Exhibit 10.10
AGREEMENT
This Agreement (AGREEMENT) is entered into as of July 4, 2001 (EFFECTIVE DATE)
between NeoGenesis Drug Discovery, Inc., a Delaware corporation (NEOGENESIS) and
Mitsubishi-Tokyo Pharmaceuticals, Inc. (MITSUBISHI), a corporation organized
under the laws of Japan, and sets forth the terms and conditions that will apply
to the provision by NeoGenesis to Mitsubishi of certain screening and analysis
services.
BACKGROUND
Mitsubishi is interested in identifying potential pharmaceutical products for
treatment of certain human diseases and wishes to identify compounds that
exhibit a high degree of chemical binding and functional activity to specific
protein targets. NeoGenesis has certain technology and know-how, including
screening processes of libraries of mass-encoded small molecule compounds,
relating to the identification, discovery, validation and optimization of novel
compounds which may be useful for development of novel therapeutics employing
targets implicated in a disease process. The parties wish to pursue a
collaborative screening process to identify compounds exhibiting a high degree
of chemical binding activity to targets designated by Mitsubishi from among the
NeoGenesis libraries of mass-encoded small molecule compounds and which have
activity in bioassays or functional assays. The terms and conditions set forth
below shall govern the performance of such collaborative effort.
1. DEFINITIONS.
1.1 DEFINED TERMS. Capitalized terms used in this Agreement and not otherwise
defined herein shall have the meaning set forth below.
AFFILIATE means with respect to either party, any Person that, directly or
indirectly, is controlled by, controls or is under common control with such
party. For purposes of this definition, CONTROL means, with respect to any party
hereto, the direct or indirect ownership of more than [*] of the voting or
income interest in such party or the possession otherwise, directly or
indirectly, of the power to direct the management or policies of such party.
ALIS means the Automated Ligand Identification System, an automated,
ultra-high throughput ligand selection system proprietary to NeoGenesis that is
used to identify multiple classes of chemical ligands against target protein.
APPLICABLE LAWS means all laws, statutes, regulations and ordinances of any
Regulatory Authority, including without limitation the FD&C Act.
CHEMOTYPE means a family or group of related Candidate Compound A (as
defined in ATTACHMENT A).
CIP means "Carriage and Insurance Paid", as that expression is defined in
INCOTERMS 2000, ICC Publishing S.A.
COMMERCIALLY REASONABLE EFFORTS means, with respect to (i) any objective by
any party, reasonable, diligent, good faith efforts to accomplish such objective
as such party would normally use to accomplish a similar objective under similar
circumstances; and (ii) with respect to any objective relating to the
development or Commercialization of any Licensed Product by any party efforts
and resources normally used by such party with respect to a product owned by
such party or to which such party has similar rights which is of similar market
potential at a similar stage in the development or life of such product, taking
into account issues of safety, efficacy, product profile, the competitiveness of
the marketplace, the proprietary position of the product, the regulatory
structure involved, profitability of the product and other relevant commercial
factors.
COMMERCIALIZATION means any and all activities of using, importing,
exporting, marketing, promoting, distributing, offering for sale and selling a
Licensed Product. When used as a verb, COMMERCIALIZE means to engage in
Commercialization.
CONFIDENTIAL INFORMATION means any proprietary or confidential information
of either party (including but not limited to all Mitsubishi Know-How and all
NeoGenesis Know-How) disclosed to the other party pursuant to this Agreement in
written or other tangible medium and marked as confidential, or if disclosed
orally or displayed, confirmed in writing within thirty (30) days of
disclosure, except any portion thereof which: (i) is known to the receiving
party, as evidenced by the receiving party's written records, before receipt
thereof under this Agreement;
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
1
(ii) is disclosed to the receiving party by a third person who is under no
obligation of confidentiality to the disclosing party hereunder with respect to
such information and who otherwise has a right to make such disclosure; (iii) is
or becomes generally known in the trade through no fault of the receiving party;
or (iv) is independently developed by the receiving party, as evidenced by the
receiving party's written records, without access to such information.
CONTROL OR CONTROLLED means with respect to any (a) item of information,
including, without limitation, Mitsubishi Know-How and NeoGenesis Know-How, or
(b) intellectual property right, the possession (whether by ownership or
license, other than pursuant to this Agreement) by a party or an Affiliate
thereof of the ability to grant to the other party access or a license as
provided herein under such item or right without violating the terms of any
agreement or other arrangements, between such party or its Affiliate and any
third party, existing before or after the Effective Date.
DERIVATIVE COMPOUNDS means any derivatives or analogs for a Designated
Compound, which have an IC(50) value against the Target of [*] or less, which
(a) results from a chemical synthesis program based on the Designated Compounds
or (b) is based on structure-activity data of the Designated Compound; PROVIDED,
that any such program or data is in respect of a target protein that is greater
than [*] homologous at the peptide level to the Target for which Mitsubishi
designated such Designated Compound.
FDA means the United States Food and Drug Administration, or any successor
thereto.
FD&C ACT means the United States Federal Food, Drug and Cosmetic Act of
1938, as amended.
FIELD means treatment of any disease in humans.
FIRST COMMERCIAL SALE of Licensed Product(s) means any transfer for value
in an arms-length transaction to an independent third party distributor, agent
or end user in a country within the Territory after obtaining all necessary
Regulatory Approvals as may be necessary for such transfer in such country.
FORCE MAJEURE means any event beyond the control of the parties, including,
without limitation, failures of computers, computer-related equipment, hardware
or software, fire, flood, riots, strikes, epidemics, war (declared or undeclared
and including the continuance, expansion or new outbreak of any war or conflict
now in existence), embargoes and governmental actions or decrees.
GOOD CLINICAL PRACTICE means the then current standards for clinical trials
for pharmaceuticals, as set forth in the FD&C Act and applicable regulations
promulgated thereunder, as amended from time to time, and such standards of good
clinical practice as are required by the European Union and other Regulatory
Authorities in countries in which the Product is intended to be sold, to the
extent such standards are not in contravention with United States Good Clinical
Practices.
GOOD LABORATORY PRACTICE means the then current standards for laboratory
activities for pharmaceuticals, as set forth in the FD&C Act and applicable
regulations promulgated thereunder, as amended from time to time, and such
standards of good laboratory practice as are required by the European Union and
other Regulatory Authorities in countries in which the Product is intended to be
sold, to the extent such standards are not in contravention with United States
Good Laboratory Practices.
GOOD MANUFACTURING PRACTICE means the current standards for the manufacture
of pharmaceuticals, as set forth in the FD&C Act and applicable regulations
promulgated thereunder, as amended from time to time, and such standards of good
manufacturing practice as are required by the European Union and other
Regulatory Authorities in countries in which the Product is intended to be sold,
to the extent such standards are not in contravention with United States Good
Manufacturing Practices.
IND means an investigational new drug application, as defined in the FD&C
Act and applicable regulations thereunder, or any equivalent document, filed
with the FDA and necessary for beginning clinical trials of any Licensed Product
in humans or any application or other documentation filed with any Regulatory
Authority of a
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
2
country other than the United States prior to beginning clinical trials of any
Licensed Product in humans in that country.
JOINT PROGRAM PATENT RIGHTS means any Program Patent Rights (defined in
below) which are jointly owned by the parties in accordance with Section 3.2(a)
and are not Mitsubishi Assigned Patent Rights (defined in below).
LICENSED PRODUCT(S) means any product: (a) which includes a Designated
Compound or a Derivative Compound; and (b) the development, manufacture, use, or
sale of which, absent the license granted to Mitsubishi under Section 3.1 or the
rights assigned to Mitsubishi under Section 3.2(d) of this Agreement, would
infringe the NeoGenesis Know-How, NeoGenesis Patent Rights, or which makes use
of any Program Patent Rights that is jointly owned by the parties.
MAJOR COUNTRY mean the United States, the United Kingdom, France, Germany,
Italy or Japan, as the case may be.
MANUFACTURING means any and all activities involved in the production of a
Licensed Product to be developed and/or Commercialized under this Agreement.
When used as a verb, MANUFACTURE means to engage in Manufacturing.
MITSUBISHI ASSIGNED KNOW-HOW means a part of Mitsubishi Know-How which is
assigned by NeoGenesis to Mitsubishi in accordance with Section 3.2(d).
MITSUBISHI ASSIGNED PATENT RIGHTS means a part of Mitsubishi Patent Rights
which is assigned by NeoGenesis to Mitsubishi in accordance with Section 3.2(d).
MITSUBISHI KNOW-HOW means all proprietary technical, Manufacturing and
clinical information, data and know-how, including but not limited to any
intellectual property relating to: (a) the Target, (b) the Derivative Compounds
or (c) the Licensed Products containing the Derivative Compounds, whether or not
patentable, Controlled by Mitsubishi or its Affiliates as of the Effective Date
or during the term of this Agreement. Mitsubishi Know-How includes, without
limitation, all processes, formulas, discoveries and inventions whether relating
to biological, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical safety, quality control and clinical data, including,
without limitation, clinical study data. Mitsubishi Know-How also includes
relevant medical information relating to the Licensed Products (such as customer
questions, responses thereto and adverse drug event) history in the possession
of Mitsubishi, its Affiliates or sublicensees. The term Mitsubishi Know-How,
however, does not include the NeoGenesis Know-How or any know-how, processes,
information and data which is, as of the Effective Date or later becomes,
generally available to the public.
MITSUBISHI PATENT RIGHTS means (a) those patents and patent applications
(other than patent applications and patents included within the NeoGenesis
Patent Rights) Controlled by Mitsubishi at any time during the term of this
Agreement which (i) relate to or otherwise would be infringed by the
manufacture, use, importation or sale of any Designated Compound or Licensed
Product or (ii) relate to Mitsubishi Know-How and (b) all divisionals,
continuations, continuations-in-part, reissues, extensions, supplementary
protection certificates and foreign counterparts thereof.
NDA means a new drug application as defined in the FD&C Act and applicable
regulations thereunder, and the non-U.S. equivalent thereof.
NEOGENESIS KNOW-HOW means all proprietary technical information, data and
know-how, including but not limited to any intellectual property relating to:
(a) the NeoMorph Screening Library, (b) the NeoMorph Focused Libraries, (c) ALIS
and QSCD, (d) the Candidate Compound A, (e) the Candidate Compound B, (d) the
Candidate Compound C, together with, where applicable, any analogs, derivatives,
fragments, sub-cellular constituents or expression products thereof and (e) any
other tangible materials provided by NeoGenesis to Mitsubishi for use in the
conduct of the Program, which (i) is Controlled by NeoGenesis, (ii) primarily
relates to a Designated Compound or Licensed Products, whether or not
patentable, and (iii) is listed in ATTACHMENT D, as ATTACHMENT D is amended from
time to time in accordance with Section 2.6 or Section 3.3. The term NeoGenesis
Know-How, HOWEVER, does not
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
3
include (1) any Mitsubishi Know-How, (2) any know-how, processes, information
and data which is, as of the Effective Date or later becomes,
generally available to the public or (3) any general manufacturing or other
know-how not specific to the Designated Compound or Licensed Products.
