EXHIBIT 10.1
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
MILLENNIUM PHARMACEUTICALS, INC.
AND
BZL BIOLOGICS, LLC
EFFECTIVE AS OF APRIL 5, 2001
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Execution Draft: 07/20/01
TABLE OF CONTENTS
PAGES
Article I Definitions........................................................1
1.1 "Affiliate".................................................1
1.2 "Antibody"..................................................2
1.3 "Antibody Products".........................................2
1.4 "Applicable Law"............................................2
1.5 "Biological Materials"......................................2
1.6 "BZL" shall have the meaning set forth in the preamble
to this Agreement..........................................2
1.7 "BZL Know-How"..............................................2
1.8 "BZL Patents"...............................................3
1.9 "Calendar Quarter"..........................................3
1.10 "Calendar Year".............................................3
1.11 "Clinical Decision Point"...................................3
1.12 "Clinical Trial"............................................3
1.13 "Commercially Reasonable Efforts"...........................3
1.14 "Competition"...............................................3
1.15 "Confidential Information"..................................3
1.16 "Control"...................................................3
1.17 "Cure Period"...............................................4
1.18 "Cytotoxin Agreement".......................................4
1.19 "Development Activities"....................................4
1.20 "Development Assistance"....................................4
1.21 "Development Budget"........................................4
1.22 "Development Plan"..........................................4
1.23 "Development Team Leader"...................................4
1.24 "Diagnostic Product"........................................4
1.25 "Effective Date"............................................4
1.26 "EMEA"......................................................4
1.27 "Europe"....................................................4
1.28 "Existing IND"..............................................4
1.29 "Exploit"...................................................4
1.30 "Exploitation"..............................................5
1.31 "Fair Market Value".........................................5
1.32 "FDA".......................................................5
1.33 "First Commercial Sale".....................................5
1.34 "Fully Burdened Manufacturing Cost".........................5
1.35 "GAAP"......................................................5
1.36 "Immunotoxin Product".......................................5
1.37 "Improvement"...............................................6
1.39 "IND".......................................................6
1.40 "Indemnification Claim Notice"..............................6
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1.41 "Indemnified Party".........................................6
1.42 "Information and Inventions"................................6
1.43 "Infringement Suit".........................................6
1.44 "In-License Agreements".....................................6
1.45 "Invoiced Sales"............................................6
1.46 "IP License"................................................6
1.47 "IP Reversion Termination"..................................6
1.48 "Joint Inventions"..........................................6
1.49 "Joint Know-How"............................................7
1.50 "Joint Patents".............................................7
1.51 "Jurisdiction"..............................................7
1.52 "Licensed BZL Patents"......................................7
1.53 "Licensed Product"..........................................7
1.54 "Lonza Agreement"...........................................7
1.55 "Lonza Transfer Date".......................................7
1.56 "Losses"....................................................7
1.57 "Major Market"..............................................7
1.58 "Manufacture" and "Manufacturing"...........................7
1.59 "Manufacturing Process".....................................7
1.60 "Marketing Authorization Application".......................7
1.61 "Millennium"................................................8
1.62 "Millennium Information"....................................8
1.63 "MTAs"......................................................8
1.64 "NDA Agreement".............................................8
1.65 "Net Sales".................................................8
1.66 "Non-United States Sublicensees"............................9
1.67 "Other BZL IND".............................................9
1.68 "Owned BZL Patents".........................................9
1.69 "Patents"...................................................9
1.70 "PCT".......................................................9
1.71 "Person"....................................................9
1.72 "Phase I"...................................................9
1.73 "Phase I Completion Point"..................................10
1.74 "Phase II"..................................................10
1.75 "Phase II Completion Point".................................10
1.76 "Phase IIa".................................................10
1.77 "Phase IIa Completion Point"................................10
1.78 "Phase IIb".................................................10
1.79 "Phase III".................................................10
1.80 "Prostate Cancer Field".....................................10
1.81 "PSMA"......................................................10
1.82 "Radiolabel Manufacturing Transfer Date"....................10
1.83 "Radiolabel Product"........................................11
1.84 "Regulatory Approval".......................................11
1.85 "Regulatory Authority"......................................11
1.86 "Regulatory Documentation"..................................11
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1.87 "Reversion Termination".....................................11
1.88 "Steering Committee"........................................11
1.89 "Sublicense Agreement"......................................11
1.90 "Sublicense Revenue"........................................11
1.91 "Territory".................................................11
1.92 "Third Party"...............................................11
1.93 "Third Party Claim".........................................11
1.94 "Trademark".................................................11
1.95 "Triggering Event"..........................................12
1.96 "United States Sublicensees"................................12
1.97 "Valid Claim"...............................................12
Article II Development and Commercialization.................................12
2.1 Co-Development Program......................................12
2.2 Development and Commercialization by Millennium.............20
2.3 Diligence Obligations.......................................20
2.4 Breach of Diligence Obligations.............................22
2.5 Development and Use of Trademarks...........................22
2.6 Records and Reporting.......................................22
2.7 Cooperation of BZL..........................................22
Article III License Grants and Assignment....................................23
3.1 Grants to Millennium........................................23
3.2 Grants to BZL...............................................23
3.3 Assignments.................................................24
3.4 Sublicenses.................................................25
3.5 License Limitations.........................................25
Article IV Payments and Royalties............................................26
4.1 Payments to BZL.............................................26
4.2 Records Retention; Audit....................................31
4.3 Mode of Payment.............................................32
Article V Reports............................................................32
5.1 Complaints..................................................32
5.2 Adverse Event Reporting.....................................32
5.3 Product Recall..............................................33
Article VI Intellectual Property Rights......................................33
6.1 Intellectual Property Ownership.............................33
6.2 Prosecution of Patents and Trademarks.......................34
6.3 Enforcement of Patents and Trademarks.......................36
6.4 Infringement of Third Party Rights..........................37
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Article VII Confidentiality and Nondisclosure................................38
7.1 Confidentiality Obligations.................................38
7.2 Permitted Disclosures.......................................39
7.3 Confidential Information....................................40
7.4 Use of Name.................................................40
7.5 Press Releases..............................................41
Article VIII Term and Termination............................................41
8.1 Term........................................................41
8.2 Termination of this Agreement for Material Breach...........41
8.3 Termination by Millennium...................................42
8.4 Consequences of Termination.................................42
8.5 Accrued Rights; Surviving Obligations.......................50
8.6 Rights in Bankruptcy........................................50
Article IX Indemnity.........................................................51
9.1 Indemnification of Millennium...............................51
9.2 Indemnification of BZL......................................51
9.3 Indemnification Procedure...................................52
9.4 Limitation on Damages.......................................54
9.5 Insurance...................................................54
Article X Representations, Warranties and Covenants..........................55
10.1 Representations, Warranties and Covenants..................55
10.2 Additional Representations, Warranties and Covenants of
Millennium..................................................56
10.3 Additional Representations, Warranties and Covenants
of BZL......................................................57
10.4 DISCLAIMER OF WARRANTIES....................................61
Article XI Miscellaneous.....................................................61
11.1 Force Majeure...............................................61
11.2 Assignment..................................................61
11.3 Severability................................................62
11.4 Governing Law...............................................62
11.5 Notices.....................................................62
11.6 Arbitration.................................................63
11.7 Affiliates and Sublicensees.................................64
11.8 Entire Agreement; Modifications.............................64
11.9 Relationship of the Parties.................................65
11.10 Equitable Relief............................................65
11.11 Waiver......................................................65
11.12 Counterparts................................................65
11.13 No Benefit to Third Parties.................................65
11.14 Further Assurance...........................................66
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11.15 References..................................................68
11.16 Construction................................................68
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DEVELOPMENT AND LICENSE AGREEMENT
THIS DEVELOPMENT AND LICENSE AGREEMENT (this "AGREEMENT") is
made and entered into effective as of April 5, 2001, by and between Millennium
Pharmaceuticals, Inc., a Delaware corporation, having its principal place of
business at 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, 00000 ("MILLENNIUM"),
and BZL Biologics, LLC, a New York limited liability company having its
principal place of business at c/o Xxxxx X. Xxxxxxxxxxx, 00 Xxxxxxx Xxxxxx,
Xxxxxxxx, Xxx Xxxx 00000 ("BZL").
RECITALS
WHEREAS, BZL has exclusive rights to certain patents claiming
antibodies directed to PSMA (as defined below) and the use of such antibodies
for treating and diagnosing cancer;
WHEREAS, BZL has developed antibodies against PSMA for the
treatment and diagnosis of prostate and certain other forms of cancer;
WHEREAS, Millennium is engaged in genomic research and drug
discovery and development endeavors, with the objective of identifying,
developing and marketing products that will serve a variety of human healthcare
needs throughout the world; and
WHEREAS, BZL desires to license Millennium, and Millennium
desires to obtain a license, to develop and commercialize antibody-based
products with respect to PSMA in accordance with the terms and conditions set
forth below.
NOW, THEREFORE, in consideration of the foregoing premises,
the mutual promises and covenants of the Parties contained herein, and other
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto, intending to be legally bound, do hereby agree
as follows:
ARTICLE I
DEFINITIONS
Unless otherwise specifically provided herein, the following
terms shall have the following meanings:
1.1 "AFFILIATE" shall mean, with respect to a Party, any corporation or other
business entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with such
Party. For purposes of this definition, "control" and, with correlative
meanings, the terms "controlled by" and "under common control with" shall mean
(a) the possession, directly or indirectly, of the power to direct the
management or policies of a business entity, whether through the ownership of
voting securities, by contract relating to voting rights or corporate
governance, or otherwise, or (b) the ownership, directly or indirectly, of at
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least fifty percent (50%) of the voting securities or other ownership interest
of a business entity (or, with respect to a limited partnership or other similar
entity, its general partner or controlling entity); provided that, if local law
restricts foreign ownership, control will be established by direct or indirect
ownership of the maximum ownership percentage that may, under such local law, be
owned by foreign interests.
1.2 "ANTIBODY" shall mean any antibody, including any murine, chimeric,
deimmunized, human or humanized, polyclonal or monoclonal antibody, whether
multiple or single chain, recombinant, transgenic animal derived, phage display
derived or naturally occurring, whole or fragment, and any constructs thereof
(including fusion proteins incorporating any such antibody or fragment thereof),
that has binding affinity for PSMA, and any nucleic acid encoding any of the
foregoing.
1.3 "ANTIBODY PRODUCTS" shall have the meaning set forth in Section 4.1(f).
1.4 "APPLICABLE LAW" shall mean the applicable laws, rules, regulations,
including any rules, regulations, guidelines, or other requirements of the
Regulatory Authorities, that may be in effect from time to time in the
Territory.
1.5 "BIOLOGICAL MATERIALS" shall mean any tissues, cells, cell lines,
organisms, blood samples, nucleic acids, genetic material, proteins, peptides,
protein fragments, plasmids, vectors, expression systems and any constituents,
progeny, mutants, derivatives or replications thereof or therefrom, and other
biological substances and materials, including any Antibodies, as well as any
reagents, cytotoxins, radioisotopes or other compositions of matter necessary or
useful for the Exploitation thereof.
1.6 "BZL" shall have the meaning set forth in the preamble to this Agreement.
1.7 "BZL KNOW-HOW" shall mean all Information and Inventions developed by or at
the request of, or in the possession or Control of, BZL or its Affiliates as of
the Effective Date or at any time during the term of this Agreement relating to
PSMA, Antibodies or the Exploitation of Licensed Products or Diagnostic Products
that are Confidential Information, but excluding (i) any Information and
Inventions to the extent covered or claimed by issued BZL Patents, and (ii) any
Joint Know-How. BZL Know-How shall include all: (a) scientific data relating to
PSMA or Antibodies, including DNA and amino acid sequences of, the human tissue
and/or cell type expression profile for, and existing and available models for
pre-clinical validation of antibody-based products against, PSMA, (b)
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical, clinical, safety, manufacturing and quality control data and
information related to Licensed Products or Diagnostic Products, (c) assays and
biological methodology necessary or useful for the Exploitation of Licensed
Products or Diagnostic Products, and (d) any and all Information and Inventions
developed in connection with or otherwise resulting from Development Activities
performed by or on behalf of BZL that is Confidential Information and is not
covered or claimed by issued BZL Patents and is not Joint Know-How.
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1.8 "BZL PATENTS" shall mean all of the Patents that BZL and its Affiliates
own, have under license, have a right to acquire (by option or otherwise) or
otherwise Control, as of the Effective Date and at any time during the term of
this Agreement, that are necessary or useful for, or otherwise related to, the
Exploitation of Licensed Products or Diagnostic Products, or that claim or cover
PSMA, any Antibody or any Licensed Product or Diagnostic Product, but excluding
the Joint Patents.
1.9 "CALENDAR QUARTER" shall mean each period of three (3) consecutive calendar
months ending on March 31, June 30, September 30 and December 31.
1.10 "CALENDAR YEAR" shall mean each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
1.11 "CLINICAL DECISION POINT" (a) with respect to an Immunotoxin Product, shall
mean the earlier of (i) the [**] for an Immunotoxin Product in the Prostate
Cancer Field set forth in the Development Plan, [**] an Immunotoxin Product
[**], in which case the "CLINICAL DECISION POINT" shall mean the [**] that is
agreed to by the Steering Committee and the FDA and identified prospectively in
the [**], [**] has achieved the [**] as set forth in the Development Plan, and
(ii) the expenditure of [**] Dollars ($[**]) by Millennium on the development of
the Licensed Product(s) pursuant to Section 2.1(i)(i)(A), and (b) with respect
to a Radiolabel Product, shall mean the earlier of (i) the [**] for a Radiolabel
Product in the Prostate Cancer Field set forth in the Development Plan, [**] for
a Radiolabel Product [**], in which case the "CLINICAL DECISION POINT" shall
mean [**] that is agreed to by the Steering Committee and the FDA and identified
prospectively in the [**], which [**] has achieved [**] as set forth in the
Development Plan, and (ii) the expenditure of [**] Dollars ($[**]) by Millennium
on the development of the Licensed Product(s) pursuant to Section 2.1(i)(i)(A).
1.12 "CLINICAL TRIAL" shall mean any Phase I, Phase II, Phase III, Phase IV
or other similar trials in human subjects.
1.13 "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the research,
development, Manufacture or commercialization of a Licensed Product or
Diagnostic Product, as applicable, efforts and resources commonly used in the
research-based pharmaceutical industry for a compound or product of similar
commercial potential at a similar stage in its lifecycle, taking into
consideration its safety and efficacy, its cost to develop, the competitiveness
of alternative products, its proprietary position, the likelihood of regulatory
approval, its profitability, and all other relevant factors. Commercially
Reasonable Efforts shall be determined on a market-by-market basis.
1.14 "COMPETITION" shall have the meaning set forth in Section 4.1(f).
1.15 "CONFIDENTIAL INFORMATION" shall have the meaning set forth in
Section 7.3(a).
1.16 "CONTROL" shall mean, with respect to any item of Information and
Invention, Patent, Trademark or other intellectual property right, possession of
the right, whether directly or indirectly, and whether by ownership, license or
otherwise, to assign, or grant a license, sublicense or other right to or under,
such Information and Invention, Patent, Trademark or right
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as provided for herein without violating the terms of any agreement or other
arrangement with any Third Party.
1.17 "CURE PERIOD" shall have the meaning set forth in Section 8.2.
1.18 "CYTOTOXIN AGREEMENT" shall have the meaning set forth in Section 10.2(b).
1.19 "DEVELOPMENT ACTIVITIES" shall mean those tests, studies and other
activities set forth in, or required in order to obtain the information set
forth in, the Development Plan, and such other tests, studies and other
activities as may be required or recommended from time to time by the Steering
Committee or the FDA with respect to an Immunotoxin Product or Radiolabel
Product prior to the Clinical Decision Point with respect thereto, including, by
way of example, the pharmacology and toxicology testing in pre-clinical models
(in vitro and animal), manufacturing process development and scale-up, clinical
development from the preparation and filing of an IND through the applicable
Clinical Decision Point and such other activities as are necessary to comply
with Applicable Law.
1.20 "DEVELOPMENT ASSISTANCE" shall have the meaning set forth in Section 2.7.
1.21 "DEVELOPMENT BUDGET" shall have the meaning set forth in Section 2.1(b).
1.22 "DEVELOPMENT PLAN" shall have the meaning set forth in Section 2.1(b)
1.23 "DEVELOPMENT TEAM LEADER" shall have the meaning set forth in
Section 2.1(c).
1.24 "DIAGNOSTIC PRODUCT" shall mean any composition, formulation or device
containing or comprising one or more Antibodies that are approved only for
diagnostic, imaging and other non-therapeutic purposes, which is covered, or the
use of which is covered, by a Valid Claim in a BZL Patent or Joint Patent, or
that is derived from or incorporates BZL Know-How or Joint Know-How.
1.25 "EFFECTIVE DATE" shall mean the effective date of this Agreement as set
forth in the preamble to this Agreement.
1.26 "EMEA" shall mean the European Agency for the Evaluation of Medicinal
Products and any successor agency thereto.
1.27 "EUROPE" shall mean the European Union as it may be constituted from time
to time.
1.28 "EXISTING IND" shall have the meaning set forth in Section 2.1(e).
1.29 "EXPLOIT" shall mean to make, have made, import, use, sell, or offer for
sale, or otherwise dispose of, including to research, develop, register, modify,
enhance, improve, Manufacture, have Manufactured, store, formulate, optimize,
export, transport, distribute, promote, market or have sold.
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1.30 "EXPLOITATION" shall mean the making, having made, importation, use, sale,
offering for sale or disposition of a product or process, including the
research, development, registration, modification, enhancement, improvement,
Manufacture, storage, formulation, optimization, export, transport,
distribution, promotion or marketing of a product or process.
1.31 "FAIR MARKET VALUE" shall have the meaning set forth in Section 4.1(d)(i).
1.32 "FDA" shall mean the United States Food and Drug Administration and any
successor agency thereto.
1.33 "FIRST COMMERCIAL SALE" shall mean the first sale for use or consumption by
the general public of a Licensed Product or Diagnostic Product, as applicable,
in a country after Regulatory Approval (including pricing and reimbursement
approval) for the marketing and sale of such Licensed Product or Diagnostic
Product has been obtained in such country.
1.34 "FULLY BURDENED MANUFACTURING COST" shall mean, with respect to each
Licensed Product, [**] Percent ([**]%) of the consolidated fully burdened cost
of Manufacturing such Licensed Product, which shall consist of (a) the process
development, engineering and scale-up costs for supply of such Licensed Product,
which shall be allocated based on the relative market potential for the markets
to which such process development and scale-up costs relate, and (b) (i) direct
labor and material costs, (ii) all manufacturing overhead costs incurred by
Millennium attributable to the costs of goods under the foregoing clause (i),
including supervisory services, quality assurance, quality control, occupancy
costs, purchasing, human resources, payroll, information system and accounting
that are allocable to company departments based on space occupied or headcount
or another activity-based method; (iii) process and packaging engineering; (iv)
costs of losses or wastage; (v) expenses with respect to the foregoing; (vi) all
of Millennium's allocable intellectual property and technology acquisition and
license costs and expenses (including royalties, license fees, milestone
payments and other payment obligations other than those due to BZL under the
terms of this Agreement) paid to Third Parties with respect to a Licensed
Product; (vii) any other costs borne by Millennium for the transport, customs
clearance, duty, insurance and/or storage of such Licensed Product; and (viii)
general and administrative costs that are allocable to company departments based
on space occupied or headcount or another activity-based method. All allocations
pursuant clause (b) above shall be made in a commercially reasonable manner
consistent with generally accepted accounting practices consistently applied and
assuming the relevant facility is operating at at least [**] percent ([**]%) of
capacity.
1.35 "GAAP" shall mean United States generally accepted accounting principles
consistently applied.
1.36 "IMMUNOTOXIN PRODUCT" shall mean any Licensed Product containing or
comprising an Antibody conjugated to a biological or chemical structure intended
to cause cell death or otherwise confer a clinical benefit.
1.37 "IMPROVEMENT" shall mean any modification, variation or revision to, or
derivative of, a compound, product or technology or any discovery, technology,
device, process or formulation related to such compound, product or technology,
whether or not patented or patentable,
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including any enhancement in the efficiency, operation, Manufacture (including
any Manufacturing Process), ingredients, preparation, presentation, formulation,
means of delivery, packaging or dosage of such compound, product or technology,
any discovery or development of any new or expanded indications for such
compound, product or technology, or any discovery or development that improves
the stability, safety or efficacy of such compound, product or technology or
would, if commercialized, replace or displace such compound, product or
technology.
1.38 "IMS" shall have the meaning set forth in Section 4.1(f).
1.39 "IND" shall mean an investigational new drug application filed with the FDA
for authorization to commence human clinical trials, and its equivalent in other
countries or regulatory jurisdictions in the Territory.
1.40 "INDEMNIFICATION CLAIM NOTICE" shall have the meaning set forth in
Section 9.3(a).
1.41 "INDEMNIFIED PARTY" shall have the meaning set forth in Section 9.3(a).
1.42 "INFORMATION AND INVENTIONS" shall mean all technical, scientific and other
know-how and information, trade secrets, knowledge, technology, means, methods,
processes, practices, formulas, instructions, skills, techniques, procedures,
experiences, ideas, technical assistance, designs, drawings, assembly
procedures, computer programs, apparatuses, specifications, data, results and
other material, including high-throughput screening, gene expression, genomics,
proteomics and other drug discovery and development technology, pre-clinical and
clinical trial results, Manufacturing procedures, test procedures and
purification and isolation techniques (whether or not confidential, proprietary,
patented or patentable) in written, electronic or any other form now known or
hereafter developed, and all Improvements, whether to the foregoing or
otherwise, and other discoveries, developments, inventions, and other
intellectual property (whether or not confidential, proprietary, patented or
patentable), but excluding the Regulatory Documentation.
1.43 "INFRINGEMENT SUIT" shall have the meaning set forth in Section 6.4(b).
1.44 "IN-LICENSE AGREEMENTS" shall have the meaning set forth in Section
10.3(f).
1.45 "INVOICED SALES" shall have the meaning set forth in Section 1.64.
1.46 "IP LICENSE" shall have the meaning set forth in Section 3.4.
1.47 "IP REVERSION TERMINATION" shall have the meaning set forth in Section
8.4(a)(ii).
1.48 "JOINT INVENTIONS" shall mean any and all Information and Inventions,
conceived, discovered, developed or otherwise made, as necessary to establish
joint authorship or joint inventorship under Applicable Law, jointly by Persons
by or on behalf of Millennium (or its Affiliates or sublicensees) and BZL (or
its Affiliates or sublicensees).
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1.49 "JOINT KNOW-HOW" shall mean any Information and Inventions included in the
Joint Inventions, but excluding any Information and Inventions to the extent
covered or claimed by issued Joint Patents.
1.50 "JOINT PATENTS" shall mean any Patents to the extent such Patents cover
or claim the Joint Inventions.
1.51 "JURISDICTION" shall mean the countries comprising Europe collectively and
each other country in the Territory.
1.52 "LICENSED BZL PATENTS" shall have the meaning set forth in Section 10.3(f).
1.53 "LICENSED PRODUCT" shall mean any composition or formulation containing or
comprising one or more Antibodies, including any Antibody conjugated to a
biological or chemical structure intended to cause cell death or otherwise
confer a clinical benefit, which is covered, or the use of which is covered, by
a Valid Claim in a BZL Patent or Joint Patent, or that is derived from or
incorporates BZL Know-How or Joint Know-How, but shall not include any
Diagnostic Products. By way of clarification, Licensed Products in different
formulations for different modes of administration (e.g., oral vs. intravenous)
or that are marketed pursuant to different XXXx in the same country shall be
deemed to be different Licensed Products.
