<PAGE>
EXHIBIT 10.1
Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
MILLENNIUM PHARMACEUTICALS, INC.
AND
AVENTIS PHARMACEUTICALS INC.
<PAGE>
Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
<S> <C> <C> <C>
ARTICLE 1 DEFINITIONS....................................................................................1
1.1 "Active".......................................................................................1
1.2 "Affiliate"....................................................................................1
1.3 "Annual Research Plan".........................................................................2
1.4 "Antibody".....................................................................................2
1.5 "Business Day".................................................................................2
1.6 "Change of Control"............................................................................2
1.7 "Commercialization"or "Commercialize"..........................................................2
1.8 "Confidential Information".....................................................................2
1.9 "Contract Year"................................................................................3
1.10 "Control"or "Controlled".......................................................................3
1.11 "Covering", "Cover", or "Covered"..............................................................3
1.12 "Development"or "Develop"......................................................................4
1.13 "Diagnostic"...................................................................................4
1.14 "Dropped EDC Compound".........................................................................4
1.15 "Dropped Target"...............................................................................4
1.16 "Druggable Target".............................................................................4
1.17 "Early Development Candidate Status"or "EDC Status"............................................4
1.18 "EDC Compound".................................................................................4
1.19 "Effective Date"...............................................................................5
1.20 "Executive Officers"...........................................................................5
1.21 "[**] Property"................................................................................5
1.22 "FDA"..........................................................................................5
1.23 "First Commercial Sale"........................................................................5
1.24 "FTE"..........................................................................................5
1.25 "Gene Therapy".................................................................................5
1.26 "HPB"..........................................................................................5
1.27 "IND"..........................................................................................6
1.28 "Inflammation Field"...........................................................................6
1.29 "Investment Agreement".........................................................................6
1.30 "Joint Commercialization Project Team".........................................................6
1.31 "Joint Development Compound"...................................................................6
1.32 "Joint Development Product"or "JD Product".....................................................6
1.33 "Joint Development Project Team"...............................................................6
1.34 "Joint Steering Committee".....................................................................6
1.35 "Laws".........................................................................................6
1.36 "Lead Compound"................................................................................6
1.37 "Lead Compound Family".........................................................................7
1.38 "NDA"..........................................................................................7
</TABLE>
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<TABLE>
<CAPTION>
<S> <C> <C>
1.39 "North America"or "NA".........................................................................7
1.40 "Party"or "Parties"............................................................................7
1.41 "Patent Rights"................................................................................7
1.42 "Phase I Study"................................................................................7
1.43 "Phase IIA Study"..............................................................................7
1.44 "Phase IIB Study"..............................................................................7
1.45 "Phase IIIA Study".............................................................................7
1.46 "Phase IIIB Study".............................................................................8
1.47 "Phase IV Study"...............................................................................8
1.48 "Pre-EDC Research Evaluation"..................................................................8
1.49 "Program Compound".............................................................................8
1.50 "Program Compound Family"......................................................................8
1.51 "Program Intellectual Property"................................................................8
1.52 "Program Material".............................................................................8
1.53 "Program Patent Rights"........................................................................9
1.54 "Program Target"...............................................................................9
1.55 "Program Technology"...........................................................................9
1.56 "Regulatory Approval"..........................................................................9
1.57 "Research Program".............................................................................9
1.58 "Research Program Chemistry Intellectual Property".............................................9
1.59 "ROW".........................................................................................10
1.60 "ROW Major Market Countries"..................................................................10
1.61 "Royalty-Bearing Product".....................................................................10
1.62 "Royalty-Paying Party"........................................................................10
1.63 "Scientifically-Qualified Target"or "SQT".....................................................10
1.64 "Significant Pharmaceutical Enterprise".......................................................10
1.65 "Single-Party Research Target"................................................................10
1.66 "Single-Party Target Product".................................................................11
1.67 "Small Molecule"..............................................................................11
1.68 "Technology Development Agreement"............................................................11
1.69 "Technology Transfer Agreement"...............................................................11
1.70 "Territory"...................................................................................11
1.71 "Third Party".................................................................................11
1.72 "Unilateral Development Compound"or "UDC".....................................................11
1.73 "Unilateral Development Compound Product"or "UDC Product".....................................11
1.74 "Unique Chemical Compound"....................................................................12
1.75 "Vaccine".....................................................................................12
1.76 "Valid Claim".................................................................................12
1.77 Additional Definitions........................................................................12
ARTICLE 2 RESEARCH PROGRAM..............................................................................16
2.1 General.......................................................................................16
2.2 Joint Research Committee......................................................................17
2.3 Joint Research Project Teams..................................................................20
2.4 Conduct of the Research Program...............................................................21
2.5 Disclosure of Financial and Other Burdens and Obligations.....................................22
2.6 Annual Research Plan..........................................................................23
</TABLE>
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<TABLE>
<CAPTION>
<S> <C> <C>
2.7 Targets.......................................................................................23
2.8 Exclusivity...................................................................................30
2.9 Third Party Opportunities.....................................................................32
2.10 Gene Therapy and Vaccine Targets..............................................................33
2.11 Antibody and Diagnostic Rights................................................................35
2.12 Use of Scientifically-Qualified Targets to Identify
Small Molecules for Use Outside of the Inflammation Field. ..................................36
2.13 Other Permitted Uses of Program Targets.......................................................37
2.14 Research Program Records......................................................................38
2.15 Disclosure of Research Program Results........................................................38
2.16 Material Transfer.............................................................................39
2.17 Liability.....................................................................................39
2.18 Subcontractors................................................................................39
ARTICLE 3 DEVELOPMENT PROGRAM...........................................................................40
3.1 EDC Compounds.................................................................................40
3.2 Joint Development Committee and Project Teams.................................................41
3.3 Development Activities........................................................................45
3.4 Joint Development Costs.......................................................................46
3.5 Joint Development Budget......................................................................46
3.6 Discontinued Development......................................................................47
3.7 Unilateral Development........................................................................48
3.8 Dropped EDC Compound..........................................................................53
3.9 Back-Up Compounds.............................................................................53
3.10 Right to Audit................................................................................54
3.11 Use of Subcontractors.........................................................................54
3.12 Pharmacovigilance.............................................................................54
ARTICLE 4 MANUFACTURE AND SUPPLY........................................................................55
4.1 Clinical Supply...............................................................................55
4.2 Commercial Supply.............................................................................55
4.3 Supply Agreement..............................................................................55
4.4 Use of Subcontractors.........................................................................55
ARTICLE 5 REGULATORY MATTERS............................................................................56
5.1 Ownership.....................................................................................56
5.2 Regulatory Coordination.......................................................................57
5.3 Regulatory Meetings and Correspondence........................................................57
5.4 Review of Correspondence......................................................................57
5.5 Assistance....................................................................................58
ARTICLE 6 COMMERCIALIZATION PROGRAM.....................................................................60
6.1 Objectives for Commercialization of Joint Development Products................................60
6.2 Joint Commercialization Committee and Project Teams...........................................61
6.3 Joint Commercialization Committee Responsibilities............................................62
6.4 Joint Commercialization Project Team Responsibilities.........................................62
6.5 Decision Making...............................................................................64
6.6 North America Commercialization Project Team..................................................65
6.7 Commercialization Strategy and Decision Making................................................68
6.8 Revenue Booking in North America..............................................................68
</TABLE>
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<TABLE>
<CAPTION>
<S> <C> <C>
6.9 Commercialization Expense and Budget..........................................................68
6.10 Public Statements Regarding Joint Development Products........................................70
6.11 Compliance with Laws..........................................................................70
6.12 Unilateral Commercialization..................................................................70
6.13 Use of Subcontractors.........................................................................72
ARTICLE 7 LICENSES......................................................................................72
7.1 Millennium Grants.............................................................................72
7.2 Aventis Grants................................................................................80
7.3 Retained Rights...............................................................................87
7.4 Section 365(n) of the Bankruptcy Code.........................................................88
7.5 Certain Covenants Regarding Ex-Program Products...............................................88
ARTICLE 8 FINANCIAL PROVISIONS..........................................................................88
8.1 Equity Investment.............................................................................88
8.2 Pre-tax Profit or Loss In North America.......................................................89
8.3 Royalties.....................................................................................91
8.4 Royalty Reports; Payments.....................................................................96
8.5 Audits........................................................................................96
8.6 Tax Matters...................................................................................97
8.7 Currency Exchange.............................................................................97
8.8 Late Payments.................................................................................98
ARTICLE 9 INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS...............................98
9.1 Ownership.....................................................................................98
9.2 Prosecution and Maintenance of Patent Rights..................................................99
9.3 Cooperation...................................................................................99
9.4 Exploitation of Joint Inventions.............................................................100
9.5 Third Party Infringement.....................................................................100
9.6 Other Intellectual Property Infringement.....................................................102
9.7 Marks for JD Products........................................................................104
ARTICLE 10 CONFIDENTIALITY..............................................................................105
10.1 Confidential Information.....................................................................105
10.2 Employee and Advisor Obligations.............................................................105
10.3 Term.........................................................................................106
10.4 Publications.................................................................................106
ARTICLE 11 Term and Termination.........................................................................106
11.1 Term; Extension..............................................................................106
11.2 Termination For Material Breach..............................................................107
11.3 Termination Upon HSR Denial..................................................................109
11.4 Dispute Resolution...........................................................................109
11.5 Residual Rights..............................................................................109
ARTICLE 12 DISPUTE RESOLUTION...........................................................................110
12.1 Joint Steering Committee.....................................................................110
12.2 Referral of Unresolved Matters to Joint Steering Committee...................................110
12.3 Referral of Unresolved Matters to Executive Officers.........................................111
12.4 Independent Experts..........................................................................111
12.5 Non-Binding Mediation........................................................................111
</TABLE>
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<TABLE>
<CAPTION>
<S> <C> <C>
ARTICLE 13 REPRESENTATIONS, WARRANTIES AND COVENANTS....................................................111
13.1 Representation of Authority; Consents........................................................111
13.2 No Conflict..................................................................................112
13.3 Knowledge of Pending or Threatened Litigation................................................112
13.4 Employee and Consultant Obligations..........................................................112
13.5 Burdened Technology Obligations..............................................................113
13.6 Intellectual Property........................................................................113
13.7 Disclaimer of Warranty.......................................................................113
ARTICLE 14 Miscellaneous Provisions.....................................................................113
14.1 Indemnification..............................................................................113
14.2 Insurance....................................................................................115
14.3 Governing Law................................................................................115
14.4 Assignment...................................................................................115
14.5 Amendments...................................................................................116
14.6 Change of Control of Millennium..............................................................116
14.7 Notices......................................................................................117
14.8 Force Majeure................................................................................117
14.9 Compliance with Export Regulations...........................................................118
14.10 Public Announcements.........................................................................118
14.11 Non-Solicitation.............................................................................118
14.12 Independent Contractors......................................................................119
14.13 No Strict Construction.......................................................................119
14.14 Headings.....................................................................................119
14.15 No Implied Waivers; Rights Cumulative........................................................119
14.16 Severability.................................................................................119
14.17 Execution in Counterparts....................................................................119
14.18 No Third Party Beneficiaries.................................................................120
14.19 No Consequential Damages.....................................................................120
ARTICLE 15 HSR FILING...................................................................................120
15.1 HSR Filing...................................................................................120
15.2 HSR-Related Definitions......................................................................120
</TABLE>
The following Exhibits are being simultaneously delivered with the execution of
this Agreement as separate documents:
<TABLE>
<CAPTION>
<S> <C>
Exhibit A Annual Research Plan for First Contract Year
Exhibit B Costs and Calculation of Pre-tax Profit or Loss
Exhibit B-1 Principles for Detail Cost
Exhibit B-2 Principles for Calculation of NA/Ex-NA Expense Related to North America
Exhibit B-3 Net Sales Definition
Exhibit B-4 Manufacturing Cost Principles
Exhibit C Certain Aventis Third Party Agreements
Exhibit D Certain Millennium Third Party Agreements
</TABLE>
The following Schedules are attached to this Agreement:
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<TABLE>
<CAPTION>
<S> <C>
Schedule 3.2.2 Form of Global Development Plan
Schedule 4.2 Criteria for the Assignment of Responsible Manufacturing Party
Schedule 6.4.4 Form of Global Commercialization Plan
</TABLE>
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<PAGE>
Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement dated the 22nd day of June, 2000 (the
"Execution Date") is by and between Millennium Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at 75 Sidney Street, Cambridge, Massachusetts 02139
("Millennium"), and Aventis Pharmaceuticals Inc., a corporation organized and
existing under the laws of the State of Delaware and having its principal office
at Route 202-206, P.O. Box 6800, Bridgewater, New Jersey 08807 ("Aventis").
INTRODUCTION
WHEREAS, Millennium and Aventis are each in the business of discovering,
developing and commercializing pharmaceutical products.
WHEREAS, Millennium and Aventis are interested in collaborating in the
identification and validation of targets for use in the discovery of small
molecules and in the discovery, development and commercialization of small
molecules all for use in the prevention and treatment of certain inflammatory
diseases.
WHEREAS, on even date herewith, Millennium and Aventis are entering into an
Investment Agreement, a Technology Development Agreement and a Technology
Transfer Agreement.
NOW, THEREFORE, Millennium and Aventis agree as follows:
ARTICLE 1
DEFINITIONS
When used in this Agreement, each of the following terms shall have the meanings
set forth in this Article I:
1.1 "ACTIVE". Active means, with respect to a Small Molecule, that the
Small Molecule (a) [**] in the case of a [**]) a
Scientifically-Qualified Target with [**], as determined by the Joint
Research Committee.
1.2 "AFFILIATE". Affiliate means any corporation, company, partnership,
joint venture and/or firm which controls, is controlled by, or is
under common control with a specified person or entity. For purposes
of this Section 1.2, "control" shall be presumed to exist if one of
the following conditions is met: (a) in the case of corporate
entities, direct or indirect ownership of at least fifty percent (50%)
of the stock or shares having the right to vote for the election of
directors, and (b) in the case of non-corporate entities, direct or
indirect ownership of at least fifty percent (50%) of the equity
interest with the power to direct the management and policies of such
non-corporate entities. The Parties acknowledge that in the case of
certain entities organized under the laws of certain countries outside
of the
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in
such case such lower percentage shall be substituted in the preceding
sentence, provided that such foreign investor has the power to direct
the management and policies of such entity.
1.3 "ANNUAL RESEARCH PLAN". Annual Research Plan means the plan to be
developed by the Joint Research Committee for each Contract Year, to
be updated as necessary during each Contract Year, setting forth,
among other things, a master plan for the Research Program during the
Research Program Term and the matters described in Section 2.6 below.
Exhibit A sets forth the master plan for the Research Program Term and
the Annual Research Plan for the First Contract Year.
1.4 "ANTIBODY". Antibody means a polyclonal or monoclonal antibody,
whether multiple or single chain, recombinant or naturally occurring,
whole or fragment and any constructs thereof.
1.5 "BUSINESS DAY". Business Day means a day on which banking institutions
in New York, New York and Frankfurt, Germany are open for business.
1.6 "CHANGE OF CONTROL". Change of Control means (a) a merger or
consolidation of Millennium and a Significant Pharmaceutical
Enterprise which results in the voting securities of Millennium
outstanding immediately prior thereto ceasing to represent at least
[**] of the combined voting power of the surviving entity immediately
after such merger or consolidation, or (b) a Significant
Pharmaceutical Enterprise, together with its Affiliates, becoming the
beneficial owner of [**] or more of the combined voting power of the
outstanding securities of Millennium, or (c) the sale or other
transfer of all or substantially all of Millennium's assets which
relate to this Agreement to a Significant Pharmaceutical Enterprise.
1.7 "COMMERCIALIZATION" or "COMMERCIALIZE". Commercialization or
Commercialize means any and all activities directed to marketing,
promoting, distributing, offering for sale and selling a product,
importing a product for sale, conducting Commercial Phase IIIB Studies
and Phase IV Studies, and manufacturing for commercial sale. When used
as a verb, "Commercialize" means to engage in Commercialization.
1.8 "CONFIDENTIAL INFORMATION". Confidential Information means all
proprietary materials, know-how or other information (whether or not
patentable) regarding a Party's technology, products, business
information or objectives, which is designated as confidential in
writing by the disclosing Party, whether by letter or by the use of an
appropriate stamp or legend, prior to or at the time any such
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material, know-how or other information is disclosed by the disclosing
Party to the other Party. Notwithstanding the foregoing to the
contrary, materials, know-how or other information which is orally,
electronically or visually disclosed by a Party, or is disclosed in
writing without an appropriate letter, stamp or legend, shall
constitute Confidential Information of a Party (a) if the disclosing
Party, within thirty (30) days after such disclosure, delivers to the
other Party a written document or documents describing the materials,
know-how or other information and referencing the place and date of
such oral, visual, electronic or written disclosure and the names of
the persons to whom such disclosure was made, or (b) such information
is of the type that is customarily considered to be confidential
information by persons engaged in activities that are substantially
similar to the activities being engaged in by the Parties (including
without limitation software source code). Notwithstanding the
foregoing, any technical or financial information of a Party disclosed
at a meeting of the Joint Research Committee, the Joint Development
Committee, the Joint Commercialization Committee or the Joint Steering
Committee (or any subcommittees or project teams of the foregoing) or
disclosed through an audit report shall constitute Confidential
Information of a Party unless otherwise specified.
1.9 "CONTRACT YEAR". Contract Year means (a) with respect to the first
Contract Year, the period beginning on the Effective Date and ending
on December 31, 2000 (the "First Contract Year"), and (b) with respect
to each subsequent Contract Year, the twelve (12) month period
beginning on the day following the end of the First Contract Year and
each succeeding twelve (12) month period thereafter during the
Research Program Term (except that the last Contract Year shall end on
the fifth anniversary of the Effective Date). Each Contract Year
(other than the First and last Contract Year) shall be divided into
four (4) "Contract Quarters" comprised of successive three (3) month
periods. In the First Contract Year, the first Contract Quarter shall
end on the first day following the Effective Date that is the last day
of a calendar quarter, and in the last Contract Year, the last
Contract Quarter shall end on the fifth anniversary of the Effective
Date.
1.10 "CONTROL" or "CONTROLLED". Control or Controlled means with respect to
any (a) material, item of information, method, data or other know-how,
or (b) intellectual property right, the possession (whether by
ownership or license, other than pursuant to this Agreement) by a
Party or its Affiliates of the ability to grant to the other Party
access and/or a license as provided herein under such item or right
without violating the terms of any agreement or other arrangement with
any Third Party existing before or after the Effective Date.
1.11 "COVERING", "COVER", or "COVERED". Covering, Cover or Covered means,
with respect to a Patent Right, that, but for a license granted to a
party under a Valid Claim included in such Patent Right, the practice
by such party of an invention claimed in such Patent Right would
infringe such Valid Claim or in the case of a Patent Right that is a
patent application, would infringe a Valid Claim in such patent
application if it were to issue as a patent.
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1.12 "DEVELOPMENT" or "DEVELOP". Development or Develop means, with respect
to a therapeutic drug candidate that has achieved EDC Status or its
equivalent (and any related Diagnostic candidates) preclinical and
clinical drug development activities, including, among other things:
test method development and stability testing, toxicology,
formulation, process development, manufacturing scale-up,
development-stage manufacturing, quality assurance/quality control
development, statistical analysis and report writing, clinical studies
and regulatory affairs, product approval and registration. When used
as a verb, "Develop" means to engage in Development. For the purposes
of this Agreement, Commercial Phase IIIB Studies or Phase IV Studies
shall constitute Commercialization.
1.13 "DIAGNOSTIC". Diagnostic means any product or service that (a)
identifies patients having a particular disease or having a
predisposition to a particular disease, and/or (b) defines the
prognosis or monitors the progress of any disease in a patient and/or
(c) is used to select between two (2) or more therapeutic or
prophylactic regimens, wherein at least one such therapeutic or
prophylactic regimen involves a compound that could be used to treat
and/or prevent a disease, and where the selected regimen is
determined, based on the use of such product or service, to be the
most effective and/or to be the most safe for a patient.
1.14 "DROPPED EDC COMPOUND". Dropped EDC Compound means an EDC Compound
that neither Party is Developing.
1.15 "DROPPED TARGET". Dropped Target means a Scientifically-Qualified
Target that was under active pursuit pursuant to the Research Program
as a Program Target or as a Single-Party Research Target but is no
longer the subject of validation and drug discovery activities
pursuant to Section 2.7.4.
1.16 "DRUGGABLE TARGET". Druggable Target means a target (i.e., a nucleic
acid sequence and/or the protein that it encodes), for which there is
reasonable evidence (based upon bioinformatics analysis) to suggest
that such target is of a class that is capable of being (a) modulated
by a Small Molecule and (b) configured into an assay for Small
Molecule high throughput screening or used for structure-based Small
Molecule drug design. By way of example, a Druggable Target may
include, without limitation, a protein in one of the following
classes: G protein-coupled receptors, nuclear hormone receptors, ion
channels and enzymes.
1.17 "EARLY DEVELOPMENT CANDIDATE STATUS" or "EDC STATUS". Early
Development Candidate Status or EDC Status means the status that may
be assigned to a Small Molecule by the Joint Development Committee
after certain Pre-EDC Research Evaluation activities have been
completed.
1.18 "EDC COMPOUND". EDC Compound means a Program Compound that has
achieved EDC Status in the Research Program, as determined in
accordance with Section 3.1.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.19 "EFFECTIVE DATE". Effective Date means the HSR Clearance Date (as
defined in Article 15) or, if the Parties mutually agree that an HSR
Filing is not required, July 6, 2000.
1.20 "EXECUTIVE OFFICERS". Executive Officers means the Chief Executive
Officer of Aventis or a parent Affiliate of Aventis (or an executive
of Aventis designated by such Chief Executive Officer) and the Chief
Executive Officer of Millennium (or an executive of Millennium
designated by such Chief Executive Officer).
1.21 "[**] PROPERTY". [**] Property means any information, methods, data,
or other know-how included in or that relate to, and/or any [**]
Property" means [**] Property [**] Property" means [**] Property [**].
1.22 "FDA". FDA means the United States Food and Drug Administration, or a
successor agency thereto.
1.23 "FIRST COMMERCIAL SALE". First Commercial Sale means, for each
Royalty-Bearing Product, on a country-by-country basis, the first
shipment of Royalty-Bearing Product to a Third Party by the
Royalty-Paying Party, its Affiliates or sublicensees in a country in
the Territory after Regulatory Approval has been achieved for such
Royalty-Bearing Product in such country. Sales for test marketing,
sampling and promotional uses, clinical trial purposes or
compassionate or similar use shall not be considered to constitute a
First Commercial Sale.
1.24 "FTE". FTE means a full time equivalent person year (consisting of a
total of 1,760 hours per year) of scientific, technical or managerial
work on or directly related to the Research Program or the Development
or Commercialization of Joint Development Compounds or Joint
Development Products.
1.25 "GENE THERAPY". Gene Therapy means treatment, prevention or control of
a disease or condition in humans, or remedying a gene deficiency of
humans, by genetic modification of human somatic cells or animal
somatic or germ cells (in vivo, in vitro or ex vivo) with DNA (RNA)
for the purpose of expressing a protein or oligo(poly)nucleotide
encoded by such DNA (RNA).
1.26 "HPB". HPB means the Health Protection Branch of Health Canada, or any
successor agency thereto.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.27 "IND". IND means (a) (i) an Investigational New Drug Application, as
defined in the U.S. Federal Food, Drug, and Cosmetic Act, as amended,
and the regulations promulgated thereunder, that is required to be
filed with the FDA before beginning clinical testing of a Joint
Development Product in human subjects, or any successor application or
procedure and (ii) any foreign counterpart of a U.S. Investigational
New Drug Application, and (b) all supplements and amendments that may
be filed with respect to the foregoing.
1.28 "INFLAMMATION FIELD". Inflammation Field means the prevention, control
and/or treatment in humans of (a) [**] inflammation (consisting of
[**]), (b) [**], (c) [**] and/or (d) [**].
1.29 "INVESTMENT AGREEMENT". Investment Agreement shall mean the Investment
Agreement entered into by the Parties on date even herewith.
1.30 "JOINT COMMERCIALIZATION PROJECT TEAM". Joint Commercialization
Project Team means a team formed pursuant to Section 6.2.
1.31 "JOINT DEVELOPMENT COMPOUND". Joint Development Compound means an EDC
Compound that the Parties jointly Develop in accordance with Article
3.
1.32 "JOINT DEVELOPMENT PRODUCT" or "JD PRODUCT". Joint Development Product
or JD Product means a product containing a Joint Development Compound
as an active ingredient that the Parties jointly Commercialize in
accordance with Article 6.
1.33 "JOINT DEVELOPMENT PROJECT TEAM". Joint Development Project Team means
a team formed pursuant to Section 3.2.
1.34 "JOINT STEERING COMMITTEE". Joint Steering Committee means a committee
comprised of an appropriate number of representatives of Millennium
and Aventis to plan and oversee the activities contemplated by this
Agreement, as well as the activities of the Parties under the
Technology Development Agreement and the Technology Transfer
Agreement, as may be provided in such agreements.
1.35 "LAWS". Laws means all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of any federal,
national, multinational, state, provincial, county, city or other
political subdivision, domestic or foreign.
1.36 "LEAD COMPOUND". Lead Compound means a Program Compound that has been
selected as a lead by the Joint Research Committee based on lead
selection criteria agreed upon by the Joint Research Committee
pursuant to Section 2.4.1.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.37 "LEAD COMPOUND FAMILY". Lead Compound Family means with respect to a
Lead Compound, such Lead Compound and all Program Compounds that are
[**] of such Lead Compound in the conduct of the Research Program.
1.38 "NDA". NDA means (a) (i) a New Drug Application pursuant to 21 U.S.C.
Section 505(b)(1) submitted to the FDA or any successor application or
procedure and (ii) any foreign counterpart of a U.S. New Drug
Application, and (b) all supplements and amendments, including
supplemental New Drug Applications (and any foreign counterparts),
that may be filed with respect to the foregoing.
1.39 "NORTH AMERICA" or "NA". North America or NA means the United States,
its territories and possessions, and Canada.
1.40 "PARTY" or "PARTIES". Party means Aventis or Millennium; "Parties"
means Aventis and Millennium.
1.41 "PATENT RIGHTS". Patent Rights means all existing patents and patent
applications and all patent applications hereafter filed, including
any continuations, continuations-in-part, divisions, provisionals or
any substitute applications, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal or
extension (including any supplemental patent certificate) of any such
patent, and any confirmation patent or registration patent or patent
of addition based on any such patent, and all foreign counterparts of
any of the foregoing.
1.42 "PHASE I STUDY". Phase I Study means a clinical study in subjects to
evaluate the pharmacokinetic and pharmacodynamic properties, maximum
tolerated dose, dosing interval, and absorption, distribution,
metabolism and excretion (ADME) of a candidate drug.
1.43 "PHASE IIA STUDY". Phase IIA Study means a dose exploration, dose
response, duration of effect, kinetic/dynamic relationship and
preliminary efficacy and safety study of a candidate drug in the
target patient population.
1.44 "PHASE IIB STUDY". Phase IIB Study means a controlled dose ranging
clinical trial to evaluate further the efficacy and safety of a
candidate drug in the targeted patient population and to define the
optimal dosing regimen.
1.45 "PHASE IIIA STUDY". Phase IIIA Study means a controlled clinical trial
to confirm with statistical significance the efficacy and safety of
the drug in larger, targeted patient populations, performed to obtain
approval of a product application.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.46 "PHASE IIIB STUDY". Phase IIIB Study means a clinical trial intended
to enhance the profile of a product for a non-approved indication and
not required or pivotal for approval of a product application. A
"Development Phase IIIB Study" means a Phase IIIB Study commenced
prior to the completion of Phase IIIA Studies required for Regulatory
Approval for the first indication for a Joint Development Product. A
"Commercial Phase IIIB Study" means a Phase IIIB Study commenced after
the completion of Phase IIIA Studies required for Regulatory Approval
for the first indication for a Joint Development Product.
1.47 "PHASE IV STUDY". Phase IV Study means a study initiated in a country
after receipt of Regulatory Approval in such country within the
approved product labeling.
1.48 "PRE-EDC RESEARCH EVALUATION". Pre-EDC Research Evaluation means any
and all of the activities relating to the qualification of a Small
Molecule for EDC Status, including, but not limited to, chemical
optimization and pre-clinical activities.
1.49 "PROGRAM COMPOUND". Program Compound means a Small Molecule that (a)
(i) is in a Party's or any of its Affiliates' possession as of the
Effective Date, or is [**] by a Party or any of its Affiliates during
the Research Program Term but [**] the Research Program, (ii) is [**]
a Program Target and (iii) is selected by the Joint Research Committee
for Pre-EDC Research Evaluation in the conduct of the Research Program
or (b) is [**]the Research Program or (c) is otherwise designated a
Program Compound by the Joint Research Committee; provided however in
no event shall the [**] Program Compound unless such designation is
affirmatively agreed to by the Joint Research Committee.
1.50 "PROGRAM COMPOUND FAMILY". Program Compound Family means, with respect
to a Program Compound, such Program Compound [**] that are [**] such
Program Compound in the conduct of the Research Program.
1.51 "PROGRAM INTELLECTUAL PROPERTY". Program Intellectual Property means
Program Patent Rights, Program Material, and Program Technology. For
clarity, Program Intellectual Property includes Research Program
Chemistry Intellectual Property.
1.52 "PROGRAM MATERIAL". Program Material means any
Scientifically-Qualified Targets (including Program Targets), Program
Compounds, and any material first identified or discovered in the
conduct of the Research Program, including, without limitation,
biological materials or chemical compounds such as tissue samples,
receptors, reagents and screens.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
1.53 "PROGRAM PATENT RIGHTS". Program Patent Rights means any Patent Rights
that are Controlled by a Party and that Cover any Program Technology
or Program Materials.
1.54 "PROGRAM TARGET". Program Target means [**] which the Joint Research
Committee has committed to initiate activities in the Research
Program that relate to (a) in vitro or in vivo modulation of the
gene corresponding to such target (e.g., through antisense, mouse
knockout, etc.), (b) drug discovery or similar activities using
such target, or (c) such other activities related to the validation
or use of the target in the Inflammation Field as are determined
appropriate by the Joint Research Committee and identified in the
Annual Research Plan.
1.55 "PROGRAM TECHNOLOGY". Program Technology means any invention,
information, methods, know how, trade secrets, data, or copyright
(excluding copyrights in North American Promotional Materials) that
(a) is Controlled by a Party or jointly by the Parties and, (b) (i)
relates to the Inflammation Field, is utilized in the Research Program
(but only to the extent so utilized), and either is in a Party's or
any of its Affiliates' possession as of the Effective Date or is
discovered or acquired by a Party and/or any of its Affiliates during
the Research Program Term but outside of the conduct of the Research
Program, or (ii) is first invented or discovered in the conduct of the
Research Program or in the course of the Development or
Commercialization of any Joint Development Compound or Joint
Development Product. For clarity, Program Technology excludes Program
Materials.
1.56 "REGULATORY APPROVAL". Regulatory Approval means any and all approvals
(including any applicable governmental price and reimbursement
approvals), licenses, registrations, or authorizations of any federal,
national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity necessary for the
manufacture, use, storage, import, transport, promotion, marketing and
sale of a product in a country.
1.57 "RESEARCH PROGRAM". Research Program means the collaborative research
program to be conducted by the Parties in accordance with the Annual
Research Plan and this Agreement. For clarity, activities conducted
pursuant to Sections 2.7.3, 2.10, 2.11 and 2.12 shall not be part of
the Research Program.
1.58 "RESEARCH PROGRAM CHEMISTRY INTELLECTUAL PROPERTY". Research Program
Chemistry Intellectual Property means any invention, information,
methods, know how, trade secrets, data, copyright or material that
relate to, or any Program Patent Rights that Cover, any Program
Compound. "Aventis Research Program Chemistry Intellectual Property"
means Research Program Chemistry Intellectual Property Controlled by
Aventis. "Millennium Research Program Chemistry Intellectual Property"
means Research Program Chemistry Intellectual Property Controlled by
Millennium.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.59 "ROW". ROW means all the countries in the Territory excluding the
countries in North America.
