DEVELOPMENT AND LICENSE AGREEMENT BETWEEN MONSANTO COMPANY
AND
IgX OXFORD HEPATITIS CORP.
As of September 1, 1998
SDM&C
XXXXXXX. DUNALJD. MERCADIER & XXXXXXXX
00 xxxxxx Xxxxxx
00000 Xxxxx
TABLE OF CONTENTS
Pages
-----
Article 1 - Definitions 2
Affiliate 2
Combination Product 3
Compound
Compounds 3
Date of First Commercial Sale 3
Development Program 4
Drug Development Committee 4
Effective Date 4
Entity 4
Field 4
Funding Agreement 4
IND 5
Know-How 5
Licensee Development Costs 5
Licensee Transfer of Rights 5
Major Markets 5
Mono Products 6
Monsanto Development Costs 6
Monsanto Intellectual Property 6
Monsanto Manufacturing Information 6
Monsanto Patents 7
Net Sales 7
Patents 7
Product 8
Regulatory Agency 8
Regulatory Delay 8
Territory 8
Third Party Transfer Compensation 8
Article 2 - Licences 8
Grant 8
Sublicenses 9
Option
No other rights 10
Article 3 - Development
Access to the MONSANTO Know-How 10
Development Program 11
Development Program Charges 11
Development Program Management 12
Source of the Compound 13
Reversion and Conveyance of Rights 14
2
Pages
-----
Article 4 - MONSANTO Rights of First Refusal
Rights in the Field 15
Second Right of First Refusal 16
Rights Outside the Field 18
Article 5 - Royalties 18
Article 6 - Representations and Warranties 20
Article 7 - Infringement and Indemnification 23
Infringement Claims 23
Indemnification 24
Article 8 - Confidentiality 27
Article 9 - Intellectual Property - Improvements 30
Article 10 - Limitations on liability 32
No Warranties 32
Force Majeure 32
Article 11- Non-use of Names 33
Article 12-Publicity 33
Article 13 - Term and Xxxxxxxxxxx 00
Xxxx 00
Events of Default 34
Termination 35
Consequences of Termination 37
Article 14 - Miscellaneous
Notices 38
Arbitration 40
Amendments 41
No waiver - Remedies 41
Successors and Assigns 41
Relationship of Parties 42
Expenses 42
Entire Agreement 42
Severability 42
Counterparts 43
Governing Law 43
3
Appendix A
MONSANTO Patents
Appendix B
Development Program
Appendix C
Funding Agreement
DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (the "Agreement") is entered into as of
September 1, 1998 by and between MONSANTO COMPANY, a Delaware corporation having
its principal place of business at 000 Xxxxx Xxxxxxxxx Xxxxxxxxx, Xxxxx Xxxxx,
Xxxxxxxx, 00000, acting on behalf of itself and on behalf of its wholly owned
subsidiary X.X. Xxxxxx & Co. (hereinafter collectively "MONSANTO") and IgX
Oxford Hepatitis Corp., a Delaware corporation having its principal place of
business at Xxx Xxxxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000.
(hereinafter "LICENSEE")
WITNESSETH:
WHEREAS, MONSANTO is the owner of patents and patent applications relating to
the use of N-nonyl DNJ (the "Compound") or a novel congener thereof
(collectively the "Compounds") for the treatment of Hepatitis B as a
mono-therapy or in a combination therapy.
2
WHEREAS, MONSANTO is the owner of certain intellectual property relating to the
Compound; and
WHEREAS, subject to the terms and conditions of this Agreement, MONSANTO wishes
to grant to LICENSEE and LICENSEE desires to obtain, an exclusive world-wide
license, with the right to sublicense. under the aforesaid patents to use,
develop, register and sell one or more of the COMPOUNDS for treatment of
Hepatitis B as a mono-therapy and/or in a combination therapy; and
WHEREAS, in connection with such license MONSANTO is willing to grant to
LICENSEE licenses to the aforesaid intellectual property as reasonably available
and accessible to MONSANTO.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
hereinafter set forth, the parties hereto agree as follows:
Article 1 - Definitions
As used in this Agreement, the following terms shall have the meanings
specified:
1.1 "Affiliate" means any other legal Entity that directly or indirectly
through one or more intermediaries, controls or is controlled by or is
under common control with such legal Entity. For purposes hereof, the term
"control" (including with its correlative meanings,
3
the terms "controlled by" and "under common control with"), means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of such Entity (whether through
the ownership of voting securities, by contract or otherwise).
1.2 "Combination Product" means a Product suitable for commercialization for
use in the Field having as its active ingredients one or more of the
Compounds and any other active ingredients.
1.3 "Compound" means N-nonyl DNJ referred to by MONSANTO as SC-48578 and
described in the MONSANTO Patents listed in Appendix A hereto.
1.4 "Compounds" means the Compound or a novel congener thereof described in the
MONSANTO Patents, wherein the term "novel" refers to specific congeners
which are structurally new after 12 February, 1997.
1.5 "Date of First Commercial Sale" shall mean the earliest date on which
LICENSEE shall have sold commercially a Product for therapeutic use in the
Field in any country or jurisdiction after having obtained all necessary
approvals for such therapeutic use in the Field in such country or
jurisdiction.
1.6 Development Program" means the program of activities and timelines for the
pre-clinical and clinical development of one or more of the Compounds for
use in the Field (including but not limited to those pre-clinical
activities and timelines set forth in
4
Appendix B hereto) and activities and timelines to be agreed by the parties
at a later date for the development of one or more of the Compounds for
which approval will be sought from a Regulatory Agency for
commercialization of one or more of the Products for use in the Field.
1.7 "Drug Development Committee" means the committee described in Article 3.4
hereof.
1.8 "Effective Date" means the earlier of (i) the date upon which the animal
studies set forth in Appendix (B) commence or (ii) October 31, 1998.
1.9 "Entity" means any individual, estate, trust, corporation, partnership,
joint venture, association, firm or company, or government body, agency or
official or any other legal entity.
1.10 "Field" shall mean the treatment of Hepatitis B.
1.11 "Funding Agreement" means the Research Agreement, dated as of the 17th day
of August, 1998 between LICENSEE and IgX Corp., a Delaware Corporation,
attached hereto and made a part hereof as Appendix C.
1.12 "IND" means an application and dossier covering an Investigational New Drug
filed or fileable with the United State Food & Drug Administration.
5
1.13 "Know-How" means any and all technology, experience, know-how, show-how,
techniques, discoveries, improvements, processes, formulae, data (including
but not limited to all formulation characterization data), structure
activity relationships,. trade secrets, technical reports, in vitro and
animal studies, clinical data, dosage information, product formulations,
metabolic studies and toxicological data relating to the Compound and its
use in the Field in Monsanto's possession or control, or to which Monsanto
has grantable rights at the date of this Agreement.