1.54 "LONZA AGREEMENT" shall mean (a) that certain Agreement, dated December 10,
1998, between Lonza Biologics PLC and BZL, and any amendments thereto, (b) that
certain Licence Agreement, dated December 10, 1998, between Lonza Biologics PLC
and BZL, and any amendments thereto, and (c) that certain Agreement, dated
December 10, 1998, among Lonza Biologics PLC, Biovation Ltd. and BZL, and any
amendments thereto.
1.55 "LONZA TRANSFER DATE" shall have the meaning set forth in Section 2.1(g).
1.56 "LOSSES" shall have the meaning set forth in Section 9.1(a).
1.57 "MAJOR MARKET" shall mean each of the United States, Europe and Japan.
1.58 "MANUFACTURE" AND "MANUFACTURING" shall mean the manufacturing, processing,
formulating, packaging, labeling, holding and quality control and release
testing of a product, including the development of processes and technology to
facilitate production, purification, evaluation, characterization, and stability
assessment of such product, as well as the validation of such product and
processes.
1.59 "MANUFACTURING PROCESS" shall mean any process or step thereof that is
necessary or useful for Manufacturing any Licensed Product or Diagnostic
Product, any Improvement thereto or any intermediate of the foregoing, including
any Improvement to such process or step.
1.60 "MARKETING AUTHORIZATION APPLICATION" OR "MAA" shall mean a New Drug
Application or Biologics License Application, each as defined in the United
States Federal Food, Drug, and Cosmetics Act, as amended, and the regulations
promulgated thereunder, and any corresponding foreign application, registration
or certification, necessary or reasonably useful to
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market Licensed Products or Diagnostic Products in the Territory, including any
governmental pricing and reimbursement approvals.
1.61 "MILLENNIUM" shall have the meaning set forth in the preamble to this
Agreement.
1.62 "MILLENNIUM INFORMATION" shall have the meaning set forth in
Section 7.1(b).
1.63 "MTAS" shall have the meaning set forth in Section 3.3(d).
1.64 "NDA AGREEMENT" shall have the meaning set forth in Section 3.3(c).
1.65 "NET SALES" shall mean, for any period, the gross amount invoiced by a
Party, its Affiliates and its permitted sublicensees for the sale of Licensed
Product(s) to Third Parties (the "INVOICED SALES"), less deductions for: (a)
normal and customary trade, quantity and cash discounts and sales returns and
allowances actually allowed and taken, including (i) those granted on account of
price adjustments, billing errors, rejected goods, damaged goods, returns and
rebates, (ii) administrative and other fees and reimbursements and similar
payments to wholesalers and other distributors, buying groups, pharmacy benefit
management organizations, health care insurance carriers and other institutions,
(iii) allowances, rebates and fees paid to distributors and (iv) chargebacks;
(b) freight, postage, shipping, insurance and any other distribution expenses to
the extent that such items are included in the gross amount invoiced; (c)
customs and excise duties and other duties related to the sales to the extent
that such items are included in the gross amount invoiced; (d) rebates and
similar payments made with respect to sales paid for by any governmental or
regulatory authority such as, by way of illustration and not in limitation of
the Parties' rights hereunder, Federal or state Medicaid, Medicare or similar
state program or equivalent foreign governmental program; (e) sales and other
taxes and duties directly related to the sale or delivery of Licensed Product(s)
(but not including taxes assessed against the income derived from such sale);
(f) any other similar and customary deductions actually allowed and taken that
are consistent with GAAP, or in the case of non-United States sales, other
applicable accounting standards; and (g) any such invoiced amounts that are not
collected by such Party, its Affiliates or its permitted sublicensees. Any of
the deductions listed above that involves a payment by such Party, its
Affiliates or its permitted sublicensees shall be taken as a deduction in the
Calendar Quarter in which the payment is accrued by such entity. Deductions
pursuant to subsection (g) above shall be taken in the Calendar Quarter in which
such sales are no longer recorded as a receivable but shall be treated as Net
Sales in the quarter of collection if subsequently collected net of any
collection expenses. For purposes of determining Net Sales, the Licensed
Product(s) shall be deemed to be sold when invoiced and a "sale" shall not
include transfers or dispositions for charitable, promotional, pre-clinical,
clinical, regulatory or governmental purposes.
For purposes of calculating Net Sales, sales between or among such Party
or its Affiliates or sublicensees shall be excluded from the computation of Net
Sales, but sales by such Party, its Affiliates or its sublicensees to Third
Parties other than sublicensees shall be included in the computation of Net
Sales; PROVIDED, HOWEVER, that with respect to Millennium only sales by United
States Sublicensees shall be included in Net Sales by sublicensees for purposes
of determining Net Sales for purposes of this Agreement.
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In the event that a Licensed Product is sold in any country in the form
of a combination product containing one or more active ingredients in
addition to the Antibody(ies), and such combination has been approved by the
appropriate Regulatory Authorities for sale as a combination product, Net Sales
of such combination product will be adjusted by multiplying actual Net Sales of
such combination product in such country calculated pursuant to the first
paragraph of this Section by the fraction A/(A+B), where A is the average
invoice price in such country of the Licensed Product containing such
Antibody(ies), if sold separately in such country, and B is the average invoice
price in such country of such other active ingredients in the combination, if
sold separately in such country. The invoice price for the Licensed Product
containing such Antibody(ies) and for each other active ingredient shall be for
a quantity comparable to that used in such combination product and of the same
class, purity and potency. If, in a specific country, a Licensed Product
containing only such Antibody(ies) or only such other therapeutically active
ingredients in such combination product are not sold separately, a market price
for such Antibody(ies) and such other therapeutically active ingredients shall
be negotiated by the Parties in good faith based on the relative values of such
Antibody(ies) and active ingredients taking into account relative prices of such
components if sold separately in other countries, relative to manufacturing
costs for such components, and the costs, overhead and profit as are then
incurred for such Antibody(ies) and active ingredients and all similar
substances then being made and marketed by such Party and having an
ascertainable market price. By way of clarification, a Radiolabel Product or
Immunotoxin Product shall not be deemed to be a combination product by virtue of
the radioisotope or cytotoxin, as applicable, that is conjugated to an Antibody.
1.66 "NON-UNITED STATES SUBLICENSEES" shall have the meaning set forth in
Section 4.1(d)(i).
1.67 "OTHER BZL IND" shall have the meaning set forth in Section 2.1(f).
1.68 "OWNED BZL PATENTS" shall have the meaning set forth in Section 10.3(f).
1.69 "PATENTS" shall mean (a) all patents and patent applications, (b) any
substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions,
supplementary protection certificates and the like, and any provisional
applications, of any such patents or patent application, and (c) any foreign or
international equivalent of any of the foregoing.
1.70 "PCT" shall mean the Patent Cooperation Treaty, opened for signature
June 19, 1970, 28 U.S.T. 7645.
1.71 "PERSON" shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.
1.72 "PHASE I" shall mean a human clinical trial, the principal purpose of which
is to evaluate the pharmacokinetic and pharmacodynamic properties, maximum
tolerated dose, dosing interval, and absorption, distribution, metabolism and
excretion of a Licensed Product in healthy individuals or patients as required
in 21 C.F.R.
-9-
ss.312, or a similar clinical study prescribed by the Regulatory Authorities in
a country other than the United States.
1.73 "PHASE I COMPLETION POINT" shall be deemed to have occurred with respect to
a Licensed Product when the Steering Committee determines to proceed with Phase
II studies, [**], in the United States for such Licensed Product.
1.74 "PHASE II" shall mean a human clinical trial, for which a primary endpoint
is a preliminary determination of efficacy or dose ranges in patients with a
disease target being studied as required in 21 C.F.R. ss.312, or a similar
clinical study prescribed by the Regulatory Authorities in a country other than
the United States. [**] the filing of an approvable MAA (such as a combined
Phase II/Phase III study, or any Phase III study [**] shall automatically be
deemed to have reached Phase II status.
1.75 "PHASE II COMPLETION POINT" shall be deemed to have occurred with respect
to a Licensed Product when the Steering Committee determines to proceed with a
Phase III study in the United States for such Licensed Product or to file an MAA
for such Licensed Product with the FDA, whichever determination is made first.
1.76 "PHASE IIA" shall mean a [**] Phase II study of a Licensed Product in
patients with a disease target being studied.
1.77 "PHASE IIA COMPLETION POINT" shall be deemed to have occurred with respect
to a Licensed Product when the Steering Committee has received the completed
data package for a Phase IIa study in the United States, which data package
shows whether such Licensed Product [**] as set forth in the Development Plan.
1.78 "PHASE IIB" shall mean a [**] of a Licensed Product [**].
1.79 "PHASE III" shall mean a human clinical trial, the principal purpose of
which is to establish safety and efficacy in patients with a disease target
being studied as required in 21 C.F.R. ss.312, or similar clinical study
prescribed by the Regulatory Authorities in a country other than the United
States. A Phase III study shall be deemed to have [**].
1.80 "PROSTATE CANCER FIELD" shall mean the treatment of prostate cancer.
1.81 "PSMA" shall mean prostate-specific membrane antigen as described in RS
Israeli, CT Xxxxxx, XX Fair and XX Xxxxxx. MOLECULAR CLONING OF A COMPLEMENTARY
DNA ENCODING A PROSTATE-SPECIFIC MEMBRANE ANTIGEN. Cancer Research
53: 227 - 230 (1993).
1.82 "RADIOLABEL MANUFACTURING TRANSFER DATE" shall have the meaning set forth
in Section 2.1(g).
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1.83 "RADIOLABEL PRODUCT" shall mean any Licensed Product containing or
comprising an Antibody conjugated with such radioisotope as is set forth in the
Development Plan or such other radioisotope as the Parties may agree.
1.84 "REGULATORY APPROVAL" shall mean any and all approvals (including
governmental pricing and reimbursement approvals), licenses, registrations or
authorizations of any Regulatory Authority, necessary for the Exploitation of
Licensed Products or Diagnostic Products in a country in the Territory,
including any (a) approval of any Licensed Product or Diagnostic Product,
including any: INDs, XXXx and supplements and amendments thereto; (b) pre- and
post-approval marketing authorizations (including any prerequisite Manufacturing
approval or authorization related thereto); (c) labeling approval; and (d)
technical, medical and scientific licenses.
1.85 "REGULATORY AUTHORITY" shall mean any applicable supra-national, federal,
national, regional, state, provincial or local regulatory agencies, departments,
bureaus, commissions, councils or other government entities regulating or
otherwise exercising authority with respect to the Exploitation of Licensed
Products or Diagnostic Products in the Territory.
1.86 "REGULATORY DOCUMENTATION" shall mean all applications, registrations,
licenses, authorizations and approvals (including all Regulatory Approvals), all
correspondence submitted to or received from Regulatory Authorities (including
minutes and official contact reports relating to any communications with any
Regulatory Authority) and all supporting documents and all clinical studies and
tests, relating to any Licensed Product or Diagnostic Product, and all data
contained in any of the foregoing, including all regulatory drug lists,
advertising and promotion documents, adverse event files, complaint files and
Manufacturing records.
1.87 "REVERSION TERMINATION" shall have the meaning set forth in
Section 8.4(a)(i).
1.88 "STEERING COMMITTEE" shall have the meaning set forth in Section 2.1(d).
1.89 "SUBLICENSE AGREEMENT" shall have the meaning set forth in
Section 4.1(d)(i).
1.90 "SUBLICENSE REVENUE" shall have the meaning set forth in Section 4.1(d)(i).
1.91 "TERRITORY" shall mean the entire world, except for those countries in
which this Agreement is terminated pursuant to Section 8.3(c).
1.92 "THIRD PARTY" shall mean any Person other than Millennium, BZL and their
respective Affiliates.
1.93 "THIRD PARTY CLAIM" shall have the meaning set forth in Section 9.3(b).
1.94 "TRADEMARK" shall include any word, name, symbol, color, designation or
device or any combination thereof, including any trademark, trade dress, brand
xxxx, service xxxx, trade name, brand name, service name, logo or business
symbol.
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1.95 "TRIGGERING EVENT" shall have the meaning set forth in Section 6.4(a).
1.96 "UNITED STATES SUBLICENSEES" shall mean Third Party sublicensees of
Millennium in the United States.
1.97 "VALID CLAIM" shall mean, with respect to a particular country, a claim of
an issued and unexpired patent in such country that (a) 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 has been taken
within the time allowed for appeal; and (b) has not been abandoned, disclaimed,
denied or admitted to be invalid or unenforceable through reissue or disclaimer
or otherwise in such country.
ARTICLE II
DEVELOPMENT AND COMMERCIALIZATION
2.1 CO-DEVELOPMENT PROGRAM.
(a) DEVELOPMENT ACTIVITIES.
(i) GENERAL. Through the Clinical Decision Point for the Immunotoxin
Product, under the direction and supervision of the Steering
Committee, (A) BZL and Millennium shall use Commercially
Reasonable Efforts to perform, or cause to be performed, the
Development Activities with respect to the Immunotoxin Products in
the Prostate Cancer Field, and (B) BZL shall use Commercially
Reasonable Efforts to perform, or cause to be performed, the
Development Activities with respect to the Radiolabel Products in
the Prostate Cancer Field, all in accordance with the Development
Plan and the Development Budget, as each may be amended from time
to time by the Steering Committee pursuant to Section 2.1(b), and
this Agreement. The Parties shall use Commercially Reasonable
Efforts to conduct and complete their respective Development
Activities with respect to the Immunotoxin Products in the
Prostate Cancer Field through the Clinical Decision Point for the
Immunotoxin Product, and BZL shall use Commercially Reasonable
Efforts to complete its Development Activities with respect to the
Radiolabel Products in the Prostate Cancer Field by the Clinical
Decision Point for the Immunotoxin Product; PROVIDED, HOWEVER,
that if BZL does not do so, it shall use Commercially Reasonable
Efforts to complete such Development Activities promptly. The
Parties acknowledge that [**] shall have the right to [**] in the
Development Plan [**], provided that (A) [**] Millennium's
clinical advisory board or the equivalent thereof for the Licensed
Products, (B) the Parties agree that [**] the Licensed Products,
(C[**] under this Agreement, and (D) [**] of Antibody and Licensed
Products considering any current and anticipated requirements of
Antibody and Licensed Products, [**]; PROVIDED, HOWEVER, in the
event [**] in connection with [**], [**] shall notify Millennium
and Millennium shall [**] under a sponsored research agreement.
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(ii) CONDUCT OF DEVELOPMENT ACTIVITIES. BZL and Millennium each
shall use Commercially Reasonable Efforts to (A) perform, or cause
to be performed, its respective Development Activities in good
scientific manner, and in compliance in all material respects with
good clinical and laboratory practices and all other Applicable
Law, and (B) achieve the objectives of the Development Plan
efficiently and expeditiously by allocating sufficient time,
effort, equipment and skilled personnel to complete such
activities successfully and promptly and in accordance with the
Development Budget.
(iii)REPORTS. Within [**] after the end of each Calendar Quarter in
which Development Activities are performed, each Party shall
provide to the Steering Committee a written progress report, which
shall describe the Development Activities it has performed, or
caused to be performed, during such Calendar Quarter, evaluate the
work performed in relation to the goals of the Development Plan
and in relation to the Development Budget, and provide such other
information as may be required by the Development Plan or
reasonably requested by a Party with respect to the Development
Activities.
(b) DEVELOPMENT PLAN AND BUDGET. Attached hereto as Exhibit A is a
preliminary development plan. Within [**] after the Effective Date, the
Steering Committee shall meet to develop and approve (i) a more
detailed plan based on the preliminary development plan for the
Development Activities (the "DEVELOPMENT PLAN"), which sets forth (A)
the tests, studies and other activities to be performed by the Parties
through each Clinical Decision Point, (B) the Party responsible for
each such activity, and (C) the period in which each such activity is
expected to be started and completed, and (ii) a detailed budget for
the Development Activities (the "DEVELOPMENT BUDGET"), which sets forth
the projected costs and expenses for the Development Activities. The
Parties currently contemplate that certain Development Activities and
clinical trials will be conducted at New York Presbyterian
Hospital/Cornell Medical Center with certain involvement of New Drug
Associates, Inc., subject to Millennium's and Cornell Medical Center's
respective internal policies, the guidelines and requirements of the
FDA and all other Applicable Law. The Steering Committee shall review
the Development Plan and Development Budget at least annually and shall
have the right to make such modifications or updates to the Development
Plans and Development Budgets that it deems appropriate. No changes
shall be made to a Development Plan or a Development Budget without the
prior written approval of the Steering Committee. Notwithstanding the
foregoing, [**] performing the Development Activities, as set forth in
a Development Plan or otherwise, with respect to the [**] through the
Clinical Decision Point for the [**] Product, unless Millennium
expressly agrees otherwise; PROVIDED, HOWEVER, that the cost of such
Development Activities shall not exceed [**] Dollars ($[**]). The
Parties acknowledge and agree that BZL's Development Activities shall
be performed by Xx. Xxxx Xxxxxx and New Drug Associates, Inc. pursuant
to the NDA Agreement as assigned to Millennium pursuant to Section
3.3(c) and that the complete cost and expense of NDA's performance of
such activities and the other development work set forth in this
Agreement is set forth in the NDA Agreement. New Drug Associates, Inc.
shall not devote more than [**] hours per
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Calendar Year during the term of the NDA Agreement to the Development
Activities for the Radiolabel Product.
(c) DEVELOPMENT TEAM LEADERS. The day-to-day Development Activities with
respect to the Immunotoxin Products shall be conducted under the joint
direction and supervision of a member of each Party's senior
development staff designated by such Party (each, a "DEVELOPMENT TEAM
LEADER"). The day-to-day Development Activities with respect to the
Radiolabel Products shall be conducted under the direction and
supervision of BZL's Development Team Leader. BZL's Development Team
Leader shall be Xx. Xxxx Xxxxxx. The Development Team Leaders shall be
the primary contacts for the Parties with respect to the Development
Activities. BZL shall not substitute anyone for its Development Team
Leader or materially reduce the time commitment of its Development Team
Leader to the Development Activities without the prior written approval
of Millennium. In the event that BZL's Development Team Leader is no
longer affiliated with BZL or is otherwise incapable of performing his
obligations under this Agreement (e.g., become disabled), the Parties
shall meet and discuss in good faith how best to proceed.
Notwithstanding the foregoing, BZL shall continue to be responsible for
performing its Development Activities, and any consent or agreement by
Millennium pursuant to this Section 2.1(c) shall not be deemed to be a
waiver of any failure of BZL to conduct its Development Activities
under this Agreement.
(d) STEERING COMMITTEE.
(i) FORMATION OF THE STEERING COMMITTEE. Millennium and BZL shall
establish a joint oversight and management committee (the
"STEERING COMMITTEE"), which shall oversee the Development
Activities performed by the Parties for the Immunotoxin Product
and the Radiolabel Product through the applicable Clinical
Decision Point. Each Party shall appoint two (2) representatives,
which representatives of BZL shall be Xxxxxx Xxxxxxxx and Xx. Xxxx
Xxxxxx, with the requisite experience and seniority to enable them
to make decisions on behalf of the Parties with respect to the
Development Activities; PROVIDED, HOWEVER, that as of the date of
the last Clinical Decision Point, the Steering Committee shall be
reduced to one (1) representative from each Party, or such other
number as the Parties may mutually agree, which representative of
BZL shall be Xx. Xxxx Xxxxxx. The Steering Committee shall
terminate upon the first approval by the Regulatory Authorities of
an MAA for the Immunotoxin Product inside the Prostate Cancer
Field and, if appropriate, one indication outside the Prostate
Cancer Field in a Major Market, unless the Steering Committee
decides to proceed with a Radiolabel Product, in which event the
Steering Committee shall terminate upon the approval of an MAA for
a Radiolabel Product inside the Prostate Cancer Field and, if
applicable, one indication outside the Prostate Cancer Field,
unless the Parties mutually agree to terminate the Steering
Committee at an earlier time; PROVIDED, HOWEVER, that the Steering
Committee shall terminate in the event of a sale of all or
substantially all of BZL's assets related to the Licensed
Product(s) or its business, or in the event of a merger,
consolidation or change in control of BZL or BZL Biologics, Inc.
Prior to serving on the Steering Committee, the
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representatives of BZL and Millennium shall enter into an
agreement to comply with and be bound by the nondisclosure and
use obligations set forth in Article VII. From time to time, each
Party may substitute its representatives on written notice to the
other Party so long as such substitute representative has the
requisite scientific or clinical expertise with respect to the
ongoing development of the Licensed Product.
(ii) RESPONSIBILITIES. The Steering Committee shall: (A) oversee
the performance by the Parties of their respective Development
Activities under the Development Plan; (B) review and amend the
Development Plan in accordance with Section 2.1(b); (C) oversee
the design and conduct of Phase I, Phase II and any Pivotal
Studies (which commenced prior to the applicable Clinical Decision
Point) with respect to the Immunotoxin Products and Radiolabel
Products in the Prostate Cancer Field through the applicable
Clinical Decision Point; and (D) take such other actions as are
set forth in this Section 2.1 or as the Parties may mutually
agree, except that the Steering Committee may not take any action
that would conflict with any provision in this Agreement.
(iii)MEETINGS. The Steering Committee shall meet quarterly, or as
otherwise agreed to by the Parties, during any period in which
Development Activities are conducted by or on behalf of the
Parties with the location of such meetings designated by
Millennium. After the last Clinical Decision Point, the Steering
Committee shall meet quarterly to review the development plan for
the Licensed Product(s) or Diagnostic Product(s) and discuss such
development plan and any modifications thereto. Any significant
changes to the development plan for the Licensed Product(s) or
Diagnostic Product(s) after the applicable Clinical Decision Point
shall be discussed at a meeting of the Steering Committee prior to
the amendment of the development plan, provided that any breach of
this obligation by Millennium shall not be deemed to be a material
breach of this Agreement and shall not be subject to the
termination provisions set forth in Section 8.2. Millennium shall
circulate an agenda in advance of each meeting. The Parties shall
agree on the minutes of each meeting within ten (10) days after
the end of such meeting. Each Party shall bear all costs and
expenses associated with its representatives' attendance at
meetings of the Steering Committee, provided that Millennium shall
reimburse Xx. Xxxxxx for his reasonable and verifiable
out-of-pocket expenses incurred in connection with his attendance
at meetings of the Steering Committee.
(iv) PROCEDURAL RULES.
(A) The Steering Committee shall adopt such standing rules as
shall be necessary for its work.
(B) A quorum of the Steering Committee shall exist whenever
there is present at a meeting at least one representative appointed by each
Party. Members of the Steering Committee may attend a meeting either in person
or by telephone,
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video conference or similar means in which each participant can hear what is
said by the other participants. Representation by proxy shall not be allowed.
(C) The Steering Committee shall take action by unanimous
consent of BZL and Millennium, with each such Party having a single vote,
irrespective of the number of representatives actually in attendance at a
meeting, or by a written resolution signed by the designated representatives
of each of BZL and Millennium. In the event that the Steering Committee cannot
or does not reach an agreement on an issue (1) if such dispute relates to the
Radiolabel Product in the Prostate Cancer Field prior to the Clinical Decision
Point for the Radiolabel Product, [**]provided that [**] on such issue and
[**] in resolving such dispute; PROVIDED, however, that any disputes with
respect to the Development Budget shall be resolved pursuant to Section 11.6,
and (2) if such dispute relates to the Radiolabel Product in the Prostate
Cancer Field after the Clinical Decision Point for the Radiolabel Product or
any other Licensed Product or Diagnostic Product at any time, [**], provided
that [**] on such issue and [**] in resolving such dispute.
