COLLABORATION AND CO-PROMOTION AGREEMENT

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BRISTOL-MYERS SQUIBB COMPANY | MEDAREX, INC

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Title: COLLABORATION AND CO-PROMOTION AGREEMENT
Governing Law: New York Date: 1/24/2005
Industry: Biotechnology and Drugs Law Firm: Covington Burling Sector: Healthcare

COLLABORATION AND CO-PROMOTION AGREEMENT, Parties: bristol-myers squibb company , medarex inc

EXHIBIT 99.1

Execution Copy

COLLABORATION AND CO-PROMOTION AGREEMENT

by and between

MEDAREX, INC.

and

BRISTOL-MYERS SQUIBB COMPANY

November 7, 2004

TABLE OF CONTENTS

ARTICLE 1 DEFINITIONS

ARTICLE 2 MANAGEMENT OF COLLABORATION

	2.1	General
		2.1.1	Role of Committees
		2.1.2	Limitations on the Authority of Committees
	2.2	Joint Executive Committee (JEC)
		2.2.1	Formation and Purpose
		2.2.2	Specific Responsibilities of the JEC
	2.3	Joint Development and Regulatory Committee (JDC)
		2.3.1	Formation and Purpose
		2.3.2	Specific Responsibilities of the JDC
		2.3.3	Regulatory Working Group
		2.3.4	Available Resources
	2.4	Joint Commercialization Committee (JCC)
		2.4.1	Formation and Purpose
		2.4.2	Specific Responsibilities of the JCC
		2.4.3	Available Resources
	2.5	Joint Manufacturing Committee (JMC)
		2.5.1	Formation and Purpose
		2.5.2	Specific Responsibilities of the JMC
	2.6	Joint Finance Committee (JFC)
		2.6.1	Formation and Purpose
		2.6.2	Specific Responsibilities of the JFC
	2.7	General Committee Membership and Procedures
		2.7.1	Membership
		2.7.2	Meetings
		2.7.3	Decision-Making
		2.7.4	Meeting Agendas and Minutes
		2.7.5	Working Groups
		2.7.6	Interactions Between Committees and Internal Teams
		2.7.7	Project Managers
	2.8	Alliance Managers
		2.8.1	Appointment
		2.8.2	Responsibilities
	2.9	Collaboration Guidelines
		2.9.1	General
		2.9.2	Independence
	2.10	General Overview of Accounting
		2.10.1	Accounting Procedures
		2.10.2	Affiliate Agreements
	2.11	Compliance with Law

ARTICLE 3 DEVELOPMENT AND REGULATORY

	3.1	Current Status of Development of Lead Product and MDX-1379
	3.2	Global Development Plans and Budgets and Annual Development Plans and Budgets
		3.2.1	Comprehensive Development Plans and Budgets
		3.2.2	Annual Development Plans and Budgets
		3.2.3	Success Criteria for Development Activities
		3.2.4	Clinical Trials Outside Plans and Budgets
		3.2.5	MDX-1379
	3.3	Lead Development Party and Lead Regulatory Party
		3.3.1	In General
		3.3.2	Designation of Lead Development Party and Lead Regulatory Party
	3.4	Clinical and Regulatory Matters in the United States; Recalls and Withdrawals
		3.4.1	Ownership of Regulatory Filings and Approvals
		3.4.2	Preparation of Regulatory Submissions
		3.4.3	Notice of Regulatory Filing Requirements
		3.4.4	Notice of Changed Regulatory Requirements
		3.4.5	Regulatory Meetings
		3.4.6	Regulatory Data
		3.4.7	Regulatory Submissions
		3.4.8	Recalls
		3.4.9	Common Efficacy Database
		3.4.10	Pricing and Reimbursement Approvals
		3.4.11	Labeling
		3.4.12	Drug Naming Approvals
		3.4.13	Rights of Reference
	3.5	Clinical and Regulatory Matters in the Royalty Territory; Recalls and Withdrawals
		3.5.1	Ownership of Regulatory Filings and Approvals
		3.5.2	Preparation of Regulatory Submissions
		3.5.3	Regulatory Meetings; Submissions and Other Communications
		3.5.4	Pricing and Reimbursement Approvals
		3.5.5	Recalls
		3.5.6	Labeling
		3.5.7	Rights of Reference
	3.6	Development Diligence
	3.7	Costs of Development
		3.7.1	Development Cost Sharing
		3.7.2	FTE Records and Calculations
		3.7.3	Reports
		3.7.4	Regulatory Expenses
	3.8	Medarex Right to Opt-Out
		3.8.1	Financial and Data Packages