NEOGENESIS PATENT RIGHTS means those (a) patents and patent applications
listed in ATTACHMENT D, as ATTACHMENT D is amended from time to time in
accordance with Section 2.6 or Section 3.3, which are Controlled by NeoGenesis;
and (b) all divisionals, continuations, continuations-in-part, reissues,
extensions, supplementary protection certificates and foreign counterparts
thereof which are Controlled by NeoGenesis and are existing as of the Effective
Date or filed or issued during the term of this Agreement.
NEOMORPH CHEMISTRY means the process, proprietary to NeoGenesis, of forming
libraries and sub-libraries of discrete compounds by coupling a broad set of
diverse cores with diverse sets of building blocks employing proprietary
mass-coding algorithms.
NEOMORPH FOCUSED LIBRARIES means those compounds synthesized by NeoGenesis
derived from Active Compounds identified by Mitsubishi in bioassays or
functional assays
NEOMORPH SCREENING LIBRARY means the entire collection of libraries
consisting of mass-encoded small molecule organic compounds owned by NeoGenesis
and developed with NeoMorph Chemistry, comprising at least 10,000,000 different
compounds.
NET SALES means the aggregate amounts invoiced for sales or transfers for
value of Licensed Products by Mitsubishi, its Affiliates or any of its
sublicensee to an independent third party distributor, agent or end user in the
Territory (other than sales of Licensed Products at cost by Mitsubishi, its
Affiliates or sublicensees to a third party for use in a clinical study prior to
Regulatory Approval of such Licensed Product) LESS deductions selected as
appropriate from: (a) credits, refunds, allowances and price adjustments
separately and actually credited to customers for defective, spoiled, damaged,
outdated, and returned Licensed Products, (b) offered and taken trade and cash
discounts and rebates in amounts customary to the trade and as required to do
business in the country in which they are made, (c) sales, excise, value added,
turnover, use, and other like taxes, and customs duties, paid, absorbed or
allowed excluding net income tax, and (d) special outbound packing,
transportation, insurance and handling charges separately billed to the customer
or prepaid. Net Sales shall not include revenue received by Mitsubishi (or any
of its Affiliates) from transactions with an Affiliate, where the Licensed
Product in question will be resold to an independent third-party distributor,
agent or end user by the Affiliate where such revenue received by the Affiliate
from such resale is included in Net Sales in accordance with Section 4.3.
Revenue received by Mitsubishi (or any of its Affiliates) from transactions with
an Affiliate, where the Licensed Product in question is used by the Affiliate
solely for such Affiliate's internal purposes shall also be included in Net
Sales at a price equal to the fair market value of such transfer(s).
PERSON means any individual, corporation, association, partnership (general
or limited), joint venture, trust, estate, limited liability company, limited
liability partnership, unincorporated organization, government (or any agency or
political subdivision thereof) or other legal entity or organization.
PROGRAM means the screening program described in ATTACHMENT A as the same
may be amended during the term of this Agreement by mutual agreement of the
parties. The Program will be directed toward the discovery and development of
Candidate Compound B and Candidate Compound C for the Targets.
PROGRAM INTELLECTUAL PROPERTY means individually and collectively all
discoveries, inventions, know-how, techniques, methodologies, modifications,
improvements, works of authorship, designs and data (whether or not protectable
under patent, copyright, trade secrecy or similar laws) that are conceived,
created, discovered, developed, or reduced to practice or tangible medium of
expression (a) solely by one or more employees or consultants of NeoGenesis
(other than consultants also affiliated with Mitsubishi in connection with the
Program) at any time in the course of the Program; (b) jointly by one or more
employees or consultants of NeoGenesis and one or more employees or consultants
of Mitsubishi at any time in the course of the Program; or (c) solely by one or
more employees or consultants of Mitsubishi (other than consultants also
affiliated with NeoGenesis in connection with the
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
4
Program) at any time in the course of the Program. Program Intellectual Property
is listed in ATTACHMENT B, which shall be amended from time-to-time to
include new Program Intellectual Property, in accordance with Section 3.3.
PROGRAM PATENT RIGHTS means (a) those patents and patent applications, the
claim of which covers all or part of Program Intellectual Property, and (b) all
divisionals, continuations, continuations-in-part, reissues, extensions,
supplementary protection certificates and foreign counterparts thereof.
QSCD means Quantisized Surface Complimentary Diversity, a model proprietary
to NeoGenesis, in terms of which discrete chemical compliments to the surfaces
of a Target are defined.
R&D PROGRAM means on a Designated Compound-by-Designated Compound or
Licensed Product-by-Licensed Product and country-by-country basis the activities
necessary or desirable to be undertaken in connection with the research and
development of such Designated Compound or Licensed Product prior to obtaining
Regulatory Approval for a Licensed Product in such country (regardless of the
country in which such activities are conducted).
REGULATORY APPROVALS means, for any country in the Territory, those
authorizations by the appropriate Regulatory Authority(ies) required for the
manufacture, importation, marketing, promotion, pricing and sale of the Licensed
Product(s) in such country.
REGULATORY AUTHORITY means any national, supra-national, regional, state or
local regulatory agency, department, bureau, commission, council or other
governmental entity in the Territory, including, without limitation, the FDA.
SUCCESS CRITERIA means the success criteria defined by the parties with
respect to Candidate Compound C that have a certain desired degree of chemical
binding activity and activity in Target-based functional assays.
TARGET means a specific protein target(s) selected by Mitsubishi for which
NeoGenesis will perform the Program. The Target(s) are identified in ATTACHMENT
C.
TERRITORY means all the countries of the world.
1.2 OTHER DEFINED TERMS. The following terms shall have the meanings set forth
in the section appearing opposite such term:
AGREEMENT Recitals
BANKRUPTCY CODE Section 3.1
CANDIDATE COMPOUNDS A ATTACHMENT A
CANDIDATE COMPOUND B ATTACHMENT A
CANDIDATE COMPOUNDS C ATTACHMENT A
CLAIM NOTICE Section 6.6
COMPOUNDS ATTACHMENT A
DESIGNATED COMPOUND Section 2.6
EFFECTIVE DATE Recitals
FDA Section 4.2
ICC Section 9.1
INDEMNIFYING PARTY Section 7.4
INDEMNIFIED PARTY(IES) Section 7.3
FINAL TARGET REPORT ATTACHMENT A
LICENSED TECHNOLOGY Section 3.1
LOSSES Section 7.2
MITSUBISHI Recitals
NEOGENESIS Recitals
PHASE I CLINICAL TRIALS Section 4.2
PHASE III CLINICAL TRIALS Section 4.2
PMA Section 4.2
SCREENING PERIOD Section 2.2
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
5
2. SCREENING PROGRAM; R&D PROGRAM; COMMERCIALIZATION
2.1 DELIVERY OF TARGET PROTEINS. Mitsubishi shall deliver the Targets to
NeoGenesis for screening within [*] following the Effective Date. Mitsubishi
shall provide Targets in the quantities and formats specified in ATTACHMENT A.
Mitsubishi shall also provide NeoGenesis at the time of delivery with a written
description of the concentration and volume of the Target. Mitsubishi shall
deliver the Targets CIP to NeoGenesis's Cambridge facility.
2.2 SCREENING PROGRAM. NeoGenesis will apply use its ALIS method to screen the
NeoMorph Library for activity with respect to each Target for purposes of
identifying potentially useful chemical compounds for further evaluation and
development. Screening will be performed pursuant to the screening protocol for
the Program set forth in ATTACHMENT A. NeoGenesis shall commence the Program
following the date the Targets are delivered to NeoGenesis and shall complete
the Program within [*] following the date that the Targets are delivered to
NeoGenesis, unless the parties agree in writing to extend the period for
performance of the Program (the SCREENING PERIOD).
2.3 GRANT OF RESEARCH LICENSE. Mitsubishi hereby grants NeoGenesis a
nonexclusive, nontransferable, royalty-free license to use Mitsubishi Know-How
and Mitsubishi Patent Rights solely for purposes of conducting the Program and
performing NeoGenesis's obligations to Mitsubishi under the Program. NeoGenesis
will not use Mitsubishi Know-How or Mitsubishi Patent Rights for any other
purpose, without Mitsubishi's prior written permission. NeoGenesis shall not (a)
grant, or attempt to grant, a sub-license to use Mitsubishi Know-How or
Mitsubishi Patent Rights to any Person without the express written consent of
Mitsubishi, (b) perform any tests on either of the Targets that are outside the
scope of the Program, or (c) modify the Targets supplied by Mitsubishi,
including, without limitation, the making of any derivatives, analogs or
components thereof. In the event that NeoGenesis does not consume all of the
Targets supplied by Mitsubishi in performance of the Program, NeoGenesis will
upon completion of the Program promptly, return to Mitsubishi any quantities of
such Target(s) and any derivatives, analogs or components thereof.
2.4 SCIENTIFIC REPORTS. (a) NeoGenesis will keep and maintain adequate records
containing laboratory data generated in the course of the Program to enable it
to furnish complete and accurate information to Mitsubishi regarding the Program
activities and results, including all Candidate Compound A, Candidate Compound B
and NeoMorph Focused Libraries identified in the Program and all Program
Intellectual Property developed by NeoGenesis during the Program. All such
written records of NeoGenesis shall be open to inspection by Mitsubishi during
normal business hours upon reasonable prior written notice.
(b) NeoGenesis shall provide Mitsubishi with reasonably-detailed written
reports describing the results of the research performed pursuant to the Program
including all Candidate Compound A, Candidate Compound B and NeoMorph Focused
Libraries identified in the Program. Such reports shall be delivered to
Mitsubishi at least monthly during the Program. NeoGenesis will deliver a Final
Target Report (as defined in ATTACHMENT A) with respect to the Program work
performed on each Target including a description of all the Candidate Compound
A, Candidate Compound B and NeoMorph Sublibraries identified during the Program
with respect to such Target.
2.5 COMMUNICATIONS. The parties shall meet or communicate from time to time
each other to conduct the Program. The parties shall designate a representative
who shall be in charge of the communication between parties during a period of
the Program. Mitsubishi shall have the right to make the final decision with
respect to the management and conduct the Program after the communication or
discussion between the parties.