(v) LIMITATIONS ON AUTHORITY OF THE STEERING COMMITTEE. Each Party
to this Agreement shall retain the rights, powers, and discretion
granted to it under this Agreement, and no such rights, powers,
or discretion shall be delegated to or vested in the Steering
Committee unless such delegation or vesting of rights is
expressly provided for in this Agreement or the Parties expressly
so agree in writing. The Steering Committee shall not have the
power to amend or modify this Agreement, which may only be
amended or modified as provided in Section 11.8.
(e) REGULATORY APPROVALS. The Steering Committee shall develop a detailed
strategy for obtaining and maintaining Regulatory Approvals for
Immunotoxin Products and Radiolabel Products in the Prostate Cancer
Field through the applicable Clinical Decision Point, provided that
all INDs (other than the IND No. 9279 for the Radiolabel Product and
any amendments or supplements thereto (the "EXISTING IND") and the
Other BZL INDs), XXXx and other filings, applications or requests
pursuant to or in connection with the Regulatory Approvals for each
Licensed Product or Diagnostic Product shall be filed in the name of
Millennium. Upon Millennium's request, BZL shall also assign all of
its right, title, and interest in and to the Existing IND, and such of
the Other BZL INDs as Millennium shall request, to Millennium as set
forth in Section 3.3(b). Subject to Section 2.3(a), Millennium shall
have the exclusive right to (i) develop and implement a strategy for
obtaining and maintaining Regulatory Approvals for Licensed Products
for non-prostate cancer indications and Diagnostic Products at any
time, and (ii) develop and implement a strategy for obtaining and
maintaining Regulatory Approvals for Licensed Products for all
indications after the applicable Clinical Decision Point. Millennium
shall have the exclusive right to conduct all communications and
filings with the Regulatory Authorities with respect to all Licensed
Products and Diagnostic Products prior to and after each Clinical
Decision Point; PROVIDED, HOWEVER, that, prior to the assignment to
Millennium of the Existing IND and the Other BZL INDs, BZL shall have
the right to conduct all communications and filings with the
Regulatory Authorities with respect to the Existing IND and the Other
BZL INDs, provided that Millennium shall have the right to participate
in such
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communications, whether by phone or in person. Millennium shall have
the right to reference the Existing IND and the Other BZL INDs for
all purposes.
(f) REGULATORY RECORDS. BZL and Millennium each shall maintain, or cause
to be maintained, records of its respective Development Activities in
sufficient detail and in good scientific manner appropriate for patent
and regulatory purposes, which shall be complete and accurate and
shall fully and properly reflect all work done and results achieved in
the performance of its respective Development Activities, and which
shall be retained by such Party for at least five (5) years after the
termination of this Agreement, or for such longer period as may be
required by Applicable Law. Millennium shall have the right, during
normal business hours and upon reasonable notice, to inspect and copy
any such records of BZL. BZL shall provide Millennium with any and all
information with respect to the Existing IND and any other INDs owned
or Controlled by BZL other than the Existing IND ("OTHER BZL INDS"),
including any communications and filings with or from the Regulatory
Authorities, which BZL shall provide to Millennium reasonably in
advance of making any such communication or filing, and Millennium
shall have the right, but not the obligation, to review and approve
any filings or communications with the Regulatory Authorities and to
participate in any meetings with the Regulatory Authorities, whether
by phone or in person, PROVIDED, HOWEVER, that, after the assignment
to Millennium of the Existing IND and the Other BZL INDs, Millennium
shall have the right to conduct meetings with the Regulatory
Authorities with respect to the Existing IND and the Other BZL INDs.
BZL shall use its Commercially Reasonable Efforts to pursue and
maintain the Existing IND and all Other BZL INDs until the Clinical
Decision Point for the Immunotoxin Product.
(g) PRE-CLINICAL AND CLINICAL SUPPLY. Upon the Effective Date, BZL shall
use Commercially Reasonable Efforts to promptly assign to Millennium
the Lonza Agreement pursuant to Section 3.3; PROVIDED, HOWEVER, that
until such time as BZL is able to make such assignment to Millennium
(the "LONZA TRANSFER DATE"), BZL shall supply all of the Parties'
pre-clinical and clinical requirements of Antibody pursuant to and in
accordance with the Lonza Agreement, unless Millennium agrees
otherwise. Millennium shall be responsible for Manufacturing and
supplying Immunotoxin Product produced with such Antibody. BZL shall
be responsible for Manufacturing and supplying Radiolabel Products
produced with such Antibody through the completion of each clinical
study underway at the time of the last Clinical Decision Point using a
Third Party manufacturer, and on terms and conditions, reasonably
acceptable to Millennium. In the event that there is an inadequate
supply of Antibody to produce both Immunotoxin Products and Radiolabel
Products, any quantities of Antibody shall first be used to produce
the Parties' requirements of the Immunotoxin Product. BZL shall
transfer to Millennium all inventories of useable Antibody that have
reasonably useful shelf lives on the Lonza Transfer Date, which shall
not be less than [**] grams of [**] Antibody and [**] grams of [**]
Antibody. Within [**] days after Millennium's receipt from BZL of such
Antibody and a written invoice and any supporting documentation with
respect thereto, Millennium shall reimburse BZL for its invoiced
direct out-of-pocket costs to Lonza Biologics PLC for the Manufacture
of such Antibody, not to exceed [**] Dollars ($[**]). Subject to
availability and, to the
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extent additional supplies of Antibody are required, Millennium's
supply of such Antibody, BZL shall also supply Millennium's
requirements of Radiolabel Product for the preclinical and clinical
development of Radiolabel Product [**] through the completion of any
clinical study underway at the last Clinical Decision Point, provided
that Millennium shall reimburse BZL for its invoiced direct
out-of-pocket costs to Xxxxxxx Biotechnology, Inc. in connection with
such supply, not to exceed [**] Dollars ($[**]) for the existing supply
of Radiolabel Product. The agreement with respect to the Manufacture
and supply of the Radiolabel Products (the "RADIOLABEL MANUFACTURING
AGREEMENT") shall be assigned to Millennium pursuant to Section 3.3
within ten (10) days of the last Clinical Decision Point or as earlier
requested by Millennium (the "RADIOLABEL MANUFACTURING TRANSFER DATE").
BZL represents and warrants to Millennium that at the time of the
transfer of the Antibodies and Radiolabel Product to Millennium
pursuant to this Section 2.1(g), such Antibodies or Radiolabel Product
(i) will have been Manufactured in accordance with Applicable Law for
use under the applicable IND, (ii) will not be adulterated or
misbranded under the Federal Food, Drug, and Cosmetic Act, 21
U.S.C.ss.ss.321 ET SEQ., as amended (the "FFDCA"), or under any other
Applicable Law, and (iii) may be introduced into interstate commerce
pursuant to the FFDCA.
(h) MATERIAL AND INFORMATION TRANSFER. BZL shall, and shall cause its
Affiliates to, without additional compensation and at its sole
expense, (i) provide to Millennium the Biological Materials in its
Control specified from time to time in this Agreement or the
Development Plan, or such other Biological Materials in its Control as
Millennium may reasonably request, and (ii) disclose and make
available to Millennium, in whatever form Millennium may reasonably
request, all Manufacturing documentation, all Regulatory
Documentation, all other BZL Know-How, all Joint Know-How and any
other Information and Inventions relating, directly or indirectly, to
the Development Activities (including a written description of each
Antibody, Licensed Product, Diagnostic Product or Improvement thereto
identified by BZL, any scientific or medical information with respect
to such Antibody, Licensed Product, Diagnostic Product or Improvement
thereto and any Patent or other information with respect to the
proprietary status of such Antibody, Licensed Product, Diagnostic
Product or Improvement thereto), immediately after the Effective Date
and thereafter promptly upon the earlier of the conception or
reduction to practice, discovery, development or making of each such
Manufacturing documentation, Regulatory Documentation, Know-How, or
other Information and Inventions, provided that, except as otherwise
provided in this Agreement, Millennium shall reimburse BZL for any
reasonable and invoiced direct out-of-pocket costs incurred in
providing such Biological Materials after the last Clinical Decision
Point. Neither BZL nor Xx. Xxxx Xxxxxx shall provide any such
Information or Inventions or Biological Materials to any Person other
than Millennium or its Affiliates, without Millennium's prior written
consent.
(i) DEVELOPMENT EXPENSES.
(i) MILLENNIUM'S OBLIGATION.
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(A) Subject to Section 2.1(a)(i), and except as otherwise
provided in this Agreement, Millennium shall be solely responsible for all
costs and expenses in connection with the development and commercialization
(including manufacturing, marketing and selling costs, subject, however, to
Millennium's ability to recover certain amounts consistent with the definition
of "Net Sales") with respect to the Licensed Product(s) and the Diagnostic
Product(s); PROVIDED, HOWEVER, that BZL shall bear, and shall not be entitled to
reimbursement for, any such costs or expenses incurred by BZL prior to the
Effective Date (except for payments made for supply of Antibody and Radiolabel
Product pursuant to Section 2.1(g)) and, unless otherwise expressly provided
herein, any costs or expenses incurred by BZL in performing its obligations
under this Agreement. Millennium shall reimburse BZL for the reasonable and
invoiced direct out-of-pocket costs and expenses incurred by BZL and its
Affiliates after the Effective Date in performing its Development Activities
with respect to the Licensed Products in accordance with the Development Plan
and the Development Budget, provided that Millennium's sole financial obligation
to New Drug Associates, Inc. and its employees and principals with respect to
such activities shall be pursuant to the NDA Agreement.
(B) Millennium agrees to fund the Development Activities
through the Phase IIa Completion Point for an Immunotoxin Product in the
Prostate Cancer Field and a Radiolabel Product in the Prostate Cancer Field,
each as set forth in the Development Plan, unless a Pivotal Study for an
Immunotoxin Product or Radiolabel Product, as applicable, is performed in lieu
of a Phase IIa study, in which case Millennium agrees to fund the Development
Activities for such Immunotoxin Product or Radiolabel Product, as applicable, in
accordance with the Development Budget prior to the completion of the data
package from the interim analysis for such Pivotal Study that is agreed to by
the Steering Committee and the FDA and identified prospectively in the protocol
for such Pivotal Study, which data package shows whether such Immunotoxin
Product or Radiolabel Product, as applicable, has achieved the predetermined
endpoints for such interim analysis as set forth in the Development Plan;
PROVIDED, HOWEVER, that in no event shall Millennium be obligated to spend more
than [**] dollars ($[**]) in connection with such Development Activities and
Millennium does hereby retain the right to terminate this Agreement pursuant to
Article VIII.
(ii) STATEMENTS AND PAYMENTS. Within [**] days after the end of each
Calendar Quarter in which Development Activities are conducted,
each Party shall furnish the Steering Committee with a statement
(A) detailing the costs and expenses actually incurred in
connection with the Development Activities performed by or on
behalf of such Party during such Calendar Quarter, provided that
such costs and expenses may not exceed (or be projected to exceed)
the amounts set forth in the Development Budget for the relevant
Development Activities by more than [**] percent ([**]%) without
the approval of the Steering Committee, and (B) comparing such
expenses to date with the projections set forth in the Development
Budget. Each Party shall promptly furnish the other with any other
documentation of such costs and expenses as such other Party may
reasonably request. Within [**] days after receipt by Millennium
of such statement and any supporting documentation from BZL,
Millennium shall reimburse BZL for all amounts set forth therein
for costs and expenses actually incurred in connection with the
Development Activities, except for amounts properly contested in
good
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faith. Millennium's reporting obligations under this Section
2.1(i)(ii) shall terminate upon the Clinical Decision Point for
the Immunotoxin Product.
(iii)BOOKS AND RECORDS. Each Party shall maintain complete and
accurate books, records and accounts that, in reasonable detail,
fairly reflect any reimbursable costs and expenses incurred by
such Party or its Affiliates in connection with the Development
Activities in conformity with GAAP. Each Party shall retain such
books, records and accounts until three (3) years after the end of
the period to which such books, records and accounts pertain, or
for such longer period as may be required by Applicable Law. Each
Party shall have the right to have its certified public
accountant, who shall be reasonably acceptable to the other Party,
audit the books and financial records of such other Party, as well
as those of such other Party's Affiliates and sublicensees,
relating to its Development Activities during one or more Calendar
Quarters; PROVIDED, HOWEVER, that if such sublicensees object to
such an audit by the auditing Party, the other Party shall have
the right to conduct such audit of such sublicensees at the
auditing Party's sole cost and expense and the other Party shall
provide the auditing Party with a written certification disclosing
the results of such audit, which certification shall be attested
to by an officer of the other Party; and PROVIDED FURTHER that the
auditing Party shall not have the right to audit a Calendar
Quarter more than two (2) years after the end of such quarter, to
conduct more than one such audit in any twelve-month period, or to
audit any Calendar Quarter more than once; and PROVIDED FURTHER
that the auditing Party shall bear the cost of such audit unless
the audit reveals a variance of more than five percent (5%) from
the reported results, in which case such other Party shall bear
the cost of the audit.
(j) COOPERATION. Each Party shall cooperate with any and all reasonable
requests for assistance from the other Party with respect to the
Development Activities, including by making its employees, consultants
and other scientific staff available upon reasonable notice during
normal business hours at their respective places of employment to
consult with such other Party on issues arising in connection with the
performance of such Development Activities.
2.2 DEVELOPMENT AND COMMERCIALIZATION BY MILLENNIUM. Millennium shall have the
exclusive right to develop, commercialize, Manufacture and otherwise Exploit in
the Territory (a) Licensed Products, [**] at any time during the term of this
Agreement, and (b) Licensed Products, [**] after the applicable Clinical
Decision Point.
2.3 DILIGENCE OBLIGATIONS.
(a) MILLENNIUM DILIGENCE. Millennium shall use Commercially Reasonable
Efforts to (i) commence a Phase I study with respect [**] prior to the
Phase I Completion Point with respect to [**]Field, (ii) after the last
Clinical Decision Point, conduct such other Clinical Trials, and make
such filings with the Regulatory Authorities, as are necessary to
obtain Regulatory Approvals for Licensed Product(s) [**], to the extent
scientifically justified and commercially reasonable, with respect to
[**] each of the
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Major Markets, (iii) once all applicable Regulatory Approvals with
respect to a Licensed Product have been obtained in a Major Market,
develop and satisfy market demand for such Licensed Product in such
Major Market, and (iv) to the extent scientifically justified and
commercially reasonable, develop, seek Regulatory Approvals for, and,
upon receipt of all such approvals, commercialize a Diagnostic Product
(or license a Third Party to do so); PROVIDED, HOWEVER, that (A) such
obligations are expressly conditioned upon (1) BZL and its Affiliates
performing their respective obligations hereunder, including the
information disclosure requirements pursuant to Section 2.1(h) and the
supply of such Antibody and Radiolabel Product pursuant to Section
2.1(g), (2) the availability of Antibody and other intermediates of
Licensed Product or Diagnostic Product, [**], and (3) the continuing
absence of any adverse condition as determined solely by Millennium
relating to the safety and efficacy or scientific or commercial
feasibility of such Licensed Products or Diagnostic Products, and (B)
such obligations shall be delayed or suspended as long as any such
condition or event exists; and PROVIDED FURTHER that Millennium shall
not be obligated to obtain Regulatory Approvals for, or commercialize,
more than one Licensed Product or Diagnostic Product, as applicable, in
any Major Market. Commercially Reasonable Efforts, for purposes of this
Section 2.3(a), shall not require that Millennium apply greater
efforts, or make any other decisions, with respect to the Licensed
Product(s) or Diagnostic Product(s) than it would were the Licensed
Product(s) or Diagnostic Product(s), as applicable, solely owned by
Millennium. BZL acknowledges and agrees that, in addition to the
foregoing, the development and commercialization of the Licensed
Product(s) or Diagnostic Product(s) may be delayed, suspended or
otherwise modified by Millennium in response to circumstances outside
the reasonable control of Millennium, including force majeure events,
changes in the requirements of the Regulatory Authorities, failed or
inconclusive clinical studies or a need for additional tests and
studies to obtain appropriate labeling, pricing, reimbursement or other
Regulatory Approvals. Further, BZL acknowledges and agrees that nothing
in this Section 2.3 is intended, or shall be construed, to require
Millennium to develop or commercialize a specific Licensed Product or
Diagnostic Product. In the event that Millennium decides to discontinue
the development or commercialization of a Licensed Product or
Diagnostic Product in favor of another Licensed Product or Diagnostic
Product, its obligations under this Section 2.3 shall cease with
respect to such initial Licensed Product or Diagnostic Product in favor
of such other Licensed Product or Diagnostic Product. BZL also
acknowledges and agrees that (x) Millennium has the right, in its sole
discretion, to develop and commercialize Diagnostic Product(s) through
one or more sublicensees, (y) Millennium's obligations with respect to
Diagnostic Product(s) shall be secondary to its obligations with
respect to Licensed Product(s), and (z) as long as Millennium is using
Commercially Reasonable Efforts to develop or commercialize an
Immunotoxin Product, Millennium shall have no obligation to develop or
commercialize a Radiolabel Product. Millennium shall perform its
obligation under this Section 2.3 in good scientific manner and in
compliance in all material respects with all Applicable Law. Except as
expressly provided in Section 2.1, Millennium shall have no other
obligation, express or implied, with respect to the Exploitation of the
Licensed Product(s) or Diagnostic Product(s).
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(b) MILLENNIUM DISCRETION. Subject to Sections 2.1(d) and 2.3(a), the
Parties acknowledge and agree that all decisions with respect to (i)
Licensed Products (other than Radiolabel Products in the Prostate
Cancer Field prior to the Clinical Decision Point for the Radiolabel
Product) and the Diagnostic Products, and (ii) Radiolabel Products in
the Prostate Cancer Field after the Clinical Decision Point for the
Radiolabel Product, including decisions relating to Millennium's
Exploitation and pricing of Licensed Products or Diagnostic Products,
shall ultimately be within the sole discretion of Millennium.
2.4 BREACH OF DILIGENCE OBLIGATIONS. If at any time BZL has a reasonable basis
to believe that Millennium is in breach of its obligations under Section 2.3,
then BZL shall so notify Millennium, specifying the basis for its belief, and
the Parties shall meet within [**] days after such notice to discuss in good
faith BZL's concerns and Millennium's development and commercialization plans
with respect to the Licensed Products. If such failure constitutes a material
breach of Millennium's obligation under Section 2.3, after such good faith
negotiations, BZL may provide Millennium with a notice of termination pursuant
to Section 8.2 subject to the right to cure as set forth therein.
2.5 DEVELOPMENT AND USE OF TRADEMARKS. Millennium shall have the sole right to
determine the Trademarks to be used with respect to the development and
commercialization of the Licensed Products or Diagnostic Products on a worldwide
basis. BZL shall not, and shall not permit its Affiliates to use in their
respective businesses, any Trademark that is confusingly similar to, misleading
or deceptive with respect to, or that dilutes any Trademark used to identify or
distinguish the Licensed Products or Diagnostic Products.
2.6 RECORDS AND REPORTING. After the Clinical Decision Point with respect to the
Immunotoxin Product, Millennium shall prepare and maintain complete and accurate
records regarding the development and commercialization of the Licensed Products
or Diagnostic Products and, after the termination of the Steering Committee,
Millennium shall provide to BZL a reasonably detailed report regarding such
development and commercialization at least once annually.
2.7 COOPERATION OF BZL. BZL shall cooperate with any and all reasonable requests
for assistance from Millennium with respect to the development and
commercialization of the Licensed Products or Diagnostic Products, including by
making its employees, consultants and other scientific staff available upon
reasonable notice during normal business hours at BZL's place of business to
consult with Millennium on issues arising during such development and
commercialization ("DEVELOPMENT ASSISTANCE"). Millennium shall reimburse BZL for
any and all reasonable and invoiced direct out-of-pocket costs and expenses
incurred by BZL in providing such assistance with respect to a Licensed Product
or Diagnostic Product after the Clinical Decision Point with respect to such
Licensed Product or Diagnostic Product. Notwithstanding the foregoing, the
Parties contemplate that Xx. Xxxx Xxxxxx will continue to provide clinical
assistance to Millennium in such capacity, and upon such terms and conditions,
as Millennium and Xx. Xxxxxx may mutually agree (but which is expected to
involve Xx. Xxxxxx in the ongoing clinical development of Licensed Product(s)).
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ARTICLE III
LICENSE GRANTS AND ASSIGNMENT
3.1 GRANTS TO MILLENNIUM. Subject to Article VIII of this Agreement, BZL and
its Affiliates hereby grant to Millennium and its Affiliates:
(a) an exclusive (including with regard to BZL and its Affiliates),
perpetual, royalty-bearing license in the Territory, with the right to
grant sublicenses solely as provided in Section 3.4, under BZL's and
its Affiliates' rights, titles, and interests in and to the BZL
Patents, the BZL Know-How, the Joint Patents and the Joint Know-How to
Exploit Licensed Products, Diagnostic Products and Improvements thereto
for all purposes;
(b) an exclusive (including with regard to BZL and its Affiliates),
perpetual, royalty-bearing license and right of reference in the
Territory, with the right to grant sublicenses solely as provided in
Section 3.4, under BZL's and its Affiliates' rights, titles and
interests in and to the Regulatory Approvals, to the extent not
otherwise assigned pursuant to Section 3.3(b), to Exploit Licensed
Products, Diagnostic Products and Improvements thereto for all
purposes; and
(c) an exclusive (including with regard to BZL and its Affiliates),
perpetual, royalty-bearing (including a [**] percent ([**]%) royalty
owed to Lonza Biologics PLC pursuant to the Lonza Agreement), license
in the Territory, with the right to grant sublicenses, under BZL's and
its Affiliates' rights, titles and interests in and to the BZL Patents,
the BZL Know-How, the Joint Patents and the Joint Know-How to use the
Manufacturing Processes to Manufacture and have Manufactured the
Licensed Products, Diagnostic Products and Improvements thereto to
Exploit for all purposes. By way of clarification, Millennium's
Manufacture of a Licensed Product shall only be royalty-bearing to the
extent that such Licensed Product is sold so as to produce Net Sales.
3.2 GRANTS TO BZL. Subject to Article VIII of this Agreement, Millennium and
its Affiliates hereby grant to BZL and its Affiliates:
(a) a limited, nonexclusive, royalty-free, license in the Territory
under Millennium's and its Affiliates' right, title and interest in and
to the Regulatory Documentation, the BZL Patents, the BZL Know-How, the
Joint Patents and the Joint Know-How to conduct the Development
Activities in accordance with the Development Plan and this Agreement;
and
(b) a limited, nonexclusive, royalty-free, license in the Territory
under Millennium's and its Affiliates' right, title and interest in and
to the Immunotoxin Product to conduct the Development Activities with
respect to the Immunotoxin Product in the Prostate Cancer Field in
accordance with the Development Plan and this Agreement.
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3.3 ASSIGNMENTS.