1.14 LICENSEE Development Costs" shall mean expenses in the form of cash outlays
to non-Affiliates of LICENSEE and other out-of-pocket costs, including
employee compensation and benefits paid to or incurred on behalf of
scientific employees, which LICENSEE incurs in, and which are attributable
to, LICENSEE's development of Product, including all costs relating to
process research, process development, and regulatory approvals for use of
such Products.
l.15" LICENSEE Transfer of Rights" shall mean and include any of the following:
(i) any sublicense granted under the authority of Articles 2.3 hereof; and
(ii) any assignment of this Agreement.
1.16 "Major Markets" means the United States, the European Union (as defined by
the European Patent Convention), Japan, and the Peoples Republic of China.
1.17 "Mono Product" means a Product suitable for commercialization for use in
the Field having as its sole active ingredient one of the Compounds.
6
1.18 "MONSANTO Development Costs" shall mean expenses in the form of cash
outlays for MONSANTO in-house activities and other variable costs which
MONSANTO has incurred in and which are directly attributable to MONSANTO's
development of the Compound for use in the Field including all costs
relating to research, development, toxicology, pharmacokinetics and
structure-activity relationships, but not including: (i) any capital
investment in, lease of, or operating costs of any commercial
manufacturing, warehousing or storage facility; (ii) any expenses relating
to the design or construction, or startup of any such facility, (iii) any
investment or expense relating to the acquisition, rent or lease of land
for any such facility; (iv) any general administrative expense; (v) any
legal expenses except those related to the filing and prosecution of
Patents in the Major Markets or (vi) any overhead cost associated with
MONSANTO's business or any part, function or activity thereof.
1.19 "MONSANTO Intellectual Property" means the MONSANTO Patents, Know-How and
MONSANTO Manufacturing Information.
1.20 "MONSANTO Manufacturing Information" means any and all information owned by
and in the possession of MONSANTO relating to Compound manufacturing
process descriptions, technical reports, manufacturing process research
data, animal studies, dosage information, product formulation, metabolic
studies and toxicological data related to such manufacturing information.
7
1.21 MONSANTO Patents" means the Patents or Patent Applications listed in
Appendix A hereto.
1.22 "Net Sales" shall mean the gross amount invoiced on sales of a Product by
LICENSEE, or its sublicensee, in any country in the Territory to
independent unrelated third parties less (a) trade, cash and promotional
discounts actually allowed and taken; (b) excise, sales taxes or
value-added taxes imposed upon and paid with respect to such sales
(excluding national, state or local taxes based on income) as adjusted for
rebates or refunds; (c) freight, insurance and other transportation charges
invoiced to third parties; (d) amounts repaid or credited by reason of
rejections, defects, recalls or returns; and (e) rebates (including
pursuant to medicaid or other similar governmental rebate, discount or
charge back programs).
1.23 "Patent" means (i) unexpired letters patent (including inventor's
certificates) including without limitation any substitutions, extensions,
registrations, confirmations, supplementary protection certificates,
reissues, re-examinations, renewals, continuations, divisionals,
continuations-in-part or any like filing thereof, and (ii) pending
applications for letters patent, including without limitation any
continuations, divisions or continuations-in-part thereof and any
provisional applications.
1.24 "Product" means either a Combination-Product or a Mono-Product which is
sold for use in the Field.
8
1.25 "Regulatory Agency" means the United States Food and Drug Administration
(FDA) or any successor agency performing a similar function or an
equivalent ex-US regulatory agency.
1.26 "Regulatory Delay" means a delay in any milestone date or other date on or
before which a specific event mentioned herein or in any Annex hereto must
occur which delay is caused by any action, request, requirement or failure
to act of a Regulatory Agency in a country of a Major Market.
1.27 "Territory" means all countries in the world.
1.28 "Third Party Transfer Compensation" shall mean funds paid or other
compensation made to LICENSEE, other than royalties measured by Net Sales
of a Product, as consideration for any LICENSEE Transfer of Rights under
this Agreement.
Article 2 - Licenses
2.1 Grant. Subject to the terms and conditions of this Agreement and in
consideration of the payments to be made hereunder, MONSANTO hereby grants
an exclusive, world-wide license, with right to sublicense, under the
MONSANTO Patents and Know-How to develop, use, import, register, offer for
sale and sell one or more Products as a mono-therapy and/or as a
combination therapy for use in the Field, wherein:
9
(a) said license shall be exclusive under the MONSANTO Patents; and
(b) said license shall be exclusive under the Know-How to the extent said
Know-How relates exclusively to Compounds for use in the Field and
said license shall otherwise be non-exclusive; provided that said
non-exclusive Know-How license shall be grantable only to the extent
that exclusive rights have not been granted to another party prior to
the date of this Agreement.
2.2 MONSANTO further grants to LICENSEE an option to obtain a non-exclusive
world-wide license under the MONSANTO Manufacturing Information to make,
have made, use and sell one or more of the Products for use in the Field.
2.3 Sublicenses. LICENSEE shall have the right to enter into sub-licensing
agreements with respect to any of the rights, privileges and licenses
granted hereunder, to the extent sub-licensing rights have been granted by
MONSANTO to LICENSEE and subject to the terms and conditions hereof. Such
sublicense(s) shall terminate upon the termination of this Agreement.
LICENSEE agrees that any sublicense granted by it hereunder shall provide
that all of the obligations to MONSANTO pursuant to this Agreement shall be
binding upon the sublicensee(s) as if they were a party to this Agreement.
2.4 Option. MONSANTO hereby grants to LICENSEE an option to be granted a
non-exclusive license under US. Patent No. 5,602913, US. Patent No.
5,610,039, and worldwide counterparts thereof (the "Compound Manufacturing
Patents"), to make or
10
have made the Compounds. LICENSEE may exercise such option at any time
during the term of this Agreement on thirty (30) days prior written
notice. Upon such exercise, LICENSEE shall negotiate in good faith with
MONSANTO a license agreement with terms and conditions customary and
usual for such non-exclusive manufacturing rights, including lump-sum
payments and royalties payable by the LICENSEE to MONSANTO in an amount
which shall be no more onerous, when considering all terms and conditions
of the license, in the aggregate, as to both amount and type of
compensation, as that paid by the most favored of MONSANTO's other
licensees under the Compound Manufacturing Patents.
2.5 No other Rights. The license granted hereunder and the option to be granted
a license hereunder shall not be construed to confer any rights on LICENSEE
(by implication, estoppel, or otherwise) as to any technology, trade
secrets or other proprietary rights of MONSANTO, except as expressly set
forth herein.
Article 3 - Development
3.1 Access to the MONSANTO Know-How. Within thirty (30) days after the date of
this Agreement, MONSANTO shall diligently begin to provide LICENSEE with
full access, to all of the MONSANTO Know-How, which is reasonably
accessible to and grantable by MONSANTO for the purpose of the development
of the Compounds for use in the Field.
