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Title: |
Collaboration Agreement |
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Entities: |
Bristol-Myers Squibb Co.; Corgentech, Inc.; Cooley Godward LLP; Hughes Hubbard & Reed LLP |
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Date: |
2004 |
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Size: |
Preview shows 41KB of 376KB total |
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Price: |
$68 |
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ID: |
#289211 |
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Start of Preview |
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COLLABORATION AGREEMENT
BY AND BETWEEN
BRISTOL-MYERS SQUIBB COMPANY
AND
CORGENTECH INC.
[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Table of Contents
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PAGE
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|---|---|---|---|---|
| ARTICLE 1 DEFINITIONS | 2 | |||
| 1.1 | "Act" | 2 | ||
| 1.2 | "Affiliate" | 2 | ||
| 1.3 | "Alliance Managers" | 2 | ||
| 1.4 | "Allowable Expenses" | 2 | ||
| 1.5 | "Annual Plan and Budget" | 2 | ||
| 1.6 | "Approval" | 2 | ||
| 1.7 | "ANDA" | 2 | ||
| 1.8 | "AVG" | 2 | ||
| 1.9 | "BMS Know-How" | 3 | ||
| 1.10 | "BMS Patent" | 3 | ||
| 1.11 | "BMS Technology" | 3 | ||
| 1.12 | "Business Day" | 3 | ||
| 1.13 | "BWH License" | 3 | ||
| 1.14 | "CABG" | 3 | ||
| 1.15 | "Call Center" | 3 | ||
| 1.16 | "CE Marking" | 3 | ||
| 1.17 | "Clinical Costs" | 3 | ||
| 1.18 | "Commercialize" | 4 | ||
| 1.19 | "Committee" | 4 | ||
| 1.20 | "Competing Product" | 4 | ||
| 1.21 | "Confidential Information" | 4 | ||
| 1.22 | "Control" | 4 | ||
| 1.23 | "Co-Promote" | 4 | ||
| 1.24 | "Co-Promotion Term" | 4 | ||
| 1.25 | "Co-Promotion Territory" | 4 | ||
| 1.26 | "Corgentech Core Technology" | 4 | ||
| 1.27 | "Corgentech Know-How" | 5 | ||
| 1.28 | "Corgentech Patents" | 5 | ||
| 1.29 | "Corgentech Technology" | 5 | ||
| 1.30 | "Development Costs" | 5 | ||
| 1.31 | "Development Plan" | 6 | ||
| 1.32 | "Diligent Efforts" | 6 | ||
| 1.33 | "Disclosure Letter" | 6 | ||
| 1.34 | "Distribution Costs" | 6 | ||
| 1.35 | "Dollars" or "$" | 6 | ||
| 1.36 | "Drug Approval Application" | 6 | ||
| 1.37 | "E2F Decoy" | 7 | ||
| 1.38 | "EMEA" | 7 | ||
| 1.39 | "Equity Agreements" | 7 | ||
| 1.40 | "EU" | 7 | ||
| 1.41 | "Existing Third Party License Agreements" | 7 | ||
| 1.42 | "FDA" | 7 | ||
| 1.43 | "Field" | 7 | ||
| 1.44 | "Final Product" | 7 | ||
| 1.45 | "FTE" | 7 | ||
| 1.46 | "FTE Cost" | 7 | ||
| 1.47 | "GAAP" | 8 | ||
i
| 1.48 | "Generic Product" | 8 | ||
| 1.49 | "Good Manufacturing Practice" | 8 | ||
| 1.50 | "Information" | 8 | ||
| 1.51 | "Initial Approval" | 8 | ||
| 1.52 | "Initial Regulatory Approval" | 8 | ||
| 1.53 | "Intermediate" | 8 | ||
| 1.54 | "Inventions" | 8 | ||
| 1.55 | "Japan" | 8 | ||
| 1.56 | "Joint Commercialization Committee" or "JCC" | 9 | ||
| 1.57 | "Joint Development and Regulatory Committee" or "JDC" | 9 | ||