1.60 "ROW MAJOR MARKET COUNTRIES". ROW Major Market Countries means the
United Kingdom, France, Germany, Spain, Italy and Japan.
1.61 "ROYALTY-BEARING PRODUCT". Royalty-Bearing Product means a Joint
Development Product, a UDC Product, a Single-Party Target Product, an
Ex-Program Product, a GT or Vaccine Product, or an Antibody or
Diagnostic Product.
1.62 "ROYALTY-PAYING PARTY". Royalty-Paying Party means, with respect to a
Royalty-Bearing Product, the Party obligated to pay royalties to the
other Party under any of the provisions of Section 8.3.
1.63 "SCIENTIFICALLY-QUALIFIED TARGET" or "SQT". Scientifically-Qualified
Target or SQT means a target (a) that is [**], and (b) for which [**]
and/or [**], or such [**] by the Joint Research Committee, of utility
of such target for the [**] for use as a drug in the [**], based on
information from (i) [**] (ii) [**], and (iii) [**] or comparable
technologies, or such other method as may otherwise be determined by
the Joint Research Committee (PROVIDED THAT in the absence of any such
determination, each of subsections (i), (ii) and (iii) shall be
required), in each case performed using [**].
1.64 "SIGNIFICANT PHARMACEUTICAL ENTERPRISE". Significant Pharmaceutical
Enterprise means (a) a company (other than Aventis or an Aventis
Affiliate) which, together with its Affiliates, had worldwide annual
revenues from the sale of pharmaceutical products in excess of $[**]
during its most recently completed fiscal year and (b) any Affiliates
of such company.
1.65 "SINGLE-PARTY RESEARCH TARGET". Single-Party Research Target means a
former Program Target that is the subject of validation and/or drug
discovery activities by only one of the Parties outside of the
Research Program in accordance with Section 2.7.3. "Aventis
Single-Party Research Target" means a Single-Party Research Target for
which Aventis is the Researching Party and "Millennium Single-Party
Research Target" means a Single-Party Research Target for which
Millennium is the Researching Party.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
1.66 "SINGLE-PARTY TARGET PRODUCT". Single-Party Target Product means a
product that contains as an active ingredient a Small Molecule first
identified, evaluated or optimized by a Party through the use of a
Single-Party Research Target, or first identified, evaluated or
optimized in the Research Program through the use of such target as a
Program Target prior to its designation as a Single-Party Research
Target and is developed as a Single Party Target Product. "Aventis
Single-Party Target Product" means a Single-Party Target Product under
investigation by Aventis, and "Millennium Single-Party Target Product"
means a Single-Party Target Product under investigation by Millennium.
1.67 "SMALL MOLECULE". Small Molecule means a compound that has a molecular
weight that is no greater than [**]. The term "Small Molecule" shall
not include any compound that is (A) a [**], (B) a [**], (C) an
[**], (D) a [**], or (E) a [**] or [**] that acts as an [**].
1.68 "TECHNOLOGY DEVELOPMENT AGREEMENT". Technology Development Agreement
means the Technology Development Agreement between Aventis and
Millennium dated as of the Execution Date.
1.69 "TECHNOLOGY TRANSFER AGREEMENT". Technology Transfer Agreement means
the Technology Transfer Agreement between Millennium and Aventis dated
as of the Execution Date.
1.70 "TERRITORY". Territory means all the countries of the world.
1.71 "THIRD PARTY". Third Party means any person or entity other than a
Party or any of its Affiliates.
1.72 "UNILATERAL DEVELOPMENT COMPOUND" or "UDC". Unilateral Development
Compound or UDC means an EDC Compound that one Party Develops in
accordance with Section 3.7. "Aventis Unilateral Development Compound"
means a Unilateral Development Compound for which Aventis is the
Developing Party, and a "Millennium Unilateral Development Compound"
means a Unilateral Development Compound for which Millennium is the
Developing Party.
1.73 "UNILATERAL DEVELOPMENT COMPOUND PRODUCT" or "UDC PRODUCT". Unilateral
Development Compound Product or UDC Product means a product containing
a Unilateral Development Compound as an active ingredient. "Aventis
UDC Product" means a product that contains as an active ingredient an
Aventis Unilateral Development Compound, and "Millennium UDC Product"
means a product that contains as an active ingredient a Millennium
Unilateral Development Compound.
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1.74 "UNIQUE CHEMICAL COMPOUND". Unique Chemical Compound means a Small
Molecule having a unique arrangement of atoms by virtue of
composition, connectivity and shape such that it can be or has been
assigned a Chemical Abstracts Registry number (CAS no.).
Notwithstanding the foregoing, (a) enantiomeric forms of the same
molecule, (b) a molecule and its salt form, or (c) a prodrug that is
metabolized to the same active moiety as the Small Molecule, shall be
considered the same Unique Chemical Compound.
1.75 "VACCINE". Vaccine means a prophylactic or therapeutic agent that acts
by inducing a humoral and/or cell-mediated immune response directed
specifically against an antigen.
1.76 "VALID CLAIM". Valid Claim means a claim (a) of any issued, unexpired
patent which has not been revoked or held unenforceable or invalid by
a decision of a court or governmental agency of competent jurisdiction
from which no appeal can be taken, or with respect to which an appeal
is not taken within the time allowed for appeal, and which has not
been disclaimed, denied or admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise, or (b) of any patent
application which shall not have been cancelled, withdrawn, abandoned
nor been pending for more than five (5) years from the earliest
priority date claimed for such application.
1.77 ADDITIONAL DEFINITIONS. Each of the following definitions is set forth
in the section of this Agreement indicated below:
<TABLE>
<CAPTION>
DEFINITION SECTION
<S> <C> <C>
Adjustment Factor Exhibit B-2
Antibody Option 2.11.1
Antibody Products 2.11.1
Aventis Ex-Program Intellectual Property 1.21
Aventis Indemnified Parties 14.1.2
Aventis Single-Party Research Target 1.65
Aventis Single-Party Target Product 1.66
Aventis UDC Product 1.71
Back-Up Compounds 3.9.1
Breach Notice 11.2.1
Breaching Party 11.2.1
Burdened Technology 2.5.1
Burdened Technology Obligations 2.5.1
Clinical Supply Cost Exhibit B
Capacity Exhibit B-4
Capacity Variance Exhibit B-4
Commercial Phase IIIB Study 1.44
Compound Expression of Interest 3.7.6(c)
Compound Notification 3.7.6(a)
</TABLE>
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<PAGE>
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
<TABLE>
<CAPTION>
<S> <C>
Compound Response Period 3.7.6(b)
Compound Right of First Negotiation 3.7.6
Contract Quarter 1.9
Contract Year 1.9
Designation Date Exhibit B-2
Detail Exhibit B
Detail Cost Exhibit B
Detail Number Exhibit B
Developing Party 3.7.1
Development Phase IIIB Study 1.44
Diagnostic Option 2.11.1
Diagnostic Products or Services 2.11.1
DOJ 15.2.1
EDC Data Package 3.1.1
Efficiency Variance Exhibit B-4
Energy/Waste & Environmental Costs for the Active
Production Plants Exhibit B-4
Essential Pharmacogenomic Product or Service 2.13.1(b)
[**] 2.12.3
[**] 2.12.3
[**] 2.12.4
[**] 2.12.2
Excess Recovery 9.5.4
Field Force Expense Exhibit B
FTE Cost Exhibit B
FTE Rate Exhibit B
FTC 15.2.2
G&A Expense Exhibit B
GT Option 2.10.1
GT Products 2.10.1
Global Commercialization Plan 6.3.4
Global Development Plan 3.2.2(h)
HSR Act 15.2.3
HSR Clearance Date 15.2.4
HSR Filing 15.2.5
Intellectual Property 13.6.1
Inventory Write-offs Exhibit B-4
Investment Agreement 8.1
Joint Research Committee 2.2.1
Joint Research Project Team 2.2.1
Labor Capacity Exhibit B-4
Lead Regulatory Party 5.1.1
Line Cost Exhibit B-4
Marks 9.7.1
Manufacturer Period Costs Exhibit B-4
Material Cost Exhibit B-4
</TABLE>
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<PAGE>
<TABLE>
<CAPTION>
<S> <C>
Material Price Variance Exhibit B-4
Millennium Ex-Program Intellectual Property 1.21
Millennium Indemnified Parties 14.1.1
Millennium Single-Party Research Target 1.63
Millennium Single-Party Target Product 1.64
Millennium UDC Product 1.71
NA Commercialization Expense Exhibit B
NA Development Cost Exhibit B
NA License Fees Exhibit B
NA Marketing Expense Exhibit B
NA Medical Expense Exhibit B
NA Percentage Exhibit B-2
NA Period Costs Exhibit B
NA/Ex-NA Commercialization 6.1.3
NA/Ex-NA Commercialization Expense Exhibit B
NA/Ex-NA Development 3.2.4(a)
NA/Ex-NA Development Cost Exhibit B
NA/Ex-NA Expense Exhibit B
NA/Ex-NA License Fees Exhibit B
NA/Ex-NA Marketing Expense Exhibit B
NA/Ex-NA Medical Expense Exhibit B
NA/Ex-NA Period Costs Exhibit B
Net Sales Exhibit B-3
Non-Breaching Party 11.2.1
Non-Selling Party 9.5.4
North America Commercialization Budget 6.6.1(c)
North America Development 3.2.4(a)
North America Promotional Materials 6.6.3(a)
North America Commercialization 6.1.3
Notice of Disagreement 5.4
Notice of Discontinuance 3.6.1
Operator Labor Costs Exhibit B-4
Opt-Out Phase 8.3.2
Other Cost of Goods Exhibit B-4
Overhead Costs Exhibit B-4
Owning Party 9.5.2(b)
Patent Prosecution 9.2.1
Period Costs Exhibit B-4
Potential Antibody Target 2.11.1
Potential Diagnostic Target 2.11.1
Potential GT Target 2.10.1
Potential Vaccine Target 2.10.1
Pre-tax Profit or Loss Exhibit B
Product Development Exhibit B-4
Product Expression of Interest 6.12.3
Product Notification 6.12.1
</TABLE>
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<PAGE>
<TABLE>
<CAPTION>
<S> <C>
Product Related Costs Exhibit B-4
Product Response Period 6.12.2
Product Right of First Negotiation 6.12
Project Start-up Exhibit B-4
Quality Testing Costs Exhibit B-4
Related Joint Development Product 8.3.1
Related UDC Product 8.3.2
Relevant Calendar Year Exhibit B-2
Relevant Five-Calendar-Year Period Exhibit B-2
Relevant Global Inflammation Sales Exhibit B-2
Relevant NA Inflammation Sales Exhibit B-2
Relevant Period Costs Exhibit B
Relevant Products Exhibit B-2
Representative Exhibit B
Research Program Term 2.1.2
Researching Party 2.7.3(a)
Revaluation Exhibit B-4
ROW Commercialization 6.5.1
ROW Development 3.2.4(b)
ROW Period Cost Exhibit B
Selling Party 9.5.4
Spending Variance Exhibit B-4
SPRT Compounds 2.7.3(b)
Standard Cost Exhibit B
Supply Price Exhibit B
Target Expression of Interest 2.7.3(f)(iii)
Target Notification 2.7.3(f)(i)
Target Response Period 2.7.3(f)(ii)
Target Right of First Negotiation 2.7.3(f)
Third Party Opportunity 2.9.1
Vaccine Option 2.10.1
Vaccine Products 2.10.1
Volume Variance Exhibit B-4
Work Center Capacity Exhibit B-4
Work Center Costs Exhibit B-4
</TABLE>
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<PAGE>
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 2
RESEARCH PROGRAM
2.1 GENERAL.
2.1.1 Objective.
(a) The Parties shall collaborate in carrying out the
Research Program as set forth in the then current
Annual Research Plan, with the global objectives of
(i) [**] Scientifically-Qualified Targets and
Program Targets identified and/or validated in the
Research Program, consistent with the resources
allocated to such activities under the Annual
Research Plan, and (ii) [**] of EDC Compounds
with potential utility in the Inflammation Field,
consistent with the resources allocated to such
activities under the Annual Research Plan.
(b) It is anticipated that during the initial years of
the Research Program, [**] to the Research
Program [**] of the Research Program. [**] of the
Research Program, [**] to the Research Program [**]
will be [**] in the [**] of the Research Program.
(c) It is intended that, to the extent practicable, both
Parties will participate in the full range of
activities to be conducted in the Research Program,
including without limitation target identification
and validation, assay configuration, high throughput
screening and Pre-EDC Research Evaluation of Program
Compounds, all of the foregoing subject to the
Parties' respective capabilities and capacities to
perform such activities.
(d) It is intended that the Research Program will be
conducted as a unified collaborative effort with
activities by the Parties carried out at each Party's
respective facilities as the foregoing may be
outlined in the Annual Research Plan.
(e) It is also intended that, during the Research Program
Term, the Parties will each be conducting broader
target identification and validation, assay
configuration, high throughput screening and Pre-EDC
Research Evaluation of Small Molecules not
specifically
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directed to the Inflammation Field and conducted
outside of the Research Program.
(f) It is also intended, notwithstanding subsection (e)
above, that during the Research Program Term the
Parties shall collaborate in making available for the
Research Program Small Molecule chemical libraries as
set forth in the then current Annual Research Plan,
with the global objectives of maximizing the quantity
and quality of the EDC Compounds with potential
utility in the Inflammation Field consistent with the
resources allocated to such activities under the
Annual Research Plan; PROVIDED THAT neither Party
shall be obligated to disclose to the other Party the
chemical structure of any compound in any chemical
library Controlled by such Party unless and until
such compound is identified and confirmed as Active
against a Program Target or is otherwise designated a
Program Compound by the Joint Research Project Team.
2.1.2 TERM. The term of the Research Program (the "Research Program
Term") shall commence on the Effective Date and end on the
fifth anniversary of the Effective Date, unless (a) earlier
terminated pursuant to the provisions of Article 11 or (b)
extended pursuant to the provisions of Section 11.1.
2.2 JOINT RESEARCH COMMITTEE.
2.2.1 FORMATION AND MEMBERSHIP. As soon as practicable after the
Execution Date, Aventis and Millennium shall establish a Joint
Research Committee (the "Joint Research Committee") comprised
of three (3) representatives designated by Aventis and three
(3) representatives designated by Millennium, each of whom
shall have experience and seniority sufficient to enable him
or her to make decisions on behalf of the Party he or she
represents; provided that Aventis and Millennium may designate
an appropriate number of additional representatives from time
to time. The Joint Research Committee shall include at least
one Development representative from each Party. From time to
time during the Research Program Term, the Joint Research
Committee shall establish one or more Joint Research Project
Teams (each, a "Joint Research Project Team") to implement
various aspects of the Annual Research Plan. Such committees
shall be governed in the same manner and subject to the
relevant requirements as set forth herein for the Joint
Research Committee.
2.2.2 ADMINISTRATIVE MATTERS. The Joint Research Committee shall
appoint a chairperson from among its members, which shall
rotate semi-annually between the representatives from
Millennium and the representatives from Aventis. The
chairperson shall be responsible for calling meetings of the
Joint Research Committee and for leading the meetings. A Joint
Research Committee member of the Party hosting a meeting of
the Joint Research
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Committee shall serve as secretary of that meeting. The
secretary of the meeting shall prepare and distribute to all
members of the Joint Research Committee minutes of the meeting
sufficiently in advance of the next meeting to allow adequate
review and comment prior to the meeting. Such minutes shall
provide a description in reasonable detail of the discussions
had at the meeting and a list of any actions, decisions or
determinations approved by the Joint Research Committee.
Minutes of each Joint Research Committee meeting shall be
approved or disapproved, and revised as necessary, at the next
meeting. Final minutes of each meeting shall be distributed to
the members of the Joint Research Committee by the
chairperson.
2.2.3 DECISION MAKING. Each Party shall have one vote on the Joint
Research Committee (and each Joint Research Project Team).
Both Parties must vote in the affirmative to allow the Joint
Research Committee (or Joint Research Project Team) to take
any action that requires the vote of the Joint Research
Committee or a Joint Research Project Team. If the Joint
Research Committee is unable to reach unanimous agreement,
such issue shall be resolved in accordance with the provisions
of Article 12. If a Joint Research Project Team is unable to
reach unanimous agreement on any matter, such matter shall be
referred to the Joint Research Committee.
2.2.4 MEETINGS.
(a) The Joint Research Committee shall meet at least four
(4) times per Contract Year (except that
proportionately fewer meetings shall be held in a
Contract Year with fewer than 12 months). Such
meetings shall be held at such times and places as
are mutually agreed upon by the Joint Research
Committee and shall be conducted in person. By
approval of the chairperson, where such approval may
not unreasonably be withheld, representatives may
participate in any meeting of the Joint Research
Committee by means of conference telephone or similar
communications equipment by means of which all
persons participating in the meeting can hear each
other.
(b) Each Party shall use commercially reasonable efforts
to cause its representatives to attend the meetings
of the Joint Research Committee in person. If a
Party's representative is unable to attend a meeting,
such Party may designate an alternate representative
to attend such meeting in place of the absent
representative. In addition, each Party may, at its
discretion, invite additional employees, and, with
the consent of the other Party, consultants or
scientific advisors, to attend the meetings of the
Joint Research Committee.
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(c) Either Party may also convene a special meeting of
the Joint Research Committee for the purpose of
resolving disputes or for the purpose of reviewing
(or making) a decision pertaining to the designation
of a target as a Scientifically-Qualified Target or a
Program Target by providing ten (10) Business Days
written notice to the other Party.
2.2.5 RESPONSIBILITIES. The Joint Research Committee shall be
responsible for, among other things:
(a) overseeing the Research Program;
(b) providing a forum for consensual decision making;
(c) reviewing recommendations from and advising the Joint
Research Project Teams;
(d) reviewing needs in areas other than projects, but
necessary to support projects;
(e) preparing and approving each Annual Research Plan for
each Contract Year after the First Contract Year;
(f) appointing one or more Joint Research Project Teams,
as may be appropriate, to implement the Annual
Research Plan;
(g) monitoring the Parties' compliance with their
respective obligations under the Annual Research
Plan, including the accomplishment of key objectives,
the devotion of an appropriate number of FTEs to the
Research Program and the expenditure of significant
out-of-pocket expenses;
(h) reviewing and approving any amendments to the Annual
Research Plan and evaluating any substantive
departures by either Party from the Annual Research
Plan;
(i) evaluating any Burdened Technology Obligations and
deciding whether to accept Burdened Technology into
the Research Program;
(j) determining whether a target is a
Scientifically-Qualified Target;
(k) selecting which Scientifically-Qualified Targets the
Parties wish to designate as Program Targets;
(l) determining which research projects will be pursued
in the Research Program and which will be
discontinued;
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(m) monitoring reports submitted by the Parties pursuant
to the Annual Research Plan; and
(n) reviewing and commenting upon (but not approving) the
patent filing strategies of the Parties as provided
in Article 9.
2.2.6 PIPELINE REVIEW. Promptly following the Effective Date, the
Joint Research Committee shall convene to review both Parties'
pre-EDC pipelines of SQT and Program Compound candidates to
determine which shall be accepted into the Research Program.
Each Party shall identify all Burdened Technology Obligations
relating to such Party's pre-EDC pipelines of SQT and Program
Compound candidates that the Joint Research Committee
identifies as desirable for inclusion in the Research Program.
2.3 JOINT RESEARCH PROJECT TEAMS
2.3.1 FORMATION OF JOINT RESEARCH PROJECT TEAMS. Aventis and
Millennium shall each make its initial designation of its
representatives not later than thirty (30) days after the
formation of a Joint Research Project Team. Either Party may
change its designees to any Joint Research Project Team at any
time upon written notice to the other Party.
2.3.2 Responsibilities. The Joint Research Project Teams shall be
responsible for, among other things:
(a) implementing aspects of the Annual Research Plan
assigned to such Joint Research Project Team by the
Joint Research Committee;
(b) recommending Scientifically-Qualified Targets for
designation as Program Targets;
(c) recommending to the Joint Research Committee which
research projects will be pursued in the Research
Program and which will be discontinued; and
(d) recommending to the Joint Development Committee
(after consultation with the Joint Research
Committee) Program Compounds for qualification for
EDC Status.
2.3.3 SPECIAL MEETING. Either Party may convene a special meeting of
the appropriate Joint Research Project Team for the purpose of
reviewing (or making) a recommendation concerning whether a
Program Compound has qualified for EDC Status by providing ten
(10) Business Days written notice to the other Party.
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2.4 CONDUCT OF THE RESEARCH PROGRAM.
2.4.1 The Joint Research Committee shall adopt project progression
guidelines, including back-up selection criteria, similar to
guidelines set forth in Appendix E to the Annual Research
Plan. The Parties shall conduct the Research Program in
accordance with such project progression guidelines. Each
Party shall use commercially reasonable efforts to conduct the
activities of the Research Program which are assigned to it in
the Annual Research Plan.
2.4.2 Each Party shall devote a substantially equal number of FTEs
to the Research Program activities and expend substantially
similar amounts in significant out-of-pocket expenditures
directly related to the Research Program, each over the course
of the Research Program. All FTE utilization and significant
out-of-pocket expenditures shall either be expressly provided
for in the Annual Research Plan or approved by the Joint
Research Committee.
2.4.3 Each Party shall submit periodic reports to the Joint Research
Committee, as may be required by the Annual Research Plan,
detailing its activities under the Research Program. The Joint
Research Committee shall use such periodic reports to monitor
the Parties' respective contributions to the Research Program.
The Joint Research Committee may amend the Annual Research
Plan as necessary to maintain substantial equality in
resources devoted and participation by the Parties over the
course of the Research Program.
2.4.4 If either Party believes that there is a material imbalance in
resources devoted to, or participation by the Parties in, the
Research Program, such Party may submit the matter to the
Joint Research Committee in writing. Taking into account
historical and prospective participation and resource devotion
of the Parties during the current Contract Year and the
immediately following Contract Year, the Joint Research
Committee shall take such steps as may be reasonably necessary
to ensure substantial equality in resources devoted and
participation by the Parties in the Research Program. At the
request of a Party, the other Party shall permit an
independent, certified accountant appointed by the requesting
Party, at reasonable times and upon reasonable notice but no
more than once per year, to examine, at the sole cost of the
requesting Party, the records of the other Party to verify the
accuracy of any reports submitted by the other Party to the
Joint Research Committee regarding the level of resources
devoted to the Research Program by such Party
2.4.5 Each Party shall identify one of its representatives to serve
as a program director with responsibility for overseeing that
Party's day-to-day activities relating to the Research Program
and to serve as a contact person for coordinating Research
Program activities between the Parties.
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2.5 DISCLOSURE OF FINANCIAL AND OTHER BURDENS AND OBLIGATIONS.
2.5.1 The Parties acknowledge that certain materials, and data and
information relating thereto, Controlled by a Party may
include financial or other obligations to Third Parties[**],
and that the use of such [**] Program Technology or Program
Materials in the Research Program and the Development and
Commercialization of products resulting from the use of such
[**], may result [**] may (1) [**] to certain Program
Technology [**] under this Agreement, (2) [**], or that
certain information [**], (3) [**] by this Agreement or (4)
[**] under this Agreement relative to the rights of such Party
in the absence of any such grant of rights [**]).
2.5.2 Each Party acknowledges its obligation to inform the other
Party of Burdened Technology Obligations relating to any
Program Technology or Program Materials which it provides to
the Research Program. With respect to any proposed
Scientifically-Qualified Target, all Burdened Technology
Obligations related thereto shall be identified and described
in reasonable detail in writing by the Party that Controls
such target to the Joint Research Committee at such time as
such target is proposed for inclusion in the Research Program
as an SQT.
2.5.3 The Burdened Technology Obligations shall be considered for
all Program Technology or Program Materials prior to its
inclusion in the Research Program. By way of example, proposed
Scientifically-Qualified Targets will only be permitted into
the Research Program after the Joint Research Committee has
evaluated the nature and scope of the Burdened Technology
Obligations.
2.5.4 [**] by the Joint Research Committee, [**] (a) [**] (including
without limitation, [**] in the [**] with respect to [**], or
(b) to [**] of the [**] with respect to such [**] that would
[**]relating to such [**] pursuant to Sections 7.1.1(d),
7.1.2(d) and 7.1.3(d), in the case of Aventis, and Sections
7.2.1(d), 7.2.2(d) and 7.2.3(d), in the case of Millennium,
[**] the other Party, [**].
2.5.5 The Party [**] shall be [**] to the Joint Research Committee
[**] provided that with regard to [**] the use of such [**]
the Party [**] shall not be [**] the other Party [**] on
such Party's [**] thereof.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
2.6 ANNUAL RESEARCH PLAN.
2.6.1 The Joint Research Committee shall prepare and approve the
Annual Research Plan for every Contract Year (other than the
First Contract Year) at least sixty (60) days prior to the
commencement of such Contract Year. The Annual Research Plan
for the First Contract Year is set forth in Exhibit A to this
Agreement.
2.6.2 The Joint Research Committee shall update and amend, as
appropriate, the then-current Annual Research Plan from time
to time.
2.6.3 Each Annual Research Plan shall contain the specific research
objectives to be achieved during the Contract Year, the
specific activities to be performed under the Research Program
and the timeline for performing such activities, and the Party
which shall be responsible for performing each of the
activities.
2.6.4 Each Annual Research Plan shall be consistent with the other
terms and conditions of this Agreement, including the
objectives set forth in Section 2.1.1, and shall be
substantially the same in form, including the items itemized
in, the Annual Research Plan attached as Exhibit A.
2.7 TARGETS.
2.7.1 [**]
(a) During the Research Program Term, each Party shall
use commercially reasonable efforts to [**]
identified and qualified in the Research Program,
[**], using the technologies, data and materials
specified in such Annual Research Plan.
(b) Each Party shall [**] provided, however, a Party
shall [**] which it is [**] accordance with
the provisions of this Section 2.7.1.
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(c) During the Research Program Term, each Party shall,
[**], make [**] that it [**] could reasonably qualify
as a [**] together with [**] relating to the [**]
for use in [**].
(d) At each meeting of the Joint Research Committee, the
Joint Research Committee shall identify [**]
based on its review of the criteria set forth in
the Annual Research Plan and the Burdened Technology
Obligations associated therewith.
2.7.2 PROGRAM TARGETS. Once the Joint Research Committee has
designated a target as [**], the Joint Research Committee
will periodically consider whether it wishes to use [**]
for identification of Small Molecules suitable for use as
drugs [**] and, among other things, conduct the activities set
forth in the definition of "Program Target". If the Joint
Research Committee wishes to so use the [**] and conduct such
activities, then the Joint Research Committee shall designate
[**] as a Program Target and the Joint Research Committee
will prepare and approve an amendment to the Annual Research
Plan to reflect the activities to be undertaken by the Parties
with respect to such Program Target.
2.7.3 SINGLE-PARTY RESEARCH TARGETS.
(a) If at any time during the Research Program Term (i)
(A) a Party desires not to participate in further
validation or drug discovery activities with respect
to a Program Target and so notifies the other Party,
or (B) a Party fails to exercise commercially
reasonable efforts in undertaking the Research Plan
activities with respect to a Program Target pursuant
to the Annual Research Plan, and does not remedy such
failure within [**] following written notice of such
failure from the other Party, and (ii) the other
Party provides written notice to the Joint Research
Committee that it wishes to continue to participate
in further validation or drug discovery Cactivities
with respect to such target within [**] of receipt of
the notice from the discontinuing Party or the
expiration of such cure period, then the Joint
Research Committee shall designate such target a
Single-Party Research Target (and such target shall
no longer constitute a Program Target) and the other
Party shall have the right, outside of the Research
Program, to continue to engage in such activities
with respect to such target [**] (such Party being
referred to herein as the "Researching Party").
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(b) The Researching Party shall have access to all
Program Technology relating to the Single-Party
Research Target and all Program Materials relating to
the Single-Party Research Target, excluding Program
Compounds except as follows: (i) all Program
Compounds that are Active against such Single-Party
Research Target and any Small Molecules that are
members of the corresponding Program Compound Family,
PROVIDED, HOWEVER, that use of any such Small
Molecule that is not Active against such Single-Party
Research Target shall be limited to internal research
purposes only, and (ii) all Small Molecules within
the Lead Compound Family of a Lead Compound directed
to such Single-Party Research Target ((i) and (ii)
collectively "SPRT Compounds"). Any rights of the
Non-Researching Party to use such Lead Compound
Family in the Research Program shall be suspended
until discontinuation of all activities by the
Researching Party relating to such Lead Compound
Family with respect to such Single-Party Research
Target.
(c) Notwithstanding the foregoing, a Party shall not have
the right to pursue as a Single-Party Research
Target, a Program Target which the other Party has
decided not to continue to pursue in the Research
Program if such target has the same biological
activity and the same relevance in Small Molecule
drug discovery as another Program Target in the
Research Program.
(d) As soon as reasonably practicable after the
designation of a target as a Single-Party Research
Target by the Joint Research Committee, the Party
that is not the Researching Party shall provide the
Researching Party with any Program Technology and all
Program Material as may be specified in subsection
(b) in its Control.
(e) The Researching Party shall have the right to:
(i) research and Develop Small Molecules
identified through the use of a Single-Party
Research Target for use [**], using such
Single-Party Research Target in such
research and Development, as necessary, and
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(ii) Commercialize any resulting Single-Party
Target Product [**], subject to the royalty
obligation set forth in Section 8.3.3.
(f) Notwithstanding the foregoing, if a Party intends to
research, Develop or Commercialize [**] any Small
Molecules identified through the use of a
Single-Party Research Target including those Small
Molecules allocated in accordance with Section
2.7.3(b) in collaboration with a Third Party, or
grant a license to a Third Party to do any of the
foregoing, such Party shall provide the other Party
with the opportunity to negotiate terms under which
the other Party would collaborate or obtain a license
with respect to such activities (a "Target Right of
First Negotiation"), provided that a Target Right of
First Negotiation shall not apply to the retention of
a contract sales force or to a product distribution
or contract manufacturing arrangement or other
outsourced marketing, advertising or promotion
activities (unless such arrangement is with a
Significant Pharmaceutical Enterprise). A Target
Right of First Negotiation shall operate as follows:
(i) The Researching Party shall promptly notify
the other Party in writing (the "Target
Notification") of its intention to seek a
collaborator or licensee for researching,
Developing and/or Commercializing [**] a
Small Molecule identified through the use of
such Single-Party Research Target and shall
provide to the other Party a reasonably
detailed written description of such
proposed collaboration or license,
including, without limitation, the identity
of the target and the data, information,
material or results and Small Molecules
identified, evaluated or developed using
such target including those Small Molecules
allocated in accordance with Section
2.7.3(b)
(ii) Within [**] of its receipt of the Target
Notification (the "Target Response Period"),
the other Party shall notify the Researching
Party of its interest, if any, in initiating
discussions regarding such proposed
collaboration or license.
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(iii) In the event that the other Party notifies
the Researching Party prior to the
termination of the Target Response Period
that it has an interest in participating in
such proposed collaboration or obtaining
such license rights (a "Target Expression of
Interest"), then the Parties shall negotiate
in good faith in an effort to reach a
definitive agreement regarding such
collaboration or license for a period of up
to [**] from the date of the Researching
Party's receipt of the Target Expression of
Interest.
(iv) In the event that the Parties reach a
definitive agreement with respect to such
collaboration or license pursuant to
subsection (iii), such target shall no
longer be designated a Single-Party Research
Target and the rights and obligations of the
Parties with respect to such target and any
Small Molecules identified, developed or
evaluated through the use of such target
including those Small Molecules allocated in
accordance with Section 2.7.3(b) shall be
governed by the terms of such definitive
agreement and not this Agreement.
(v) In the event that (A) the other Party fails
to notify the Researching Party prior to the
termination of the Target Response Period
that it is interested in collaborating with
or obtaining a license from the Researching
Party with respect to such Single-Party
Research Target, or (B) the other Party
notifies the Researching Party prior to the
termination of the Target Response Period
that it has no interest in collaborating
with or obtaining a license from the
Researching Party with respect to such
Single-Party Research Target, or (C) the
other Party timely provides the Researching
Party with an Expression of Interest but the
Parties fail to reach definitive agreement
within the [**] period specified in
subsection (iii), then the Researching Party
shall be free to enter into a collaboration
or license with a Third Party with respect
to such Single-Party Research Target;
PROVIDED, HOWEVER, that the Researching
Party may not enter into any collaboration
or license with a Third Party [**] to the
Third Party, [**] to the non-Researching
Party.