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3.2 Development Program. LICENSEE shall use its best commercially reasonable
efforts to pursue the development of one or more of the Compounds for use
in the Field. Appendix B hereto sets forth a near term development plan
(the "Near Term Development Plan") with timelines set forth therein. The
parties acknowledge that time is of the essence in completing the Near Term
Development Plan. Upon successful completion, to the satisfaction of
LICENSEE and the Drug Development Committee, of paragraphs (a), (b) and (c)
of the Near Term Development Plan and during the six (6) month period set
forth in paragraph (d) of the Near Term Development Plan, LICENSEE shall
provide to MONSANTO for MONSANTO's approval, which approval shall not be
unreasonably withheld or delayed, a development plan (the "Development
Plan") containing milestone events and timelines for the clinical
development and registration with a Regulatory Agency in each of the Major
Markets of one or more Products for sale for use in the Field. MONSANTO
acknowledges and agrees that the LICENSEE may use one or more contractors
to perform the Near Term Development Plan and/or the Development Plan and
hereby authorizes the LICENSEE to make available to such contractor(s) any
of the MONSANTO Know-How or MONSANTO Intellectual Property provided
hereunder, subject to such contractor(s) agreeing to be bound by the
confidentiality obligations set forth in Article 8. hereof
3.3 Development Program Charges. All costs incurred by LICENSEE in the Near
Term Development Plan and the Development Plan, including, without
limitation, payments for clinical trials and other studies, tests and all
filings and applications and other actions necessary for achieving the
approval of any Regulatory Agency for marketing
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one or more of the Compounds for use in the Field shall be the sole
responsibility of LICENSEE.
3.4 Development Program Management.
(a) The Development Program shall be managed by the Drug Development Committee
which shall administer and be responsible for (i) oversight of the research
and development program to be carried out and (ii) setting and approving
budgets, releasing funds, approving charges to the Near Term Development
Plan or the Development Plan and in general approving all tasks and the
timetable for completion of such task in the development of one or more
Compounds for use in the Field.
(b) The Drug Development Committee shall include a designee of LICENSEE,
Xxxxxxxxx Xxxxxxx X. Xxxx of Oxford University, and until such time as
MONSANTO shall have declined all of its Rights of First Refusal as set
forth in Article 4 hereof, or having exercised such rights failed to
negotiate a definitive license agreement with LICENSEE, a designee of
MONSANTO. Xxxxxxxxx Xxxx shall serve as Chairman of the Committee. All
decisions taken by the Drug Development Committee shall be by consensus;
provided, however, that until such time as MONSANTO shall have exercised
its Rights of First Refusal pursuant to Article 4.1 hereof and entered into
either the Development and License Agreement or the Marketing Agreement, as
therein specified, MONSANTO shall have an advisory role but no vote on
decisions relating to setting and approving budgets or releasing funds.
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(c) The Drug Development Committee shall meet at least quarterly to review and
revise, if necessary, the Drug Development Program. Written minutes of all
decisions taken by the Drug Development Committee shall be signed by all
members of the Drug Development Committee. The Drug Development Committee
shall provide MONSANTO with detailed quarterly reports describing progress
of the development of the Compound(s) for use in the Field including any
information with respect to side effects or contraindications noted.
3.5 Source of the Compound
MONSANTO shall provide to LICENSEE, at no additional cost, and as available in
storage to MONSANTO for use in the Development Program a sample of SC-48578 in
an amount of approximately 100 grams. If requested by LICENSEE, MONSANTO shall
provide to LICENSEE at no additional cost, and as available in storage to
MONSANTO reasonable amounts of samples of synthesis intermediates.
The Compound or synthesis intermediates to be provided hereunder shall be
delivered to LICENSEE or as LICENSEE directs as soon as practicable after a
written request for such Compound or intermediates is received by MONSANTO from
LICENSEE. MONSANTO shall ship these materials by a suitable carrier in packaging
appropriate for the materials, and shall provide a Material Safety and Data
Sheet and certificate of weight and analysis for each shipment as available to
MONSANTO. MONSANTO shall not be required to warrant that the material contained
in each shipment shall conform to the certificate of analysis provided
therefor. LICENSEE shall bear all costs and responsibility for acquiring
appropriate import
14
and export approvals and certificates related to shipment of Compound and/or
synthesis intermediates.
3.6 Reversion and Conveyance of Rights. If LICENSEE or its sub-licensee shall
cease development efforts of a Compound for use in the Field, or shall have
failed to achieve a mutually-agreed milestone in the development of a Compound
in the time period agreed upon, or if the License Agreement is for any reason
terminated prior to registration of a Compound, then all rights, licenses and
options granted under this Agreement in any MONSANTO Intellectual Property shall
immediately revert to MONSANTO without compensation to any other party, and all
right, title and interest in and to any intellectual property generated during
the Development program, including all Know-How and data acquired by LICENSEE by
conveyance, grant or transfer under Article. 6.3 hereof, related to the use of
the Compound in the Field shall be conveyed to MONSANTO without compensation to
any other party. These obligations of reversion and conveyance of rights shall
be assumed by all licensees and/or assignees of LICENSEE. If LICENSEE fails or
ceases to commercialize a Compound in any country other than a country of a
Major Market, then all rights in such Compound in such country shall revert to
MONSANTO without compensation to any other party.
Article 4 - MONSANTO Rights of First Refusal
4.1 Rights in the Field, LICENSEE hereby grants to MONSANTO the following rights
of first refusal:
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(a) First Right of First Refusal. At least one hundred and twenty (120) days
prior to the inception of Phase I clinical trials of one or more of the
Compounds for use in the Field, LICENSEE shall provide MONSANTO full access
to, and a comprehensive final report on, all information developed by or
for LICENSEE on Compounds for use in the Field, said final report to
contain sufficient animal data for submission of an IND to the FDA. After
receiving said final report MONSANTO shall have at least ninety (90) days
prior to such inception of Phase I clinical trials, to negotiate in good
faith for a period not to exceed ninety (90) days a Development and License
Agreement (the "Development and License Agreement") covering the clinical
development, registration and marketing of a Compound for use in the Field.
The Development and License Agreement shall contain terms and conditions
substantially similar to those contained in this Agreement including
exclusive licenses to MONSANTO under all intellectual property generated
during the Development Program except that it shall include compensation to
LICENSEE in a form that will take into consideration the following factors:
(a) the reimbursement to LICENSEE of all LICENSEE Development Costs
incurred to the date of the Development and License Agreement by MONSANTO
upon signature of such Development and License Agreement less the MONSANTO
Development Costs (b) the payment of a normal and customary lump sum
representing the net present value of a world-wide license to manufacture,
market and distribute the Compound to be developed through clinical trials
for use in the Field, as negotiated between the parties (c) the payment of
agreed milestone payments by MONSANTO (the "Milestone Payments') for the
funding of the clinical development and
16
registration of a Compound for use in the Field (d) the payment by MONSANTO
of reasonable and customary royalties calculated as a percentage of the Net
Sales of the Product incorporating the Compound for use in the Field.
