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TABLE OF CONTENTS
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Table of Contents

As filed with the United States Securities and Exchange Commission on December 17, 2019.

Registration Statement No. 333-            


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



Form F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



Addex Therapeutics Ltd
(Exact name of registrant as specified in its charter)



Switzerland
(State or other jurisdiction of
incorporation or organization)
  2834
(Primary Standard Industrial
Classification Code Number)
  Not applicable
(I.R.S. Employer
Identification Number)



Chemin des Mines 9,
CH-1202 Geneva,
Switzerland
Tel: +41 (0)22884 1555
(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)



Addex Pharmaceuticals Inc.
650 California Street
San Francisco, CA 94108
Tel: +1 415 429 2591
(Name, address, including zip code, and telephone number, including area code, of agent for service)



Copies to:

Marc Recht
Joshua A. Kaufman
Cooley LLP
55 Hudson Yards
New York, New York 10001
+1 212 479 6000

 

Frank Gerhard
Homburger AG
Prime Tower
Hardstrasse 201 CH-8005
Zürich, Switzerland
+41 43 222 10 00



APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after this registration statement is declared effective.



           If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.    ý

           If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act.

    Emerging growth company    ý

           If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act.    o

CALCULATION OF REGISTRATION FEE

               
 
Title of Each Class of Securities
to be Registered

  Amount to be
Registered(1)

  Proposed Maximum
Aggregate Offering
Price Per
Share(2)

  Proposed Maximum
Aggregate Offering
Price

  Amount of
Registration Fee

 

Shares, nominal value CHF 1.00 per share(3)

  11,439,511   $1.73   $19,790,354   $2,568.79

 

(1)
The registrant is filing this registration statement in part in respect of its obligations under a Registration Rights Agreement, dated March 22, 2018, concerning an aggregate of 7,818,830 shares that it privately placed with investors identified herein on the same date and an aggregate of 3,493,608 shares issuable upon the exercise of warrants issued on the same date to such investors. The registrant is also registering hereby an aggregate of 127,073 shares held by other shareholders identified herein.

(2)
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Sections 457(c) under the Securities Act, based on the average of the high and low prices of the shares on SIX Swiss Exchange on December 12, 2019 (CHF 1.73), as expressed in U.S. dollars based on the noon treasury exchange rate quoted as of September 30, 2019, the U.S. Federal Reserve Bank ($1.0029 per CHF).

(3)
All shares will be represented by American Depositary Shares, or ADSs, with each ADS representing six shares. ADSs issuable upon deposit of the shares registered hereby are being registered pursuant to a separate Registration Statement on Form F-6.

           The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

   


The term "new or revised financial accounting standards" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.


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The information contained in this preliminary prospectus is not complete and may be changed. No securities may be sold pursuant to this prospectus until the registration statement filed with the Securities and Exchange Commission with respect to such securities has been declared effective thereby. This preliminary prospectus is not an offer to sell these securities and no offers to buy these securities are being solicited in any jurisdiction where their offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED DECEMBER 17, 2019

PRELIMINARY PROSPECTUS

LOGO

11,439,511 Shares

Represented by Approximately 1,906,585 American Depositary Shares

        We have applied to list American Depositary Shares, or ADSs, each representing six shares of Addex Therapeutics Ltd, on the Nasdaq Stock Market, or Nasdaq, under the symbol "ADXN." The ADSs are expected to begin trading on Nasdaq on                        , 2020. Our shares are currently traded on SIX Swiss Exchange, or SIX, under the ticker symbol "ADXN." The closing price of our shares on SIX on December 12, 2019 was CHF 1.74 per share, which is equivalent to $1.74 per share based on the noon buying rate of the Federal Reserve Bank of New York on September 30, 2019, or $10.44 per ADS, after giving effect to the 6:1 share            :            ADS ratio. We have appointed Citibank, N.A. to act as the depositary for the ADSs representing our shares, including the Registered Shares, as defined below. Upon the effectiveness of the registration statement of which this prospectus forms a part, holders of shares registered hereby are expected to be able to deposit such shares with the depositary in exchange for ADSs representing such shares at the ratio referred to in the first sentence of this paragraph. ADSs representing the shares registered hereby will be freely tradeable on the effective date of the registration statement of which this prospectus forms a part.

        We are filing the registration statement of which this prospectus forms a part in part in respect of our obligations under a Registration Rights Agreement, dated March 22, 2018, concerning an aggregate of 7,818,830 shares that we privately placed with certain investors identified herein on the same date, and an aggregate of 3,493,608 shares issuable upon the exercise of warrants issued on the same date to such investors. The registrant is also registering hereby an aggregate of 127,073 shares held by other shareholders identified herein. Holders of all such shares are identified in this prospectus as the Registered Holders and the aggregate 11,439,511 shares registered hereby as the Registered Shares. Any Registered Shares offered and sold in the United States by the Registered Holders will be in the form of ADSs. The Registered Holders are also permitted to sell shares not represented by ADSs in private transactions, including on SIX, which resales are not covered by this prospectus. Unlike an initial public offering, any disposition by the Registered Holders of the Registered Shares represented by ADSs is not being underwritten by any investment bank. The Registered Holders may, or may not, elect to dispose of Registered Shares represented by ADSs as and to the extent that they may individually determine. Such dispositions, if any, will be made through brokerage transactions on Nasdaq or other securities exchanges in the United States at prevailing market prices. See the section entitled "Plan of Distribution." We will not receive proceeds from any disposition of Registered Shares in the form of ADSs by Registered Holders.

        We are an "emerging growth company" and a "foreign private issuer," each as defined under the federal securities laws, and, as such, we will be subject to reduced public company reporting requirements. See the section entitled "Prospectus Summary—Implications of Being an Emerging Growth Company and a Foreign Private Issuer" for additional information.

        Neither the U.S. Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

        Investing in ADSs representing our shares involves a high degree of risk. Before buying any ADSs representing our shares you should carefully read the discussion of material risks of investing in such securities in "Risk Factors" beginning on page 11 of this prospectus.


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TABLE OF CONTENTS

MARKET, INDUSTRY AND OTHER DATA

    ii  

ABOUT THIS PROSPECTUS

    iii  

PRESENTATION OF FINANCIAL INFORMATION

    iv  

PROSPECTUS SUMMARY

    1  

THE REGISTERED SHARES

    8  

SUMMARY CONSOLIDATED FINANCIAL DATA

    9  

RISK FACTORS

    11  

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

    36  

USE OF PROCEEDS

    38  

DIVIDEND POLICY

    39  

SELECTED CONSOLIDATED FINANCIAL DATA

    40  

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

    42  

BUSINESS

    59  

MANAGEMENT

    98  

RELATED PARTY TRANSACTIONS

    106  

PRINCIPAL HOLDERS

    108  

REGISTERED HOLDERS

    110  

DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

    112  

COMPARISON OF SWISS LAW AND DELAWARE LAW

    117  

DESCRIPTION OF AMERICAN DEPOSITARY SHARES

    126  

SHARES AND ADSs ELIGIBLE FOR FUTURE SALE

    138  

MATERIAL INCOME TAX CONSIDERATIONS

    140  

PLAN OF DISTRIBUTION

    151  

EXPENSES OF THIS OFFERING

    154  

LEGAL MATTERS

    155  

EXPERTS

    156  

SERVICE OF PROCESS AND ENFORCEMENT OF JUDGMENTS

    157  

WHERE YOU CAN FIND ADDITIONAL INFORMATION

    158  

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

    F-1  

        We are responsible for the information contained in this prospectus and any free writing prospectus that we may prepare or authorize. We have not authorized anyone to provide you with different or additional information, and we do not take any responsibility for any other information that others may give you. We are not making an offer to sell ADSs representing our shares in any jurisdiction where the offer or sale thereof is not permitted. You should not assume that the information contained in this prospectus is accurate as of any date other than the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or the sale of any ADSs representing our shares.

        For investors outside the United States: Neither we nor the Registered Holders have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction other than the United States where action for that purpose is required. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the ADSs and the distribution of this prospectus outside the United States.

        We are organized under the laws of Switzerland. Under the rules of the U.S. Securities and Exchange Commission, we are currently eligible for treatment as a "foreign private issuer." As a foreign private issuer, we will not be required to file periodic reports and financial statements with the U.S. Securities and Exchange Commission as frequently or as promptly as domestic registrants whose securities are registered under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

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MARKET, INDUSTRY AND OTHER DATA

        This prospectus contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties such as investment banking analysts, industry, medical and general publications, government data and similar sources. In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section entitled "Risk Factors." These and other factors could cause our future performance to differ materially from our assumptions and estimates. See the section entitled "Special Note Regarding Forward-Looking Statements."

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ABOUT THIS PROSPECTUS

        Unless otherwise indicated or the context otherwise requires, all references in this prospectus to the terms "Addex," "Addex Therapeutics," "Addex Therapeutics Ltd," "the company," "we," "us" and "our" refer to Addex Therapeutics Ltd together with its subsidiaries.

        We own trademarks for Addex Therapeutics in Switzerland. We also have trademarks for AddeLite and ProxyLite in relation to our screening technologies in the United States, Switzerland and the People's Republic of China and, in the case of ProxyLite, the EU. All other trade names, trademarks and service marks of other companies appearing in this prospectus are the property of their respective holders. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

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PRESENTATION OF FINANCIAL INFORMATION

        Our reporting currency is the Swiss franc. The exchange rate between the Swiss franc and the U.S. dollar as of September 30, 2019 was $1.0029 per CHF 1.0. We present our consolidated financial statements in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, or IASB. Readers of this prospectus should note that there may be certain differences between the presentation of our financial position, results of operations and cash flows under IFRS and U.S. generally accepted accounting principles.

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PROSPECTUS SUMMARY

        The following summary highlights information contained elsewhere in this prospectus and does not contain all of the information you should consider before investing in ADSs representing our shares. You should read the entire prospectus carefully, including "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," and our consolidated financial statements and the related notes included in this prospectus before making an investment decision.

Overview

        We are a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators. Allosteric modulators target a specific receptor or protein and alter the effect of the body's own signaling molecules on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. To date, our research and development efforts have been primarily focused on building a portfolio of proprietary drug candidates based on our allosteric modulator development capability. The allosteric modulator principle has broad applicability across a wide range of biological targets and therapeutic areas, but our primary focus is on G-protein coupled receptors, or GPCR, targets implicated in neurological diseases, where we believe there is a clear medical need for new therapeutic approaches.

        Using our allosteric modulator discovery capabilities, we have developed a pipeline of proprietary clinical and preclinical stage drug candidates. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed. These include levodopa-induced dyskinesia associated with Parkinson's disease, or PD-LID, non-parkinsonian dystonia, addiction, epilepsy, Charcot-Marie-Tooth type 1A neuropathy, or CMT1A, and other neurodegenerative diseases. Some of these indications are classified as rare diseases that may allow for orphan drug designation by regulatory agencies in major commercial markets, such as the United States, Europe and Japan. Orphan drug designation may entitle the recipient to benefits, in the jurisdiction granting the designation, such as market exclusivity following approval and assistance in clinical trial design, a reduction in user fees or tax credits related to development expenses.

        We are developing our lead drug candidate, dipraglurant, as an oral negative allosteric modulator, or NAM, of the metabotropic glutamate receptor subtype 5, or mGlu5, for the treatment of PD-LID. We are planning to initiate a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at approximately 50 sites in the United States and will target enrolment of approximately 140 patients. We have received orphan drug designation from the United States Food and Drug Administration, or FDA, for dipraglurant in PD-LID and expect to report topline results in the third quarter of 2021. In parallel, dipraglurant's therapeutic use in dystonia is being investigated in preclinical models.

        We are also conducting a research program under our strategic partnership with Indivior UK Limited, or Indivior, to discover novel orally available positive allosteric modulators, or PAMs, of the gamma-aminobutyric acid subtype B receptor, or GABAB. We are currently in late lead optimization and expect to deliver a drug candidate by the end of 2020 for Indivior to develop for addiction. Under terms of the agreement with Indivior, we have the right to select drug candidates for development in certain exclusive indications outside of addiction. We plan to develop our selected drug candidate in CMT1A, an indication that has been clinically validated with baclofen, an orthosteric agonist of GABAB.

        Allosteric modulators have broad applicability for many clinically validated GPCR targets which are implicated in multiple therapeutic indications. We intend to continue to leverage our scientific

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expertise in allosteric modulation and our proprietary technology platform to discover novel drug candidates for the treatment of neurological diseases.

        Based on our expertise in allosteric modulation, our goal is to build a leading neuroscience company focused on conditions where current treatment options are limited and where unmet medical needs exist. Our business strategy includes the possibility of entering into collaborative arrangements with third parties to complete the development and commercialization of our proprietary drug candidates, such as our partnership with Janssen Pharmaceuticals, Inc., or Janssen, a subsidiary of Johnson & Johnson, for ADX71149 and our strategic partnership with Indivior for GABAB PAM. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and other funding from: The Michael J. Fox Foundation for Parkinson's Research, or MJFF, for the development of dipraglurant for the treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in addiction; the Swiss Innovation Agency, or Innosuisse, to advance our understanding of the role of our drug candidates in neurodegenerative and psychiatric diseases; and the Eurostars Joint Programme, or Eurostars to identify novel drug candidates on mGlu7 NAM for post traumatic stress disorder, or, PTSD. As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored studies that could offset or reduce our development costs.

        The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or product candidates under development, for each of the product candidates and each of the indications for which we are developing. Furthermore, government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.

Research and Development Portfolio

        Using our allosteric modulator platform and drug discovery and development expertise, we have established a portfolio of clinical and preclinical programs, both internally and with partners.

Internally Developed Product Candidates

GRAPHIC

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        Dipraglurant, for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease.    We are developing dipraglurant as a novel orally available mGlu5 NAM for the treatment of PD-LID. PD-LID is a disease with significant commercial opportunity as improved therapies are needed. We believe that, subject to regulatory approval, dipraglurant may offer an innovative and differentiated treatment approach from existing therapies. In a 28 day Phase 2a placebo-controlled clinical trial, conducted in the United States and Europe, in patients with PD-LID, dipraglurant met its primary end point, was generally well tolerated and no clinically significant abnormalities of safety monitoring parameters occurred. In addition, at Day 1 and Day 14, dipraglurant showed statistically significant effects on PD-LID clinical symptoms, as measured using the modified abnormal involuntary movement scale, or mAIMs. However, an increasing placebo response resulted in the effect of dipraglurant on PD-LID clinical symptoms not showing statistical significance at Day 28. We have substantially completed the preparation of dipraglurant to start registration studies in PD-LID and expect to initiate a Phase 2b/3 placebo-controlled pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at approximately 50 sites in the United States and will target enrolment of approximately 140 patients. We have also received orphan drug designation from the US FDA for dipraglurant in PD-LID and expect to report topline results in the third quarter of 2021.

        Dipraglurant, for the treatment of non-Parkinsonian dystonia.    We are developing an extended release formulation of dipraglurant as a novel orally available NAM for the treatment of dystonia. At the appropriate time we expect to be able to start a Phase 2a proof of concept clinical trial. There are many types of dystonias that present a commercial opportunity for dipraglurant. Subject to regulatory approval, we believe that dipraglurant may offer an innovative and differentiated treatment approach for multiple types of dystonia. We are currently evaluating dipraglurant in preclinical models of dystonia.

Externally Developed Out-licensed Product Candidate

        ADX71149 (mGlu2 PAM) for the treatment of epilepsy.    Our partnered drug candidate, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2, or mGlu2 PAM. Our partner, Janssen, has completed Phase 1 and two Phase 2a clinical trials in schizophrenia and anxious depression, respectively, and is currently evaluating future development in epilepsy. Under our agreement with Janssen, Janssen is responsible for financing the development and commercialization, if any, of ADX71149.

Material Internal Research Programs

GRAPHIC

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        GABAB PAM for the treatment of addiction.    Our partner, Indivior, has licensed worldwide rights to our GABAB PAM program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidates. Under the agreement, we are responsible for executing a research program funded by Indivior to discover novel drug candidates. Indivior has the right to select GABAB PAM drug candidates from our research program. We expect to deliver drug candidates for selection in 2020. We believe that addiction is an indication with a significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. Subject to regulatory approval, we believe that GABAB PAM may offer an innovative and differentiated treatment approach from existing therapies and may provide benefit to patients.

        GABAB PAM for the treatment of CMT1A.    Our license agreement with Indivior provides for a funded research program, under which we have the right to select drug candidates for exclusive development in certain indications outside of addiction, including CMT1A, a rare disease indication. We plan to pursue orphan drug designation for a selected drug candidate for CMT1A. Subject to regulatory approval, we believe an oral small molecule GABAB PAM with a once-a-day dosing and without the adherence-limiting side effects of baclofen, which is currently used off label, could bring benefit to patients and consequently present a strong commercial opportunity for us.

        mGlu7 NAM for the treatment of post-traumatic stress disorder, or PTSD:    We are developing metabotropic glutamate receptor subtype 7, or mGlu7 NAM as a novel orally available treatment to reduce fear memory in PTSD. This is a disorder that can lead to intense fear and anxiety. Current medication is unspecific and ineffective, with a number of side effects. By selectively targeting mGlu7 with NAMs, the brain circuitries involved in fear and anxiety can be more precisely modulated, potentially resulting in a more focused response and fewer side effects than current therapeutic approaches. Subject to regulatory approval, we believe our mGlu7 NAM may offer an innovative and differentiated treatment approach from existing therapies. We are in late lead optimization and a consortium led by us has been awarded a €4.85 million grant from the Eurostars Joint Programme to advance the program to drug candidate stage.

Early Stage Internal Research Programs

GRAPHIC

        mGlu2 NAM for the treatment of mild neurocognitive disorders, or mNCD:    We are developing mGlu2 NAM as a novel orally available treatment for mNCD associated with Alzheimer's disease, Parkinson's disease and depressive disorders. We are currently optimizing multiple chemical series of highly selective mGlu2 NAMs offering advanced compounds at the late stage of lead optimization.

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        mGlu4 PAM for the treatment of Parkinson's disease:    We are developing mGlu4 PAM as a novel orally available treatment for Parkinson's disease. We are currently optimizing multiple chemical series of highly selective mGlu4 PAMs with compounds in early lead optimization.

        mGlu3 PAM for the treatment of neurodegenerative disorders:    We are developing mGlu3 PAM as a novel orally available treatment for neurodegenerative disorders. We are currently optimizing multiple chemical series of highly selective mGlu3 PAMs, with compounds in early lead optimization.

Corporate Information

        We are organized as a stockholding company under the laws of Switzerland. Our shares have been listed on the Swiss SIX Exchange since May 2007 and the shares currently trade thereon under the symbol "ADXN".

        Our corporate headquarters is located at Chemin des Mines 9, CH-1202 Geneva, Switzerland, where the telephone number is +41 (0)22 884 1555, and our registered office is located at Chemin des Aulx 12, CH-1228 Plan-les-Ouates, Geneva, Switzerland. Our website address is www.addextherapeutics.com. The information contained on, or that can be accessed from, our website does not form part of this prospectus. Our agent for service of process in the United States is Addex Pharmaceuticals Inc., 650 California Street, San Francisco, CA 94108.

Risks Associated with Our Business

        Our business is subject to a number of risks of which you should be aware before making an investment decision. You should carefully consider all of the information set forth in this prospectus and, in particular, should evaluate the specific factors set forth in the section titled "Risk Factors" before deciding whether to invest in ADSs representing our shares. These important risks include, but are not limited to, the following:

    We will need significant amounts of additional new capital to fund our continued development activities.

    We cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or future drug candidates.

    We have a history of net losses and negative cash flows, and we expect that such losses will continue for the foreseeable future and that we may never achieve or maintain profitability.

    We are a development-stage company working with novel approaches to therapeutics, which may not be successful.

    We have no products on the market and we may never generate revenue from the sale or licensing of product candidates.

    The future of our business and operations depends on the success of our allosteric modulator development programs, including our most advanced proprietary product candidate, dipraglurant.

    Our dependence on Janssen to develop and commercialize ADX71149 and Indivior to develop and commercialize our GABAB PAM program exposes us to significant risks.

    If third parties on which we depend to conduct our clinical trials do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our clinical development program could be delayed and otherwise adversely affected.

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    Because we rely on third party manufacturing and supply partners, our clinical development supplies and other materials may become limited or interrupted or may not be of satisfactory quality.

    Our drug candidates must prove their efficacy and safety in rigorous clinical testing that is expensive, time-consuming and may be delayed, suspended or terminated at any time.

    We face competition from entities that have developed or may develop similar or different product candidates aimed at the indications on which we are focusing.

    Any commercialization efforts by us will require us to develop sales, marketing and distribution capabilities internally or through arrangements with third parties.

Implications of Being an Emerging Growth Company and a Foreign Private Issuer

Emerging Growth Company

        We are an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As such, we may take advantage of certain exemptions from various reporting requirements that are applicable to other publicly traded entities that are not emerging growth companies. These exemptions include:

    the option to present only two years of audited financial statements and related discussion in the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" in this prospectus;

    not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002;

    not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);

    not being required to submit certain executive compensation matters to stockholder advisory votes, such as "say-on-pay," "say-on-frequency," and "say-on-golden parachutes;" and

    not being required to disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer's compensation to median employee compensation.

        We will remain an emerging growth company until the earliest of: (1) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion; (2) the last day of 2024; (3) the date that we become a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, which would occur on the last day of any fiscal year that the aggregate worldwide market value of our common equity held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter; or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during any three year period.

Foreign Private Issuer

        Upon the effectiveness of the registration statement of which this prospectus forms a part, we will report under the Exchange Act as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we qualify as a foreign private issuer

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under the Exchange Act we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

    the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;

    the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

    the rules under the Exchange Act requiring the filing with the U.S. Securities and Exchange Commission, or the SEC, of quarterly reports on Form 10-Q containing unaudited financial and other specific information, and current reports on Form 8-K upon the occurrence of specified significant events.

        Foreign private issuers are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.

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THE REGISTERED SHARES

Nasdaq Stock Market listing

  We have applied to list ADSs representing our shares on the Nasdaq Stock Market under the symbol "ADXN"

SIX trading symbol for our shares

 

"ADXN"

Registered Shares being registered on behalf of the Registered Holders

 

11,439,511 shares, represented by an aggregate of approximately 1,906,585 ADSs

Shares issued and outstanding immediately before and after the effectiveness of the registration statement of which this prospectus forms a part

 

32,848,635 shares

American Depositary Shares

 

Each ADS represents six shares, nominal value CHF 1.00 per share. Holders of ADSs have the rights of an ADS holder or beneficial owner (as applicable) as provided in the deposit agreement amongst us, the depositary and all holders and beneficial owners of ADSs issued thereunder. To better understand the terms of ADSs representing our shares, see the section entitled "Description of American Depositary Shares." We also encourage you to read the deposit agreement, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part.

Depositary

 

Citibank, N.A.

Use of proceeds

 

We will not receive proceeds from the disposition, if any, of Registered Shares in the form of ADSs by the Registered Holders.

Risk factors

 

See the section entitled "Risk Factors" and the other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in ADSs representing our shares.

        Unless otherwise stated in this prospectus, the number of our shares set forth herein is as of September 30, 2019 and is based on 32,848,635 shares issued and outstanding on such date but excludes:

    authorized (but unissued) capital of 16,424,317 shares as of September 30, 2019;

    conditional (but unissued) capital of 16,424,317 shares, including 5,866,898 shares reserved for issuance pursuant to outstanding warrants and 6,124,975 shares reserved for issuance pursuant to our equity incentive plans, each as of September 30, 2019;

    1,700 equity sharing certificates (bons de jouissance/Genussscheine) as of September 30, 2019, of which 1,434 were issued to our subsidiary, Addex Pharma SA, and 266 were outstanding.

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SUMMARY CONSOLIDATED FINANCIAL DATA

        The following tables set forth, for the periods and as of the dates indicated, our summary consolidated financial data. We have derived the consolidated statements of operations data for the years ended December 31, 2018 and 2017 and the consolidated balance sheet data as of December 31, 2018 and 2017 from our audited consolidated financial statements appearing elsewhere in this prospectus. The consolidated statements of operations data for the six months ended June 30, 2019 and 2018 and the consolidated balance sheet data as of June 30, 2019 are derived from our unaudited consolidated financial statements appearing elsewhere in this prospectus. Our consolidated financial statements included in this prospectus have been prepared in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, or IASB. You should read this data together with our consolidated financial statements and related notes included elsewhere in this prospectus and the information under the captions "Selected Consolidated Financial Data" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." Our historical results are not necessarily indicative of our future results. The exchange rate between the Swiss franc and the U.S. dollar as of September 30, 2019 was $1.0029 per CHF 1.0

 
  For the six months
ended June 30,
  For the years
ended December 31,
 
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands except share and per share data)
 

Consolidated statement of operations data:

                         

Revenue from contract with customer

    1,220     4,834     6,044      

Other income

    7     534     659     500  

Operating costs

   
 
   
 
   
 
   
 
 

Research and development

    (5,894 )   (2,084 )   (4,919 )   (2,629 )

General and administration

    (2,821 )   (826 )   (3,209 )   (1,106 )

Total operating costs

    (8,715 )   (2,910 )   (8,128 )   (3,735 )

Operating income / (loss)

   
(7,488

)
 
2,458
   
(1,425

)
 
(3,235

)

Finance income

   
21
   
   
   
 

Finance costs

    (74 )   (104 )   (220 )   (45 )

Net loss before tax

    (7,541 )   2,354     (1,645 )   (3,280 )

Income tax expense

                 

Net income / (loss) for the period

    (7,541 )   2,354     (1,645 )   (3,280 )

Weighted average shares outstanding

   
26,378,503
   
19,962,969
   
23,293,237
   
12,941,439
 

Number of shares outstanding

    32,848,635     28,564,031     28,564,031     15,384,988  

Income / (loss) per share for income / (loss) attributable to the ordinary equity holders of the company:

   
 
   
 
   
 
   
 
 

Basic income / (loss) per share

    (0.29 )   0.12     (0.07 )   (0.25 )

Diluted income / (loss) per share(1)

    (0.29 )   0.09     (0.07 )   (0.25 )

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  As of June 30,   As of December 31,  
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands)
 

Consolidated balance sheet data:

                         

Cash and cash equivalents

    36,748     43,574     41,670     2,579  

Working capital(2)

    33,091     42,506     39,817     1,576  

Total assets

    37,969     44,870     42,214     3,063  

Debt

                 

Total liabilities

    5,696     2,597     2,973     1,721  

Share capital

    32,849     26,372     28,564     15,385  

Accumulated losses

    (293,607 )   (282,068 )   (286,067 )   (284,422 )

Total equity

    32,273     42,274     39,241     1,343  

(1)
See Note 20 to our audited consolidated financial statements and Note 21 to our unaudited consolidated interim financial statements appearing elsewhere in this prospectus for a description of the method used to compute diluted net (loss)/income per share.

(2)
We define working capital as current assets less current liabilities.

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RISK FACTORS

        Investing in ADSs representing our shares involves a high degree of risk. Before deciding whether to invest, you should carefully consider the risks described below, and all other information contained in this prospectus, including our consolidated financial statements and the related notes included elsewhere in this prospectus. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of ADSs representing our shares or our shares could decline and you may lose all or part of your investment.

Risks Related to Our Business

We will need significant amounts of additional new capital to fund our continued development activities.

        As of June 30, 2019, we had CHF 36.8 million of cash and cash equivalents. Our monthly spending levels vary based on new and ongoing development and corporate activities. Currently, on a going concern basis, we expect to be able to finance our operations through at least December 2021, unless we are able to raise new funds. Accordingly, we intend to primarily focus our resources on continuing to investigate dipraglurant, an mGlu5 negative allosteric modulator, for use in Parkinson's disease and dystonia and corporate development activities aimed at securing resources from investors, partners and grant providers to advance our other clinical and preclinical programs, as well as our allosteric modulator discovery platform.

        Our budgeted external costs for the development plans described above and further detailed in "Business" are for the most part based on our initial discussions with contract research organizations and other external suppliers, and we have not entered into any agreements or other arrangements that would establish or guarantee the costs of these programs. There is a risk that these development plans could be more costly than we anticipate, including as a result of unanticipated delays.

        Although we believe that we will have sufficient resources to fund our intended operations through at least December 2021, we cannot assure you of this and our ability to finance our operations and pursue our intended development plans beyond that date which will depend on our ability to generate additional funding through further partnerships or grants and amounts we may raise through further financings such as additional equity offerings. If our development plans are not successful, we may not be able to generate additional funding through partnerships or grants, or raise further financing through equity offerings or otherwise, or we may only be able to do so on terms that are not favorable to our shareholders.

        To the extent that we raise additional capital through the issuance of shares or other securities convertible into shares, our existing shareholders will be diluted. Future issuances of such securities, or the perception that such sales may occur, could adversely affect the trading price of our shares and impair our ability to raise capital through future offerings of shares or other equity securities. No prediction can be made as to the effect, if any, that future sales of shares or the availability of shares for future sales will have on the trading price of our shares.

We cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or future drug candidates.

        We have limited sources of revenue and will need substantial additional capital to develop and commercialize our product candidates. We may be unable to raise additional capital when needed, or at all, which would force us to reduce or discontinue operations. We do not expect to realize meaningful revenue from product sales, milestone payments or royalties in the foreseeable future, if at all. Our revenue sources are, and, we believe, will remain, extremely limited until and unless our product candidates are clinically tested, approved for commercialization and successfully marketed. To date, we have primarily financed our operations through the sale of securities, milestone payments from partners

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and grants from foundations and governmental agencies. Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. Under Swiss law, shareholders have certain preemptive rights to subscribe for newly issued securities in proportion to the nominal value of shares held. These preemptive rights, unless waived, may cause delays and uncertainties in any future equity offering, including in pricing, number of shares offered and dilutive effects, which discourage investment in our securities. We can provide no assurance that we can obtain access to sufficient funds when needed. If we fail to obtain additional funds at acceptable terms when needed, we may have to delay, reduce or terminate our research and development programs, limit strategic opportunities or be forced to cease operations, which may adversely affect our business, financial condition, results of operations and prospects.

We have a history of net losses and negative cash flows, and we expect that such losses will continue for the foreseeable future and that we may never achieve or maintain profitability.

        Since we began operations in 2002, we have not had product revenue and our expenses have substantially exceeded our revenue, resulting in continuing operating losses and an accumulated deficit of CHF 293.6 million at June 30, 2019. For the six-month period ended June 30, 2019, we incurred a net loss of CHF 7.5 million. These losses have resulted principally from costs incurred in research and development of our drug candidates and general and administrative expense.

        We expect to continue to incur significant operating losses in the foreseeable future, primarily due to the cost of our research and development programs, preclinical studies and clinical trials and the regulatory approval process for drug candidates. The amount of future losses is uncertain and our ability to achieve profitability, if ever, will depend on, among other things, us or partners successfully developing drug candidates, obtaining regulatory approval to market and commercialize drug candidates, manufacturing any approved products on commercially reasonable terms, establishing a sales and marketing organization or suitable third party alternatives for any approved product and raising sufficient funds to finance our activities. If we and/or our partners are unable to develop and commercialize one or more of our drug candidates or if sales revenue from any drug candidate that receives approval is insufficient, we will not achieve profitability, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We are a development-stage company working with novel approaches to therapeutics, which may not be successful.

        We have devoted our resources to the discovery and development of allosteric modulators for neurological diseases. Since inception, we have focused on building a drug discovery platform, including a knowledge-based library and proprietary biological screening tools as well as a portfolio of drug candidates. Discovery and development of allosteric modulators involves novel approaches to therapeutics. We are subject to the risks of failure inherent in the development of product candidates based on new technologies. There is little precedent for the successful commercialization of products based on our technologies, and there are a number of technological challenges that we must overcome to complete most of our development efforts. If we are not successful in development, it will have a material adverse effect on our business, financial condition, results of operations and prospects.

We have no products on the market and we may never generate revenue from the sale or licensing of product candidates.

        Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and successfully commercializing our product candidates, either alone or with third parties, such as our partner for ADX71149, Janssen, and our partner for GABAB PAM, Indivior. Currently, none of our product candidates has been approved for marketing and commercialization or is in Phase 3 trials. We cannot guarantee that any of our product candidates will be successfully tested, approved by the U.S.

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Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, Swissmedic, Swiss Agency for Therapeutic Products, or any other regulatory agency or marketed and commercialized at any time in the foreseeable future or at all. If approval is obtained for a product candidate, we cannot assure you that we will be able to generate or sustain revenue from any sales due to factors such as whether the product is manufactured at a competitive cost or accepted in the market, as well as general and industry-specific local and international economic pressures. With our strategy to focus on allosteric modulator development, these risks continue to be significant and may increase to the extent the space becomes more competitive or less favored in the commercial marketplace. Our focus on rare disease indications with the potential for orphan drug designation limits the size of the patient population for even an approved product, unless approval is expanded for use beyond a particular rare disease. Because of the inherently small patient population for treatment of a rare disease, an approved product with orphan drug designation for which pricing is not approved or accepted in the market at an appropriate level may not generate enough revenue to offset costs of development, manufacturing, marketing and commercialization despite any benefits received from the designation, such as market exclusivity, assistance in clinical trial design, a reduction in user fees or tax credits related to development expense, and our business may be adversely affected.

We have been granted U.S. Orphan Drug Designation for dipraglurant for PD-LID and may seek Orphan Drug Designation for other product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.

        Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs and therapeutic biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the United States, Orphan Drug Designation entitles a party to financial incentives such as opportunities for grant funding toward clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has Orphan Drug Designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full NDA, to market the same product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.

        We have obtained Orphan Drug Designation for dipraglurant and if we may be able to obtain Orphan Drug Designation for any of our future product candidates in specific indications, we may not be the first to obtain marketing approval for dipraglurant or any other such product candidates for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

        Further, even if we obtain orphan drug exclusivity in the U.S. for a product, that exclusivity may not effectively protect the product from competition because different drugs or therapeutic biologics with different active moieties can be approved for the same condition. Even after an orphan product is approved, the FDA can subsequently approve the same drug or therapeutic biologic with the same active moiety for the same condition if the FDA concludes that the later drug or therapeutic biologic is safer, more effective or makes a major contribution to patient care. In Europe, we could be prevented

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from marketing our products if a similar medicinal product is granted orphan drug designation for the same indications that we are pursuing. Once authorized, with a limited number of exceptions, neither the competent authorities of the EU member states, the EMA, or the European Commission are permitted to accept applications or grant marketing authorization for other similar medicinal products with the same therapeutic indication. Marketing authorization could also be granted to a similar medicinal product with the same orphan indication if the latter product is safer, more effective or otherwise clinically superior to the original orphan medicinal product. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug or therapeutic biologic nor gives the drug or therapeutic biologic any advantage in the regulatory review or approval process. In addition, while we may seek Orphan Drug Designation for our future product candidates, we may never receive such designations.

The future of our business and operations depends on the success of our allosteric modulator development programs, including our most advanced proprietary product candidate, dipraglurant.

        We are substantially dependent on the success of our current lead drug candidate, dipraglurant, which we are developing ourselves. In March 2012, we announced the completion of a Phase 2a clinical trial in the United States and Europe with dipraglurant for the treatment of PD-LID. Though the development so far has produced positive results, further development and commercialization for the treatment of PD-LID or other disease indications may not be successful or may experience additional significant delays and setbacks. For example, we are undertaking significant risk in planning a pivotal development program for dipraglurant for the treatment of PD-LID, without having conducted any additional exploratory clinical trials beyond the Phase 2a proof of concept clinical trial; our last clinical trial of dipraglurant in PD-LID was completed seven years ago and the diagnosis and standard of care for PD-LID may have changed in the interim, including standards for marketing authorization. We believe that a failure to develop our most advanced drug candidates, or to do so in a timely manner, would not only harm those programs but also industry and investor confidence in our other programs and could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our dependence on Janssen to develop and commercialize ADX71149 and Indivior to develop and commercialize GABAB PAM exposes us to significant risks.

        Our collaboration with Janssen, Indivior and any future partner, may not be scientifically, clinically or commercially successful. We are dependent upon Janssen and Indivior, and may be dependent upon any other partners with which we may collaborate in the future, to perform and fund development activities, including clinical testing, regulatory filings and the manufacture and marketing of products. Under our collaboration and license agreements with our partners, our partners have sole responsibility for the financing and development of selected compounds through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Our partners have authority over all aspects of the development of selected compounds and may develop or commercialize third-party compounds with a different mechanism of action for identical use. Our role on the joint development committee formed under the collaboration and license agreement is advisory and we do not have authority to determine or veto actions. Our partners may take independent action concerning product development, marketing strategies, manufacturing and supply issues and rights relating to intellectual property. Thus, the success of ADX71149 and GABAB PAM for the treatment of CNS and related diseases currently depends entirely upon the efforts of Janssen and Indivior, respectively. Janssen and Indivior each have significant discretion in determining the efforts and resources it applies to the development and, if approval is obtained, commercialization and marketing of ADX71149 and GABAB PAM, respectively. Janssen and Indivior may not be effective in obtaining approvals in their respective fields of use, marketing any approved products or arranging for any necessary sublicense, supply, manufacturing or

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distribution relationships, or our partners may change their strategic focus or pursue alternative technologies in a manner that results in reduced or delayed revenue to us. Our partners have a variety of marketed products and their own corporate objectives may not be consistent with our best interests. Changes of this nature might also occur if our partners are acquired or experience changes in management. In any future disagreement with us, our partners will have significantly greater financial and managerial resources on which to draw. Any disagreement could lead to lengthy and expensive litigation or other dispute resolution proceedings as well as extensive financial and operational consequences to us and have a material adverse effect on our business, financial conditions, results of operations and prospects

Our failure to collaborate successfully with partners may delay, impair or prevent the development or commercialization of our drug candidates.

        Our business strategy requires us to enter into various forms of collaboration arrangements with other companies, licensors or licensees to research, develop and commercialize our drug candidates. We are unlikely to be able to enter into new collaborative arrangements, with respect to the drug candidates we are currently developing internally, until we complete at least the next stage of their respective development activities. We cannot assure you that we will be able to maintain our existing collaborations with Janssen and Indivior, negotiate collaboration arrangements in the future on acceptable terms with first choice partners, if at all, or that any such collaboration arrangements will be successful. To the extent that we are not able to maintain or establish such arrangements, we would be forced to seek alternatives, including undertaking drug development and commercialization activities on our own, which would increase our capital requirements and could require us to limit the scope of some or all of our other research and development activities. Under a collaboration agreement, we are likely to have limited influence over the future development or commercialization of the relevant drug candidates. Such development or commercialization may depend significantly on the efforts and activities of the collaborator. Under the terms of an agreement, a collaborator may have significant discretion in determining the efforts and resources it dedicates to the collaboration, which may change over time depending on the collaborator's overall strategic priorities. The suspension or termination of our collaboration arrangements, the failure of our collaboration arrangements to be successful or the delay in the development or commercialization of drug candidates pursuant to collaborations could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

        We are highly dependent on members of our executive team. The loss of the services of any of them may adversely impact the achievement of our objectives.

        Recruiting and retaining qualified employees, consultants and advisors for our business, including scientific and technical personnel, is also critical to our success. Competition for skilled personnel is intense and the turnover rate can be high. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies and academic institutions for skilled individuals. In addition, failure to succeed in preclinical studies, clinical trials or applications for marketing approval may make it more challenging to recruit and retain qualified personnel. The inability to recruit, or loss of services of certain executives, key employees, consultants or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business, financial condition, results of operations and prospects.

        Furthermore, a number of our key employees reside in California, which in the past has experienced both severe earthquakes and wildfires. Disruptions to the services provided by our

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employees based in California due to earthquakes, wildfires or other natural disasters could delay or disrupt our business and operations.

If third parties on which we depend to conduct our clinical trials do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our clinical development programs could be delayed and otherwise adversely affected.

        We rely on third party clinical investigators, contract research organizations, or CROs, clinical data management organizations, medical institutions and consultants to design, conduct, supervise and monitor preclinical studies and clinical trials in relation to our product candidates. Because we rely on third parties and do not have the ability to conduct clinical trials independently, we have less control over the timing, quality and other aspects of clinical trials than we would if we conducted them on our own. These investigators, CROs and consultants are not our employees and we have limited control over the amount of time and resources that they dedicate to our programs. These third parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources from our programs. If we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory requirements for the conduct of clinical trials or meet expected deadlines, our clinical development program could be delayed or otherwise adversely affected. In all events, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. The FDA requires us to comply with good clinical practices for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. The third parties with which we contract might not be diligent, careful or timely in conducting our clinical trials, as a result of which the clinical trials could be delayed or unsuccessful. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.

Because we rely on third party manufacturing and supply partners, our clinical development supplies and other materials may become limited or interrupted or may not be of satisfactory quantity.

        We rely on third party manufacturing and supply partners for our research and development, preclinical studies and clinical trials. We currently do not have in-house facilities to manufacture our research and development, preclinical and clinical drug supplies. In the event that any of our suppliers, for research and development, or preclinical studies or clinical trials, fail to perform their respective obligations in terms of quality, timing or otherwise, or if our supply of such components or other materials become limited or interrupted for other reasons, we may not be able to develop or market our drug candidates on a timely and cost-competitive basis, if at all, which may have a material adverse effect on our business, financial condition, results of operations and prospects. There can be no assurance that our supply of research and development, preclinical and clinical development drugs and other materials will not be limited, interrupted, restricted in certain geographic regions or of satisfactory quality. If the suppliers that currently manufacture our clinical drug supplies cannot continue to do so, we can provide no assurance that we will be able to obtain alternative components and materials from other manufacturers of acceptable quality, or on terms or in quantities acceptable to us, or that we will not require additional components and other materials to manufacture or use our drug candidates. In addition, suppliers need to meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with applicable regulatory standards, such as current Good Manufacturing Practices, or cGMP. We cannot provide assurance that our suppliers will comply with such requirements.

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Our product candidates may not successfully obtain regulatory approval.

        Even if we are able to initiate Phase 3 clinical trials and they are completed, there can be no assurance that we will receive approval from the FDA, the EMA, Swissmedic, Swiss Agency for Therapeutic Products, or any other relevant government agencies. Any approval, if any, may be delayed or may be obtained on restrictive terms. This may occur if a drug candidate does not show acceptable safety and efficacy in preclinical studies and clinical trials or otherwise does not meet applicable regulatory standards for approval or the drug candidate does not prove as effective as, or does not offer therapeutic or other improvements over, existing or future drugs used to treat the same or similar illness or conditions. Failure by us or a partner to obtain approval for products candidates could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our drug candidates must prove their efficacy and safety in rigorous clinical testing that is expensive, time-consuming and may be delayed, suspended or terminated at any time.

        Drug approval requires extensive, time consuming and expensive clinical testing to demonstrate safety, tolerability and efficacy of a drug and meet other regulatory standards for authorization to market and commercialize. The development of innovative drugs is inherently risky and the utility and success of a drug will depend on its efficacy and side effect profile for the target patient population. Preclinical studies and clinical trials are long, expensive and uncertain processes. Successful results obtained in preclinical studies and early clinical trials may not be predictive of results in later clinical trials and do not ensure that later preclinical studies or clinical trials will be successful. Clinical trials may be delayed, suspended or terminated as a result of many factors, many of which are or may be beyond our control, such as:

        We or a partner may be required to conduct clinical trials or other testing of drug candidates beyond those currently contemplated, in particular, if the currently contemplated trials fail to complete successfully or if the results of those trials or tests are negative or inconclusive. It may take us several years to complete this testing, if at all, and failure can occur at any stage of the process, which could delay, increase costs associated with or prevent approval or commercialization of a drug candidate. Even after approval, if any, a drug may be shown to be unsafe or not have its purported effect. As a result, we or a partner may be required to conduct additional trials or studies, be subject to fines, suspension or withdrawal of approval, drug recalls, product seizures, operating restrictions or criminal prosecution. In all such cases, our anticipated development or commercialization timelines may not be met, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We face competition from entities that have developed or may develop similar or different product candidates aimed at the indications on which we are focusing.

        The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including

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products approved for marketing and/or product candidates under development, for each of the product candidates and each of the indications for which we are developing our product candidates. Competitor firms include Adamas Pharmaceuticals, Avanir Pharmaceuticals, Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Heptares Therapeutics Ltd, Indivior (as certain to product candidates outside the scope of our collaboration with Indivior), Lundbeck Pharmaceuticals Ltd, Medytox Korea Co., Ltd., Merck & Co. Inc., Neuraltus Pharmaceuticals, Inc., Newron Pharmaceuticals, Inc. and Novartis Pharma AG, as well as technology being developed at universities and other research institutions. Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we have. Our competitors have developed, are developing or will develop drug candidates and processes that will compete with our drug candidates. Competitors may enjoy a significant competitive advantage if they are able to achieve patent protection, obtain marketing authorizations and commence commercial sales of their drugs before us. Competing drugs could present superior treatment alternatives for our targeted indications, including by being more effective, safer or convenient, and even make our drug candidates or know-how obsolete before we reach the market. In addition, competitors may sell drugs below the price level at which appropriate return for our investment in drug development is possible. As a result of these factors, we may be unable to successfully develop commercially feasible drugs and our commercial opportunities may be reduced or eliminated, and we may not be able to successfully compete. This would have a material adverse effect on our business, financial condition, results of operations and prospects.

We may fail to obtain, maintain or enforce licenses, patents and proprietary technology.

        Our success depends in part on our ability to obtain patent protection for our drug candidates and processes, preserve our trade secrets and other proprietary rights and to defend and enforce our rights against infringement in Europe, the United States and other countries. If we are unable to do so, our drugs, technologies and know-how may not provide us with a competitive advantage. The validity and breadth of claims in patent applications involve complex legal and factual questions and, therefore, involve uncertainty. We own 13 U.S. and 238 foreign patents and a number of pending patent applications that cover various aspects of our technologies. No assurance can be given that patents based on pending patent applications or any future patent applications will be issued. We may need to refine or narrow our claims. Due to their broad scope, some of our generic compound claims may not be patentable. Other of our patent applications may not be granted if third parties have earlier filed applications for inventions covered by our pending patent applications. The scope of any patent protection we are able to obtain may not provide us with sufficient protection against competing drugs or provide competitive advantages to us. Any of the patents that have been or may be issued to us may be held invalid or unenforceable if subsequently challenged by competitors or other third parties. Furthermore, there can be no assurance that others have not developed or will not develop similar drugs, duplicate any of our drugs or design around any patents that have been or may be issued to us. Any of our granted, valid and enforceable patents will provide protection for only a limited period of time. We cannot assure that we will obtain any extensions of patent protection that are sometimes offered if certain clinical development extension application deadlines are met or that we will be successful in seeking any method of use patent. If a method of use patent is granted but product patents are not granted or expire, third parties would be able to develop products using the method in indications not covered by the method of use patent.

We may be restricted in our development and any commercialization activities by third-party patents and patent applications.

        Our commercial success depends on our ability to operate without infringing third-party patents and other intellectual property or market exclusivity rights. If we are not able to do so, we may be subject to infringement actions. We may not be aware of all patents and patent applications that may

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impact our ability to make, use or sell our product candidates. Other parties may have filed, or may file in the future, patent applications covering compounds or drug candidates that are similar to ours. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, because patent applications can take many years to issue and are not published for a period of time ranging on the jurisdictions in which we applied for registration, there may be applications currently pending, unknown to us, which may later result in patents that our drug candidates or technology may infringe. Any conflicts arising from the patent rights of others could significantly reduce the scope of our patents and limit our ability to obtain meaningful patent protection. We may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization, if any, of our product candidates.

We may fail to protect our intellectual property rights, including trade secrets and know-how.

        Our success depends on our ability to obtain and enforce intellectual property rights, including trade secrets and non-patentable know-how related to our allosteric modulator platform. We seek to protect or secure this intellectual property, in part, by entering confidentiality agreements with and receiving assignments from our employees, consultants, suppliers, licensees, funding partners and other contractual partners and advisers. We may not always be able to obtain these agreements or assignments. Even if we obtain these agreements or assignments, there can be no assurance that they will effectively protect our intellectual property rights or prevent improper use or disclosure of confidential information or that they will not be breached. We may not have adequate remedies for any breach of these agreements or assignments, or our trade secrets or non-patentable know-how may otherwise become known or be independently developed by competitors. In addition, these agreements or assignments may conflict with, or be subject to, the rights of third parties with which our employees, consultants, suppliers, licensees, funding partners or other contractual partners or advisers had previous employment, consulting or other relationships. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may have to defend against or initiate lawsuits to protect our intellectual property rights.

        In the future, third parties with patent claims that overlap with our intended activities may decide to sue us for monetary damages or to prevent us from manufacturing, selling or developing our drug candidates. We could also become subject to claims that we or our employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of an employee's former employer, particularly if such employer is a university or pharmaceutical company. Additionally, to protect our patent rights, we may decide to initiate lawsuits against third parties. Defending against or initiating such claims, which typically go on for years before a legal judgment or settlement is obtained, would involve significant effort and expense and could divert management's attention from the operation of our business. Any such proceedings could involve prior art and put our patents at risk of being invalidated or interpreted narrowly and our pending patent applications at risk of not being issued. In addition, there is a risk that some of our confidential information could be compromised by disclosure in such proceedings and provide competitors with access to our proprietary information. Further, the outcome of any such proceedings may be unfavorable to us. If the manufacture, use or sale of any of our drug candidates infringes the patents, or violates other proprietary rights, of third parties, a court or settlement agreement may require us to pay actual damages and, potentially, penalties, including the other party's attorney's fees, which may be substantial. We could also be required to cease the development, manufacture, use and sale of drugs that infringe the patent rights of others, to expend significant resources to redesign our technology so that it does not infringe the patent rights of others, to develop or acquire non-infringing technology, which may not be possible, or to obtain licenses to the infringed intellectual property, which may not

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be available to us on acceptable terms or at all. We cannot guarantee that we will have sufficient financial or other resources to protect intellectual property significant to the development of our product candidates.

Even if a product candidate receives regulatory approval, lack of market acceptance may prevent us from generating revenue from commercialization of the product.

        Even if a product candidate is approved, if we or a partner are not successful in commercializing the product, we will not generate revenue from sales. Revenue generated from an approved product depends on its successful commercialization. Many factors may impede successful commercialization, many of which are or may be beyond our or a partner's control. These factors include the proprietary rights of third parties, including our competitors, the failure of a product to prove effective as, or offer therapeutic or other improvements over, existing or future drugs used to treat the same or similar conditions or the inability of a product to gain acceptance by patients, the medical community or third-party payers, such as insurance companies or government reimbursement programs, or the inability of produce a product in commercial quantities at an acceptable cost, or at all. Even if our drug development is successful and marketing authorization has been obtained, our ability, or our partners' ability, to generate significant revenue will depend on the acceptance of our drugs by physicians, patients, third-party payers and the medical community. We cannot assure you that we or our partners will achieve market acceptance of our drug candidates or generate revenue once we or our partners obtain marketing authorization. The market acceptance of any of our drug candidates depends on a number of factors, including the continued demonstration of efficacy and safety in commercial use, cost-effectiveness, convenience and ease of administration, competition, marketing and distribution support, the scope of the approved uses and labeling requirements, prevalence and severity of any side effects, and adequate government or other third-party coverage or reimbursement for the cost of the drug. To the extent competitors are able to commercialize competing drugs before our drugs have achieved market approval and acceptance, we may have difficulty gaining market acceptance if physicians, patients, third- party payers and the medical community have grown accustomed to use of the competing drugs, whether or not such competing drugs are more effective or have other advantages over our drug.

Any commercialization efforts by us will require us to develop sales, marketing and distribution capabilities internally or through arrangements with third parties.

        Sales, marketing and distribution capabilities are key elements of a successful commercialization strategy, none of which we currently have internally. If any of our product candidates are approved, we intend to market the product either directly or through other strategic alliances and distribution arrangements with third parties. To commercialize our drugs, we will need to enter into new collaborations with third parties or develop our own marketing and sales force with technical expertise and supporting distribution capability. If we decide to market our products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution, administration and compliance capabilities. If we rely on third parties with such capabilities to market our products, we will need to establish and maintain partnership arrangements, and there can be no assurance that we will be able to enter into third-party marketing or distribution arrangements on acceptable terms or at all. To the extent that we do enter into such arrangements, we will be dependent on our marketing and distribution partners. In entering into third-party marketing or distribution arrangements, we expect to incur significant additional expense and there can be no assurance that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for our products and services. Any factors preventing or limiting the market acceptance of our drug candidates could have a material adverse effect on our business, financial condition, results of operations and prospects. There can be no assurance that we will be able to build up our own marketing and sales organization, to

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attract and maintain established collaboration partners for the third-party commercialization of our drug candidates, to enter into agreements on acceptable terms for sales and marketing, if at all, or that any such collaboration arrangements will be successful. As a consequence, we would be forced to seek alternatives, redirect our resources or have to limit the scope of our research and development activities in other fields and thereby delay the launch and sales of any or all of our drug candidates, or raise new funds. Accordingly, this could have a material adverse effect on our business, financial condition, results of operations and prospects.

We may become exposed to costly and damaging liability claims and may not be able to maintain sufficient liability insurance to cover these claims.

        Our business with pharmaceutical drugs entails a potential risk of substantial liability for damages, including drug liability and environmental liability, which are inherent in the development, testing and manufacturing of our drug candidates. It is always possible that a drug, even after marketing authorization, may exhibit unforeseen failures or adverse side effects. We can provide no assurance that sufficient insurance coverage will be available to us at acceptable terms, or at all, for any damages or costs in connection with any liability claims. Liability lawsuits are costly and time consuming and may divert management's attention from their normal responsibilities. If any of our drugs were to fail or produce adverse side effects, substantial uninsured losses could result, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Even where drug failures or side effects are not so serious as to warrant withdrawing the drug from the market or liability in damages, they may reduce the drug's competitiveness or adversely affect our reputation, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We and our partners are subject to significant government regulation, including marketing authorization requirements, which could increase the cost of developing our drug candidates or delay, prevent or limit the commercialization of our drug candidates.

        We and our partners are subject to extensive and rigorous governmental regulation and the applicable regulatory requirements are subject to change. Our and our partner's research and development, preclinical studies and clinical trials, manufacturing, safety, efficacy, record-keeping, labeling, marketing, sales and distribution of our drug candidates are regulated by the EMA, the FDA, Swissmedic, Swiss Agency for Therapeutic Products, and other government agencies in countries where we are testing or intend to test and market our drug candidates. Before a clinical trial can begin, we and our partners must obtain approval from the competent national authority in the country where the trial is planned to be conducted. A favorable opinion from a competent ethics committee or an independent institutional review board on the clinical trial application is also needed. We cannot assure we or our partners will obtain authorization for further testing of drug candidates already in clinical trials or for human clinical trials of any or all of our other candidates currently in research or pre-clinical development. We, and our partners or regulatory authorities may suspend or terminate clinical trials at any time if it is thought that the participants are being exposed to unacceptable health risks. It may take us or our collaborators several years to complete this testing, and failure can occur at any stage of the process.

        The governmental regulation of development of drug candidates extends beyond clinical trials to approvals required for their sale and monitoring after sale, including safety reporting requirements, regulatory oversight of drug promotion and marketing and cGMP. A failure by us or our partners to obtain marketing authorization or a delay in obtaining and maintaining approval could damage our reputation and adversely affect the marketing of our drugs and our ability to generate revenue, which could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, marketing authorizations, if granted, may not include all uses for which we may seek to market a drug, thereby limiting the potential market for the drug. Moreover, even after

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marketing authorization is obtained, a marketed drug, its manufacturer and its manufacturing facilities are subject to continual review and periodic inspections by the relevant authorities. Consequently, any discovery of previously unknown problems with an approved drug, manufacturer or manufacturing facilities may result in restrictions on the drug or manufacturer, including a requirement to withdraw the drug from the market. In addition, regulatory requirements are evolving in a manner that cannot be predicted. Changes in existing regulations of EMA, FDA, Swissmedic, Swiss Agency for Therapeutic Products or other regulations or the adoption of new regulations could prevent us from obtaining or maintaining, or affect the timing of, future marketing authorizations. Changes in regulatory policy during the period of development of a drug or regulatory review may result in delays or rejections of approvals of the drug candidates. Any change in the regulations governing us could have a material adverse effect on our business, financial condition, results of operations and prospects.

Current healthcare laws and regulations and future legislative or regulatory changes to the healthcare system may affect our ability to sell any drugs we may develop.

        Healthcare laws are subject to change, which may affect our ability to sell any product candidates for which we receive marketing and commercialization approval. In the U.S., an important potential market for our drug candidates, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs.

        Individual states in the United States have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally-mandated price controls on payment amounts by third-party payers or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals in the United States are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce ultimate demand for our products or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

        In addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. While we cannot predict the full outcome of any such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug prices. This could harm our ability to generate revenue. In addition, legislation has been introduced in Congress that, if enacted, would permit more widespread importation or re-importation of pharmaceutical products from foreign countries into the United States, including from countries where the products are sold at lower prices than we might sell our products in the United States. Such legislation, or similar regulatory changes, could put competitive pressure on our ability to profitably price our products, which, in turn, could adversely affect our business, results of operations, financial condition and prospects. It is also possible that other legislative proposals having similar effects will be adopted.

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Certain European countries utilize reference pricing to control the prices of drugs. Use of reference pricing may increase, which could restrict the sales potential for many new drugs unless the drug can be significantly differentiated from existing drugs.

        Additional governmental and regulatory proposals and health care reforms are possible. However, we are unable to forecast what additional legislation or regulation relating to the health care industry or third-party reimbursement may be enacted in the future, or what effect such legislation or regulation would have on our business. Our business could be harmed by other health care reforms that may be erected or adopted in the future, and in particular this could have a material adverse effect on the amounts that private payers will pay for drugs. As a consequence, we may not be able to realize an appropriate return on our investment in research and development and generate revenue sufficient to attain profitability, even if our drugs are approved for marketing. This could have a material adverse effect on our business, financial condition, results of operations and prospects.

The availability and level of third-party reimbursement for our potential drugs will be uncertain, and it may be difficult to obtain or maintain expected price levels.

        Our or a partner's ability successfully to commercialize our drug candidates and to attract strategic partners for our drug candidates or future drugs will depend in part on price levels and on the extent to which reimbursement for the costs of treatment with these drug candidates will be available from government health administration authorities, private health insurers and other third-party payers, as well as government health care programs. Governments and other third-party payers are increasingly attempting to contain health care costs, in part by challenging the price of medical drugs and services or by restricting the eligibility for reimbursement. Health care cost pressure could lead to pricing pressure which could adversely affect pricing of dipraglurant, ADX71149, GABAB PAM and our other potential drugs. Seeking third-party reimbursement is a time-consuming and costly process, which will require us and our partners to provide scientific and clinical support for the use of each of our drug candidates to each third-party payer separately. Significant uncertainty exists as to the payment status of newly approved medical drugs. The unavailability or inadequacy of third-party reimbursement, or legislation controlling treatments or prices, could have an adverse effect on the price level and consequently the market acceptance of our drug candidates and may have a material adverse effect on our results or operations, financial condition and prospects.

Any non-compliance by us with the environmental, health and safety laws and regulations that we are subject to could result in fines, suspension of drugs research and development or cessation of our operations or civil liability.

        We are subject to a variety of health, safety and environmental laws and regulations in the jurisdictions in which we operate, particularly in our research and development activities, as well as in our pre-clinical studies. These laws and regulations govern, among other things, the use, storage, handling and discharge or disposal of hazardous materials, chemicals and compounds, including wastewater discharge, air emissions and waste management, where we operate. Our research and development programs involve the controlled use of hazardous materials, chemical and biological materials and controlled pre-clinical animal studies. Although we believe that we hold all permits currently required to operate our business and otherwise comply with current laws and regulations, any failure by us to comply with present or future laws and regulations could result in fines, suspension of research and development or cessation of our operations. We, like many of our competitors, have incurred, and will continue to incur, capital and operating expenditures and other costs in the ordinary course of our business in complying with such laws and regulations in most of the jurisdictions in which we operate. We do not currently anticipate any material additional capital expenditures in respect of such regulations outside of the ordinary course of our business. However, the risk of environmental liability is inherent in our business and there can be no assurance that additional material costs of complying with environmental regulations will not arise in the future. Our research and manufacturing

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activities involve the use of hazardous materials. Although we believe that our safety procedures for handling and disposing of hazardous materials (including medical and biological waste) comply with relevant laws and regulations, we cannot eliminate the risk of accidental or manmade contamination, injury or damage from these materials. In the event of an accident or environmental discharge, we may be held liable for any resulting damages. We cannot assure you that the amount of our insurance coverage will be sufficient to satisfy any such damages. As a result, any such accident could have a material adverse effect on our business, financial condition, results of operation and prospects. In addition, changes to existing or future laws and regulations may result in the imposition on us of significant additional environmental, health and safety compliance costs.

We are exposed to currency fluctuation risks and other financial risks.

        For the six-month period ended June 30, 2019, approximately 38% and 100% of our costs and revenue, respectively, were denominated in currencies other than the Swiss franc. As a result, our business is affected by fluctuations in foreign exchange rates between the Swiss franc and other currencies, particularly U.S. dollars, the Euro and the British pound. A significant amount of our costs are denominated in currencies other than Swiss francs as we source supplies, research and development, consulting and other services in several countries other than Switzerland. On the revenue side, a significant amount relates to currencies other than Swiss francs. The research grants from The Michael J. Fox Foundation for Parkinson's Research are paid in U.S dollars, whereas under our agreement with Janssen, all milestone payments and royalties payable by Janssen to us are denominated in Euros. Furthermore, under our agreement with Indivior, all research funding, milestones payments and royalties payable by Indivior to us are denominated in U.S dollars. Since our reporting currency is the Swiss francs, we convert financial line items into Swiss francs at the applicable foreign exchange rates. As our business grows, we expect that a significant part of our revenue, including milestone payments and royalties, and of our costs, including costs for clinical trials, will be denominated in U.S. dollars, the Euro or the British pound. Unfavorable fluctuations in the value of the Swiss franc compared to these other currencies could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our current operations are concentrated in one location and any events affecting this location may have material adverse consequences.

        Our current operations are located in our facilities situated in Plan-les-Ouates, Geneva, Switzerland. Any unplanned event, such as flood, fire, explosion, earthquake or other accidents that result in us being unable to fully utilize the facilities, may have a material adverse effect on our ability to operate our business, particularly on a daily basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these facilities may result in increased costs, delays in the development of our product candidates or interruption of our business operations. As part of our risk management policy, we maintain insurance coverage at levels we believe are appropriate for our business. However, in the event of an accident at these facilities, we cannot assure you that the amounts of insurance will be sufficient to satisfy any damages and losses. If our facilities are unable to operate because of an accident or for any other reason, even for a short period of time, any or all of our research and development programs may be harmed. Any business interruption may have a material adverse effect on our business, financial position, results of operations and prospects.

We are subject to risks related to data privacy concerns, cyber security breaches and failure to comply with privacy regulations and security requirements relating to data.

        In the ordinary course of our business we come to possess sensitive personal data, including information from clinical trials, and health data obtained in connection with reporting of adverse events. We are subject to data protection laws, privacy requirements and other regulatory restrictions in the various jurisdictions in which we operate.

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        Our failure to keep apprised of, and comply with, privacy, data use and security laws, standards and regulations, including, for instance, unauthorized disclosure of, or access to, data, could result in the suspension or revocation of our approvals or registrations, the limitation, suspension or termination of services or the imposition of administrative, civil or criminal penalties, including fines which may be as high as €20 million or 4% of our annual worldwide revenue (whichever is greater) for serious infringements of the EU General Data Protection Regulation that became effective in May 2018. In addition, we may obtain health information from third parties in the United States (including research institutions from which we may obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended, or HIPAA. Depending on the facts and circumstances, we could be subject to criminal penalties, including if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. In addition, such failure or non-compliance may cause existing or potential partners, including hospitals, physicians and patients to cease interacting with us, and could damage our reputation and brand. In addition, to the extent more restrictive laws, rules or security requirements relating to business and personal data are adopted in the future in the various jurisdictions in which we operate, such changes could have an adverse impact on our business by increasing our costs or imposing restrictions on our business processes. Accordingly, our failure to keep apprised of, and comply with, privacy, data use and security laws, standards and regulations could have a material adverse effect on our reputation, business, financial condition, results and prospects. Our financial exposure to any actual or alleged breach of such regulations or standards may either not be insured against or not fully covered through our current insurance.

        Cyber security attacks on our servers, information systems and databases, or the third party servers, information systems and databases on which our information is stored, could compromise the security of our data or could cause interruptions in the operations of our businesses. Notwithstanding safeguards, cyber security breaches, internal security breaches, physical security breaches or other unauthorized or accidental access to our servers, other information systems or databases could result in tampering with, or the theft or publication of, sensitive information or the deletion or modification of data, or could otherwise cause interruptions in our operations.

        The tampering with, disruption to, or the theft or publication of, sensitive information or the deletion or modification of records held either in our systems or the systems of others to which we have access, could subject us to increased costs and exposure to litigation. The loss of confidential information could result in the payment of damages and reputational harm and have a material adverse effect on our business, financial condition, results and prospects.

        Our financial exposure from the items referenced above could either not be insured against or not fully covered through any insurance that we maintain and could have a material adverse effect on our business, financial condition, results and prospects.

Risks Related to our ADSs and Shares and our Prospective Nasdaq Listing

An investment in our securities is speculative, and there can be no assurance of any return on any such investment.

        An investment in our securities is highly speculative, and there is no assurance that investors will obtain any return on their investment. Investors will be subject to substantial risks involved in their investment, including the risk of losing their entire investment.

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The market price for our shares and ADSs may be highly volatile and could decline significantly.

        Our securities have a relatively small public float and may be less liquid and more volatile than securities of companies with broader public ownership. Factors affecting the market price of the securities, many of which are beyond our control, include:

        In addition, securities markets in general have from time to time, and in particular in recent years, experienced significant price and volume fluctuations. Such fluctuations, as well as the economic environment as a whole, can have a substantial negative effect on the market price of our securities, regardless of our operating results or our financial position. Any such broad market fluctuations may adversely affect the trading price of our securities.

We will incur increased costs as a result of operating as a company with securities listed in the United States in addition to Switzerland, and our senior management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

        As a company with securities listed in the United States in addition to Switzerland, and particularly after we no longer qualify as an emerging growth company, we will incur significant legal, accounting, and other expenses that we did not incur previously. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations impose various requirements on non-U.S. reporting public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our senior management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

        Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, we will be required to furnish a report by our senior management on our internal control over financial reporting beginning with our second annual report to be filed with the U.S. Securities and Exchange Commission, or SEC. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To prepare for eventual compliance with Section 404, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as

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documented, and implement a continuous reporting and improvement process for internal control over financial reporting. We anticipate that the process to document and evaluate our internal control over financial reporting will be both costly and challenging.

To date, there has been no public market for ADSs representing our shares, and an active market may not develop in which investors can resell such ADSs.

        To date, there has been no public market for ADSs representing our shares although our shares have traded on SIX since 2007. We cannot predict the extent to which an active market for ADSs representing our shares will develop or be sustained after the listing of such securities on Nasdaq, or how the development of such a market might affect the market price for our shares on SIX. The price at which ADSs representing our shares trade on Nasdaq may or may not be correlated with the price at which our shares trade on SIX.

Fluctuations in the exchange rate between the U.S. dollar and the Swiss franc may increase the risk of holding the ADSs.

        Our share price is quoted on SIX in Swiss francs, while the ADSs will trade on Nasdaq in U.S. dollars. Fluctuations in the exchange rate between the U.S. dollar and the Swiss franc may result in temporary differences between the value of the ADSs and the value of our shares, which may result in heavy trading by investors seeking to exploit such differences. In addition, as a result of fluctuations in the exchange rate between the U.S. dollar and the Swiss franc, the U.S. dollar equivalent of the proceeds that a holder of the ADSs would receive upon the sale in Switzerland of any shares withdrawn from the depositary receipts facility, and the U.S. dollar equivalent of any cash dividends paid in Swiss francs on our shares represented by the ADSs, could also decline.

Future sales, or the possibility of future sales, of a substantial number of ADSs representing our shares or our shares could adversely affect the price of such securities.

        Future sales of a substantial number of ADSs representing our shares or our shares, or the perception that such sales will occur, could cause a decline in the market price of ADSs representing our shares and our shares. As of September 30, 2019, we had 32,848,645 shares issued and outstanding. There were no ADSs representing our shares outstanding as of such date. All of our outstanding shares are freely tradeable on SIX. Upon the effectiveness of the registration statement of which this prospectus forms a part, holders of our shares registered hereby are expected to be able to deposit such shares with the depositary in exchange for ADSs representing such shares at the ratio referred to on the cover page of this prospectus, which ADSs will be freely tradeable. If holders sell substantial amounts of ADSs or shares in the respective public markets therefor, or if the market perceives that such sales may occur, the market price of ADSs representing our shares and our shares and our ability to raise capital through an issue of equity securities in the future could be adversely affected.

We have never paid dividends on our share capital, and we do not anticipate paying cash dividends in the foreseeable future.

        We have never declared or paid cash dividends on our share capital. We do not anticipate paying cash dividends on our registered Shares in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. Any future determination to declare cash dividends will be made at the discretion of our Board of Directors, subject to compliance with applicable laws and covenants under current or future credit facilities, which may restrict or limit our ability to pay dividends and will depend on our financial condition, operating results, capital requirements, distributable profits and/or distributable reserves from capital contributions, general business conditions and other factors that our Board of Directors may

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deem relevant. As a result, capital appreciation, if any, of our securities will be your sole source of gain for the foreseeable future.

The exercise of equity incentive instruments granted under our equity incentive plan could dilute our share capital.

        Pursuant to our existing equity incentive plan, ESCs with subscription rights to purchase shares, employee stock option plan, or ESOP, and warrants may be exercisable at prices below the market price of our shares at the time of exercise. To the extent that these instruments are exercised in the future, holders of our registered shares will be diluted. As of September 30, 2019, there were 11,991,873 shares reserved for issuance pursuant to subscription rights outstanding under our existing equity incentive plan, including 265,600 shares reserved for ESCs, 5,559,375 shares reserved for the ESOP, 5,866,898 shares reserved for warrants, and 1,700 equity sharing certificates.

Holders of ADSs may not have the same voting rights as the holders of our shares and may not receive voting materials in time to be able to exercise their right to vote.

        Except as described in this prospectus, holders of ADSs representing our shares will not be able to exercise voting rights attaching to the underlying shares on an individual basis. Holders of ADSs representing our shares will appoint the depositary or its nominee as their representative to exercise the voting rights attaching to the shares underlying such ADSs. Holders of ADSs representing our shares may not receive voting materials in time to instruct the depositary to vote, and it is possible that holders or persons who hold such ADSs through brokers, dealers or other third parties, will be treated as having instructed the depositary to give a discretionary proxy to the independent proxy holder elected by the Company's shareholders to vote the shares represented by your ADSs. We are permitted to, in certain circumstances, instruct the depository how to rate the shares represented by ADSs that have not been voted. Furthermore, the depositary may not be liable for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, holders of ADSs representing our shares may not be able to exercise voting rights and may lack recourse if such ADSs are not voted as requested. In addition, holders of ADSs representing our shares will not be able to call a shareholders' meeting.

Holders of ADSs representing our shares may not receive distributions on our shares underlying our ADSs or any value for them if it is illegal or impractical to make them available to such holders.

        The depositary for ADSs representing our shares has agreed to pay to holders of such ADSs cash dividends or other distributions that it or the custodian receives on our shares after deducting its fees and expenses. Holders of ADSs representing our shares will receive these distributions in proportion to the number of our shares underlying their ADSs. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical for the depositary to make a distribution available to holders of ADSs representing our shares. We have no obligation to take any other action to permit the distribution of ADSs representing our shares, shares themselves, rights or anything else to holders of ADSs representing our shares. This means that holders of ADSs representing our shares may not receive any distributions that we make on our shares or any value from them if it is unlawful or impractical to make such distributions available to holders. These restrictions may negatively impact the trading value of ADSs representing our shares.

Holders of ADSs may be subject to limitations on transfer of their ADSs.

        ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer, or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if

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we or the depositary deems it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason in accordance with the terms of the deposit agreement.

ADSs holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s) in any such action.

        The deposit agreement governing the ADSs representing our shares provides that holders and beneficial owners of ADSs irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including claims under federal securities laws, against us or the depositary to the fullest extent permitted by applicable law. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. To our knowledge, the enforceability of a jury trial waiver under the federal securities laws has not been finally adjudicated by a federal court. However, we believe that a jury trial waiver provision is generally enforceable under the laws of the State of New York, which govern the deposit agreement, by a court of the State of New York or a federal court, which have non-exclusive jurisdiction over matters arising under the deposit agreement, applying such law. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor's negligence in failing to liquidate collateral upon a guarantor's demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs. No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision of the federal securities laws. If you or any other holder or beneficial owner of ADSs brings a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, you or such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and / or the depositary. If a lawsuit is brought against us and / or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may augur different results than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the venue of the hearing.

The rights accruing to holders of our shares may differ from the rights typically accruing to shareholders of a U.S. corporation.

        We are organized under the law of Switzerland. The rights of holders of shares are governed by the laws of Switzerland and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. See the sections entitled "Description of Share Capital and Articles of Association—Differences in Corporate Law" and "Description of Share Capital and Articles of Association—Articles of Association—Other Swiss Law Considerations" in this prospectus for a description of the principal differences between the provisions of Swiss law applicable to us and, for example, the Delaware General Corporation Law relating to shareholders' rights and protections.

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Claims of U.S. civil liabilities may not be enforceable against us.

        We are incorporated under the law of Switzerland. Certain of our directors reside outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or to enforce judgments obtained in U.S. courts against them or us, including judgments predicated upon the civil liability provisions of the U.S. federal securities laws. The United States and Switzerland do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in Switzerland. In addition, uncertainty exists as to whether Swiss courts would entertain original actions brought in Switzerland against us or our directors predicated upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite sum obtained against us in U.S. courts would be treated by the courts of Switzerland. Whether these requirements are met in respect of a judgment based upon the civil liability provisions of the U.S. securities laws, including whether the award of monetary damages under such laws would constitute a penalty, is an issue for the court making such decision. If a Swiss court gives judgment for the sum payable under a U.S. judgment, the Swiss judgment will be enforceable by methods generally available for this purpose. These methods generally permit the Swiss court discretion to prescribe the manner of enforcement. As a result, U.S. investors may not be able to enforce against us or our certain of our directors, or certain experts named herein who are residents of Switzerland or countries other than the United States, any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.

        We are organized under the laws of Switzerland and our jurisdiction of incorporation is Plan-les-Ouates, Geneva, Switzerland. Moreover, a number of our directors and executive officers and a number of directors of each of our subsidiaries are not residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon us or upon such persons or to enforce against them judgments obtained in U.S. courts, including judgments in actions predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our Swiss counsel that there is doubt as to the enforceability in Switzerland of original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent predicated upon the federal and state securities laws of the United States. Original actions against persons in Switzerland based solely upon the U.S. federal or state securities laws are governed, among other things, by the principles set forth in the Swiss Federal Act on International Private Law of 1987, as amended, or PILA. This statute provides that the application of provisions of non-Swiss law by the courts in Switzerland shall be precluded if the result was incompatible with Swiss public policy. Also, mandatory provisions of Swiss law may be applicable regardless of any other law that would otherwise apply.

        Switzerland and the United States do not have a treaty providing for reciprocal recognition of and enforcement of judgments in civil and commercial matters. The recognition and enforcement of a judgment of the courts of the United States in Switzerland is governed by the principles set forth in the PILA. This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if:

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We currently qualify as a foreign private issuer and, as a result, we will not be subject to U.S. proxy rules and will be subject to reporting obligations under the Exchange Act, that, to some extent, are more lenient and less frequent than those of a U.S. domestic public company.

        Upon the effectiveness of the registration statement of which this prospectus forms a part, we will report under the Exchange Act, as a non-U.S. company with foreign private issuer status. Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents, or authorizations in respect of a security registered under the Exchange Act; (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K, upon the occurrence of specified significant events. In addition, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each fiscal year, while U.S. domestic issuers that are accelerated filers are required to file their annual report on Form 10-K within 75 days after the end of each fiscal year. Foreign private issuers also are exempt from Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information. As a result of the above, you may not have the same protections afforded to shareholders of companies that are not foreign private issuers.

As a foreign private issuer and as permitted by the listing requirements of Nasdaq, we may follow Swiss corporate governance rules instead of certain corporate governance requirements of Nasdaq.

        As a foreign private issuer, we may follow our home country corporate governance rules instead of certain corporate governance requirements of Nasdaq. For example, we are exempt from Nasdaq regulations that require a listed U.S. company to:

        For an overview of our corporate governance principles, including those which comply with certain of the requirements above, see the section entitled "Description of Share Capital and Articles of Association—Articles of Association."

        In accordance with our Nasdaq listing, our Audit Committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act of 2002 and Rule 10A-3 of the Exchange Act, both of which also are applicable to Nasdaq-listed U.S. companies.

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        To the extent we determine to follow Swiss corporate governance practices instead of Nasdaq governance requirements applicable to domestic issuers, you may not have the same protections afforded to shareholders of companies that are subject to these Nasdaq requirements.

We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act's domestic reporting regime and Nasdaq's corporate governance requirements applicable to a domestic issuer, and cause us to incur significant incremental legal, accounting and other expenses.

        Although we currently qualify as a foreign private issuer, in order to maintain this status, either (a) a majority of our shares, including shares represented by ADSs, must be either directly or indirectly owned of record by non-residents of the United States or (b)(i) a majority of our executive officers or directors must not be U.S. citizens or residents, (ii) more than 50 percent of our assets must be located outside of the United States and (iii) our business must be administered principally outside of the United States. If we lose our status as a foreign private issuer, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers. We would also be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer will be significantly higher than the costs that we would incur as a foreign private issuer. As a result, we expect that the loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time consuming and costly.

We are an "emerging growth company," and we cannot be certain if the reduced reporting requirements applicable to "emerging growth companies" will make ADSs representing our shares or our shares less attractive to investors.

        We are an "emerging growth company" as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. As an emerging growth company, we are required to report only two years of financial results and selected financial data in this prospectus compared to three and five years, respectively, for comparable data reported by other public companies. We may take advantage of these exemptions until we are no longer an emerging growth company. We could be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier, including if the aggregate market value of ADSs representing our shares and our shares held by non-affiliates exceeds $700 million as of any June 30 (the end of our second fiscal quarter) before that time, in which case we would no longer be an emerging growth company as of the following December 31 (our fiscal year-end). We cannot predict if investors will find ADSs representing our shares or our shares less attractive because we may rely on these exemptions. If some investors find such securities less attractive as a result, there may be a less active trading market for ADSs representing our shares or our shares and the price of such securities may be more volatile.

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If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of ADSs representing our shares or our shares.

        Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inadequate internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of ADSs representing our shares or our shares.

        Management will be required to assess the effectiveness of our internal controls annually. However, for as long as we are an "emerging growth company" under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal controls could detect problems that our management's assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements requiring us to incur the expense of remediation and could also result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, the price of ADSs representing our shares or our shares and the trading volume thereof could decline.

        The trading market for ADSs representing our shares and our shares will depend in part on the research and reports that securities or industry analysts publish about us or our business. Since we have not undertaken an initial public offering of ADSs representing our shares in connection with the listing of ADSs on Nasdaq, we do not anticipate that many or any industry analysts in the United States will publish such research and reports in the United States about our shares or ADSs. If no or too few securities or industry analysts commence or continue coverage on us, the trading price for ADSs representing our shares and our shares could be affected. If one or more of the analysts who may eventually cover us downgrade such ADSs or shares or publish inaccurate or unfavorable research about our business, the trading price of ADSs representing our shares or our shares would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for ADSs representing our shares or our shares could decrease, which might cause the price of such securities and the trading volume thereof to decline.

If we are a passive foreign investment company, or PFIC, for U.S. federal income tax purposes, the consequences to U.S. holders of our shares or ADSs representing our shares may be adverse.

        Based on our analysis of our income, assets, activities and market capitalization for our taxable year ended December 31, 2018, we believe that we are classified as a "passive foreign investment company," or PFIC, for our taxable year ended December 31, 2018. Based on the expected nature and composition of our income, assets, activities and market capitalization for our taxable year ending December 31, 2019, we anticipate that we may be classified as a PFIC for our taxable year ending December 31, 2019. If we are a PFIC for our taxable year ending December 31, 2019, or any subsequent taxable years, we intend to annually provide U.S. Holders, upon request, a "PFIC Annual

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Information Statement", with the information required to allow U.S. Holders to make a "qualified electing fund" election, or "QEF Election" for United States federal income tax purposes. The application of the PFIC rules is subject to uncertainty in several respects, and therefore, no assurances can be provided with respect to our PFIC status for our taxable year ended December 31, 2018 or with regard to our PFIC status in the past or in the future. Under the Code, a non-U.S. company will be considered a PFIC for any taxable year in which (1) 75% or more of its gross income consists of passive income or (2) 50% or more of the average quarterly value of its assets consists of assets that produce, or are held for the production of, passive income. For purposes of these tests, passive income includes dividends, interest, gains from the sale or exchange of investment property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets and received directly its proportionate share of the income of such other corporation. If we are a PFIC for any taxable year during which a U.S. Holder (as defined below under "Material Income Tax Considerations—Material U.S. Federal Income Tax Considerations for U.S. Holders") holds our shares or ADSs representing our shares, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the shares or ADSs representing our shares, regardless of whether we continue to meet the PFIC test described above, unless the U.S. Holder makes a specified election once we cease to be a PFIC. If we are classified as a PFIC for any taxable year during which a U.S. Holder holds our shares or ADSs representing our shares, the U.S. Holder may be subject to adverse tax consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see the section entitled "Material Income Tax Considerations—Material U.S. Federal Income Tax Considerations For U.S. Holders."

If a United States person is treated as owning at least 10% of our shares, such holder may be subject to adverse U.S. federal income tax consequences.

        If a U.S. Holder is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting power of our shares (directly or in the form of ADSs representing our shares), such U.S. Holder may be treated as a "United States shareholder" with respect to each "controlled foreign corporation" in our corporate group, if any. If such group includes one or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as controlled foreign corporations, regardless of whether we are treated as a controlled foreign corporation. A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of "Subpart F income," "global intangible low-taxed income" and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. Failure to comply with these reporting obligations may subject a United States shareholder to significant monetary penalties and may prevent the statute of limitations with respect to such shareholder's U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we will assist our investors in determining whether any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations. Further, we cannot provide any assurances that we will furnish to any United States shareholder information that may be necessary to comply with the reporting and tax paying obligations described in this risk factor. U.S. Holders should consult their tax advisors regarding the potential application of these rules to their investment in our shares or ADSs representing our shares.

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Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.

        A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. A tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a "permanent establishment" under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the result could increase our anticipated effective tax rate.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This prospectus contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this prospectus are based upon information available to us as of the date of this prospectus and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include statements about:

        You should refer to the section entitled "Risk Factors" for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by

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us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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USE OF PROCEEDS

        We will not receive proceeds from the disposition, if any, of Registered Shares in the form of ADSs by Registered Holders.

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DIVIDEND POLICY

        We have never paid a dividend, and we do not anticipate paying dividends in the foreseeable future. We intend to retain all available funds and any future earnings to fund the development and expansion of our business. As a result, investors in our shares will benefit in the foreseeable future only if our shares appreciate in value.

        Under Swiss law, any dividend must be proposed by our board of directors and approved by a shareholders' meeting. In addition, our auditors must confirm that the dividend proposal of our board of directors conforms to Swiss statutory law and our articles of association. A Swiss corporation may pay dividends only if it has sufficient distributable profits brought forward from the previous business years ("Gewinnvortrag") or if it has distributable reserves ("frei verfügbare Reserven"), each as evidenced by its audited standalone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and its articles of association have been deducted. Distributable reserves are generally booked either as "free reserves" ("freie Reserven") or as "reserve from capital contributions" ("Reserven aus Kapitaleinlagen"). Distributions out of issued share capital, which is the aggregate nominal value of a corporation's issued shares, may be made only by way of a share capital reduction. See "Description of Share Capital and Articles of Association."

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SELECTED CONSOLIDATED FINANCIAL DATA

        The following tables set forth, for the periods and as of the dates indicated, our selected consolidated financial data. We have derived the consolidated statements of operations data for the years ended December 31, 2018 and 2017 and the consolidated balance sheet data as of December 31, 2018 and 2017 from our audited consolidated financial statements appearing elsewhere in this prospectus. The consolidated statements of operations data for the six months ended June 30, 2019 and 2018 and the consolidated balance sheet data as of June 30, 2019 are derived from our unaudited consolidated financial statements appearing elsewhere in this prospectus. Our consolidated financial statements included in this prospectus have been prepared in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, or IASB. You should read this data together with our consolidated financial statements and related notes included elsewhere in this prospectus and the information under the caption "Management's Discussion and Analysis of Financial Condition and Results of Operations." Our historical results are not necessarily indicative of our future results. The exchange rate between the Swiss franc and the U.S. dollar as of September 30, 2019 was $1.0029 per CHF 1.0.

 
  For the six months
ended June 30,
  For the years
ended December 31,
 
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands except share and per share data)
 

Consolidated statement of operations data:

                         

Revenue from contract with customer

    1,220     4,834     6,044      

Other income

    7     534     659     500  

Operating costs

   
 
   
 
   
 
   
 
 

Research and development

    (5,894 )   (2,084 )   (4,919 )   (2,629 )

General and administration

    (2,821 )   (826 )   (3,209 )   (1,106 )

Total operating costs

    (8,715 )   (2,910 )   (8,128 )   (3,735 )

Operating income / (loss)

   
(7,488

)
 
2,458
   
(1,425

)
 
(3,235

)

Finance income

   
21
   
   
   
 

Finance costs

    (74 )   (104 )   (220 )   (45 )

Net loss before tax

    (7,541 )   2,354     (1,645 )   (3,280 )

Income tax expense

                 

Net income / (loss) for the period

    (7,541 )   2,354     (1,645 )   (3,280 )

Weighted average shares outstanding

   
26,378,503
   
19,962,969
   
23,293,237
   
12,941,439
 

Number of shares outstanding

    32,848,635     28,564,031     28,564,031     15,384,988  

Income / (loss) per share for income / (loss) attributable to the ordinary equity holders of the Company:

   
 
   
 
   
 
   
 
 

Basic income / (loss) per share

    (0.29 )   0.12     (0.07 )   (0.25 )

Diluted income / (loss) per share(1)

    (0.29 )   0.09     (0.07 )   (0.25 )

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  As of June 30,   As of December 31,  
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands)
 

Consolidated balance sheet data:

                         

Cash and cash equivalents

    36,748     43,574     41,670     2,579  

Working capital(2)

    33,091     42,506     39,817     1,576  

Total assets

    37,969     44,870     42,214     3,063  

Debt

                 

Total liabilities

    5,696     2,597     2,973     1,721  

Share capital

    32,849     26,372     28,564     15,385  

Accumulated losses

    (293,607 )   (282,068 )   (286,067 )   (284,422 )

Total equity

    32,273     42,274     39,241     1,343  

(1)
See Note 20 to our audited consolidated financial statements and Note 21 to our unaudited consolidated interim financial statements appearing elsewhere in this prospectus for a description of the method used to compute diluted net (loss)/income per share.

(2)
We define working capital as current assets less current liabilities.

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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

        You should read the following discussion in conjunction with our audited consolidated financial statements, including the related notes thereto, beginning on page F-1. In addition to historical information, this discussion contains forward-looking statements that involve risks and uncertainties. You should read the sections of this prospectus titled "Risk Factors" and "Special Note Regarding Forward-Looking Statements" for a discussion of the factors that could cause our actual results to differ materially from our expectations.

Overview

        We are a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators. Allosteric modulators target a specific receptor or protein and alter the effect of the body's own signaling molecules on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. To date, our research and development efforts have been primarily focused on building a portfolio of proprietary candidates based on our allosteric modulator development capability. The allosteric modulator principle has broad applicability across a wide range of biological targets and therapeutic areas, but our primary focus is on G-protein coupled receptors, or GPCR, targets implicated in neurological diseases, where we believe there is a clear medical need for new therapeutic approaches.

        Using our allosteric modulator discovery capabilities, we have developed a pipeline of proprietary clinical and preclinical stage drug candidates. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed. These include levodopa induced dyskinesia associated with Parkinson's disease, non-parkinsonian dystonia, addiction, epilepsy, Charcot-Marie-Tooth type 1A neuropathy, or CMT1A, and other neurodegenerative diseases. Some of these indications are classified as rare diseases that may allow for orphan drug designation by regulatory agencies in major commercial markets, such as the United States, Europe and Japan. Orphan drug designation may entitle the recipient to benefits in the jurisdiction granting the designation, such as market exclusivity following approval and assistance in clinical trial design, a reduction in user fees or tax credits related to development expense.

        Our Partner, Janssen Pharmaceuticals Inc., or Janssen, has licensed worldwide rights to our second clinical program, ADX71149 (mGlu2 PAM), and is responsible for development, manufacture and commercialization. Janssen has completed two Phase 2 studies in schizophrenia and anxious depression generating mixed results. Janssen has conducted several preclinical studies in epilepsy and continues to evaluate the program in other neurological disorders.

        Our Partner, Indivior PLC, or Indivior, has licensed worldwide rights to our GABAB PAM, program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidate. Under the agreement, we are responsible for executing a research program funded by Indivior to discovery novel GABAB PAM drug candidates. Indivior's primary therapeutic focus is addiction and under the agreement we have the right to select certain drug candidates for future independent development in certain exclusive indications including CMT1A. The program is currently in late lead optimization.

        In addition, we are conducting a number of early stage research program including mGlu7 NAM, mGlu2 NAM, mGlu4 PAM and mGlu3 PAM.

        We were founded in May 2002 and completed our initial public offering of ordinary shares on the Swiss SIX Exchange in May 2007. Our operations to date have included organizing and staffing our

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company, raising capital, out-licensing rights to our mGlu2 PAM and GABAB PAM programs and conducting preclinical studies and clinical trials. To date, we have generated CHF 55 million of revenue from the sale of license rights to certain of our research programs. We have historically financed our operations mainly through the sale of equity. As of August 31, 2019, we had raised an aggregate of CHF 325 million of gross proceeds.

        We have never been profitable and have incurred significant net losses in each period since our inception. Our net losses were CHF 1.7 million and CHF 3.3 million for years ended December 31, 2018 and 2017, respectively. As of December 31, 2018, we had accumulated losses of CHF 286.1 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities as we:

        We will need substantial additional funding to support our operating activities as we advance our research and product candidates through clinical development, seek regulatory approval and prepare for, and if any of our product candidates are approved, proceed to commercialization. Adequate funding may not be available to us on acceptable terms, or at all.

