to file
patent applications(s).
4.3 Disclosure of Inventions. Each party shall promptly inform the Joint
Management Committee about all inventions within OSI Patent Rights, Bayer Patent
Rights and OSI/Bayer Patent Rights.
4.4 Restrictions on Transferring Materials. Bayer and OSI recognize that
the biological, chemical and biochemical materials which are part of OSI
Technology, Bayer Technology or Bayer/OSI Technology represent valuable
commercial assets. Accordingly, throughout the Contract Period and for five (5)
years thereafter, OSI and Bayer agree not to transfer to any Third Person any
such material which constitute Technology owned solely by the other party.
Additionally, throughout the Contract Period and for six (6) months thereafter,
or for the life of any License Agreement applicable thereto, whichever is later,
OSI and Bayer agree not to transfer to any Third Person any biological, chemical
or biochemical materials which are part of Bayer/OSI Technology and which
comprise, consist of or are useful in the manufacture of any Product, unless
prior consent for any such transfer is obtained from the other party, which
consent may not be unreasonably withheld and unless such Third Person agrees as
a condition of any
- 22 -
24
such transfer not to transfer the material further and to use the material for
research purposes not directed toward the development of Clinical Diagnostic
Products. The provisions of this Section 4.4 specifically do not apply to any
transfer to any of the Other Companies pursuant to the agreements between OSI
and any of the Other Companies in effect prior to the Effective Date, as set
forth in Exhibit A, attached hereto.
5. Licenses.
5.1 License Granted to Bayer.
5.1.1 Exclusive License. OSI hereby grants to Bayer the exclusive,
worldwide license, including the right to grant sublicenses to parties
reasonably acceptable to OSI, to use OSI Technology (i) during the Contract
Period, to carry out the Research Program and (ii) during the Contract
Period and thereafter, to make, have made for itself, use and sell Clinical
Diagnostic Products based upon analytes with respect to which Bayer
commenced development during the Contract Period, subject to the following
conditions:
(a) Such license shall be subject to the prior rights granted to and
held by the Other Companies to any OSI Technology and OSI Patent Rights as
set forth on Exhibit A, attached hereto.
(b) OSI and/or its licensees shall retain the exclusive right to make,
have made for itself, use and sell Clinical Research Products for all
applications, including, without limitation, for use in developing clinical
research data in support of product development programs.
- 23 -
25
The exclusive license granted in clause (ii) above shall (i) with
respect to OSI Patent Rights, continue for the life of such patents and
(ii) with respect to unpatented OSI Technology, continue in perpetuity
provided, however, that in the event that Bayer does not introduce a
commercial Clinical Diagnostic Product based upon a particular analyte
within five (5) years of the termination of this Agreement, then the
license under OSI Technology with regard to such Clinical Diagnostic
Product based upon such analyte shall become non-exclusive.
5.1.2 Non-exclusive License. In the event that Bayer desires to extend
this Agreement upon expiration of the initial 5-year term or any extension
period thereafter pursuant to Section 10.2 hereof and OSI desires not to
renew, upon expiration of such initial 5-year term or any extension period
thereafter, as the case may be, OSI grants to Bayer a nonexclusive license
to use the OSI Technology to make, have made for itself, use and sell
Clinical Diagnostic Products other than those based upon analytes with
respect to which Bayer has been granted the exclusive license pursuant to
Section 5.1.1 above, subject to the prior rights granted to and held by the
Other Companies to any OSI Technology and OSI Patent Rights as set forth on
Exhibit A, attached hereto.
5.2 License Granted to OSI. Bayer hereby grants to OSI the exclusive,
worldwide license, including the right to grant sublicenses to parties
reasonably acceptable to Bayer, to use Bayer Technology and Bayer/OSI Technology
(i) during the Contract Period, to carry out the Research Program and (ii)
during the Contract Period and thereafter, to make, have made for itself, use
- 24 -
26
'
and sell Clinical Research Products based upon analytes with respect to which
OSI commenced development during the Contract Period.