(b) Second Right of First Refusal. If MONSANTO shall not exercise its First
Right of First Refusal and/or shall have failed to agree with LICENSEE the
terms of the Development and License Agreement, LICENSEE agrees to notify
MONSANTO at the end of Phase II Clinical Trials of one or more of the
Compounds for use in the Field and provide MONSANTO with full access to,
and a comprehensive final report on all information developed by or for
LICENSEE in Phase II Clinical Trials on Compounds for use in the Field and
containing all data appropriate for deciding to commence Phase III Clinical
Trials, and MONSANTO shall have ninety (90) days after receiving said final
report within which to notify LICENSEE of its exercise of its Second Right
of First Refusal. If MONSANTO shall exercise its Second Right of First
Refusal, LICENSEE agrees to negotiate in good faith with MONSANTO for a
period not to exceed ninety (90) days an agreement for the clinical
development, registration and marketing of the Compound for use in the
Field (the "Marketing Agreement"). The Marketing Agreement shall contain
terms and conditions substantially similar to those contained in this
Agreement including exclusive licenses to MONSANTO under all intellectual
property generated during the Development Program except that it shall
include compensation to LICENSEE in a form that will take into
consideration the following factors: (a) the .reimbursement to LICENSEE of
all LICENSEE Development Costs incurred to the date of the Marketing
Agreement
17
less the MONSANTO Development Costs by MONSANTO upon signature of such
Marketing Agreement, (b) the payment of a normal and customary lump sum
representing the net present value of a world-wide license to manufacture,
market and distribute the Compound for use in the Field, as negotiated
between the parties (c) the payment by MONSANTO to LICENSEE of all costs
and expense set forth in the Development Program for the clinical
development of the Compound for use in the Field and the registration of
the Product for sale for use in the Field in the Territory and (d) the
payment by MONSANTO of reasonable and customary royalties calculated as a
percentage of the Net Sales of the Product incorporating the Compound for
use in the Field.
(c) Agreements with Third Parties. If MONSANTO shall have failed to exercise
any of its rights of first refusal contained herein and/or following the
good faith negotiations between the parties, LICENSEE and MONSANTO are
unable to agree to the terms and conditions of a Development and License
Agreement or a Marketing Agreement, LICENSEE shall be free to negotiate
with any third party any agreement; provided, however, that such agreement
with a third party shall be consistent with MONSANTO's rights and
LICENSEE's obligations herein and further that no such agreement with such
third party shall contain terms and conditions, including payments and
compensation, which in the aggregate are more favorable to such third party
than the terms and conditions negotiated between MONSANTO and LICENSEE.
Prior to execution of any such agreement with a third party, LICENSEE shall
provide MONSANTO with a fully negotiated version of such agreement, which
does not reveal the identity of such third party.
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MONSANTO shall have five (5) business days after receipt of such agreement
to review it. Neither the failure of MONSANTO to exercise its First Right
of First Refusal, nor the failure of MONSANTO and LICENSEE to negotiate to
conclusion a Development and License Agreement shall result in the
abrogation of MONSANTO's Second Right of First Refusal and LICENSEE's
obligation to negotiate in good faith a Marketing Agreement.
4.2 Rights Outside the Field. LICENSEE hereby grants to MONSANTO the same
rights of first refusal for uses of the Compounds outside the Field as set
forth in Article 4.1 hereof if MONSANTO can conclusively show that any such
uses outside the Field were developed using any of the Compound or the
synthesis intermediates provided by MONSANTO to LICENSEE pursuant to
Article 3.5 hereof, failing which MONSANTO shall have no rights with
respect to uses of the Compounds outside the Field owned by LICENSEE. The
terms of Articles 4.1 are incorporated by reference herein mutatis
mutandis.
Article 5 - Royalties
5.1 In consideration of the licenses granted in Article 2.1 hereof, LICENSEE
agrees to pay MONSANTO a royalty equal one and one half per cent (1.5%) of
the actual Net Sales of the Product sold by LICENSEE or its sub-licensee to
unaffiliated third parties for use in the Field. The royalty shall only be
payable on Net Sales of a Product in each country
19
in the Territory where a valid MONSANTO Patent is pending or issued, or
where LICENSEE has substantial market exclusivity, said royalty to be paid
for the life of said Patent or for the duration of said market exclusivity.
5.2 All Royalty payments shall be made within sixty (60) days after the end of
each calendar quarter during each calendar year and shall be calculated on
actual Net Sales of Products during the quarter concerned. All royalties
shall be paid in United States Dollars and Net Sales of Products
denominated in a currency other than Dollars shall be converted to Dollars
at the exchange rate for purchasing Dollars with such currency prevailing
on the last day of the quarter in question as quoted in the Wall Street
Journal. Each royalty payment shall be accompanied by a statement showing
Net Sales and calculation of royalties due.
5.3 If LICENSEE receives Third Party Transfer Compensation resulting from a
LICENSEE Transfer of Rights, LICENSEE shall pay over to MONSANTO
twenty-five per cent (25%) of such Third Party Transfer Compensation within
thirty (30) days of receipt thereof.
5.4 Any Affiliate of MONSANTO may, at MONSANTO's discretion, receive on behalf
of MONSANTO any payment obligation of LICENSEE under this AGREEMENT and
such payment shall be received by MONSANTO's Affiliate in lieu of payment
to MONSANTO with the same effect as if payment has been tendered to
MONSANTO in satisfaction of such obligation under this Agreement. LICENSEE
will complete
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requisite forms to obtain any reduced withholding tax rate under the Income
Tax treaties between US. and a relevant country.
5.5 LICENSEE shall keep (or cause to be kept) and maintain complete and
accurate records of its sales of product, in accordance with US. Generally
Accepted Accounting Practices, such records shall be accessible to an
independent certified public accountant selected by MONSANTO. Such records
may be inspected at reasonable times during business hours within two (2)
years after the end of the period to which such records relate, for the
purpose of verifying Net Sales and any remittance of royalties due thereon.
Such accountant shall be paid by MONSANTO and shall disclose to MONSANTO
only such information as relates to the accuracy of the records kept and
payments made.
Article 6 - Representations and Warranties
6.1 By LICENSEE. LICENSEE hereby represents and warrants to MONSANTO that (a)
LICENSEE has full legal right, power and authority to execute, deliver and
perform its obligations under this Agreement, (b) the execution, delivery
and performance by LICENSEE of this Agreement do not contravene or
constitute a default under any provision of applicable law or its articles
of incorporation or by-laws (or equivalent documents) or of any agreement,
judgment, injunction, order, decree or other instrument binding upon
LICENSEE, (c) all licenses, consents, authorizations and approvals, if any,
required for the execution, delivery and performance by LICENSEE of this
Agreement have been obtained and are in full force and effect and all
conditions
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thereof have been complied with, and no other action by or with respect
to, or filing with, any governmental authority or any other entity or
person is required in connection with this execution, delivery and
performance by LICENSEE of this Agreement, and (d) this Agreement
constitutes a valid and binding agreement of LICENSEE, enforceable
against LICENSEE in accordance with its terms.