        We have no manufacturing facilities, and all of our manufacturing activities are contracted out to third parties. Additionally, we currently utilize third-party clinical research organizations, or CROs, to carry out our clinical development and trials. We do not yet have a sales organization.

License Agreement with Indivior

        In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.

        Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

        Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior

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including Charcot-Marie-Tooth type 1A neuropathy, or CMT1A. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

        Under terms of the agreement, we received a non-refundable upfront fee of $5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. In addition, we are eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling $330 million, and royalties on net sales of mid-single digits to low teens double-digit. On February 14th, 2019, Indivior terminated the development of their selected compound, ADX71441.

        Separately, Indivior funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term of two years, that can be extended by twelve-month increments and a minimum annual funding of $2 million for the Addex R&D costs incurred. Following Indivior's selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. On October 7th, 2019, Indivior agreed an additional research funding of $0.8 million for the research period.

        The contract contains two distinct material promises and performance obligations: (1) the selected compound ADX71441 which falls within the definition of a licensed compound, whose rights of use and benefits thereon was transferred in January 2018; and, (2) the research services to be conducted by Addex and funded by Indivior to discover novel GABAB PAM compounds for clinical development that may be discovered over the research term of the agreement and selected by Indivior.

License Agreement with Janssen

        Under our agreement with Janssen Pharmaceuticals Inc. (formerly known as Ortho-McNeil-Janssen Pharmaceuticals Inc), or Janssen, we granted Janssen an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Janssen under the agreement and a non-exclusive worldwide license to conduct research on the collaboration compounds using relevant patents and know-how. Subject to certain conditions, we and they agreed to own, jointly, all intellectual property rights that we develop jointly and, individually, all intellectual property rights that either party develops individually. Under certain conditions, but subject to certain consequences, Janssen may terminate the agreement for any reason, subject to a 90-day notice period.

        Janssen has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Janssen has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Janssen. However, Janssen has authority over all aspects of the development of selected compounds and may develop or commercialize third-party compounds.

        Under the terms of the Janssen agreement, we received an upfront fee of CHF 4.6 million and research funding of CHF 6.4 million during the research period, which ran from 2005 to 2007. In addition, we are eligible for payments on successful achievement of pre-specified clinical and regulatory milestones and a low double-digit royalty on net sales. We received a CHF 1.5 million milestone payment in relation to the entry of ADX71149 into Phase 1 in July 2009 and a CHF 2.6 million milestone payment in relation to the entry of ADX71149 into Phase 2 in June 2011. We are eligible for

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a further €109 million in success-based development and regulatory milestones and low double digit royalties on net sales.

Components of Results of Operations

Revenue

        From the beginning of January 2017 through December 2018, we recognized CHF 6.0 million as revenue primarily under our license agreement with Indivior. We do not have approval to market or commercialize any of our product candidates, we have never generated revenue from the sale of products and we do not expect to generate any revenue from product sales for the foreseeable future. Prior to approval of a product candidate, we will seek to generate revenue from a combination of license fees, milestone payments in connection with collaborative or strategic relationships, royalties resulting from the licensing of our drug candidates and payments from sponsored research and development activities.

        Revenue from collaborative arrangements comprises the fair value for the sale of products and services, net of value-added tax, rebates and discounts. Revenue from the rendering of services is recognized in the accounting period in which the services are rendered, by reference to completion of the specific transaction assessed on the basis of the actual service provided as a proportion of the total service to be provided. Revenue from collaborative arrangements may include the receipt of non-refundable license fees, milestone payments, and research and development payments. When we have continuing performance obligations under the terms of the arrangements, non-refundable fees and payments are recognized as revenue by reference to the completion of the performance obligation and the economic substance of the agreement.

        Our revenue has varied, and we expect revenue to continue to vary, substantially from year to year, depending on the structure and timing of milestone events, as well as our development and commercialization strategies and those of our collaboration partners for our product candidates. We, therefore, believe that historical period to period comparisons are not meaningful and should not be relied upon as an indicator of our future revenue and performance potential.

Other Income

        From the beginning of January 2017 through December 2018, we recognized CHF 1.1 million as other income primarily relating to grants from The Michael J. Fox Foundation for Parkinson's Research, or MJFF, relating to certain clinical activities related to dipraglurant development in Parkinson's disease levodopa-induced dyskinesia, or PD-LID, and TrKB PAM discovery activities.

        Grants are recognized at their fair value where there is reasonable assurance that the grant will be received and that we will comply with all associated conditions. Grants relating to costs are recognized as other income in the statement of income over the period necessary to match them with the costs that they are intended to compensate.

Operating Expenses

Research and Development Costs

        From the beginning of January 2017 through December 2018, we incurred CHF 7.6 million in research and development costs. They consist mainly of direct research costs, which include: costs associated with the use of contract research organizations, or CROs, and consultants hired to assist on our research and development activities, personnel costs, share-based compensation for our employees and consultants, costs related to regulatory affairs and intellectual property, and depreciation for assets used in research and development activities.

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        We typically use our employee, consultant and infrastructure resources across our research and development programs. We track by program the directly attributable costs from CROs and consultants.

        The following table provides a breakdown of our outsourced research and development costs that are directly attributable to the specified programs for the years ended December 31, 2018 and 2017 and the six-month periods ended June 30, 2019 and 2018:

 
  For the six
months
ended June 30,
  For the years
ended December 31
 
 
  2019   2018   2018   2017  
 
  (unaudited)
In thousands of Swiss Francs

 

Dipraglurant—PD-LID

    3,197     634     1,416     816  

GABAB PAM

    821     58     477      

Other discovery programs

    337     191     486     264  

Total outsourced research and development costs

    4,355     883     2,379     1,080  

        We expect our research and development costs will increase for the foreseeable future as we seek to advance the development of our programs. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates. This is due to the numerous risks and uncertainties associated with developing such product candidates, including:

    uncertainty to discover efficacious clinical candidate;

    uncertainty to be able to efficiently manufacture and distribute drug products;

    competitor intellectual property restraining our freedom to operate;

    the number of patients and sites required for clinical trials;

    the length of time required to enroll patients, run the clinical study and analyze the results; and

    the results of our clinical trials.

        In addition, the probability of success for any of our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability. A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.

General and Administrative Costs

        General and administrative costs consist primarily of personnel costs, including salaries, benefits and share-based compensation cost for certain executives, finance, business development, legal and human resource functions. General and administrative costs also include corporate facility costs not otherwise included in research and development expenses, legal fees related to corporate matters and fees for accounting and financial or tax consulting services.

        We anticipate that our general and administrative costs will increase in the future to support continued research and development activities. We also anticipate that we will incur increased accounting, audit, legal, compliance and director and officer insurance costs, as well as investor and public relations expenses, associated with listing on an additional stock market.

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Finance Result, Net

        Finance result, net, consists mainly of foreign exchange losses and interest expense due to the negative interest rate on Swiss franc cash deposits since January 2018.

Taxation

        We are subject to corporate taxation in Switzerland. We are also entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes. As of December 31, 2018, we had tax loss carry forwards totaling CHF 56 million of which CHF 44 million will expire by the end of 2020. Deferred income taxes are not recognized as we do not believe it is probable that we will generate sufficient taxable profits to utilize these tax loss carry forwards.

Analysis of Results of Operations

        The following table presents our consolidated results of operations for the fiscal years 2018 and 2017 and the six-month periods ended June 30, 2019 and 2018:

 
  For the six months
ended June 30,
  For the years ended
December 31,
 
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands)
 

Revenue

    1,220     4,834     6,044      

Other Income

    7     534     659     500  

Research and development costs

    (5,894 )   (2,084 )   (4,919 )   (2,629 )

General and administrative costs

    (2,821 )   (826 )   (3,209 )   (1,106 )

Operating loss

    (7,488 )   2,458     (1,425 )   (3,235 )

Finance income

    21              

Finance result, net

    (74 )   (104 )   (220 )   (45 )

Net loss

    (7,541 )   2,354     (1,645 )   (3,280 )

Six Months Ended June 30, 2019 Compared to Six Months Ended June 30, 2018

Revenue

        The following table sets forth our revenue for the six months ended June 30, 2019 and 2018.

 
  For the six months
ended June 30,
 
 
  2019   2018  
 
  (CHF in
thousands -
unaudited)

 

Fees from sale of license rights

        4,760  

Collaborative research funding

    1,220     74  

Total

    1,220     4,834  

        Revenue decreased by CHF 3.6 million during the six-month period ended June 30, 2019 compared to the six-month period ended June 30, 2018 primarily due to the absence in 2019 of CHF 4.8 million in fees from sale of license rights to Indivior recognized in 2018. This decrease was partially offset by an increase in research funding from Indivior.

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Other operating income

        The following table sets forth the other income for the six months ended June 30, 2019 and 2018.

 
  For the six months
ended June 30,
 
 
  2019   2018  
 
  (CHF in thousands -
unaudited)

 

Research grants

        507  

Other service income

    7     27  

Total

    7     534  

        Other income decreased by CHF 0.5 million during the six-month period ended June 30, 2019 compared to the six-month period ended June 30, 2018, primarily due to the absence in 2019 of MJFF research grants recognized in 2018. Other income relates to consulting services.

Research and development Expenses

        The following table sets forth our research and development expenses for the six months ended June 30, 2019 and 2018.

 
  For the six months
ended June 30,
 
 
  2019   2018  
 
  (CHF in thousands -
unaudited)

 

Dipraglurant—PD-LID

    3,197     634  

GABAB PAM

    821     58  

Other discovery programs

    337     191  

Subtotal outsourced R&D per program

    4,355     883  

Staff costs

    957     440  

Depreciation and amortization

    125      

Professional fees

    64     462  

Laboratory consumables

    104     46  

Patent maintenance and registration costs

    139     136  

Operating leases

        53  

Short term leases

    18      

Other operating expenses

    132     64  

Subtotal unallocated R&D expenses

    1,539     1,201  

Total

    5,894     2,084  

        Our research and development costs increased by CHF 3.8 million during the six-month period ended June, 30 2019 compared to the six-month period ended June 30, 2018 primarily due to increased outsourced R&D expenses of CHF 2.6 million related to our dipraglurant PD-LID program and CHF 0.8 million related to our GABAB PAM program. In addition to increased directly attributable CRO and consulting costs, we significantly increased our headcount resulting in a CHF 0.5 million increase in staff costs. The increase in depreciation and amortization relates to the recognition of the right-of-use assets of long-term operating leases in accordance with IFRS16 effective from January 1, 2019. The decrease in professional fees is due to consultants joining as employees and therefore being recorded in staff costs.

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General and administrative costs

        The following table sets forth our general and administrative costs for the six months ended June 30, 2019 and 2018.

 
  For the six months
ended June 30,
 
 
  2019   2018  
 
  (CHF in thousands -
unaudited)

 

Staff costs

    1,271     171  

Depreciation and amortization

    32     1  

Professional fees

    1,052     196  

Operating leases

        24  

Other operating costs

    466     434  

Total

    2,821     826  

        General and administrative costs increased by CHF 2.0 million during the six-month period ended June 30, 2019 compared to the six-month period ended June 30, 2018, primarily due to the costs associated with the preparation of our listing of the American Deposit Shares and the grant of equity incentive units to employees and board members, which in turn resulted in an increase in share-based compensation.

Finance Result, net

        Finance result, net primarily relates to currency exchange differences and negative interest on Swiss francs cash deposits.

Year Ended December 31, 2018 Compared to Year Ended December 31, 2017

Revenue

        The following table sets forth our revenue in 2018 and 2017.

 
  For the years
ended December 31,
 
 
  2018   2017  
 
  (CHF in thousands)
 

Fees from sale of license rights

    4,876      

Collaborative research funding

    1,168      

Total

    6,044      

        Revenue increased to CHF 6.0 million in 2018 compared to zero in 2017 due to amounts received under our license and research agreement with Indivior related to our GABAB PAM program.

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Other Income

        The following table sets forth the other income in 2018 and 2017.

 
  For the years ended
December 31,
 
 
  2018   2017  
 
  (CHF in thousands)
 

Research grants

    609     465  

Other service income

    50     35  

Total

    659     500  

        Other income increased by CHF 0.2 million in 2018 compared to 2017 primarily due to increased income recognized from MJFF research grants. The MJFF research grants fund certain activities related to our dipraglurant PD-LID program and TrKB PAM discovery program. Other service income relates to consulting services performed by our finance and administration department.

Research and Development Expenses

        The following table sets forth our research and development expenses in 2018 and 2017.

 
  For the years ended
December 31,
 
 
  2018   2017  
 
  (CHF in thousands -
unaudited)

 

Dipraglurant—PD-LID

    1,416     816  

GABAB PAM

    477      

Other discovery programs

    486     264  

Subtotal outsourced R&D per program

    2,379     1,080  

Staff costs

    1,307     491  

Depreciation and amortization

    2     12  

Professional fees

    494     566  

Laboratory consumables

    144     30  

Patent maintenance and registration costs

    262     180  

Operating leases

    134     75  

Other operating expenses

    197     195  

Subtotal unallocated R&D expenses

    2,540     1,549  

Total

    4,919     2,629  

        Research and development expenses increased by CHF 2.3 million in 2018 compared to 2017 primarily due to CHF 0.6 million increase in the costs of outsourced development activities related to our dipraglurant PD-LID program and CHF 0.5 million increase in the costs of outsourced research activities related to our GABAB PAM program and to a lesser extent our mGlu4 PAM program. In addition to increased directly attributable CRO and consulting costs we significantly increased our headcount in 2018 resulting in a CHF 0.8 million increase in staff costs.

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General and Administrative Costs

        The following table sets forth our general and administrative costs in 2018 and 2017.

 
  For the years ended
December 31,
 
 
  2018   2017  
 
  (CHF in thousands -
unaudited)

 

Staff costs

    918     260  

Depreciation and amortization

    1     4  

Professional fees

    1,809     543  

Operating leases

    45     22  

Other operating costs

    436     277  

Total

    3,209     1,106  

        General and administrative costs increased by CHF 2.1 million in 2018 compared to 2017 primarily due to grants of equity incentive units to employees, consultants and board members which in turn resulted in an increase in share-based compensation being recorded in professional fees and staff costs.

Finance Result, Net

        Finance result, net increased to a net expense of CHF 0.2 million in 2018 compared to virtually zero in 2017 primarily due to currency exchange differences and interest expenses related to the negative interest rate charged on Swiss francs cash deposits.

Liquidity and Capital Resources

        Since our inception, we have generated CHF 55 million of revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity. From inception through June 30, 2019, we raised an aggregate of CHF 325 million of gross proceeds from the sale of equity. As of June 30, 2019, we had CHF 36.8 million in cash and cash equivalents.

        Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the changes in our outstanding accounts payable and accrued expenses. We currently have no ongoing material financing commitments, such as lines of credit or guarantees.

        We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to advance our portfolio of product candidates, initiate further clinical trials and seek marketing approval for our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Furthermore, in connection with and following our planned listing of ADS on the Nasdaq, we expect to incur additional costs associated with operating as a public company in the United States. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

        We expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on

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assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

    the scope, progress, results and costs of our ongoing and planned preclinical studies and clinical trials for dipraglurant;

    the timing and amount of milestone and royalty payments we may receive under our license agreements;

    the extent to which we in-license or acquire other product candidates and technologies;

    the number and development requirements of other product candidates that we may pursue;

    the costs, timing and outcome of regulatory review of our product candidates;

    the costs associated with building out our Swiss and U.S. operations; and

    the costs and timing of future commercialization activities, including drug manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval.

        Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

        Until such time, if ever, as we can generate substantial product revenue, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of any additional securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

        If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

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        The following table shows a summary of our cash flows for the periods indicated:

 
  For the
six months ended
June 30,
  For the
years ended
December 31,
 
 
  2019   2018   2018   2017  
 
  (unaudited)
   
   
 
 
  (CHF in thousands)
 

Cash and cash equivalents at the beginning of the period

    41,670     2,579     2,579     1,410  

Net cash flows from / (used in) operating activities

    (4,615 )   3,582     1,752     (2,140 )

Net cash flows from / (used in) investing activities

    (24 )   (3 )   (62 )   (1 )

Net cash flows from / (used in) financing activities

    (284 )   37,458     37,390     3,355  

Increase/(Decrease) in cash and cash equivalents

    (4,923 )   41,037     39,080     1,214  

Effect of the exchange rates

    1     (53 )   11     (45 )

Cash and cash equivalents at end of period

    36,748     43,563     41,670     2,579  

Operating Activities

        Net cash flows from or used in operating activities consist of the net loss adjusted for changes in working capital, that are current assets and current liabilities, and for non-cash items such as depreciation and the value of share-based services.

        During the six-month period ended June 30, 2019, operating activities used CHF 4.6 million of cash primarily due to our net loss of CHF 7.5 million, changes in net working capital of CHF 1.7 million and non-cash items of CHF 1.3 million. Non-cash items relate mainly to the value of share-based services. Changes in the net working capital included primarily a CHF 1.1 million increase in accrued expenses, mainly due to dipraglurant manufacturing and PD-LID clinical trial preparation costs.

        During the six-month period ended June 30, 2018, operating activities generated a positive cash flow of CHF 3.6 million primarily due to the revenue of CHF 4.8 million from the licensing and research agreement with Indivior and non-cash items of CHF 1.1 million primarily consisting of the value of the share-based services.

        During the year ended December 31, 2018, operating activities generated a positive cash flows of CHF 1.8 million primarily due to the revenue of CHF 6.0 million from the licensing and research agreement with Indivior that limited the consolidated net loss to CHF 1.7 million and non-cash items of CHF 2.4 million primarily consisting of the value of share-based services. Changes in net working capital of CHF 0.7 million primarily include a CHF 1.1 million increase in payables and accruals related to dipraglurant manufacturing and PD-LID clinical trial preparation costs off-set by a decrease of CHF 0.4 million in deferred income, primarily related to the recognition of research grants from MJFF.

        During the year ended December 31, 2017, operating activities used CHF 2.1 million of cash primarily as the result of our net loss of CHF 3.3 million, as adjusted for the positive change in net working capital of CHF 0.3 million and non-cash items of CHF 0.8 million relating mainly to the value of share-based services.

Investing Activities

        Net cash used in investing activities consist primarily of investments in computer and laboratory equipment, security rental deposits related to laboratory and office space and purchase of our own shares.

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        During the six-month period ended June 30, 2019 net cash used in investing activities primarily related to investments in computer and laboratory equipment.

        During the six-month period ended June 30, 2018, net cash used in investing activities primarily related to investments in computer equipment.

        During the year ended December 31, 2018, net cash used in investing activities primarily related to investments in security rental deposits related to laboratory and office space, and to a lesser extent computer and laboratory equipment.

        During the year ended December 31, 2017, net cash used in investing activities primarily related to investments in computer and laboratory equipment.

Financing Activities

        Net cash flows from financing activities consisted of proceeds from the sale of equity securities.

        During the six-month period ended June 30, 2019, net cash used in financing activities primarily related to the principal element of lease payments and associated interest expense, as the result of the adoption of IFRS16, effective from January 1, 2019.

        During the six-month period ended June 30, 2018 and the year ended December 31, 2018, net cash from financing activities primarily related to proceeds from the sale of equity securities. During the year ended December 31, 2017, net cash from financing activities primarily related to proceeds from the sale of treasury shares.

Contractual Obligations and Commitments

        The following table summarizes our contractual obligations at June 30, 2019

 
  Less than
1 Year
  1 to 3 Years   3 to 5 Years   More than
5 Years
  Total cash
out flows
  Carrying
amount
liabilities
 
 
  (in thousands of Swiss Francs)
   
 

Lease liabilities

    295     98     21         414     395  

Total

    295     98     21         414     395  

        Lease liabilities commitments consist mainly of rental contracts for laboratories, offices and related spaces used by Addex Pharma SA, our fully owned Swiss operating subsidiary.

        We enter into contracts in the normal course of business with CROs for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

        For the years ended December 31, 2018 and 2017 and the six-month periods ended June 30, 2019 and 2018 we did not have, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the U.S. Securities and Exchange Commission.

Outstanding Debt

        We do not engage in trading activities involving non-exchange traded contracts nor do we currently have any debt outstanding. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.

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Critical Accounting Policies and Significant Judgments and Estimates

        Our management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we have prepared in accordance with International Financial Reporting Standards, or IFRS. The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

        While our significant accounting policies are described in more detail in Note 4 to our consolidated financial statements appearing elsewhere in this prospectus. We believe the following accounting policies to be most critical to understanding our historical financial performance as they relate to the more significant areas involving management's judgments and estimates.

Revenue recognition

        Under IFRS 15, we recognize as revenue our non-refundable license fees, milestone, research activities and royalties when our customer obtains control of promised services, in an amount that reflects the consideration which we expect to receive in exchange for those rendered services. To assess revenue recognition for arrangements that we determine are within the scope of IFRS 15, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of IFRS 15, we assess the services promised within each contract and determine those that are performance obligations and assess whether each promised service is distinct. We use the most likely method to estimate any variable consideration and include such consideration in the amount of the transaction price based on an estimated stand-alone selling price. Revenue is recognized for the respective performance obligation when (or as) the performance obligation is satisfied.

Other income

        We recognized grants at their fair value when we have the reasonable assurance that we will receive them and we will comply with all conditions. Grants are recognized in the accounting period as costs they intend to compensate are incurred.

Recognition of Research and Development Costs

        We recognize expenses incurred in carrying out our research and development activities in line with our best estimation of the stage of completion of each separately contracted study or activity. This includes the calculation of research and development accruals at the end of each period to account for expenditure that has been incurred. This requires us to estimate the full costs to complete each study or activity and to estimate the current stage of completion. There have been no material adjustments to estimates based on the actual costs incurred for the periods presented. In all cases, we expense the full cost of each study or activity by the time the final study report or, where applicable, product, has been received.

        We will recognize an internally-generated intangible asset arising from our development activities only when an asset is created that can be identified, it is probable that the asset created will generate future economic benefits and the development cost of the asset can be measured reliably. We have determined that regulatory and marketing approvals are the earliest points at which the probable

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threshold for the creation of an internally generated intangible asset can be achieved. We therefore expense all research and development expenditure incurred prior to achieving such approvals as it is incurred. None of our product candidates have yet received regulatory and marketing approvals.

Share-Based Compensation

        We measure and recognize compensation expense for all equity incentive units based on the estimated fair value of the award on the grant date. We only grant equity incentive units to our employees, key consultants and board members. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award.

        The fair value at the grant date of the equity incentive units is determined using either an option pricing method that uses a Black-Scholes model or a binomial valuation model. In establishing these models, a number of assumptions are made by management. The fair value per share for our shares is the closing price of our shares as reported by the Swiss SIX exchange on the applicable grant date. A number of assumptions on the volatility of the underlying shares and on the risk free rate are made in these models.

Employee Benefits

        We maintain a pension plan for all employees in Switzerland that is maintained through payments to a legally independent collective foundation. This pension plan qualifies under IFRS as a defined benefit pension plan. There are no pension plans for the subsidiaries in the United States.

        The liability recognized in the balance sheet in respect of defined benefit pension plans is the present value of the defined benefit obligation at the end of the reporting period less the fair value of plan assets. The defined benefit obligation is calculated annually by an independent actuary, using the projected unit credit method. The present value of the defined benefit obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating to the terms of the related pension obligation.

        Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are charged or credited to equity in other comprehensive income in the period in which they arise. Past-service costs are recognized immediately in the consolidated statement of comprehensive loss.

Recent Accounting Pronouncements

        See Note 2.2 to our consolidated financial statements beginning on page F-1 of this prospectus for a description of recent accounting pronouncements applicable to our consolidated financial statements

Qualitative and Quantitative Disclosures about Financial Risks

        We operate primarily in Switzerland, Europe and in the United States and are therefore exposed to market risk, which represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates.

        As of June 30, 2019, we had CHF 36.8 million of cash and cash equivalents and we had no debt.

Interest Rate Risk

        Our cash is held in readily available checking and money market accounts. As of June 30, 2019, Swiss francs balance represents 73% of the cash and cash equivalents of the company. From January 1st

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2018, the banks partially reinvoice to their clients a part of the negative interests on swiss francs deposit that they pay to the Swiss National Bank. For the six-month period ended June 30, 2019 the effective negative interest rate on swiss francs cash deposits paid by Addex was limited to –0.45%. As a result, a change in market interest rates would not have any significant impact on our financial position or results of operations. As of June 30, 2019, we had no debt and, therefore, no material interest rate risk exposure.

Foreign Currency Exchange Risk

        We operate primarily in Switzerland, the United States and Europe more broadly and our functional currency is the Swiss franc, and as a result, we are exposed to (1) transactional foreign exchange risk when we or a subsidiary enter into a transaction in a currency other than our or its functional currency and (2) translational foreign exchange risk when we translate financial statements of our foreign subsidiaries from their functional currency into Swiss francs.

Transactional Risk

        Our expenses are generally denominated in the currencies of the countries where the relevant transaction takes place, which is primarily in Switzerland, the United States, and to a lesser extent in the Euro-zone countries and United Kingdom. Transactions in foreign currencies of our Swiss company are recorded in Swiss francs at the applicable exchange rate on the date of the relevant transaction. Our results of operations and cash flows are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign currency exchange rates.

Translational Risk

        Because our reporting currency is the Swiss franc, or CHF, we may be exposed to translation risk when the income statements of our subsidiaries located in countries outside Switzerland are converted into Swiss francs using the average exchange rate for the period, and whilst revenues and costs are unchanged in local currency, changes in exchange rates may lead to effects on the converted balances of revenue, costs and the result in Swiss francs .

        To date, our risk management policy is to economically hedge 100% of anticipated transactions in each major currency for the subsequent 12 months. As our operations grow, we will continue to reassess our approach to manage our risk relating to fluctuations in foreign currency rates.

Capital Risk

        We are not regulated and not subject to specific capital requirements, however, we aim to be compliant with the specific needs of the Swiss law. To ensure that statutory capital requirements are met, we monitor capital periodically on an interim basis as well as annually. From time to time, we may take appropriate measures or propose capital increases at the shareholders' meeting to ensure the necessary capital remains intact.

JOBS Act Transition Period

        Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, including without limitation, (1) providing an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will

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remain an emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a "large accelerated filer" under the rules of the U.S. Securities and Exchange Commission, which means the market value of our common shares that is held by non-affiliates exceeds $700 million as of the prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

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BUSINESS

Overview

        We are a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators. Allosteric modulators target a specific receptor or protein and alter the effect of the body's own signaling molecules on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. To date, our research and development efforts have been primarily focused on building a portfolio of proprietary drug candidates based on our allosteric modulator development capability. The allosteric modulator principle has broad applicability across a wide range of biological targets and therapeutic areas, but our primary focus is on G-protein coupled receptors, or GPCR, targets implicated in neurological diseases, where we believe there is a clear medical need for new therapeutic approaches.

        Using our allosteric modulator discovery capabilities, we have developed a pipeline of proprietary clinical and preclinical stage drug candidates. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed. These include PD-LID, non-parkinsonian dystonia, addiction, epilepsy, Charcot-Marie-Tooth type 1A neuropathy, or CMT1A, and other neurodegenerative diseases. Some of these indications are classified as rare diseases that may allow for orphan drug designation by regulatory agencies in major commercial markets, such as the United States, Europe and Japan. Orphan drug designation may entitle the recipient to benefits, in the jurisdiction granting the designation, such as market exclusivity following approval and assistance in clinical trial design, a reduction in user fees or tax credits related to development expenses.

        We are developing our lead drug candidate, dipraglurant, as an mGlu5 NAM, for the treatment of PD-LID. We are planning to initiate a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at approximately 50 sites in the United States and will target enrolment of approximately 140 patients. We have received orphan drug designation from the United States Food and Drug Administration, or FDA, for dipraglurant in PD-LID and expect to report topline results in the third quarter of 2021. In parallel, dipraglurant's therapeutic use in dystonia is being investigated in preclinical models.

        We are also conducting a research program under our strategic partnership with Indivior UK Limited, or Indivior, to discover novel orally available GABAB PAMs. We are currently in late lead optimization and expect to deliver a drug candidate by the end of 2020 for Indivior to develop for addiction. Under terms of the agreement with Indivior, we have the right to select drug candidates for development in certain exclusive indications outside of addiction. We plan to develop our selected drug candidate in CMT1A, an indication that has been clinically validated with baclofen, an orthosteric agonist of GABAB.

        Allosteric modulators have broad applicability for many clinically validated GPCR targets which are implicated in multiple therapeutic indications. We intend to continue to leverage our scientific expertise in allosteric modulation and our proprietary technology platform to discover novel drug candidates for the treatment of neurological diseases.

        Based on our expertise in allosteric modulation, our goal is to build a leading neuroscience company focused on conditions where current treatment options are limited and where unmet medical needs exist. Our business strategy includes the possibility of entering into collaborative arrangements with third parties to complete the development and commercialization of our proprietary drug candidates, such as our partnership with Janssen Pharmaceuticals, Inc., or Janssen, a subsidiary of Johnson & Johnson, for ADX71149 and our strategic partnership with Indivior for GABAB PAM. We

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cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and other funding from: The Michael J. Fox Foundation for Parkinson's Research, or MJFF, for the development of dipraglurant for the treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in addiction; the Swiss Innovation Agency, or Innosuisse, to advance our understanding of the role of our drug candidates in neurodegenerative and psychiatric diseases; and the Eurostars Joint Programme, or Eurostars to identify novel drug candidates on mGlu7 NAM for PTSD. As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored studies that could offset or reduce our development costs.

        The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or product candidates under development, for each of the product candidates and each of the indications for which we are developing. Furthermore, Government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.

Research and Development Portfolio

        Using our allosteric modulator platform and drug discovery and development expertise, we have established a portfolio of clinical and preclinical programs, both internally and with partners.

Internally Developed Product Candidates

GRAPHIC

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        Dipraglurant, for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease.    We are developing dipraglurant as a novel orally available mGlu5 NAM for the treatment of PD-LID. PD-LID is a disease with significant commercial opportunity as improved therapies are needed. We believe that, subject to regulatory approval, dipraglurant may offer an innovative and differentiated treatment approach from existing therapies. In a 28 day Phase 2a placebo-controlled clinical trial, conducted in the United States and Europe, in patients with PD-LID, dipraglurant met its primary end point, was generally well tolerated and no clinically significant abnormalities of safety monitoring parameters occurred. In addition, at Day 1 and Day 14, dipraglurant showed statistically significant effects on PD-LID clinical symptoms, as measured using mAIMs. However, an increasing placebo response resulted in the effect of dipraglurant on PD-LID clinical symptoms not showing statistical significance at Day 28. We have substantially completed the preparation of dipraglurant to start registration studies in PD-LID and expect to initiate a Phase 2b/3 placebo-controlled pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at approximately 50 sites in the United States and will target enrolment of approximately 140 patients. We have also received orphan drug designation from the US FDA for dipraglurant in PD-LID and expect to report topline results in the third quarter of 2021.

        Dipraglurant, for the treatment of non-Parkinsonian dystonia.    We are developing an extended release formulation of dipraglurant as a novel orally available NAM for the treatment of dystonia. At the appropriate time we expect to be able to start a Phase 2a proof of concept clinical trial. There are many types of dystonias that present a commercial opportunity for dipraglurant. We believe that subject to regulatory approval, dipraglurant may offer an innovative and differentiated treatment approach for multiple types of dystonia. We are currently completing preclinical evaluations of dipraglurant in preclinical models of dystonia.

Externally Developed Out-licensed Product Candidate

        ADX71149 (mGlu2 PAM) for the treatment of epilepsy.    Our partnered drug candidate, ADX71149 is a novel orally active mGlu2 PAM. Our partner, Janssen, has completed Phase 1 and two Phase 2a clinical trials in schizophrenia and anxious depression, respectively, and is currently evaluating future development in epilepsy. Under our agreement with Janssen, Janssen is responsible for financing the development and commercialization, if any, of ADX71149.

Material Internal Research Programs

GRAPHIC

        GABAB PAM for the treatment of addiction.    Our partner, Indivior, has licensed worldwide rights to our GABAB PAM program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidates. Under the agreement, we are responsible for executing

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a research program funded by Indivior to discover novel drug candidates. Indivior has the right to select GABAB PAM drug candidates from our research program. We expect to deliver drug candidates for selection in 2020. We believe that addiction is a indication with a significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. Subject to regulatory approval, we believe that GABAB PAM may offer an innovative and differentiated treatment approach from existing therapies and may provide benefit to patients.

        GABAB PAM for the treatment of CMT1A.    Our license agreement with Indivior provides for a funded research program, under which we have the right to select drug candidates for exclusive development in certain indications outside of addiction, including CMT1A, a rare disease indication. We plan to pursue orphan drug designation for a selected drug candidate for CMT1A. We believe an oral small molecule GABAB PAM with a once-a-day dosing and without the adherence-limiting side effects of baclofen, which is currently used off label, could bring benefit to patients and consequently present a strong commercial opportunity for us.

        mGlu7 NAM for the treatment of PTSD:    We are developing mGlu7 NAMs as a novel orally available treatment to reduce fear memory in PTSD. This is a disorder that can lead to intense fear and anxiety. Current medication is unspecific and ineffective, with a number of side effects. By selectively targeting mGlu7 with NAMs, the brain circuitries involved in fear and anxiety can be more precisely modulated, potentially resulting in a more focused response and fewer side effects than current therapeutic approaches. Subject to regulatory approval, we believe our mGlu7 NAM may offer an innovative and differentiated treatment approach from existing therapies. We are in late lead optimization and a consortium led by us has been awarded a €4.85 million grant from the Eurostars Joint Programme to advance the program to drug candidate stage.

Early Stage Internal Research Programs

GRAPHIC

        mGlu2 NAM for the treatment of mNCD:    We are developing mGlu2 NAM as a novel orally available treatment for mNCD associated with Alzheimer's disease, Parkinson's disease and depressive disorders. We are currently optimizing multiple chemical series of highly selective mGlu2 NAMs offering advanced compounds at the late stage of lead optimization.

        mGlu4 PAM for the treatment of Parkinson's disease:    We are developing mGlu4 PAM as a novel orally available treatment for Parkinson's disease. We are currently optimizing multiple chemical series of highly selective mGlu4 PAMs with compounds in early lead optimization.

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        mGlu3 PAM for the treatment of neurodegenerative disorders:    We are developing mGlu3 PAM as a novel orally available treatment for neurodegenerative disorders. We are currently optimizing multiple chemical series of highly selective mGlu3 PAMs, with compounds in early lead optimization.

Introduction to Allosteric Modulation

Disease and the Role of Proteins

        Proteins are complex biological molecules that have many structural and functional roles in the body. They are critical components in the lines of communication between the cells of the body known as signaling pathways. It is now recognized that signaling pathways are altered in many disease states through changes in the function of essential proteins underlying the series of cellular events required for normal biological activity. Most drug treatments are focused on modifying these biological signaling pathways by altering the activity profile of selected proteins suspected to play a key role in the manifestation of a particular disease. The major proteins targeted in drug discovery include membrane-bound receptors, such as G-protein coupled receptors, or GPCRs, or ionotropic (ion channels) receptors and enzymes.

GPCRs as Drug Targets

        GPCRs are the largest family of integral membrane receptors, accounting for approximately 3-4% of the human genome. GPCRs have evolved to recognize a range of endogenous stimuli and act to transmit messages encoded in stimuli from the exterior to the interior of the cell. The ubiquitous cell surface distribution of GPCRs and their involvement in virtually all biological processes have made GPCRs extremely attractive targets for drug development. In fact, most currently marketed drugs act on GPCRs, emphasizing their importance for drug development.

Conventional Approaches to GPCR Drug Discovery

        The drug discovery process involves the design of molecules that interact with a target with high specificity and efficacy. Traditional approaches to drug discovery focus on mimicking or inhibiting the actions of the endogenous activator for a target receptor. Conventionally, this has been done by the design and chemical synthesis of small molecule agonists (activators) or antagonists (inhibitors) that act in a competitive manner through interaction with the same binding site as the endogenous activator.

        Competitive agonists and antagonists must have a sufficiently high affinity for the target receptor to displace the endogenous activator and must be maintained at a sufficiently high concentration in the region of the receptor in order to exert an effect. Under these conditions, agonists will induce an activated state and antagonists will induce an inactivated state, and in both states, receptors will not be responsive to natural fluctuations in the levels of endogenous activator, thereby interfering with normal physiological signaling.

        Although this approach has historically yielded a number of blockbuster drugs, such as Clopidogrel, or Plavix, Salmeterol, or Serevent, and Aripiprazole, or Abilify, significant challenges remain with respect to the continued development of therapeutically useful GPCR competitive agonists or antagonists due to either lack of receptor selectivity or undesirable side effects.

Allosteric Modulators as GPCR Drugs

        In contrast to competitive orthosteric compounds, allosteric modulators of GPCRs interact with binding sites that are topographically distinct from the binding site of the endogenous activator, and therefore do not compete with the endogenous activator. This means that allosteric modulators do not activate or inhibit receptors on their own, but only in the presence of an endogenous activator do they enhance (positively modulate) or inhibit (negatively modulate) the natural physiological activity of the

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receptor. Consequently, allosteric modulators offer the possibility to preserve normal physiological receptor function while controlling pathologic activity caused by over- or under-activation of an endogenous receptor.

        We believe that by applying this non-competitive allosteric modulator approach, we may be able to produce efficacious drug candidates with potentially beneficial properties:

        Orally available brain penetrant small molecule drug candidates that are highly selective for their therapeutic targets and interact with their target in a modulatory manner preserving natural physiological signaling are particularly suitable for neurological diseases.

Our Platform and Competitive Positioning in Allosteric Modulation

        We believe that we have a recognized expertise in allosteric modulator R&D. Since our inception in 2002, we have focused exclusively on allosteric modulation drug discovery and development. We have engaged leading experts in the field of allosteric modulation who have years of experience in both industry and academia, including Robert Lutjens, our head of discovery biology and Jean-Philippe Rocher, our head of discovery chemistry.

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        We have established a unique chemical library of more than 70,000 allosteric modulator compounds, in addition to highly specialized biological systems that are required for the identification and screening of high affinity, orally active small molecule allosteric modulators. Combined with our allosteric modulator library, these high-throughput detection systems have enabled us to build what we believe to be the largest clinical and pre-clinical portfolio of proprietary allosteric modulator compounds.

        Dipraglurant, an mGlu5 NAM, is our lead development compound. It is in late-stage development and scheduled to start a placebo-controlled Phase 2b/3 pivotal clinical trial in PD-LID patients in the first quarter of 2020. Topline results are expected in the third quarter of 2021. ADX71149, a mGlu2 PAM licensed to Janssen, has completed Phase 1 and two Phase 2a clinical trials demonstrating good tolerability. Its further development is being evaluated by our partner, Janssen, with a key focus on evaluating it for the treatment of epilepsy. Furthermore, we believe the depth of our in-house discovered portfolio further demonstrates our expertise in the allosteric modulation field.

Our Strategy

        Based on our expertise in allosteric modulation, our goal is to build a leading neuroscience company focused on conditions where current treatment options are limited and where unmet medical needs exist. Since our inception, we have raised an aggregate of CHF 325 million in equity financing and generated an aggregate of CHF 55 million of revenues, which we have used to build our proprietary allosteric modulator technology platform and our pipeline of drug products and candidates. We have secured financing from leading U.S. healthcare investors, including New Enterprise Associates, New Leaf Venture Partners and CAM Capital. The key elements of our strategy include the following:

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Our Strengths

        Our current strategic focus is the development of certain proprietary drug candidates in our existing portfolio. We believe that we have a number of competitive advantages that distinguish us from our competitors.

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Our Internally Developed Product Candidates

Dipraglurant

        Dipraglurant is a selective, orally active small molecule drug product which acts as an mGlu5 NAM. We discovered dipraglurant and hold composition of matter and polymorph patents granted in the United States and Europe. Dipraglurant is selective for mGlu5 and does not have significant activity or binding affinity to other mGlu or other CNS receptors, such as serotonin, GABA or dopamine receptors. There are currently no drugs of this class on the market.

Dipraglurant for the treatment of Parkinson's disease levodopa induced dyskinesia (PD-LID)

        We have conducted a Phase 2a proof of concept clinical trial of dipraglurant in PD-LID, in which dipraglurant met its primary end point, was generally well tolerated. We expect to initiate a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients the first quarter of 2020. This registration clinical trial will be powered at 90%, the industry norm with the objective of demonstrating benefits on clinical symptoms in PD-LID patients over a 12-week treatment duration. The term "power" of a study is a measure of the probability that a clinical trial is a meaningful test of the hypotheses (or primary endpoints) that the clinical trial is designed to test. The study will be conducted at approximately 50 sites in the United States and will target enrolment of approximately 140 patients.

        Parkinson's disease is a progressive neurodegenerative disease that results in the loss of dopaminergic neurons in the substantia nigra, or SN. One consequence of the depletion of dopamine in this disease is a series of movement disorders, including bradykinesia, akinesia, tremor, gait disorders and problems with balance. Early in the course of the disease, these motor symptoms of Parkinson's disease are effectively treated by dopamine replacement with the use of levodopa or dopamine D2 receptor agonists or monoamine oxidase B inhibitors. However, as the disease progresses, these agents become less effective in controlling motor symptoms and PD-LID often emerges.

        PD-LID is involuntary movement that may affect any body area, including the face, trunk or limbs. Oral levodopa is currently the most effective treatment available for motor symptoms associated with Parkinson's disease. However, long term levodopa use is often associated with the development of dyskinesia, which may be as disabling as the symptoms of Parkinson's disease.

        Dyskinesias are comprised principally of two types of movement: chorea, which is a rapid uncontrolled movement, and dystonia, which is a slow, often painful, writhing movement.

        Even though levodopa provides more effective motor symptom control than other currently available therapies, physicians tend to delay use of levodopa use for as long as possible, using dopamine agonists or monoamine oxidase B inhibitors in the early stages of the disease, due to the

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inexorable onset of dyskinesia onset with levodopa use. Dopamine agonists and monoamine oxidase B inhibitors become less effective as Parkinson's disease progresses and are associated with dose limiting side effects, including Impulse Control Disorders, or ICDs, such as pathological addictions to gambling, shopping, eating or sex.

        The occurrence of PD-LID is linked to the neurodegenerative process of PD and is not solely related to the duration of dopamine replacement therapy. For instance, in severe advanced stage Parkinson's disease patients, dyskinesia can be provoked after a first high dose of levodopa. Chronic or high dose dopamine replacement treatments alone do not lead to dyskinesia, but may lower the threshold for dyskinesia occurrence following dosing, as neurodegeneration progresses. Efforts to reduce the use of high doses of levodopa or dopamine agonists, by using more frequent lower doses or extended release formulations, can improve dyskinesias but may be at the expense of optimal motor function. In the later stages of Parkinson's disease, the patient and physician have to juggle good motor symptom control against the occurrence of levodopa-induced dyskinesia.

        If dyskinesia could be effectively treated, or even delayed or eliminated, it is likely that doctors would use levodopa earlier in the treatment of Parkinson's disease. Currently available therapies, such as amantadine and Deep Brain Stimulation, or DBS surgery, often have limited effectiveness or tolerance in patients. The response of patients varies widely to amantadine, which in its generic form is commonly used off label to treat dyskinesia. Typically, amantadine only works for some, if any, dyskinesias suffered by a patient. Amantadine often has side effects which may limit its use, and some patients do not tolerate it at all. Some of the more common side effects of amantadine include blurred vision, digestive issues, postural hypotension, dizziness, falls, ankle oedema, drowsiness, trouble sleeping, depression and psychotic symptoms. DBS surgery, a non-pharmacological treatment strategy, is used primarily for patients whose symptoms cannot be satisfactorily controlled with medications. Patients experience varied results with DBS surgery, and even patients who experience better motor symptom control with DBS surgery may have continued symptoms of dyskinesia. Further, many patients are unwilling to undergo DBS surgery, since it is a costly, invasive surgical procedure that could result in complications.

Figure 1: Pharmacokinetic profile of Dipraglurant and L-Dopa in Humans

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        The rapid absorption and relatively short half-life of dipraglurant in the current immediate-release, or IR, formulation are thought to be well suited for use in LID. The pharmacokinetic, or PK, profile of dipraglurant (IR) mirrors that of levodopa with peak plasma concentration occurring around the same time as that of levodopa and the duration of plasma exposure covering that of the "On" period (the time when levodopa is having its effect, Figure 1). Dyskinesia occurs predominantly during the period immediately following levodopa dosing; troublesome peak-dose dyskinesia (dyskinesia which severely interferes with the patient's daily activity) usually appears as levodopa reaches Cmax and parallels the period of maximal clinical benefit. Based on its similar PK profile, dipraglurant is expected to optimally inhibit the abnormal glutamate stimulation during peak levodopa dose, while releasing the receptor during normal activity. Furthermore, dipraglurant will wash out between doses, releasing the mGlu5 receptor when not required, i.e. when levodopa has worn off.

Dipraglurant completed Phase 2a PD-LID clinical trial

        We evaluated the efficacy, safety and tolerability of dipraglurant at 50 and 100 mg in a Phase 2a proof-of-concept four weeks, randomized, double-blind, placebo-controlled, parallel-group out-patient clinical trial in 76 patients with Parkinson's disease (dipraglurant n = 52, placebo n = 24) with moderate or severe LID. The study was conducted in 25 centers in the United States, France, Germany and Austria. The severity of LID was evaluated by both clinicians and the patients using the modified Abnormal Involuntary Movement Scale, or mAIMS, patient diaries and the patient global impression of change, or PGIC, and the clinician global impression of change, or CGIC, for both dyskinesia and motor symptoms of Parkinson's disease. Motor symptoms of Parkinson's disease were assessed using the Unified Parkinson Disease Rating Scale, or UPDRS.

        The Phase 2a proof of concept clinical trial of dipraglurant in PD-LID met its primary end point, was generally well tolerated and no clinically significant abnormalities of safety monitoring parameters occurred. In addition, dipraglurant showed statistically significant effects on PD-LID as measured using mAIMS at Day 1 and Day 14. However, an increasing placebo response resulted in the effect of dipraglurant on PD-LID symptoms not showing statistical significance at Day 28.

Figure 2: Dipraglurant Phase 2a PD-LID clinical trial design

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Figure 3: Dipraglurant Phase 2a PD-LID clinical trial dosing schedule

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        Patients were randomized to receive either active or placebo treatment at a 2:1 ratio. A blinded dose-titration regimen was employed over the first 3 weeks of treatment. Following the initial intake of a single capsule containing 50 mg or matching placebo, dose and dosing frequency were progressively escalated up to the target regimen of 100 mg tid (total daily dose of 300 mg) beginning on Day 22; the up-titration scheme was customizable based on tolerability. Dyskinesia was measured using the mAIMS at the mid-day does of dipraglurant and L-dopa on Day 1, 14 and 28. Due to the short half-life of dipraglurant the acute effect of 50mg dose was measured on Day 1 and the acute effect of 100mg dose was measure on Day 14 and Day 28.

Outcome Measures

        The primary objective of the study was safety and tolerability. This was assessed based on vital signs, physical and neurological examination, electrocardiogram, or ECG, laboratory tests, and AE monitoring.

        Secondary efficacy outcome measures included the mAIMS, UPDRS and patient diaries.

        The main efficacy endpoint was severity of dyskinesia determined with mAIMS for dyskinesia in face, neck, trunk, and each of the upper and lower limbs. At screening, patients had to specify a dose of levodopa between 10.30 am and 3.30 pm that was regularly associated with moderate to severe dyskinesia. As severity of dyskinesia generally correlates with the plasma concentration of levodopa (peak dose dyskinesia) and as Tmax of dipraglurant is comparable, study medication was to be taken within 15 minutes prior to levodopa. Dyskinesia following this midday dose was assessed by the mAIMS on Days 0, 1, 14 and 28.

Figure 4: MMRM analysis of the effect of dipraglurant on the peak mAIMS score reported as reduction from baseline

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        The above figure shows the effect of dipraglurant on dyskinesia as measured using the mAIMS at Day 1, 14 and 28. Dipraglurant reduced dyskinesia compared to placebo at all visits over the 28 days and showed statistically significant effects at Day 1 and 14 as well as improvements of ³30% at Day 14 which were sustained through Day 28. The level of improvement with dipraglurant at each time point and Day 28 was about twice that of placebo. However, an increasing placebo response resulted in the effect of dipraglurant on PD-LID symptoms not showing statistical significance at Day 28. We believe the dose titration technique employed along with the 2:1 randomization of active to placebo, as well as the fact that placebo-mitigating techniques were not deployed in the study, contributed to the placebo response.

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Figure 5: Dipraglurant cumulative % of PD-LID patients showing > 30% change of peak mAIMS from baseline

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        Responders were defined as those patients reaching at least 30% improvement in peak mAIMS scores compared to baseline. At all visits, the percentage of responders was higher in the dipraglurant-treated group than in the placebo group and, on Days 14 and 28, exceeded 50% and showed a statistically significant difference over placebo.

Figure 6: Clinician rated global impression of change in LID patients after administration of dipraglurant and placebo

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        There was a significant improvement in the CGI-C as determined by the investigators. Figure 6 summarizes the results across each score level and for each treatment group at Day 28. The CGIC for improvement of dyskinesia was assessed by the investigating physician at Day 28 compared to baseline. The dipraglurant group improved by 71.2% versus 49.9% for the placebo group at Day 28 (p < 0.05).

Other Secondary Measures of Efficacy

Dipraglurant did not worsen motor control

        UPDRS Part III scores in the post-levodopa dosing period did not differ between treatment groups. There was no evidence that dipraglurant led to increased parkinsonism or "Off" periods. This was an expected result given the mechanism of action, but was important to establish, as it confirms that the anti-dyskinetic benefits observed with treatment did not come at the cost of worsened motor control.

Patient reported effects on PD motor symptoms and dyskinesia—diary data

        Mean daily "Off" time tended to decrease in each treatment group in weeks 1, 2 and 3, but at week 4, "Off" time decreased by about 50 minutes per day in the dipraglurant group versus an increase of about 9 minutes in the placebo group. Although, the week 4 difference was not statistically significant, or NSS (the study was not powered to detect such changes), it remains interesting and suggests the potential for additional benefits of treatment in this patient population.

Figure 7. Pattern of motor complications of dipraglurant group patients over the course of a day, as reported in patients' diaries—baseline versus week 4

Baseline

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Week 4

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        The mean daily percentage of time in "On" with no dyskinesia increased in both treatment groups. At week 4, the dipraglurant group showed a 2.28 hours increase compared to 1.78 hours for the placebo group (NSS).

        Overall, there were more patients in the dipraglurant group who reported "On" time without (w/o) dyskinesia and fewer patients reporting "On" time with dyskinesia (Figure 7). In this analysis, dipraglurant treatment improved the percentage of patients in "On" time without LID from morning to late afternoon.

Safety and Tolerability Data

        This first study in PD patients met its primary objective and generally demonstrated tolerability for dipraglurant taken at doses of up to 100 mg tid for 4 weeks. The types of adverse events, or AEs, observed in PD patients up to 75 years of age were generally similar to those seen in healthy normal subjects. Fifty-two patients were exposed to the study drug vs. 24 patients on placebo.

        The overall incidence of treatment emergent adverse events, or TEAEs, for the 4-week treatment period was 88.5% for the dipraglurant group compared to 75% for placebo. As doses increased over the titration period, an increase in AE incidence was observed. In Weeks 1 and 2, AE incidence was 53.8% for patients receiving dipraglurant 50 mg vs. 58.3% for placebo and, in Weeks 3 and 4, it was 73.1% for dipraglurant 100 mg vs. 62.5% for placebo. In both treatment groups, AEs occurred most commonly in the central nervous system (51.9% dipraglurant vs. 45.8% placebo).

        The only significantly increased event compared to placebo was nausea. Although dyskinesia or worsening of dyskinesia was reported more frequently for dipraglurant than for placebo (n=11 vs. 3; 21.2% vs. 12.5%), there was no pattern to these reports and most were transient. In addition, 3 of the 11 patients who reported worsening dyskinesia in the treated group did so only in the follow-up period (i.e. when not taking the drug), thus the dyskinesia recurred only after therapy had stopped. Therefore, the adjusted AE% was similar, 15.3% for dipraglurant vs. 12.5% for placebo.

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        Two patients withdrew due to TEAEs. Both were in the dipraglurant group at the 100 mg dose level.

        Only one SAE occurred in the dipraglurant group, and, as it occurred 2 days after the end of treatment, it was considered unrelated to study medication.

        Clinical laboratory tests in the study (biochemistry, hematology and urinalysis) did not show any relevant differences, neither over time nor between groups. There were no clinically significant ECG changes that occurred in the study in patients receiving dipraglurant.

Dipraglurant clinical development plan—registration program in PD-LID

        The pivotal program for LID currently comprises two placebo-controlled studies that are intended to support registration. The 100 mg tid dose of dipraglurant will be evaluated versus placebo in both studies, as it showed a significant reduction in LID symptoms at Day 1 and Day 14, in the earlier in the earlier POC clinical trial, the drug was also generally well tolerated and no clinically significant abnormalities of safety monitoring parameters occurred. Following successful completion of the first Phase 2b/3 pivotal clinical trial, an End of Phase 2, or EOP2, meeting with the FDA will be planned to obtain agreement on the final design of a confirmatory Phase 3 clinical trial and any remaining elements of the registration program.

Dipraglurant Phase 2b/3 pivotal clinical trial in PD-LID patients—Study 301

        We have substantially completed preparation to start registration studies in PD-LID and expect to initiate a double-blind, placebo-controlled, parallel group design Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients in the first quarter of 2020. The study will be conducted at approximately 50 sites in the United States and will target enrollment of approximately 140 patients. Furthermore, the primary endpoint will be efficacy in reducing PD-LID measured as the change over time in Unified Dyskinesia Rating Scale, or UDysRS at week 12 compared to baseline. We expect to report data in the third quarter of 2021.

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Figure 8: Design of dipraglurant PD-LID Phase 2b/3 study 301 clinical trial

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        The study will enroll patients 30-85 years of age with PD and clinically relevant LID. At screening, LID severity will be assessed to determine eligibility using the UDysRS and the Movement Disorder Society Unified Parkinson's Rating Scales (MDS-UPDRS) in order to ensure that only patients with moderate to severe LID are included in the study. During the screening period, patients will receive Brief Psychosocial Therapy adapted for dyskinesia, or BPST-Dys. This is a structured intervention, directed by trained site-staff, BPST has been demonstrated to reduce anxiety associated with neurodegenerative disease including PD. The aim is to ensure that any anxiety overlay is reduced before patients enter the randomized period of the study such that the baseline symptom severity is more reflective of the condition itself. At the baseline visit, the severity of LID symptoms will be reassessed using the UDysRS, the MDS-UPDRS and PD diary entries to confirm that the patient continues to meet the study entry criteria. Subjects who have improved during the screening period and do not meet the inclusion criteria at their baseline visit will be excluded prior to randomization. Although this may result in a higher screen-failure rate, it is intended to reduce placebo response and ensure that patients randomized to study require pharmacologic treatment for their condition.

        All PD medications will be required to be stable prior to screening and remain so during the course of the study.

        Following completion of the 12-week randomized study, patients who choose to do so will be allowed to enroll in a separate open label safety study, or OLS, if the investigator considers it to be of benefit.

        Objectives and endpoints.    The key objectives of the study are to evaluate the efficacy and safety of dipraglurant in reducing dyskinesia symptoms in PD patients with LID without worsening of the Parkinson's disease. The primary and secondary endpoints that are currently planned in the protocol include the following:

        Primary Endpoint.    Change in the Unified Dyskinesia Rating Scale (UDysRS) total score from baseline to week 12.

Key Secondary Endpoints—Efficacy

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Safety Assessments

        Safety measures will be assessed during the course of the study and during a one week follow-up period for those patients not electing to enter the open-label study.

UDysRS, the Primary Endpoint

        In this study, the primary endpoint will be the UDysRS. The UDysRS was the endpoint that was used in the Gocovri pivotal studies leading to the drug's FDA approval for PD Dyskinesia. Of all the scales used for assessing dyskinesia, only the UDysRS contains anchored, clinician-evaluated measures of dyskinesia. In this scale, patients perform 4 tasks, and raters evaluate dyskinesia severity and disability for each. Although this rating measure incorporates the concepts of the mAIMS, the UDysRS has the advantage of consolidating both patient-based perceptions of disability and objective rater-based assessments of impairment and disability (Goetz et al., Mov Disord 2008).

Placebo-minimization procedures

        A number of factors may have contributed to the high placebo response in the Phase 2a POC study. A number of steps will therefore be taken in the pivotal studies to curb excessive placebo response, reduce variability and therefore enable a more precise estimate of treatment effect of dipraglurant in the treatment of LID:

Dipraglurant confirmatory Phase 3 pivotal clinical trial in PD-LID patients—Study 303

        The confirmatory Phase 3 study will also be a two-arm double-blind, placebo-controlled, parallel group design comparing 100 mg dipraglurant versus placebo in PD patients with LID. Treatment will be over a 6 month period to meet FDA requirements. The Phase 3 trial will follow a similar study design to the Phase 2b/3 pivotal clinical trial. Although the treatment duration will be 24 weeks in total, the primary endpoint will remain the change in UDysRS total score from baseline to week 12. The 24 week UDysRS score will evaluate maintenance of effect as a secondary endpoint. At the completion of the study, eligible patients will have the option of rolling into the ongoing OLS study, if the investigator considers it to be of benefit.

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Dipraglurant in PD motor symptoms

        There is an increasing body of literature that suggests that inhibiting mGlu5 in the striatopallidal pathway may also improve the motor symptoms of PD and may also prevent excitotoxic damage to the substantia nigra. Dipraglurant was investigated in the haloperidol induced catalepsy (HIC) model, an animal model of Parkinson's disease. Haloperidol is an antagonist of the dopamine D2 receptor and overcoming the catalepsy (immobility) induced by haloperidol administration is suggestive of antiparkinsonian activity and may also have relevance for other movement disorders, such as tardive dyskinesia and dystonia, where reduced activity of dopamine D2 receptors is implicated. In the rat HIC model, dipraglurant reduced the amount of time rats were immobile, in a dose dependent manner. The effective plasma concentration was similar to that for the treatment of dyskinesia in the MPTP macaque and that which was seen to be effective in PD-LID patients. The suggestion of antiparkinsonian activity was also supported by observations in the Phase 2a clinical trial. In week 4 of treatment, patients reported an average "Off" time reduction of 50 minutes per day. Also, both patients and clinicians reported improvements in PD symptoms compared to placebo. Although none of these results were statistically significant, the observations were interesting and were noted by the PD experts who took part in the trials. PD motor symptom effects will continue to be evaluated in the larger pivotal clinical trials.

Dipraglurant in PD non-motor symptoms

        As well as suffering from difficulty with poor and uncontrolled motor symptoms, PD patients also suffer from a wide variety of non-motor symptoms. Among these are affective disorders (e.g., anxiety, depression and anhedonia) and compulsive behavioral disorders (e.g., sex, alcohol, gambling, and shopping addiction). These compulsive behaviors are particularly linked to treatment with dopamine agonists and more specifically to those which act on the dopamine D3 receptor as well as D2 (e.g. pramipexole). Inhibition of mGlu5 is pre-clinically and clinically validated for the treatment of anxiety and depression, although no mGlu5 inhibitors are yet marketed for these indications. Also, inhibition of mGlu5 has been shown to have anti-addictive properties in a number of animal models, including cocaine self-administration in rats. These data suggest that mGlu5 inhibition may potentially have utility in treating certain non-motor symptoms of PD.

Dipraglurant for the treatment of non-Parkinsonian dystonia

        Dystonia is a movement disorder that causes the muscles to contract and spasm involuntarily. There are about 500,000 people with one or other form of dystonia in North America. The involuntary muscle contractions force the body into repetitive and often twisting movements as well as awkward, irregular, sometimes painful postures. Dystonia aetiologies and symptoms are heterogenous. There are approximately 23 forms of dystonia, and dozens of diseases and conditions include dystonia as a major symptom. Dystonia may affect a single body area (focal), multiple areas (segmental) or be generalized throughout multiple muscle groups. Further, dystonias are distinguished as either primary, with idiopathic or genetic causes, or secondary, induced by drugs or toxins. A number of types of dystonia are classified as rare, including cervical dystonia, DYT1 familial generalized dystonia or X-linked dystonia parkinsonism. It is estimated that over 30% of PD patients experience dystonia as a symptom or a complication of treatment.

        Dystonia affects people of all ages and backgrounds. Dystonia causes varying degrees of disability and pain, from mild to severe. Presently, there is no cure for dystonia. Doctors often prescribe drugs for the treatment of dystonia off-label, i.e., drugs that have not been approved for the indication being treated. Since these drugs have not been approved for the treatment of dystonia, they have not undergone rigorous clinical trials for the indication.

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        Current therapies include oral drugs such as anticholinergic agents, dopamine receptor agonists/antagonists and baclofen. The efficacy of these drugs is marginal and side effects further limit compliance and usage. The only available indicated treatment is botulinum toxin injections, which are only suitable for focal or segmental dystonia treatment. In addition, Deep Brain Stimulation, or DBS, surgery is sometimes used for both focal and generalized refractory dystonia. However, for both of these approaches, patients are left with inadequate response, and therefore a need exists for an oral, safe and effective treatment for dystonia.

        Initial data from the testing of dipraglurant in the MPTP macaque model of LID and a small subset of patients in the Phase 2a clinical trial of dipraglurant in patients with PD-LID suggest that dipraglurant may have a role in treating dystonia. In the MPTP macaque model of LID, dipraglurant reduced dystonia following levodopa administration to the same extent as chorea. We are currently evaluating dipraglurant in preclinical models of dystonia.

Externally Developed Out-licensed Product Candidate

ADX71149 for the treatment of Epilepsy

        Epilepsy is one of the most common serious neurological disorders affecting about 65 million people globally (Thurman et al. 2011). It affects 1% of the population by age 20 and 3% of the population by age 75 (Holmes et al. 2008). Epilepsy describes a condition in which a person has recurrent seizures due to a chronic, underlying process. Epilepsy refers to a clinical phenomenon rather than a single disease entity, since there are many forms and causes. Epilepsy is defined by any of the following conditions: (1) at least two unprovoked (or reflex) seizures occurring >24 h apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome (Fisher et al. 2014). The synaptic vesicle protein 2A (SV2A) has been identified as a broad spectrum anti-convulsant target in models of partial and generalized epilepsy, and studies in animal models and human tissue suggest that changes in the expression of SV2A are implicated in epilepsy (Mendoza-Torreblanca et al. 2013; Kaminski et al. 2012). SV2A ligands include levetiracetam (Lynch et al. 2004), which is an anti-epileptic drug commercialized under trademark Keppra®, which is approved in Europe and the USA as a monotherapy or add-on therapy in patients diagnosed with epilepsy.

        Our partnered drug candidate ADX71149 is a novel orally active mGlu2 PAM. Our partner, Janssen, has completed Phase 1 and two Phase 2a clinical trials in schizophrenia and anxious depression, respectively. Janssen has announced that ADX71149 has been extensively profiled in preclinical models of epilepsy showing both standalone activity and in combination with SV2A ligands including levetiracetam (a commercialized antiepileptic drug). Janssen has patented the combination of mGlu2 PAM with SV2A ligands for the treatment of epilepsy and is currently evaluating the development path forward for ADX71149. Epilepsy is an indication with a large commercial opportunity. Existing therapies frequently provide ineffective control of symptoms or have side effects that discourage adherence. We believe that, subject to regulatory approval, ADX71149 may provide a substantial benefit to patients. Under our agreement with Janssen, Janssen is responsible for, including the financing of, development and commercialization, if any, of ADX71149.

Material Internal Research Programs

GABAB PAM

        Activation of the GABAB, receptor, a Family C class of GPCR, is clinically and commercially validated. Generic GABAB receptor agonist, baclofen, also known as chlorophenibut, is marketed for spasticity and some spinal cord injuries, and used for overactive bladder, or OAB, but is not commonly used due to a variety of side effects of the drug and its rapid clearance. Researchers have shown that

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baclofen is effective in reducing drug self-administration, cravings, and anxiety, and thus promotes abstinence.

        Our GABAB PAM drug candidates are novel, orally available, small molecules that have demonstrated positive effects and tolerability in several preclinical rodent models of pain, anxiety, addiction and OAB and have also shown activity in a genetic model of CMT1A. A GABAB PAM differs from the generic drug baclofen in that it is a PAM rather than an orthosteric agonist at the GABAB receptor. The GABAB PAM only acts when the natural ligand (GABA) activates the receptor, and therefore respecting the physiological cycle of activation. It has been proposed that PAMs produce fewer adverse effects and lead to less tolerance to effect than direct agonists (May and Christopoulos 2003; Langmead and Christopoulos 2006; Perdona et al. 2011; Urwyler 2011; Gjoni et al., 2008; Ahnaou et al).

GABAB PAM for the treatment of addiction

        Our Partner, Indivior, has licensed worldwide rights to our GABAB PAM program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidates. Under the agreement, we are responsible for executing a research program funded by Indivior to discover novel drug candidates. Indivior has the right to select GABAB PAM drug candidates from our research program and we expect to deliver drug candidates by the end of 2020. Addiction is an indication with a significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. Subject to regulatory approval, we believe that GABAB PAM offers an innovative and differentiated treatment approach from existing therapies and may be of substantial benefit to patients.

        Scientific advances have revolutionized our understanding of addiction as a chronic, relapsing disease and not a moral failure. Drug addiction is a complex illness which is characterized by intense and, at times, uncontrollable drug craving, along with compulsive drug seeking and use that persist even in the face of devastating consequences. Addiction affects multiple brain circuits, including those involved in reward and motivation, learning and memory, and inhibitory control over behavior. While a person initially chooses to take drugs, over time the effects of prolonged exposure on brain functioning compromise the ability to choose, and seeking and consuming the drug become compulsive, often eluding a person's self-control or willpower. Because drug abuse and addiction have so many dimensions and disrupt so many aspects of an individual's life, treatment is not simple. Addiction treatment must help the individual stop using drugs, maintain a drug-free lifestyle, and achieve productive functioning in the family, at work and in society. Patients typically require long-term or repeated episodes of care to achieve the ultimate goal of sustained abstinence and recovery of their lives.

GABAB PAM for the treatment of CMT1A

        Our license agreement with Indivior provides for a funded research program, under which we have the right to select drug candidates for exclusive development in certain indications outside of addiction, including CMT1A, a rare disease indication. We plan to pursue orphan drug designation for a selected drug candidate in CMT1A. Subject to regulatory approval, believe an oral small molecule GABAB PAM without the adherence-limiting side effects of baclofen and with a once-a-day dosing could bring benefit to patients and consequently present a strong commercial opportunity for us. Our GABAB PAM compounds have demonstrated the potential role of this mechanism in CMT1A and we plan to complete lead optimization and select a clinical candidate for this indication.

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        Charcot-Marie-Tooth disease, previously classified as a subtype of muscular dystrophy, is a rare hereditary motor and sensory neuropathy, or HMSN, which causes demyelination of the peripheral nerves. The disease leads to damage or destruction to the myelin sheath covering nerve fibers. The nerve fibers most severely affected are those that stimulate movement, with the nerves in the legs being affected first and most severely. Similar symptoms may appear in the arms and hands, which may include a claw- like hand.

        The disease is very impactful for patients due to the neurological pain and muscular disability. A combination of lower motor neuron-type motor deficits and sensory symptoms are observed, and paresis and muscle atrophy develop with areflexia. The chronic nature of the motor neuropathy commonly results in foot deformity, hammertoes, very high-arched feet, loss of lower leg musculature, resulting in skinny calves, numbness of the foot or leg, "slapping" gait (feet hit the floor hard when walking), foot drop (inability to hold foot horizontal) and weakness of the hips, legs or feet. Involvement of the hands may follow as the disease progresses. Signs of sensory system dysfunction are common and include loss of vibration and joint position sense followed by decreased pain and temperature sensation. Onset of CMT1A occurs between age 5 and 25 years, with a prevalence of 1 in 5,000. There are no known cures for this debilitating condition. Current therapies are primarily symptomatic, such as physiotherapy.

        We expect to select a drug candidate for development by the end of 2020.

mGlu7 NAM

        The mGlu7 receptor, is a class C GPCR and is the most highly conserved of all mGlu subtypes, exhibiting the widest distribution in the brain. It is localized pre-synaptically at a broad range of glutamatergic and GABAergic synapses and is thought to be one of the most important mGlu subtypes in regulating CNS function.

mGlu7 NAM for the treatment of PTSD

        Preclinical data suggest that mGlu7 antagonism could alleviate stress-related anxiety and depressive symptoms and deficits in amygdala-dependent behaviors (fear response and conditioned taste aversion). These data are consistent with the abundant localization of mGlu7 in brain regions involved in the control of fear and emotion supporting the potential use of mGlu7 NAM for the treatment of PTSD.

        PTSD is a serious anxiety disorder that can occur in people who have experienced or witnessed a traumatic event such as a natural disaster, a serious accident, a terrorist act, war/combat, rape or other violent personal assault. PTSD can occur in all people, in people of any ethnicity, nationality or culture, and any age. PTSD affects approximately 3.5 percent of U.S. adults, and an estimated one in 11 people will be diagnosed with PTSD in their lifetime. Women are twice as likely as men to have PTSD. People with PTSD have intense, disturbing thoughts and feelings related to their experience that last long after the traumatic event has ended. They may relive the event through flashbacks or nightmares; they may feel sadness, fear or anger; and they may feel detached or estranged from other people. People with PTSD may avoid situations or people that remind them of the traumatic event, and they may have strong negative reactions to something as ordinary as a loud noise or an accidental touch.

        Current treatments are primarily based on psychotherapy, as medication is nonspecific and usually ineffective, often with a number of side effects.

        We are developing mGlu7 NAM as a novel orally available treatment to reduce fear memory in PTSD. By selectively targeting mGlu7 with NAMs, the brain circuitries involved in fear and anxiety can be more precisely modulated, potentially resulting in higher efficacy and fewer side effects. Subject to regulatory approval, we believe the mGlu7 NAM may offer an innovative and differentiated treatment approach from existing therapies. We are in late lead optimization and a consortium led by us has been

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awarded a €4.85 million grant from the Eurostars Joint Programme, to advance the program to drug candidate stage.

Internal Early Stage Research Programs

mGlu2 NAM

        The mGlu2 receptor, is a class C GPCR and is broadly distributed throughout the cortex as well as highly expressed in the hippocampus and perforant path. Activation of mGlu2 leads to inhibition of glutamate release in the synapse and therefore mGlu2 NAM has the potential to treat medical conditions linked to lowered glutamate levels in the brain via restoration of a normalized glutamatergic tone such as cognitive impairment in Alzheimer's disease and depression.

mGlu2 NAM for the treatment of mild neurocognitive disorders

        mGlu2 NAM is one of the most promising experimental therapeutic strategies for the treatment of mNCD. Our mGlu2 NAM has been tested in the beta amyloid-induced memory impairment model in rodents which mimics aspects of pathophysiology and progressive memory impairment observed in Alzheimer's disease or, AD. In this study, our mGlu2 NAM dose-dependently reversed working memory impairment in the novel object recognition test, without affecting locomotor activity. Donepezil, a marketed drug currently used to treat symptoms of AD, was used as the positive control and the magnitude of the effect induced by the mGlu2 NAM was similar to that of donepezil. Preclinical research from other groups suggest not only that mGlu2 NAM might slow the progression of AD, an effect not seen with any marketed drug, but also that it may have a synergistic effect on cognition when combined with donepezil.

        We are currently optimizing multiple chemical series of highly selective, orally active mGlu2 NAMs offering advanced compounds at the late stage of lead optimization.

mGlu4 PAM

        The mGlu4 receptor, is a class C GPCR and is expressed primarily on presynaptic terminals, functioning as an autoreceptor or heteroceptor with its activation leading to decreases in neurotransmitter release from presynaptic terminals. The mGlu4 is uniquely distributed in key brain regions involved in multiple CNS disorders. In particular, mGlu4 is abundant in striato-pallidal synapses and on the subthalamo-nigral projections within the basal ganglia circuitry, a key area implicated in movement disorders, like Parkinson's disease.

mGlu4 PAM for the treatment of Parkinson's disease

        Parkinson's disease (PD) is a progressive neurodegenerative disorder that is caused by loss of dopaminergic neurons in the basal ganglia, the brain center for movement initiation and coordination. mGlu4 receptors are strategically localized to counteract neurotransmitter imbalance and restore motor behavior in patients.

        Parkinson's disease is characterized by motor symptoms such as slowness in initiating and executing movements (akinesia and bradykinesia, respectively), muscular rigidity, resting tremor, postural instability, gait dysfunction and freezing. These symptoms are caused by the degeneration of dopaminergic neurons in the substantia nigra and depletion of dopamine in the striatum. Actually, in a healthy brain, there is a balance between the direct and indirect pathways of the basal ganglia. The direct pathway stimulates the initiation of movements through an activation of the thalamocortical neurons. By contrast, the indirect pathway leads to the inhibition of the thalamocortical neurons, and subsequently inhibition of movements. These two pathways are modulated by the dopaminergic neurons from the substantia nigra, that activate the direct pathway and inhibit the indirect pathway. In PD,

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these dopaminergic neurons degenerate, and dopamine loss in the striatum leads to an over-stimulation of glutamate transmission at the subthalamo-nigral synapses, and then an over-inhibition of the thalamocortical neurons. The ability to carry out voluntary movements is impaired, and this leads to the motor symptoms of PD.

        Current treatments are aimed at replacing dopamine or mimicking its effects by chronically administering patients with the dopamine precursor L-DOPA, inhibitors of dopamine catabolic enzymes or direct dopamine receptor agonists. Although these treatments provide good symptomatic relief in the early to middle stages of PD, they lose their efficacy as the disease progresses and their chronic administration is associated with invalidating side effects (dyskinesia, motor fluctuations, behavior disturbances). Finally, no PD therapies have demonstrated neuroprotection and delaying disease progression. Therefore, new treatments are required for PD that target the neurochemical systems downstream dopamine itself in the basal ganglia.

        By decreasing GABAergic and glutamatergic transmission in the indirect pathway, mGlu4 activation is expected to restore the equilibrium between the direct and indirect pathways, and then to restore motor behaviors in PD. This has been demonstrated in animal models, including the MPTP monkey model. Several studies in animal models have demonstrated that this strategy is promising for the treatment of motor and non-motor symptoms of PD, as well as for disease modification. In the immune system mGlu4 has been found on dendritic cells. Emerging data implicate mGlu4 in several indications such as multiple sclerosis, Parkinson's disease, anxiety, neuropathic and inflammatory pain, schizophrenia, autism and diabetes.

        We are developing mGlu4 PAM as a novel orally available treatment for PD. Lundbeck are currently testing Foliglurax, an mGlu4 PAM in a Phase 2 POC study. Subject to regulatory approval, we believe our mGlu4 PAM program may offer an innovative and differentiated treatment approach from existing therapies.

mGlu3 PAM

        The mGlu3 receptor, is a class C GPCR involved in modulation of glutamatergic neurotransmission. Expression of mGlu3 receptors is high in pyramidal cells in the prefrontal cortex and neocortical regions, as well as in astrocytes and oligodendrocytes. So far, industry has only found orthosteric compounds that act as mGlu3 receptor agonists or antagonists. All of these compounds suffer from poor selectivity and have activity on other mGlu receptors, and in particular the mGlu2 receptor. Targeting the allosteric site of the mGlu3 receptor provides a unique approach to find subtype selective compounds and will allow a focused strategy to modulate specifically those pathways involving the mGlu3 receptor.

mGlu3 PAM for the treatment of neurodegeneration

        Scientific evidence suggests astroglial mGlu3 receptor activation leads to neuroprotection, through modulation of glutamate excitotoxicity and glutamate transport, neurotrophin production and reduction of oxidative damage. This points to the potential utility of mGlu3 PAMs for neurodegenerative disease such as Alzheimer's or Parkinson's diseases.

        We are currently optimizing multiple chemical series of highly selective, orally active mGlu3 PAMs offering compounds at the lead optimization stage.

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Material agreements

Collaboration Agreement with Indivior for Development of novel GABAB PAM Compounds, including for the Treatment of Addiction and Other CNS Diseases

        In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.

        Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

        Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including Charcot-Marie-Tooth type 1A neuropathy, or CMT1A. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

        Under terms of the agreement, we received a non-refundable upfront fee of $5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. In addition, we are eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling $330 million. In addition, we are eligible for a royalty in the low teens on net sales of applicable products on a country-by country-basis. On February 14th, 2019, Indivior terminated the development of their selected compound, ADX71441.

        Separately, Indivior funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term and duration of two years, that can be extended by twelve-month increments and a minimum annual funding of $2 million for the Addex R&D costs incurred. Following Indivior's selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. On October 7, 2019, Indivior agreed an additional research funding of $0.8 million for the research period.

        Indivior may terminate the Agreement in its entirety or with respect to one or more countries or products upon 90 days' prior written notice prior to receipt of marketing approval for product candidates or twelve months' prior written notice after the receipt of marketing approval.

        Addex may terminate the agreement if Indivior commits a material breach of the agreement and fails to cure such breach within 90 days of Addex's written notification to Indivior or fails to cure breaches to any payment obligations breach within 30 days.

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Collaboration Agreement with Janssen for Development of Novel mGlu2 PAM Compounds, including ADX71149, for the Treatment of CNS and Related Diseases

        On December 31, 2004, we entered into a collaboration and license agreement with Janssen Pharmaceuticals Inc., or Janssen, for the discovery, development and commercialization of novel mGlu2 PAM compounds for the treatment of CNS and related diseases. We agreed with Janssen to an initial research term and duration of two years that can be extended if parties mutually agree thereto in writing. The agreement was not extended. ADX71149 is one of the drug candidates discovered and selected for development by Janssen under the agreement. In 2012, Janssen announced completion of a Phase 2a clinical trial in Europe with ADX71149 for the treatment of schizophrenia demonstrating proof of principal in patients with negative symptoms of schizophrenia, such as apathy, social withdrawal, loss of emotional expression or sleep disorders. Janssen also conducted a Phase 2a clinical trial with ADX71149 for the treatment of patients with anxious depression, which failed to show statistically significant effects. In addition, Janssen announced in 2015 that ADX71149 demonstrated synergies with levetiracetam (a globally commercialized antiepileptic drug) in preclinical models of epilepsy.

        Under our agreement with Janssen, we have granted Janssen an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Janssen under the agreement and a non-exclusive worldwide license to conduct research on the collaboration compounds using relevant patents and know-how. Subject to certain conditions, we and Janssen own, jointly, all intellectual property rights that we and Janssen develop jointly, and we or Janssen own all intellectual property rights that we or Janssen develop individually. Under certain conditions, but subject to certain consequences, Janssen may terminate the agreement for any reason, subject to a 90-day notice period.

        Janssen has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Janssen has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Janssen. However, Janssen has authority over all aspects of the development of selected compounds and may develop or commercialize third-party compounds with a different mechanism of action for identical use.

        Under the terms of the Janssen agreement, we received an upfront fee of CHF 4.6 million and research funding of CHF 6.4 million during the research period, which ran from 2005 to 2007. In addition, we are eligible for payments on successful achievement of pre-specified clinical and regulatory milestones. We are also eligible for a royalty in the low teens on net sales of applicable products on a country-by country-basis and on a product by product basis, for a period commencing on the date of first sale and ending upon the latest of the expiration of twelve years from the date of first sale of a product in a given country or the last to expire of our patents containing a claim covering composition of compound comprised in a product sold by Janssen, its affiliates or sublicensees in such country. We received a CHF 1.5 million milestone payment in relation to the entry of ADX71149 into Phase 1 in July 2009 and a CHF 2.6 million milestone payment in relation to the entry of ADX71149 into Phase 2 in June 2011. We are eligible for a further €109 million in success-based development and regulatory milestones and low double digit royalties on net sales.

        In the event that no compounds are discovered or identified during the research period, the agreement shall terminate.

        In the event that there are compounds but no mGlu2 PAM are discovered during the research period or 6 months thereafter, our and Janssen's rights and obligations to develop commercialize, pay

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royalties and milestones on mGlu2 PAM compounds will terminate. The contract also contains termination rights for non-defaulting parties upon breach.

Intellectual Property

Patents and Proprietary Rights

        We own thirteen U.S. and 228 foreign patents and a number of pending patent applications that cover various aspects of our allosteric modulator technologies and discovery platform, including several classes of compounds which are potentially useful as modulators of mGlu5, mGlu2, mGlu4 and GABAB. More specifically, our patents and patent applications cover compounds, pharmaceutical compositions, polymorphs and uses of compounds for medical treatment.

        Our patent strategy is to file patent applications on innovations and improvements to cover a majority of the major pharmaceutical markets in the world. We typically file priority applications at the United Kingdom Patent Office to establish a priority date for the generic subject matter and examples which are available at the filing date of each invention. Subsequently, we file international applications under the Patent Cooperation Treaty or PCT, with extra examples to support the scope of the claims (International Phase). After the International Phase, we file patent applications in selected countries representing potential major markets for our drug candidates (National/Regional Phase).

        Generally, patents have a term of twenty years from the earliest priority date, assuming all maintenance fees are paid. In some instances, patent terms can be increased or decreased, depending on the laws and regulations of the country or jurisdiction that issued the patent. Wherever appropriate and legally possible, we aim at obtaining patent protection for novel molecules, composition of matter and uses for drugs and inventions originating from our research and development efforts, as well as new manufacturing and other processes and formulations. In each case, we carefully balance the value of patent protection against the advantage of keeping the know-how regarding the invention confidential. We aim to position the claims of our applications to exploit gaps in prior art.

        We have two patent families covering dipraglurant as a composition of matter and its polymorphs which are useful as mGlu5 NAMs: 71 patents have been granted to us, including 4 in the United States and 67 in other international jurisdictions (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Armenia, Australia, Azerbaijan, Belarus, Brazil, Canada, China Hong Kong, Indonesia, India, Israel, Japan, Kazakhstan, South Korea, Kyrgyzstan, Moldova, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, Tajikistan and Turkmenistan). We also have 39 patent applications pending.

        We have one patent family covering compounds which are useful as GABAB PAMs, of which 49 patents have been granted, including two in the United States and 47 in other international jurisdictions (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Australia, Azerbaijan, Belarus, Brazil, Canada, China, India, Indonesia, Israel, Japan, Kazakhstan, New Zealand, Russia and South Africa).

        Jointly with Janssen, we have 81 patents in three patent families covering compounds which are useful as mGlu2 PAMs, including ADX71149, which is explicitly exemplified and claimed as a compound and as a pharmaceutical composition, we have five patents in the United States and 86 in other international jurisdictions (Albania, Austria, Belgium, Bosnia & Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, North Macedonia, Turkey, Ukraine, United Kingdom,

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Algeria, Argentina, Australia, Bahrain, Brazil, Canada, China, Chile, Hong Kong, Israel, India, Indonesia, Japan, Kuwait, Republic of Korea, Malaysia, Mexico, New Zealand, Oman, Philippines, Qatar, Russia, Singapore, Saudi Arabia, South Africa, Vietnam, Taiwan, Thailand and United Arab Emirates).

        Furthermore, we have 17 patents in two patent families covering compounds that have potential utility as mGlu4 PAMs, which include two patents granted in the United States and 15 in Europe (Belgium, France, Germany, Great Britain, Hungary, Italy, Spain and Switzerland). One family is owned by us and a second family is jointly owned by us and Merck & Co Inc. pursuant to our collaboration agreement for the development of mGlu4 PAM, which we entered into in 2007. Our granted patents have expiration dates ranging from 2025 to 2034 without extensions.

        The patent positions of pharmaceutical and biotechnology companies are uncertain and involve complex legal and factual issues. There can be no assurance that patents that have been issued will be held valid and enforceable in a court of law. Even for patents that are held valid and enforceable, the legal process associated with obtaining such a judgment is time consuming and costly. Additionally, issued patents can be subject to opposition or other proceedings that can result in the revocation of the patent or maintenance of the patent in amended form, and potentially in a form that renders the patent without commercially relevant or broad coverage. Further, our competitors may be able to circumvent and otherwise design around our patents. Even if a patent is issued and enforceable, because development and commercialization of pharmaceutical products can be subject to substantial delays, patents may expire early and provide only a short period of protection, if any, following the commercialization of a product covered by any of our patents. We may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office, which could result in a loss of the patent or substantial cost to us.

        U.S. and foreign patent rights and other proprietary rights exist that are owned by third parties and relate to pharmaceutical compositions and reagents, medical devices and equipment and methods for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any certainty which, if any, of these rights will be considered relevant to our technology by authorities in the various jurisdictions where such rights exist, nor can we predict with certainty which, if any, of these rights will or may be asserted against us by third parties. We could incur substantial costs in defending ourselves and our partners against any such claims. Furthermore, parties making such claims may be able to obtain injunctive or other equitable relief, which could effectively block our ability to develop or commercialize some or all of our products in the U.S. and abroad and could result in the award of substantial damages. In the event of a claim of infringement, we or our partners may be required to obtain one or more licenses from third parties. There can be no assurance that we can obtain a license to any technology that we determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain alternative technology. The failure to obtain licenses if needed may have a material adverse effect on our business, results of operations and financial condition.

        We also rely on trade secret protection for our confidential and proprietary information. No assurance can be given that we can meaningfully protect our trade secrets. Others may independently develop substantially equivalent confidential and proprietary information or otherwise gain access to, or disclose, our trade secrets. Our success will depend in part on our ability to obtain and maintain patent protection for our drugs, preserve trade secrets, prevent third parties from infringing upon our proprietary rights and operate without infringing upon the proprietary rights of others, both in Switzerland and in other territories worldwide.

        It is our policy to require our employees and consultants, outside scientific collaborators, sponsored researchers and other advisors who receive confidential information from us to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual

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during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. The agreements provide that all inventions conceived by an employee shall be our property. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.

Trademarks

        We own trademarks for Addex Pharmaceuticals in Switzerland. We also have trademarks for AddeLite and ProxyLite in relation to our screening technologies in the United States, Switzerland and the People's Republic of China and, in the case of ProxyLite, the EU.

Competition

        The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or product candidates under development, for each of the product candidates and each of the indications for which we are developing our product candidates, as follows:

Dipraglurant for the treatment of PD-LID

        Amantadine, Gocovri (extended release amantadine) and Deep Brain Stimulation (DBS) surgery are currently available therapies for the treatment of PD-LID. In addition, several drug candidates currently in clinical development could compete with dipraglurant for the treatment of PD-LID. Avanir Pharmaceuticals, Inc. is developing AVP-923 (NMDA antagonist), Neuraltus Pharmaceuticals, Inc. is developing NP002 (nicotine receptor agonist), Newron Pharmaceuticals, Inc. is developing safinamide (MAO-B inhibitor), Novartis Pharma AG is developing AQW051 (alpha 7 nAChR inhibitor), and Prilenia Therapeutics Inc. is developing pridopidine (D2 receptor agonist).

Dipraglurant for the treatment of dystonia

        Currently available therapies include tetrabenazine (a dopamine antagonist), with a broad label for movement disorders, levodopa for levodopa responsive dystonia, botulinum toxin for focal and limb dystonia and DBS surgery. Other compounds, such as baclofen, anticholinergic drugs and benzodiazepines, are used off label or within the broad label context of treating muscle spasms. In addition, drug candidates currently in development could compete with dipraglurant for the treatment of dystonias, including MT10109 clostridium botulinum toxin, currently in development by Medytox Korea Co., Ltd. for cervical dystonia and transcranial magnetic stimulation.

GABAB PAM for the treatment of addiction

        Currently available treatments of addiction include Buprenorphine (Suboxone®, Subutex®, Probuphine®, Sublocade™), naltrexone (Vivitrol®) to treat opioid addiction; bupropion (Zyban®) and varenicline (Chantix®) to treat nicotine addiction; and naltrexone (Vivitrol®), Acamprosate (Campral®), Disulfiram (Antabuse®) to treat alcohol addiction. Baclofen (a GABAB agonist) has been largely used off-label to treat alcohol abuse, and its approval is under review in France. In addition, several novel derivatives of baclofen are in clinical development.

GABAB PAM for the treatment of CMT1A

        Currently, there is no disease-modifying treatment available for CMT1A. Currently approved therapies for relief from certain symptoms of CMT1A, including musculoskeletal and neuropathic pain, include anti-inflammatory drugs, tricyclic antidepressants and anticonvulsants. In addition, Pharnext is

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seeking approval in the US and Europe of PXT3003, a novel oral fixed-dose combination of baclofen, naltrexone and sorbitol.

ADX71149 for the treatment of epilepsy

        Currently available therapies treatment of epilepsy includes racetams such as Brivaracetam (Briviact) or Levetiracetam (Keppra); benzodiazepines such as diazepam (Valium), clonazepam (Klonopin), lorazepam (Ativan); carboxamides such as Carbamazepine (Carbatrol or Tegretol) and Eslicarbazepine (Aptiom); GABA analogs such as Gabapentin (Neurotin) or Pregabalin (Lyrica); Perampanel (Fycompa). Late stage drug candidates in development which could compete with ADX714419 include Ganaxolone, Cannabidiol (Epidiolex), Everolimus (Afinitor / Votubia), ZX008.

Government Regulation and Product Approval

        Government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.

Marketing

United States Government Regulation

        In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the drug development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA's refusal to approve pending new drug applications, or NDAs, withdrawal of an approval, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

        The process required by the FDA before a drug may be marketed in the United States generally involves:

    completion of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA's good laboratory practice, or GLP, regulations, including laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy;

    submission to the FDA of an Investigational New Drug, or IND, which must become effective before human clinical trials may begin;

    approval by an independent institutional review board, or IRB, at each clinical site before each clinical trial may be initiated;

    performance of adequate and well-controlled clinical trials in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug for each indication;

    submission to the FDA of an NDA;

    satisfactory completion of an FDA advisory committee review, if applicable;

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    satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity;

    satisfactory completion of an FDA inspection of selected clinical sites to assure compliance with GCPs and the integrity of the clinical data;

    payment of user fees; and

    FDA review and approval of the NDA.

Clinical Trials

        Prior to the initiation of clinical testing, a sponsor must submit to the FDA an IND, application to the FDA, including the results of pre-clinical studies, manufacturing information, analytical data and any available clinical data or literature. Some pre-clinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

        Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must continue to oversee the clinical trial while it is being conducted. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website.

        Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase 1, the drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an initial indication of its effectiveness. In Phase 2, the drug typically is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. In Phase 3, the drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the safety and efficacy of the product for approval, to establish the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.