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(vi) For the duration of the Target Response
Period, and if the other Party timely
delivers the Target Expression of Interest,
the [**] term specified in Section
2.7.3(f)(iii), the Researching Party may
discuss with a Third Party the general
outline of such collaboration or license;
provided however, that the Researching Party
shall not negotiate such collaboration or
license with a Third Party, enter into any
agreements with such Third Party or propose
terms to such Third Party on which the
Researching Party would be willing to
consummate such collaboration or license.
(g) For the avoidance of doubt, a Program Target which
becomes a Single-Party Research Target shall continue
to remain a Scientifically-Qualified Target and the
non-Researching Party shall continue to have the
right to use such Scientifically-Qualified Target to
the extent provided in Section 2.12.
2.7.4 DROPPED TARGETS.
(a) If at any point in time (i) neither Party desires to
continue validation and drug discovery activities
with respect to a Program Target, (ii) both Parties
fail to exercise commercially reasonable efforts to
conduct validation and drug discovery activities with
respect to such target and do not cure such failure
or both Parties fail to exercise commercially
reasonable efforts in undertaking such validation and
drug discovery activities and neither cures such
failure within [**] after receipt of written notice
from the other Party asserting such failure (PROVIDED
THAT if the first Party to receive such written
notice responds within such [**] period
with a notice to the other Party asserting that such
other Party has also failed to exercise commercially
reasonable efforts in undertaking such validation and
drug discovery activities, both written notices
shall, for purposes of this subsection, be deemed to
have been given concurrently on the date that the
first notice was given), (iii) the Joint Research
Project Team decides to discontinue validation and
drug discovery activities with respect to such
target, or (iv) the Researching Party fails to
exercise commercially reasonable efforts to conduct
validation and drug discovery activities with respect
to a Single-Party Research Target, then such target
shall thereafter be deemed a Dropped Target and not a
Program Target or a Single Party Research Target, as
applicable.
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(b) Either Party shall thereafter during the Research
Program Term have the right to pursue such target as
a Single-Party Research Target, PROVIDED THAT such
Party first gives written notice of its desire to the
other Party, together with any data, results, or
information in its Control relating to such target
and not already provided to the other Party. If the
other Party does not give notice of its desire to
pursue such target within [**], such target shall
thereafter be a Single-Party Research Target and not
a Dropped Target and the Researching Party's rights
and obligations with respect to such Single-Party
Research Target shall be as set forth in Section
2.7.3.
(c) If the other Party desires to participate in such
research and/or drug discovery activities with
respect to such target, such target shall thereafter
be a Program Target and not a Dropped Target, and the
Annual Research Plan shall be appropriately amended
to include such activities in the Research Program.
(d) For the avoidance of doubt, a Program Target or
Single Party Target which becomes a Dropped Target
shall continue to remain a Scientifically-Qualified
Target and both Parties shall continue to have the
right to use such Scientifically-Qualified Target to
the extent provided in Section 2.12.
2.7.5 [**] Research Program [**]. [**] the Research Program, [**]
this Agreement [**] the Parties [**] shall be as follows:
(a) Each Party shall [**] by such Party [**] by a Party
shall [**], the other Party.
(b) Each Party shall [**] and any Program [**]. Any such
[**] shall be [**] and a [**] and [**] by a Party
[**] by the relevant provisions set forth [**],
PROVIDED, HOWEVER, that (i) the [**] shall [**] and
(ii) the [**] of a Party set forth in [**] with
respect to the [**] Product shall only apply in the
event that [**] the other Party in the [**] Product.
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(c) With respect to each [**] that has been used [**],
the Parties shall [**] in the [**] in the [**]. In
the event that the Parties [**] reach a final
agreement [**] for a period of up to [**] from the
date on which the Parties [**]. If the Parties enter
into a final agreement [**] of the Parties [**]
(which shall be[**] in the same [**] in accordance
with the provisions [**] shall be governed by the
terms of [**]. In the event that (i) the Parties [**]
or (ii) [**] with respect to [**] the [**] period
specified above, then [**] from which the Parties
shall [**]. The[**] of the Parties [**], as necessary
to have [**] which Party shall make the first
selection). Each target selected from the [**] shall
[**] shall be deemed to be [**], as the case may be,
and the [**] a Party shall be governed by the
relevant provisions set forth in [**], PROVIDED,
HOWEVER, that the [**] shall not apply [**].
2.8 EXCLUSIVITY.
2.8.1 GENERAL. During the Research Program Term, and subject to the
exceptions set forth in Section 2.8.3, neither Party nor its
Affiliates shall, either alone or in collaboration with a
Third Party, engage in any activity, the goal of which is
(a) the identification or validation of targets for the
discovery of Small Molecules intended for use [**];
or
(b) the discovery and Pre-EDC Research Evaluation of
Small Molecules intended for use[**],
in each case except pursuant to the Research Program
and excepting Small Molecules that have achieved EDC
Status prior to the Effective Date.
2.8.2 [**] LICENSING. During the Research Program Term, and subject
to the exceptions set forth in Section 2.8.3, [**] (a) [**]
license to, or any [**] license, any target, or any Patent
Rights Covering, or know-how embodied in, the use of such
target, [**], or (b) [**] any license to, or any option to
license, any target, or any Patent Rights Covering, or
know-how embodied, in the use of such target, [**] such
license or option grant [**].
2.8.3 EXCEPTIONS. The prohibitions set forth in Sections 2.8.1 and
2.8.2 are not intended to apply to any activity directed to
the identification or validation of targets or the discovery
and Pre-EDC Research Evaluation of Small Molecules,
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Commission. Asterisks denote omissions.
(a) where such activity is undertaken in fulfillment of
an obligation of a Party existing as of the Execution
Date pursuant to an agreement that is set forth in
EXHIBIT C or EXHIBIT D;
(b) where such activity is undertaken with respect to any
assets Controlled by a Party as of the Execution Date
and identified in EXHIBIT C or EXHIBIT D;
(c) where such activity is undertaken in fulfillment of
an obligation of a Party pursuant to an agreement
with an academic, research or other non-commercial
institution, which agreement provides that such Party
shall be granted the right (or the option to obtain
the right), with the right to grant sublicenses to
the other Party, [**] to use any targets, Small
Molecules and related know-how for the research,
Development and Commercialization under this
Agreement;
(d) where a Party's involvement in such activity results
from such Party's acquisition of or by a Third Party
(by merger or otherwise), which Third Party, prior to
such acquisition or merger, was already engaged in
such activity, and such Party does not expand the
scope of, or financial commitment to, such activity;
provided that no Program Technology that was
identified or developed during the course of the
Research Program and no Program Materials are
disclosed to the Third Party; and provided further
that to the extent any other technology Controlled by
the Party in the form of biological materials (e.g.
genes, gene fragments, vectors, cell lines, cells,
organelles, DNA and DNA fragments, proteins and
peptides) or chemical compounds (e.g. small molecule
and natural product compounds and libraries), or any
data relating to the foregoing, are disclosed to such
Third Party, such Third Party shall (i) undertake in
writing not to use such technology or data in any
activities prohibited by Section 2.8.1, and (ii)
agree that the other Party shall be a third party
beneficiary of such undertaking. For clarity, the
exception as set forth in this subsection (d) shall
not apply where substantially all of such Third
Party's activities are encompassed by Section 2.8.1
(e) where such activity is undertaken by a Party with
respect to a Single-Party Research Target to the
extent otherwise permitted by the provisions of this
Agreement; or
(f) where such activity is undertaken with respect to a
Third Party Opportunity, pursuant to the relevant
provisions of Section 2.9.
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Commission. Asterisks denote omissions.
2.8.4 OTHER PERMITTED ACTIVITIES. For purposes of clarity,
activities that are not prevented by the prohibitions set
forth in Section 2.8.1 include, without limitation, the
following:
(a) either Party may, outside of the conduct of the
Research Program, engage in target identification and
validation activities and/or drug discovery or
Pre-EDC Research Evaluation of Small Molecules [**],
subject to the provisions of Section 2.8.1;
(b) either Party may, outside of the conduct of the
Research Program, engage in Pre-EDC Research
Evaluation of or Development of a Small Molecule for
use [**], provided that such Small Molecule (i) is
in-licensed from a Third Party, (ii) has achieved the
equivalent of EDC Status at the time of such
in-licensing (as long as the structure of such Small
Molecule is not modified), and (iii) is not generally
known or known by such Party to exert its action
through a Program Target; and
(c) either Party may, outside of the conduct of the
Research Program, engage in Pre-EDC Research
Evaluation or Development of a Small Molecule for use
[**], provided that such Small Molecule (i) had
achieved the equivalent of EDC Status as of the
Effective Date, and (ii) the structure of such Small
Molecule is not modified.
2.8.5 SCOPE OF RESTRICTIONS. The Parties agree that, given the high
costs and significant risks involved in discovering and
developing pharmaceutical products, and given that the Parties
will be exchanging Confidential Information in order to
perform the Research Program, the exclusive relationship
between them regarding the Research Program and the
Inflammation Field, which is reflected herein, is a fair and
efficient means to reach a satisfactory conclusion from their
cooperative efforts.
2.9 THIRD PARTY OPPORTUNITIES.
2.9.1 In the event that a Party is presented with an opportunity to
collaborate with a Third Party (a "Third Party Opportunity")
with respect to
(a) the identification and/or validation of a target or
family of related targets (not to exceed [**] targets
in number) for the discovery of Small Molecules for
use [**], and/or
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(b) the discovery and/or Pre-EDC Research Evaluation of a
Small Molecule and its related lead series [**],
then such Party may pursue such Third Party
Opportunity, but only in the manner provided in this
Section 2.9, such Party shall present the Third Party
Opportunity, including all material terms and
conditions relating thereto, to the Joint Research
Committee for the Joint Research Committee's
consideration for inclusion in the Research Program.
2.9.2 The Joint Research Committee shall then have [**] to decide
whether to pursue such Third Party Opportunity. In the event
that the Joint Research Committee elects to pursue such Third
Party Opportunity, then the Parties shall negotiate with the
Third Party that presented such Third Party Opportunity in a
good faith effort to reach an agreement with the Third Party
whereby the Third Party Opportunity can be included in the
Research Program. In the event that the Parties and the Third
Party that presented such Third Party Opportunity reach an
agreement to include such Third Party Opportunity in the
Research Program, then
(i) the Third Party Opportunity shall be
included in the Research Program; and
(ii) the Annual Research Plan shall be
appropriately amended to include, without
limitation, provisions for the sharing by
the Parties of the costs associated with the
Third Party Opportunity.
2.9.3 In the event that the Joint Research Committee does not elect
to pursue such Third Party Opportunity or the Parties fail,
despite a good faith effort, to reach agreement with the Third
Party that presented such Third Party Opportunity to include
the Third Party Opportunity in the Research Program, then the
Party that was initially presented with such Third Party
Opportunity shall have the right to pursue such Third Party
Opportunity outside of the conduct of the Research Program,
PROVIDED, HOWEVER, that such Party shall not pursue such Third
Party Opportunity outside of the conduct of the Research
Program if the target that is the subject of such Third Party
Opportunity is a Program Target or if the Small Molecule that
is the subject of such Third Party Opportunity is generally
known or is known by such Party to exert its action through a
Program Target.
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2.10 GENE THERAPY AND VACCINE TARGETS.
2.10.1 With respect to each Program Target that has relevance for
Gene Therapy or Vaccines (a "Potential GT Target" or a
"Potential Vaccine Target", as the case may be), Aventis shall
have an option (a "GT Option" or "Vaccine Option", as the case
may be) to exclusively license Millennium's rights in such
Program Target, if any, to validate and use such Potential GT
Target or Potential Vaccine Target, as the case may be, to
discover and evaluate Gene Therapy and/or Vaccine products
("GT Products" or "Vaccine Products", as the case may be) [**]
and to exclusively license Millennium's rights in such Program
Target, if any, to Develop and Commercialize such GT Products
or Vaccine Products, as the case may be.
2.10.2 Each GT Option and Vaccine Option will expire [**] after the
designation of the underlying target as a Program Target by
the Joint Research Committee. With respect to any Potential GT
Target or Potential Vaccine Target, Aventis may exercise
either the GT Option or the Vaccine Option, or both the GT
Option and the Vaccine Option.
2.10.3 In the event that Aventis elects to exercise a GT Option
and/or a Vaccine Option, Aventis shall provide written notice
of such exercise to Millennium prior to the expiration of the
[**] option period and, thereupon, Aventis shall automatically
be granted the licenses set forth in Section 7.1.4(a) or
7.1.4(b), as the case may be, and Aventis' subsequent
discovery and development work with respect to such Potential
GT Target or Potential Vaccine Target in the Gene Therapy or
Vaccine area, as applicable, shall be funded separately by
Aventis and conducted outside of the Research Program, any
Global Development Plan or any Global Commercialization Plan.
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2.10.4 In the event that, with respect to any Potential GT Target or
Potential Vaccine Target, (a) Aventis does not exercise the GT
Option or the Vaccine Option within the [**] option period for
the GT Option or the Vaccine Option, then Aventis shall no
longer be entitled to a license to Millennium's Gene Therapy
or Vaccine rights, and (b) Aventis fails to exercise
commercially reasonable efforts to research, Develop and
Commercialize a GT Product or a Vaccine Product based on the
use of such Potential GT Target or Potential Vaccine Target
and does not remedy such failure within [**] following written
notice of such failure from Millennium, then Aventis' license
to Millennium's Gene Therapy or Vaccine rights, as applicable,
with respect to such Potential GT Target or Potential Vaccine
Target and such Gene Therapy or Vaccine rights, as
applicable, shall be nonexclusive, subject to the payment of
royalties under Section 8.3.5.
2.10.5 During the period that any license granted to Aventis pursuant
to this Agreement is in effect, Aventis shall provide
Millennium with an annual report concerning the status of its
research, Development and Commercialization efforts with
respect to such Potential GT Target or Potential Vaccine
Target.
2.11 ANTIBODY AND DIAGNOSTIC RIGHTS.
2.11.1 With respect to each Program Target that has relevance for the
development of Antibody-based therapeutics or Diagnostics (a
"Potential Antibody Target" or a "Potential Diagnostic
Target", as the case may be), Millennium shall have an option
(an "Antibody Option" or a "Diagnostic Option", as the case
may be) to exclusively license Aventis' rights in such Program
Target, if any, to validate and use such Potential Antibody
Target or Potential Diagnostic Target, as the case may be, to
discover and evaluate Antibody-based therapeutic products
and/or Diagnostics ("Antibody Products" or "Diagnostic
Products or Services", as the case may be) [**] and to
exclusively license Aventis' rights in such Program Target, if
any, to Develop and Commercialize such Antibody Products or
Diagnostic Products or Services.
2.11.2 Each Antibody Option and Diagnostic Option will expire [**]
after the designation of the underlying target as a Program
Target by the Joint Research Committee. With respect to any
Potential Antibody Target or Potential Diagnostic Target,
Millennium may exercise either the Antibody Option or the
Diagnostic Option, or both the Antibody Option and the
Diagnostic Option.
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Commission. Asterisks denote omissions.
2.11.3 In the event that Millennium elects to exercise an Antibody
Option and/or a Diagnostic Option, Millennium shall provide
written notice of such exercise to Aventis prior to the
expiration of the [**] option period and, thereupon,
Millennium shall automatically be granted the licenses set
forth in Section 7.2.4(a) or 7.2.4(b) and Millennium's
subsequent discovery and development work with respect to such
Potential Antibody Target or Potential Diagnostic Target in
the antibody or diagnostic area, as applicable, shall be
funded separately by Millennium and conducted outside of the
Research Program, any Global Development Plan or any Global
Commercialization Plan.
2.11.4 In the event that, with respect to any Potential Antibody
Target or Potential Diagnostic Target, (a) Millennium does not
exercise the Antibody Option or the Diagnostic Option within
the [**] option period for the Antibody Option or the
Diagnostic Option, then Millennium shall no longer be entitled
to a license to Aventis' Antibody or Diagnostic rights, and
(b) Millennium fails to exercise commercially reasonable
efforts to research, Develop and Commercialize an Antibody
Product or Diagnostic Product or Service based on the use of
such Potential Antibody Target or Potential Diagnostic Target
and does not remedy such failure within [**] following written
notice of such failure from Aventis, then Millennium's license
to Aventis' antibody or diagnostic rights, as applicable, with
respect to such Potential Antibody Target or Potential
Diagnostic Target and such antibody or diagnostic rights, as
applicable, shall be nonexclusive, subject to the payment of
royalties under Section 8.3.5.
2.11.5 During the period that any license granted to Millennium
pursuant to this Agreement is in effect, Millennium shall
provide Aventis with an annual report concerning the status of
its research, Development and Commercialization efforts with
respect to such Potential Antibody Target or Potential
Diagnostic Target.
2.12 USE OF SCIENTIFICALLY-QUALIFIED TARGETS TO IDENTIFY SMALL MOLECULES
[**].
2.12.1 Each Party shall [**] for purposes of the identification,
evaluation and optimization of [**], PROVIDED THAT any [**]
identified, evaluated or optimized [**]
(a) [**] in an indication [**] or
(b) be the same [**] Compound as (i) any Program [**]),
(ii) any [**] Compound [**] by the Parties, (iii) any
[**] Compound [**] by a Party, or (iv) with respect
to [**].
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
2.12.2 Any product Developed pursuant to this Section 2.12 [**]. For
clarity, [**] Products, [**] Products and [**] Products that
are [**] pursuant to the relevant provisions of this Agreement
[**] .
2.12.3 Each Party hereby agrees that, [**] under agreements [**],
it will [**] pursuant to [**] for use solely [**] under
the terms of this Agreement, [**] in such [**] Products,
[**] and any [**] Product shall contain [**] Product and
was [**] in connection with a [**] Product. Any such
[**] Data [**] pursuant to this Section 2.12.3 shall be
deemed to be Confidential Information [**] in the
Research Program and/or as permitted under the applicable
license grants set forth in Article 7.
2.12.4 In addition to its obligations pursuant to Section 2.12.3,
each Party agrees that, [**] under agreements [**] , it will
[**] relating to [**] to the extent [**] activities related to
(a) the validation of such Scientifically-Qualified Target in
the [**] and/or (b) the [**] for use in the [**] (e.g.,
including, but not limited to, [**]. Any such [**] disclosed
pursuant to this Section 2.12.4 shall be deemed to be
Confidential Information [**] in the Research Program and/or
as permitted under the license grants set forth in Article 7.
For purposes of clarity, it is understood that nothing in this
Section 2.12.4 shall [**] to the [**].
2.12.5 If (a) [**] the Research Program, and (b) such [**] of the
Research Program [**] of such Program Target in the Research
Program, but [**] such Party is [**] of the Research Program.
Notwithstanding the foregoing, [**] such Program [**] of the
Research Program.
2.12.6 If a Party [**], and such [**] by such Party [**] in the
Research Program, such Party [**] with respect to Research
Program [**] Party within the [**] of the Research Program.
2.13 OTHER PERMITTED USES OF PROGRAM TARGETS.
2.13.1 Notwithstanding the provisions of Section 2.11, each Party
shall have the non-exclusive right to use
Scientifically-Qualified Targets in association with UDC
Products, Single-Party Target Products, GT Products, Vaccine
Products, Antibody Products and Ex-Program Products, the
Development and Commercialization of which such Party is
permitted to undertake in accordance with this Agreement:
(a) for internal research purposes; and
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(b) to develop a Diagnostic used to ascertain the
predisposition of an individual to respond favorably
or unfavorably to the administration of such UDC
Products, Single-Party Target Products, GT Products,
Vaccine Products, Antibody Products and Ex-Program
Products, where such Diagnostic is required by
applicable regulatory authorities to be utilized
prior to the administration of any such therapeutic
product, or where such Party reasonably determines
that such Diagnostic would be reasonably necessary
for such therapeutic product to achieve significant
market penetration (an "Essential Pharmacogenomic
Product or Service").
2.14 RESEARCH PROGRAM RECORDS.
2.14.1 All work conducted by either Party in the course of the
Research Program shall be completely and accurately recorded,
in sufficient detail and in good scientific manner, in
separate laboratory notebooks. On reasonable notice, and at
reasonable intervals, each Party shall have the right to
inspect and copy all such records of the other Party
reflecting Program Technology or work done under the Research
Program, to the extent reasonably required to carry out its
respective obligations and to exercise its respective rights
hereunder. Notwithstanding the definition of "Confidential
Information", all such records shall constitute Confidential
Information of the Party creating such records. The Parties
acknowledge and agree that neither Party guarantees the
success of the Research Program tasks undertaken hereunder.
2.14.2 In order to protect the Parties' Patent Rights under U.S. law
in any inventions conceived or reduced to practice during or
as a result of the Research Program, each Party agrees to
maintain a policy which requires its employees to record and
maintain all data and information developed during the
Research Program in such a manner as to enable the Parties to
use such records to establish the earliest date of invention
and/or diligence to reduction to practice. At a minimum, the
policy shall require such individuals to record all inventions
generated by them in standard laboratory notebooks which are
dated and corroborated by non-inventors on a regular,
contemporaneous basis.
2.15 DISCLOSURE OF RESEARCH PROGRAM RESULTS. Subject to restrictions imposed
by a Party's confidentiality obligations to any Third Party, each Party
will disclose to the other all Program Technology discovered, invented,
or made by such Party during the course of the Research Program and
that is useful in or relates to the Research Program, including,
without limitation, information regarding potential
Scientifically-Qualified Targets, Small Molecules identified in the
Research Program through the use of Program Targets, activities of such
Small Molecules, derivatives, and results of in vitro and in vivo
studies, assay techniques and new assays. Such Program Technology will
be promptly disclosed to the other Party,
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with meaningful discoveries or advances being communicated as promptly
as practicable after such information is obtained or its significance
is appreciated. Each Party will provide the other with copies of the
raw data generated in the course of the Research Program, if reasonably
necessary to the other Party's work under the Research Program. Any
information disclosed pursuant to this Section 2.15 may be used by the
other Party solely for the purposes of the Research Program or as
otherwise expressly permitted in this Agreement. For clarity, nothing
in this Section 2.15 shall be deemed to require a Party to disclose to
the other Party the actual sequence of any target being pursued in the
Research Program unless and until such target is designated as a
Scientifically-Qualified Target.
2.16 MATERIAL TRANSFER. In order to facilitate the Research Program, either
Party may provide to the other Party certain Program Materials (other
than Program Compounds or Program Targets) Controlled by the supplying
Party (other than under this Agreement) for use by the other Party in
furtherance of the Research Program. Except as otherwise provided under
this Agreement, all such Program Materials delivered to the other Party
shall remain the sole property of the supplying Party, shall be used
only in furtherance of the Research Program and solely under the
control of the other Party and its Affiliates, shall not be used or
delivered to or for the benefit of any Third Party without the prior
written consent of the supplying Party, and shall not be used in
research or testing involving human subjects. The Program Materials
supplied under this Section 2.16 must be used with prudence and
appropriate caution in any experimental work, since not all of their
characteristics may be known. THE MATERIALS ARE PROVIDED "AS IS" AND
WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF
FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE
MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY
RIGHTS OF ANY THIRD PARTY.
2.17 LIABILITY. In connection with conduct of the Research Program, each
Party shall be responsible for, and hereby assumes, any and all risks
of personal injury or property damage attributable to the negligent
acts or omissions of that Party or its Affiliates, and their respective
directors, officers, employees and agents.
2.18 SUBCONTRACTORS. Either Party may perform some of its obligations under
the Research Program through one or more subcontractors; provided that
(a) none of the rights of the other Party hereunder are diminished or
otherwise adversely affected as a result of such subcontracting, (b)
such Party obtains the written approval of the other Party prior to
engaging any subcontractor, which approval shall not be unreasonably
withheld or delayed, and (c) the subcontractor undertakes in writing
obligations of confidentiality and non-use regarding the other Party's
Confidential Information which are substantially the same as those
undertaken by Aventis and Millennium pursuant to Article 10 hereof. In
the event a Party performs one or more of its obligations under the
Research Program
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
through a subcontractor, then such Party shall at all times be
responsible for the performance of such subcontractor. For the
avoidance of doubt, it is understood that an Affiliate of a Party shall
not be deemed to be a subcontractor of such Party. For clarity, it is
understood that the provisions of Section 2.18(b) do not apply to
contracts for (i) tissue procurement and analysis, (ii) sequencing,
(iii) protein and peptide production and analysis, (iv) purchasing
tools or services for target validation (e.g., transgenic mice,
antibodies, or antisense molecules), and (v) purchasing tools or
services for the performance of affinity-based interactions and other
contractual arrangements of a similar nature, PROVIDED, HOWEVER, that
significant out-of-pocket costs must be approved in accordance with
Section 2.4.2.
ARTICLE 3
DEVELOPMENT PROGRAM
3.1 EDC Compounds.
3.1.1 The Joint Research Committee shall notify the Joint
Development Committee in writing when a Joint Research Project
Team has recommended a Program Compound for EDC Status. Such
notification shall (1) identify the Program Compound with
specificity, (2) identify the related Program Target, if any,
and (3) identify the Back-Up Compounds in accordance with
Section 3.9. Such notification shall be accompanied by any
pertinent data, information, results and materials relating to
the foregoing available to the Joint Research Committee (the
"EDC Data Package").
3.1.2 If the Joint Development Committee believes that the EDC Data
Package is (a) complete, it shall approve the EDC Data Package
and such Program Compound shall be deemed to have achieved EDC
Status, or (b) insufficient to make a determination whether to
Develop and Commercialize such EDC Compound, it shall
promptly, but in no event later than [**] following receipt of
the EDC Data Package, notify the Joint Research Committee and
specifically identify any additional data, information,
results or materials which should be provided.
3.1.3 Each Party shall, as soon as possible, but in all cases within
[**] after the Joint Development Committee has approved the
EDC Data Package as complete, provide the Joint Development
Committee with written notification of its interest in
Developing such EDC Compound. Such notification shall be
provided under seal. Failure by a Party to provide written
notification within such [**] period shall be deemed to
constitute an indication that such Party is not interested in
Developing such EDC Compound.
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3.1.4 Once the Parties have provided notification under seal of
their respective interests in Developing such EDC Compound,
the Joint Development Committee, or its designee, shall unseal
both Party's respective notifications, and designate the
characterization of such EDC Compound (i.e., Joint Development
Compound, Unilateral Development Compound or Dropped EDC
Compound) for the purposes of this Agreement based on the
interests expressed in the Parties' written notifications.
(a) JOINT DEVELOPMENT COMPOUND. If both Parties have
notified the Joint Development Committee of their
interest in Developing the EDC Compound, then such
compound shall be developed jointly by the Parties as
a Joint Development Compound, subject to the terms of
this Agreement.
(b) UNILATERAL DEVELOPMENT COMPOUND. If only one Party
has notified the Joint Development Committee of its
interest in Developing the EDC Compound, then,
subject to the provisions of Section 3.9.2, such
compound shall be developed unilaterally by such
Party as a Unilateral Development Compound, subject
to the terms of this Agreement.
(c) DROPPED EDC COMPOUND. If neither Party has notified
the Joint Development Committee of its interest in
Developing the EDC Compound, then such EDC Compound
shall be deemed a Dropped EDC Compound, subject to
the terms of this Agreement.
3.2 JOINT DEVELOPMENT COMMITTEE AND PROJECT TEAMS.
3.2.1 FORMATION OF JOINT DEVELOPMENT COMMITTEE. As soon as
reasonably necessary, and in any event prior to the
identification of the first EDC Compound, the Parties shall
establish a Joint Development Committee to oversee the
Development of all Joint Development Compounds. As soon as
practicable after designation of each EDC Compound as a Joint
Development Compound, the Joint Development Committee shall
establish a Joint Development Project Team for such Joint
Development Compound. The Joint Development Committee shall be
comprised of an equal number of Millennium and Aventis
representatives and shall include at least one marketing
representative from each Party, with each Party having one
vote. Each Joint Development Project Team shall be comprised
of Millennium and Aventis representatives and shall include at
least one marketing representative, with each Party having one
vote. In addition, the Joint Development Committee and each
Joint Development Project Team shall appoint a Chairperson and
otherwise follow the organizational and meeting procedures set
forth in Article 2 with respect to the Joint Research
Committee and Joint Research Project Teams, respectively.
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3.2.2 JOINT DEVELOPMENT COMMITTEE RESPONSIBILITIES. The Joint
Development Committee shall be responsible for:
(a) determining the completeness of, and whether to
approve, an EDC Data Package;
(b) overseeing the Development of all Joint Development
Compounds;
(c) providing a forum for consensual decision making;
(d) reviewing recommendations from and advising the Joint
Development Project Teams;
(e) approving target product profiles for Joint
Development Compounds;
(f) making modifications to and performing quarterly
monitoring of progress of studies (including
quarterly review of NA/Ex-NA Development Costs, NA
Development Costs and activities against the Global
Development Plan) and proposing additional product
studies;
(g) reviewing needs in areas other than projects but
necessary to support the projects: E.G. project
progression guidelines and criteria, development
processes and systems, SOPs, etc.; and
(h) reviewing and approving the Global Development Plan
for each Joint Development Compound, which shall
address the items outlined in Schedule 3.2.2 (the
"Global Development Plan"), and any updates thereto,
including, without limitation:
(i) reviewing each Global Development Plan and
ensuring that such Plan addresses the items
outlined in Schedule 3.2.2;
(ii) ensuring that the Global Development Plan
provides for the Development of Joint
Development Compounds on a global basis;
(iii) approving the Global Development Plans and
identifying key Joint Development Project
Team objectives, the Lead Regulatory Partner
for each Joint Development Compound,
expected associated resources, risk factors,
manufacturing strategy and timelines related
to the Development of each Joint Development
Compound, Go/No Go decision points and
relevant decision criteria and, where
appropriate, decision trees; and
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(iv) indicating how resources are expected to be
provided by both Parties to support the
Global Development Plans (consistent with
the provisions of Section 3.3), including
reviewing budgets for NA/Ex-NA Development
Costs and NA Development Costs (which, for
purposes of clarity, do not include ROW
Development costs that are not relevant to
NA/Ex-NA Development) approved by the Joint
Development Project Teams, and monitoring
the allocation and assignment of North
America Development and NA/Ex NA Development
activities between the Parties to ensure
such allocation is consistent with the
provision of Section 3.3.2.
3.2.3 JOINT DEVELOPMENT PROJECT TEAM RESPONSIBILITIES. The Joint
Development Project Team shall be responsible for (i)
Developing the applicable Joint Development Product in a
manner directed to ensure its marketability (as determined by
the marketing representatives of each Party on the Joint
Development Project Team) and approvability; and (ii)
preparing the Global Development Plan for the applicable Joint
Development Product; and (iii) implementing the North America
Development and NA/Ex-NA Development of the applicable Joint
Development Compounds in accordance with the Global
Development Plan for such compound, as well as overseeing the
day-to-day operational activities related to North America
Development and NA/Ex-NA Development of the Joint Development
Compound, including:
(a) preparing and annually updating the Global
Development Plan for such Joint Development Compound,
and submitting the same to the Joint Development
Committee for review and approval;
(b) implementing the North America Development and NA/Ex
NA Development of a Joint Development Compound in
accordance with the Global Development Plan;
(c) preparing and approving protocols for pre-clinical
studies and Phase I Studies, Phase IIA Studies, Phase
IIB Studies, Phase IIIA Studies and Development Phase
IIIB Studies, pharmaceutical stability studies and
manufacturing scale-up studies related to North
America Development and NA/Ex NA Development of the
applicable Joint Development Compound, consistent
with the mandate that each such study conducted
should, to the extent possible and to the extent
consistent with the best interests of the Joint
Development Product globally, be suitable for use in
the maximum number of the major pharmaceutical
markets;
(d) overseeing pre-clinical studies, Phase I Studies,
Phase IIA Studies, Phase IIB Studies, Phase IIIA
Studies and Development Phase IIIB
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Studies in accordance with the Global Development
Plan for the applicable Joint Development Compound,
including specifying timelines and priorities and
making recommendations to the Joint Development
Committee regarding which Party, or whether a Third
Party, should be responsible for the various North
America Development and NA/Ex-NA Development
activities;
(e) reviewing and commenting on material regulatory
correspondence and submissions relating to North
America Development and NA/Ex-NA Development and
facilitating the exchange of all data, information,
material or results relating to the Development of
the Joint Development Compound;
(f) establishing procedures for the collection, sharing
and reporting of adverse event information related to
the Joint Development Compound and making
recommendations to the Joint Development Committee
with respect to any appropriate actions to be taken;
(g) recommending a target product profile for the Joint
Development Product to the Joint Development
Committee, including indications for which the Joint
Development Product will be Commercialized, key
labeling claims required for commercial success of
the Joint Development Product given the competitive
environment, and any other key product features and
benefits which will be used to develop or support a
promotional message for the Joint Development
Product;
(h) preparing and approving budgets for NA Development
Costs and NA/Ex-NA Development Costs for each
calendar year based on the activities to be conducted
under the Global Development Plan;
(i) determining the specific Development activities to be
undertaken by each of the Parties with respect to
North America Development and NA/Ex-NA Development,
subject to the oversight of the Joint Development
Committee; and
(j) reviewing on a quarterly basis the NA Development
Costs and NA/Ex-NA Development Costs against the
budget for such expenses, and making appropriate
adjustments to the budgets, all in accordance with
Section 3.5.
