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Form F-1
OBSEVA SA filed this Form F-1 on 12/30/2016
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Entire Document (5256.6 KB)
Subdocument 1 - F-1 - FORM F-1
Page 1 - As filed with the Securities and Exchange Commission on December 30, 2016.
Page 2 - The information contained in this preliminary prospectus is not complete and may be changed. We may
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - OBE2109 for the Treatment of Pain Associated with Endometriosis and Heavy Menstrual Bleeding Associa
Page 6 - OBE001 (nolasiban) to Improve IVF Outcomes
Page 7 - OBE022 for the Treatment of Preterm Labor
Page 8 - Risks Associated with Our Business
Page 9 - Implications of Being an Emerging Growth Company and a Foreign Private Issuer
Page 10 - The Offering
Page 11 - Summary Consolidated Financial Data
Page 12 - N/A
Page 13 - RISK FACTORS
Page 14 - We have a limited operating history and have never generated any revenue from product sales, which m
Page 15 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 16 - Fluctuations in exchange rates may adversely affect our results of operations.
Page 17 - Clinical trials are very expensive, time-consuming and difficult to design and implement and involve
Page 18 - The European Phase 3 clinical trial for OBE001 based on observations from our post-hoc analysis of t
Page 19 - N/A
Page 20 - The regulatory approval process of the FDA, EMA or any comparable foreign regulatory agency may be l
Page 21 - Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or se
Page 22 - We depend on enrollment of patients in our clinical trials for our product candidates. If we are una
Page 23 - We may not be successful in our efforts to in-license or acquire additional product candidates for o
Page 24 - We may expend our limited resources to pursue a particular product candidate or indication and fail
Page 25 - We operate in a highly competitive and rapidly changing industry.
Page 26 - The successful commercialization of certain of our product candidates will depend in part on the ext
Page 27 - Even if we obtain regulatory approval for OBE2109, OBE001, OBE022 or future product candidates, they
Page 28 - Off-label use is common in the indications for which our product candidates are under development, w
Page 29 - Even if any of our product candidates receives marketing approval, it may fail to achieve the degree
Page 30 - We currently have no marketing, sales or distribution infrastructure. If we are unable to develop sa
Page 31 - Risks Related to Our Dependence on Third Parties
Page 32 - We currently rely on third parties for the production of our clinical supply of our product candidat
Page 33 - We rely on our third-party manufacturers to source the supply of the materials for our product candi
Page 34 - We may in the future enter into collaborations with third parties to develop our product candidates.
Page 35 - If we are not able to establish or maintain collaborations, we may have to alter some of our future
Page 36 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 37 - Risks Related to Regulatory Compliance
Page 38 - N/A
Page 39 - Our business operations and current and future relationships with investigators, health care profess
Page 40 - N/A
Page 41 - Risks Related to Our Intellectual Property
Page 42 - We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope o
Page 43 - Patent terms may be inadequate to protect our competitive position on our product candidates for an
Page 44 - Changes in patent laws or patent jurisprudence could diminish the value of patents in general, there
Page 45 - Molecular Pathology v. Myriad Genetics, Inc.
Page 46 - We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors o
Page 47 - We may not be able to protect our intellectual property rights throughout the world, which could neg
Page 48 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 49 - Intellectual property litigation could cause us to spend substantial resources and distract our pers
Page 50 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 51 - Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be s
Page 52 - We expect to expand our development and regulatory capabilities and potentially implement sales, mar
Page 53 - Risks Related to This Offering and Our Common Shares
Page 54 - We will incur increased costs as a result of operating as a public company, and our management and b
Page 55 - We do not expect to pay dividends in the foreseeable future.