		3.8.2	Right to Opt-Out
		3.8.3	Effect of Opt-Out
		3.8.4	Material Changes Prior to the Commencement of a Pivotal Trial
		3.8.5	Forced Opt-In
	3.9	Regulatory Exclusivity
	3.10	Coordination of Clinical Strategy
	3.11	Pharmacovigilance Responsibilities
	3.12	Notice of Investigation or Inquiry
	3.13	Additional Agent Selection, Development and Commercialization; Third Party Royalties
		3.13.1	Identification and Selection of Agents
		3.13.2	Agent Exclusivity

ARTICLE 4 COMMERCIALIZATION IN ROYALTY TERRITORY

	4.1	Lead Marketing Party
	4.2	Diligence for Commercialization of Products in Royalty Territory
		4.2.1	Diligent Efforts
		4.2.2	Appointment of Distributors and Co-Promoters
	4.3	Royalty Territory Commercialization Plans and Budgets
		4.3.1	Global Commercialization Plans and Budgets
		4.3.2	Pre-Launch RT Commercialization Plans and Budgets and Annual RT Commercialization Plans and Budgets
	4.4	Sales and Distribution in Royalty Territory
	4.5	Coordination of Commercialization Strategy

ARTICLE 5 COMMERCIALIZATION IN THE UNITED STATES

	5.1	General Principles of Commercialization of Products in the United States; Diligence
		5.1.1	General Principles
		5.1.2	Diligence
	5.2	Commercialization Plans and Budgets; Pre-Launch US Commercialization Plan and Budget
		5.2.1	Commercialization Plans and Budgets
		5.2.2	Global Commercialization Plan and Budget
		5.2.3	Pre-Launch US Commercialization Plans and Budgets; Annual US Commercialization Plans and Budgets
	5.3	Medarex Option to Co-Promote
		5.3.1	Option Exercise
		5.3.2	Termination of Co-Promotion Term
		5.3.3	Failure to Exercise/Expiration of Co-Promotion Rights
	5.4	Diligent Efforts for Co-Promotion Products; Lead Marketing Party; Principles of Commercialization
		5.4.1	Diligent Efforts
		5.4.2	Lead Marketing Party

iii

		5.4.3	Principles of Commercialization
	5.5	Sales Efforts and Sales Representative Deployment for Co-Promotion Products in the United States; Training
		5.5.1	Selling Effort
		5.5.2	Position of the Details to be Provided
		5.5.3	Detailing of Other Products by a Party’s Sales Force Representatives
		5.5.4	Additional Commercialization Expertise
		5.5.5	Records
		5.5.6	Determination of Sales Representative Costs Allocated to Profit and Loss
		5.5.7	Medical Liaisons
	5.6	Sales Force Capabilities; Training in the United States
	5.6	Sales Force Capabilities; Training in the United States TC
		5.6.1	General Sales Training
		5.6.2	Product-Specific Sales Training
		5.6.3	Co-Promotion-Related Meetings
		5.6.4	Training Materials
		5.6.5	Copyrights
	5.7	Co-Promotion Advertising and Promotional Materials
		5.7.1	Marketing and Other Materials
		5.7.2	Specific Responsibilities of the Parties
		5.7.3	Approval of Materials Other Than Marketing Materials
		5.7.4	Research Data
	5.8	Sales and Distribution in the United States
	5.9	Incentive Plans for Sales Representatives
	5.10	Sales Representatives
		5.10.1	Employees
		5.10.2	Independent Contractors
		5.10.3	Allocation; Turnover
		5.10.4	Inadequate Performance
		5.10.5	Compliance with Applicable Law
		5.10.6	Agreements with Sales Representatives
		5.10.7	Worker’s Compensation
		5.10.8	Employees of Hiring Party
		5.10.9	Responsibility for Employees
		5.10.10	Indemnification by Hiring Party
		5.10.11	Responsibility for Employment Terms and Policies
	5.11	Government, Managed Care and Other Accounts