3.2.4 DECISION MAKING.
(a) All decisions of the Joint Development Committee and
the Joint Development Project Teams relevant solely
for the Development of a Joint Development Compound
for Commercialization in North America ("North
America Development") or relevant for the
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Development of a Joint Development Compound for
Commercialization both in North America and outside
of North America ("NA/Ex-NA Development") shall be
made by the unanimous decision of Millennium and
Aventis, with the representatives of each Party who
are members of the Joint Development Committee or the
applicable Joint Development Project Team
collectively having one vote in any matter requiring
the approval of the Joint Development Committee or
the applicable Joint Development Project Team.
(b) Aventis shall be entitled to make unilateral
decisions on matters relevant solely for the
Development of a Joint Development Compound for
Commercialization outside of North America ("ROW
Development"); provided that such decisions do not
conflict with the applicable Global Development Plan.
3.2.5 DISPUTE RESOLUTION. If a Joint Development Project Team is
unable to reach unanimous agreement on any issue within its
purview relating to North America Development or NA/Ex-NA
Development of a Joint Development Compound, it shall refer
such issue to the Joint Development Committee for resolution.
If a Joint Development Committee is unable to reach unanimous
agreement on any issue within its purview relating to North
America Development or NA/Ex-NA Development (including without
limitation any issue referred to it by a Joint Development
Project Team), such issue shall be resolved in accordance with
the provisions of Article 12. Each of the members of each
Joint Development Committee shall have experience and
seniority sufficient to enable him or her to make decisions on
behalf of the Parties.
3.3 DEVELOPMENT ACTIVITIES.
3.3.1 GENERALLY. All Development of Joint Development Compounds
shall be conducted in accordance with the project progression
guidelines and criteria established by the Joint Development
Committee. The Parties shall use commercially reasonable
efforts to conduct the Development activities assigned to them
by the Joint Development Project Team in accordance with the
Global Development Plan as may be amended from time to time.
Furthermore, each Party agrees to conduct such Development
activities in compliance with all Laws that are applicable to
the particular stage of Development of the Joint Development
Compound, including without limitation, GLPs, GCPs and GMPs.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.3.2 ASSIGNMENT AND RESPONSIBILITY FOR DEVELOPMENT ACTIVITIES. The
Joint Development Committee shall oversee the allocation and
assignment of Development activities in the Global Development
Plans between the Parties with the goal that each Party's
participation in North America Development and NA/Ex-NA
Development of Joint Development Compounds shall be
substantially equal on an ongoing basis, taking into account
the levels of participation in prior years and the
participation specified in the Global Development Plans for
the following calendar year; [**]. Notwithstanding the
foregoing, Aventis shall be responsible for the Development
activities in the Global Development Plan that relate solely
to ROW Development (subject to Joint Development Committee
oversight), and Millennium and Aventis shall be jointly
responsible for the Development activities in the Global
Development Plan that relate to North America Development, as
well as those aspects of the Global Development Plan that
relate to NA/Ex-NA Development, in each case in a manner
consistent with the Global Development Plan. For the purposes
of clarity, the allocation of regulatory activities relating
to Development of Joint Development Products or Joint
Development Compounds shall be governed by Section 5.1.2 and
not by this Section.
3.4 JOINT DEVELOPMENT COSTS. NA/Ex-NA Development Costs and NA Development
Costs for a Joint Development Compound shall be provided for in a
budget to be included in the Global Development Plan, and shall be
shared on a Joint Development Compound-by-Joint Development Compound
basis pursuant to Section 8.2 as follows: (a) Millennium and Aventis
shall each bear fifty percent (50%) of the NA Development Costs for the
Joint Development Compound, and (b) Millennium and Aventis shall each
bear a portion of all NA/Ex-NA Development Costs for the Joint
Development Compound equal to fifty percent (50%) of the NA Percentage.
For clarity, Aventis shall also bear a percentage of the NA/Ex-NA
Development Costs for the Joint Development Compound equal to one
hundred percent (100%) less the NA Percentage and shall bear one
hundred percent (100%) of ROW Development costs that are not relevant
to NA/Ex-NA Development.
3.5 JOINT DEVELOPMENT BUDGET. The budgets set forth in each Global
Development Plan shall estimate the internal and external costs
required to complete the Development of the Joint Development Compound,
broken down by NA Development Costs and NA/Ex-NA Development Costs. The
budgets for NA Development Cost and NA/Ex-NA Development Cost for the
current and next succeeding calendar years shall be specified in more
detail to include, without limitation, on a study-by-study or
activity-by-activity basis any (i) investigator fees and expert fees,
(ii) CRO costs, lab fees and scientific service fees, (iii) FTE Cost
and (iv) Clinical Supply Cost. The budgets shall be updated at least
once
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annually on a timeline that meets the budget planning requirements of
both Parties. Each Joint Development Project Team shall review on a
quarterly basis the NA Development Costs and NA/Ex-NA Development Costs
against the budget for such expenses in the applicable calendar year.
If in the course of its quarterly review of NA Development Costs and
NA/Ex-NA Development Costs, any Joint Development Project Team should
determine for any Joint Development Compound that for any study or
activity the actual amounts incurred for (i) investigator fees and
expert fees, (ii) CRO costs, lab fees and scientific service fees,
(iii) FTE Cost or (iv) Clinical Supply Cost are likely to be higher
than budgeted, the Joint Development Project Team shall review the
reasons for such potential overrun and determine whether such overrun
is appropriate. If the Joint Development Project Team determines that
such overrun is appropriate, the Joint Development Project Team will
assess whether such overrun is likely to result in an overrun of the
budget for NA Development Costs and NA/Ex-NA Development Costs for such
Joint Development Compound and if required, will agree on a revised
budget for NA Development Costs or NA/Ex-NA Development Costs for such
Joint Development Compound so that no overrun is expected. If the Joint
Development Project Team determines that such overrun is not
appropriate, the Joint Development Project Team will take such actions
as required to remedy the situation.
3.6 DISCONTINUED DEVELOPMENT.
3.6.1 In the event that the Parties undertake the Development of a
Joint Development Compound and thereafter either Party elects
not to continue its participation in the Development of such
Joint Development Compound, it shall provide written notice to
the other Party of such election (a "Notice of
Discontinuance").
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.6.2 Upon receipt of a Notice of Discontinuance, the other Party
may, subject to the provisions of Section 3.9, elect to
continue the Development of such Joint Development Compound
and Pre-EDC Research Evaluation related to its Back-Up
Compounds by providing written notice of such election to the
other Party within [**] of receipt of the Notice of
Discontinuance, in which case such Joint Development Compound
shall thereafter be a Unilateral Development Compound (and not
a Joint Development Compound).
3.6.3 In the event that (a) both Parties (i) elect not to continue
their participation in the Development of a Joint Development
Compound and Pre-EDC Research Evaluation related to its
Back-Up Compounds, or (ii) fail to exercise commercially
reasonable efforts in undertaking such Development and Pre-EDC
Research Evaluation and neither cures such failure within [**]
after receipt of written notice from a Party asserting such
failure (PROVIDED THAT if the first Party to receive such
written notice responds within such [**] period with a
notice to the other Party asserting that such other Party has
also failed to exercise commercially reasonable efforts in
undertaking such Development and Pre-EDC Research Evaluation,
both written notices shall, for purposes of this subsection,
be deemed to have been given concurrently on the date that the
first notice was given), or (b) the Developing Party elects
not to continue the Development of a Unilateral Development
Compound and Pre-EDC Research Evaluation related to its
Back-Up Compounds, or (ii) fails to exercise commercially
reasonable efforts in undertaking such Development and Pre-EDC
Research Evaluation and does not cure such failure within [**]
after receipt of written notice from the other Party asserting
such failure, then such compound shall thereafter be a Dropped
EDC Compound (and not a Joint Development Compound or a
Unilateral Development Compound, as the case may be).
3.7 UNILATERAL DEVELOPMENT.
3.7.1 GENERAL. A Party undertaking the development of a Unilateral
Development Compound (the "Developing Party") shall do so at
its own expense and, other than as provided in this Section
3.7, independent of the other Party; provided that the
Developing Party shall provide the other Party with an annual
report concerning the status of the Development of the
Unilateral Development Compound. The Parties will cooperate to
the extent practicable and at the Developing Party's expense
(subject to the provisions of Section 3.7.2) to transition
such Joint Development Compound to a Unilateral Development
Compound.
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3.7.2 ONGOING STUDIES. With respect to a Unilateral Development
Compound that was previously a Joint Development Compound,
upon designation of such compound as a Unilateral Development
Compound:
(a) CLINICAL STUDIES. With respect to any clinical
studies for a Unilateral Development Compound which
have been initiated at the time the non-Developing
Party provides the Notice of Discontinuance and which
were under the responsibility of the non-Developing
Party per the Global Development Plan, the
non-Developing Party shall complete such studies,
with the costs associated with such studies to be
shared as if such UDC had continued to be a JDC;
provided, however, that in the case in which the
Joint Development Compound does not meet its
pre-determined criteria for development at a Go/No Go
decision point as specified in the Global Development
Plan, but the Developing Party nevertheless wishes to
continue the Development of the Joint Development
Compound as a Unilateral Development Compound, then
any such continued activity by the non-Developing
Party shall be at the cost and expense of the
Developing Party. With respect to any other clinical
studies included in the Global Development Plan that
were under the responsibility of the non-Developing
Party and that were scheduled to be initiated (i.e.,
scheduled for enrollment of a patient) in the same
calendar year in which the Notice of Discontinuance
is provided, the non-Developing Party shall, upon the
written request of the Developing Party, initiate
such study and transfer the same to the Developing
Party as soon as is reasonably practicable, all at
the cost and expense of the Developing Party, with
such costs to be determined in a manner consistent
with the manner in which NA Development Costs and
NA/Ex-NA Development Costs are determined. Such
transfer shall be conducted in a manner that does not
adversely affect the Development of the Unilateral
Development Compound (other than in an immaterial
manner).
(b) PRE-CLINICAL AND OTHER NON-CLINICAL STUDIES. If the
non-Developing Party is conducting any pre-clinical
or other non-clinical studies for the Unilateral
Development Compound that have been initiated prior
to the Notice of Discontinuance, such non-Developing
Party shall complete such studies, unless the Parties
mutually agree otherwise, with the costs associated
with such studies to be shared as if such UDC had
continued to be a JDC.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.7.3 REGULATORY REQUIREMENTS. The Parties will cooperate to ensure
that the Developing Party, at its sole expense, has access to
any Regulatory Approvals obtained under the Global Development
Plan prior to the Notice of Discontinuance that are relevant
to such Unilateral Development Compound as shall be reasonably
necessary to enable the Developing Party to continue the
Development and Commercialization of such Unilateral
Development Compound. Such access shall be provided by license
under the applicable Regulatory Approvals, transfer of the
applicable Regulatory Approvals, or a letter of reference with
respect to the applicable Regulatory Approvals, or such other
action as shall be mutually agreed by the Parties.
3.7.4 INFORMATION TRANSFER. As soon as reasonably practicable, the
non-Developing Party will transfer any material, data,
information or results obtained in the Development under the
Global Development Plan of the Joint Development Compound (as
predecessor of the Unilateral Development Compound), and its
Back-Up Compounds, to the Developing Party.
3.7.5 MANUFACTURE OF CLINICAL SUPPLY OF UNILATERAL DEVELOPMENT
COMPOUND.
(a) If the non-Developing Party is manufacturing the
Unilateral Development Compound, then the Parties
will meet to discuss the cooperation to transfer
any required manufacturing technology to the
Developing Party (or Third Party designee reasonably
acceptable to the non-Developing Party), at the
Developing Party's expense.
(b) In addition, the non-Developing Party will, for a
period not to exceed [**], use commercially
reasonable efforts to supply the Developing Party
with sufficient quantities of Unilateral Development
Compound to enable the Developing Party to continue
the Development of the Unilateral Development
Compound in accordance with the scope of the Global
Development Plan as it existed as of the date of the
Notice of Discontinuance; PROVIDED, HOWEVER, nothing
contained in this Section shall require the
non-Developing Party to increase its scale of
manufacturing beyond the scale which existed as of
the date of the Notice of Discontinuance.
(c) The non-Developing Party shall supply Unilateral
Development Compound to the Developing Party at the
Supply Price, plus charges for Relevant Period Costs,
and upon such other reasonable and customary terms as
to forecasting, shipment, delivery and similar
matters as may be agreed.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.7.6 RIGHT OF FIRST NEGOTIATION. If, at any time, the
Developing Party intends to undertake research,
Development or Commercialization activities with
respect to a Unilateral Development Compound and/or
its Back-Up Compounds in collaboration with a Third
Party (or grant a license to a Third Party to do any
of the foregoing), the Developing Party shall provide
the other Party with the opportunity to negotiate
terms under which the other Party would collaborate
in or obtain a license for undertaking such
activities (a "Compound Right of First Negotiation"),
provided that a Compound Right of First Negotiation
shall not apply to the retention of a contract sales
force or to a product distribution or contract
manufacturing arrangement or other outsourced
marketing, advertising or promotion activities
(unless such arrangement is with a Significant
Pharmaceutical Enterprise). A Compound Right of First
Negotiation shall operate as follows:
(a) The Developing Party shall promptly notify
the other Party in writing (the "Compound
Notification") of its intention to seek a
collaborator or licensee for the research,
Development and/or Commercialization of the
relevant Unilateral Development Compound
and/or its Back-Up Compounds and shall
provide to the other Party a reasonably
detailed written description of such
proposed collaboration or license, together
with any data, results materials or
information related to such Unilateral
Development Compound and/or its Back-Up
Compounds which has not previously been
provided to the non-Developing Party.
(b) Within [**] of its receipt of the Compound
Notification (the "Compound Response
Period"), the other Party shall notify the
Developing Party of its interest, if any, in
initiating discussions regarding such
proposed collaboration or license.
(c) In the event that the other Party notifies
the Developing Party prior to the
termination of the Compound Response Period
that it has an interest in participating in
such proposed collaboration or in obtaining
such license (a "Compound Expression of
Interest"), then the Parties shall negotiate
in good faith in an effort to reach a
definitive agreement regarding such
collaboration or license for a period of up
to [**] from the date of the Developing
Party's receipt of the Compound Expression
of Interest.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(d) In the event that the Parties reach a
definitive agreement with respect to such
Unilateral Development Compound and/or its
Back-Up Compounds pursuant to subsection
(c), such Unilateral Development Compound
shall no longer be designated a Unilateral
Development Compound and the rights and
obligations of the Parties with respect to
such compound shall be governed by the terms
of such definitive agreement and not this
Agreement.
(e) In the event that (i) the other Party fails
to notify the Developing Party prior to the
termination of the Compound Response Period
that it is interested in collaborating or
obtaining a license with the Developing
Party with respect to such Unilateral
Development Compound and/or its Back-Up
Compounds, or (ii) the other Party notifies
the Developing Party prior to the
termination of the Compound Response Period
that it has no interest in such
collaboration or license, or (iii) the other
Party timely provides the Developing Party
with a Compound Expression of Interest but
the Parties fail to reach a definitive
agreement within the [**] period specified
in subsection (c), then the Developing Party
shall be free to enter into a collaboration
or license with a Third Party with respect
to such Unilateral Development Compound
and/or its Back-Up Compounds; PROVIDED,
HOWEVER, that the Developing Party may not
enter into any collaboration or license with
a Third Party on terms which are more
favorable to the Third Party, taken as a
whole, than those last offered to the
non-Developing Party.
(f) For the duration of the Compound Response
Period, and if the other Party timely
delivers the Compound Expression of
Interest, the [**] term specified in Section
3.7.6(c), the Developing Party may discuss
with a Third Party the general outline of
such collaboration or license; provided,
however, that the Developing Party shall not
negotiate such collaboration with a Third
Party, enter into any agreements with such
Third Party or propose terms to such Third
Party on which the Developing Party would be
willing to consummate such collaboration or
license.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.8 DROPPED EDC COMPOUND.
3.8.1 Subject to the provisions of Section 3.9, either Party shall
have the right to elect to re-initiate Development activities
with respect to a Dropped EDC Compound and Pre-EDC Research
Evaluation related to its Back-Up Compounds; PROVIDED THAT
such Party first gives notice of its intent to re-initiate
Development activities to the other Party, and provides the
other Party with any data, results, materials or information
related to such Dropped EDC Compound and its Back-Up Compounds
which was not previously provided to the other Party.
3.8.2 If the other Party acknowledges that it does not at such time
desire to participate in the Development of such Dropped EDC
Compound and Pre-EDC Research Evaluation related to its
Back-Up Compounds, the electing Party may resume Development
of such compound and such compound shall thereafter be a
Unilateral Development Compound (and not a Dropped EDC
Compound or a Joint Development Compound) and its Development
shall be governed by the provisions set forth in Section 3.7.
3.8.3 If the other Party desires to participate in the Development
of such Dropped EDC Compound and Pre-EDC Research Evaluation
related to its Back-Up Compounds, and so notifies the electing
Party within [**] of receipt of notice from the notifying
Party, such compound shall thereafter be a Joint Development
Compound (and not a Dropped EDC Compound or a Unilateral
Development Compound) for the purposes of this Agreement.
3.9 BACK-UP COMPOUNDS
3.9.1 When a Program Compound is nominated for EDC Status, the EDC
Data Package shall identify other Program Compounds which
shall serve as "Back-Up Compounds". Back-Up Compounds shall be
identified by the Joint Research Committee based on back-up
selection criteria agreed upon by the Joint Research Committee
pursuant to 2.4.1.
3.9.2 Notwithstanding anything contained in this Agreement to the
contrary, neither Party shall have the right to Develop as a
Unilateral Development Compound any Back-Up Compound if the
Parties are Developing or Commercializing one or more Joint
Development Compounds or Joint Development Products which are
Active against the same Program Target as such Back-Up
Compound. In addition, neither Party may unilaterally Develop
a Back-Up Compound [**] as an EDC Compound which is being
Developed unilaterally by the other Party and which is Active
against the same Program Target.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
3.9.3 The selection of an EDC Compound as a Joint Development
Compound or Unilateral Development Compound shall include
Back-Up Compounds.
3.10 RIGHT TO AUDIT. Each Party shall ensure that the other Party's
authorized representatives, and regulatory authorities to the extent
permitted by Law, may, during regular business hours, (a) examine and
inspect the facilities of any subcontractor or any investigator site
used in the performance of North America Development or NA/Ex NA
Development involving a Joint Development Compound, and (b) inspect and
copy all data, documentation and work products relating to the
activities performed by the subcontractor or investigator site,
including, without limitation, the medical records of any patient
participating in any clinical study. A Party's right to inspect and
copy all data, documentation, and work products relating to a Joint
Development Compound study included in North America Development or
NA/Ex-NA Development shall survive the completion of the study for a
period of [**] after the study is completed, or such longer period as
shall be required by Law.
3.11 USE OF SUBCONTRACTORS. To the extent either Party wishes to perform
some of its obligations regarding the Development of Joint Development
Compounds in North America Development or NA/Ex-NA Development,
including without limitation any activities under Article 5, through
one or more subcontractors, it must obtain the written approval of the
other Party prior to engaging such subcontractor, which approval shall
not be unreasonably withheld or delayed. As a condition to granting
such approval, (a) the other Party shall be entitled to audit the
proposed subcontractor using the same standards which it applies to the
use of subcontractors in the Development of its other products, and (b)
the subcontractor must undertake in writing obligations of
confidentiality and non-use regarding the other Party's Confidential
Information which are substantially the same as those undertaken by
Aventis or Millennium pursuant to Article 9 hereof. In the event a
Party performs one or more of its obligations regarding the North
America Development or NA/Ex NA Development of a Joint Development
Compound through the use of a subcontractor, then such Party shall at
all times be responsible for the performance of such subcontractor. For
the avoidance of doubt, it is understood that an Affiliate of a Party
shall not be deemed to be a subcontractor of such Party. For clarity,
it is understood that the provisions of this Section 3.11 do not apply
to contracts with individual clinical sites and other contractual
arrangements of a similarly small financial magnitude.
3.12 PHARMACOVIGILANCE. No later than initiation of the first toxicology
studies for a Joint Development Compound, the pharmacovigilance
departments of both Parties shall meet and determine the approach to be
taken for the collection, review, assessment, tracking and filing of
information related to adverse events associated with the Joint
Development Compound.
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ARTICLE 4
MANUFACTURE AND SUPPLY
4.1 CLINICAL SUPPLY. As part of the first Global Development Plan for each
Joint Development Compound, the Joint Development Committee shall
specify which Party shall be responsible for manufacturing quantities
of such compound for use in pre-clinical and clinical trials. It is
expected that only one Party shall be responsible for manufacturing all
quantities of a Joint Development Compound and the related Joint
Development Product necessary for pre-clinical and clinical studies
throughout the Territory.
4.2 COMMERCIAL SUPPLY. As part of the first Global Commercialization Plan
for each Joint Development Product, the Joint Commercialization
Committee shall specify which Party shall be responsible for
manufacturing the Joint Development Compound (as the active ingredient)
and Joint Development Product for commercial sale, as described in
Schedule 4.2 It is expected that only one Party shall be responsible
for manufacturing all necessary quantities of a Joint Development
Compound and the related Joint Development Product for commercial sale
throughout the Territory.
4.3 SUPPLY AGREEMENT. In the case where Millennium is responsible for
manufacturing a Joint Development Compound and/or Joint Development
Product or in the case where Aventis is responsible for manufacturing a
Joint Development Compound and/or a Joint Development Product and
Millennium is responsible for clinical studies, Development activities
for the Joint Development Compound or distributing the Joint
Development Product in North America, the Parties shall enter into a
clinical supply agreement or commercial supply agreement, as
applicable, on customary and reasonable terms and conditions. Each such
supply agreement shall provide, among other things, for pricing at the
manufacturing Party Supply Price, plus charges for Relevant Period
Costs, forecasting and ordering requirements, inventory maintenance
requirements, and for manufacturing in compliance with applicable
regulatory requirements, and shall meet the guidelines of both
Millennium and Aventis.
4.4 USE OF SUBCONTRACTORS. To the extent either Party wishes to perform
some of its obligations regarding the manufacturing and supply of Joint
Development Compounds and/or Joint Development Products for North
America through one or more subcontractors, it must obtain the written
approval of the other Party prior to engaging such subcontractor, which
approval shall not be unreasonably withheld or delayed. It is
understood that as a condition to granting such approval, (a) the other
Party shall be entitled to audit the proposed subcontractor using the
same standards which it applies to the use of subcontractors in the
manufacturing of its other products, (b) the subcontractor must
undertake in writing obligations of confidentiality and non-use
regarding the other Party's Confidential Information which are
substantially the same as those undertaken by Aventis or Millennium
pursuant to Article 9 hereof, and (c) the other Party shall have
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the right to approve any of the financial terms of the arrangement
which affect the Supply Price. In the event a Party performs one or
more of its obligations regarding the manufacturing and supply of a
Joint Development Compound or a Joint Development Product for North
America through the use of a subcontractor, then such Party shall at
all times be responsible for the performance of such subcontractor. For
the avoidance of doubt, it is understood that an Affiliate of a Party
shall not be deemed to be a subcontractor of such Party.
ARTICLE 5
REGULATORY MATTERS.
5.1 OWNERSHIP.
5.1.1 The Joint Development Committee shall identify the Party which
shall own in North America the INDs for each Joint Development
Compound and the NDAs for each Joint Development Product (the
"Lead Regulatory Party") in accordance with Section 3.3.2. The
Lead Regulatory Party shall license, transfer, provide a
letter of reference with respect to, or take other action
necessary to make available such INDs or NDAs to the other
Party as may be reasonably necessary to enable such other
Party to fulfill its obligations under the Global Development
Plan with respect to the Development of such Joint Development
Compound and under the Global Commercialization Plan with
respect to the Commercialization of such Joint Development
Product.
5.1.2 Subject to Section 3.3.2, it is the intention of the Parties
that ownership of Regulatory Approvals in North America
relating to Joint Development Products shall be divided
equally between the Parties on an ongoing basis, taking into
account Regulatory Approvals relating to Joint Development
Products that are currently owned by each of the Parties, as
well as additional Regulatory Approvals in North America
relating to Joint Development Products to be allocated to the
Parties in the following calendar year. Aventis shall hold all
Regulatory Approvals for Joint Development Compounds and Joint
Development Products for all countries outside of North
America, unless otherwise determined by the Joint Development
Committee.
5.1.3 To the extent that the Joint Development Committee assigns
Development activities to Millennium to be conducted outside
of North America, Aventis shall take such action as may be
reasonably necessary to permit such activities to be performed
under Aventis' Regulatory Approvals in such country.
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5.2 REGULATORY COORDINATION.
5.2.1 The Lead Regulatory Party shall oversee, monitor and
coordinate all regulatory actions, communications and filings
with and submissions, including filings and submissions of
supplements and amendments thereto, to the FDA or HPB with
respect to the relevant Joint Development Compound or Joint
Development Product. Aventis shall oversee, monitor and
coordinate all regulatory actions, communications and filings
with and submissions to, including filings and submissions of
supplements and amendments thereto, regulatory authorities
outside of North America with respect to the relevant Joint
Development Compound or Joint Development Product unless
otherwise determined by the Joint Development Committee.
5.2.2 In the event that Millennium is the Lead Regulatory Party, the
Parties shall establish procedures to ensure that the Parties
exchange on a timely basis all necessary information to enable
compliance with all regulatory obligations on a global basis,
including without limitation filing updates, pharmacovigilance
filings and investigator notifications.
5.3 REGULATORY MEETINGS AND CORRESPONDENCE. The Lead Regulatory Party shall
be responsible for interfacing, corresponding and meeting with the FDA
and HPB with respect to the relevant Joint Development Compound or
Joint Development Product. To the extent practicable, the other Party
shall have the right to have a representative participate in all
material meetings and telephone discussions between representatives of
the Lead Regulatory Party and the FDA or HPB with respect to such Joint
Development Compound or Joint Development Product. Aventis shall be
responsible for interfacing, corresponding and meeting with regulatory
authorities outside of North America with respect to all Joint
Development Compounds and Joint Development Products unless otherwise
determined by the Joint Development Committee.
5.4 REVIEW OF CORRESPONDENCE. To the extent practicable, the Lead
Regulatory Party shall provide the other Party with drafts of any
documents or other correspondence to be submitted to the FDA or HPB
pertaining to the relevant Joint Development Compound or Joint
Development Product, sufficiently in advance of submission so that the
other Party may review and comment on such documents and other
correspondence and have a reasonable opportunity to influence the
substance of such submissions. The Lead Regulatory Party shall promptly
provide to the other Party copies of any documents or other
correspondence received from the FDA and HPB pertaining to the relevant
Joint Development Compound or Joint Development Product (including
without limitation any meeting minutes). To the extent relevant to the
Development of a Joint Development Compound for North America, Aventis
shall, subject to applicable Laws, provide Millennium with drafts of
any documents or other correspondence to be submitted to regulatory
authorities outside of North America pertaining to the relevant Joint
Development Compound or Joint
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Development Product, sufficiently in advance of submission so that
Millennium may review and comment on such documents and other
correspondence and have a reasonable opportunity to influence the
substance of such submissions, as it may affect the Development of such
Joint Development Compound for North America. Aventis agrees to
consider all such comments in good faith, taking into account the best
interest of the Joint Development Compound on a global basis. If after
considering in good faith Millennium's comments regarding the content
of a proposed submission to a regulatory authority outside of North
America, Aventis disagrees with Millennium's view, Aventis shall notify
Millennium in writing (a "Notice of Disagreement"). If Millennium
believes that Aventis' proposed submission is likely to have a material
adverse effect on the Development of the Joint Development Product on a
global basis, it shall so notify Aventis, and provided that such
notification is delivered to Aventis within three (3) business days
following receipt of Aventis' Notice of Disagreement, Millennium shall
have the right to request that the Joint Development Committee
immediately convene, either in person or by telephone, in order to
discuss the matter. Any such meeting shall occur within three (3)
business days following Millennium's request. If after the discussions
of the Joint Development Committee Aventis still disagrees with
Millennium's view regarding the proposed submission, Aventis has the
right to file such submission as it reasonably deems appropriate;
provided, however, that any such submission shall not be inconsistent
with the best interest of the Joint Development Product on a global
basis, and shall not be inconsistent with the Global Development Plan.
To the extent relevant to the Development of a Joint Development
Compound for North America, Aventis shall promptly provide to
Millennium copies of any documents or other correspondence received
from regulatory authorities outside of North America pertaining to the
relevant Joint Development Compound or Joint Development Product.
5.5 ASSISTANCE.
5.5.1 Each Party shall cooperate with the other Party to provide all
reasonable assistance and take all actions reasonably
requested by the other Party that are necessary or desirable
to enable the other Party to comply with any Law applicable to
any Joint Development Product, including, but not limited to,
report adverse drug experience reports (and serious adverse
drug experience reports) to the FDA or other governmental or
regulatory authorities and submit or file North America
promotional materials with the FDA.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
5.5.2 Such assistance and actions shall include, among other things,
keeping the other Party informed, commencing within [**] of
notification of any action by, or notification or other
information which it receives (directly or indirectly) from,
the FDA or any other governmental or regulatory authority,
which (a) raises any material concerns regarding the safety or
efficacy of any Joint Development Product, (b) which indicates
or suggests a potential material liability for either Party to
Third Parties arising in connection with any Joint Development
Product, or (c) which is reasonably likely to lead to a recall
or market withdrawal of any Joint Development Product,
provided that neither Party shall be obliged to disclose
information in breach of any contractual restriction which it
could not reasonably have avoided. Information that shall be
disclosed pursuant to this Section 5.5.2 shall include, but
not be limited to:
(a) governmental or regulatory inspections of
manufacturing, distribution or other related
facilities used for Joint Development Compounds or
Joint Development Products;
(b) inquiries by governmental or regulatory authorities
concerning clinical investigation activities
(including inquiries of investigators, clinical
monitoring organizations and other related parties)
relating to Joint Development Compounds or Joint
Development Products;
(c) any communication from governmental or regulatory
authorities pertaining to the manufacture, sale,
promotion or distribution of Joint Development
Compounds or Joint Development Products;
(d) any other governmental or regulatory authority
reviews or inquiries relating to Joint Development
Compounds or Joint Development Products;
(e) receipt of a warning letter relating to any of the
Joint Development Compounds or Joint Development
Products; and
(f) an initiation of any governmental or regulatory
authority investigation, detention, seizure or
injunction concerning any Joint Development Compound
or Joint Development Product.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
5.5.3 Each Party shall provide (i) notice of patents relevant to an
NDA, prior to the time the NDA is filed, and (ii) immediate
notice of the issuance of any patent which will be a patent
relevant to a Joint Development Product, giving the date of
issue and patent number for each such patent and the Parties
will jointly decide within [**] of the patent issue if the
patent is to be listed pursuant to any NDA submission for such
Joint Development Product. Similarly, the Parties shall
provide immediate notice of any approved NDA and of patent
term extensions in any country. The Parties will cooperate
with each other in the preparation and filing of patent
listings and patent term extensions, and in mutually deciding
whether one, or both Parties will proceed in filing of
appropriate listing and patent term extension documents. Each
Party will provide prompt notice to the other of any inquiries
as to any relevant patent which has claims to manufacturing
processes, which inquiries are provided pursuant to 35 USC
Section 271(g), and will cooperate with respect to responses
thereto.