(a) MANUFACTURING RIGHTS. Upon the Lonza Transfer Date and the Radiolabel
Manufacturing Transfer Date, BZL and its Affiliates shall and do hereby
(i) transfer to Millennium the Lonza Agreement and the Radiolabel
Manufacturing Agreement, respectively, and all Regulatory
Documentation, and Biological Materials with respect to the
Manufacturing of the Licensed Products or Diagnostic Products,
including all inventories of Antibodies, cell lines, research cell
banks, master cell banks, DNA, reagents, testing and stability data,
Manufacturing standard operating procedures, batch records and any
other production or quality control records with respect to the
Licensed Products or Diagnostic Products or the Manufacturing thereof,
and (ii) assign and transfer to Millennium all of BZL's and its
Affiliates' rights, titles and interests in and to the foregoing.
Millennium hereby agrees that it shall assume, insofar as they relate
to the time period beginning on and including the day following Lonza
Transfer Date and Radiolabel Manufacturing Transfer Date, all the
obligations and liabilities of BZL under the Lonza Agreement and the
Radiolabel Manufacturing Agreement, respectively.
(b) REGULATORY DOCUMENTATION. BZL and its Affiliates hereby assign and
transfer to Millennium all of their respective rights, titles and
interests in and to all Regulatory Documentation, including, to the
extent permitted by Applicable Law, all Regulatory Approvals, but
excluding the Existing IND and Other BZL INDs, Controlled by BZL or its
Affiliates as of the Effective Date and from time to time during the
term of this Agreement. Millennium hereby agrees that it shall assume,
insofar as they relate to the time period beginning on and including
the day following the date hereof, all the obligations and liabilities
of BZL under the Regulatory Documentation. Upon Millennium's request,
BZL shall assign and transfer to Millennium all of its and its
Affiliates' rights, titles and interests in and to the Existing IND and
such of the Other BZL INDs as Millennium may from time to time request.
Millennium hereby agrees that it shall assume, insofar as they relate
to the time period beginning on and including the day following the
date of the assignment of the Existing IND and Other BZL INDs to
Millennium, all the obligations and liabilities of BZL under the
Existing IND and Other BZL INDs.
(c) NDA AGREEMENT. BZL and its Affiliates hereby assign and transfer to
Millennium all of their respective rights, titles and interests in and
to that certain Amended and Restated Management Agreement between New
Drug Associates, Inc., BZL and the NDA Principals as defined therein,
effective as of January 1, 2001 (the "NDA AGREEMENT"). Millennium
hereby agrees that it shall assume, insofar as they relate to the time
period beginning on and including the day following the date hereof,
all the obligations and liabilities of BZL under the NDA Agreement.
Millennium shall indemnify and hold harmless BZL and its Affiliates
from any Losses with respect to any breach of the NDA Agreement by
Millennium or its Affiliates pursuant to Article IX.
(d) MATERIAL TRANSFER AGREEMENTS. BZL and its Affiliates hereby assign
and transfer to Millennium all of their respective rights, titles and
interests in and to those material transfer agreements set forth on
Schedule 3.3(d) hereto (the "MTAs"), which schedule
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is a true and complete list of all MTAs entered into by BZL or BZL
Biologics, Inc. Millennium hereby agrees that it shall assume, insofar
as they relate to the time period beginning on and including the day
following the date hereof, all the obligations and liabilities of BZL
under the MTAs. Millennium shall indemnify and hold harmless BZL and
its Affiliates from any Losses with respect to any breach of any such
MTA by Millennium or its Affiliates pursuant to Article IX.
(e) LIABILITIES. Notwithstanding anything to the contrary in this
Section 3.3, BZL shall (i) be and remain liable for any obligation or
liability under the Lonza Agreement, the Radiolabel Manufacturing
Agreement, the Regulatory Documentation, the Existing IND and Other BZL
INDs, the NDA Agreement and the MTAs to the extent that such obligation
or liability relates to the period, or any actions or omissions, prior
to the date of assignment of BZL's rights, titles and interests with
respect thereto to Millennium, and (ii) indemnify and hold harmless
Millennium and its Affiliates and sublicensees from any Losses with
respect thereto pursuant to Article IX.
(f) FURTHER ASSURANCES. BZL shall duly execute and deliver, or cause to
be duly executed and delivered, such instruments and shall do and cause
to be done such acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be necessary
under, or as Millennium may reasonably request in connection with, or
to carry out more effectively the purpose of, or to better assure and
confirm unto Millennium its rights under, this Section 3.3.
3.4 SUBLICENSES. Millennium shall have the right, in its sole discretion, to
grant to Third Parties sublicenses under the licenses granted in Section 3.1 (a)
with respect to Licensed Products (i) outside the United States, (ii) inside the
United States if such sublicense is with respect to (A) contract, manufacturing
or other services, or (B) is in connection with a strategic alliance or
collaboration that includes co-exclusive rights with respect to a field that
includes prostate cancer together with one or more of: breast cancer, colon
cancer, lung cancer or another cancer with comparable market potential, or with
respect to one or more products for one or more of such cancers in addition to a
Licensed Product, in which Millennium has a substantial ongoing role in and
responsibility for product development and sales in the field or with respect to
such products, or (iii) in settlement of any actual, threatened or potential
Patent or other intellectual property dispute or proceeding related to the BZL
Patents or Licensed Products or in connection with any cross-license to obtain
rights to any Patent, trade secret or other intellectual property which
Millennium reasonably believes would impede the Exploitation of any Licensed
Product by Millennium or its Affiliates or otherwise permitted sublicensees in
the Territory (each such sublicense, an "IP LICENSE"), or (b) with respect to
Diagnostic Products throughout the Territory, in each case without the prior
approval of BZL. All other sublicenses in the United States shall require the
prior approval of BZL. Before granting any IP License, Millennium shall consult
with BZL and its patent counsel regarding the advisability of granting such IP
License, including with respect to information relating to rights to be obtained
by Millennium under any cross-license.
3.5 LICENSE LIMITATIONS. Millennium acknowledges and agrees that it has no right
to use the BZL Know-How or BZL Patents outside of the Exploitation of the
Licensed Products, Diagnostic Products and Improvements thereto as set forth in
Section 3.1, including for
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the development of products that are not Antibodies, Licensed Products or
Diagnostic Products, but that bind to PSMA. In the event that Millennium
desires to use the BZL Patents or BZL Know-How for any other purpose, the
Parties shall negotiate in good faith for [**] days the appropriate terms and
conditions for such use, provided that neither Party shall have any obligation
to enter into an agreement with respect thereto.
ARTICLE IV
PAYMENTS AND ROYALTIES
4.1 PAYMENTS TO BZL. In partial consideration of the licenses and other rights
granted herein and subject to the terms and conditions set forth in this
Agreement, Millennium shall make the following payments to BZL:
(a) MILESTONE PAYMENTS.
(i) Millennium shall make the milestone payments provided below to
BZL within [**] days following achievement, after the Effective
Date, of the corresponding milestone event:
MILESTONE EVENT MILESTONE PAYMENT
(A) The [**] Immunotoxin Product; $[**]
(B) [**] an Immunotoxin Product; $[**]
(C) [**] an Immunotoxin Product; and $[**]
(D) [**] an Immunotoxin Product. $[**]
In the event that the Steering Committee decides to proceed
with a Radiolabel Product in lieu of an Immunotoxin Product, Millennium shall
pay BZL [**] percent ([**]%) of the above milestone payments set forth in this
Section 4.1(a)(i) within [**] days following achievement, after the Effective
Date, of the corresponding milestone, provided that if an Immunotoxin Product
subsequently achieves any of the above milestones after the [**]%) payment for
the Radiolabel Product for such milestone, Millennium shall pay BZL the
remaining [**] percent ([**]%) of the applicable milestone payment within [**]
days after such Immunotoxin Product achieves such milestone.
(ii) Millennium shall make the milestone payments provided below to
BZL within [**] days following achievement, after the Effective
Date, of the corresponding milestone event:
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MILESTONE EVENT MILESTONE PAYMENT
(A) [**] Licensed Products ([**] Licensed $[**]
Products [**] for [**] consecutive
Calendar Quarters first reach $[**];
(B) [**] Licensed Products ([**] Licensed $[**]
Products [**]) for [**] consecutive
Calendar Quarters first reach $[**]; and
(C) [**] Licensed Products ([**]Licensed $[**]
Products [**]) for [**]consecutive
Calendar Quarters first reach $[**].
(iii)For clarification, subject to the last paragraph of Section
4.1(a)(i), each milestone payment shall be payable only once
irrespective of the number of Licensed Products that have
achieved or the number of times Licensed Products achieve the
milestone events set forth in this Section 4.1(a).
(b) ROYALTIES PAYABLE BY MILLENNIUM. Millennium shall pay to BZL the
following royalties based on worldwide aggregate Net Sales by
Millennium, its Affiliates and its United States Sublicensees of
Licensed Products during each Calendar Year:
[**] Percent ([**]%) of Net Sales for that portion of
aggregate Net Sales of Licensed Products in such Calendar
Year that is less than $[**];
[**] Percent ([**]%) of Net Sales for that portion of
aggregate Net Sales of Licensed Products in such Calendar
Year that equals or exceeds $[**] but is less than $[**]; and
[**] Percent ([**]%) of Net Sales for that portion of
aggregate Net Sales of Licensed Products in such Calendar
Year that equals or exceeds $[**].
(c) ADJUSTMENTS. Any and all sales by Non-United States Sublicensees
shall be excluded from the Net Sales calculations in Section 4.1(b)
(including for purposes of the thresholds and ceilings).
(d) SUBLICENSE REVENUE.
(i) In the event that Millennium enters into a license agreement to
sublicense to a Third Party (a "NON-UNITED STATES Sublicensee")
Millennium's rights under this Agreement to market a Licensed
Product outside of the United States (a "SUBLICENSE AGREEMENT"),
Millennium shall pay BZL a portion, as set forth in Section
4.1(d)(ii), of any net license fees, milestone payments and net
royalty payments or net profits, as applicable (collectively,
"SUBLICENSE REVENUE"), paid to Millennium by such sublicensee in
consideration for the sublicensing of such right to market outside
the United States. For the sake of clarity, if Millennium is
Manufacturing the Licensed Products, or any intermediary thereof,
for such Third
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Parties, amounts paid by the Sublicensee to Millennium for
purchase of such Licensed Products or intermediate up to the Fair
Market Value of such Licensed Products or intermediate shall not
be considered to be Sublicense Revenue. For purposes of this
Section 4.1(d), "FAIR MARKET VALUE" shall mean [**] percent
([**]%) of the Fully Burdened Manufacturing Cost for Millennium to
Manufacture such Licensed Product or intermediate. To the extent
that the manufacturing fee paid to Millennium under a Sublicense
Agreement is above the Fair Market Value, any amount over such
Fair Market Value shall be included in Sublicense Revenue and
shall be shared with BZL pursuant to Section 4.1(d)(ii).
(ii) If a Sublicense Agreement for a Licensed Product is executed
(A) prior to the first Phase I Completion Point for an Immunotoxin
Product, Millennium shall pay BZL [**] percent ([**]%) of the
Sublicense Revenue under such Sublicense Agreement, (B) after the
completion of the first Phase I Completion Point for an
Immunotoxin Product but prior to the first Clinical Decision Point
for an Immunotoxin Product, Millennium shall pay BZL [**] percent
([**]%) of the Sublicense Revenue under such Sublicense Agreement,
(C) after the first Clinical Decision Point for an Immunotoxin
Product but prior to the filing of the first MAA (but excluding
pricing and reimbursement approvals) for an Immunotoxin Product,
Millennium shall pay BZL [**] percent ([**]%) of the Sublicense
Revenue under such Sublicense Agreement, and (D) after the first
filing of a MAA (but excluding pricing and reimbursement
approvals) for an Immunotoxin Product, Millennium shall pay BZL
[**] percent ([**]%) of the Sublicense Revenue under such
Sublicense Agreement; PROVIDED, HOWEVER, that if Millennium elects
to proceed with a Radiolabel Product in lieu of an Immunotoxin
Product, such thresholds shall be based on a Radiolabel Product
and not an Immunotoxin Product.
(iii)Notwithstanding the foregoing, if the portion of the Territory
subject to the Sublicense Agreement includes at least two of the
following countries: United Kingdom, France, Germany, or Italy,
and if the Sublicense Agreement is entered into prior to approval
by the EMEA of a MAA for the Licensed Product, the first $[**] (or
the first $[**] if such Licensed Product is a Radiolabel Product)
of any such payments for Sublicense Revenue other than for
royalties shall be retained by Millennium, provided that upon the
approval by the EMEA of a MAA for a Licensed Product, the
applicable milestone payment shall be due pursuant to Section
4.1(a).
(iv) Millennium's obligations to share Sublicense Revenue with BZL
pursuant to Section 4.1(d)(ii) shall terminate, on a
country-by-country basis, with respect to each Licensed Product
upon the later of (i) [**] years after the First Commercial Sale
in such country of such Licensed Product, and (ii) the expiration
date in such country of the last to expire of any issued BZL
Patent or Joint Patent that includes at least one Valid Claim
covering the Licensed Product, or the use of the Licensed Product,
sold in such country, or covering the Manufacturing of such
Licensed Product in the country in which such Licensed Product is
Manufactured. Upon termination of Millennium's obligations to
share Sublicense Revenue with respect
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to a Licensed Product in a country in which there is a Sublicense
Agreement, the license grants to Millennium in Section 3.1 shall
become fully paid-up exclusive licenses with respect to such
Licensed Product in such country.
(e) ROYALTY TERM. Millennium's royalty obligations under Section 4.1(b)
shall terminate, on a country-by-country basis, with respect to each
Licensed Product on the later of (i) [**] years after the First
Commercial Sale in such country of such Licensed Product, and (ii) the
expiration date in such country of the last to expire of any issued BZL
Patent or Joint Patent that includes at least one Valid Claim covering
the Licensed Product, or the use of the Licensed Product, sold in such
country, or covering the Manufacturing of such Licensed Product in the
country in which such Licensed Product is Manufactured. Upon
termination of the royalty obligations of Millennium under this Section
4.1(e) with respect to a Licensed Product in a country, the license
grants to Millennium in Section 3.1 shall become fully paid-up
exclusive licenses with respect to such Licensed Product in such
country and Net Sales of such Licensed Product in such country shall be
excluded from the royalty calculations set forth in Section 4.1(b)
(including the thresholds and ceilings).
(f) [**]. If, following the [**] anniversary of January 1st in the
Calendar Year in which the First Commercial Sale of a Licensed Product
occurred, product(s) that contain or comprise one or more Antibodies
(collectively, "ANTIBODY PRODUCTS") are sold [**]) and [**] of such
Antibody Product(s) represent [**] percent ([**]%) of the aggregate
sales in United States dollars of all Antibody Products, including
Licensed Products, in all of the Major Markets as reported by IMS
America, Ltd. ("IMS") or any comparable reporting agency in a Calendar
Year ([**]), and if Millennium's and its Affiliates' and sublicensees'
(but excluding Non-United States Sublicensees) Net Sales is less
[**]Dollars ($[**]) for such Calendar Year, Millennium's royalty
obligations under Section 4.1(b) shall be adjusted for such Calendar
Year as follows:
(A) With respect to that portion of worldwide Net Sales by
Millennium and its Affiliates and sublicensees (but excluding sales by
Non-United States Sublicensees) that is less than [**] Dollars ($[**]),
Millennium's milestones and royalty obligations under Section 4.1(a) and 4.1(b)
shall be reduced by [**]percent ([**]%); and
(B) With respect to that portion of worldwide Net Sales by
Millennium and its Affiliates and sublicensees (but excluding sales by
Non-United States Sublicensees) that equals or exceeds [**] Dollars ($[**]) but
is less than [**] Dollars ($[**]), Millennium's milestones and royalty
obligations under Section 4.1(a) and 4.1(b) shall be reduced by [**] percent
([**]%).
By way of clarification, there shall be no adjustment pursuant
to this Section if Net Sales by Millennium and its Affiliates and sublicensees
(but excluding sales by Non-United States Sublicensees) equals or exceeds [**]
Dollars ($[**]).
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(g) ROYALTY PAYMENTS. Running royalties shall be calculated on an annual
basis but shall be payable on a quarterly basis, within [**] after the
end of each Calendar Quarter, based upon the Net Sales during such
Calendar Quarter, commencing with the Calendar Quarter in which the
First Commercial Sale of a Licensed Product is made, provided that
after the [**] anniversary of January 1st of the Calendar Year in which
the First Commercial Sale of a Licensed Product occurred, the royalty
rate and payment schedule for each Calendar Quarter and Calendar Year
shall be adjusted as follows:
(i) The royalty rate for purposes of payments for the first three
(3) Calendar Quarters of a Calendar Year shall be based on [**]
the previous Calendar Year.
(ii) The royalty rate for each Calendar Year shall be based on the
actual level of Net Sales [**] for such Calendar Year, and any
payments owed by Millennium in addition to those made in the first
three (3) Calendar Quarters for each such Calendar Year shall be
made by the later of (A) [**] after the end of such Calendar Year,
and (B) [**] after the publication of an IMS report or other
comparable report of aggregate sales in United States dollars of
all Antibody Products in all of the Major Markets for such
Calendar Year.
(iii)In the event that the amount of royalties paid by Millennium
in the first three (3) Calendar Quarters of a Calendar Year exceed
the actual royalties owed for such Calendar Year, Millennium shall
have the right to offset such excess payments against any royalty
payments owed for the last Calendar Quarter in such Calendar Year
and any other payments owed to BZL under this Agreement.
(iv) If, in the last Calendar Year in which royalties are due under
this Agreement, Millennium reasonably determines that royalties
paid on a quarterly basis may exceed the actual royalties owed for
such Calendar Year, Millennium shall have the right to deposit the
estimated excess of such royalty payments for such Calendar Year
in an interest-bearing escrow account, with the costs and expenses
of such escrow account shared equally (50%) by the Parties, until
the actual royalties are calculated for such Calendar Year, after
which such royalties shall be paid as provided in clause (ii)
above and any remainder shall be returned to Millennium. The
Parties agree that interest shall follow principal.
Royalties shall be calculated in accordance with GAAP and with the terms of this
Article IV. Only one royalty payment will be due on Net Sales even though the
Manufacture, sale or use of a Licensed Product may be covered by more than one
BZL Patent or BZL Know-How in a country.
(h) ROYALTY STATEMENTS. Each royalty payment hereunder shall be
accompanied by a statement showing (i) Invoiced Sales and Net Sales,
(ii) the number of units of each Licensed Product sold by the paying
Party on a country-by-country basis during the applicable Calendar
Quarter, and (iii) the amount of royalties due on such Net Sales.
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(i) INTEREST ON OVERDUE PAYMENTS. Each Party shall pay to the other
interest on any royalty, milestone or other payments due and payable in
the event that such payments are not made within the applicable time
periods set forth in this Agreement at the prime rate plus 2% per
annum, as published in THE XXXX XXXXXX XXXXXXX, Xxxxxxx Xxxxxx Xxxxxx
Edition, on the last business day preceding the date such payment was
originally due.
(j) DIAGNOSTIC PRODUCTS. Notwithstanding anything to the contrary in this
Agreement, no royalty, milestone or other payments under this Agreement
shall be owed by or on behalf of Millennium or its Affiliates or
sublicensees with respect to the Exploitation of Diagnostic Products
except as provided in the next succeeding sentence. The Parties shall
[**] net profits, the calculation of which shall be agreed to by the
Parties in good faith, or any net royalties and milestones from
sublicensees, received by Millennium or its Affiliates from the sale of
Diagnostic Products. Millennium's payment obligations under this
Section shall terminate, on a country-by-country basis, with respect to
each Diagnostic Product on the later of (i) [**] years after the First
Commercial Sale in such country of such Diagnostic Product, and (ii)
the expiration date in such country of the last to expire of any issued
BZL Patent or Joint Patent that includes at least one Valid Claim
covering the Diagnostic Product, or the use of the Diagnostic Product,
sold in such country or covering the Manufacturing of such Diagnostic
Product in the country in which such Diagnostic Product is
Manufactured. Upon termination of the royalty obligations of Millennium
under this Section with respect to a Diagnostic Product in a country,
the license grants to Millennium in Section 3.1 shall become fully
paid-up exclusive licenses with respect to such Diagnostic Product in
such country.
4.2 RECORDS RETENTION; AUDIT.
(a) RECORD RETENTION. Until the third anniversary of the end of the
Calendar Year in which a Licensed Product or Diagnostic Product is
sold, Millennium shall keep (and shall ensure that its Affiliates and
sublicensees shall keep) records of such sales in sufficient detail to
confirm the accuracy of the royalty calculations hereunder.
(b) AUDIT. Upon the written request of BZL and not more than once in each
Calendar Year, Millennium shall permit an independent certified public
accounting firm of nationally recognized standing selected by BZL, and
reasonably acceptable to Millennium, at BZL's expense, to have access
during normal business hours, and upon reasonable prior written notice,
to such of the records of Millennium and its Affiliates and
sublicensees as may be reasonably necessary to verify the accuracy of
the royalty reports hereunder for any Calendar Year ending not more
than twenty-four (24) months prior to the date of such request;
PROVIDED, HOWEVER, that if such sublicensees object to such an audit by
BZL, Millennium shall have the right to conduct such audit of such
sublicensees at BZL's sole cost and expense and Millennium shall
provide BZL with a written certification disclosing the results of such
audit, which certification shall be attested to by an officer of
Millennium. The accounting firm shall disclose to Millennium and BZL
whether the royalty reports are correct or incorrect and the specific
details concerning its calculations and any discrepancies. No other
information shall be provided to BZL. Any failure by BZL to exercise
its right under
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this Section 4.2(b) with respect to a Calendar Year within the time
period allotted therefor, shall constitute a waiver by BZL of its right
to later object to any payments made by Millennium under this Agreement
during such Calendar Year.
(c) PAYMENT OF ADDITIONAL ROYALTIES. If such accounting firm correctly
concludes that additional royalties were owed during such period,
Millennium shall pay the additional royalties, with interest from the
date originally due at the prime rate plus 2% per annum, as published
in THE XXXX XXXXXX XXXXXXX, Xxxxxxx Xxxxxx Xxxxxx Edition, on the last
business day preceding such date, within sixty (60) days after the date
on which such accounting firm's written report is delivered to
Millennium. If, and only if, the amount of the underpayment is greater
than five percent (5%) of the total amount owed, then Millennium shall
reimburse BZL for all costs related to such audit.
(d) CONFIDENTIALITY. BZL shall treat all information subject to review
under this Section 4.2 in accordance with the confidentiality
provisions of Article VII and shall cause its accounting firm to enter
into a reasonably acceptable confidentiality agreement with Millennium
obligating such firm to retain all such financial information in
confidence pursuant to such confidentiality agreement.
4.3 MODE OF PAYMENT. All payments to BZL or Millennium under this Agreement
shall be made by deposit of United States Dollars in the requisite amount to
such bank account as the receiving Party may from time to time designate by
notice to the paying Party. Payments shall be free and clear of any taxes (other
than withholding and other taxes imposed on the receiving Party), fees or
charges, to the extent applicable. With respect to sales outside the United
States, payments shall be calculated based on currency exchange rates for the
Calendar Quarter for which remittance is made for royalties as set forth below.
For each Calendar Quarter and each currency, such exchange rate shall equal the
arithmetic average of the exchange rates (obtained as described below) for the
last business day of each month during such Calendar Quarter; each daily
exchange rate shall be obtained from THE XXXX XXXXXX XXXXXXX, Xxxxxxx Xxxxxx
Xxxxxx Edition, or, if not so available, as otherwise agreed by the Parties.