        Progress reports detailing the results of the clinical trials must be submitted, at least annually, to the FDA, and more frequently if certain serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being

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conducted in accordance with the IRB's requirements, or if the drug has been associated with unexpected serious harm to patients.

Marketing Approval

        Assuming successful completion of the required clinical testing, the results of the pre-clinical and clinical studies, together with detailed information relating to the product's chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of "filing" of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to the FDA because the FDA has sixty days from submission to make a "filing" decision.

        In addition, under the Pediatric Research Equity Act, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation.

        The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and / or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.

        The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product's continued safety, quality and purity.

        The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

        Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP requirements.

        The testing and approval process for an NDA requires substantial time, effort and financial resources, and takes several years to complete. Data obtained from pre-clinical and clinical testing are

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not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval of an NDA on a timely basis, or at all.

        After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or pre-clinical testing in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA's satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

        Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Orange Book Listing

        In seeking approval for a drug through an NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant's product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. Any applicant who files an Abbreviated New Drug Application, or ANDA, seeking approval of a generic equivalent version of a drug listed in the Orange Book referencing a drug listed in the Orange Book must certify, for each patent listed in the Orange Book for the referenced drug, to the FDA that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA, (2) such patent has expired, (3) the date on which such patent expires or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. The fourth certification described above is known as a paragraph IV certification. A notice of the paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA. The applicant may also elect to submit a "section viii" statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. This section viii statement does not require notice to the patent holder or NDA owner. There might also be no relevant patent certification.

        If the reference NDA holder and patent owners assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the paragraph IV certification notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the paragraph IV certification expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the applicant. Even if the 45 days expire, a patent infringement lawsuit can be brought and could delay market entry, but it would not extend the FDA-related 30-month stay of approval.

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Post-Approval Requirements

        Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior FDA review and approval. There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as application fees for supplemental applications with clinical data.

        Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs.

        In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

        Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

    restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

    fines, warning letters or holds on post-approval clinical trials;

    refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;

    product seizure or detention, or refusal to permit the import or export of products; or

    injunctions or the imposition of civil or criminal penalties.

        The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved drugs for unapproved indications. The FDA and other agencies actively enforce the

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laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to liability.

        In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

Federal and State Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations

        In addition to FDA restrictions on marketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, including our clinical research activities, and proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including, without limitation, those laws described below.

        The federal Anti-Kickback Statute prohibits, among other things, individuals or entities from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term "remuneration" has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers and formulary managers on the other hand. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

        The reach of the federal Anti-Kickback Statute was also broadened by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, which, among other things, amended the intent requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act and the civil monetary penalties statute.

        The federal civil and criminal false claims laws, including the False Claims Act, which prohibit, among other things, any individual or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes "any request or demand" for money or property presented to the U.S. government. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies' marketing of products for unapproved, and thus non-reimbursable, uses.

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        The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

        HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization on certain health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates, independent contractors that perform certain services involving the use or disclosure of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys' fees and costs associated with pursuing federal civil actions.

        The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

        We may also be subject to state and foreign law equivalents of each of the above federal laws; state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or that otherwise restrict payments that may be made to healthcare providers; state and local laws that require the registration of pharmaceutical sales representatives; as well as state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in substantial ways and often are not preempted by HIPAA, thus complicating compliance efforts.

        Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to substantial civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse

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laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

Coverage and Reimbursement

        Market acceptance and sales of any drug products depend in part on the extent to which reimbursement for drug products will be available from third party payors, including government health administration authorities, managed care organizations and other private health insurers. third party payors decide which drug products they will pay for and establish reimbursement levels. third party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for drug products are made on a payor-by-payor basis. One payor's determination to provide coverage for a drug product does not assure that other payors will also provide coverage, and adequate reimbursement, for the drug product. Additionally, a third party payor's decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Each payor determines whether or not it will provide coverage for a drug product, what amount it will pay the manufacturer for the therapy, and on what tier of its formulary it will be placed. The position on a payor's list of covered drugs, or formulary, generally determines the co-payment that a patient will need to make to obtain the drug product and can strongly influence the adoption of such drug product by patients and physicians. Patients who are prescribed drug products for their conditions and providers prescribing such drug products generally rely on third party payors to reimburse all or part of the associated costs. Patients are unlikely to use a drug product unless coverage is provided and reimbursement is adequate to cover a substantial portion of the cost of the drug product.

        Reimbursement by a third party payor may depend upon a number of factors, including the third party payor's determination that a drug product is neither experimental nor investigational, safe, effective, and medically necessary, appropriate for the specific patient, cost-effective, supported by peer-reviewed medical journals and included in clinical practice guidelines.

        Third party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular drug products. Even if reimbursement is available, the level of reimbursement is unpredictable. Inadequate coverage and reimbursement can impact the demand for, or the price of, drug products. If coverage and adequate reimbursement are not available, or are available only to limited levels, drug products may not be successfully commercialized. Further, adequate third party payor reimbursement may not be available to enable price levels sufficient to realize appropriate returns on investment in drug product development.

        In addition, the federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement. To contain costs, governmental healthcare programs and third party payors are increasingly challenging the price, scrutinizing the medical necessity and reviewing the cost-effectiveness of drug products.

Impact of Healthcare Reform on our Business

        In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of drug product candidates, restrict or regulate post-approval activities, and affect the profitable sale of drug product candidates.

        Among policy makers and payors in the United States and elsewhere, there is substantial interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and / or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been affected by major legislative initiatives. In March 2010,

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the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and greatly impacts the U.S. pharmaceutical industry. The ACA, among other things: (i) increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (ii) established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; (iii) expanded the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; (iv) increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; (v) expanded the eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers' Medicaid rebate liability; (vi) established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70%, commencing January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D; (vii) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and (viii) established a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug.

        Some of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law. On December 22, 2017, new legislation was signed into law (H.R. 1, "An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018," or the Tax Cuts and Jobs Act) that significantly revised the U.S. Internal Revenue Code of 1986, as amended, or the Code. The Tax Cuts and Jobs Act includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate". Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, or the BBA, among other things, amends the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole".

        Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013, and due to subsequent legislative amendments to the statute, including the BBA, will remain in effect through 2027 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, and

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increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have an adverse effect on customers for our drug candidates, if approved, and, accordingly, our financial operations.

        Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the Trump administration's budget proposal for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. While any proposed measures will require authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and / or administrative measures to control drug costs. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Manufacturing and Supply

        We rely on third party manufacturing and supply partners for our supply for, preclinical studies and clinical trials. We currently do not have in-house facilities to manufacture our research and development, preclinical and clinical drug supplies.

Employees

        We had 17 full-time employees and consultants as of June 30, 2019. None of our employees are represented by any collective bargaining unit. We believe that we maintain good relations with our employees.

Property and Facilities

        Our registered office is located in 12, Chemin des Aulx, Plan-les-Ouates, Geneva, Switzerland. Our headquarters are located in Campus Biotech, Chemin des Mines 9, Geneva, Switzerland, and consist of approximately 500 square meters of office and lab space, which houses our in-house R&D function, under a lease that expires in 2020. We may require additional space and facilities as our business expands.

Legal Proceedings

        From time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of business. There are currently no claims or actions pending against us that, in the opinion of our management, are likely to have a material adverse effect on our results of operations, financial condition or cash flows.

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MANAGEMENT

Executive Officers and Directors

        The following table sets forth information regarding our executive officers and directors as of September 30, 2019.

NAME
  AGE   POSITION(S)  

Executive Officers:

             

Tim Dyer

    51     Chief Executive Officer and Director  

Roger Mills

    61     Chief Medical Officer and Director  

Robert Lütjens

    51     Head of Discovery—Biology  

Jean-Philippe Rocher

    60     Head of Discovery—Chemistry  

Lénaic Teyssédou(3)

    34     Head of Finance  

Non-Executive Directors:

   

 

   

 

 

Vincent Lawton(1)(2)

    70     Chairman  

Raymond Hill(1)

    74     Director  

Isaac Manke(2)

    42     Director  

Jake Nunn(2)

    49     Director  

(1)
Member of the Compensation Committee

(2)
Member of the Audit Committee

(3)
Mr. Teyssédou is not a member of the Executive Committee

Executive Officers

        Tim Dyer, Co-Founder, Director and Chief Executive Officer:    Since co-founding Addex in 2002, Mr. Dyer has played a pivotal role in building the Addex Group, raising CHF 300 million of capital, including Addex IPO and negotiating licensing agreements with pharmaceutical industry partners that generated more than CHF 55 million in cash inflows. Prior to founding Addex, he spent 10 years with Price Waterhouse, or PW, and PricewaterhouseCoopers, or PwC, in the UK and Switzerland as part of the audit and business advisory group. At PwC in Switzerland, Mr. Dyer's responsibilities included managing the service delivery to a diverse portfolio of clients including high growth start-up companies, international financial institutions and venture capital and investment companies. Mr. Dyer has extensive experience in finance, corporate development, business operations and the building of start-up companies. He is a UK Chartered Accountant and holds a BSc (Hons) in Biochemistry and Pharmacology from the University of Southampton, UK.

        Roger Mills, Director and Chief Medical Officer:    Dr. Mills brings more than 30 years of biopharmaceutical industry experience at both large global pharmaceutical companies and smaller biotechnology companies, including Acadia Pharmaceuticals, Pfizer, Gilead Sciences, Abbott Laboratories and The Wellcome Foundation, across a spectrum of disease areas. His extensive track record includes managing drug development programs from Investigational New Drug Application preparation through to post-marketing and OTC products, including NUPLAZID™ for the treatment of Parkinson's Disease Psychosis, as well as regulatory affairs and business development activities. Most recently, Dr. Mills was with Acadia Pharmaceuticals for nine years, serving as Executive Vice President, Development and Chief Medical Officer. In this role, he oversaw the largest ever international phase III program in Parkinson's Disease Psychosis, and led its New Drug Application submission to the US Food and Drug Administration (FDA) for NUPLAZID, which was subsequently approved and remains the first and only medication approved by the FDA in this indication. Dr. Mills currently serves as a Visiting Professor at the Centre for Age Related Diseases, Institute of Psychiatry,

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Psychology and Neuroscience, King's College London. He received his medical degree from Imperial College, Charing Cross Hospital Medical School, London, United Kingdom.

        Robert Lütjens, Head of Discovery—Biology:    Dr. Lütjens is responsible for all biology activities and has extensive experience in drug discovery. He established the biology capabilities and built the Company's small molecule allosteric modulator biology platform. He played a pivotal role in the success of both internal and partnered programs, including the discovery of dipraglurant and ADX71149, both of which progressed into phase II clinical development. Prior to joining Addex at inception in 2002, Dr. Lütjens completed a postdoctoral fellowship in the Department of Neuropharmacology at the Scripps Research Institute, in La Jolla, CA, where he focused on understanding molecular changes involved in addiction disorders. Dr. Lütjens obtained his degrees in Biology from the University of Geneva, his master's at the Swiss Institute for Experimental Cancer Research and his Ph.D. thesis at the Glaxo Institute for Molecular Biology in Geneva and the Institute for Cellular Biology and Morphology in Lausanne. Dr. Lütjens is co-author of over 30 peer-reviewed publications and patents.

        Jean-Philippe Rocher, Head of Discovery—Chemistry:    Dr. Rocher is responsible for all chemistry activities and has extensive experience in drug discovery. He returns to Addex from Pierre Fabre where he was Director of CNS Programs from March 2014 to May 2018. Joining Addex at its inception in 2002, Dr. Rocher established the company's chemistry capabilities and built its small molecule allosteric modulator chemistry platform. He played a pivotal role in the success of both internal and partnered programs, including the discovery of dipraglurant and ADX71149, both of which progressed into phase II clinical development. Prior to joining Addex, Dr. Rocher was director of chemistry at Devgen NV (Gent, Belgium), senior research scientist for GlaxoSmithKline KK (Tsukuba, Japan), scientific project leader in CNS at Mitsubishi Tanabe (Yokohama, Japan) and Head of Drug Discovery Unit for Battelle (Geneva, Switzerland). He started his career as a research scientist in the dermatology research center of Galderma (Sophia-Antipolis, France) following a PhD in medicinal chemistry and Pharm D at the Faculty of Pharmacy of Lyon (France). He is a co-author of more than 40 research publications and patents.

        Lénaic Teyssédou, Head of Finance:    Mr Teyssédou has served as our Head of Finance since June 2017 and is responsbile for finances and administration at Addex. Prior to joining the company, Mr Teyssédou worked for four years in the transaction support department of French audit company, where he was responsible for the acquisition due diligence of various clients, including major financial institutions. Mr Teyssédou is a French Chartered Accountant and holds two Master degrees in Finance and Management from EM Strasbourg Business School, France.

Non-Executive Directors

        Vincent Lawton, Chairman of the Board of Directors:    Professor Lawton was Vice President Merck Europe and Managing Director of MSD UK until he stepped down in 2006, after 26 years' service internationally for Merck & Co Inc. He was appointed CBE (Commander of the British Empire) by the Queen of England for services to the Pharmaceutical Industry. During his tenure, MSD UK achieved sustained commercial success, launching many new medicines to the market in a wide range of therapeutic areas, becoming the fastest growing company in the market over a number of years. He worked in commercial, research and senior management roles in France, the US and Canada, Spain and throughout Europe. As President of the UK Industry Association, the ABPI, he negotiated industry pricing, worked with Government bodies to help establish the UK globally as a leading center of clinical research. He served on the board of the UK regulatory authority (MHRA) from 2008 to 2015. He is a Senior Strategy Advisor for Imperial College Department of Medicine, University of London and serves as a consultant to a number of leading healthcare organizations. He studied Psychology at the University of London and holds an undergraduate degree and PhD.

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        Raymond Hill, Director:    Raymond Hill was previously a member of the Board of Directors from the Annual General Meetings of 2008 until 2012. Currently Visiting Professor of Pharmacology at Imperial College in London, and Non-Executive Director of Avilex (DMK), Asceneuron (CH) and was NED of Orexo AB (SE) from 2008 to 2019. Prior to his retirement, he was Executive Director, Licensing and External Researcher at Merck/MSD in Europe (2002 - 2008); Executive Director, Pharmacology (1990-2002) at the Merck Neuroscience Research Centre and had oversight responsibility for Neuroscience research at the Banyu Research Labs in Tsukuba, Japan (1997-2002). At Merck, he chaired a number of discovery project teams including those responsible for the marketed products Maxalt® and Emend®. Dr. Hill received his academic training (BPharm PhD) at the University of London. He was awarded an Honorary DSc by the University of Bradford in 2004 and was elected to Fellowship of the Academy of Medical Sciences in 2005. He was a lecturer in Pharmacology at the University of Bristol School of Medicine from 1974 to 1983 and supervisor in Pharmacology at Downing College, University of Cambridge from 1983 to 1988. He joined the pharmaceutical industry in 1983 as Head of Biology and founder member of the Park Davis Research Unit at Cambridge. In 1988, he joined SK&F (UK) as Group Director of Pharmacology and in 1990 moved to Merck. He is a past Council Member of the UK Academy of Medical Sciences and President Emeritus of the British Pharmacological Society. He is a Visiting Professor at the University of Bristol and was a member of the UK Government Advisory Council on the Misuse of Drugs from 2010 to 2019. He continues to serve on the ACMD Working Group on the Medicinal Uses of Cannabis and is a member of the Royal Pharmaceutical Society Science and Research Board.

        Isaac Manke, Director:    Isaac has more than 15 years of experience in the life science industry as an investor, research analyst, consultant and scientist. Isaac joined New Leaf Venture Partners, or NLV, in 2009 and was promoted to Partner in 2014. Isaac's investment activities with NLV started with a focus on venture investments in the biopharmaceutical sector. He has led the firm's public investment activities initially with the public portfolio within NLV-II, and since 2014 has day-to-day management and oversight responsibility for the NLV Biopharma Opportunities Funds. Isaac has been a board member or observer for several companies, including the boards of True North Therapeutics (acquired by Bioverativ) and Karos Pharmaceuticals (acquired by an undisclosed company). Prior to joining NLV, Isaac was an Associate in the Global Biotechnology Equity Research group at Sanford C. Bernstein. Previously, Isaac worked as an Associate in the Biotechnology Equity Research group at Deutsche Bank and was a Senior Analyst at Health Advances, a biopharmaceutical and medical device strategy consulting firm. Isaac received a B.A. in Biology and a B.A. in Chemistry at Minnesota State University (Moorhead), and a Ph.D. in Biophysical Chemistry and Molecular Structure at the Massachusetts Institute of Technology, or MIT. Isaac's discoveries led to several publications in top journals, including Science and Cell, and were selected by Science as one of the "2003: Signaling Breakthroughs of the Year". These discoveries also resulted in four issued patents.

        Jake Nunn, Director:    Jake has more than 25 years of experience in the life science industry as an investor, independent director, research analyst and investment banker. Jake is currently a venture advisor at New Enterprise Associates, or NEA, where he was a partner from 2006 to 2018, focusing on later-stage specialty pharmaceuticals, biotechnology and medical device investments and managing a number of NEA's public investments in healthcare. Jake is a Director of Dermira, Inc. (Nasdaq: DERM), Regulus Therapeutics (Nasdaq: RGLS) and Trevena, Inc. (Nasdaq: TRVN). He previously was a Director of Hyperion Therapeutics (acquired by Horizon Pharma PLC), TriVascular (acquired by Endologix), Aciex Therapeutics (acquired by Nicox SA), Transcept Pharmaceuticals (merged with Paratek) and a board observer at Vertiflex, Inc. (acquired by Boston Scientific). Prior to NEA, Jake worked at MPM Capital as a Partner with the MPM BioEquities Fund, where he specialized in public, PIPE and mezzanine-stage life sciences investing. Previously, he was a healthcare research analyst and portfolio manager at Franklin Templeton Investments. Jake was also an investment banker with Alex. Brown & Sons. He received an MBA from the Stanford Graduate School of Business and an AB in Economics from Dartmouth College. Jake holds the Chartered Financial Analyst designation, is a

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member of the CFA Society of San Francisco, and recently completed the Stanford GSB Directors' Consortium executive education program.

Foreign Private Issuer Exemption

        As a "foreign private issuer," as defined by the SEC, we are permitted to follow home country corporate governance practices, instead of certain corporate governance practices required by Nasdaq for U.S. domestic issuers. While we intend to follow most Nasdaq corporate governance rules, we intend to follow Swiss corporate governance practices in lieu of Nasdaq corporate governance rules as follows:

    We do not intend to comply with Nasdaq Rule 5605(b)(1), which requires that our board of directors be comprised of a majority of independent directors. Such requirements are not required under the laws of Switzerland. However, we do make an assessment of the independence of our directors under Swiss corporate governance practices and have concluded that the majority of our directors are independent based upon those standards.

    We do not intend to follow Nasdaq Rule 5605(d)(1) regarding the compensation committee charter or Nasdaq Rule 5605(d)(2) regarding compensation committee composition. Such requirements are not required under the laws of Switzerland. However, we do maintain a remuneration committee in line with Swiss law. See the section entitled "Management—Committees of Our Board of Directors—Remuneration Committee" for additional information.

    We do not intend to follow Nasdaq Rule 5605(e)(1)(A) with respect to having director nominees selected by independent directors constituting a majority of our board's independent directors in a vote in which only independent directors participate or Nasdaq Rule 5605(e)(2) regarding the adoption of a formal written charter or board resolution, as applicable, addressing the nominations process. Such requirements are not required under the laws of Switzerland.

    We do not intend to follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under the laws of Switzerland.

        We must comply with Nasdaq Rule 5640 Notification of Noncompliance and Rule 5640 Voting Rights. Further, we must have an audit committee that satisfies Rule 5605(c)(3), which addresses audit committee responsibilities and authority, and that consists of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii), subject to a transition period for newly public companies.

        Because we are a foreign private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations under Section 16 of the Exchange Act. They and our other shareholders will, however, be subject to the obligations to report changes in share ownership under Section 13 of the Exchange Act and related SEC Rules.

Composition of Our Board of Directors

        Our board of directors is currently composed of six members. As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except that our audit committee is required to consist fully of independent directors, subject to certain phase-in schedules. However, our board of directors has determined that Vincent Lawton and Jake Nunn do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of director and that each of these directors is "independent" as that term is defined under Nasdaq rules. There are no family relationships among any of our directors or senior management.

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Committees of Our Board of Directors

        The audit committee, which consists of Vincent Lawton, Isaac Manke and Jake Nunn, assists the board of directors in overseeing our accounting and financial reporting processes. Vincent Lawton serves as chairman of the audit committee. The audit committee consists exclusively of members of our board who are financially literate, and Jake Nunn is considered an "audit committee financial expert" as defined by applicable SEC rules and has the requisite financial sophistication as defined under the applicable Nasdaq rules and regulations. Our board of directors has determined that Vincent Lawton, Isaac Manke and Jake Nunn are independent directors under Nasdaq listing rules and under Rule 10A-3 under the Exchange Act. The audit committee is governed by a charter that complies with Nasdaq rules. The audit committee's responsibilities include:

    to review and assess the effectiveness of the statutory auditors and the group auditors, in particular their independence from Addex. In connection therewith, it reviews in particular additional assignments given by the Company or its subsidiaries. It may issue binding regulations or directives in connection with such additional assignments;

    to review and assess the scope and plan of the audit, the examination process and the results of the audit and to examine whether the recommendations issued by the auditors have been implemented by management;

    to review the auditors' reports, to discuss their contents with the auditors and with the management;

    to approve the terms and conditions of the engagement of the auditors;

    to review the effectiveness of the internal audit function, its professional qualifications, resources and independence and its cooperation with external audit;

    to approve the annual internal audit concept and the annual internal audit report, including the responses of the management thereto

    to assess the risk assessment established by the management and the proposed measures to reduce risks;

    to assess the state of compliance with norms within Addex;

    to review in cooperation with the auditors, the CEO and Head of Finance whether the accounting principles and the financial control mechanism of Addex and its subsidiaries are appropriate in view of our size and complexity;

    to review the annual and interim statutory and consolidated financial statements intended for publication. It should discuss these with the CEO and the Head of Finance and, separately, with the head of external audit; and

    to make a proposal to the Board with respect to these annual and interim statutory and consolidated financial statements; the responsibility for approving the annual financial statements remains with the Board.

Compensation Committee

        The compensation committee, which consists of Vincent Lawton and Raymond Hill, advises the board in determining executive compensation. The remuneration committee's responsibilities include:

    to review and assess on a regular basis the remuneration system of Addex (including the management incentive plans) and to make proposals in connection thereto to the Board;

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    to recommend the terms of employment, in particular the remuneration package, of the CEO and to make proposals in relation to the remuneration of Directors;

    to recommend upon proposal of the CEO the terms of employment, in particular the remuneration package, of employees reporting directly to the CEO as well as review matters related to the compensation of other top managers, as well as the general employee compensation, benefit policies and HR practices of Addex; and

    to make recommendations on the grant of options or other securities under any management incentive plan of Addex.

Code of Business Conduct and Ethics

        In connection with our listing on Nasdaq, we intend to revise our Code of Business Conduct and Ethics applicable to our employees, executive officers and directors.

Compensation of Directors and Executive Management

Board of Directors

        The compensation of the member of the Board consists of fixed and variable elements. The fixed element comprises a fixed annual monetary compensation per board term from one general meeting of shareholders to the next. The variable element comprises a monetary compensation based on board meeting attendance and equity incentive units (share options and equity sharing certificates). Our social security contributions are accrued on the fixed and variable elements. Board member social security contributions are accrued on the fair value of equity incentive units. Equity incentive units are granted based on the discretion of the Board. In addition, we reimburse members of the Board for out-of-pocket expenses incurred in relation to their services on an on-going basis upon presentation of the corresponding receipts. The most recent review of compensation for members of the Board took place on December 13, 2018. For further information on the compensation for members of the Board, please refer to the section "—Compensation of the Board in 2018 and 2017."

Executive Management

        The compensation of members of the Executive Management consists of fixed and variable elements. The fixed element may include a base salary or a cash retainer paid under a consulting contract. The variable element may include performance-related cash or share based bonuses, consulting fees based on chargeable hours and equity incentive units (equity sharing certificates and share options). Company contributions to pension plans, death and invalidity insurances and social security contributions are accrued on all fixed and variable element compensation that relates to an employment relationship. Both company and employee social security contributions are accrued for all shares or equity incentive unit compensation. The amount of the fixed element depends on the position, responsibilities, experience and skills, and takes into account individual performance. The fixed element is reviewed at the end of each year by the Board. Any changes in the fixed elements are made effective in January of the following year. The variable elements are based on individual and company performance. The potential variable cash bonus is determined in the employment contract and in general is a percentage of the base salary. Where the Executive Manager has been engaged under a consulting contract, the variable element is based on the time spent at the contractually defined rate of remuneration. At the beginning of each year the Board decides, on the total amount of variable elements including the amount of cash and equity incentive units to be granted for the previous year based on the achievement of Company goals. Equity incentive units are granted based on the discretion of the Board. Variable cash compensation paid to Executive Managers in 2018 relates to consulting fees.

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Equity Incentive Plans

        The purpose of our share purchase, share option and equity sharing certificate programs (refer to note 12 of the consolidated financial statements) is to provide members of the Board, Executive Management, employees and certain consultants with an opportunity to benefit from the potential appreciation in the value of our shares, thus providing an increased incentive for participants to contribute to our future success and prosperity, enhancing the value of the shares for the benefit of our shareholders and increasing our ability to attract and retain individuals of exceptional skill. In addition, these plans provide us with a mechanism to engage services for non-cash consideration. The grant of any share option or equity sharing certificate is at the discretion of the Board. Key factors considered by the Board in making grants of share options or equity sharing certificates are the amount of shareholder approved conditional capital, the benchmarking with other companies as well as individual performance. The strike price is determined by the Board and is primarily based on the closing price of our shares on the SIX Swiss Exchange on the grant date. The transfer of treasury shares under the share purchase plan to settle consulting services are based on predefined terms of the consulting contract.

Indirect benefits

        We may contribute to the pension plan and maintains certain insurance for death and invalidity for the members of the Executive Management. New entrants may be eligible for reimbursement of relocation costs, compensation for lost benefits or stock granted by a previous employer, international school for children or language courses for a limited time period. No Indirect benefits have been paid to Executive Management in 2018. We have not granted any loans, credits or guarantees to members of the Board or of the Executive Management in 2018.

Measurement basis for compensation

        The measurement basis for each component of compensation is described below:

Compensation of the Board of Directors in 2018 and 2017

 
   
  Variable compensation (Value in CHF)    
 
 
  Fixed    
 
 
   
  number of
equity
incentive
units(1)
  value of
equity
incentive
units(1)
   
 
2018
  cash
compensation
  cash
attendance
  Total
2018
 

Vincent Lawton

    25,858     25,858     262,929     285,451     337,167  

Raymond Hill

    15,341     15,341     155,841     169,190     199,872  

Tim Dyer

                     

Roger Mills

                     

Jake Nunn

    6,642     6,642             13,284  

Isaac Manke

    5,314     5,314             10,628  

Total

    53,155     53,155     418,770     454,641     560,951  

(1)
Equity incentive units include share options granted under our share option plan (refer to note 12 of the consolidated financial statements).

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  Variable compensation
(Value in CHF)
   
 
 
  Fixed    
 
 
   
  number of
equity
incentive
units(1)
  value of
equity
incentive
units(1)
   
 
2017
  cash
compensation
  cash
attendance
  Total
2017
 

Vincent Lawton

    25,858     25,858     163,850     173,081     224,797  

Raymond Hill

    15,341     15,341     100,310     105,961     136,643  

Tim Dyer

                     

Roger Mills

                     

Total

    41,199     41,199     264,160     279,042     361,440  

(1)
Equity incentive units include share options granted under our share option plan (refer to note 12 of the consolidated financial statements).

Compensation to the Executive Management in 2018 and 2017

 
   
  Variable compensation
(Value in CHF)
   
 
 
  Fixed    
 
 
   
  number of
equity
incentive
units(2)
   
   
 
2018
  cash
compensation
  Cash(3)   value of
shares(2)
  Total
2018
 

Total Executive Management(1)

    415,853     408,539     1,804,351     2,070,240     2,894,632  

(1)
The highest paid member of Executive Management in 2018 was the CEO, Tim Dyer, who received CHF 392,293 of variable cash compensation and 1,199,662 equity incentive units. The value of equity incentive units including accrued social charges amounted to CHF 1,316,068.

(2)
Equity incentive units include shares awarded for consulting services under the share purchase plan and options, equity sharing certificates granted under our share option plan.

(3)
Executive managers have been engaged under consulting contracts which include hourly and daily rates with a monthly cap.
 
   
  Variable compensation
(Value in CHF)
   
 
 
  Fixed    
 
 
   
  number of
equity
incentive
units(2)
   
   
 
2017
  cash
compensation
  Cash(3)   value of
shares(2)
  Total
2017
 

Total Executive Management(1)

    49,554     704,496     1,440,287     1,661,158     2,415,208  

(1)
The highest paid member of Executive Management in 2017 was the CEO, Tim Dyer, who received CHF 384,000 of variable cash compensation and 1,099,956 equity incentive units. The value of equity incentive units including accrued social charges amounted to CHF 1,220,733.

(2)
Equity incentive units include shares awarded for consulting services under the share purchase plan and options, equity sharing certificates granted under our share option plan.

(3)
Executive managers have been engaged under consulting contracts which include hourly and daily rates with a monthly cap.

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RELATED PARTY TRANSACTIONS

        The following is a description of related party transactions we have entered into since January 1, 2016 with any members of our board of directors or executive officers and each holder of more than 5% of our shares.

2018 Private Placement

        On March 28, 2018, we issued an aggregate of 13,037,577 of our shares, 136,561 of which were recorded as treasury shares, and warrants to purchase up to 5,866,898 of our shares. The price per share plus warrant to purchase 0.45 of a share was CHF 3.13. Each warrant has an exercise price per ordinary share of CHF 3.43 and a term of seven years. We utilized the net proceeds of the private placement of units primarily to advance our drug development programs and for general corporate purposes. The table below summarizes the issuance of such shares and warrants that were issued to members of our board of directors, our executive officers or holders of more than 5% of our shares.

 
  Shares
purchased
  Shares issuable
upon
exercise of warrants
purchased
 

5% or Greater Shareholders

             

Growth Equity Opportunities Fund IV, LLC(1)

    4,568,690     2,055,910  

New Leaf Biopharma Opportunities I, L.P.(2)

    1,597,444     718,849  

CDK Associates, LLC(3)

    1,597,444     718,849  

Credit Suisse Funds AG(4)

    1,500,000     675,000  

Executive Officers and Directors

             

Tim Dyer(5)

    31,948     14,376  

(1)
Growth Equity Opportunities Fund IV, wholly owned by New Enterprise Associate LP, is a holder of more than 5% of our shares and has appointed Jake Nunn as Board Member

(2)
New Leaf Biopharma Opportunities I, L.P, owned by New Leaf Venture Management III LLC, is a holder of more than 5% of our shares and has appointed Isaac Manke as Board Member

(3)
CDK Associates LLC, owned by Bruce Kovner, is a holder of more than 5% of our shares.

(4)
Credit Suisse Funds AG indirectly holds more than 5% of our shares, through collective investment schemes whose CS (CH) Small Cap Switzerland directly holds more than 5%.

(5)
Mr. Tim Dyer is a holder of more than 5% of our shares and is a board member.

        In connection with the foregoing private placement of securities, we entered into a registration rights agreement with the purchasers of the securities, pursuant to which we granted such purchasers the right to have their ordinary shares and ordinary shares issuable upon the exercise of warrants purchased in the private placement registered with the SEC for resale in the United States. The registration statement of which this prospectus forms a part has been filed in part in satisfaction of such purchasers' rights thereunder.

Agreements with Our Executive Officers and Directors

        We have entered into employment agreements with certain of our executive officers and service agreements with our non-executive directors. See the section entitled "Management—Compensation of Directors and Executive Management."

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        We have entered into indemnification agreements with each of our directors and executive officers. These agreements require us to indemnify our directors and executive officers to the fullest extent permitted by law. Tim Dyer, our CEO, provided his services to us through TMD Advisory, or TMDA, until November 1, 2018. He is now employed by us. The company TMDA has rent administrative offices to us for CHF 27 thousand in 2018, CHF 23 thousand in 2017 and CHF 20 thousand in 2016. We have performed accounting services to TMDA for respectively CHF 50 thousand in 2018, CHF 35 thousand in 2017 and CHF 39 thousand in 2016.

Related-Party Transactions Policy

        For purposes of our policy, a related-party transaction is a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related parties are, were or will be participants, which are not (1) in the ordinary course of business, (2) at arms' length and (3) in which the amount involved exceeds CHF 120,000. Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. For purposes of this policy, a related party is any executive officer, director (or nominee for director) or beneficial owner of more than 5% of any class of our shares, including any of their immediate family members and any entity owned or controlled by such persons.

        Under the policy, if a transaction has been identified as a related-party transaction, including any transaction that was not a related-party transaction when originally consummated or any transaction that was not initially identified as a related-party transaction prior to consummation, our management must present information regarding the related-party transaction to our board of directors for review, consideration and approval. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related parties, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant shareholder to enable us to identify any existing or potential related-party transactions and to effectuate the terms of the policy. In addition, our employees and directors will have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related-party transactions, our audit committee, or other independent body of our board of directors, will take into account the relevant available facts and circumstances including:

        The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our audit committee, or other independent body of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our shareholders, as our audit committee, or other independent body of our board of directors, determines in the good faith exercise of its discretion

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PRINCIPAL HOLDERS

        The following table sets forth information with respect to the beneficial ownership of our shares as of September 30, 2019 by:

        Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include shares that can be acquired within 60 days of September 30, 2019. Percentage ownership calculations are based on 32,848,635 shares issued and outstanding as of September 30, 2019 plus, consistent with SEC rules on disclosure of beneficial ownership, shares that each security holder has the ability to acquire within 60 days of September 30, 2019, due to outstanding equity interests becoming vested or exercisable. The percentage of shares beneficially owned before offering shown on the table reflect these incremental shares that a security holder has the ability to acquire within the time frame noted. Except as otherwise indicated in the table below, addresses of the directors and executive officers are c/o Addex Therapeutics Ltd, Chemin des Mines 9, 1202 Geneva, Switzerland.

 
  Number of
shares
beneficially
owned
  Percentage
of
shares
beneficially
owned
 

5% or Greater Shareholders:

             

Addex Pharma SA(1)

    6,513,620     19.8 %

Growth Equity Opportunities Fund IV, LLC(2)

    6,679,852     19.1 %

New Leaf Biopharma Opportunities I, L.P.(3)

    2,316,293     6.9 %

CDK Associates, LLC(4)

    2,316,293     6.9 %

Credit Suisse Funds AG(5)

    2,177,390     6.5 %

Executive Officers and Directors:

   
 
   
 
 

Tim Dyer(6)

    2,087,195     6.1 %

Vincent Lawton

    *     *  

Raymond Hill

    *     *  

Isaac Manke

    *     *  

Roger Mills

    *     *  

Jake Nunn

    *     *  

Robert Lütjens

    *     *  

Jean-Philippe Rocher

    *     *  

Lénaïc Teyssédou

    *     *  

All current directors and executive officers as a group (9 persons)

    3,142,706     8.9 %

*
Represents beneficial ownership of less than one percent.

(1)
Consists of 6,452,167 shares and 61,453 shares issuable upon exercise of outstanding warrants directly held by Addex Pharma SA that is wholly owned by Addex Therapeutics Ltd. Tim Dyer, Chief Executive Officer of the Group is the sole board member of Addex Pharma SA and one of the board members of Addex Therapeutics Ltd. Tim Dyer makes investment decisions on behalf of Addex Pharma SA based on instructions from the board of directors of Addex Therapeutics Ltd. A full list of

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    members of the board of directors of Addex therapeutics Ltd is disclosed elsewhere in the prospectus. The address of Addex Pharma SA is Chemin des Mines 9, 1202 Geneva, Switzerland.

(2)
Consist of 4,623,942 shares and 2,055,910 shares issuable upon exercise of outstanding warrants directly held by Growth Equity Opportunities Fund IV LLC ("GEO IV") that is wholly owned by New Enterprise Associates 15, L.P ("NEA 15"). The shares directly held by GEO IV are indirectly held by NEA 15, whose general partner is NEA Partners 15, L.P ("NEA Partners 15"). The general partner of NEA Partners 15 is NEA 15 GP, LLC ("NEA 15 LLC"). The individual Managers of NEA 15 LLC, or collectively, the NEA 15 Managers are Peter J. Barris, Forest Baskett, Anthony A. Florence Jr., Joshua Makower, Mohamad Makhzoumi, David M.Mott, Scott D.Sandell and Peter W.sonsini. GEO IV, NEA 15, NEA Partners 15, NEA 15 LLC and the NEA 15 Managers share voting and dispositive power with regard to our securities held directly by GEO IV. The address of Growth Equity Opportunities Fund IV LLC is c/o New Enterprise Associate 15 L.P, Timonium, MD 21093.

(3)
Consist of 1,597,444 shares and 718,849 shares issuable upon exercise of outstanding warrants directly held by New Leaf Biopharma Opportunities I, L.P and indirectly held by New Leaf Venture Management III LLC. The individual Managers of New Leaf Venture Management III LLC are Ronald Hunt and Vijay Lathi. The address of New Leaf Biopharma Opportunities I, L.P is c/o Corporation Trust Company/Center, 1209 Orange street, Wilmington, DE 19801.

(4)
Consist of 1,597,444 shares and 718,849 shares issuable upon exercise of outstanding warrants directly held by CDK Associates LLC and indirectly held by Bruce Kovner who can exercise the voting rights and investment control at his own discretion. The address of CDK Associates LLC is Princeton, New Jersey 08540.

(5)
Consist of 1,502,390 shares and 675,000 shares issuable upon the exercise of warrants indirectly held by Credit Suisse Funds AG with voting power whilst Credit Suisse Asset Management AG, has investing power. The collective investment scheme CS (CH) Small Cap Switzerland directly holds 1,221,551 shares and 675,000 shares issuable upon exercise of warrants. The individual Managers of Credit Suisse Funds AG and Credit Suisse Asset Management AG are Simon Götschmann, Thomas Schärer, Emil Stark and Gabriele Wyss. The address of Credit Suisse Funds AG is Kalandergasse 4, 8045 Zurich, Switzerland.

(6)
The 2,087,195 shares consist of 435,192 shares and 1,652,003 shares issuable upon the exercise of 1,637,627 outstanding options and 14,376 outstanding warrants.

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REGISTERED HOLDERS

        The following table sets forth information with respect to the beneficial ownership of our shares as of September 30, 2019 by each of our other shareholders who is a Registered Holder hereunder. Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include shares that can be acquired within 60 days of September 30, 2019. Percentage ownership calculations are based on 32,848,645 shares issued and outstanding as of September 30, 2019 plus, consistent with SEC rules on disclosure of beneficial ownership, shares that each security holder has the ability to acquire within 60 days of September 30, 2019, due to outstanding equity interests becoming vested or exercisable. The percentage of shares beneficially owned shown on the table reflect these incremental shares that a security holder has the ability to acquire within the time frame noted. To the extent that any shareholder is a Registered Holder who sells ADSs representing its shares following registration pursuant to the registration statement of which this prospectus forms a part or otherwise, the shareholder's percentage ownership will decrease accordingly. Except as otherwise indicated in the table below, addresses of the directors and executive officers are c/o Addex Therapeutics Ltd, Chemin des Mines 9, 1202 Geneva, Switzerland.

Name of Beneficial owner
  Number of
shares
beneficially
owned
  Percentage of
shares
beneficially
owned before
offering
  Number of
shares
being registered
in the offering
  Pro forma
potential
number of
shares
beneficially
owned
following
the
offering(1)
  Pro forma
potential
percentage
of shares
beneficially
owned
following
the offering(1)
 

5% or Greater Shareholder

                               

Growth Equity Opportunities Fund IV, LLC(2)

    6,679,852     19.1 %   6,679,852     2,055,910     5.9 %

New Leaf Biopharma Opportunities I, L.P.(3)

    2,316,293     6.9 %   2,316,293     718,849     2.1 %

CDK Associates, LLC(4)

    2,316,293     6.9 %   2,316,293     718,849     2.1 %

Executive Officers and Directors:

   
 
   
 
   
 
   
 
   
 
 

Roger Mills(5)

    217,215     0.7 %   95,630     121,585     0.4 %

Other Holder:

   
 
   
 
   
 
   
 
   
 
 

Hilde Williams(6)

    40,479     0.1 %   31,443     9,036      

(1)
Unlike an initial public offering, any disposition by the Registered Holders of the Registered Shares represented by ADSs is not being underwritten by any investment bank. The Registered Holders may or may not elect to dispose of Registered Shares represented by ADSs as and to the extent that they may individually determine. Such dispositions, if any, will be made through brokerage transactions on Nasdaq or other securities exchanges in the United States at prevailing market prices, and the post-offering ownership figures in these columns represent the lowest level of ownership that would exist if the Registered Holders sold 100% of the Registered Shares owned by them, which may or may not happen.

(2)
Consist of 4,623,942 shares and 2,055,910 shares issuable upon exercise of outstanding warrants directly held by Growth Equity Opportunities Fund IV LLC ("GEO IV") that is wholly owned by New Enterprise Associates 15, L.P ("NEA 15"). The shares directly held by GEO IV are indirectly held by NEA 15, whose general partner is NEA Partners 15, L.P ("NEA Partners 15"). The general partner of NEA Partners 15 is NEA 15 GP, LLC ("NEA 15 LLC"). The individual Managers of NEA 15 LLC, or collectively, the NEA 15 Managers are Peter J. Barris, Forest

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    Baskett, Anthony A. Florence Jr., Joshua Makower, Mohamad Makhzoumi, David M.Mott, Scott D.Sandell and Peter W.Sonsini. GEO IV, NEA 15, NEA Partners 15, NEA 15 LLC and the NEA 15 Managers share voting and dispositive power with regard to our securities held directly by GEO IV. The address of Growth Equity Opportunities Fund IV LLC is c/o New Enterprise Associate 15 L.P, Timonium, MD 21093.

(3)
Consist of 1,597,444 shares and 718,849 shares issuable upon exercise of outstanding warrants directly held by New Leaf Biopharma Opportunities I, L.P and indirectly held by New Leaf Venture Management III LLC. The individual Managers of New Leaf Venture Management III LLC are Ronald Hunt and Vijay Lathi. The address of New Leaf Biopharma Opportunities I, L.P is c/o Corporation Trust Company/Center, 1209 Orange street, Wilmington, DE 19801.

(4)
Consist of 1,597,444 shares and 718,849 shares issuable upon exercise of outstanding warrants directly held by CDK Associates LLC and indirectly held by Bruce Kovner who can exercise the voting rights and investment control at his own discretion. The address of CDK Associates LLC is Princeton, New Jersey 08540.

(5)
Consist of 121,585 shares issuable upon the exercise of outstanding options directly held by Roger Mills and 95,630 shares directly held by Vincere Consulting LLC owned by Roger Mills and Linda Marontate Robertson.

(6)
Consist of 9,036 shares issuable upon exercise of outstanding options directly held by Hilde Williams and 31,443 shares directly held by Pharmastory Corp. owned by Hilde Williams and Paul Williams.

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DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

        The following section describes our issued share capital, summarizes the material provisions of our Articles of Association and highlights certain differences in corporate law in Switzerland and the United States.

Capital structure

        There were 2,346 shareholders registered in the share register on December 31, 2018. The distribution of shareholdings is divided as follows:

Number of shares
  Number of
registered
shareholders on
December 31, 2018
 

1 to 100

    268  

101 to 1,000

    1010  

1,001 to 10,000

    931  

10,001 to 100,000

    126  

100,001 to 1,000,000

    8  

1,000,001 to 10,000,000

    3  

        The shareholder base on December 31, 2018 was constituted as follows:

Shareholder structure according to category of investors
(weighted by number of shares)
   
 

Private persons

    27.45 %

Institutional shareholders

    34.23 %

Not registered

    38.32 %

Shareholder structure by country
(weighted by number of shares)
   
 

United States

    16.09 %

Switzerland

    41.04 %

United Kingdom

    2.51 %

Other

    2.04 %

Not registered

    38.32 %

1.1. Capital

        As of September 30, 2019, the share capital amounted to CHF 32,848,635 consisting of 32,848,635 issued shares with a nominal value of CHF 1 per share. As of September 30, 2019 we indirectly held 6,452,167 of our own shares through our wholly-owned subsidiary Addex Pharma SA. These shares are recorded as treasury shares.

Authorized and conditional capital

        Authorized share capital as of September 30, 2019 and according to the article 3b of the Articles, the Board of Directors ("Board") is authorized, at any time until June 19, 2021 to increase the share capital in an amount of CHF 16,424,317 through the issuance of 16,424,317 fully paid registered shares with a nominal value of CHF 1 each. An increase in partial amounts is permitted. The Board shall determine the issue price, the type of payment, the date of issue of new shares, the conditions for the exercise of pre-emptive rights and the beginning date for dividend entitlement. In this regard, the Board may issue new shares by means of a firm underwriting through a banking institution, a syndicate

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or another third party with a subsequent offer of these shares to the current shareholders (unless the pre-emptive rights of current shareholders are excluded). The Board may permit pre-emptive rights that have not been exercised to expire or it may place these rights and/or shares as to which pre-emptive rights have been granted but not exercised, at market conditions or use them for other purposes in our interest.

        The subscription and acquisition of the new shares, as well as each subsequent transfer of the shares, shall be subject to the restrictions set forth in article 5 of the Articles.

        The Board is authorized to restrict or exclude the pre-emptive rights of shareholders and allocate such rights to third parties if the shares are to be used:

Conditional share capital

        According to article 3c of the Articles, our share capital may be increased by a maximum aggregate amount of CHF 10,557,419 through the issuance of a maximum of 10,557,419 registered shares, which shall be fully paid-in, with a par value of CHF 1 per share by the exercise of option rights or subscription rights attached to equity sharing certificates or bons de jouissance which our employees, directors and/or consultants are granted according to respective regulations of the Board. The pre-emptive rights of the shareholders are excluded. The acquisition of registered shares through the exercise of option rights or subscription rights granted to the holders of bons de jouissance and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in article 5 of the Articles.

        Our share capital may be increased by a maximum aggregate amount of CHF 5,866,898 through the issuance of a maximum of 5,866,898 registered shares, which shall be fully paid-in, with a par value of CHF 1 per share by the exercise of option and/or conversion rights which are granted to our shareholders and/or in connection with the issue of bonds, similar obligations or other financial instruments by us. In the case of such grants of option and/or conversion rights, the advanced subscription right of shareholders is excluded. The holders of option and/or conversion rights are entitled to receive the new shares. The Board shall determine the terms of the option and/or conversion rights. The acquisition of registered shares through the exercise of option or conversion rights and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in article 5 of the Articles.

        The Board is authorized to restrict or exclude the advanced subscription rights of shareholders:

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Changes in capital

Nominal share capital
   
 

December 31, 2017

    CHF 15,384,988  

December 31, 2018

    CHF 28,564,031  

September 30, 2019

    CHF 32,848,635  

 

Conditional share capital
   
 

December 31, 2017

    CHF 7,692,494  

December 31, 2018

    CHF 14,282,015  

September 30, 2019

    CHF 16,424,317  

 

Authorized share capital
   
 

December 31, 2017

    CHF 7,692,494  

December 31, 2018

    CHF 14,282,015  

September 30, 2019

    CHF 16,424,317  

Changes in capital in 2017

        On May 29, 2017, we increased our capital from CHF 13,454,553 to CHF 15,384,988 through the issue of 1,930,435 new registered shares at nominal value of CHF 1 each.

Changes in capital in 2018

        On March 16, 2018, we increased our capital from CHF 15,384,988 to CHF 15,526,454 through the issue of 141,466 new registered shares at nominal value of CHF 1 each, in connection with the exercise of equity incentive units.

        On March 28, 2018, we increased our capital from CHF 15,526,454 to CHF 28,564,031 through the issue of 13,037,577 new registered shares at nominal value of CHF 1 each, in connection with a private placement to institutional investors. Of these new shares, 136,561 were recorded as treasury shares.

Changes in capital in 2019

        On May 17, 2019, we increased our capital from CHF 28,564,031 to CHF 32,848,635 through the issue of 4,284,604 new registered shares at nominal value of CHF 1 each, fully subscribed by our 100% owned subsidiary, Addex Pharma SA. The shares are held as treasury shares.

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        For further information on changes in capital including changes in reserves, refer to the consolidated statements of changes in equity as well as note 11 of the consolidated financial statements included in this registration statement.

Shares and participation certificates

        Addex has one class of shares, i.e. registered shares with a nominal value of CHF 1 per share. Each share is fully paid up and carries one vote and equal dividend rights, with no privileges. We have no participation certificates (bons de participation / Partizipationsscheine).

Equity Sharing certification

        Equity sharing certificates are available for granting to our employees and/or directors and/or consultants under our equity incentive plan. Equity sharing certificates do not form part of the share capital, have no nominal value, and do not grant any right to vote nor to attend meetings of shareholders. There are 1,700 equity sharing certificates (bons de jouissance / Genussscheine), of which 1,434 were issued to our subisidary, Addex Pharma SA and 266 were outstanding. Each equity sharing certificate grants the right to subscribe for 1,000 of our shares and a right to liquidation proceeds calculated in accordance with article 34 of the Articles.

        Our shares and equity sharing certificates are not certificated. Shareholders and equity sharing certificate holders are not entitled to request printing and delivery of certificates, however, any shareholder or equity sharing certificate holder may at any time request that we issue a confirmation of its holdings.

Limitations on transferability of shares and nominee registration

        A transfer of uncertified shares is affected by a corresponding entry in the books of a bank or depository institution following an assignment in writing by the selling shareholder and notification of such assignment to Addex by the bank or the depository institution. A transfer of shares further requires that a shareholder files a share registration form in order to be registered in Addex' share register with voting rights. Failing such registration, a shareholder may not vote at or participate in a shareholders' meeting.

        A purchaser of shares will be recorded in Addex' share register as a shareholder with voting rights if the purchaser discloses its name, citizenship or registered office and address and gives a declaration that it has acquired the shares in its own name and for its own account.

        Article 5 of the Articles provides that a person or entity that does not explicitly state in its registration request that it will hold the shares for its own account (Nominee) may be entered as a shareholder in the share register with voting rights for shares up to a maximum of 5% of the share capital as set forth in the commercial register. Shares held by a Nominee that exceed this limit are only registered in the share register with voting rights if such Nominee declares in writing to disclose the name, address and shareholding of any person or legal entity for whose account it is holding 1% or more of the share capital as set forth in the commercial register. The limit of 1% shall apply correspondingly to Nominees who are related to one another through capital ownership or voting rights or have a common management or are otherwise interrelated. A share being indivisible, hence only one representative of each share will be recognized. Furthermore, shares may only be pledged in favor of the bank that administers the bank entries of such shares for the account of the pledging shareholders. If the registration of shareholdings with voting rights was effected based on false information, the Board may cancel such registration with retroactive effect.

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Convertible bonds and options

        As of September 30, 2019, we had no convertible or exchangeable bonds or loans outstanding. As of December 31, 2018, we had 5,866,898 options (warrants) outstanding which have been granted in connection with the capital increase of March 28, 2018. For each new share, the investors received 0.45 of a warrant. Each warrant entitles the investor to subscribe (which may be exercised without any specific conditions) to one registered share at a price of CHF 3.43 during a seven year period. For information on equity incentive plans for non-executive Directors, executive management and employees, refer to note 12 of the consolidated financial statements included in this registration statement.

Stock Exchange Listing

        We have applied to list American Depositary Shares, or ADSs, each representing six shares of Addex Therapeutics, Ltd on Nasdaq under the symbol "ADXN." ADSs are expected to begin trading on Nasdaq on                        , 2020. Our shares are currently listed for trading on the SIX Swiss Exchange under the ticker symbol "ADXN."

Registrar of Shares, Depositary for ADSs

        Our share register is maintained by ShareCommService AG. The share register reflects only record owners of our shares. Holders of ADSs representing our shares will not be treated as our shareholders and their names will therefore not be entered in our share register. Citibank, N.A. has agreed to act as the depositary for the ADSs representing our shares and the custodian for shares represented by ADSs is Citibank Zurich. Holders of ADSs representing our shares have a right to receive the shares underlying such ADSs. For discussion on ADSs representing our shares and rights of ADS holders, see the section entitled "Description of American Depositary Shares" in this prospectus.

Selective "opting-out"

        The shareholders have resolved to include in our Articles of Association an opting-out provision exempting Growth Equity Opportunities Fund IV, LLC, c/o New Enterprise Associates, 1954 Greenspring Drive, Suite 600, Timonium, MD 21093, and New Leaf Biopharma Opportunities I, L.P., 7 Times Square, Suite 3502, New York, NY 10036, United Stated, in each case including their direct or indirect partners or shareholders as well as any other entity or person (whether incorporated or not) that alone or together with others controls or otherwise holds any interest in them, from the duty to make a mandatory tender offer pursuant to Art. 135 of the Swiss Financial Markets Infrastructure Act (FMIA) based on Art. 125 para. 3 FMIA. The opting-out clause is limited in time and will expire on March 21, 2023, with effect for any crossing of the threshold pursuant to Art. 135 FMIA which occurs thereafter. As a result, until expiration of the opting-out clause, when exceeding the threshold of 33 1/3% of the voting rights (whether exercisable or not) of us, the investors mentioned in the opting-out clause are, when acting alone or in concert pursuant to Art. 135 FMIA, exempted from the duty pursuant to Art. 135 FMIA to make a mandatory tender offer to the other shareholders. Different from other companies listed in Switzerland which have no opting-out clause, upon reaching the threshold of 33 1/3% of our voting rights (whether exercisable or not) by the investors mentioned in the opting-out clause, the shareholders will neither benefit from the option to sell their shares in a mandatory tender offer nor from minority shareholder protection rules related to such mandatory tender offers.

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COMPARISON OF SWISS LAW AND DELAWARE LAW

        The Swiss laws applicable to Swiss corporations and their shareholders differ from laws applicable to U.S. corporations and their shareholders. The following table summarizes significant differences in shareholder rights between the provisions of the Swiss Code of Obligations (Code suisse des obligations) and the Swiss Ordinance against excessive compensation in listed stock corporations applicable to our company and the Delaware General Corporation Law applicable to companies incorporated in Delaware and their shareholders. Please note that this is only a general summary of certain provisions applicable to companies in Delaware. Certain Delaware companies may be permitted to exclude certain of the provisions summarized below in their charter documents.

DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Mergers and similar arrangements

Under the Delaware General Corporation Law, with certain exceptions, a merger, consolidation, sale, lease or transfer of all or substantially all of the assets of a corporation must be approved by the board of directors and a majority of the outstanding shares entitled to vote thereon. A shareholder of a Delaware corporation participating in certain major corporate transactions may, under certain circumstances, be entitled to appraisal rights pursuant to which such shareholder may receive cash in the amount of the fair value of the shares held by such shareholder (as determined by a court) in lieu of the consideration such shareholder would otherwise receive in the transaction. The Delaware General Corporation Law also provides that a parent corporation, by resolution of its board of directors, may merge with any subsidiary, of which it owns at least 90.0% of each class of capital stock without a vote by the shareholders of such subsidiary. Upon any such merger, dissenting shareholders of the subsidiary would have appraisal rights.

 

Under Swiss law, with certain exceptions, a merger or a division of the corporation or a sale of all or substantially all of the assets of a corporation must be approved by two-thirds of the shares represented at the relevant general meeting of shareholders as well as the absolute majority of the par value of the shares represented at such shareholders' meeting. The articles of association may increase the voting threshold. A shareholder of a Swiss corporation participating in a statutory merger or demerger pursuant to the Swiss Merger Act can file an appraisal right lawsuit against the surviving company. As a result, if the consideration is deemed "inadequate," such shareholder may, in addition to the consideration (be it in shares or in cash) receive an additional amount to ensure that such shareholder receives the fair value of the shares held by such shareholder. Swiss law also provides that a parent corporation, by resolution of its board of directors, may merge with any subsidiary, of which it owns at least 90.0% of the voting rights without a vote by shareholders of such subsidiary, if the shareholders of the subsidiary are offered the payment of the fair value in cash as an alternative to shares.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Shareholders' suits

Class actions and derivative actions generally are available to shareholders of a Delaware corporation for, among other things, breach of fiduciary duty, corporate waste and actions not taken in accordance with applicable law. In such actions, the court has discretion to permit the winning party to recover attorneys' fees incurred in connection with such action.

 

Class actions and derivative actions as such are not available under Swiss law. Nevertheless, certain actions may, to a limited extent, have a similar effect. An appraisal lawsuit won by a shareholder can be acted upon by any person who has the same legal status as the claimant. Also, a shareholder is entitled to bring suit against directors for breach of, among other things, their fiduciary duties and claim the payment of damages. However, unless the company is subject to bankruptcy proceedings, or if the relevant shareholder can demonstrate having suffered a loss in a personal capacity, a shareholder will only be allowed to ask for payment of damages to the corporation. Likewise, an appraisal lawsuit won by a shareholder may indirectly compensate all shareholders. Under Swiss law, the winning party is generally entitled to recover a limited amount of attorneys' fees incurred in connection with such action, provided, however, that the court has discretion to permit the shareholder whose claim has been dismissed to recover attorneys' fees incurred to the extent he acted in good faith.

Shareholder vote on board and management compensation

Under the Delaware General Corporation Law, the board of directors has the authority to fix the compensation of directors, unless otherwise restricted by the certificate of incorporation or bylaws.

 

Pursuant to the Swiss Ordinance against excessive compensation in listed stock corporations, the general meeting of shareholders has the non-transferable right, amongst others, to have a binding vote each year on the compensation due to the board of directors, executive management and advisory boards.

Annual vote on board renewal

Unless directors are elected by written consent in lieu of an annual meeting, directors are elected in an annual meeting of stockholders on a date and at a time designated by or in the manner provided in the bylaws. Re-election is possible.

Classified boards are permitted.


 

The general meeting of shareholders elects annually (i.e. until the end of the following annual general meeting) the members of the board of directors, the chairman of the board and the members of the compensation committee individually for a term of office of one year. Re-election is possible.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Indemnification of directors and executive management and limitation of liability
The Delaware General Corporation Law provides that a certificate of incorporation may contain a provision eliminating or limiting the personal liability of directors (but not other controlling persons) of the corporation for monetary damages for breach of a fiduciary duty as a director, except no provision in the certificate of incorporation may eliminate or limit the liability of a director for:

any breach of a director's duty of loyalty to the corporation or its shareholders;

acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;

statutory liability for unlawful payment of dividends or unlawful stock purchase or redemption; or

any transaction from which the director derived an improper personal benefit.

A Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any proceeding, other than an action by or on behalf of the corporation, because the person is or was a director or officer, against liability incurred in connection with the proceeding if the director or officer acted in good faith and in a manner reasonably believed to be in, or not opposed to, the best interests of the corporation; and the director or officer, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

Unless ordered by a court, any foregoing indemnification is subject to a determination that the director or officer has met the applicable standard of conduct:

by a majority vote of the directors who are not parties to the proceeding, even though less than a quorum;

by a committee of directors designated by a majority vote of the eligible directors, even though less than a quorum;

by independent legal counsel in a written opinion if there are no eligible directors, or if the eligible directors so direct; or

by the shareholders.

 

Under Swiss corporate law, an indemnification of a director or member of the executive management in relation to potential personal liability is not effective to the extent the director or member of the executive management intentionally or negligently violated his or her corporate duties towards the corporation (certain views advocate that at least a grossly negligent violation is required to exclude the indemnification). Furthermore, the general meeting of shareholders may discharge (release) the directors and members of the executive management from liability for their conduct to the extent the respective facts are known to shareholders. Such discharge is effective only with respect to claims of the company and of those shareholders who approved the discharge or who have since acquired their shares in full knowledge of the discharge. Most violations of corporate law are regarded as violations of duties towards the corporation rather than towards the shareholders. In addition, indemnification of other controlling persons is not permitted under Swiss corporate law, including shareholders of the corporation.

The articles of association of a Swiss corporation may also set forth that the corporation shall indemnify and hold harmless, to the extent permitted by the law, the directors and executive managers out of assets of the corporation against threatened, pending or completed actions. Also, a corporation may enter into and pay for directors' and officers' liability insurance which typically covers negligent acts as well.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Moreover, a Delaware corporation may not indemnify a director or officer in connection with any proceeding in which the director or officer has been adjudged to be liable to the corporation unless and only to the extent that the court determines that, despite the adjudication of liability but in view of all the circumstances of the case, the director or officer is fairly and reasonably entitled to indemnity for those expenses which the court deems proper.    

Directors' fiduciary duties

  

 

 
A director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components:

the duty of care; and

the duty of loyalty.

The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction. The duty of loyalty requires that a director act in a manner he reasonably believes to be in the best interests of the corporation. He must not use his corporate position for personal gain or advantage. This duty prohibits self-dealing by a director and mandates that the best interest of the corporation and its shareholders take precedence over any interest possessed by a director, officer or controlling shareholder and not shared by the shareholders generally. In general, actions of a director are presumed to have been made on an informed basis, in good faith and in the honest belief that the action taken was in the best interests of the corporation. However, this presumption may be rebutted by evidence of a breach of one of the fiduciary duties. Should such evidence be presented concerning a transaction by a director, a director must prove the procedural fairness of the transaction, and that the transaction was of fair value to the corporation.

  The board of directors of a Swiss corporation manages the business of the corporation, unless responsibility for such management has been duly delegated to the executive management based on organizational rules. However, there are several non-transferable duties of the board of directors:

the overall management of the corporation and the issuing of all necessary directives;

determination of the corporation's organization;

the organization of the accounting, financial control and financial planning systems as required for management of the corporation;

the appointment and dismissal of persons entrusted with managing and representing the corporation;

overall supervision of the persons entrusted with managing the corporation, in particular with regard to compliance with the law, articles of association, operational regulations and directives;

compilation of the annual report, preparation for the general meeting of the shareholders, the compensation report and implementation of its resolutions; and

notification of the court in the event that the company is over-indebted.

A director of a Swiss corporation has a fiduciary duty to the corporation only. This duty has two components:

the duty of care; and

the duty of loyalty.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
    The duty of care requires that a director act in good faith, with the care that an ordinarily prudent director would exercise under similar circumstances.

The duty of loyalty requires that a director safeguard the interests of the corporation and requires that directors act in the interest of the corporation and, if necessarily, put aside their own interests. If there is a risk of a conflict of interest, the board of directors must take appropriate measures to ensure that the interests of the company are duly taken into account.

The burden of proof for a violation of these duties is with the corporation or with the shareholder bringing a suit against the director.

Directors also have an obligation to treat shareholders that are in similar situations equally.


Shareholder action by written consent

A Delaware corporation may, in its certificate of incorporation, eliminate the right of shareholders to act by written consent.

 

Shareholders of a Swiss corporation may only exercise their voting rights in a general meeting of shareholders and may not act by written consents.

Shareholder proposals

A shareholder of a Delaware corporation has the right to put any proposal before the annual meeting of shareholders, provided it complies with the notice provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the governing documents, but shareholders may be precluded from calling special meetings.

 

At any general meeting of shareholders any shareholder may put proposals to the meeting if the proposal is part of an agenda item. No resolution may be taken on proposals relating to the agenda items that were not duly notified. Unless the articles of association provide for a lower threshold or for additional shareholders' rights:

 

one or several shareholders representing 10.0% of the share capital may ask that a general meeting of shareholders be called for specific agenda items and specific proposals; and

 

one or several shareholders representing 10.0% of the share capital or CHF 1.0 million of nominal share capital, whichever is lower may ask that an agenda item including a specific proposal be put on the agenda for a regularly scheduled general meeting of shareholders, provided such request is made with appropriate notice.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
    Any shareholder can propose candidates for election as directors or make other proposals within the scope of an agenda item without prior written notice.

 

 

In addition, any shareholder is entitled, at a general meeting of shareholders and without advance notice, to (1) request information from the Board on the affairs of the company (note, however, that the right to obtain such information is limited), (2) request information from the auditors on the methods and results of their audit, (3) request that the general meeting of shareholders resolve to convene an extraordinary general meeting and (4) request, under certain circumstances and subject to certain conditions, that the general meeting of shareholders resolve a special audit.

Cumulative voting

Under the Delaware General Corporation Law, cumulative voting for elections of directors is not permitted unless the corporation's certificate of incorporation provides for it.

 

Cumulative voting is not permitted under Swiss corporate law. Pursuant to Swiss law, shareholders can vote for each proposed candidate, but they are not allowed to cumulate their votes for single candidates. An annual individual election of all members of the board of directors for a term of office of one year (i.e. until the end of the following annual general meeting) is mandatory for listed companies.

Removal of directors

A Delaware corporation with a classified board may be removed only for cause with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.

 

A Swiss corporation may remove, with or without cause, any director at any time with a resolution passed by an absolute majority of the shares represented at a general meeting of shareholders concerned. The articles of association may require the approval by a qualified majority of the shares represented at a meeting for the removal of a director. Our articles of association require that a shareholder resolution to remove an acting director be passed with an absolute majority of the shares represented.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Transactions with interested shareholders

The Delaware General Corporation Law generally prohibits a Delaware corporation from engaging in certain business combinations with an "interested shareholder" for three years following the date that such person becomes an interested shareholder. An interested shareholder generally is a person or group who or which owns or owned 15.0% or more of the corporation's outstanding voting stock within the past three years.

 

No such specific rule applies to a Swiss corporation.

Dissolution; Winding up

Unless the board of directors of a Delaware corporation approves the proposal to dissolve, dissolution must be approved by shareholders holding 100.0% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority of the corporation's outstanding shares. Delaware law allows a Delaware corporation to include in its certificate of incorporation a supermajority voting requirement in connection with dissolutions initiated by the board.

 

A dissolution and winding up of a Swiss corporation requires the approval by two-thirds of the shares represented as well as the absolute majority of the par value of the shares represented at a general meeting of shareholders passing a resolution on such dissolution and winding up. The articles of association may increase the voting thresholds required for such a resolution.

Variation of rights of shares

A Delaware corporation may vary the rights of a class of shares with the approval of a majority of the outstanding shares of such class, unless the certificate of incorporation provides otherwise.

 

The general meeting of shareholders of a Swiss corporation may resolve that preference shares be issued or that existing shares be converted into preference shares with a resolution passed by a majority of the shares represented at the general meeting of shareholders. Where a company has issued preference shares, further preference shares conferring preferential rights over the existing preference shares may be issued only with the consent of both a special meeting of the adversely affected holders of the existing preference shares and of a general meeting of all shareholders, unless otherwise provided in the articles of association. The issuance of shares that are granted more voting power requires the approval by two-thirds of the shares represented as well as the absolute majority of the par value of the shares represented at the relevant general meeting of shareholders.

 

 

Shares with preferential voting rights are not regarded as preference shares for these purposes.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Amendment of governing documents

A Delaware corporation's governing documents may be amended with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.

 

The articles of association of a Swiss corporation may be amended with a resolution passed by an absolute majority of the shares represented at such meeting, unless otherwise provided in the articles of association. There are a number of resolutions, such as an amendment of the stated purpose of the corporation and the introduction of authorized and conditional capital, that require the approval by two-thirds of the votes and an absolute majority of the par value of the shares represented at a shareholders' meeting. The articles of association may increase the voting thresholds.

Inspection of books and records

Shareholders of a Delaware corporation, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose, and to obtain copies of list(s) of shareholders and other books and records of the corporation and its subsidiaries, if any, to the extent the books and records of such subsidiaries are available to the corporation.

 

Shareholders of a Swiss corporation may only inspect books and records if the general meeting of shareholders or the board of directors approved such inspection and only if confidential information possessed by a corporation is protected. A shareholder is only entitled to receive information to the extent required to exercise such shareholders' rights, subject to the interests of the corporation. The right to inspect the share register is limited to the right to inspect that shareholder's own entry in the share register.

Payment of dividends
The board of directors may approve a dividend without shareholder approval. Subject to any restrictions contained in its certificate of incorporation, the board may declare and pay dividends upon the shares of its capital stock either:

out of its surplus; or

in case there is no such surplus, out of its net profits for the fiscal year in which the dividend is declared or the preceding fiscal year.

Stockholder approval is required to authorize capital stock in excess of that provided in the charter. Directors may issue authorized shares without stockholder approval.

 

Dividend payments are subject to the approval of the general meeting of shareholders. The board of directors may propose to shareholders that a dividend shall be paid but cannot itself authorize the distribution.

Payments out of the Company's stated share capital (in other words, the aggregate par value of the Company's registered share capital) in the form of dividends are not allowed; payments out of stated share capital may be made by way of a capital reduction only. Dividends may be paid only from the profits brought forward from the previous business years or if the Company has distributable reserves, each as will be presented on the Company's audited annual stand-alone balance sheet. The dividend may be determined only after the allocations to reserves required by the law and the articles of association have been made.

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DELAWARE CORPORATE LAW   SWISS CORPORATE LAW
Creation and issuance of new shares

All creation of shares require the board of directors to adopt a resolution or resolutions, pursuant to authority expressly vested in the board of directors by the provisions of the company's certificate of incorporation.

 

All creation of shares require a shareholders' resolution. The creation of authorized or contingent share capital requires at least two-thirds of the voting rights represented at the general meeting of shareholders and an absolute majority of the nominal value of shares represented at such meeting. The board of directors may issue shares out of the authorized share capital during a period of up to two years. Shares are created and issued out of contingent share capital through the exercise of options or of conversion rights that the board of director may grant in relation to, e.g., debt instruments or employees.

Rights plans / poison pills

 

 

Under Swiss corporation law, shareholders have pre-emptive rights to subscribe for new issuances of shares. Under certain circumstances, shareholders may authorize the board of directors to limit or withdraw pre-emptive rights or advance subscription rights in certain circumstances. However, limitation or withdrawal of shareholders' pre-emptive rights can only be decided for valid reasons. Preventing a particular shareholder to exercise influence over the company is generally believed not to be a valid reason to limit or withdraw shareholders' pre-emptive rights.

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DESCRIPTION OF AMERICAN DEPOSITARY SHARES

American Depositary Shares

        Citibank, N.A., or Citibank, has agreed to act as the depositary for the ADSs representing our shares. Citibank's depositary offices are located at 388 Greenwich Street, New York, New York 10013. ADSs represent ownership interests in securities that are on deposit with the depositary. ADSs may be represented by certificates that are commonly known as American Depositary Receipts, or ADRs. The depositary typically appoints a custodian to safekeep the securities on deposit. In this case, the custodian is Citibank Zurich, located at 25 Seestrasee, 8021 Zurich, Switzerland.

        We have appointed Citibank as depositary pursuant to a deposit agreement. The form of the deposit agreement is on file with the SEC under cover of a Registration Statement on Form F-6. You may obtain a copy of the deposit agreement from the SEC's website (www.sec.gov). Please refer to Registration Number 333-                         when retrieving such copy.

        We are providing you with a summary description of the material terms of the ADSs and of your material rights as an owner of ADSs. Please remember that summaries by their nature lack the precision of the information summarized and that the rights and obligations of an owner of ADSs will be determined by reference to the terms of the deposit agreement and not by this summary. We urge you to review the deposit agreement in its entirety. The portions of this summary description that are italicized describe matters that may be relevant to the ownership of ADSs but that may not be contained in the deposit agreement.

        Each ADS represents the right to receive, and to exercise the beneficial ownership interests in, six shares that are on deposit with the depositary and/or custodian. An ADS also represents the right to receive, and to exercise the beneficial interests in, any other property received by the depositary or the custodian on behalf of the owner of the ADS but that has not been distributed to the owners of ADSs because of legal restrictions or practical considerations. We and the depositary may agree to change the ADS-to-share ratio by amending the deposit agreement. This amendment may give rise to, or change, the depositary fees payable by ADS owners. The custodian, the depositary and their respective nominees will hold all deposited property for the benefit of the holders and beneficial owners of ADSs. The deposited property does not constitute the proprietary assets of the depositary, the custodian or their nominees. Beneficial ownership in the deposited property will under the terms of the deposit agreement be vested in the beneficial owners of the ADSs. The depositary, the custodian and their respective nominees will be the record holders of the deposited property represented by the ADSs for the benefit of the holders and beneficial owners of the corresponding ADSs. A beneficial owner of ADSs may or may not be the holder of ADSs. Beneficial owners of ADSs will be able to receive, and to exercise beneficial ownership interests in, the deposited property only through the registered holders of the ADSs, the registered holders of the ADSs (on behalf of the applicable ADS owners) only through the depositary, and the depositary (on behalf of the owners of the corresponding ADSs) directly, or indirectly, through the custodian or their respective nominees, in each case upon the terms of the deposit agreement.

        If you become an owner of ADSs, you will become a party to the deposit agreement and therefore will be bound to its terms and to the terms of any ADR that represents your ADSs. The deposit agreement and the ADR specify our rights and obligations as well as your rights and obligations as owner of ADSs and those of the depositary. As an ADS holder you appoint the depositary to act on your behalf in certain circumstances. The deposit agreement, the ADRs and ADSs are governed by New York law. However, our obligations to the holders of shares will continue to be governed by the laws of Switzerland, which may be different from the laws in the United States.

        In addition, applicable laws and regulations may require you to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. You are solely responsible for complying with such

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reporting requirements and obtaining such approvals. Neither the depositary, the custodian, us or any of their or our respective agents or affiliates shall be required to take any actions whatsoever on your behalf to satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

        As an owner of ADSs, we will not treat you as one of our shareholders and you will not have direct shareholder rights. The depositary will hold on your behalf the shareholder rights attached to the shares underlying your ADSs. As an owner of ADSs you will be able to exercise the shareholders rights for the shares represented by your ADSs through the depositary only to the extent contemplated in the deposit agreement. To exercise any shareholder rights not contemplated in the deposit agreement you will, as an ADS owner, need to arrange for the cancellation of your ADSs and become a direct shareholder.

        The manner in which you own the ADSs (e.g., in a brokerage account versus as a registered holder, or as a holder of certificated versus uncertificated ADSs) may affect your rights and obligations, and the manner in which, and extent to which, the depositary's services are made available to you.

        As an owner of ADSs, you may hold your ADSs either by means of an ADR registered in your name, through a brokerage or safekeeping account, or through an account established by the depositary in your name reflecting the registration of uncertificated ADSs directly on the books of the depositary (commonly referred to as the direct registration system or DRS). The direct registration system reflects the uncertificated (book-entry) registration of ownership of ADSs by the depositary. Under the direct registration system, ownership of ADSs is evidenced by periodic statements issued by the depositary to the holders of the ADSs. The direct registration system includes automated transfers between the depositary and The Depository Trust Company, or DTC, the central book-entry clearing and settlement system for equity securities in the United States. If you decide to hold your ADSs through your brokerage or safekeeping account, you must rely on the procedures of your broker or bank to assert your rights as ADS owner. Banks and brokers typically hold securities such as the ADSs through clearing and settlement systems such as DTC. The procedures of such clearing and settlement systems may limit your ability to exercise your rights as an owner of ADSs. Please consult with your broker or bank if you have any questions concerning these limitations and procedures. All ADSs held through DTC will be registered in the name of a nominee of DTC. This summary description assumes you have opted to own the ADSs directly by means of an ADS registered in your name and, as such, we will refer to you as the "holder." When we refer to "you," we assume the reader owns ADSs and will own ADSs at the relevant time.

        The registration of the shares in the name of the depositary or the custodian shall, to the maximum extent permitted by applicable law, vest in the depositary or the custodian the record ownership in the applicable shares with the beneficial ownership rights and interests in such shares being at all times vested with the beneficial owners of the ADSs representing the shares. The depositary or the custodian shall at all times be entitled to exercise the beneficial ownership rights in all deposited property, in each case only on behalf of the holders and beneficial owners of the ADSs representing the deposited property.

Dividends and Other Distributions

        As a holder of ADSs, you generally have the right to receive the distributions we make on the securities deposited with the custodian. Your receipt of these distributions may be limited, however, by practical considerations and legal limitations. Holders of ADSs will receive such distributions under the terms of the deposit agreement in proportion to the number of ADSs held as of the specified record date, after deduction the applicable fees, taxes and expenses.

Distributions of Cash

        Whenever we make a cash distribution for the securities on deposit with the custodian, we will deposit the funds with the custodian. Upon receipt of confirmation of the deposit of the requisite

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funds, the depositary will arrange for the funds received in a currency other than U.S. dollars to be converted into U.S. dollars and for the distribution of the U.S. dollars to the holders, subject to the laws and regulations of Switzerland. The conversion into U.S. dollars will take place only if practicable and if the U.S. dollars are transferable to the United States. The depositary will apply the same method for distributing the proceeds of the sale of any property (such as undistributed rights) held by the custodian in respect of securities on deposit.

        The distribution of cash will be made net of the fees, expenses, taxes and governmental charges payable by holders under the terms of the deposit agreement. The depositary will hold any cash amounts it is unable to distribute in a non-interest bearing account for the benefit of the applicable holders and beneficial owners of ADSs until the distribution can be effected or the funds that the depositary holds must be escheated as unclaimed property in accordance with the laws of the relevant states of the United States.

Distributions of Shares

        Whenever we make a free distribution of shares for the securities on deposit with the custodian, we will deposit the applicable number of shares with the custodian. Upon receipt of confirmation of such deposit, the depositary will either distribute to holders new ADSs representing the shares deposited or modify the ADS-to-shares ratio, in which case each ADS you hold will represent rights and interests in the additional shares so deposited. Only whole new ADSs will be distributed. Fractional entitlements will be sold and the proceeds of such sale will be distributed as in the case of a cash distribution.

        The distribution of new ADSs or the modification of the ADS-to-shares ratio upon a distribution of shares will be made net of the fees, expenses, taxes and governmental charges payable by holders under the terms of the deposit agreement. In order to pay such taxes or governmental charges, the depositary may sell all or a portion of the new shares so distributed.

        No such distribution of new ADSs will be made if it would violate a law (e.g., the U.S. securities laws) or if it is not operationally practicable. If the depositary does not distribute new ADSs as described above, it may sell the shares received upon the terms described in the deposit agreement and will distribute the proceeds of the sale as in the case of a distribution of cash.

Distributions of Rights

        Whenever we intend to distribute rights to subscribe for additional shares, we will give prior notice to the depositary and we will assist the depositary in determining whether it is lawful and reasonably practicable to distribute rights to subscribe for additional ADSs to holders.

        The depositary will establish procedures to distribute rights to purchase additional ADSs to holders and to enable such holders to exercise such rights if it is lawful and reasonably practicable to make the rights available to holders of ADSs, and if we provide all of the documentation contemplated in the deposit agreement (such as opinions to address the lawfulness of the transaction). You may have to pay fees, expenses, taxes and other governmental charges to subscribe for the new ADSs upon the exercise of your rights. The depositary is not obligated to establish procedures to facilitate the distribution and exercise by holders of rights to purchase new shares other than in the form of ADSs.

        The depositary will not distribute the rights to you if:

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        The depositary will sell the rights that are not exercised or not distributed if such sale is lawful and reasonably practicable. The proceeds of such sale will be distributed to holders as in the case of a cash distribution. If the depositary is unable to sell the rights, it will allow the rights to lapse.

Elective Distributions

        Whenever we intend to distribute a dividend payable at the election of shareholders either in cash or in additional shares, we will give prior notice thereof to the depositary and will indicate whether we wish the elective distribution to be made available to you. In such case, we will assist the depositary in determining whether such distribution is lawful and reasonably practicable.

        The depositary will make the election available to you only if it is reasonably practicable and if we have provided all of the documentation contemplated in the deposit agreement. In such case, the depositary will establish procedures to enable you to elect to receive either cash or additional ADSs, in each case as described in the deposit agreement.

        If the election is not made available to you, you will receive either cash or additional ADSs, depending on what a shareholder in Switzerland would receive upon failing to make an election, as more fully described in the deposit agreement.

Other Distributions

        Whenever we intend to distribute property other than cash, shares or rights to purchase additional shares, we will notify the depositary in advance and will indicate whether we wish such distribution to be made to you. If so, we will assist the depositary in determining whether such distribution to holders is lawful and reasonably practicable.

        If it is reasonably practicable to distribute such property to you and if we provide to the depositary all of the documentation contemplated in the deposit agreement, the depositary will distribute the property to the holders in a manner it deems practicable.

        The distribution will be made net of fees, expenses, taxes and governmental charges payable by holders under the terms of the deposit agreement. In order to pay such taxes and governmental charges, the depositary may sell all or a portion of the property received.

        The depositary will not distribute the property to you and will sell the property if:

        The proceeds of such a sale will be distributed to holders as in the case of a cash distribution.

Redemption

        Whenever we decide to redeem any of the securities on deposit with the custodian, we will notify the depositary in advance. If it is practicable and if we provide all of the documentation contemplated in the deposit agreement, the depositary will provide notice of the redemption to the holders.

        The custodian will be instructed to surrender the shares being redeemed against payment of the applicable redemption price. The depositary will convert into U.S. dollars upon the terms of the deposit agreement the redemption funds received in a currency other than U.S. dollars and will establish procedures to enable holders to receive the net proceeds from the redemption upon surrender of their

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ADSs to the depositary. You may have to pay fees, expenses, taxes and other governmental charges upon the redemption of your ADSs. If less than all ADSs are being redeemed, the ADSs to be retired will be selected by lot or on a pro rata basis, as the depositary may determine.

Changes Affecting Shares

        The shares held on deposit for your ADSs may change from time to time. For example, there may be a change in nominal or par value, split-up, cancellation, consolidation or any other reclassification of such shares or a recapitalization, reorganization, merger, consolidation or sale of assets of the Company.

        If any such change were to occur, your ADSs would, to the extent permitted by law and the deposit agreement, represent the right to receive the property received or exchanged in respect of the shares held on deposit. The depositary may in such circumstances deliver new ADSs to you, amend the deposit agreement, the ADRs and the applicable Registration Statement(s) on Form F-6, call for the exchange of your existing ADSs for new ADSs and take any other actions that are appropriate to reflect as to the ADSs the change affecting the shares. If the depositary may not lawfully distribute such property to you, the depositary may sell such property and distribute the net proceeds to you as in the case of a cash distribution.

Issuance of ADSs upon Deposit of Shares

        Any shares being offered pursuant to this prospectus will be deposited by the Registered Holders named in this prospectus with the custodian. Upon receipt of confirmation of such deposit, the depositary will issue ADSs to such Registered Holders.

        The depositary may also create ADSs on your behalf if you or your broker deposit shares with the custodian. The depositary will deliver these ADSs to the person you indicate only after you pay any applicable issuance fees and any charges and taxes payable for the transfer of the shares to the custodian and provide such documentation as may be required pursuant to the deposit agreement. Your ability to deposit shares and receive ADSs may be limited by U.S. and Swiss legal considerations applicable at the time of deposit.

        The issuance of ADSs may be delayed until the depositary or the custodian receives confirmation that all required approvals have been given and that the shares have been duly transferred to the custodian. The depositary will only issue ADSs in whole numbers.

        When you make a deposit of shares, you will be responsible for transferring good and valid title to the depositary. As such, you will be deemed to represent and warrant that:

        If any of the representations or warranties are incorrect in any way, we and the depositary may, at your cost and expense, take any and all actions necessary to correct the consequences of the misrepresentations.

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Transfer, Combination and Split Up of ADRs

        As an ADR holder, you will be entitled to transfer, combine or split up your ADRs and the ADSs evidenced thereby. For transfers of ADRs, you will have to surrender the ADRs to be transferred to the depositary and also must:

        To have your ADRs either combined or split up, you must surrender the ADRs in question to the depositary with your request to have them combined or split up, and you must pay all applicable fees, charges and expenses payable by ADR holders, pursuant to the terms of the deposit agreement, upon a combination or split up of ADRs.

Withdrawal of Shares Upon Cancellation of ADSs

        As a holder, you will be entitled to present your ADSs to the depositary for cancellation and then receive the corresponding number of underlying shares at the custodian's offices. Your ability to withdraw the shares held in respect of the ADSs may be limited by U.S. and Swiss considerations applicable at the time of withdrawal. In order to withdraw the shares represented by your ADSs, you will be required to pay to the depositary the fees for cancellation of ADSs and any charges and taxes payable upon the transfer of the shares. You assume the risk for delivery of all funds and securities upon withdrawal. Once canceled, the ADSs will not have any rights under the deposit agreement.

        If you hold ADSs registered in your name, the depositary may ask you to provide proof of identity and genuineness of any signature and such other documents as the depositary may deem appropriate before it will cancel your ADSs. The withdrawal of the shares represented by your ADSs may be delayed until the depositary receives satisfactory evidence of compliance with all applicable laws and regulations. Please keep in mind that the depositary will only accept ADSs for cancellation that represent a whole number of securities on deposit.

        You will have the right to withdraw the securities represented by your ADSs at any time except as a result of:

        The deposit agreement may not be modified to impair your right to withdraw the securities represented by your ADSs except to comply with mandatory provisions of law.

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Voting Rights

        As a holder, you generally have the right under the deposit agreement to instruct the depositary to exercise the voting rights for the shares represented by your ADSs. The voting rights of holders of shares are described in "Description of Share Capital and Articles of Association" in this prospectus.

        At our request, the depositary will distribute to you any notice of shareholders' meeting received from us together with information explaining how to instruct the depositary to exercise the voting rights of the securities represented by ADSs. In lieu of distributing such materials, the depositary may distribute to holders of ADSs instructions on how to retrieve such materials upon request.

        If the depositary timely receives voting instructions from a holder of ADSs, it will endeavor, as far as practicable, subject to the laws of Switzerland and of our Articles of Association or similar documents, to vote, or have its agents vote, the securities (in person or by proxy) represented by the holder's ADSs in accordance with such voting instructions.

        Securities for which no voting instructions have been received will not be voted (except as otherwise contemplated in the deposit agreement). If the depositary timely receives voting instructions which fail to specify the manner in which the depositary is to vote the securities represented by such holder's ADSs, the depositary will deem such holder (unless otherwise specified in the notice distributed to holders or otherwise contemplated in the deposit agreement) to have instructed the depositary to take all steps necessary to enable the independent proxy holder, as elected by the shareholders of the Company, to vote in accordance with the written proposals or recommendations of the board of directors. Please note that the ability of the depositary bank to carry out voting instructions may be limited by practical and legal limitations and the terms of the securities on deposit. We cannot assure you that you will receive voting materials in time to enable you to return voting instructions to the depositary bank in a timely manner.

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Fees and Charges

        As an ADS holder, you will be required to pay the following fees under the terms of the deposit agreement:

Service
  Fee

Issuance of ADSs (e.g., an issuance of ADS upon a deposit of shares, upon a change in the ADS(s)-to-shares ratio, or for any other reason), excluding ADS issuances as a result of distributions of shares)

  Up to U.S. 5¢ per ADS issued

Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property, upon a change in the ADS(s)-to-shares ratio, or for any other reason)

 

Up to U.S. 5¢ per ADS cancelled

Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)

 

Up to U.S. 5¢ per ADS held

Distribution of ADSs pursuant to (i) stock dividends or other free stock distributions, or (ii) exercise of rights to purchase additional ADSs

 

Up to U.S. 5¢ per ADS held

Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)

 

Up to U.S. 5¢ per ADS held

ADS Services

 

Up to U.S. 5¢ per ADS held on the applicable record date(s) established by the depositary

Registration of ADS transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other reason)

 

Up to U.S. 5¢ per ADS (or fraction thereof) transferred

Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs, or upon conversion of Restricted ADSs (each as defined in the Deposit Agreement) into freely transferable ADSs, and vice versa).

 

Up to U.S. 5¢ per ADS (or fraction thereof) converted

        As an ADS holder you will also be responsible to pay certain charges such as:

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        ADS fees and charges for (i) the issuance of ADSs, and (ii) the cancellation of ADSs are charged to the person for whom the ADSs are issued (in the case of ADS issuances) and to the person for whom ADSs are cancelled (in the case of ADS cancellations). In the case of ADSs issued by the depositary into DTC, the ADS issuance and cancellation fees and charges may be deducted from distributions made through DTC, and may be charged to the DTC participant(s) receiving the ADSs being issued or the DTC participant(s) holding the ADSs being cancelled, as the case may be, on behalf of the beneficial owner(s) and will be charged by the DTC participant(s) to the account of the applicable beneficial owner(s) in accordance with the procedures and practices of the DTC participants as in effect at the time. ADS fees and charges in respect of distributions and the ADS service fee are charged to the holders as of the applicable ADS record date. In the case of distributions of cash, the amount of the applicable ADS fees and charges is deducted from the funds being distributed. In the case of (i) distributions other than cash and (ii) the ADS service fee, holders as of the ADS record date will be invoiced for the amount of the ADS fees and charges and such ADS fees and charges may be deducted from distributions made to holders of ADSs. For ADSs held through DTC, the ADS fees and charges for distributions other than cash and the ADS service fee may be deducted from distributions made through DTC, and may be charged to the DTC participants in accordance with the procedures and practices prescribed by DTC and the DTC participants in turn charge the amount of such ADS fees and charges to the beneficial owners for whom they hold ADSs. In the case of (i) registration of ADS transfers, the ADS transfer fee will be payable by the ADS Holder whose ADSs are being transferred or by the person to whom the ADSs are transferred, and (ii) conversion of ADSs of one series for ADSs of another series, the ADS conversion fee will be payable by the Holder whose ADSs are converted or by the person to whom the converted ADSs are delivered.

        In the event of refusal to pay the depositary fees, the depositary may, under the terms of the deposit agreement, refuse the requested service until payment is received or may set off the amount of the depositary fees from any distribution to be made to the ADS holder.

        Note that the fees and charges you may be required to pay may vary over time and may be changed by us and by the depositary. You will receive prior notice of such changes. The depositary may reimburse us for certain expenses incurred by us in respect of the ADR program, by making available a portion of the ADS fees charged in respect of the ADR program or otherwise, upon such terms and conditions as we and the depositary agree from time to time.

Amendments and Termination

        We may agree with the depositary to modify the deposit agreement at any time without your consent. We undertake to give holders 30 days' prior notice of any modifications that would materially prejudice any of their substantial rights under the deposit agreement. We will not consider to be materially prejudicial to your substantial rights any modifications or supplements that are reasonably necessary for the ADSs to be registered under the Securities Act or to be eligible for book-entry settlement, in each case without imposing or increasing the fees and charges you are required to pay. In addition, we may not be able to provide you with prior notice of any modifications or supplements that are required to accommodate compliance with applicable provisions of law.

        You will be bound by the modifications to the deposit agreement if you continue to hold your ADSs after the modifications to the deposit agreement become effective. The deposit agreement cannot

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be amended to prevent you from withdrawing the shares represented by your ADSs (except as permitted by law).