ARTICLE 6
COMMERCIALIZATION PROGRAM
6.1 OBJECTIVES FOR COMMERCIALIZATION OF JOINT DEVELOPMENT PRODUCTS.
6.1.1 The Joint Commercialization Committee shall oversee the
allocation of North America Commercialization and NA/Ex-NA
Commercialization strategic activities (i.e., responsibility
for promotion, distribution, detailing, marketing) between the
Parties for Joint Development Products with the goal that each
Party's participation in North America Commercialization and
NA/Ex-NA Commercialization of Joint Development Products in
North America shall, to the extent practicable, be
substantially equal on an ongoing basis, taking into account
the levels of participation in prior years and the
participation specified in the North America Commercialization
Plans and/or Global Commercialization Plans for the following
calendar year, PROVIDED THAT a Party shall not be assigned a
particular Commercialization activity or responsibility unless
it has the capacity and capability to undertake such activity
or responsibility, as determined by the Joint
Commercialization Committee.
6.1.2 Aventis will have the sole discretion and exclusive right to
promote, sell and distribute Joint Development Products in the
ROW, so long as such activities are not inconsistent with the
Global Commercialization Plan.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
6.1.3 Without limiting the provisions of Section 6.1.2, Aventis
shall have sole discretion and primary responsibility for the
implementation of those elements of the Global
Commercialization Plan that are solely related to ROW
Commercialization (subject to Joint Commercialization
Committee oversight) and Millennium and Aventis shall be
jointly responsible for implementation of those elements of
the Global Commercialization Plan that relate to North America
Commercialization and NA/Ex-NA Commercialization, in each
case, in a manner consistent with the Global Commercialization
Plan. NA/Ex-NA Commercialization means activities relating to
the Commercialization of a Joint Development Product which are
primarily global in nature (e.g., sponsoring international
symposia, publications in international medical journals and
any global Commercial Phase IIIB Studies, Phase IV Studies and
investigator-initiated studies). For clarity, NA/Ex-NA
Commercialization is not intended to include activities which
are primarily directed outside of North America but which may
affect North America (e.g., product promotion in ROW). As used
herein, the term "North America Commercialization" or "NA
Commercialization" means all activities solely relating to the
Commercialization of a Joint Development Product in North
America.
6.2 JOINT COMMERCIALIZATION COMMITTEE AND PROJECT TEAMS.
6.2.1 FORMATION. As soon as reasonably practicable and in any event
not later than [**] after the initiation of the first Phase
IIA Study for any Joint Development Compound, Aventis and
Millennium shall establish a Joint Commercialization Committee
to oversee the Commercialization of all Joint Development
Products under this Agreement. As soon as practicable
following the initiation of the first Phase IIA study for each
Joint Development Compound, the Joint Commercialization
Committee shall establish a Joint Commercialization Project
Team for such Joint Development Compound and related Joint
Development Product. The Joint Commercialization Committee
shall consist of an appropriate number of Millennium and
Aventis representatives, with each Party having one vote, and
shall include at least one medical representative from each
Party. Each Joint Commercialization Project Team shall be
comprised of an appropriate number of representatives from
each Party, as may be designated by the Joint
Commercialization Committee, with each Party having one vote.
6.2.2 SUBCOMMITTEES. The Joint Commercialization Committee and each
Joint Commercialization Project Team shall act directly or
through such working groups or sub-committees as it may deem
appropriate to establish. In particular, the applicable North
America Commercialization Project Team shall be responsible
for matters that relate to North America
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Commercialization. Each Joint Commercialization Project Team
and any subcommittees will be structured and operated in the
same manner as the Joint Commercialization Committee,
including without limitation, in decision making.
6.2.3 QUALIFICATIONS. Each of the members of the Joint
Commercialization Committee and each Joint Commercialization
Project Team shall have experience and seniority sufficient to
enable him or her to make decisions on behalf of the Parties.
6.3 JOINT COMMERCIALIZATION COMMITTEE RESPONSIBILITIES. To the extent
permitted by applicable Law, the Joint Commercialization Committee will
oversee the global Commercialization of all Joint Development Products
that are identified for launch in North America, including, among other
things:
6.3.1 maintaining global oversight of the Commercialization process;
6.3.2 providing a forum for consensual decision making;
6.3.3 reviewing and approving recommendations from and advising the
Joint Commercialization Project Teams;
6.3.4 reviewing and approving the Global Commercialization Plan for
each Joint Development Product which shall address the items
outlined in Schedule 6.4.4 (the "Global Commercialization
Plan") and reflect the objectives of Section 6.1.1;
6.3.5 reviewing, at its option, market research plans and research
results, product development data and results and similar
information related to Commercialization of each Joint
Development Product in North America;
6.3.6 monitoring the Parties' compliance with the requirements of
the Global Commercialization Plan's NA/Ex-NA Commercialization
Budget;
6.3.7 establishing procedures regarding the collection, sharing and
reporting of adverse event information related to each Joint
Development Product on a global basis; and
6.3.8 monitoring the allocation of North America Commercialization
and NA/Ex-NA Commercialization strategic activities between
the Parties across all of the Joint Development Products to
ensure that such allocation is consistent with the provisions
of Section 6.1.
6.4 JOINT COMMERCIALIZATION PROJECT TEAM RESPONSIBILITIES. To the extent
permitted by applicable Law, the Joint Commercialization Project Teams
will establish the global strategy and oversee the global
Commercialization for a specific Joint Development Product that is
identified for launch in North America, including, among other things:
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6.4.1 defining the initial customer group or target group to be
covered, including without limitation, the identification and
promotional targeting of key opinion leaders, physician
groups, hospitals and regional buying groups, including
managed care organizations and governmental and
government-affiliated buyers;
6.4.2 forming the North America Commercialization Project Teams;
6.4.3 making recommendations to the Joint Commercialization
Committee regarding the manufacturing and supply chain
strategy for the Joint Development Compound (as active
ingredient) and the Joint Development Product, including
without limitation which Party (or a Third Party) shall be
responsible for specific activities in the supply chain;
6.4.4 preparing the Global Commercialization Plan for the Joint
Development Product reflecting the objectives of Section 6.1.1
and the items identified in the content outline of the Global
Commercialization Plan attached hereto as Schedule 6.4.4, as
well as updating the Global Commercialization Plan on an
annual basis to reflect materially changed circumstances;
6.4.5 reviewing and making recommendations to the Joint Development
Project Team regarding changes to the target product profile;
6.4.6 preparing and approving the budget for NA/Ex-NA
Commercialization Expense and NA/Ex-NA License Fees based on
the NA/Ex NA Commercialization activities set forth in the
Global Commercialization Plan (the "NA/Ex-NA Commercialization
Budget"), and submitting the same to the Joint
Commercialization Committee for its review (but not approval);
6.4.7 determining the specific Commercialization activities to be
undertaken by the Parties relating to NA/Ex-NA
Commercialization, subject to the oversight of the Joint
Commercialization Committee;
6.4.8 reviewing on a quarterly basis the NA/Ex-NA Commercialization
Expense and NA/Ex-NA License Fees against the budget for such
expenses in the applicable calendar year, and making
appropriate adjustments to the budgets, all in accordance with
Section 6.9.3;
6.4.9 reviewing the North American Commercialization Plans to ensure
that such plans are consistent with the Global
Commercialization Plans; and
6.4.10 in consultation with the North America Commercialization
Project Team, reviewing and approving the selection of
trademarks for Joint Development Products.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
6.5 DECISION MAKING.
6.5.1 Subject to Sections 6.5.2 and 6.7, all decisions of each Joint
Commercialization Committee and each Joint Commercialization
Project Team related to the North America Commercialization
and NA/Ex-NA Commercialization of a Joint Development Product
shall, to the extent permitted by applicable Law, be made by
the unanimous decision of Millennium and Aventis and shall not
be inconsistent with the Global Commercialization Plan;
PROVIDED HOWEVER, for clarity, Aventis shall have the sole
discretion in any decision that is relevant solely to the
Commercialization of a Joint Development Product outside of
North America ("ROW Commercialization"), as long as such
decision is not inconsistent with the Global Commercialization
Plan.
6.5.2 The objective of the Joint Commercialization Committee and
each Joint Commercialization Project Team shall be to reach
agreement by consensus on all matters falling within its
authority hereunder with the goal of realizing the best
overall commercial potential of Joint Development Products on
a global basis. In the event that the Joint Commercialization
Committee or any Joint Commercialization Project Team is
unable to reach a unanimous decision with respect to any
proposed action requiring its vote, [**]; provided, however,
[**] pursuant to this Section 6.5.2 to determine which Party
shall perform a particular Commercialization activity or
whether Millennium has the capability or capacity to perform a
particular Commercialization activity.
6.5.3 All decisions [**] pursuant to Section 6.5.2 shall be made:
(a) only after referral of the matter [**]; PROVIDED,
HOWEVER, [**], as may be reasonably required, to meet
deadlines imposed by Third Parties (e.g., deadlines
for responses imposed by regulatory authorities) or
as otherwise needed to respond to competition in the
market. For clarity, [**] to decide the matter, then
[**] to decide the matter;
(b) with the goal of realizing the best overall
commercial potential of Joint Development Products on
a global basis;
(c) in a manner [**] relative [**] in any significant
respect; and
(d) in a manner that [**] in the quarterly determination
and reconciliation under Section 8.2.2 of actual
financial results, including without limitation Net
Sales, NA/Ex-NA Expense, NA Development Costs, NA
Commercialization Expense and Pre-tax Profit or Loss.
For clarity, nothing in this subsection (d) shall
[**] make the final determination [**] .
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6.6 NORTH AMERICA COMMERCIALIZATION PROJECT TEAM.
6.6.1 ROLE OF NORTH AMERICA COMMERCIALIZATION PROJECT TEAM. To the
extent permitted by applicable Law, the North America
Commercialization Project Team shall, among other things,
(a) prepare and approve the North America
Commercialization Plan, such plan to be consistent
with the Global Commercialization Plan;
(b) develop and discuss strategies for the
Commercialization of the Joint Development Product in
North America, including (i) contracting strategies
and procedures and (ii) the annual North America
marketing and promotion activities, detailing
activities and sampling strategies;
(c) preparing and approving the budget for NA
Commercialization Expense and NA License Fees based
on the North America Commercialization Plan (the
"North America Commercialization Budget");
(d) review on a quarterly basis progress of (i) the
current North America Commercialization Plan, (ii) NA
Commercialization Expense and NA License Fees in each
calendar year against the budget for such expenses in
the applicable calendar year (in accordance with the
provisions of Section 6.9.4), (iii) Joint Development
Product sales in North America against the forecast
included in the current North America
Commercialization Plan and (iv) any Commercial Phase
IIIB Studies, Phase IV Studies and
investigator-initiated studies conducted in
connection with North America Commercialization;
(e) determining the specific Commercialization activities
to be undertaken by the Parties relating to NA
Commercialization, subject to the oversight of the
Joint Commercialization Committee; and
(f) in consultation with the Joint Commercialization
Project Team, reviewing and approving the selection
of the trademarks for Joint Development Products.
6.6.2 NORTH AMERICA COMMERCIALIZATION PLANS. Each North America
Commercialization Plan shall be reviewed by the Joint
Commercialization Project Team to ensure consistency with the
Global Commercialization Plan and shall stipulate the way in
which the Joint Development Product is to be marketed,
promoted and detailed in North America during the applicable
calendar year to which the plan relates and shall include,
inter alia: (a) the number, type and position of Details to be
performed and strategies relating to such detailing activity,
(b) contracting
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strategies and procedures to be followed by the Parties
relating to North America Commercialization, (c) other
advertising and promotional activity to be undertaken in North
America, and the Party responsible for undertaking such
activities, (d) any training or sampling programs to be
conducted in North America, (e) disease management programs to
be conducted in North America, (f) medical education programs
to be conducted in North America, (g) public relations
activities to be conducted in North America and (h) such other
activities as may be requested by the Joint Commercialization
Project Team to be performed by the North America
Commercialization Project Team. The North America
Commercialization Plan shall not address sales force
incentives or compensation, and each Party shall have sole
authority and responsibility for designing and executing any
such program for its sales force.
6.6.3 REVIEW AND APPROVAL OF PROMOTIONAL MATERIALS.
(a) The North America Commercialization Project Team
shall be responsible for creating and developing
advertising, promotional, educational and
communication materials for marketing, advertising
and promotion of the Joint Development Products in
North America which are intended for distribution to
Third Parties (including medical professionals) and
to the Parties' respective sales forces in accordance
with the terms of the North America Commercialization
Plan (the "North America Promotional Materials"),
provided, however, it is understood that all North
America Promotional Materials shall be consistent
with the Global Commercialization Plan and any core
promotional materials prepared by the Joint
Commercialization Project Team. The North America
Commercialization Project Team shall be responsible
for establishing procedures for the review and
approval of North America Promotional Materials. All
product labeling for Joint Development Products in
North America shall, to the extent permitted by law,
contain equally prominent references to both Aventis
and Millennium.
(b) The Parties shall jointly own (without any duty to
account to the other) all copyrights in and to any
North America Promotional Materials which are
specifically directed to the Joint Development
Products and each Party shall execute all documents
and take all actions as are reasonably requested by
the other Party to effectuate such joint ownership in
such North America Promotional Materials.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(c) Neither Party shall produce (other than as concepts
for consideration by the North America
Commercialization Project Team), distribute or
otherwise use in North America any promotional or
communications material or any label or labeling
relating to the Joint Development Products which has
not been approved in accordance with the procedures
established by the North America Commercialization
Project Team pursuant to this Section 6.6.3.
6.6.4 ADDITIONAL ACTIVITIES OF THE NORTH AMERICA COMMERCIALIZATION
PROJECT TEAM. In addition, the North America Commercialization
Project Team shall have the additional role of establishing
procedures for: handling of any recalls or customer complaints
with respect to Joint Development Products in North America;
and responding to medical inquiries regarding the Joint
Development Products in North America.
6.6.5 NORTH AMERICA COMMERCIALIZATION PROJECT TEAM DECISION MAKING.
Subject to Sections 6.6.6 and 6.7, all decisions of each North
America Commercialization Project Team shall, to the extent
permitted by applicable Law, be made by the unanimous decision
of Aventis and Millennium and shall not be inconsistent with
the Global Commercialization Plan. The objective of each North
America Commercialization Project Team shall be to reach
consensus on all matters falling within its authority
hereunder with the goal of realizing the best overall
commercial potential of the applicable Joint Development
Product on a global basis. In the event that a North America
Commercialization Team is unable to reach a unanimous decision
with respect to any proposed action requiring its vote, the
issue shall be referred for resolution to the senior executive
of each Party responsible for North America (or his or her
designee). If such senior executives are unable to resolve
such matter within [**] after referral of such matter, Aventis
shall have the right to decide the matter, subject to the
provisions of Section 6.6.6. Notwithstanding the foregoing,
Aventis shall not be entitled to exercise its casting vote
pursuant to this Section 6.6.5 to determine which Party shall
perform a particular Commercialization activity or whether
Millennium has the capability or capacity to perform a
particular Commercialization Activity in North America.
6.6.6 All decisions by Aventis pursuant to Section 6.6.5 shall be
made:
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(a) only after referral of the matter to the Executive
Officers as provided in Section 12.3; provided,
however, the dispute resolution process shall be
accelerated, as may be reasonably required, to meet
deadlines imposed by Third Parties or as otherwise
needed to respond to competition in the market. For
clarity, if the Executive Officers are unable to
decide the matter, then Aventis shall have the right
to decide the matter;
(b) with the goal of realizing the best overall
commercial potential of Joint Development Products on
a global basis; and
(c) in a manner that does not solely disadvantage
Millennium relative to Aventis in any significant
respect.
6.7 COMMERCIALIZATION STRATEGY AND DECISION MAKING. Notwithstanding
anything to the contrary in this Article 6, in the event that the
Parties are precluded by applicable Law from jointly establishing
Commercialization strategy or making Commercialization decisions
pursuant to Article 6 and relating to a Joint Development Product in
any country in North America or ROW, then [**] such decisions, PROVIDED
THAT such establishment of strategy and decision-making shall be
subject to the provisions of Section 6.5.3(b), (c) and (d) and made in
a manner that preserves the intent of Section 6.8.
6.8 REVENUE BOOKING IN NORTH AMERICA. To the extent permissible under
applicable Law, the Parties shall cooperate to coordinate the
Commercialization activities through the Joint Commercialization
Committee so that, throughout the course of North America
Commercialization of Joint Development Products, each Party has an
opportunity to distribute, and book revenue for, Joint Development
Products in North America accounting for approximately [**] of all the
aggregate gross sales of Joint Development Products in North America
made by the Parties under this Agreement; PROVIDED, HOWEVER, that a
Party shall not have the right to distribute a Joint Development
Product in North America unless it has the capability and capacity to
do so, as determined by the applicable North America Commercialization
Project Team; and further provided that [**] shall require the Parties
to [**].
6.9 COMMERCIALIZATION EXPENSE AND BUDGET.
6.9.1 Expenses related to Commercialization of Joint Development
Products sold in North America shall be provided for in a
budget to be included in the Global Commercialization Plan and
the North America Commercialization Plan, and shall be shared
on a Joint Development Product-by-Joint Development Product
basis pursuant to Section 8.2 as follows: (a) Millennium and
Aventis shall each bear fifty percent (50%)
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of NA Commercialization Expense and NA License Fees for the
Joint Development Product, and (b) Millennium and Aventis
shall each bear a portion of all NA/Ex-NA Commercialization
Expenses and NA/Ex-NA License Fees for the Joint Development
Product equal to fifty percent (50%) of the NA Percentage. For
clarity, Aventis shall also bear a percentage of the NA/Ex-NA
Commercialization Expenses and NA/Ex-NA License Fees for the
Joint Development Product equal to one hundred percent (100%)
less the NA Percentage and shall bear one hundred percent
(100%) of the Commercialization expense relating solely to ROW
Commercialization that is not relevant to NA/Ex-NA
Commercialization.
6.9.2 The budget set forth in each Global Commercialization Plan
shall detail the NA/Ex-NA Marketing Expense, NA/Ex-NA Medical
Expense and NA/Ex-NA License Fees budgeted to be incurred by
each Party during each calendar year. The budget set forth in
each North America Commercialization Plan shall detail the NA
Marketing Expense, NA Medical Expense, Field Force Expense and
NA License Fees budgeted to be incurred by each Party during
each calendar year.
6.9.3 Each Joint Commercialization Project Team shall review on a
quarterly basis the NA/Ex-NA Commercialization Expense and
NA/Ex-NA License Fees against the budget for such expenses in
the applicable calendar year. If in the course of its
quarterly review of NA/Ex-NA Commercialization Expense and
NA/Ex-NA License Fees, any Joint Commercialization Project
Team should determine for any Joint Development Product that
the actual amounts incurred for NA/Ex-NA Marketing Expense,
NA/Ex-NA Medical Expense or NA/Ex-NA License Fees are likely
to be higher than budgeted, the Joint Commercialization
Project Team shall review the reasons for such potential
overrun and determine whether such overrun is appropriate. If
the Joint Commercialization Project Team determines that such
overrun is appropriate, the Joint Commercialization Project
Team will assess whether such overrun is likely to result in
an overrun of the overall NA/Ex-NA Commercialization Budget
and if required, will agree on a revised NA/Ex-NA
Commercialization Budget so that no overrun is expected. If
the Joint Commercialization Project Team determines that such
overrun is not appropriate, the Joint Commercialization
Project Team will take such actions as required to remedy the
situation.
6.9.4 Each North America Commercialization Project Team shall review
on a quarterly basis the NA Commercialization Expense and NA
License Fees against the budget for such expenses in the
applicable calendar year. If in the course of its quarterly
review of NA Commercialization Expense and NA License Fees,
any North America Commercialization Project Team should
determine for any Joint Development Product that the actual
amounts incurred for NA Marketing Expense, NA Medical Expense,
Field Force Expense or NA License Fees are likely to be higher
than budgeted, the North America Commercialization Project
Team shall review the
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reasons for such potential overrun and determine whether such
overrun is appropriate. If the North America Commercialization
Project Team determines that such overrun is appropriate, the
North America Commercialization Project Team will assess
whether such overrun is likely to result in an overrun of the
overall NA Commercialization Budget and if required, will
agree on a revised NA Commercialization Budget so that no
overrun is expected. If the North America Commercialization
Project Team determines that such overrun is not appropriate,
the North America Commercialization Project Team will take
such actions as required to remedy the situation.
6.10 PUBLIC STATEMENTS REGARDING JOINT DEVELOPMENT PRODUCTS. Each Party
shall ensure that no claims or representations in respect of the Joint
Development Products or the characteristics thereof are made by or on
behalf of it (by members of its sales force or otherwise) which do not
represent an accurate summary or explanation of the labeling of the
Joint Development Product or a portion thereof, except to the extent
permitted by Law.
6.11 COMPLIANCE WITH LAWS. Each Party agrees to comply with all applicable
Laws with respect to the Commercialization of Joint Development
Products in North America. Neither Party shall be required to undertake
any activity relating to the Commercialization of Joint Development
Products in North America that it believes, in good faith, may violate
any Law.
6.12 UNILATERAL COMMERCIALIZATION. The Developing Party with respect to a
Unilateral Development Compound shall have the right to Commercialize
related UDC Products on a worldwide basis; provided that the Developing
Party shall provide the other Party with a quarterly report concerning
the status of its Commercialization of any such UDC Products.
Notwithstanding the foregoing, if the Developing Party intends to
Commercialize a UDC Product in collaboration with a Third Party (or
grant a license to a Third Party to do any of the foregoing), the
Developing Party shall provide the other Party with an opportunity to
negotiate terms under which the other Party would collaborate in or be
granted a license with respect to such Commercialization (a "Product
Right of First Negotiation"), provided that a Product Right of First
Negotiation shall not apply to the retention of a contract sales force
or to a product distribution or contract manufacturing arrangement or
other outsourced marketing, advertising or promotion activities (unless
such arrangement is with a Significant Pharmaceutical Enterprise). A
Product Right of First Negotiation shall operate as follows:
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
6.12.1 The Developing Party shall promptly notify the other Party in
writing (the "Product Notification") of its intention to seek
a collaborator or licensee for the Commercialization of the
relevant UDC Product and shall provide to the other Party a
reasonably detailed written description of the UDC Product and
such proposed UDC collaboration or license, together with all
relevant data and information relating to the Joint
Development Product which has not previously been provided to
the other Party.
6.12.2 Within [**] of its receipt of the Product Notification (the
"Product Response Period"), the other Party shall notify the
Developing Party of its interest, if any, in initiating
discussions regarding such proposed UDC collaboration or
license.
6.12.3 In the event that the other Party notifies the Developing
Party prior to the termination of the Product Response Period
that it has an interest in participating in such proposed UDC
collaboration or in receiving such license (a "Product
Expression of Interest"), then the Parties shall negotiate in
good faith in an effort to reach a definitive agreement
regarding such UDC collaboration or license for a period of up
to [**] from the date of the Developing Party's receipt of the
Product Expression of Interest.
6.12.4 In the event that the Parties reach a definitive agreement
with respect to such UDC Product pursuant to Section 6.12.3,
such UDC Product shall no longer be designated a Unilateral
Development Product and the rights and obligations of the
Parties with respect to such product shall be governed by the
terms of such definitive agreement and not this Agreement.
6.12.5 In the event that (a) the other Party fails to notify the
Developing Party prior to the termination of the Product
Response Period that it is interested in collaborating with or
obtaining a license from the Developing Party with respect to
such Unilateral Development Product, or (b) the other Party
notifies the Developing Party prior to the termination of the
Product Response Period that it has no interest in such
collaboration or license, or (c) the other Party timely
provides the Developing Party with a Product Expression of
Interest but the Parties fail to reach a definitive agreement
within the [**] period specified in Section 6.12.3, then the
Developing Party shall be free to enter into a collaboration
or license with a Third Party with respect to such UDC
Product; PROVIDED, HOWEVER, that the Developing Party may [**]
with a Third Party [**] to the Third Party, [**] to the
non-Developing Party.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
6.12.6 For the duration of the Product Response Period, and if the
other Party timely delivers the Product Expression of
Interest, the [**] term specified in Section 6.12.3, the
Developing Party may discuss the general outline of such
collaboration or license; PROVIDED HOWEVER, that the
Developing Party shall not negotiate such collaboration or
license with a Third Party, enter into any agreements with
such Third Party or propose terms to such Third Party on which
Millennium would be willing to consummate such collaboration
or license.
6.13 USE OF SUBCONTRACTORS. To the extent either Party wishes to perform
some of its obligations regarding the North America Commercialization
or NA/Ex-NA Commercialization through one or more subcontractors, it
must obtain the written approval of the other Party prior to engaging
such subcontractor, which approval shall not be unreasonably withheld
or delayed. It is understood that as a condition to granting such
approval, (a) the other Party shall be entitled to audit the proposed
subcontractor using the same standards which it applies to the use of
subcontractors in the Commercialization of its other products, and (b)
the subcontractor must undertake in writing obligations of
confidentiality and non-use regarding the other Party's Confidential
Information which are substantially the same as those undertaken by
Aventis or Millennium pursuant to Article 9 hereof. In the event a
Party performs one or more of its obligations regarding North America
Commercialization or NA/Ex-NA Commercialization through the use of a
subcontractor, then such Party shall at all times be responsible for
the performance of such subcontractor. For the avoidance of doubt, it
is understood that an Affiliate of a Party shall not be deemed to be a
subcontractor of such Party. For clarity, the provisions of this
Section 6.13 are not intended to apply to contracts with individual
consultants, small market research studies and other contracts of
similarly small financial magnitude.
ARTICLE 7
LICENSES
7.1 MILLENNIUM GRANTS
7.1.1 RESEARCH LICENSES.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(a) ACTIVITIES UNDER RESEARCH PROGRAM. Subject to the
terms and conditions of this Agreement (including the
license grants set forth in this Article 7 [**]) and
any applicable [**], Millennium hereby grants to
Aventis a worldwide, co-exclusive,
non-royalty-bearing license during the Research
Program Term, under Millennium's rights to the
Millennium Ex-Program Intellectual Property and the
Program Intellectual Property, to (A) identify and
validate targets for the identification, evaluation
and optimization of Small Molecules for use [**], (B)
identify Small Molecules through the use of such
targets, and (C) undertake Pre-EDC Research
Evaluation of such Small Molecules, in each case, in
the conduct of the Research Program. Such license
shall further include the right to grant sublicenses
to Affiliates of Aventis and to Third Parties that
are approved by the Joint Research Committee.
(b) AVENTIS SINGLE-PARTY RESEARCH TARGETS. Subject to the
terms and conditions of this Agreement and any
applicable Burdened Technology Obligations,
Millennium hereby grants to Aventis a worldwide,
non-exclusive, non-royalty-bearing license, under
Millennium's rights to the Millennium Ex-Program
Intellectual Property and the Program Intellectual
Property (excluding Program Compounds other than the
related SPRT Compounds), to (A) validate Aventis
Single-Party Research Targets for the identification,
evaluation and optimization of Small Molecules for
use [**], (B) identify Small Molecules through the
use of such Aventis Single-Party Research Targets and
(C) undertake Pre-EDC Research Evaluation of such
Small Molecules; PROVIDED, HOWEVER, THAT, with
respect to each Aventis Single-Party Research Target,
such license shall be limited to know-how disclosed
to Aventis prior to, and to Patent Rights which exist
as of or which claim priority from Patent Rights
which exist as of, the date such target is designated
an Aventis Single-Party Research Target. Such license
shall further include the right to grant sublicenses
to Affiliates of Aventis and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
Millennium hereby grants to Aventis a worldwide,
non-exclusive, non-royalty-bearing license, under
Millennium's rights to the Program Intellectual
Property, to use Scientifically-Qualified Targets to
identify, evaluate and optimize Essential
Pharmacogenomic Products or Services. Such license
shall further include the right to grant sublicenses
to Affiliates of Aventis and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable [**],
and on a Scientifically-Qualified
Target-by-Scientifically-Qualified Target basis,
Millennium hereby grants to Aventis a worldwide,
non-exclusive, non-royalty-bearing license, under
Millennium's Patent Rights (excluding the Millennium
Research Program Chemistry Intellectual Property), to
use Scientifically-Qualified Targets to identify,
evaluate and optimize Small Molecules for use [**];
PROVIDED, HOWEVER, that with respect to each
Scientifically-Qualified Target, such license shall
be limited to (i) know-how disclosed to Aventis prior
to the date such target is designated a
Scientifically-Qualified Target, (ii) Patent Rights
which exist as of the date such target is designated
a Scientifically-Qualified Target, and (iii) any
claim of a patent which (A) claims priority from a
patent application within Patent Rights which exists
as of the date such target is designated an
Scientifically-Qualified Target and (B) is adequately
supported in such application from which it claims
priority to satisfy the requirements of 35 U.S.C.
112. Such license shall further include the right to
grant sublicenses to Affiliates of Aventis and to
Third Parties in accordance with the terms set forth
in Section 7.2.5.
(e) RESEARCH LICENSE TO PROGRAM COMPOUNDS.
(i) Subject to the terms and conditions of this
Agreement and any applicable Burdened
Technology Obligations, Millennium hereby
grants to Aventis a worldwide,
non-exclusive, non-royalty-bearing license,
under Millennium's Program Patent Rights to
use a Program Compound for internal research
purposes only; provided, however, such
license shall not include the right to use
the corresponding Program Compound Family
outside the Research Program to identify,
evaluate and optimize Small Molecules as
Ex-
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Program Products directed to the same
Scientifically-Qualified Target as to which
such Program Compound Family was generated.
Such license shall remain in effect in
perpetuity except during the periods
described in Sections 7.1.1(e)(ii) and
(iii).
(ii) Upon selection of a Lead Compound, with
respect to a Program Compound within the
corresponding Lead Compound Family, the
license of Section 7.1.1(e)(i) shall be
suspended with respect to such Program
Compound during the period from selection of
such Lead Compound until the earlier of (A)
discontinuation of all activities in the
Research Program relating to such Lead
Compound Family or (B) the decision of the
Joint Research Committee not to select such
Program Compound as an EDC Compound or a
Back-Up Compound.
(iii) If a Lead Compound directed to a target has
been selected by the Joint Research
Committee prior to such target being
designated as a Millennium Single-Party
Research Target, with respect to the
corresponding Lead Compound Family, the
license of Section 7.1.1(e)(i) shall be
suspended with respect to such Lead Compound
Family during the period from designation of
such Millennium Single-Party Research Target
until the discontinuation of all activities
by Millennium relating to such Lead Compound
Family with respect to such Millennium
Single-Party Research Target.
7.1.2 DEVELOPMENT LICENSES.
(a) JOINT DEVELOPMENT PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on an EDC
Compound-by-EDC Compound basis, Millennium hereby
grants to Aventis a worldwide, non-royalty-bearing
license, under Millennium's rights to the Millennium
Ex-Program Intellectual Property and the Program
Intellectual Property, to Develop Joint Development
Compounds for JD Products. Such license shall be
exclusive outside of North America and shall be
co-exclusive (with Millennium) within North America,
and shall further include the right to grant
sublicenses to Affiliates of Aventis and to Third
Parties that are approved by the relevant Joint
Development Committee.