ARTICLE V
REPORTS
5.1 COMPLAINTS. BZL shall maintain a record of any and all complaints it
receives with respect to the Licensed Products or Diagnostic Products. BZL shall
notify Millennium in reasonable detail of any complaint received by BZL or any
of its Affiliates within forty-eight (48) hours after the event, and in any
event in sufficient time to allow Millennium and its Affiliates and sublicensees
to comply with any and all regulatory and other requirements imposed upon it in
any Jurisdiction in which the Licensed Products or Diagnostic Products are being
marketed or tested in clinical trials.
5.2 ADVERSE EVENT REPORTING. BZL shall provide Millennium with all information
in its Control necessary or desirable for Millennium to comply with all
Applicable Law with respect to the Licensed Products or Diagnostic Products;
PROVIDED, HOWEVER, that BZL shall provide Millennium with all information in its
Control necessary or desirable for Millennium to comply with all Applicable Law
with respect to the Radiolabel Products prior to the Clinical Decision
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Point with respect thereto. In furtherance thereof, BZL shall (a) develop
appropriate adverse experience reporting procedures; (b) provide to Millennium
any material information on the Licensed Products or Diagnostic Products from
pre-clinical or clinical laboratory, animal toxicology and pharmacology studies,
as well as serious or unexpected adverse experience reports from clinical trials
and commercial experiences with the Licensed Products or Diagnostic Products;
and (c) report and provide such information to Millennium in such a manner and
time so as to enable Millennium to comply with all Applicable Law in countries
for which Regulatory Approval is or will be sought. Notwithstanding the
foregoing, prior to BZL assigning the Existing IND or Other BZL IND to
Millennium pursuant to Section 3.3(b), Millennium shall provide BZL with all
information in its Control necessary or desirable for BZL to comply with all
Applicable Law with respect to the Existing IND or Other BZL IND.
5.3 PRODUCT RECALL.
(a) NOTIFICATION AND RECALL. In the event that any Regulatory Authority
issues or requests a recall or takes similar action in connection with
a Licensed Product or Diagnostic Product, or in the event Millennium
determines that an event, incident or circumstance has occurred that
may result in the need for a recall or market withdrawal, the Party
notified of such recall or similar action, or Millennium if it desires
such recall or similar action, shall, within twenty-four (24) hours,
advise the other Party thereof by telephone or facsimile. Millennium
shall decide whether to conduct a recall (except in the case of a
government-mandated recall) and the manner in which any such recall
shall be conducted.
(b) RECALL EXPENSES. Millennium shall bear the expenses of any recall of
a Licensed Product or Diagnostic Product; PROVIDED, HOWEVER, that BZL
shall bear the expense of a recall to the extent that such recall
resulted from Antibody supplied prior to the Lonza Transfer Date or
Radiolabel Product supplied prior to the Radiolabel Manufacturing
Transfer Date, BZL's or its Affiliates' breach of its obligations
hereunder or the gross negligence or willful misconduct of BZL or its
Affiliates. Such expenses of recall shall include expenses for
notification, destruction or return of the recalled Licensed Product or
Diagnostic Product and any refund to consumers of amounts paid for the
recalled Licensed Product or Diagnostic Product.
ARTICLE VI
INTELLECTUAL PROPERTY RIGHTS
6.1 INTELLECTUAL PROPERTY OWNERSHIP.
(a) OWNERSHIP OF SOLE INVENTIONS. Subject to Section 6.1(b) and the
license grants under Article III, each Party shall own and retain all
right, title and interest in and to any and all: (i) Information and
Inventions that are conceived, discovered, developed or otherwise made,
as necessary to establish authorship, inventorship or ownership under
Applicable Law, by or on behalf of such Party (or its Affiliates or its
licensees or sublicensees (other than the other Party and its
Affiliates)), whether or not patented or patentable, and any and all
Patent and other intellectual property rights with respect thereto,
except to the extent that any such Information and Inventions, or any
Patent or
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other intellectual property rights with respect thereto, are Joint
Inventions, Joint Patents or Joint Know-How; and (ii) other Information
and Inventions, and Patent and other intellectual property rights that
are Controlled (other than pursuant to the license grants set forth in
Article III) by such Party, its Affiliates or its licensees or
sublicensees (other than the other Party and its Affiliates).
(b) OWNERSHIP OF JOINT INVENTIONS, JOINT PATENTS AND JOINT KNOW-HOW.
Subject to the license grants under Article III, Millennium or its
Affiliates, as applicable, together with BZL or its Affiliates, as
applicable, shall each own an equal, undivided interest in (i) any
Joint Inventions, and (ii) all Joint Patents and Joint Know-How. Each
Party and any of its Affiliates shall have the right to Exploit and to
grant licenses to Third Parties to Exploit any Joint Invention, Joint
Patent or Joint Know-How without the consent of the other Party,
provided that such Exploitation is not in violation of or in a manner
inconsistent with the license grants in Article III.
(c) OWNERSHIP OF PRODUCT TRADEMARKS. Millennium shall own and retain all
right, title and interest in and to any and all Trademarks with respect
to the Licensed Product(s) and Diagnostic Product(s) except as set
forth in Section 8.4(a)(i).
(d) OWNERSHIP OF REGULATORY DOCUMENTATION. Subject to the license grants
in Article III, as between the Parties, Millennium shall own and retain
all right, title and interest in and to any and all Regulatory
Documentation, including Regulatory Approvals, with respect to the
Licensed Products or Diagnostic Products and any data contained or
referenced therein; except as set forth in Section 8.4(a)(i); PROVIDED,
HOWEVER, that BZL shall own and retain all right, title and interest in
and to the Existing IND or Other BZL INDs until such time as they are
assigned to Millennium pursuant to Section 3.3(b).
6.2 PROSECUTION OF PATENTS AND TRADEMARKS.
(a) BZL PATENTS. Subject to Sections 6.2(d) and 6.2(e), as between the
Parties, Millennium shall be responsible, at its sole cost and expense,
for obtaining, prosecuting and maintaining throughout the world the BZL
Patents, provided that Millennium shall only be responsible for costs
and expenses arising after the Effective Date. BZL shall (i) be
responsible for the costs and expenses arising prior to the Effective
Date for obtaining, prosecuting and maintaining throughout the world
the BZL Patents, including as of the Effective Date, any unreimbursed
expenses of Cornell Research Foundation, Inc., and (ii) indemnify and
hold harmless Millennium and its Affiliates from any Losses with
respect thereto pursuant to Article IX. In this regard, Millennium
shall use Commercially Reasonable Efforts to file, prosecute and
maintain Patent applications to secure claims in the BZL Patents that
cover Licensed Products or Diagnostic Products or their use (except to
the extent that a Third Party licensor has retained the right to do so,
in which case BZL shall use Commercially Reasonable Efforts to cause
such Third Party licensor to do so). BZL covenants that within two (2)
weeks of the Effective Date, BZL shall provide Cornell Research
Foundation, Inc. and its patent counsel with copies of all patent
prosecution and other patent correspondence and other documents
produced by its patent counsel since transfer of prosecution
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activities from Xxxxx Xxxxxxx. Millennium shall use Commercially
Reasonable Efforts, at its sole cost and expense, to obtain, prosecute
and maintain any Patents owned by Millennium claiming Licensed Products
or Diagnostic Products.
(b) ELECTION NOT TO PROSECUTE. If Millennium elects not (i) to pursue the
filing, prosecution or maintenance of a BZL Patent or any claim therein
in a particular country, or (ii) to take any other action with respect
to a BZL Patent or any claim therein in a particular country that is
necessary or useful to establish or preserve rights thereto, then in
each such case Millennium shall so notify BZL promptly in writing and
in reasonable time to enable BZL to meet any deadlines by which an
action must be taken to establish or preserve any such rights in such
BZL Patent or any such claim therein, as applicable, in such country.
Upon receipt of each such notice by Millennium or if, at any time,
Millennium fails to initiate any such action after a request by BZL
that it do so (and thereafter use Commercially Reasonable Efforts to
timely pursue such action), BZL shall, subject to that certain Letter
Amendment dated April 4, 2001 to the Exclusive License Agreement, dated
as of April 1, 1997, between Cornell Research Foundation, Inc., Xxxxxx
Institute for Cancer Research and BZL, have the right, but not the
obligation, to pursue the filing or registration, or support the
continued prosecution or maintenance, of such BZL Patent or any claim
therein at its expense in such country. If BZL elects to pursue such
filing or registration, as the case may be, or continue such support,
then BZL shall notify Millennium of such election.
(c) JOINT PATENTS. Millennium shall have the sole right to obtain,
prosecute and maintain the Joint Patents throughout the world.
Millennium shall have the sole right to determine in which countries to
obtain, prosecute and maintain the Joint Patents. Millennium and BZL
shall, and shall cause their respective Affiliates, as applicable, to
assist and cooperate with one another in, and share equally the cost
and expense of, filing, prosecuting and maintaining the Joint Patents.
Notwithstanding the above, either Party may decline to pay its share of
costs for filing, prosecuting and maintaining any Joint Patent(s) in a
particular country or particular countries, in which case the declining
Party shall assign, and shall cause its Affiliates to assign, to the
other Party all or their rights, titles and interests in and to any
such Joint Patent(s) in the relevant country or countries whereupon
such Joint Patent(s) shall become Millennium Patent(s) or BZL Patent(s)
in such country or countries, as the case may be.
(d) COOPERATION. Millennium shall regularly provide BZL with copies of
all patent applications for the BZL Patents and the Joint Patents and
trademark registrations filed hereunder and other material submissions
and correspondence with any patent or trademark authorities, as
applicable, in sufficient time to allow for review and comment by BZL.
In addition, Millennium shall provide BZL and its counsel with an
opportunity to consult with Millennium and its counsel regarding the
filing and contents of any application, amendment, registration,
submission, response or correspondence with any patent or trademark
authorities. Each Party shall, at the other Party's request, assist and
cooperate in the filing, registration and prosecution of any
application, amendment, registration, submission, response or
correspondence with respect to any Patents and Trademarks related to
the Licensed Products or Diagnostic Products. Millennium shall grant
BZL's patent attorney a limited power of attorney to
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inspect the files with respect to the BZL Patents and the Joint Patents
in the office of the Patent and Trademark Office.
6.3 ENFORCEMENT OF PATENTS AND TRADEMARKS.
(a) RIGHTS AND PROCEDURES. If either Party determines that any BZL Patent
or Joint Patent is being infringed by a Third Party's activities and
that such infringement could affect the exercise by Millennium of its
rights and obligations under this Agreement, it shall notify the other
Party in writing and provide it with any evidence of such infringement
that is reasonably available. Millennium shall have the first right,
but not the obligation, to attempt to remove any such infringement by
commercially appropriate steps, including filing an infringement suit
or taking other similar action. If required by law in order for
Millennium to prosecute such suit, BZL shall join such suit as a Party
(and to the extent that BZL has licensed its rights from a Third Party,
BZL shall use Commercially Reasonable Efforts to cause such Third Party
to do so). In the event Millennium fails within [**]days following
notice of such infringement, or earlier notifies BZL in writing of its
intent not, to take steps to remove any infringement, BZL shall have
the right to do so at BZL's expense; PROVIDED, HOWEVER, that if
Millennium has commenced negotiations with an alleged infringer for
discontinuance of such infringement within such [**] day period,
Millennium shall have an additional [**] days to conclude its
negotiations before BZL may bring suit for such infringement. The Party
not enforcing the applicable Patent shall provide reasonable assistance
to the other Party, including providing access to relevant documents
and other evidence, making its employees available at reasonable
business hours, and joining the action to the extent necessary to allow
the enforcing Party to maintain the action.
(b) COSTS AND EXPENSES. Any amounts recovered by either Party pursuant to
Section 6.3(a), whether by settlement or judgment, shall be used to
reimburse the Parties for their reasonable costs and expenses in making
such recovery (which amounts shall be allocated pro rata if
insufficient to cover the totality of such expenses), with any
remainder being retained by or paid to Millennium and being deemed "Net
Sales" for which Millennium shall pay BZL a royalty under Section
4.1(b); PROVIDED, HOWEVER, if BZL initiates an infringement suit in
accordance with Section 6.3(a) after the third anniversary of the First
Commercial Sale with respect to Antibody Products that constitute
Competition, any amounts attributable to such Competition that are
recovered after reimbursing the Parties' costs and expenses shall be
shared by BZL and Millennium with BZL receiving [**] percent ([**]%)
and Millennium receiving [**] percent ([**]%) of such remainder.
Notwithstanding the foregoing, in the event Millennium grants an IP
License to a Third Party pursuant to Section 3.4 to any of its rights
under the BZL Patents, the Parties shall [**] in any milestone or
royalty payments or license fees made by such Third Party to Millennium
in connection with such license remaining after Millennium has been
reimbursed for its reasonable costs and expenses in connection with the
settlement and negotiation of such IP License and in connection with
any related dispute, proceeding or negotiations. In the event that a
Party, in an action permitted by Section 6.3(a), fails to recover an
amount, whether by settlement or judgment, in excess of reasonable
costs and expenses, including
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attorneys' fees and costs of litigation, incurred by the Parties and
their respective Affiliates and sublicensees in connection with such
action, Millennium and BZL shall share all such costs and expenses
equally. Millennium shall have the right to offset any amounts owed by
BZL under this Section 6.3(b) but not paid against any payments owed by
Millennium under this Agreement.
(c) RETAINED RIGHTS AND JOINT PATENTS. Except as otherwise provided by
the provisions of Section 6.3(a), each Party shall retain the sole
right to enforce its rights under any Patents (other than the Joint
Patents) and to any Trademarks against all infringers at its sole cost
and expense. In the event of any infringement of any Joint Patent that
does not affect the exercise by Millennium of its rights and
obligations under this Agreement, the Parties shall meet to discuss how
to proceed with respect to such infringement. If the Parties are not
able to agree on a course of action, either Party may assert such Joint
Patent and initiate an action with respect to such infringement,
provided that such Party has given the other Party the opportunity to
join in such assertion and action and to share equally in any expenses
and recoveries in connection therewith. The Party not enforcing such
Joint Patent shall provide reasonable assistance to the other Party,
including providing access to relevant documents and other evidence,
making its employees available at reasonable business hours, and
joining the action to the extent necessary to allow the enforcing Party
to maintain the action.
6.4 INFRINGEMENT OF THIRD PARTY RIGHTS.
(a) THIRD PARTY LICENSES. If (i) in the opinion of Millennium, one or
more Patents have issued to, or other trade secret or intellectual
property rights are owned or controlled by, a Third Party in any
country such that Millennium cannot Exploit the Licensed Products or
Diagnostic Products in such country without infringing such Patent,
trade secret or intellectual property right, or (ii) as a result of any
claim made against Millennium or any of its Affiliates or sublicensees
alleging that the Exploitation of Licensed Products or Diagnostic
Products by Millennium, its Affiliates or any of its sublicensees
infringes or misappropriates any such Patent or any other intellectual
property right in any country, a judgment is entered by a court of
competent jurisdiction from which no appeal is taken within the time
permitted for appeal, such that Millennium cannot Exploit the Licensed
Products or Diagnostic Products in such country without infringing such
Patent or other proprietary rights (each, a "TRIGGERING EVENT"), then,
in either case, Millennium shall have the sole right to negotiate and
obtain a license from such Third Party under such Patent or other
intellectual property rights as necessary for Millennium and its
Affiliates and sublicensees to Exploit the Licensed Products or
Diagnostic Products in such country. Millennium shall be solely
responsible for any and all payments due under any such license. By way
of clarification, BZL shall be solely responsible for any milestone,
royalty or other payments owed under or in connection with any
In-License Agreement.
(b) THIRD PARTY LITIGATION. In the event that a Third Party institutes a
patent, trade secret, trademark or other infringement suit against
Millennium or its Affiliates or sublicensees during the term of this
Agreement, alleging that the Exploitation of a
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Licensed Product or a Diagnostic Product infringes one or more patent,
trade secret or other intellectual property rights held by such Third
Party (an "INFRINGEMENT SUIT"), then Millennium shall have the sole
right, at its sole cost and expense, to assume direction and control of
the defense of claims arising therefrom (including the right to settle
such claims at its sole discretion).
(c) COOPERATION. In the event that a Third Party institutes a Patent,
Trademark, trade secret or other infringement suit against Millennium
or its Affiliates or sublicensees during the term of this Agreement,
BZL shall, and shall cause its Affiliates to, use its best efforts to
cause any Third Parties owning BZL Patents licensed to BZL, to use all
reasonable efforts to assist and cooperate with Millennium in
connection with the defense of such suit.
(d) RETAINED RIGHTS. Nothing in this Section 6.4 shall prevent either
Party, at its own expense, from obtaining any license or other rights
from Third Parties it deems appropriate in order to permit the full and
unhindered exercise of its rights under this Agreement.
ARTICLE VII
CONFIDENTIALITY AND NONDISCLOSURE
7.1 CONFIDENTIALITY OBLIGATIONS.
(a) GENERAL OBLIGATIONS. At all times during the term of this Agreement
and for a period of [**] years following termination or expiration
hereof, each Party shall, and shall cause its officers, directors,
employees and agents to, keep completely confidential and not publish
or otherwise disclose and not use, directly or indirectly, for any
purpose, any Confidential Information furnished or otherwise made known
to it, directly or indirectly, by the other Party, except to the extent
such disclosure or use is expressly permitted by the terms of this
Agreement or is reasonably necessary for the performance of this
Agreement.
(b) BZL OBLIGATIONS. BZL recognizes that by reason of Millennium's
status as an exclusive licensee pursuant to the grant under Section
3.1, Millennium has an interest in BZL's retention in confidence of
certain information of BZL. Accordingly, BZL shall, and shall cause its
officers, directors, employees and agents to, keep completely
confidential, and not publish or otherwise disclose, and not use
directly or indirectly for any purpose, any information relating to the
Licensed Products or Diagnostic Products, the Regulatory Documentation,
including the Regulatory Approvals, or the development, sales or
marketing plans for the Licensed Products or Diagnostic Products or any
Manufacturing Process for the Licensed Products or Diagnostic Products
(the "MILLENNIUM INFORMATION"), except to the extent (i) the Millennium
Information is in the public domain through no fault of BZL, its
Affiliates or any of their respective officers, directors, employees
and agents, (ii) such disclosure or use would be permitted under
Section 7.2, or (iii) such disclosure or use is otherwise expressly
permitted by the terms of this Agreement or is reasonably necessary for
the performance of this Agreement. For clarification, the disclosure by
BZL to
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Millennium or by Millennium to BZL of Millennium Information shall not
cause such information to cease to be subject to the confidentiality
provisions of this Section 7.1(b).
7.2 PERMITTED DISCLOSURES. Each Party may disclose Confidential Information
to the extent that such disclosure is:
(a) Made in response to a valid order of a court of competent jurisdiction
or other supra-national, federal, national, regional, state, provincial
or local governmental or regulatory body of competent jurisdiction;
PROVIDED, HOWEVER, that the receiving Party shall first have given
notice to the disclosing Party and given the disclosing Party a
reasonable opportunity to quash such order and to obtain a protective
order requiring that the Confidential Information and documents that
are the subject of such order be held in confidence by such court or
agency or, if disclosed, be used only for the purposes for which the
order was issued; and PROVIDED FURTHER that if a disclosure order is
not quashed or a protective order is not obtained, the Confidential
Information disclosed in response to such court or governmental order
shall be limited to that information which is legally required to be
disclosed in response to such court or governmental order;
(b) Otherwise required by law, in the opinion of legal counsel to the
receiving Party as expressed in an opinion letter in form and substance
reasonably satisfactory to the disclosing Party, which shall be
provided to the disclosing Party at least two (2) business days prior
to the receiving Party's disclosure of the Confidential Information
pursuant to this Section 7.2(b);
(c) Made by the receiving Party to the Regulatory Authorities or Patent
authorities as required in connection with any filing, application or
request for Regulatory Approval, Patent approval or other intellectual
property protection; PROVIDED, HOWEVER, that reasonable measures shall
be taken to assure confidential treatment of such information to the
extent available;
(d) Made by Millennium or its Affiliates or sublicensees to Third Parties
as may be necessary or useful in connection with the Exploitation of
any Licensed Product or Diagnostic Product, including subcontracting
and sublicensing transactions in connection therewith;
(e) Upon a Reversion Termination, made by BZL or its Affiliates to Third
Parties in connection with the Exploitation of any Licensed Product or
Diagnostic Product, as applicable, including permissible subcontracting
and sublicensing transactions in connection therewith; or
(f) Upon an IP Reversion Termination in a country, made by BZL or its
Affiliates to Third Parties in connection with the Exploitation of any
Licensed Product or Diagnostic Product, as applicable, solely in such
country, including permissible subcontracting and sublicensing
transactions in connection therewith.
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7.3 CONFIDENTIAL INFORMATION.
(a) DEFINED. "CONFIDENTIAL INFORMATION" shall mean all information and
know-how and any tangible embodiments thereof provided by such Party to
the other Party either in connection with the discussions and
negotiations pertaining to this Agreement or in the course of
performing this Agreement, including the terms of this Agreement; data;
knowledge; practices; processes; ideas; research plans; engineering
designs and drawings; research data; manufacturing processes and
techniques; scientific, manufacturing, marketing and business plans;
and financial and personnel matters relating to the disclosing Party or
to its present or future products, sales, suppliers, customers,
employees, investors or business.
(b) EXCLUSIONS. Notwithstanding the foregoing, Confidential Information
shall not include any information that:
(i) is or hereafter becomes part of the public domain by public use,
publication, general knowledge or the like through no wrongful
act, fault or negligence on the part of receiving Party;
(ii) can be demonstrated by documentation or other competent proof to
have been in the receiving Party's possession prior to disclosure
by the disclosing Party;
(iii)is subsequently received by the receiving Party from a Third
Party who is not bound by any obligation of confidentiality with
respect to said information;
(iv) is generally made available to Third Parties by disclosing Party
without restriction on disclosure; or
(v) is independently developed by or for the receiving Party without
reference to the disclosing Party's Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of the receiving Party merely
because the Confidential Information is embraced by more general information in
the public domain or in the possession of the receiving Party. Further, any
combination of Confidential Information shall not be considered in the public
domain or in the possession of the receiving Party merely because individual
elements of such Confidential Information are in the public domain or in the
possession of the receiving Party unless the combination and its principles are
in the public domain or in the possession of the receiving Party.
7.4 USE OF NAME. Neither Party shall mention or otherwise use the name,
insignia, symbol, trademark, trade name or logotype of the other Party (or any
abbreviation or adaptation thereof) in any publication, press release,
promotional material or other form of publicity without the prior written
approval of such other Party in each instance. The restrictions imposed by this
Section shall not prohibit either Party from making any disclosure identifying
the other Party that is required by Applicable Law. Further, Millennium and its
Affiliates and sublicensees shall have the right to use the name of BZL and its
Affiliates to the extent necessary in connection
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with the Exploitation of Licensed Products or Diagnostic Products, including
subcontracting and sublicensing transactions in connection therewith.
7.5 PRESS RELEASES. Press releases or other similar public communication by
either Party relating to this Agreement shall be approved in advance by the
other Party, which approval shall not be unreasonably withheld or delayed,
except for those communications required by Applicable Law (which shall be
governed by Section 7.2(b)), disclosures of information for which consent has
previously been obtained, information that has been previously disclosed
publicly or as otherwise set forth in this Agreement.