2.6 DESIGNATED COMPOUNDS. (a) Within [*] following the delivery of the Final
Target Report for each Target by NeoGenesis in accordance with Section 2.4 and
ATTACHMENT A, Mitsubishi shall notify NeoGenesis whether it will classify any
Candidate Compound C (or any derivative compound(s) of such Candidate Compound
C) as candidates for drug development based on Mitsubishi's good faith
evaluation of the satisfaction of the Success Criteria by such Candidate
Compound C (or any derivative compound(s) of such Candidate Compound C) (each, a
DESIGNATED COMPOUND). Mitsubishi may select [*] Designated Compounds for each
Target. If Mitsubishi does not identify any Designated Compound(s) within such
period, then upon [*] notice from NeoGenesis and unless Mitsubishi identifies
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
6
such Designated Compound(s) within such [*] period, the license granted
Mitsubishi shall terminate and be of no further force or effect with respect to
the applicable Target, and no further payment from Mitsubishi shall be due with
respect to such Target.
(b) Within [*] following receipt of notification from Mitsubishi
identifying Designated Compounds, NeoGenesis shall amend ATTACHMENT D to
identify any applicable NeoGenesis Patent Rights not previously identified to
Mitsubishi.
2.7 PRODUCT DEVELOPMENT. Mitsubishi, at its sole expense, shall be solely
responsible for conducting the R&D Program related to Designated Compounds and
Licensed Products and shall use its Commercially Reasonable Efforts to develop
and obtain Regulatory Approvals for Licensed Products in at least one of the
Major Countries. Mitsubishi shall conduct the R&D Program in accordance with all
Applicable Laws, Good Laboratory Practices and Good Clinical Practices.
2.8 MANUFACTURE OF PRODUCT. Mitsubishi shall be solely responsible, at its sole
expense, for and shall use its Commercially Reasonable Efforts to Manufacture
the Licensed Products in accordance with the Regulatory Approvals, Applicable
Laws, Good Laboratory Practices and Good Manufacturing Practices.
2.9 REGULATORY MATTERS. Mitsubishi shall be solely responsible, at its sole
expense, for the preparation and filing, in its own name or in the name of a
sublicensee (if Mitsubishi sublicenses its rights under Section 3.1), with the
appropriate Regulatory Authorities, of all documents that are necessary to
conduct clinical studies of Licensed Products and Regulatory Approval
applications that are necessary to market and sell Licensed Products. Mitsubishi
shall use Commercially Reasonable Efforts to file Regulatory Approval
applications in the Major Countries. Simultaneously with the submission of each
such regulatory filing, Mitsubishi shall notify NeoGenesis, in writing, that
such regulatory filing has been made. Mitsubishi shall be solely responsible for
reporting all adverse events associated with any Licensed Product to the
appropriate Regulatory Authorities in accordance with Applicable Laws.
2.10 MARKETING AND SALE. Mitsubishi, at its sole expense, shall be solely
responsible for the Commercialization of Licensed Products in the Territory and
shall use its Commercially Reasonable Efforts to Commercialize each Licensed
Product in at least one of the Major Countries. Mitsubishi shall be solely
responsible for establishing the price of each Licensed Product sold by or on
behalf of it pursuant to this Agreement.
2.11 THIRD PARTY LICENSES. Mitsubishi shall be solely responsible for (a)
obtaining any and all licenses from third parties necessary or desirable to
perform the R&D Program and/or to Commercialize any Licensed Product and (b) any
and all consideration payable with respect to such licenses.
2.12 COMPLIANCE WITH LAW. Mitsubishi shall conduct the R&D Program and conduct
its Manufacturing operations in a safe and prudent manner, in compliance with
all Applicable Laws (including, but not limited to, occupational safety and
health, public safety and health, protecting the environment, the disposal of
wastes, Good Clinical Practices, Good Laboratory Practices and Good
Manufacturing Practices), and in compliance with all applicable provisions of
this Agreement. Mitsubishi shall obtain all necessary registrations and permits
pertaining to activities contemplated by this Agreement.
2.13 PERIODIC REVIEW. Mitsubishi shall periodically, at least once a year,
provide NeoGenesis with an update on the status of the progress of Mitsubishi's
R&D Program and Commercialization of each Licensed Product.
3. LICENSE; PROPRIETARY RIGHTS
3.1 GRANT OF LICENSE. (a) Subject to the terms and conditions of this
Agreement, including the payment of all applicable fees, NeoGenesis hereby
grants to Mitsubishi, and Mitsubishi hereby accepts, an exclusive, worldwide,
right and license, within the Territory, to use the NeoGenesis Know-How and
NeoGenesis Patent Rights and NeoGenesis' undivided interest in any Program
Intellectual Property and Joint Program Patent Rights, as embodied in or related
to any Designated Compound(s) (collectively, the LICENSED TECHNOLOGY), to (i)
research, develop, make, have made and use such Designated Compound to develop
Licensed Products and (ii) to make, have made, use, distribute for sale,
promote, market, offer for sale, sell, have sold, import and export Licensed
Products.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
7
Mitsubishi may grant sublicenses of its rights under this Section 3.1; PROVIDED
that Mitsubishi: (1) obtains each sublicensee's written agreement to be subject
to the same obligations as is Mitsubishi under Sections 2.12, 2.13, 3.1(c), 3.2,
4.4-4.7, 5.2 and 8.3(c) (last sentence) of this Agreement (or substantially
identical provisions) and (2) shall remain responsible for the performance of
all of its obligations under this Agreement, whether such obligations are
performed by Mitsubishi, its Affiliates or any of its sublicensees. Mitsubishi
shall also ensure that all sublicensees are required to indemnify NeoGenesis
with respect to the matters that are addressed in Section 7.2(b) and Section
7.3(b) (it being further understood that NeoGenesis need not be identified by
name). For purposes of clarity, it is expressly understood and agreed that in
the event and to the extent that any NeoGenesis Know-How or NeoGenesis Patent
Rights (including NeoGenesis' undivided interest in any Program Intellectual
Property and Joint Program Patent Rights) are the subject of the assignment
under Section 3.2(d), this Section 3.1(a) shall not apply to such NeoGenesis
Know-How or NeoGenesis Patent Rights (including Program Intellectual Property
and Joint Program Patent Rights).
(b) The license granted under this Section 3.1 shall be treated as a
license of rights to "intellectual property" (as defined in Section 101(56) of
Title 11 of the United States Code, as amended (the BANKRUPTCY CODE)) for
purposes of Section 365(n) of the Bankruptcy Code. The parties agree that
Mitsubishi may elect to retain and may fully exercise all of its rights and
elections under the Bankruptcy Code PROVIDED, that it abides by the terms of
this Agreement.
(c) Mitsubishi shall xxxx or have marked all containers or packages of
Licensed Products that are the subject of the license granted under this Section
3.1 in accordance with the patent marking laws of the jurisdiction in which such
Licensed Products are manufactured, used or sold.
3.2 RETAINED RIGHTS. (a) This Agreement does not convey to Mitsubishi any
ownership rights in any NeoGenesis Know-How or NeoGenesis Patent Rights by
implication, estoppel or otherwise except for the rights expressly granted in
Section 3.1 and specifically does not convey to Mitsubishi any rights with
respect to ALIS or QSCD. Title to the NeoGenesis Know-How and NeoGenesis Patent
Rights shall at all times remain vested in NeoGenesis. This Agreement does not
convey to NeoGenesis any ownership rights in any Mitsubishi Know-How or
Mitsubishi Patent Rights by implication, estoppel or otherwise except for the
rights expressly granted in Section 2.3. Unless otherwise provided herein, title
to the Mitsubishi Know-How and Mitsubishi Patent Rights shall at all times
remain vested in Mitsubishi. Title to and any interest in Program Intellectual
Property described in clause (a) of the Program Intellectual Property definition
(including corresponding Program Patent Rights) shall be the property of
NeoGenesis and is included in the definition of NeoGenesis Know-How or
NeoGenesis Patent Rights, as the case may be. Title to and any interest in
Program Intellectual Property described in clause (b) of the Program
Intellectual Property definition (including corresponding Program Patent Rights)
shall be jointly held by Mitsubishi and NeoGenesis. Title to and any interest in
Program Intellectual Property described in clause (c) of the Program
Intellectual Property definition (including corresponding Program Patent Rights)
shall be the property of Mitsubishi and is included in the definition of
Mitsubishi Know-How or Mitsubishi Patent Rights, as the case may be.
(b) If required, patent counsel mutually acceptable to the parties and
selected by the parties shall determine inventorship of all Program Intellectual
Property and Program Patent Rights that arises from the transactions
contemplated by this Agreement in accordance with U.S. patent law (and other
U.S. intellectual property law) when determining whether such intellectual
property is (i) Mitsubishi Know-How or Mitsubishi Patent Rights or (ii)
NeoGenesis Know-How or NeoGenesis Patent Rights or (iii) whether Program
Intellectual Property or Program Patent Rights is jointly owned or is owned
solely by NeoGenesis or by Mitsubishi.
(c) NeoGenesis shall retain the following rights with respect to the
following NeoGenesis Know-How and NeoGenesis Patent Rights and Program
Intellectual Property and Program Patent Rights:
(i) NeoGenesis shall continue to use its compound screening library to
screen target proteins for other parties; PROVIDED, that (a) for a
period of [*] from the date of the notice in which NeoGenesis
identifies Candidate Compound A, NeoGenesis shall mask the Candidate
Compound A that are in the Chemotype of the Designated Compound(s)
relating to such Target from the NeoGenesis NeoMorph Screening Library
and (b) for a period of [*] from the Effective Date, NeoGenesis shall
not use its NeoMorph Screening Library to screen a target protein that
is greater than [*] homologous at the peptide level to the Target for
itself or other parties.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
8
(ii) NeoGenesis shall continue to use Candidate Compound B and
Candidate Compound C that are not selected as Designated Compounds, as
embodied in focused/optimization libraries developed as part of the
Program to support NeoGenesis patent applications outside the
transactions contemplated by the Program.
(iii) NeoGenesis shall retain all rights and continue to use
optimization compounds created as part of the Program but not selected
as Candidate Compound B or Candidate Compound C.
(iv) NeoGenesis shall retain all rights in and continue to use compound
libraries that are designed as part of the Program using QSCD or other
structural information.
(d) In addition to the license granted under Section 3.1 with respect to
Licensed Technology, effective on Mitsubishi's notice date of Designated
Compounds (as specified in ATTACHMENT A), NeoGenesis hereby assigns and agrees
to assign to Mitsubishi all of NeoGenesis' right, title and interest in any and
all Designated Compounds including any patent rights or other intellectual
property rights embodied in or relating to such Designated Compounds within
Program Patent Rights or Program Intellectual Property. Such assigned Designated
Compounds and the corresponding Mitsubishi Assigned Patent Rights shall, from
the date of assignment by NeoGenesis, be treated as Mitsubishi Patent Rights for
purposes of this Agreement (including Section 3.3(d) and Section 3.4) and such
assigned Designated Compounds and the corresponding Mitsubishi Assigned Know-How
shall, from the date of assignment by NeoGenesis, be treated as Mitsubishi
Know-How and Mitsubishi's Confidential Information; PROVIDED, that
notwithstanding any provision of this Agreement to the contrary, Mitsubishi
shall remain obligated to pay NeoGenesis in respect of all such assigned
Designated Compounds (and any related Licensed Products) the milestone fees and
royalties due NeoGenesis under Section 4.2 and Section 4.3 of this Agreement.