Page 56 - We are a Swiss stock corporation. The rights of our shareholders may be different from the rights of
Page 57 - Our status as a Swiss stock corporation means that our shareholders enjoy certain rights that may li
Page 58 - As a foreign private issuer and as permitted by the listing requirements of NASDAQ, we will have the
Page 59 - While we do not expect to be a passive foreign investment company, or PFIC, for U.S. federal income
Page 60 - We are an emerging growth company, and we cannot be certain if the reduced reporting requirements ap
Page 61 - If securities or industry analysts do not publish research, or publish inaccurate or unfavorable res
Page 62 - PRESENTATION OF FINANCIAL AND OTHER INFORMATION
Page 63 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 64 - N/A
Page 65 - INDUSTRY AND MARKET DATA
Page 66 - USE OF PROCEEDS
Page 67 - DIVIDEND POLICY
Page 68 - CAPITALIZATION
Page 69 - DILUTION
Page 70 - N/A
Page 71 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 72 - N/A
Page 73 - MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
Page 74 - Strategic Licensing Agreements
Page 75 - OBE022
Page 76 - General and Administrative Expenses
Page 77 - Analysis of Results of Operations
Page 78 - General and Administrative Expenses
Page 79 - General and Administrative Expenses
Page 80 - N/A
Page 81 - Operating Activities
Page 82 - Financing Activities
Page 83 - Recognition of Research and Development Expenses
Page 84 - Impairments
Page 85 - Recent Accounting Pronouncements
Page 86 - Capital Risk
Page 87 - BUSINESS
Page 88 - N/A
Page 89 - N/A
Page 90 - Our Strengths
Page 91 - N/A
Page 92 - OBE2109: Investigational GnRH Receptor Antagonist for Symptoms Associated with Endometriosis and Ute
Page 93 - The Role of GnRH
Page 94 - Mechanism of Action and Limitations of GnRH Agonists
Page 95 - OBE2109 s Mechanism of Action and Solution to GnRH Agonist Drawbacks and Limitations
Page 96 - OBE2109 Preclinical and Clinical Development for Pain Associated with Endometriosis
Page 97 - Completed Phase 2a Clinical Trials
Page 98 - Figure 3: Average Change in Severity of Pelvic Pain Over Time (Menstrual and Non-menstrual Pain Comb
Page 99 - Figure 4: Median Estradiol Levels Over Time
Page 100 - Figure 5: Percent of Patients at Various Estradiol Levels in KLH1202 Trial at Week 12
Page 101 - Figure 6: Design of Phase 2b EDELWEISS Clinical Trial
Page 102 - Completed Phase 2a Clinical Trial
Page 103 - Figure 8: Time to No Bleeding for Uterine Fibroids Patients in KLH1202 Trial
Page 104 - Safety Results
Page 105 - OBE001 (nolasiban) in IVF
Page 106 - N/A
Page 107 - N/A
Page 108 - Role of Oxytocin in Embryo Implantation
Page 109 - Potential Therapeutic Benefits of OBE001
Page 110 - Phase 2 Clinical Trial
Page 111 - Figure 11
Page 112 - Figure 12
Page 113 - Figure 13
Page 114 - OBE022: Our PGF2
Page 115 - Figure 15: Weighted Percentages of Tocolytic Agents for Efficacy
Page 116 - Preclinical Development
Page 117 - Commercialization
Page 118 - Competition
Page 119 - Intellectual Property
Page 120 - 2013 License Agreement with Merck Serono
Page 121 - 2015 License Agreement with Merck Serono
Page 122 - Government Regulation
Page 123 - Clinical Trials