The license granted in clause (ii) above shall (i) with respect to
Bayer and Bayer/OSI Patent Rights, continue for the life of such patents
and (ii) with respect to unpatented Bayer and Bayer/OSI Technology,
continue in perpetuity; provided, however, that in the event that OSI does
not introduce a commercial Clinical Research Product based upon a
particular analyte within five (5) years of the termination of this
Agreement, then the license under Bayer Technology and Bayer/OSI Technology
with regard to such Clinical Research Product based upon such analyte shall
become non-exclusive.
6. Royalties, Payments of Royalties, Accounting for Royalties and
Recordkeeping .
6.1 Royalties to be Paid by Bayer.
Bayer shall pay to OSI a royalty of * of Net Sales by Bayer of any
Clinical Diagnostic Product (net of all other royalties) utilizing
Bayer/OSI Patent Rights or OSI Patent Rights in countries where such sales
are covered by a Valid Claim. Such royalty shall be paid for two (2) full
years from the date of first commercial sale of each of such products and,
thereafter, such royalty shall be *, continuing for the life of such
patents. For sales of Clinical Diagnostic Products utilizing OSI
Technology or Bayer/OSI Technology in countries and not
--------
* This portion redacted pursuant to a request for confidential treatment.
- 25 -
27
covered by a Valid Claim, the royalty rate (net of all other royalties)
shall be * of Net Sales for two (2) full years from the date of first
commercial sale of each of such products and, thereafter, such royalty
shall be * of Net Sales until the expiration of ten (10) years from the
date of first commercial sale of each of such Products.
6.2 Royalties to be Paid by OSI.
6.2.1 OSI shall pay to Bayer a royalty of * of Net Sales by OSI of
Clinical Research Products based on Bayer/OSI Patent Rights or Bayer Patent
Rights in countries where such sales are covered by a Valid Claim. Such
royalty shall be paid for two (2) full years from the date of first
commercial sale of each of such products and, thereafter, such royalty
shall be *, continuing for the life of such patents. For sales of Clinical
Research Products utilizing Bayer/OSI Technology or Bayer Technology in
countries not covered by a Valid Claim, the royalty rate shall be * of Net
Sales for two (2) full years from the date of first commercial sale of each
of such products and, thereafter, such royalty shall be * of Net Sales
until the expiration of ten (10) years from the date of first commercial
sale of each of such Products.
6.2.2 With respect to royalties received by OSI from Third Persons
pursuant to permitted licenses under Bayer or Bayer/OSI Technology, OSI
shall pass on to Bayer * of all revenues in whatever form received
(earned royalties,
--------
* This portion redacted pursuant to a request for confidential treatment.
- 26 -
28
licensing fees and the like) from such Third Persons; provided, however,
that the foregoing obligation shall not take effect until OSI shall have
received the amounts provided for in Sections 3.2.2 and 3.2.3 hereof from
the sources listed therein, i.e., $500,000 per each Commitment Year.
6.3 Single Royalty. The parties acknowledge that only one royalty rate, the
highest one applicable, will apply to Net Sales of each Clinical Diagnostic
Product or Clinical Research Product regardless of the number of patents (or
patent applications) within the Patent Rights or the extent of Technology
licensed under this Agreement which may apply.
6.4 Payment Dates. Within sixty (60) days after March 31, June 30,
September 30 and December 31 of each year during the term of this Agreement
occurring after the date of the first commercial sale of its first Licensed
Product, each party shall deliver to the other party a true and accurate report
stating for each royalty-bearing Clinical Diagnostic Product or Clinical
Research Product, as the case may be, for the preceding three (3) calendar
months (a) Net Sales, (b) the royalties payable thereon, and (c) the amount of
any credit taken against royalties payable not already taken in computing Net
Sales. Except as otherwise provided, simultaneously with the delivery of each
such report, each party shall pay to the other party the amount, if any, due for
the period of such report. If no payments are due, it shall be so reported.
6.5 Accounting. All amounts payable hereunder shall be payable in United
States Dollars; provided, however, that if any
- 27 -
29
payment on account of Net Sales by a party, its Affiliates or sublicensees is
received in a foreign currency, such amount shall be converted monthly to United
States funds at the rate set by the party's finance department for internal
financial reporting purposes.
