Back to top

COLLABORATION AND CO-PROMOTION AGREEMENT

Promotion Agreement

COLLABORATION AND CO-PROMOTION AGREEMENT You are currently viewing:
This Promotion Agreement involves

BRISTOL-MYERS SQUIBB COMPANY | MEDAREX, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: COLLABORATION AND CO-PROMOTION AGREEMENT
Governing Law: New York     Date: 1/24/2005
Industry: BIOTRX     Law Firm: Covington Burling     Sector: HEALTH

Search Promotion Agreement by:

Document Title:

Entire Document: (optional)

50 of the Top 250 law firms use our Products every day
EXHIBIT 99

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

 

 

i



 

 

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