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Form S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 04/09/2007
Document Outline
Entire Document (3467 KB)
Subdocument 1 - S-1/A - AMENDMENT NO. 3 TO FORM S-1
Page 1 - As filed with the Securities and Exchange Commission on April 9, 2007
Page 2 - Subject to Completion
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - Contrave
Page 6 - Empatic
Page 7 - Commercialization
Page 8 - Corporate Information
Page 9 - THE OFFERING
Page 10 - SUMMARY FINANCIAL DATA
Page 11 - N/A
Page 12 - RISK FACTORS
Page 13 - Our clinical trials may fail to demonstrate acceptable levels of safety and efficacy of our product
Page 14 - N/A
Page 15 - Delays in the commencement or completion of clinical testing could result in increased costs to us a
Page 16 - Our product candidates are combinations of generically-available pharmaceutical products, and our su
Page 17 - N/A
Page 18 - We have limited sales and marketing experience or resources, and we may not be able to effectively m
Page 19 - Even if our product candidates receive regulatory approval, they may still face future development a
Page 20 - If the suppliers upon whom we rely for active pharmaceutical ingredients, or API, fail to produce su
Page 21 - N/A
Page 22 - We are combining drugs in novel combinations and cannot be sure that the combined drugs can co-exist
Page 23 - We are subject to uncertainty relating to reimbursement policies which, if not favorable to our prod
Page 24 - Our failure to successfully acquire, develop and market additional product candidates or approved pr
Page 25 - We will need to increase the size of our organization, and we may experience difficulties in managin
Page 26 - We will need to obtain FDA approval of our proposed product names, Contrave and Empatic, and any fai
Page 27 - If we fail to comply with healthcare regulations, we could face substantial penalties and our busine
Page 28 - Our business involves the use of hazardous materials and we and our third-party manufacturers must c
Page 29 - Although we have international patent applications pending, we do not currently have patent protecti
Page 30 - We have in-licensed the rights to our product candidates from third parties. If we default on any of
Page 31 - If we are sued for infringing intellectual property rights of third parties, it will be costly and t
Page 32 - Although we have entered into a settlement agreement designed to prevent the parties to the agreemen
Page 33 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 34 - We have not yet registered our trademarks in all of our potential markets, and failure to secure tho
Page 35 - We have not generated any revenue from our product candidates and may never be profitable.
Page 36 - Our quarterly operating results may fluctuate significantly.
Page 37 - Raising additional funds by issuing securities may cause dilution to existing stockholders and raisi
Page 38 - Risks Relating to Securities Markets and Investment in Our Stock
Page 39 - Our management team may invest or spend the proceeds of this offering in ways with which you may not
Page 40 - Our executive officers and directors and their affiliates will exercise control over stockholder vot
Page 41 - We have never paid dividends on our capital stock, and because we do not anticipate paying any cash
Page 42 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 43 - N/A
Page 44 - USE OF PROCEEDS
Page 45 - CAPITALIZATION
Page 46 - N/A
Page 47 - DILUTION
Page 48 - N/A
Page 49 - SELECTED FINANCIAL DATA
Page 50 - N/A
Page 51 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 52 - General and Administrative
Page 53 - Beneficial Conversion Feature
Page 54 - N/A
Page 55 - N/A
Page 56 - Accounting for Equity Instruments That are Issued to Other Than Employees for Acquiring, or in Conju
Page 57 - Research and Development Expenses.
Page 58 - N/A
Page 59 - Contractual Obligations and Commitments
Page 60 - Related Party Transactions
Page 61 - Off-Balance Sheet Arrangements
Page 62 - BUSINESS
Page 63 - The Obesity Epidemic
Page 64 - The Orexigen Solution
Page 65 - Our Lead Product Candidates
Page 66 - Scientific Rationale
Page 67 - Contrave Clinical Results
Page 68 - Contrave Phase II Mean Weight Loss through 24 Weeks
Page 69 - N/A
Page 70 - Contrave Phase IIb Mean Weight Loss at 24 Weeks
Page 71 - N/A
Page 72 - Contrave Phase IIb Mean Weight Loss at 48 Weeks
Page 73 - Contrave Phase IIb Mean Weight Loss Over 48 Weeks
Page 74 - Future Contrave Clinical Development Plans
Page 75 - Empatic
Page 76 - Scientific Rationale
Page 77 - Empatic Phase II Mean Weight Loss at 24 Weeks
Page 78 - Empatic Phase II Mean Weight Loss Over 24 Weeks
Page 79 - Future Empatic Clinical Development Plans
Page 80 - Intellectual Property
Page 81 - Licensing Agreements
Page 82 - Lee Dante License Agreement
Page 83 - Cypress Bioscience, Inc. License Agreement
Page 84 - Manufacturing
Page 85 - N/A
Page 86 - Third-Party Reimbursement
Page 87 - Government Regulation
Page 88 - N/A
Page 89 - Section 505(b)(2) New Drug Applications
Page 90 - Manufacturing cGMP Requirements
Page 91 - Employees
Page 92 - N/A
Page 93 - MANAGEMENT
Page 94 - Graham K. Cooper
Page 95 - James C. Lancaster, Jr.