| 1.58 | "Joint Finance Committee" or "JFC" | 9 | ||
| 1.59 | "Joint Inventions" | 9 | ||
| 1.60 | "Joint Manufacturing Committee" or "JMC" | 9 | ||
| 1.61 | "Joint Patent" | 9 | ||
| 1.62 | "Joint Steering Committee" or "JSC" | 9 | ||
| 1.63 | "Koseisho" | 9 | ||
| 1.64 | "Launch" | 9 | ||
| 1.65 | "Lead Development and Regulatory Party" | 9 | ||
| 1.66 | "Lead Manufacturing Party" | 9 | ||
| 1.67 | "Lead Marketing Party" | 9 | ||
| 1.68 | "Licensed Device" | 9 | ||
| 1.69 | "Licensed Product" | 9 | ||
| 1.70 | "Major European Countries" | 9 | ||
| 1.71 | "Manufacturing Costs" | 9 | ||
| 1.72 | "Manufacturing Plan and Budget" | 11 | ||
| 1.73 | "Marketing Plan and Budget" | 11 | ||
| 1.74 | "Medical Liaisons" | 11 | ||
| 1.75 | "Net Sales" | 11 | ||
| 1.76 | "NDA" | 12 | ||
| 1.77 | "Other Licensed Product" | 12 | ||
| 1.78 | "PABG" | 12 | ||
| 1.79 | "Patent" | 12 | ||
| 1.80 | "Patent Costs" | 12 | ||
| 1.81 | "Phase I Clinical Trial" | 13 | ||
| 1.82 | "Phase II Clinical Trial" | 13 | ||
| 1.83 | "Phase I/II Clinical Trial" | 13 | ||
| 1.84 | "Phase III Clinical Trial" | 13 | ||
| 1.85 | "Phase IIIB Clinical Trial" | 13 | ||
| 1.86 | "Phase IV Clinical Trial" | 13 | ||
| 1.87 | "Pre-Launch Marketing Plan and Budget" | 13 | ||
| 1.88 | "Previously Disclosed" | 13 | ||
| 1.89 | "Product-Specific Corgentech Patent" | 13 | ||
| 1.90 | "Profit or Loss" | 14 | ||
| 1.91 | "QA" | 14 | ||
| 1.92 | "QC" | 14 | ||
| 1.93 | "Quarter" | 14 | ||
| 1.94 | "Regulatory Authority" | 14 | ||
| 1.95 | "Regulatory Expenses" | 14 | ||
| 1.96 | "Regulatory Working Group" or "RWG" | 14 | ||
| 1.97 | "Royalty Term" | 14 |
ii
| 1.98 | "Royalty Territory" | 14 | ||
| 1.99 | "Royalty-Bearing Sales" | 14 | ||
| 1.100 | "Sales and Marketing Costs" | 14 | ||
| 1.101 | "Sales Representative" | 16 | ||
| 1.102 | "Semi-Annual Period" | 17 | ||
| 1.103 | "Sole Invention" | 17 | ||
| 1.104 | "Specifications" | 17 | ||
| 1.105 | "Stanford License" | 17 | ||
| 1.106 | "Supply Chain Management" | 17 | ||
| 1.107 | "Territory" | 17 | ||
| 1.108 | "Third Party" | 17 | ||
| 1.109 | "Third Party Royalties" | 17 | ||
| 1.110 | "Trademark Costs" | 17 | ||
| 1.111 | "Transcription Factor Decoy" | 17 | ||
| 1.112 | "Valid Claim" | 17 | ||
| 1.113 | "Vialed Product" | 18 | ||
| 1.114 | "Working Group" | 18 | ||
| 1.115 | "Year" | 18 | ||
| 1.116 | Additional Defined Terms | 18 | ||
ARTICLE 2 MANAGEMENT |
19 | |||
| 2.1 | General | 19 | ||
| 2.2 | Joint Steering Committee (JSC) | 20 | ||
| 2.3 | Joint Development and Regulatory Committee (JDC) | 21 | ||
| 2.4 | Joint Commercialization Committee (JCC) | 23 | ||
| 2.5 | Joint Manufacturing Committee (JMC) | 25 | ||
| 2.6 | Joint Finance Committee (JFC) | 27 | ||
| 2.7 | General Committee Membership and Procedures | 28 | ||
| 2.8 | Alliance Managers | 30 | ||
| 2.9 | Collaboration Guidelines | 31 | ||
| 2.10 | General Overview of Accounting | 31 | ||
| 2.11 | Compliance with Law | 32 | ||
ARTICLE 3 DEVELOPMENT AND REGULATORY |
32 | |||
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