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Agreement#: AG-52587
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DEVELOPMENT AND LICENSE AGREEMENT

Effective Date: September 01, 1998
Parties:

IGX, Monsanto

Sectors: Biotechnology / Pharmaceuticals, Chemicals
Governing Law:  New York
DEVELOPMENT AND LICENSE AGREEMENT BETWEEN MONSANTO COMPANY


AND


IgX OXFORD HEPATITIS CORP.


As of September 1, 1998

SDM&C
SOKOLOW. DUNALJD. MERCADIER & CARRERAS
55 avenue Kleber
75116 Paris


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 Termination 34


Term 34
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


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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 800 North Lindbergh Boulevard, Saint Louis, Missouri, 63167, acting on behalf of itself and on behalf of its wholly owned subsidiary G.D. Searle & Co. (hereinafter collectively "MONSANTO") and IgX Oxford Hepatitis Corp., a Delaware corporation having its principal place of business at One Springfield Avenue, Summit, New Jersey 07901.


(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,


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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


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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.


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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.


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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.


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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:


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(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


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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,
Professor Raymond A. Dwek 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. Professor Dwek 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


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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 ...

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