6.2 By MONSANTO. MONSANTO hereby represents and warrants to LICENSEE that (a)
MONSANTO has full legal right, power and authority to execute, deliver and
perform its obligations under this Agreement, (b) the execution, delivery
and performance by MONSANTO of this Agreement do not contravene or
constitute a default under any provisions of applicable law or of its
articles of incorporation or by-laws (or equivalent documents) or of any
agreement, judgment, injunction, order, decree or other instrument binding
upon MONSANTO, (c) all licenses, consents, authorizations and approvals, if
any, required for the execution, delivery and performance by MONSANTO of
this Agreement have been obtained and are in full force and effect and all
conditions thereof have been complied with, and no other action by or with
respect to, or filing with, any governmental authority or any other entity
or person is required in connection with the execution, delivery and
performance by MONSANTO of this Agreement, and (d) this Agreement
constitutes a valid and binding agreement of MONSANTO, enforceable against
MONSANTO in accordance with its terms. MONSANTO makes no representation or
warranty that the use or sale of the Compound in the Field will not
infringe any patent or proprietary rights of third parties. MONSANTO
further represents and warrants that to the best of its knowledge all of
the patents listed in Appendix A, as of the Date of this Agreement, are not
being
22
infringed by any third parties, are to the extent held by MONSANTO or
controlled by MONSANTO free and clear of all liens, encumbrances and other
claims, and are not subject to any pending cancellation or reexamination
proceeding or any other pending proceeding challenging their scope or
validity, except as may occur during prosecution of said Patents in patent
offices in which said Patents are pending
6.3 LICENSEE further warrants and represents that, at the date of this
Agreement with respect to any party other than MONSANTO, LICENSEE shall
have obtained appropriate instruments showing:
(a)conveyance to LICENSEE of all right, title and interest in and to the
Patents listed in Appendix A, to the extent that any parties other than
MONSANTO may hold any such right, title or interest in said Patents, and
(b) grant to LICENSEE of exclusive, sub-licensable, world-wide,
royalty-free, irrevocable license rights to all know-how, including but not
limited to all information, data, and structure-activity relationships,
relating to the Field.
6.4 LICENSEE further warrants and represents that the Funding Agreement, and
any other contract related to development of Compounds between LICENSEE and
any third party, shall have terms and conditions consistent with this
Agreement including, specifically, provisions covering intellectual
property which are consistent with the conveyances and grants of this
Agreement and which provide ownership of all intellectual property in
LICENSEE and/or grant of exclusive, sub-licensable,
23
world-wide, irrevocable licenses of rights to LICENSEE in any such
intellectual property without any other encumbrances.
6.5 Survival of Representations and Warranties. The representations and
warranties contained herein shall survive the execution, delivery and
performance of this Agreement by the parties, notwithstanding any
investigation at any time made by or on behalf of any party or parties.
Article 7 - Infringement and Indemnification
7.1 Infringement Claims. Each party shall promptly advise the other party of
any infringements or suspected infringements of any MONSANTO Patents of
which such party becomes aware, and each party shall cooperate with and
assist the other party in any action undertaken for the assertion of
infringement of any MONSANTO Patent. In the event that either party
concludes that activities of third parties, in the opinion of their
counsel, constitutes an actionable infringement of a MONSANTO Patent,
MONSANTO shall within ninety (90) days initiate action, not necessarily
formal litigation, to terminate or xxxxx such activity. MONSANTO shall keep
LICENSEE advised of the status of MONSANTO's efforts to terminate the
infringing activity. In the event that MONSANTO shall fail to commence
action to terminate or xxxxx infringing activity within the ninety (90) day
period set forth above, then LICENSEE shall have the right at its cost, to
proceed under such MONSANTO Patent to terminate the infringement. In such
event, LICENSEE shall have the right to proceed through
24
counsel of its own selection and to initiate and control all proceedings
associated therewith. MONSANTO shall render reasonable assistance and
cooperate with LICENSEE as needed, at LICENSEE's expense. If in any
infringement proceeding commenced under this Article, whether the same be
commenced or controlled by LICENSEE or MONSANTO, damages or the like are
recovered in an amount exceeding the cost and fees incurred in obtaining
the same, such excess amounts shall be the property of the party
controlling the proceeding.
7.2 Indemnification
(a) Indemnification by LICENSEE. LICENSEE hereby agrees that it shall be
responsible for, indemnify, hold harmless and defend MONSANTO, MONSANTO's
Affiliates and their respective directors, officers, managing members,
shareholders, partners, attorneys, accountants, agents, employees and
consultants and their heirs, successors and assigns (collectively the
"MONSANTO Indemnitees") from and against any and all claims, demands,
losses, liabilities, damages, costs and expenses (including the cost of
settlement, reasonable, legal and accounting fees and any other expenses
for investigating or defending any actions or threatened actions)
(collectively, "Losses" suffered or incurred by any MONSANTO Indemnitee
arising out of, relating to, resulting from or in connection with (a) any
actual or alleged injury or death of any third party or damage to any
property caused or claimed to be caused by the Product or by any act of
LICENSEE or any third party acting for LICENSEE in the development or
commercialization of the Product for use in the Field, at any time prior to
the exercise by MONSANTO of any of its rights of first refusal contained in
Article 4.1,
25
provided that such injury, death or damage is not directly attributable to
MONSANTO Intellectual Property. (b) the breach of any representation or
warranty made by LICENSEE herein, or (c) any action, suit or other
proceeding, or compromise, settlement or judgment, relating to any of the
foregoing matters with respect to which MONSANTO Indemnitees are entitled
to indemnification hereunder. The foregoing shall not apply to the extent
that such Losses are due to the willful misconduct or negligence of any
MONSANTO Indemnitees, as finally determined by a court of competent
jurisdiction.
(b) Prior to initiation of any human clinical trial, LICENSEE shall have
obtained an insurance policy from an insurer which is reasonably acceptable
to MONSANTO in an amount not less than ten million United States dollars
(US$10,000,000) to cover claims, liability, expenses, damages and costs due
to injury to persons or damage to property arising or resulting from the
manufacture, use or sale of any Product, or the practice of any process, as
set forth herein and shall name MONSANTO as primary insured to be
compensated for any claims made against MONSANTO prior to any other named
insured under such policy. LICENSEE shall furnish to MONSANTO a Certificate
of Insurance corroborating the issue of such policy, and copies of all
renewal certificates corroborating the continued force of such policy.
Further, LICENSEE shall require the insurer provide to MONSANTO with
notices of any policy cancellation, non-renewal or modification.
(c) Indemnification by MONSANTO. MONSANTO' hereby agrees that it shall be
responsible for, indemnify, hold harmless and defend LICENSEE's Affiliates
and their
26
respective directors, officers, managing members, shareholders, partners.
attorneys, accountants, agents. employees and consultants and their heirs,
successors and assigns (collectively, the "LICENSEE Indemnities") from and
against any and all claims, demands, losses, liabilities, damages costs and
expenses (including the cost of settlement, reasonable legal and accounting
fees and any other expenses for investigating or defending any actions or
threatened actions) (collectively "Losses") suffered or incurred by any
LICENSEE Indemnitee arising out of, relating to, resulting from or in
connection with (a) the breach of any representation or warranty made by
MONSANTO herein, and (b) any action, suit or other proceeding, or
compromise, settlement or judgment, relating to any of the foregoing
matters with respect to which LICENSEE Indemnitees are entitled to
indemnification hereunder. The foregoing shall not apply to the extent that
such Losses are due to the willful misconduct or negligence of any LICENSEE
Indemnitees, as finally determined by a court of competent jurisdiction.