Page 96 - Joseph S. Lacob
Page 97 - Board Committees
Page 98 - Compensation Committee Interlocks and Insider Participation
Page 99 - COMPENSATION DISCUSSION AND ANALYSIS
Page 100 - Long-Term Incentive Program.
Page 101 - Restricted Stock and Restricted Stock Units.
Page 102 - Executive Compensation
Page 103 - Grants of Plan-Based Awards
Page 104 - Employee Benefit and Stock Plans
Page 105 - Administration.
Page 106 - N/A
Page 107 - Change in Control.
Page 108 - Amendment and Termination of the 2007 Plan.
Page 109 - Eligibility.
Page 110 - Change in Control.
Page 111 - Option Exercises and Stock Vested at Fiscal Year End
Page 112 - Potential Payments Upon Termination Without Cause
Page 113 - Potential Payments Upon Termination Due to Change in Control
Page 114 - Limitations of Liability and Indemnification Matters
Page 115 - N/A
Page 116 - PRINCIPAL STOCKHOLDERS
Page 117 - (footnotes continued on following page)
Page 118 - N/A
Page 119 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 120 - Common Stock Issuances
Page 121 - Investors Rights Agreement
Page 122 - Employment Agreements
Page 123 - Other Transactions and Arrangements
Page 124 - DESCRIPTION OF CAPITAL STOCK
Page 125 - Registration Rights
Page 126 - Stockholder Meetings
Page 127 - SHARES ELIGIBLE FOR FUTURE SALE
Page 128 - Rule 144
Page 129 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO
Page 130 - Gain on Disposition of Common Stock
Page 131 - Federal Estate Tax
Page 132 - UNDERWRITING
Page 133 - No Sales of Similar Securities
Page 134 - Price Stabilization, Short Positions and Penalty Bids
Page 135 - LEGAL MATTERS
Page 136 - Orexigen Therapeutics, Inc.
Page 137 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 138 - OREXIGEN THERAPEUTICS, INC.
Page 139 - OREXIGEN THERAPEUTICS, INC.
Page 140 - OREXIGEN THERAPEUTICS, INC.
Page 141 - OREXIGEN THERAPEUTICS, INC.
Page 142 - OREXIGEN THERAPEUTICS, INC.
Page 143 - OREXIGEN THERAPEUTICS, INC.
Page 144 - OREXIGEN THERAPEUTICS, INC.
Page 145 - OREXIGEN THERAPEUTICS, INC.
Page 146 - OREXIGEN THERAPEUTICS, INC.
Page 147 - OREXIGEN THERAPEUTICS, INC.
Page 148 - OREXIGEN THERAPEUTICS, INC.
Page 149 - OREXIGEN THERAPEUTICS, INC.
Page 150 - OREXIGEN THERAPEUTICS, INC.
Page 151 - OREXIGEN THERAPEUTICS, INC.
Page 152 - OREXIGEN THERAPEUTICS, INC.
Page 153 - OREXIGEN THERAPEUTICS, INC.
Page 154 - OREXIGEN THERAPEUTICS, INC.
Page 155 - OREXIGEN THERAPEUTICS, INC.
Page 156 - OREXIGEN THERAPEUTICS, INC.
Page 157 - OREXIGEN THERAPEUTICS, INC.
Page 158 - OREXIGEN THERAPEUTICS, INC.
Page 159 - OREXIGEN THERAPEUTICS, INC.