Page 124 - Submission of an NDA
Page 125 - The FDA s Decision on an NDA
Page 126 - Post-approval Requirements
Page 127 - Healthcare Reform
Page 128 - Coverage, Reimbursement and Pricing
Page 129 - Sales and Marketing
Page 130 - N/A
Page 131 - Foreign Regulation
Page 132 - National Authorization Procedures
Page 133 - Employees
Page 134 - MANAGEMENT
Page 135 - Fabien Lefebvre de Ladonchamps
Page 136 - James I. Healy
Page 137 - Jacky Vonderscher
Page 138 - Compensation, Nominating and Corporate Governance Committee
Page 139 - N/A
Page 140 - Other Corporate Governance Matters
Page 141 - RELATED-PARTY TRANSACTIONS
Page 142 - Sale of Series B Preferred Shares
Page 143 - Registration Rights Agreement
Page 144 - N/A
Page 145 - PRINCIPAL SHAREHOLDERS
Page 146 - N/A
Page 147 - N/A
Page 148 - DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION
Page 149 - droit pr f rentiel de souscription
Page 150 - Conditional Share Capital for Equity Incentive Plans
Page 151 - Voting and Quorum Requirements
Page 152 - Notice
Page 153 - Dividends and Other Distributions
Page 154 - registre des actions
Page 155 - Board of Directors
Page 156 - Indemnification of Executive Management and Directors
Page 157 - Borrowing Powers
Page 158 - Repurchases of Shares and Purchases of Own Shares
Page 159 - COMPARISON OF SWISS LAW AND DELAWARE LAW
Page 160 - N/A
Page 161 - N/A
Page 162 - N/A
Page 163 - N/A
Page 164 - N/A
Page 165 - N/A
Page 166 - COMMON SHARES ELIGIBLE FOR FUTURE SALE
Page 167 - Affiliates
Page 168 - MATERIAL INCOME TAX CONSIDERATIONS
Page 169 - soci t de domicile
Page 170 - remboursements li s la r duction de la valeur nominale des actions
Page 171 - Capital Gains on Disposal of Common Shares
Page 172 - Material U.S. Federal Income Tax Consequences for U.S. Holders
Page 173 - Passive Foreign Investment Company Rules
Page 174 - de minimis
Page 175 - Taxation of Distributions
Page 176 - Information With Respect to Foreign Financial Assets
Page 177 - UNDERWRITING
Page 178 - N/A
Page 179 - NASDAQ
Page 180 - Price Stabilization, Short Positions and Penalty Bids
Page 181 - Selling Restrictions
Page 182 - Notice to Prospective Investors in Switzerland
Page 183 - Notice to Prospective Investors in Hong Kong
Page 184 - Notice to Canadian Residents
Page 185 - Other Relationships
Page 186 - EXPENSES OF THIS OFFERING
Page 187 - LEGAL MATTERS
Page 188 - ENFORCEMENT OF JUDGMENTS
Page 189 - WHERE YOU CAN FIND ADDITIONAL INFORMATION
Page 190 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 191 - ObsEva SA
Page 192 - ObsEva SA
Page 193 - ObsEva SA
Page 194 - ObsEva SA
Page 195 - ObsEva SA
Page 196 - ObsEva SA
Page 197 - ObsEva SA
Page 198 - ObsEva SA
Page 199 - ObsEva SA
Page 200 - ObsEva SA
Page 201 - ObsEva SA
Page 202 - ObsEva SA
Page 203 - ObsEva SA
Page 204 - ObsEva SA
Page 205 - ObsEva SA
Page 206 - ObsEva SA
Page 207 - ObsEva SA
Page 208 - ObsEva SA
Page 209 - ObsEva SA
Page 210 - ObsEva SA
Page 211 - ObsEva SA
Page 212 - ObsEva SA
Page 213 - ObsEva SA
Page 214 - ObsEva SA
Page 215 - ObsEva SA
Page 216 - ObsEva SA
Page 217 - ObsEva SA
Page 218 - ObsEva SA
Page 219 - ObsEva SA
Page 220 - ObsEva SA
Page 221 - ObsEva SA
Page 222 - ObsEva SA
Page 223 - ObsEva SA