(d) Notice of Claims. In the event that a claim is made pursuant to Article
7.2.(a) or 7.2(c) above against any party which seeks indemnification
hereunder (the "Indemnitee"), the Indemnitee agrees to promptly notify the
other party (the "Indemnitor") of such claim or action and, in the case of
any claim by a third person against the Indemnitee, the Indemnitor may, at
its option, elect to assume control of the defense of such claim or action;
provided that (a) the Indemnitee shall be entitled to participate therein
(through counsel of its own choosing) at the Indemnitee's sole cost and
expense, and (b) the Indemnitor shall not settle or compromise any such
claim or action without the prior written consent of the Indemnitee, unless
such settlement or compromise includes a
27
general release of the Indemnitee and all of the other LICENSEE Indemnitees
or MONSANTO Indemnitees. as the case may be, from any and all liability
with respect hereto.
Article 8 - Confidentiality
8.1 During the term of this Agreement and for a period of ten (10) years after
the termination hereof for any reason, LICENSEE agrees to hold in
confidence this Agreement and its terms and all MONSANTO Know-How and any
other confidential information disclosed by MONSANTO to the LICENSEE
(collectively the "Confidential Information") and not use the same for any
purpose other than as set forth in this Agreement nor disclose the same to
any other person except to the extent that it is necessary for LICENSEE to
enforce its rights under this Agreement or if required by law; provided,
that if LICENSEE shall be required by law to disclose any such Confidential
Information to any third party, LICENSEE shall give prompt written notice
thereof to MONSANTO and shall minimize such disclosure to the amount
required. Notwithstanding the foregoing, LICENSEE may disclose Confidential
Information (a) to its attorneys, accountants and other professional
advisors under an obligation of confidentiality, (b) to its banks, other
financial institutions or investors under an obligation of confidentiality,
for the purpose of raising capital or borrowing money or maintaining
compliance with agreements, arrangements and understandings relating
thereto, and (c) to any Entity who proposes to purchase or otherwise
succeed (by merger, operation of law or otherwise) to all of LICENSEE's
right, title and interest in, to and under this Agreement, if such Entity
agrees to maintain the confidentiality of
28
such Confidential Information pursuant to a written agreement. The standard
of care required to be observed hereunder shall be not less than the degree
of care which LICENSEE uses to protect its own information of a similar and
confidential nature.
8.2 During the term of this Agreement and for a period of ten (10) years after
the termination hereof for any reason, MONSANTO agrees to hold in
confidence this Agreement and its terms and any other confidential
information disclosed by LICENSEE to MONSANTO (collectively the
"Confidential Information") and not use the same for any purpose other than
as set forth in this Agreement nor disclose the same to any other person
except to the extent that it is necessary for MONSANTO to enforce its
rights under this Agreement or if required by law; provided, that if
MONSANTO shall be required by law to disclose any such Confidential
Information to any third party, MONSANTO shall give prompt written notice
thereof to the LICENSEE and shall minimize such disclosure to the amount
required. Notwithstanding the foregoing, MONSANTO may disclose Confidential
Information (a) to its attorneys, accountants and other professional
advisors under an obligation of confidentiality, (b) to its banks, other
financial institutions or investors under an obligation of confidentiality,
for the purpose of raising capital or borrowing money or maintaining
compliance with agreements, arrangements and understandings relating
thereto, and (c) to any Entity who proposes to purchase or otherwise
succeed (by merger, operation of law or otherwise) to all of MONSANTO's
right, title and interest in, to and under this Agreement, if such Entity
agrees to maintain the confidentiality of such Confidential Information
pursuant to a written agreement. The standard of care required to be
29
observed hereunder shall be not less than the degree of care which MONSANTO
uses to protect its own information of a similar and confidential nature.
8.3 The restrictions set forth in Articles 8.1 and 8.2 hereof shall not apply
to any Confidential Information which:
(a) was already known to LICENSEE or MONSANTO, as the case may be, prior
to its disclosure by the other party, as shown by the recipient's
written records;
(b) at the time of the disclosure is or subsequently thereto becomes
generally available to the public other than by speculation, rumor or
by a violation of the terms of this Agreement;
(c) subsequent to disclosure is acquired from or made available to a party
by a third party and neither disclosure to nor use by such party
violates any obligation of said third party to MONSANTO or LICENSEE,
as the case may be; and
(d) LICENSEE is required to disclose to a Regulatory Agency in connection
with the preparation and filing of applications for marketing approval
of a Product.
(e) LICENSEE includes in any articles published in recognized scientific
publications in connection with the development of the Compounds.
30
Article 9 - Intellectual Property - Improvements
9.1 Rights to Proprietary Technology. Neither party shall through this
Agreement obtain any rights to the other party's proprietary technology
except for such rights as are expressly granted or allocated under this
Agreement.
9.2 Improvements and Filing, Prosecution and Maintenance of Patents. Any
invention, discovery or development (including, without limitation, data,
formulae or research results) generated in the course of the Development
Program pertaining directly to the Compound, including formulation
technology for the Compound, shall be owned solely by LICENSEE. In the
event that any such invention, discovery or development is deemed
patentable, LICENSEE may, at its option and cost, elect to seek patent
protection thereon and MONSANTO shall render reasonable assistance to
LICENSEE whenever requested to do so, at LICENSEE's cost, to the extent
MONSANTO is required to sign and execute such forms and documents as may be
necessary to assist LICENSEE in the filing and prosecution of such
applications.
9.3 MONSANTO agrees to file, maintain and defend the MONSANTO Patents in the
Major Markets for the term of this Agreement. The scope of additional
international patent filings necessary to protect the marketing and
licensing interests of the parties will be determined in advance of actual
filings on a country-by-country or regional basis in discussions between
representatives of each party, said discussions to be initiated by
LICENSEE, with appropriate consideration of filing, prosecution and
maintenance costs, and the enforceability of patent claims in the country
or region. The
31
costs of all such filings and maintenance costs shall be borne by MONSANTO,
until such time as MONSANTO gives at least ninety (90) days written notice
of its intention to abandon any such Patent for which MONSANTO is paying
such costs. At LICENSEE's request MONSANTO shall provide LICENSEE with
evidence of the payment of all such costs at least thirty (30) days prior
to the date upon which failure to have paid such cost will result in the
abandonment or lapse of the Patent. MONSANTO shall have no liability for
any inadvertent lapse of a Patent.
9.4 In the event that MONSANTO intends to abandon or discontinue maintenance or
prosecution of any MONSANTO Patent in any country of the Major Markets,
MONSANTO shall give LICENSEE sufficient advance notice to allow LICENSEE to
take any action necessary to renew, maintain or revive such MONSANTO
Patents at LICENSEE's expense. MONSANTO shall provide all reasonable
assistance required for LICENSEE to accomplish such result.