        We have the right to direct the depositary to terminate the deposit agreement. Similarly, the depositary may in certain circumstances on its own initiative terminate the deposit agreement. In either case, the depositary must give notice to the holders at least 30 days before termination. Until termination, your rights under the deposit agreement will be unaffected.

Termination

        After termination, the depositary will continue to collect distributions received (but will not distribute any such property until you request the cancellation of your ADSs) and may sell the securities held on deposit. After the sale, the depositary will hold the proceeds from such sale and any other funds then held for the holders of ADSs in a non-interest bearing account. At that point, the depositary will have no further obligations to ADS holders other than to account for the funds then held for the holders of ADSs still outstanding (after deduction of applicable fees, taxes and expenses).

        In connection with any termination of the deposit agreement, the depositary may make available to owners of ADSs a means to withdraw the shares represented by their ADSs and to direct the depositary of such shares into an unsponsored American depositary share program established by the depositary. The ability to receive unsponsored American depositary shares upon termination of the deposit agreement would be subject to satisfaction of certain U.S. regulatory requirements applicable to the creation of unsponsored American depositary shares and the payment of applicable depositary fees.

Books of Depositary

        The depositary will maintain ADS holder records at its depositary office. You may inspect such records at such office during regular business hours but solely for the purpose of communicating with other holders in the interest of business matters relating to the ADSs and the deposit agreement.

        The depositary will maintain in New York facilities to record and process the issuance, cancellation, combination, split-up and transfer of ADSs. These facilities may be closed from time to time, to the extent not prohibited by law.

Limitations on Obligations and Liabilities

        The deposit agreement limits our obligations and the depositary's obligations to you. Please note the following:

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Taxes

        You will be responsible for the taxes and other governmental charges payable on the ADSs and the securities represented by the ADSs. We, the depositary and the custodian may deduct from any distribution the taxes and governmental charges payable by holders and may sell any and all property on deposit to pay the taxes and governmental charges payable by holders. You will be liable for any deficiency if the sale proceeds do not cover the taxes that are due.

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        The depositary may refuse to issue ADSs, to deliver, transfer, split and combine ADRs or to release securities on deposit until all taxes and charges are paid by the applicable holder. The depositary and the custodian may take reasonable administrative actions to obtain tax refunds and reduced tax withholding for any distributions on your behalf. However, you may be required to provide to the depositary and to the custodian proof of taxpayer status and residence and such other information as the depositary and the custodian may require to fulfill legal obligations. You are required to indemnify us, the depositary and the custodian for any claims with respect to taxes based on any tax benefit obtained for you.

Foreign Currency Conversion

        The depositary will arrange for the conversion of all foreign currency received into U.S. dollars if such conversion is practical, and it will distribute the U.S. dollars in accordance with the terms of the deposit agreement. You may have to pay fees and expenses incurred in converting foreign currency, such as fees and expenses incurred in complying with currency exchange controls and other governmental requirements.

        If the conversion of foreign currency is not practical or lawful, or if any required approvals are denied or not obtainable at a reasonable cost or within a reasonable period, the depositary may take any of the following actions in its discretion:

Governing Law / Waiver of Jury Trial

        The deposit agreement and the ADRs and ADSs will be interpreted in accordance with the laws of the State of New York. The rights of holders of shares (including shares represented by ADSs) are governed by the laws of Switzerland. As an owner of ADSs, you irrevocably agree that any legal action arising out of the Deposit Agreement, the ADSs or the ADRs, involving the Company or the Depositary, may only be instituted in a state or federal court in the city of New York.

        AS A PARTY TO THE DEPOSIT AGREEMENT, YOU IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, YOUR RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF THE DEPOSIT AGREEMENT OR THE ADRs AGAINST US AND/OR THE DEPOSITARY.

        The deposit agreement provides that, to the extent permitted by law, ADS holders waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares, the ADSs or the deposit agreement, including any claim under U.S. federal securities laws. If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable in the facts and circumstances of that case in accordance with applicable case law. However, you will not be deemed, by agreeing to the terms of the deposit agreement, to have waived our or the depositary's compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.

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SHARES AND ADSs ELIGIBLE FOR FUTURE SALE

        Although our shares are currently listed for trading on SIX, to date there has not been any market for ADSs representing our shares. Future sales of substantial amounts of ADSs representing our shares in the United States or of our shares in Switzerland, or the perception that such sales may occur, could adversely affect prevailing market prices of such ADSs and of our shares. As of September 30, 2019, we had outstanding 32,848,645 shares and no ADSs representing our shares. Upon the effectiveness of the registration statement of which this prospectus forms a part, holders of shares registered hereby are expected to be able to deposit such shares with the depositary in exchange for ADSs representing such shares at the ratio referred to on the cover page of this prospectus, which ADSs will be freely tradeable. Holders of issued but unexercised options and warrants to purchase our shares not registered hereby will have to comply with one of the exceptions from U.S. registration requirements set forth below in order to exchange any shares issued upon exercise thereof.

Rule 144

        In general, a person who has beneficially owned our unregistered shares for at least six months would be entitled to sell ADSs representing our shares pursuant to Rule 144 of the Securities Act, provided that (1) such person is not deemed to have been one of our affiliates at the time of, or at any time during the 90 days preceding, a sale and (2) we are subject to Exchange Act periodic reporting requirements for at least 90 days before the sale. Persons who are our affiliates at the time of, or any time during the 90 days preceding, a sale of ADSs representing such shares, are subject to additional restrictions, as follows:

provided that, in each case, that we are subject to the Exchange Act periodic reporting requirements for at least 90 days before the sale. Such sales by affiliates must also comply with the manner of sale, current public information and notice provisions of Rule 144 to the extent applicable.

        Prior to the 90th day following the effective date of the registration statement of which this prospectus forms a part when we become subject to the Exchange Act periodic reporting requirements, non-affiliates who have not been affiliates of ours within the 90 days preceding the sale and who acquired their securities at least one year following their sale by us or our affiliates, may freely resell such securities under Rule 144.

Rule 701

        In general, under Rule 701 under the Securities Act, any of our employees, board members, senior management, consultants or advisors who purchases shares from us in connection with a compensatory share or option plan or other written agreement before the effective date of the registration statement of which this prospectus forms a part, or the effective date, is entitled to resell such shares 90 days after the effective date in reliance on Rule 144, without having to comply with the holding period requirements or other restrictions contained in Rule 701. The SEC has indicated that Rule 701 will apply to typical share options granted by an issuer before it becomes subject to the reporting requirements of the Exchange Act, along with the shares acquired upon exercise of such options, including exercises after the date of this prospectus. Securities issued in reliance on Rule 701 are

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restricted securities and, beginning 90 days after the date of this prospectus, may be sold by persons other than "affiliates," as defined in Rule 144, subject only to the manner of sale provisions of Rule 144 and by affiliates under Rule 144 without compliance with the holding period requirement.

Regulation S

        Regulation S provides generally that sales made in offshore transactions, including on SIX, as well as the resale of any such securities issued by foreign private issuers such as us (including resales into the United States) are not subject to the registration or prospectus delivery requirements of the Securities Act.

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MATERIAL INCOME TAX CONSIDERATIONS

        The following summary contains a description of material Swiss and U.S. federal income tax consequences of the acquisition, ownership and disposition of our shares or ADSs representing our shares. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to the decision to acquire ADSs representing our shares.

Material U.S. Federal Income Tax Considerations for U.S. Holders

        The following is a description of the material U.S. federal income tax consequences to the U.S. Holders described below of acquiring, owning and disposing of our shares or ADSs representing our shares. It is not a comprehensive description of all tax considerations that may be relevant to a particular person's decision to acquire securities. This discussion applies only to U.S. Holders that are initial purchasers of our ADSs representing our shares and that will hold such ADSs as a capital asset for tax purposes (generally, property held for investment). In addition, it does not describe all of the tax consequences that may be relevant in light of a U.S. Holder's particular circumstances, including state and local tax consequences, estate tax consequences, alternative minimum tax consequences, the potential application of the Medicare contribution tax, and tax consequences applicable to U.S. Holders subject to special rules, such as:

        Holders of our shares or ADSs representing our shares who fall within one of the categories above are advised to consult their tax advisor regarding the specific tax consequences which may apply to their particular situation.

        If an entity that is classified as a partnership for U.S. federal income tax purposes holds our shares or ADSs representing our shares, the U.S. federal income tax treatment of a partner will generally

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depend on the status of the partner and the activities of the partnership. Partnerships holding our shares or ADSs representing our shares and partners in such partnerships are encouraged to consult their tax advisers as to the particular U.S. federal income tax consequences of holding and disposing of such shares or ADSs representing our shares.

        The discussion is based on the Internal Revenue Code of 1986, as amended, or the Code, administrative pronouncements, judicial decisions, final, temporary and proposed Treasury Regulations, and the Convention between the United States of America and the Swiss Confederation for the Avoidance of Double Taxation with Respect to Taxes on Income, signed on October 2, 1996, as amended and currently in force, or the U.S.-Swiss Tax Treaty, in each case, as in effect and available on the date hereof. All of the foregoing are subject to change, which change could apply retroactively, and to differing interpretations, all of which could affect the tax considerations described below. There can be no assurances that the U.S. Internal Revenue Service, or the IRS, will not take a position concerning the tax consequences of the acquisition, ownership and disposition of our shares or ADSs representing our shares or that such a position would not be sustained by a court. We have not obtained, nor do we intend to obtain, a ruling with respect to the U.S. federal income tax considerations in the purchase, ownership or disposition of our shares or ADSs representing our shares. Accordingly, holders should consult their own tax advisors concerning the U.S. federal, state, local and non-U.S. tax consequences of acquiring, owning and disposing of our shares or ADSs representing our shares in their particular circumstances.

        A "U.S. Holder" is a holder who, for U.S. federal income tax purposes, is a beneficial owner of our shares or ADSs representing our shares who is eligible for the benefits of the U.S.-Swiss Tax Treaty and is:

        U.S. Holders are encouraged to consult their tax advisers concerning the U.S. federal, state, local and foreign tax consequences of owning and disposing of our shares or ADSs representing our shares in their particular circumstances.

        The discussion below assumes that the representations contained in the deposit agreement are true and that the obligations in the deposit agreement and any related agreement will be complied with in accordance with their terms. Generally, a holder of an ADS should be treated for U.S. federal income tax purposes as holding the shares represented by the ADS. Accordingly, no gain or loss will be recognized upon an exchange of ADSs representing our shares for shares. The U.S. Treasury has expressed concerns that intermediaries in the chain of ownership between the holder of an ADS and the issuer of the security underlying the ADS may be taking actions that are inconsistent with the beneficial ownership of the underlying security. Accordingly the creditability of foreign taxes, if any, as described below, could be affected by actions taken by intermediaries in the chain of ownership between the holders of ADSs representing our shares and our company if, as a result of such actions, the holders of ADSs representing our shares are not properly treated as beneficial owners of the underlying shares.

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Passive Foreign Investment Company Rules

        Based on our analysis of our income, assets, activities and market capitalization for our taxable year ended December 31, 2018, we believe that we are classified as a "passive foreign investment company," or PFIC, for our taxable year ended December 31, 2018. Based on the expected nature and composition of our income, assets, activities and market capitalization for our taxable year ending December 31, 2019, we anticipate that we may be classified as a PFIC for our taxable year ending December 31, 2019. The application of the PFIC rules is subject to uncertainty in several respects, and therefore, no assurances can be provided with respect to our PFIC status for our taxable year ended December 31, 2018 or with regard to our PFIC status in the past or in the future. If we are classified as a PFIC in any taxable year, a U.S. Holder will be subject to special rules generally intended to reduce or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. Holder could derive from investing in a non-U.S. company that does not distribute all of its earnings on a current basis.

        A non-U.S. corporation will be classified as a PFIC for any taxable year in which, after applying certain look-through rules with respect to the income and assets of its subsidiaries, either:

        For this purpose, cash is a passive asset and passive income generally includes dividends, interest, royalties and rents (other than royalties and rents derived in the active conduct of a trade or business and not derived from a related person). We will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation, the equity of which we own, directly or indirectly, 25% or more (by value).

        The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation. If we are a PFIC for any taxable year during which a U.S. Holder holds our shares or ADSs representing our shares, such U.S. Holder will be subject to special tax rules discussed below and could suffer adverse tax consequences.

        A separate determination must be made after the close of each taxable year as to whether we are a PFIC for that year. As a result, our PFIC status may change from year to year. The total value of our assets for purposes of the asset test generally will be calculated using the market price of our shares or ADSs representing our shares, which may fluctuate considerably. Fluctuations in the market price of the shares or ADSs representing our shares may result in our being a PFIC for any taxable year. Because of the uncertainties involved in establishing our PFIC status, our United States tax counsel expresses no opinion regarding our PFIC status.

        If we are classified as a PFIC in any year with respect to which a U.S. Holder owns our shares or ADSs representing our shares, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the shares or ADSs representing our shares, regardless of whether we continue to meet the tests described above unless (i) we cease to be a PFIC and the U.S. Holder has made a "deemed sale" election under the PFIC rules, or (ii) the U.S. Holder makes a "QEF Election" (defined below) or is eligible to make and makes a mark-to-market election (as described below), with respect to all taxable years during such U.S. Holder's holding period in which we are a PFIC. If the "deemed sale" election is made, a U.S. Holder will be deemed to have sold the shares or ADSs representing our shares the U.S. Holder holds at their fair market value as of the date of such deemed sale and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the U.S. Holder's shares or ADSs representing our shares with respect to which such election was made will not be treated as shares in a PFIC and the U.S. Holder will not be subject to

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the rules described below with respect to any "excess distribution" the U.S. Holder receives from us or any gain from an actual sale or other disposition of the shares or ADSs representing our shares. U.S. Holders should consult their tax advisors as to the possibility and consequences of making a deemed sale election if such election becomes available.

        For each taxable year we are treated as a PFIC with respect to U.S. Holders, U.S. Holders will be subject to special tax rules with respect to any "excess distribution" such U.S. Holder receives and any gain such U.S. Holder recognizes from a sale or other disposition (including a pledge) of our shares or ADSs representing our shares, unless (i) such U.S. Holder makes a QEF Election or (ii) our shares or ADSs representing our shares constitute "marketable" securities, and such U.S. Holder makes a mark-to-market election as discussed below. Distributions a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions a U.S. Holder received during the shorter of the three preceding taxable years or the U.S. Holder's holding period for the shares or ADSs representing our shares will be treated as an excess distribution. Under these special tax rules:

        The tax liability for amounts allocated to years prior to the year of disposition or "excess distribution" cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale of the shares or ADSs representing our shares cannot be treated as capital gains, even if a U.S. Holder holds the shares or ADSs representing our shares as capital assets. In addition, dividend distributions made to you will not qualify for the lower rates of taxation applicable to qualified dividends discussed below under "Taxation of Distributions."

        If we are a PFIC, a U.S. Holder will generally be subject to similar rules with respect to distributions we receive from, and our dispositions of the stock of, any of our direct or indirect subsidiaries that also are PFICs, as if such distributions were indirectly received by, and / or dispositions were indirectly carried out by, such U.S. Holder. U.S. Holders should consult their tax advisors regarding the application of the PFIC rules to our subsidiaries.

        U.S. Holders can avoid the interest charge on excess distributions or gain relating to our shares or ADSs representing our shares by making a mark-to-market election with respect to the shares or ADSs representing our shares, provided that the shares or ADSs representing our shares are "marketable." Shares or ADSs representing our shares will be marketable if they are "regularly traded" on certain U.S. stock exchanges or on a foreign stock exchange that meets certain conditions. For these purposes, the shares or ADSs representing our shares will be considered regularly traded during any calendar year during which they are traded on, other than in de minimis quantities, at least 15 days during each calendar quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. Our ADSs representing our shares will be listed on Nasdaq, which is a qualified exchange for these purposes. Consequently, if our ADSs representing our shares remain listed on Nasdaq and are regularly traded, and you are a U.S. Holder of ADSs representing our shares, we expect the mark-to-market election would be available to you if we are a PFIC. Each U.S. Holder should consult its tax advisor as to the whether a mark-to-market election is available or advisable with respect to the shares or ADSs representing our shares. It should be noted that it is intended that only our ADSs representing our shares and not our shares will be listed on Nasdaq. Consequently, our shares may not be marketable if SIX Swiss Exchange (where our shares are listed) does not meet the applicable

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requirements. U.S. Holders should consult their tax advisors regarding the availability of the mark-to-market election for shares that are not represented by ADSs.

        A U.S. Holder that makes a mark-to-market election must include in ordinary income for each year an amount equal to the excess, if any, of the fair market value of our shares or ADSs representing our shares at the close of the taxable year over the U.S. Holder's adjusted tax basis in the shares or ADSs representing our shares. An electing holder may also claim an ordinary loss deduction for the excess, if any, of the U.S. Holder's adjusted basis in the shares or ADSs representing our shares over the fair market value of the shares or ADSs representing our shares at the close of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains for prior years. Gains from an actual sale or other disposition of the shares or ADSs representing our shares will be treated as ordinary income, and any losses incurred on a sale or other disposition of the shares will be treated as an ordinary loss to the extent of any net mark-to-market gains for prior years. Once made, the election cannot be revoked without the consent of the IRS unless the shares or ADSs representing our shares cease to be marketable.

        However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower-tier PFIC are themselves "marketable." As a result, even if a U.S. Holder validly makes a mark-to-market election with respect to our shares or ADSs representing our shares, the U.S. Holder may continue to be subject to the PFIC rules (described above) with respect to its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. U.S. Holders should consult their tax advisors as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.

        Alternatively, a U.S. Holder can make an election, if we provide the necessary information, to treat us and each lower-tier PFIC as a qualified electing fund, or a QEF Election, in the first taxable year we (and our relevant subsidiaries) are treated as a PFIC with respect to the U.S. Holder. If such election remains in place while we and any lower-tier PFIC subsidiaries are PFICs, we and our subsidiaries will not be treated as PFICs with respect to such U.S. Holder. A U.S. Holder must make the QEF Election for us and for each of our subsidiaries that is a PFIC by attaching a separate properly completed IRS Form 8621 for each such PFIC to the U.S. Holder's timely filed U.S. federal income tax return. If we are a PFIC for our taxable year ending December 31, 2019, or any subsequent taxable years, we expect to provide U.S. Holders, upon request, a "PFIC Annual Information Statement", with the information required to allow U.S. Holders to make a QEF Election for United States federal income tax purposes.

        If a U.S. Holder makes a QEF Election with respect to a PFIC in lieu of the tax consequences described above, the U.S. Holder will be currently taxable on its pro rata share of the PFIC's ordinary earnings and net capital gain (at ordinary income and capital gain rates, respectively) for each taxable year that the entity is classified as a PFIC. If a U.S. Holder makes a QEF Election with respect to us, any distributions paid by us out of our earnings and profits that were previously included in the U.S. Holder's income under the QEF Election would not be taxable to the holder. A U.S. Holder will increase its tax basis in its shares or ADSs representing our shares by an amount equal to any income included under the QEF Election and will decrease its tax basis by any amount distributed on the shares or ADSs representing our shares that is not included in the holder's income. In addition, a U.S. Holder will recognize capital gain or loss on the disposition of shares or ADSs representing our shares in an amount equal to the difference between the amount realized and the holder's adjusted tax basis in the shares or ADSs representing our shares. U.S. Holders should note that if they make QEF Elections with respect to us and lower-tier PFICs, they may be required to pay U.S. federal income tax with respect to their shares or ADSs representing our shares for any taxable year significantly in excess of any cash distributions (which may be zero) received on the shares or ADSs representing our shares for such taxable year. U.S. Holders should consult their tax advisors regarding making QEF Elections

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in their particular circumstances. If a U.S. Holder does not make and maintain a QEF election for the U.S. Holder's entire holding period for the shares or ADSs representing our shares by making the election for the first year in which the U.S. Holder owns the shares or ADSs representing our shares, the U.S. Holder will be subject to the adverse PFIC rules discussed above unless the U.S. Holder can properly make a 'purging election' with respect to the shares or ADS representing our shares in connection with the U.S. Holder's QEF Election. A purging election may require the U.S. Holder to recognize taxable gain on the U.S. Holder's shares or ADSs representing our shares. No purging election is necessary for a U.S. Holder that timely makes a QEF election for the first year in which the U.S. Holder acquired our shares or ADSs representing our shares.

The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urged to consult their own tax advisors with respect to the acquisition, ownership and disposition of our shares or ADSs representing our shares, the consequences to them of an investment in a PFIC, any elections available with respect to our shares or ADSs representing our shares and the IRS information reporting obligations with respect to the acquisition, ownership and disposition of our shares or ADSs representing our shares.

Taxation of Distributions

        Subject to the discussion above under "Passive Foreign Investment Company Rules," distributions paid on our shares or ADSs representing our shares will generally be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we may not calculate our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders as dividends. Subject to applicable limitations, dividends paid to certain non-corporate U.S. Holders may be taxable at preferential rates applicable to "qualified dividend income" if we are a "qualified foreign corporation" and certain other requirements (discussed below) are met. A non-U.S. corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange of information provision, or (b) with respect to any dividend it pays on ADSs representing our shares which are readily tradable on an established securities market in the United States. We have applied to list our ADSs representing our shares on Nasdaq, which is an established securities market in the United States, and we expect the ADSs representing our shares to be readily tradable on Nasdaq. There can be no assurance that the ADSs representing our shares will be considered readily tradable on an established securities market in the United States in later years. The Company, which is incorporated under the laws of Switzerland, believes that it qualifies as a resident of Switzerland for purposes of, and is eligible for the benefits of, the U.S.-Swiss Tax Treaty, although there can be no assurance in this regard. Further, the IRS has determined that the U.S.-Swiss Tax Treaty is satisfactory for purposes of the qualified dividend rules and that it includes an exchange-of-information program. Therefore, subject to the discussion under "Passive Foreign Investment Company Rules," above, such dividends will generally be "qualified dividend income" in the hands of individual U.S. Holders, provided that a holding period requirement (more than 60 days of ownership, without protection from the risk of loss, during the 121-day period beginning 60 days before the ex-dividend date) and certain other requirements are met. The dividends will not be eligible for the dividends-received deduction generally allowed to corporate U.S. holders.

        However, the qualified dividend income treatment will not apply if we are treated as a PFIC. In addition, the amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will generally be included in a U.S. Holder's income on the date of the U.S.

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Holder's receipt of the dividend. The amount of any dividend income paid in foreign currency will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt. Such gain or loss would generally be treated as U.S.-source ordinary income or loss. The amount of any distribution of property other than cash generally will be the fair market value of such property on the date of distribution.

        A U.S. Holder generally may claim the amount of any Swiss withholding tax as either a deduction from gross income or a credit against its U.S. federal income tax liability. The foreign tax credit is subject to numerous complex limitations that must be determined and applied on an individual basis. Generally, the credit cannot exceed the proportionate share of a U.S. Holder's U.S. federal income tax liability that such U.S. Holder's taxable income bears to such U.S. Holder's worldwide taxable income. In applying this limitation, a U.S. Holder's various items of income and deduction must be classified, under complex rules, as either "foreign source" or "U.S. source." In addition, the creditability of foreign taxes could be affected by actions taken by intermediaries in the chain of ownership between the holders of our shares or ADSs representing our shares and our company if, as a result of such actions, the holders of our shares or ADSs representing our shares are not properly treated as beneficial owners of the underlying shares. Each U.S. Holder should consult its own tax advisors regarding the foreign tax credit rules.

Sale or Other Taxable Disposition of Shares and ADSs Representing Our Shares

        Subject to the discussion above under "Passive Foreign Investment Company Rules," gain or loss realized on the sale or other taxable disposition of our shares or ADSs representing our shares will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder held the shares or ADSs representing our shares for more than one year. The amount of the gain or loss will equal the difference between the U.S. Holder's adjusted tax basis in the shares or ADSs representing our shares disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. The adjusted tax basis in our shares or ADSs representing our shares generally will be equal to the cost of such shares or ADSs. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to limitations.

        If the consideration received by a U.S. Holder is not paid in U.S. dollars, the amount realized will be the U.S. dollar value of the payment received determined by reference to the spot rate of exchange on the date of the sale or other disposition. However, if the shares or ADSs representing our shares are treated as traded on an "established securities market" and you are either a cash basis taxpayer or an accrual basis taxpayer that has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS), you will determine the U.S. dollar value of the amount realized in a non-U.S. dollar currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If you are an accrual basis taxpayer that is not eligible to or does not elect to determine the amount realized using the spot rate on the settlement date, you will recognize foreign currency gain or loss to the extent of any difference between the U.S. dollar amount realized on the date of sale or disposition and the U.S. dollar value of the currency received at the spot rate on the settlement date.

Information Reporting and Backup Withholding

        U.S. Holders generally will be subject to information reporting requirements with respect to dividends on our shares or ADSs representing our shares and on the proceeds from the sale, exchange or disposition of our shares or ADSs representing our shares that are paid within the United States or

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through certain U.S.-related financial intermediaries, unless the U.S. Holder is an "exempt recipient." In addition, U.S. Holders may be subject to backup withholding on such payments, unless the U.S. Holder provides a correct taxpayer identification number and a duly executed IRS Form W-9 or otherwise establishes an exemption. Backup withholding is not an additional tax, and the amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against a U.S. Holder's U.S. federal income tax liability and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.

Certain Reporting Requirements

        U.S. Holders paying more than $100,000 for our shares or ADSs representing our shares generally may be required to file IRS Form 926 reporting the payment of the offer price for our shares or ADSs representing our shares to us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. Each U.S. Holder should consult its own tax advisor as to the possible obligation to file IRS Form 926.

Information with Respect to Foreign Financial Assets

        Certain U.S. Holders who are individuals (and, under regulations, certain entities) may be required to report information relating to our shares or ADSs representing our shares, subject to certain exceptions (including an exception for shares or ADSs representing our shares held in accounts maintained by certain U.S. financial institutions). Such U.S. Holders who fail to timely furnish the required information may be subject to a penalty. Additionally, if a U.S. Holder does not file the required information, the statute of limitations with respect to tax returns of the U.S. Holder to which the information relates may not close until three years after such information is filed. U.S. Holders should consult their tax advisers regarding their reporting obligations with respect to their ownership and disposition of our shares or ADSs representing our shares.

Swiss Tax Considerations

Swiss Federal, Cantonal and Communal Individual Income Tax and Corporate Income Tax

Non-Resident Shareholders

        Holders of or shares or ADSs representing our shares who are not resident in Switzerland for tax purposes, and who, during the relevant taxation year, have not engaged in a trade or business carried on through a permanent establishment or fixed place of business situated in Switzerland for tax purposes (all such shareholders are hereinafter referred to as the "Non-Resident Shareholders"), will not be subject to any Swiss federal, cantonal and communal income tax on dividends and similar cash or in-kind distributions on ADSs representing our shares (including dividends on liquidation proceeds and stock dividends) (hereinafter referred to as the "Dividends"), distributions based upon a capital reduction (Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen) on shares underlying the ADSs, or capital gains realized on the sale or other disposition of ADSs (see, however, paragraph 1.3 "Swiss Federal Withholding Tax" for a summary of Swiss federal withholding tax on Dividends).

Resident Private Shareholders

        Swiss resident individuals who hold their ADSs as private assets all such shareholders are hereinafter referred to as the "Resident Private Shareholders") are required to include Dividends, but not distributions based upon a capital reduction (Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen) of the shares underlying the ADSs, in their personal income tax return and are subject to Swiss federal, cantonal and communal income tax on any net taxable income for the relevant taxation period, including the Dividends, but not the distributions based

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upon a capital reduction (Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen). Capital gains resulting from the sale or other dispositions of ADSs are not subject to Swiss federal, cantonal and communal income tax, and conversely, capital losses are not tax-deductible for Resident Private Shareholders. See paragraph 1.1(C) "Domestic Commercial Shareholders" for a summary of the taxation treatment applicable to Swiss resident individuals, who, for income tax purposes, are classified as "professional securities dealers".

(C) Domestic Commercial Shareholders

        Corporate and individual shareholders who are resident in Switzerland for tax purposes and corporate and individual shareholder who are not resident in Switzerland, and who, in each case, hold their ADSs as part of a trade or business carried on in Switzerland, in the case of corporate and individual shareholders not resident in Switzerland, through a permanent establishment or fixed place of business situated, for tax purposes, in Switzerland, are required to recognize Dividends, distributions based upon a capital reduction (Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen) received on shares underlying the ADSs and capital gains or losses realized on the sale or other disposition of ADSs in their income statement for the relevant taxation period and are subject to Swiss federal, cantonal and communal individual or corporate income tax, as the case may be, on any net taxable earnings for such taxation period. The same taxation treatment also applies to Swiss-resident private individuals who, for income tax purposes, are classified as "professional securities dealers" for reasons of, inter alia, frequent dealing, or leveraged investments in ADSs and other securities (the shareholders referred to in this paragraph 1.1.(C), hereinafter for the purposes of this section, as the "Domestic Commercial Shareholders"). Domestic Commercial Shareholders who are corporate taxpayers may be eligible for dividend relief (Beteiligungsabzug) in respect of Dividends and distributions based upon a capital reduction (Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen) if the shares underlying the ADSs held by them as part of a Swiss business have an aggregate market value of at least CHF 1 million.

Swiss Cantonal and Communal Private Wealth Tax and Capital Tax

Non-Resident Shareholders

        Non-Resident Shareholders are not subject to Swiss cantonal and communal private wealth tax or capital tax.

Resident Private Shareholders and Domestic Commercial Shareholders

        Resident Private Shareholders and Domestic Commercial Shareholders who are individuals are required to report their ADSs as part of private wealth or their Swiss business assets, as the case may be, and will be subject to Swiss cantonal and communal private wealth tax on any net taxable wealth (including the ADSs), in the case of Domestic Commercial Shareholders to the extent the aggregate taxable wealth is allocated in Switzerland. Domestic Commercial Shareholders who are corporate taxpayers are subject to Swiss cantonal and communal capital tax on taxable capital to the extent the aggregate taxable capital is allocated to Switzerland.

Swiss Federal Withholding Tax

        Dividends that the Company pays on the shares underlying the ADSs are subject to Swiss Federal withholding tax (Verrechnungssteuer) at a rate of 35% on the gross amount of the Dividend. The Company is required to withhold the Swiss federal withholding tax from the Dividend and remit it to the Swiss Federal Tax Administration. Distributions based upon a capital reduction

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(Nennwertrückzahlungen) or paid out of reserves from capital contributions (Reserven aus Kapitaleinlagen) are not subject to Swiss federal withholding tax.

        The Swiss federal withholding tax on a Dividend will be refundable in full to a Resident Private Shareholder and to a Domestic Commercial Shareholder, who, in each case, inter alia, as a condition to refund, duly reports the Dividend in his or her individual income tax return as income or recognizes the Dividends in its income statement as earnings, as applicable.

        A Non-Resident Shareholder may be entitled to a partial refund of the Swiss federal withholding tax on Dividend if the country of his or her residence for tax purposes has entered into a bilateral treaty for the avoidance of double taxation with Switzerland and the conditions of such treaty are met. Such shareholders should be aware that the procedures for claiming tax treaty benefits (and the time required for obtaining a refund) might be different from country to country. For example, a shareholder who is resident of the U.S. for the purposes of the bilateral treaty between the U.S. and Switzerland is eligible for a refund of the amount of the withholding tax in excess of the 15% treaty rate, provided such shareholder: (i) qualifies for benefits under this treaty and qualifies as beneficial owner of the Dividends; (ii) hold, directly or indirectly, less than 10% of the voting stock of the Company; (iii) does not qualify as a pension scheme or retirement arrangement for the purpose of the bilateral treaty; and (iv) does not conduct business through a permanent establishment or fixed base in Switzerland to which the ADSs are attributable. Such an eligible U.S. shareholder may apply for a refund of the amount of the withholding tax in excess of the 15% treaty rate. The applicable refund request form may be filed with the Swiss Federal Tax Administration following receipt of the dividend and the relevant deduction certificate, however no later than December 31 of the third year following the calendar year in which the dividend was payable.

Swiss Federal Stamp Taxes

        Any dealings in the ADSs, where a bank or another securities dealer in Switzerland, as defined in the Swiss Federal Stamp Tax Act, acts as intermediary or is a party to the transaction, are, subject to certain exemptions provided for in the Swiss Federal Stamp Tax Act, subject to Swiss securities turnover tax at an aggregate tax rate of up to 0.3% of the consideration paid for such ADSs.

International Automatic Exchange of Information in Tax Matters

        On November 19, 2014, Switzerland signed the Multilateral Competent Authority Agreement, which is based on article 6 of the OECD/Council of Europe administrative assistance convention and is intended to ensure the uniform implementation of automatic exchange of information (the "AEOI"). The Federal Act on the International Automatic Exchange of Information in Tax Matters (the "AEOI Act") entered into force on January 1, 2017. The AEOI Act is the legal basis for the implementation of the AEOI standard in Switzerland.

        The AEOI is being introduced in Switzerland through bilateral agreements or multilateral agreements. The agreements have, and will be, concluded on the basis of guaranteed reciprocity, compliance with the principle of specialty (i.e., the information exchanged may only be used to assess and levy taxes (and for criminal tax proceedings)) and adequate data protection.

        Based on such multilateral agreements and bilateral agreements and the implementing laws of Switzerland, Switzerland exchanges data in respect of financial assets, including the Shares, held in, and income derived thereon and credited to, accounts or deposits with a paying agent in Switzerland for the benefit of individuals resident in a EU member state or in a treaty state.

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Swiss Facilitation of the Implementation of the U.S. Foreign Account Tax Compliance Act

        Switzerland has concluded an intergovernmental agreement with the U.S. to facilitate the implementation of FATCA. The agreement ensures that the accounts held by U.S. persons with Swiss financial institutions are disclosed to the U.S. tax authorities either with the consent of the account holder or by means of group requests within the scope of administrative assistance. Information will not be transferred automatically in the absence of consent, and instead will be exchanged only within the scope of administrative assistance on the basis of the double taxation agreement between the U.S. and Switzerland. On 8 October 2014, the Swiss Federal Council approved a mandate for negotiations with the U.S. on changing the current direct-notification-based regime to a regime where the relevant information is sent to the Swiss Federal Tax Administration, which in turn provides the information to the U.S. tax authorities.

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PLAN OF DISTRIBUTION

        The registration statement of which this prospectus forms a part has been filed in part in respect of our obligations under a Registration Rights Agreement, dated March 22, 2018, concerning an aggregate of 9,348,319 shares that we privately placed with investors on the same date and an aggregate of 4,168,608 shares issuable upon the exercise of warrants issued on the same date. Such shares, together with an aggregate of 95,630 shares held by other shareholders, are referred to collectively herein as the Registered Shares, and the holders of all such shares are identified in this prospectus as the Registered Holders. Any Registered Shares offered and sold in the United States by the Registered Holders will be in the form of ADSs. The Registered Holders are also permitted to sell shares not represented by ADSs in private or offshore transactions, including on SIX, which resales are not covered by this prospectus. Unlike an initial public offering, any resale by the Registered Holders of the Registered Shares represented by ADSs is not being underwritten by any investment bank. The Registered Holders may, or may not, elect to sell Registered Shares represented by ADSs as and to the extent that they may individually determine. Such sales, if any, will be made through brokerage transactions on Nasdaq or other securities exchange in the United States at prevailing market prices.

        The Registered Holders may dispose of all or a portion of the Registered Shares from time to time directly or through one or more underwriters, broker-dealers or agents. If ADSs representing our shares are sold through underwriters or broker-dealers, the Registered Holders will be responsible for any applicable underwriting discounts or commissions or agent's commissions. ADSs representing our shares may be sold on Nasdaq or any other national securities exchange or quotation service on which the securities may be listed or quoted at the time of disposition, in the over-the-counter market or in transactions otherwise than on these exchanges or systems or in the over-the-counter market and in one or more transactions at fixed prices, at prevailing market prices at the time of the disposition, at varying prices determined at the time of disposition, or at negotiated prices. These dispositions may be effected in transactions, which may involve crosses or block transactions. The Registered Holders may use any one or more of the following methods when disposing of shares:

        The Registered Holders also may resell all or a portion of the Registered Shares in offshore transactions or open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(a)(1) under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conform to the requirements of those provisions.

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        Broker-dealers engaged by the Registered Holders may arrange for other broker-dealers to participate in dispositions. If the Registered Holders effect such transactions by selling ADSs representing our shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive applicable commissions in the form of discounts, concessions or commissions from the Registered Holders or commissions from purchasers of ADSs representing our shares for whom they may act as agent or to whom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2121 and Supplementary Material .01 and Supplementary Material .02 thereto.

        In connection with dispositions of ADSs representing Registered Shares, the Registered Holders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of ADSs representing Registered Shares in the course of hedging in positions they assume. The Registered Holders may also sell ADSs representing Registered Shares short and, if such short sale shall take place after the date that the registration statement of which this prospectus forms a part is declared effective by the Commission, the Registered Holders may deliver ADSs representing Registered Shares to close out short positions and to return borrowed shares in connection with such short sales. The Registered Holders may also loan or pledge ADSs representing Registered Shares to broker-dealers that in turn may sell such shares, to the extent permitted by applicable law. The Registered Holders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of Registered Shares, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the Registered Holders have been advised that they may not use Registered Shares to cover short sales of our shares (or ADSs representing shares) made prior to the date the registration statement of which this prospectus forms a part has been declared effective by the SEC.

        The Registered Holders may, from time to time, pledge or grant a security interest in some or all of the warrants or ADSs representing Registered Shares owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the ADSs representing Registered Shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending, if necessary, the list of Registered Holders to include the pledgee, transferee or other successors in interest as Registered Holders under this prospectus. The Registered Holders also may transfer and donate the ADSs representing Registered Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

        The Registered Holders and any broker-dealer or agents participating in the distribution of the ADSs representing Registered Shares may be deemed to be "underwriters" within the meaning of Section 2(a)(11) of the Securities Act in connection with such dispositions. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agent and any profit on the resale of the ADSs representing our Registered Shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Registered Holders who are "underwriters" within the meaning of Section 2(a)(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

        Each Registered Holder has informed us that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to

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distribute ADSs representing Registered Shares. Upon our being notified in writing by a Registered Holder that any material arrangement has been entered into with a broker-dealer for the sale of ADSs representing Registered Shares through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of each such Registered Holder and of the participating broker-dealer(s), (ii) the number of ADSs representing Registered Shares involved, (iii) the price at which such ADSs representing Registered Shares were sold, (iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction.

        Each Registered Holder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of ADSs representing Registered Shares by the Registered Holder and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the ADSs representing Registered Shares to engage in market-making activities with respect thereto. All of the foregoing may affect the marketability of ADSs representing Registered Shares and the ability of any person or entity to engage in market-making activities with respect thereto.

        We will pay all expenses of the registration of ADSs representing our shares pursuant to the registration rights agreement with respect thereto, including, without limitation, SEC filing fees and expenses of compliance with state securities or "blue sky" laws, if any; provided, however, that each Registered Holder will pay all underwriting discounts and selling commissions, if any, incurred by such Registered Holder in connection with the disposition of Registered Shares. We will indemnify the Registered Holders against certain liabilities, including some liabilities under the Securities Act, in accordance with the Registration Rights Agreement, or the Registered Holders will be entitled to contribution. We may be indemnified by the Registered Holders against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by the Registered Holders specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled to contribution.

        We are not party to any arrangement with any Registered Holder or any broker-dealer with respect to disposition of ADSs or Registered Shares, other than the Registration Rights Agreement described in the foregoing paragraph. Therefore, we will not have any input if, when and how any Registered Holder elects to dispose of ADSs representing such Registered Holder's Registered Shares or the price or prices at which any such disposition may occur, and there can be no assurance that any Registered Holder will exchange its Registered Shares for ADSs or dispose of any or all of the ADSs representing such shares even if so exchanged pursuant to the deposit agreement. We will not receive proceeds from any disposition of Registered Shares in the form of ADSs by the Registered Holders.

        To date, there has not been a public market for ADSs representing our shares. We offer no assurances that an active trading market for ADSs representing our shares will develop or, if developed, be maintained.

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EXPENSES OF THIS OFFERING

        Set forth below is an itemization of the total expenses which are expected to be incurred in connection registration of the shares registered hereby. With the exception of the registration fee payable to the SEC and the Nasdaq listing fee, all amounts are estimates.

EXPENSE
  AMOUNT  

SEC registration fee

  $ 2,568.79  

Nasdaq listing fee

      *

FINRA filing fee

     

Printing expenses

      *

Legal fees and expenses

      *

Accounting fees and expenses

      *

Miscellaneous

      *

Total

  $   *

*
To be filed by amendment

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LEGAL MATTERS

        The validity of the shares registered hereby and certain other matters of the laws of Switzerland will be passed upon for us by Homburger AG and certain matters of U.S. law will be passed on for us by Cooley LLP, New York, New York.

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EXPERTS

        The financial statements as of December 31, 2018 and 2017 and for the years then ended included in this Prospectus have been so included in reliance on the report of PricewaterhouseCoopers SA, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. PricewaterhouseCoopers SA is a member of EXPERTsuisse.

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SERVICE OF PROCESS AND ENFORCEMENT OF JUDGMENTS

        We are organized under the laws of Switzerland and our registered office and domicile is located in Plan-les-Ouates, Geneva, Switzerland. Moreover, a number of our directors and executive officers and a number of directors of each of our subsidiaries are not residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon us or upon such persons or to enforce against them judgments obtained in U.S. courts, including judgments in actions predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our Swiss counsel that there is doubt as to the enforceability in Switzerland of original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent solely predicated upon the federal and state securities laws of the United States. Original actions against persons in Switzerland based solely upon the U.S. federal or state securities laws are governed, among other things, by the principles set forth in the Swiss Federal Act on International Private Law of 1987, as amended, or PILA. This statute provides that the application of provisions of non-Swiss law by the courts in Switzerland shall be precluded if the result was incompatible with Swiss public policy. Also, mandatory provisions of Swiss law may be applicable regardless of any other law that would otherwise apply.

        Switzerland and the United States do not have a treaty providing for reciprocal recognition of and enforcement of judgments in civil and commercial matters. The recognition and enforcement of a judgment of the courts of the United States in Switzerland is governed by the principles set forth in the PILA. This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if:

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WHERE YOU CAN FIND ADDITIONAL INFORMATION

        We have filed with the SEC a registration statement on Form F-1 under the Securities Act. A related registration statement on Form F-6 has been filed with the SEC to register the ADSs representing our shares. This prospectus, which forms a part of the registration statement on Form F-1, does not contain all of the information that is included in such registration statement and the exhibits and schedules thereto. Certain information is omitted and you should refer to such registration statement and its exhibits and schedules for that information. If a document has been filed as an exhibit to such registration statement, we refer you to the copy of the document that has been filed. Each statement in this prospectus relating to a document filed as an exhibit is qualified in all respects by the filed exhibit.

        You may review a copy of our registration statement on Form F-1 as well as the registration statement on Form F-6, including exhibits thereto and any schedules filed therewith, and obtain copies of such materials at the SEC's website (www.sec.gov), which contains reports and other information regarding issuers like us that file electronically with the SEC.

        Upon the effectiveness of the registration statement of which this prospectus forms a part, we will become subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers. Accordingly, we will be required to file reports and other information with the SEC, including annual reports on Form 20-F and periodic reports on Form 6-K. Those reports may be obtained at the website described above. As a foreign private issuer, we will be exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of such act. In addition, we will not be required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered thereunder.

        We maintain a corporate website at https://www.addextherapeutics.com/en/. Information contained in, or that can be accessed through, our website is not a part of, and shall not be incorporated by reference into, this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.

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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Unaudited Condensed Consolidated Interim Financial Statements

       

Condensed Consolidated Interim Balance Sheets as at June 30, 2019 and December 31, 2018

   
F-2
 

Condensed Consolidated Interim Statements of Income for the six-month periods ended June 30, 2019 and 2018

   
F-3
 

Condensed Consolidated Interim Statements of Comprehensive Income for the six-month periods ended June 30, 2019 and 2018

   
F-4
 

Condensed Consolidated Interim Statements of Changes in Equity for the six-month periods ended June 30, 2019 and 2018

   
F-5
 

Condensed Consolidated Interim Statements of Cash Flows for the six-month periods ended June 30, 2019 and 2018

   
F-6
 

Notes to the Condensed Consolidated Interim Financial Statements for the six-month periods ended June 30, 2019 and December 31, 2018

   
F-7
 

Audited Consolidated Financial Statements

   
 
 

Report of Independent Registered Public Accounting Firm

   
F-22
 

Consolidated Balance Sheets as at December 31, 2018 and December 31, 2017

   
F-23
 

Consolidated Statements of Loss for the years ended December 31, 2018 and 2017

   
F-24
 

Consolidated Statements of Comprehensive Loss for the years ended December 31, 2018 and 2017

   
F-25
 

Consolidated Statements of Changes in Equity for the years ended December 31, 2018 and 2017

   
F-26
 

Consolidated Statements of Cash Flows for the years ended December 31, 2018 and 2017

   
F-27
 

Notes to the Consolidated Financial Statements for the years ended December 31, 2018 and 2017

   
F-28
 

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Addex Therapeutics Ltd

Condensed Consolidated Interim Balance Sheets

as at June 30, 2019 and December 31, 2018

(unaudited)

 
  Notes   June 30,
2019
  December 31,
2018
 
 
   
  Amounts in Swiss francs
 

ASSETS

                 

Current assets

                 

Cash and cash equivalents

  7     36,747,903     41,670,158  

Other financial assets

  13     6,486     7,983  

Receivables

  8     286,312     273,016  

Prepayments

        454,814     199,410  

Total current assets

        37,495,515     42,150,567  

Non-current assets

                 

Right-of-use assets

  3.2/9     392,338      

Property, plant and equipment

  10     26,712     8,868  

Non-current financial assets

  11     54,400     54,404  

Total non-current assets

        473,450     63,272  

Total assets

        37,968,965     42,213,839  

LIABILITIES AND EQUITY

                 

Current liabilities

                 

Current lease liabilities

  3.2     281,375      

Payables and accruals

  12     4,123,512     2,121,084  

Contract liability

  16         212,744  

Total current liabilities

        4,404,887     2,333,828  

Non-current liabilities

                 

Non-current lease liabilities

  3.2     114,018      

Retirement benefits obligations

  15     1,177,074     639,351  

Total non-current liabilities

        1,291,092     639,351  

Equity

                 

Share capital

  13     32,848,635     28,564,031  

Share premium

        286,458,420     286,476,912  

Reserves

        6,573,245     10,266,402  

Accumulated deficit

        (293,607,314 )   (286,066,685 )

Total equity

        32,272,986     39,240,660  

Total liabilities and equity

        37,968,965     42,213,839  

   

The accompanying notes form an integral part of these condensed consolidated interim
financial statements.

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Addex Therapeutics Ltd

Condensed Consolidated Interim Statements of Income

for the six-month periods ended June 30, 2019 and 2018

(unaudited)

 
  Notes   June 30, 2019   June 30, 2018  
 
   
  Amounts in Swiss francs
 

Revenue from contract with customer

  16     1,220,301     4,833,800  

Other income

  17     6,620     533,650  

Operating costs

 

 

   
 
   
 
 

Research and development

        (5,893,830 )   (2,083,868 )

General and administration

        (2,820,717 )   (825,665 )

Total operating costs

  18     (8,714,547 )   (2,909,533 )

Operating (loss)/income

        (7,487,626 )   2,457,917  

Finance income

       
20,952
   
 

Finance expense

        (73,955 )   (103,638 )

Finance result, net

  20     (53,003 )   (103,638 )

Net (loss)/income before tax

        (7,540,629 )   2,354,279  

Income tax expense

             

Net (loss)/income for the period

        (7,540,629 )   2,354,279  

(Loss)/income per share for (loss)/income attributable to the ordinary equity holders of the Company:

  21              

Basic (loss)/income per share

        (0.29 )   0.12  

Diluted (loss)/income per share

        (0.29 )   0.09  

   

The accompanying notes form an integral part of these condensed consolidated interim
financial statements.

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Addex Therapeutics Ltd

Condensed Consolidated Interim Statements of Comprehensive Income

for the six-month periods ended June 30, 2019 and 2018

(unaudited)

 
  June 30, 2019   June 30, 2018  
 
  Amounts in Swiss francs
 

Net (loss)/income for the period

    (7,540,629 )   2,354,279  

Other comprehensive (loss)/income

   
 
   
 
 

Items that will never be reclassified to the statement of income:

             

Remeasurements of retirement benefits obligations

    (487,488 )   7,698  

Items that may be classified subsequently to the statement of income:

             

Exchange difference on translation of foreign operations differences

    (48 )   (32 )

Other comprehensive (loss)/income for the period, net of tax

    (487,536 )   7,666  

Total comprehensive (loss)/income for the period

   
(8,028,165

)
 
2,361,945
 

   

The accompanying notes form an integral part of these condensed consolidated interim
financial statements.

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Addex Therapeutics Ltd

Condensed Consolidated Interim Statements of Changes in Equity

for the six-month periods ended June 30, 2019 and 2018

(unaudited)

 
  Amounts in Swiss francs  
 
  Notes   Share
Capital
  Share
Premium
  Treasury
Shares
Reserve
  Foreign
Currency
Translation
Reserve
  Other
Reserves
  Accumulated
Deficit
  Total  

Balance at January 1, 2018

        15,384,988     264,852,008     (2,019,877 )   (652,142 )   8,199,437     (284,421,887 )   1,342,527  

Net income for the period

                            2,354,279     2,354,279  

Other comprehensive income for the period

                    (32 )   7,698         7,666  

Total comprehensive income for the period

                    (32 )   7,698     2,354,279     2,361,945  

Issue of shares

  13     13,179,043     24,460,237                     37,639,280  

Cost of share capital issuance

            (2,920,612 )                   (2,920,612 )

Value of share-based services

                        969,981         969,981  

Value of warrants

                        3,309,801         3,309,801  

Movement in treasury shares:

  13                                            

Capital increase

                (518,468 )               (518,468 )

Settlement of supplier invoices

            57,276     34,970                 92,246  

Net purchases under Liquidity agreement

            (2,923 )   (266 )               (3,189 )

Balance at June 30, 2018

        28,564,031     286,445,986     (2,503,641 )   (652,174 )   12,486,917     (282,067,608 )   42,273,511  

Balance at January 1, 2019

        28,564,031     286,476,912     (2,513,148 )   (652,323 )   13,431,873     (286,066,685 )   39,240,660  

Net loss for the period

                                      (7,540,629 )   (7,540,629 )

Other comprehensive loss for the year

                          (48 )   (487,488 )         (487,536 )

Total comprehensive loss for the period

                    (48 )   (487,488 )   (7,540,629 )   (8,028,165 )

Issue of shares

  13     4,284,604                         4,284,604  

Cost of share capital issuance

            (61,242 )                   (61,242 )

Value of share-based services

                        999,420         999,420  

Movement in treasury shares:

  13                                            

Capital increase

                (4,284,604 )               (4,284,604 )

Settlement of supplier invoices

            42,972     80,837                 123,809  

Net purchases under liquidity agreement

            (222 )   (1,274 )               (1,496 )

Balance at June 30, 2019

        32,848,635     286,458,420     (6,718,189 )   (652,371 )   13,943,805     (293,607,314 )   32,272,986  

   

The accompanying notes form an integral part of these condensed consolidated interim
financial statements.

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Addex Therapeutics Ltd

Condensed Consolidated Interim Statements of Cash Flows

for the six-month periods ended June 30, 2019 and 2018

(unaudited)

 
  Notes   June 30, 2019   June 30, 2018  
 
   
  Amounts in Swiss francs
 

Net (loss)/income for the period

        (7,540,629 )   2,354,279  

Adjustments for:

                 

Depreciation

  9/10     156,793     746  

Value of share-based services

        999,420     969,981  

Pension costs

        50,235     7,289  

Finance costs, net

        72,616     103,310  

Decrease in other financial assets

  8     1,496     1,123  

Increase in receivables

  8     (13,296 )   (662,617 )

Increase in prepayments

  8     (255,404 )   (160,591 )

Increase in payables and accruals

  12     2,002,428     963,467  

(Decrease)/increase in contract liability

  16     (212,744 )   352,148  

(Decrease) in deferred income

  16         (439,022 )

Services paid in shares

        123,767     92,525  

Net cash (used in)/from operating activities

        (4,615,318 )   3,582,638  

Cash flows from investing activities

                 

Purchase of property, plant and equipment

  10     (22,465 )   (2,059 )

Purchase of treasury shares

        (1,496 )   (1,123 )

Net cash used in investing activities

        (23,961 )   (3,182 )

Cash flows from financing activities

                 

Proceeds from issue of shares—capital increase

  13         40,428,549  

Costs paid on issue of shares

            (2,920,612 )

Costs paid on issue of shares subscribed by the Group

        (61,242 )    

Principal element of lease payment

        (149,118 )    

Interest paid

  20     (73,955 )   (49,974 )

Net cash (used in)/from financing activities

        (284,315 )   37,457,963  

(Decrease)/increase in cash and cash equivalents

        (4,923,594 )   41,037,419  

Cash and cash equivalents at beginning of the period

  7     41,670,158     2,579,248  

Exchange difference on cash and cash equivalents

        1,339     (53,336 )

Cash and cash equivalents at end of the period

  7     36,747,903     43,563,331  

   

The accompanying notes form an integral part of these condensed consolidated interim
financial statements.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

1. General information

        Addex Therapeutics Ltd (the "Company"), formerly Addex Pharmaceuticals Ltd, and its subsidiaries (together, the "Group") are a clinical stage pharmaceutical group applying its leading allosteric modulator drug discovery platform to discovery and development small-molecule pharmaceutical products, with an initial focus on central nervous system disorders.

        The Company is a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH-1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA, Addex Pharmaceuticals France SAS and Addex Pharmaceuticals Inc., company created on May 29, 2019 registered in Delaware with its principal business location in San Francisco, California, United States. Its registered shares are traded at the SIX, Swiss Exchange, under the ticker symbol ADXN.

        These condensed consolidated interim financial statements have been approved by the Board of Directors on September 27, 2019.

2. Basis of preparation

        These condensed consolidated interim financial statements for the six months ended June 30, 2019, have been prepared under the historic cost convention and in accordance with IAS 34 "Interim Financial Reporting" and are presented in a format consistent with the consolidated financial statements presented in the 2018 annual report under IAS 1 "Presentation of Financial Statements". However, they do not include all of the notes that would be required in a complete set of financial statements. Thus, this interim financial report should be read in conjunction with the consolidated financial statements for the year ended December 31, 2018. The accounting policies have changed as of January 1, 2019, due to the adoption of the new IFRS standard, IFRS 16 Leases. The updated accounting policies are disclosed in Note 3.2 to these condensed consolidated interim financial statements.

        The preparation of financial statements in accordance with IAS 34 requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on management's best knowledge of current events and actions, actual results ultimately may differ from those estimates. The areas involving a higher degree of judgment which are significant to the condensed consolidated interim financial statements are disclosed in note 4 to the consolidated financial statements for the year ended December 31, 2018. Certain prior period figures have been corrected or re-classed to be consistent with the current period presentation.

        Due to rounding, numbers presented throughout these consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying amount rather than the presented rounded amount.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

3. Accounting policies

3.1   New or revised IFRS Standards and Interpretations

        A number of new or amended standards and interpretations which are mandatory for financial periods beginning on or after January 1, 2019 did not have a material impact on the Group financial position or disclosures made in condensed consolidated interim financial statements.

        IAS 19 (amendment), Employee Benefits (effective from January 1, 2019). This standard has been applied for the first time for the annual reporting period commencing January 1, 2019. This amendment relates accounting for plan amendments, curtailments and settlements where changes are made to pension plans. The amendments require an entity: first to use updated assumptions to determine current service cost and net interest for the remainder of the period after a plan amendment, curtailment or settlement; and second to recognise in profit or loss as part of past service cost, or a gain or loss on settlement, any reduction in a surplus, even if that surplus was not previously recognised because of the impact of the asset ceiling. On this basis, the Group has completed its assessment and has concluded that the adoption of this standard has no impact on its half year consolidated financial statements.

        There are other new standards, amendments to standards and interpretations, which have been deemed by the Group as currently not relevant, hence are not listed or discussed further here.

3.2   IFRS 16 Leases

        The Group has adopted IFRS16 Leases from January 1, 2019, but has not restated comparatives for the year ended December 31, 2018 reporting period as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the opening balance sheet on January 1, 2019.

        On the adoption of IFRS16, the Group recognized lease liabilities reflecting future lease payments for lease contracts previously classified as operating leases under the principles of IAS 17 Leases. These liabilities were measured at the present value of the remaining lease payments, discounted using a weighted average incremental borrowing rate of 4.70% applied to the lease liabilities on January 1, 2019. The Group has recognized right-of-use ("ROU") assets measured at an amount equal to the lease liability. Since there were no prepaid/accrued lease payments relating to leases recognized in the balance sheet as at December 31, 2018, no adjustments have been made. The Group has exercised the optional exemption and recognized certain short-term leases (i.e. with a lease term of 12 months or less) and leases of low-value assets (of less than USD 5 thousand) on a straight-line basis as an expense in the statement of income.

        Extension and termination options are included in a number of property leases across the Group. These terms are used to maximize operational flexibility in terms of managing contracts. The majority of extension and termination options held are exercisable only by the Group and not by the respective lessor. In determining the lease term, management considers all facts and circumstances including extension and termination options. Extension options (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). The assessment is reviewed if a significant event or a significant change in circumstances occurs which

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

3. Accounting policies (Continued)

affects this assessment and is within the control of the Group. During the period ended June 30, 2019, there was no revision of lease terms applicable to reflect the effect of exercising extension and termination options.

        The following table presents the reconciliation between the non-cancellable operating lease commitments reported as of December 31, 2018 and the lease liabilities recognized on January 1, 2019:

 
  Total  

Operating lease commitments disclosed as at December 31, 2018

    272,498  

Additional operating lease commitments under IFRS 16 as at December 31, 2018

    297,721  

Total operating lease commitments under IFRS 16 as at December 31, 2018

    570,219  

Discount using the incremental borrowing rate at the date of the initial application

    (24,015 )

Gross liabilities as per January 1, 2019 under IFRS 16

    546,204  

Short term leases

    (1,694 )

Lease liability recognized as at January 1, 2019

    544,510  

Of which are:

       

Current lease liabilities

    303,627  

Non-current lease liabilities

    240,883  

        Right-of-use assets were measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognized in the balance sheet as at December 31, 2018. The right-of-use assets relate to the following types of assets:

 
  June 30, 2019   January 1, 2019  

Properties

    345,354     483,350  

Equipment

    46,984     61,160  

Total right-of-use assets

    392,338     544,510  

        The adoption of IFRS 16 Leases did not have a material impact on the Group's net loss after tax or on the Group's loss per share.

4. Critical accounting estimates and judgments

        The Group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities or may have had a significant impact on the reported results are disclosed below:

Going concern

        The Group's accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances and licensing certain of its research and development

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

4. Critical accounting estimates and judgments (Continued)

stage products. The Group is a development-stage enterprise and is exposed to all the risks inherent in establishing a business. The Group maintains detailed financial forecasts and monitors actual results on a regular basis so that measures can be taken to ensure the Group remains solvent.

Revenue recognition

        Revenue is primarily from fees related to licenses, milestones, research services and royalties. Given the complexity of the relevant agreements, judgements are required to identify distinct performance obligations; allocate the transaction price to these performance obligations and determine when the performance obligations are met. In particular the Group's judgement over the estimated stand alone selling price which is used to allocate the transaction price to the performance obligations is disclosed in note 16.

Grants

        Grants are recorded at their fair value when there is reasonable assurance that they will be received and recognized as income when the group has satisfied the underlying grant conditions. In certain circumstances, grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.

Accrued research and development costs

        The Group records accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records accrued expenses for estimated costs of research and development activities based upon the estimated amount of services provided-but-not-yet-invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements of loss. These costs are a significant component of research and development expenses. Accrued expenses for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third parties.

        To date, the Group has not experienced significant changes in the estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, the Group may be required to make changes to the estimates in the future as it becomes aware of additional information about the status or conduct of its research activities.

Research and development costs

        The Group recognizes expenditure incurred in carrying out its research and development activities, including development supplies, until it becomes probable that future economic benefits will flow to the Group, which results in recognizing such costs as intangible assets, involving a certain degree of judgement. Currently, such development supplies are associated with pre-clinical and clinical trials of specific products that have not demonstrated technical feasibility.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

4. Critical accounting estimates and judgments (Continued)

Share-based compensation

        The Group recognizes an expense for share-based compensation based on the valuation of equity incentive units using binomial and Black-Scholes valuation models. A number of assumptions are made in these models. Should the assumptions and estimates underlying the fair value of these instruments vary significantly from management's estimates, then the share-based compensation expense would be materially different from the amounts recognized.

Warrants

        The Group recognized the fair value of warrants issued in connection with the March 2018 capital increase as a cost of share capital issuance. The fair value has been calculated using the Black-Scholes valuation model. A number of assumptions are made in this model. Should the assumptions and estimates underlying the fair value of these instruments vary significantly from management's estimates, then the charge recorded in cost of share capital issuance would be materially different.

5. Interim measurement note

        Seasonality of the business:    The business is not subject to any seasonality, but expenses and corresponding revenue are largely determined by the phase of the respective projects, particularly with regard to external research and development expenditures.

        Costs:    Costs that incur unevenly during the financial year are anticipated or deferred in the interim report only if it would also be appropriate to anticipate or defer such costs at the end of the financial year.

6. Segment reporting

6.1   Reportable segments

        The Group operates in one segment, which is the business of developing drugs for human health.

6.2   Entity wide information

Information about products, services and major customers

        External income of the Group for the six-month periods ended June 30, 2019 and 2018 is derived from the business of discovery development and commercialization of pharmaceutical products. Income was earned from the sale of license rights and rendering of research services to a pharmaceutical company and grants earned.

Information about geographical areas

        External income is recorded in the Swiss operating company.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

6. Segment reporting (Continued)

        Analysis of revenue from contract with customer and other income by nature is detailed as follows:

 
  June 30, 2019   June 30, 2018  

Fees from sale of license rights

        4,760,220  

Collaborative research funding

    1,220,301     73,580  

Grants earned

        507,150  

Other service income

    6,620     26,500  

Total

    1,226,921     5,367,450  

        Analysis of revenue from contract with customer and other income by major counterparties is detailed as follows:

 
  June 30, 2019   June 30, 2018  

Indivior PLC

    1,220,301     4,833,800  

The Michael J. Fox Foundation

        507,150  

Other counterparties

    6,620     26,500  

Total

    1,226,921     5,367,450  

        For more detail, refer to note 16, "Revenue from contract with customer" and note 17 "Other income".

        The geographical allocation of long-lived assets is detailed as follows:

 
  June 30, 2019   December 31, 2018  

Switzerland

    473,049     62,866  

France

    401     406  

Total

    473,450     63,272  

        The geographical analysis of operating costs is as follows:

 
  June 30, 2019   June 30, 2018  

Switzerland

    8,711,096     2,905,691  

France

    3,451     3,842  

Total operating costs (note 18)

    8,714,547     2,909,533  

        The capital expenditure during the six-month period ended June 30, 2019 is CHF 22,465 (CHF 2,059 for the first half 2018)

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

7. Cash and cash equivalents

 
  June 30, 2019   December 31, 2018  

Cash at bank and on hand

    36,747,903     41,670,158  

Total cash and cash equivalents

    36,747,903     41,670,158  

        Split by currency:

 
  June 30, 2019   December 31, 2018  

CHF

    72.82 %   72.33 %

USD

    26.82 %   26.87 %

GBP

    0.30 %   0.29 %

EUR

    0.06 %   0.51 %

Total

    100.00 %   100.00 %

        The effective interest rate on Swiss francs cash and cash equivalent was –0.45% for the six-month period ended June 2019 (–0.43% for the twelve-months period ended December 2018), as a consequence of the banks reinvoicing a part of the negative interest on Swiss francs deposits that they pay to the Swiss national bank. All cash and cash equivalents were held either at bank or on hand as at June 30, 2019 and December 31, 2018.

8. Other current assets

 
  June 30, 2019   December 31, 2018  

Other financial assets

    6,486     7,983  

Receivables

    286,312     273,016  

Prepayments

    454,814     199,410  

Total other current assets

    747,612     480,409  

        The Group applies the IFRS 9 simplified approach to measuring expected credit losses ("ECL"), which uses a lifetime expected loss allowance for all trade receivables and contract assets. As of June 30, 2019, the receivables comprise of three non-governmental debtors whose combined outstanding balances are CHF 175,723 (As of December 2018 the Company had two non-governmental debtors for CHF 115,949). The Group has considered these customers have a low risk of default based on historic loss rates and forward-looking information on macroeconomic factors affecting the ability of the customers to settle the receivables. Based on this the ECL is immaterial. The increase in prepayments primarily relates to insurances and retirement benefits paid annually at the beginning of the year.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

9. Right-of-use assets

 
  Properties   Equipment   Total  

At June 30, 2019

                   

Opening net book amount

             

Adoption of IFRS16 as at January 1, 2019

    483,350     61,160     544,510  

Depreciation charge

    (137,996 )   (14,176 )   (152,172 )

Closing net book amount

    345,354     46,984     392,338  

At June 30, 2019

                   

Cost

    483,350     61,160     544,510  

Accumulated depreciation

    (137,996 )   (14,176 )   (152,172 )

Net book value

    345,354     46,984     392,338  

10. Property, plant and equipment

 
  Equipment   Furniture &
fixtures
  Chemical
Library
  Total  

Year ended December 31, 2018

                         

Opening net book amount

    2,464         287     2,751  

Additions

    9,054             9,054  

Depreciation charge

    (2,650 )       (287 )   (2,937 )

Closing net book amount

    8,868             8,868  

At December 31, 2018

                         

Cost

    1,594,405     7,564     1,207,165     2,809,134  

Accumulated depreciation

    (1,585,537 )   (7,564 )   (1,207,165 )   (2,800,266 )

Net book value

    8,868             8,868  

For the period ended June 30, 2019

                         

Opening net book amount

    8,868             8,868  

Additions

    22,465             22,465  

Depreciation charge

    (4,621 )           (4,621 )

Closing net book amount

    26,712             26,712  

At June 30, 2019

                         

Cost

    1,616,870     7,564     1,207,165     2,831,599  

Accumulated depreciation

    (1,590,158 )   (7,564 )   (1,207,165 )   (2,804,887 )

Net book value

    26,712             26,712  

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

11. Non-current financial assets

 
  June 30, 2019   December 31, 2018  

Security rental deposits

    54,400     54,404  

Total non-current financial assets

    54,400     54,404  

        Security rental deposits relate to laboratory and office space. The applicable interest rate to such deposits is immaterial, and therefore, the value approximates amortized cost.

12. Payables and accruals

 
  June 30, 2019   December 31, 2018  

Trade payables

    1,893,678     1,148,801  

Social security and other taxes

    188,206     14,921  

Accrued expenses

    2,041,628     957,362  

Total payables and accruals

    4,123,512     2,121,084  

        All payables mature within 3 months. The increase in accrued expenses, is primarily related to R&D service contracts and professional fees.

13. Share capital

 
  Number of shares  
 
  Common
shares
  Treasury
shares
  Total  

Balance at January 1, 2018

    15,384,988     (1,964,973 )   13,420,015  

Issue of shares—capital increase

    13,179,043     (261,914 )   12,917,129  

Net sale of treasury shares

        34,704     34,704  

Balance at June 30, 2018

    28,564,031     (2,192,183 )   26,371,848  

Balance at January 1, 2019

    28,564,031     (2,158,476 )   26,405,555  

Issue of shares—capital increase

    4,284,604     (4,284,604 )    

Net sale of treasury shares

        79,564     79,564  

Balance at June 30, 2019

    32,848,635     (6,363,516 )   26,485,119  

        The Company maintains a liquidity contract with Kepler Capital Markets SA ("Kepler"). Under the agreement, the Group has provided Kepler with cash and shares to enable them to buy and sell the Company's shares. At June 30, 2019, 45,786 (December 31, 2018: 44,513) treasury shares are recorded in the treasury share reserve and CHF 6,486 (December 31 2018: CHF 7,983) is recorded in other financial assets.

        At June 30, 2019, the total outstanding share capital is CHF 32,848,635 (June 30, 2018: CHF 28,564,031), consisting of 32,848,635 shares (June 30, 2018: 28,564,031). All shares have a nominal value of CHF 1.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

13. Share capital (Continued)

        On May 17, 2019, the Company issued 4,284,604 new shares from the authorized capital to its 100% owned subsidiary, Addex Pharma SA at CHF 1. These shares are held as treasury shares.

        During the six-month period ended 30 June 2019, the Group used 80,837 treasury shares to purchase services from consultants including 50,433 shares for Roger Mills, the Group's Chief Medical Officer

        At June 30, 2018, the total outstanding share capital is CHF 28,564,031 (June 30, 2017: CHF 15,384,988), consisting of 28,564,031 shares (June 30, 2017: 15,384,988). All shares have a nominal value of CHF 1 and fully paid on June 30, 2018, except for 133,318 shares which were in the process of being settled at June 30, 2018.

        On March 28, 2018, the Company increased its share capital by issuing 13,037,577 new shares with a nominal value of CHF 1 each at an issue price of CHF 3.13 per share, bringing the total outstanding issued share capital to 28,564,031. Each new share received a 7 year warrant to purchase 0.45 of a share at a price of CHF 3.43. A total of 5,866,898 warrants were granted of which 5,806,882 were granted to investors. The fair value of each of the warrants issued to investors is CHF 0.56 and has been calculated using the Black-Scholes valuation model and recorded in equity as a cost of the capital increase, with a volatility of 37.15% and an annual risk free rate of 0.13%. The total value of the warrants granted to investors amounts to CHF 3,309,801.

        On March 16, 2018, the Company issue 141,466 new shares from the conditional capital to its 100% owned subsidiary, Addex Pharma SA at CHF 1. These shares have been issued to replenish the treasury share reserve which had previously been used to settle the exercise of share options.

14. Share-based compensation

        The total share-based compensation expense recognized in the statement of loss for equity incentive units granted to directors, executives, consultants and investors for the six-month period ended June 30, 2019 amounts to CHF 999,420 (Half year June 30, 2018: CHF 969,981).

        As of June 30, 2019, 5,372,186 options were outstanding (December 31, 2018: 5,128,680 options). During the six-month period ended June 30, 2019, 243,506 options were granted and the exercise period of 506,351 vested options have been extended for 5 years. Include in share-based compensation for the six-month period ended June 30, 2019, CHF 73,912 relates to options granted in the period and CHF 75,331 relates to the fair value adjustment for exercise period extensions of vested options.

        As of June 30, 2019, a total of 265,600 Equity Sharing certificates (ESCs) were outstanding (December 31, 2018: 265,600 ESC). During the six-month period ended June 30, 2019, the exercise period of 90,750 vested ESCs have been extended for 5 years. Include in share-based compensation for the six-month period ended June 30, 2019, CHF 13,285 relates to the fair value adjustment for exercise period extensions of vested ESCs.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

15. Retirement benefits obligations

        The amounts recognized in the income statement are as follows:

 
  June 30, 2019   June 30, 2018  

Current service cost

    (143,256 )   (33,425 )

Interest cost

    (40,916 )   (12,442 )

Interest income

    36,048     11,579  

Company pension cost (note 19)

    (148,124 )   (34,288 )

        The amounts recognized in the balance sheet are determined as follows:

 
  June 30, 2019   December 31, 2018  

Defined benefit obligation

    (7,914,420 )   (7,060,278 )

Fair value of plan assets

    6,737,346     6,420,927  

Unfunded status

    (1,177,074 )   (639,351 )

        The principal actuarial assumptions used are as follows:

 
  June 30, 2019   December 31, 2018

Discount rate

  0.45%   0.90%

Mortality tables

  BVG2015 GT   BVG2015 GT

16. Revenue from contract with customer

License & research agreement with Indivior PLC

        On January 2, 2018, the Group entered into an agreement with Indivior PLC (Indivior) for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program conducted by the Group to discover novel GABAB PAM compounds.

        Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through the Group's participation in a joint development committee, the Group reviews, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

        Under terms of the agreement, the Group has granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed, and the Group or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained the right to

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

16. Revenue from contract with customer (Continued)

select compounds from the research program for further development in areas outside the interest of Indivior including Charcot-Marie-Tooth type 1A neuropathy or CMT1A. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

        The Group received a non-refundable upfront fee of $5.0 million (CHF4.9 million) in January 2018 for the right granted to Indivior to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate which was defined as a licensed compound under the agreement. The Group determined that this license of ADX71441 was a distinct performance obligation, and the full upfront fee was allocated to the right-of-use license of the intellectual property based on the stand-alone selling price and was recorded when the right to use the intellectual property and benefits thereon was transferred in January 2018.

        Separately, Indivior funds research conducted by the Group, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. Indivior's ability to develop and commercialize ADX71441 is not dependent on this separate research program. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. The Group agreed with Indivior to an initial research term of two years, that can be extended by twelve-month increments and a minimum annual funding of $2 million for the Group's R&D costs incurred, which are due monthly in arrears, over 2 years. Following Indivior's selection of one newly identified compound, the Group has the right to also select one additional newly identified compound. The Group is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Group's selected compounds. The initial two-year research term is expected to run from May 2018 to April 2020. The Group has allocated USD 4 million to the research services based on the estimated stand-alone sales price for this second performance obligation based on the agreed research plan. The Company has concluded that the standalone selling price of the research services is effectively their cost plus the future margin to be gained by the opportunity to own one or more novel compounds with the right to exclusively develop and commercialize in the retained indications i.e. future molecules. The Group recognizes this revenue overtime based on the costs incurred and in accordance with the conceptional framework initially developed in a research plan and regularly reviewed by a Joint Research Committee. On October 7th, 2019, Indivior agreed an additional research funding of $0.8 million for the research period.

        The research activities started on May 1, 2018 and the Group has recognized revenue of CHF 1,220,301 under this research agreement during the six-month period ending June 30, 2019 (CHF 73,580 for the first half 2018) and the contract liability is nil as of June 30, 2019 (December 31, 2018: CHF 212,744).

        In addition, the Group is eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling $330 million, and royalties on net sales of mid-single digits to low teens double-digit. The Group considers these various milestones to be variable consideration. However, no variable consideration was included at inception as the most likely amount to be recognized was determined to be zero, since revenue is contingent upon achieving uncertain, future development stages and net sales. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

16. Revenue from contract with customer (Continued)

Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc).

        On December 31, 2004, the Group entered into a research collaboration and license agreement with Janssen Pharmaceuticals Inc. (JPI). In accordance with this agreement, JPI has acquired an exclusive worldwide license to develop mGluR2 PAM compounds for the treatment of human health. The Group is eligible to receive up to EUR 109 million in development and regulatory milestone payments, as well as double-digit royalties on net sales. The Group considers these various milestones to be variable consideration as they are contingent upon achieving uncertain, future development stages and net sales. For this reason the Group considers the achievement of the various milestones as binary events that will be recognized as revenue upon occurrence. No amounts have been recognized under this agreement for the six-month periods ended June 30, 2019 and 2018.

17. Other income

        During the six-month period ended June 30, 2019, the Group has recognized as other income CHF 6,620 from IT consultancy agreements. There was no grant income recognized for the six-month period ended June 30, 2019 (CHF 0.5 million for the first half 2018). The Grants are recognized as other income in the statement of loss over the period according to when the Group has satisfied the underlying grant conditions.

18. Operating costs

 
  June 30, 2019   June 30, 2018  

Staff costs (note 19)

    2,227,497     611,343  

Depreciation (notes 9/10)

    156,793     746  

External research and development costs

    4,419,295     553,258  

Laboratory consumables

    103,466     45,762  

Patent maintenance and registration costs

    138,754     136,324  

Professional fees

    1,052,165     987,480  

Operating leases

        77,058  

Short-term leases

    18,236      

Other operating costs

    598,341     497,562  

Total operating costs

    8,714,547     2,909,533  

19. Staff costs

 
  June 30, 2019   June 30, 2018  

Wages and salaries

    1,170,554     346,456  

Social charges and insurances

    121,380     33,263  

Value of share-based services

    787,439     197,336  

Retirement benefit expenses (note 15)

    148,124     34,288  

Total staff costs

    2,227,497     611,343  

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

20. Finance costs

 
  June 30, 2019   June 30, 2018  

Interest cost

    (62,944 )   (49,974 )

Interest expense on leases

    (11,011 )    

Foreign exchange gains/(losses)

    20,952     (53,664 )

Finance costs

    (53,003 )   (103,638 )

21. (Loss)/income per share

 
  June 30, 2019   June 30, 2018  

(Loss)/income attributable to equity holders of the Company

    (7,540,629 )   2,354,279  

Weighted average number of shares in issue

    26,378,503     19,962,969  

Basic (loss)/income per share

    (0.29 )   0.12  

        Basic (loss)/income per share is calculated by dividing the (loss)/income attributable to equity holders of the Company by the weighted average number of shares in issue during the period excluding shares purchased by the Group and held as treasury shares.

 
  June 30, 2019   June 30, 2018  

(Loss)/income attributable to equity holders of the Company

    (7,540,629 )   2,354,279  

Weighted average number of shares in issue

    26,378,503     26,923,779  

Diluted (loss)/income per share

    (0.29 )   0.09  

        The Company has three categories of dilutive potential shares as at June 30, 2019 and 2018: equity sharing certificates (ESCs), share options and warrants. As of June 30, 2019, equity sharing certificates, share options and warrants have been ignored in the calculation of the result per share, as they would be anti-dilutive.

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Addex Therapeutics Ltd

Notes to the Condensed Consolidated Interim Financial Statements (Continued)

for the six-month periods ended June 30, 2019 and December 31, 2018

(Amounts in Swiss francs)

22. Related party transactions

        Related parties include members of the Board of Directors and the Executive Management of the Group. The following transactions were carried out with related parties:

Key management compensation

 
  June 30, 2019   June 30, 2018  

Salaries and other short-term employee benefits

    638,232     166,206  

Consulting fees

    156,692     304,827  

Share-based compensation

    218,889     839,073  

    1,013,813     1,310,106  

        Salaries and other short-term employee benefits relate to members of the Board of Directors and Executive Management who are employed by the Group. Consulting fees relate to Roger Mills, a member of the Executive Management who delivers his services to the Group under a consulting contract. The Group has a net payable to the Board of Directors and Executive Management of CHF 200,367 at June 30, 2019 (December 31, 2018: CHF 169,486).

23. Events after the balance sheet date

        There were no material events between the balance sheet date and the date on which these financial statements were approved by the board of directors that would require adjustment to the financial statements or disclosure under this heading.

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Addex Therapeutics Ltd

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of Addex Therapeutics Ltd

Opinion on the Financial Statements

        We have audited the accompanying consolidated balance sheets of Addex Therapeutics Ltd and its subsidiaries (the "Company") as of December 31, 2018 and December 31, 2017, and the related statements of loss, comprehensive loss, changes in equity and cash flows for the years then ended, including the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2018 and 2017, and the results of its operations and its cash flows for the years then ended in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Basis for Opinion

        These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

        We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

        Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ PricewaterhouseCoopers SA


Geneva, Switzerland
September 23, 2019

We have served as the Company's auditor since 2002.

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Addex Therapeutics Ltd

Consolidated Balance Sheets

as at December 31, 2018 and December 31, 2017

 
  Notes   December 31,
2018
  December 31,
2017
 
 
   
  Amounts in Swiss francs
 

ASSETS

                 

Current assets

                 

Cash and cash equivalents

  6     41,670,158     2,579,248  

Other financial assets

  7     7,983     11,291  

Receivables

  7     273,016     303,882  

Prepayments

  7     199,410     158,923  

Total current assets

        42,150,567     3,053,344  

Non-current assets

                 

Property, plant and equipment

  8     8,868     2,751  

Non-current financial assets

  9     54,404     7,087  

Total non-current assets

        63,272     9,838  

Total assets

        42,213,839     3,063,182  

LIABILITIES AND EQUITY

                 

Current liabilities

                 

Payables and accruals

  10     2,121,084     1,037,769  

Contract liability

  13     212,744      

Deferred income

  14         439,022  

Total current liabilities

        2,333,828     1,476,791  

Non-current liabilities

                 

Retirement benefits obligations

  18     639,351     243,864  

Total non-current liabilities

        639,351     243,864  

Equity

                 

Share capital

  11     28,564,031     15,384,988  

Share premium

  11     286,476,912     264,852,008  

Reserves

        10,266,402     5,527,418  

Accumulated deficit

        (286,066,685 )   (284,421,887 )

Total equity

        39,240,660     1,342,527  

Total liabilities and equity

        42,213,839     3,063,182  

   

The accompanying notes form an integral part of these consolidated financial statements.

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Addex Therapeutics Ltd

Consolidated Statements of Loss

for the years ended December 31, 2018 and 2017

 
  Notes   2018   2017  
 
   
  Amounts in Swiss francs
 

Revenue from contract with customer

  13     6,043,855      

Other income

  14     658,818     499,894  

Operating costs

 

 

   
 
   
 
 

Research and development

        (4,918,793 )   (2,628,901 )

General and administration

        (3,208,505 )   (1,106,049 )

Total operating costs

  15     (8,127,298 )   (3,734,950 )

Operating loss

        (1,424,625 )   (3,235,056 )

Finance costs

  19     (220,173 )   (45,350 )

Net loss before tax

        (1,644,798 )   (3,280,406 )

Income tax expense

  17          

Net loss for the year

        (1,644,798 )   (3,280,406 )

Basic and diluted loss per share for loss attributable to the ordinary equity holders of the Company

  20     (0.07 )   (0.25 )

   

The accompanying notes form an integral part of these consolidated financial statements.

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Addex Therapeutics Ltd

Consolidated Statements of Comprehensive Loss

for the years ended December 31, 2018 and 2017

 
  Notes   2018   2017  
 
   
  Amounts in Swiss francs
 

Net loss for the year

        (1,644,798 )   (3,280,406 )

Other comprehensive loss

                 

Items that will never be reclassified to the statement of income:

                 

Remeasurements of retirement benefits obligations

  18     (375,479 )   (9,909 )

Items that may be classified subsequently to the statement of income

                 

Exchange difference on translation of foreign operations differences

        (181 )   (871 )

Other comprehensive loss for the year, net of tax

        (375,660 )   (10,780 )

Total comprehensive loss for the year

       
(2,020,458

)
 
(3,291,186

)

   

The accompanying notes form an integral part of these consolidated financial statements.

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Addex Therapeutics Ltd

Consolidated Statements of Changes in Equity

for the years ended December 31, 2018 and 2017

 
  Amounts in Swiss Francs  
 
  Share
Capital
  Share
Premium
  Treasury
Shares
Reserve
  Foreign
Currency
Translation
Reserve
  Other
Reserves
  Accumulated
Deficit
  Total  

Balance at January 1, 2017

    13,454,553     263,100,700     (1,953,067 )   (651,271 )   7,409,158     (281,141,481 )   218,592  

Net loss for the year

                        (3,280,406 )   (3,280,406 )

Other comprehensive loss for the year

                (871 )   (9,909 )       (10,780 )

Total comprehensive loss for the year

                (871 )   (9,909 )   (3,280,406 )   (3,291,186 )

Issue of shares (Note 11)

    1,930,435                         1,930,435  

Cost of share capital issuance

        (25,573 )                   (25,573 )

Value of share-based services

                    800,188         800,188  

Movement in treasury Shares:

                                           

Capital increase

            (1,930,435 )               (1,930,435 )

Sale of shares to investors

        1,647,645     1,617,523                 3,265,168  

Net sales under liquidity agreement

            6,006                       6,006  

Exercise of ESC

            108,000                 108,000  

Settlement of supplier invoices

        129,236     132,096                 261,332  

Balance at January 1, 2018

    15,384,988     264,854,008     (2,019,877 )   (652,142 )   8,199,437     (284,421,887 )   1,342,527  

Net loss for the year

                        (1,644,798 )   (1,644,798 )

Other comprehensive loss for the year

                (181 )   (375,479 )       (375,660 )

Total comprehensive loss for the year

                (181 )   (375,479 )   (1,644,798 )   (2,020,458 )

Issue of Shares (Note 11)

    13,179,043     24,461,056                     37,640,099  

Cost of share capital issuance

        (2,963,415 )                   (2,963,415 )

Value of share-based services

                    2,298,933         2,298,933  

Value of Warrants

                    3,308,982         3,308,982  

Movement in treasury Shares:

                                           

Capital increase

            (568,902 )               (568,902 )

Settlement of suppliers invoices

        120,908     87,176                 208,084  

Net purchases under liquidity agreement

        6,355     (11,545 )               (5,190 )

Balance at December 31, 2018

    28,564,031     286,476,912     (2,513,148 )   (652,323 )   13,431,873     (286,066,685 )   39,240,660  

   

The accompanying notes form an integral part of these consolidated financial statements.

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Addex Therapeutics Ltd

Consolidated Statements of Cash Flows

for the years ended December 31, 2018 and 2017

 
  Notes   2018   2017  
 
   
  Amounts in Swiss francs
 

Net loss for the year

        (1,644,798 )   (3,280,406 )

Adjustments for:

                 

Depreciation

  8     2,937     15,249  

Value of share-based services

  12     2,298,933     800,188  

Pension costs

  18     20,008     19,520  

Finance costs

        123,840     45,471  

Decrease / (increase) in other financial assets

        3,308     (4,992 )

Increase in receivables

        (77,134 )   (83,159 )

Increase in prepayments

        (40,487 )   (137,488 )

Increase / (decrease) in payables and accruals

        1,083,315     (212,131 )

Increase in contract liability

        212,744      

Increase / (decrease) in deferred income

        (439,022 )   439,022  

Services paid in shares

        208,085     258,903  

Net cash (used in) / from operating activities

        1,751,729     (2,139,823 )

Cash flows from investing activities

                 

Purchase of property, plant and equipment

  8     (9,054 )   (697 )

Purchase of non-current financial assets

  9     (47,317 )    

Purchase of treasury shares

        (5,373 )    

Net cash used in investing activities

        (61,744 )   (697 )

Cash flows from financing activities

                 

Proceeds from issue of shares—capital increase

  11     40,488,180      

Proceeds from sales of treasury shares

            3,380,747  

Costs paid on issue of shares

        (2,963,415 )   (25,573 )

Interests paid

  19     (134,307 )   (171 )

Net cash from financing activities

        37,390,458     3,355,003  

Increase in cash and cash equivalents

        39,080,443     1,214,483  

Cash and cash equivalents at beginning of the year

  6     2,579,248     1,410,065  

Exchange difference on cash and cash equivalents

        10,467     (45,300 )

Cash and cash equivalents at end of the year

  6     41,670,158     2,579,248  

   

The accompanying notes form an integral part of these consolidated financial statements.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

1. General information

        Addex Therapeutics Ltd (the "Company"), formerly Addex Pharmaceuticals Ltd, and its subsidiaries (together, the "Group") are a clinical stage pharmaceutical group applying its leading allosteric modulator drug discovery platform to discovery and development small-molecule pharmaceutical products, with an initial focus on central nervous system disorders.

        The Company is a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH-1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA and Addex Pharmaceuticals France SAS. Its registered shares are traded at the SIX, Swiss Exchange, under the ticker symbol ADXN.

        These consolidated financial statements have been approved for issuance by the Board of Directors on April 25, 2019.

2. Summary of significant accounting policies

        The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.

2.1   Basis of preparation

        The consolidated financial statements of Addex Therapeutics Ltd have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board ("IASB"), and under the historical cost convention.

        The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Group's accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in note 4 "Critical accounting estimates and judgements".

        Due to rounding, numbers presented throughout these consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying amount rather than the presented rounded amount.

2.2   Standards and interpretations published by the IASB

New standards adopted by the Group

        The following new standards, amendments to standards and interpretations which are mandatory for the financial periods beginning on January 1, 2018 did not have any material impact on the consolidated financial statements:

    IFRS 15, Revenue from contracts with customers (effective from January 1, 2018). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under IFRS 15, an entity recognizes revenue when its customer obtains control of promised

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

      goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of IFRS 15, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Group only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of IFRS 15, the Group assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Group then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. This standard has been applied for the first time for the annual reporting period commencing January 1, 2018 and would have recognized the cumulative effect of initially applying the new revenue standard as an adjustment to the opening balance of accumulated losses; however, the Group did not deem any adjustments required in the transition to the new standard. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. We expect the impact of the adoption of the new standard to be immaterial to our net profit / loss on an ongoing basis, and as of January 1, 2018 it applies to the Indivior PLC ("Indivior") contract signed on January 2, 2018.

    IFRS 9, Financial instruments (effective from January 1, 2018), replacing IAS 39 Financial Instruments: Recognition and Measurement. This standard has been applied for the first time for the annual reporting period commencing January 1, 2018. This standard includes requirements on the classification and measurement of financial assets and liabilities. It defines three classification categories for debt instruments: amortized cost, fair value through other comprehensive income ("FVOCI") and fair value through profit or loss ("FVPL"). Classification for investments in debt instruments is driven by the entity's business model for managing financial assets and their contractual cashflows. Investments in equity instruments are always measured at fair value. However, management can make an irrevocable election to present changes in fair value in other comprehensive income, provided the instrument is not held for trading. The standard does not introduce any changes for the classification and measurement of financial liabilities, except for the recognition of changes in own credit risk in other comprehensive income for liabilities designated at fair value through profit or loss. IFRS 9 also contains a new impairment model which will result in earlier recognition of losses. The expected credit losses ("ECL") model is a 'three-stage' model for impairment based on changes in credit quality since initial recognition. In addition, the new standard contains amendments to general hedge accounting that will enable entities to better reflect their risk management activities in their financial statements. The Group is affected by only one section of this standard, namely the ECL model. As at January 1, 2018, all receivables were due from 2 counter-parties with no defaults in the past, and based on Management's forward-looking analysis, there is no material

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Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

      expected credit default risk. On this basis, the Group has completed its assessment and has concluded that the adoption of this standard has no material impact on its consolidated financial statements.