Page 224 - ObsEva SA
Page 225 - N/A
Page 226 - PART II
Page 227 - Issuances Under Our Equity Plans
Page 228 - bona fide
Page 229 - SIGNATURES
Page 230 - N/A
Page 231 - EXHIBIT INDEX
Subdocument 2 - EX-3.1 - EX-3.1
Page 1 - Exhibit 3.1
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 - N/A
Page 9 - N/A
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - N/A
Page 18 - N/A
Page 19 - N/A
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - N/A
Page 24 - N/A
Page 25 - Modifications of the Articles of Association adopted during the December 6, 2016 EGM and already in
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Subdocument 3 - EX-3.2 - EX-3.2
Page 1 - Exhibit 3.2
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 - N/A
Page 9 - N/A
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - N/A
Page 18 - N/A
Page 19 - N/A
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - La version anglaise de ces statuts est une traduction de l original en langue fran aise. En cas de c
Subdocument 4 - EX-4.2 - EX-4.2
Page 1 - Exhibit 4.2
Page 2 - OrbiMed Private Investments V, LP
Page 3 - Table of Contents
Page 4 - Preamble
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - N/A
Page 10 - License Agreement
Page 11 - N/A
Page 12 - Nomination Committee
Page 13 - N/A
Page 14 - Exhibit 2
Page 15 - N/A
Page 16 - N/A
Page 17 - N/A
Page 18 - N/A
Page 19 - N/A
Page 20 - N/A
Page 21 - N/A
Page 22 - N/A
Page 23 - N/A
Page 24 - N/A
Page 25 - N/A
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Page 29 - N/A
Page 30 - N/A
Page 31 - N/A
Page 32 - N/A
Page 33 - N/A
Page 34 - N/A
Page 35 - Schiedsgutachter
Page 36 - Call Option
Page 37 - N/A
Page 38 - N/A
Page 39 - N/A
Page 40 - N/A
Page 41 - N/A
Page 42 - N/A
Page 43 - EXHIBITS TO THE
Subdocument 5 - EX-10.1 - EX-10.1
Page 1 - Exhibit 10.1
Page 2 - LICENSE AGREEMENT
Page 3 - 1.4 Calendar Year
Page 4 - 1.11 Controlled
Page 5 - 1.20 IND
Page 6 - 1.31 NDA
Page 7 - 1.33 Patent Right(s)
Page 8 - 1.43 Territory
Page 9 - 2.2 Grant of Sublicense by Licensee
Page 10 - 3.4 Diligence by Licensee.
Page 11 - (c) Third Party License Agreements.
Page 12 - (g) Record Retention, Inspection.
Page 13 - 5.3 Title to Inventions.
Page 14 - (d) Patent Term Extension
Page 15 - (d) Settlement
Page 16 - (e) Costs of an Action
Page 17 - 6.2 Publications.
Page 18 - ARTICLE 7 - REPRESENTATIONS AND WARRANTIES
Page 19 - 7.2 Licensee representations and warranties.
Page 20 - ARTICLE 9 TERM AND TERMINATION
Page 21 - 9.6 No Challenge.
Page 22 - ARTICLE 10 - MISCELLANEOUS
Page 23 - 10.2 Assignment.
Page 24 - 10.7 Entire Agreement of the Parties; Amendments.
Page 25 - 10.12 Waiver.
Page 26 - IN WITNESS WHEREOF
Page 27 - Schedule 1.23
Page 28 - Schedule 1.27
Page 29 - Schedule 1.28
Page 30 - Schedule 1.29
Page 31 - Exhibit A
Subdocument 6 - EX-10.2 - EX-10.2
Page 1 - Exhibit 10.2
Page 2 - LICENSE AGREEMENT
Page 3 - 1.4 Calendar Year
Page 4 - 1.14 EMA
Page 5 - 1.21 Know-How
Page 6 - 1.31 Net Sales
Page 7 - 1.34 Phase I Trial
Page 8 - 1.47 Other Terms.
Page 9 - 2.3 Transfer.
Page 10 - ARTICLE 4 FINANCIAL TERMS
Page 11 - (d) Royalty Term.
Page 12 - 4.4 Late Payment.
Page 13 - (b) Merck Serono Patents
Page 14 - 5.5 Enforcement of Patents.