ARTICLE VIII
TERM AND TERMINATION
8.1 TERM. This Agreement shall commence upon the Effective Date and shall
continue until terminated in accordance with this Article VIII.
8.2 TERMINATION OF THIS AGREEMENT FOR MATERIAL BREACH. Any material failure by
a Party to comply with any of its material obligations contained herein or any
material breach by a Party of any representation, warranty or covenant set forth
in Article X, shall entitle the Party not in default to give to the Party in
default notice specifying the nature of the default, requiring the defaulting
Party to make good or otherwise cure such default, and stating its intention to
terminate if such default is not cured. If such default is not cured within [**]
[**] in the case of a default relating to payment of money or [**] in the case
of any other default (the "CURE PERIOD") after the receipt of such notice (or,
if such default cannot be cured within such Cure Period, if the Party in default
does not commence actions to cure such default within [**] after the receipt of
such notice and thereafter use Commercially Reasonable Efforts to continue such
actions), the Party not in default shall be entitled, without prejudice to any
of its other rights conferred on it by this Agreement, and in addition to any
other remedies available to it by law or in equity, to terminate this Agreement
in its entirety; PROVIDED, HOWEVER, that in the event that Millennium is the
Party in default and the default is with respect to Millennium's failure to
comply with its obligation to use Commercially Reasonable Efforts as required
under Section 2.3 with respect to a Licensed Product in a particular Major
Market, BZL shall have the right to terminate this Agreement only after it
complies with Section 2.4 and only with respect to such Major Market and not in
its entirety; and PROVIDED FURTHER that any right to terminate under this
Section 8.2 shall be stayed in the event that, during any Cure Period, the Party
alleged to have been in default shall have initiated dispute resolution in
accordance with Section 11.6 with respect to the alleged default, which stay
shall last so long as the initiating Party diligently and in good faith
cooperates in the prompt resolution of such dispute resolution proceedings. Any
breach by Xx. Xxxx Xxxxxx of that certain letter agreement between Millennium
and Xx. Xxxxxx, dated April 4, 2001, shall be deemed to be a material breach of
this Agreement and Millennium shall have the right to terminate this Agreement
in accordance with this Section 8.2 subject to the right to cure set forth
above. Notwithstanding the foregoing, in the event of a material breach by
Millennium of its obligations under this Agreement with respect to the
Diagnostic Product, BZL shall only have the right to terminate this Agreement
with respect to the Diagnostic Product and not with respect to the Licensed
Product.
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8.3 TERMINATION BY MILLENNIUM.
(a) AT WILL. Millennium shall have the right in its sole discretion to
terminate this Agreement with respect to the Licensed Product and/or
the Diagnostic Product, for any reason or for no reason, at any time,
upon [**] prior written notice to BZL.
(b) FOR CAUSE. Millennium shall also have the right to terminate this
Agreement with respect to the Licensed Product and/or the Diagnostic
Product upon written notice to BZL if at any time Millennium
determines, in its sole discretion, (i) that the safety or efficacy of
a Licensed Product or a Diagnostic Product, as applicable, does not
support its Exploitation, or (ii) that medical, scientific or technical
considerations could adversely affect the Exploitation of such Licensed
Product or Diagnostic Product, as applicable.
(c) INFRINGEMENT OF THIRD PARTY RIGHTS.
(i) If a Triggering Event occurs with respect to a country,
Millennium shall have the right upon written notice to BZL to
terminate this Agreement with respect to the Licensed Product
and/or the Diagnostic Product, as applicable, in such country if
at any time (A) Millennium is unable to obtain such a license, or
(B) Millennium in good faith believes that negotiation with a
Third Party pursuant to Section 6.4(a) with respect to such
country is not likely to result in a commercially reasonable
agreement; PROVIDED, HOWEVER, that Millennium shall have the right
to terminate this Agreement with respect to all of Europe if such
country is in Europe and Millennium shall have the right to
terminate this Agreement in its entirety if such country is or is
in a Major Market.
(ii) If a Third Party institutes an Infringement Suit with respect
to a Licensed Product and/or a Diagnostic Product in country,
Millennium shall have the right upon written notice to BZL to
terminate this Agreement with respect to such product in such
country if (A) within [**] of filing, such Infringement Suit is
not settled, dismissed or otherwise disposed of on terms
reasonably acceptable to Millennium, or (B) Millennium in good
faith believes that the outcome of such Infringement Suit is not
likely to be favorable; PROVIDED, HOWEVER, that Millennium shall
have the right to terminate this Agreement with respect to all of
Europe if such country is in Europe and Millennium shall have the
right to terminate this Agreement in its entirety if such country
is or is in a Major Market.
8.4 CONSEQUENCES OF TERMINATION.
(a) RETURN OF MATERIAL; TERMINATION OF RIGHTS.
(i) Upon termination of this Agreement by Millennium pursuant to
Sections 8.3(a) or 8.3(b) or BZL pursuant to Section 8.2 with
respect to the Licensed Product and/or the Diagnostic Product, as
applicable, in the entire Territory (each, a "REVERSION
TERMINATION"):
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(A) Each Party shall return all data, files, records and
other documents containing or comprising such other Party's Information and
Inventions or other Confidential Information and to which such Party does not
retain rights hereunder (except one copy of which may be retained for archival
purposes);
(B) If BZL so requests in writing within [**]after notice of
a Reversion Termination, Millennium shall use Commercially Reasonable Efforts to
assign to BZL or its designee the Lonza Agreement, the Radiolabel Manufacturing
Agreement, and other Third Party agreements only with respect to the manufacture
of Licensed Product (other than an Immunotoxin Product) or Diagnostic Product,
as applicable, or any intermediate thereof, as well as any quantities of
Licensed Products (other than Immunotoxin Product) or Diagnostic Products, as
applicable, in Millennium's control, provided that (1) BZL shall bear any and
all costs and expenses of such transfer and shall reimburse Millennium for the
cost of any such Licensed Product or Diagnostic Product, as applicable, (2) BZL
shall assume, insofar as they relate to the time period beginning on and
including the day following the date of such assignments, any and all of
Millennium's and its Affiliates' and sublicensees' financial and other
obligations under such agreements and shall reimburse Millennium for any and all
license fees, milestone, royalties or other payments made by Millennium under
such agreements with respect to any such Licensed Products or Diagnostic
Products, and (3) BZL shall indemnify and hold harmless Millennium and its
Affiliates and sublicensees from any Losses with respect to any breach of any
such agreement by BZL or its Affiliates or its sublicensees or any use of any
such Licensed Products or Diagnostic Products, as applicable, or intermediates
pursuant to Article IX;
(C) If BZL notifies Millennium in writing within [**] after
notice of a Reversion Termination for the Licensed Product that it wishes to
obtain rights to the immunotoxin that is included in the Immunotoxin Product,
Millennium shall sublicense Millennium's rights to such immunotoxin under the
Cytotoxin Agreement to BZL for use in connection with the Antibody that is
included in the lead Immunotoxin Product that is being developed or
commercialized as of the effective date of such termination and any Improvements
to such Antibody made by BZL or its Affiliates or sublicensees, provided that
(1) BZL shall bear any and all costs and expenses of such sublicense and shall
reimburse Millennium for the cost of any such Licensed Product, (2) BZL shall
assume, insofar as they relate to the time period beginning on and including the
day following the effective date of such sublicense, any and all of Millennium's
and its Affiliates' and sublicensees' financial and other obligations under the
Cytotoxin Agreement and shall reimburse Millennium for any and all license fees,
milestone, royalties or other payments made by Millennium under the Cytotoxin
Agreement with respect to any Licensed Products, and (3) BZL shall indemnify and
hold harmless Millennium and its Affiliates and sublicensees from any Losses
with respect to any breach by BZL or its Affiliates or its sublicensees of any
such agreement or BZL's performance thereunder pursuant to Article IX;
(D) If BZL so requests in writing within [**] after notice of
a Reversion Termination with respect to the Licensed Product or the Diagnostic
Product, Millennium and its Affiliates shall grant to BZL and its Affiliates a
nonexclusive, royalty-bearing license in the Territory, with the right to grant
sublicenses, under Millennium's and its Affiliates' rights, titles and interests
in and to any Patents owned or Controlled by
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Millennium that are Improvements to the BZL Patents and any Patents owned or
Controlled by Millennium that cover the Manufacture or use of the lead (and only
the lead) Licensed Product or Diagnostic Product, as applicable, as was being
developed or commercialized by Millennium or its Affiliates as of the effective
date of such termination (as distinguished from the general Exploitation of the
Antibodies) to develop and commercialize only such lead Licensed Product or
Diagnostic Product for all purposes, and to develop and commercialize
Improvements to such Licensed Product or Diagnostic Product made by BZL or its
Affiliates or sublicensees, provided that such Improvements are Licensed
Products or Diagnostic Products, as applicable, and in each case only for so
long as BZL or its Affiliates or its sublicensees are using Commercially
Reasonable Efforts to develop and commercialize such Licensed Product,
Diagnostic Product or Improvement, as applicable, and provided that BZL shall
indemnify and hold harmless Millennium and its Affiliates and sublicensees from
any Losses with respect to such license pursuant to Article IX, and provided
that BZL does hereby, and shall cause its Affiliates and sublicensees to, grant
to Millennium and its Affiliates and sublicensees, a nonexclusive, perpetual,
irrevocable, worldwide, royalty-free license, with the right to grant
sublicenses, under BZL's and its Affiliates' and sublicensees' rights, titles
and interests in and to any Patents or Information and Inventions with respect
to such Improvements that are Improvements to the Patents owned or Controlled by
Millennium or the inventions claimed therein; PROVIDED, HOWEVER, that to the
extent that any such Patents are licensed by Millennium or its Affiliates from a
Third Party, BZL shall, in addition to any royalty obligations to Millennium
under Section 8.4(a)(i)(I), (x) bear any and all costs and expenses of such
sublicense, (y) assume, insofar as they relate to the time period beginning on
and including the day following the effective date of such sublicense, any and
all of Millennium's and its Affiliates' and sublicensees' financial and other
obligations under such Third Party agreement with respect to any Licensed
Products, Diagnostic Products and Improvements, and shall reimburse Millennium
for any and all license fees, milestone, royalties or other payments made by
Millennium under such agreement with respect to any Licensed Products,
Diagnostic Products or Improvements, and (z) indemnify and hold harmless
Millennium and its Affiliates and sublicensees from any Losses with respect to
any breach by BZL or its Affiliates or its sublicensees of any such Third Party
agreement or sublicense or BZL's performance thereunder pursuant to Article IX;
(E) If BZL so requests in writing within [**] after notice of
a Reversion Termination with respect to the Licensed Product or the Diagnostic
Product, Millennium and its Affiliates shall assign to BZL and its Affiliates
the Regulatory Documentation to Exploit Licensed Products or Diagnostic
Products, as applicable, for all purposes, provided that BZL shall indemnify and
hold harmless Millennium and its Affiliates and sublicensees from any Losses
with respect to the use of such Regulatory Documentation pursuant to Article IX;
(F) If Millennium has commercialized a Licensed Product or
Diagnostic Product prior to a Reversion Termination with respect thereto, and
BZL so requests in writing within [**] after notice thereof, Millennium shall
assign to BZL any Trademarks owned by Millennium or its Affiliates that are used
solely to market such Licensed Product or Diagnostic Product, as applicable,
provided that BZL shall indemnify and hold harmless Millennium and its
Affiliates and sublicensees from any Losses with respect to any the use of such
Trademarks pursuant to Article IX;
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(G) All licenses and other rights granted by each Party to
the other under Article III with respect to the Licensed Product or Diagnostic
Product, as applicable, shall terminate;
(H) Upon a Reversion Termination, Millennium hereby assigns
and transfers to BZL all of its respective rights, titles and interests in and
to the NDA Agreement. BZL hereby agrees that it shall assume, insofar as they
relate to the time period beginning on and including the day following the date
of such assignment, all the obligations and liabilities of Millennium under the
NDA Agreement;
(I) In consideration for the foregoing license grants and
assignments, BZL shall pay to Millennium:
(1) the following royalties on Net Sales of any
Licensed Products Exploited by or on behalf of BZL, its Affiliates or
sublicensees based on the phase of development that was underway for the first
Immunotoxin Product or Radiolabel Product at the effective date of a Reversion
Termination:
TERMINATION PHASE ROYALTY
Prior to [**] Product [**]%
After [**] Product [**] [**]%
At the [**] Clinical Trials [**] Clinical Trials [**]%
After [**] [**]%
By way of clarification, once the first Immunotoxin Product or
Radiolabel Product achieves a royalty threshold, all subsequent Immunotoxin
Products or Radiolabel Products, as applicable, shall be subject to such royalty
obligation, with the royalty rate for Immunotoxin Products based on the phase of
development for Immunotoxin Products and the royalty rate for Radiolabel
Products based on the phase of development for Radiolabel Products, and
(2) the following portion of any net profits, the
calculation of which shall be agreed to by the Parties in good faith, or
royalties and milestone payment from sublicensees, received by BZL or its
Affiliates from the sale of Diagnostic Products based on the phase of
development that was underway for the first Immunotoxin Product at the effective
date of a Reversion Termination, unless Millennium elects to proceed with a
Radiolabel Product in lieu of an Immunotoxin Product, in which case such
portions shall be based on the first Radiolabel Product:
TERMINATION PHASE OF IMMUNOTOXIN PRODUCT OR,
IN THE ALTERNATIVE, RADIOLABEL PRODUCT PORTION
Prior to [**] [**]%
After [**] [**]%
After [**] [**]%
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By way of clarification, once the first Immunotoxin Product or
Radiolabel Product, as applicable, achieves a phase of development, all
Diagnostic Products shall be subject to the applicable sharing obligation.
(ii) Upon termination of this Agreement by Millennium pursuant to
Section 8.3(c) with respect to the Licensed Product and/or
Diagnostic Product, as applicable, in one or more countries (an
"IP REVERSION TERMINATION"):
(A) Each Party shall return all data, files, records and
other documents containing or comprising such other Party's Information and
Inventions or other Confidential Information with respect to such country or
countries and to which such Party does not retain rights hereunder (except one
copy of which may be retained for archival purposes);
(B) If BZL so requests in writing within [**]after notice of
an IP Reversion Termination with respect to such country or countries,
Millennium and its Affiliates shall grant to BZL and its Affiliates a
nonexclusive, royalty-bearing license in such country or countries, with the
right to grant sublicenses, under Millennium's and its Affiliates' rights,
titles and interests in and to any Patents owned or Controlled by Millennium
that are Improvements to the BZL Patents and any Patents owned or Controlled by
Millennium that cover the Manufacture or use of the lead (and only the lead)
Licensed Product or Diagnostic Product, as applicable, as was being developed or
commercialized by Millennium or its Affiliates in such country or countries as
of the effective date of such termination (as distinguished from the general
Exploitation of the Antibodies) to develop and commercialize only such lead
Licensed Product or Diagnostic Product for all purposes, and to develop and
commercialize Improvements to such Licensed Product or Diagnostic Product made
by BZL or its Affiliates or sublicensees, provided that such Improvements are
Licensed Products or Diagnostic Products, as applicable, and in each case only
in such country or countries and only for so long as BZL or its Affiliates or
its sublicensees are using Commercially Reasonable Efforts to develop and
commercialize such Licensed Product or Diagnostic Product, as applicable, in
such country or countries and provided that BZL shall indemnify and hold
harmless Millennium and its Affiliates and sublicensees from any Losses with
respect to such license pursuant to Article IX, and provided that BZL does
hereby, and shall cause its Affiliates and sublicensees to, grant to Millennium
and its Affiliates and sublicensees a nonexclusive, perpetual, irrevocable,
worldwide, royalty-free license, with the right to grant sublicenses, under
BZL's and its Affiliates' and sublicensees' rights, titles and interests in and
to any Patents or Information and Inventions with respect to such Improvements
that are Improvements to the Patents owned or Controlled by Millennium or the
inventions claimed therein, PROVIDED, HOWEVER, that to the extent that any such
Patents are licensed from a Third Party, BZL shall, in addition to any royalty
obligations to Millennium under Section 8.4(a)(ii)(G), (x) bear any and all
costs and expenses of such sublicense in such country or countries, (y) assume,
insofar as they relate to the time period beginning on and including the day
following the effective date of such sublicense, any and all of Millennium's and
its Affiliates' and sublicensees' financial and other obligations under such
Third Party agreement with respect to Licensed Products, Diagnostic Products and
Improvements with respect to such country or countries, and shall reimburse
Millennium for any and all license fees, milestone, royalties or other payments
made by Millennium under such Third Party agreement with respect to any Licensed
Products, Diagnostic
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Products or Improvements that relate to such country or countries, and (z)
indemnify and hold harmless Millennium and its Affiliates and sublicensees from
any Losses with respect to any breach by BZL or its Affiliates or its
sublicensees of any such sublicense or Third Party agreement or BZL's
performance thereunder pursuant to Article IX;
(C) If BZL so requests in writing within [**] after notice of
an IP Reversion Termination with respect to such country or countries and if
Millennium is Manufacturing such Licensed Product or Diagnostic Product, as
applicable, at such time, and if after meeting the requirements of Millennium,
its Affiliates and other sublicensees, Millennium has excess production
capability, Millennium and its Affiliates shall Manufacture and supply BZL with
a reasonable amount of Licensed Product or Diagnostic Product, as applicable, in
such country or countries on commercially reasonable terms, for two (2) years or
such other time period as the Parties may agree to enable BZL to obtain an
alternate supplier; PROVIDED, HOWEVER, that Millennium shall have no such supply
obligation if it reasonably believes that such supply would cause Millennium to
infringe or contributorily infringe or induce another to infringe any Patents,
trade secrets or intellectual property rights of others and, in any event, BZL
shall indemnify and hold harmless Millennium and its Affiliates and sublicensees
from any Losses with respect to any such infringement pursuant to Article IX;
(D) If BZL so requests in writing within [**] after notice of
an IP Reversion Termination with respect to such country or countries,
Millennium and its Affiliates shall grant to BZL and its Affiliates an exclusive
(including with regard to Millennium and its Affiliates), royalty-bearing,
license in such country or countries, with the right to grant sublicenses, to
use and reference the Regulatory Documentation to Exploit Licensed Products or
Diagnostic Products, as applicable, for all purposes solely in such country or
countries, provided that BZL shall indemnify and hold harmless Millennium and
its Affiliates and sublicensees from any Losses with respect to the use of such
Regulatory Documentation pursuant to Article IX;
(E) If Millennium has commercialized a Licensed Product or
Diagnostic Product in a country prior to an IP Reversion Termination in such
country, and BZL so requests in writing within [**] after notice thereof,
Millennium and its Affiliates shall grant to BZL and its Affiliates an exclusive
(including with regard to Millennium and its Affiliates), royalty-bearing,
license in such country, with the right to grant sublicenses, to use any
Trademarks owned by Millennium or its Affiliates that are used in such country
solely to market such Licensed Product or Diagnostic Product, as applicable, in
such country solely for purposes of marketing such Licensed Product or
Diagnostic Product, as applicable, in such country, provided that BZL shall
indemnify and hold harmless Millennium and its Affiliates and sublicensees from
any Losses with respect to any the use of such Trademarks pursuant to Article
IX;
(F) All licenses and other rights granted by each Party to
the other under Article III with respect to the Licensed Product or Diagnostic
Product, as applicable, in such country or countries shall terminate;
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(G) In consideration for the foregoing license grants and
assignments, BZL shall pay to Millennium:
(1) the following royalties on Net Sales of any
Licensed Products Exploited by or on behalf of BZL, its Affiliates or
sublicensees in such country or countries based on the phase of development that
was underway for the first Immunotoxin Product or Radiolabel Product at the
effective date of an IP Reversion Termination:
TERMINATION PHASE ROYALTY
Prior to [**] Product [**]%
After [**] Product [**] [**]%
At the [**] Clinical Trials [**] Clinical Trials [**]%
After [**] [**]%
By way of clarification, once the first Immunotoxin Product or
Radiolabel Product achieves a royalty threshold, all subsequent Immunotoxin
Products or Radiolabel Products, as applicable, shall be subject to such royalty
obligation, with the royalty rate for Immunotoxin Products based on the phase of
development for Immunotoxin Products and the royalty rate for Radiolabel
Products based on the phase of development for Radiolabel Products.
(2) the following portion of any net profits, the
calculation of which shall be agreed to by the Parties in good faith, or
royalties and milestone payment from sublicensees, received by BZL or its
Affiliates from the sale of Diagnostic Products in such country or countries
based on the phase of development that was underway for the first Immunotoxin
Product at the effective date of an IP Reversion Termination, unless Millennium
elects to proceed with a Radiolabel Product in lieu of an Immunotoxin Product,
in which case such percentages shall be based on the first Radiolabel Product:
TERMINATION PHASE OF IMMUNOTOXIN PRODUCT OR,
IN THE ALTERNATIVE, RADIOLABEL PRODUCT PORTION
Prior to [**] [**]%
After the [**] [**]%
After [**] [**]%
By way of clarification, once the first Immunotoxin Product or
Diagnostic Product, as applicable, achieves a phase of development, all
Diagnostic Products shall be subject to the applicable sharing obligation.
(H) Any Net Sales with respect to such country or countries
shall be excluded from the royalty calculations set forth in Section 4.1(c) with
respect to any remaining countries within the Territory; PROVIDED, HOWEVER, that
if BZL or any of its Affiliates or sublicensees sells a Licensed Product or
Diagnostic Product, as applicable, outside
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the Territory, then, to the extent permitted by law, each Party (A) shall, and
shall cause its Affiliates and sublicensees to, Manufacture, distribute, market,
promote, offer for sale and sell Licensed Products or Diagnostic Products, as
applicable, and intermediates thereof only in those countries in which it is
permitted to do so under this Agreement, and (B) shall not, and shall not permit
its Affiliates and permitted sublicensees to, distribute, market, promote, offer
for sale or sell Licensed Products or Diagnostic Products, as applicable, or
intermediates thereof directly or indirectly (1) to any Person outside such
countries, or (2) to any Person inside such countries that such Party has reason
to believe (Y) might directly or indirectly distribute, market, promote, offer
for sale or sell Licensed Products or Diagnostic Products, as applicable, or
intermediates thereof outside such countries or assist another Person to do so,
or (X) has directly or indirectly distributed, marketed, promoted, offered for
sale or sold Licensed Products or Diagnostic Products, as applicable, or
intermediates thereof outside such countries or assisted another Person to do
so; and
(iii)Upon termination of this Agreement by Millennium pursuant to
Section 8.2, (A) BZL shall return all data, files, records and
other materials in its possession or control relating to the
Licensed Products or Diagnostic Products or containing or
comprising Millennium's Information and Inventions or other
Confidential Information (including Millennium Information, as
applicable) (except one copy of which may be retained for archival
purposes), (B) all licenses and other rights granted by Millennium
to BZL under Articles III and V shall terminate, (C) at
Millennium's election, all licenses and other rights granted by
BZL and its Affiliates to Millennium and its Affiliates under
Article III shall continue in perpetuity subject to the milestone
and royalty obligations set forth under Article IV, (D) Millennium
shall have the right, in its sole discretion, to grant to Third
Parties sublicenses under the licenses granted in Sections 3.1 in
the Territory without the consent of BZL, and (E) any amounts
recovered by Millennium, whether by settlement or judgment, may be
offset against any amounts owed to BZL pursuant to this Agreement.