New standards and interpretations not yet adopted

        New standards, amendments to standards and interpretations which have been published, but are not yet effective and have not been early adopted by the Group:

    IFRS 16 (amendment), Leases (effective from January 1, 2019). Under IAS 17, lessees were required to make a distinction between a finance lease (on balance sheet) and an operating lease (off balance sheet). IFRS 16 now requires lessees to recognize a lease liability reflecting future lease payments and a right-of-use asset for virtually all lease contracts. The IASB has included an optional exemption for certain short-term leases and leases of low-value assets, although this exemption can only be applied by lessees. IFRS 16 is likely to have a significant impact on the financial statements of a number of lessees, as it will result in almost all leases being recognized on the balance sheet (as the distinction between operating and finance leases is removed), while for lessors the accounting stays almost the same. Under the new standard, an asset (the right to use the leased item) and a financial liability to pay rentals are recognized. The Group will apply IFRS 16 from January 1, 2019. It will affect primarily the accounting for the Group's operating leases. The Group intends to apply the simplified transition approach and will not restate comparative amounts for the year prior to adoption. Right-of-use assets will be measured at the amount of the lease liability on adoption (adjusted for any prepaid or accrued lease expenses). As at December 31, 2018, the Group has non-cancellable operating lease commitments of CHF 272,498 (see note 21 "Commitments and contingencies"). Of these commitments, approximately CHF 26,142 relate to short-term leases, which will be recognized on a straight-line basis as an expense in the income statement. Based on certain assumptions, including but not limited to the term life of the leases, early termination clauses, on January 1, 2019, the Group will recognize estimated right-of-use assets and lease liabilities of approximately CHF 221,852. However, the Group will continue to assess the impact of the implementation and update the assumptions used in the estimate.

      There are other new standards, amendments to standards and interpretations that are not yet effective, which have been deemed by the Group as currently not relevant, hence are not listed or discussed further here.

2.3   Consolidation

        Subsidiaries are all entities over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are de-consolidated from the date that control ceases.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

        Inter-company transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of an impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. The reporting date of all Group companies is December 31.

2.4   Segment reporting

        The Group operates in one segment, which is the discovery, development and commercialization of small-molecule pharmaceutical products. A single management team that reports to the chief executive officer comprehensively manages the entire business. The chief operating decision-maker, is the Chief Executive Officer who reviews the statement of operations of the Group on a consolidated basis, makes decisions and manages the operations of the Group as a single operating segment. The Group's activities are not affected by any significant seasonal effect. Revenue is attributable to the Company's country of domicile, Switzerland.

2.5   Foreign currency transactions

Functional and presentation currency

        Items included in the financial statements of each of the Group's entities are measured using the currency of the primary economic environment in which the entity operates ("the functional currency"). The consolidated financial statements are presented in Swiss francs, which is the Company's functional and presentation currency.

Transactions and balances

        Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions or valuation where items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the statement of income.

        Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of income within 'finance cost'.

Group companies

        The results and financial position of the Group's subsidiary that has a functional currency different from the presentation currency are translated into the presentation currency as follows:

    assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet;

    income and expenses for each statement of income are translated at the average exchange rate; and

    all resulting exchange differences are recognized in other comprehensive income.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

2.6   Property, plant and equipment

        Property, plant and equipment are stated at historical cost less accumulated depreciation, and impairment (if any). Historical cost includes expenditure that is directly attributable to the acquisition of the item. Subsequent costs are included in the asset's carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. All other repairs and maintenance are charged to the statement of income during the financial period in which they are incurred. Depreciation is calculated using the straight-line method to allocate their cost to their residual values over their estimated useful lives as follows:

Computer equipment   3 years
Laboratory equipment   4 years
Furniture and fixtures   5 years
Chemical library   5 years

        The assets' residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date. An asset's carrying amount is written down immediately to its recoverable amount if the asset's carrying amount is greater than its estimated recoverable amount (see note 2.7). Gains and losses on disposals are determined by comparing proceeds with the carrying amount, and are included in the statement of income.

2.7   Impairment of non-financial assets

        Assets that are subject to depreciation or amortization are reviewed for impairment annually, and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset's fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash generating units). Prior impairment of non-financial assets other than goodwill is reviewed for possible reversal at each reporting date.

2.8   Financial assets

        The Group has one category of financial assets, namely "receivables". Receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. These assets are held for collection of contractual cash flows which represent solely the payment of principal and interest. They arise when the Group provides money, goods or services directly to a debtor with no intention of trading the receivable. They are included in current assets, except for maturities greater than 12 months after the balance sheet date, which are classified as non-current assets. Receivables are included in other current assets in the balance sheet (see note 7).

        Receivables are initially measured at fair value and subsequently measured at amortized cost. Amortized cost is the amount at which the receivable is measured at initial recognition plus or minus

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

the cumulative amortization using the effective interest method of any difference between that initial amount and the maturity amount. Receivables are derecognized when settled.

        In 2017, a provision for impairment of loans and receivables is established when there is objective evidence that the Group will not be able to collect all amounts due. The amount of impairment is the difference between the carrying amount and the present value of estimated future cash flows discounted at the financial asset's original effective interest rate, and is recognized in the statement of income. If, in a subsequent period, the amount of the impairment loss decreases and the decrease can be related objectively to an event occurring after the impairment loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized, the reversal of the previously recognized impairment loss is recognized in the statement of loss.

        From 1 January 2018, the Group assesses on a forward looking basis the expected credit losses associated with its debt instruments carried at amortised cost. The impairment methodology applied depends on whether there has been a significant increase in credit risk. For trade receivables, the Group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables.

        The Company classifies a contract asset as a receivable when the Company's right to consideration is unconditional. If the Company transfers control of goods or services to a customer before the customer pays consideration, the Company records either a contract asset or a receivable depending on the nature of the Company's right to consideration for its performance. Contract assets and contract liabilities arising from the same contract are netted and presented as either a single net contract asset or net contract liability.

2.9   Cash and cash equivalents

        Cash and cash equivalents include cash on hand, deposits held at call with banks and other short-term highly liquid investments with original maturities of three months or less. They are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Any bank overdrafts are not netted against cash and cash equivalents, but are shown as part of current liabilities on the consolidated balance sheet.

2.10 Share capital

        Shares are classified as equity. Incremental costs directly attributable to the issue of new shares are shown as a deduction, net of tax, from the proceeds.

        Where any Group company purchases the Company's equity share capital (treasury shares), the consideration paid, including any directly attributable incremental cost (net of income taxes) is recorded as a deduction from equity attributable to the Company's equity holders as a treasury share reserve until the shares are cancelled, reissued or disposed of. When such shares are subsequently sold or reissued, any consideration received, net of any directly attributable incremental transaction costs and the related income tax effect, the nominal amount is reversed from the treasury share reserve, with any remaining difference to the total transaction value being recognized in share premium.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

        The Company has entered into a liquidity contract where an independent broker buys and sells the Company's shares held in the broker's custody. Such shares are presented in the treasury share reserve.

        The Company also uses treasury shares to partially settle services rendered by third and related parties. When shares are issued for this purpose, the nominal share value is recognized as a treasury share reserve and the value above par is presented as a share premium.

2.11 Equity instruments

        Equity instruments issued by the Group are recorded at the fair value of the proceeds received, net of direct issuance costs.

2.12 Trade payables

        Trade payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. All payables have a contract maturity within 1 year.

2.13 Grants

        Grants are recognized at their fair value where there is reasonable assurance that the grant will be received and the Group will comply with all attached conditions. Grants are deferred and recognized as other income in the statement of income over the period necessary to match them to the costs they are intended to compensate.

2.14 Deferred income tax

        Deferred income tax is recorded in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, if the deferred income tax arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss, it is not accounted for. Deferred income tax is determined using tax rates and laws that have been enacted or substantively enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realized or the deferred income tax liability is settled.

        Deferred income tax assets are recognized to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized.

        Deferred income tax is recorded on temporary differences arising on investments in subsidiaries, except where the timing of the reversal of the temporary differences is controlled by the Group and it is probable that the temporary difference will not reverse in the foreseeable future.

        Potential deferred income tax assets from tax loss carry forwards exceed deferred tax liabilities. Deferred income tax assets from tax loss carry forwards are initially recognized to the extent that there are suitable deferred income tax liabilities, then to the extent that the realization of the related tax benefit through future taxable profits is probable.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

2.15 Pension obligations

        The Group operates one pension scheme. The scheme is generally funded through payments to insurance companies or trustee-administered funds, determined by periodic actuarial calculations. The Group has defined benefit plans. A defined benefit plan is a pension plan that defines an amount of pension benefit that an employee will receive on retirement, usually dependent on one or more factors such as age, years of service and compensation. Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions are recognized immediately in other comprehensive income and past-service costs are recognized immediately in the statement of income.

        The liability recognized in the balance sheet in respect of defined benefit pension plans is the defined benefit obligation at the balance sheet date minus the fair value of the plan assets. The defined benefit obligation is calculated annually by an independent actuary using the projected unit credit method. The present value of the defined obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating to the terms of the related pension liability.

2.16 Share-based compensation

        The Group operates an equity sharing certificates' equity incentive plan, a share option plan, and a share purchase plan. The Group also from time to time grants warrants to brokers and investors. The fair value of the services received in exchange for the grant or transfer of equity sharing certificates, options, shares or warrants is recognized in the Consolidated Financial Statements. The total amount to be recognized over the vesting period is determined by reference to the fair value of the equity incentive unit granted or transferred. The fair value of instruments granted includes any market performance conditions and excludes the impact of any service and non-market performance vesting conditions. Service and non-market performance conditions are included in assumptions about the number of equity incentive units that are expected to vest.

        At each balance sheet date, the Group revises its estimates for the number of equity incentive units that are expected to vest. It recognizes the impact of the revision to original estimates, if any, in the statement of income, with a corresponding adjustment to equity.

        The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the equity incentive units are exercised.

2.17 Revenue recognition

        Effective January 1, 2018, the Group adopted IFRS 15 Revenue from Contracts with Customers, without deeming any adjustments necessary in the transition to the new standard. Under IFRS 15, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of IFRS 15, the entity performs the following five steps: (i) identify the contract(s) with a

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Group only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of IFRS 15, the Group assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Group uses the most likely method to estimate any variable consideration and includes such consideration in the amount of the transaction price based on an estimated stand-alone selling price. Revenue is recognized for the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for revenue recognition, see Note 13, "Revenue from contract with customer".

        The Group recognizes revenue from the licence of intellectual property and providing research and development services:

License of intellectual property

        If the license to the Group's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Group recognizes revenues when the license conveys a right of use or right of access to the underlying intellectual property. For licenses that are sold in conjunction with a related service, the Group uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the performance obligation is settled over time, the Group determines the appropriate method of measuring progress for purposes of recognizing license revenue. The Group evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Research and development services

        The Group has an arrangement with its partner that includes deploying its full-time employees for research and development activities. The Group assesses if these research and development activities areconsidered distinct in the context of the respective contract and, if so, they are accounted for as a separate performance obligation. This revenue is recorded within "Revenue from contract with customer" over time as the activities are performed.

Contract balances

        The Group receives payments and determines credit terms from its customers for its various performance obligations based on billing schedules established in each contract. The actual timing of the income recognition, billings and cash collections may result in other current receivables, accrued revenue (contract assets), and deferred revenue (contract liabilities) being recorded on the balance sheets. Amounts are recorded as other current receivables when the Group's right to consideration is unconditional. The Group does not assess whether a contract has a significant financing component if

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

2. Summary of significant accounting policies (Continued)

the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

2.18 Finance income and expense

        Interest received and interest paid are classified in the statement of cash flows under investing activities and financing activities, respectively.

2.19 Leases

        Leases in which a significant portion of the risks and rewards of ownership are retained by the lessor are classified as operating leases. Payments made under operating leases (net of any incentives received from the lessor) are charged to the statement of income on a straight-line basis over the period of the lease.

2.20 Research and development

        Research and development costs are expensed as incurred. Costs incurred on development projects are recognized as intangible assets when the following criteria are fulfilled:

    it is technically feasible to complete the intangible asset so that it will be available for use or sale;

    management intends to complete the intangible asset and use or sell it;

    there is an ability to use or sell the intangible asset;

    it can be demonstrated how the intangible asset will generate probable future economic benefits;

    adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available; and

    the expenditure attributable to the intangible asset during its development can be reliably measured.

        In the opinion of management, due to uncertainties inherent in the development of the Group's products, the criteria for development costs to be recognized as an asset, as prescribed by IAS 38, "Intangible Assets", are not met.

3. Financial risk management

3.1   Financial risk factors

        The Group's activities expose it to a variety of financial risks: market risk, credit risk, liquidity risk and capital risk. The Group's overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the Group's financial performance. Risk management is carried out by the Group's finance department (Group Finance) under the policies approved by the Board. Group Finance identifies, evaluates and in some instances economically hedges

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

3. Financial risk management (Continued)

financial risks in close co-operation with the Group's operating units. The Board provides written guidances for overall risk management, as well as written policies covering specific areas, such as foreign exchange risk, interest-rate risk, use of derivative financial instruments and non-derivative financial instruments, credit risk and investing excess liquidity.

Market risk and foreign exchange risk

        The Group operates internationally and is exposed to foreign exchange risk arising from various exposures, primarily with respect to the Euro, US dollar and UK pound. Foreign exchange risk arises from future commercial transactions, recognized assets and liabilities and net investments in foreign operations. To manage foreign exchange risk Group Finance maintains foreign currency cash balances to cover anticipated future requirements. The Group's risk management policy is to economically hedge 50% to 100% of anticipated transactions in each major currency for the subsequent 12 months. The Group has a subsidiary in France, whose net assets are exposed to foreign currency translation risk. In 2018, a 10% increase or decrease in the EUR/CHF exchange rate would have resulted in a CHF 52,398 (2017: CHF 11,144) increase or decrease in net income and shareholders' equity as at December 31, 2018, a 10% increase or decrease in the GBP/CHF exchange rate would have resulted in a CHF 15,965 (2017: CHF 3'791) increase or decrease in net income and shareholders' equity as at December 31, 2018 and a 10% increase or decrease in the USD/CHF exchange rate would have resulted in a CHF 1,224,506 (2017: CHF 86,326) increase or decrease in net income and shareholders' equity as at December 31, 2018. Movements in other currencies would not have had a material impact. The Group is not exposed to equity price risk or commodity price risk as it does not invest in these classes of investment.

Interest rate risk

        The Group's exposure to interest rate fluctuations is limited because the Group has no interest-bearing indebtedness. The Group's income and operating cash flows are substantially independent of changes in market interest rates Therefore the Group has no significant interest rate risk exposure..

Credit risk

        Credit risk is managed on a Group basis. Credit risk arises from cash and cash equivalents and deposits with banks, as well as credit exposures to collaboration partners. The Group has a limited number of collaboration partners and consequently has a significant concentration of credit risk. The Group has policies in place to ensure that credit exposure is kept to a minimum and significant concentrations of credit risk are only granted for short periods of time to high credit quality partners. The Group's policy is to invest funds in low risk investments including interest bearing deposits. For banks and financial institutions, only independently rated parties with a minimum rating of "A" are accepted (see note 6).

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

3. Financial risk management (Continued)

Liquidity risk

        The Group's principal source of liquidity is its cash reserves which are obtained through the sale of new shares and to a lesser extent the sale of its research and development stage products. Group Finance monitors rolling forecasts of the Group's liquidity requirements to ensure it has sufficient cash to meet operational needs. The ability of the Group to maintain adequate cash reserves to sustain its activities in the medium term is highly dependent on the Group's ability to raise further funds from the licensing of its development stage products and the sale of new shares. Consequently, the Group is exposed to significant liquidity risk (see note 4).

3.2   Capital risk management

        The Group is not regulated and not subject to specific capital requirements. The amount of equity depends on the Group's funding needs and statutory capital requirements. The Group monitors capital periodically on an interim and annual basis. From time to time, the Group may take appropriate measures or propose capital increases to its shareholders to ensure the necessary capital remains intact. The Group did not have any short-term or long-term debt outstanding as of December 31, 2018 and 2017.

3.3   Fair value estimation

        The nominal value less estimated credit adjustments of trade receivables and payables are assumed to approximate to their fair values due to the short-term maturity of these instruments and are held at their amortized cost in accordance with IFRS 9. The fair value of other financial assets and liabilities for disclosure purposes is estimated by discounting the future contractual cash flows at the current market interest rate that is available to the Group for similar financial instruments.

4. Critical accounting estimates and judgments

        The Group makes estimates and assumptions concerning the future. These estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities or may have had a significant impact on the reported results are disclosed below:

Going concern

        The Group's accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances and licensing certain of its research and development stage products. The Group is a development-stage enterprise and is exposed to all the risks inherent in establishing a business. The Group maintains detailed financial forecasts and monitors actual results on a regular basis so that measures can be taken to ensure the Group remains solvent.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

4. Critical accounting estimates and judgments (Continued)

Revenue recognition

        Revenue is primarily from fees related to licenses, milestones, research services and royalties. Given the complexity of the relevant agreements, judgements are required to identify distinct performance obligations; allocate the transaction price to these performance obligations and determine when the performance obligations are met. In particular the Group's judgement over the estimated stand alone selling price which is used to allocate the transaction price to the performance obligations is disclosed in note 13.

Grants

        Grants are recorded at their fair value when there is reasonable assurance that they will be received and recognized as income when the group has satisfied the underlying grant conditions. In certain circumstances, grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.

Accrued research and development costs

        The Group records accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records accrued expenses for estimated costs of research and development activities based upon the estimated amount of services provided-but-not-yet-invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements of loss. These costs are a significant component of research and development expenses. Accrued expenses for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third parties.

        To date, the Group has not experienced significant changes in the estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, the Group may be required to make changes to the estimates in the future as it becomes aware of additional information about the status or conduct of its research activities.

Research and development costs

        The Group recognizes expenditure incurred in carrying out its research and development activities, including development supplies, until it becomes probable that future economic benefits will flow to the Group, which results in recognizing such costs as intangible assets, involving a certain degree of judgement. Currently, such development supplies are associated with pre-clinical and clinical trials of specific products that do not have any demonstrated technical feasibility.

Deferred taxes

        As disclosed in note 17 the Group has significant Swiss tax losses. These tax losses represent potential value to the Group to the extent that the Group is able to create taxable profits within 7 years of the end of the year in which the losses arose. The Group has not recorded any deferred tax

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

4. Critical accounting estimates and judgments (Continued)

assets in relation to these tax losses. The key factors which have influenced management in arriving at this evaluation are the fact that the Group has not yet a history of making profits and product development remains at an early stage. Should management's assessment of the likelihood of future taxable profits change, a deferred tax asset will be recorded.

Share-based compensation

        The Group recognizes an expense for share-based compensation based on the valuation of equity incentive units using binomial and Black-Scholes valuation models. A number of assumptions on the volatility of the underlying shares and on the risk free rate are made in these models. Should the assumptions and estimates underlying the fair value of these instruments vary significantly from management's estimates, then the share-based compensation expense would be materially different from the amounts recognized. Had these assumptions been modified within their feasible ranges and the Group calculated the share-based compensation based on the higher and lower values of these ranges, share-based compensation expense in 2018 would have been CHF 1,696,301 or CHF 2,762,285, respectively (2017: CHF 711,856 or CHF 911,946, respectively). This is compared to the amount recognized as an expense in 2018 of CHF 2,298,934 (2017: CHF 800,188). Additional information is disclosed in note 12.

Pension obligations

        The present value of the pension obligations depends on a number of assumptions that are determined on an actuarial basis such as discount rates, future salary and pension increases, and mortality rates. Any changes in these assumptions will impact the carrying amount of pension obligations. The Group determines the appropriate discount rate at the beginning of each year. This is the interest rate that should be used to determine the present value of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate, the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating the terms of the related pension liability. Other key assumptions for pension obligations are based in part on current market conditions. Additional information is disclosed in note 18.

5. Segment information

Information about products, services and major customers

        External income of the Group for the years ended December 31, 2018 and 2017 is derived from the business of discovery, development and commercialization of pharmaceutical products. Income was earned from the sale of license rights, and rendering of research services to a pharmaceutical company and grants earned.

Information about geographical areas

        External income is recorded in the Swiss operating company.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

5. Segment information (Continued)

        Analysis of revenue from contract with customer and other income by nature is detailed as follows:

 
  2018   2017  

Fees from sale of license rights

    4,876,000      

Collaborative research funding

    1,167,855      

Grants earned

    609,212     464,916  

Other service income

    49,606     34,978  

Total

    6,702,673     499,894  

        Analysis of revenue from contract with customer and other income by major counterparties is detailed as follows:

 
  2018   2017  

Indivior PLC

    6,043,855      

The Michael J. Fox Foundation

    609,212     464,916  

Other counterparties

    49,606     34,978  

Total

    6,702,673     499,894  

        For more detail, refer to note 13, "Revenue from contract with customer" and note 14 "Other Income".

        The geographical allocation of long-lived assets is detailed as follows:

 
  December 31,
2018
  December 31,
2017
 

Switzerland

    62,866     9,417  

France

    406     421  

Total

    63,272     9,838  

        The geographical analysis of operating costs is as follows:

 
  2018   2017  

Switzerland

    8,119,953     3,719,191  

France

    7,345     15,759  

Total operating costs (note 15)

    8,127,298     3,734,950  

        There was capital expenditure of CHF 9,054 in 2018 and CHF 697 in 2017.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

6. Cash and cash equivalents

 
  December 31,
2018
  December 31,
2017
 

Cash at bank and on hand

    41,670,158     2,579,248  

Total cash and cash equivalents

    41,670,158     2,579,248  

        Split by currency:

 
  December 31,
2018
  December 31,
2017
 

CHF

    72,33 %   73,39 %

USD

    26.87 %   23,55 %

EUR

    0,51 %   2,63 %

GBP

    0,29 %   0,43 %

Total

    100,00 %   100,00 %

        The effective interest rate on Swiss francs cash and cash equivalent was –0.43% in 2018 (2017: 0.0%). The Swiss national bank applies negative interests on Swiss francs deposits. All cash and cash equivalents were held either at bank or on hand as at December 31, 2018 and December 31, 2017.

Credit quality of cash and cash equivalents

        The table below shows the cash and cash equivalents by credit rating of the major counterparties:

 
  December 31,
2018
  December 31,
2017
 

P-1 / A-1

    41,670,040     2,579,124  

Cash on hand

    118     124  

Total cash and cash equivalents

    41,670,158     2,579,248  

        External credit ratings of counterparties were obtained from Moody's (P-1) or Standard & Poor's (A-1), respectively.

7. Other current assets

 
  December 31,
2018
  December 31,
2017
 

Other financial assets

    7,983     11,291  

Receivables

    273,016     303,882  

Prepayments

    199,410     158,923  

Total other current assets

    480,409     474,096  

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

7. Other current assets (Continued)

        The Group applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance for all trade receivables and contract assets. As of December 31, 2018, the receivables comprise of only two non-governmental debtors, one of which is also a related party and whose combined outstanding balances are CHF 115,949. The Group has considered both customers have a low risk of default based on historic loss rates and forward-looking information on macroeconomic factors affecting the ability of the customers to settle the receivables. Based on this the ECL is immaterial.

8. Property, plant and equipment

 
  Equipment   Furniture &
fixtures
  Chemical
Library
  Total  

Year ended December 31, 2017

                         

Opening net book amount

    9,343         7,960     17,303  

Additions

    697             697  

Depreciation charge

    (7,576 )       (7,673 )   (15,249 )

Closing net book amount

    2,464         287     2,751  

At December 31, 2017

                         

Cost

    1,585,351     7,564     1,207,165     2,800,080  

Accumulated depreciation

    (1,582,887 )   (7,564 )   (1,206,878 )   (2,797,329 )

Net book value

    2,464         287     2,751  

Year ended December 31, 2018

                         

Opening net book amount

    2,464         287     2,751  

Additions

    9,054             9,054  

Depreciation charge

    (2,650 )       (287 )   (2,937 )

Closing net book amount

    8,868             8,868  

At December 31, 2018

                         

Cost

    1,594,405     7,564     1,207,165     2,809,134  

Accumulated depreciation

    (1,585,537 )   (7,564 )   (1,207,165 )   (2,800,266 )

Net book value

    8,868             8,868  

        The Group recorded a depreciation charge in 2018 of CHF 2,068 (2017: CHF 11,541) as part of research and development expenses and CHF 869 (2017: CHF 3,708) as part of general and administration expenses.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

9. Non-current financial assets

 
  December 31,
2018
  December 31,
2017
 

Security rental deposits

    54,404     7,087  

Total non-current financial assets

    54,404     7,087  

        Security rental deposits relate to laboratory and office space which has increased during 2018. The applicable interest rate to such deposits is immaterial, and therefore, the value approximates amortised cost.

10. Payables and accruals

 
  December 31,
2018
  December 31,
2017
 

Trade payables

    1,148,801     383,211  

Social security and other taxes

    14,921     10,979  

Accrued expenses

    957,362     643,579  

Total payables and accruals

    2,121,084     1,037,769  

        All payables mature within 3 months. Accrued expenses relate primarily to amounts accrued under R&D service contracts and professional fees. At December 31, 2018, amounts have increased in line with increased R&D activities. The carrying amounts of trade payables do not materially differ from their fair values, due to their short-term nature.

11. Share capital

 
  Number of shares  
 
  Common
shares
  Treasury
shares
  Total  

Balance at January 1, 2017

    13,454,553     (1,891,006 )   11,563,547  

Issue of shares—capital increase

    1,930,435     (1,930,435 )    

Sale of treasury shares

        1,856,468     1,856,468  

Balance at December 31, 2017

    15,384,988     (1,964,973 )   13,420,015  

Issue of shares—capital increase

    13,179,043     (278,027 )   12,901,016  

Net sale of treasury shares

        84,524     84,524  

Balance at December 31, 2018

    28,564,031     (2,158,476 )   26,405,555  

        The Company maintains a liquidity contract with Kepler Capital Markets SA ("Kepler"). Under the agreement, the Group has provided Kepler with cash and shares to enable them to buy and sell the Company's shares. At December 31, 2018, 44,513 (2017: 42,561) treasury shares are recorded in the treasury share reserve and CHF 7,983 (2017: CHF 11,291) is recorded in other financial assets.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

11. Share capital (Continued)

        At December 31, 2018, the total issued share capital is CHF 28,564,031 (December 31, 2017: CHF 15,384,988), consisting of 28,564,031 shares (December 31, 2017: 15,384,988). All shares have a nominal value of CHF 1.

        On March 28, 2018, the Company increased its share capital by issuing 13,037,577 new shares with a nominal value of CHF 1 each at an issue price of CHF 3.13 per share. Of these new shares, 12,901,016 were placed with investors raising CHF 40.4 million of gross proceeds and the remaining 136,561 new shares were recorded as treasury shares at the issue price of CHF 427,436. Each new share received a 7-year warrant to purchase 0.45 of a share at a price of CHF 3.43 per share. A total of 5,866,898 warrants were granted of which 5,806,882 to investors. The fair value of each of the warrants issued to investors is CHF 0.56, and has been calculated using the Black-Scholes valuation model and recorded in equity as a cost of the capital increase, with a volatility of 37.15% and an annual risk free rate of 0.13%. The total value of the warrants granted to investors amounts to CHF 3,308,982.

        On March 16, 2018, the Group issued 141,466 new shares from the conditional capital to its 100% owned subsidiary, Addex Pharma SA at CHF 1. These shares have been issued to replenish the treasury share reserve, which had previously been used to settle the exercise of share options.

        For the fiscal year ended December 31, 2018, the Group used 87,176 treasury shares (2017: 132,096) to purchase services from consultants including 37,824 (2017: 66,727) shares for Roger Mills, and 32,362 (2017: 47,706) shares for Tim Dyer. The total value of consulting services settled in shares was CHF 208,084. Under a liquidity agreement, the Group recorded net purchases of treasury shares of CHF 5,190.

        On May 29, 2017, the Group increased its share capital by CHF 1,930,435 (1,930,435 registered shares with nominal value of CHF 1 per share) out of authorized share capital. The 1,930,435 new shares were subscribed by the Company's 100% owned subsidiary, Addex Pharma SA at CHF 1 and recorded as treasury shares.

        For the fiscal year ended December, 31 2017, the Group sold 1,617,523 treasury shares for gross proceeds of CHF 3,265,168 and used 132,096 treasury shares to purchase services from consultants including 66,727 shares for Roger Mills, and 47,706 shares for Tim Dyer. The total value of consulting services settled in shares was CHF 261,332. 108,000 treasury shares were used to settle the exercise of subscription rights attached to equity sharing certificates. Under a liquidity agreement, the Group recorded net sale of treasury shares of CHF 6,006.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

12. Share-based compensation

        The total share-based compensation expense recognized in the statement of loss for equity incentive units granted to directors, executives, employees, consultants and investors has been recorded under the following headings:

 
  2018   2017  

Research and development

    880,982     511,789  

General and administration

    1,417,951     288,399  

Total share-based compensation

    2,298,933     800,188  

        Analysis of share-based compensation by equity incentive plan is detailed as follows:

 
  2018   2017  

Equity sharing certificate plan

    77,336     28,588  

Share purchase plan

    38,296     34,821  

Share option plans

    2,183,301     736,779  

Total share-based compensation

    2,298,933     800,188  

Equity Sharing Certificate Equity Incentive Plan

        On June 1, 2010, the Company established an equity incentive plan based on equity sharing certificates (ESCs) to provide incentives to directors, executives, employees and consultants of the Group. Each ESC provides the holder (i) a right to subscribe for 1,000 shares in the Company, and (ii) a right to liquidation proceeds equivalent to that of shareholders. All rights of the ESCs expire after their defined exercise period with the ownership of the ESCs reverting to the Group. ESCs granted are subject to certain vesting conditions which are defined in each grant agreement. The holder of vested ESCs has the right to subscribe to shares at the subscription price if the underlying share price has reached the floor price. The floor and subscription price are defined by the Board of Directors. In the event of a change in control, all ESCs automatically vested. The Group has no legal or constructive obligation to repurchase or settle ESCs in cash.

        Movements in the number of subscription rights attached to the ESCs outstanding are as follows:

 
  2018   2017  

At January 1

    275,933     354,433  

Granted

        108,000  

Expired

    (10,333 )   (78,500 )

Exercised

        (108,000 )

At December 31

    265,600     275,933  

        At December 31, 2018, of the outstanding 265,600 subscription rights (2017: 275,933) attached to the ESCs, 184,600 were exercisable (2017: 128,533). On December 31 2017, the Group granted 108,000

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

12. Share-based compensation (Continued)

ESC at an exercise price of CH2 and a floor of CHF 2.30 with a vesting period of 4 years and a 10 year exercise period.

        The outstanding subscription rights as at December 31, 2018 and 2017 have the following expiry dates, subscription prices and floor prices:

 
  Subscription prices / floor prices (CHF)  
At December 31, 2018
Expiry date
  1.00 / 2.30   2.00 / 2.30   5.00 /10.00   7.00 / 14.00   Total  

2019

    151,600                 151,600  

2020

    6,000                 6,000  

2027

        108,000             108,000  

Total subscription rights

    157,600     108,000             265,600  

 

 
  Subscription prices / floor prices (CHF)  
At December 31, 2017
Expiry date
  1.00 / 2.30   2.00 / 2.30   5.00 /10.00   7.00 / 14.00   Total  

2018

            8,000     2,333     10,333  

2019

    151,600                 151,600  

2020

    6,000                 6,000  

2027

        108,000             108,000  

Total subscription rights

    157,600     108,000     8,000     2,333     275,933  

Share option plans

        The Company established a share option plan to provide incentives to directors, executives, employees and consultants of the Group.

        On June 1, 2018 the Group granted 2,467,584 options at an exercise price of CHF 3. Options vest over 4 years and expire in 2028. On December 23, 2017 the Group granted 1,609,022 options at an exercise price of CHF 2 with vesting over 4 years and a 10 year exercise period. On February 28, 2017, the Group granted 292,261 options at an exercise price of CHF 1 with a vesting period of 1 year and a 10 year exercise period.

        Movements in the number of options outstanding are as follows:

 
  2018   2017  

At January 1

    2,661,096     779,813  

Granted

    2,467,584     1,901,283  

Forfeited

        (20,000 )

At December 31

    5,128,680     2,661,096  

        At December 31, 2018, of the outstanding 5,128,680 share options (2017: 2,661,096), 1,736,764 were exercisable (2017: 773,489).

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

12. Share-based compensation (Continued)

        The outstanding share options as at December 31, 2018 have the following expiry dates:

 
  Exercises prices (CHF)  
At December 31, 2018
Expiry date
  1.00   2.00   2.08   3.00   Total  

2019

        555,126             555,126  

2020

        49,687             49,687  

2021

        105,000     50,000         155,000  

2027

    292,261     1,609,022             1,901,283  

2028

                2,467,584     2,467,584  

Total

    292,261     2,318,835     50,000     2,467,584     5,128,680  

 

 
  Exercises prices (CHF)  
At December 31, 2017
Expiry date
  1.00   2.00   2.08   3.00   Total  

2019

        555,126             555,126  

2020

        49,687             49,687  

2021

        105,000     50,000         155,000  

2027

    292,261     1,609,022             1,901,283  

Total

    292,261     2,318,835     50,000         2,661,096  

        The weighted average fair value of share options granted during 2018 determined using a Black-Scholes model was CHF 1.03 (2017: CHF 1.08). The significant inputs to the model were:

 
  2018   2017  

Weighted average share price per share at the grant date

    CHF 2.94     CHF 2.27  

Weighted average strike price per share

    CHF 3.00     CHF 1.85  

Weighted average volatility

    36.86 %   43.00 %

Dividend yield

         

Weighted average annual risk free rate / annual risk-free rate

    0.13 %   0.13 %

Share purchase plan

        The Group established a share purchase plan under which services are settled for shares. Under the plan directors, executives, employees and consultants may receive fully paid ordinary shares from the Group's treasury share reserve for services rendered. During 2018, 87,176 shares (2017: 132,096 shares) were transferred to settle CHF 208,085 (2017: CHF 258,903) of consulting fees.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

13. Revenue from contract with customer

License & research agreement with Indivior PLC

        On January 2, 2018, the Group entered into an agreement with Indivior PLC (Indivior) for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program conducted by the Group to discover novel GABAB PAM compounds.

        Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through the Group's participation in a joint development committee, the Group reviews, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

        Under terms of the agreement, the Group has granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed, and the Group or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including Charcot-Marie-Tooth type 1A neuropathy or CMT1A. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

        The Group received a non-refundable upfront fee of $5.0 million (CHF4.9 million) in January 2018 for the right granted to Indivior to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate which was defined as a licensed compound under the agreement. The Group determined that this license of ADX71441 was a distinct performance obligation, and the full upfront fee was allocated to the right-of-use license of intellectual property based on the stand-alone selling price and was recorded when the right to use the intellectual property and benefits thereon was transferred in January 2018.

        Separately, Indivior funds research conducted by the Group, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. Indivior's ability to develop and commercialize ADX71441 is not dependent on this separate research program. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. The Group agreed with Indivior to an initial research term of two years, that can be extended by twelve-month increments and a minimum annual funding of $2 million for the Group's R&D costs incurred, which are due monthly in arrears, over 2 years. Following Indivior's selection of one newly identified compound, the Group has the right to also select one additional newly identified compound. The Group is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Group's selected compounds. The initial two-year research term is expected to run from May 2018 to April 2020. The Group has allocated USD 4 million to the research services based on the estimated stand-alone sales price for this second performance obligation based on the agreed research plan. The Company has concluded that the standalone selling price of the

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

13. Revenue from contract with customer (Continued)

research services is effectively their cost plus the future margin to be gained by the opportunity to own one or more novel compounds with the right to exclusively develop and commercialize in the retained indications i.e. future molecules. The Group recognizes this revenue over time based on the costs incurred and in accordance with the conceptional framework initially developed in a research plan and regularly reviewed by a Joint Research Committee.

        The research activities started on May 1, 2018 and the Group has recognized revenue of CHF 1.2 million under this research agreement for the year ended December 31, 2018 and recorded CHF0.2 million as contract liability at December 31, 2018.

        In addition, the Group is eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totalling $330 million, and royalties on net sales of mid-single digits to low teens double-digit. The Group considers these various milestones to be variable consideration. However, no variable consideration was included at inception as the most likely amount to be recognized was determined to be zero, since revenue is contingent upon achieving uncertain, future development stages and net sales. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.

Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc).

        On December 31, 2004, the Group entered into a research collaboration and license agreement with Janssen Pharmaceuticals Inc. (JPI). In accordance with this agreement, JPI has acquired an exclusive worldwide license to develop mGluR2PAM compounds for the treatment of human health. The Group is eligible to receive up to EUR 109 million in development and regulatory milestone payments, as well as double-digit royalties on net sales. The Group considers these various milestones to be variable consideration as they are contingent upon achieving uncertain, future development stages and net sales. For this reason the Group considers the achievement of the various milestones as binary events that will be recognized as revenue upon occurrence. No amounts have been recognized under this agreement in 2018 and 2017.

14. Other income

        Under the agreements with The Michael J. Fox Foundation for Parkinson's Research (MJFF), the Group is required to complete specific research activities within a defined period of time. The Group's funding is fixed and received based on the satisfactory completion of these agreed research activities and incurring the related costs. For the year ended December 31, 2018, the Group recognized as income CHF 0.6 million from MJFF (2017: CHF 0.5 million). The Grants are deferred and recognized as other income in the statement of loss over the period according to when the Group has satisfied the underlying grant conditions. As of December 31, 2018 there was no deferred income (2017: CHF 439,022). Other income from related party transactions is further disclosed in note 22.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

15. Operating costs

 
  2018   2017  

Staff costs (note 16)

    2,224,206     751,277  

Depreciation

    2,938     15,249  

External research and development costs

    2,368,457     841,308  

Laboratory consumables

    144,169     29,764  

Patent maintenance and registration costs

    261,954     180,125  

Professional fees

    2,313,722     1,347,913  

Operating leases

    179,102     96,889  

Other operating costs

    632,750     472,425  

Total operating costs

    8,127,298     3,734,950  

        Operating lease contracts are renewable on normal business terms and provide for annual rent increases based on the Swiss consumer price index.

        Operating expenses have increased significantly during the year due to increases in R&D activities. Professional fees primarily relate to legal, accounting and auditing, and R&D consulting fees.

16. Staff costs

 
  2018   2017  

Wages and salaries

    1,273,382     544,912  

Social charges and insurances

    112,524     59,749  

Value of share-based services (note 12)

    719,374     83,459  

Retirement benefit expenses (note 18)

    118,926     63,157  

Total staff cost

    2,224,206     751,277  

17. Taxes

 
  December 31, 2018   December 31, 2017  

Loss before tax

    1,644,798     3,280,406  

Tax calculated at a tax rate of 7.8% (2017: 7.8%)

    128,294     255,872  

Effect of different tax rates in other countries

    (573 )   (1,229 )

Expenses charged against equity

    (231,146 )   (1,995 )

Expenses not deductible for tax purposes

    (180,877 )   (62,415 )

Total tax losses not recognized as deferred tax asset

    (284,302 )   (190,233 )

Income tax expense

         

        On the basis of Note 2.14, the Company has decided not to recognize any deferred income tax assets at December 31, 2018 or 2017. The amounts of deferred income tax assets that arise from

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

17. Taxes (Continued)

sources other than tax loss carry forwards and the amounts of deferred income tax liabilities are insignificant in comparison to the unrecognized tax loss carry forwards.

        The tax losses carry forwards of the Group and their respective expiring dates are as follows :

 
  December 31, 2018   December 31, 2017  

2018

        28,861,010  

2019

    28,287,766     28,287,766  

2020

    15,982,220     15,982,220  

2021

    1,224,210     1,224,210  

2022

    3,540,541     3,540,541  

2023

    3,309,636     3,309,636  

2024

    1,125,258     1,125,258  

2025

    2,147,924      

Total unrecorded tax losses carry forwards

    55,617,555     82,330,641  

18. Retirement benefits obligations

        Apart from the social security plans fixed by the law, the Group sponsors an independent pension plan. The Group has contracted with Swiss Life based in Lausanne for the provision of occupational benefits. All benefits in accordance with the regulations are reinsured in their entirety with Swiss Life within the framework of the corresponding contract. This pension solution fully reinsures the risks of disability, death and longevity with Swiss Life. The latter invests the vested pension capital and provides a 100% capital and interest guarantee. The pension plan is entitled to an annual bonus from Swiss Life comprising the effective savings, risk and cost results. Although, as is the case with many Swiss pension plans, the amount of ultimate pension benefit is not defined, certain legal obligations of the plan create constructive obligations on the employer to pay further contributions to fund an eventual deficit; this results in the plan nevertheless being accounted for as a defined benefit plan. All employees are covered by this plan, which is a defined benefit plan. Retirement benefits are based on contributions, computed as a percentage of salary, adjusted for the age of the employee and shared approximately 46% / 54% by employee and employer. In addition to retirement benefits, the plans provide death and long-term disability benefits to its employees. Liabilities and assets are revised every year by an independent actuary. Assets are held in the insurance company. In accordance with IAS 19 (revised), plan assets have been estimated at fair market values and liabilities have been calculated according to the "projected unit credit" method. The Group recorded a pension benefit charge in 2018 of CHF 118,926 (2017: CHF 63,157) as part of staff costs.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

18. Retirement benefits obligations (Continued)

Employment benefit obligations

        The amounts recognized in the balance sheet are determined as follows:

 
  2018   2017  

Defined benefit obligation

    (7,060,278 )   (3,607,276 )

Fair value of plan assets

    6,420,927     3,363,412  

Funded status

    (639,351 )   (243,864 )

        The amounts recognized in the statements of loss are as follows:

 
  2018   2017  

Current service cost

    (115,146 )   (61,375 )

Interest cost

    (37,903 )   (22,865 )

Interest income

    34,123     21,083  

Company pension cost (note 16)

    (118,926 )   (63,157 )

        The movement in the defined benefit obligations at the beginning of the year is as follows:

 
  2018   2017  

Defined benefit obligation at beginning of year

    (3,607,276 )   (2,152,878 )

Service cost

    (115,146 )   (61,375 )

Interest cost

    (37,903 )   (22,825 )

Employee contribution

    (84,096 )   (38,920 )

Actuarial gain / (loss) arising from changes in financial assumptions

    197,291     (65,563 )

Actuarial gain / (loss) arising from changes in demographic assumptions

         

Actuarial gain / (loss) on experience adjustment

    (573,684 )   45,513  

Benefits deposited

    (2,839,464 )   (1,311,188 )

Defined benefit obligations at end of year

    (7,060,278 )   (3,607,276 )

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

18. Retirement benefits obligations (Continued)

        The movements in the fair value of plan assets during the year are as follows:

 
  2018   2017  

Fair value of plan assets at beginning of year

    3,363,412     1,938,443  

Interest income

    34,123     21,083  

Employees' contributions

    84,096     38,920  

Company contribution

    98,918     43,637  

Plan assets gains

    914     10,141  

Benefits deposited

    2,839,464     1,311,188  

Fair value of plan assets at end of year

    6,420,927     3,363,412  

        The principal actuarial assumptions used were as follows:

 
  December 31, 2018   December 31, 2017

Discount rate

  0.90%   0.80%

Mortality tables

  BVG2015 GT   BVG2015 GT

        The discount rate and the life expectancy were identified as significant actuarial assumptions for the Swiss pension plan. The following impacts on the defined benefit obligation are to be expected:

    0.25% increase or decrease in the discount rate would lead to an increase of 4.74% (2017: 5.30%) or a decrease of 4.38% (2017: 4.90%) in the defined benefit obligation of the Swiss pension plan;

    0.25% increase or decrease in the interest rate on retirement savings capital would lead to an increase of 1.19% (2017 : 0.53%) or a decrease of 1.16% (2017 : 0.51%) in the defined benefit obligation of the Swiss pension plan;

    0.25% increase or decrease in salaries would lead to an increase of 0.18% (2017 : 0.07%) or a decrease of 0.18% (2017: 0.06%) in the defined benefit obligation of the Swiss pension plan.

    +/-1 year in the life expectancy would lead to an increase of 1.55% (2017: 1.78%) or a decrease of 1.56% (2017: 1.82%) in the defined benefit obligation of the Swiss pension plan.

        The above sensitivity analyses are based on a change in an assumption while holding all other assumptions constant. In practice, this is unlikely to occur, and changes in some of the assumptions may be correlated. When calculating the sensitivity of the defined benefit obligations to significant actuarial assumptions the same method (present value of the defined benefit obligation calculated with the projected unit credit method at the end of the reporting period) has been applied as when calculating the pension liability recognized within the consolidated balance sheets.

        The methods and types of assumptions used in preparing the sensitivity analysis did not change compared to the prior period.

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

18. Retirement benefits obligations (Continued)

        The estimated Group contributions to pension plans for the financial year 2019 amounts to CHF 186,928. The following table shows the funding of the defined benefit pensions and actuarial adjustments on plan liabilities:

 
  2018   2017  

Present value of defined benefit obligation

    (7,060,278 )   (3,607,276 )

Fair value of plan assets

    6,420,927     3,363,412  

Deficit in the plan

    (639,351 )   (243,864 )

Experience adjustment

    (376,393 )   (20,050 )

Actuarial gains on plan assets

    914     10,141  

        The following table shows the estimated benefit payments for the next ten years where the number of employees remains constant:

2019

    100,354  

2020

    105,406  

2021

    110,792  

2022

    116,607  

2023

    125,302  

2024-2028

    1,317,664  

19. Finance costs

 
  2018   2017  

Interests cost

    (134,307 )   (171 )

Foreign exchange losses

    (85,866 )   (45,179 )

Finance costs

    (220,173 )   (45,350 )

20. Loss per share

        Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of shares in issue during the year excluding shares purchased by the Group and held as treasury shares.

 
  2018   2017  

Loss attributable to equity holders of the Company

    (1,644,798 )   (3,280,406 )

Weighted average number of shares in issue

    23,293,237     12,941,439  

Basic and diluted loss per share

    (0.07 )   (0.25 )

        The Company has one category of dilutive potential shares as at December 31, 2018 and December 31, 2017: equity sharing certificates (ESCs), share options and warrants. As of December 31,

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

20. Loss per share (Continued)

2018 and December 31, 2017, equity sharing certificates, share options and warrants have been ignored in the calculation of the loss per share, as they would be antidilutive.

21. Commitments and contingencies

Operating lease commitments

 
  2018   2017  

Within 1 year

    142,298     19,656  

Later than 1 year and no later than 5 years

    130,200     1,776  

Total operating lease commitments

    272,498     21,432  

        Operating lease commitments consist mainly of rental contracts for laboratories, offices and related spaces used by Addex Pharma SA. There are no commitments over 5 years.

Capital commitments

        As at December 31, 2018 and 2017, the Group has no contracted capital expenditure.

Contingencies

        As part of the ordinary course of business, the Group is subject to contingent liabilities in respect of certain litigation. In the opinion of management, none of the outstanding litigation will have a significant adverse effect on the Group's results of operations, financial position or cash flows

22. Related party transactions

        Related parties include members of the Board of Directors and the Executive Management of the Group. The following transactions were carried out with related parties:

Key management compensation

 
  2018   2017  

Salaries and other short-term employee benefits

    522,163     133,180  

Consulting fees

    577,078     737,685  

Share-based compensation

    2,357,067     595,835  

    3,456,308     1,466,700  

        Salaries and other short-term employee benefits relate to members of the Board of Directors and Executive Management who are employed by the Group including Tim Dyer, the CEO since November 1, 2018. Consulting fees include members of the Executive Management who deliver their services to the Group under consulting contracts including Tim Dyer until October 31, 2018 and Roger Mills. Tim Dyer delivered his consulting services through TMD Advisory Ltd ("TMDA"). TMDA invoiced the Group for the rent of administrative premises, CHF 26,682 in 2018 (2017: CHF 22,536),

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Addex Therapeutics Ltd

Notes to the Consolidated Financial Statements (Continued)

for the years ended December 31, 2018 and 2017

(Amounts in Swiss francs)

22. Related party transactions (Continued)

whilst the Group invoiced accounting services to TMDA of CHF 49,606 in 2018 (2017: CHF 34,978), recorded in other income. The Group has a net payable to the Board of Directors and Executive Management of CHF 169,486 at December 31, 2018 and a net receivable of CHF 6,087 at December 31, 2017. In addition, the Group has a net payable to TMDA of CHF 116,994 at December 31, 2018 (2017: CHF 176,640) for consulting services and a net receivable of CHF 82,589 at December 31, 2018 (2017 : CHF 43,105) for invoiced administrative services. For more detail, refer to Note 11, "Share capital".

23. Events after the balance sheet date

        On May 17, 2019, the Group increased its share capital by issuing 4,284,604 new shares from the authorized capital to its 100% owned subsidiary, Addex Pharma SA at an issue price of CHF 1 per share. These shares, held as treasury shares, bring the total outstanding issued share capital to 32,848,635.

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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS

Item 6.    Indemnification of Directors and Officers.

        We have entered into indemnification agreements with each of our directors and executive officers. These agreements require us to indemnify our directors and executive officers to the fullest extent permitted by law. However, under Swiss corporate law, the indemnification of our directors and executive officers is not effective if such director or executive officer intentionally or grossly negligently violated his or her corporate duties towards the corporation, each of its shareholders or creditors. See "Comparison of Swiss Law and Delaware Law—Indemnification of directors and executive management and limitation of liability".

Item 7.    Recent Sales of Unregistered Securities.

        Set forth below is information regarding sales of unregistered securities by Addex Therapeutics, Ltd since May 31, 2016:

        On May 29, 2017, we increased our capital from CHF 13,454,553 to CHF 15,384,988 through the issue of 1,930,435 new registered shares at nominal value of CHF 1 each. The shares were created as treasury shares.

        On March 28, 2018, we issued an aggregate of 13,037,577 of our shares and warrants to purchase up to 5,866,898 of our shares. The price per share plus warrant to purchase 0.45 of a share was CHF 3.13. Each warrant has an exercise price per ordinary share of CHF 3.43 and a term of seven years. We utilized the net proceeds of the private placement of units primarily to advance our drug development programs and for general corporate purposes. The table below summarizes the issuance of such shares and warrants that were issued to members of our board of directors, our executive officers or holders of more than 5% of our shares.

        The offers, sales and issuances of the securities described above were exempt from registration (i) under Section 4(a)(2) of the Securities Act in transactions did not involve any public offering, (ii) under Regulation D promulgated under the Securities Act for sales for offers, sales and issuances made to accredited investors, (iii) under Regulation S promulgated under the Securities Act for offers, sales and issuances not made to persons in the United States and as to which no directed selling efforts were made in the United States, or (iv) under Rule 701 promulgated under the Securities Act in transactions under compensatory benefit plans and contracts relating to compensation.

Item 8.    Exhibits and Financial Statement Schedules

Exhibits

        The exhibits to this registration statement are listed in the exhibit index attached hereto and are incorporated by reference herein.

Financial Statement Schedules

        None. All schedules have been omitted because the information required to be set forth therein is not applicable or has been included in the consolidated financial statements and notes thereto.

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Item 9.    Undertakings.

        The undersigned registrant hereby undertakes:

    (1)
    To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

    (i)
    To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

    (ii)
    To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table in the effective registration statement;

    (iii)
    To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

    (2)
    That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

    (3)
    To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

    (4)
    To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided, that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements.

    (5)
    That, for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of the registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of the registration statement as of the time it was declared effective.

    (6)
    That, for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the U.S. Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore,

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unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

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EXHIBIT INDEX

EXHIBIT
NUMBER
  DESCRIPTION OF EXHIBIT
  3.1   Articles of Association of Addex Therapeutics Ltd
        
  3.2   Organizational Rules of Addex Therapeutics Ltd
        
  4.1 * Form of Deposit Agreement (incorporated by reference to Exhibit (a) of the Registration Statement on Form F-6 (No. 333-        ), filed on December     , 2019)
        
  4.2 * Form of American Depositary Receipt (included in Exhibit 4.1)
        
  4.3   Form of Warrant issued by the Registrant to certain investors on March 28, 2018
        
  5.1 * Opinion of Homburger AG
        
  10.1 License Agreement between Ortho-McNeil Pharmaceuticals Inc and the Registrant, dated December 31, 2004, as amended
        
  10.2 License Agreement between Indivior UK Limited and the Registrant, dated January 2, 2018
        
  10.3   Registration Rights Agreement among the Registrant and certain investors, dated March 22, 2018
        
  10.4   Addex Therapeutics Ltd Share Option Plan, as amended
        
  10.5 * Addex Therapeutics Ltd Equity Sharing Certificate Plan, as amended
        
  21.1   Subsidiaries of the Registrant
        
  23.1   Consent of PricewaterhouseCoopers SA
        
  23.2 * Consent of Homburger AG (included in Exhibit 5.1)
        
  24.1   Powers of Attorney (included on signature page)

*
To be filed by amendment

Portions of this exhibit (indicated by asterisks) have been omitted under rules of the U.S. Securities and Exchange Commission permitting the confidential treatment of select information.

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SIGNATURES

        Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Geneva, Switzerland, on the 16th day of December, 2019.

Addex Therapeutics Ltd    

By:

 

/s/ TIM DYER

Tim Dyer
Chief Executive Officer

 

 

POWERS OF ATTORNEY

        KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Tim Dyer and Lénaic Teyssédou, and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution, for him or her in any and all capacities, to file a registration statement with the U.S. Securities and Exchange Commission on behalf of Addex Therapeutics Ltd (the "Company") on Form F-1 for the registration of shares of the Company (the "Registration Statement") and to sign any and all amendments to such Registration Statement, including post-effective amendments or any abbreviated registration statement and any amendments thereto filed pursuant to Rule 462(b) increasing the number of securities for which registration is sought, and to file the same, with all exhibits thereto and other documents in connection therewith, with the U.S. Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

 
 
SIGNATURE
 
TITLE
 
DATE

 

 

 

 

 

 

 
By:   /s/ TIM DYER

Tim Dyer
  Chief Executive Officer and Director (Principal Executive Officer)   December 16, 2019

By:

 

/s/ LENAIC TEYSSEDOU

Lénaic Teyssédou

 

Head of Finance (Principal Financial Officer and Principal Accounting Officer)

 

December 16, 2019

By:

 

/s/ VINCENT LAWTON

Vincent Lawton

 

Chairman of the Board of Directors

 

December 16, 2019

By:

 

/s/ RAY HILL

Ray Hill

 

Director

 

December 16, 2019

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SIGNATURE
 
TITLE
 
DATE

 

 

 

 

 

 

 
By:   /s/ ISAAC MANKE

Isaac Manke
  Director   December 16, 2019

By:

 

/s/ ROGER MILLS

Roger Mills

 

Director

 

December 16, 2019

By:

 

/s/ JAKE NUNN

Jake Nunn

 

Director

 

December 16, 2019

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Authorized Representative in the United States

Addex Pharmaceuticals Inc.

/s/ TIM DYER

By: Tim Dyer
Title:
Chief Executive Officer

 

Authorized Representative in the United States

 

December 16, 2019

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Exhibit 3.1

 

Statuts

 

de

 

Addex Therapeutics Ltd

 

I.                                        Raison sociale, Siege, Durée, But

 

Article 1

 

Raison sociale, siège, durée

 

Il existe sous la raison sociale Addex Therapeutics Ltd (Addex Therapeutics SA) (la “Société”) une société anonyme qui est régie par les présents Statuts et par le titre XXVI du Code suisse des Obligations (“CO”). Le siège de Ia Société est à Plan-les-Ouates, canton de Genéve. La durée de Ia Société est indéterminée.

 

Article 2

 

But

 

La Société a pour but l’acquisition, la détention, la gestion, l’aliénation et le financement de participations dans toutes sociétés ou entreprises, suisses ou étrangères, à l’exclusion de participations immobilières, sauf dans les cas où la législation suisse le permet.

 

La Société peut créer des filiales, succursales et bureaux de représentation en Suisse et a l’étranger. Elle peut se porter garante ou accorder tout autre type de garantie en relation avec des engagements de sociétés affiliées. Elle peut en outre faire toutes opérations commerciales, financières et autres en vue de promouvoir, ou en relation avec, le but de la Société.

 

La Société peut acquérir, gérer, exploiter et vendre, en Suisse et a l’étranger, des droits de propriété intellectuelle et, dans le cas où la législation suisse le permet, des biens immobiliers.

 

1


 

II.                                   Capital-actions, Bons de jouissance, Certificats d’actions, Registre des Actionnaires, Représentants

 

Article 3

 

Capital-actions

 

Le capital-actions de la Société est de CHF 13’454’553.-. Il est divisé en 13’454’553 actions nominatives d’une valeur nominale de CHF 1.- chacune.

 

Les actions sont entièrement libérées.

 

Par une modification des presénts Statuts, l’assemblée générale des actionnaires peut en tout temps convertir des actions nominatives en actions au porteur ou des actions au porteur en actions nominatives et, le cas échéant, des bons de participation en actions

 

Article 3a

 

Bons de jouissance

 

La Société a émis 1’700 (mille sept cents) bons de jouissance nominatifs destinés aux employés, aux membres du conseil d’administration et/ou consultants de la Société ou d’une autre société du groupe en fonction des règles adoptées par le conseil d’administration de la Société.

 

Les bons de jouissance ne sont pas incorporés dans un titre.

 

Les bons de jouissance ne sont transmissibles qu’avec l’accord préalable du conseil d’administration.

 

Les bons de jouissance ne constituent pas un élément du capital-actions et n’ont pas de valeur nominale. Ils ne confèrent ni droit de vote, ni le droit de participer aux assemblées générales. Chaque bon de jouissance confère (i) le droit de souscrire à 1’000 actions, ainsi que (ii) un droit à une part du produit de liquidation déterminée conformément à l’article 34 des presents Statuts.

 

La Société tient un registre des détenteurs de bons de jouissance qui mentionne les nom et prénom(s) (ou, dans le cas de personnes morales, la raison sociale), l’adresse et la nationalité (ou, dans le cas de personnes morales, le siège) des détenteurs de bons de jouissance. A l’égard de la Société, est considérée comme détenteur, la personne inscrite au registre des détenteurs de bons de jouissance. Les dispositions relatives au registre

 

2


 

des actionnaires (article 5 des présents Statuts) sont applicables par analogie au registre des détenteurs de bons de jouissance.

 

Le conseil d’administration peut en tout temps détenir, acquérir et aliéner des bons de jouissance pour le compte de la Société. La Société peut en tout temps annuler des bons de jouissance.

 

Article 3b

 

‘Capital-actions autorisé

 

Jusqu’au 23 juin 2018, le conseil d’administration peut augmenter le capital-actions d’un montant de CHF 6’727’276.- par l’émission de 6’727’276 actions nominatives entièrement libérées d’une valeur nominate de CHF 1 chacune. Une augmentation du capital-actions en plusieurs tranches est autorisée. Le conseil d’administration détermine le prix d’émission, le moyen de paiement, la date d’émission des nouvelles actions, les conditions d’exercice des droits de souscription préferentiels et la date à partir de laquelle les nouvelles actions donnent droit au paiement d’un dividende. A cet égard, le conseil d’administration peut émettre de nouvelles actions par une souscription ferme opérée au travers d’une institution bancaire, d’un syndicat ou de tout autre tiers comprenant une offre subséquente de ces actions aux actionnaires actuels (à moins que les droits de souscription préférentiels des actionnaires actuels ne soient supprimés). Le conseil d’administration peut laisser se périmer les droits de souscription préférentiels qui n’ont pas été exercés; il peut également vendre aux conditions du marché ces droits et/ou les actions liées aux droits de souscription préférentiels accordés mais non exercés, ou les utiliser dans un autre but conforme à l’intérêt de la Société.

 

La souscription et l’acquisition des nouvelles actions, ainsi que tout transfert subséquent, sont soumis aux restrictions prévues à l’article 5 des présents Statuts.

 

Le conseil d’administration peut restreindre ou exclure les droits de souscription préférentiels des actionnaires et les attribuer à des tiers si les actions liées à ces droits doivent être utilisées (1) pour acquérir des entreprises, des parties d’entreprises ou des participations, ou pour réaliser de nouveaux investissements, ou, dans l’hypothèse d’un placement d’actions, pour financer ou refinancer de telles transactions; ou (2) dans le but de faire participer un partenaire stratégique (y compris dans l’hypothèse d’une offre publique d’acquisition) ou dans le but d’étendre le cercle de l’actionnariat dans certains marchés financiers; ou (3) pour l’octroi aux banques impliquées dans le placement des actions d’une option de sur-allocation (greenshoe) jusqu’a 20 pour cent, ou (4) afin de lever

 

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des capitaux de façon rapide et flexible, dans les cas où cela ne pourrait pas être réalisé sans exclure les droits de souscription préférentiels légaux des actionnaires actuels.

 

Article 3c

 

Capital-actions conditionnel

 

A)                                   Le capital-actions de la Société peut être augmenté d’un montant total maximum de CHF 2’600’000.- par l’émission de 2’600’000 actions nominatives au maximum, entièrement libérées et d’une valeur nominale de CHF 1 chacune, liées à l’exercice des droits d’option ou des droits de souscription attachés aux bons de jouissance attribués aux employés, aux membres du conseil d’administration et/ou consultants de la Société ou d’une autre société du groupe en fonction des règles adoptées adoptées par le conseil d’administration. Les droits de souscription préférentiels des actionnaires sont exclus. L’acquisition d’actions nominatives par l’exercice des droits d’option ou des droits de souscription attachés aux bons de jouissance et le transfert subséquent des actions nominatives sont soumis aux restrictions prévues à l’article 5 des présents Statuts.

 

B)                                   Le capital-actions de la Société peut être augmenté d’un montant maximal de CHF 4’127’276.- par l’emission de 4’127’276 actions nominatives au maximum, entièrement libérées et d’une valeur nominale de CHF 1 chacune, liées à l’exercice de droits d’option et/ou de conversion attribués en relation avec l’émission par la Société ou par une autre société du groupe d’obligations ou de tout autre instrument financier. En cas d’émission d’obligations ou de tout autre instrument financier couplés avec des droits d’option et/ou de conversion, les droits de souscription préférentiels des actionnaires sont exclus. Les détenteurs de droits d’option et/ou de conversion ont un droit de recevoir les nouvelles actions. Le conseil d’administration détermine les termes des droits d’option et/ou de conversion. L’acquisition d’actions nominatives par l’exercice de droits d’option ou de conversion et le transfert subséquent des actions nominatives sont soumis aux restrictions prévues à l’article 5 des présents Statuts.

 

Le conseil d’administration peut restreindre ou exclure les droits de souscription préférentiels des actionnaires (1) si une obligation ou tout autre instrument financier est émis avec un droit de conversion ou un warrant dans le but de financer ou de refinancer l’acquisition d’entreprises, de parties d’entreprises, ou de participations, ou de réaliser de nouveaux investissements, ou (2) si une obligation ou tout autre instrument financier est offert sur les marchés des capitaux nationaux ou internationaux avec une souscription ferme par une institution bancaire ou un

 

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consortium bancaire comprenant une offre subséquente au public. Si les droits de souscrire par avance sont exclus par le conseil d’administration, les règles suivantes s’appliquent: l’éemission d’obligations convertibles ou de warrants ou de tout autre instrument financier doit être réalisée aux conditions du marché (y compris les règles de protection contre la dilution applicables en fonction de la pratique du marché) et les nouvelles actions doivent être émises en application des droits de conversion ou d’exercice prévus à l’émission de l’obligation ou du warrant en cause. Les droits de conversion peuvent être exercés pendant 10 ans au maximum, et les warrants pendant 7 ans, dans les deux cas à compter de leurs dates d’émission respectives.

 

Article 4

 

Non impression des certificats d’actions

 

Les actionnaires peuvent en tout temps requérir de la Société qu’elle émette une confirmation du nombre d’actions nominatives détenues par I’actionnaire requérant. Les actionnaires n’ont cependant pas le droit de requérir l’impression ou la délivrance de certificats d’actions pour leurs actions nominatives. La Société peut toutefois en tout temps imprimer et remettre des certificats d’actions pour actions nominatives et peut, avec I’accord de I’actionnaire concerné, annuler les certificats d’actions qui Iui ont été remis sans devoir les remplacer.

 

Les actions nominatives dématérialisées, y compris les droits liés à de telles actions, se transfèrent uniquement par cession. Une telle cession n’est valable que si elle est notifiée a la Société.

 

Lorsque, au nom d’un actionnaire, une banque administre les droits issus d’actions nominatives dématérialisées, de telles actions et les droits qui y sont liés ne peuvent être cédés qu’avec le concours de la banque. En outre, ils ne peuvent être mis en gage qu’en faveur de la banque, auquel cas aucune notification à la Société n’est nécessaire.

 

Article 5

 

Registre des actionnaires, représentants (nominees)

 

La Société tient un registre des actionnaires qui mentionne les nom et prénom(s) (ou, dans le cas de personnes morales, la raison sociale), l’adresse et la nationalité (ou, dans le cas de personnes morales, le siège) des propriétaires et usufruitiers d’actions nominatives. Lorsqu’un actionnaire enregistré change d’adresse, il doit communiquer sa nouvelle adresse a la Société. Dans l’intervalle, toutes les communications par courrier sont

 

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réputées avoir été faites valablement Iorsqu’elles ont été envoyées à l’adresse figurant dans le registre des actionnaires.

 

Les acquéreurs d’actions nominatives sont, sur demande, enregistrés comme actionnaires avec droit de vote, à condition qu’ils déclarent expressément qu’ils ont acquis les actions nominatives en cause en leur propre nom et pour leur propre compte.

 

Le conseil d’administration peut inscrire dans le registre des actionnaires des représentants (nominees) avec droit de vote qui possèdent jusqu’à 5 pour cent du capital-actions tel qu’indiqué au registre du commerce. Les actions nominatives détenues par un représentant (nominee) dépassant cette limite peuvent être inscrites avec droit de vote dans le registre des actionnaires, à condition que le représentant (nominee) révèle les nom et adresse des personnes, ainsi que le nombre d’actions des personnes, pour le compte desquelles it détient plus de 1 pour cent du capital-actions tel qu’indiqué au registre du commerce. Au sens du présent article, représentant (nominee) signifie toute personne qui ne déclare pas explicitement dans sa demande d’inscription qu’elle détient les actions concernées pour son propre compte et avec laquelle le conseil d’administration a conclu un accord à cet égard.

 

Les entités juridiques, les sociétés simples ou les autres groupes de personnes ou les propriétaires en commun, qui sont liés entre eux par une participation au capital, des droits de vote, une gestion uniforme ou de tout autre manière, ainsi que les personnes physiques ou morales qui agissent de concert afin de contourner les règles concernant les représentants (en particulier les syndicats) sont traités comme un seul et unique représentant (nominee) au sens du paragraphe précédent.

 

Après avoir entendu I’actionnaire inscrit ou le représentant (nominee), le conseil d’administration peut annuler, avec effet rétroactif à compter de la date d’inscription si nécessaire, I’inscription d’un actionnaire si celle-ci a été effectuée sur la base de fausses informations ou en violation de l’accord passé entre le représentant (nominee) et le conseil d’administration. L’actionnaire ou le représentant (nominee) en cause sont informés immédiatement de I’annulation de leur inscription.

 

Le conseil d’administration est habilité à prendre les dispositions d’application et les mesures nécessaires concernant le respect des règles qui précédent. Dans des cas particuliers, il peut octroyer des exemptions au régime des représentants (nominees). Il peut déléguer ces fonctions.

 

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Les restrictions à I’inscription dans le registre des actionnaires prévues au présent article sont également applicables aux actions acquises ou souscrites par l’exercice de droits de souscription, d’option ou de conversion.

 

Article 6

 

Exercice des droits des actionnaires

 

Les actions ne sont pas divisibles. La Société n’accepte qu’un seul représentant par action.

 

Les droits de vote et autres droits liés à une action nominative peuvent être exercés uniquement par un actionnaire, un usufruitier ou un représentant inscrit dans le registre des actionnaires avec un droit de vote, ou par des personnes habilitées à exercer un tel droit de vote de par la loi, sous réserve de l’article 13 des présents Statuts, qui réglemente la représentation des actionnaires.

 

III.                              Organisation de Ia Société

 

Article 7

 

Organes de Ia Société

 

Les organes de Ia Société sont:

 

a)                                     L’assemblée générale;

 

b)                                     Le conseil d’administration; et

 

c)                                      L’organe de révision.

 

A.                                    L’assemblée générale

 

Article 8

 

Compétences de l’assemblée générale

 

L’assemblée générale des actionnaires est le pouvoir suprême de la Société. Elle a les droits inaliénables suivants:

 

1.                                      adopter et modifier les statuts;

 

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2.                                      nommer et révoquer les membres du conseil d’administration, le président du conseil d’administration, les membres du comité de rémunération, I’organe de révision et le représentant indépendant;

 

3.                                      approuver le rapport annuel et les comptes de groupe;

 

4.                                      approuver les comptes annuels et déterminer I’emploi du bénéfice résultant du bilan, en particulier fixer le dividende;

 

5.                                      approuver Ia rémunération du conseil d’administration et de Ia direction exécutive selon l’article 27 des présents statuts;

 

6.                                      donner décharge aux membres du conseil d’administration et de Ia direction;

 

7.                                      prendre toutes les décisions qui lui sont réservées par la loi ou les statuts.

 

Article 9

 

Assemblées générales ordinaires et extraordinaires

 

L’assemblée générale ordinaire se réunit cheque année dans les six mois qui suivent Ia clôture de l’exercice social.

 

Une assemblée générale extraordinaire des actionnaires est réunie aussi souvent que le conseil d’administration ou l’organe de révision le juge nécessaire ou lorsque l’assemblée générale des actionnaires le demande. En outre, une assemblée générale extraordinaire est convoquée lorsqu’un ou plusieurs actionnaires représentant ensemble le dixième au moins du capital-actions le requièrent et soumettent par écrit une demande spécifiant les objets à placer à l’ordre du jour et, dans le cas d’une élection, le nom des candidats proposés.

 

Article 10

 

Convocation

 

L’assemblee générale des actionnaires est convoquée par le conseil d’administration ou, si nécessaire, par l’organe de révision vingt jours au moins avant la date de sa réunion. Les liquidateurs ont aussi Ia faculté de convoquer une assemblée générale des actionnaires.

 

La convocation a l’assemblée est faite par une annonce unique dans l’organe de publication officiel de la Société. Les détenteurs d’actions ordinaires peuvent aussi être informés par courrier ordinaire.

 

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Le rapport de gestion, le rapport de compensation et les rapports de l’organe de révision doivent être mis à Ia disposition des actionnaires au siège de Ia Société au moins vingt jours avant la date de l’assemblée générale ordinaire. Une mention dans ce sens est faite dans l’invitation à l’assemblée générale des actionnaires.

 

La convocation à l’assemblée mentionne les objets à l’ordre du jour, les propositions du conseil d’administration et, le cas échéant, celles des actionnaires qui requièrent Ia tenue d’une assemblée des actionnaires ou la mention d’un objet à l’ordre du jour, et, dans le cas d’élections, les noms des candidats proposés.

 

Article 11

 

Ordre du jour

 

Un ou plusieurs actionnaires représentant des actions totalisant une valeur nominate de CHF 1’000’000 au moins ou dix pour cent au moins du capital-actions peuvent requérir l’inscription d’un objet à l’ordre du jour. Une telle requête doit être faite au conseil d’administration par écrit au moins 60 jours avant l’assemblée et doit spécifier les objets à l’ordre du jour et les propositions qui sont faites.

 

Aucune décision ne peut être prise sur des objets qui n’ont pas été portés valablement à l’ordre du jour. Cette disposition ne s’applique toutefois pas aux propositions faites durant une assemblée générale des actionnaires de convoquer une assemblée générale extraordinaire ou d’instituer un contrôle special.

 

ll n’est pas nécessaire d’annoncer à l’avance les propositions entrant dans le cadre des objets portés a l’ordre du jour, ni les déliberations qui ne doivent pas être suivies d’un vote.

 

Article 12

 

Président, scrutateur, procès-verbal

 

L’assemblée générale est présidée par le président du conseil d’administration. En son absence, c’est le vice-président ou tout autre membre du conseil d’administration désigne par celui-ci qui préside a L’assemblée générale.

 

Le président de l’assemblée désigne le secrétaire et le scrutateur, qui ne doivent pas nécessairement être actionnaires. Le procès-verbal est signé par le président de l’assemblée et par le secrétaire.

 

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Article 13

 

Droits de vote, procurations, représentant indépendant

 

Chaque action inscrite en tant qu’action avec droit de vote dans le registre des actionnaires confère une voix à l’actionnaire inscrit.

 

Le conseil d’administration émet des règles de procvdure concernant la participation et la representation à l’assemblée générale des actionnaires. Chaque actionnaire peut être représenté à I’assemblée générale des actionnaires par le représentant indépendant ou une personne dûment autorisée par une procuration écrite. Le représentant n’a pas besoin d’être actionnaire.

 

L’assemblée générale des actionnaires élit le représentant indépendant pour une durée de fonctions s’achevant à la fin de l’assemblée générale ordinaire des actionnaires suivante. Une reelection est possible

 

Si la Société n’a pas de représentant indépendant, le conseil d’administration le désigne en vue de la prochaine assemblée générale des actionnaires.

 

Article 14

 

Décisions, élections

 

Sauf indication contraire de la loi ou des présents Statuts, l’assemblée générale des actionnaires décide et élit à la majorité absolue des voix attribuées aux actions représentées. En cas d’ègalite des voix, celle du président de l’assemblée est prépondérante.

 

Les décisions sont prises et les élections effectuées à mains levées, sauf si l’assemblée générale des actionnaires ou le président de l’assemblée décide de procéder à un vote par bulletin ou par voie électronique. S’il a un doute quant au résultat du vote, le président de l’assemblée peut à tout moment ordonner de procéder à nouveau à une élection ou à une décision à mains levées, par bulletin ou par voie électronique. Dans cette hypothèse, l’élection ou la dècision antérieure est reputée non avenue.

 

Si le premier scrutin n’aboutit pas à une élection et si plus d’un candidat s’est présenté à l’élection, le président de l’assemblée ordonne un second scrutin où prévaut le principe de majorité relative.

 

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B.                                    Conseil d’administration

 

Article 15

 

Nombre de membres

 

Le conseil d’administration est composé de 1 membre au moins et de 11 membres au plus.

 

Article 16

 

Election, durée des fonctions

 

Les membres du conseil d’administration et le président du conseil d’administration sont élus individuellement par l’assemblée générale des actionnaires pour une durée de fonctions s’achevant à la fin de l’assemblée générale ordinaire des actionnaires suivante.

 

Les membres dont la durée des fonctions a expiré sont immédiatement rééligibles.

 

Lorsque la fonction de président du conseil d’administration est vacante, le conseil d’administration désigne un nouveau président parmi ses membres pour une durée de fonctions s’achevant à la fin de I’assemblée générale ordinaire des actionnaires suivante.

 

Article 17

 

Organisation

 

A l’exception de l’élection du président du conseil d’administration et des membres du comité de rémuneration par l’assemblée générale des actionnaires, le conseil d’administration détermine sa propre organisation. Il peut désigner parmi ses membres un, ou si nécessaire plusieurs, vice-président(s). Le conseil d’administration désigne en outre un secrétaire, qui n’a pas besoin d’être membre du conseil d’administration.

 

Le conseil d’administration peut déléguer à certains de ses membres en comités permanents ou ad hoc la preparation et l’exécution de ses décisions ou la supervision de parties spécifiques des affaires de la Société. Le conseil d’administration s’assure qu’il demeure dûment informé.

 

Sous réserve de dispositions imperatives de la loi ou des présents Statuts, le conseil d’administration détermine son organisation interne et Ia manière dont il prend ses décisions dans un règlement d’organisation.

 

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Article 18

 

Convocation, décisions, procès-verbal

 

Le président, en son absence le vice-président ou tout autre membre du conseil d’administration, convoque une réunion aussi souvent que Ia marche des affaires l’exige ou lorsqu’un membre en fait Ia demande par écrit en précisant les raisons de Ia réunion. Une réunion peut également être tenue par téléphone ou par vidéoconférence.

 

Le conseil d’administration prend ses décisions à Ia majorité des voix exprimées.

 

Les décisions peuvent egalement être prises par écrit (y compris par fax ou par signature électronique) à moins qu’un membre ne réclame une délibération orate.

 

Article 19

 

Attributions

 

Le conseil d’administration peut prendre des décisions sur toutes les affaires qui ne sont pas attribuées à un autre organe social par Ia loi, les présents Statuts ou un règlement.

 

Le conseil d’administration possède en particulier les attributions intransmissibles et inaliénables suivantes:

 

1.                                      exercer Ia haute direction de Ia Société et établir les instructions nécessaires;

 

2.                                      fixer l’organisation de Ia Société;

 

3.                                      fixer les principes de la comptabilité, du contrôle financier et le plan financier;

 

4.                                      nommer et révoquer les personnes chargées de Ia gestion et de la représentation, ainsi que leur pouvoir de signature;

 

5.                                      exercer Ia haute surveillance sur les personnes chargées de Ia gestion pour s’assurer en particulier qu’elles observent la loi, les présents Statuts, les règlements et les instructions données;

 

6.                                      établir le rapport annuel et le rapport de rémunération, préparer les assemblée des actionnaires et exécuter les décisions prises par les assemblées des actionnaires;

 

7.                                      prendre les décisions nécessaires concernant le paiement subséquent relatif aux actions qui ne sont pas entièrement libérées;

 

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8.                                      prendre les décisions concernant I’augmentation du capital-actions pour autant que ce pouvoir soit conféré au conseil d’administration (article 651 para. 4 CO) et concernant la confirmation d’augmentations de capital avec les modifications y relatives des statuts, ainsi que préparer le rapport d’augmentation;

 

9.                                      toutes les attributions et tous les pouvoirs intransmissibles et inaliénables du conseil d’administration tels que prévus dans la loi suisse sur la fusion et dans toutes autres lois;

 

10.                               informer le juge en cas de surendettement.

 

En outre, le conseil d’administration peut, dans les limites de la loi et sur Ia base du règlements d’organisation, déléguer entièrement ou partiellement ses pouvoirs, ainsi que Ia gestion et la représentation de la Société, à un ou plusieurs de ses membres ou à des tiers.

 

C.                                    Comité de rémunération

 

Article 20

 

Nombre de membres, élection, durée de fonctions

 

Le comité de rémunération est constitué de 1 à 3 membres du conseil d’administration.

 

Si le conseil d’administration compte moins de 4 membres, le comité de rémunération peut également se composer des mêmes membres que le conseil d’administration.

 

L’assemblée générale des actionnaires élit individuellement les membres du comité de rémunération pour une durée de fonctions s’achevant à la fin de l’assemblée générale des actionnaires ordinaire suivante.

 

Les membres dont Ia durée des fonctions à expiré sont immédiatement rééligibles.

 

Article 21

 

Organisation du comité de rémunération

 

Le comité de rémunération détermine sa propre organisation, le conseil d’administration élit le président du comité de rémunération.

 

Le conseil d’administration édicte un règlement fixant l’organisation et le processus de prise de décision du comité de rémunération.

 

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Article 22

 

Attributions du comité de rémunération

 

Le comité de rémunération assiste le conseil d’administration dans l’établissement et la révision de la stratégie et des directives de rémunération, ainsi que dans la preparation des propositions à soumettre à l’assemblée générale des actionnaires concernant la rémunération du conseil d’administration et de la direction exécutive et peut soumettre au conseil d’administration des propositions en toutes autres matières relatives à la rémunération.

 

Le conseil d’administration établit un règlement déterminant pour quelles fonctions du conseil d’administration et de la direction exécutive le comité de rémunération propose au conseil d’administration les mesures de performances, les valeurs cibles et la rémunération, et pour quelles autres fonctions it aura compétence de déterminer de son propre chef, en accord avec les statuts et les directives de rémunération établies par le conseil d’administration, les mesures de performances, les valeurs cibles et la rémunération.

 

Le conseil d’administration peut déléguer au comité de rémunération d’autres tâches définies dans un règlement.

 

D.                                    Organe de révision

 

Article 23

 

Election, durée des fonctions

 

L’assemblée générale des actionnaires élit l’organe de révision.

 

La durée des fonctions de l’organe de révision est d’une année. Les fonctions de l’organe de révision débutent avec leur élection et s’achèvent le jour de l’assemblée générale ordinaire des actionnaires suivant ladite élection.

 

Aux fins des vérifications spéciales prévues en rapport avec les augmentations de capital (articles 652f, 653f, 653i CO), l’assemblée générale des actionnaires peut élire des réviseurs spéciaux. Si aucun réviseur spécial n’a été élu, l’organe de révision est chargé de ces fonctions.

 

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Article 24

 

Devoirs de révision et de faire rapport

 

L’organe de révision exerce ses fonctions conformément aux dispositions applicables du Code suisse des obligations.

 

Article 25

 

Audits spéciaux et intérimaires

 

Le conseil d’administration peut en tout temps requérir de l’organe de révision qu’il procède à des audits spéciaux, y compris des audits intérimaires, et qu’il lui soumette ses rapports.

 

IV.                  Rémunération des membres du conseil d’administration et de la direction exécutive

 

Article 26

 

Principes généraux de rémunération

 

La rémunération des membres du conseil d’administration est constituée d’une rémunération fixe et variable. La rémunération totale prend en compte la position et le niveau de responsabilité du bénéficiaire.

 

La remunération des membres de la direction exécutive est constituée d’éléments de rémunération fixes et variables. La rémunération fixe comprend le salaire de base et d’autres éléments de rémunération. La rémunération variable peut comprendre des éléments de rémunération variable à court et à long terme. La rémunération prend en compte la position et le niveau de responsabilité du bénéficiaire.

 

Les élements de rémunération variables à court terme sont régis par des mesures de performance qui prennent en compte la performance de la Société ou de tout ou partie du groupe, des buts en relation avec le marché, d’autres sociétés ou d’autres repères comparables et/ou des buts personnels, leur accomplissement est généralement mesuré sur une période d’une année.

 

Les élements de rémunération variables à long terme sont régis par des mesures de performance qui prenne en compte des objectifs stratégiques et/ou financiers, leur accomplissement est généralement mesuré sur une période pluriannuelle, ainsi que des

 

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éléments de maintien en poste. Selon la performance atteinte, la rémunération peut se monter à un multiplicateur prédéterminé du niveau cible.

 

Le conseil d’administration ou le comité de rémunération, si cette compétence lui a été déléguée, détermine les mesures de performance et les niveaux cibles des éléments de rémunération variables à court et long terme ainsi que leur accomplissement.

 

La rémunération peut être versée en espèces, sous forme d’actions, d’instrument ou d’unité sur la base d’action et/ou d’autres types de prestations. Le conseil d’administration ou le comité de rémunération, si cette compétence lui a été déléguée, détermine les conditions d’octroi, d’acquisition (vesting), d’exercice et de révocation. II peut en particulier prévoir la continuation, l’accéleration ou la suppression des conditions d’acquisition (vesting) et d’exercice, le versement d’une rémunération présumant l’atteinte des objectifs ou encore la déchéance des droits dans chaque cas lors d’événements prédétermines tels que notamment un changement de contrôle ou la fin d’un contrat de travail ou de mandat. La Société peut se procurer les actions requises par le biais d’achats sur le marché ou en utilisant son capital-actions conditionnel.

 

La rémunération peut être versée par la Société ou toute autre société qu’elle contrôle.

 

Article 27

 

Approbation de la rémunération par l’assemblée générale des actionnaires

 

L’assemblée générale des actionnaires approuve les propositions du conseil d’administration en relation avec le montant maximal total de :

 

1)                                     la rémunération du conseil d’administration pour la prochaine durée de fonctions ;

 

2)                                     la rémunération de Ia direction exécutive pour l’exercice social à venir.

 

Le conseil d’administration peut soumettre à l’approbation de l’assemblée générale des actionnaires des propositions différentes ou supplémentaires concernant les mêmes périodes ou des périodes différentes.

 

Si l’assemblée générale des actionnaires n’approuve pas une proposition du conseil d’administration, le conseil d’administration détérmine, en prenant en compte tous les critères pertinents, le montant (maximal) total ou des montants (maximaux) partiels respectifs, et soumet le(s) montant(s) ainsi déterminé(s) à l’approbation de la même assemblée générale des actionnaires, d’une assemblée extraordinaire des actionnaires ou de la prochaine assemblée générale des actionnaires.

 

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La rémunération peut être versée avant l’approbation de I’assemblée générale des actionnaires, sous réserve d’une approbation ultérieure.

 

Article 28

 

Montant complémentaire en cas de changements au sein de Ia direction exécutive

 

Si le montant global maximal de la rémunération déjà approuvé par l’assemblée générale des actionnaires n’est pas suffisant pour couvrir également Ia rémunération d’une ou plusieurs personnes devenant membre(s) de Ia direction exécutive ou étant promue(s) au sein de la direction exécutive après que l’assemblée générale des actionnaires a approuvé la rémunération de Ia direction exécutive pour la période visée, Ia Societé ou toute autre société qu’elle contrôle est alors autorisée à verser à ce(s) membre(s) un montant complémentaire au cours de la (des) période(s) de rémunération déjà approuvée(s). Le montant maximal total par période de rémunération ne doit au total pas dépasser 100% du montant global de la rémunération de la direction exécutive approuvé en dernier par l’assemblée générale.

 

V.                       Contrats avec les membres du conseil d’administration et de Ia direction exécutive, prêts

 

Article 29

 

Contrats avec les membres du conseil d’administration et de Ia direction exécutive

 

La Société, ou toute société qu’elle contrôle, peut conclure des contrats de durée déterminée ou indéterminée avec les membres du conseil d’administration en relation avec leur rémunération. La durée et la résiliation doivent être conformes avec Ia durée de fonctions ainsi qu’avec les dispositions légates applicables.

 

La Société, ou toute société qu’elle contrôle, peut conclure des contrats de travail de durée déterminée ou indéterminée avec les membres de la direction exécutive. Les contrats de travail de durée déterminée peuvent avoir une durée maximale d’une année. Ils peuvent être renouvelés. Les contrats de travail de durée indéterminée peuvent prévoir un période de préavis d’au maximum douze mois.

 

La Société, ou toute société qu’elle contrôle peut conclure des accords de non concurrence avec les membres de Ia direction exécutive pour Ia période suivant la fin des rapports de travail. Leur durée ne peut excéder une année et l’indemnisation versée en relation avec

 

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un tel accord de non concurrence ne peut excéder la dernière rémunération annuelle totale du membre concerné de la direction exécutive.

 

Article 30

 

Prêts

 

Aucun prêt ne peut être octroyé aux membres du conseil d’administration ou de la direction générale.

 

VI.                  Mandats en dehors du groupe

 

Article 31

 

Aucun membre du conseil d’administration ne peut exercer plus de quatorze mandats supplémentaires, dont au maximum quatre dans des sociétés cotées.

 

Aucun membre de la direction exécutive ne peut exercer plus de cinq mandats, dont au maximum deux dans une société cotée.

 

Les mandats suivants ne sont pas soumis aux limites mentionnées ci-dessus :

 

1)                                     les mandats dans des sociétés contrôlées par la Société ou ayant le contrôle sur la Société

 

2)                                     les mandats assumés sur requête de la Société ou de toute autre société qu’elle contrôle. Aucun membre du conseil d’administration ou de la direction exécutive ne peut exercer plus de dix mandats de ce genre ; et

 

3)                                     les mandats dans des associations, organisation caritatives, fondations, trusts, fondations de prévoyance professionnelle, institutions éducatives, institutions sans buts lucratifs et d’autres organisations similaires. Aucun membre du conseil d’administration ou de la direction générale ne peut exercer plus de vingt-cinq mandats de ce genre.

 

Le terme mandat désigne tout mandat au sein d’organes supérieurs de direction ou d’administration d’entités juridiques qui ont l’obligation de s’inscrire au registre du commerce ou dans un registre similaire à I’etranger. Sont considérés comme étant un seul mandat, les mandats dans différentes entités légates sous contrôle commun (de droit ou de fait).

 

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VII.             Comptes annuels, Dividendes

 

Article 32

 

Comptes annuels, rapport annuel

 

Le conseil d’administration détermine le début et la fin de I’exercice social.

 

Pour chaque exercice social, le conseil d’administration prépare un rapport annuel composé des comptes annuels (y compris le compte de pertes et profits, le bilan, le tableau des flux de trésorerie et l’annexe), le rapport de gestion et les comptes de groupe.

 

Article 33

 

Affectation du bénéfice, réserves

 

L’affectation du bénéfice ressortant du bilan est décidée par l’assemblée générale des actionnaires dans les limites de la loi. Le conseil d’administration soumet une proposition à cet égard à l’assemblée générale des actionnaires.

 

L’assemblée générale des actionnaires peut décider de constituer des réserves additionnelles excédant les réserves légales.

 

Tout dividende non réclamé après une période de cinq ans à compter de son échéance est alloué à la Société et attribué à la réserve générale.

 

VIII.                     Dissolution

 

Article 34

 

Dissolution, liquidation

 

L’assemblée générale des actionnaires peut décider en tout temps la dissolution et la liquidation de la Société en application de la loi et des présents Statuts.

 

A moins que I’assemblée générale n’ait confié cette tâche à une autre personne, la liquidation est exercée par le conseil d’administration.

 

La liquidation de la Société est effectuée en application des articles 742 ss CO. Le liquidateur est autorisé à aliéner des biens (y compris immobiliers) par contrat privé.

 

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Après paiement de toutes les dettes, l’actif est réparti entre les actionnaires et les détenteurs de bons de jouissance au pro rata du nombre d’actions et de droits de souscription attachés aux bons de jouissance.

 

IX.                              Avis, communications

 

Article 35

 

Avis, communications

 

L’organe de publication officiel de la Société est la Feuille Officielle Suisse du Commerce. Le conseil d’administration peut désigner d’autres organes de publication.

 

Sous réserve des cas où la loi prévoit une notification personnelle, toutes les communications aux actionnaires sont réputées valablement effectuées si elles ont été publiées dans la Feuille Officielle Suisse du Commerce.

 

En cas de communications écrites de la Société aux actionnaires, celles-ci sont envoyées par courrier ordinaire à leur dernière adresse figurant dans le registre des actionnaires de la Société.

 

X.                                   Apports en nature, Reprise de biens

 

Article 36

 

Apports en nature

 

Monsieur Timothy Dyer fait apport, en son nom et à titre fiduciaire, à la Société de:

 

(i)                                     3’317’492 (trois millions trois cent dix-sept mille quatre cent nonante deux) actions d’une valeur nominale de CHF 1 (un franc suisse) chacune, entièrement libérées, d’Addex Pharma SA (anciennement Addex Pharmaceuticals SA) à Plan-les-Ouates (Genève).

 

Cet apport est fait et accepté pour le prix de CHF 3’317’492 (trois millions trois cent dix-sept mille quatre cent nonante deux francs suisses), montant imputé en totalité sur le capital-actions.

 

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En contrepartie de cet apport, il est remis à Monsieur Timothy Dyer 3’317’492 (trois millions trois cent dix-sept mille quatre cent nonante deux) actions nominatives de CHF 1 chacune, entièrement libérées.

 

(ii)                                  670’000 (six cent septante mille) bons de participation d’une valeur nominale de CHF 1 (un franc suisse) chacun, entièrement libérés, représentant la totalité du capital-participation d’Addex Pharma SA (anciennement Addex Pharmaceuticals SA) à Plan-les-Ouates (Genève).