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(b) AVENTIS SINGLE-PARTY TARGET PRODUCTS AND AVENTIS UDC
PRODUCTS. Subject to the terms and conditions of this
Agreement (including the license grants set forth in
this Article 7 with respect to Ex-Program Products)
and any applicable Burdened Technology Obligations,
and on a compound-by-compound basis, Millennium
hereby grants to Aventis a worldwide, exclusive,
non-royalty-bearing license, under Millennium's
rights to the Millennium Ex-Program Intellectual
Property and the Program Intellectual Property
(excluding Program Compounds other than the related
SPRT Compounds that are specified in Section
2.7.3(b)(ii) or that are Active against the relevant
Single-Party Research Target), to (i) Develop Small
Molecules identified through the use of Aventis
Single-Party Research Targets for Aventis
Single-Party Target Products and (ii) Develop Aventis
Unilateral Development Compounds for Aventis UDC
Products; PROVIDED, HOWEVER, that, with respect to
each Aventis Single-Party Research Target or Aventis
Unilateral Development Compound, as the case may be,
such license shall be limited to know-how disclosed
to Aventis prior to, and to Patent Rights which exist
as of or which claim priority from Patent Rights
which exist as of, the date such target is designated
an Aventis Single-Party Research Target or such
compound is designated an Aventis Unilateral
Development Compound, as the case may be. Such
license shall further include the right to grant
sublicenses to Affiliates of Aventis and to Third
Parties in accordance with the terms set forth in
Section 7.2.5.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
and on a compound-by-compound basis, Millennium
hereby grants to Aventis a worldwide, non-exclusive,
non-royalty-bearing license, under Millennium's
rights to the Program Intellectual Property, to use
Scientifically-Qualified Targets to Develop Essential
Pharmacogenomic Products or Services. Such license
shall further include the right to grant sublicenses
to Affiliates of Aventis and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on a
compound-by-compound basis, Millennium hereby grants
to Aventis a worldwide, non-exclusive,
non-royalty-bearing license, under Millennium's
rights to the Program Intellectual Property
(excluding the Millennium Research Program Chemistry
Intellectual Property), to use
Scientifically-Qualified Targets to Develop
Ex-Program Products [**]; PROVIDED, HOWEVER, that,
with respect to each Scientifically-Qualified Target,
such license shall be limited to (i) know-how
disclosed to Aventis prior to the date such target is
designated a Scientifically-Qualified Target, (ii)
Patent Rights which exist as of the date such target
is designated a Scientifically-Qualified Target, and
(iii) any claim of a patent which (A) claims priority
from a patent application within Patent Rights which
exists as of the date such target is designated a
Scientifically-Qualified Target and (B) is adequately
supported in such application from, which it claims
priority to satisfy the requirements of 35 U.S.C.
112. Such license shall further include the right to
grant sublicenses to Affiliates of Aventis and to
Third Parties in accordance with the terms set forth
in Section 7.2.5.
7.1.3 COMMERCIALIZATION LICENSES.
(a) JD PRODUCTS. Subject to the terms and conditions of
this Agreement and any applicable Burdened Technology
Obligations, and on a JD Product-by-JD Product basis,
Millennium hereby grants to Aventis a worldwide
license, under Millennium's rights to the Millennium
Ex-Program Chemistry Intellectual Property and the
Program Intellectual Property, to Commercialize JD
Products in the Territory. Such license shall be
exclusive outside of North America and shall be
co-exclusive (with Millennium) within North America,
and shall carry an obligation of profit-sharing with
respect to JD Products sold in North America and
shall be royalty-bearing with respect to JD Products
sold outside of North America. Such license shall
further include the right to grant sublicenses to
Affiliates of Aventis and to Third Parties in
accordance with the terms set forth in Section 7.2.5
(provided that within North America, any sublicense
to a Third Party must be approved by the relevant
Joint Commercialization Committee).
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(b) AVENTIS SINGLE-PARTY TARGET PRODUCTS AND AVENTIS UDC
PRODUCTS. Subject to the terms and conditions of this
Agreement and any applicable Burdened Technology
Obligations, and on a product-by-product basis,
Millennium hereby grants to Aventis a worldwide,
exclusive, royalty-bearing license, under
Millennium's rights to the Millennium Ex-Program
Intellectual Property and the Program Intellectual
Property (excluding Program Compounds other than the
related SPRT Compounds that are specified in Section
2.7.3(b)(ii) or that are Active against the relevant
Single-Party Research Target), to Commercialize
Aventis Single-Party Target Products and Aventis UDC
Products in the Territory; PROVIDED, HOWEVER, that,
with respect to each Aventis Single-Party Target
Product or Aventis Unilateral Development Compound,
as the case may be, such license shall be limited to
know-how disclosed to Aventis prior to, and to Patent
Rights which exist as of or which claim priority from
Patent Rights which exist as of, the date the target
used to identify, evaluate, optimize and/or Develop
such Aventis Single-Party Target Product is
designated an Aventis Single-Party Research Target or
such compound is designated an Aventis Unilateral
Development Compound, as the case may be. Such
license shall further include the right to grant
sublicenses to Affiliates of Aventis and to Third
Parties in accordance with the terms set forth in
Section 7.2.5.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
and on a product-by-product or service-by-service
basis, Millennium hereby grants to Aventis a
worldwide, non-exclusive, non-royalty-bearing
license, under Millennium's rights to the Program
Intellectual Property, to Commercialize Essential
Pharmacogenomic Products or Services in the
Territory. Such license shall further include the
right to grant sublicenses to Affiliates of Aventis
and to Third Parties in accordance with the terms set
forth in Section 7.2.5.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on an Ex-Program
Product-by-Ex-Program Product basis, Millennium
hereby grants to Aventis a worldwide, non-exclusive,
royalty-bearing license, under Millennium's rights to
the Program Intellectual Property (excluding the
Millennium Research Program Chemistry Intellectual
Property), to Commercialize Ex-Program Products [**]
in the Territory; PROVIDED, HOWEVER, that, with
respect to each Ex-Program Product, such license
shall be limited
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
to (i) know-how disclosed to Aventis prior to the
date the target used to identify, evaluate, optimize
and/or Develop such Ex-Program Product is designated
a Scientifically-Qualified Target, (ii) Patent Rights
which exist as of the date the target used to
identify, evaluate, optimize and/or Develop such
Ex-Program Product is designated a
Scientifically-Qualified Target, and (iii) any claim
of a patent which (A) claims priority from a patent
application within Patent Rights which exists as of
the date the target used to identify, evaluate,
optimize and/or Develop such Ex-Program Product is
designated a Scientifically-Qualified Target, and (B)
in adequately supported in such application from
which it claims priority to satisfy the requirements
of 35 U.S.C. 112. Such license shall further include
the right to grant sublicenses to Affiliates of
Aventis and to Third Parties in accordance with the
terms set forth in Section 7.2.5.
7.1.4 LICENSE GRANTS ON THE EXERCISE OF AN OPTION.
(a) GT PRODUCTS. Subject to the terms and conditions of
this Agreement and any applicable Burdened Technology
Obligations, upon the exercise of a GT Option,
Millennium hereby grants to Aventis (A) a worldwide,
exclusive, non-royalty bearing license, under
Millennium's rights to Program Intellectual Property,
to validate and use the Potential GT Target that is
the subject of such option for the discovery and
evaluation of GT Products [**] and (B) a worldwide,
exclusive, royalty-bearing license, under
Millennium's rights to the Program Intellectual
Property, to Develop and Commercialize such GT
Products. Such license shall further include the
rights to grant sublicenses to Affiliates of Aventis
and to Third Parties in accordance with the terms set
forth in Section 7.2.5.
(b) VACCINE PRODUCTS. Subject to the terms and conditions
of this Agreement and any applicable Burdened
Technology Obligations, upon the exercise of a
Vaccine Option, Millennium hereby grants to Aventis
(A) a worldwide, exclusive, non-royalty bearing
license, under Millennium's rights to Program
Intellectual Property, to validate and use the
Potential Vaccine Target that is the subject of such
option for the discovery and evaluation of Vaccine
Products [**] and (B) a worldwide, exclusive,
royalty-bearing license, under Millennium's rights to
the Program Intellectual Property, to Develop and
Commercialize such Vaccine Products. Such license
shall further include the rights to grant sublicenses
to Affiliates of Aventis and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
7.2 AVENTIS GRANTS.
7.2.1 RESEARCH LICENSES.
(a) ACTIVITIES UNDER RESEARCH PROGRAM. Subject to the
terms and conditions of this Agreement (including the
license grants set forth in this Article 7 with
respect to Ex-Program Products) and any applicable
Burdened Technology Obligations, Aventis hereby
grants to Millennium a worldwide, co-exclusive,
non-royalty-bearing license during the Research
Program Term, under Aventis' rights to the Aventis
Ex-Program Intellectual Property and the Program
Intellectual Property, to (A) identify and validate
targets for the identification, evaluation, and
optimization of Small Molecules [**], (B) identify
Small Molecules through the use of such targets and
(C) undertake Pre-EDC Research Evaluation of such
Small Molecules, in each case, in the conduct of the
Research Program. Such license shall further include
the right to grant sublicenses to Affiliates of
Millennium and to Third Parties that are approved by
the Joint Research Committee.
(b) MILLENNIUM SINGLE-PARTY RESEARCH TARGETS. Subject to
the terms and conditions of this Agreement and any
applicable Burdened Technology Obligations, Aventis
hereby grants to Millennium a worldwide,
non-exclusive, non-royalty-bearing license, under
Aventis' rights to the Aventis Ex-Program
Intellectual Property and the Program Intellectual
Property (excluding Program Compounds other than the
related SPRT Compounds), to (A) validate Millennium
Single-Party Research Targets for the identification,
evaluation and optimization of Small Molecules [**],
(B) identify Small Molecules through the use of such
Millennium Single-Party Research Targets and (C)
undertake Pre-EDC Research Evaluation of such Small
Molecules; PROVIDED, HOWEVER, THAT, with respect to
each Millennium Single-Party Research Target, such
license shall be limited to know-how disclosed to
Millennium prior to, and to Patent Rights which exist
as of or which claim priority from Patent Rights
which exist as of, the date such target is designated
a Millennium Single-Party Research Target. Such
license shall further include the right to grant
sublicenses to Affiliates of Millennium and to Third
Parties in accordance with the terms set forth in
Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
Aventis hereby grants to Millennium a worldwide,
non-exclusive, non-royalty-bearing license, under
Aventis' rights to the Program Intellectual Property,
to use Scientifically-Qualified Targets to identify,
evaluate and optimize Essential Pharmacogenomic
Products or Services. Such license shall further
include the right to grant sublicenses to Affiliates
of Millennium and to Third Parties in accordance with
the terms set forth in Section 7.2.5.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on a
Scientifically-Qualified
Target-by-Scientifically-Qualified Target basis,
Aventis hereby grants to Millennium a worldwide,
non-exclusive, non-royalty-bearing license under
Aventis' rights to the Program Intellectual Property
(excluding the Aventis Research Program Chemistry
Intellectual Property), to use
Scientifically-Qualified Targets to identify,
evaluate and optimize Small Molecules [**]; PROVIDED,
HOWEVER, that with respect to each Scientifically-
Qualified Target, such license shall be limited to
(i) know-how disclosed to Millennium prior to the
date such target is designated a Scientifically-
Qualified Target, (ii) Patent Rights which exist as
of the date such target is designated a
Scientifically-Qualified Target, and (iii) any
claim of a patent which (A) claims priority from a
patent application within Patent Rights which exists
as of the date such target is designated a
Scientifically-Qualified Target and (B) is adequately
supported in such application from, which it claims
priority to satisfy the requirements of 35 U.S.C.
112. Such license shall further include the right to
grant sublicenses to Affiliates of Millennium and to
Third Parties in accordance with the terms set forth
in Section 7.2.5.
(e) RESEARCH LICENSE TO PROGRAM COMPOUNDS.
(i) Subject to the terms and conditions of this
Agreement and any applicable Burdened
Technology Obligations, Aventis hereby
grants to Millennium a worldwide,
non-exclusive, non-royalty-bearing license,
under Aventis' Program Patent Rights to use
a Program Compound for internal research
purposes only; provided, however, such
license shall not include the right to use
the corresponding Program Compound Family
outside the Research Program to identify,
evaluate and optimize Small Molecules as
Ex-
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Program Products directed to the same
Scientifically-Qualified Target as to which
such Program Compound Family was generated.
Such license shall remain in effect in
perpetuity except during the periods
described in Sections 7.1.1(e)(ii) and
(iii).
(ii) Upon selection of a Lead Compound, with
respect to a Program Compound within the
corresponding Lead Compound Family, the
license of Section 7.2.1(e)(i) shall be
suspended with respect to such Program
Compound during the period from selection of
such Lead Compound until the earlier of (A)
discontinuation of all activities in the
Research Program relating to such Lead
Compound Family or (B) the decision of the
Joint Research Committee not to select such
Program Compound as an EDC Compound or a
Back-Up Compound.
(iii) If a Lead Compound directed to a target has
been selected by the Joint Research
Committee prior to such target being
designated as an Aventis Single-Party
Research Target, with respect to the
corresponding Lead Compound Family, the
license of Section 7.2.1(e)(i) shall be
suspended with respect to such Lead Compound
Family during the period from designation of
such Aventis Single-Party Research Target
until the discontinuation of all activities
by Aventis relating to such Lead Compound
Family with respect to such Aventis
Single-Party Research Target.
7.2.2 DEVELOPMENT LICENSES.
(a) JOINT DEVELOPMENT PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on an EDC
Compound-by-EDC Compound basis, Aventis hereby grants
to Millennium a worldwide, co-exclusive (with
Aventis), non-royalty-bearing license, under Aventis'
rights to the Aventis Ex-Program Intellectual
Property and the Program Intellectual Property, to
Develop Joint Development Compounds for JD Products.
Such license shall be limited to Development relevant
for North America and shall further include the right
to grant sublicenses to Affiliates of Millennium and
to Third Parties that are approved in by the relevant
Joint Development Committee.
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(b) MILLENNIUM SINGLE-PARTY TARGET PRODUCTS AND
MILLENNIUM UDC PRODUCTS. Subject to the terms and
conditions of this Agreement (including the license
grants set forth in this Article 7 with respect to
Ex-Program Products) and any applicable Burdened
Technology Obligations, and on a compound-by-compound
basis, Aventis hereby grants to Millennium a
worldwide, exclusive, non-royalty-bearing license,
under Aventis' rights to the Aventis Ex-Program
Intellectual Property and the Program Intellectual
Property (excluding Program Compounds other than the
related SPRT Compounds that are specified in Section
2.7.3(b)(ii) or that are Active against the relevant
Single-Party Research Target), to (i) Develop Small
Molecules identified through the use of Millennium
Single-Party Research Targets for Millennium
Single-Party Target Products, and (ii) Develop
Millennium Unilateral Development Compounds for
Millennium UDC Products; PROVIDED, HOWEVER, that,
with respect to each Millennium Single-Party Research
Target or Millennium Unilateral Development Compound,
as the case may be, such license shall be limited to
know-how disclosed to Millennium prior to, and to
Patent Rights which exist as of or which claim
priority from Patent Rights which exist as of, the
date such target is designated a Millennium
Single-Party Research Target or such compound is
designated a Millennium Unilateral Development
Compound, as the case may be. Such license shall
further include the right to grant sublicenses to
Affiliates of Millennium and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
and on a compound-by-compound basis, Aventis hereby
grants to Millennium a worldwide, non-exclusive,
non-royalty-bearing license, under Aventis' rights to
the Program Intellectual Property, to use
Scientifically-Qualified Targets to Develop Essential
Pharmacogenomic Products or Services. Such license
shall further include the right to grant sublicenses
to Affiliates of Millennium and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on a
compound-by-compound basis, Aventis hereby grants to
Millennium a worldwide, non-exclusive,
non-royalty-bearing license, under Aventis' rights to
the Program Intellectual Property (excluding the
Aventis Research Program Chemistry Intellectual
Property), to use Scientifically-Qualified Targets to
Develop Ex-Program Products [**]; PROVIDED, HOWEVER,
that with respect to each Scientifically-Qualified
Target, such license shall be limited to (i) know-how
disclosed to Millennium prior to the date such target
is designated a Scientifically-Qualified Target, (ii)
Patent Rights which exist as of the date such target
is designated a Scientifically-Qualified Target, and
(iii) any claim of a patent which (A) claims priority
from a patent application within Patent Rights which
exists as of the date such target is designated a
Scientifically-Qualified Target and (B) is adequately
supported in such application from which it claims
priority to satisfy the requirements of 35 U.S.C.
112. Such license shall further include the right to
grant sublicenses to Affiliates of Millennium and to
Third Parties in accordance with the terms set forth
in Section 7.2.5.
7.2.3 COMMERCIALIZATION LICENSES.
(a) JD PRODUCTS. Subject to the terms and conditions of
this Agreement and any applicable Burdened Technology
Obligations, and on a JD Product-by-JD Product basis,
Aventis hereby grants to Millennium a, co-exclusive
(with Aventis) license, under Aventis' rights to the
Aventis Ex-Program Intellectual Property and the
Program Intellectual Property, to Commercialize JD
Products in North America. Such license shall carry
an obligation of profit-sharing with respect to JD
Products sold in North America. Such license shall
further include the right to grant sublicenses to
Affiliates of Millennium, and to Third Parties that
are approved by the relevant Joint Commercialization
Committee.
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(b) MILLENNIUM SINGLE-PARTY TARGET PRODUCTS AND
MILLENNIUM UDC PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on a
product-by-product basis, Aventis hereby grants to
Millennium a worldwide, exclusive, royalty-bearing
license, under Aventis' rights to the Aventis
Ex-Program Intellectual Property and the Program
Intellectual Property (excluding Program Compounds
other than the related SPRT Compounds that are
specified in Section 2.7.3(b)(ii) or that are Active
against the relevant Single-Party Research Target),
to Commercialize Millennium Single-Party Target
Products and Millennium UDC Products in the
Territory; PROVIDED, HOWEVER, that, with respect to
each Millennium Single-Party Target Product or
Millennium Unilateral Development Compound, as the
case may be, such license shall be limited to
know-how disclosed to Millennium prior to, and to
Patent Rights which exist as of or which claim
priority from Patent Rights which exist as of, the
date the target used to identify, evaluate, optimize
and/or Develop such Millennium Single-Party Target
Product is designated a Millennium Single-Party
Research Target or such compound is designated a
Millennium Unilateral Development Compound, as the
case may be. Such license shall further include the
right to grant sublicenses to Affiliates of
Millennium and to Third Parties in accordance with
the terms set forth in Section 7.2.5. Aventis shall
also assign to Millennium all of its rights, title
and interest in any trademark or service mark adopted
by Aventis in connection with the Millennium UDC
Product.
(c) ESSENTIAL PHARMACOGENOMIC PRODUCTS OR SERVICES.
Subject to the terms and conditions of this Agreement
and any applicable Burdened Technology Obligations,
and on a product-by-product or service-by-service
basis, Aventis hereby grants to Millennium a
worldwide, non-exclusive, non-royalty-bearing
license, under Aventis' rights to the Program
Intellectual Property, to Commercialize Essential
Pharmacogenomic Products or Services in the
Territory. Such license shall further include the
right to grant sublicenses to Affiliates of
Millennium and to Third Parties in accordance with
the terms set forth in Section 7.2.5.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(d) EX-PROGRAM PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, and on an Ex-Program
Product-by-Ex-Program Product basis, Aventis hereby
grants to Millennium a worldwide, non-exclusive,
royalty-bearing license, under Aventis' rights to the
Program Intellectual Property (excluding the Aventis
Research Program Chemistry Intellectual Property), to
Commercialize Ex-Program Products [**] in the
Territory; PROVIDED, HOWEVER, that with respect to
each Ex-Program Product, such license shall be
limited to (i) know-how disclosed to Millennium prior
to the date the target used to identify, evaluate,
optimize and/or Develop such Ex-Program Product is
designated a Scientifically-Qualified Target, (ii)
Patent Rights which exist as of the date the target
used to identify, evaluate, optimize and/or Develop
such Ex-Program Product is designated a
Scientifically-Qualified Target, and (iii) any claim
of a patent which (A) claims priority from a patent
application within Patent Rights which exists as of
the date the target used to identify, evaluate,
optimize and/or Develop such Ex-Program Product is
designated a Scientifically-Qualified Target, and (B)
is adequately supported in such application from
which it claims priority to satisfy the requirements
of 35 U.S.C. 112. Such license shall further include
the right to grant sublicenses to Affiliates of
Millennium and to Third Parties in accordance with
the terms set forth in Section 7.2.5.
7.2.4 LICENSE GRANTS ON THE EXERCISE OF AN OPTION.
(a) ANTIBODY PRODUCTS. Subject to the terms and
conditions of this Agreement and any applicable
Burdened Technology Obligations, upon the exercise of
an Antibody Option, Aventis hereby grants to
Millennium (A) a worldwide, exclusive, non-royalty
bearing license, under Aventis' rights to the Program
Intellectual Property, to validate and use the
Potential Antibody Target that is the subject of such
option for the discovery and evaluation of Antibody
Products [**] and (B) a worldwide, exclusive,
royalty-bearing license, under Aventis' rights to the
Program Intellectual Property, to Develop and
Commercialize such Antibody Products. Such license
shall further include the rights to grant sublicenses
to Affiliates of Millennium and to Third Parties in
accordance with the terms set forth in Section 7.2.5.
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(b) DIAGNOSTIC PRODUCTS OR SERVICES. Subject to the terms
and conditions of this Agreement and any applicable
Burdened Technology Obligations, upon the exercise of
a Diagnostic Option, Aventis hereby grants to
Millennium (A) a worldwide, exclusive, non-royalty
bearing license, under Aventis' rights to the Program
Intellectual Property, to validate and use the
Potential Diagnostic Target that is the subject of
such option for the discovery and evaluation of
Diagnostic Products or Services to diagnose, in
humans, asthma, chronic obstructive pulmonary
disease, rheumatoid arthritis, multiple sclerosis
and/or inflammatory bowel disease and (B) a
worldwide, exclusive, royalty-bearing license, under
Aventis' rights to the Program Intellectual Property,
to Develop and Commercialize such Diagnostic Products
or Services. Such license shall further include the
rights to grant sublicenses to Affiliates of
Millennium and to Third Parties in accordance with
the terms set forth in Section 7.2.5.
7.2.5 SUBLICENSE RIGHTS. Wherever in this Agreement either Party is
granted the right to grant sublicenses subject to this Section
7.2.5, such Party may exercise such right without obtaining
the prior approval of the other Party, provided that if such
sublicensee is a Third Party, the sublicensing Party shall
promptly notify the other Party of the identity of such Third
Party sublicensee; and PROVIDED, FURTHER, THAT such sublicense
occurs pursuant to a written agreement that subjects such
sublicensee to all relevant restrictions and limitations in
this Agreement. Each Party shall be jointly and severally
responsible with its sublicensees for failure by its
sublicensees to comply with, and each Party guarantees the
compliance by each of its sublicensees with, all such
applicable restrictions and limitations in accordance with the
terms and conditions of this Agreement.
7.3 RETAINED RIGHTS.
7.3.1 AVENTIS RETAINED RIGHTS. With respect to this Agreement, any
rights of Aventis not expressly granted to Millennium under
the provisions of this Agreement shall be retained by Aventis,
including, without limitation, Aventis' rights to exploit
Program Intellectual Property Controlled by Aventis for (a)
any human health care applications based upon database and
information products or patient management tools and (b) any
applications outside of the human health care field.
7.3.2 MILLENNIUM RETAINED RIGHTS. With respect to this Agreement,
any rights of Millennium not expressly granted to Aventis
under the provisions of this Agreement shall be retained by
Millennium, including, without limitation, Millennium's rights
to exploit Program Intellectual Property Controlled by
Millennium for (a) any human health care applications based
upon database and information products or patient management
tools and (b) any applications outside of the human health
care field.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
7.4 SECTION 365(n) OF THE BANKRUPTCY CODE. All rights and licenses granted
under or pursuant to any section of this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, licenses of rights to "intellectual property" as
defined under Section 101(35A) of the Bankruptcy Code. The Parties
shall retain and may fully exercise all of their respective rights and
elections under the Bankruptcy Code. Upon the bankruptcy of any Party,
the non-bankrupt Party shall further be entitled to a complete
duplicate of (or complete access to, as appropriate) any such
intellectual property, and such, if not already in its possession,
shall be promptly delivered to the non-bankrupt Party, unless the
bankrupt Party elects to continue, and continues, to perform all of its
obligations under this Agreement.
7.5 CERTAIN COVENANTS REGARDING EX-PROGRAM PRODUCTS.
7.5.1 Aventis hereby covenants to Millennium that (a) Aventis and
its Affiliates shall not research, Develop or Commercialize,
license any Third Party to research, Develop or Commercialize,
or provide any financial or other support to any Third Party
to enable such Third Party to research or conduct any clinical
study relating to the use of, any Ex-Program Product [**], and
Aventis shall impose such restriction on all its sublicensees
and distributors of Ex-Program Products.
7.5.2 Millennium hereby covenants to Aventis that (a) Millennium and
its Affiliates shall not research, Develop or Commercialize,
license any Third Party to research, Develop or Commercialize,
or provide any financial or other support to any Third Party
to enable such Third Party to research or conduct any clinical
study relating to the use of, any Ex-Program Product [**], and
Millennium shall impose such restriction on all its
sublicensees and distributors of Ex-Program Products.
ARTICLE 8
FINANCIAL PROVISIONS
8.1 EQUITY INVESTMENT. On the date hereof, Aventis and Millennium are
entering into an Investment Agreement (the "Investment Agreement")
pursuant to which, subject to the terms and conditions contained
therein, Aventis shall purchase common stock of Millennium for an
aggregate purchase price of Two Hundred Fifty Million Dollars
($250,000,000) at such times and at such per share prices as provided
for in the Investment Agreement.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
8.2 PRE-TAX PROFIT OR LOSS IN NORTH AMERICA.
8.2.1 PRE-TAX PROFIT OR LOSS. The Parties shall share equally in all
Pre-tax Profit or Loss. It is understood that costs and
expenses included in components of Pre-tax Profit or Loss
shall not be double counted. For clarity, (i) costs and
expenses included in any one of the component categories of
Pre-tax Profit or Loss shall not be included in any other
component categories of Pre-tax Profit or Loss, (ii) costs and
expenses included in any of the component categories of
pre-tax Profit or Loss shall not also be deductible under the
definition of Net Sales, (iii) deductions under the definition
of Net Sales shall not also be included as costs and expenses
in any of the component categories of Pre-tax Profit or Loss,
and (iv) costs incurred by a manufacturing Party and charged
under a supply agreement relevant for North America pursuant
to Section 4.3 shall not be separately included in the
calculation of Pre-tax Profit or Loss.
8.2.2 QUARTERLY RECONCILIATION OF PRE-TAX PROFIT OR LOSS.
(a) Within [**] days following the end of each calendar
quarter, Millennium shall submit to Aventis a written
report setting forth in reasonable detail, separately
with respect to each Joint Development Compound and
Joint Development Product, to the extent made or
incurred by Millennium (i) Net Sales of Joint
Development Products in North America, (ii) G&A
Expense, (iii) Supply Price of Joint Development
Product sold in North America, (iv) NA Period Costs,
(v) NA Commercialization Expense, (vi) NA Development
Cost, (vii) NA License Fees and (viii) NA/Ex-NA
Expense (including a breakdown of NA/Ex-NA Period
Costs, NA/Ex-NA Commercialization Expense, NA/Ex-NA
Development Cost and NA/Ex-NA License Fees, before
multiplication by the NA Percentage).
(b) Within [**] days following the end of each calendar
quarter, Aventis shall submit to Millennium a written
report setting forth in reasonable detail, separately
with respect to each Joint Development Compound and
Joint Development Product, to the extent made or
incurred by Aventis (i) Net Sales of Joint
Development Products in North America, (ii) G&A
Expense, (iii) Supply Price of Joint Development
Product sold in North America, (iv) NA Period Costs,
(v) NA Commercialization Expense, (vi) NA Development
Cost, (vii) NA License Fees, and (viii) NA/Ex-NA
Expense (including a breakdown of NA/Ex-NA Period
Costs, NA/Ex-NA Commercialization Expense, NA/Ex-NA
Development Cost and NA/Ex-NA License Fees, before
multiplication by the NA Percentage).
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Commission. Asterisks denote omissions.
(c) In performing the reconciliations contemplated by
Sections 8.2.2(a) and 8.2.2(b), costs and expenses
shall be submitted as part of NA Commercialization
Expense, NA Development Cost, NA License Fees,
NA/Ex-NA Commercialization Expense, NA/Ex-NA
Development Cost or NA/Ex-NA License Fees for
inclusion in the reconciliation of Pre-tax Profit or
Loss only to the extent made or incurred in
conjunction with an approved budget line item, as
approved and revised from time to time by the Joint
Development Committee or the relevant Joint
Commercialization Project Team or North America
Commercialization Project Team, as applicable.
(d) Within [**] days following the end of each calendar
quarter, Millennium shall submit to Aventis a written
report setting forth in reasonable detail the
calculation of Pre-tax Profit or Loss and the
calculation of any net amount owed by Millennium to
Aventis or by Aventis to Millennium, as the case may
be, in order to ensure an equal sharing of Pre-tax
Profit of Loss. The net amount payable shall be paid
by Aventis or Millennium, as the case may be, within
[**] days after receipt of such written report,
without regard to any dispute as to the amounts under
this subsection 8.2.2(d); provided, that, in the
event of a dispute, the disputing Party shall provide
written notice within such [**] day period after
receipt of the written report in question, specifying
in detail such dispute. The Parties shall promptly
thereafter meet and negotiate in good faith a
resolution to such dispute. In the event that the
Parties are unable to resolve such dispute within
[**] days after notice by the disputing Party, the
matter shall be resolved in a manner consistent with
the procedures set forth in Article 12 (PROVIDED,
that, in the case that the matter has not been
resolved by the Executive Officers, such matter shall
be referred to an internationally recognized
independent accounting firm acceptable to both
Parties for non-binding resolution, rather than
to non-binding mediation under Section 12.5), and
interest shall be payable on any additional amounts
determined to be due in the same manner as provided
for in Section 8.8.
(e) At least [**] days prior to the end of each calendar
quarter, Millennium shall submit to Aventis
reasonable estimates of the items listed in
subsection 8.2.2(a) and Aventis shall submit to
Millennium reasonable estimates of the items listed
in subsection 8.2.2(b), in order to allow the Parties
to comply with internal reporting requirements.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
8.2.3 USE OF DATA DEVELOPED IN ROW. In the event that the Parties
wish to use for Development or Commercialization in North
America data, information, material or results relating to a
Joint Development Product which was generated and paid for
solely by Aventis, then Millennium would be required to
reimburse Aventis an amount equal to 50% of the arithmetic
average of (i) the NA Percentage and (ii) 100% of the costs
incurred by Aventis in generating such data, such costs to be
determined in a manner consistent with the manner in which NA
Development Cost is determined.
8.2.4 USE OF DATA DEVELOPED FOR NORTH AMERICA. In the event that
Aventis wishes to use for Development or Commercialization in
ROW data, information, material or results relating to a Joint
Development Product which was paid for equally by Aventis and
Millennium (i.e., such costs were part of NA Development
Costs), then Aventis would be required to reimburse Millennium
an amount equal to (a) 0.75 times (b) 100% less the NA
Percentage of (c) the costs incurred by the Parties in
generating such data, information, materials or results, such
costs to be determined in a manner consistent with the manner
in which NA Development Cost is determined.
8.3 ROYALTIES.
8.3.1 JOINT DEVELOPMENT PRODUCTS SOLD OUTSIDE OF NORTH AMERICA.
Aventis shall pay to Millennium royalties on Net Sales outside
of North America for each Joint Development Product as
follows:
<TABLE>
<CAPTION>
Annual Net Sales
LEVEL OUTSIDE OF NORTH AMERICA ROYALTY RATE
<S> <C> <C>
[**] million [**] %
Above [**] million [**] %
Above [**] million [**] %
</TABLE>
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
Royalties on Net Sales of each Joint Development Product in a calendar
year shall be paid at the rate applicable to the portion of Net Sales
within each of the Net Sales levels above during such calendar year.