6.6 Records. During the term of this Agreement, each party shall keep
complete and accurate records of Net Sales in sufficient detail to enable the
other party to determine payments owed to it under this Agreement for a period
of three (3) years after such payments are due. Each party shall permit an
independent certified public accountant, acceptable to the other party and
appointed by the requesting party and at the requesting party'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 royalty 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 the party requesting
examination 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 a party has paid less
than ninety-five percent (95%) of the amount due to the other party, the party
being examined 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.
- 28 -
30
7. Legal Action.
7.1 Actual or Threatened Disclosure or Infringement. If information comes
to the attention of Bayer or OSI to the effect that any Patent Rights relating
to a Clinical Diagnostic Product, have been or are threatened to be infringed,
Bayer shall have 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.
Bayer shall notify OSI promptly of the receipt of any such information and of
the commencement of any such suit, action or proceeding. If Bayer determines
that it is necessary or desirable for OSI to join any such suit, action or
proceeding, OSI shall execute all papers and perform such other acts as may be
reasonably required to permit Bayer to act in OSI's name. In the event that
Bayer brings a suit, it shall be entitled to all sums recovered in such suit or
in its settlement without any further obligation to OSI. If Bayer does not,
within 120 days after giving notice to OSI of the above-described information,
notify OSI of Bayer's intent to bring suit against any infringer, OSI shall have
the right to bring suit for such alleged infringement, but it shall not be
obligated to do so. OSI may join Bayer as party plaintiff, if appropriate, in
which event OSI shall hold Bayer free, clear and harmless from any and all costs
and expenses of such litigation, including reasonable attorneys' fees, and all
sums recovered in any such suit or in its settlement shall belong to OSI without
any further obligation to Bayer. Each party shall always have the right to be
represented by counsel of its
- 29 -
31
own selection and at its own expense in any suit instituted by the other for
infringement, under the terms of this Section. If Bayer lacks standing to bring
any such suit, action or proceeding, then OSI shall do so at the request of
Bayer and at Bayer's expense. If neither party brings suit, then the applicable
royalty rate set forth in Section 6.1 hereof shall be reduced by fifty percent
(50%) with regard to Net Sales made 60 days after expiration of the 120-day
notice period set forth above.
If information comes to the attention of Bayer or OSI to the effect that
any Patent Rights relating to a Product to which rights have been retained by
OSI pursuant to this Agreement or to a Clinical Research Product have been or
are threatened to be infringed, OSI shall have 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. OSI shall notify Bayer promptly of
the receipt of any such information and of the commencement of any such suit,
action or proceeding. If OSI determines that it is necessary or desirable for
Bayer to join any such suit, action or proceeding, Bayer shall execute all
papers and perform such other acts as may be reasonably required to permit OSI
to act in Bayer'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 without any
further obligation to Bayer. Bayer shall 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
- 30 -
32
lacks standing to bring any such suit, action or proceeding, then Bayer
shall do so at the request of OSI and at OSI's expense.
7.2 Infringement Claims.
7.2.1 Defense of Infringement Claims. Each party will cooperate with
the other in the defense of any suit, action or proceeding against either
such party or any sublicensee of such party alleging the infringement of
the intellectual property rights of a Third Person by reason of the use of
Patent Rights or other Technology in the manufacture, use or sale of a
Clinical Diagnostic Product or a Clinical Research Product. Each party
shall give the other party prompt written notice of the commencement of any
such suit, action or proceeding or claim of infringement and will furnish
the other party with a copy of each communication relating to the alleged
infringement. The party defending any such suit or action shall have full
authority (including the right to exclusive control of 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), to
defend or settle any such suit, action or proceeding. If the parties agree
that the other party should institute or join any suit, action or
proceeding pursuant to this Section 7.2.1, the non-moving party may join
the other party as a defendant if necessary or desirable, and each such
party shall execute all documents and take all other actions, including
giving testimony, which may reasonably be required in connection with the
prosecution of such suit, action or proceeding.
- 31 -
33
7.2.2 Costs of Infringement Claims. In any given year, with regard to
a suit, action or proceeding brought against Bayer, OSI will be responsible
for the lesser of (a) 50% of the costs incurred under Section 7.2.1 above
("Infringement Litigation Costs") for such year or (b) 50% of total amount
of royalties due to OSI for such year (such amount being herein referred to
as "OSI's Share"). Bayer shall recoup from the royalties due to OSI in such
year 50% of the OSI Share and shall recoup the remaining 50% in the
succeeding year. If additional Infringement Litigation Costs are incurred
in the next year, the formula set forth above shall be applicable to such
costs; provided, however, the amount carried over from the preceding year
shall not be included in the determination of the OSI Share for such year.