Page 160 - 6,000,000 Shares
Page 161 - PART II
Page 162 - N/A
Page 163 - Exhibits
Page 164 - Financial Statement Schedules
Page 165 - SIGNATURES
Page 166 - EXHIBIT INDEX
Subdocument 2 - EX-1.1 - EXHIBIT 1.1
Page 1 - EXHIBIT 1.1
Page 2 - PURCHASE AGREEMENT
Page 3 - Representations and Warranties
Page 4 - bona fide
Page 5 - Independent Accountants
Page 6 - Authorization of Agreement
Page 7 - Accuracy of Exhibits
Page 8 - Absence of Further Requirements
Page 9 - Tests and Preclinical and Clinical Studies
Page 10 - Registration Rights
Page 11 - NASD Matters
Page 12 - Money Laundering Laws
Page 13 - Payment
Page 14 - Filing of Amendments and Exchange Act Documents
Page 15 - Blue Sky Qualifications
Page 16 - Reporting Requirements
Page 17 - Termination of Agreement
Page 18 - Officers Certificate
Page 19 - Opinion of Counsel for Underwriters
Page 20 - provided
Page 21 - Settlement without Consent if Failure to Reimburse
Page 22 - Representations, Warranties and Agreements to Survive
Page 23 - Tax Disclosure
Page 24 - Parties
Page 25 - N/A
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Page 29 - N/A
Subdocument 3 - EX-3.2 - EXHIBIT 3.2
Page 1 - EXHIBIT 3.2
Page 2 - N/A
Subdocument 4 - EX-4.1 - EXHIBIT 4.1
Page 1 - EXHIBIT 4.1
Page 2 - OREXIGEN THERAPEUTICS, INC.
Subdocument 5 - EX-5.1 - EXHIBIT 5.1
Page 1 - EXHIBIT 5.1
Page 2 - April 9, 2007
Subdocument 6 - EX-10.7 - EXHIBIT 10.7
Page 1 - EXHIBIT 10.7
Page 2 - N/A
Page 3 - Agreement
Page 4 - N/A
Page 5 - N/A
Page 6 - Licensed Mouse Patent Rights
Page 7 - Licensed Screening Patent Rights
Page 8 - Net Sales
Page 9 - Licensed Products
Page 10 - LICENSEE
Page 11 - Screening Products
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - SIGNATURES ON NEXT PAGE
Page 17 - SIGNATURE PAGE
Page 18 - LICENSEE
Page 19 - OREXIGEN THERAPEUTICS, INC.
Page 20 - Representations and Warranties of OHSU
Page 21 - Accredited Investor
Page 22 - N/A
Subdocument 7 - EX-10.10 - EXHIBIT 10.10
Page 1 - EXHIBIT 10.10
Page 2 - ARTICLE 1 DEFINITIONS
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - ARTICLE 2 LICENSE
Page 8 - N/A
Page 9 - ARTICLE 3 LICENSE FEE, ROYALTIES AND OTHER FEES
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - For delivery via the U.S. Postal Service:
Page 15 - ARTICLE 5 REPORTS AND RECORDS
Page 16 - ARTICLE 6 PATENTS
Page 17 - N/A
Page 18 - N/A
Page 19 - ARTICLE 7 INFRINGEMENT OF THIRD-PARTY RIGHTS
Page 20 - ARTICLE 8 INFRINGEMENT OF DUKE PATENT RIGHTS BY THIRD PARTIES
Page 21 - N/A
Page 22 - ARTICLE 9 GOVERNMENT CLEARANCE, PUBLICATION, EXPORT
Page 23 - ARTICLE 10 DURATION AND TERMINATION
Page 24 - N/A
Page 25 - ARTICLE 11 CONFIDENTIALITY
Page 26 - ARTICLE 12 NOTICES
Page 27 - ARTICLE 13 ASSIGNMENT
Page 28 - ARTICLE 14 INDEMNITY, INSURANCE, REPRESENTATIONS, STATUS
Page 29 - N/A
Page 30 - ARTICLE 15 USE OF A PARTY S NAME
Page 31 - ARTICLE 19 GOVERNING LAW
Page 32 - IN WITNESS WHEREOF
Page 33 - APPENDICES
Page 34 - APPENDIX A
Page 35 - APPENDIX B
Page 36 - AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
Page 37 - Original Issue Price
Page 38 - N/A
Page 39 - Redemption of Series A Preferred Stock
Page 40 - Voting Rights
Page 41 - Conversion of Preferred Stock
Page 42 - Adjustments to Conversion Price for Stock Dividends and for Combinations or Subdivisions of Common S
Page 43 - No Adjustment of Conversion Price
Page 44 - N/A