Page 15 - 5.6 Third Party Actions Claiming Infringement.
Page 16 - ARTICLE 6 CONFIDENTIALITY
Page 17 - 6.2 Publications.
Page 18 - (c)
Page 19 - ARTICLE 8 - INDEMNIFICATION
Page 20 - 9.4 Termination for Breach
Page 21 - (b) Termination by Licensee pursuant to Section 9.2 or by Merck Serono pursuant to Sections 9.3, 9.4
Page 22 - ARTICLE 10 MISCELLANEOUS
Page 23 - 10.6 No Trademark Rights.
Page 24 - 10.12 Waiver.
Page 25 - IN WITNESS WHEREOF
Page 26 - Schedule 1.23
Page 27 - Schedule 1.27
Page 28 - Schedule 1.28
Page 29 - Schedule 1.29
Page 30 - FIRST AMENDMENT TO THE
Page 31 - III. Patent Maintenance.
Page 32 - N/A
Page 33 - EXHIBIT A
Subdocument 7 - EX-10.3 - EX-10.3
Page 1 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Page 2 - Affiliate
Page 3 - Generic Competition
Page 4 - MAA
Page 5 - ObsEva Know-How
Page 6 - Royalty Term
Page 7 - Kissei Relevant Patents
Page 8 - Milestone Payments
Page 9 - N/A
Page 10 - Accrual of Royalties
Page 11 - Exchange Rates
Page 12 - The Joint Development Committee
Page 13 - provided
Page 14 - provided
Page 15 - Regulatory Filings
Page 16 - Commercially Reasonable Efforts
Page 17 - Option to Co-Promote
Page 18 - Choice of Trademark
Page 19 - Supply Conditions.
Page 20 - Buffer stock and sourcing
Page 21 - Abandonment of Supply Right by Kissei.
Page 22 - Disclaimer
Page 23 - ObsEva
Page 24 - Limitation of Warranty
Page 25 - Updates
Page 26 - Notification of Infringement
Page 27 - ObsEva Improvements
Page 28 - Publication
Page 29 - ObsEva Confidential Information
Page 30 - N/A
Page 31 - N/A
Page 32 - N/A
Page 33 - Organization Resolution
Page 34 - N/A
Page 35 - Indemnification by Kissei
Page 36 - provided
Page 37 - N/A
Page 38 - N/A
Page 39 - Exhibit A
Page 40 - Exhibit B-1
Page 41 - Exhibit B-2
Page 42 - Exhibit C
Subdocument 8 - EX-10.4 - EX-10.4
Page 1 - Exhibit 10.4
Page 2 - Provisional advance payments: CHF 40.00/m2 (plus VAT), i.e., CHF 21,440.00/year (plus the VAT), i.e.
Page 3 - The tenant
Page 4 - N/A
Page 5 - GENERAL CONDITIONS FOR COMMERCIAL PREMISES
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - N/A
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - Annex:
Page 15 - SPECIFIC TERMS
Page 16 - Art. 39 - Additional services
Page 17 - Art. 44 - Delay in finishing the work
Page 18 - LEASE-RELATED RULES AND USAGE
Page 19 - N/A
Page 20 - N/A
Page 21 - N/A
Page 22 - GARAGE RENTAL LEASE AGREEMENT
Page 23 - II. GENERAL CONDITIONS
Page 24 - Art. 9. Sublease
Page 25 - N/A
Page 26 - Annexes:
Page 27 - N/A
Page 28 - Amendment 2
Page 29 - Amendment 2
Page 30 - N/A
Page 31 - Amendment 2
Page 32 - Amendment 2
Page 33 - Amendment 2
Subdocument 9 - EX-21.1 - EX-21.1
Page 1 - Exhibit 21.1
Subdocument 10 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 11 - EX-99.1 - EX-99.1
Page 1 - Confidential Draft Registration Statement on Form F-1
Page 2 - vast majority