For example, if Net Sales in a given calendar year outside of North
America for a Joint Development Product are $[**] million, then the
royalty rate for the first $[**] million of such Net Sales would be
[**] %, for such Net Sales in excess of $[**] million up to $[**]
million would be [**] % and for such Net Sales in excess of $[**]
million would be [**] %, for a total royalty payment under this example
of $[**] million. Royalties shall be payable, on a country-by-country
basis, for the longer of (a) the term of any patents Controlled by
Aventis or Millennium with a Valid Claim Covering the composition of
matter or therapeutic use of the Joint Development Product in such
country or (b) [**] years after the First Commercial Sale of such Joint
Development Product in such country. The royalties set forth above
shall be subject to the following reductions: (x) from and after the
expiration, invalidation, surrender or cancellation of the last patent
Controlled by Aventis or Millennium with a Valid Claim Covering the
composition of matter or therapeutic use of a Joint Development Product
in a particular country, the royalty rate for sales of such Joint
Development Product in such country for any remaining term in
accordance with the preceding sentence shall be reduced by [**] %; (y)
Aventis may deduct [**] of payments related to Burdened Technology
Obligations relating to, and royalty payments made to Third Parties to
obtain licenses to, patents Covering the composition of matter or
therapeutic use of a Joint Development Product in a country; and (z) in
countries other than ROW Major Market Countries where Aventis
reasonably demonstrates to Millennium that a lower royalty is required
in order to permit Aventis to Commercialize the Joint Development
Product with a reasonable profit (it being understood and agreed that
such demonstration shall be satisfied if Aventis' gross margin after
royalty obligations with respect to such Joint Development Product is
less than [**] % during any calendar year), the royalty rate for such
calendar year under this subsection with respect to Net Sales of such
Joint Development Product in such country shall be reduced to the
extent necessary to enable Aventis to achieve such reasonable profit;
provided that, notwithstanding the foregoing reductions, in no event
shall the royalties received by Millennium under this subsection be
less than [**] % of Net Sales. Net Sales of Related Joint Development
Products (as defined below) shall be aggregated for purposes of
determining Annual Net Sales Level Outside of North America in the
above table. In the event that the royalty period specified above with
respect to one of such Related Joint Development Products expires, then
Net Sales of such Related Joint Development Product whose royalty
period has expired thereafter shall not be counted into the Annual Net
Sales Level Outside of North America in the above table for purposes of
determining the applicable royalty rate under this subsection. As used
above, a "Related Joint Development Product" means a Joint Development
Product that contains as its sole active ingredient the same Joint
Development Compound as
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Commission. Asterisks denote omissions.
another Joint Development Product, PROVIDED THAT a Joint Development
Product shall not constitute a Related Joint Development Product to
another Joint Development Product if such Joint Development Product (i)
is approved for a different disease state than such other Joint
Development Product, (ii) requires a different package insert from such
other Joint Development Product and (iii) has a different SKU from such
other Joint Development Product.
8.3.2 UNILATERAL DEVELOPMENT COMPOUND PRODUCTS. The Developing Party
shall pay royalties to the other Party on Net Sales of each
UDC Product as follows:
<TABLE>
<CAPTION>
OPT-OUT PHASE
From EDC Status
up to but not including
Annual Worldwide Phase IIIA Phase IIIA
NET SALES LEVEL COMPLETION COMPLETION OR LATER
<S> <C> <C> <C>
[**] million [**] % [**] %
Above [**] million [**] % [**] %
</TABLE>
In the table above, "Opt-Out Phase" means the most advanced development
phase of an EDC Compound when the other Party elected not to
participate further in Development or Commercialization of such
Unilateral Development Compound. Royalties on Net Sales of each UDC
Product in a calendar year shall be paid at the rate applicable to the
portion of Net Sales within each of the Net Sales levels above during
such calendar year. Royalties shall be payable, on a country-by-country
basis, for the longer of (a) the term of any patents Controlled by
Aventis or Millennium with a Valid Claim Covering the composition of
matter or therapeutic use of the UDC Product in such country or (b)
[**] years after the First Commercial Sale of such UDC Product in such
country. The royalties set forth above shall be subject to the
following reductions: (x) from and after the expiration, invalidation,
surrender or cancellation of the last patent Controlled by Aventis or
Millennium with a Valid Claim Covering the composition of matter or
therapeutic use of a UDC Product in a particular country, the royalty
rate for sales of such UDC Product in such country for any remaining
term in accordance with the preceding sentence shall be reduced by
[**]%; (y) the Developing Party may deduct [**] of payments related to
Burdened Technology Obligations relating to, and royalty payments made
to Third Parties to obtain licenses to, patents Covering the
composition of matter or therapeutic use of a UDC Product in a country;
and (z) in countries other than the United States, Canada and the ROW
Major Market Countries where the Developing Party reasonably
demonstrates to the other Party that a lower royalty is required in
order to permit the Developing Party to Commercialize the UDC Product
with a reasonable profit (it being understood and agreed that such
demonstration shall be satisfied if the Developing Party's gross
margin after royalty obligations with respect to such
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Commission. Asterisks denote omissions.
UDC Product is less than [**] % during any calendar year), the royalty
rate for such calendar year under this subsection with respect to Net
Sales of such UDC Product in such country shall be reduced to the
extent necessary to enable the Developing Party to achieve such
reasonable profit; provided that, notwithstanding the foregoing
reductions, in no event shall the royalties received by the other Party
under this subsection be less than [**] % of Net Sales. Net Sales of
Related UDC Products (as defined below) shall be aggregated for
purposes of determining Annual Net Sales Level worldwide in the above
table. In the event that the royalty period specified above with
respect to one of such Related UDC Products expires, then Net Sales of
such Related UDC Product whose royalty period has expired thereafter
shall not be counted into the Annual Net Sales Level worldwide in the
above table for purposes of determining the applicable royalty rate
under this subsection. As used above, a "Related UDC Product" means a
UDC Product that contains as its sole active ingredient the same
compound as another UDC Product, PROVIDED THAT a UDC Product shall not
constitute a Related UDC Product to another UDC Product if such UDC
Product (i) is approved for a different disease state than such other
UDC Product, (ii) requires a different package insert from such other
UDC Product, and (iii) has a different SKU from such other UDC Product.
8.3.3 SINGLE-PARTY TARGET PRODUCTS. The Party that Commercializes a
Single-Party Target Product shall pay a royalty of [**] % of
Net Sales of such Single-Party Target Product to the other
Party. Royalties shall be payable, on a country-by-country
basis, for the longer of (a) the term of any patents
Controlled by Aventis or Millennium with a Valid Claim
Covering the composition of matter or therapeutic use of the
Single-Party Target Product in such country or (b) [**] years
after the First Commercial Sale of such Single-Party Target
Product in such country. The royalty rate set forth in this
subsection 8.3.3, and the royalties payable under this
subsection, shall not be subject to any reductions, deductions
or offsets of any kind.
8.3.4 EX-PROGRAM PRODUCTS. The Party that Commercializes an
Ex-Program Product based upon an SQT Covered by any
intellectual property Controlled by the other Party shall pay
a royalty of [**] % of Net Sales of such Ex-Program Product to
the other Party. Royalties shall be payable, on a
country-by-country basis, for [**] years after the First
Commercial Sale of such Ex-Program Product in such country.
The royalty rate set forth in this subsection 8.3.4, and the
royalties payable under this subsection, shall not be subject
to any reductions, deductions or offsets of any kind.
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Commission. Asterisks denote omissions.
8.3.5 GT OR VACCINE PRODUCTS. If Aventis elects to exercise a GT or
Vaccine Option with respect to a Program Target, Aventis shall
pay Millennium a royalty of [**]% of Net Sales of any
resulting GT or Vaccine Products. Royalties shall be payable,
on a country-by-country basis, for [**] years after the First
Commercial Sale of such GT or Vaccine Product in such country.
The royalty rate set forth in this subsection 8.3.5, and the
royalties payable under this subsection, shall not be subject
to any reductions, deductions or offsets of any kind.
8.3.6 ANTIBODY PRODUCTS OR DIAGNOSTIC PRODUCTS OR SERVICES. If
Millennium elects to exercise an Antibody or Diagnostic Option
with respect to a Program Target, Millennium shall pay Aventis
a royalty of (a) [**] % of Net Sales of any resulting Antibody
Products, and (b) [**] % of any resulting Diagnostic Products
or Services. Royalties shall be payable, on a
country-by-country basis, for 14 years after the First
Commercial Sale of such Antibody Product or Diagnostic Product
or Service in such country. The royalty rate set forth in this
subsection 8.3.6, and the royalties payable under this
subsection, shall not be subject to any reductions, deductions
or offsets of any kind.
8.4 ROYALTY REPORTS; PAYMENTS. Within sixty (60) days after the end of each
calendar quarter in which a Party is the Royalty-Paying Party with
respect to Net Sales subject to any of the provisions of Section 8.3,
such Party shall submit to the other Party a report, on the basis of
each product and country, providing in reasonable detail an accounting
of all Net Sales made during such calendar quarter and the calculation
of the applicable royalty under Section 8.3. Concurrently with such
report, the Royalty-Paying Party submitting the report shall pay to the
other Party all royalties payable by it under Section 8.3 as indicated
in the report.
8.5 AUDITS. Each Party shall keep complete and accurate records of the
underlying revenue and expense data relating to the reports and
payments required by Sections 8.2 and 8.4. Each Party will have the
right once annually at its own expense to have an independent,
certified public accountant, selected by such Party and reasonably
acceptable to the other Party, review any such records of the other
Party in the location(s) where such records are maintained by the other
Party upon reasonable notice and during regular business hours and
under obligations of strict confidence, for the sole purpose of
verifying the basis and accuracy of payments made under Sections 8.2
and 8.4, in each case within the prior twenty-four (24) month period.
If the review of such records reveals that the other Party has failed
to accurately report information pursuant to Section 8.2 or Section
8.4, then the other Party shall promptly pay to the auditing Party any
resulting amounts due under Section 8.2 or Section 8.4, together with
interest calculated in the manner provided in Section 8.8. If any
amounts due under Section 8.2 or
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Section 8.4 as a result of such audit are greater than five percent
(5%) of the amounts actually due for a calendar year under Section 8.2
or Section 8.4, as applicable, the other Party shall pay all of the
costs of such review. If a Party in good faith disputes any conclusion
of the accounting firm under this Section 8.5, including that such
Party owes additional amounts, then such Party shall inform the other
Party by written notice within thirty (30) days of receipt of a copy of
the audit in question, specifying in detail such dispute. The Parties
shall promptly thereafter meet and negotiate in good faith a resolution
to such dispute. In the event that the Parties are unable to resolve
such dispute within sixty (60) days after notice by the disputing
Party, the matter shall be resolved in a manner consistent with the
procedures set forth in Article 12 (provided, that, in the case that
the matter has not been resolved by the Executive Officers, such matter
shall be referred to an internationally recognized independent
accounting firm acceptable to both Parties for rather than non-binding
mediation under Section 12.5), and interest shall be payable on any
additional amounts determined to be due in the same manner as provided
for in Section 8.8.
8.6 TAX MATTERS.
8.6.1 Any income or other taxes which a paying Party is required by
law to pay or withhold on behalf of a receiving Party with
respect to royalties or other payments payable to a receiving
Party under this Agreement shall be deducted from the amount
of such royalties or other payments due, and paid or withheld,
as appropriate, by the paying Party on behalf of the receiving
Party. Any such tax required by law to be paid or withheld
shall be an expense of, and borne solely by, the receiving
Party. The paying Party shall furnish the receiving Party with
reasonable evidence of such payment or amount withheld, in
electronic or written form, as soon as practicable after such
payment is made or such amount is withheld. The Parties will
reasonably cooperate in completing and filing documents
required under the provisions of any applicable tax laws or
under any other applicable law in connection with the making
of any required tax payment or withholding payment, or in
connection with any claim to a refund of or credit for any
such payment.
8.6.2 The Parties shall work together with respect to each Joint
Development Product to determine the appropriate structure for
the sharing of Pre-tax Profit or Loss in Canada, based on the
respective roles of the Parties in the Commercialization
activities, including without limitation distribution and
manufacturing. Such structuring shall conform to the
principles described in Section 8.2.
8.7 CURRENCY EXCHANGE. With respect to Net Sales invoiced or expenses
incurred in U.S. dollars, the Net Sales or expense amounts and the
amounts due to the receiving Party hereunder shall be expressed in U.S.
dollars. With respect to Net Sales invoiced or expenses incurred in a
currency other than U.S. dollars, the Net Sales or expense shall be
expressed in the domestic currency of the entity making
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the sale or incurring the expense, together with the U.S. dollar
equivalent, calculated using the arithmetic average of the spot rates
on the last business day of each month of the calendar quarter in which
the Net Sales were made or the expense was incurred. The "closing
mid-point rates" found in the "dollar spot forward against the dollar"
table published by THE FINANCIAL TIMES or any other publication as
agreed to by the Parties shall be used as the source of spot rates to
calculate the average as defined in the preceding sentence. All
payments shall be made in U.S. dollars. If at any time legal
restrictions in any country in the Territory prevent the prompt
remittance of any payments with respect to sales in that country, the
paying Party shall have the right and option to make such payments by
depositing the amount thereof in local currency to the receiving
Party's account in a bank or depository in such country.
8.8 LATE PAYMENTS. The paying Party shall pay interest to the
receiving Party on the aggregate amount of any payments that
are not paid on or before the date such payments are due under
this Agreement at a rate per annum equal to the lesser of the
prime rate of interest plus one percent (1%), as reported by
THE WALL STREET JOURNAL, or the highest rate permitted by
applicable law, calculated on the number of days such payments
are paid after the date such payments are due.
ARTICLE 9
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
9.1 OWNERSHIP.
9.1.1 INVENTIONS. Inventorship for patentable inventions conceived
or reduced to practice during the course of the performance of
activities pursuant to this Agreement shall be determined in
accordance with U.S. patent laws for determining inventorship.
Subject to the provisions set forth in Section 9.1.2,
ownership shall be initially determined based on inventorship.
In the event of a dispute regarding inventorship, if the
Parties are unable to resolve such inventorship dispute, the
Joint Steering Committee shall establish a procedure to
resolve such dispute, which may include engaging a Third Party
patent attorney jointly selected by the Parties to resolve
such dispute.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
9.1.2 ASSIGNMENT OF OWNERSHIP.
(a) TARGET RELATED INVENTIONS. In the event a Party [**]
in the conduct of the Research Program and [**], then
such Party or Parties, as the case may be, shall [**]
to the Party or Parties, if any, [**] to the Research
Program pursuant to Section 2.7.1(b).
(b) COMPOUND RELATED INVENTIONS. In the event a Party
[**] in the conduct of the Research Program [**] then
the Party or Parties, as the case may be, shall [**]
to the Party or Parties, if any, [**].
9.2 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
9.2.1 The responsibility for (a) preparing, filing and prosecuting
patent applications (including reissue, continuing,
divisional, and substitute applications and any foreign
counterparts thereof); (b) for maintaining any Patent Rights;
and (c) for managing any interference or opposition
proceedings relating to the foregoing ("Patent Prosecution")
Covering an invention conceived or reduced to practice during
the course of the performance of activities pursuant to this
Agreement shall be the responsibility of the Party owning such
invention, PROVIDED, HOWEVER, that with respect to any such
invention that is jointly owned by the Parties, such
responsibility shall be shared by the Parties as determined by
agreement of the Parties on a case-by-case basis. All Patent
Prosecution expenses, including attorneys' fees, incurred by a
Party in the performance of Patent Prosecution shall be borne
by such Party or, in the case of an invention that is jointly
owned, shared by the Parties as agreed.
9.2.2 SECONDARY PROSECUTION RIGHTS. If the prosecuting Party elects
not to continue pursuing Patent Prosecution with respect to
any rights within Patent Rights (and the other Party has
rights under such Patent Right), then the prosecuting Party
shall, subject to any contractual obligations to Third
Parties, notify the other Party in writing of such election at
least thirty (30) days prior to the last available date for
action to preserve such Patent Rights. If such other Party
elects to continue Patent Prosecution, such other Party may do
so at its sole expense.
9.3 COOPERATION. Each Party hereby agrees
9.3.1 to make its employees, agents and consultants reasonably
available to the other Party (or to the other Party's
authorized attorneys, agents or representatives), to the
extent reasonably necessary to enable the prosecuting Party to
undertake Patent Prosecution,
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Commission. Asterisks denote omissions.
9.3.2 to provide the other Party with copies of all material
correspondence pertaining to Patent Prosecution with the U.S.
Patent and Trademark Office or its foreign counterparts;
9.3.3 to cooperate, if necessary and appropriate, with the other
Party in gaining patent term extensions wherever applicable to
Patent Rights; and
9.3.4 to endeavor in good faith to coordinate its efforts with the
other Party to minimize or avoid interference with the Patent
Prosecution of the other Party's patent applications.
9.4 EXPLOITATION OF JOINT INVENTIONS. Subject to any provision of this
Agreement to the contrary, each of the Parties shall be free to exploit
any invention conceived or reduced to practice during the course of the
performance of activities pursuant to this Agreement and that is
jointly owned by the Parties without payment of any additional
compensation to the other Party; PROVIDED, HOWEVER, that either Party
may only sell, license or otherwise transfer its rights in any such
invention without the consent of the other Party in a manner that is
consistent with the licenses granted pursuant to this Agreement and is
otherwise consistent with this Agreement.
9.5 THIRD PARTY INFRINGEMENT.
9.5.1 NOTICE. Each Party shall promptly provide, but in on event
later than [**], the other with written notice reasonably
detailing any known or alleged infringement of the other
Party's Program Patent Rights by a Third Party.
9.5.2 JOINT DEVELOPMENT PRODUCTS.
(a) In North America each Party shall have the sole
right, but not the obligation, to institute and
direct legal proceedings against any Third Party
believed to be infringing the Patent Rights of such
Party ("Owing Party"), that Covers an invention that
relates to a Joint Development Product; PROVIDED,
HOWEVER, that the Parties shall mutually agree on a
course of action for instituting and directing legal
proceedings against any Third Party believed to be
infringing any such Patent Rights that are jointly
owned by the Parties. If the Owning Party, within
[**] of a notice of infringement pursuant to Section
9.5.1, has not taken action with respect to a Third
Party, the other Party may request consent from the
Owning Party to institute and direct legal
proceedings against such Third Party, including in
the name of the Owning Party, which consent shall not
be unreasonably withheld. The Owning Party shall
respond to such request within [**] of receipt of
such
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
request in writing. All costs, including attorneys'
fees, relating to such legal proceedings shall be
borne by the Party that owns such Patent Rights or,
in the case of Patent Rights that are jointly owned,
shared by the Parties as agreed by the Parties. If
the Parties share the expense, the recoveries shall
be divided between the Parties in proportion with
their contribution to the expenses. If only one Party
is bearing the expense, then the Party not bearing
any of the expense shall receive [**] of the all
recoveries directed to compensatory damages and [**]
of all recoveries directed to punitive or other
damages in excess of such Party's costs, including
attorney's fees.
(b) Outside North America, Aventis shall have the sole
right, but not the obligation, to institute legal
proceedings against any Third Party believed to be
infringing the Patent Rights of either Party that
Cover an invention that relates to a Joint
Development Product. All costs, including attorneys'
fees, relating to such legal proceedings shall be
borne by Aventis. All recoveries resulting from such
legal proceedings that are in excess of Aventis'
cost, including attorney's fees, shall be deemed to
be Ex-NA Net Sales of such Joint Development Product.
9.5.3 OTHER PROGRAM PATENT RIGHTS. Each Party shall have the sole
right, but not the obligation, to institute and direct legal
proceedings against any Third Party believed to be infringing
the Program Patent Rights of such Party that do not Cover an
invention that relates to a Joint Development Product,
PROVIDED, HOWEVER, that the Parties shall mutually agree on a
course of action for instituting and directing legal
proceedings against any Third Party believed to be infringing
any such Program Patent Rights that are jointly owned by the
Parties. All costs, including attorneys' fees, or recoveries
relating to such legal proceedings shall be borne by the Party
that owns such Program Patent Rights or, in the case of
Program Patent Rights that are jointly owned, shall be shared
by the Parties as agreed. All recoveries resulting from such
legal proceeding in excess of the Party's or Parties' costs,
including attorneys' fees, shall be deemed to be Net Sales of
the applicable Royalty-Bearing Product.
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Commission. Asterisks denote omissions.
9.5.4 FAILURE TO INSTITUTE PROCEEDINGS. With respect to Program
Patent Rights which are solely owned by a Party ("Non-Selling
Party") Covering a UDC Product, a Single-Party Target Product,
GT Product, a Vaccine Product, an Antibody Product or a
Diagnostic Product or Service sold or provided by the other
Party ("Selling Party"), if the Non-Selling Party, within [**]
of a notice of infringement from the Selling Party pursuant to
Section 9.5.1, has not taken action pursuant to Sections 9.5.2
or 9.5.3 with respect to a Third Party that is selling a
product or providing a service in competition with such
Selling Party's product or service, such Selling Party may
request consent from the Non-Selling Party to institute such
legal proceedings, including in the name of the Non-Selling
Party, which consent shall not be unreasonably withheld. The
Non-Selling Party shall respond to such request within [**] of
receipt of such request in writing. All costs, including
attorneys' fees, relating to such legal proceedings shall be
borne by the Selling Party. Any recoveries in excess of costs
incurred by the Selling Party in pursuing any such legal
proceedings ("Excess Recovery") shall belong to the Selling
Party; PROVIDED, HOWEVER, that the Selling Party shall pay to
the Non-Selling Party the amount of any royalty that would be
due to the Non-Selling Party if such Excess Recovery had been
Net Sales made by the Selling Party of such Selling Party's
product.
9.5.5 COOPERATION IN PATENT INFRINGEMENT PROCEEDINGS. In the event
that either Aventis or Millennium takes action pursuant to
this Section 9.5, the other Party shall cooperate to the
extent reasonably necessary and at the first Parties' sole
expense. Upon the reasonable request of the first Party, such
other Party shall join the suit and shall be represented in
any such legal proceedings using counsel of its own choice.
Neither Party shall settle any claim or proceeding relating to
Program Patent Rights owned in whole or in part by the other
Party without the prior written consent of such other Party,
which consent shall not be unreasonably withheld.
9.6 OTHER INTELLECTUAL PROPERTY INFRINGEMENT.
9.6.1 NOTICE.
(a) Each Party shall notify the other in writing of any
allegations it receives from a Third Party that
Program Technology, Program Materials or any
Royalty-Bearing Product infringes the intellectual
property rights of such Third Party. Such notice
shall be provided promptly, but in no event after
more than [**], following receipt of such allegations
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
(b) In the event that a Party receives notice that it or
any of its Affiliates have been individually named as
a defendant in a legal proceeding by a Third Party
alleging infringement of a Third Party patent or
other intellectual property right as a result of the
manufacture, production, use, development, sale or
distribution of Program Technology, Program Materials
or Royalty-Bearing Product, such Party shall
immediately notify the other Party in writing and in
no event notify them later than [**] after the
receipt of such notice. Such written notice shall
include a copy of any summons or complaint (or the
equivalent thereof) received regarding the foregoing.
(c) Each Party shall provide to the other Party copies of
any allegations of alleged patent invalidity or
non-infringement of a patent or patents with respect
to Program Technology, Program Materials or
Royalty-Bearing Product pursuant to a Paragraph IV
Patent Certification by a Party filing an Abbreviated
New Drug Application. Such copies shall be provided
promptly, but in any event within [**], of receipt of
such certification.
(d) Each Party shall provide to the other Party copies of
any notices it receives from Third Parties regarding
any patent nullity actions, any declaratory judgment
actions, any alleged infringement of Program Patent
Rights or any alleged misappropriation of
intellectual property with respect to Program
Technology, Program Materials or Royalty-Bearing
Product. Such notices shall be provided promptly, but
in no event after more than [**], following receipt
thereof.
9.6.2 In all cases where a claim is made by a Third Party and for
which notice was given in accordance with Section 9.6.1(c),
the Parties shall cooperate and the Party owning the NDA for
the Joint Development Product at issue shall determine the
appropriate course of action in consultation with the Party
not owning the NDA for such Joint Development Product. In all
cases where a claim is made by a Third Party and for which
notice was given in accordance with Section 9.6.1(a), (b) or
(d), the Parties shall cooperate and mutually determine a
course of action. In both of the foregoing, the Parties shall
share the expenses equally. If such claim is against only one
Party with respect to a Unilateral Development Compound, a UDC
Product, a Single-Party Target Product, a GT Product, a
Vaccine Product, an Antibody Product, a Diagnostic Product or
Service or an Ex-Program Product such Party shall have sole
discretion in determining and executing an appropriate course
of action at its sole expense.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
9.7 MARKS FOR JD PRODUCTS.
9.7.1 [**] shall also [**] shall [**] under this Section 9.7 [**].
9.7.2 Aventis shall grant to Millennium a license to such Marks
solely for the purposes of performing its obligations and
exercising its rights relating to the Development and
Commercialization of a JD Product in North America. Such
license shall be exclusive with respect to use of the Marks in
a country in North America in connection with the distribution
of JD Products in such country that Millennium has the right
to distribute.
9.7.3 Except as expressly stated in this Agreement, Millennium shall
not have any right, title, interest or other license in or to
any of the Marks, and all uses of such Marks shall inure
solely to the benefit of Aventis.
9.7.4 Each Party agrees not to contest the validity of, by act or
omission jeopardize, or take any action inconsistent with, the
other Party's rights or goodwill in any of its Marks in any
country, including, without limitation, attempted registration
of any such Mark, or use or attempted registration of any
confusingly similar names, trademarks or logos.
9.7.5 In the event that either Party becomes aware of any
infringement of a Mark in North America by a Third Party, it
shall promptly notify the other and the Parties shall consult
with each other and jointly determine the best way to prevent
such infringement, including without limitation by the
institution of legal proceedings against such Third Party. To
the extent that the Parties agree that Millennium shall be
responsible for instituting legal proceedings against a Third
Party and Millennium does not have the right under applicable
law to bring such legal proceedings in its own name, then
Aventis shall provide Millennium with such authorizations to
institute legal proceedings in Aventis' name. All costs,
including attorneys' fees, relating to such legal proceedings
shall be borne by the Party that institutes such proceedings
or shall be shared by the Parties as agreed and shall be
included in NA Marketing Expense. All recoveries resulting
from such legal proceedings shall be deemed to be Net Sales of
the Joint Development Product with which the infringed Mark is
used.
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ARTICLE 10
CONFIDENTIALITY
10.1 CONFIDENTIAL INFORMATION. All Confidential Information disclosed by a
Party to the other Party during the term of this Agreement shall not be
used by the receiving Party except in connection with the activities
contemplated by this Agreement, shall be maintained in confidence by
the receiving Party and shall not otherwise be disclosed by the
receiving Party to any other person, firm, or agency, governmental or
private (other than a Party's Affiliates), without the prior written
consent of the disclosing Party, except to the extent that the
Confidential Information (as determined by competent documentation):
10.1.1 was known or used by the receiving Party or its Affiliates
prior to its date of disclosure to the receiving Party; or
10.1.2 either before or after the date of the disclosure to the
receiving Party is lawfully disclosed to the receiving Party
or its Affiliates by sources other than the disclosing Party
rightfully in possession of the Confidential Information; or
10.1.3 either before or after the date of the disclosure to the
receiving Party or its Affiliates becomes published or
generally known to the public (including information known to
the public through the sale of products in the ordinary course
of business) through no fault or omission on the part of the
receiving Party, its Affiliates or its sublicensees; or
10.1.4 is independently developed by or for the receiving Party or
its Affiliates without reference to or reliance upon the
Confidential Information.
In addition, the provisions of this Section 10.1 shall not
preclude the receiving Party or its Affiliates from disclosing
Confidential Information to the extent such Confidential
Information is required to be disclosed by the receiving Party
or its Affiliates to comply with applicable laws, to defend or
prosecute litigation or to comply with governmental
regulations, provided that the receiving Party provides prior
written notice of such disclosure to the disclosing Party and
takes reasonable and lawful actions to avoid and/or minimize
the degree of such disclosure. Specific information shall not
be deemed to be within any of the foregoing exclusions merely
because it is embraced by more general information falling
within these exclusions.
10.2 EMPLOYEE AND ADVISOR OBLIGATIONS. Millennium and Aventis each agree
that they shall provide Confidential Information received from the
other Party only to their respective employees, consultants and
advisors, and to the employees, consultants and advisors of such
Party's Affiliates, who have a need to know and have an obligation to
treat such information and materials as confidential.
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10.3 TERM. All obligations of confidentiality imposed under this Article 10
shall expire five (5) years following termination or expiration of this
Agreement.
10.4 PUBLICATIONS. Neither Party nor its Affiliates shall publish or present
the results of the Research Program or clinical studies on any Joint
Development Compound or Joint Development Product until after
completion of a Phase I Study with respect thereto. Subject to the
foregoing and the restrictions provided below, either Party may publish
or present the results of the Research Program or of Development
carried out on such Joint Development Compound or Joint Development
Product, subject to the prior review by the other Party for
patentability and protection of such other Party's Confidential
Information. Each Party shall provide to the other Party the
opportunity to review any proposed abstracts, manuscripts or summaries
of presentations which cover the results of the Research Program or of
the Development of such Joint Development Compound or Joint Development
Product. Each Party shall designate a person who shall be responsible
for approving such publications. Such designated person shall respond
in writing promptly and in no event later than sixty (60) days after
receipt of the proposed material with either approval of the proposed
material or a specific statement of concern, based upon either the need
to seek patent protection or concern regarding competitive disadvantage
arising from the proposal. In the event of concern, the submitting
Party agrees not to submit such publication or to make such
presentation that contains such information until the other Party is
given a reasonable period of time (not to exceed ninety (90) days) to
seek patent protection for any material in such publication or
presentation which it believes is patentable or to resolve any other
issues. With respect to any proposed abstracts, manuscripts or
summaries of presentations by investigators or other Third Parties,
such materials shall be subject to review under this Section 10.4 to
the extent that Aventis or Millennium (as the case may be) has the
right to do so.
ARTICLE 11
TERM AND TERMINATION
11.1 TERM; EXTENSION. This Agreement becomes effective as of the Effective
Date and may be terminated as set forth in this Article 11. The Parties
acknowledge that they may find it to be mutually beneficial to continue
the Research Program after the end of the Research Program Term.
Consequently, the Parties hereby agree to negotiate in good faith,
prior to six (6) months before the end of the Research Program Term,
whether or not to extend the Research Program Term on terms and
conditions that are mutually acceptable to the Parties. Should the
Parties choose to extend the Research Program, they may choose to limit
such extension to ongoing collaboration with respect to particular
targets, compounds or products, or otherwise.
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11.2 TERMINATION FOR MATERIAL BREACH.
11.2.1 TERMINATION RIGHTS. Upon a material breach of this Agreement
by Aventis or Millennium (in such capacity, the "Breaching
Party"), the other Party (in such capacity, the "Non-Breaching
Party") may provide written notice (a "Breach Notice") to the
Breaching Party specifying the material breach. If (i) the
Breaching Party fails to cure such material breach during the
sixty (60) day period (or, if such material breach, by its
nature, is a curable breach that is not curable within the
sixty (60) day period, such longer period as would be
reasonably necessary for a diligent party to cure such
material breach) following the date on which the Breach Notice
is provided, or (ii) such material breach, by its nature, is
incurable, then the Agreement shall terminate. The Parties
shall use reasonable efforts to work together to cure any
breach.
11.2.2 MATERIAL BREACH RELATING TO THE RESEARCH PROGRAM.
Notwithstanding the provisions of Section 11.2.1, if the
material breach relates to the Breaching Party's obligations
under the Research Program, then only the Research Program
shall terminate.
11.2.3 MATERIAL BREACH RELATING TO EXCLUSIVITY PROVISIONS.
Notwithstanding the provisions of Section 11.2.1, if the
material breach relates to the Breaching Party's obligations
under Section 2.8, the other Party may terminate any of the
covenants set forth in Sections 2.8.1 and 2.8.2 as it applies
to such Party, as one of its remedies and not to the exclusion
of any other remedy such Party may have.
11.2.4 MATERIAL BREACH RELATING TO THE DEVELOPMENT OR
COMMERCIALIZATION OF CERTAIN ROYALTY-BEARING PRODUCTS.