 

Cet apport est fait et accepté pour le prix de CHF 670’000 (six cent septante mille francs suisses), montant imputé en totalité sur le capital-participation.

 

En contrepartie de cet apport, il est remis à Monsieur Timothy Dyer 670’000 (six cent septante mille) bons de participation nominatifs de CHF 1 (un franc suisse) chacun, entièrement libérés.

 

Article 37

 

Reprise de biens

 

La Société à repris d’Addex Pharma SA (anciennement Addex Pharmaceuticals SA) à Plan-les-Ouates (Genève) I’intégralité du capital-actions de Addex Pharmaceuticals France SAS, société de droit français ayant son siège à Archamps (France), soit 37’000 (trente sept mille) actions d’une valeur nominale de EUR 1 (un Euro) chacune, pour le prix total de CHF 1 (un franc suisse).

 

XI.                              Divers

 

Article 38

 

Traduction des statuts

 

Les présents Statuts sont traduits du français en anglais. Seul le texte français fait foi.

 

**********

 

Genéve, le 23 juin 2016

 

 

David LACIN, notaire

 

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Articles of Association

 

of

 

Addex Therapeutics Ltd

 

I.                                        Corporate Name, Registered Office, Duration, Purpose

 

Article 1

 

Corporate Name, Registered Office, Duration

 

Under the name Addex Therapeutics Ltd (Addex Therapeutics SA) (the “Company”) exists a corporation which is subject to these Articles of Association and the provisions of Chapter 26 of the Swiss Code of Obligations (CO). The registered office of the Company is in Plan-les-Ouates, canton of Geneva. The duration of the Company shall be unlimited.

 

Article 2

 

Purpose

 

The purpose of the Company is to acquire, to hold, to administer continuously, to sell and to finance participations in companies of all kinds in Switzerland and abroad, to the exclusion of real estate participations, except where permitted under Swiss law.

 

The Company may open branch offices and subsidiaries and agencies in Switzerland and abroad. It may grant guarantees or other security in relation to liabilities of affiliated companies. In addition, the Company may engage in any other commercial, financial and other activities which may promote or relate to the purpose of the Company.

 

The Company may acquire, manage, exploit and sell in Switzerland and abroad intellectual property rights and, where permitted under Swiss law, real estate.

 

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II.                                   Share Capital, Bons de Jouissance, Shares Certificates, Shares Register, Nominees

 

Article 3

 

Share Capital

 

The share capital of the Company is CHF 13’454’553.— It is divided into 13’454’553 registered shares with a nominal value of CHF 1 each.

 

All shares are fully paid-in.

 

The Meeting of Shareholders may at any time convert registered shares into bearer shares or bearer shares into registered shares and, as the case may be, non-voting shares into shares, by amending these Articles of Association

 

Article 3a

 

Bons de jouissance

 

The Company has issued 1,700 (one thousand seven hundred) registered bons de jouissance (profit sharing certificates/Genussscheine) to be granted to employees and/or directors of the Company or a group company according to respective regulations of the Board of Directors.

 

The bons de jouissance are uncertificated.

 

The bons de jouissance are transmissible only with the prior consent of the Board of Directors.

 

The bons de jouissance do not form part of the share capital and do not have a nominal value. They do not grant any right to vote nor the right to attend Meetings of Shareholders. Each bon de jouissance grants (i) a right to subscribe for 1,000 shares and (ii) a right to liquidation proceeds of the Company calculated in accordance with Article 34 of the Articles of Association.

 

The Company shall maintain a register of holders of bons de jouissance listing the surname and first name (in the case of legal entities, the company name), address and nationality (in the case of legal entities, the registered office) of the holders of bons de jouissance.

 

The provisions regarding the share register (Article 5 of the Articles of Association) shall apply mutatis mutandis to the register of holders of bons de jouissance.

 

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The Board of Directors may at any time hold, acquire or alienate bons de jouissance for the account of the Company. The Company can at any time cancel bons de jouissance.

 

Article 3b

 

Authorized Share Capital

 

The Board of Directors shall be authorized, at any time until 23 June 2018 to increase the share capital in an amount of CHF 6’727’276.- through the issuance of 6’727’276 fully paid registered shares with a nominal value of CHF 1 each. An increase in partial amounts shall be permitted. The Board of Directors shall détermine the issue price, the type of payment, the date of issue of new shares, the conditions for the exercise of pre-emptive rights and the beginning date for dividend entitlement. In this regard, the Board of Directors may issue new shares by means of a firm underwriting through a banking institution, a syndicate or another third party with a subsequent offer of these shares to the current shareholders (unless the pre-emptive rights of current shareholders are excluded). The Board of Directors may permit pre-emptive rights that have not been exercised to expire or it may place these rights and/or shares as to which pre-emptive rights have been granted but not exercised, at market conditions or use them for other purposes in the interest of the Company.

 

The subscription and acquisition of the new shares, as well as each subsequent transfer of the shares, shall be subject to the restrictions of Article 5 of the Articles of Association.

 

The Board of Directors is authorized to restrict or exclude the pre-emptive rights of shareholders and allocate such rights to third parties if the shares are to be used (1) for the acquisition of enterprises, parts of an enterprise, or participations, or for new investments, or, in case of a share placement, for the financing or refinancing of such transactions; or (2) for the purpose of the participation of strategic partners (including in the event of a public tender offer) or for the purpose of an expansion of the shareholder constituency in certain investor markets or (3) for the granting of an over-allotment option (Greenshoe) of up to 20 percent to the banks involved in connection with a placement of shares, or (4) for raising capital in a fast and flexible manner, which would not be achieved without the exclusion of the statutory pre-emptive rights of the existing shareholders.

 

Article 3c

 

Conditional Share Capital

 

A)                                   The share capital of the Company may be increased by a maximum aggregate amount of CHF 2’600’000.- through the issuance of a maximum of 2’600’000

 

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registered shares, which shall be fully paid-in, with a par value of CHF 1 per share by the exercise of option rights or subscription rights attached to bons de jouissance which the employees, directors and/or consultants of the Company or a group company are granted according to respective regulations of the Board of Directors. The pre-emptive rights of the shareholders are excluded. The acquisition of registered shares through the exercise of option rights or subscription rights granted to the holders of bons de jouissance and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in Article 5 of the Articles of Association.

 

B)                                   The share capital of the Company may be increased by a maximum aggregate amount of CHF 4’127’276.- through the issuance of a maximum 4’127’276 registered shares, which shall be fully paid-in, with a par value of CHF 1 per share by the exercise of option and/or conversion rights which are granted in connection with the issue of bonds, similar obligations or other financial instruments by the Company or another group company. In the case of the issue of bonds, similar obligations or other financial instruments linked with option and/or conversion rights, the pre-emptive right of shareholders is excluded. The holders of option and/or conversion rights are entitled to receive the new shares. The Board of Directors shall détermine the terms of the option and/or conversion rights. The acquisition of registered shares through the exercise of option or conversion rights and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in Article 5 of the Articles of Association.

 

The Board of Directors shall be authorized to restrict or exclude the pre-emptive rights of shareholders (1) if the debt or other financial instruments issued with conversion rights or warrants are for the purpose of financing or refinancing of the acquisition of enterprises, parts of an enterprise, or participations or new investments or (2) if such debt or other financial instruments are issued on the national or international capital markets and for the purpose of a firm underwriting by a banking institution or a con¬sortium of banks with subsequent offering to the public. If the advance subscription rights are excluded by the Board of Directors, the following shall apply: the issuance of convertible bonds or warrants or other financial market instruments shall be made at the prevailing market conditions (including dilution protection provisions in accordance with market practice) and the new shares shall be issued pursuant to the relevant conversion or exercise rights in connection with bond or warrant issue conditions. Conversion rights may be exercised during a maximum 10-year period, and warrants may be exercised

 

25


 

during a maximum 7-year period, in each case from the date of the respective issuance.”

 

Article 4

 

Abolished Printing of Share Certificates

 

The shareholder may at any time request the Company to issue a confirmation of the number of registered shares held by such shareholder. The shareholder is not entitled, however, to request the printing or delivery of share certificates for registered shares. The Company may, on the other hand, at any time print and deliver share certificates for registered shares, and may, with the consent of the shareholder, cancel share certificates that are delivered to it, without replacement.

 

Uncertificated registered shares, including any uncertificated rights arising thereunder, may be transferred only by way of assignment. In order to be valid, such assignment requires notification to the Company.

 

If a bank administers uncertificated registered shares on a shareholders’ behalf, such shares and the uncertificated rights arising thereunder may only be transferred with the bank’s cooperation. Furthermore, they can only be pledged in favor of such bank, in which case no notification to the Company is required.

 

Article 5

 

Share Register, Nominees

 

The Company shall maintain a share register listing the surname and first name (in the case of legal entities, the company name), address and nationality (in the case of legal entities, the registered office) of the owners and usufructuaries of the registered shares. If a registered shareholder changes his address, the new address must be communicated to the Company. As long as this has not been done, all notices by letter will be sent validly to the address entered in the share register.

 

Acquirers of registered shares shall upon application be registered as shareholders with the right to vote, provided that they expressly declare that they acquired the registered shares in their own name and for their own account.

 

The Board of Directors may register nominees with the right to vote in the share register to the extent of up to 5% of the registered share capital as set forth in the commercial register. Registered shares held by a nominee that exceed this limit may be registered in the share register with the right to vote if the nominee discloses the names, addresses and the

 

26


 

number of shares of the persons for whose account it holds 1% or more of the registered share capital as set forth in the commercial register. Nominees within the meaning of this provision are persons who do not explicitly declare in the request for registration to hold the shares for their own account and with whom the Board of Directors has entered into a corresponding agreement.

 

Corporate bodies and partnerships or other groups of persons or joint owners who are interrelated to one another through capital ownership, voting rights, uniform management or otherwise as well as individuals or corporate bodies and partnerships who act in concert to circumvent the regulations concerning the nominees (especially as syndicates), shall be treated as one single nominee within the meaning of the preceding paragraph.

 

After hearing the registered shareholder or nominee, the Board of Directors may cancel, with retroactive effect as of the date of registration if appropriate, the registration of shareholders if the registration was effected based on false information or in case of breach of the agreement between the nominee and the Board of Directors. The respective shareholder or nominee shall be informed immediately of the cancellation of the registration.

 

The Board of Directors shall specify the details and give the necessary orders concerning the adherence to the preceding regulations. In particular cases it may allow exemptions from the regulation concerning nominees. It may delegate its duties.

 

The limitation for registration in the share register provided for in this Article shall also apply to shares acquired or subscribed by the exercise of subscription, option or conversion rights.

 

Article 6

 

Exercise of Shareholders’ Rights

 

Shares are not divisible. The Company shall only accept one representative per share.

 

The voting rights and other rights associated with a registered share may only be exercised by a shareholder, usufructuary or nominee registered in the share register with the right to vote, or by persons who are entitled by law to the voting right of a share, subject to Article 13, which regulates the representation of the shareholders.

 

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III.                              Corporate Bodies

 

Article 7

 

Corporate Bodies

 

The corporate bodies of the Company are:

 

a)                                     The Meeting of Shareholders;

 

b)                                     The Board of Directors;

 

c)                                      The (statutory) Auditors.

 

B.                                    The Meeting of Shareholders

 

Article 8

 

Powers of the Shareholders Meeting

 

The Meeting of Shareholders is the supreme body of the Company. The following non-delegable powers are vested in the Meeting of Shareholders:

 

1.                                      to adopt and amend the Articles of Association;

 

2.                                      to elect and remove the members of the Board of Directors, the Chairman of the Board of Directors, the members of the Compensation Committee, the Auditors and the Independent Voting Rights Representative;

 

3.                                      to approve the annual report and the consolidated financial statements;

 

4.                                      to approve the annual financial statements and to détermine the allocation of profits as shown on the balance sheet, in particular with regard to dividends;

 

5.                                      to approve the compensation of the Board of Directors and the Executive Management in accordance with Article 27 of these Articles of Association;

 

6.                                      to grant discharge to the members of the Board of Directors and the persons entrusted with management;

 

7.                                      to pass resolutions concerning all matters reserved to the authority of the Meeting of Shareholders by law or under the Articles of Association.

 

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Article 9

 

Ordinary and Extraordinary Meeting of Shareholders

 

The Ordinary Meeting of Shareholders shall be held each year within six months after the close of the business year.

 

Extraordinary Meetings of Shareholders shall be held when deemed necessary by the Board of Directors or the Auditors or demanded by a resolution of the shareholders in a Meeting of Shareholders. Furthermore, an Extraordinary Meeting of Shareholders shall be convened if this is requested by one or more shareholder(s) who represent an aggregate amount of at least 10 percent of the share capital and who submit in writing a petition specifying the items for the agenda and the proposals, and, in case of elections, the name of the proposed candidates.

 

Article 10

 

Convocation

 

The Meeting of Shareholders shall be called by the Board of Directors or, if necessary, the Auditors, no later than 20 days prior to the meeting date. The liquidators shall also be entitled to call a Meeting of Shareholders.

 

Notice of the meeting shall be given by way of an announcement appearing once in the official publication organ of the Company. Holders of registered shares may also be informed by ordinary mail.

 

The annual business report, the Compensation Report and the Auditor’s report and, if any, the Group Auditor’s report must be available for examination by the Shareholders at the registered office of the Company at least 20 days prior to the date of the Ordinary Meeting of Shareholders. Such reference shall be included in the invitation to the Ordinary Meeting of Shareholders.

 

The notice of a meeting shall state the items on the agenda and the proposals of the Board of Directors and, if applicable, of the shareholders who demanded that a Meeting of Shareholders be held or that an item be included in the agenda and, in case of elections, the names of the nominated candidates.

 

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Article 11

 

Agenda

 

One or more shareholders whose combined shareholdings represent an aggregate nominal value of at least CHF 1,000,000 or at least 10 percent of the share capital may demand that an item be included on the agenda of a Meeting of Shareholders. Such a request must be made in writing to the Board of Directors at the latest 60 days before the Meeting and shall specify the agenda items and the proposals made.

 

No resolution may be passed on agenda items for which no proper notice was given; this prohibition does not apply, however, to proposals made during a Meeting of Shareholders to call an Extraordinary Meeting of Shareholders or to initiate a special audit.

 

No prior notice is required for proposals concerning items included on the agenda and for debates as to which no vote is taken.

 

Article 12

 

Chairman, Vote Counters, Minutes

 

The Meeting of Shareholders shall be chaired by the Chairman of the Board. In his absence, the Vice-Chairman or any other member of the Board designated by the Board shall take the chair.

 

The Chairman of the Meeting shall designate the Secretary and the vote counters, who need not be shareholders. The minutes shall be signed by the Chairman of the Meeting and the Secretary.

 

Article 13

 

Voting Rights, Proxies, Independent Voting Rights Representative

 

Each share recorded as share with voting rights in the share register confers one vote on its registered holder.

 

The Board of Directors shall issue procedural rules regarding participation in and representation at the Meeting of Shareholders. Every shareholder may be represented at the Meeting of Shareholders by the Independent Voting Rights Representative or any person who is authorized by a written proxy. A proxy need not be a shareholder.

 

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The General Meeting of Shareholders shall elect the Independent Voting Rights Representative for a term of office extending until completion of the next Annual General Meeting of Shareholders. Re-election is permitted.

 

If the Company does not have an Independent Voting Rights Representative, the Board of Directors shall appoint the Independent Voting Rights Representative for the next General Meeting of Shareholders.

 

Article 14

 

Resolutions, Elections

 

Unless otherwise required by law or these Articles of Association, the Meeting of Shareholders shall pass resolutions and decide elections upon an absolute majority of votes represented. In case of a tie, the Chairman of the Meeting shall have a casting vote. Resolutions and elections shall be decided by a show of hands, unless a vote by written ballot or in electronic manner is resolved by the Meeting of Shareholders or ordered by the Chairman of the Meeting. The Chairman of the Meeting may at any time order to repeat an election or resolution taken on a show of hands with a written or electronic ballot, if he doubts the results of the vote. In this case, the preceding election or resolution taken on a show of hands is deemed not to have occurred.

 

If the first ballot fails to result in an election and more than one candidate is standing for election, the Chairman of the Meeting shall order a second ballot in which a relative majority shall be decisive.

 

C.                                    Board of Directors

 

Article 15

 

Number of Directors

 

The Board of Directors shall consist of a minimum of 1 member and a maximum of 11 members.

 

Article 16

 

Election, Term of Office

 

The members of the Board of Directors and the Chairman of the Board of Directors are elected individually by the General Meeting of Shareholders for a term of office extending until completion of the next Annual General Meeting of Shareholders.

 

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Members whose term of office has expired are immediately eligible for re-election.

 

Should the position of Chairman of the Board of Directors become vacant, the Board of Directors shall appoint a new Chairman from among its members for a term of office extending until completion of the next Ordinary General Meeting of Shareholders.

 

Article 17

 

Organization of the Board of Directors

 

Except for the election of the Chairman of the Board of Directors and the members of the Compensation Committee by the General Meeting of Shareholders, the Board of Directors shall determinate its own organisation. It may elect from its members one or, if necessary, several Vice-Chairmen. The Board of Directors shall further appoint a Secretary, who need not be a member of the Board of Directors.

 

The Board of Directors may appoint from amongst its members standing or ad hoc committees entrusted with the preparation and execution of its décisions or the supervision of specific parts of the business. The Board of Directors shall ensure that it is kept properly informed.

 

Subject to mandatory law and the provisions of these Articles of Association, the Board of Directors détermines its own internal organization and the modalities for the passing of resolutions in Organizational Rules.

 

Article 18

 

Convening of Meetings, Resolutions, Minutes

 

The Chairman, in his absence the Vice-Chairman or any other member of the Board of Directors shall convene meetings if and when the need arises or whenever a member requests a meeting in writing setting forth the reasons for the meeting. A meeting may also be held by telephone or video conference.

 

The adoption of resolutions of the Board of Directors requires a majority of the votes cast.

 

Resolutions may also be passed in writing (including by telefax or by electronic signature) unless a member of the Board of Directors requests oral deliberation.

 

32


 

Article 19

 

Attributions

 

The Board of Directors may pass resolutions concerning all matters not reserved to the authority of any other corporate body by law, these Articles of Association or regulations.

 

The Board of Directors has, in particular, the following non-delegable and inalienable duties:

 

1.                                      the ultimate direction of the Company and the issuance of the necessary instructions;

 

2.                                      the determination of the organization of the Company;

 

3.                                      the structuring of the accounting system, financial control and financial planning;

 

4.                                      the appointment and removal of the persons entrusted with management and representation of the Company, as well as the determination of their signatory power;

 

5.                                      the ultimate supervision of the persons entrusted with management of the Company, specifically in view of their compliance with the law, these Articles of Association, the regulations and directives;

 

6.                                      the preparation of the business report and the Compensation report, preparation of the Meetings of Shareholders and the implementation of the resolutions adopted by the Meeting of Shareholders;

 

7.                                      the passing of resolutions regarding the subsequent payment of capital with respect to non fully paid-in shares;

 

8.                                      the passing of resolutions concerning an increase in share capital to the extent that such power is vested in the Board of Directors (art. 651 para. 4 CO) and of resolutions concerning the confirmation of capital increases and corresponding amendments to the Articles of Association, as well as making the required report on the capital increase;

 

9.                                      the non-delegable and inalienable duties and powers of the board of directors pursuant to the Swiss Merger Act and any other law;

 

10.                               the notification of the judge if liabilities exceed assets.

 

33


 

In addition, the Board of Directors may, within the limits of the law and by virtue of the Organizational Rules, delegate in whole or in part, its powers, as well as management and the representation of the Company to one or several members of the Board of Directors or to third parties.

 

D.                                    Compensation Committee

 

Article 20

 

Number of members, election, term of office

 

The Compensation Committee shall comprise 1 to 3 members of the Board of Directors. If the Board of Directors consists of less than 4 members, the Compensation Committee may consist of the same members as the Board of Directors.

 

Members of the Compensation Committee shall be elected individually by the General Meeting of Shareholders for a term of office extending until completion of the next Ordinary General Meeting of Shareholders.

 

The members of the Compensation Committee are immediately eligible for re-election at the end of their term of office.

 

Article 21

 

Organization of the Compensation Committee

 

The Compensation Committee shall détermine its own organization. The Board of Directors shall elect the Chairman of the Compensation Committee.

 

The Board of Directors shall issue regulations establishing the organization and décision making process of the Compensation Committee.

 

Article 22

 

Powers and Duties of the Compensation Committee

 

The Compensation Committee shall support the Board of Directors in establishing and reviewing the compensation strategy and guidelines as well as in preparing the proposals to the General Meeting of Shareholders regarding the compensation of the Board of Directors and of the Executive Management, and may submit proposals to the Board of Directors in other compensation-related issues.

 

34


 

The Board of Directors shall détermine in regulations for which positions of the Board of Directors and of the Executive Management the Compensation Committee shall submit proposals for the performance metrics, target values and the compensation to the Board of Directors, and for which positions it shall itself détermine, in accordance with the Articles of Association and the compensation guidelines established by the Board of Directors, the performance metrics, target values and the compensation.

 

The Board of Directors may delegate further tasks to the Compensation Committee that shall be détermined in regulations.

 

Article 23

 

Election, Term of Office

 

The Meeting of Shareholders shall elect the Auditors.

 

The term of office of the Auditors shall be one year. The term of office commences on the day of the election and expires on the day of the next Ordinary Meeting of Shareholders.

 

The Meeting of Shareholders may for purposes of the special reviews required in connection with capital increases (articles 652f, 653f, 653i CO) elect special auditors. If no special auditors have been elected, the regular Auditors are in charge of these tasks.

 

Article 24

 

Duty to Audit and Report

 

The Auditors perform their duties in accordance with the applicable provisions of the Swiss Code of Obligations.

 

Article 25

 

Special Audits, Interim Audits

 

The Board of Directors may at any time request the Auditors to conduct special audits, including interim audits, and to submit their reports.

 

35


 

IV.                               Compensation of the Board of Directors and Executive Management

 

Article 26

 

General principals of compensation

 

The compensation of the members of the Board of Directors consists of fixed and variable compensation elements. The total compensation shall take into consideration position and level of responsibility of the recipient.

 

The compensation of the members of the Executive Management consists of fixed and variable compensation elements. The fixed compensation comprises the base salary and other compensation elements. The variable compensation may comprise short-term and long term variable compensation elements. The compensation shall take into consideration position and level of responsibility of the recipient.

 

The short-term variable compensation elements shall be governed by performance metrics that take into account the performance of the Company, the group or parts thereof, targets in relation to the market, other companies or comparable benchmarks and/or individual targets, and achievement of which is generally measured during a one-year period.

 

Long-term variable compensation elements shall be governed by performance metrics that take into account strategic and/or financial objectives, achievement of which is generally measured during a perennial period, as well as retention elements.

 

Depending on achieved performance, the compensation may amount to a predétermined multiplier of target level.

 

The Board of Directors or, to the extent delegated to it, the Compensation Committee shall détermine the performance metrics and target levels of the short- and long-term variable compensation elements, as well as their achievement.

 

The compensation may be paid in the form of cash, shares, share-based instruments or units or in the form of other types of benefits. The Board of Directors or, to the extent delegated to it, the Compensation Committee shall détermine grant, vesting, exercise and forfeiture conditions. In particular, they may provide for continuation, acceleration or removal of vesting and exercise conditions, for payment or grant of compensation based upon assumed target achievement, or for forfeiture, in each case in the event of pre¬détermined events such as a change-of-control or termination of an employment or

 

36


 

mandate agreement. The Company may procure the required shares through purchases in the market or by using conditional share capital.

 

Compensation may be paid by the Company or companies controlled by it.

 

Article 27

 

Approval of Compensation by the General Meeting of Shareholders

 

The General Meeting of Shareholders shall approve the proposals of the Board of Directors in relation to the maximum aggregate amounts of:

 

1.                                      the compensation of the Board of Directors for the next term of office;

 

2.                                      the compensation of the Executive Management for current financial year.

 

The Board of Directors may submit for approval by the General Meeting of Shareholders deviating or additional proposals relating to the same or different periods.

 

In the event the General Meeting of Shareholders does not approve a proposal of the Board of Directors, the Board of Directors shall détermine, taking into account all relevant factors, the respective (maximum) aggregate amount or (maximum) partial amounts, and submit the amount(s) so détermined for approval by the same Annual General Meeting of Shareholders, an Extraordinary General Meeting of Shareholders or the next Annual General Meeting of Shareholders.

 

The compensation may be paid out prior to approval by the General Meeting of Shareholders subject to sub - sequent approval.

 

Article 28

 

Additional amounts in case of changes in the Executive Management

 

If the maximum aggregate amount of compensation already approved by the General Meeting of Shareholders is not sufficient to also cover the compensation of one or more persons who become members of the Executive Management or are being promoted within the Executive Management after the General Meeting of Shareholders has approved the compensation of the Executive Management for the relevant period then the Company or companies controlled by it shall be authorised to pay such member(s) a supplementary amount during the compensation period(s) already approved. The supplementary amount per compensation period shall in total not exceed 100% of the maximum aggregate amount of compensation of the Executive Management last approved.

 

37


 

V.                                    Agreements with members of the Board of Directors and of the Executive Management, loans

 

Article 29

 

Agreements with members of the Board of Directors and of the Executive Management

 

The Company or companies controlled by it may enter into agreements for a fixed term or for an indefinite term with members of the Board of Directors with respect to their compensation. The duration and termination shall comply with the term of office and the law.

 

The Company or companies controlled by it may enter into employment agreements for a fixed term or for an indefinite term with members of the Executive Management. Employment agreement for a fixed term may have a maximum duration of one year; renewal is permitted. Employment agreements for an indefinite term may have a termination notice period of maximum twelve months.

 

The Company or companies controlled by it may enter agreements on non-compete with members of the Executive Management for the time after termination of employment. Their duration shall not exceed one year, and consideration paid for such non-compete undertaking shall not exceed the last total annual compensation of such member of the Executive Management.

 

Article 30

 

Credits

 

Credits may not be granted to members of the Board of Directors or the Executive Management

 

VI.                               Mandates Outside the Group

 

Article 31

 

No member of the Board of Directors may hold more than fourteen additional mandates of which no more than four mandates may be in companies listed on a stock exchange.No member of Executive Management may hold more than five mandates of which no more than two may be in companies listed on a stock exchange.

 

38


 

The following mandates shall not be subject to the above mentioned limitations:

 

1.                                      Mandates in companies that are controlled by the Company or which control the Company;

 

2.                                      Mandates that are carried out at the request of the Company or companies controlled by it. No member of the Board of Directors or of the Executive Management shall carry out more than ten such mandates; and

 

3.                                      Mandates in associations, non-profit organizations, foundations, trusts and employee welfare foundations, education institutions, non-profit institutions and other similar organisations. No members of the Board of Director or of the Executive Management may carry out more than twenty-five such mandates.

 

Mandates shall mean mandates in the supreme governing body of a legal entity which is required to be registered in the commercial register or a comparable foreign register. Mandates in different legal entities that are under joint control or same beneficial ownership are deemed one mandate.

 

VII.                          Financial Year, Allocation of Profits

 

Article 32

 

Financial Year, Annual Report

 

The Board of Directors détermines the beginning and the end of the business year.

 

For each business year, the Board of Directors shall prepare an annual report consisting of the annual financial statements (including the profit and loss statements, balance sheet and notes to the financial statements), the business report and the consolidated financial statements.

 

Article 33

 

Allocation of Profits, Reserves

 

The profit shown on the balance sheet shall be allocated by the Meeting of Shareholders within the limits set by applicable law. The Board of Directors shall submit its proposals to the Meeting of the Shareholders.

 

Further reserves may be taken in addition to the reserves required by law.

 

39


 

Dividends that have not been claimed within five years after their due date shall pass to the Company and be allocated to the general reserves.

 

VIII.                     Dissolution

 

Article 34

 

Dissolution, Liquidation

 

The Meeting of Shareholders may at any time resolve the dissolution and liquidation of the Company in accordance with the provisions of the law and of the Articles of Association.

 

The liquidation shall be carried out by the Board of Directors to the extent that the Meeting of Shareholders has not entrusted the same to other persons.

 

The liquidation of the Company shall take place in accordance with article 742 seq. CO. The liquidators are authorized to dispose of the assets (including real estate) by way of private contract.

 

After all debts have been satisfied, the net proceeds shall be distributed among the shareholders and the holders of bons de jouissance in proportion to the number of shares and the number of subscription rights attached to the bons de jouissance.

 

IX.                              Notices, Communications

 

Article 35

 

Notices, Communications

 

The official publication organ of the Company shall be the Swiss Official Gazette of Commerce (Feuille Officielle Suisse du Commerce). The Board of Directors may designate other publication organs as well.

 

To the extent that personal notification is not mandated by law, all communications to the shareholders shall be deemed valid if published in the Swiss Official Gazette of Commerce.

 

In case of written communications by the Company to its shareholders, such shall be sent by ordinary mail to the last address of the shareholder entered in the share register of the Company.

 

40


 

X.                                   Contribution in Kind, Acquisition of Assets

 

Article 36

 

Contribution in Kind

 

Mr. Timothy Dyer contributes to the Company, on its own behalf and on a fiduciary basis:

 

(i)                                     3,317,492 (three-million-three-hundred-seventeen-thousand-and-four-hundred-ninety-two) fully paid-in shares of Addex Pharma SA (formerly Addex Pharmaceuticals SA) in Plan-les-Ouates (Geneva) with a nominal value of CHF 1 (one Swiss Franc) each.

 

This contribution in kind is made and accepted at the price of CHF 3,317,492 (three-million-three-hundred-seventeen-thousand-four-hundred ninety-two Swiss Francs), entirely made on account of the share capital.

 

In consideration for this contribution in kind, the Company allots 3,317,492 (three¬million-three-hundred-seventeen-thousand-four-hundred-ninety-two) fully paid-in registered shares with a nominal value of CHF 1 (one Swiss Franc) each.

 

(ii)                                  670,000 (six-hundred-seventy-thousand) fully paid-in non-voting shares (bons de participation) with a nominal value of CHF 1 (one Swiss Franc) each, representing the entire capital of non-voting shares (capital-participation) of Addex Pharma SA (formerly Addex Pharmaceuticals SA) in Plan-les-Ouates (Geneva).

 

This contribution in kind is made and accepted at the price of CHF 670,000 (six¬hundred-seventy-thousand), entirely made on account of the share capital.

 

In consideration for this contribution in kind, the Company allots 670,000 (six¬hundred-seventy-thousand) fully paid-in non-voting shares (bons de participation) with a nominal value of CHF 1 (one Swiss Franc) each.

 

Article 37

 

Acquisitions of Assets

 

The Company has acquired from Addex Pharma SA (formerly Addex Pharmaceuticals SA) in Plan-les-Ouates (Geneva) the entire share capital of Addex Pharmaceuticals France SAS, a company incorporated under the laws of France with registered seat in Archamps (France), that is, 37,000 (thirty-seven-thousand) shares with a nominal value of EUR 1 each (one Euro), for the total purchase price of CHF 1 (one Swiss Franc).

 

41


 

XI.                              Miscellaneous

 

Article 38

 

Translation of the Articles of Association

 

The Articles of Association are translated in English. The French text is the only official version.

 

*********

 

Genève, le 23 juin 2016

 

David LACIN, notaire

 

42




Exhibit 3.2

 

Addex Therapeutics Ltd

 

Organizational Rules

 


 

 

Table of Contents

 

 

 

 

1.

Legal and Statutory Basis

4

 

 

 

2.

Corporate Bodies

4

 

 

 

3.

The Board of Directors

4

3.1

Constitution

4

3.2

Function and Competences

4

3.3

Duties

5

3.4

Powers and Duties of the Chairman

6

3.5

Delegation of Powers

7

3.6

Convening

7

3.7

Agenda

8

3.8

Presence and Quorum

8

3.9

Resolutions

9

3.10

Information and Reporting

9

3.11

Remuneration

9

 

 

 

4.

The Audit Committee

10

4.1

Composition and Constitution

10

4.2

Powers and Duties

10

4.3

Meeting, Minutes

12

4.4

Quorum and Resolutions

12

 

 

 

5.

The Compensation Committee

12

5.1

Composition and Constitution

12

5.2

Powers and Duties

12

5.3

Meeting, Minutes

13

5.4

Quorum and Resolutions

13

 

 

 

6.

The Nomination Committee

13

6.1

Composition and Constitution

13

6.2

Powers and Duties

13

6.3

Meeting, Minutes

14

6.4

Quorum and Resolutions

14

 

 

 

7.

The Chief Executive Officer

14

7.1

Appointment and Responsibility

14

7.2

Powers and Duties

14

7.3

Duty to Report

15

 

 

 

8.

The Addex Executive Management

15

8.1

Composition

15

8.2

Powers and Duties

15

8.3

Constitution

15

 

 

 

9.

Signatory Power

16

 

 

 

10.

Confidentiality

16

 

 

 

11.

Conflict of Interests

16

 

2


 

11.1

General Principles

16

11.2

Duty to Disclose

16

11.3

Conflicts

17

11.4

Measures

17

 

 

 

12.

Final Provisions

18

 

3


 

1.                                      Legal and Statutory Basis

 

Based on Art. 716b of the Swiss Code of Obligations (CO) and Art. 19 of the Articles of Association, the Board of Directors of Addex Therapeutics Ltd (the Company) adopts these Organizational Rules (the Organizational Rules).

 

The Organizational Rules define the organization, operation and powers and responsibilities of the corporate bodies of the Company, as well as the principles for the governance of the Addex Group (the Group).

 

2.                                      Corporate Bodies

 

The corporate bodies of the Company are:

 

·                                          the board of directors (the Board) and the members of the Board (the Directors);

 

·                                          the chairman (the Chairman) and secretary (the Secretary) of the Board;

 

·                                          the chief executive officer (the CEO) and the Addex Executive Management (the AEM); and

 

·                                          if constituted, the standing committees of the Board (the Committees), i.e. the Audit Committee (the AC), the Compensation Committee (the CC) and the Nomination Committee (NC).

 

3.                                      The Board of Directors

 

3.1                               Constitution

 

The members of the Board of Directors and Chairman are elected by the annual general meeting of shareholders. Should the position of Chairman become vacant during the year, the members of the Board of Directors will elect from its members an Interim Chairman. The Board further appoints the Secretary who does not need to be a Director. The Committees may designate their own secretaries.

 

3.2                               Function and Competences

 

The Board is, subject to the advisory functions, the legal and statutory duties and competences of the Company’s general shareholders’ meeting and the statutory auditors, the supreme executive body of the Company. The Board is further responsible for the ultimate supervision of the Group.

 

4


 

The Board shall have authority to perform all acts which the business purpose of the Company may entail.

 

The Board shall have authority to pass resolutions in all matters which are not reserved to the meeting of shareholders by law, the Articles of Association (Art. 698 and 716 CO) or these Organizational Rules.

 

3.3                               Duties

 

The Board has, in particular, the following non-delegable and inalienable duties (Art. 716b CO and 19 of the Articles of Association):

 

1.                                      the ultimate direction of the Company and the Group and the issuance of the necessary instructions;

 

2.                                      the determination of the organization of the Company, including the adoption and revision of the Organizational Rules;

 

3.                                      the organization of the accounting system, the financial control and the financial planning;

 

4.                                      the appointment, remuneration and dismissal of the CEO of the company and of managers directly reporting to the CEO, as well as the determination of their signatory power;

 

5.                                      the ultimate supervision of the persons entrusted with management of the Company, specifically in view of their compliance with the law, the Articles of Association, the Organizational Rules and directives given from time to time by the Board;

 

6.                                      the preparation of the business report, the preparation for the meetings of shareholders and the implementation of the resolutions adopted by the meeting of shareholders;

 

7.                                      the notification of the judge if liabilities exceed assets.

 

8.                                      the passing of resolutions regarding the supplementary contribution for shares not fully paid-in (Art. 634a CO);

 

9.                                      the passing of resolutions concerning an increase in share capital to the extent that such power is vested in the Board (Art. 651 al. 4 CO), and of resolutions concerning the confirmation of capital increases and corresponding amendments to the Articles of Association (Art. 651a, 652g, 652h, 653g and 653h CO), as well as making the required report on the capital increase;

 

5


 

10.                               the non-delegable and inalienable duties and powers of the Board pursuant to the Swiss Merger Act and any other law;

 

11.                               the examination of the necessary qualifications of the auditors.

 

In addition, the Board has the following exclusive power and duties:

 

12.                               the adoption of, and any amendments or modifications (except for immaterial changes) to, any equity incentive plan, stock option agreement, restricted stock purchase agreement, etc.

 

13.                               the decisions regarding entering into any financing arrangement in excess of CHF 2 million including loan agreements, credit lines, letters of credit or capitalized leases;

 

14.                               the issuance of convertible debentures, debentures with option rights or other financial market instruments;

 

15.                               the approval of the business strategy and the approval and adoption of the budget of the Company;

 

16.                               decisions or actions in excess of CHF 1 million which are not in accordance with the budget;

 

17.                               the approval of any recommendation made by any of the Committees.

 

The Board may entrust some or several of its members, as individuals or as members of a committee, with the duty to prepare and carry out its resolutions or to supervise certain matters. The Board keeps its members duly informed on these matters.

 

3.4                               Powers and Duties of the Chairman

 

The Chairman has the following powers and duties:

 

1.                                      to organize and prepare the agenda for the meetings of the shareholders and of the Board;

 

2.                                      to convene the meetings of the shareholders;

 

3.                                      to preside over the meetings of the shareholders and of the Board.

 

Should the Chairman be unable to exercise his functions, his/her functions shall be assumed by the Interim Chairman, or if the latter should also be unable, another Director appointed by the Board, to the extent permitted by law.

 

6


 

3.5                               Delegation of Powers

 

The Board herewith delegates to the CEO all other duties, including the preparation and implementation of the Board resolutions as well as the supervision of particular aspects of the business in the sense of Art. 716a para. 2 CO, as well as the management of the Company and the Group in the sense of Art. 716b CO.

 

The Board may, upon giving appropriate notice to the corporate body to whom it has delegated any of its powers and duties, re-assume responsibility for such powers and duties. Similarly, the Board may, upon giving appropriate notice, delegate such powers and duties to any other corporate body or persons as it may from time to time deem appropriate.

 

3.6                               Convening

 

The Board shall meet regularly and as often as necessary, but in any event at least five times per year.

 

The Chairman or, if he is not in a position to do so, the Interim Chairman or the Secretary on their behalf convenes the meeting. In addition, each Director can, by stating the reasons and the items to be placed on the agenda, request the Chairman, to convene a meeting. In such event the Chairman or, if he is not in a position to do so, the Interim Chairman or the Secretary on their behalf shall convene the meeting within 14 days after receipt of the respective demand.

 

Notice of meetings shall be given at least 10 days in advance in writing by any suitable means (e.g., email, telefax). In urgent cases a meeting may be held on 48 hours notice. Any Director who is unable to attend a meeting in person shall have the right to attend the meeting by means of telephone or video conference so that all persons so participating and attending such meeting in person can hear and be heard by all others so participating and attending. The Board may take without a meeting any action it would be permitted to take at a meeting by a written consent signed by each Director.

 

Meetings of the Board may be held by telephone-conference or other means of direct communication.

 

In the event that the Board is to resolve on the certification of a capital increase or on supplementary contributions for shares not fully paid-in, as well as on the subsequent amendment of the Articles of Association (Art. 652g and 634a CO), no invitations have to be sent out and any of the Directors shall be authorized to make the respective certifications before the notary public.

 

7


 

3.7                               Agenda

 

The items on the agenda of the meetings of the Board shall be determined by the Chairman after consultation with the CEO.

 

The agenda of the meetings shall be communicated to the Directors when the convening occurs and shall be accompanied by the materials belonging to the items on the agenda.

 

Each Director is entitled to request that further items be put on the agenda provided that such items are submitted to the Chairman not later than 5 (five) days before the meeting. In such event, the Chairman shall communicate the additional items on the agenda to the other Directors before the beginning of the meeting.

 

No resolution shall be taken on items which were not on the agenda of the meeting unless every Director is present at the meeting and consents to the proposed resolution.

 

3.8                               Presence and Quorum

 

The Chairman or, if he is not in a position to do so, the Interim Chairman or any other Director, shall direct the debate during the meeting and determine the non-members who may attend as guests the meetings as such or the deliberation of particular items on its agenda.

 

The Board may pass resolutions when the majority of the Directors are present. Absent Directors cannot be represented.

 

No quorum is required if the meeting is called to

 

·                                          certify an increase of capital or supplementary contributions for shares not fully paid-in, and to effect the amendment of the Articles of Association related thereto pursuant to Art. 651a, 652g, 653g and 634a CO;

 

·                                          approve the execution of a merger agreement in case of a simplified merger pursuant to Art. 23 of the Swiss Merger Act;

 

·                                          approve the execution of a transfer agreement pursuant to Art. 70 of the Swiss Merger Act in case that the transferred assets do not exceed 10% of the total assets of the Company.

 

The CEO shall be entitled to attend every meeting of the Board and to participate in its debate and deliberations with the exception of executive sessions. However, he shall not be entitled to vote, unless he is a member of the Board.

 

8


 

3.9                               Resolutions

 

Resolutions of the Board shall be adopted by a majority of the votes cast. In case of a tie, the Chairman has the casting vote.

 

Resolutions on any given motion by written or telecommunicated (telefax, telex, email) votes shall be permissible, but need to be properly minuted. Resolutions may also be passed by written or telecommunicated (telefax, telex, email) consent to a motion unless a Director requests oral deliberation.

 

Minutes shall be kept of the deliberations and resolutions of the Board. The minutes shall contain a summary of the deliberations and the resolutions with the result of the vote. The minutes shall be signed by the Chairman and the Secretary. They shall be approved by the Board at the next meeting. Minutes shall also be kept if the Board consists only of a sole member.

 

3.10                        Information and Reporting

 

Each Director shall be entitled to request information concerning all affairs of the Company. In the meetings, all Directors and all persons entrusted with the management of the Company’s business shall furnish the requested information.

 

Outside the meetings of the Board, each Director may request information from the persons entrusted with the management of the Company’s business concerning the course of business and, upon authorization by the Chairman, concerning particular aspects thereof. In such case, he/she shall address a written request to the Chairman indicating the reasons for his/her request.

 

To the extent necessary to fulfil his duties, each Director may request that the Chairman authorize the inspection of the books and records of the Company. If the Chairman rejects a request for information, hearing or inspection, the Board shall decide whether to grant such request.

 

Notwithstanding the foregoing, individual resolutions of the Board may confer upon the Directors additional rights to request information and inspection.

 

3.11        Remuneration

 

The Board determines the amount of the fixed remuneration of its members, taking into account their respective responsibilities, experience and the time which they invest in their activity as members of the Board. Extraordinary assignments or work which a Director accomplishes outside of his/her activity as a Director shall be specifically remunerated. Such remuneration shall be approved by the Board and the total annual remuneration of the Board shall be approved by the shareholders at the annual general meeting.

 

9


 

In addition, the Directors shall be reimbursed all reasonable cash expenses properly incurred by them in the discharge of their duties, including their reasonable expenses of traveling to and from the meetings of the Board, committee meetings and meetings of shareholders.

 

4.                                      The Audit Committee

 

4.1                               Composition and Constitution

 

Should the Board elect to constitute an AC then the AC consists of three non-executive and independent Directors. The members have to be financially literate.

 

For the purpose of these Organizational Rules, a “non-executive” Director shall be a Director who does not perform any line management function within the Company; an “independent” Director shall be a non-executive Director and a Director who never was or was more than three years ago a member of the executive management and who has no or comparatively minor business relations with the Company.

 

The members of the AC shall be appointed, as a rule, for the entire duration of their mandate as Directors and shall be re-eligible.

 

The AC constitutes itself, including shall appoint a chairman, each year at its first meeting after the annual general meeting of shareholders.

 

4.2                               Powers and Duties

 

The AC has following powers and duties:

 

(a)                                 with respect to the statutory auditors and group auditors:

 

·                                          to review and assess the effectiveness of the statutory auditors and the group auditors (Auditors), in particular their independence from the Company. In connection therewith, it reviews in particular additional assignments given by the Company or its subsidiaries. The AC may issue binding regulations or directives in connection with such additional assignments;

 

·                                          to review and assess the scope and plan of the audit, the examination process and the results of the audit and to examine whether the recommendations issued by the Auditors have been implemented by management;

 

·                                          to review the Auditors’ reports, to discuss their contents with the Auditors and with the management;

 

10


 

·                            to approve the terms and conditions of the engagement of the Auditors.

 

(b)                   with respect to internal audit and risk management, to the extent implemented:

 

·                            to review the effectiveness of the internal audit function, its professional qualifications, resources and independence and its cooperation with external audit;

 

·                            to approve the annual internal audit concept and the annual internal audit report, including the responses of the management thereto;

 

·                            to assess the risk assessment established by the management and the proposed measures to reduce risks;

 

·                            to assess the state of compliance with norms within the Company.

 

(c)                    with respect to accounting principles and control mechanism:

 

·                            to review in cooperation with the Auditors, the CEO and the Chief Financial Officer (the CFO) whether the accounting principles and the financial control mechanism of the Company and its subsidiaries are appropriate in view of the size and complexity of the Group.

 

(d)                   with respect to financial statements:

 

·                            to review the annual and interim statutory and consolidated financial statements intended for publication. It should discuss these with the CFO and the head of internal audit and, separately, with the head of external audit;

 

·                            to make a proposal to the Board with respect to these annual and interim statutory and consolidated financial statements; the responsibility for approving the annual financial statements remains with the Board.

 

The Board may entrust the AC with additional duties in financial matters, e.g. the analysis of the financial consequences of specific transactions or specific events.

 

In discharging its responsibilities, the AC shall have unrestricted access to the Company’s and the Group’s management, books and records.

 

The AC shall regularly report to the Board on its findings and propose appropriate actions.

 

11


 

4.3                               Meeting, Minutes

 

The AC shall meet as often as necessary, and at the written (e.g. email) request of any of its members.

 

It shall keep its own minutes.

 

4.4                               Quorum and Resolutions

 

The AC shall pass resolutions when the majority of its members are present. Resolutions of the AC shall be adopted by a majority of the votes cast. In case of a tie, the chairman of the AC has the casting vote.

 

5.                                      The Compensation Committee

 

5.1                               Composition and Constitution

 

The CC consists of a minimum of two Directors, the majority of which shall be non-executive and independent as defined under Section 4.1.

 

The members of the CC shall be appointed, as a rule, for the entire duration of their mandate as Director and shall be re-eligible.

 

The CC is elected by the shareholders at the annual general meeting. The Board shall appoint a chairman of the CC, each year at its first meeting after the annual meeting of shareholders.

 

5.2                               Powers and Duties

 

The CC has the following powers and duties:

 

·                            to review and assess on a regular basis the remuneration system of the Company and the Group (including the management incentive plans) and to make proposals in connection thereto to the Board;

 

·                            to recommend the terms of employment, in particular the remuneration package, of the CEO and to make proposals in relation to the remuneration of Directors;

 

·                            to recommend upon proposal of the CEO the terms of employment, in particular the remuneration package, of employees reporting directly to the CEO as well as review matters related to the compensation of other top managers, as well as the general employee compensation, benefit policies and HR practices of the Company;

 

12


 

·                            to make recommendations on the grant of options or other securities under any management incentive plan of the Company.

 

The Board may entrust the CC with additional duties in compensation matters.

 

In discharging its responsibilities, the CC shall have unrestricted access to the Company’s and the Group’s management, books and records.

 

The CC shall regularly report to the Board on its findings and propose appropriate actions.

 

5.3                               Meeting, Minutes

 

The CC shall meet as often as necessary, and at the written (e.g. email) request of any of its members.

 

The CC shall record its resolution and shall keep its own minutes.

 

5.4                               Quorum and Resolutions

 

The CC shall pass resolutions when the majority of its members are present. Resolutions of the CC shall be adopted by a majority of the votes cast. In case of a tie, the chairman of the CC has the casting vote.

 

6.                                      The Nomination Committee

 

6.1                               Composition and Constitution

 

Should the Board elect to constitute an NC then the NC shall consist of three Directors, the majority of which shall be non-executive and independent as defined under Section 4.1.

 

The members of the NC shall be appointed, as a rule, for the entire duration of their mandate as Director and shall be re-eligible.

 

The NC constitutes itself, including shall appoint a chairman, each year at its first meeting after the annual meeting of shareholders.

 

6.2                               Powers and Duties

 

The NC has the following powers and duties:

 

·                            to assure a long-term planning of appropriate appointments to the position of CEO and to the Board;

 

13


 

·                            to nominate candidates to fill vacancies on the Board or for the position of CEO;

 

·                            to make recommendations on board composition and balance.

 

The Board may entrust the NC with additional duties in nomination matters.

 

In discharging its responsibilities, the NC shall have unrestricted access to the Company’s and the Group’s management, books and records.

 

The NC shall regularly report to the Board on its findings and propose appropriate actions.

 

6.3                               Meeting, Minutes

 

The NC shall meet as often as necessary, and at the written (e.g. email) request of any of its members.

 

The NC shall record its resolution and shall keep its own minutes.

 

6.4                               Quorum and Resolutions

 

The NC shall pass resolutions when the majority of its members are present. Resolutions of the NC shall be adopted by a majority of the votes cast. In case of a tie, the chairman of the NC has the casting vote.

 

7.                                      The Chief Executive Officer

 

7.1                               Appointment and Responsibility

 

The CEO shall be appointed by the Board and shall have the primary responsibility for the management of the Company and the Group.

 

7.2                               Powers and Duties

 

The CEO shall have all the powers and duties that are not explicitly reserved to the Board or a Board committee by these Organizational Rules.

 

In particular, he/she shall have the following powers and duties:

 

·                            the provision of all information and documents necessary to the Board;

 

·                            the implementation of the resolutions passed by the Board;

 

·                            the organization, management and control of the day-to-day business of the Company;

 

14


 

·                            the proposal to the Board for the approval of transactions to be resolved by the Board;

 

·                            the proposal to the Board for the appointment and removal of members of the AEM;

 

·                            the organisation of the AEM and the preparation, calling and presiding of the meetings of the AEM.

 

7.3                               Duty to Report

 

The CEO shall at each meeting of the Board report to the Board on the course of business of the Company and the Group in a manner agreed upon from time to time between the Board and the CEO.

 

Apart from the meetings, the CEO reports immediately any extraordinary event and any change within the Company and within the Group to the Chairman.

 

8.                                      The Addex Executive Management

 

8.1                               Composition

 

The AEM consists of the CEO, as chairman, as well as of officers of the Group designated by the CEO and directly reporting to the CEO. The members of the AEM may be formally employed by the Company or by a Group company

 

8.2                               Powers and Duties

 

The members of the AEM attend to the day-to-day business of the Company and the Group under the supervision of the CEO.

 

Each member of the AEM informs the CEO in the AEM meetings about the evolution of the business and the most important events regarding the Company and the Group. Apart from the meetings, each member of the AEM reports immediately any extraordinary event and any change within the Company and within the Group to the CEO who shall immediately inform the Chairman.

 

The members of the AEM shall make proposals to the CEO who will take the final executive decision

 

8.3                               Constitution

 

The AEM shall constitute and organize itself under the supervision of the CEO, who shall establish the necessary regulations of the AEM.

 

15


 

9.                                      Signatory Power

 

The Board appoints those of its members who shall have the power to represent the Company. Those members shall have the power to sign collectively by two. The Board has further the authority to determine and confer the power to sign. Such persons shall only have the collective signature by two. Since 2013, the Company has had a significantly reduced Board and AEM and therefore the Chairman and the CEO have been granted individual signature powers.

 

The signature powers shall be registered with the Commercial Register.

 

10.                               Confidentiality

 

The Directors and the members of the AEM shall keep confidential all information and documents obtained in connection with the exercise of their function for the Company and the Group, including these Organizational Rules. Persons who have received confidential information shall not disclose its content to third parties, and shall take all measures to prevent third parties from having access to its content. This obligation and duty shall continue even after the term of office of the member has expired.

 

Upon termination of their function they shall return to the Company all documents obtained in connection therewith.

 

11.                               Conflict of Interests

 

11.1                        General Principles

 

Each Director and member of the AEM is responsible for organizing his/her private and business relationships in order to avoid conflicts of interests with the Company or the Group. A Director or a member of the AEM who is in a permanent conflict of interest shall no longer fulfill his/her function.

 

Directors and members of the AEM shall abstain from dealing or exercising their voting rights (if applicable) in matters involving their personal interests or the interests of individuals or entities related to them.

 

11.2                        Duty to Disclose

 

A Director or a member of the AEM shall disclose all board memberships she/he holds, as well as any other interests, mandates, functions or activities which could potentially lead to a point of contact with the Company or the Group. Each such person shall disclose such interests on a continuing basis to the Secretary of the Board who shall convey them to the Chairman.

 

16


 

If Directors or the Chairman determine a potential conflict of interests, the Chairman may conduct supplemental investigations and shall issue a recommendation for the Board. The Board shall treat this recommendation at the latest at its next meeting.

 

In connection with the corporate governance report to be published with the annual report of the Company, the Secretary of the Board shall additionally circulate at the beginning of each fiscal year a questionnaire to all Directors and members of the AEM with respect to such interests, mandates or activities.

 

11.3                        Conflicts

 

A conflicting interest shall mean the special interest the Director or the member of the AEM has, which could be opposite to the interest of the Company or the Group, with respect to a transaction or matter due to the fact he/she or a related person has a financial or non-financial interest in, or is otherwise closely linked to, the transaction or matter. A related person of a Director means

 

(i)                       the spouse (or a parent or sibling thereof) of the Director or the member of the AEM, or a child, grandchild, sibling, parent (or spouse of any thereof) of the Director or the member of the AEM, or an individual having the same home as the Director or the member of the AEM, or trust or estate of which an individual specified in this clause (i) is a substantial beneficiary;

 

(ii)                    a trust, estate, incompetent or minor of which the Director or the member of the AEM is a trustee, administrator or guardian; or

 

(iii)                 one of the following persons or entities: (A) an entity of which the Director or the member of the AEM is a director, general partner, agent, major shareholder or employee; (B) a person or entity that controls one or more of the entities specified in subclause (A) or an entity that is controlled by, or is under common control with, one or more of the entities specified in subclause (A); or (C) an individual who is a general partner, principal or employer of the Director or the member of the AEM.

 

11.4                        Measures

 

The Chairman should request a decision by the Board which reflects the seriousness of the conflict of interest. The Board shall decide without the participation of the person concerned.

 

If a Director or a member of the AEM is required to abstain from voting in a transaction or matter, he/she shall not be counted in the quorum of the meeting in question. Also, such Director or member of the AEM shall not receive any confidential information with respect to such transaction or matter and shall use best efforts to ensure that he/she does not receive such information. Neither

 

17


 

shall such Director or member of the AEM participate in meetings to the extent such transaction or matter is discussed and/or resolved. Finally, such Director or member of the AEM shall not have access to the minutes of such meeting or to any relevant materials or information. This provision shall act as a limitation of information rights a Director or a member of the AEM may have pursuant to Section 3.10 or otherwise pursuant to this Organizational Rules or under applicable law.

 

Any transaction between the Company or a Group company and a Director or a member of the AEM shall be carried out “at arm’s length” and shall be approved without participation of the party concerned. If appropriate, a neutral opinion shall be obtained.

 

12.                               Final Provisions

 

These Organizational Rules shall take effect immediately.

 

These Organizational Rules and its appendices shall be reviewed when necessary, but at least every 2 years at the first meeting of the Board following the annual general shareholders’ meeting.

 

Geneva, 1 July 2017.

 

 

 

 

 

Vincent Lawton

 

Tim Dyer

Chairman of the Board

 

Secretary to the Board

 

18




Exhibit 4.3

 

Execution Version

 

WARRANT AGREEMENT

 

made on February 14, 2018

 

among

 

Addex Therapeutics Ltd, c/o Addex Pharma SA, Chemin des Aulx 12, 1228 Plan-les-Ouates, Switzerland (hereinafter referred to as “Company”)

 

and

 

Growth Equity Opportunities Fund IV, LLC, c/o New Enterprise Associates, 1954 Greenspring Drive, Suite 600, Timonium, MD 21093 (hereinafter referred to as “NEA” or the “Lead Investor”)

 

New Leaf Biopharma Opportunities I, L.P., 7 Times Square, Suite 3502, New York, NY 10036, United States (hereinafter referred to as “NLV”)

 

(hereinafter NEA and NLV together the “Investors” and each an “Investor”)

 

(the Company together with the Investors the “Parties” and each a “Party”)

 

regarding

 

the issuance of warrants by the Company to the Investors

 


 

Contents

 

Clause

 

Page

 

 

RECITALS

3

 

 

 

1.

DEFINITIONS

3

 

1.1

Definitions

3

 

1.2

Terms defined elsewhere in this Agreement

4

 

 

 

 

2.

ISSUANCE OF THE WARRANTS

5

 

2.1

Undertaking to issue the Warrants

5

 

2.2

Form of the Warrants

5

 

2.3

Issue Date, Grant Letter

5

 

2.4

Underlying

6

 

2.5

Consideration for the Warrants

6

 

2.6

Warrant Holder Register

6

 

2.7

Transfer of Warrants

7

 

2.8

Exercise Period

7

 

2.9

Exercise of the Warrants

7

 

2.10

Listing of the Warrant Shares

7

 

2.11

Stamp Tax

8

 

2.12

Anti-Dilution

8

 

 

 

 

3.

COVENANT TO PERFORM; NONCIRCUMVENTION

17

 

 

 

4.

MISCELLANEOUS

18

 

4.1

Confidentiality

18

 

4.2

Obligations Several but not Joint

18

 

4.3

Taxes

18

 

4.4

Waiver

18

 

4.5

Entire Agreement

18

 

4.6

Amendments

18

 

4.7

Notices

19

 

4.8

Severability

19

 

4.9

Governing Law and Jurisdiction

20

 

4.10

Counterparts

20

 

 

 

 

SIGNATORIES

21

 

 

List of Annexes

 

 

 

ANNEX 2.3(B): GRANT LETTER

22

ANNEX 2.4(A): CONDITIONAL SHARE CAPITAL

23

ANNEX 2.9(A): WARRANT EXERCISE NOTICE

25

 

2


 

RECITALS

 

(A)                                         The Company is a corporation organized and existing under the laws of Switzerland with its registered office at c/o Addex Pharma SA, Chemin des Aulx 12, 1228 Plan-les-Ouates, Switzerland. The Company has a share capital of CHF 13,454,553.00, divided into 13,454,553 fully paid in registered shares with a nominal value of CHF 1.00 each (the “Existing Shares”). The Existing Shares are listed in accordance with the International Reporting Standard of the SIX Swiss Exchange Ltd. (the “SIX”) and traded under the ticker symbol “ADXN”.

 

(B)                                         The Company intends to raise up to CHF 40,000,000 of new equity capital by way of an ordinary capital increase of up to CHF 12,779,553 by issuing up to 12,779,553 new registered shares of the Company with a nominal value of CHF 1.00 each under exclusion of the statutory preemptive rights of the existing shareholders of the Company (the “Capital Increase”).

 

(C)                                         On the date hereof, the Parties entered into an investment agreement (the “Investment Agreement”) whereby (i) the Investors agreed, subject to the certain conditions, to participate in the Capital Increase with a total amount of CHF 20,000,000 and (ii) the Company agreed to issue to the Investors an aggregate number of 2,875,398 warrants (each a “Warrant” and together the “Warrants”), each Warrant exercisable to purchase, at the Warrant Exercise Price (as defined below), one (1) registered share of the Company with a nominal value of CHF 1.00 each to be issued out of conditional share capital of the Company (the “Warrant Shares”), subject to the terms and conditions set out in this Agreement.

 

(D)                                         The Company has received signed subscription forms from certain other investors who have committed to participate in the Capital Increase with a total amount of CHF 10,505,000. The Company may seek to receive further commitments from investors for up to CHF 9,495,000 in aggregate (all such investors investing alongside the Investors in the Capital Increase together the “Other Investors”). The Other Investors will be entitled to receive up to 2,875,399 warrants having the same terms as the Warrants.

 

IT IS AGREED as follows:

 

1.                                                DEFINITIONS

 

1.1                                         Definitions

 

(a)                            Agreement”: This agreement together with its Annexes and other schedules.

 

(b)                            Articles of Association”: The articles of association of the Company.

 

(c)                             Bank”: Swissquote Bank SA, Chemin de la Crétaux 33, Gland, Switzerland, or such other Swiss bank designated by the Company in the respective grant letter pursuant to Clause 2.3(b).

 

(d)                            Board of Directors”: The board of directors of the Company.

 

(e)                             Business Day”: Each day of the week (other than Saturday or Sunday) on which banking institutions in Geneva are not generally authorized or obligated by law or

 

3


 

statutory regulation to close.

 

(f)                              CO”: Swiss Code of Obligations.

 

(g)                             Commercial Register”: The commercial register of the Canton of Geneva.

 

1.2                                         Terms defined elsewhere in this Agreement

 

Term

 

Clause / Recital

Black Scholes Value

 

2.12(i)(i)

Bloomberg

 

2.12(i)(ii)

Capital Increase

 

Recital (B)

Cash-Out Fundamental Transaction

 

2.12(i)(iii)

Common Expert

 

2.12(i)(iv)

Company

 

Cover page

Conditional Share Capital

 

2.4(a)

Conditional Share Capital Shortfall

 

2.4(c)

Current Market Price

 

2.12(i)(v)

Distribution

 

2.12(c)

Distribution Date

 

2.12(c)

Dividend

 

2.12(i)(vi)

Effective Date

 

2.12(i)(vii)

Ex-Date

 

2.12(i)(viii)

Existing Shares

 

Recital (A)

Expert

 

2.12(i)(ix)

Fundamental Transaction

 

2.12(i)(x)

Fundamental Transaction Notice

 

2.12(e)(iv)

Fundamental Transaction Redemption No- tice

 

2.12(e)(ii)

Investment Agreement

 

Recital (C)

Investor(s)

 

Cover page

Issue Date

 

2.3(a)

Lead Investor

 

Cover page

Mixed Fundamental Transaction

 

2.12(i)(xi)

NEA

 

Cover page

NLV

 

Cover page

Other Investors

 

Recital (D)

Other Securities

 

2.12(i)(xii)

Parties

 

Cover page

Party

 

Cover page

Purchase Rights

 

2.12(b)

Put Option

 

2.12(d)

Redemption Upon Fundamental Transaction

 

2.12(e)(ii)

Shareholders’ General Meeting

 

2.4(a)

SIX

 

Recital (A)

Trading Day

 

2.12(i)(xv)

VWAP

 

2.12(i)(xvi)

Warrant Exercise Notice

 

2.9(a)

Warrant Exercise Period

 

2.8(a)

Warrant Exercise Price

 

2.1(b)

Warrant Expiration

 

2.8(b)

Warrant Holder

 

2.1(b)

Warrant Holder Register

 

2.6(a)

Warrant Shares

 

Recital (B)

Warrant(s)

 

Recital (C)

 

4


 

2.                                                ISSUANCE OF THE WARRANTS

 

2.1                                         Undertaking to issue the Warrants

 

(a)                       Subject to the terms and conditions of this Agreement, the Company undertakes to issue to the Investors on the Issue Date (as defined below) a total of 2,875,398 Warrants as follows:

 

(i)                           2,156,549 Warrants shall be issued to NEA;

 

(ii)                        718,849 Warrants shall be issued to NLV.

 

(b)                       Each Warrant entitles the holder thereof (the “Warrant Holder”) to subscribe and purchase during the Warrant Exercise Period one (1) Warrant Share for a subscription price of CHF 3.43 (as may be reduced pursuant to Clause 2.4(c) below and/or adjusted pursuant to Clause 2.12) (the “Warrant Exercise Price”).

 

(c)                        The obligation of the Company to issue the Warrants shall be subject to the satisfaction of the following conditions:

 

(i)                           the Capital Increase and the Conditional Share Capital have been registered in the Commercial Register;

 

(ii)                        the Investment Agreement has not been terminated in accordance with its terms.

 

(d)                       The number of Warrants to be issued by the Company to the Investors has been calculated such that for each share subscribed in the Capital Increase an Investor receives 0.45 Warrants. If an Investor does not comply with its obligation to subscribe for the shares and pay the investment amount in accordance with the Investment Agreement, the number of Warrants to be issued to such Investor shall be reduced by the number of shares not subscribed by such Investor in the Capital Increase multiplied by 0.45.

 

2.2                                         Form of the Warrants

 

(a)                       The Warrants shall not be issued in the form of uncertificated securities (Wertrechte) in the sense of article 973c CO.

 

(b)                       Neither the Company nor any of the Warrant Holders shall deposit or register the Warrants with SIX SIS AG or any other depository to the effect that the Warrants become intermediated securities (Bucheffekten) pursuant to FISA.

 

(c)                        The Warrants shall not be listed on SIX or on any other stock exchange.

2.3                                         Issue Date, Grant Letter

 

(a)                       The Company undertakes to issue the Warrants to the Investors on the same date when

 

5


 

the Capital Increase and the Conditional Share Capital are registered in the Commercial Register in accordance with the Investment Agreement, immediately after such registration (the “Issue Date”).

 

(b)                       The Company shall issue the Warrants to the Investors by providing each Investor a duly executed grant letter (signed by the chairman of the Board of Directors and the CEO of the Company) substantially in the form set out in Annex 2.3(b) and dated the Issue Date.

 

2.4                                         Underlying

 

(a)                       The Board of Directors shall convene a general meeting of shareholders to be held on March 21, 2018 (the “Shareholders’ General Meeting”) and seek approval from the Shareholders’ General Meeting to amend article 3c (Conditional Share Capital) of the Articles of Association in the form as set forth in Annex 2.4(a) (the “Conditional Share Capital”).

 

(b)                       The Warrant Shares to be issued upon the exercise of Warrants pursuant to Clause 2.9 shall be issued from the Conditional Share Capital (article 3c B) (as amended) of the Articles of Association). On the Issue Date, the Board of Directors shall (i) resolve that all shares issuable pursuant to article 3c B) (as amended) of the Articles of Association) shall be reserved for the Warrants and the warrants of the Other Investors and (ii) deliver a copy of such resolution to the Investors.

 

(c)                        The Company agrees to take all steps necessary within its power to ensure that the Warrants are at all times during the Warrant Exercise Period fully covered by the Conditional Share Capital. If at any time during the Warrant Exercise Period the Company has insufficient Conditional Share Capital for the Warrant Holders to exercise all of their outstanding Warrants and the Company at such time is not able to compensate such shortfall with treasury shares designated by a resolution of the Board of Directors as underlying for the Warrants (the “Conditional Share Capital Shortfall”), the Warrant Exercise Price of the Warrants shall be automatically and permanently reduced to the nominal value of the Warrant Shares (i.e. CHF 1.00 per Warrant Share).

 

(d)                       In the event of a Conditional Share Capital Shortfall, the Company shall promptly convene a general meeting of shareholders to increase the Conditional Share Capital to such amount which is sufficient to cover all of the outstanding Warrants.

 

2.5                                         Consideration for the Warrants

 

The Warrants shall be issued without consideration, i.e. at a price of CHF 0.

 

2.6                                         Warrant Holder Register

 

(a)                       The Company shall maintain a register of the Warrant Holder (the “Warrant Holder Register”). On the Issue Date and thereafter upon request by a Warrant Holder, the Company shall confirm to the Warrant Holder its registration in the Warrant Holder Register including the number of Warrants held by such Warrant Holder.

 

6


 

(b)                       The Company shall not issue any Warrant Shares to any person claiming to be a Warrant Holder, unless such person has been registered on the Warrant Holder Register pursuant to the terms and conditions of this Agreement, including, without limitation, Clause 2.7 herein.

 

2.7                                         Transfer of Warrants

 

(a)                       The Warrants shall be transferable by written assignment.

 

(b)                       Any transfer of Warrants shall further only be valid and the transferee shall only be entitled to exercise Warrants if such transfer is duly notified to the Company and the transferee is entered into the Warrant Holder Register (such entry only conditional on the satisfaction of the conditions set forth of this Clause 2.7).

 

2.8                                         Exercise Period

 

(a)                       The Warrants shall be exercisable at any time during a period of seven (7) years starting on the Issue Date (the “Warrant Exercise Period).

 

(b)                       Warrants not validly exercised prior to the end of the Warrant Exercise Period will lapse without compensation (the “Warrant Expiration”).

 

2.9                                         Exercise of the Warrants

 

(a)                       In case a Warrant Holder wishes to exercise some or all of its Warrants, it must provide the Company and the Bank during the Warrant Exercise Period a duly completed notice of exercise substantially in the form set out in Annex 2.9(a) (the “Warrant Exercise Notice”) and pay the aggregate Warrant Exercise Price to the blocked bank account at the Bank as further specified in the Warrant Exercise Notice.

 

(b)                       A Warrant Exercise Notice, once delivered, shall be irrevocable.

 

(c)                        Upon receipt by the Company of the written confirmation from the Bank of payment of the aggregate Warrant Exercise Price, the Company shall in good faith cooperate with the exercising Warrant Holder and promptly take all steps necessary to ensure that the Warrant Shares for which Warrants have been duly exercised in accordance with Clause 2.9(a) will be (i) duly recorded in the Company’s main register (Hauptregister) maintained by SIX SIS AG, (ii) through the facilities of SIX SIS AG and in accordance with the provision of FISA, timely booked to the deposit of the exercising Warrant Holder with the custody bank as instructed by the exercising Warrant Holder in the Warrant Exercise Notice and (iii) enter the exercising Warrant Holder into the Company’s share register as a shareholder of the Company with full voting rights as to the Warrant Shares purchased by the exercising Warrant Holder pursuant to the Warrant Exercise Notice.

 

2.10                                  Listing of the Warrant Shares

 

The Company undertakes to formally list the Warrant Shares on the SIX prior to the Issue Date in accordance with the Investment Agreement.

 

7


 

2.11                                  Stamp Tax

 

Any Swiss stamp issue tax which may be due in connection with the exercise of the Warrants and the issuance of the Warrant Shares shall be borne by the Company.

 

2.12                                  Anti-Dilution

 

(a)                       Change in the Company’s share capital as a result of capitalisation of reserves, profits or premiums, by means of the distribution of Shares, or a division or a consolidation of Shares:

 

In the event of a change in the Company’s share capital as a result of capitalisation of reserves, profits or premiums, by means of the distribution of Shares, save for a distribution of Shares as a Dividend as set out in Clause 2.12(d) below, the Warrant Exercise Price shall be adjusted by multiplying the Warrant Exercise Price in force immediately prior to such change by the result of the following formula:

 

NOld / NNew

 

where:

 

NOld                        is the number of Shares existing before the change in share capital; and

 

NNew                     is the number of Shares existing after the change in share capital.

 

In the event of a division or consolidation of Shares, the number of Warrant Shares is- suable on the exercise of these Warrants shall forthwith be proportionately increased in the case of a division, or proportionately decreased in the case of a consolidation. Appropriate adjustments shall also be made to the Warrant Exercise Price payable per Warrant Share, but the aggregate Warrant Exercise Price payable for the total number of Warrant Shares purchasable under the Warrants (as adjusted) shall remain the same.

 

Such adjustment shall become effective on the date on which such Shares are distributed or, in the event of division or consolidation of Shares, on the first day the Shares are traded on the new basis on the Relevant Exchange.

 

(b)                       Issues of Shares or Other Securities by way of conferring subscription or purchase rights:

 

If (a) the Company grants to holders of Shares any rights or options, warrants or other rights to subscribe for or acquire Shares, Other Securities or securities convertible or exchangeable into Shares or Other Securities, or (b) any third party with the agreement of the Company issues to holders of Shares any rights, options or warrants to purchase any Shares, Other Securities or securities convertible or exchangeable into Shares or Other Securities (the rights referred to in (a) and (b) collectively and individually being the “Purchase Rights”), the Warrant Exercise Price shall be adjusted by multiplying the Warrant Exercise Price in force immediately prior to such issue or grant by the result of the following formula:

 

(Pcum – R) / Pcum

 

8


 

where:

 

Pcum                         is the Current Market Price of one Share by reference to whichever is the later of (x) the date on which the Shares are first traded ex-Purchase Rights on the Relevant Exchange or (y) the Trading Day when the subscription or purchase price for Shares or Other Securities under the Purchase Right is announced, or, if the day the subscription or purchase price is announced is not a Trading Day, the next following Trading Day; and

 

R                                       is the value of the Purchase Right(s) relating to one Share or Other Security, such value to be calculated as follows:

 

(i)                                     in the event the Purchase Rights relate to Shares:

 

R = Pcum – TERP

 

where:

 

TERP = (Nold x Pcum + Nnew x (Prights + Div)) / (Nold + Nnew) and:

 

TERP                is the theoretical ex-Purchase Rights price; and

 

Nold                          is the number of Shares existing before the change in share capital; and

 

Nnew                       is the number of offered Shares contemplated to be newly is- sued; and

 

Prights                   is the price at which one new Share can be subscribed, exer- cised or purchased; and

 

Div                             is the amount (in CHF) by which the entitlement to Divi- dends per existing Share exceeds the entitlement to Dividends per new Share, (x) if Dividends have already been proposed to the general meeting of shareholders but not yet paid, based on the proposed amount of the Dividends, or (y) if Dividends have not yet been proposed based on the Dividends paid in the immediately preceding financial year;

 

provided, however, that no such adjustment shall be made if the subscription or purchase price at which one new Share can be subscribed or purchased is at least ninety-five (95) per cent of the Current Market Price of one Share on whichever is the later of (x) the date on which the Shares are first traded ex-Purchase Rights on the Relevant Exchange or (y) the Trading Day when the subscription or purchase price for the Purchase Right is announced, or, if the day the subscription or purchase price is announced is not a Trading Day, the next following Trading Day;

 

9


 

(ii)                                  in the event the Purchase Rights relate to Other Securities or to securities convertible or exchangeable into Shares or Other Securities and where such Purchase Rights are traded on a regulated stock exchange in Switzerland, the United Kingdom, the European Union, the United States of America, Canada or Japan:

 

R = Nrights x Prights

 

where:

 

Nrights                 is the number of Purchase Rights granted per Share; and

 

Prights                   is the VWAP of the Purchase Rights on the Relevant Ex- change (or, if no dealing is recorded, the arithmetic mean of the bid and offered prices) during the time Purchase Rights are traded, but not longer than the first ten (10) Trading Days.

 

(iii)                               in all other cases where neither of the previous paragraphs (i) or (ii) is applicable, R will be determined by a Common Expert.

 

Such adjustment pursuant to Clause 2.12(b) shall become effective:

 

(1)                                 in the case of Clause 2. 12(b)(i), on the first day on which the Shares are traded ex-Purchase Rights on the Relevant Exchange;

 

(2)                                 in the case of Clause 2. 12(b)(ii), five (5) Trading Days after (x) the end of the period during which the Purchase Rights are traded or (y) the tenth (10th) Trading Day of the Purchase Rights, whichever is sooner; and

 

(3)                                 in the case of Clause 2.12(b)(iii), on the date determined by the Common Expert.

 

(c)                        Spin-offs and Capital Distributions other than Dividends:

 

If, in respect of a spin-off or a capital distribution other than Dividends as referred to in Clause 2.12(d) below, the Company shall issue or distribute to holders of its Shares any assets, evidence of indebtedness of the Company, shares or other rights (other than as referred to in Clause 2.12(b) above) (the “Distribution”), the Warrant Exercise Price shall be adjusted as follows:

 

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(i)                                     In case the Distribution (x) consists of securities that are traded on a regulated stock exchange in Switzerland, the European Union, the United Kingdom, the United States of America, Canada or Japan or (y) has otherwise a value which is determinable by reference to a stock exchange quotation or otherwise, by multiplying the Warrant Exercise Price in force immediately prior to such issue or distribution by the result of the following formula:

 

(Pcum – D) / Pcum

 

where:

 

Pcum                         is the Current Market Price of one Share by reference to the date on which the Shares are first traded ex-Distribution on the Relevant Exchange following the relevant Distribution; and

 

D                                       is the value of the Distribution (in CHF) per Share in case of Clause 2.1 2(c)(i)(x) equal to the current market price on the Relevant Exchange on the date by reference to which Pcum has been determined, calculated on a per Share basis, and in case of Clause 2.1 2(c)(i)(y) as determined by the Common Expert.

 

where for purposes of this provision, the current market price (to determine D) in case of Clause 2.1 2(c)(i)(x) shall be deemed to be the average of the VWAPs on the five (5) consecutive Trading Days ending on and including the Trading Day preceding the day on which the Shares are first traded ex-Distribution.

 

(ii)                                  In all other cases and where there is one (but not more than one) Distribution on a given Trading Day, by multiplying the Warrant Exercise Price in force immediately prior to such issue or distribution by the result of the following formula:

 

Pafter / Pbefore

 

where:

 

Pafter                        is the current market price per Share after the date of such Distribution (the “Distribution Date”); and

 

Pbefore                 is the current market price per Share before the Distribution Date;

 

whereby for purposes of this provision the current market price per Share shall be deemed to be the average of the VWAPs, (x) in the case of Pbefore, on the five (5) consecutive Trading Days before the Distribution Date, and (y) in the case of Pafter, on the five (5) consecutive Trading Days after the Distribution Date. When calculating the average of the VWAPs the gross dividend amount (or any other entitlement), if any, of any dividend paid (or any other entitlement) during either of the above mentioned periods of five (5) consecutive Trading Days, shall be added back to the VWAPs on each of the Trading Days on which the Shares are traded ex-dividend (or any other entitlement).

 

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(iii)                               If the Company issues or distributes to its shareholders tradable put options as a Dividend with respect to any financial year, the Warrant Exercise Price shall be adjusted according to the formula set out in Clause 2.12(d).

 

(iv)                              In all other cases where there is more than one such Distribution on a given Trading Day, the Common Expert will determine the necessary adjustment.

 

Such adjustment pursuant to Clause 2.12(c) shall become effective, in the case of (i), on the date on which the Distribution is made and, in the case of (ii) and (iii), on the sixth (6th) Trading Day after the Distribution Date.

 

(d)                                 Dividends

 

If the Company pays a Dividend, the Warrant Exercise Price shall be adjusted by multiplying the Warrant Exercise Price by the following fraction:

 

(Pcum – D) / (Pcum)

 

where:

 

Pcum                         is the Current Market Price on the Effective Date;

 

D                                       is the portion of the Dividend attributable to one Share as set out below;

 

Any reference to D in the above formula shall be a reference to:

 

(i)                                     the cash amount in case of a cash dividend or a repayment of paid-in capital;

 

(ii)                                  an amount as calculated by the following formula in case of a stock dividend in lieu of a cash dividend:

 

Current Market Price - (Current Market Price x (NOld / NNew))

 

where:

 

Current Market Price is the average of the daily VWAP of one Share on each of the five (5) consecutive Trading Days ending on and including the Trading Day immediately prior to the Ex-Date;

 

NOld                        is the number of Shares existing before the change in share capital; and

 

NNew                     is the number of Shares existing after the change in share capital;

 

(iii)                               an amount as calculated by the following formula in case of tradable put options in lieu of a cash dividend (the “Put Option”):

 

Current Market Price x (P/N)

 

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where:

 

Current Market Price                               is the average of the daily VWAP of the Put Option on each of the five (5) consecutive Trading Days commencing on the Ex-Date;

 

P                                                                                                                                         is the number of Put Options to be issued; and

 

N                                                                                                                                       is the number of Shares existing prior to the Ex-Date.

 

Such adjustment pursuant to Clause 2.12(d) shall become effective on the Ex-Date and in case of Put Options according to (iii) above, on the sixth (6th) Trading Day following the Ex-Date.

 

(e)                                  Consolidation, Mergers and other Fundamental Transactions

 

(i)                                     In the event of a Fundamental Transaction, the Company shall ensure that each Warrant shall be exercisable into the number of shares (or other equity securities) and any other consideration (including cash) issued or delivered to the holder of the number of Shares which such holder could have subscribed through the exercise of Warrants held by such holder immediately prior to one of the aforementioned events. Thereafter, the adjustment provisions of this Clause 2.12 shall apply mutatis mutandis in respect of such shares or other equity securities and reference to Shares and Warrant Shares in this Agreement shall be construed as references to such shares or equity securities.

 

(ii)                                  Notwithstanding Clause 2.1 2(e)(i) above, at any time during the period beginning after the Warrant Holder’s receipt of a Fundamental Transaction Notice from the Company and ending ten (10) trading days prior to the scheduled consummation of such Fundamental Transaction, the Warrant Holder may require the Company to redeem (a “Redemption Upon Fundamental Transaction”) all of its Warrants by delivering written notice thereof (“Fundamental Transaction Redemption Notice”) to the Company; provided, that such Fundamental Transaction Redemption Notice shall be irrevocable by the Warrant Holder. If the Warrant Holder properly delivers a Fundamental Transaction Redemption Notice to the Company and such Fundamental Transaction is consummated, the Warrants shall be redeemed by the Company at a price payable (x) in the case of a Cash-Out Fundamental Transaction or in the case of a Mixed Fundamental Transaction to the extent of the percentage of the cash consideration in such Mixed Fundamental Transaction (determined in accordance with the definition of a Mixed Fundamental Transaction below), in cash equal to the Black Scholes Value (as defined below) of its Warrant, and (y) in the case of a Fundamental Transaction not described in the foregoing sub-clause (x) or to the extent of the percentage of the consideration represented by securities of the successor entity in a Mixed Fundamental Transaction (as determined in accordance with the definition of Mixed Fundamental Transaction below), in a number of shares equal to the Black Scholes Value of its Warrants subject to redemption under this sub- clause (y) divided by the VWAP of the Shares on the Trading Day immediately preceding the date on which the Fundamental Transaction is consummated, provided such redemption does not constitute a breach of any applicable minimum and/or best price rule under any applicable takeover regulations.

 

13


 

(iii)                               The terms of any agreement pursuant to which a Fundamental Transaction is effected shall include terms requiring any such successor or surviving entity to comply with the provisions of this Clause 2.12(e) and ensuring that the provisions of the Warrants (or any such replacement security) shall similarly apply to subsequent transactions analogous to a Fundamental Transaction.

 

(iv)                              The Company shall provide written notice to the Warrant Holder of a Fundamental Transaction reasonably promptly after public announcement thereof (and, in any event, not less than twenty (20) days prior to the consummation of such Fundamental Transaction) and such notice shall include (i) the projected date of consummation of the Fundamental Transaction to the extent known at the time such notice is delivered and (ii) the expected consideration to be received by the Company’s shareholders in such Fundamental Transaction (including an indication as to whether the Fundamental Transaction is expected to constitute a Cash-Out Fundamental Transaction or Mixed Fundamental Transaction or other form of Fundamental Transaction) (such notice, the “Fundamental Transaction Notice”).

 

(f)                                   No adjustment to the Warrant Exercise Price will be made:

 

(i)                                     as a result of any issue or distribution of Shares or Other Securities if the preemptive right (Bezugsrecht) in respect thereof under the Swiss Code of Obligations has been validly excluded by resolution of the general meeting of shareholders of the Company unless a pre-emptive right in respect thereof is granted indirectly to the shareholders by a third party with the agreement of the Company; or

 

(ii)                                  as a result of any issue of bonds convertible or exchangeable into Shares or bonds with options to subscribe for Shares, such issue being in connection with a conditional increase of the share capital of the Company, irrespective of whether in respect of such issue the advance subscription rights to acquire such bonds (Vorwegzeichnungsrecht) have been excluded or not, unless advance subscription rights have been granted and are traded on the Relevant Exchange; or

 

(iii)                               if Shares or Other Securities (including pre-emptive rights, options or warrants in relation to Shares or Other Securities) are issued, offered or granted to, or for the benefit of, members of the Board of Directors, officers or employees, or former members of the Board of Directors, officers, employees or advisors, of the Company or any of its subsidiaries or any associated company or to trustees to be held for the benefit of any such person in any such case pursuant to any employee share or option scheme; or

 

(iv)                              if an increase of the Warrant Exercise Price would result from such adjustment, except in case of an exchange of the Shares for Other Securities or a consolidation of Shares; or

 

(v)                                 if the Warrant Exercise Price would fall below the nominal value of a Warrant Share. In this case the Warrant Exercise Price will be adjusted to the nominal value of a Warrant Share.

 

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(g)                                  When any adjustment is required to be made pursuant to this Clause 2.12, the Company shall promptly notify the Warrant Holders of such event. Each determination and adjustment to be made pursuant to this Clause 2.12 shall be calculated in good faith by the Company in consultation with the Warrant Holder. If any doubt shall arise as to whether an adjustment is to be made to the Warrant Exercise Price or as to the appropriate adjustment to the Warrant Exercise Price (including, without limitation, as to the appropriate determination of any calculation, factor or element), and following consultation between the Company and the Common Expert, a written opinion of the Common Expert in respect thereof shall be conclusive and binding on all parties, save in case of manifest error.

 

(h)                                 No adjustment in the Warrant Exercise Price shall be required unless such adjustment would require an increase or decrease of at least CHF 0.01 in such price; provided, however, that any adjustment which by reason of this Clause 2.12(i) is not required to be made shall be carried forward and taken into account in any subsequent adjustments under this Clause 2.12. All calculations under this Clause 2.12 shall be made by the Company in good faith and shall be made to the nearest cent.

 

(i)                                     Definitions:

 

(i)                                     Black Scholes Value” shall mean the value of a Warrant based on the Black and Scholes Option Pricing Model obtained from the OV function on Bloomberg determined as of the day of the closing of the applicable Fundamental Transaction for pricing purposes and reflecting (i) a risk-free interest rate corresponding to the Swiss government bond rate for a period equal to the remaining term of the Warrants as of such date of request, (ii) an expected volatility equal to the greater of 100% and the 100-day volatility obtained from the HVT function on Bloomberg as of the day immediately following the public announcement of the applicable Fundamental Transaction and (iii) the underlying price per share used in such calculation shall be the sum of the price per share being offered in cash, if any, plus the value of any non-cash consideration, if any, being offered in the Fundamental Transaction, such non-cash values to be as set forth in any definitive agreement for the Fundamental Transaction that has been executed around the time of the first public announcement of the Fundamental Transaction or, if no such value is determinable from such definitive agreement, based on the closing market price for shares of the successor entity on its principal securities exchange or quotation system on the trading day preceding the first public announcement of the Fundamental Transaction or, if the successor entity is not a publicly traded successor entity, then as mutually determined in good faith by the Warrant Holder and the Company’s Board of Directors. In addition, for purposes of determining the Black Scholes Value, the Warrants shall be deemed to be exercisable from and after the Issue Date of the Warrants regardless of any restrictions on exercisability.

 

(ii)                                  Bloomberg” means Bloomberg Financial Markets.

 

(iii)                               Cash-Out Fundamental Transaction” shall mean a Fundamental Transaction in which the consideration payable to holders of the Shares in connection with the Fundamental Transaction consists solely of cash.

 

15


 

(iv)                              Common Expert” means an independent investment bank of international repute or a “Big 4” accounting firm of international repute or an independent financial advisor with relevant expertise of international repute (an “Expert”) selected by the Company and the Warrant Holder by mutual agreement. If the Company and the Warrant Holder do not mutually agree on an Expert within seven (7) days from the beginning of the appointment process, each of the Parties shall select an Expert, whereby the so elected Experts shall select together a third Expert. In case the two selected Experts do not mutually agree on a third Expert within seven (7) days after being appointed, each of them shall select another Expert, whereby a Swiss Notary Public appointed by the Warrant Holders will pick one of these two Experts as third Expert by drawing lots. In the case of the appointment of three Experts, references herein to a Common Expert shall be deemed to refer to these three Experts, deciding by majority decision. Decisions of the Common Expert shall be final and binding on the Parties. The fees and costs of the Common Expert shall be borne by the Company;

 

(v)                                 Current Market Price” means the average of the daily VWAP of one Share on each of the five (5) consecutive Trading Days ending on (and including) the Trading Day immediately preceding the date by reference to which such average is calculated, provided that when calculating the average of the VWAPs the gross dividend amount (or any other entitlement), if any, of any dividend (or any other entitlement) paid during either of the above mentioned period of five (5) consecutive Trading Days, shall be added back to the VWAPs on each of the Trading Days on which the Shares are traded ex-dividend (or any other entitlement).

 

(vi)                              Dividend” means a distribution per Share made by the Company to holders of the Shares at any time as (i) a cash dividend, (ii) a repayment of paid-in capital, (iii) a stock dividend in lieu of a cash dividend, or (iv) tradable put options in lieu of a cash dividend.

 

(vii)                           Effective Date” means the last date on which the Shares are traded cum — dividend on the Relevant Exchange or, in the case of a purchase, redemption or buy back of Shares or any depositary or other receipts or certificates representing Shares, the date on which such purchase, redemption or buy back is made or in the case of a spin-off, the last date on which the Shares are traded cum — the relevant spin-off on the Relevant Exchange.

 

(viii)                        Ex-Date” means the first day on which the Shares are traded on the Relevant Exchange without entitlement (ex).

 

(ix)                              Expert” shall have the meaning given to it in the definition of Common Expert.

 

(x)                                 Fundamental Transaction” shall mean (i) a merger or consolidation of the Company with another entity, in which the Company is not the survivor or the shareholders of the Company immediately prior to such merger or consolidation do not own, directly or indirectly, at least 50% of the voting securities of the surviving entity, (ii) the Company effects any sale of all or substantially all of its assets or a majority of its shares is acquired by a third party, or (iii) a purchase,

 

16


 

tender or exchange offer accepted by the holders of a majority of the outstanding shares of the Company, directly or indirectly, in one or more related transactions.

 

(xi)                              Mixed Fundamental Transaction” shall mean a Fundamental Transaction where the consideration payable to shareholders of the Company consists partially of cash and partially of securities of a successor entity. If the successor entity is a publicly traded entity whose shares are listed on a stock exchange, the percentage of consideration represented by securities of such successor entity shall be equal to the quotient of (x) the product of the aggregate anticipated number of shares of the publicly traded successor entity to be issued (based on the trading day preceding the first public announcement of the Mixed Fundamental Transaction) to holders of the Shares multiplied by the closing market price for such shares of the publicly traded successor entity on its principal securities exchange on the trading day preceding the first public announcement of the Mixed Fundamental Transaction, divided by (y) the sum of the amount determined in sub-clause (x) plus the aggregate value of other consideration, including cash consideration, in such Fundamental Transaction. If the successor entity is not a publicly traded successor entity, the percentage of consideration represented by securities of such successor entity shall be as determined in good faith by the Common Expert.

 

(xii)                           Other Securities” means equity securities of the Company other than Shares.