NeoGenesis shall cooperate with Mitsubishi with respect to the preparation,
filing and maintenance of Mitsubishi Assigned Patent Rights if Mitsubishi
requires.
3.3 DISCLOSURE; PATENT PROSECUTION. (a) Each of NeoGenesis and Mitsubishi shall
promptly disclose to the other knowledge of any Program Intellectual Property;
such Program Intellectual Property will be added to ATTACHMENT B (and ATTACHMENT
D if applicable) and will be subject to the provisions of this Agreement. Within
forty-five (45) days following the date of such disclosure regarding the
existence of particular Program Intellectual Property that is jointly owned, the
parties shall confer as to appropriate protection for such Program Intellectual
Property. Notwithstanding the provision of this Section 3.3, no party shall
file, prosecute and maintain any Program Patent Right without the other party's
prior written consent before the date specified in ATTACHMENT A for Mitsubishi's
notice of Designated Compounds.
(b) NeoGenesis shall have the sole right, but not the obligation, to file,
prosecute, and maintain each of the NeoGenesis Patent Rights throughout the
Territory. NeoGenesis shall be responsible for all cost and expenses incurred by
NeoGenesis for the filing, prosecution and maintenance of NeoGenesis Patent
Rights. NeoGenesis shall keep Mitsubishi currently advised as to the status of
all patents and patent applications with respect to the NeoGenesis Patent Rights
and shall supply Mitsubishi promptly with copies of all patents, patent
applications, substantive patent office actions, substantive responses received
or filed in connection with such applications. Mitsubishi may itself or through
its attorney offer comments and suggestions with respect to the matters that are
the subject of this Section 3.3(b) and NeoGenesis agrees to consider such
comments and suggestions; PROVIDED that nothing herein shall obligate NeoGenesis
to adopt or follow such comments or suggestions. In the event that NeoGenesis
elects not to file for patent protection under the NeoGenesis Patent Rights or
elects not to prosecute or maintain a patent or patent application under the
NeoGenesis Patent Rights it shall notify Mitsubishi of such decision at least
forty-five (45) days prior to the due date of any action or payment due.
Mitsubishi shall have the right, but not the obligation, to be assigned such
patents from NeoGenesis and to assume the responsibility therefor then at its
own cost and expense.
(c) Mitsubishi and NeoGenesis shall discuss Joint Program Patent Rights
issues, and shall select and retain patent counsel mutually acceptable to each
of them, which patent counsel may be Mitsubishi patent counsel or NeoGenesis
patent counsel or third party patent counsel as the parties mutually agree, for
the purpose of preparing, prosecuting, issuing and maintaining appropriate
patent applications concerning Joint Program Patent Rights. Mitsubishi, in
consultation with NeoGenesis, shall be responsible for the preparation, filing
(including foreign filing
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
9
decisions), prosecution and maintenance of such jointly owned Program Patents
Rights. Designated patent counsel shall furnish or have furnished to Mitsubishi
and NeoGenesis copies of documents relevant to the same and provide Mitsubishi
and NeoGenesis with the opportunity to review and comment on patent decisions
made by patent counsel. Any differences between NeoGenesis and Mitsubishi with
respect to preparation, filing, prosecution, issuance and maintenance matters
will be discussed and resolved to their mutual satisfaction using the procedures
specified in Section 9.1, if necessary; PROVIDED, that if any disagreement
regards solely the costs associated with a particular proposed action, either
party may assume responsibility for such costs and the requirement that the
parties mutually agree upon resolution of the matter shall not apply. NeoGenesis
and Mitsubishi shall equally be responsible for all expenses associated with the
preparation, filing, prosecution, issuance and maintenance of Joint Program
Patent Rights; PROVIDED, that in the event that either party elects not to
pursue a particular action with respect to which the parties disagree regarding
costs, the other party shall have the right to assume such costs and to have
such action taken; PROVIDED FURTHER that the rights of the party that does not
pay its portion of such costs shall exclude any intellectual property rights
that are the subject of such action (e.g., patent coverage in a particular
country) unless such party reimburses the other party for one-half (50%) of the
costs of such action.
(d) Mitsubishi shall have the sole right, but not the obligation, to file,
prosecute, and maintain, at Mitsubishi's sole expense, each of the Mitsubishi
Patent Rights throughout the Territory.
3.4 ENFORCEMENT. (a) NeoGenesis shall be solely responsible for defense and
enforcement of NeoGenesis Know-How and NeoGenesis Patent Rights but excluding
Licensed Technology within the Field and the Territory. Mitsubishi shall be
solely responsible for the defense and enforcement of Mitsubishi Know-How and
Mitsubishi Patent Rights.
(b) Except as otherwise provided in Section 3.4(a), NeoGenesis shall have
the first option to pursue any enforcement or defense of NeoGenesis Patent
Rights within Licensed Technology ; PROVIDED, that NeoGenesis pays all costs and
expenses related to the same, keeps Mitsubishi reasonably informed of its
progress and provides Mitsubishi with copies of any documents related to such
proceedings and reasonable notice of all proceedings relating to same.
NeoGenesis shall notify Mitsubishi of its decision to exercise its right to
enforce Licensed Technology as soon as possible, but not later than sixty (60)
days following its discovery or receipt of notice of the alleged infringement.
(c) If NeoGenesis does not exercise its option to enforce or defend any
NeoGenesis Patent Rights within Licensed Technology or (within ninety (90) days
of commencing to prosecute any enforcement or defense action) Mitsubishi and
NeoGenesis have not otherwise agreed not to pursue such infringement for
business reasons, and NeoGenesis (i) has not persuaded the alleged infringer to
desist, (ii) is not diligently pursuing an infringement action or diligently
defending the validity or enforceability of Licensed Technology at issue, as
determined by Mitsubishi in its reasonable discretion, or (iii) has not provided
Mitsubishi with evidence of bona fide negotiations of an acceptable sublicense
agreement with the alleged infringer, then Mitsubishi shall have the right to
pursue the alleged infringer or take control of any action initiated by
NeoGenesis at Mitsubishi's own expense. In any such case, NeoGenesis will
substitute NeoGenesis as party plaintiff for purposes of pursuing any alleged
infringer.
(d) Any recovery of damages with regard to NeoGenesis Patent Rights within
Licensed Technology in any suit handled by one party pursuant to Section 3.4(b)
or Section 3.4(c) shall be applied first in satisfaction of any unreimbursed
expenses and legal fees of the litigant relating to the suit or settlement
thereof. Any remaining recoveries shall (i) to the extent that the infringement
is based on the development, manufacture, commercialization or use of Licensed
Products in the Field, be deemed Net Sales and NeoGenesis shall receive an
amount equal to the royalty due on such Net Sales and Mitsubishi shall receive
the balance of such remainder; or (ii) to the extent that the infringement is
not based on the development, manufacture, commercialization or use of Licensed
Products in the Field, such remainder shall be paid (1) one hundred percent
(100%) to NeoGenesis if NeoGenesis is the prosecuting party or (2) one hundred
percent (100%) to Mitsubishi if Mitsubishi is the prosecuting party.
(e) Mitsubishi shall have the first option to pursue any enforcement or
defense of Licensed Technology (other than NeoGenesis Patent Rights); PROVIDED,
that Mitsubishi pays all costs and expenses related to the same, Mitsubishi
keeps NeoGenesis reasonably informed of its progress and Mitsubishi provides
NeoGenesis with copies of any documents related to such proceedings and
reasonable notice of all proceedings relating to same. Mitsubishi
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
10
shall notify NeoGenesis of its decision to exercise its right to enforce such
Licensed Technology (other than NeoGenesis Patent Rights) as soon as possible,
but not later than sixty (60) days following its discovery or receipt of notice
of the alleged infringement.
(f) If Mitsubishi does not exercise its option to enforce or defend any
Licensed Technology (other than NeoGenesis Patent Rights) or (within ninety (90)
days of commencing to prosecute any enforcement or defense action) Mitsubishi
and NeoGenesis have not otherwise agreed not to pursue such infringement for
business reasons, and Mitsubishi has not persuaded the alleged infringer to
desist, then NeoGenesis shall have the right to pursue the alleged infringer or
take control of any action initiated by Mitsubishi at NeoGenesis's own expense.
In any such case, Mitsubishi will substitute NeoGenesis as party plaintiff for
purposes of pursuing any alleged infringer.
(g) Any recovery of damages with regard to any suit handled by one party
pursuant to Section 3.4(e) or Section 3.4(f) shall be applied first in
satisfaction of any unreimbursed expenses and legal fees of the litigant
relating to the suit or settlement thereof. Any remaining recoveries shall (i)
to the extent that the infringement is based on the development, manufacture,
commercialization or use of Licensed Products in the Field, be deemed Net Sales
and NeoGenesis shall receive an amount equal to the royalty due on such Net
Sales and Mitsubishi shall receive the balance of such remainder; or (ii) to the
extent that the infringement is not based on the development, manufacture,
commercialization or use of Licensed Products in the Field, such remainder shall
be paid (1) one hundred percent (100%) to NeoGenesis if NeoGenesis is the
prosecuting party or (2) one hundred percent (100%) to Mitsubishi if Mitsubishi
is the prosecuting party.
(h) Notwithstanding the provisions of Section 3.4(b), in the event that a
declaratory judgment action alleging invalidity or non-infringement of any of
the patents within Licensed Technology that are within NeoGenesis Patent Rights
but are not within Joint Program Patent Rights, NeoGenesis shall have the first
option, within sixty (60) days after notification of same, to assume defense of
the action concerning its own technology at its expense, but Mitsubishi shall be
entitled to participate in such action, at its own expense.
(i) In any infringement suit as either party may institute to enforce
Licensed Technology, Joint Program Patent Rights, Mitsubishi Assigned Patent
Rights, or in any declaratory judgment action alleging invalidity or
non-infringement of any Licensed Technology, Joint Program Patent Rights,
Mitsubishi Assigned Patent Rights brought against NeoGenesis or Mitsubishi, the
other party shall, at the request and expense of the party initiating or
defending the suit or action, cooperate and assist in all reasonable respects,
having its employees testify when requested and making available relevant
records, papers, information, specimens and the like.
(j) Notwithstanding any provisions of Section 3.4 to the contrary, each
party shall immediately give written notice to the other of any certification of
which it becomes aware filed pursuant to the Xxxxxx-Xxxxx Act (21 U.S.C.