Page 45 - Adjustment of the Series A Conversion Price Upon Issuance of Additional Shares of Common Stock
Page 46 - Certificates as to Adjustments
Page 47 - Issue Taxes
Page 48 - N/A
Page 49 - No Reissuance of Preferred Stock
Page 50 - Section 145
Page 51 - N/A
Page 52 - APPENDIX B
Page 53 - Quorum
Page 54 - Organization
Page 55 - Stock List
Page 56 - Consent of Stockholders in Lieu of Meeting
Page 57 - ARTICLE II
Page 58 - Vacancies
Page 59 - Quorum
Page 60 - Compensation of Directors
Page 61 - Conduct of Business
Page 62 - President
Page 63 - Secretary
Page 64 - ARTICLE V
Page 65 - N/A
Page 66 - Lost, Stolen or Destroyed Certificates
Page 67 - Waivers
Page 68 - Fiscal Year
Page 69 - Right to Advancement of Expenses
Page 70 - Right of Indemnitee to Bring Suit
Page 71 - Non-Exclusivity of Rights
Page 72 - Insurance
Page 73 - ARTICLE IX
Page 74 - September 15, 2003
Page 75 - January 14, 2004
Page 76 - N/A
Page 77 - APPENDIX C
Page 78 - APPENDIX D
Page 79 - APPENDIX D
Page 80 - N/A
Page 81 - N/A
Page 82 - APPENDIX E
Page 83 - OREXIGEN THERAPEUTICS , INC.
Page 84 - Valid Issuance of Common Stock
Page 85 - Rule 144
Page 86 - Entire Agreement
Page 87 - N/A
Page 88 - APPENDIX F
Page 89 - Agreement
Page 90 - Company Notice
Page 91 - No Adverse Effect
Page 92 - No Adverse Effect
Page 93 - Legended Certificates
Page 94 - Removal of Legend
Page 95 - Additional Parties
Page 96 - SIGNATURE PAGE TO RIGHT OF FIRST REFUSAL AND
Page 97 - SIGNATURE PAGE TO RIGHT OF FIRST REFUSAL AND
Page 98 - SIGNATURE PAGE TO RIGHT OF FIRST REFUSAL AND
Page 99 - SIGNATURE PAGE TO RIGHT OF FIRST REFUSAL AND
Page 100 - INVESTORS:
Page 101 - SIGNATURE PAGE TO RIGHT OF FIRST REFUSAL AND
Page 102 - EXHIBIT A
Page 103 - APPENDIX G
Page 104 - OREXIGEN THERAPEUTICS, INC.
Page 105 - TABLE OF CONTENTS
Page 106 - TABLE OF CONTENTS
Page 107 - OREXIGEN THERAPEUTICS, INC.
Page 108 - Securities
Page 109 - N/A
Page 110 - Company Registration
Page 111 - N/A
Page 112 - Furnish Information
Page 113 - Underwriting Requirements
Page 114 - Indemnification
Page 115 - Form S-3 Registration
Page 116 - N/A
Page 117 - Limitations on Subsequent Registration Rights
Page 118 - Reports Under the Securities Exchange Act of 1934
Page 119 - Covenants of the Company
Page 120 - Inspection
Page 121 - N/A
Page 122 - Vesting of Stock; Co-Sale Rights
Page 123 - Proprietary Rights Agreements
Page 124 - Allocation of Securities and Payment
Page 125 - Termination
Page 126 - Amendments and Waivers
Page 127 - IN WITNESS WHEREOF
Page 128 - IN WITNESS WHEREOF
Page 129 - IN WITNESS WHEREOF
Page 130 - In Witness Whereof
Page 131 - SCHEDULE A
Subdocument 8 - EX-10.13 - EXHIBIT 10.13
Page 1 - EXHIBIT 10.13
Page 2 - N/A
Page 3 - N/A
Page 4 - N/A
Page 5 - ARTICLE 2 LICENSE
Page 6 - ARTICLE 3 LICENSE FEE, ROYALTIES AND OTHER FEES
Page 7 - N/A
Page 8 - ARTICLE 4 DUE DILIGENCE REQUIREMENTS
Page 9 - ARTICLE 6 PATENTS
Page 10 - N/A
Page 11 - ARTICLE 7 INFRINGEMENT OF THIRD-PARTY RIGHTS
Page 12 - N/A
Page 13 - ARTICLE 9 GOVERNMENT CLEARANCE, PUBLICATION
Page 14 - ARTICLE 10 DURATION AND TERMINATION
Page 15 - ARTICLE 11 CONFIDENTIALITY
Page 16 - ARTICLE 12 NOTICES
Page 17 - ARTICLE 13 ASSIGNMENT
Page 18 - N/A
Page 19 - N/A
Page 20 - ARTICLE 15 USE OF A PARTY S NAME
Page 21 - ARTICLE 17 TITLES
Page 22 - ARTICLE 21 ENTIRE UNDERSTANDING
Page 23 - APPENDICES
Page 24 - APPENDIX A
Page 25 - APPENDIX B
Page 26 - OREXIGEN THERAPEUTICS, INC.