(b) REMEDIES. The rights and remedies in Section 8.4(a)(i), 8.4(a)(ii)
and 8.4(a)(iii) shall be cumulative and in addition to any other rights
or remedies that may be available to Millennium. Except in the event of
Millennium's failure to make any milestone or royalty payments or
reimbursement payments due and payable to BZL hereunder and except as
set forth in Section 11.10, the rights and remedies in Section
8.4(a)(i) and 8.4(a)(ii) shall be BZL's sole and complete remedy in the
event of a Reversion Termination or an IP Reversion Termination;
PROVIDED, HOWEVER, that in the event that Millennium terminates
pursuant to Section 8.3(a) prior to the Clinical Decision Point for the
Immunotoxin Product or BZL terminates for a breach by Millennium prior
to the Clinical Decision Point for the Immunotoxin Product, BZL shall
have the right to xxx to recover any damages that it proves, provided
that in no event shall BZL's recovery exceed the greater of (i) [**],
and (ii) the sum of (A) $[**] (B) the [**] in connection with the
Development Activities (including [**] through the effective date of
such termination); and PROVIDED FURTHER that BZL shall have no right to
recover any amount under this Section (1) if Millennium materially
complied with the Development Plan for the relevant period that was
agreed to by the Parties, or (2) if Millennium's costs and expenses for
the relevant period equal or exceed those set forth
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in a Development Budget for such period that was agreed to by the
Parties, or (3) if any such failure was a result of, or any such
termination was a result of, a force majeure event or any act or
omission of BZL or NDA.
(c) FURTHER ASSURANCES. Upon a termination pursuant to this Article VIII,
each Party shall duly execute and deliver, or cause to be duly executed
and delivered, such instruments and shall do and cause to be done such
acts and things, including the filing of such assignments, agreements,
documents and instruments, as may be necessary under, or as the other
Party may reasonably request in connection with, or to carry out more
effectively the purpose of, or to better assure and confirm unto the
Parties their respective rights under this Article VIII.
8.5 ACCRUED RIGHTS; SURVIVING OBLIGATIONS.
(a) ACCRUED RIGHTS. Termination or expiration of this Agreement for any
reason shall be without prejudice to any rights that shall have accrued
to the benefit of a Party prior to such termination or expiration. Such
termination or expiration shall not relieve a Party from obligations
that are expressly indicated to survive the termination or expiration
of this Agreement.
(b) SURVIVAL. Without limiting the foregoing, Sections 2.1(f), 2.1(i)
(with respect to obligations arising prior to expiration or
termination), 3.5, 5.1 (in the event of termination by Millennium for
BZL's breach of this Agreement), 5.2 (in the event of termination by
Millennium for BZL's breach of this Agreement), 5.3 (with respect to
Licensed Product supplied by Millennium prior to such termination),
6.1, 6.2(a) (in the event of termination by Millennium for BZL's breach
of this Agreement), 6.2(b) (in the event of termination by Millennium
for BZL's breach of this Agreement), 6.2(c), 6.2(d), 8.4, 8.5, 8.6,
10.4 and Articles IV, VII, IX and XI of this Agreement shall survive
the termination or expiration of this Agreement for any reason.
(c) WORK-IN-PROGRESS. Upon termination of this Agreement with respect to
one or more countries by BZL pursuant to Section 8.2, Millennium shall
be entitled, during the following [**], to finish any work-in-progress
and to sell any inventory of the Licensed Product(s) or Diagnostic
Product(s) that remains on hand as of the date of the termination, so
long as Millennium pays BZL the royalties applicable to said subsequent
sales in accordance with the terms and conditions set forth in this
Agreement.
8.6 RIGHTS IN BANKRUPTCY. All rights and licenses granted under or pursuant to
this Agreement by Millennium or BZL are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of
right to "intellectual property" as defined under Section 101 of the United
States Bankruptcy Code. The Parties agree that the Parties, as licensees of such
rights under this Agreement, shall retain and may fully exercise all of their
rights and elections under the United States Bankruptcy Code. The Parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against either Party under the United States Bankruptcy Code, the Party
hereto that is not a Party to such proceeding shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any such
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intellectual property and all embodiments of such intellectual property, which,
if not already in the non-subject Party's possession, shall be promptly
delivered to it (a) upon any such commencement of a bankruptcy proceeding upon
the non-subject Party's written request therefor, unless the Party subject to
such proceeding continues to perform all of its obligations under this Agreement
or (b) if not delivered under (a) above, following the rejection of this
Agreement by or on behalf of the Party subject to such proceeding upon written
request therefor by the non-subject Party.
ARTICLE IX
INDEMNITY
9.1 INDEMNIFICATION OF MILLENNIUM. BZL shall indemnify Millennium, its
Affiliates and their respective directors, officers, employees and agents, and
defend and save each of them harmless, from and against any and all losses,
damages, liabilities, costs and expenses (including reasonable attorneys' fees
and expenses) in connection with any and all suits, investigations, claims or
demands by Third Parties (collectively, "LOSSES") arising from or occurring as a
result of (a) (i) the breach by BZL of this Agreement, (ii) the gross negligence
or willful misconduct on the part of BZL or its Affiliates in performing their
obligations under this Agreement, (iii) any defect in the supply and Manufacture
of any component of the Radiolabel Product or the inventory of Antibody supplied
by BZL pursuant to Section 2.1(g), (iv) any actions or omissions of BZL or its
Affiliates prior to the Effective Date, or (v) any Exploitation of Licensed
Products or Diagnostic Products by BZL or its Affiliates or sublicensees after a
termination by Millennium pursuant to Article VIII, except for those Losses for
which Millennium has an obligation to indemnify BZL pursuant to Section 9.2, as
to which Losses each Party shall indemnify the other to the extent of their
respective liability for the Losses, and (b) upon a Reversion Termination or an
IP Reversion Termination, product liability or personal injury claims regarding
testing, production, Manufacture, promotion, import, sale or use by any person
of a Licensed Product or Diagnostic Product which is Manufactured or sold by BZL
or an Affiliate or sublicensee of BZL.
9.2 INDEMNIFICATION OF BZL. Millennium shall indemnify BZL, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all Losses arising from or
occurring as a result of (a) the breach by Millennium of this Agreement or (b)
the gross negligence or willful misconduct on the part of Millennium or its
Affiliates in performing their obligations under this Agreement, or (c) product
liability or personal injury claims regarding testing, production, Manufacture,
promotion, import, sale or use by any person of a Licensed Product or Diagnostic
Product (except for any defect in the supply and Manufacture of any component of
the Radiolabel Product or the inventory of Antibody supplied by BZL pursuant to
Section 2.1(g)) which is Manufactured or sold by Millennium or an Affiliate or
sublicensee of Millennium, except for those Losses for which BZL has an
obligation to indemnify Millennium and its Affiliates pursuant to Section 9.1,
as to which Losses each Party shall indemnify the other to the extent of their
respective liability for the Losses.
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9.3 INDEMNIFICATION PROCEDURE.
(a) NOTICE OF CLAIM. The indemnified Party shall give the indemnifying
Party prompt written notice (an "INDEMNIFICATION CLAIM NOTICE") of any
Losses or discovery of fact upon which such indemnified Party intends
to base a request for indemnification under Section 9.1 or Section 9.2,
but in no event shall the indemnifying Party be liable for any Losses
that result from any delay in providing such notice. Each
Indemnification Claim Notice must contain a description of the claim
and the nature and amount of such Loss (to the extent that the nature
and amount of such Loss is known at such time). The indemnified Party
shall furnish promptly to the indemnifying Party copies of all papers
and official documents received in respect of any Losses. All
indemnification claims in respect of a Party, its Affiliates or their
respective directors, officers, employees and agents shall be made
solely by such Party to this Agreement (the "INDEMNIFIED PARTY").
(b) THIRD PARTY CLAIMS. The obligations of an indemnifying Party under
this Article IX with respect to Losses that are subject to
indemnification as provided for in Sections 9.1 or 9.2 (a "THIRD PARTY
CLAIM") shall be governed by and be contingent upon the following
additional terms and conditions:
(i) CONTROL OF DEFENSE. At its option, the indemnifying Party may
assume the defense of any Third Party Claim by giving written
notice to the Indemnified Party within [**] after the indemnifying
Party's receipt of an Indemnification Claim Notice. The assumption
of the defense of a Third Party Claim by the indemnifying Party
shall not be construed as an acknowledgment that the indemnifying
Party is liable to indemnify any indemnified Party in respect of
the Third Party Claim, nor shall it constitute a waiver by the
indemnifying Party of any defenses it may assert against any
indemnified Party's claim for indemnification. Upon assuming the
defense of a Third Party Claim, the indemnifying Party may appoint
as lead counsel in the defense of the Third Party Claim any legal
counsel reasonably selected by the indemnifying Party. In the
event the indemnifying Party assumes the defense of a Third Party
Claim, the Indemnified Party shall immediately deliver to the
indemnifying Party all original notices and documents (including
court papers) received by any indemnified Party in connection with
the Third Party Claim. Should the indemnifying Party assume the
defense of a Third Party Claim, the indemnifying Party shall not
be liable to the Indemnified Party or any other indemnified Party
for any legal expenses subsequently incurred by such indemnified
Party in connection with the analysis, defense or settlement of
the Third Party Claim, unless such lead counsel determines that it
cannot, consistent with professional ethics, represent both
Parties, in which case the indemnifying Party shall be responsible
for separate counsel for the indemnified Party in accordance with
this Section. In the event that it is ultimately determined that
the indemnifying Party is not obligated to indemnify, defend or
hold harmless an indemnified Party from and against the Third
Party Claim, the Indemnified Party shall reimburse the
indemnifying Party for any and all costs and expenses (including
attorneys' fees and costs of suit) and
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any Losses incurred by the indemnifying Party in its defense of
the Third Party Claim with respect to such indemnified Party.
(ii) RIGHT TO PARTICIPATE IN DEFENSE. Without limiting Section
9.3(b)(i), any indemnified Party shall be entitled to participate
in, but not control, the defense of such Third Party Claim and to
employ counsel of its choice for such purpose; PROVIDED, HOWEVER,
that such employment shall be at the indemnified Party's own
expense unless (A) the employment thereof has been specifically
authorized by the indemnifying Party in writing or (B) the
indemnifying Party has failed to assume the defense and employ
counsel in accordance with Section 9.3(b)(i) (in which case the
Indemnified Party shall control the defense).
(iii)SETTLEMENT. With respect to any Losses relating solely to the
payment of money damages in connection with a Third Party Claim
and that will not result in the Indemnified Party's becoming
subject to injunctive or other relief or otherwise adversely
affect the business of the Indemnified Party in any manner, and as
to which the indemnifying Party shall have acknowledged in writing
the obligation to indemnify the Indemnified Party hereunder, the
indemnifying Party shall have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise
dispose of such Loss, on such terms as the indemnifying Party, in
its sole discretion, shall deem appropriate. With respect to all
other Losses in connection with Third Party Claims, where the
indemnifying Party has assumed the defense of the Third Party
Claim in accordance with Section 9.3(b)(i), the indemnifying Party
shall have authority to consent to the entry of any judgment,
enter into any settlement or otherwise dispose of such Loss
provided it obtains the prior written consent of the Indemnified
Party (which consent shall not be unreasonably withheld or
delayed). The indemnifying Party shall not be liable for any
settlement or other disposition of a Loss by an indemnified Party
that is reached without the written consent of the indemnifying
Party. Regardless of whether the indemnifying Party chooses to
defend or prosecute any Third Party Claim, no indemnified Party
shall admit any liability with respect to, or settle, compromise
or discharge, any Third Party Claim without the prior written
consent of the indemnifying Party.
(iv) COOPERATION. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, the
Indemnified Party shall, and shall cause each other indemnified
Party to, cooperate in the defense or prosecution thereof and
shall furnish such records, information and testimony, provide
such witnesses and attend such conferences, discovery proceedings,
hearings, trials and appeals as may be reasonably requested in
connection therewith. Such cooperation shall include access during
normal business hours afforded to indemnifying Party to, and
reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party
Claim, and making indemnified Parties and other employees and
agents available on a mutually convenient basis to provide
additional information and explanation of any material provided
hereunder, and the indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in
connection therewith.
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(v) EXPENSES. Except as provided above, the costs and expenses,
including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any claim shall be reimbursed
on a Calendar Quarter basis by the indemnifying Party, without
prejudice to the indemnifying Party's right to contest the
Indemnified Party's right to indemnification and subject to refund
in the event the indemnifying Party is ultimately held not to be
obligated to indemnify the Indemnified Party.
9.4 LIMITATION ON DAMAGES. EXCEPT (x) IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT, (y) WITH RESPECT TO THE INDEMNIFICATION OBLIGATIONS
PURSUANT TO SECTION 9.1 OR 9.2, OR (z) AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NONE OF MILLENNIUM, BZL OR ANY OF THEIR RESPECTIVE AFFILIATES SHALL
BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING
FOR LOST PROFITS, MILESTONES OR ROYALTIES), WHETHER IN CONTRACT, WARRANTY,
NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a) THE
DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT OR DIAGNOSTIC
PRODUCT OR ANTIBODY DEVELOPED, MANUFACTURED OR MARKETED HEREUNDER, OR (b) ANY
BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT;
PROVIDED, HOWEVER, that the foregoing limitations shall not apply to any
liability of BZL or its affiliates resulting from tHE TERMINATION OF THIS
aGREEMENT BY MILLENNIUM PURSUANT TO SECTION 8.2.
9.5 INSURANCE. Each Party shall have and maintain such type and amounts of
liability insurance covering the Manufacture, supply, use and sale of the
Licensed Product(s) or Diagnostic Product(s) as is normal and customary in the
pharmaceutical industry generally for Parties similarly situated, and shall upon
request provide the other Party with a copy of its policies of insurance in that
regard, along with any amendments and revisions thereto. Notwithstanding the
foregoing, at a minimum, BZL shall maintain until the third anniversary of the
Clinical Decision Point with respect to each Licensed Product and during any
period in which BZL has indemnification obligations to Millennium, (a)
commercial general liability insurance covering bodily injury and third party
property damage with minimum limits of One Million U.S. Dollars ($1,000,000) per
occurrence and Two Million U.S. Dollars ($2,000,000) general aggregate, (b)
products liability/completed operations coverage with minimum limits of Five
Million U.S. Dollars ($5,000,000) each occurrence and Five Million U.S. Dollars
($5,000,000) general aggregate, and (c) an all-risks fire and extended coverage
insurance on a "replacement cost" basis covering real and personal property and
including business income coverage sufficient to assure continuing operations in
the event of a major casualty. Each of the above policies of insurance (x) shall
cover claims arising out of the performance of this Agreement that are made
within a period of not less than three (3) years after its expiration or earlier
termination and during any period in which BZL has indemnification obligations
to Millennium, and (y) shall be primary to any liability insurance carried by
Millennium, which insurance shall be excess and non-contributory for claims and
losses arising out of the performance of this Agreement. The general and product
liability policies shall be specifically endorsed to list Millennium as an
additional insured. In addition, BZL shall maintain worker's compensation
insurance as required by all applicable laws and employer's liability coverage
of
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not less than Five Hundred Thousand U.S. Dollars ($500,000). Prior to the
commencement of this Agreement and upon each renewal of each policy, BZL shall
provide Millennium with a certificate of insurance evidencing the insurance
coverage required under this Section 9.5, which certificate shall provide at
least thirty (30) days notice of cancellation or termination of such insurance
coverage. Such policies shall remain in effect throughout the term of this
Agreement and during any period in which BZL has indemnification obligations to
Millennium and shall not be canceled without the prior written authorization of
Millennium or until BZL's obligations hereunder (including indemnification
obligations) have terminated. Maintenance of such insurance coverage shall not
relieve BZL of any responsibility under this Agreement for damages in excess of
insurance limits or otherwise. Should BZL at any time or for any reason fail to
obtain the insurance required herein, or should such insurance be canceled or
materially modified, Millennium shall have the right to procure the same and the
cost thereof shall be deducted from any compensation then due or thereafter to
become due to BZL.
ARTICLE X
REPRESENTATIONS, WARRANTIES AND COVENANTS
10.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party hereby represents,
warrants and covenants to the other Party as of the Effective Date as follows:
(a) Such Party (i) has the power and authority and the legal right to
enter into this Agreement and perform its obligations hereunder, and
(ii) has taken all necessary action on its part required to authorize
the execution and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and
delivered on behalf of such Party and constitutes a legal, valid and
binding obligation of such Party and is enforceable against it in
accordance with its terms subject to the effects of bankruptcy,
insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity,
whether enforceability is considered a proceeding at law or equity.
(b) Except as set forth in Schedule 10.1(b), such Party is not aware of
any pending or threatened litigation (and has not received any
communication and has no information in its possession) that alleges or
implies that such Party's activities related to this Agreement have
violated, or that by conducting the activities as contemplated herein
such Party would violate, any of the intellectual property rights of
any other Person.
(c) All necessary consents, approvals and authorizations of all regulatory
and governmental authorities and other Persons required to be obtained
by such Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been
obtained.
(d) The execution and delivery of this Agreement and the performance of
such Party's obligations hereunder (i) do not conflict with or violate
any requirement of applicable law or regulation or any provision of the
articles of incorporation or organization, bylaws, limited liability
company operating agreement or any similar instrument of such Party, as
applicable, in any material way, and (ii) do not conflict with,
violate, or
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breach or constitute a default or require any consent under, any
contractual obligation or court or administrative order by which such
Party is bound.
10.2 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF MILLENNIUM.
(a) Millennium represents, warrants and covenants to BZL that Millennium
(i) is a corporation duly organized and in good standing under the laws
of the State of Delaware, and (ii) has full power and authority and the
legal right to own and operate its property and assets and to carry on
its business as it is now being conducted and as it is contemplated to
be conducted by this Agreement.
(b) Millennium has an exclusive option to obtain an exclusive license to
make, use and sell products that contain an Antibody conjugated to
maytansine compounds (the "CYTOTOXIN AGREEMENT"), and except for
certain payments owed to the licensor thereunder, such rights are not
subject to any encumbrance, lien or claim of ownership by any Third
Party. During the term of this Agreement, Millennium shall promptly
provide BZL with notice of any alleged, threatened, or actual breach of
the Cytotoxin Agreement. As of the date hereof, none of Millennium, its
Affiliates and, to the best of their knowledge, any Third Party is in
breach of the Cytotoxin Agreement. Millennium covenants to BZL that
Millennium shall exercise the option for the Immunotoxin Product set
forth in the Cytotoxin Agreement prior to initiating Phase I studies
for the Immunotoxin Product.
(c) Neither Millennium nor any of its Affiliates has been debarred or is
subject to debarment and neither Millennium nor any of its Affiliates
will use in any capacity, in connection with the services to be
performed under this Agreement, any Person who has been debarred
pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, or
who is the subject of a conviction described in such section.
Millennium agrees to inform BZL in writing immediately if it or any
Person who is performing services hereunder is debarred or is the
subject of a conviction described in Section 306, or if any action,
suit, claim, investigation or legal or administrative proceeding is
pending or, to the best of Millennium's knowledge, is threatened,
relating to the debarment or conviction of Millennium or any Person
performing services hereunder.
(d) Except as permitted hereunder, at no time shall Millennium or its
Affiliates, directly or indirectly, expressly or by implication, by
action or omission or otherwise assign, transfer, or convey any right,
title or interest in or to the BZL Patents, the BZL Know-How, the Joint
Patents or the Joint Know-How that is inconsistent with the grants,
assignments and other rights reserved to BZL and its Affiliates under
this Agreement.
(e) Millennium shall use its Commercially Reasonable Efforts to obtain
from each of its Affiliates, sublicensees, employees and agents, and
from the employees and agents of its Affiliates, sublicensees and
agents, who are performing the Development Activities, involved in the
Manufacture of the Licensed Product(s) or Diagnostic Product(s) or are
otherwise participating in the Exploitation of the Licensed Products or
Diagnostic Products or who otherwise have access to Confidential
Information of BZL, rights to any and all Information and Inventions
that relate to the Licensed Products or
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Diagnostic Products, such that BZL shall, by virtue of this Agreement,
receive from Millennium, without payments beyond those required under
this Agreement, the licenses and other rights granted to BZL and its
Affiliates hereunder.
10.3 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF BZL. BZL
represents, warrants and covenants to Millennium that:
(a) BZL is a limited liability company duly organized, validly existing
and in good standing under the laws of the State of New York, and has
full power and authority and the legal right to own and operate its
property and assets and to carry on its business as it is now being
conducted and as it is contemplated to be conducted by this Agreement.
(b) The Regulatory Documentation that BZL has provided to Millennium prior
to the Effective Date is true, complete and correct in all material
respects. BZL has made (and will make) available to Millennium all
Regulatory Documentation, BZL Know-How and any other data, clinical
studies, pre-clinical studies and other Information and Inventions in
its or its Affiliates possession or Control regarding or related to any
Licensed Products or Diagnostic Products and all such Regulatory
Documentation, BZL Know-How and other Information and Inventions are
(and, if made available after the Effective Date, will be) true,
complete and correct in all material respects. As of the Effective
Date, BZL has prepared, maintained and retained all Regulatory
Documentation that is known to BZL to be required to be maintained or
reported pursuant to and in accordance with good laboratory and
clinical practices and Applicable Law and all such information is true,
complete and correct in all material respects and what it purports to
be. Schedule 10.3(b) is a complete list of all agreements, other than
confidentiality agreements and the stock option agreements with New
Drug Associates, Inc., Xxxx Xxxxxx and Xxxx Xxxxx, entered into by BZL
or BZL Biologics, Inc. on or prior to the Effective Date and BZL has
provided Millennium with true, complete and correct copies of all such
agreements and any amendments thereto prior to the Effective Date. BZL
shall notify Millennium of any breach by it or any Third Party of any
confidentiality agreement entered into by BZL or BZL Biologics, Inc.
and shall, at the request and expense (for reasonable and direct
out-of-pocket costs actually incurred, including reasonable attorney's
fees and disbursements) of Millennium, enforce its rights under such
confidentiality agreements. Neither BZL nor BZL Biologics, Inc. has
transferred or encumbered any of BZL's intellectual property rights
under any such confidentiality agreements.
(c) Prior to the Effective Date, BZL has provided Millennium with a
written report that describes in detail all material adverse
information with respect to the safety and efficacy of the Licensed
Products or Diagnostic Products known to BZL and its Affiliates as of
the Effective Date and such report is true, complete and correct in all
material respects as of the Effective Date. Except as set forth in such
written report, neither BZL nor any of its Affiliates, to their
knowledge, is aware of any scientific or technical facts or
circumstances that they believe would adversely affect the scientific,
therapeutic or commercial potential of the Licensed Products or
Diagnostic Products.
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(d) BZL has conducted those activities listed on Schedule 10.3(d) in
accordance with the terms thereof and completed such activities with
respect to the Licensed Product(s) or Diagnostic Product(s) in
accordance with good laboratory and clinical practices and Applicable
Law. BZL has conducted, and has caused its contractors and consultants
to conduct, any and all pre-clinical and clinical studies related to
the Licensed Products or Diagnostic Products in accordance with good
laboratory and clinical practices, to the extent required, and in
material compliance with all Applicable Law. Except as set forth in the
written report provided to Millennium pursuant to Section 10.3(c),
neither BZL nor any of its Affiliates is, to the best of their
knowledge, aware of anything that it believes would adversely effect
the acceptance, or the subsequent approval, by any Regulatory Authority
of any filing, application or request for Regulatory Approval.