Sections 355(b)(2)(A), or Sections 355(j)(2)(A)(vii)), or any amendment or
successor statute thereto, at least fourteen (14) days prior to expiration of
the forty five (45) day period set forth in 21 U.S.C. Sections 355(c)(3)(c) (or
any amendment or successor statute thereto), then Mitsubishi shall have the
right to bring such an infringement action, in its sole discretion and at its
own expense, in its own name and/or in the name of NeoGenesis. Any recoveries
obtained (by settlement or otherwise) by either party as a result of any
proceeding against a third party infringer brought under this Section 3.4(j)
shall first be used to reimburse each party for all litigation costs in
connection with such proceeding paid by that party and second, to the extent
that the infringement is based on the development, manufacture,
commercialization or use of Licensed Products in the Field, any remainder shall
be deemed Net Sales and NeoGenesis shall receive an amount equal to the royalty
due on such Net Sales and Mitsubishi shall receive the balance of such
remainder, and, to the extent that the infringement is not based on the
development, manufacture, commercialization or use of Licensed Products in the
Field, any remainder shall be paid (x) one hundred percent (100%) to Mitsubishi
if Mitsubishi is the prosecuting party or (y) one hundred percent (100%) to
NeoGenesis if NeoGenesis is the prosecuting party. If Mitsubishi or its
sublicensee initiate suit pursuant to this Section 3.4(j), it will promptly
notify NeoGenesis.
4. PRICING; PAYMENT
4.1 SCREENING FEE. Mitsubishi will pay NeoGenesis a screening fee of [*] for
the NeoGenesis services pursuant to the Program. Mitsubishi will pay this fee
within thirty (30) days of the Effective Date.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
11
4.2 MILESTONES. (a) Mitsubishi will pay NeoGenesis milestone payments in
respect of Licensed Products as specified in this Section 4.2.
(i) Within thirty (30) days following the date on which Mitsubishi
identifies any Designated Compound in accordance with Section 2.6,
Mitsubishi will pay NeoGenesis [*].
(ii) Within thirty (30) days following the date on which Mitsubishi
administers any Licensed Product to a human subject in the first
Phase I Clinical Trials relating to any Licensed Product,
Mitsubishi will pay NeoGenesis [*]. PHASE I CLINICAL TRIALS means
any safety and/or efficacy clinical studies of any Licensed
Product in healthy individuals or patients to support its
continued testing in similar clinical trials prescribed by the
relevant Regulatory Authority.
(iii)Within thirty (30) days following the date on which the first
administration or dosing of any Licensed Product occurs in the
first Phase III Clinical Trials relating to any Licensed Product,
Mitsubishi will pay NeoGenesis [*]. PHASE III CLINICAL TRIALS
means any safety and/or efficacy clinical studies of any Licensed
Product in human patients with the disease target being studied to
determine safety and efficacy of a Licensed Product in patients as
required by the relevant Regulatory Authorities.
(iv) Within thirty (30) days following the date on which Mitsubishi
submits a NDA covering any Licensed Product with the FDA, or makes
a comparable filing with regulatory authorities in another Major
Country, Mitsubishi will pay NeoGenesis [*].
(v) Within thirty (30) days following the date on which Mitsubishi
receives a product manufacturing approval (PMA) or similar
Regulatory Approval from the FDA permitting the manufacture and
sale of a Licensed Product or a comparable Regulatory Approval for
another Major Country, Mitsubishi will pay NeoGenesis [*].
(b) Milestones identified in Section 4.2(a)(i)-(iii) shall be due only for
the first Licensed Product, regardless of the number of Licensed Products
identified by the Program or developed and/or commercialized by Mitsubishi.
Milestones identified in Section 4.2(a)(iv)-(v) shall be due for both the first
and the second Licensed Product, regardless of the number of Licensed Products
identified by the Program or developed or Commercialized by Mitsubishi;
PROVIDED, that the payment will not be due in respect of the second Licensed
Product if the second Licensed Product is a replacement for the first Licensed
Product due to the failure of the first Licensed Product to receive a Section
4.2(a)(v) Regulatory Approval. On the date any one milestone with respect to a
Licensed Product is achieved, all lower numbered unachieved milestones shall be
deemed to have been achieved with respect to that Licensed Product.
4.3 ROYALTIES. (a) Not later than sixty (60) days following each March 31, June
30, September 30 and December 31 commencing with the First Commercial Sale of
Licensed Products in any country, Mitsubishi shall pay to NeoGenesis royalties
by country for the most recent three-month period then ended, equal to [*] of
Net Sales. Mitsubishi shall pay royalties with respect to each Licensed Product
on a country by country basis (i) until the expiration or revocation or complete
rejection of the last to expire or to be revoked or to be completely rejected of
any NeoGenesis Patent Right or Joint Program Patent Rights or Mitsubishi
Assigned Patent Rights covering such Licensed Product in the country in which
the Licensed Product is manufactured or sold, or (ii) if no such patent right
exists in the relevant country covering the manufacture, use or sale of the
relevant Licensed Product, until [*] from the First Commercial Sale of such
Licensed Product in such country.
(b) If Mitsubishi obtains one or more licenses under patents owned by a
third party to avoid infringement by any Licensed Product of such third party
patent(s), Mitsubishi may, beginning from the date of such third party
license, deduct [*] of the amount of royalties paid to such third party on
sales of Licensed Product under such licenses, provided that: (i) such
infringement is primarily due to the Designated Compound as licensed or
assigned by NeoGenesis and not related to changes or additions to the
Designated Compound made by a party other than NeoGenesis and (ii) such
deductions reduce by no more than [*] the royalties otherwise due NeoGenesis
under this Section 4.3 with respect to such Licensed Product.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
12
4.4 REMITTANCE. (a) All royalties and milestone payments required under this
Section 4 shall be payable in full in the United States in United States
Dollars, regardless of the countries in which sales are made. For the purpose of
computing Net Sales for which a currency other than United States Dollars is
received, such currency shall be converted into United States Dollars at the
simple average of all Mondays' exchange rate for buying United States Dollars
set forth in THE WALL STREET JOURNAL for the calendar quarter in which such
sales were made.
(b) In the event that any payment due NeoGenesis under this Agreement is
not made when due, the amount due shall accrue interest beginning on the
thirtieth (30th) day following the final date on which such payment was due,
calculated at the annual rate equal to two percent (2%) above the prime interest
rate reported in the WALL STREET JOURNAL for the due date, calculated from the
due date until paid in full. Such payment when made shall be accompanied by all
interest so accrued. Said interest and the payment and acceptance thereof shall
not negate or waive the right of NeoGenesis to any other remedy, legal or
equitable, to which it may be entitled because of the delinquency of the
payment.
(c) If at any time legal restrictions within any country in the Territory
prevent the conversion of the local currency and such currency cannot be removed
from such country such that prompt remittance by Mitsubishi of any royalties
owed by Mitsubishi to NeoGenesis in respect of sales in such country is
prevented, Mitsubishi shall use its best efforts to make payment through any
lawful means or methods that may be available as Mitsubishi shall reasonably
determine. If royalties in any country cannot be remitted within three (3)
months after the end of the relevant royalty period then Mitsubishi shall pay
NeoGenesis in the local currency of such country by deposit of the relevant
royalties sin a bank account in such country designated by NeoGenesis.
4.5 RECORDS. Mitsubishi, its Affiliates and sublicensees shall keep and
maintain for a period of at least three (3) years from the date of each payment
of royalties, records (prepared in accordance with United States Generally
Accepted Accounting Principles, consistently applied) sufficient to determine
the amounts of Net Sales and payments due under Section 4.3. Within sixty (60)
days following each March 31, June 30, September 30 and December 31 in which
payments are due under Section 4.3, Mitsubishi shall provide NeoGenesis with a
report including at least: (a) the quantities of Licensed Products that
Mitsubishi, its Affiliate(s) and sublicensee(s) sold during the preceding
quarter in each country in which Licensed Products or package products
containing Licensed Products were sold; (b) the monetary amount, in the
national currency of such country, of such sales; (c) actual Net Sales, by
country; (d) the currency conversion rate used and U.S. dollar-equivalent of
such sales; (e) the calculation of royalties thereon; and (f) the total
royalties so computed and due NeoGenesis. Such reports shall be submitted to
NeoGenesis whether or not any sales of Licensed Product have been made during
such period. Upon delivery of the report due for the period ending December 31
of each year, Mitsubishi shall also report to NeoGenesis the aggregate
royalties due NeoGenesis for the entire preceding year.
4.6 INSPECTION. Mitsubishi and its Affiliates and sublicensees shall each make
its records available for inspection by an independent certified public
accountant, appointed by NeoGenesis and reasonably acceptable to Mitsubishi,
during regular business hours at such place or places where such records are
customarily kept, upon reasonable notice from NeoGenesis, solely to verify the
accuracy of the reports and payments. Such inspection right shall not be
exercised more than once in any calendar year nor more than once with respect to
sales of Licensed Products in any given payment period. NeoGenesis agrees to
hold in strict confidence all information concerning royalty payments and
reports, and all information learned in the course of any audit or inspection,
except to the extent necessary for NeoGenesis to reveal such information in
order to enforce its rights under this Agreement or if disclosure is required by
law, regulation or judicial order. Any person or entity conducting such audit or
inspection will agree in writing with NeoGenesis to treat all records reviewed
in the course of the audit or inspection as the Confidential Information of
Mitsubishi under terms and conditions no less restrictive than the terms
contained in Section 5.2. The results of each inspection, if any, shall be
binding on both parties. NeoGenesis shall pay for such inspections, except that
in the event there is any upward adjustment in aggregate royalties payable for
any year shown by such inspection of more than five percent (5%) of the amount
paid, Mitsubishi shall pay for such inspection.
4.7 TAXES. Except for income taxes that may be assessed against NeoGenesis, all
taxes and charges that may be imposed by any government taxing authority on the
amounts paid by Mitsubishi to NeoGenesis under this Agreement shall be paid by
Mitsubishi for NeoGenesis's account. With respect to Section 4.2 and 4.3, in the
event and to the
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
13
extent that Mitsubishi is required to pay the taxes or charges for the account
of NeoGenesis, and therefore withholds such taxes or charges from the amounts
paid to NeoGenesis under this Agreement, Mitsubishi may withhold such taxes or
charges from the amounts paid to NeoGenesis under this Agreement and Mitsubishi
shall deliver to NeoGenesis true copies of the receipts and/or returns covering
all such payments and Mitsubishi shall "gross up" NeoGenesis in respect of such
taxes so that NeoGenesis receives the full purchase price for the Products after
accounting for such withholding taxes. The parties will cooperate to minimize,
to the extent legally permissible, the tax liabilities related to this
Agreement. Notwithstanding the foregoing, such cooperation shall not cause any
adverse tax consequences to be incurred by either party which would not have
been incurred under the provisions of this Agreement, including this Section
4.7.
5. CONFIDENTIALITY
5.1 PUBLICITY. Except as is necessary to comply with applicable laws and
regulations or to enforce their respective rights under this Agreement, or to a
party's legal or financial advisors, and except as otherwise agreed to by the
parties in writing, the parties shall: (a) keep the material terms of this
Agreement confidential; (b) agree upon the text and the exact timing of an
initial public announcement relating to the transactions contemplated by this
Agreement as soon as practicable after the Effective Date (such agreement not to
be unreasonably withheld or delayed); and (c) agree on the text and the timing
of any subsequent public announcements regarding this Agreement or the
transactions contemplated herein.