Bayer shall be responsible for the Infringement Litigation Costs in excess
of OSI's Share.
7.3 Licenses under Patents. If Bayer obtains a license under a patent owned
by a Third Person, which patent in the opinion of Bayer would be infringed by
the manufacture, use or sale of a Clinical Diagnostic Product, then one-half
(1/2) of any payments made by Bayer to such Third Person during a reporting
period shall be fully creditable under Section 6.1 hereof against royalty
payments due from Bayer to OSI under Section 6.1 hereof for such reporting
period or subsequent reporting periods, but in no event during a reporting
period shall the royalty payment be reduced by more than fifty percent (50%) in
any reporting period. If OSI is of the opinion that such manufacture, use or
sale would not infringe such patent owned by a Third Person, OSI may, at its
- 32 -
34
election, bring suit against such Third Person seeking a declaration that such
patent is invalid or not infringed by Bayer's manufacture, use or sale of the
Product involved, or may bring opposition, nullity or other proceedings against
such patent, as appropriate. If OSI is successful in such suit, Bayer shall
resume paying royalties in such country as provided in Section 6.1. If OSI does
not bring such suit or is unsuccessful in such suit, it shall join Bayer in an
attempt to obtain a license under such patent, and one-half (1/2) of any
payments made by Bayer to such Third Person for such license shall be fully
creditable under Section 6.2 hereof against royalty payments due from Bayer to
OSI as to that patent and that country pursuant to this Agreement but in no
event shall the royalty payment be reduced by more than fifty percent (50%) in
any reporting period.
8. Provisions Concerning the Filing, Prosecution and Maintenance of Patent
Rights.
8.1 The Joint Management Committee shall decide whether (and where) to file
any patent application within the Bayer/OSI Patent Rights. The Joint Management
Committee also shall select counsel, reasonably acceptable to both parties, to
prepare and prosecute such applications. Counsel selected shall report to the
Joint Management Committee or its designees. Bayer shall be responsible for in
all expenses incurred by such counsel.
8.2 In the event the Joint Management Committee elects not to file or
elects not to continue prosecution of an application on any invention covered by
Section 8.1, Bayer may file and prosecute any such application(s) at its own
expense.
- 33 -
35
8.3 In the event that OSI determines that it is no longer interested in
prosecuting or maintaining a particular patent application or granted patent
included in OSI Patent Rights, OSI shall so inform Bayer in sufficient time to
permit Bayer to assume the responsibility and expense for the further
prosecution and/or maintenance of such application or patent. If Bayer assumes
such responsibility and expense, any royalty thereafter due OSI from Bayer based
on such application or patent shall cease.
9. Other Rights of the Parties.
9.1 Research Outside the Field. During the Contract Period, OSI shall have
the right to apply for and receive grants or contracts from public or private
sources, including, without limitation, the National Institutes of Health, the
American Cancer Society and the National Science Foundation, for research to be
performed outside the Field. OSI shall also have the right to enter into
co-venture arrangements, whether written or oral, with Third Persons, including,
without limitation, the National Institutes of Health, the American Cancer
Society and the National Science Foundation, to develop any product for use
outside the Field. In any contract or arrangement entered into by OSI outside
the Field, OSI shall take all steps necessary to prevent the use of any Bayer
Technology or Bayer/OSI Technology. OSI shall have no right to disclose any
Bayer Technology or Bayer/OSI Technology to a Third Person with whom it may
contract.
9.2 No Rights to Technology or Products Outside the Field. Bayer and OSI
acknowledge that neither party is granting to the
- 34 -
36
other, pursuant to this Agreement, any rights or licenses to Technology or
Products outside the Field.
10. Term Extension, Termination and Disengagement.
10.1 Term. This Agreement shall commence as of the Effective Date and shall
expire five (5) years from the Effective Date unless sooner terminated or unless
extended under Section 10.2.
10.2 Extension. After the initial five (5) year term, this Agreement shall
be automatically extended for additional successive one-year terms unless a
party gives six months' written notice to the other party of its intent not to
renew.