Notwithstanding the provisions of Section 11.2.1, if the
material breach relates to the Breaching Party's obligations
relating to the Development or Commercialization of a
Royalty-Bearing Product (other than a Joint Development
Product), then the licenses granted to the Breaching Party
under this Agreement with respect to the Development and
Commercialization of such Royalty-Bearing Product shall
terminate and this Agreement shall not otherwise terminate;
provided that if this Agreement would terminate but for the
immediately preceding clause, then the Breaching Party hereby
grants to the Non-Breaching Party a worldwide, exclusive (even
as to the Breaching Party), non-royalty bearing, perpetual
license to the sole or undivided one half (as applicable)
right, title and interest in the Patent Rights of the
Breaching Party directly relating to such Royalty Bearing
Product and previously assigned by the Non-Breaching Party to
the Breaching Party pursuant to Section 9.1.2.
11.2.5 MATERIAL BREACH RELATING TO THE DEVELOPMENT OR
COMMERCIALIZATION OF A JOINT DEVELOPMENT COMPOUND OR A JOINT
DEVELOPMENT PRODUCT. Notwithstanding the provisions of Section
11.2.1, if the material breach
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relates to the Breaching Party's obligations relating to the
Development and/or Commercialization of a Joint Development
Compound and/or a Joint Development Product, including without
limitation a material breach in the exercise of commercially
reasonable efforts to undertake Development and/or
Commercialization of such Joint Development Compound and/or
Joint Development Product, then this Agreement shall not
terminate in its entirety, but the licenses granted to the
Breaching Party under this Agreement with respect to the
Development and Commercialization of such Joint Development
Compound and/or Joint Development Product shall terminate;
PROVIDED, HOWEVER, that if such material breach relates solely
to the Breaching Party's obligations relating to the
Development and/or Commercialization of a Joint Development
Compound and/or a Joint Development Product in ROW, including
without limitation a material breach in the exercise of
commercially reasonable efforts to undertake such Development
and/or Commercialization, then only the licenses granted to
the Breaching Party under this Agreement with respect to
(i) the Development of such Joint Development Compound and/or
Joint Development Product for Commercialization in ROW and
(ii) Commercialization of such Joint Development Product in
ROW, shall terminate. Notwithstanding the foregoing, the
licenses to the Breaching Party shall terminate pursuant
to this subsection only if the Non-Breaching Party agrees
to use commercially reasonable efforts to continue the
worldwide (or, in the case of a material breach that relates
solely to the Breaching Party's obligations relating to the
Development and/or Commercialization of a Joint Development
Compound and/or a Joint Development Product in ROW, ROW-wide)
Development and Commercialization of the Joint Development
Compound and/or Joint Development Product as a Unilateral
Development Compound and/or Unilateral Development Product,
as the case may be, under this Agreement, in which case such
Joint Development Compound and/or Joint Development Product
shall for all purposes under this Agreement, including
(subject to the immediately following sentence) the payment
of royalties, be deemed a Unilateral Development Compound
and/or Unilateral Development Product, as the case may be
and the Non-Breaching Party shall for purposes of Section 3.7
be deemed the Developing Party. If the Non-Breaching Party
continues the ROW-wide Development and Commercialization of a
Joint Development Compound and/or Joint Development Product
as a Unilateral Development Compound and/or Unilateral
Development Product, as the case may be, pursuant to this
subsection, then the Non-Breaching Party shall be required to
pay royalties with respect to Net Sales of such Unilateral
Development Product in ROW at the same rate that Aventis
would be required to pay royalties on such Net Sales under
Section 8.3.1 if Aventis were the Commercializing Party and
such Unilateral Development Product were a Joint Development
Product.
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
11.2.6 MATERIAL BREACH OF INVESTMENT AGREEMENT. If Aventis commits a
material breach of its obligations to purchase common stock of
Millennium under the Investment Agreement and does not cure
such breach within [**] after written notice thereof by
Millennium, then Millennium may terminate the licenses granted
under this Agreement to Aventis and upon any termination under
this Section 11.2.6, the Breaching Party hereby grants to the
Non-Breaching Party a worldwide, exclusive (even as to the
Breaching Party), non-royalty-bearing, perpetual license under
the sole or undivided one-half (as applicable) right, title
and interest of the Non-Breaching Party in all intellectual
property rights assigned to the Breaching Party pursuant to
Section 9.1.2, for all purposes.
11.3 TERMINATION UPON HSR DENIAL. The Agreement shall immediately terminate
in the event that either (a) the FTC and/or the DOJ shall seek a
preliminary injunction under the HSR Act against Millennium and Aventis
to enjoin the transactions contemplated by this Agreement, the
Technology Development Agreement, the Technology Transfer Agreement
and/or the Investment Agreement, or (b) the HSR Clearance Date shall
not have occurred on or prior to December 31, 2000. Notwithstanding
the foregoing, this Section 11.3 shall not apply in the event the
Parties mutually agree that an HSR Filing is not required.
11.4 DISPUTE RESOLUTION. Termination under this Article for whatever reason
will be automatically stayed for the duration of any dispute resolution
proceedings initiated under Article 12.
11.5 RESIDUAL RIGHTS. Upon termination of this Agreement, except as
specifically provided herein to the contrary, all rights and
obligations of the Parties under this Agreement shall cease, except as
follows:
11.5.1 Obligations to pay amounts accruing hereunder up to the date
of termination;
11.5.2 The obligations regarding confidentiality as set forth in
Article 10;
11.5.3 All obligations for record keeping and accounting reports;
11.5.4 The Parties' right to inspect books and records of each other
as set forth in Section 8.5;
11.5.5 The Parties' rights with respect to the ownership of
intellectual property as set forth in Article 9; and
11.5.6 Obligations of defense and indemnity, which obligations shall
continue in full force and effect for an unlimited period.
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ARTICLE 12
DISPUTE RESOLUTION
12.1 JOINT STEERING COMMITTEE.
12.1.1 As soon as practicable after the Execution Date, Aventis and
Millennium shall establish a Joint Steering Committee
comprised of three (3) senior executives of Aventis and three
(3) senior executives of Millennium.
12.1.2 The Joint Steering Committee shall meet at least four times
annually to (a) review the efforts of the Parties in the
conduct of the Research Program and Development and
Commercialization activities, and (b) attempt to resolve any
disputes relating to this Agreement that may arise between the
Parties that are referred to the Joint Steering Committee by
the Joint Research Committee, Joint Development Committee or
Joint Commercialization Committee or either of the Parties.
12.1.3 The location of such meetings of the Joint Steering Committee
shall be as agreed by the Parties. The Joint Steering
Committee may also meet by means of a telephone conference
call or by videoconference.
12.1.4 Each Party may change any one or more of its representatives
to the Joint Steering Committee at any time upon written
notice to the other Party.
12.1.5 Each Party shall use commercially reasonable efforts to cause
its representatives to attend the meetings of the Joint
Steering Committee. If a representative of a Party is unable
to attend a meeting, such Party may designate an alternative
to attend such meeting in place of the absent representative,
and such alternate shall have full voting power at such
meeting.
12.1.6 In addition, each Party may, at its discretion, invite
non-voting employees, and, with the consent of the other
Party, consultants or scientific advisors, to attend meetings
of the Joint Steering Committee.
12.1.7 Decisions of the Joint Steering Committee shall be made by
unanimous consent of Aventis and Millennium, with each Party
having one vote. Either Party may convene a special meeting of
the Joint Steering Committee for the purpose of resolving
disputes.
12.2 REFERRAL OF UNRESOLVED MATTERS TO JOINT STEERING COMMITTEE. If the
Joint Research Committee, Joint Development Committee or a Joint
Commercialization Committee is unable to reach a decision on any matter
within the scope of its responsibilities within thirty (30) days after
such matter is first considered by it, either Party may refer such
unresolved matter to the Joint Steering Committee for consideration and
resolution. Unresolved matters pertaining to intellectual property
matters shall be governed by Article 9. In such
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event, a meeting of the Joint Steering Committee shall be convened as
soon as practicable in order to consider and resolve the unresolved
matter. Any determination by the Joint Steering Committee shall be
final and binding upon the Parties.
12.3 REFERRAL OF UNRESOLVED MATTERS TO EXECUTIVE OFFICERS. If the Joint
Steering Committee is unable to resolve any matter referred to it under
Section 12.2 within thirty (30) days after the matter is referred to
it, the matter shall be referred to the Executive Officers to be
resolved by negotiation in good faith as soon as is practicable but in
no event later than thirty (30) days after referral. Such resolution,
if any, of a referred issue by the Executive Officers shall be final
and binding on the Parties.
12.4 INDEPENDENT EXPERTS. Each Executive Officer shall have the right to
engage the services of any number of independent experts in the field
in question (the individual(s) so engaged by each Executive Officer to
be engaged under obligations of confidentiality) to assist the
Executive Officer in making a determination on the unresolved matter,
and each Executive Officer shall be obligated to consider in good faith
the analyses and opinions of any such independent experts engaged by
either of them in making a determination.
12.5 NON-BINDING MEDIATION. Subject to Sections 6.5.2 and 6.5.3(a), if the
matter has not been resolved by the Executive Officers within thirty
(30) days of referral in accordance with Section 12.3, or if the
Executive Officers fail to meet within such thirty (30) days, either
Party may initiate a non-binding mediation procedure. The non-binding
mediation shall be administered by the American Arbitration Association
in accordance with its commercial mediation rules. Unless otherwise
mutually agreed upon by the Parties, the mediation proceedings shall be
conducted at the location chosen by the Party not originally requesting
the resolution of the dispute. The Parties agree that they shall share
equally the cost of the mediation, including filing and hearing fees,
and the cost of the mediator(s). Each Party shall have the right, at
its own expense, to be represented by counsel in such a proceeding. If
any unresolved matter is not resolved following non-binding mediation
pursuant to this Section 12.5, either Party may seek any remedy, at law
or in equity, that may be available.
ARTICLE 13
REPRESENTATIONS, WARRANTIES AND COVENANTS
13.1 REPRESENTATION OF AUTHORITY; CONSENTS. Millennium and Aventis each
represent and warrant to the other Party that as of the Execution Date
it has full right, power and authority to enter into this Agreement,
this Agreement has been duly executed by such Party and constitutes a
legal, valid and binding obligation of such Party, enforceable in
accordance with its terms, and all necessary consents, approvals and
authorizations of all government authorities and other persons required
to be obtained by such Party in connection with the execution,
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delivery and performance of this Agreement have been and shall be
obtained except with respect to FTC clearance pursuant to the HSR Act.
13.2 NO CONFLICT. Each Party represents to the other Party that
notwithstanding anything to the contrary in this Agreement, the
execution and delivery of this Agreement and the performance of such
Party's obligations hereunder (a) do not conflict with or violate such
Party's corporate charter and bylaws or any requirement of applicable
laws of regulations and (b) do not and shall not conflict with, violate
or breach or constitute a default or require any consent under, any
contractual obligation of such Party.
13.3 KNOWLEDGE OF PENDING OR THREATENED LITIGATION. Each Party represents
and warrants to the other Party that there is no claim, investigation,
suit, action or proceeding pending or, to the knowledge of such Party,
expressly threatened, against such Party before or by any governmental
entity or arbitrator that, individually or in the aggregate, could
reasonably be expected to (i) materially impair the ability of such
Party to perform any obligation under this Agreement or (ii) prevent or
materially delay or alter the consummation of any or all of the
transactions contemplated hereby.
13.4 EMPLOYEE AND CONSULTANT OBLIGATIONS.
13.4.1 Each Party represents and warrants that all of its employees,
officers, and consultants that are supporting the performance
of its obligations under this Agreement shall have executed
agreements or have existing obligations under law requiring,
in the case of employees and officers, assignment to such
Party of all inventions made during the course of and as the
result of their association with such Party and, in the case
of employees, officers and consultants, obligating the
individual to maintain as confidential such Party's
Confidential Information as well as confidential information
of a Third Party which such Party may receive, to the extent
required to support such Party's obligations under this
Agreement.
13.4.2 Each Party represents and warrants that it is not in breach of
any agreement with any Third Party which would affect its
obligations under this Agreement and that it is not in default
under any of its existing licenses with any Third Party
reasonably necessary for it to fulfill its duties and
obligations under this Agreement. Each Party further
represents and warrants that it shall use commercially
reasonable efforts to maintain such Third Party licenses in
effect during the Agreement Term and if it has been accused of
a material breach under any such Third Party agreements or
licenses, it shall within ten (10) days of such accusation
notify the other Party of such accusation.
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13.5 BURDENED TECHNOLOGY OBLIGATIONS. Set forth on Exhibit C is a list,
which is true, complete and correct in all material respects, of each
agreement between a Third Party and Aventis pursuant to which any
Burdened Technology Obligations exist as of the Execution Date. Set
forth on Exhibit D is a list, which is true, complete and correct in
all material respects, of each agreement between a Third Party and
Millennium pursuant to which any Burdened Technology Obligations exist
as of the Execution Date.
13.6 INTELLECTUAL PROPERTY. Each Party represents and warrants to the other
that as of the Execution Date:
13.6.1 it is not aware of any claim made against it asserting the
invalidity, misuse, unregisterability, unenforceability or
non-infringement of any of its intellectual property which is
the subject of this Agreement (the "Intellectual Property") or
challenging its right to use or ownership of any of the
Intellectual Property or making any adverse claim of ownership
thereof; and
13.6.2 it is not aware of any pending or threatened claim or
litigation which alleges that its activities to date relating
to the Intellectual Property have violated, or by conducting
its business as currently proposed to be conducted hereunder
would violate, the intellectual property rights of any other
person.
13.7 DISCLAIMER OF WARRANTY. Nothing in this Agreement shall be construed as
a representation made or warranty given by either Party that any
patents will issue based on pending applications or that any such
pending applications or patents issued thereon will be valid. EXCEPT AS
EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS,
WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 14
MISCELLANEOUS PROVISIONS
14.1 INDEMNIFICATION.
14.1.1 AVENTIS. Aventis agrees to defend Millennium and its
Affiliates at Aventis' cost and expense, and will indemnify
and hold Millennium and its Affiliates and their respective
directors, officers, employees and agents (the "Millennium
Indemnified Parties") harmless from and against any losses,
costs, damages, fees or expenses arising out of any Third
Party claim relating to (i) any breach by Aventis of any of
its representations, warranties or obligations pursuant to
this Agreement, (ii) the gross negligence or willful
misconduct of Aventis, or (iii) injuries resulting from
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the development, manufacture, use, sale or other disposition
of any Joint Development Product outside of North America
(provided, however, the foregoing shall not apply with respect
to any injuries arising out of NA/Ex-NA Development), or of
any Single-Party Target Product, Unilateral Development
Product, Ex-Program Product, GT Product, Vaccine Product or
any other product or service offered by Aventis, its
Affiliates and/or its licensees or collaborators outside of
the Research Program or Development and Commercialization
activities. In the event of any such claim against the
Millennium Indemnified Parties by any Third Party, Millennium
shall promptly notify Aventis in writing of the claim and
Aventis shall manage and control, at its sole expense, the
defense of the claim and its settlement. The Millennium
Indemnified Parties shall cooperate with Aventis and may, at
their option and expense, be represented in any such action or
proceeding. Aventis shall not be liable for any litigation
costs or expenses incurred by the Millennium Indemnified
Parties without Aventis' prior written authorization. In
addition, Aventis shall not be responsible for the
indemnification or defense of any Millennium Indemnified Party
arising from any negligent or intentional acts by any
Millennium Indemnified Party or the breach by Millennium of
any obligation or warranty under this Agreement, or any claims
compromised or settled without its prior written consent.
14.1.2 MILLENNIUM. Millennium agrees to defend Aventis and its
Affiliates at Millennium's cost, and will indemnify and hold
Aventis and its Affiliates and their respective directors,
officers, employees and agents (the "Aventis Indemnified
Parties") harmless from and against any losses, costs,
damages, fees or expenses arising out of any Third Party claim
relating to (i) any breach by Millennium of any of its
representations, warranties or obligations pursuant to this
Agreement or (ii) the gross negligence or willful misconduct
of Millennium, or (iii) injuries resulting from the
development, manufacture, use, sale or other disposition of
any Single-Party Target Product, Unilateral Development
Product, Ex-Program Product, Antibody Product, Diagnostic
Product or Service or any other product or service offered by
Millennium and/or its licensees or collaborators outside of
the Research Program or Development and Commercialization
activities. In the event of any claim against the Aventis
Indemnified Parties by any Third Party, Aventis, shall
promptly notify Millennium in writing of the claim and
Millennium shall manage and control, at its sole expense, the
defense of the claim and its settlement. The Aventis
Indemnified Parties shall cooperate with Millennium and may,
at their option and expense, be represented in any such action
or proceeding. Millennium shall not be liable for any
litigation costs or expenses incurred by the Aventis
Indemnified Parties without Millennium's prior written
authorization. In addition, Millennium shall not be
responsible for the indemnification or defense of any Aventis
Indemnified Party arising from any negligent or intentional
acts by any Aventis Indemnified Party, or the breach by
Aventis of any obligation or
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warranty under this Agreement, or any claims compromised or
settled without its prior written consent.
14.1.3 INSURANCE PROCEEDS. Any indemnification hereunder shall be
made net of any insurance proceeds recovered by the
Indemnified Party; provided, however, that if, following the
payment to the Indemnified Party of any amount under this
Article 14, such Indemnified Party recovers any insurance
proceeds in respect of the claim for which such
indemnification payment was made, the Indemnified Party shall
promptly pay an amount equal to the amount of such proceeds
(but not exceeding the amount of such indemnification payment)
to the Indemnifying Party.
14.2 INSURANCE. Each Party shall use all commercially reasonable efforts to
maintain insurance, including product liability insurance, with respect
to its activities hereunder.
14.2.1 Such insurance shall be in such amounts and subject to such
deductibles as the Parties may agree based upon standards
prevailing in the industry at the time.
14.2.2 Either Party may satisfy its obligations under this Section
through self-insurance to the same extent.
14.2.3 At such time as a product is being manufactured by a Party for
commercial sale, that Party shall name the other Party as an
additional insured on any such policies.
14.3 GOVERNING LAW. This Agreement shall be construed and the respective
rights of the Parties determined according to the substantive laws of
the State of Delaware notwithstanding the provisions governing conflict
of laws under such Delaware law to the contrary, except matters of
intellectual property law which shall be determined in accordance with
the intellectual property laws relevant to the intellectual property in
question.
14.4 ASSIGNMENT. Neither Millennium nor Aventis may assign this Agreement in
whole or in part without the consent of the other, except (subject to
Section 14.6) if such assignment occurs in connection with the sale or
transfer (by merger or otherwise) of all or substantially all of the
business and assets of Millennium or Aventis to which the subject
matter of this Agreement pertains, provided that the acquirer confirms
to the other Party in writing its agreement to be bound by all of the
terms and conditions of this Agreement. Each Party agrees that,
notwithstanding any provisions of this Agreement to the contrary, in
the event that this Agreement is assigned by Millennium in connection
with the sale or transfer of all or substantially all of the business
and assets of the Millennium to which the subject matter of this
Agreement pertains (including in the context of a Change of Control),
such assignment shall not provide the non-assigning Party with rights
or access to intellectual property or technology of the acquirer of the
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Confidential Materials omitted and filed with the Securities and Exchange
Commission. Asterisks denote omissions.
Assigning Party. Notwithstanding the foregoing, either Party may assign
this Agreement to an Affiliate, provided that such Party shall
guarantee the performance of such Affiliate, and provided further that
either Party may assign its rights (but not its obligations) pursuant
to this Agreement in whole or in part to an Affiliate of such Party
that is controlled by such Party.
14.5 AMENDMENTS. This Agreement and the Exhibits and Schedules referred to
in this Agreement constitute the entire agreement between the Parties
with respect to the subject matter hereof, and supersede all previous
arrangements with respect to the subject matter hereof, whether written
or oral. The Parties acknowledge that the Exhibits and Schedules
referred to in this Agreement are being simultaneously delivered by the
Parties on or before the Execution Date. The Parties also acknowledge
the simultaneous execution and delivery of the Technology Development
Agreement, the Technology Transfer Agreement and the Investment
Agreement, none of which shall be superseded by this Agreement. Any
amendment or modification to this Agreement shall be made in writing
signed by both Parties.
14.6 CHANGE OF CONTROL OF MILLENNIUM.
14.6.1 If a Change of Control occurs during the term of this
Agreement, Millennium shall promptly notify Aventis in
writing, [**] the Research Program and [**] the Research
Program and the Development and Commercialization activities
undertaken pursuant to this Agreement (a "Change of Control
[**]"). A Change of Control [**] may be made [**] after
Aventis' receipt of notice of such Change of Control, such
Change of Control [**] to be effective [**] after provision of
written notice thereof.
14.6.2 [**] a Change of Control [**], then the Program Technology and
Program Materials of the Research Program shall be [**].
14.6.3 If Aventis makes a Change of Control [**], the Parties will
then [**] all then existing Joint Development Compounds and/or
Joint Development Products, [**] after the effectiveness of
the Change of Control [**] shall be made [**]. For the
purposes of this Agreement, including the payment of royalties
under Section 8.3.2, such Joint Development Compounds and/or
Joint Development Products will [**] Compounds and/or [**]
Products. The provisions of Sections 3.7.1 through and
including Section 3.7.5 shall apply with respect to such [**]
Compounds and/or [**] Products; PROVIDED THAT, with respect to
Section 3.7.2, any costs and expenses associated with the
transfer of such UDC or UDC Products shall be the
responsibility of [**] such costs to be determined in a manner
consistent with the manner in which NA Development Costs and
NA/Ex-NA Development Costs are determined. For clarity, the
provisions of Section 3.7.6 shall not apply to any such [**]
Compounds and/or [**] Products.
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14.7 NOTICES. Notices to Millennium shall be addressed to:
Millennium Pharmaceuticals, Inc.
75 Sidney Street
Attention: Chief Executive Officer
Cambridge, Massachusetts 02139
Facsimile No.: (617) 621-0264
with a copy to:
Attention: Legal Department
Notices to Aventis shall be addressed to:
Aventis Pharmaceuticals Inc.
Route 202-206
P.O. Box 6800
Bridgewater, New Jersey 08807-0800
Attention: Vice President, Technology Licensing
and Alliances
Facsimile No.: (908) 231-3777
with a copy to:
Attention: Vice President, Legal Corporate
Department
Facsimile: (908) 231-4480
Either Party may change its address to which notices shall be sent by
giving notice to the other Party in the manner herein provided. Any
notice required or provided for by the terms of this Agreement shall be
in writing and shall be (a) sent by registered or certified mail,
return receipt requested, postage prepaid, (b) sent via a reputable
overnight courier service, or (c) sent by facsimile transmission, in
each case properly addressed in accordance with the paragraph above.
The effective date of notice shall be the actual date of receipt by the
Party receiving the same.
14.8 FORCE MAJEURE. No failure or omission by either Party in the
performance of any obligation of this Agreement shall be deemed a
breach of this Agreement or create any liability if the same shall
arise from any cause or causes beyond the control of such Party,
including, but not limited to, the following: acts of gods; acts or
omissions of any government; any rules, regulations or orders issued by
any governmental authority or by any officer, department, agency or
instrumentality thereof; fire; storm; flood; earthquake; accident; war;
rebellion; insurrection; riot; and invasion; provided that such failure
or omission resulting from one of the above causes is cured as soon as
is practicable after the occurrence of one or more of the above
mentioned causes and in no event more than 270 days after the date of
occurrence.
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14.9 COMPLIANCE WITH EXPORT REGULATIONS. Neither Party shall export any
technology licensed to it by the other Party under this Agreement
except in compliance with U.S. export laws and regulations.
14.10 PUBLIC ANNOUNCEMENTS. On the Execution Date, the Parties shall issue
one or more press releases, the timing and content of which shall be
mutually agreed. Any announcements or similar publicity with respect to
the execution of this Agreement shall be agreed upon between the
Parties in advance of such announcement. The Parties understand that
this Agreement is likely to be of significant interest to investors,
analysts and others, and that the Parties therefore may make such
public announcements with respect thereto, subject to the remainder of
this Section 14.10. The Parties agree that any such announcement will
not contain confidential business or technical information and, if
disclosure of confidential business or technical information is
required by law or regulation, will make commercially reasonable
efforts to minimize such disclosure and obtain confidential treatment
for any such information which is disclosed to a governmental agency or
group. Each Party agrees to provide to the other Party a copy of any
public announcement as soon as reasonably practicable under the
circumstances prior to its scheduled release. Except under
extraordinary circumstances, each Party shall provide the other with an
advance copy of any press release at least five (5) business days prior
to the scheduled disclosure. Each Party shall have the right to
expeditiously review and recommend changes to any announcement
regarding this Agreement or the subject matter of this Agreement.
Except as otherwise required by law, the Party whose press release has
been reviewed shall remove any information the reviewing Party
reasonably deems to be inappropriate for disclosure. The contents of
any such announcement or similar publicity which has been reviewed and
approved by the reviewing Party can be re-released by either Party
without a requirement for re-approval. Furthermore, each Party shall
give the other Party a reasonable opportunity to review all filings
with the United States Securities and Exchange Commission describing
the terms of this Agreement prior to submission of such filings, and
shall give due consideration to any reasonable comments by the
non-filing Party relating to such filing, including without limitation
the provisions of this Agreement for which confidential treatment
should be sought.
14.11 NON-SOLICITATION. During the Research Program Term, and for a period of
one (1) year thereafter, neither Party shall either directly or
indirectly solicit, recruit, induce, encourage or attempt to induce or
encourage any employee of the other Party or any independent contractor
primarily dedicated to the Research Program, or in Development or
Commercialization activities to terminate his or her employment with
such other Party and become employed by or consult for such other Party
whether or not such employee is a full-time employee of such other
Party, whether or not such employment is pursuant to a written
agreement or is at-will.
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14.12 INDEPENDENT CONTRACTORS. It is understood and agreed that the
relationship between the Parties is that of independent contractors and
that nothing in this Agreement shall be construed as authorization for
either Millennium or Aventis to act as agent for the other. Members of
the Joint Steering Committee, the Joint Research Committee, the Joint
Development Committee, the Joint Commercialization Committee and any
subcommittees thereof shall be, and shall remain, employees of
Millennium or Aventis, as the case may be. No Party shall incur any
liability for any act or failure to act by members of the Joint
Steering Committee, the Joint Research Committee, the Joint Development
Committee, the Joint Commercialization Committee and any subcommittees
thereof who are employees of such other Party.
14.13 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.
14.14 HEADINGS. The captions or headings of the sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions
hereof.
14.15 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE. No failure on the part of
Millennium or Aventis to exercise, and no delay in exercising, any
right, power, remedy or privilege under this Agreement, or provided by
statute or at law or in equity or otherwise, shall impair, prejudice or
constitute a waiver of any such right, power, remedy or privilege or be
construed as a waiver of any breach of this Agreement or as an
acquiescence therein, nor shall any single or partial exercise of any
such right, power, remedy or privilege preclude any other or further
exercise thereof or the exercise of any other right, power, remedy or
privilege.
14.16 SEVERABILITY. If any provision hereof should be held invalid, illegal
or unenforceable in any respect in any jurisdiction, the Parties hereto
shall substitute, by mutual consent, valid provisions for such invalid,
illegal or unenforceable provisions which valid provisions in their
economic effect are sufficiently similar to the invalid, illegal or
unenforceable provisions that it can be reasonably assumed that the
Parties would have entered into this Agreement with such valid
provisions. In case such valid provisions cannot be agreed upon, the
invalid, illegal or unenforceable of one or several provisions of this
Agreement shall not affect the validity of this Agreement as a whole,
unless the invalid, illegal or unenforceable provisions are of such
essential importance to this Agreement that it is to be reasonably
assumed that the Parties would not have entered into this Agreement
without the invalid, illegal or unenforceable provisions.
14.17 EXECUTION IN COUNTERPARTS. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which
counterparts, taken together, shall constitute one and the same
instrument.
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14.18 NO THIRD PARTY BENEFICIARIES. No person or entity other than Aventis,
Millennium and their respective Affiliates and permitted assignees
hereunder shall be deemed an intended beneficiary hereunder or have any
right to enforce any obligation of this Agreement.
14.19 NO CONSEQUENTIAL DAMAGES. UNLESS RESULTING FROM A PARTY'S GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT, NEITHER PARTY HERETO WILL BE LIABLE
FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT
LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS
SECTION 14.19 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF EITHER PARTY.
ARTICLE 15
HSR FILING
15.1 HSR FILING. To the extent necessary, each of Millennium and Aventis
shall, within fifteen (15) days after the Execution Date, file with the
Federal Trade Commission and the Antitrust Division of the U.S.
Department of Justice, any notification and report form required of it
in the reasonable opinion of both Parties under the HSR Act with
respect to the transactions contemplated hereby. The parties shall
cooperate with one another to the extent necessary in the preparation
of any notification and report form required to be filed under the HSR
Act. Each Party shall be responsible for its own costs, expenses, and
filing fees associated with any filing under the HSR Act.
15.2 HSR-RELATED DEFINITIONS. As used in Section 15.1, the following terms
have the following meanings:
15.2.1 "DOJ" means the United States Department of Justice.
15.2.2 "FTC" means the United States Federal Trade Commission.
15.2.3 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended (15 U.S.C. Sec. 18a), and the rules
and regulations promulgated thereunder.
15.2.4 "HSR Clearance Date" means the earlier of (i) the date on
which the FTC shall notify Millennium and Aventis of early
termination of the applicable waiting period under the HSR Act
or (ii) the day after the date on which the applicable waiting
period under the HSR Act expires, but in no event earlier than
July 6, 2000.
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15.2.5 "HSR Filing" means filings by Aventis and Millennium with the
FTC and the Antitrust Division of the DOJ of a Notification
and Report Form for Certain Mergers and Acquisitions (as that
term is defined in the HSR Act) with respect to the matters
set forth in this Agreement, together with all required
documentary attachments thereto.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
MILLENNIUM PHARMACEUTICALS, INC.
By: /s/ Steven H. Holtzman
------------------------------------
Title: Chief Business Officer
---------------------------------
AVENTIS PHARMACEUTICALS INC.
By: /s/ Frank Douglas, M.D.
-------------------------------------
Title: Executive Vice President
---------------------------------
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SCHEDULE 4.2.
CRITERIA FOR THE ASSIGNMENT OF RESPONSIBLE MANUFACTURING PARTY
When considering which partner will be the responsible manufacturing Party for a
given Joint Development Compound or Joint Development Product, the following
guidelines should be reviewed at a minimum at the time of the sourcing decision:
1. Systems must be in place OR described clearly in detail, including
resource allocation, management structure and responsibilities, and
time-line for implementation, for the qualification of suppliers of raw
materials, packaging components, and pharmaceutical excipients.
2. A Sales and Operations Planning system must be in place OR be clearly
outlined in detail, including how the system functions, responsible
functions participating in the process, and a time-line when the
process will be fully functional.
3. Inventory Management Systems must be in place, OR be clearly outlined
in detail, including how the system functions, responsible functions
participating in the process, and a time-line when the process will be
fully functional, including but not limited to:
- ability to trace product throughout the distribution network
- ability to rapidly recall product through the distribution
network
- management of pharmaceutical technical complaints, at least in
as much as the manufacturer contributes to the investigation
of the complaint.
4. A system for management of third party contractors (in as much as they
participate in the manufacturing, testing, validation, storage,
distribution, and supply chain management of the Compound or product),
must be in place or clearly outlined in detail, including system
description, resource allocation, and implementation time-line.
5. An EHS management system that is supported by qualified personnel must
be in place, OR clearly outlined in detail including timelines for
implementation,. To assure protection of employee health and safety,
protection of the environment and regulatory compliance, the EHS
program shall address safety, industrial hygiene, process safety,
environmental protection, occupational medicine and product
stewardship.
6. Systems for insuring compliance to world-wide cGMPs, including but not
limited to:
- qualification and training of staff
- qualification and validation of facilities and equipment for
manufacturing, storage, and testing of Compound and Product
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- qualification and validation of processes, manual or
computerized, pertaining to manufacturing, testing, cleaning,
storing, distributing, and inventory tracking of Compound and
Product
- Change Control, Batch Record Review, Batch Releasing, and
Failure Investigation
- must be in place OR clearly outlined in detail, including
process descriptions, resource allocation, management
structure, and implementation time-lines.
7. The Manufacturing Party must accept and be able to meet world-wide
demand for the Compound or Product, unless mutually agreed by both
parties in writing at the time of the sourcing decision.
8. The Manufacturing Party must bear all capital costs associated with
manufacturing the Compound or Product
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