5.2 CONFIDENTIALITY. (a) Confidential Information of each party will be used by
the other party solely for the purposes permitted by this Agreement. All
Confidential Information of each party will be received and held in confidence
by the other party, subject to the provisions of this Agreement. Each party
acknowledges that it will not obtain any rights of any sort in or to the
Confidential Information of the other party as a result of such disclosure and
that any such rights must be the subject of separate written agreement(s).
Either party may only disclose the general nature, but not the specific
financial terms, of this Agreement without the prior consent of the other party;
PROVIDED that either party may provide a copy of this Agreement or disclose the
terms of this Agreement (i) to any finance provider in conjunction with a
financing transaction, if such finance provider agrees to keep this Agreement
confidential, (ii) to any legal or financial advisor of such party, or (iii) in
response to a subpoena or other validly issued administrative or judicial
process requesting disclosure of same; PROVIDED, the party that receives such
order or process provides prompt notice to the other party before making any
disclosure and permits such other party to oppose or narrow such request for
disclosure and supports any of such other party's reasonable efforts to oppose
such request (at such other party's expense) and shall disclose the terms of
this Agreement only in the event of a final judgment or administrative order
requiring such disclosure, and only to the extent necessary to comply with such
request.
(b) Each party will restrict disclosure of the other party's Confidential
Information to those of its employees to whom it is necessary to disclose such
Confidential Information in connection with the purposes permitted under Section
5.2(a). Each party shall use reasonable efforts, including at least efforts
fully commensurate with those employed by the party for the protection of its
own Confidential Information, to protect the Confidential Information of the
other party.
(c) Each party may at any time notify the other party that such other party
must return such party's Confidential Information. Each party hereby agrees to,
within thirty (30) days of such notification: (i) return all documents and
tangible items it or its employees or agents have received or created pursuant
to this Agreement pertaining, referring or relating to the other party's
Confidential Information; and (ii) return or certify (in a writing attested to
by a duly authorized officer of such party) destruction of all copies,
summaries, modifications or adaptations that such party or its employees or
agents have made from the materials provided by the other party.
(d) Nothing herein shall prevent either party from disclosing all or part
of the other party's Confidential Information as necessary pursuant to the
lawful requirement of a governmental agency or when disclosure is required by
operation of law; PROVIDED that prior to any such disclosure, such party shall
use reasonable efforts to: (i) promptly notify the other party in writing of
such requirement to disclose; and (ii) cooperate fully with the other party in
protecting against any such disclosure or obtaining a protective order.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
14
6. REPRESENTATIONS AND WARRANTIES.
6.1 AUTHORIZATION; ENFORCEABILITY. Each of Mitsubishi and NeoGenesis represent
and warrant to the other that: (a) it is a corporation or limited liability
company, as applicable, duly organized and validly existing under the laws of
its jurisdiction of organization and has all requisite power and authority to
enter into this Agreement; (b) it is duly authorized by all requisite action to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby, and that the same do not conflict or cause a default with
respect to such party's obligations under any other agreement; (c) it has duly
executed and delivered this Agreement; and (d) (i) it is authorized to disclose
any and all Confidential Information made available to the other party pursuant
to this Agreement; and (ii) it shall not disclose to the other party any
information that is confidential or proprietary to itself or to a third party
unless such information is identified as Confidential Information.
6.2 NEOGENESIS PERFORMANCE. NeoGenesis hereby represents and warrants to
Mitsubishi that: (a) NeoGenesis shall perform the Program using qualified
personnel and in a good and workmanlike manner consistent with industry
standards of companies that are comparable to NeoGenesis performing similar
activities under similar circumstances; and (b) as of the Effective Date, there
is no agreement known to NeoGenesis to which it is a party and by which it is
bound that would conflict with or be breached by NeoGenesis granting Mitsubishi
the license in Section 3.1 and assigning Mitsubishi Assigned Patent Rights to
Mitsubishi in Section 3.2(d).
6.3 DISCLAIMER. (a) EXCEPT FOR THE WARRANTIES EXPRESSLY MADE IN SECTIONS
6.1-6.2, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY, EITHER
EXPRESS OR IMPLIED (WHETHER WRITTEN OR ORAL), INCLUDING, WITHOUT LIMITATION ANY
WARRANTY AGAINST INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL
PROPERTY RIGHTS, ANY WARRANTY OF MERCHANTABILITY OR ANY WARRANTY OF FITNESS FOR
A PARTICULAR PURPOSE WITH RESPECT TO THE NEOMORPH SCREENING LIBRARY, THE
NEOMORPH FOCUSED LIBRARIES, QSCD, ALL CANDIDATE COMPOUND A, ALL CANDIDATE
COMPOUND B, ALL CANDIDATE COMPOUND C, THE DESIGNATED COMPOUNDS, THE TARGETS, THE
LICENSED PRODUCTS, THE NEOGENESIS KNOW-HOW, THE MITSUBISHI KNOW-HOW, THE SCOPE,
VALIDITY OR ENFORCEABILITY OF THE NEOGENESIS PATENT RIGHTS OR THE MITSUBISHI
PATENT RIGHTS, OR SUCH PARTY'S OBLIGATIONS UNDER THIS AGREEMENT.
(b) THE REPRESENTATIONS AND WARRANTIES OF EACH OF NEOGENESIS AND MITSUBISHI
EXTEND ONLY TO THE OTHER PARTY. NEITHER PARTY WILL BE LIABLE FOR ANY CLAIM OR
DEMAND AGAINST SUCH OTHER PARTY BY A THIRD PARTY, EXCEPT TO THE EXTENT PROVIDED
IN SECTIONS 7.2-7.3.
7. RISK ALLOCATION
7.1 LIMITATION OF LIABILITY. EXCEPT FOR INFRINGEMENT OF THE OTHER PARTY'S
INTELLECTUAL PROPERTY RIGHTS OR BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER
SECTION 5 AND EXCEPT AS OTHERWISE PROVIDED IN SECTIONS 7.2-7.3 WITH RESPECT TO
THIRD PARTY CLAIMS, THE AGGREGATE LIABILITY OF EITHER PARTY FOR DIRECT DAMAGES
ARISING OUT OF THIS AGREEMENT AND THE TRANSACTIONS CONTEMPLATED HEREBY SHALL BE
LIMITED TO THE AGGREGATE AMOUNT PAID TO SUCH PARTY BY THE OTHER PARTY AS OF THE
DATE SUCH CLAIM IS FINALLY RESOLVED. EXCEPT FOR INFRINGEMENT OF THE OTHER
PARTY'S INTELLECTUAL PROPERTY RIGHTS OR BREACH OF CONFIDENTIALITY OBLIGATIONS
UNDER SECTION 5 AND EXCEPT AS OTHERWISE PROVIDED IN SECTIONS 7.2-7.3 WITH
RESPECT TO THIRD PARTY CLAIMS, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER FOR LOST PROFITS OR SAVINGS OR FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES IN CONNECTION WITH THIS
AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, HOWEVER CAUSED,
UNDER ANY THEORY OF LIABILITY.
7.2 INFRINGEMENT INDEMNIFICATION. (a) Subject to the provisions of Section 7.4,
NeoGenesis shall defend, indemnify and hold harmless Mitsubishi, its
subsidiaries, parent corporations, Affiliates, officers, directors,
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
15
independent contractors, partners, members, employees, agents, successors and
assigns from and against any claim, suit, demand, loss, damage, expense
(including reasonable attorney's fees of indemnitee(s) and those that may be
asserted by a third party) or liability (collectively, LOSSES) imposed upon them
by any third party and arising from or related to a third party claim that (i)
use of NeoGenesis Know-How or (ii) practice of the NeoGenesis Patent Rights by
Mitsubishi in accordance with the terms of this Agreement violates or infringes
the intellectual property rights of any third party. NeoGenesis shall have no
liability or obligation to Mitsubishi under this Section 7.2(a) in the event and
to the extent that the alleged infringement is caused by: (1) modifications,
alterations, combinations or enhancements of the Designated Compounds not
created by NeoGenesis, or (2) or results from willful misconduct or negligent
acts or omissions of Mitsubishi or its Affiliates, or its or their respective
employees, officers, directors or agents.
(b) Subject to the provisions of Section 7.4, Mitsubishi shall defend,
indemnify and hold harmless NeoGenesis, its subsidiaries, parent corporations,
Affiliates, officers, directors, independent contractors, partners,
shareholders, employees, agents, successors and assigns from and against any
Losses imposed upon them by any third party and arising from or related to a
third party claim that (i) the R&D Program or any modifications, alterations,
combinations or enhancements of the Designated Compounds; (ii) the use of the
Mitsubishi Know-How, (iii) the practice of the Mitsubishi Patent Rights, (iv)
the Designated Compound or any Licensed Product; or (vii) the Manufacture,
development, testing, Commercialization, use or other disposition of any of the
foregoing, violates or infringes the intellectual property rights of any third
party. Mitsubishi shall have no obligation or liability to NeoGenesis under this
Section 7.2(b) in the event and to the extent that the alleged infringement (1)
is covered by Section 7.2(a) or (2) results from willful misconduct or negligent
acts or omissions of NeoGenesis or its Affiliates, or its or their respective
employees, officers, directors or agents.
7.3 OTHER CLAIMS. (a) Subject to the provisions of Section 7.4, NeoGenesis will
defend, indemnify and hold harmless Mitsubishi, its subsidiaries, parent
corporations, affiliates, officers, directors, partners, members, shareholders,
employees, agents, and their successors and assigns (each, in such capacity, an
INDEMNIFIED PARTY) from and against any Losses imposed upon the Indemnified
Party(s) by any third party arising from or related to: (i) any material breach
of the NeoGenesis's representations and warranties under this Agreement; or (ii)
any negligence or intentional misconduct by NeoGenesis (or its employees, agents
or representatives) in performing its obligations under this Agreement,
including the performance of the Program. The foregoing indemnification action
shall not apply in the event and to the extent that a court of competent
jurisdiction determines that such Losses arose as a result of any Indemnified
Party's negligence, intentional misconduct or breach of this Agreement.