(e) Neither BZL nor any of its Affiliates has been debarred or is subject
to debarment and neither BZL nor any of its Affiliates will use in any
capacity, in connection with the services to be performed under this
Agreement, any Person who has been debarred pursuant to Section 306 of
the Federal Food, Drug, and Cosmetic Act, or who is the subject of a
conviction described in such section. BZL agrees to inform Millennium
in writing immediately if it or any Person who is performing services
hereunder is debarred or is the subject of a conviction described in
Section 306, or if any action, suit, claim, investigation or legal or
administrative proceeding is pending or, to the best of BZL's
knowledge, is threatened, relating to the debarment or conviction of
BZL or any Person performing services hereunder.
(f) BZL is the sole and exclusive owner of all right, title and interest
in and to the Patents listed on Schedule 10.3(f) (the "OWNED BZL
PATENTS") and, except as provided in Schedule 10.3(f), such rights are
not subject to any encumbrance, lien or claim of ownership by any Third
Party. BZL is the sole and exclusive licensee of and Controls all
right, title and interest in and to the Patents listed on Schedule
10.3(f) (the "LICENSED BZL PATENTS") and, except as provided in
Schedule 10.3(f), such rights are not subject to any encumbrance, lien
or claim of ownership by any Third Party. True, complete and correct
copies of all license agreements regarding the Licensed BZL Patents
(the "IN-LICENSE AGREEMENTS"), as amended to the date hereof, have been
provided to Millennium. BZL shall be solely responsible for any
royalty, milestone or other payments owed in connection with the
In-License Agreements. The Owned BZL Patents and the Licensed BZL
Patents constitute all of the BZL Patents as of the Effective Date.
During the term of this Agreement, BZL shall not encumber or diminish
the rights granted to Millennium hereunder with respect to the BZL
Patents, including by not (i) committing any acts or permitting the
occurrence of any omissions that would cause the breach or termination
of any In-License Agreement, or (ii) amending or otherwise modifying,
or permitting to be amended or modified, any In-License Agreement.
During the term of this Agreement, BZL shall not assign any of its
rights, titles or interest in or to any In-License Agreement to a Third
Party. BZL shall promptly provide Millennium with notice of any
alleged, threatened, or actual breach of any In-License Agreement. As
of the date hereof, none of BZL, its Affiliates and, to the best of
their knowledge, any Third Party is in breach of any In-License
Agreement. BZL Biologics, Inc. has assigned to BZL all of its rights,
titles and interests in and to PSMA and any and all Antibodies,
Licensed Products or Diagnostic
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Products, Regulatory Documentation and other Information and Inventions
with respect to the foregoing, as well as any Patent or other
intellectual property rights with respect thereto.
(g) BZL hereby represents and warrants that (a) true, complete and correct
copies of the Exclusive License Agreement dated April 1, 1997 among
Cornell Research Foundation ("CRF") and Xxxxxx Institute for Cancer
Research ("Xxxxxx") (the "Cornell License Agreement"), the Agreement
dated May 14, 1997 between BZL and Cornell University (the "Sponsored
Research Agreement"), and the Amended and Restated Consulting Agreement
dated February 1997 between BZL and Xx. Xxxx Xxxxxx (the "Consulting
Agreement") have been provided to Millennium by BZL, (b) there are no
patentable inventions pertaining to Antibodies made by Xx. Xxxx Xxxxxx,
or any other researchers or employees of Cornell University that have
or have had access to the Antibody covered by the BZL Patents, since
April 1, 1997 other than those covered by the claims of the patent
applications and patents listed on Schedule 10.3(f) to this Agreement,
and (c) there are no biological materials or technical information
(including preclinical and clinical data) developed by Xx. Xxxx Xxxxxx,
or any other researchers or employees of Cornell University that have
or have had access to the Antibody covered by the BZL Patents, since
April 1, 1997 that would be unavailable to Millennium from CRF because
of restrictions or obligations imposed by Third Parties or because such
biological materials or technical information was developed by
researchers or employees of Cornell University working on projects that
were not supervised or directed by Xx. Xxxx Xxxxxx.
(h) Prior to the Effective Date, BZL has provided Millennium with a
written report that describes in detail all information regarding the
proprietary status of PSMA, the intellectual property rights Controlled
by BZL and its Affiliates with respect to PSMA, and any potential
restrictions (contractual, patent or otherwise) that it believes would
limit or otherwise affect Millennium's right to fully Exploit the
Licensed Products or Diagnostic Products with respect thereto, and such
report is true, complete and correct as of the Effective Date.
(i) The BZL Patents and the BZL Know-How existing as of the Effective Date
are subsisting and, to BZL's knowledge, no BZL Patent or BZL Know-How
is invalid or unenforceable, in whole or in part. To BZL's knowledge,
the conception, development and reduction to practice of the Regulatory
Documentation, the BZL Patents and BZL Know-How existing as of the
Effective Date have not constituted or involved the misappropriation of
trade secrets or other rights or property of any Third Party. Except as
set forth in Schedule 10.1(b), there are no claims, judgments or
settlements against or amounts with respect thereto owed by BZL or any
of its Affiliates relating to the Regulatory Documentation, the BZL
Patents, the BZL Know-How or the Licensed Products or Diagnostic
Products. Except as set forth in Section 10.1(b), no claim or
litigation has been brought or threatened by any Person alleging, and
BZL, to the best of its knowledge, is not aware of any likely claim,
whether or not asserted, that (i) the BZL Patents or the BZL Know-How
are invalid or unenforceable or (ii) the Regulatory Documentation, the
BZL Patents or the BZL Know-How or the disclosing, copying, making,
assigning, licensing or Exploiting of the Regulatory Documentation, the
BZL
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Patents, BZL Know-How, or products and services embodying the
Regulatory Documentation, the BZL Patents or the BZL Know-How,
including the Exploitation of any Licensed Products or Diagnostic
Products, violates, infringes or otherwise conflicts or interferes with
any intellectual property or proprietary right of any Third Party.
(j) Except for the license grants and assignments in Section 3.1 and
3.3, neither BZL nor any of its Affiliates has, directly or indirectly,
expressly or by implication, by action or omission or otherwise (i)
assigned, transferred, conveyed or otherwise encumbered any right,
title or interest in or to the Regulatory Documentation, the BZL
Patents or the BZL Know-How, (ii) granted any license or other right,
title or interest in or to the Regulatory Documentation, the BZL
Patents or the BZL Know-How in any manner, or (iii) agreed to or is
otherwise bound by any covenant not to xxx for any infringement, misuse
or otherwise with respect to the Regulatory Documentation, the BZL
Patents or the BZL Know-How.
(k) Except to the extent expressly permitted hereunder with respect to a
Reversion Termination or an IP Reversion Termination, at no time shall
BZL or its Affiliates, directly or indirectly, expressly or by
implication, by action or omission or otherwise (i) assign, transfer,
convey or otherwise encumber any right, title or interest in or to the
BZL Patents, the BZL Know-How, the Joint Patents or the Joint Know-How
(ii) grant any license or other right, title or interest in or to the
BZL Patents, the BZL Know-How, the Joint Patents or the Joint Know-How
in any manner, or (iii) agree to or otherwise become bound by any
covenant not to xxx for any infringement, misuse or other action or
inaction with respect to the BZL Patents, the BZL Know-How, the Joint
Patents or the Joint Know-How, in each case that is inconsistent with
the grants, assignments and other rights reserved to Millennium and its
Affiliates under this Agreement.
(l) BZL shall obtain from each of its Affiliates, sublicensees, employees
and agents, and from the employees and agents of its Affiliates,
sublicensees and agents, who are performing the Development Activities,
involved in the Manufacture of the Licensed Product(s) or Diagnostic
Product(s) or are otherwise participating in the Exploitation of the
Licensed Products or Diagnostic Products or who otherwise have access
to any Millennium Information or other Confidential Information of
Millennium, rights to any and all Information and Inventions that
relate to the Licensed Products or Diagnostic Products, such that
Millennium shall, by virtue of this Agreement, receive from BZL,
without payments beyond those required by Article IV, the licenses and
other rights granted to Millennium and its Affiliates hereunder.
(m) Except as set forth in Schedule 10.3, to the best of BZL's and its
Affiliate's knowledge, there is no actual or threatened infringement by
a Third Party of the Regulatory Documentation, the BZL Patents or the
BZL Know-How.
(n) BZL and its Affiliates shall perform any Development Assistance and
its other activities under this Agreement in good scientific manner and
in compliance in all material respects with all Applicable Law.
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10.4 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
SECTIONS 10.1, 10.2 AND 10.3, Millennium AND BZL MAKE NO REPRESENTATIONS AND
GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND Millennium AND BZL EACH SPECIFICALLY DISCLAIM ANY
OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. Each Party acknowledges and
agrees that the exploitation of the Licensed Products or Diagnostic Products
requires the use of experimental technology and neither Party guarantees that
any Licensed Product or Diagnostic Product can be successfully developed and
commercialized as contemplated in this agreement.
ARTICLE XI
MISCELLANEOUS
11.1 FORCE MAJEURE. Neither Party shall be held liable or responsible to the
other Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the non-performing Party, including fires, floods, embargoes,
shortages, epidemics, quarantines, war, acts of war (whether war be declared or
not), insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority. Millennium shall not be held liable or responsible to
BZL or be deemed to have defaulted under or breached this Agreement for failure
or delay in fulfilling or performing any term of this Agreement when such
failure or delay is caused by or results from New Drug Associates, Inc.'s
performance under the NDA Agreement or any actions or omissions of NDA. The
non-performing Party shall notify the other Party of such force majeure within
ten (10) days after such occurrence by giving written notice to the other Party
stating the nature of the event, its anticipated duration, and any action being
taken to avoid or minimize its effect. The suspension of performance shall be of
no greater scope and no longer duration than is necessary and the non-performing
Party shall use Commercially Reasonable Efforts to remedy its inability to
perform.
11.2 ASSIGNMENT. Without the prior written consent of the other Party hereto,
neither Party shall sell, transfer, assign, delegate, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; PROVIDED,
HOWEVER, that either Party may, subject to that certain Transfer Restrictions
Agreement, entered into as of the date hereof, among BZL Biologics, Inc.,
Millennium, BZL and the other Persons listed on Exhibit A thereto, without such
consent, assign this Agreement and its rights and obligations hereunder to an
Affiliate, the purchaser of all or substantially all of its assets related to
the Licensed Product(s) or Diagnostic Product(s) or its business, or to its
successor entity or acquirer in the event of a merger, consolidation or change
in control of such Party. Any attempted assignment or delegation in violation of
the preceding sentence shall be void and of no effect. All validly assigned and
delegated rights and obligations of the Parties
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hereunder shall be binding upon and inure to the benefit of and be enforceable
by and against the successors and permitted assigns of Millennium or BZL, as the
case may be. In the event either Party seeks and obtains the other Party's
consent to assign or delegate its rights or obligations to another Party, the
assignee or transferee shall assume all obligations of its assignor or
transferor under this Agreement.
11.3 SEVERABILITY. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, and if the rights or
obligations of any Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties herein. To the fullest extent permitted by applicable law, each
Party hereby waives any provision of law that would render any provision hereof
prohibited or unenforceable in any respect.
11.4 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts, without reference
to the rules of conflict of laws thereof.
11.5 NOTICES. All notices or other communications that are required or permitted
hereunder shall be in writing and delivered personally, sent by telecopier (and
promptly confirmed by personal delivery, certified mail or overnight courier as
provided herein), sent by nationally-recognized overnight courier providing
evidence of delivery or sent by certified mail, postage prepaid, return receipt
requested, addressed as follows:
If to BZL, to:
BZL Biologics, LLC
c/o Xxxx Xxxxxx
Cornell Medical School
New York Presbyterian Hospital
000 Xxxx 00xx Xxxxxx
X-000, Xxx 00
Xxx Xxxx, XX 00000
Telecopier: (000) 000-0000
with a copy to:
Xxxxx X. Xxxxxxxxxxx, Esq.
Muchnick, Golieb, Golieb, P.C.
000 Xxxx Xxxxxx Xxxxx
Xxxxx 0000
Xxx Xxxx, XX 00000
Telecopier: (000) 000-0000
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And:
Xxxxxxx X. Xxxxxx, Esq.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Telecopier: (000) 000-0000
If to Millennium, to:
Millennium Pharmaceuticals, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Chief Executive Officer
Telecopier: (000) 000-0000
with a copy to:
Millennium Pharmaceuticals, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: General Counsel
Telecopier: (000) 000-0000
or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such
communication shall be deemed to have been given (i) when delivered, if
personally delivered or sent by telecopier on a business day, (ii) on the
business day after dispatch, if sent by nationally-recognized overnight courier,
and (iii) on the third business day following the date of mailing, if sent by
certified mail. It is understood and agreed that this Section 11.5 is not
intended to govern the day-to-day business communications necessary between the
Parties in performing their duties, in due course, under the terms of this
Agreement.
11.6 ARBITRATION.
(a) GENERAL. In the event of any dispute, controversy or claim arising
out of or relating to this Agreement and not expressly provided for
elsewhere herein, the Parties shall try to settle such disputes,
controversies or claims amicably between themselves including referring
such dispute, controversy or claim to the Chief Executive Officer of
Millennium, or any other officer designated by such Chief Executive
Officer, and Xx. Xxxx Xxxxxx, or any officer of BZL designated by Xx.
Xxxxxx. If the Parties are unable to so settle such dispute,
controversy or claim, then unless there is another resolution mechanism
set forth herein, any such dispute, controversy or claim arising out of
or relating to any provision of this Agreement, or the interpretation,
enforceability, performance, breach, termination or validity hereof,
including the details of implementing this arbitration clause, shall be
solely and finally settled by
-63-
arbitration in the manner specified in this Section 11.6, except to the
extent such dispute, controversy or claim relates to intellectual
property matters, in which case the Parties shall have the right to
litigate such dispute. All arbitration proceedings shall be conducted
in New York City, if such proceeding is brought by Millennium, or
Boston, Massachusetts, if such proceeding is brought by BZL, or such
other location as is mutually agreed to by the Parties. The arbitration
proceedings shall be conducted under the procedural rules of the
American Arbitration Association. The Party requesting arbitration
shall serve upon the other Party a written demand for arbitration
stating the substance of the controversy, dispute or claim, and the
contention of the Party requesting arbitration. Within thirty (30) days
after the demand, the Parties shall select three (3) mutually
acceptable arbitrators. The arbitrators are to act as neutral
arbitrators and shall have no past, present or anticipated future
affiliation with the Parties or any relationship with the Parties that
would, in the reasonable opinion of either Party, unduly influence the
independence of an arbitrator. If the Parties are unable to agree upon
three (3) mutually acceptable arbitrators, the Parties shall each
designate one arbitrator, and those two shall designate a third, all of
whom shall have no past, present or anticipated future affiliation with
the Parties or any relationship with the Parties that would, in the
reasonable opinion of either Party, unduly influence the independence
of an arbitrator. The decision of the arbitrators shall be in writing
setting forth the basis therefor. The arbitrators shall have no
authority to award punitive damages. The Parties shall abide by the
award rendered in such arbitration proceeding, and such award shall be
final and binding upon both Parties and may be enforced and executed
upon in any court having jurisdiction over the Party against whom
enforcement of such award is sought. The Parties shall divide equally
the administrative charges, arbitrators' fees and related expenses of
arbitration, but each Party shall pay its own attorney's fees incurred
in connection with such arbitration; PROVIDED, HOWEVER, if the
arbitrators determine that one Party prevailed clearly and
substantially over the other Party, then the non-prevailing Party shall
also pay the prevailing Party's reasonable attorney's fees and expert
witness costs and arbitration costs.
(b) INTERIM RELIEF. Notwithstanding anything herein to the contrary,
nothing in this Section shall preclude either Party from seeking
interim or provisional relief, including a temporary restraining order,
preliminary injunction or other interim equitable relief concerning a
dispute, if necessary to protect the interests of such Party. This
Section shall be specifically enforceable.
11.7 AFFILIATES AND SUBLICENSEES. Any and all rights of Millennium under this
Agreement are intended, and shall be construed, to benefit such of its
Affiliates and its permitted sublicensees as and to the extent Millennium may,
from time to time, designate. Further, Millennium shall have the right to
satisfy any or all of its obligations under this Agreement through one or more
of its Affiliates or permitted sublicensees.
11.8 ENTIRE AGREEMENT; MODIFICATIONS. This Agreement sets forth and constitutes
the entire agreement and understanding between the Parties with respect to the
subject matter hereof and all prior agreements, understanding, promises and
representations, whether written or oral, with respect thereto are superseded
hereby. Each Party confirms that it is not relying on any
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representations or warranties of the other Party except as specifically set
forth herein. No amendment, modification, release or discharge hereof shall be
binding upon the Parties unless in writing and duly executed by authorized
representatives of both Parties.
11.9 RELATIONSHIP OF THE PARTIES. It is expressly agreed that BZL, on the one
hand, and Millennium, on the other hand, shall be independent contractors and
that the relationship between the two Parties shall not constitute a
partnership, joint venture or agency. Neither BZL, on the one hand, nor
Millennium, on the other hand, shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior written consent of the other Party to
do so. All persons employed by a Party shall be employees or consultants of such
Party and not of the other Party and all costs and obligations incurred by
reason of any such employment shall be for the account and expense of such
Party.
11.10 EQUITABLE RELIEF. Each Party acknowledges and agrees that the restrictions
set forth in Section 3.5 and Articles VI and VII of this Agreement are
reasonable and necessary to protect the legitimate interests of the other Party
and that such other Party would not have entered into this Agreement in the
absence of such restrictions, and that any violation or threatened violation of
any provision of Section 3.5 or Article VI or VII will result in irreparable
injury to such other Party. Each Party also acknowledges and agrees that in the
event of a violation or threatened violation of any provision of Section 3.5 or
Article VI or VII, the other Party shall be entitled to preliminary and
permanent injunctive relief, without the necessity of proving irreparable injury
or actual damages and without the necessity of having to post a bond, as well as
to an equitable accounting of all earnings, profits and other benefits arising
from any such violation. The rights provided in the immediately preceding
sentence shall be cumulative and in addition to any other rights or remedies
that may be available to such other Party. Nothing in this Section 11.10 is
intended, or should be construed, to limit such other Party's right to
preliminary and permanent injunctive relief or any other remedy for a breach of
any other provision of this Agreement.
11.11 WAIVER. Any term or condition of this Agreement may be waived at any time
by the Party that is entitled to the benefit thereof, but no such waiver shall
be effective unless set forth in a written instrument duly executed by or on
behalf of the Party waiving such term or condition. The waiver by either Party
hereto of any right hereunder or of the failure to perform or of a breach by the
other Party shall not be deemed a waiver of any other right hereunder or of any
other breach or failure by said other Party whether of a similar nature or
otherwise.
11.12 COUNTERPARTS. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Copies of executed
counterparts transmitted by telecopy, facsimile or other electronic transmission
service shall be considered original executed counterparts for purposes of this
Section, provided receipt of copies of such counterparts is confirmed.
11.13 NO BENEFIT TO THIRD PARTIES. The representations, warranties, covenants
and agreements set forth in this Agreement, including the indemnification
obligations set forth in Sections 9.1 and 9.2, are for the sole benefit of the
Parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other Persons.
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11.14 FURTHER ASSURANCE. Each Party shall duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes hereof, or to better assure and confirm
unto such other Party its rights and remedies under this Agreement.
11.15 REFERENCES. Unless otherwise specified, (a) references in this Agreement
to any Article, Section, Schedule or Exhibit shall mean references to such
Article, Section, Schedule or Exhibit of this Agreement, (b) references in any
section to any clause are references to such clause of such section, and (c)
references to any agreement, instrument or other document in this Agreement
refer to such agreement, instrument or other document as originally executed or,
if subsequently varied, replaced or supplemented from time to time, as so
varied, replaced or supplemented and in effect at the relevant time of reference
thereto.
11.16 CONSTRUCTION. Except where the context otherwise requires, wherever used,
the singular shall include the plural, the plural the singular, the use of any
gender shall be applicable to all genders and the word "or" is used in the
inclusive sense. The captions of this Agreement are for convenience of reference
only and in no way define, describe, extend or limit the scope or intent of this
Agreement or the intent of any provision contained in this Agreement. The term
"including" as used herein shall mean including, without limiting the generality
of any description preceding such term. The term "knowledge" or "best knowledge"
shall mean, with respect to a Party, the knowledge that any officer, any
director or any manager of such Party or any Affiliate of such Party (including,
with respect to BZL, Xx. Xxxx Xxxxxx, Xxxxxx Xxxxxxxx and Xxxxx Xxxxxxxxxxx),
have or would have, without special investigation, if he or she had performed
his or her services and duties in the ordinary course on behalf of such Party or
Affiliate in a reasonably diligent manner. For purposes of this Agreement,
"belief" and, with its correlative meaning, "believe" shall mean, with respect
to the representation, warranty or covenant of a Person, what such Person
actually believed or reasonably should have believed, based on information known
to such person and information generally known or knowable, at the time such
representation, warranty or covenant is made. The language of this Agreement
shall be deemed to be the language mutually chosen by the Parties and no rule of
strict construction shall be applied against either Party hereto. Any item
disclosed in a schedule or report provided pursuant to this Agreement shall be
deemed to have been disclosed for purposes of all schedules and reports provided
pursuant to this Agreement, to the extent such disclosure is true, complete and
correct and not misleading.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the date first above
written.
MILLENNIUM PHARMACEUTICALS, INC. BZL BIOLOGICS, LLC
BY: BZL BIOLOGICS, INC.
By: /s/XXXX XXXXX By: /s/XXXXXX XXXXXXXX
--------------------------- ---------------------------
Name: XXXX XXXXX Name: XXXXXX XXXXXXXX
------------------------- -------------------------
Title: CHIEF EXECUTIVE OFFICER Title: MANAGER
------------------------ ------------------------
In consideration of the benefits to be derived by BZL Biologics, Inc., as the
holder of the majority of interests in BZL, and as an inducement for Millennium
to enter into this Agreement, BZL Biologics, Inc., does hereby expressly agree
to be bound by Articles III and X of this Agreement.
BZL BIOLOGICS, INC.
By: /s/XXXXXX XXXXXXXX
------------------------
Name: XXXXXX XXXXXXXX
------------------------
Title: PRESIDENT & CEO
------------------------
In consideration of the benefits to be derived by Xx. Xxxx Xxxxxx and as an
inducement for Millennium to enter into this Agreement, Xx. Xxxx Xxxxxx does
hereby expressly agree to be bound by the last sentence of Section 2.1(a)(i) and
Section 2.1(h) of this Agreement.
XX. XXXX XXXXXX
/s/XXXX XXXXXX
------------------------
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Exhibit A
PRELIMINARY DEVELOPMENT PLAN
To be provided
Schedule 3.3(d)
MTAs
MATERIAL TRANSFER AGREEMENTS
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[**]* BZL agrees to use Commercially Reasonable Efforts to obtain, promptly
after the Effective Date, the consent of [**] to the assignment by BZL of its
and its Affiliates' rights, titles, and interests in and to the Material
Transfer Agreement by and between BZL Biologics LLC and [**] to Millennium.
Schedule 10.3(b)
BZL AGREEMENTS
MATERIAL TRANSFER AGREEMENTS
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CONFIDENTIALITY AGREEMENTS
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CONSULTING AGREEMENTS
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[**]MANUFACTURING-RELATED AGREEMENTS[**]
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OTHER AGREEMENTS
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Execution Draft: 07/20/01