Article 10 - Limitations on Liability
10.1 No Warranties. Except as expressly set forth in Article 6 hereof, neither
party makes any representations or warranties as to any matter whatsoever.
EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE COMPOUND, THE PRODUCTS
AND THE MONSANTO INTELLECTUAL PROPERTY, INCLUDING WITHOUT LIMITATION, ANY
WARRANTIES OF
32
MERCHANTABILITY OR FITNESS FOR ANY PART1CULAR PURPOSE TO THE EXTENT
PROVIDED BY LAW, MONSANTO SHALL NOT BE LIABLE UNDER ANY CONTRACT.
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
10.2 Force Majeure. No party shall be liable for failure or delay in performing
any of its obligations hereunder if such failure or delay is occasioned by
compliance with any governmental regulation, request or order, or by
circumstances beyond the reasonable control of the party so failing or
delaying, including without limitation. Acts of God, war, insurrection,
fire, flood, accident, labor strikes, work stoppage or slowdown (whether or
nor such labor events is within the reasonable control of the parties). or
inability to obtain power or necessary to enable such party to perform its
obligations hereunder. Each party shall (a) promptly notify the other party
in writing of any such event of force majeure, the expected duration
thereof and its anticipated effect on the ability of such party to perform
its obligations hereunder, and (b) make reasonable efforts to remedy any
such event of force majeure.
Article 11 - Non-use of Names
Neither party shall use the name of the other party or the name of any
Affiliates or employees of such party, nor any adaptation thereof, in any
advertising, promotional or sales literature or other publication without prior
written consent obtained from such other party in each case. In the event that a
party is required by law by the SEC or ex-U.S. counterpart thereof to
33
disclose the name of the other party, the parties shall agree on the scope and
nature of such disclosure, within the requirements of the law, prior to any such
disclosure.
Article 12 - Publicity
12.1 The terms of this Agreement shall be considered confidential information of
MONSANTO and subject to the provisions of this Article 8 hereof
12.2 If LICENSEE determines to issue any press release or other public statement
or announcement of or relating to this Agreement (hereinafter collectively
"LICENSEE Announcement"), MONSANTO shall have the right to review such
LICENSEE Announcement, and to make reasonable revisions thereof, prior to
release or publication thereof by LICENSEE or any LICENSEE agent or
contractor. MONSANTO shall have the absolute right to block the issuance of
any press release or other public announcement which refers directly or
indirectly to MONSANTO, its Affiliates or new venture partners, other than
announcements contemplated in the second sentence of Article 11 hereof.
12.3 It is agreed and understood that LICENSEE may disclose the terms of this
Agreement under obligations of confidentiality to a prospective sublicensee
pursuant to the negotiation of a sublicense authorized under Article 2
hereof, provided that such prospective sublicensee agrees to a
confidentiality agreement at least as restrictive as the provisions of
Article 8 hereof, and MONSANTO is expressly named as a third party
beneficiary of such confidentiality agreement.
34
Article 13 - Term and Termination
13.1 Term. This agreement shall be effective from the date first above written
and, unless sooner terminated in accordance with the provisions of this
Article 13, shall continue until the later to occur of (a) fifteen (15)
years from the date of this Agreement, or (b) the expiration of all royalty
duration obligations set forth in Article 5.1 hereof
13.2 Events of Default. Each party shall have the right to terminate this
Agreement upon the occurrence of any of the following events (each, an
"Event of Default") with respect to the other party (the "Defaulting
Party"): (a) a decree or order shall have been entered by a court of
competent jurisdiction adjudging the Defaulting Party bankrupt or
insolvent, or approving as properly filed a petition - seeking
reorganization, readjustment arrangement, composition or similar relief for
the Defaulting Party under any bankruptcy law or any other similar
applicable statute, law or regulation, or a decree or order of a court of
competent jurisdiction shall have been entered for the appointment of a
receiver or liquidator or trustee or assignee in bankruptcy or insolvency
of the Defaulting Party or a substantial part of its property, or for the
winding up or liquidation of its affairs; or (b) the Defaulting Party shall
institute proceedings to be adjudicated a voluntary bankrupt, or shall
consent to the filing of a bankruptcy petition against it, or shall file a
petition or answer or consent seeking reorganization, readjustment,
arrangement, composition, liquidation or similar relief under any
bankruptcy law or any other similar applicable statute, law or regulation
or shall consent to the appointment of a receiver or liquidator or trustee
or assignee in bankruptcy or insolvency of it or of a substantial part of
its property, or shall make an
35
assignment for the benefit of creditors, or shall be unable to pay its
debts generally as they become due; or (c) the Defaulting Party shall
commit a material breach of the terms of this Agreement and the Defaulting
Party does not undertake diligent and continuous efforts to remedy such
breach and all of its effects within thirty (30) days after written notice
thereof is given by the other party to the Defaulting party and such breach
is not fully remedied within a reasonable period.
13.3 Termination. Each party may terminate this Agreement upon the occurrence of
any Event of Default by the other party by giving written notice thereof to
the other party, which notice shall specifically identify the reason(s) for
such termination. LICENSEE shall have the right, as its option, to
terminate this Agreement on a country-by-country basis (a) at any time if
LICENSEE unilaterally elects to discontinue development or marketing of the
Compound; (b) immediately if the manufacture, use, sale or distribution of
the Product is enjoined permanently and unavoidably by a court or
administrative agency of competent jurisdiction as infringing the patent
rights of any third party in any country; or if it reasonably determines on
the advice of competent patent counsel, that the manufacture, use, sale or
distribution of the Product unavoidably infringes the patent rights of any
third party in any Major Market; and (c) immediately in the event that the
Product is deemed unmarketable for any reason.
13.4 (a) MONSANTO shall have the right, at its option to terminate this
Agreement (i) if LICENSEE has (x) not provided the final report pursuant to
the terms of Article 4.1 (a) hereof within two years of the Effective Date
of this Agreement or (y) not provided the final report pursuant to the
terms of Article 4.1 (b) hereof, or (ii) the Date of First
36
Commercial Sale of a Product in a Major Market shall not have occurred
within six (6) years of the Effective Date of this Agreement or (iii) IgX
Corp. shall default in its obligations to LICENSEE under the Funding
Agreement and such default is not remedied within thirty (30) days if such
default. The time limits set forth in Articles 13.4 (a) (i) or 13.4 (a)
(ii) hereof shall be extended on a day-to-day basis for any Regulatory
Delays.
(b) If the Date of First Commercial Sale of a Product in any particular
Major Market shall not have occurred within the period set forth in Section
13.4 (a) (ii), MONSANTO shall have an option, exercisable within ninety
(90) days following such date, to request an exclusive license for such
Product for such Major market. If MONSANTO shall exercise such option, the
parties agree to negotiate in good faith a license agreement for such Major
Market pursuant to the terms of Section 4.1(b) hereof, the terms of which
are incorporated herein by reference mutatis mutandis.
13.5 Consequences of Termination. The termination of this Agreement for any
reason shall be without prejudice to (a) the rights and obligations of the
parties pursuant to Sections 7 and 10 hereof, and (b) any other remedies as
may now or hereafter be available to any party, whether under this
Agreement or otherwise.