(b) Subject to the provisions of Section 7.4, Mitsubishi will defend,
indemnify and hold harmless NeoGenesis, its subsidiaries, parent corporations,
affiliates, officers, directors, partners, members, shareholders, employees,
agents, and their successors and assigns (each, in such capacity Indemnified
Party) from and against any Losses imposed upon the Indemnified Party(s) by any
third party arising from or related to: (i) any material breach of Mitsubishi's
representations and warranties under this Agreement; (ii) any negligence or
intentional misconduct by Mitsubishi (or its employees, agents or
representatives) or by an Affiliate, licensee, sublicensee, distributor or agent
of Mitsubishi in performing its obligations under this Agreement, including the
performance of the R&D Program; or (iii) the labeling, packaging, package
insert, other materials or promotional claims with respect to any Licensed
Product or the development, testing, Manufacturing, Commercialization, use or
other disposition of any Licensed Product by Mitsubishi or by an Affiliate,
licensee, sublicensee, distributor or agent of Mitsubishi. The foregoing
indemnification action shall not apply in the event and to the extent that a
court of competent jurisdiction determines that such Losses arose as a result of
any Indemnified Party's negligence, intentional misconduct or breach of this
Agreement.
7.4 PROCEDURE. To receive the benefit of indemnification under Sections 7.2 or
7.3, the Indemnified Party must (a) promptly notify the party from whom
indemnification is sought (the INDEMNIFYING PARTY) in writing of a claim or
suit; PROVIDED, that failure to give such notice shall not relieve Indemnifying
Party of its indemnification obligations except where, and solely to the extent
that, such failure actually and materially prejudices the rights of Indemnifying
Party); (b) provide reasonable cooperation (at the Indemnifying Party's
expense); and (c) tender to the Indemnifying Party (and its insurer) full
authority to defend or settle the claim or suit; PROVIDED that no settlement
requiring any admission by the Indemnified Party or that imposes any obligation
on the Indemnified Party shall be made without
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
16
the Indemnified Party's consent. Neither party has any obligation to indemnify
the other party in connection with any settlement made without the Indemnifying
Party's written consent. The Indemnified Party has the right to participate at
its own expense in the claim or suit and in selecting counsel therefor. The
Indemnified Party shall cooperate with Indemnifying Party (and its insurer), as
reasonably requested, at Indemnifying Party's cost and expense.
7.5 INDEMNIFICATION AS SOLE REMEDY. To the fullest extent permitted by law, the
indemnification provided in this Section 7, subject to the limitations set forth
herein, shall be the exclusive remedy for damages available to any Indemnified
Party.
8. TERM AND TERMINATION
8.1 TERM. This Agreement shall take effect as the Effective Date and shall
remain in effect until the expiration date(s) specified in this Section 8.1,
unless sooner terminated in accordance with Section 8.2. The Program will remain
in effect for a period of twelve (12) months, with an option by Mitsubishi to
renew for an additional 1-year period on terms and conditions, including level
of support, that are mutually agreeable. Mitsubishi shall notify NeoGenesis
whether Mitsubishi wishes to extend the Program for additional periods, no later
than 150 days prior to termination of initial term. If the license under Section
3.1 is exercised, such license will remain in effect on a country-by-country
basis until the LATER OF: (a) the expiration of the term of the last-to-expire
of the patent rights within the NeoGenesis Patent Rights or Mitsubishi Assigned
Patent Rights or Joint Program Patent Rights, which cover the Licensed Product
in any country in which such Licensed Product is manufactured or sold or (b) [*]
following the First Commercial Sale in the last country in which sales of
Licensed Products are made (if the Licensed Products do not embody any patents
within the NeoGenesis Patent Rights or Mitsubishi Assigned Patent Rights or
Joint Program Patent Rights). Thereafter Mitsubishi's license shall be perpetual
and fully paid-up.
8.2 TERMINATION. (a) Either party may terminate the Program with thirty (30)
days notice to the other party if the other party fails to pay fees or patent
expenses due under the Agreement or commits a material breach unless the
nonpayment or breach is cured within the thirty (30)-day notice period. In
addition, NeoGenesis may suspend work pursuant to the Program with notice to
Mitsubishi if Mitsubishi fails to pay NeoGenesis any amount due NeoGenesis under
this Agreement.
(b) Following completion of the Program, either party may terminate the
license with sixty (60) days notice if the other commits a material breach
unless the breach is cured within the sixty (60)-day notice period; PROVIDED
that such notice and cure period shall be reduced to thirty (30) days in the
case of payment obligations.
(c) Either party shall have the right to terminate this Agreement upon
thirty (30) days notice if a Force Majeure condition has prevented performance
by the other party for more than one hundred twenty (120) consecutive days. The
parties may also terminate this Agreement at any time upon mutual written
agreement of the parties.
(d) Mitsubishi shall have the right to terminate this Agreement with sixty
(60) days notice, if Mitsubishi reasonably determines that the conduct of the
Program has resulted in a minimal number of Candidate Compound C being
identified as potential candidates for drug development.
(e) If Mitsubishi decides, at any time following completion of the Program
by NeoGenesis, to terminate the R&D Program or Commercialization of a Designated
Compound or a Licensed Product, Mitsubishi shall promptly notify NeoGenesis of
said decision and shall have the right to terminate this Agreement with sixty
(60) days notice. In such case, if Mitsubishi shall decide whether (1)
Mitsubishi and NeoGenesis will enter into a separate patent assignment agreement
under which Mitsubishi will assign to NeoGenesis all Mitsubishi Assigned Patent
Rights; or (2) Mitsubishi and NeoGenesis will enter into a separate license
agreement under which Mitsubishi will grant NeoGenesis an exclusive,
royalty-free license in the Territory to use all Mitsubishi Assigned Patent
Rights to research, develop, make, have made and use such Designated Compound
and to make, have made, use, distribute for sale, promote, market, offer for
sale, sell, have sold, import and export a Licensed Product containing such
Designated Compound, any such separate agreement shall contain mutually
acceptable terms. Thereafter, subject to the provisions of Section 7.4,
NeoGenesis shall defend, indemnify and hold harmless Mitsubishi, its
subsidiaries, parent corporations, Affiliates, officers, directors, independent
contractors, partners, members, employees, agents,
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
17
successors and assigns from and against any Losses imposed upon them by any
third party and arising from or related to a third party claim that (i) such
development or Commercialization activities of NeoGenesis or its Affiliates or
sublicensees with respect to such Designated Compound or Licensed Product or the
Manufacture, development, testing, Commercialization, use or other disposition
of any of the foregoing, violates or infringes the intellectual property rights
of any third party; or (ii) any negligence or intentional misconduct by
NeoGenesis (or its employees, agents or representatives) or by an Affiliate,
licensee, sublicensee, distributor or agent of NeoGenesis in performing such
development or Commercialization activities; or (iii) the labeling, packaging,
package insert, other materials or promotional claims with respect to any such
Licensed Product or the development, testing, Manufacturing, Commercialization,
use or other disposition of any such Licensed Product by NeoGenesis or by an
Affiliate, licensee, sublicensee, distributor or agent of NeoGenesis. The
foregoing indemnification action shall not apply in the event and to the extent
that a court of competent jurisdiction determines that such Losses arose as a
result of any Mitsubishi Indemnified Party's negligence, intentional misconduct
or breach of this Agreement.
8.3 EFFECT OF TERMINATION. (a) Upon termination (including expiration) of this
Agreement: (i) NeoGenesis will terminate all tasks in an orderly manner, as soon
as practical and in accordance with a schedule agreed to by Mitsubishi and
NeoGenesis; (ii) if termination occurs prior to completion of the Program then
NeoGenesis shall deliver to Mitsubishi all materials developed through the
termination of this Agreement; (iii) Mitsubishi shall pay NeoGenesis any monies
due and owing NeoGenesis up to the time of termination, for services actually
performed (including all work-in process (if any) pursuant to the last sentence
of Item 6 or the last sentence of Item 7 of ATTACHMENT A) an amount calculated
using NeoGenesis's then-current daily charge for similar services and
deliverables, PROVIDED, such fee shall not exceed the price specified in this
Agreement and (iv) within thirty (30) days following termination (including
expiration) of this Agreement, NeoGenesis shall deliver to Mitsubishi a
reasonably-detailed written report describing the results of the research
performed up to the date of such termination.
(b) Upon termination (including expiration) of this Agreement each party
shall return to the other party or certify in writing to the other party that it
has destroyed all documents and other tangible items it or its employees or
agents have received or created pertaining, referring or relating to the
Confidential Information of the other party.
(c) The licenses granted to Mitsubishi by NeoGenesis under Section 3.1
shall survive any expiration or termination of the Program or this Agreement
with respect to any Designated Compound or Licensed Product for which the
applicable service fees and milestone fees and royalties have been paid (when
due in accordance with the terms of this Agreement) and Mitsubishi shall
continue to have the right to develop, have developed, make, have made, use,
distribute, offer for sale, import, export and sell Licensed Products relating
to such Designated Compounds; PROVIDED that Mitsubishi continues to pay
NeoGenesis milestone fees and royalties as required by Sections 4.2 and 4.3 and
complies with Sections 4.4-4.7. The license granted under Section 3.1 shall not
survive termination or expiration with respect to Designated Compounds or
Licensed Products for which Mitsubishi has not made payment in accordance with
this Agreement and shall immediately terminate with respect to any Designated
Compound or Licensed Product for which the applicable service fees and milestone
fees are not timely paid (should such payment become due after termination of
this Agreement or for any Licensed Product for which Mitsubishi fails to pay
NeoGenesis milestone fees and royalties as required by Sections 4.2 and 4.3 or
fails to comply with Sections 4.4-4.7. In the event the license granted to
Mitsubishi under Section 3.1 terminates for any reason, each of Mitsubishi's
sublicensees at such time shall continue to have the rights and license set
forth in their sublicense agreements, PROVIDED such sublicensee agrees in
writing that NeoGenesis is entitled to enforce all relevant provisions directly
against such sublicensee.
(d) Except as otherwise provided herein, neither party shall be liable to
the other party for any compensation or damages by reason of termination of this
Agreement in accordance with this Section 8.
(e) Nothing herein shall be construed to release either party of any
obligation which matured prior to the effective date of any termination.
Mitsubishi's liability for any charges, payments or expenses due to NeoGenesis
that accrued prior to the termination date shall not be extinguished by
termination, and such amounts (if not otherwise due on an earlier date) shall be
immediately due and payable on the termination date.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
18
8.4 SURVIVAL. Sections 1, 2.6, 3.2, 3.3, 6, 7 8.1 and 8.3 shall survive any
termination or expiration of this Agreement. Section 5 shall survive any
termination or expiration of this Agreement for a period of ten (10) years after
such termination or expiration. Section 4 shall survive any termination of this
Agreement with respect to Licensed Products (including Licensed Products that
are covered by Section 3.2(d)) PROVIDED, that Section 4 shall not survive
expiration of this Agreement with respect to any Licensed Product in accordance
with the penultimate sentence of Section 8.1.