 

(xiii)                        Relevant Exchange” means (i) in the case of Shares, SIX Swiss Exchange or any successor thereof or, if the Shares are no longer admitted to trading on the SIX Swiss Exchange, the principal stock exchange or securities market on which the Shares are traded, and (ii) in the case of other securities, the principal stock exchange or securities market on which such other securities are traded.

 

(xiv)                       Shares” means the shares in the Company

 

(xv)                          Trading Day” means any day (other than a Saturday or Sunday) on which (i) the Relevant Exchange is open for business and Shares may be dealt in or (ii) (if the Shares are not listed or admitted to trading on the Relevant Exchange) closing bid and offered prices are furnished as aforesaid

 

(xvi)                       VWAP” means with respect to any Trading Day, the volume-weighted average price of one Share (or other security, as the case may be) published by Bloomberg Page HP (setting Weighted Average Line) or, if there is none, such other source as shall be determined to be appropriate by the Common Expert on such Trading Day, provided that if on any Trading Day on which such price is not available or cannot otherwise be determined as provided above, the volume- weighted average price of a Share in respect of such Trading Day shall be the volume-weighted average price, determined as provided above, on the immediately preceding Trading Day on which the same can be so determined.

 

3.                                      COVENANT TO PERFORM; NONCIRCUMVENTION

 

The Company hereby covenants and agrees that the Company will at all times in good faith

 

17


 

carry out all the provisions of this Agreement and will not, by amendment of its Articles of Association, bylaws or other organizational documents or through a Fundamental Transaction, dissolution, sale of assets or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Agreement. Without limiting the generality of the foregoing, the Company (i) shall not increase the nominal value of any of the Warrant Shares receivable upon the exercise of the Warrants above the Warrant Exercise Price then in effect, and (ii) shall take such actions as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of the Warrants.

 

4.                                      MISCELLANEOUS

 

4.1                               Confidentiality

 

Each Party shall keep confidential the contents of this Agreement and confidential information received from another Party and shall not disclose any such information to any third party; it being understood and agreed that the foregoing shall not restrict (i) any Party from pursuing its rights and exercising its remedies under this Agreement, and (ii) any Party from a disclosure of information which is required by applicable law or regulation or based on an order of any competent judicial or regulatory authority or any competent securities exchange in which case the Parties shall endeavour in good faith to agree on the content of any such disclosure prior to it being made.

 

4.2                               Obligations Several but not Joint

 

The obligations of the Investors under this Agreement shall be several but not joint.

 

4.3                               Taxes

 

Each Party shall bear all taxes incurred by it in connection with the transactions contemplated by this Agreement and for which each Party is statutorily liable, provided, that notwithstanding the foregoing, the Company shall bear the Swiss issuance stamp tax payable upon the issuance of the Warrant Shares.

 

4.4                               Waiver

 

Except where this Agreement provides otherwise, the partial exercise of a right arising under this Agreement or any delay in the exercise or failure to exercise such right shall not be deemed to constitute a waiver of such right or of other rights under this Agreement.

 

4.5                               Entire Agreement

 

This Agreement together with the Annexes constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and shall replace all other prior agreements or understandings of the Parties relating thereto. All references to this Agreement shall be deemed to include the Annexes hereto.

 

4.6                               Amendments

 

This Agreement, including this provision, may not be amended or modified except by a

 

18


 

document in writing duly executed by the Parties hereto.

 

4.7                               Notices

 

All notices or other communications to be given under or in connection with this Agreement shall be made in writing and shall be delivered or sent by mail, courier or telefax to the following addresses:

 

If to the Company:

 

Addex Therapeutics Ltd

 

 

Attn.: Timothy Dyer

 

 

PO Box 68

 

 

Chemin des Aulx 12

 

 

1228 Plan-les-Ouates

 

 

Switzerland

 

 

Fax:

 

 

 

 

 

With copy to Homburger AG

 

 

Attn: Dr. Frank Gerhard

 

 

Hardstrasse 201

 

 

8005 Zurich

 

 

Switzerland

 

 

Fax:

 

 

 

If to Growth Equity Opportunities Fund IV, LLC:

 

New Enterprise Associates

 

 

Attn.: Louis S. Citron

 

 

1954 Greenspring Drive, Suite 600

 

 

Timonium, MD 21093

 

 

Email:

 

 

Fax:

 

 

 

 

 

With copy, which copy shall not constitute notice, to:

 

 

 

 

 

Greenberg Traurig, LLP

 

 

Attn.: Trevor Chaplick

 

 

2101 L St. NW, Suite 1000

 

 

Washington, DC 20037

 

 

Email:

 

 

Fax:

 

 

 

If to New Leaf Biopharma Opportunities I, L.P.:

 

New Leaf Biopharma Opportunities I, L.P.

 

 

Attn: Craig L. Slutzkin

 

 

7 Times Square, Suite 3502

 

 

New York, NY 10036

 

 

Fax:

 

4.8                               Severability

 

If any provision of this Agreement should be invalid or unenforceable under applicable laws, the relevant provision shall be ineffective only to the extent of such unenforceability or invalidity, and the remaining provisions of the Agreement shall continue to be binding and in full force and effect. Instead of the invalid or unenforceable provision, a rule shall apply that achieves as closely as possible the initial intention of the Parties in drafting the invalid or

 

19


 

unenforceable provision.

 

4.9                               Governing Law and Jurisdiction

 

(a)                                 This Agreement shall be governed by and construed in accordance with Swiss substantive law (excluding international treaties, in particular the Vienna Convention on the International Sale of Goods dated April 11, 1980).

 

(b)                                 In the case of a dispute as to the determination of the Warrant Exercise Price, the arithmetic calculation of the Warrant Shares or under Clause 2.12, the disputing party shall submit the disputed determinations or arithmetic calculations to the other Party. If the Warrant Holder and the Company are unable to agree upon such determination or calculation of the Warrant Exercise Price or the Warrant Shares within three (3) Business Days of such disputed determination or arithmetic calculation being submitted to the non-disputing party, then the Company shall, within two (2) Business Days submit the dispute to an independent, reputable accountant. The Company shall cause, at the expense of the prevailing party, the accountant to perform the determinations or calculations and notify the Company and the Warrant Holder of the results no later than ten (10) Business Days from the time it receives the disputed determinations or calculations. Such accountant’s determination or calculation shall be binding upon all Parties absent demonstrable error. Any other dispute, controversy or claim arising out of or in connection with this Agreement, including the validity, invalidity, breach, or termination thereof, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one arbitrator appointed in accordance with the said Rules. The seat of the arbitration shall be Geneva unless the arbitration is sought by the Company, in which case the seat shall be New York. The arbitral proceeding shall be conducted in English.

 

4.10                        Counterparts

 

This Agreement shall be signed in three (3) original counterparts.

 

[Signatures on next page]

 

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SIGNATORIES

 

Place, Date:

 

 

Addex Therapeutics Ltd

 

 

 

 

 

 

 

 

/s/ Tim Dyer

 

 

Name: Tim Dyer

 

 

Title: CEO

 

 

 

 

 

 

Place, Date:

 

 

Growth Equity Opportunities Fund IV, LLC

 

 

 

 

 

 

 

 

By:

/s/ Louis S. Citron

 

 

Name:

Louis S. Citron

 

 

Title:

Chief Legal Officer

 

 

 

 

 

 

 

 

 

 

 

 

Place, Date:

New York 14 Feb 2018

 

New Leaf Biopharma Opportunities I, L.P.

 

 

 

 

 

 

 

 

By:

New Leaf BPO Associates I, L.P.

 

 

Its:

General Partner

 

 

 

 

 

 

By:

New Leaf Venture Management III, L.L.C.

 

 

Its:

General Partner

 

 

 

 

 

 

 

 

 

 

By:

/s/ Craig L. Slutzkin

 

 

 

Craig L. Slutzkin

 

 

 

Chief Financial Officer

 

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ANNEX 2.3(B): GRANT LETTER

 

[Company’s Letter Head]

 

To: [Name and address of Investor]

 

Geneva, [date]

 

Dear Sirs

 

Reference is made to the Warrant Agreement dated as of February 14, 2018 between us and, inter alia, you as Investor. Capitalized terms used in this Grant Letter shall have the same meaning as ascribed to them in the Warrant Agreement.

 

In accordance with the Warrant Agreement, we herewith irrevocably and unconditionally grant [number] Warrants to you.

 

In case you wish to exercise some or all of your Warrants, please provide the Company and [name of bank] (the “Bank”) a duly completed Warrant Exercise Notice and pay the aggregate Warrant Exercise Price to the blocked bank account at the Bank with the account number [·] (IBAN [·] and Swift [·]).

 

Please find attached the relevant excerpt of the Warrant Holder Register.

 

Sincerely yours,

 

 

Addex Therapeutics Ltd

 

 

 

 

 

Vincent Lawton

 

Timothy Dyer

Chairman

 

CEO

 

 

Enclosure: mentioned

 

22


 

ANNEX 2.4(A): CONDITIONAL SHARE CAPITAL

 

Conditional Share Capital

 

Amendment to the allocation of the conditional share capital and amendment to article 3c of the Articles of Association

 

The Board of Directors proposes (i) to amend - without increasing - the existing allocation of the conditional share capital as further explained below and accordingly (ii) to amend article 3c of the Articles of Association as follows

 

Version telle que proposée par le Conseil d’administration (texte actuel et inchangé en caractères normaux; suppressions en gras, italique et barré; modifications en gras et italique):

 

Version as proposed by the Board of Directors (current and unchanged wording in normal font; deletions in bold, italics and stricken through; amendments in bold and italics):

 

 

 

Texte faisant foi / Binding version:

 

Traduction informelle en anglais / Informal English translation:

 

 

 

Article 3c

 

Capital-actions conditionnel

 

Article 3c

 

Conditional Share Capital

 

 

 

A) Le capital-actions de la Société peut être augmenté d’un montant total maximum de CHF1’941’696 par l’émission de 1’941’696 actions nominatives au maximum, entièrement libérées et d’une valeur nominale de CHF1 chacune, liées à l’exercice des droits d’option ou des droits de souscription attachés aux bons de jouissance attribués aux employés, aux membres du conseil d’administration et/ou aux consultants de la Société ou d’une autre société du groupe en fonction des règles respectives adoptées par le conseil d’administration. Les droits de souscription préférentiels des actionnaires sont exclus. L’acquisition d’actions nominatives par l’exercice des droits d’option ou des droits de souscription attachés aux bons de jouissance et le transfert subséquent des actions nominatives sont soumis aux restrictions prévues à l’article 5 des présents Statuts.

 

A) The share capital of the Company may be increased by a maximum aggregate amount of CHF1’941’696 through the issuance of a maximum of 1’941’696 registered shares, which shall be fully paid-in, with a par value of CHF1 per share by the exercise of option rights or subscription rights attached to bons de jouissance which the employees, directors and/or consultants of the Company or a group company are granted according to respective regulations of the Board of Directors. The pre-emptive rights of the shareholders are excluded. The acquisition of registered shares through the exercise of option rights or subscription rights granted to the holders of bons de jouissance and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in Article 5 of the Articles of Association.

 

 

 

B) Le capital-actions de la société peut être augmenté d’un montant maximal de CHF5’750’798 par l’émission de 5’750’798 actions nominatives au maximum, entièrement libérées et d’une valeur nominale de CHF 1 chacune, liées à l’exercice de droits d’option et/ou de conversion attribués à des actionnaires de la société et/ou en relation avec l’émission par la Société ou par une autre société du groupe d’obligations ou de tout autre instrument financier. En cas de telles attributions de

 

B) The share capital of the Company may be increased by a maximum aggregate amount of CHF5’750’798 through the issuance of a maximum 5’750’798 registered shares, which shall be fully paid-in, with a par value of CHF 1 per share by the exercise of option and/or conversion rights which are granted to shareholders of the company and/or in connection with the issue of bonds, similar obligations or other financial instruments by the Company or another group company.

 

23


 

droits d’option et/ou de conversion, les droits de souscription préférentiels des actionnaires sont exclus. Les détenteurs de droits d’option et/ou de conversion ont un droit de recevoir les nouvelles actions. Le conseil d’administration détermine les termes des droits d’option et/ou de conversion. L’acquisition d’actions nominatives par l’exercice de droits d’option ou de conversion et le transfert subséquent des actions nominatives sont soumis aux restrictions prévues à l’article 5 des présents Statuts.

 

(...)

 

In the case of such grants of option and/or conversion rights, the advanced subscription right of shareholders is excluded. The holders of option and/or conversion rights are entitled to receive the new shares. The Board of Directors shall determine the terms of the option and/or conversion rights. The acquisition of registered shares through the exercise of option or conversion rights and the subsequent transfer of the registered shares shall be subject to the transfer restrictions provided in Article 5 of the Articles of Association.

 

(...)

 

24


 

ANNEX 2.9(A): WARRANT EXERCISE NOTICE

 

From:                                       [Name and address of Warrant Holder] (the “Warrant Holder”)

 

To:                                                     Addex Therapeutics Ltd, c/o Addex Pharma SA, Chemin des Aulx 12, 1228 Plan-les-Ouates, Switzerland

 

To:                                                     [Swissquote Bank SA] (the “Bank”)

 

Date:                                          [date]

 

Warrant Exercise Notice

 

Reference is made to the warrant agreement dated February 14, 2018 between, among others Addex Therapeutics Ltd and the Warrant Holder (the “Warrant Agreement”). Unless defined otherwise herein, capitalized terms used in this Warrant Exercise Notice shall have the same meaning as ascribed to them in the Warrant Agreement.

 

We hereby irrevocably elect to exercise [number] Warrants and to purchase thereunder [number] Warrant Shares for a total purchase price of CHF [amount] (the “Total Purchase Price”).

 

We make payment, with value date [date], of the Total Purchase Price to the bank account at the Bank with the account number [·] (IBAN [·] and Swift [·]).

 

We hereby request you to deliver the Warrant Shares to:

 

·                  Name of the bank: [·]

 

·                  Account No.: [·] (IBAN [·] and Swift [·])

 

·                  Name of the account holder: [·]

 

 

Sincerely yours,

 

 

[Name of Warrant Holder]

 

 

 

 

 

Name:

 

Name:

Title:

 

Title:

 

25




EXHIBIT 10.1

 

AGREEMENT

 

This Agreement made and entered into this 31st day of December, 2004 by and between

 

ADDEX PHARMACEUTICALS Ltd. , a company organised and existing under the laws of and having its registered office at 12, chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland (hereinafter referred to as “ADDEX” or “a Party”)

 

and

 

ORTHO-MCNEIL PHARMACEUTICALS Inc, a company having its principle place of business at 1000 U.S. Route # 202, Raritan, New Jersey 08869-0602, USA. (hereinafter referred to as “OMP” or “a Party”)

 

WHEREAS, ADDEX has an on-going research program in the field of metabotropic G protein-coupled glutamate receptor 2 (hereinafter, mGlu2-R) and has developed certain hit compounds, know-how and patent applications in this field. In addition ADDEX possess technology related to assaying for and developing positive allosteric modulators and negative allosteric modulators for mGlu2-R;

 

WHEREAS, OMP has on-going research and development programs in the field of central nervous system and has developed certain know-how in this field. In addition, OMP possesses medicinal chemistry and other research, development and commercialization capabilities, as well as proprietary technology in a broad range of therapeutic fields;

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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WHEREAS, OMP has a very large library of commercially valuable proprietary compounds in its control that OMP would like to screen with ADDEX’s assays to identify compounds that are positive allosteric modulators and negative allosteric modulators for mGlu2-R and could be developed into therapeutic compounds for the treatment of animals or humans;

 

WHEREAS, the Parties desire to engage in collaborative research and conduct a drug discovery program as generally described in the Research Program attached hereto as Appendix A and OMP will fund such efforts;

 

WHEREAS, if the research collaboration is successful, the resulting compounds may have a broad range of applications, such as but not limited to the therapeutic treatment and/or prevention of certain CNS disorders and diseases, such as, for example, cognition, anxiety, depression, schizophrenia and drug abuse; and

 

WHEREAS, the Parties are interested in such a collaborative research and development arrangement with OMP developing and commercializing compounds that act on mGlu2-R.

 

NOW THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

Article 1:  DEFINITIONS

 

1.1                               “ADDEX Change of Control” means any transaction or series of related transactions in which a Major Health Care Company acquires or becomes the beneficial owner of (i) more than fifty-one percent (51%) of the outstanding voting securities of ADDEX or the surviving entity, whether by merger, consolidation, reorganization, tender offer or similar means, or (ii) all or substantially all of the assets of ADDEX.

 

1.2                               “ADDEX Know-How” shall mean all Information Controlled by ADDEX or its Affiliates which is necessary for the formulation, manufacture, use, development and/or regulatory approval of the Collaboration Compounds and/or Collaboration Products in the Field.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

2


 

1.3                               “ADDEX Patents” shall mean Patents which are Controlled by ADDEX or its Affiliates during the term of this Agreement which Patents contain method of use, method of manufacture or composition of matter claims covering Collaboration Compounds, including without limitation ADDEX Program Patents, and Joint Program Patents.

 

1.4                               “ADDEX Program Patent” shall mean a Program Patent which claims inventions solely invented by the employees of ADDEX or its Affiliates, or Third Parties with an obligation to assign to ADDEX, inventorship shall be determined under United States patent law, and such inventions shall be owned by ADDEX.

 

1.5                               “Affiliate” of a Party hereto shall mean any person, corporation, joint venture or business entity of such Party which, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such Party, as the case may be. As used in this Section, “control” means the possession of the power to direct or cause the direction of the management and policies of an entity, through the ownership of more than fifty percent (50%) (or such lesser percent as may be the maximum that may be owned in accordance with the applicable laws) of the outstanding voting securities.

 

1.6                               “Agonist” shall mean a small molecule that activates mGlu2-R in absence of glutamate, but does not bind to the binding site of any Allosteric Modulator.

 

1.7                               “Agonist Compound” shall mean Collaboration Compound that is an Agonist and all its salts, esters, polymorphs, enantiomers, rotamers, hydrates, anhydrides and prodrugs.

 

1.8                               “Allosteric Modulator” shall mean a small molecule that reacts with or binds to a portion of mGlu2-R other than the binding site for glutamate and causes a change in the function of mGlu2-R in the presence of glutamate or an Agonist.

 

1.9                               “Antagonist” shall mean a small molecule that blocks or inhibits the activation of mGlu2-R.

 

1.10                        “Bulk Drug Substance” shall mean a Collaboration Compound in bulk form which, if appropriately formulated and finished, would constitute Collaboration Product.

 

1.11                        “Calendar Quarter” shall mean each one of four time periods in any calendar year comprising approximately a three-month period which will be determined in

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

3


 

accordance with the Johnson & Johnson Universal Calendar. The 2005 Calendar is attached hereto as Appendix F. For any year during this Agreement after 2005, OMP will provide ADDEX with the then current Johnson & Johnson Universal Calendar as requested by ADDEX.

 

1.12                        “Calendar Year” shall mean a calendar year based on the J&J Universal Calendar for that year.

 

1.13                        “Co-Develop” shall mean the joint development of a Collaboration Compound as described in Article 3.7.

 

1.14                        “Collaboration Compound” shall mean, except as provided below, any composition of matter that (or, in the case of prodrugs, an active metabolite of which):

 

(a)                                 demonstrates in vitro activity as

 

(i)                                     an Agonist with [***] as determined by one of the Agonist Assays specified in Appendix B; or

 

(ii)                                  an Antagonist with [***] as determined by one of the Antagonist Assays specified in Appendix B; or

 

(iii)                               a Negative Allosteric Modulator with [***] or less as determined by one of the NAM Assays specified in Appendix B or

 

(iv)                              a Positive Allosteric Modulator with [***] or less as determined by one of the PAM Assays specified in Appendix B; and

 

(b)                                 either

 

(i)                                     first discovered, identified, synthesized or acquired by ADDEX or its Affiliate (in case ADDEX has extended its rights pursuant to Article 8.2) or on behalf of ADDEX or said Affiliate by a Third Party contractor having no property right in such composition of matter prior to the end of the Research Period, and is recognized by either Party to meet the condition of (a) hereof prior to the expiration of [***] months following the end of the Research Period; or

 

(ii)                                  is first discovered, identified, synthesized or acquired by OMP or its Affiliate (in case OMP has extended its rights pursuant to Article 8.2) or on behalf of OMP or said Affiliate by a

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

4


 

Third Party contractor having no property right in such composition of matter during the Research Period and is recognized by either Party to meet the condition of (a) hereof prior to the expiration of [***] months following the end of the Research Period; or

 

(iii)                               is Jointly Invented by the parties described in subsection (i) and (ii) above during the Research Period and is recognized by either Party to meet the condition of (a) hereof prior to the expiration of [***] months following the end of the Research Period; or

 

(c)                                  [***] any issued claim of any unexpired Program Patent [***], or in a claim of a pending application for such a Program Patent (including such a claim of a PCT application [***]) to the extent that said claim is [***] and is [***], and as to which claim at least [***], whether or not [***].

 

Collaboration Compounds shall not include any composition of matter that as of the Effective Date a) [***]; b) [***]; or c) [***]. As used in this Article 1.14, the term “acquired” shall include the acquisition of absolute or contingent rights, such as rights under an option.

 

1.15                        “Collaboration Product” shall mean a Product containing a Collaboration Compound.

 

1.16                        “Combination Product” shall mean a Collaboration Product that contains a Collaboration Compound and one or more active ingredients in physical admixture, and/or a Collaboration Product in which a Collaboration Compound is contained separately but marketed as a unit with one or more other active ingredients.

 

1.17                        “Collaboration Tangible Research Product” shall mean any composition of matter or other tangible asset, including but not limited to compounds, natural products or fermentation broths and/or extracts or fractions thereof, immunoglobulin molecules, including active fragments thereof and monoclonal antibodies, cells and cell lines, DNA and RNA molecules, plasmids, proteins, peptides, receptors, receptor fragments, research tools, materials for use in screening methods and techniques, made or synthesized by either Party in the course of Research, or acquired by

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

5


 

ADDEX in the course of the Research with funds provided by OMP under Article 2.4 as mutually agreed.

 

1.18                        “Control” or “Controlled” shall mean the right to grant a license or sublicense to intangible property rights (including patent rights, know-how and/or trade secret information), and the right to provide access to or cross-reference to regulatory filings and any thereto related raw data, in each case to the extent not in violation of the terms of any pre-existing agreement or other arrangement with any Third Party. “Control” or “Controlled” expressly includes the right of ownership, in whole or in part.

 

1.19                        “CTA” shall mean Clinical Trial Application filed with a regulatory agency with respect to development of a Product applicable in a Major European Country or other countries.

 

1.20                        “Date of First Sale” shall mean, on a country by country basis and product by product basis, the date on which each Collaboration Product is first sold in each country in the Territory by OMP, its Affiliate or its Sublicensee to a Third Party in a commercial arm’s length transaction. For the purpose of clarification of “product by product” used in this Agreement, Collaboration Products having the same Collaboration Compound as an active ingredient shall be deemed to be the same Collaboration Product regardless of difference in indications or formulations.

 

1.21                        “Development Costs” shall have such meaning as defined in Appendix D hereto

 

1.22                        “Development Program” shall mean the program for the Development, which will be set forth in Article 3.1 and following.

 

1.23                        “Development Program Patent” shall mean any Patent, other than a Program Patent, owned or Controlled by OMP (other than [***]) or ADDEX (or their Affiliates) having a priority date for the purpose of determining prior art before the expiration or termination of this Agreement, the invention of which was applied to a Collaboration Compound or Collaboration Product initially by the Party or with permission of the Party owning or controlling the Patent and the invention of which is used: (i) [***]; or (ii) [***]. Provided, however, Development Program Patent shall not include Patents covering [***].

 

1.24                        “Development Work” or “Development” shall mean all activities relating to obtaining Regulatory Approval of a Collaboration Compound and/or Collaboration

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

6


 

Product in the Territory, and activities relating to developing the ability to manufacture and continue to manufacture a Collaboration Compound and/or Collaboration Product, for the Territory, including but not limited to pre-clinical testing, toxicology, formulation, bulk production, manufacturing process development, quality assurance and quality control technical support, pharmacokinetics, clinical studies, regulatory affairs and outside counsel regulatory legal services.

 

1.25                        “Early Stage Development” means the development activities that are conducted in connection with a Collaboration Compound during the period of time beginning on the date a Collaboration Compound’s Selection through the completion of [***] and ending at the start of [***].

 

1.26                        “Effective Date” shall mean the date first written above.

 

1.27                        “EMEA” shall mean the European Health Authorities including the European Medicines Evaluation Agency and the Committee for Medicinal Products for Human Use or any successor agency thereof or, to the extent the mutual recognition procedure is used for a Collaboration Product in the EU, any governmental authority having the authority to regulate the sale of medicinal or pharmaceutical products in any country of the EU.

 

1.28                        “Euros” shall mean the currency of the European Union.

 

1.29                        “FDA” shall mean the United States Food and Drug Administration or any successor agency thereof performing similar functions.

 

1.30                        “Field” shall mean any and all applications of Collaboration Compounds arid/or Collaboration Products for pharmaceutical use in humans and animals.

 

1.31                        “FTE” shall mean the equivalent of the work of one (1) scientific or clinical qualified person who is employed by either Party full time for one (1) calendar year to carry out work pursuant to the Research Program during the Research Period. It is understood that one FTE can be several individual persons each working part time but where the total work time equals one full time employee.

 

1.32                        “Information” shall mean information, exchanged between the Parties during the Research Period (including any extensions thereof as provide in Article 2.2), and which is developed or acquired independently by or on behalf of a Party or jointly by

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

7


 

or on behalf of both Parties prior to the Effective Date or during the term of this Agreement, which is Controlled by a Party or its Affiliates, and which relates to Collaboration Compounds, Collaboration Products, Joint Non-collaboration Compounds or the Field, including but not limited to: (i) inventions, practices, methods, knowledge, know-how, skill, experience, test data including, pharmacological, toxicological, pre-clinical and clinical test data, analytical and quality control data, regulatory applications, marketing, pricing, distribution, sales and manufacturing data or descriptions regarding manufacturing processes, and (ii) compounds, chemical structures, assay results and formulations related thereto.

 

1.33                        “IND” shall mean an Investigational New Drug Application filed with the FDA or a corresponding application filed with a regulatory agency with respect to development of a Collaboration Compound or Collaboration Product.

 

1.34                        “Independent Product” shall have such meaning as set forth in Article 3.10.

 

1.35                        “OMP Know-How” shall mean all Information Controlled by OMP or its Affiliates which is necessary for the formulation, manufacture, use, development and/or regulatory approval of the Collaboration Compounds and/or Collaboration Products as developed and/or commercialized by OMP or its Affiliates in the Field.

 

1.36                        “OMP Library” shall mean that group of compounds at OMP or its Affiliates that potential targets are normally screened against in existence on the Effective Date.

 

1.37                        “OMP Patents” shall mean Patents which are Controlled by OMP or its Affiliates during the term of this Agreement which Patents contain method of use, method of manufacture or composition of matter claims covering a Collaboration Compound.

 

1.38                        “OMP Program Patent” shall mean a Program Patent which claims inventions solely invented by the employees of OMP or its Affiliates, or Third Parties with an obligation to assign to OMP, inventorship shall be determined under United States patent law and such inventions shall be owned by OMP.

 

1.39                        “JDC” shall mean the Joint Development Committee.

 

1.40                        “Joint Collaboration Compound” shall mean any and all Collaboration Compound (and know-how related thereto) which are Jointly Invented in accordance with the Research Program and during the Research Program and [***] months thereafter.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

8


 

1.41                        “Joint Non-collaboration Compound” shall mean any and all compositions of matter that are not Collaboration Compounds (and know-how related thereto) which are Jointly Invented, in accordance with the Research Program and during the Research Period and [***] months thereafter.

 

1.42                        “Joint Non-Collaboration Compound Patent” shall mean any Patent claiming a Joint Non-collaboration Compound.

 

1.43                        “Joint Invention” or “Jointly Invented” shall mean discoveries, inventions or improvements (whether or not patentable) of both 1) employees of ADDEX, or on behalf of ADDEX by its Third Party contractor who has assigned or owes a duty to assign beneficial ownership or a license to such discovery or invention to ADDEX; and 2) OMP (or an Affiliate of either), or on behalf of OMP (or an Affiliate of either) by its Third Party contractors who has assigned or owes a duty to assign beneficial ownership or a license to such discovery or invention to OMP, determined to be joint inventions under United States patent law

 

1.44                        “Joint Program Patent” shall mean any and all Program Patents that claim Joint Inventions made during the Research Program and [***] months thereafter.

 

1.45                        “JRC” shall mean the Joint Research Committee.

 

1.46                        “Late Stage Development” means the development activities that are conducted in connection with a Collaboration Compound during the period of time beginning on the date a Collaboration Compound enters [***] up until Regulatory Approval.

 

1.47                        “MAA” shall mean a Marketing Authorization Application submitted (and the submission of which has been accepted) with FDA in the United States or a corresponding application which has been submitted (and the submission of which has been accepted) with a regulatory agency either (i) under the centralized European system or (ii) in any European Country under the Mutual Recognition system, in each case for Product or (iii) with any other national government regulatory approval agency.

 

1.48                        “Major European Countries” shall mean the United Kingdom, Germany, France Spain and Italy.

 

1.49                        “Major Health Care Company” shall mean a Third Party pharmaceutical or biotechnology company (including a “group” within the meaning of Section 13(d)(3)

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

9


 

of the Securities Exchange Act of 1934 but excluding OMP and any Affiliates) whereby (i) the worldwide net sales of human pharmaceutical products, including consumer over-the-counter pharmaceutical products, in the most recently completed fiscal year for which audited financial statements are publicly available at the time such Change of Control occurs, causes such company (or group) to rank within the top [***] companies as reported in such financial statements, or (ii) the worldwide net sales of human pharmaceutical products, including consumer over-the-counter pharmaceutical products, in the most recently completed fiscal year for which audited financial statements are publicly available at the time such Change of Control occurs, causes such company (or group) to rank outside the top [***] but within the top [***] companies as reported in such financial statements, or if such information is not publicly available, as appropriately provided by ADDEX and such company (or group) is known to be active in research and/or development and/or commercialisation of human pharmaceutical products, including consumer over-the-counter pharmaceutical products, in the central nervous system (CNS) therapeutic area .

 

1.50                        “Manufacturing Cost” shall mean the Manufacturing Costs of the Bulk Drug Substance calculated by methods generally used in the pharmaceutical industry. The Manufacturing Cost is composed of MATERIAL COSTS, DIRECT LABOR COSTS, OVERHEAD COSTS, and EQUIPMENT DEPRECIATION (further defined below).

 

(a)                                 MATERIAL COSTS — the actual acquisition costs of all materials that are physically identified and traceable as part of the Bulk Drug Substance or used in the manufacturing of the Bulk Drug Substance. If a Party, in accordance with the terms of this Agreement, subcontracts the manufacturing of the Bulk Drug Substance and purchases from such subcontractor the Bulk Drug Substances, the purchase price actually paid by the Party to such subcontractor for the Bulk Drug Substance as evidenced by the relevant invoices of such subcontractor shall be deemed MATERIAL COSTS.

 

(b)                                 DIRECT LABOR COSTS — the actual wages (hourly rate plus employee benefits) of all direct labor that can be traced specifically and exclusively to the Bulk Drug Substance.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

10


 

(c)                                  OVERHEAD COSTS the actual cost of specific activities that are not provided by direct labor and are performed at a frequency in direct correlation to the Bulk Drug Substance production and activities required in accordance with Good Manufacturing Practices.

 

(d)                                 EQUIPMENT DEPRECIATION — the amortization of the costs of machinery/equipment used in the manufacture of the Bulk Drug Substance calculated in accordance with generally accepted accounting practices. In instances where the machinery/equipment may be used by one or more products in addition to the Bulk Drug Substance, machine hours (or other reasonable driver) should be used to allocate the amortization among all the products including the Bulk Drug Substance. The allocation of amortization is based upon the Bulk Drug Substance’s percentage of capacity used over the total Potential Capacity for the Machinery/Equipment; provided, however, this shall not be the case if the machinery/equipment is solely dedicated to the manufacture of the Bulk Drug Substance in which case any idle capacity may be allocated to the Manufacturing Cost of the Bulk Drug Substance. As used herein, “Potential Capacity for the Machinery/Equipment” means the average hours used for other machinery/equipment in the Party’s facility.

 

In no event shall OVERHEAD COST combined with EQUIPMENT DEPRECIATION exceed [***] of MATERIAL COSTS combined with DIRECT LABOR COSTS. This cap will only apply for [***].

 

1.51                        “Negative Allosteric Modulator” shall mean an Allosteric Modulator that reduces or inhibits the activity of mGlu2-R in the presence of glutamate.

 

1.52                        “NAM Compound” shall mean a Collaboration Compound that is a Negative Allosteric Modulator or an Antagonist and all its salts, esters, polymorphs, enantiomers, rotamers, hydrates, anhydrides and prodrugs.

 

1.53                        “NAM Field” shall mean the use of NAM Compounds and/or Collaboration Products made therefrom for pharmaceutical use in humans in the treatment of [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.54                        “Net Sales” shall mean (1) with respect to Collaboration Product other than Combination Product, the amount invoiced by a Party, its Affiliates or Sublicensees for sales of Collaboration Products to a Third Party in the Territory less estimates which will be adjusted to actual on a periodic basis of: (i) discounts, including cash discounts, discounts to managed care or similar organizations or government organizations, rebates paid, credit, accrued or actually taken, including government rebates such as Medicaid chargebacks or rebates, and retroactive price reductions or allowances actually allowed or granted from the billed amount, and commercially reasonable and customary fees paid to distributors (other than to a distributor that is an Affiliate of such Party), (ii) credits or allowances actually granted upon claims, rejections or returns of such sales of Products, including recalls, regardless of such Party requesting such recalls, (iii) taxes, duties or other governmental charges levied on or measured by the billing amount when included in billing, as adjusted for rebates, charge-backs, and refunds, and (iv) freight, postage, shipping and insurance charges paid for delivery of such Collaborations Products, to the extent billed; or (2) with respect to Combination Product, the gross invoice price of such Combination Product sold by such Party, its Affiliates or Sublicensees billed to independent customers, less all the allowances, adjustments, reductions, discounts, taxes, duties, rebates or other items referred to in Article 1.54 (1) above multiplied by a fraction, the numerator of which shall be the average invoice price per gram of Collaboration Compound contained in the most comparable stock keeping unit of any product having such Collaboration Compound as the sole active ingredient during the applicable royalty accounting period in the applicable country, when such comparable product is sold for the same indication as such Combination Product and the denominator of which shall be the average invoice price per gram of the Collaboration Compound sold alone as described immediately above plus the average invoice price(s) per gram of the other active ingredient(s) contained in such Combination Product in such country during the applicable royalty accounting period when such active ingredients are sold alone for the same indication as such Combination Product. If there is no average invoice price per gram in a given country for one or more of the active ingredients comprising a Combination Product, the Parties shall discuss in good faith and agree separately on the Net Sales with respect to such Combination Product, taking medical effects and general prices of other active ingredients into account; or (3) in the event of the sale or other disposal for value of Collaboration Product other than in a bona fide arm’s-length transaction exclusively for money that sale or other disposal for value shall be deemed to constitute a sale at the then current relevant open market price for the Collaboration

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Product in the country where such sale or other disposal took place. If the open market price of the Collaboration Product in such country is not reasonably ascertainable then such price shall be based on the price or value (as determined on an arm’s-length basis) of the goods and/or services provided in exchange for the supply of such Collaboration Product in the country. For the avoidance of doubt, distribution of Collaboration Product for, or use of Collaboration Product in, clinical or pre-clinical trials shall not give rise to any deemed sale under this definition.

 

1.55                        “Non -Collaboration Compound” shall mean a Compound synthesized by ADDEX and/or OMP in the course of the Research that is not a Collaboration Compound.

 

1.56                        “PAM Compound” shall mean a Collaboration Compound that is a Positive Allosteric Modulator and all its salts, esters, polymorphs, enantiomers, rotamers, hydrates, anhydrides and prodrugs

 

1.57                        “PAM/Agonist Field” shall mean the use of a PAM Compounds, Agonist Compounds and/or Collaboration Products made therefrom for pharmaceutical use in humans in the treatment of [***].

 

1.58                        “Patent” shall mean issued Letters Patent, including any extension, supplemental protection certification, registration, confirmation, reissue, continuation, divisional, continuation-in-part, re-examination or renewal thereof, and pending applications for Letters Patent including without limitation, inventors’ certificates and foreign counterparts to any of the foregoing.

 

1.59                        “Phase I Studies” shall mean that portion of the clinical development program which provides for the first introduction into humans of a Product including small scale clinical studies conducted in healthy volunteers or patients to get information on Product safety, as more fully defined in 21 C.F.R. 312.21(a).

 

1.60                        “Phase II Studies” shall mean that portion of the clinical development program which provides for initial trials of a Product on limited numbers of patients for the purpose of determining dose and evaluating safety and efficacy in the proposed therapeutic indication more fully defined in 21 C.F.R. 312.21(b).

 

1.61                        “Phase IIA Studies” shall mean that portion of the clinical development program that provides for the initial trials of a Product on a limited number of patients for the purpose of determining whether the Product affects a marker or indicator of pharmacological or clinical activity in the proposed therapeutic indication.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.62                        “Phase IIB Studies” shall mean that portion of the clinical development program that provides for the definitive, well controlled clinical trials of a Product in patients for the purpose of determining the safe and effective dose range in the proposed therapeutic indication, as more fully described in 21 C.F.R. § 312.21(b).

 

1.63                        “Phase III Studies” shall mean that portion of the clinical development program which provides for large scale clinical studies conducted in a sufficient number of patients to establish Product clinical efficacy for one or more indications and its safety, as more fully defined in 21 C.F.R. § 312.21(c).

 

1.64                        “Positive Allosteric Modulator” shall mean an Allosteric Modulator that potentiates or enhances the activity of mGlu2-R in the presence of glutamate.

 

1.65                        “Pre-Phase I” shall mean that portion of the Development Program that starts with the selection of a Collaboration Compound for Development by OMP into a Collaboration Product or the beginning of toxicological studies related to such Collaboration Compound. Pre-Phase I includes, but is not limited to, toxicological, pharmacological and any other studies, the results of which are required for filing IND, as well as Collaboration Product formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin and continue subsequent human clinical testing. Toxicology as used in this definition means full-scale toxicology using “Good Laboratory Practices” for obtaining approval from a regulatory authority to administer the Collaboration Product to humans. This toxicology is distinguished from initial dose range finding toxicology, which usually includes a single and repeated dose ranging study in two species with less than half of the animals required by the FDA, an Ames test and a related chromosome test.

 

1.66                        “Product” shall mean any form or dosage of a composition of matter for pharmaceutical use in humans.

 

1.67                        “Program Patent” shall mean any Patent, the subject of which is an invention (i) that was conceived and reduced to practice by OMP or ADDEX (or an Affiliate of either) or by a Third Party under a contract with OMP or ADDEX (or an Affiliates of either) including Jointly Invented Patents, in the course of the Research, or their respective work in connection with the discovery identification and synthesis of Collaboration Compounds during the [***] month period following the Research Period and (ii) that comprises a Collaboration Compound or a formulation, method of use or method of manufacture thereof. Regardless of the above, Program Patent

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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specifically includes the ADDEX Patents listed in Appendix II and worldwide equivalents thereof.

 

1.68                        “Regulatory Approval” shall mean all official approvals by government, pricing or health authorities in a country (or supra-national organizations, such as the EMEA) which are required for first use in sale, including, importation, manufacture (where manufacture is required), acceptable pricing or reimbursement of a pharmaceutical product in such country where required.

 

1.69                        “Research” shall mean all work performed by the Parties or on their behalf directed towards or in connection with the discovery, identification and synthesis of Collaboration Compounds during the Research Period.

 

1.70                        “Research Period” shall mean the period commencing on the Effective Date and ending on the first to occur of (i) termination of this Agreement by either Party under Article 15 below; or (ii) subject to extension under Article 2.2, two (2) years after the Effective Date.

 

1.71                        “Research Program” shall mean the program attached hereto as Appendix A as may be amended from time to time in accordance with Article 2.3.

 

1.72                        “Second Indication” shall mean an indication for a Collaboration Product that requires a new filing with the regulatory authority for the treatment of a disorder not listed in the originally submitted MAA and does not include filing for different dosage sizes, or reformulations of the Collaboration Product for the first indication in the originally submitted MAA such as with different excipients or drug delivery profiles (e.g. extended release, etc.).

 

1.73                        “Selection” shall mean the selection of a Collaboration Compound for further Development as provided in Article 2.8.

 

1.74                        “Sublicensee” shall mean a Third Party to whom a Party grants a sublicense to develop and commercialise a Collaboration Product in accordance with Article 8 hereof It is understood that a Third Party distributor to whom OMP grants the right to promote and sell a Collaboration Product in accordance with its then current normal business practices is not a Sublicensee.

 

1.75                        “Tax” or “Taxes” shall be as defined in Article 10.3.6.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.76                        “Territory” shall mean all countries in the world.

 

1.77                        “Third Party” shall mean any entity other than ADDEX or OMP, excepting Affiliates of either.

 

1.78                        “Trademark” shall mean the trademark that shall be used for the marketing of the Product in the Territory.

 

1.79                        “Valid Claim” shall mean a claim of an issued, unexpired patent within a Patent or a claim being prosecuted in a pending application within a Patent. A claim of an issued, unexpired patent shall be presumed to be valid unless and until it has been held to be invalid by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken. For the purpose of royalty determination and payment, any claim being prosecuted in a pending patent application shall be deemed to be the equivalent of a Valid Claim of an issued, unexpired patent, provided it is not anticipated or pending for greater than [***] in which case it shall cease being a Valid Claim until the patent issues.

 

Article 2:  RESEARCH

 

2.1                               Collaborative Research Program.  As from the Effective Date, ADDEX and OMP, by themselves or through their Affiliates or on behalf of OMP by Johnson & Johnson Pharmaceutical Research and Development, a division of JANSSEN Pharmaceutica N.V., will each conduct their part of the Research, in accordance with the Research Program, on a collaborative basis with a goal of discovering, identifying and synthesizing Collaboration Compounds that are suitable for development into Collaboration Products. To facilitate the Research ADDEX will transfer within [***] calendar days of the Effective Date to OMP any cells, cell-lines, research tools or materials necessary performing the screening assays described in Appendix B. The initial Research Program shall be mutually agreed upon between the Parties and attached hereto as Appendix A. Parties acknowledge that the initial primary focus of the Research Program is to identify Collaboration Compounds with potential for treatment or prevention of diseases and disabilities related to the central nervous system. However Parties equally acknowledge that mGlu2-R may play an important role with respect to other diseases and disabilities than those related to the central nervous system. Hence, Parties acknowledge that the eventual Development of a Collaboration Compound may include other indications

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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than diseases and disabilities related to the central nervous system. Any amendments to the Research Program shall be made through the JRC in accordance with the provisions of Article 2.3 hereafter.

 

2.2                               Duration. The Research shall run for an initial term of two (2) years from the Effective Date. After such initial term it may be extended [***] if Parties mutually agree thereto in writing. It shall be discussed and agreed in the JRC as to when both Parties shall complete (such completion at the latest upon the end of the Research Period) synthesis of new compounds.

 

2.3                               The JRC and NAM and PAM Operational Teams. Parties will establish the JRC promptly after the Effective Date. The JRC shall consist of at least [***] representatives from each Party. In addition to the specific responsibilities expressly recited in this Agreement, the JRC shall be responsible for the over-all co-ordination and management of the Research on a strategic level, to exchange information, to review completed Research activities, to select Collaboration Compounds for further development and oversee the activities of the Operational Teams in performance of the Research Program. The Operational Teams shall consist of a NAM Operational Team and a PAM Operational Team. The NAM and PAM Operational Teams shall also have [***] representatives from each Party. The NAM and PAM Operational Teams shall oversee and manage the day-to-day collaboration activities directed respectively to the development of NAM Compounds on the one hand and PAM Compounds and Agonist Compounds on the other under the Research Program. Either Party may through the JRC suggest modifications to the Research Program. Any changes will be appended to Appendix A attached hereto. The Parties will decide on the frequency and modalities of the meetings. Irrespective of the number of representatives, each Party will represent one consolidated vote in JRC and in the NAM and PAM Operational Teams. The JRC and in the NAM and PAM Operational Teams shall decide by consensus. The representatives in the JRC and in the NAM and PAM Operational Teams may be the same physical persons. If the NAM or PAM Operational Teams fail to reach a unanimous decision on any matter before either team the matter shall be escalated to the JRC. If the JRC fails to reach a unanimous decision on any matter before it, the matter shall be escalated to the CEO of ADDEX and [***] or any successor thereto, who will have authority to act on behalf of OMP in such matters. If they are not able to agree after negotiation in good faith, the matter shall be resolved consistent with OMP’s position and is not subject to the provisions of Article 18 hereof.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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However, notwithstanding the foregoing, any decision by the JRC relating to [***] shall require the mutual agreement of both Parties in the event that the change [***] (such as but not limited to [***]).

 

2.4                               ADDEX Research Efforts.

 

(a)                                 ADDEX agrees to commit to the Research such efforts and resources as are specified in the Research Program during the Research Period, to maintain and utilize the scientific staff laboratories, offices and other facilities consistent with such undertaking, and to reasonably cooperate with OMP in the conduct of the Research and to use reasonable efforts consistent with its normal business practices to carry out its commitments and obligations undertaken in conducting Research. ADDEX agrees that, during the first year of the Research Period, ADDEX shall dedicate [***] FTEs to the Research, and during the second year of the Research Period ADDEX shall dedicate [***] FTEs to the Research.

 

(b)                                 OMP agrees to fund the Research at ADDEX at the rate specified below through the end of the Research Period. Such funding shall be provided in four equal quarterly instalments during each Calendar Year payable in advance on the first day of each Calendar Quarter, provided however, that the first payment for the first Calendar Year shall be due and payable within [***] calendar days from the Effective Date. Any payment for a portion of a Calendar Quarter shall also be made on such pro rata basis. The funding rates shall be as follows:

 

(i)                                     for the first Calendar Year of the Research Period, the funding shall be at the rate of [***], per quarter;

 

(ii)                                  for the second Calendar Year of the Research Period, the funding shall be at the rate of [***], per quarter;

 

Provided however, that upon mutual agreement of the Parties the number of FTEs that ADDEX is performing Research with may be increased beyond the number provided in Article 2.4 (a) during the first and second Calendar Year of the Research Period and during any extensions of the Research Period under Article 2.2 above, at the rate of [***], per year per additional FTEs which will be indexed for inflation in Switzerland after the Research Period. All funds provided by OMP under this Article 2.4 shall be used by ADDEX in the conduct of Research. ADDEX shall provide OMP with

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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appropriate invoices in Euros for any and all of the payments to be made under this Article 2.4(b) and all such payments shall be made by OMP in Euros.

 

2.5                               OMP Research Efforts. OMP agrees to commit to the Research such efforts and resources as are specified in the Research Program during the Research Period and agrees to maintain and utilize the scientific staff laboratories, offices and other facilities consistent with such undertaking, and to reasonably cooperate with ADDEX in the conduct of the Research and to use reasonable efforts consistent with its normal business practices to carry out its commitments and obligations undertaken in conducting Research. In any event, OMP shall during the Research Period dedicate a minimum of [***] FTEs to the Research Program for each Calendar Year.

 

2.6                               Exchange of Information. The Parties shall make reasonable efforts to make available and disclose to each other all Information known by OMP or ADDEX as of the Effective Date and at any time on or before the end of the Research Period. Such efforts shall include reasonable efforts to disclose discoveries or invention made by either Party in the course of Research, including but not limited to Information regarding compounds synthesized or discovered, initial leads, activities of leads, derivatives, and results, with significant discoveries being communicated as soon as possible after such Information is obtained or its significance is appreciated. Such disclosure shall take place under the provisions of Article 14 (“Confidentiality”). Each Party will use reasonable efforts consistent with its normal business practices not to communicate information to the other which has no application to the Research or Research Program. Each Party will provide the other with raw data for work carried out in the course of the Research to the extent reasonably requested by the other Party.

 

2.7                               Compound Design, Synthesis and Testing. It is the intent of both Parties to design, synthesize and test compounds to determine their activity as Allosteric Modulators, Agonists, and/or Antagonists of mGlu2-R in accordance with the Research Program. The Research Program will amongst other things define the types of scaffolds that will be further explored and synthesized by either Party. It is the intention that all compounds newly synthesized in accordance with the Research Program will be [***] either [***] or [***]. Each Party shall make available to the other Party sufficient amounts of Collaboration Tangible Research Products to reasonably allow

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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the other Party to complete Research employing the same as required by the Research Program. As to certain ADDEX originated compounds, it is understood that a certain amount of research work has been done by ADDEX as of the Effective Date, and that the Research Program shall, with respect to such ADDEX originated compounds, include further research work, to be done by Parties in due course after the Effective Date in accordance with the Research Program.

 

It is understood that Parties may also test certain compounds for mGlu2-R activity, which have been synthesized prior to the Effective Date hereof and such compounds shall be designated as Collaboration Compounds when the minimum in vitro activity as defined in Article 1.14 (a) has been reached.

 

The respective responsibilities of the Parties with respect to Research will be further specified in the Research Program.

 

2.8                               Selection of Collaboration Compounds for Development. The Selection of Collaboration Compounds for Development during the term of this Agreement will be discussed by the JRC, but any decision on Selection will be made by OMP. OMP shall base its decision on certain distinct criteria set forth in the Research Program and other considerations such as but not limited to data on the profile of competing compounds of Third Parties (hereafter “Selection Criteria”). Parties acknowledge that the Selection Criteria may be subject to such changes as, OMP, in its discretion, deems necessary in order to take into account new data and novel scientific insights.

 

During the Research Period (and any extension thereof under Article 2.2) and [***] thereafter, OMP shall have the exclusive right and responsibility to select [***] from the Collaboration Compound(s) for Development. OMP shall not unreasonably delay Selection of [***] for Development if it meets all Selection Criteria set forth above. Thereafter, as long as [***], OMP shall have the exclusive right, but not the obligation, to select other back-up PAM Compounds or Agonist Compounds from the Collaboration Compounds for Development and commercialization and as long as [***], OMP shall have the exclusive right, but not the obligation, to select other back-up NAM Compounds from the Collaboration Compounds for Development and commercialization. For the purpose of the sentence directly preceding this one, “[***]” means [***]. If on the first day following [***] months after the Research Period (and any extension thereof under Article 2.2), OMP has not selected for Development at least one Collaboration Compound, subject to Articles 3.5.2 and

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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3.5.3 ADDEX shall have the right to seek an election of remedies by OMP as provided in Articles 3.5.4.

 

2.9                               Reporting. Parties will regularly report to each other on the progress of their respective parts of the Research in such form and with such frequency as to be mutually agreed upon. In any event the NAM and PAM Operational Teams will meet [***] to discuss the Research activities and developments. These meetings may be in person or by teleconference. Written minutes of these meeting will be kept by the Parties on an alternating basis unless otherwise mutually agreed in writing. [***] a written report shall be prepared presenting a meaningful summary of the Research accomplished under this Agreement.

 

2.10                        Collaboration Tangible Research Products. The Collaboration Tangible Research Products supplied under this Agreement must be used with prudence and appropriate caution in any experimental work because not all of their characteristics may be known. Except as expressly set forth herein, THE Collaboration Tangible Research Products ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

 

2.11                        Exclusive use of Non-collaboration Compounds. During the Research Period and for [***] months thereafter Non-collaboration Compounds shall be used exclusively by the Parties solely to develop and discover Collaboration Compounds.

 

2.12                        Return of Non-collaboration Compounds.

 

Within [***] months of the end of the Research Period the Parties shall take the following steps:

 

2.12.1                                      Each Party shall return to the other Party all Non-collaboration Compounds invented, owned or Controlled by the other Party and cease performing Research on the other Party’s proprietary Non-collaboration Compounds.

 

2.12.2                                      Joint Non-collaboration Compound shall be the joint property of the Parties and to the extent possible the physical samples of such Joint Non-collaboration Compounds shall be equally divided by the Party in

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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possession and one-half thereof shall be promptly provided to the other Party. Both Parties shall retain any and all rights that they initially had to such Non-collaboration Compounds and such Non-collaboration Compounds may be used for any purpose. The Parties shall have a world-wide non-exclusive license to make, have made, use, distribute, develop, export, import, formulate, package, offer for sale and sell under Joint Non-collaboration Compounds Patents in any field with the right to sublicense

 

2.13                        Failure of the Research. If at the end of the Research Period no Collaboration Compounds have been discovered or identified by the Parties there shall be no obligation to make a Selection any Collaboration Compound and this Agreement shall terminate as provided in Article 15.2. If at the end of the Research Period no PAM Compounds or Agonist Compounds are discovered or identified there shall be no obligation to make a Selection of a PAM Compound or Agonist Compound and certain obligations and rights of the Parties shall be terminated as provided in Article 15.3.2. If at the end of the Research Period no NAM Compounds are discovered or identified there shall be no obligation to make a Selection of a NAM Compound and certain obligations and rights of the Parties shall be terminated as provided in Article 15.3.1.

 

Article 3:  DEVELOPMENT

 

3.1                               Joint Development. Promptly after the Selection of [***] in accordance with Article 2.8, OMP shall start to carry out or have carried out under its sole responsibility the Development of such Collaboration Compound into a Collaboration Product through Phases I, II and III Studies up to and including the filing in Territory of the MAA for such Collaboration Product in accordance with Development Program(s) corresponding to each indication of each Collaboration Product. Such Development Program, including Development schedules, shall be designed by OMP and discussed with ADDEX through the JDC following Selection of a Collaboration Compound for Development. For clarification, after discussion and in the event of a disagreement, OMP shall have the final say on all aspects of Development, including, indication, dose, formulation, morphology, trial design, trial schedule, manufacturing scale-up, etc., except as provided in Articles 3.6 (as described in Article 3.4) and Article 3.7.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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3.2                               Registration of Products. OMP shall be fully responsible for undertaking the compilation and submission of all necessary data information, documents and INDs, CTAs and MAAs relating to the Collaboration Compound and/or Collaboration Product obtained by OMP from ADDEX and/or through the conduct of the Development Work in a format acceptable to the applicable health authorities of the Territory, including but not limited to the FDA and the EMEA, required to obtain Regulatory Approval for the Collaboration Compound and/or Collaboration Product. OMP shall solely own all INDs, CTAs, MAAs, and Regulatory Approvals in the Territory. In the event that ADDEX is developing a Collaboration Compound pursuant to Article 3.6 ADDEX shall undertake this obligations, with respect to such Collaboration Compound, while ADDEX, its Affiliates or Sublicensee is developing such Collaboration Compound.

 

3.3                               ADDEX’s responsibilities. Parties may agree that certain specific tasks under the Development Program shall be carried out by ADDEX in accordance with the Development Program.

 

ADDEX shall provide to OMP any Information that ADDEX may have and OMP needs for inclusion into any MAA and in support of OMP’s attempt to obtain, maintain and renew Regulatory Approval of Collaboration Compound and/or Collaboration Product. Reports of studies conducted by ADDEX that are intended to be included as such in any MAA, will be provided in a format that allows direct inclusion in accordance with standard of FDA or other regulatory authority. In the event that ADDEX is developing a Collaboration Compound under Article 3.6 OMP shall have the same obligation to provide such Information as ADDEX has under this Article.

 

3.4                               The JDC. Promptly upon the Selection of a Collaboration Compound for Development by OMP, ADDEX and OMP shall each appoint [***] representatives (unless otherwise mutually agreed) to serve as members of the JDC. The JDC shall generally review and comment on the Development in Territory. In any event, the representatives of each Party may be changed from time to time at the discretion of that Party upon written notification by the Party making such change to the other. The JDC will meet on [***] basis (unless decided otherwise) and will decide on the manner and place of its meetings (including, if appropriate, video conferencing). Notwithstanding the existence of the JDC and its comments and suggestions, OMP has the final say regarding Development for any and all Collaboration Compounds

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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that OMP is developing. The NAM Operational Team shall cease to exist on the [***] for the first NAM Compound. The PAM Operational Team shall cease to exist on the [***] for the first PAM Compound or Agonist Compound. When both the NAM Operational Team and PAM Operational Teams cease to exist the JDC shall cease to exist. In the event that ADDEX has taken a Collaboration Compound in Development pursuant to Article 3.6 hereof, OMP shall be entitled, but not obligated to request that a new JDC would be established that will have the same duties as set forth in this Article 3.4 for such Collaboration Compound where OMP shall have [***] representative and where ADDEX shall always have the final say. The OMP representative may be a person with an alliance management function. The JDC for such Collaboration Compounds shall cease to exist on the [***] for such Collaboration Compound under Development by ADDEX.

 

3.5                               Diligence.

 

3.5.1                                             In carrying out the Development and in seeking Regulatory Approval, OMP agrees to use such commercially reasonable and diligent efforts as are commensurate with the level of time, effort and funding expended by OMP on other projects at a similar stage of development, with a target market of a similar size, patient population and importance, and as otherwise consistent with its overall business strategy. OMP does not in any way represent or warrant that a Collaboration Compound hereunder shall be the only compound that OMP will at the same time develop or commercialize for identical or similar therapeutic uses. Without limitation to the foregoing, non-achievement of the following development milestones within the Time to Complete set forth below shall be an objective measure of OMP’s non-performance for the time periods specified:

 

Milestones

 

Time to Complete

 

 

 

[***]

 

[***]

 

OMP shall promptly notify ADDEX upon the accomplishment of each of the foregoing Milestones.

 

3.5.2                                             If, notwithstanding OMP’s exercise of the efforts recited in Article 3.5.1 above, OMP is unable to meet or anticipates that it may not be able to make a Selection or to meet any of the Milestones within the Time to

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Complete set forth above, OMP shall have the right to request an extension for such Milestone(s), which shall not be unreasonably refused. Without limitation, the following shall be examples of instances in which OMP shall be entitled to such extension: [***], to the extent that [***].

 

In addition, Parties recognize that OMP may, after discussion with the JDC, need to discontinue the Development of a Collaboration Compound for reasons outside its reasonable control, in which case the following shall apply, depending on the stage of Development:

 

(i)                                     If OMP prior to [***] OMP has initiated [***] of a Collaboration Compound and such Collaboration Compound fails during such studies, for reasons outside of OMP’s reasonable control, then the time periods set forth in Article 3.5.1 above shall be extended for a period [***]

 

(ii)                                  If OMP initiates [***] with respect to a Collaboration Compound and such Collaboration Compound fails [***], for reasons outside of OMP’s reasonable control, the time periods specified in Article 3.5.1 above shall be extended for a period [***];

 

3.5.3                                             If the Parties disagree as to whether OMP is entitled to an extension of the time to make a Selection under Article 2.8 or to the Time to Complete as set forth in 3.5.2 above for any Milestone specified in 3.5.1 above, or whether or not OMP is complying with its obligations under 3.5.1 above, then, upon the written request by either Party, such matter shall be resolved in accordance with Article 18. However, notwithstanding any other provision of Article 18 and Appendix C, the mediation procedure of Section 1.1 of Appendix C shall not apply. Moreover the arbitration shall be concluded within [***] calendar days after the Panel of Arbitrators has been appointed in accordance with Section 1.2 of Appendix C, and the time periods recited in Appendix C shall be reset accordingly to achieve the [***] day completion date. Subsection (c) of Section 1.2 of Appendix C shall not apply. As circumstances may warrant the Parties will seek arbitrators with appropriate commercial and technical backgrounds to resolve disputes under this Article.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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3.5.4                                             In the event that OMP or its Affiliate or Sublicensee in charge of Early Stage Development of a Collaboration Compound fails to make a Selection or achieve the Milestones set forth in Article 3.5.1 within the Times to Complete with respect to [***] with any applicable extensions under Article 3.5.2 and any disputes of the fact having been resolved under Article 3.5.3 and determine that OMP or its Affiliate or Sublicensee did not comply with its obligations under Article 3.5.1, then OMP shall have [***] calendar days to provide a written election which at its sole discretion of the two remedies set forth below in Articles 3.6 and 3.7 to offer ADDEX, provided, however, these remedies shall not be available to ADDEX if [***]. If OMP fails to elect within said [***] days, ADDEX shall have the right to elect which of the two remedies set forth below in Articles 3.6 and 3.7 that ADDEX wishes to pursue. If neither Party elects to elect a remedy, then OMP’s failure of diligence under Article 3.5.1 shall be waived and OMP will have the right to proceed with the development of the Collaboration Compound that gave rise to the failure of diligence or replacement thereto subject to the diligence requirements of Article 3.5. The remedies provided by Article 3.6 and Article 3.7 [***] and such failure [***]

 

3.5.5                                             [***] OMP’s diligence obligation shall [***]

 

3.6                               Remedies in case OMP does not Develop Diligently Option 1. If OMP elects this option as provided in Article 3.5.4, then under the circumstances specified below ADDEX shall have the rights set forth therein:

 

[***]

 

3.6.1                                             In the event that OMP or its Affiliate or Sublicensee fails [***], ADDEX shall be entitled to give written notice [***]. ADDEX shall have the exclusive right [***] calendar days after giving such notice to [***]. If OMP believes that [***], OMP shall send a written notice to that effect to ADDEX. Upon receipt of such written notice the running of said [***] day period shall be tolled. The Parties shall promptly meet to discuss the matter in good faith and determine whether or not [***]. If Parties cannot agree on said matter within a reasonable period of time, it shall be resolved in accordance with Article 18 hereof.

 

[***] pursuant to this provision shall be subject to [***] and [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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3.6.2                                             Provided that [***]; ADDEX shall be entitled to give written notice to OMP [***]. ADDEX shall have the exclusive right [***] calendar days after giving such notice to [***]. If OMP believes that [***], as the case may be, OMP shall send a written notice to that effect to ADDEX. Upon receipt of such written notice the running of said [***] day period shall be tolled. The Parties shall promptly meet to discuss the matter in good faith and determine whether or not [***]. If Parties cannot agree on said matter within a reasonable period of time, it shall be resolved in accordance with Article 18 hereof.

 

[***] pursuant to this provision shall be subject to [***] and [***]

 

3.6.3                                             Provided that [***]; ADDEX shall be entitled to give written notice to OMP [***]. ADDEX shall have the exclusive right [***] calendar days after giving such notice to [***]. If OMP believes that [***], as the case may be, OMP shall send a written notice to that effect to ADDEX. Upon receipt of such written notice the running of said [***] day period shall be tolled. The Parties shall promptly meet to discuss the matter in good faith and determine [***].

 

[***] pursuant to this provision shall be subject to [***] and [***].

 

3.6.4                                             Disputes between the Parties under Articles 3.6.1, 3.6.2, and 3.6.3 shall be settled by Arbitration as is provided in Article 3.5.3.

 

[***]

 

3.6.5                                             In the event that OMP or its Affiliate or Sublicensee in charge of Development of [***] fails to [***] and any disputes of the fact having been resolved [***] and determining that OMP or its Affiliate or Sublicensee did not comply with its obligations [***], and OMP provides written notice to ADDEX that it has elected to provide this remedy to ADDEX, ADDEX shall be entitled to give written notice to OMP [***], provided however, ADDEX shall not have the right to give such notice if [***]. ADDEX shall have the exclusive right [***] calendar days after giving such notice to [***], subject to [***]. [***] pursuant to this provision shall be subject to [***] and [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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3.6.6                                             In the event that OMP or its Affiliate or Sublicensee in charge of Development of a [***] fails to [***] and any disputes of the fact having been resolved [***] and determining that OMP or its Affiliate or Sublicensee did not comply with its obligations [***] and OMP provides written notice to ADDEX that it has elected to provide this remedy to ADDEX, ADDEX shall be entitled to give written notice to OMP [***], provided however, ADDEX shall not have the right to give such notice if [***]. ADDEX shall have the exclusive right [***] calendar days after giving such notice to [***]. [***] pursuant to this provision shall be subject to [***] and [***]

 

3.6.7                                             To be effective, any notice provided by ADDEX under this Article 3.6 must be given within [***] calendar days after the date on which such notice can first be given.

 

3.6.8                                             If [***] and [***] or [***], then [***] shall [***] and [***] develop the Collaboration Compound that gave rise to the failure of diligence or replacements thereto subject to [***].

 

3.6.9                                             Notwithstanding the foregoing provisions ADDEX shall not have the right to [***].

 

3.7                               Remedies in case OMP does not Develop Diligently Option 2. If OMP elects this option as provided in Article 3.5.4, then ADDEX shall be entitled to [***]. For the avoidance of doubt, in the event ADDEX exercises its right to [***], OMP shall retain its right to [***]. ADDEX shall have [***] calendar days from notification of OMP election to provide this remedy to confirm in writing that ADDEX wishes to pursue this remedy.

 

If ADDEX [***] pursuant to this Article 3.7, [***], ADDEX shall [***] and ADDEX shall [***]. OMP shall [***] such Collaboration Compound.

 

[***] under which ADDEX [***]. Within [***] calendar days of the end of each month during which [***], each Party shall [***]. The Parties shall [***] within [***] calendar days of the end of such month, [***], within [***] calendar days of [***]. Each Party shall [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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If [***] and [***] or [***], then [***] shall [***] and [***] develop the Collaboration Compound that gave rise to the failure of diligence or replacements thereto subject to [***].

 

3.8                               Right to Reacquire Development Rights. If [***], ADDEX shall notify OMP in writing [***], as the case may be [***]. If OMP agrees to further discuss the further development of such Collaboration Compound OMP shall notify ADDEX in writing within [***] calendar days. If OMP notifies ADDEX within said [***] calendar days, ADDEX shall [***], as the case may be, of such Collaboration Compound. OMP shall have a total of [***] calendar days from [***], to elect whether to reacquire said Collaboration Compound. If OMP elects in writing to further develop such Collaboration Compound and/or Collaboration Products made therewith, OMP shall [***]. ADDEX shall [***]. ADDEX shall, [***]. Thereafter OMP shall [***].

 

Within [***] calendar days from such election OMP shall pay ADDEX (i) all milestones that had accrued on such Collaboration Compound that were not previously paid by OMP and (ii) ADDEX’s invoice for the Development Cost determined as provided in Article 4.4, that ADDEX incurred in developing such Collaboration Compound from the point at which ADDEX took over development of such Collaboration Compound. Such payment to be made within [***] calendar days of receipt of the relevant invoice and the supportive documents by such method of payment as agreed upon.

 

3.9                               [***] set forth in this Article 3.6 and 3.7 shall [***]

 

3.10                        Independent Product. In the event that OMP does not agree to further discuss the further development of such Collaboration Compound or upon review of the detailed written description of the Collaboration Compound decides not to further develop such Collaboration Compound, ADDEX shall be free to develop, commercialise and market such Collaboration Compound (which shall become an “Independent Product”). In the event that OMP is developing, commercialising or marketing a Collaboration Compound and/or Collaboration Product then ADDEX shall be granted a license as provided in Article 8.5 with no further obligation to OMP, other than an obligation to pay OMP a royalty as provided in Article 9.4. In the event that OMP is not developing, commercialising or marketing a Collaboration Compound and/or Collaboration Product then this Agreement shall terminate as provided in Article 15.5. This provision shall survive termination of this Agreement.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Article 4:  DEVELOPMENT FUNDING.

 

4.1                               OMP Funding. For Collaboration Compounds that OMP Develops, OMP shall bear all cost and expenses incurred for the Development of such Collaboration Compound and/or Collaboration Product except as provided in Articles 3.6 and 3.7.

 

4.2                               For the purpose of [***], when [***], each Party shall maintain records of all internal and out-of-pocket expenses incurred by such Party for the Development of such Collaboration Compound and/or Collaboration Product in accordance with the provisions of Appendix D hereto (“Development Costs”). These Development Costs shall be the basis of determining that [***].

 

4.3                               For the purposes of [***] in the event that [***], ADDEX shall maintain records of all internal and out-of-pocket expenses incurred by ADDEX for the Development of such Collaboration Compound and/or Collaboration Product in accordance with the provisions of Appendix D hereto (“Development Costs”).

 

4.4                               If OMP decides to exercises its right to re-acquire a Collaboration Compound under Article 3.8, ADDEX shall be entitled to payment of [***] times the total of the Development Costs set forth under Article 4.3 above and OMP shall reimburse ADDEX for the same. Invoices therefore will be made up in US Dollars and will be sent with supportive documents.

 

4.5                               If the Parties are proceeding under [***], Development Costs shall be the basis of determining that [***]. For the avoidance of doubt, if as a consequence of the [***], such amount shall [***]. The same shall apply in case [***]. Invoices therefore will be made up in US Dollars and will be sent with supportive documents.

 

Article 5:  COMMERCIALIZATION

 

5.1                               Diligence.  OMP agrees that it shall use its reasonable efforts to market Collaboration Product that it Develops in the Territory consistent with its efforts expended on other of its products of similar commercial importance in such country, and consistent with sound commercial practices applied in the pharmaceutical industry. Notwithstanding the generality of the foregoing, as from the moment OMP has obtained Regulatory Approval for Collaboration Product and has effectively launched Collaboration Product in all of the following countries, OMP shall have no

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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further obligations (but shall retain all rights) to commercialise Collaboration Product in any other countries:

 

[***]

 

OMP does not in any way represent or warrant that Collaboration Product shall be the only Product that OMP will at the same time commercialise for identical or similar therapeutic uses.

 

5.2                               Pricing, Pricing Approvals and Product Distribution. OMP shall set all prices for all Collaboration Products in the Territory, shall obtain for Products pricing approvals as may be required, shall be responsible for distribution of each Collaboration Product in the Territory and shall record all sales for Collaboration Products in the Territory.

 

Article 6:  MANUFACTURE AND SUPPLY OF BULK DRUG SUBSTANCE

 

6.1                               Bulk Drug Substance and Product supply by OMP. Except as otherwise expressly set forth in Article 6.2 hereafter, OMP shall be solely responsible for the development, manufacture and supply of the entire requirement of Bulk Drug Substance of all Collaboration Compound(s) and of finished pharmaceutical formulations of all Product(s) both for Development and commercialisation purposes, either by itself or through a Third Party designated by OMP.

 

6.2                               Transfer of Manufacture and Supply. In the event that ADDEX takes over the Development of a Collaboration Compound under Article 3.6, ADDEX shall, either by itself or through a Third Party designated by ADDEX, assume sole responsibility for the development, manufacture and supply of the entire requirement of Bulk Drug Substance of any such Collaboration Compound and of finished pharmaceutical formulations of any such Product for Development and commercialisation purposes. ADDEX shall not enter into any arrangements with any Third Party designated by ADDEX for the manufacture and supply of such Bulk Drug Substance or finished pharmaceutical formulations, whereby binding commitments are made for the purchase of quantities beyond the requirements for [***]. In the event OMP reacquires rights to such Collaboration Compounds under Article 3.8, OMP shall again assume sole responsibility for the development, manufacture and supply, either by itself or through a Third Party designated by OMP, of the entire requirement of

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Bulk Drug Substance of all Collaboration Compound(s) and of finished pharmaceutical formulations of all Product(s) both for Development and commercialisation. In the event that OMP does not exercise its option to reacquires rights to such Collaboration Compounds under Article 3.8, ADDEX shall remain solely responsible for the development, manufacture and supply, either by itself or through a Third Party designated by ADDEX, of the entire requirement of Bulk Drug Substance the relevant Collaboration Compound and of finished pharmaceutical formulations of the relevant Independent Product for Development and commercialisation purposes.

 

6.3                               In the event of a transfer of manufacturing and supply responsibility from one Party (the “first Party”) to the other Party (the “Second Party”), pursuant to Article 6.2 above, the first Party shall, if so requested by the second Party, promptly transfer to the second Party (i) any and all regulatory filings and approvals and manufacturing data in Control of the first Party that the second Party may reasonable require to take over the manufacture and supply as well as (ii) any quantities of Bulk Drug Substance and finished pharmaceutical product, including clinical trial drug, that the first Party may have in its possession at the moment of transfer. The transfer of Bulk Drug Substance and finished pharmaceutical product shall be made against payment of documented Manufacturing Cost without mark-up. Parties will discuss in good faith a temporary continued supply of clinical trial drug from the first Party if so requested by the second Party and as reasonably required to ensure a smooth transfer of clinical trials. The transfer of regulatory filings and approvals and manufacturing data shall be made free of cost.

 

Article 7:  OWNERSHIP OF RESULTS

 

7.1                               Each Party shall remain the sole owner of its Information that it has brought into the collaboration contemplated hereunder and the other Party shall have no rights therein, except as provided in Article 8 (“Licenses”) hereof. OMP shall in any event remain the owner of compounds in the OMP Library.

 

7.2                               Any and all Collaboration Compounds (and Information relating thereto) which were not identified and/or covered by a claim of a ADDEX Patent or of OMP Patent as of the Effective Date of this Agreement, and discovered, identified, synthesized or acquired by employees of ADDEX or its Affiliate and/or by employees of OMP or

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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its Affiliate or on behalf of ADDEX and/or OMP (and/or an Affiliate of either) by its Third Party contractor having no property right in such composition of matter, in the course of the Research after the Effective Date or during the [***] months period following the end of the Research Period, shall be owned by the Party who invented the same, notwithstanding otherwise provided herein (as determined by US patent law). The Parties will execute Assignments to the extent necessary to comply with this Article 7.2.

 

7.3                               Collaboration Compounds shall in all aspects in this Agreement be considered shared Information of both Parties, provided, however, ownership of Program Patents shall belong to the Party or Parties who invented the same.

 

7.4                               Any findings related to new uses of a Collaboration Compound and/or Collaboration Product discovered in the course of the Development, shall be solely owned by OMP if such findings are discovered solely by OMP, its Affiliate and/or its Sublicensee, or jointly owned by the Parties if such findings are discovered jointly by the Parties (and/or Affiliates and/or Sublicensees of both), or solely owned by ADDEX if such findings are discovered solely by ADDEX, its Affiliate and/or its Sublicensee.

 

Article 8:  LICENSES

 

8.1                               Grant.

 

8.1.1                                             Product. ADDEX hereby grants to OMP an exclusive (except as provided in Article 8.5) royalty-bearing license to use, distribute, develop, make, have made, export, import, formulate, package, offer for sale and sell Collaboration Compounds and/or Collaboration Products in the Territory for use within the Field under ADDEX Patents and ADDEX Know-How.

 

8.1.2                                             Research. ADDEX grants to OMP a nonexclusive, paid-up, worldwide license, with no right to grant sublicenses except to Affiliates, under ADDEX Patents, Joint Non-collaboration Patents and ADDEX Know-How to conduct research in the Field for the purpose of this Agreement. OMP grants to ADDEX a nonexclusive, paid-up, worldwide license, with no right to grant sublicenses except to Affiliates, under OMP Patents, Joint Non-collaboration Patents and OMP Know-How to conduct research in the Field for the purpose of this Agreement during the Research Period.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

33


 

8.2                               Sublicense to Affiliates. Each Party shall have the right to sublicense its rights under the license granted under Article 8.1 hereof to one or more of its Affiliates, provided, that such Party shall (a) retain control over that portion of Development Work which such Affiliate is performing and (b) remain responsible to the other Party for such Affiliate’s compliance with all obligations under this Agreement which apply to such Affiliate.

 

8.3                               Sublicense. OMP may grant a sublicense under the licenses granted under Article 8.1.1 and 8.1.2 hereof to non-Affiliate Third Parties upon ADDEX’s prior written approval (which approval shall not be unreasonably withheld). Notwithstanding the foregoing, it is understood that OMP shall be entitled to sublicense its rights hereunder to promote and sell product to the Third Party distributors that it would normally use in line with its then current business practices, on a country by country basis, without obtaining ADDEX’s approval therefor. OMP shall provide ADDEX, at ADDEX’s request, with a list of all such Third Party distributors who are selling Collaboration Product. OMP shall (a) retain control over that portion of Development Work which such Sublicensee is performing and (b) remain responsible to ADDEX for such Sublicensee’s compliance with all obligations for development and/or commercialisation under this Agreement which apply to such Sublicensee.

 

8.4                               Nonexclusive Information Cross License. Subject to the provisions of Article 14 (“Confidentiality”), ADDEX hereby grants OMP a non-exclusive, paid-up, world-wide license to use Information of ADDEX according to provisions of this Agreement. Such license shall include the right to grant sublicense to Affiliates. Subject to the provisions of Article 14 (“Confidentiality”), OMP hereby grants ADDEX a non-exclusive, paid-up, world-wide license to use Information of OMP according to provisions of this Agreement. Such license shall include the right to grant sublicense to Affiliates.

 

8.5                               Grant of License to Collaboration Compounds Being Developed by ADDEX.  After the Research Period, only if ADDEX is developing a Collaboration Compound pursuant to 3.6.1, 3.6.2, 3.6.3, 3.6.5, 3.6.6 and 3.10, the following license shall be granted with the following field limitations because of the previous and continued sharing of Information by the Parties on the Collaboration Compound being developed by OMP:

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

34


 

8.5.1                                             If OMP is diligently developing, commercialising or marketing a PAM Compound or Agonist Compound,

 

(a)                                 OMP hereby grants to ADDEX an exclusive royalty-bearing sublicense under ADDEX Program Patents and ADDEX Know-How to use, distribute, develop, make, have made, export, import, formulate, package, offer for sale and sell NAM Compounds and/or Collaboration Products made therefrom in the Territory for use within the NAM Field subject to a higher royalty provided in Article 9.4 outside the NAM Field under

 

(b)                                 OMP hereby grants to ADDEX an exclusive royalty bearing license with the right to sublicense to make, have made, use, distribute, develop, export, import, offer for sale and sell one (1) NAM Compound actually synthesized during the Research Period under OMP Program Patents and Joint Program Patents in the Territory for use in all indications in the NAM Field, provided however, if such NAM compound should fail in its development ADDEX shall be entitled to replace such failed NAM Compounds from such group of all NAM Compounds actually synthesized during the Research Period with a first replacement NAM Compound thereafter, should the first replacement NAM Compound fail in its development, ADDEX has the right to a second replacement NAM Compound from such group of all NAM Compounds actually synthesized during the Research Period, no further replacement compounds shall be available under this grant. Provided, however, that ADDEX must diligently develop such Collaboration Compounds as provided in 3.5 (however an additional year shall be added to the Time to Complete for commencing Phase I for the first Collaboration Compound pursued under this provision). Failure to exercise diligence shall cause the grant to the OMP Program Patents and Joint Program Patents to lapse.

 

8.5.2                                             If OMP is diligently developing, commercialising or marketing a NAM Compound,

 

(a)                                 OMP hereby grants to ADDEX an exclusive royalty-bearing license ADDEX Program Patents and ADDEX Know-How to use, distribute, develop, make, have made, export, import, formulate, package, offer for sale and sell PAM Compounds or Agonist Compounds and/or

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Collaboration Products made therefrom in the Territory for use within the PAM Field and subject to a higher royalty provided in Article 9.4 outside the PAM Field.

 

(b)                                 OMP hereby grants to ADDEX an exclusive royalty bearing license with the right to sublicense to make, have made, use, distribute, develop, export, import, offer for sale and sell one (1) PAM Compound or Agonist Compound actually synthesized during the Research Period under OMP Program Patents and Joint Program Patents in the Territory for use in all indications in the PAM Field, provided however, if such PAM compound or Agonist Compound should fail in its development ADDEX shall be entitled to replace such failed PAM Compounds or Agonist Compounds from such group of all PAM Compounds or Agonist Compounds actually synthesized during the Research Period with a first replacement PAM Compound or Agonist Compound thereafter, should the first replacement PAM Compound or Agonist Compound fail in its development, ADDEX has the right to a second replacement PAM Compound or Agonist Compound from such group of all PAM Compounds or Agonist Compounds actually synthesized during the Research Period thereafter, no further replacement compounds shall be available under this grant. Provided, however, that ADDEX must diligently develop such Collaboration Compounds as provided in 3.5 (however an additional year shall be added to the Time to Complete for commencing Phase I for the first Collaboration Compound pursued under this provision). Failure to exercise diligence shall cause the grant to the OMP Program Patents and Joint Program Patents to lapse.

 

8.5.3                                             In the event that ADDEX in Late Stage Development wants to develop an indication outside the NAM Field or the PAM/Agonist Field for a Collaboration Product under Article 8.5.1 (b) or 8.5.2 (b), ADDEX shall request in writing OMP’s permission to pursue such indication, which request OMP shall not unreasonably withhold or delay. However, OMP may reasonably withhold permission, for among other reasons, if OMP is actively developing a Collaboration Compound for such indication or with respect to such indication OMP has specific plans to commence

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Development in the foreseeable future or which the JDC is considering as a potential candidate for Development in the foreseeable future.

 

8.5.4                                             OMP grants, under Article 8.5 subject to the limitations in Articles 8.5.2 and 8.5.3, ADDEX an exclusive license to undertake Early Stage Development of 1) PAM Compounds or Agonist Compounds and Collaboration Products made therefrom; and 2) NAM Compounds and Collaboration Products made therefrom in any indication provided that such clinical studies are completed and reported to OMP in accordance with Section 3.8 prior to the expiry of OMP’s rights under Section 3.8 and OMP shall have the same ninety (90) calendar days period to review such results and make its election. In the event that ADDEX desire more time to complete a Phase I or Phase IIA Study it can in its sole discretion extend the timelines in Article 3.8 to allow for completion of the relevant study and reporting to OMP.

 

8.5.5                                             If OMP ceases to develop, commercialize or market Collaborations Compounds, this Agreement shall be terminated as provided in Article 15.5.

 

Article 9:  ROYALTIES AND MILESTONE PAYMENTS

 

9.1                               Initial and Milestone Payments. In consideration of the license granted by ADDEX to OMP hereunder and upon the terms and conditions contained herein, OMP shall pay to ADDEX the following amounts:

 

9.1.1                                             [***] within [***] calendar days of the Effective Date;

 

9.1.2                                             Milestones for PAM Compound or Agonist Compounds

 

(a)                                 [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon treatment with such Collaboration Product of the [***];

 

(b)                                 [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon treatment with such Collaboration Product of the [***];

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(c)                                  [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon [***];

 

(d)                                 [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon [***];

 

(e)                                  [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon [***];

 

(f)                                   [***] for only the first Collaboration Product containing a PAM Compound or Agonist Compound upon [***];

 

(g)                                  [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(h)                                 [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(i)                                     [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(j)                                    [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(k)                                 [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(l)                                     [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(m)                             [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(n)                                 [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

(o)                                 [***] upon [***] a Collaboration Product containing a PAM Compound or Agonist Compound [***];

 

9.1.3                                             Milestones for NAM Compounds

 

(a)                                 [***] for only the first Collaboration Product containing a NAM Compound upon [***];

 

(b)                                 [***] for only the first Collaboration Product containing a NAM Compound upon [***];

 

(c)                                  [***] for only the first Collaboration Product containing a NAM Compound upon [***];

 

(d)                                 [***] for only the first Collaboration Product containing a NAM Compound upon [***];

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

38


 

(e)                                  [***] for only the first Collaboration Product containing a NAM Compound upon [***]

 

(f)                                   [***] for only the first Collaboration Product containing a NAM Compound upon [***];

 

(g)                                  [***];

 

(h)                                 [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(i)                                     [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(j)                                    [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(k)                                 [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(l)                                     [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(m)                             [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

(n)                                 [***] upon [***] Collaboration Product containing a NAM Compound [***];

 

(o)                                 [***] upon [***] a Collaboration Product containing a NAM Compound [***];

 

OMP shall notify ADDEX in writing within [***] calendar days upon the achievement of each milestone excluding 9.1.1. Each milestone payment shall be payable in Euros within [***] calendar days from the achievement of such milestone. ADDEX shall provide OMP with an appropriate invoice in Euros for each payment. With respect to the milestones set forth in subsections [***] of Articles 9.1.2 and 9.1.3 above, each milestone payment shall be payable only upon the initial achievement of such milestone and no amount shall be due with respect to subsequent or repeated achievement of such a milestone, whether for additional indications, for different formulations of a Collaboration Product, for a replacement Collaboration Product, for a second generation Collaboration Product, for a Combination Product, or otherwise. However a replacement Collaboration Product or a second generation Collaboration Product [***] or [***], will again trigger payments set forth in Articles 9.1.2 and 9.1.3 subsections [***] above if and when such Collaboration Product achieves such milestones. However, a Collaboration Product shall be subject to only one payment [***], so that [***] shall not trigger

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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any additional payments for such Collaboration Product. For the avoidance of doubt if a Collaboration Product contains a Collaboration Compound would qualify as both a 1) PAM Compound or Agonist Compound: and 2) NAM Compound such Collaboration Product shall be subject only to one set of the milestones either under 9.1.2 or 9.1.3, based on the major activity of the compounds as determined in assays in Appendix B.

 

9.2                               Royalties; Duration and Reduction.

 

9.2.1                                             Royalties

 

a) In addition to the milestones recited in Article 9.1 above and in consideration of the licenses granted to OMP by ADDEX pursuant to Article 8 above, OMP shall pay to ADDEX a royalty equal to the following percentage of Net Sales of Collaboration Product sold hereunder by OMP, its Affiliates and Sublicensees during the period set forth in Subsection b) below.

 

Collaboration Products containing a
PAM Compound or Agonist
Compound

 

Collaboration Products containing
Compound

 

[***]

%

[***]

%

 

For the avoidance of doubt if a Collaboration Product contains a Collaboration Compound would qualify as both 1) a PAM Compound or Agonist Compound; and 2) a NAM Compound such Collaboration Product shall be subject only to one royalty provided a Collaboration Product containing a PAM Compound or Agonist Compound. There will be no royalty stacking. Royalty will be determined as based upon the major activity of the compounds as determined in assays in Appendix B.

 

b) Royalties shall be paid in respect of the total Net Sales of a given Collaboration Product inclusive of all indications and all formulations, on a country by country basis and on a product by product basis, for a period commencing on the Date of First Sale and ending upon the latest of the expiration of (i) twelve (12) years from the Date of First Sale of a Collaboration Product in a given country or (ii) the last to expire ADDEX Patent containing a Valid Claim covering composition of matter of

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Collaboration Compound comprised in a Collaboration Product sold by OMP, its Affiliates or Sublicensees in such country.

 

c) If at any time during which Royalties are being paid, (i) a Third Party other than Sublicensee of OMP commences selling the Product containing the same compound as Collaboration Compound contained in such Collaboration Product in a country where no ADDEX Patent or OMP Patent exists with an enforceable Valid Claim on the Collaboration Compound and (ii) such unlicensed unit sales amount to [***] or more of OMP’s (and/or its Affiliate’s and/or its Sublicensee’s) unit sales in units of the Collaboration Product in such country in the same period, the royalty applied in such country in such period shall be reduced by [***], such reduction shall apply as long as the unlicensed unit sales amount to [***] or more of OMP’s (and/or its Affiliate’s and/or its Sublicensee’s) unit sales in units of the Collaboration Product in such country in the same period. For the convenience of calculating such reduced royalty and for the purpose of determining the applicable royalty rates from the Table set forth in subsection (a), [***] of the Net Sales of the Collaboration Product in such country in such period shall be deemed total Net Sales of the Collaboration Product in such country in such period. For purposes of this subsection (c) “unlicensed unit sales” and “OMP’s (and/or its Affiliate’s and/or its Sublicensee’s) unit sales” shall be deemed to mean the grams of Collaboration Compound contained in the Third Party product (irrespective of dosage form) or the Collaboration Product (irrespective of dosage form), respectively, as reflected on the label of each such unit; and (ii) unlicensed unit sales shall be determined by the sales reports of IMS America Ltd. of Plymouth Meeting, Pennsylvania (“MS”) or where applicable its non-US affiliate or any successor to IMS or any other independent market auditing firm selected by OMP, its Affiliate or its Sublicensees and reasonably acceptable to ADDEX. If OMP is entitled to a royalty reduction based on unlicensed unit sales pursuant to this subsection (c) for any royalty period, it, its Affiliates or its Sublicensees shall submit the sales report of IMS or such other independent firm, as applicable, for the relevant royalty period to ADDEX, together with OMP’s, its Affiliates’ or its Sublicensees’ sales report for the relevant royalty period.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Such sales reports for each royalty accounting period in which OMP is entitled to such royalty reduction shall be submitted with the royalty report for such royalty accounting period submitted pursuant to Article 10.1.

 

9.3                               Accrual of Royalties. No royalties shall be payable on sales among OMP, its Affiliates and Sublicensees, but royalties shall be payable on subsequent sales by OMP, its Affiliates or Sublicensees to an independent Third Party. No royalties shall be payable on Phase I Studies, Phase II Studies or Phase III Studies to obtain the initial approval of a Collaboration Product or Collaboration Product used in studies to obtain approval of a Second Indication.

 

9.4                               ADDEX Independent Products Payments. ADDEX shall pay to OMP a royalty on Independent Products equal to the greater of:

 

9.4.1                                             In the event that ADDEX, its Affiliates or Sublicensees would commercialize by itself or through a Third Party an Independent Product comprising a Collaboration Compound [***], then, in consideration of OMP’s contribution to the Research, ADDEX shall pay OMP a royalty equal to (i) [***] of Net Sales of such Independent Product that was [***] or (ii) [***] of Net sales of such Independent Product that was [***] sold by ADDEX, its Affiliates and/or Sublicensees during a period of either (i) [***] years from Date of First Sale of such Independent Product on a country-by-country basis or (ii) on a country by country basis until the last to expire Joint Program Patent or OMP Program Patent containing a Valid Claim covering [***] a Collaboration Product, whichever is longer.

 

9.4.2                                             In the event that ADDEX, its Affiliates or Sublicensee would commercialize by itself or through a Third Party an Independent Product containing a Collaboration Compound [***], while OMP, its Affiliates or Sublicensee is Developing, commercializing or marketing a Collaboration Product, then, an additional royalty of [***] shall be added to the royalty rate provided in 9.4.1 (i) and 9.4.1 (ii) on the total of Net Sales if such Independent Product receives Regulatory Approval for and is sold outside the NAM Field or PAM/Agonist Field of Collaboration Products.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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9.4.3                                             In the event that ADDEX, its Affiliates or Sublicensee would commercialize by itself or through a Third Party an Independent Product containing a Collaboration Compound [***], while OMP, its Affiliates or Sublicensee is Developing, commercializing or marketing a Collaboration Product, then, in consideration of OMP’s contribution to the Research, ADDEX shall pay OMP a royalty equal to [***] of the total of Net Sales of such Independent Product if such Independent Product receives Regulatory Approval and is sold by ADDEX, its Affiliates and Sublicensee outside of the NAM Field or PAM/Agonist Field. Said obligation to pay royalties shall apply for a period of either (i) twelve (12) years from Date of First Sale of such Independent Product on a country-by-country basis or (ii) on a country by country basis until last to expire ADDEX Program Patent containing a Valid Claim covering composition of matter of Collaboration Compound contained in a Collaboration Product whichever is longer.