ARTICLE 6 FINANCIAL TERMS

	6.1	Initial Payment
	6.2	Equity Investment
	6.3	Milestone Payments
		6.3.1	Regulatory Milestone Payments
		6.3.2	[*]

[*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

	6.4	Profit or Loss in the United States
		6.4.1	In General
		6.4.2	Additional Share; Allocation of Off-Label Sales
		6.4.3	Commercialization Overruns
	6.5	Calculation and Payment of Profit or Loss Share
		6.5.1	Reports and Payments in General
		6.5.2	Last Calendar Quarter
	6.6	Royalties to Medarex
		6.6.1	United States
		6.6.2	Japan
		6.6.3	Rest of the World
		6.6.4	Proration
	6.7	Royalty Adjustments and Other Third Party Payments
		6.7.1	Generic Products
		6.7.2	Certain Third Party Payments
		6.7.3	Existing In-License Agreements
		6.7.4	PHS License Agreement
	6.8	Reimbursement to Medarex for Certain Additional Costs
	6.9	Term of Royalties on Products and Profit Sharing
		6.9.1	Royalties
		6.9.2	Profit Sharing
		6.9.3	Non-Co-Promoted Products
	6.10	Royalties on Non-Antibody Competing Products
		6.10.1	Competing Product Royalty Rate
		6.10.2	Determination
		6.10.3	Royalty Term
	6.11	Royalty Payments and Reports
	6.12	Payment Method
	6.13	Taxes
	6.14	Blocked Currency
	6.15	Sublicenses
	6.16	Non-Monetary Consideration
	6.17	Cross Border Transactions
	6.18	Foreign Exchange
	6.19	Payments to or Reports by Affiliates
	6.20	Adjustment of FTE Rates
	6.21	[*]

ARTICLE 7 MANUFACTURE AND SUPPLY

	7.1	Current Status of Manufacture of Lead Product
	7.2	Manufacturing Plan and Budget
	7.3	Lead Manufacturing Party
		7.3.1	In General
		7.3.2	Lead Products and Additional Products
		7.3.3	Obligations of Lead Manufacturing Party
		7.3.4	[*]
	7.4	Manufacturing Responsibilities
		7.4.1	Chemistry, Manufacturing and Controls

		7.4.2	Lead Product
		7.4.3	Back-Up Supply
	7.5	Specifications and Terms of Supply
		7.5.1	Specifications
		7.5.2	Forecasts
		7.5.3	Diligent Efforts
	7.6	Shortage of Supply
	7.7	Inventory
	7.8	Manufacturing Costs and Fees
		7.8.1	In General
		7.8.2	Capital Equipment
		7.8.3	Stability Testing and Validation Batches
	7.9	Term of Supply Obligation
	7.10	Label

ARTICLE 8 REPRESENTATIONS AND COVENANTS

	8.1	Mutual Representations and Warranties
		8.1.1	Corporate Power
		8.1.2	Due Authorization
		8.1.3	Binding Agreement
		8.1.4	Grant of Rights; Maintenance of Agreements
		8.1.5	No Restrictions
	8.2	Manufacturing Covenant
	8.3	No Debarment
	8.4	Intellectual Property Representations and Warranties
	8.5	Medarex Representations and Warranties
	8.6	DISCLAIMER

ARTICLE 9 RECORDS AND AUDIT

	9.1	Information Disclosure and Materials Transfer
		9.1.1	Manufacturing Information
		9.1.2	Information Disclosure Generally
		9.1.3	Materials Transfer
	9.2	Records and Audit
		9.2.1	Records
		9.2.2	Audits

ARTICLE 10 LICENSES AND OTHER RIGHTS

	10.1	License Grants to BMS
		10.1.1	Technology
		10.1.2	Licensed Know-How
		10.1.3	Collaboration Technology
		10.1.4	Trademarks
		10.1.5	Effect of Change of Control

	10.2	License Grants to Medarex
		10.2.1	Technology
		10.2.2	Collaboration Technology
		10.2.3	Trademarks
		10.2.4	Effect of Change of Control
	10.3	Third Party Technology
		10.3.1	Existing In-License Agreements
		10.3.2	Existing Grants
		10.3.3	Retained Rights
		10.3.4	Additional Third Party Technology
	10.4	Sublicensing; Subcontracting
		10.4.1	Sublicenses
		10.4.3	Limitation on Grant of Licenses With Respect to Technology that is the Subject of a Co-Exclusive License
	10.5	Exclusivity; Competing Product
		10.5.1	Competing Product
		10.5.2	Breach
		10.5.3	Merger or Acquisition
		10.5.4	Medarex Divestiture of its Product Rights [*]
		10.5.5	Divestment; Failure to Divest
		10.5.5	BMS Non-Antibody Competing Product
		10.5.7	Equitable Relief
	10.6	Certain Covenants; Waiver
		10.6.1	By Medarex
		10.6.2	By BMS
		10.6.3	By BMS
	10.7	Exclusive Rights
	10.8	No Implied Licenses
	10.9	No Patent Challenges
	10.10	Bankruptcy
		10.10.1	In General
		10.10.2	Access or License
		10.10.3	Rights in Bankruptcy
	10.11	HSR Act Filing