9. GENERAL PROVISIONS.
9.1 ISSUE RESOLUTION. (a) The parties shall use their best efforts to resolve
any controversy or dispute that arises under or relates to this Agreement
through good faith discussions. The parties shall initiate such discussions
using the following procedure. Either party shall notify the other party of the
nature of the controversy or dispute, providing sufficient detail to permit the
other party to understand same (a DISPUTE NOTICE). The representatives of the
parties shall meet within 30 days after the date that the non-sending party
receives the Dispute Notice to attempt to reach an agreement about the nature of
the dispute and a resolution of the dispute. If they are unable to resolve the
dispute within 60 days after their meeting, and do not agree to extend the time
period for resolving the dispute, or if the terms and conditions of the
resolution or settlement of the dispute are breached, the dispute shall be
resolved by arbitration pursuant to the provisions of Section 9.1(b). Pending
resolution of any dispute covered by this Section 9.1, both parties will
continue their performance under this Agreement including, without limitation,
the payment of all amounts due to the other party that are not in dispute.
(b) Except in the case of a breach of Section 3.2 or Section 5.2, any
claim, dispute, or controversy arising out of or relating to this Agreement that
is not resolved in accordance with the provisions of Section 9.1(a) within the
time period specified in Section 9.1(a) will be submitted by the parties to
arbitration in accordance with the terms of Section 9.1(b)-(d); PROVIDED, that
actions by either party seeking equitable or declaratory relief may be brought
in court without resort to any of the provisions of Section 9.1(b)-(e). This
agreement to arbitrate shall continue in full force and effect despite the
expiration, rescission or termination of this Agreement.
(c) Any arbitration shall be conducted pursuant to the Commercial
Arbitration Rules of the International Chamber of Commerce (ICC) under the rules
then in effect for the ICC, as such rules may be modified by this Agreement or
by agreement of the parties. Any such arbitration shall be conducted in
New York
City by one arbitrator. Each party irrevocably and unconditionally (i) consents
to the jurisdiction of any such proceeding and waives any objection that it may
have to personal jurisdiction or the laying of venue of any such proceeding; and
(ii) knowingly and voluntarily waives its rights to have disputes tried and
adjudicated by a judge and jury except as otherwise expressly provided herein.
The parties will cooperate with each other in causing the arbitration to be held
in as efficient and expeditious a manner as practicable. The parties will
attempt to agree upon a mutually acceptable arbitrator within 30 days of receipt
of the notice of intent to arbitrate. If the parties are unable to agree upon a
single arbitrator within such 30-day period or any extension of time which is
mutually agreed upon, three (3) arbitrators shall be used, one selected by each
party within ten (10) days after the conclusion of the 30-day period and a third
selected by the first two within ten (10) days thereafter. Unless the parties
agree otherwise, they shall be limited in their discovery to directly relevant
documents. Responses or objections to a document request shall be served twenty
(20) days after receipt of the request. The arbitrator(s) shall resolve any
discovery disputes. It is understood that the parties may (but are not required
to) submit disputes concerning any breach of Section 3.2 or Section 5.2 to
arbitration in accordance with this Section 9.1. Nothing herein shall prevent
the parties from settling any dispute by mutual agreement at any time.
(d) The arbitrator(s) shall apply the substantive laws of
New York when
construing this Agreement and attempting to resolve any dispute relating to the
transactions contemplated by this Agreement, without regard for any choice or
conflict of laws rule or principle that would result in the application of the
substantive law of any other jurisdiction. The arbitration shall be of each
party's individual claims only, and no claim of any other party shall be subject
to arbitration in such proceeding. Except as otherwise required by law, the
parties and the arbitrator(s) shall maintain as confidential all information or
documents obtained during the arbitration process, including the resolution of
the dispute.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
19
(e) The arbitrator(s) shall not have the authority to award exemplary or
punitive damages, and the parties expressly waive any claimed right to such
damages. The arbitrator(s) shall have the authority to award actual money
damages (with interest on unpaid amounts from the date due) and may grant
equitable relief as is just and provided by the ICC Rules, in each case except
as specifically provided to the contrary herein The costs and expenses of the
arbitration, but not the costs and expenses of the parties, shall be shared
equally by the parties. Any award rendered by the arbitrator(s) shall be final
and binding upon the parties. Judgment upon the award may be entered in any
court of competent jurisdiction. If a party fails to proceed with arbitration,
unsuccessfully challenges the arbitration award, or fails to comply with the
arbitration award, the other party is entitled to costs, including reasonable
attorneys' fees, for having to compel arbitration or defend or enforce the
award.
9.2 GOVERNING LAW. This Agreement shall be governed and construed in accordance
with the internal, substantive laws of the State of
New York (except for Section
5-1401 of the
New York General Obligations Law) to the exclusion of any choice
or conflict of laws rule or provision that would result in the application of
the substantive law of any other jurisdiction. Notwithstanding the foregoing,
the parties (and the arbitrators) shall use United States (Federal) patent and
copyright laws for purposes of governing and construing Sections 3.2-3.4 of this
Agreement. The United Nations Convention on Contracts for the International Sale
of Goods shall not apply to the transactions contemplated by this Agreement.
9.3 AMENDMENT AND WAIVER. No provision of or right under this Agreement shall
be deemed to have been waived by any act or acquiescence on the part of either
party, its agents or employees, but only by an instrument in writing signed by
an authorized officer of each party. No waiver by either party of any breach of
this Agreement by the other party shall be effective as to any other breach,
whether of the same or any other term or condition and whether occurring before
or after the date of such waiver.
9.4 INDEPENDENT CONTRACTORS. Each party represents that it is acting on its own
behalf as an independent contractor and is not acting as an agent for or on
behalf of any third party. This Agreement and the relations hereby established
by and between Mitsubishi and NeoGenesis do not constitute a partnership, joint
venture, franchise, agency or contract of employment. Neither party is granted,
and neither party shall exercise, the right or authority to assume or create any
obligation or responsibility on behalf of or in the name of the other party or
its Affiliates. NeoGenesis shall be solely responsible for compensating all its
personnel and for payment of all related FICA, workers' compensation,
unemployment and withholding taxes. Mitsubishi shall not provide NeoGenesis
personnel with any benefits, including but not limited to compensation for
insurance premiums, paid sick leave or retirement benefits.
9.5 ASSIGNMENT. Neither party may assign this Agreement or any of its rights
and obligations under this Agreement without the prior written consent of the
other party; PROVIDED, that either party may assign this Agreement to (a) any
Person to which such party transfers all or substantially all of its assets or
with which such party is consolidated or merged; (b) any Person that owns a
majority of the voting stock of such party; or (c) a single Person of which
such party owns a majority of the voting stock; PROVIDED, FURTHER, that in each
instance the assignee Person expressly assumes all obligations imposed on the
assigning party by this Agreement in writing and the other party is notified in
advance of such assignment.
9.6 SUCCESSORS AND ASSIGNS. This Agreement shall bind and inure to the benefit
of the parties hereto and their respective successors and permitted assigns.
9.7 NOTICES. Unless otherwise provided herein, any notice, report, payment or
document to be given by one party to the other shall be in writing and shall be
deemed given when delivered personally or mailed by certified or registered
mail, postage prepaid (such mailed notice to be effective on the date which is
three (3) business days after the date of mailing), or sent by nationally
recognized overnight courier (such notice sent by courier to be effective one
business day after it is deposited with such courier), or sent by telefax (such
notice sent by telefax to be effective when sent, if confirmed by certified or
registered mail or overnight courier as aforesaid) to the address set forth on
the signature page to this Agreement or to such other place as any party may
designate as to itself by written notice to the other party.
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
20
9.8 SEVERABILITY. In the event any provision of this Agreement shall for any
reason be held to be invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any other term or
provision hereof. The parties agree that they will negotiate in good faith or
will permit a court or arbitrator to replace any provision hereof so held
invalid, illegal or unenforceable with a valid provision which is as similar as
possible in substance to the invalid, illegal or unenforceable provision.
9.9 CAPTIONS. Captions of the sections and subsections of this Agreement are
for reference purposes only and do not constitute terms or conditions of this
Agreement and shall not limit or affect the meaning or construction of the
terms and conditions hereof.
9.10 WORD MEANINGS. Words such as HEREIN, HEREINAFTER, HEREOF and HEREUNDER
refer to this Agreement as a whole and not merely to a section or paragraph in
which such words appear, unless the context otherwise requires. The singular
shall include the plural, and each masculine, feminine and neuter reference
shall include and refer also to the others, unless the context otherwise
requires.
9.11 ENTIRE AGREEMENT. The terms and provisions contained in this Agreement
(including the Attachments) constitute the entire understanding of the parties
with respect to the transactions and matters contemplated hereby and supersede
all previous communications, representations, agreements and understandings
relating to the subject matter hereof. No representations, inducements, promises
or agreements, whether oral or otherwise, between the parties not contained in
this Agreement shall be of any force or effect. No agreement or understanding
extending this Agreement or varying its terms (including any inconsistent terms
in any purchase order, acknowledgment or similar form) shall be binding upon
either party unless it is in a writing specifically referring to this Agreement
and signed by a duly authorized representative of the applicable party.
9.12 RULES OF CONSTRUCTION. The parties agree that they have participated
equally in the formation of this Agreement and that the language and terms of
this Agreement shall not be construed against either party by reason of the
extent to which such party or its professional advisors participated in the
preparation of this Agreement.
9.13 COUNTERPARTS. This Agreement may be executed in multiple counterparts, each
of which shall be deemed an original, but all of which together shall constitute
one and the same instrument. In making proof of this Agreement, it shall not be
necessary to produce or account for more than one such counterpart.
9.14 FORCE MAJEURE. Except as otherwise provided in this Agreement, in the event
that a delay or failure of a party to comply with any obligation, other than a
payment obligation, created by this Agreement is caused by a Force Majeure
condition, that obligation shall be suspended during the continuance of the
Force Majeure condition.
9.15 FURTHER ASSURANCES. Each party covenants and agrees that, subsequent to the
execution and delivery of this Agreement and without any additional
consideration, it will execute and deliver any further legal instruments and
perform any acts which are or may become reasonably necessary to effectuate the
purposes of this Agreement.
IN WITNESS WHEREOF the parties have caused this Agreement to be executed ontheir
behalf by their duly authorized representatives intending it to take effect as
an instrument under seal as of the Effective Date.
NeoGenesis DRUG DISCOVERY, INC.
By /s/ XXXXXX XXXXXXX
---------------------------------
Xxxxxx Xxxxxxx
Vice President Business Development
NOTICE ADDRESS:
NeoGenesis Drug Discovery, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Phone: 000.000.0000
Fax: 000.000.0000
Mitsubishi-Tokyo PHARMACEUTICALS, INC.
BY /s/ XXXXXXX XXXX
---------------------------------
Xxxxxxx Xxxx
President of Research and Development Division
NOTICE ADDRESS:
Mitsubishi-Tokyo Pharmaceuticals, Inc.
2-6, Xxxxxxxxxx-Xxxxxx 0-xxxxx, Xxxx-xx,
Xxxxx 000-0000, Xxxxx
Phone: 00.00.0000.0000
Fax: 00.00.0000.0000
* = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION.
21