13.6 In the event of termination under Article 13.3(b) if LICENSEE can obtain a
reasonable license or settlement agreement with regard to the third party
patent rights, LICENSEE may elect to continue the Agreement and reduce the
royalty to be paid hereunder by up
37
to 50% in each quarter to offset actual expenses incurred in obtaining the
license or settlement.
13.7 Within twenty (20) days after termination of this Agreement, irrespective
of the basis for termination, LICENSEE shall promptly return to MONSANTO
all materials and data comprising MONSANTO Intellectual Property or
otherwise relating to the manufacture of products. If any inventory of
finished Products remains in LICENSEE's inventory after termination,
MONSANTO at its sole election may purchase all or a portion of such
inventory of finished products at LICENSEE's list price.
Within a period of ninety (90) days after the date of termination, any
finished Products which MONSANTO has not elected to purchase from LICENSEE
may be disposed by LICENSEE by use or sale within the limitations of
Article 2 hereof; provided, however. that LICENSEE shall not have the right
to dispose of finished Products if actual or potential injury to persons or
property, and/or creation or extension of actual or potential liability of
MONSANTO, either forms any part of the basis for termination or is
otherwise incurred or threatened or is reasonably anticipated by MONSANTO.
13.8 Any inventory of finished Products, raw materials therefor and/or
intermediates therefor not used or sold under the provisions of Article
12.6 hereof shall be destroyed by LICENSEE within one hundred (100) days
after termination of this Agreement.
13.9 The obligations contained in Articles 7, 8, 9, 10, 11, 42 and 14 shall
survive termination of this Agreement.
38
Article 14 - Miscellaneous
14.1 Notices. All payments, notices, reports and/or other communications
accordance with this Agreement, shall be sufficiently made or given on the
date of the mailing if delivered by hand, by facsimile or sent by first
class mail postage prepaid and addressed as follows:
In the case of LICENSEE:
IgX Oxford Hepatitis Corp.
Attn: Xxxxxx X. Xxxxx, Chairman
Xxx Xxxxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
with a copy to:
Xxxxx & Co.
Attn.: June Knaudt
0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxx Xxxxxxxxxx 00000-0000
In the case of MONSANTO:
MONSANTO Company
000 X. Xxxxxxxxx Xxxxxxxxx
Xx. Xxxxx Xxxxxxxx 00000
XXX
Attention: General Counsel
39
with a copy to:
X.X. Xxxxxx & Co.
0000 Xxx Xxxxxxx Xxxx
Xxxxxx, Xxxxxxxx 00000
Attention: Licensing Dept.
or such other address as either party shall notify the other in writing.
14.2 Arbitration. Any dispute, controversy or claim arising out of or relating
to this Agreement shall be settled by arbitration under the American
Arbitration Association by a panel of three arbitrators, one selected by
each party and the third selected by the other two arbitrators. Any
arbitration proceeding commenced by either party shall be held in the New
York City, New York metropolitan area (including northern New Jersey). The
decision of the arbitrators may be entered in any court of competent
jurisdiction, and execution may be had thereon. In any arbitration pursuant
to this Agreement, each party shall be entitled to discovery proceedings in
accordance with the United States Federal Rules of Civil Procedure
governing discovery as then in effect. The expenses of such arbitration,
including attorneys' fees, shall be allocated between the parties as the
arbitrators may decide and as the claims and interests of each party may
prevail. Notwithstanding anything to the contrary contained herein, any
dispute, controversy or claim relating to the actual or threatened
unauthorized use of any Confidential Information, or the validity,
enforceability or infringement of any patent rights, shall not be submitted
to arbitration hereunder and shall be resolved by a court of competent
jurisdiction.
40
14.3 Amendments. etc. This Agreement may not be amended or modified, nor may any
right or remedy of any party be waived, unless the same is in writing and
signed by such party or a duly authorized representative of such party. The
waiver by any party of the breach of any term or provision hereof by any
other party shall not be construed as a waiver of any other subsequent
breach.
14.4 No Waiver: Remedies. No failure or delay by any party in exercising any of
its rights or remedies hereunder shall operate as a waiver thereof, nor
shall any single or partial exercise of any such right or remedy preclude
any other or further exercise thereof or the exercise of any other right or
remedy. The rights and remedies of the parties provided in this Agreement
are cumulative and not exclusive of any rights or remedies provided by law.
14.5 Successors and Assigns. This Agreement shall be binding upon and inure to
the benefit of the parties and their respective heirs, legal
representatives, successors and permitted assigns; provided that, LICENSEE
may assign or otherwise transfer this Agreement or any of its rights,
duties or obligations hereunder without the prior written consent of
MONSANTO and MONSANTO may assign or otherwise transfer this Agreement
without the prior written consent of LICENSEE to any company which merges
with or is merged into MONSANTO or any company to which MONSANTO shall
transfer the line of business associated with this Agreement. Any agreement
between LICENSEE and any third party assigning or transferring any of its
rights, duties or obligations hereunder shall contain the obligation by
such third party to maintain and fulfill all obligations owed by LICENSEE
to MONSANTO hereunder.
41
14.6 Relationship of Parties. LICENSEE and MONSANTO are not (and nothing in this
Agreement shall be construed to constitute them) partners, joint ventures,
agents. representatives or employees of the other party. nor to create any
relationships between them other than that of an independent contractor.
Neither party shall have any responsibility or liability for the actions of
the other party except as specifically provided herein. Neither party shall
have any right or authority to bind or obligate the other party in any
manner or make any representation or warranty on behalf of the other party.
14.7 Expenses. Unless otherwise provided herein, all costs and expenses incurred
in connection with this Agreement and the transactions contemplated hereby
shall be paid by the party which shall have incurred the same and the other
party shall have no liability relating thereto.
14.8 Entire Agreement. This Agreement constitutes the entire agreement between
the parties and supersedes all prior proposals, communications,
representations and agreements, whether oral or written, with respect to
the subject matter hereof
14.9 Severability. Any term or provision of this Agreement which is invalid or
unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such invalidity or unenforceability without
rendering invalid or unenforceable the remaining terms and provisions of
this Agreement or affecting the validity or enforceability of any of the
terms or provisions hereof in any other jurisdiction.
42
14.10 Counterparts. This Agreement may be signed in any number of counterparts.
each of which shall be deemed an original and all of which when taken
together shall constitute but one and the some instrument.
14.11 Governing Law. This Agreement, including the performance and
enforceability hereof, shall be governed by and construed in accordance
with the laws of the State of New York without reference to choice of law
doctrine.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first written above.
IgX Oxford Hepatitis Corp.
By: /s/ Xxxxxx X. Xxxxx
--------------------------
Chairman
IgX Oxford Hepatitis Corp.
MONSANTO Conipany
By: /s/ Xxxxxxx X. Xx Xxxxxxxx
--------------------------
Xxxxxxx X. Xx Xxxxxxxx
Vice Chairman
MONSANTO Co.