ARTICLE 11 INTELLECTUAL PROPERTY

	11.1	Ownership of Collaboration Technology and Mice-Related Technology
		11.1.1	Collaboration Technology
		11.1.2	Mice-Related Technology
	11.2	Patent Prosecution
		11.2.1	Medarex Patents and BMS Patents
		11.2.2	Medarex Collaboration Patents and BMS Collaboration Patents
		11.2.3	Joint Collaboration Patents
		11.2.4	Patent Expenses
		11.2.5	Nondisclosure

vii

		11.2.6	Patent Term Extension
	11.3	Infringement Defense
		11.3.1	Defense of Third Party Claims for a Product in the United States
		11.3.2	Defense of Third Party Claims for a Product in the Royalty Territory
		11.3.3	Settlement of Third Party Claims for a Product
		11.3.4	Allocation of Costs
	11.4	Infringement by Third Parties in the United States
		11.4.1	Notification
		11.4.2	Medarex Patents and BMS Patents
		11.4.3	Joint Collaboration Patents
		11.4.4	Enforcement Procedure
		11.4.5	Costs and Recovery
	11.5	Infringement by Third Parties in the Royalty Territory
		11.5.1	Notification
		11.5.2	Medarex Patents and BMS Patents
		11.5.3	Joint Collaboration Patents
		11.5.4	Enforcement Procedure
		11.5.5	Costs and Recovery
	11.6	Patent Marking
	11.7	Product Trademarks
		11.7.1	Ownership of Product Trademarks
		11.7.2	Use of Product Trademarks
		11.7.3	Costs
		11.7.4	Cooperation
	11.8	Other Proprietary Trademarks
		11.8.1	Ownership of Corporate Names
		11.8.2	Use of Corporate Names
		11.8.3	Cooperation
	11.9	Trademark Infringement by Third Parties
		11.9.1	Product Trademarks in the United States
		11.9.2	Defense of Third Party Claims in the Royalty Territory
		11.9.3	Infringement by Third Parties

ARTICLE 12 CONFIDENTIALITY AND PUBLICATIONS

	12.1	Treatment of Confidential Information
	12.2	Publicity
	12.3	Securities Filings
	12.4	Publications
	12.5	Patient Information

ARTICLE 13 EXPORT CONTROL

	13.1	Authority

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ARTICLE 14 TERM AND TERMINATION

	14.1	Term
	14.2	Termination of Agreement
		14.2.1	Voluntary Termination of Agreement or Certain Rights Hereunder by BMS
		14.2.2	Additional Rights to Terminate Agreement or Certain Rights Hereunder
		14.2.3	Termination as to One or More Countries or Products
		14.2.4	Termination of the Lead Manufacturing Party
	14.3	Licenses and Royalties Upon Termination by BMS pursuant to Section 14.2
		14.3.1	Entire Agreement
		14.3.2	Product-by-Product
		14.3.3	Country-by-Country
		14.3.4	Sublicenses
		14.3.5	Sale of Inventory
		14.3.6	Survivability of Sublicense Grants
		14.3.7	Effect of Termination on Sublicenses Granted by BMS Pursuant to Section 10.4.1
		14.3.8	Covenant Regarding Assigned Product Trademarks
	14.4	Other Effects of Termination under Section 14.2
		14.4.1	Transfer of Regulatory Documentation
		14.4.2	Transfer of Manufacturing Responsibilities
		14.4.3	Return of Information and Materials
		14.4.4	Milestone Payments
		14.4.5	Reconciliation of Profit and Loss
		14.4.6	Assistance
		14.4.7	Royalties to BMS
		14.4.8	Royalties to Medarex
		14.4.9	Indemnification
	14.5	Consequences of Material Breach by Either Party
	14.6	Survival
	14.7	Remedies
	14.8	Limited Termination Right

ARTICLE 15 INDEMNIFICATION

	15.1	Indemnification in the Territory with respect to Products other than Co-Promotion Products in the United States
		15.1.1	Indemnification by BMS
		15.1.2	Indemnification by Medarex
		15.1.3	Excluded Losses
	15.2	Indemnification with respect to Co-Promotion Products in the United States
		15.2.1	In General
		15.2.2	Certain Losses

		15.2.3	Notices of Co-Promotion Product Claims
	15.3	Claims for Indemnification
	15.4	Insurance

ARTICLE 16 DISPUTE RESOLUTION

	16.1	Disputes Arising from the JEC
		16.1.2	Litigable and Arbitrable Matters
		16.1.3	Expert Matters
		16.1.4	Post-DO Party Matters
		16.1.5	BMS Final Decision-Making Authority
	16.2	Expert Resolution of Certain Disputes
	16.3	Intellectual Property Disputes
	16.4	Expedited Arbitration
	16.5	Governing Law, Jurisdiction, Venue and Service
		16.5.1