Page 27 - N/A
Page 28 - OREXIGEN THERAPEUTICS, INC.
Page 29 - Method of Exercise
Page 30 - Termination of Relationship
Page 31 - Incentive Stock Option
Page 32 - Effect of Agreement
Page 33 - N/A
Page 34 - EXHIBIT A
Page 35 - Proposed Transferee
Page 36 - Involuntary Transfer
Page 37 - Investment and Taxation Representations
Page 38 - Restrictive Legends and Stop-Transfer Orders
Page 39 - Lock-Up Agreement
Page 40 - Counterparts
Page 41 - N/A
Page 42 - RECEIPT
Page 43 - RECEIPT
Page 44 - APPENDIX C
Page 45 - Orexigen Therapeutics, Inc.
Page 46 - Independent Contractor
Page 47 - Security
Page 48 - Conflict of Interest
Page 49 - Prior Agreements
Subdocument 9 - EX-10.14 - EXHIBIT 10.14
Page 1 - EXHIBIT 10.14
Page 2 - N/A
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - ARTICLE 2 OPTION/LICENSE/SUBLICENSES
Page 9 - N/A
Page 10 - ARTICLE 3 LICENSE FEE, ROYALTIES AND OTHER FEES
Page 11 - N/A
Page 12 - N/A
Page 13 - ARTICLE 4 COLLABORATIVE WORK/DUE DILIGENCE REQUIREMENTS
Page 14 - N/A
Page 15 - N/A
Page 16 - ARTICLE 5 REPORTS AND RECORDS
Page 17 - ARTICLE 6 PATENTS
Page 18 - N/A
Page 19 - ARTICLE 7 INFRINGEMENT OF THIRD-PARTY RIGHTS
Page 20 - N/A
Page 21 - ARTICLE 9 GOVERNMENT CLEARANCE, PUBLICATION, EXPORT
Page 22 - ARTICLE 10 DURATION AND TERMINATION
Page 23 - N/A
Page 24 - ARTICLE 11 CONFIDENTIALITY
Page 25 - N/A
Page 26 - N/A
Page 27 - ARTICLE 12 NOTICES
Page 28 - ARTICLE 14 INDEMNITY, INSURANCE, REPRESENTATIONS, STATUS
Page 29 - N/A
Page 30 - N/A
Page 31 - ARTICLE 15 USE OF A PARTY S NAME
Page 32 - ARTICLE 19 GOVERNING LAW
Page 33 - N/A
Page 34 - ARTICLE 21 ENTIRE UNDERSTANDING
Page 35 - IN WITNESS WHEREOF
Page 36 - APPENDICES
Page 37 - APPENDIX A
Page 38 - APPENDIX B
Page 39 - providing
Subdocument 10 - EX-10.21 - EXHIBIT 10.21
Page 1 - EXHIBIT 10.21
Page 2 - ARTICLE III COMPENSATION
Page 3 - ARTICLE VI EQUIPMENT
Page 4 - ARTICLE X PATENTS AND INVENTIONS
Page 5 - ARTICLE XI LICENSE
Page 6 - ARTICLE XIV NOTICES
Page 7 - ARTICLE XV CHANGES AND AMENDMENTS
Page 8 - In Witness Whereof
Page 9 - Attachment A
Page 10 - Attachment B
Page 11 - Attachment C
Page 12 - Yr 1
Subdocument 11 - EX-10.22 - EXHIBIT 10.22
Page 1 - EXHIBIT 10.22
Page 2 - Schedule A:
Page 3 - CONFIDENTIAL
Page 4 - CONFIDENTIAL
Page 5 - Schedule B:
Page 6 - Part A: Project Scope
Page 7 - Part B: Budget Summary
Subdocument 12 - EX-23.1 - EXHIBIT 23.1
Page 1 - EXHIBIT 23.1