10.3 Event(s) of Termination. The following events shall constitute Events
of Termination under this Agreement:
(a) Any representation or warranty by OSI or Bayer, or any of its
officers, under or in connection with this Agreement shall prove to have
been incorrect in any material respect when made; or
(b) OSI or Bayer 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 ninety (90) days after written notice to the failing party.
10.4 Termination. Upon the occurrence of any Event of Termination, the
party not responsible shall have the right, by written notice to the other
party, to immediately terminate this Agreement.
- 35 -
37
10.5 Early Termination. Bayer shall have the right to terminate this
Agreement for any reason to be effective at any time after this Agreement has
been in effect for a period of twenty-four (24) months from the Effective Date,
provided that Bayer has given (12) months' prior written notice to OSI.
10.6 Survival. Without limitation, the rights and obligations arising from
the following provisions shall survive any expiration or termination of this
Agreement: Articles 1, 4, 5, 7 and 13-16.
11. Representations and Warranties. OSI and Bayer each represent and warrant as
follows:
11.1 It is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and Indiana, respectively. It
is qualified to do business and is in good standing 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.
11.2 The execution, delivery and performance by it of this Agreement has
been duly 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
- 36 -
38
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.
11.3 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.
11.4 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.
11.5 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 licensors.
12. Covenants of OSI and Bayer. Throughout the Contract Period, each of OSI
and Bayer 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 in each
jurisdiction in which such qualification is from time to time necessary or
desirable in view
- 37 -
39
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/Bayer Annual Operating Plan and
Budget.
13. Dispute Resolution. The parties recognize that disputes arise from time to
time regarding either party's rights or obligations under this Agreement. The
parties agree to follow the procedures set forth below in this Article in order
to facilitate the speedy resolution of any disputes under this Agreement. The
parties agree to cooperate and attempt in good faith to resolve any dispute
between them. Any dispute that cannot be resolved by good faith negotiation
shall be referred, by written notice from either party or to the other, to the
respective officers of the parties designated below (or their successors):
For Bayer: Senior Vice President
Finance and Administration
For OSI: Vice President
Finance
These executive officers shall negotiate in good faith to achieve a resolution
of the dispute within thirty (30) days after they are notified of the dispute.
If the designated officers are not able to resolve the dispute within this
thirty (30) day period, either party may then initiate binding arbitration
proceedings to resolve the dispute in accordance with the Commercial Arbitration
Rules of the American Arbitration Association, and judgment upon the award
- 38 -
40
rendered by the arbitrator may be entered in any court having jurisdiction
thereof; provided, however, any claim for consequential, special, or punitive
damages shall not be heard or considered by the arbitrator and any finding or
award of consequential, special, or punitive damages shall be null, void and
unenforceable as if never having been made.
14. 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:
If to Bayer: To Bayer at its address as set
forth at the beginning of this
Agreement,
Attention:
with a copy to: Legal Department
If to OSI: To OSI at its address as set forth
at the beginning of this Agreement,
Attention: President
with a copy to: *
Services shall be deemed given as of the date of receipt.
15. Governing Law. This Agreement shall be construed in accordance with the laws
of the State of New York.
--------
* This portion redacted pursuant to request for confidential treatment.
- 39 -
41
16. Miscellaneous.
16.1 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.
16.2 Headings. Paragraph headings are inserted for convenience of reference
only and do not form a part of this Agreement.
16.3 Counterparts. This Agreement may be executed simultaneously in two or
more counterparts, each of which shall be deemed an original.
16.4 Amendment; Waiver; etc. This Agreement may be amended, modified,
superseded or cancelled, 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 waiving 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.
16.5 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
rights by reason of this Agreement. Neither party shall enter into 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.
- 40 -
42
16.6 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.
16.7 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.
16.8 Unforeseen Circumstances. Neither party shall be liable in damages
for, nor shall this Agreement be terminable or cancelable 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.
- 41 -
43
16.9 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.
- 42 -
44
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives.
BAYER CORPORATION
By:
-----------------------------
Title:
--------------------------
ONCOGENE SCIENCE, INC.
By:
-----------------------------
Title:
--------------------------
- 43 -