 

For the purpose of this Article 9.4 the Net Sales of such Independent Product will be calculated in accordance with the definition of Article 1.54. For these royalties ADDEX shall have the same rights and obligations as OMP to comply with Article 9, 10, 11 and 12 and OMP shall have the same rights and obligations granted to ADDEX under such Articles 9, 10, 11 and 12 with respect to such royalties. In the event that OMP ceases to develop, commercialize or market a Collaboration Compound, the obligation to pay royalties under Article 9.4.3 shall terminate.

 

9.5                               Aggregate Reduction. In no event shall the royalties payable to ADDEX, totally or in any calendar year, on a country by country basis, be reduced by more than [***] of the total amount OMP would have paid without any reduction.

 

Article 10:  PAYMENTS AND ACCOUNTING

 

10.1                        Royalty Reports and Records.

 

Within [***] calendar days after the end of each Calendar Quarter for which royalty fees are payable by OMP to ADDEX with respect to Net Sales in the Territory pursuant to Article 9.2, OMP shall submit to ADDEX a report, on a country by country basis, providing in reasonable detail an accounting of all Net Sales

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(including an accounting of all unit sales of Product) made during such calendar quarter and the calculation of such applicable royalty fees under Section 9.2. Within [***] calendar days after submission of such report, OMP shall pay ADDEX all royalties payable by it under Article 9.2 as indicated in the report by wire transfer. OMP will pay ADDEX royalties on Net Sales of each Product invoiced by OMP, its Affiliates and its sub-licensees at the rates shown in Article 9.2 above.

 

10.2                        Right to Audit. Each Party, its Affiliates and Sublicensees shall keep or cause to be kept complete and accurate records which are relevant to any payment to be made under this agreement, including without limitation, records on Net Sales, Development Cost and manufacturing costs.

 

At the request and expense of either Party, the other Party, its Affiliates and its Sublicensees shall permit an independent certified public accountant (or equivalent) appointed by such Party and reasonably acceptable to the other Party, at reasonable times and upon reasonable notice, to examine such records as may be necessary to determine, with respect to any Year ending not more than [***] Years prior to such Party’s request, the correctness or completeness of any report or payment made under this Agreement.

 

The foregoing right of review may be exercised only [***]. Results of any such examination shall be (a) limited to information relating to Product, (b) made available to both Parties. The Party requesting the audit shall bear the expenses of such independent certified public accountant related to the performance of any such audit, unless such audit discloses a variance to the detriment of the auditing Party of more than [***] from the amount of the original report, or payment calculation. In such case, the Party being audited shall bear the full cost of the performance of such audit.

 

If such audit reveals that the audited Party, its Affiliate or Sublicensee has failed to accurately report information, and the result was underpayment, the relevant Party shall promptly pay any amounts due to the inspecting Party together with interest on such amount, calculated from the date accruable at a rate of [***]. In the event of overpayment, any royalty shall be fully creditable against amount payable in subsequent periods.

 

Audit Disagreement. If there is a dispute between the Parties related to GAAP compliance following any audit performed pursuant to this Section 10.2, either Party may refer the issue (an “Audit Disagreement”) to an independent certified public

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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accountant for resolution. In the event an Audit Disagreement is submitted for resolution by either Party, the Parties shall comply with the following procedures:

 

(i)                                     The Party submitting the Audit Disagreement for resolution shall provide written notice to the other Party that it is invoking the procedures of this Section.

 

(ii)                                  Within [***] calendar days of the giving such notice, the Parties shall jointly select a recognized international accounting firm to act as an independent expert to resolve such Audit Disagreement.

 

(iii)                               The Audit Disagreement submitted for resolution shall be described by the Parties to the independent expert, which description may be in written or oral form, within [***] calendar days of the selection of such independent expert.

 

(iv)                              The independent expert shall render a decision on the matter as soon as practicable.

 

(v)                                 The decision of the independent expert shall be final and binding and shall not be subject to Article 18 hereof, unless such Audit Disagreement involves alleged fraud, breach of this Agreement or construction or interpretation of any of the terms and conditions hereof.

 

(vi)                              All fees and expenses of the independent expert, including any Third Party support staff or other costs incurred with respect to carrying out the procedures specified at the direction of the independent expert in connection with such Audit Disagreement, shall be borne by the Party against whom such expert rules.

 

10.3                        Tax Matters.

 

10.3.1                                      OMP will make all payments to ADDEX under this Agreement without deduction or withholding except to the extent that any such deduction or withholding is required by law to be made on account of Taxes (as that term is defined in Section 10.3.6 below).

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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10.3.2                                      Any Tax required to be withheld under applicable law on amounts payable under this Agreement will promptly be paid by OMP on behalf of ADDEX to the appropriate governmental authority. Any such Tax required to be withheld will be an expense of and borne by ADDEX. Notwithstanding the foregoing sentence, any Tax required to be withheld for which ADDEX is not entitled to a credit or refund will be an expense of and borne by OMP (an “OMP Withholding Expense”) to the extent that such amount exceeds the amount of Tax that OMP would be required to withhold under law applicable at the time of payment if payment were made by a United States tax-resident licensee to ADDEX or, if applicable, to any successor or assignee of ADDEX then entitled to receive payment. In the event of any OMP Withholding Expense, OMP shall pay to ADDEX an additional amount that shall result in ADDEX receiving such payment as it would have been entitled to had there been no OMP Withholding Expense.

 

10.3.3                                      Except with respect to any Tax that is an OMP Withholding Expense, OMP will furnish ADDEX with proof of payment of any Tax withheld under this Section 10.3.

 

10.3.4                                      OMP and ADDEX will cooperate with respect to all documentation required by any government taxing authority or reasonably requested by J&JPR to secure a reduction in the rate of applicable withholding Taxes. As soon as practicable following the execution of this Agreement, ADDEX will deliver to OMP an accurate and complete Internal Revenue Service Form W-8BEN certifying that ADDEX is entitled to the applicable benefits under the Income Tax Treaty between Switzerland and the United States.

 

10.3.5                                      If OMP had a duty to withhold Tax that would be an expense of and borne by ADDEX (as provided in Section 10.3.2) in connection with any payment it made to ADDEX under this Agreement, but (i) OMP failed to withhold, (ii) such Taxes were assessed against and paid by OMP, and (iii) OMP provided written notice to ADDEX within thirty (30) months of such failure to withhold, then ADDEX will indemnify and hold harmless OMP from and against, such Taxes. If OMP makes a claim under this Section 10.3.5, it will comply with the obligations imposed by

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Section 10.3.3 as if OMP had withheld Taxes from a payment to ADDEX.

 

10.3.6                                      Solely for purposes of this Article 10.3, “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, but not including penalties and additions thereto) that are imposed by any governmental or taxing authority.

 

10.4                        Overdue payment. In the event any payment due hereunder is not made when due, the payment shall accrue interest (beginning on the date such payment is due) calculated at the rate of [***] and such payment when made shall be accompanied by all interest so accrued.

 

10.5                        Foreign Exchange. Unless otherwise expressly set forth in Article 2.4 and 9.1, all payments to be made by OMP to ADDEX under this Agreement shall be made in US Dollars, to an ADDEX bank account able to receive US Dollars. Royalty fee payments by OMP to ADDEX shall be converted to US Dollars in accordance with the following: the rate of currency conversion shall be calculated using a simple average of the daily rates as provided by Bloomberg or some other known and reliable source, for each relevant period, or if such rates are not available. Non-royalty fee payments by OMP to ADDEX shall be converted to US Dollars applying the currency conversion rate applicable on the day on which the invoice is raised as provided by Bloomberg or some other known and reliable source. These methods of conversion are and shall be consistent with OMP’s then current methods. OMP shall give ADDEX prompt written notice of any changes to OMP’s customary and usual procedures for currency conversion, which shall only apply after such notice has been delivered and provided that such changes continue to maintain a set methodology for currency conversion.

 

Article 11:  INTELLECTUAL PROPERTY AND PATENT RIGHTS

 

11.1                        Ownership Each Party shall solely own, and that Party alone shall have the right to apply for, patents within the Territory for any inventions made solely by it in the course of performing work under this Agreement. Joint Inventions shall be owned jointly by Parties.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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11.2                        Disclosure of Provisional and Non-Provisional Patent Applications Each Party shall give the opportunity to the other Party to review patent applications before filing under Article 11.1 and shall provide to the other, within a reasonable time after filing, a copy of each patent application filed by such Party, which is licensed to the other Party hereunder during the term of this Agreement.

 

11.3                        Patent Filings.

 

11.3.1                                      Each Party shall at its own cost and on its own responsibility prepare, file, prosecute and maintain Patents solely owned by it, relating to any Collaboration Compound and/or any Collaboration Product being developed or sold hereunder by OMP, its Affiliates or Sublicensees and use reasonable efforts to file initially all such applications in the United States, Japan, Europe, or the appropriate forum under the circumstances. The determination of which Party to prepare, file, prosecute and maintain Patents jointly owned by Parties shall be made by the JRC or JDC and the out-of-pocket expenses thereof shall be equally borne by Parties. The determination of the countries in the Territory in which to file the jointly owned Patents shall be made by the JRC or JDC. Parties shall agree on all material actions relating to the prosecution or maintenance of the jointly owned Patents.

 

11.3.2                                      The Party who is responsible for filing the Patent (hereinafter referred to as “filing Party”) shall keep the other Party apprised of the status of each such Patent and provide the other Party with all material information relating thereto, including all material communications from patent offices, promptly after receipt of such information.

 

11.3.3                                      If, during the term of this Agreement, the filing Party intends to abandon any such Patent to which the other Party has rights hereunder, the filing Party shall, whenever practicable, notify the other Party of such intention at least [***] calendar days prior to the date upon which such Patent shall lapse or become abandoned, and the other Party shall thereupon have the right, but not the obligation, to assume responsibility for the prosecution, maintenance and defense thereof and all expenses related thereto. Where OMP assumes such responsibility, the affected ADDEX Patent shall [***]. Where ADDEX assumes such responsibility, the affected OMP Patent shall [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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11.3.4                                      The Parties agree to use reasonable efforts to ensure that any Patent filed outside of the United States prior to a filing in the United States will be in a form sufficient to establish the date of original filing as a priority date for the purpose of a subsequent filing in the United States.

 

11.3.5                                      The Parties agree to use reasonable and prudent efforts consistent with good patent practice to separately file patent applications claiming 1) NAM Compounds and 2) PAM Compounds or Agonist Compounds.

 

11.3.6                                      Notwithstanding 11.3.1., OMP shall have the right but not the obligation to elect to pay the out-of-pocket expenses for the preparation, filing, prosecution, and maintenance of any ADDEX Program Patent. In the event that OMP makes this election ADDEX shall grant (i) OMP the right to [***] and (ii) the right to [***]. The counsel selected under this Article shall solely represent and be responsible to ADDEX. ADDEX will remain solely responsible for such preparation, filing, prosecution and maintenance of such ADDEX Program Patent. ADDEX will invoice OMP for such out-of-pocket expenses on a [***] basis (with appropriate supporting documentation), and OMP will pay each such invoice within [***] calendar days of receipt (subject to OMP right to elect not to pay the out-of-pocket expenses for particular ADDEX Program Patents as provided below). ADDEX will keep OMP informed of the progress with regard to all activities relating to such ADDEX Program Patent, including providing to OMP copies of all proposed filings and patent office responses and of all office actions and other material communications from patent offices relating to such prosecution efforts a reasonable time in advance of any proposed filing or required response, and OMP will have the right to comment on any such filing or response, and ADDEX will consider in good faith the timely received requests and suggestions of OMP with respect to such filings or responses and ADDEX’s strategies for filing and prosecuting the ADDEX Patents. As to any particular ADDEX Program Patent in a country or jurisdiction, OMP may elect, in writing to ADDEX, to cease paying any future incurred out-of-pocket expenses for the ongoing prosecution and/or maintenance of such ADDEX Program Patent.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Article 12:  INFRINGEMENT

 

12.1                        Third Party Infringement. If OMP or ADDEX becomes aware of any activity that it believes represents a substantial infringement of the ADDEX Patents, and/or OMP Program Patents, the Party obtaining such knowledge shall promptly advise the other of all relevant facts and circumstances pertaining to the potential infringement. OMP and ADDEX shall thereafter consult and cooperate fully to determine a course of action, including but not limited to, the commencement of legal action by either or both of OMP and ADDEX to terminate any infringement of the ADDEX Patents and/or the Program Patents. However, ADDEX shall have the first and exclusive right, but not the obligation to initiate and prosecute such legal proceedings, at its own expense and in the name of ADDEX, and to control the defense of any declaratory judgement action relating to the ADDEX Patents and its Program Patents. OMP shall have the sole right, not the obligation to enforce any rights under OMP Patents and its Program Patents (except as provided hereinafter), at its expense.

 

12.2                        OMP Right to Pursue Third Party Infringers. If ADDEX after consultation with OMP as provide in Article 12.1 regarding the infringement of such ADDEX Patents and request by OMP that ADDEX act against such infringement fails within [***] calendar days after receiving such request from OMP, either (a) to terminate such infringement or (b) to institute an action to prevent continuation thereof and, thereafter, to prosecute such action diligently, or if ADDEX notifies OMP that it does not plan to terminate the infringement of ADDEX Patents and/or ADDEX’s Program Patents or institute any such action, then OMP shall have the right, but not the obligation to do so at its own expense. ADDEX shall cooperate with OMP in such effort, including, if necessary, being joined as a Party to such action at OMP’s expense.

 

12.3                        ADDEX Right to Pursue Third Party Infringers. In the event that ADDEX is selling a Collaboration Product pursuant to Articles 8.5, 15.8 and 15.9 that contains a Collaboration Compound within the scope of a OMP Program Patent containing a Valid Claim to a composition of matter for such Collaboration Compound, if OMP after consultation with ADDEX as provided in Article 12.1 and request by ADDEX that OMP act against such infringement fails, within [***] calendar days after receiving such request from ADDEX, either (a) to terminate such infringement or (b) to institute an action to prevent continuation thereof and, thereafter, to prosecute such action diligently, or if OMP notifies ADDEX that it does not plan to terminate the infringement of such OMP Program Patents or institute any such action, then

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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ADDEX shall have the right, but not the obligation to do so at its own expense. OMP shall cooperate with ADDEX in such effort, including, if necessary, being joined as a Party to such action at ADDEX’s expense.

 

12.4                        Updating. Each Party shall keep the other Party informed of development in any action or proceeding under Article 12 relating to the ADDEX Patents, arid/or OMP Program Patents including, to the extent permissible by law, the state of any settlement negotiations and the terms of any offer related thereto.

 

12.5                        Damage award or settlement payments. Any damage award or settlement payments made to either or both of ADDEX and/or OMP in connection with any action under Article 12 relating to infringement of ADDEX Patents and OMP Program Patents, whether obtained by judgement, settlement or otherwise shall be allocated, (i) first, to the Party which initiated and prosecuted the action to recoup all of its out-of-pocket expenses incurred in connection with the action, (ii) second, to the other Party, to recover its out-of-pocket expenses (not otherwise previously reimbursed by the first Party) incurred in connection with the action, and (iii) third, the amount of any recovery remaining shall [***]. Any damage award or settlement payments [***] in connection with any action relating to infringement of [***] shall be [***].

 

12.6                        Defense and Settlement of Third Party Claims. If a Third Party asserts that a patent or other intellectual properties owned by it is infringed by using or selling Collaboration Compound in the Territory, (excepting infringement relating to manufacture of the Bulk Drug Substance in case ADDEX is manufacturing such Bulk Drug Substance, in which case ADDEX shall be solely responsible for defending), OMP will be solely responsible for defending against any such assertions at its cost and expense, but no settlement may be entered into without the written consent of ADDEX if such settlement would materially and adversely affect ADDEX’s interests. OMP shall have the right to defend against such charge of infringement. During the period in which such litigation is pending, OMP shall have the right to [***] in the event that. If, as a result of judgment in the litigation or settlement with the Third Party, OMP is required to pay royalties or other monies to such Third Party, OMP may thereafter deduct from the amount of royalties due ADDEX on Net Sales of the Product charged to infringe, an amount which is the lesser of [***] all sums actually paid by OMP to such Third Party or [***] of all royalty payments otherwise payable to ADDEX on the Net Sales of such

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Collaboration Product calculated using an average royalty rate. Such application and deduction shall not apply to infringement caused by any act of OMP using [***].

 

12.7                        Third Party Patents. If a patent or patents should issue to a Third Party in any country of the Territory during the term of this Agreement, which OMP believes, in its reasonable judgment, would be infringed by the use or sale of a Collaboration Compound in such country, and if OMP believes, in its reasonable judgment, that it would be impractical or impossible to commercialize a Collaboration Product containing such Collaboration Product without obtaining a royalty-bearing license from such Third Party under such patent or patents in said country, then OMP shall promptly notify ADDEX in writing to that effect with legal opinions. The Parties shall meet to discuss such opinions and appropriate actions to address such potential patent infringement. OMP will have the right to obtain a royalty-bearing license to such patent or patents being infringed by OMP, subject to ADDEX’s approval, which approval shall not be unreasonably withheld. OMP may deduct from the amount of royalties due ADDEX on Net Sales of Collaboration Product charged to infringe, an amount which is the lesser of [***] all sums actually paid by OMP to such Third Party or [***] of all royalty payments otherwise payable to ADDEX on the Net Sales of such Collaboration Product calculated using an average royalty rate. Such application and deduction shall not apply to such license obtained for any act of OMP using [***]. If ADDEX believes that there is no reasonably basis for believing that there is infringement of such Third Party patent or patents, ADDEX may request arbitration under Article 18 on said issue to avoid reduction of ADDEX’s royalty payments.

 

12.8                        Patent Issuance and Abandonment. Each Party shall promptly give notice in writing to the other Party of the grant, lapse, revocation, surrender, invalidation or abandonment of any of its Patents, which is licensed to the other Party hereunder during the term of this Agreement. In case of intended abandonment, Article 11.3.3 will apply.

 

Article 13:  WARRANTIES AND INDEMNIFICATION

 

13.1                        Warranties of Each Party. Each Party hereto represents to the other that it is free to enter into this Agreement and to carry out all of the provisions hereof.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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13.2                        Right To License. ADDEX warrants that, to its knowledge, it exclusively owns or Controls by agreement, assignment or license the entire right, title and interest in the presently existing ADDEX Patents and ADDEX Know-How and that it has full power and authority to execute, deliver and perform this Agreement and the obligations hereunder. OMP warrants that, to its knowledge, it exclusively owns or Controls by agreement, assignment or license the entire right, title and interest in the presently existing OMP Patents and OMP Know-How and that it has full power and authority to execute, deliver and perform this Agreement and the obligations hereunder.

 

13.3                        Encumbrances. Each Party expressly warrants and represents that it has no outstanding encumbrances or agreements, either written, oral, or implied, in connection herewith, and that it has not granted and will not grant during the term of this Agreement or any renewal hereof, any rights, license, consent or privilege that conflict with the rights granted herein.

 

13.4                        Authorization. Each Party hereby warrants that the execution, delivery and performance of this Agreement has been duly approved and authorized by all necessary corporate or partnership actions of both Parties; do not require any shareholder or partnership approval which has not been obtained or the approval and consent of any trustee or the holders of any indebtedness of either Party; do not contravene any law, regulation, rules or order binding on either Party, and do not contravene the provisions of or constitute a default under any indenture, mortgage, contract or other agreement or instrument to which either Party is a signatory.

 

13.5                        Patent and Patent Applications. ADDEX warrants that the patent applications listed in Appendix H are all the Patents that are currently Controlled by ADDEX having claims related to Positive Allosteric Modulators, Negative Allosteric Modulators, Agonists and Antagonist of mGlu2-R, such as claims for composition of matter, formulations, dosage forms, and method of uses thereof (e.g. use in the treatment of humans for any condition, methods of manufacture, methods of administration, method of synthesis, and assays for such compounds).

 

13.6                        No Liability for Consequential Damages and Limitation of Liability. Neither Party shall be liable to the other for special, incidental, consequential damages arising out of or related to the subject matter of this Agreement including but not limited to profit loss, damage to reputation and loss of opportunity.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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13.7                        Indemnification.

 

13.7.1                                      Subject to compliance by ADDEX with its obligations set forth in Article 13.8, OMP shall defend, indemnify, and hold harmless ADDEX, its Affiliates, its Sublicensees and their respective directors, officers, shareholders, employees and agents, from and against any and all claims, demands, losses, liabilities, expenses, and damages including reasonable attorneys’ fees (collectively, the “Liabilities”) which they may suffer, pay, or incur to the extent resulting from (i) any breach of a representation, warranty, covenant or agreement of OMP under this Agreement, (ii) any negligent or more culpable act of OMP under this Agreement, or (iii) any and all personal injury (including death) and property damage to the extent caused by development, manufacture, use, sale, or labeling of defective clinical trial drug (finished tablets) and for Collaboration Product by OMP or its Affiliates or its Sublicensees, excluding, however, (a) any Liabilities arising as a result of ADDEX’s breach of its obligations under the Supply Agreement, and (b) any Liabilities otherwise subject to ADDEX’s indemnification obligation under Article 13.7.2. OMP’s obligations under this Article 13.7 shall survive the expiration or termination of this Agreement for any reason.

 

13.7.2                                      Subject to compliance by OMP with its obligations set forth in Article 13.8, ADDEX shall indemnify and hold OMP, its Affiliates, its Sublicensees and their respective directors, officers, shareholders, employees and agents, harmless from and against any and all Liabilities which OMP may suffer, pay or incur to the extent resulting from (i) any breach of a representation, warranty, covenant or agreement of ADDEX under this Agreement, (ii) any negligent or more culpable act of ADDEX under this Agreement, or (iii) any and all personal injury (including death) and property damage to the extent caused by development, manufacture, use, sale, or labeling of Bulk Drug Substance, defective clinical trial drug (finished tablets) and /or Product by ADDEX or its Affiliates, excluding, however, any Liabilities otherwise subject to OMP’s indemnification obligation under Article 13.7.1. ADDEX’s obligations under this Article 13.7 shall survive expiration or termination of this Agreement for any reason.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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13.8                        Indemnification Procedures. Any indemnitee (the “Indernnitee”) which intends to claim indemnification under Article 13.7 shall promptly notify the other Party (the “Indemnitor”) in writing of any matter in respect of which the Indemnitee intends to claim such indemnification. The Indemnitee shall permit the Indemnitor, at its discretion, to settle any such matter and agrees to the complete control of such defence or settlement by the Indemnitor; provided, however, that such settlement does not adversely (a) affect the Indemnitee’s rights under this Agreement or (b) impose any material obligations on the Indemnitee in addition to those set forth herein in order for Indemnitee to exercise rights under this Agreement. No settlement of any such matter which materially and adversely affect the Indemnitee’s rights under this Agreement or impose any material obligations on the Indemnitee in addition to those set forth herein in order for Indemnitee to exercise rights under this Agreement may be made by the Imdemnitor without the prior written consent of the Indemnitee. The Indemnitee shall not be responsible for any legal fees or other costs incurred other than as provided herein.

 

The Indemnitee and its employees shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defence of any matter covered by the applicable indemnification.

 

The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and at its own expenses in connection with any matter that is subject to indemnification.

 

13.9                        Exclusivity — Non Competition. [***], ADDEX and OMP and their respective Affiliates shall not conduct, have conducted or fund any research or development activities directed at [***], except as permitted under this Agreement.

 

Article 14:  CONFIDENTIALITY

 

14.1                        Confidentiality Exceptions. Except to the extern expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for [***] years thereafter, the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as permitted in this Agreement any Information and other information and materials furnished to it by the other Party pursuant to this Agreement and any Information developed during the term of, and pursuant to, this Agreement (collectively,

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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“Confidential Information”), except to the extent that it can be established by the receiving Party that such Confidential Information:

 

14.1.1                                      was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

 

14.1.2                                      was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

14.1.3                                      became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

14.1.4                                      was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others; and

 

14.1.5                                      was independently developed by the receiving Party without reliance on Confidential Information of the other Party as shown by documentary evidence.

 

14.2                        Authorized Disclosure.

 

14.2.1                                      Each Party may disclose Confidential Information hereunder to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations, or conducting Pre-Clinical Studies or Clinical Trials; provided, however, that if a Party is required by law or regulation to make any such disclosures of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures, for example in the event of medical emergency, give reasonable advance notice to the other Party of such disclosure requirement (e.g., filings with the SEC and stock markets) and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed, unless in the opinion of such disclosing Party’s legal counsel such Confidential Information is legally required to be fully disclosed. In addition, and with prior notice to the other Party of each Third Party with whom a confidential disclosure agreement is being entered into, each Party shall be entitled to disclose, under a binder of confidentiality containing provisions as protective as those of this Article, Confidential

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Information to any Third Party for the purpose of carrying out the purposes of this Agreement. Nothing in this Article shall restrict any Party from using for any purpose any Confidential Information independently developed by it without access to or use of the other Party’s Confidential Information during the term of this Agreement, or from using Confidential Information that is specifically derived from Pre-Clinical Studies or Clinical Studies to perform marketing, sales or professional services support functions as is customary in the pharmaceutical industry.

 

14.2.2                                      Notwithstanding anything herein to the contrary, either Party (and any employee, representative, or other agent of either Party) may disclose to any and all persons, without limitation of any kind, the tax treatment and tax structure of the transactions contemplated by this Agreement and all materials of any kind (including opinions or other tax analyses) that are provided to it relating to such tax treatment and tax structure; provided however, that such disclosure shall not be made to the extent reasonably necessary to comply with any applicable federal or state securities laws. For the purposes of the foregoing sentence, (i) the “tax treatment” of a transaction means the purported or claimed federal income tax treatment of the transaction, and (ii) the “tax structure” of a transaction means any fact that may be relevant to understanding the purported or claimed federal income tax treatment of the transaction.

 

14.3                        Survival. Sections 14.1 through 14.4 of this Article shall survive the termination or expiration of this Agreement for a period of [***] years.

 

14.4                        Termination of Prior Agreement. This Agreement supersedes the Confidentiality Agreement between ADDEX and OMP’s Affiliate Janssen Pharmaceutica NV dated [***]. All Information exchanged between the Parties under that Agreement shall be deemed Confidential Information and shall be subject to the terms of this Article, and shall be included, respectively, within the definitions of ADDEX Know-how if ADDEX is the disclosing Party and OMP Know-how if OMP is the disclosing Party.

 

14.5                        Shared Confidential Information.  Notwithstanding the foregoing, it is understood that either Party shall be entitled to use shared Confidential Information relating to jointly developed Collaboration Compounds and Program Patents, subject to the non-disclosure provisions of this Article 14.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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14.6                        Scientific Publication. Each Party shall provide to the other the opportunity to review any proposed scientific/technical publications or scientific presentations which relate to Collaboration Compounds or Collaboration Products as early as reasonably practical, but at least [***] calendar days prior to the intended submission for publication (except with the written consent of the other Party). The reviewing Party will provide the publishing Party with its response to the publishing Party’s request to publish within [***] calendar days of receipt of such request. No publication shall be made by any Party without the written agreement of or approval by the other Party. However, the failure of the receiving Party to respond to such request within such [***] calendar day period shall be deemed to be approval of such request and the publishing Party shall then be free to proceed with said publication or presentation. Notwithstanding the foregoing, publications regarding development and commercialization activities or that are reasonably needed to effectively develop and commercialize the Collaboration Product may be made by OMP even if ADDEX does not approve, provided that ADDEX may request a reasonable delay on such publication to seek patent protection on any patentable inventions disclosed therein.

 

Article 15:  TERM AND TERMINATION

 

15.1                        Term. Unless sooner terminated as otherwise provided in this Agreement, the term of this Agreement shall commence on Effective Date and shall on a country-by-country basis continue in full force and effect until the expiration of all of OMP or ADDEX obligations to pay royalties hereunder; thereafter, (a) OMP shall have a perpetual, fully paid-up non-exclusive license to use ADDEX Know-How in the Territory related to a Collaboration Product that it commercialises, ADDEX shall have a perpetual, fully paid-up non-exclusive license to use OMP Know-How in the Territory related to a Collaboration Product that it commercialises, and (b) other matter expressly provided to survive herein.

 

15.2                        Termination of the entire Agreement for Failure of the Research. In the event that no Collaboration Compounds are discovered or identified during the Research Period this Agreement shall terminate as follows:

 

15.2.1                                      All other rights and obligations shall terminate excepts as otherwise expressly provided.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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15.2.2                                      The Parties shall cooperate in the handling and return of Collaboration Tangible Research Products as follows: 1) Collaboration Tangible Research Product shall be promptly returned to the Party who invented, owns or Controls the underlying asset (e.g. cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction; and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly, to the extent possible, be equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Tangible Research Product.

 

15.3                        Termination of Certain Rights and Obligations. In the event that there are Collaboration Compounds but either 1) no NAM Compound; or 2) no PAM Compounds or Agonist Compounds are discovered during the Research Period certain rights and obligation of this Agreement shall terminate as follows:

 

15.3.1                                      In the event that no NAM Compounds are discovered or identified during the Research Period or six (6) months thereafter:

 

(a)                                 OMP’s rights and obligations to make a Selection, Develop, commercialise, market, pay royalties and milestones on NAM Compounds under Articles 2, 3, 5, 9.1.3 and 9.2.1 shall terminate.

 

(b)                                 ADDEX’s rights and obligations under Articles 3 and 8.5 to develop or offer such NAM Compounds to OMP shall also terminate.

 

(c)                                  The license granted to OMP under Article 8.1.1 to patent application GB 04 22748.4 in Appendix H shall terminate, if and only if, such patent application does not claim or does not issue with claims to a PAM Compound or Agonist Compound.

 

(d)                                 The license granted to OMP under 8.1.2 to conduct research with ADDEX Patent and ADDEX Know-How for the purpose of discovering and identifying NAM Compounds shall terminate.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(e)                                  The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Products (other than Non-collaboration Compounds) which were specifically used in the research to discover and identify NAM Compound as follows: 1) Collaboration Tangible Research Product shall be returned to the Party who invented, owns or Controls the underlying asset (e.g. cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction ;and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible be equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party; The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product;

 

15.3.2                                      In the event that no PAM Compounds or Agonist Compounds are discovered or identified during the Research Period or six (6) months thereafter:

 

(a)                                 OMP’s rights and obligations to select, Develop, Commercialise, pay royalties and milestones on a PAM Compound or Agonist Compound under Articles 2, 3, 5, 9.1.2 and 9.2.1 shall terminate.

 

(b)                                 ADDEX’s rights and obligations under Article 3 and 8.5 to develop or offer such PAM Compounds or Agonist Compound to OMP shall also terminate.

 

(c)                                  The license granted to OMP under Article 8.1.1 to patent application GB 04 20722.1, GB 04 20721.3 and GB 04 20719.7 in Appendix H shall terminate, if and only if, such patent application do not claim or does not issue with claims to a NAM Compound.

 

(d)                                 The license granted to OMP under 8.1.2 to conduct research under ADDEX Patent and ADDEX Know-How for the purpose of discovering and identifying PAM Compounds and Agonist Compounds shall terminate.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(e)                                  The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Products (other than Non-collaboration Compounds) which were specifically used in the research to discover and identify PAM Compound and Agonist Compounds as follows: 1) Collaboration Tangible Research Product shall be returned to the Party who invented, owns or Controls the underlying asset (e.g. cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction; and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product.

 

15.4                        Termination by Either Party.

 

15.4.1                                      If either Party defaults in the performance of, or fails to be in compliance with, any material agreement, condition or covenant of this Agreement, the non-defaulting Party may terminate this Agreement if such default or non-compliance shall not have been remedied, or reasonable steps shall not have been initiated to remedy the same, within sixty (60) calendar days after receipt by the defaulting Party of a written notice thereof from the non-defaulting Party, provided that the period to remedy such breach shall be tolled for the period that the Parties are in dispute resolution under Article 18 related to the existence or materiality of such breach.

 

15.4.2                                      Either Party shall have the right to terminate this Agreement forthwith by way of a written notice to the other Party (i) if the other Party is declared insolvent or bankrupt by a court of competent jurisdiction, (ii) if a voluntary or involuntary petition in bankruptcy is filed against the other Party and such petition is not dismissed within ninety (90) calendar days after filing, or (iii) if the other Party shall make or execute an assignment of substantially all of its assets for the benefit of creditors.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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15.4.3                                      Failure to make a Selection or achieve the Milestones set forth in Article 3.5.1 within the Times to Complete with respect to 1) a NAM Compounds or 2) a PAM Compounds or Agonist Compounds shall not provide a basis to terminate this Agreement under Article 15.4.

 

15.5                        Termination by OMP for Convenience. OMP may terminate this Agreement at any time upon ninety (90) calendar days prior written notice for any reason after the Research Period ends. OMP shall also have the right to terminate this Agreement as it relates to its obligations to all NAM Compounds and Collaboration Products made there from or to all PAM Compounds or Agonist Compound and Collaboration Products made there from separately, after the Research Period as follows.

 

15.5.1                                      In the event that OMP terminates its obligation to Develop, commercialize and market NAM Compounds:

 

(a)                                 OMP’s rights and obligations to make a Selection, Develop, commercialise, market, pay royalties and milestones on NAM Compounds under Articles 2, 3, 5, 9.1.3 and 9.2.1 shall terminate.

 

(b)                                 ADDEX’s rights under Article 3 and 8.5 to develop or obligation to offer such NAM Compounds to OMP shall also terminate.

 

(c)                                  The license granted to OMP under Article 8.1.1 to patent application GB 04 22748.4 in Appendix H and to ADDEX Program Patents that is not intended to claim, does not claim or does not issue with claims to PAM Compound or Agonist Compound shall terminate.

 

(d)                                 The license granted to OMP under 8.1.2 to conduct research with ADDEX Patent and ADDEX Know-How for the purpose of discovering and identifying NAM Compounds shall terminate.

 

(e)                                  Provided that ADDEX has not already exercised its rights under 8.5.1.b, ADDEX is hereby granted an exclusive royalty bearing license with the right to sublicense to make, have made, use, distribute, develop, export, import, offer for sale and sell one (1) NAM Compound actually synthesized during the Research Period under OMP Program Patents and Joint Program Patents in the Territory for use in all indications in the Field, provided however, if such NAM compound should fail in its development ADDEX shall be

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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entitled to replace such failed NAM Compounds from such group of all NAM Compounds actually synthesized during the Research Period with a first replacement NAM Compound thereafter, should the first replacement NAM Compound fail in its development, ADDEX has the right to a second replacement NAM Compound from such group of all NAM Compounds actually synthesized during the Research Period, no further replacement compounds shall be available under this grant. Provided, however, that ADDEX must diligently develop such Collaboration Compounds as provided in 3.5 (however an additional year shall be added to the Time to Complete for commencing Phase I for the first Collaboration Compound pursued under this provision). If Addex fails to exercise diligence OMP shall have the right to terminate, on ninety (90) days written notice, the grant to the OMP Program Patents and Joint Program Patents. NAM Compounds commercialised under this Article shall be treated as Independent Products and shall be subject to the royalty obligations set forth in Article 9.4.

 

(f)                                   ADDEX and OMP shall have a non-exclusive royalty-free license to make, have made, use, distribute, develop, export, import, formulate, package, offer for sale and sell Joint Collaboration Compounds for all uses except the regulation of mGlu2-R and compounds acting primarily on mGlu2-R for the treatment of human disorders in the Territory under Joint Program Patents, except for Joint Program Patents that claim or disclose PAM Compound or Agonist Compound.

 

(g)                                  The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Products (other than. Non-collaboration Compounds) which were specifically used in the research to discover and identify NAM Compound as follows: 1) Collaboration Tangible Research Product shall be returned to the Party who invented, owns or Controls the underlying asset (e.g. cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction; and 2) Collaboration Tangible Research Product wherein

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product.

 

15.5.2                                      In the event that OMP terminates its obligation to Develop, commercialize and market PAM Compounds or Agonist Compounds:

 

(a)                                 OMP’s rights and obligations to select, Develop, commercialise, pay royalties and milestones on a PAM Compound or Agonist Compound under Articles 2, 3, 5, 9.1.2 and 9.2.1 shall terminate.

 

(b)                                 ADDEX’s rights and obligations under Article 3 and 8.5 to develop or offer such PAM Compounds or Agonist Compound to OMP shall also terminate.

 

(c)                                  The license granted to OMP under Article 8.1.1 to patent application GB 04 20722.1, GB 20721.3 and GB 04 20719.7 in Appendix H and to ADDEX Program Patents, if and only if, such patent application is not intended to claim, does not claim or does not issue with claims to a NAM Compound shall terminate.

 

(d)                                 The license granted to OMP under 8.1.2 to conduct research with ADDEX Patent and ADDEX Know-How for the purpose of discovering and identifying PAM Compounds and Agonist Compounds shall terminate.

 

(e)                                  Provided that ADDEX has not already exercised its rights under 8.5.2.b, ADDEX is hereby granted an exclusive royalty bearing license with the right to sublicense to make, have made, use, distribute, develop, export, import, offer for sale and sell one (1) PAM Compound or Agonist Compound actually synthesized during the Research Period under OMP Program Patents and Joint Program Patents in the Territory for use in all indications in the Field, provided however, if such PAM Compound or Agonist Compound should fail in its development ADDEX shall be entitled to replace such failed

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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PAM Compounds or Agonist Compounds from such group of all PAM Compounds or Agonist Compounds actually synthesized during the Research Period with a first replacement PAM Compound or Agonist Compound thereafter, should the first replacement PAM Compound or Agonist Compound fail in its development, ADDEX has the right to a second replacement PAM Compound or Agonist Compound from such group of all PAM Compounds or Agonist Compounds actually synthesized during the Research Period, no further replacement compounds shall be available under this grant. Provided, however, that ADDEX must diligently develop such Collaboration Compounds as provided in 3.5 (however an additional year shall be added to the Time to Complete for commencing Phase I for the first Collaboration Compound pursued under this provision). If Addex fails to exercise diligence OMP shall have the right to terminate, on ninety (90) days written notice, the grant to the OMP Program Patents and Joint Program Patents. PAM Compounds or Agonist Compounds commercialised under this Article shall be treated as Independent Products and shall be subject to the royalty obligations set forth in Article 9.4.

 

(f)                                   ADDEX and OMP shall have a non-exclusive royalty-free license to make, have made, use, distribute, develop, export, import, formulate, package, offer for sale and sell Joint Collaboration Compounds for all uses except the regulation of mGlu2-R and compounds acting primarily on mGlu2-R for the treatment of human disorders in the Territory under Joint Program Patents except for Joint Program Patents that claim or disclose NAM Compounds.

 

(g)                                  The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Products (other than Non-collaboration Compounds) which were specifically used in the research to discover and identify PAM Compound and Agonist Compounds follows: 1) Collaboration Tangible Research Product shall be returned to the Party who invented, owns or Controls the underlying asset (e.g. cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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expenses related to such return or destruction; and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product.

 

15.5.3                                      In the event that OMP terminates its obligation to Develop, commercialize and market 1) NAM Compounds and 2) PAM Compounds or Agonist Compounds then in addition to the effects of termination specified in Articles 15.5.1 and 15.5.2 the following shall also occur:

 

(a)                                 The license granted to OMP under Article 8.1.1 shall completely terminate.

 

(b)                                 Save as set out in this Article 15.5.3 (b), ADDEX and OMP shall have a non-exclusive royalty-free license to make, have made, use, distribute, develop, export, import, formulate, package, offer for sale and sell Joint Collaboration Compounds for all uses except the regulation of mGlu2-R and compounds acting primarily on mGlu2-R for the treatment of human disorders in the Territory under Joint Program Patents. Addex shall have the exclusive right in all fields and OMP shall have no rights in any field pursuant to this Article 15.5.3 (b) to make, have made, use, distribute, develop, export, import, formulate, package, offer for sale and sell any Joint Collaboration Compound (including all its salts, esters, polymorphs, enantiomers, rotamers, hydrates, anhydrides and prodrugs) in respect of which Addex , an Affiliate or sublicensee has commenced Development, marketing or commercialisation in the PAM Field or the NAM Field during the term of this Agreement

 

15.6                        Obligations Upon Termination. If this Agreement is terminated for convenience by OMP under Article 15.5 or as a result of OMP’s breach or bankruptcy pursuant to Article 15.4 or is terminated by ADDEX pursuant to Article 3.10,

 

15.6.1                                      OMP shall transfer free of charge to ADDEX or its nominee any IND, CTA, MAA or other documents filed with any government agency in

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Territory and any registration, including but not limited to Regulatory Approval, obtained in Territory and any data and information relating to such filings or registrations, provided however if the terminations is a partial termination as to one Research Program the materials provided shall only relate to that Research Program. OMP shall, at the request of ADDEX, cooperate with ADDEX or its nominee for the smooth transfer of the same. If termination notice is given after the Research Period, OMP shall continue to carry out any Development Work, both non-clinical and clinical studies, that is ongoing at the moment when termination notice is given until the effective date of termination. Moreover, after the effective date of termination, if ADDEX so requests, OMP shall endeavour to complete such ongoing Development studies on behalf of and at the expense of ADDEX.

 

15.6.2                                      To such Collaboration Compound and/or Collaboration Product that are in Development, commercialized or marketed, but only to such Collaboration Compound and/or Collaboration Product, to the extent available OMP, shall offer a license or sublicense to any Development Program Patents that OMP may Control directed to such Collaboration Compound and/or Collaboration Product made therewith, under the same terms and conditions as such rights were extended to OMP to ADDEX.

 

15.7                        Non-collaboration Compounds and Joint Non-collaboration Patents. If this Agreement is terminated for any reason Non-collaboration Compounds and Joint Non-collaboration Patents shall be handled as provided in Article 2.12. Article 2.12 shall survive termination of this Agreement.

 

15.8                        Termination by ADDEX for Cause. If this Agreement is terminated as a result of OMP’s breach or bankruptcy pursuant to Article 15.4 shall be treated as if OMP terminates its obligation to Develop, commercialise and market both 1) PAM Compounds or Agonist Compound; and 2) NAM Compounds under Article 15.5, provided however, that if the material breach is specific and traceable to only the Development, commercialization or marketing of either 1) PAM Compounds or Agonist Compound or Collaboration Products containing such compounds; or 2) NAM Compounds or Collaboration Products containing such compounds; then this Agreement will terminate only with respect to the Development, commercialization or marketing of 1) PAM Compounds, Agonist Compound or Collaboration Products containing such Collaboration Compounds; or 2) NAM Compounds or Collaboration

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Products containing such Collaboration Compounds; wherein said material breach occurred as is provided in Article 15.5.1 and Article 15.5.2 respectively.

 

15.9                        Termination by ADDEX without cause. If ADDEX is Developing, commercialising or marketing an Independent Product under Article 3.10 and the Agreement is terminated pursuant to Article 3.10 this termination shall be treated as if OMP terminates its obligation to Develop, commercialise and market both 1) PAM Compounds or Agonist Compound; and 2) NAM Compounds under 15.5.

 

15.10                 Termination of Certain Rights and Obligations As A Result of an ADDEX Change of Control. In the event of an ADDEX Change of Control, OMP may terminate certain rights and obligations of the Agreement or the Research Program, for the purposes of this Article 15.10:

 

15.10.1                               The Agreement shall remain in effect except, at OMP’s sole discretion the JRC or JDC under Articles 2.3 and 3.4 shall cease to exist, OMP’s obligations under Article 2.5, 2.6, 2.7, 2.8, 2.9 and 3.5 shall terminate and each Party’s obligations under Articles 3, 4, and 5, shall terminate and ADDEX’s rights under Articles 3.5, 3.6, 3.7, 3.8, 3.10, 8.5 and Article 15.6 shall terminate, provided that OMP shall have the obligation to exercise the diligence specified in the first two sentence of Article 3.5 only with respect to Collaboration Compounds within the scope of the Patent GB 04 20722.1, GB 20721.3, GB 20719.7 and GB 04 22748.4 Program Patents.

 

15.10.2                               In OMP’s sole discretion it may terminate ADDEX’s rights under Article 8.1.2.

 

15.10.3                               The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Product (other than Non-collaboration Compounds) as follows: 1) Collaboration Tangible Research Product shall be returned to the Party who owns the underlying asset (e.g. Collaboration Compounds, cell lines, research tools etc.) or destroyed at such party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction; and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible equally divided by the Party in possession and one half thereof shall be promptly provided to the other

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product.

 

15.11                 Termination by OMP for cause. If this Agreement is terminated by OMP as a result of a material breach by ADDEX or bankruptcy of ADDEX:

 

15.11.1                               The Agreement shall remain in effect except that OMP shall be entitled to recover its direct damages from the milestones payments and royalties payable to ADDEX under Articles 9.1 and 9.2, however such payment may only be reduced to 50% until OMP shall recover its direct damages, at OMP’s sole discretion the JRC or JDC under Articles 2.3 and 3.4 shall cease to exist, OMP’s obligations under Article 2.5, 2.6, 2.7, 2.8, 2.9, 3.5, shall terminate and each Party’s obligations under Articles 3, 4 and 5, shall terminate and ADDEX’s rights under Articles 3.5, 3.6, 3.7, 3.10, 8.5 and 15.6 shall terminate.

 

15.11.2                               In OMP’s sole discretion it may terminate ADDEX’s rights under Article 8.1.2.

 

15.11.3                               The Parties shall cooperate in the handling and return of the Collaboration Tangible Research Product (except Non-collaboration Compounds) as follows: 1) Collaboration Tangible Research Product shall be returned to the Party who owns the underlying asset (e.g. Collaboration Compounds, cell lines, research tools etc.) or destroyed at such Party’s written request; the Party who invented, owns or Controls the underlying asset shall bear the direct out-of-pocket expenses related to such return or destruction and 2) Collaboration Tangible Research Product wherein the underlying asset is Jointly Invented or jointly owned shall be promptly to the extent possible equally divided by the Party in possession and one half thereof shall be promptly provided to the other Party. The Parties shall equally share the direct out-of-pocket expenses related to such division and provision of Collaboration Tangible Research Product.

 

15.11.4                               The remedies set forth in this Article 15.11 shall be OMP’s sole remedy for ADDEX’s breach or bankruptcy.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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15.12                 Effects of Termination. In the event of any expiration or termination pursuant to this Article 15, neither Party shall have any remaining rights or obligations under this Agreement other than as provided below:

 

(a)                                 ADDEX will have the right to receive all payments accrued prior to the effective date of termination or expiration;

 

(b)                                 termination or expiration of this Agreement for any reason shall have no effect on the Parties’ obligations under Articles 14, 18 and 20;

 

(c)                                  If Jointly Invented Patents exist and have not expired, been abandoned, or held invalid then Article 11 shall survive.

 

(d)                                 the Parties shall retain any other remedies for breach of this Agreement they may otherwise have, unless otherwise explicitly set forth in this Agreement.

 

Article 16:  ASSIGNMENT

 

Neither Party shall assign this Agreement or any part thereof without the prior written consent of the other Party, provided, however, that either Party may, without such consent, (i) assign this Agreement and its rights and obligations hereunder either in whole or in part to its Affiliate if the assignor guarantees the full performance of this Agreement by its assignee, provided that if such Affiliate ceases to be an Affiliate and the Affiliate does not have all the assets required to comply with all of its obligations under this Agreement, this Agreement shall be automatically assigned back to the party which made the assignment and (ii) assign this Agreement in connection with the transfer or sale of all or substantially all of its assets related to the development or marketing of a bona fide ongoing pharmaceutical business, or in the event of its merger or similar transaction if, in any such case, the assignor guarantees the full performance of this Agreement by its assignee.

 

Any permitted assignee shall assume all obligations of its assignor under this Agreement. In the event of any such assignment, each Party shall comply with the other Party’s reasonable requests to safeguard any confidential information. No assignment shall relieve any Party of responsibility for the performance of any accrued obligation which such Party has under this Agreement.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Article 17:  NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT

 

17.1                        Notices Relating to the Act. ADDEX shall notify OMP of (a) the issuance of each patent included among the ADDEX Patents, giving the date of issue and patent number for each such patent; and (b) communications pertaining to any patent included among the ADDEX Patents which ADDEX receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter the “Act”), including but not necessarily limited to notices pursuant to §§101 and 103 of the Act from persons who have filed an abbreviated MAA (“AMAA”) or a “paper” MAA.

 

17.2                        Authorization Relating to Patent Term Extension. ADDEX hereby authorizes OMP to (a) provide in any MAA for Collaboration Product in the Territory a list of Patents which includes ADDEX Patents that relate to the Collaboration Compound and Collaboration Product and such other information as OMP believes is appropriate; (b) commence suit for infringement of ADDEX Patents under § 271(e) (2) of Title 35 of the United States Code; and (c) exercise any rights that may be exercisable by ADDEX as patent owner under the Act, including without limitation, applying for an extension of the term of any patent included in ADDEX Patents. In the event that applicable law in any country of Territory provides for the extension of the term of any Patent included among ADDEX Patents, OMP shall use its reasonable efforts to obtain such an extension or, in lieu thereof, OMP may request ADDEX to file an application for such patent term extension. OMP and ADDEX agree to cooperate with one another in obtaining such extension. It is understood that OMP will decide on how to make the patent protection extension. ADDEX agrees to cooperate with OMP or its Sublicensees, as applicable, in the exercise of the authorization granted herein and will execute such documents and take such additional action as OMP may reasonably request in connection therewith, including, if necessary, permitting itself to be joined as a party in any suit for infringement brought by OMP under subsection (b) above.

 

Article 18:  DISPUTE RESOLUTION AND ARBITRATION

 

18.1                        Initial Resolution. In the case of any disputes between the Parties arising from this Agreement, and in case this Agreement does not provide a solution for how to resolve such disputes, the Parties shall discuss and negotiate in good faith a solution acceptable to both Parties and in the spirit of this Agreement. If after negotiating in good faith pursuant to the foregoing sentence, the Parties fail to reach agreement,

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

71


 

then the CEO of ADDEX and for OMP the [***], who will have authority to act for OMP in these matters, shall discuss in good faith an appropriate resolution to the dispute. If these executives fail, after good faith discussions, to reach an amicable agreement, then either Party may upon written notice to the other submit to binding arbitration pursuant to Article 18.2.

 

18.2                        Arbitration. Any claim, dispute or controversy arising out of or in connection with or relating to this Agreement, (including, without limitation, disputes with respect to the rights and obligations of the Parties following termination) not settled by the procedures set forth in Article 18.1 above or the breach or alleged breach of a material provision of this Agreement shall be adjudicated by arbitration in accordance with the Arbitration Proceedings as set forth in Appendix C attached hereto.

 

Article 19:  TRADEMARK

 

The Party commercialising a Collaboration Product shall be solely responsible for the selection and registration of all Trademarks which it employs in connection with Collaboration Products in the Territory and shall own such Trademarks.

 

Article 20:  GENERAL PROVISIONS

 

20.1                        Legal Compliance. Each Party shall comply with all laws and regulations relating to the performance of its obligation or the exercise of its rights hereunder.

 

20.2                        Independent Contractors. It is understood and agreed that the Parties hereto are independent contractors and are engaged in the operation of their own respective businesses, and neither Party hereto is to be considered the agent of the other Party for any purpose whatsoever, and neither Party shall have any authority to enter into any contracts or assume any obligations for the other Party nor make any warranties or representations on behalf of that other Party.

 

20.3                        Publicity. Each Party agrees that the other Party may issue a press release concerning the entering into of this Agreement, with the content of such releases to be approved by the non-issuing Party (which consent shall not be unreasonably withheld or delayed). In all other respects, except as required by law, neither Party shall publicly

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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use the name of the other Party or any logos or symbols associated with the other Party without the prior written permission of such other Party. Except as provided above, such as wherein OMP is permitted to use ADDEX’s name and logo in connection with the Collaboration Product, neither Party shall publicly disclose the terms of this Agreement or issue any publicity release with regard thereto unless expressly authorized to do so by the other Party.

 

20.4                        Governing Law. This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties hereunder, shall be construed under and governed by the laws of the State of New Jersey, USA, exclusive of its conflicts of laws principles.

 

20.5                        Entire Agreement. This Agreement, including the Appendices hereto constitutes the entire agreement between ADDEX and OMP with respect to the subject matter hereof and shall not be modified, amended or terminated, except as herein provided or except by another agreement in writing executed by the Parties hereto. All previous or other negotiations, representations and understandings between ADDEX and OMP shall be merged herein.

 

20.6                        Severability. All rights and restrictions contained herein may be exercised and shall be applicable and binding only to the extent that they do not violate any applicable laws and are intended to be limited to the extent necessary so that they will not render this Agreement illegal, invalid or unenforceable. If any provision or portion of any provision of this Agreement, not essential to the commercial purpose of this Agreement, shall be held to be illegal, invalid or unenforceable by a court of competent jurisdiction, it is the intention of the Parties that the remaining provisions or portions hereof shall constitute their agreement with respect to the subject matter hereof, and all such remaining provisions, or portions hereof, shall remain in full force and effect. To the extent legally permissible, any illegal, invalid or unenforceable provision of this Agreement shall be replaced by a valid provision which shall implement the commercial purpose of the illegal, invalid, or unenforceable provision. In the event that any provision essential to the commercial purpose of this Agreement is held to be illegal, invalid or unenforceable and cannot be replaced by a valid provision which will implement the commercial purpose of this Agreement, this Agreement and the rights granted herein shall terminate.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

73


 

20.7                        Force Majeure.

 

(a)                                 Any delays in, or failure of performance of any Party to this Agreement, shall not constitute a default hereunder, or give rise to any claim for damages, if and to the extent caused by occurrences beyond the control of the Party affected, including, but not limited to, acts of God, strikes or other concerted acts of workmen, civil disturbances, fires, floods, explosions, riots, war, rebellion, sabotage, acts of governmental authority or failure of governmental authority to issue licenses or approvals which may be required (“Force Majeure”).

 

(b)                                 The Party asserting the Force Majeure shall promptly notify the other Party of the event constituting Force Majeure and of all relevant details of the occurrence and where appropriate an estimate of how long such Force Majeure event shall continue.

 

(c)                                  If such Force Majeure event continues thereafter and in any event, the Parties shall consult with each other in order to find a fair solution and shall use all reasonable endeavors to minimize the consequences of such Force Maj eure.

 

20.8                        Counterparts. This Agreement shall be executed in two (2) counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

20.9                        Notices. All notices, statements, and reports required to be given under this Agreement shall be in writing and shall be addressed as follows:

 

To ADDEX:                              ADDEX Pharmaceutical Ltd.

12, chemin des Aulx

1228 Plan-les-Ouates

Geneva, Switzerland

Attn: Chief Executive Officer, Vincent Mutel

Fax: +41 22 884 15 56

Phone: +41 22 884 15 55

With a copy to: Chief Financial Officer, Tim Dyer, same address

 

To OMP                                                  Ortho-McNeil Pharmaceuticals Inc U.S. Route 202

P.O. Box 300

Raritan, New Jersey, USA 08869-0602

Attn: President

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

74


 

With a copy to:                                    Janssen Pharmaceutica, N.V.

Turnhoutseweg 30 B-2340

Beerse, Belguim

Attn: Didier De Chaffoy

Fax: 32 14 60 5625

Phone: 32 14 60 3710

 

With a copy to:                                    Johnson & Johnson Law Department Europe,

Lenneke Marelaan 6,

1932 St-Stevens Woluwe, Belgium

 

Any Party hereto may change the address to which notices to such Party are to be sent by giving notice to the other Party at the address and in the manner provided above. Any notice may be given, in addition to the manner set forth above, by telex, facsimile or cable, provided that the Party giving such notice obtains acknowledgment by telex, facsimile or cable that such notice has been received by the Party to be notified. Notices made in this manner shall be deemed to have been given when such acknowledgment has been transmitted. Otherwise, notice shall be deemed to have been given when delivered if personally delivered on a business day, on the fifth (5th) business day after dispatch if sent by a professional courier and on the tenth (10th) business day following the date of mailing if sent by registered or certified mail.

 

20.10                 Waiver. The failure of either Party to enforce any provision of this Agreement at any time shall not be construed as a present or future waiver of such or any other provision of this Agreement. The express waiver in writing by either Party of any provision or requirement hereunder shall neither be deemed nor operate as a future waiver of such or any other provision or requirement.

 

20.11                 Modifications. No amendment, waiver or modification of this Agreement shall be valid or binding on either Party unless made in writing and signed by duly authorized representatives of both Parties.

 

20.12                 Headings. All headings and captions used in this Agreement are for convenience only, and are not intended to have any substantive effect.

 

20.13                 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by each Party as a licensor are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, U.S. Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under section 101(35A) of the Bankruptcy Code if

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

75


 

the Code applies to this Agreement. The Parties agree that each licensee of such rights under this Agreement, shall retain and may fully exercise all rights and elections it would have in the case of a licensor bankruptcy under the Bankruptcy Code if the Code applies to this Agreement. Each Party agrees during the term of this Agreement to create or maintain current copies, or if not amenable to copying, detailed descriptions or other appropriate embodiments, of all such intellectual property licensed to the other Party to the extent applicable laws permit.

 

20.14                 Patent Marking. Each Party shall, if applicable, mark and cause its Affiliates and Sublicensees to mark Collaboration Product sold with the appropriate patent numbers of the relevant Patents, provided such marking is required by law or required to assert patent infringement against a Third Party. The foregoing obligation shall be subject to size and space limitations.

 

20.15                 Anti-Trust Filings.

 

The Parties shall co-operate fully and comply with the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations issues thereunder, to file at OMP’s expense any required Notification and report form with the Federal Trade Commission (FTC) and the Department of Justice (DOJ) in accordance with the rules and regulations with respect to the transactions contemplated under this Agreement. In the event such a filing is required, no payments hereunder shall be due until after expiration of the appropriate waiting period as prescribed by such rules and regulations. In the event this Agreement is not approved by the FTC and DOJ, this Agreement will be modified to comply with such requirements or, if impracticable, terminate and no payments will be due.

 

IN WITNESS WHEREOF, ADDEX and OMP have caused this instrument to be executed in duplicate by their respective duly authorized officers.

 

 

ORTHO-MCNEIL

 

PHARMACEUTICALS Inc.

 

 

 

Date:

 

 

 

 

 

By:

 

 

Title:

 

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

76


 

 

ADDEX PHARMACEUTICALS Ltd.

 

 

 

Date:

 

 

 

 

 

By:

 

 

Title:

 

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

77


 

APPENDIX A

 

DETAILED RESEARCH PLAN BETWEEN OMP AND ADDEX

 

[***]

 


 

APPENDIX B

 

[***]

 


 

APPENDIX C

 

1.                                      ARBITRATION PROCEEDINGS

 

1.1                               Mediation of Disputes

 

a.              Any dispute, controversy or claim arising out of or related to this agreement, or the interpretation, application, breach, termination or validity thereof, including any claim of inducement by fraud or otherwise, which claim would, but for this provision, be submitted to arbitration shall, before submission to arbitration, first be mediated through non-binding mediation in accordance with [***], except where that procedure conflicts with these provisions, in which case these provisions control. The mediation shall be conducted in [***] and shall be attended by a senior executive with authority to resolve the dispute from each of the operating companies that are parties.

 

b.              The mediator shall be neutral, independent, disinterested and shall be selected from a professional mediation firm such as [***].

 

c.               The parties shall promptly confer in an effort to select a mediator by agreement. In the absence of such an agreement within [***] calendar days of initiation of the mediation, the mediator shall be selected by [***] as follows: [***] shall provide the parties with a list of at least [***] names from the [***]. Each party shall exercise challenges for cause, [***] peremptory challenges, and rank the remaining candidates within [***] working calendar days of receiving the [***] list. The parties may together interview the [***] top-ranked candidates for no more than [***] each and, after the interviews, may each exercise one peremptory challenge. The mediator shall be the remaining candidate with the highest aggregate ranking.

 

d.              The mediator shall confer with the parties to design procedures to conclude the mediation within no more than [***] calendar days after initiation. Under no circumstances may the commencement of arbitration under paragraph 1.1 (a) above be delayed more than [***] calendar days by the mediation process specified herein absent contrary agreement of the parties.

 

e.               Each party agrees not to use the period or pendency of the mediation to disadvantage the other party procedurally or otherwise. No statements made by either side during the mediation may be used by the other or referred to during any subsequent proceedings.

 


 

f.                Each party has the right to pursue provisional relief from any court, such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration, even though mediation has not been commenced or completed.

 

1.2                               Arbitration of Dispute Resolution

 

a.              Any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach, termination or validity thereof, including any claim of inducement of this Agreement by fraud or otherwise, will be submitted for resolution to arbitration pursuant to the rules then pertaining of the [***], except where those rules conflict with these provisions, in which case these provisions control. The arbitration will be held in [***].

 

b.              The panel shall consist of three arbitrators chosen from the [***] (or, by agreement, from another provider of arbitrators) each of whom is a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. In the event the aggregate damages sought by the claimant are stated to be less than [***], and the aggregate damages sought by the counterclaimant are stated to be less than [***], and neither side seeks equitable relief; then a single arbitrator shall be chosen, having the same qualifications and experience specified above. Each arbitrator shall be neutral, independent, disinterested, impartial and shall abide by [***]

 

c.               The parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement within [***] calendar days of initiation of the arbitration, including jointly interviewing the final candidates, (2) to meet with the arbitrator(s) within [***] calendar days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than [***] months after selection of the arbitrator(s) and in the award being rendered within [***] calendar days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within [***] calendar days after the conclusion of the hearings.

 

d.              In the event the parties cannot agree upon selection of the arbitrator(s), the [***] will select arbitrator(s) as follows: [***] shall provide the parties with a list of no less than [***] proposed arbitrators ([***] if a single arbitrator is to be selected) having the credentials referenced above. Within [***] calendar days of receiving such list, the parties shall rank at least [***] of the proposed arbitrators on the initial [***] list, after exercising cause challenges. The parties may then interview the [***] candidates ([***] if a single arbitrator is to be selected) with the highest combined rankings for no more than [***] each and,

 


 

following the interviews, may exercise one peremptory challenge each. The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings. In the event these procedures fail to result in selection of the required number of arbitrators, [***] shall select the appropriate number of arbitrators from among the members of the various [***] peremptory challenges each.

 

e.               In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in paragraph c above, then the arbitrator(s) shall set dates for the hearing, any post-hearing briefing, and the issuance of the award in accord with the paragraph c schedule. The arbitrator(s) shall provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the paragraph c schedule may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than a total of ten calendar days for the hearing or permit either side to obtain more than a total of [***] hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than [***] individual requests for documents, including subparts, or [***] individual requests for admission or interrogatories, including subparts. Multiple hearing calendar days will be scheduled consecutively to the greatest extent possible.

 

f.                The arbitrator(s) must render their award by application of the substantive law of New Jersey and are not free to apply “amiable compositeur” or “natural justice and equity.” The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either party. The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence. To the extent possible, the arbitration hearings and award will be maintained in confidence.

 

g.               In the event the panel’s award exceeds [***] by agreement or, failing agreement within seven working days, pursuant to the selection procedures specified in paragraph d above. If [***] cannot provide such services, the parties will together select another provider of arbitration services that can. No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within [***] calendar days following oral argument as provided in paragraph h. Any such review must be initiated within [***] calendar days following the rendering of the award referenced in f above.

 


 

h.              The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings. The Appeal Arbitrator will consider only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering brief of the opposing party, plus a total of no more than [***] hours of oral argument evenly divided between the parties. The party seeking review must submit its opening brief and any reply brief within [***] and [***] calendar days, respectively, following the date of the award under review, whereas the opposing party must submit its responsive brief within [***] calendar days of that date. Oral argument shall take place within [***] months after the date of the award under review, and the Appeal Arbitrator shall render a decision within [***] calendar days following oral argument. That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act.

 

i.                  The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement of these provisions and the entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction shall act in the same fashion.

 

j.                 Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

 

k.              EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.

 

l.                 EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE OTHER.

 

m.          EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER.

 

n.              EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER.

 


 

APPENDIX D

 

[***]

 


 

APPENDIX F

 

JOHNSON & JOHNSON UNIVERSAL CALENDAR (2005)

 

 


 

APPENDIX H

 

ADDEX PATENTS

 

ADDEX’s Program Patents as of the Effective Date including but are not limited to.

 

[***]

 




EXHIBIT 10.2

 

LICENSE AGREEMENT

 

BETWEEN

 

INDIVIOR UK LIMITED

 

AND

 

ADDEX PHARMA S.A.

 

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 


 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

1.

DEFINITIONS

1

 

 

 

2.

LICENSE

10

 

 

 

3.

JOINT RESEARCH ACTIVITIES

12

 

 

 

4.

DEVELOPMENT ACTIVITIES

16

 

 

 

5.

DILIGENCE

17

 

 

 

6.

PAYMENT

17

 

 

 

7.

INTELLECTUAL PROPERTY

21

 

 

 

8.

WARRANTIES

27

 

 

 

9.

CERTAIN COVENANTS AND AGREEMENTS

29

 

 

 

10.

TERM; TERMINATION

30

 

 

 

11.

INDEMNIFICATION

33

 

 

 

12.

INSURANCE

34

 

 

 

13.

CONFIDENTIALITY

35

 

 

 

14.

MISCELLANEOUS

36

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 


 

LICENSE AGREEMENT

 

This License Agreement (this “Agreement”) is entered into as of this 2nd day of January 2018, by and between Indivior UK Limited (Co. No. 7183451) with a registered address of 103-105 Bath Road, Slough, Berkshire, SL1 3UH (“Indivior”), and Addex Pharma S.A., a company organized under the laws of Switzerland (“Addex”).

 

INTRODUCTION

 

WHEREAS, Indivior is engaged in the business of, among other things, developing, marketing and distributing pharmaceutical products;

 

WHEREAS, Addex owns certain intellectual property rights related to its GABAb program, including, but not limited to, ADX 71441 compound for the treatment of addictive disorders; and

 

WHEREAS, the Parties desire to enter into an agreement granting Indivior a license to such intellectual property to enable Indivior to develop, manufacture, market and distribute Product(s) (as defined below), subject to and in accordance with the terms and conditions of this Agreement.

 

In consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt of which is hereby acknowledged, Addex and Indivior agree as follows:

 

1.                                      DEFINITIONS

 

When used in this Agreement, each of the following terms, whether used in the singular or plural, shall have the meanings set forth in this Section 1:

 

1.1                               Accounting Standards” means, with respect to a Person, International Financial Reporting Standards (IFRS), as consistently applied by such Person across its operations.

 

1.2                               Addex Development Patent Rights” means any Patent Right generated from the activities of this Agreement that Covers a Licensed Compound but which Patent Right does not Cover any Addex Retained Compound, and which is not an Indivior Improvement Patent Right or a Joint Patent Right.

 

1.3                               Addex Existing Patent Rights” means the patents and patent applications set forth on Schedule 1.3 and Patent Rights relating or claiming priority thereto.

 

1.4                               Addex Improvements” means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Addex other than Joint Improvements.

 

1.5                               Addex Know-How” means all Know-How owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates (a) as of the date hereof or (b) which is created or acquired by Addex in the course of carrying out its obligations under this Agreement, in each case that is necessary or useful for the research, development, manufacture, use or commercialization of the Licensed Compounds and/or the Products.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.6                               Addex Other Patent Rights” means such rights that Addex has in any Patent Rights that are not: (a) Addex Existing Patent Rights, (b) Addex Development Patent Rights or (c) Addex Overlapping Patent Rights, but are other Patent Rights owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates and are filed or claim priority to an application filed before or during the Term and that contain a claim that Covers a Licensed Compound.

 

1.7                               Addex Overlapping Patent Rights” means any Patent Rights generated from the activities of this Agreement that Cover a Licensed Compound and also Cover an Addex Retained Compound, and which are not Indivior Improvement Patent Rights or Joint Patent Rights.

 

1.8                               Addex Patent Rights” means (a) the Addex Existing Patent Rights, (b) the Addex Development Patent Rights, (c) the Addex Overlapping Patent Rights and (d) Addex’s interest in any Addex Other Patent Rights and, to the extent Addex has a non-exclusive right to any Addex Other Patent Rights, reference to the Addex Other Patent Rights shall mean such non-exclusive right.

 

1.9                               Addex Product” means any pharmaceutical product that contains or comprises an Addex Retained Compound.

 

1.10                        Addex Retained Compounds” means (a) the Compounds that cease to be Development Compounds and become Addex Retained Compounds pursuant to Section 3.4 and (b) any Compounds discovered by Addex after the expiry of the Research Term.

 

1.11                        Addex Retained Patent Rights” means Patent Rights generated from the activities of this Agreement that Cover an Addex Retained Compound and that do not Cover any Licensed Compound.

 

1.12                        Affected Product” has the meaning set forth in Section 6.5(d).

 

1.13                        Agreed Assay” means the assay set out in Schedule 1.13.

 

1.14                        Affiliate(s)” means, with respect to a Party, any Person that is directly or indirectly controlled by, controlling, or under common control with such Party. For purposes of this definition only, the term “control” (including, with correlative meaning, the terms “controlling”, “controlled by”, and “under common control with”), as used with respect to the applicable Party, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Party, whether through ownership of interests representing equity, securities, or partnership interests or by contract, or otherwise. Ownership of more than fifty percent (50%) of such equity, securities or partnership interests in a Person shall, without limitation, be deemed to be control for purposes of this definition. For the purposes of this Agreement, an Addex Affiliate shall exclude any entity that, after the Effective Date, acquires control of Addex.

 

1.15                        ANDA” means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.16                        Annual Net Sales” means, with respect to any jurisdiction, the total Net Sales of all Products sold in such jurisdiction during any twelve (12) month period.

 

1.17                        Applicable Law” means federal, state, local and national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.

 

1.18                        Bankruptcy Code” has the meaning set forth in Section 2.3.

 

1.19                        Commercially Reasonable Efforts” means, with respect to the performance of development or commercialization activities with respect to the Licensed Compound, Development Compound or a Product by a Party, the performance of obligations or tasks in a manner consistent with the reasonable practices of a similarly situated biotechnology (in the case of Addex) or pharmaceutical (in the case of Indivior) company having similar resources for the development or commercialization (as applicable) of a product having similar technical and regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its development or product life cycle as such Licensed Compound, Development Compound or Product; provided that [***] Commercially Reasonable Efforts require a Party to take any actions that (a) require such Party to [***] under this Agreement, (b) would [***] or (c) [***] so long as [***].

 

1.20                        Compound” means any molecule that is a positive allosteric modulator of the GABAb receptors (a) with [***] or less as determined in the Agreed Assay and (b) at least [***], as determined in the Agreed Assay, and any racemate or enantiomer of such molecule, and any salt or hydrate of any of the foregoing.

 

1.21                        Cover” means, with respect to a patent or patent application for a Compound or Product, that a Third Party’s unlicensed research on, development, manufacture, or commercialization of such Compound, or a pharmaceutical product containing or comprising such Compound, or such Product would fall within at least one claim of such patent or patent application or would cause indirect infringement of the claim by a Third Party. With respect to a pending patent application, the phrase “would fall within the claim” intends such analysis to be based on the claims of such pending application as if they were contained in an issued or granted patent.

 

1.22                        Development Compound” has the meaning set forth in Section 3.4.

 

1.23                        Development Milestone Payments” has the meaning set forth in Section 6.3.

 

1.24                        Effective Date” means the date first written above.

 

1.25                        European Major Market” means any of the following countries in Europe: France, Germany, Italy, Spain and the United Kingdom.

 

1.26                        FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.27                        Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications.

 

1.28                        Filing Acceptance” means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in Europe for the manufacture, supply, marketing and sale of a pharmaceutical product.

 

1.29                        FTE” means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period (consisting of at least a total of [***] hours per year of dedicated effort). FTE efforts shall not include the work of general corporate or administrative personnel but a single FTE may comprise the work of one or more individuals.

 

1.30                        FTE Rate” means, for the period from the Effective Date to 31 December 2018, [***]. Thereafter, the FTE Rate shall be increased or decreased on 1 January of each year by the annual percentage increase or decrease in the UK Consumer Price Inflation published by the UK Office of National Statistics.

 

1.31                        Generic Product” means, with respect to any Product, a non-proprietary drug product that is a pharmaceutical equivalent to such Product, meaning that: (a) it is placed on the market pursuant to a validly granted marketing authorization by a Third Party and such Third Party has not been granted any rights by Indivior to place such product on the market, except in cases where (i) such Third Party has filed an ANDA and such rights were granted as part of an ANDA litigation settlement, (ii) Indivior did not receive monetary consideration from such Third Party and (iii) the grant of rights by Indivior was a good faith attempt to maximize the expected length of market exclusivity for such Product; (b) it contains the same active ingredient(s), has the same dosage form and route of administration; (c) the marketing authorization for which such product was obtained by making a cross reference to the data provided by Indivior to the relevant Regulatory Authority in the application for Marketing Approval for the corresponding Product; and (d) it is AB rated in the United States (or similar designation of therapeutic substitutability outside the United States).

 

1.32                        Good Clinical Practice” or “GCP” means, as to the United States and the European Union, good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

 

1.33                        Good Manufacturing Practice” or “GMP” means (a) as to the United States and the European Union, good manufacturing practices and general biological products standards as promulgated by the FDA pursuant to 21 CFR Parts 210, 211, 600 and 610 and as promulgated by the European Union pursuant to Commission Directive 2003/94/EC, respectively, each as may be amended from time to time, and (b) with respect to any other jurisdiction, manufacturing practices equivalent to the aforementioned good manufacturing practices as then in effect in the United

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

 

1.34                        Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of any government or a federal, state, province, county, city or other political subdivision thereof.

 

1.35                        Guaranteed Spend” has the meaning set forth in Section 3.1.

 

1.36                        IND” means an investigational new drug application filed with the FDA pursuant to 21 C.F.R. §312 or any similar authorization outside the US.

 

1.37                        Indication(s)” means a disease classification as defined within the “International Statistical Classification of Diseases and Related Health Problems” as published on the date hereof by the World Health Organization (e.g. F10 Mental and Behavioral Disorders due to the use of Alcohol is a distinct indication from F14 Mental and Behavioral Disorders due to the use of Cocaine).

 

1.38                        Indivior Exclusive Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications and/or the Shared Indications.

 

1.39                        Indivior Improvements” means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Indivior other than Joint Improvements.

 

1.40                        Indivior Improvement Patent Rights” means any Patent Rights, excluding any Joint Patent Rights, that Cover an Indivior Improvement.

 

1.41                        Initiation” means, with respect to a clinical study, the first dosing of the first patient in such client study.

 

1.42                        IP License” has the meaning set forth in Section 2.1.

 

1.43                        Joint Improvements” has the meaning set forth in Section 7.1(d).

 

1.44                        Joint Patent Rights” means any Patent Rights based on an invention made while carrying out the Parties’ activities pursuant to this Agreement which have multiple inventors, as defined by U.S. patent law, where there is at least one inventor, employed by or otherwise obligated to assign their rights in the invention to Addex, and at least one inventor employed by or otherwise obligated to assign their rights in the invention to Indivior.

 

1.45                        Joint Research Committee” and “JRC” have the meaning set forth in Section 3.8.

 

1.46                        Know-How” means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology (whether patentable or not) which are confidential to the relevant Party, including discoveries, formulae, materials (including

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions.

 

1.47                        Knowledge” means, with respect to Addex, facts or other information [***].

 

1.48                        Launch Date” means, on a country-by-county basis, the date of the first commercial sale of a Product by Indivior, its Affiliate or sublicensee to a Third-Party after Marketing Approval together with any required pricing and reimbursement approvals for such·Product has been obtained in such country; provided that sales prior to receipt of Marketing Approval for such Product, such as so-called “treatment IND sales,” “named patient sales”, “Temporary Authorization for Use in France”, and “compassionate use sales,” shall not be construed as comprising a Launch Date.

 

1.49                        Licensed Compound” means any molecule that is (a) Covered by the Addex Existing Patent Rights, as well as any enantiomer or racemate of such molecule, and/or any salt or hydrate of any of the foregoing; and/or (b) any Compound that is selected by Indivior as a Licensed Compound pursuant to Section 3.4.

 

1.50                        Licensed IP” means the Addex Patent Rights and Addex Know-How and Addex’s ownership interest in Joint Improvements and Joint Patent Rights.

 

1.51                        Major Market” means the United States, Canada, Australia and each of the European Major Markets.

 

1.52                        Marketing Approval” means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in any other country or jurisdiction for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, “Marketing Approval” shall not include any governmental pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction.

 

1.53                        NDA” means a New Drug Application, as defined in 21 U.S.C. §355(b) et seq., and the regulations promulgated thereunder, as such application may be amended or supplemented from time to time.

 

1.54                        Net Sales” means the gross amounts invoiced by Indivior, its Affiliates or their respective sublicensees (each, an “Indivior Party”) for the sale of a Licensed Compound or Product to Third Parties, less the following:

 

(i)                                     customary trade, quantity and cash discounts and any other adjustments, including granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care insurance carriers, governments, government-subsidized programs or managed care organizations,

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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or other institutions, or adjustments arising from consumer discount programs, in each case actually allowed and taken by a Third Party with respect to amounts invoiced for such Product;

 

(ii)                                  sales taxes or similar taxes, including duties or other governmental charges imposed on the sale of Product to a Third Party (excluding any taxes imposed on or measured by the net income or profits of the Indivior Party), not reimbursable, refundable or creditable to the Indivior Party; and

 

(iii)                               prepaid freight, insurance and handling fees actually invoiced (to the extent that the Indivior Party actually incurs the cost of freight, insurance and handling fees for Product and are not reimbursable, refundable or creditable to the Indivior Party);

 

in each case (i)-(iii) as determined from books and records of the Indivior Party maintained in accordance with applicable Accounting Standards. Amounts invoiced for sales or other transfer of such Product between or among Indivior, its Affiliates and/or other Indivior Parties shall be excluded from the computation of Net Sales unless such sales are intended for end use, in which case the fair market value of such sale shall be applied. If a sale or transfer of Product involves consideration other than cash or is not at arm’s length, then the Net Sales from such sale or transfer shall be the arm’s length fair market value, which generally will mean the Indivior Party’s average sales price for the Quarter.

 

1.55                        “[***]” means [***].

 

1.56                        “[***]” means [***].

 

1.57                        Party” means Indivior or Addex, as applicable, and “Parties” means both Indivior and Addex.

 

1.58                        Patent Filing Jurisdictions” means the United States, the European Major Markets and Japan.

 

1.59                        Patent Rights” means all issued patents, pending patent applications and additional patent applications, provisionals, continuations, continuations-in-part, divisions, reissues, reexaminations, extensions, supplementary protection certificates, substitutions and renewals of any of the foregoing, all foreign counterparts of any of the foregoing, and all new patents that may issue from or claim priority to any of the foregoing.

 

1.60                        Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

 

1.61                        Phase Ib Study” means a study in healthy subjects (rather than patients in the proposed indication) with a primary endpoint of safety and tolerability and which has the additional purpose of investigating the pharmacokinetics, pharmacodynamics and preliminary·indications of efficacy of the Product.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.62                        Phase II” means a human clinical trial, the principal purpose of which is to establish a dose and/or dose range and which is intended to generate additional safety data that will support the design of Phase III research protocols in a patient population that has the disease or condition being studied, as further described in 21 C.F.R. §312.21(b).

 

1.63                        Phase III” means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease or condition being studied, as further described in 21 C.F.R. §312.21(c), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an application for Marketing Approval for the indication being studied.

 

1.64                        Post-Grant Proceeding” means any re-examination, inter-partes review, re-issue, opposition, interference, cancellation, prior use, derivation, or other proceeding before an administrative agency or administrative tribunal (but excluding routine ex-parte patent prosecution and its associated administrative appeals) related to the validity, scope, ownership, or inventorship of a patent or allowed patent application, as well as any judicial appeals resulting from such a proceeding.

 

1.65                        Presentation” means, in relation to a Product or Generic Product, the pharmaceutical form of such product in combination with the route of administration such that, by way of example and without limitation, immediate release oral formulations are distinct presentations from sustained release formulations, buccal delivery is distinct from tablets that release in the digestive tract, injectable formulations are distinct presentations from tablets or inhalers and an injectable depot is a distinct presentation from a liquid injection.

 

1.66                        Product” means any pharmaceutical product that comprises or contains a Licensed Compound.

 

1.67                        Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Quarter shall end on the last day of the Term.

 

1.68                        Regulatory Authorities” means, with respect to any jurisdiction, the applicable Governmental Authority responsible for regulating the manufacture, distribution and sale of pharmaceutical products in such jurisdiction.

 

1.69                        Representatives” has the meaning set forth in Section 4.3.

 

1.70                        Research Activities” means the activities carried out by the Parties in the conduct of the Research Plan.

 

1.71                        Research Plan” has the meaning set forth in Section 3.2.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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1.72                        Research Term” means the period commencing on May 1, 2018 and expiring on the second anniversary thereof unless the Parties agree to extend the Research Term pursuant to Section 3.3.

 

1.73                        Reserved Indications” means the following Indications:

 

(a)                                 [***] including but not limited to Charcot Marie Tooth (G60);

 

(b)                                 [***] including but not limited to [***];

 

(c)                                  [***] including but not limited to [***]; and

 

(d)                                 [***].

 

1.74                        Royalty” has the meaning set forth in Section 6.4.

 

1.75                        Royalty Term” means, with respect to each Product in a particular country, the period of time commencing on the Launch Date of such Product and ending on the later of (a) ten (10) years after the Launch Date of the applicable Product in such country, (b) expiration in such country of the last Valid Patent Claim of the last-to-expire of any Joint Patent Rights or Addex Patent Rights that Cover such Product in the country of its manufacture or sale, and (c) expiration of any applicable marketing or data exclusivity conferred by, or as a consequence of a right, designation or authorisation granted by, a Regulatory Authority in a particular country with respect to such Product in such country.

 

1.76                        Sales Milestone Payments” has the meaning set forth in Section 6.6.

 

1.77                        Shared Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans for the Shared Indications.

 

1.78                        Shared Indications” means following Indications: [***].

 

1.79                        Successful Completion of a Phase I Study of a Product” means the first to occur of the following:

 

(a)                                 (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [***] that indicates that the [***] has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

 

(b)                                 (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [***] of a Product that indicates that the relevant study has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(c)                                  the dosing by or on behalf of Indivior, an Affiliate or sublicensee of a Product in a Phase II study for a Product.

 

1.80                        Term” has the meaning set forth in Section 10.1.

 

1.81                        Territory” means, subject to Section 10.2, worldwide.

 

1.82                        Third Party” means any Person other than Indivior, Addex or their respective Affiliates.

 

1.83                        Third Party Licenses” has the meaning set forth in Section 2.4.

 

1.84                        Valid Patent Claim” means an issued, unexpired claim of a patent or patent application within the Addex Patent Rights or Joint Patent Rights, in each case, that (a) has not been revoked, cancelled or held unenforceable, unpatentable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be, or has been, taken and (b) has not been abandoned or expired, except where such abandonment is a result of Indivior’s failure to maintain the Addex Patent Rights or Joint Patent Rights in the Patent Filing Jurisdictions as required herein, [***].

 

2.                                      LICENSE

 

2.1                               License Grant. Addex hereby grants to Indivior a world-wide, royalty-bearing, right and license, under the Licensed IP, to develop, conduct research related to, manufacture, make, have made, use, lease, license, import, offer for sale, commercialize, distribute, sell and have sold, or otherwise transfer the Licensed Compounds and/or Products in the Field (“IP License”). The IP License (a) is exclusive to Indivior (even as to Addex) and (b) includes the exclusive right to sublicense as described below.

 

2.2                               Affiliates; Right to Sublicense. Indivior shall have the right to (a) exercise the license granted under Section 2.1 through its Affiliates for so long as such entity remains an Affiliate of Indivior and (b) grant sublicenses of the Licensed IP to Third Parties without the prior written consent of Addex; provided that [***], Indivior shall not grant sublicenses of the Licensed IP to Third Parties for [***] without the prior written consent of Addex, which consent shall not be unreasonably withheld, delayed or conditioned. All such sublicenses shall be consistent with this Agreement and terminate automatically on the termination or expiry of this Agreement. Indivior shall remain responsible to Addex for all activities of its Affiliates and sublicensees to the same extent as if such activities had been undertaken by Indivior itself, subject to Section 10.2(c)(iv).

 

2.3                               Rights Under Bankruptcy. All rights and licenses granted under or pursuant to any section of this Agreement in connection with U.S. intellectual property rights are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code. Indivior, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding by or against

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Addex under the Bankruptcy Code, Indivior will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in Indivior’s possession, will be promptly delivered to it upon Indivior’s written request thereof. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code. Addex agrees that it shall not take any action in any bankruptcy or similar proceeding related solely to and commenced as a direct consequence of the insolvency of Addex to reject or object to this Agreement or any rights granted herein.

 

2.4                               Third Party Licenses.

 

(a)                                 In the event that it is necessary or useful to obtain licenses under any Patent Rights claiming the use of, or composition of matter of any Licensed Compound from any Third Party (“Third Party Licenses”) in order to commercialize any Product(s), Indivior may, in its discretion and cost, obtain such Third Party Licenses. For the avoidance of doubt, the term Third Party Licenses shall not include intellectual property licenses for new manufacturing process or formulation technologies that may be selected by Indivior.

 

(b)                                 Indivior shall be responsible for the royalty costs or other fees payable with respect to such Third Party Licenses; provided that Indivior may deduct up to [***] of the amounts paid to the relevant Third Party under the relevant Third Party License from the Royalty payable by Indivior to Addex pursuant to Section 6.4; provided further that in no event shall any such offset reduce the Royalty payable to Addex in respect of a country to less than [***] of the royalty rates set out in the table in Section 6.4.

 

2.5                               Retained Rights. Addex retains the right under any Licensed IP to research, develop, manufacture, commercialize and otherwise exploit any Addex Retained Compounds and/or Addex Products solely in the Reserved Indications and the Shared Indications by itself, through Affiliates and/or through sublicensees and Addex shall have no obligation to account to Indivior for any consideration it may receive in respect of such Addex activities; provided that any license granted by Addex in respect of any Addex Retained Compounds or Addex Products shall not be inconsistent with the terms of this Agreement. The Parties may, from time to time, discuss any advances in the understanding of the use of Compounds in the treatment, diagnosis and/or prevention of any disease in humans and, subject to the prior written agreement of the Parties, any indications discussed may be included in the Reserved Indications or the Shared Indications.

 

2.6                               Joint Patent Rights. It is agreed between the Parties as follows:

 

(a)                                 Unless otherwise expressly provided herein, Addex retains all of its ownership rights to the Joint Patent Rights. Addex’s rights to any Joint Patent Rights shall be included in the scope of the Licensed IP, solely to the extent they contain a claim that Covers a Licensed Compound and are applicable in the Field.

 

(b)                                 Unless otherwise expressly provided herein, Indivior retains all of its ownership rights to the Joint Patent Rights. Indivior’s rights to any Joint Patent Rights which relate solely to an Addex Retained Compound shall be licensed to Addex: (i) for the Reserved Indications

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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only on an exclusive basis (even as to Indivior); and (ii) for the Shared Indications on a non-exclusive basis, and in each case on a sublicensable, perpetual, irrevocable and royalty free basis.

 

The Parties agree that, except to the extent that Indivior has exclusively licensed the relevant Joint Patent Rights to Addex or Addex has exclusively licensed the Joint Patent Rights to Indivior hereunder, either Party may license, assign, mortgage or exploit its interest in an invention claimed in such Joint Patent Rights without the consent of the other Party and either Party may otherwise undertake all activities a sole owner might undertake with respect to its interest in such joint invention without the consent of the other Party, except as otherwise provided for in this Agreement or as the Parties may otherwise agree in writing.

 

2.7                               Exclusivity. During the Term, neither Party, by itself, its Affiliates or through any Third Party (including licensees or sublicensees), shall develop, seek Marketing Approval for, manufacture, import, market, sell, distribute, license or otherwise commercialize any [***], except pursuant to this Agreement.

 

2.8                               Field Restrictions. During the Term, Indivior shall not, directly or indirectly (including through sublicensees and Affiliates), conduct activities with respect to Compounds, Licensed Compounds or Products outside of the Field and Addex shall not, directly or indirectly (including through licensees and Affiliates), conduct activities with respect to Compounds (except as expressly provided in this Agreement), Addex Retained Compounds or Addex Products within the Indivior Exclusive Field or, with respect to Licensed Compounds or Products, outside the Indivior Exclusive Field.

 

3.                                      JOINT RESEARCH ACTIVITIES

 

3.1                               Guaranteed Spend. Indivior shall pay to Addex at least $2 million ($2,000,000) per twelve (12) month period during the Research Term and Addex shall use such sums to carry out its research and/or discovery activities into the Compounds (including dedicating the number of FTEs required); provided that in no event shall Indivior be required to pay more than $2 million ($2,000,000) for such research and/or discovery activities in any 12-month period (“Guaranteed Spend”), unless otherwise agreed. Once the Research Plan has been agreed upon pursuant to Section 3.2, the Guaranteed Spend shall be used to fund the Research Plan. During the Research Term, payment of the Guaranteed Spend shall be paid [***] prior to agreement of the Research Plan and thereafter in accordance with the budget agreed as a part of the Research Plan, in each case within [***] days of receipt of an invoice from Addex.

 

3.2                               Research Plan. The Parties shall each use their reasonable endeavors to reach agreement on, and execute, within [***] days of the Effective Date, a written plan for joint research and/or discovery of Compounds pursuant to this Article 3 (“Research Plan”), which plan shall specify, among other things, the obligations of each Party and the budget for implementing such Research Plan. Addex shall, subject to Sections 3.4 and 3.5 carry out its responsibilities (including dedicating the number of FTEs required) under the Research Plan during the Research Term. Any disputes related to the preparation of or amendment to the Research Plan shall be handled in accordance with Section 14.12.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

12


 

3.3                               Research Term. The initial Research Term may be extended [***] if both Parties agree in writing, at least [***] days prior to the expiry of the then-current Research Term, to extend the Research Term, such agreement to include a revised Research Plan to cover the additional work, the number of FTEs to be provided by each Party for such work and a budget for the additional work.

 

3.4                               Selection of Compounds. Within [***] days of the end of the Research Term, Addex shall compile a report that sets out all of the Compounds identified in the course of undertaking the Research Plan and the Parties shall discuss whether any of the Compounds so identified meet the target product profile in the Research Plan and are suitable for further development (each such Compound, subject to this Section 3.4, a “Development Compound”). In the event that Indivior considers any of the Compounds suitable for further development, it shall have the right to select such Compounds as follows for further development on the following basis:

 

(a)                                 Indivior shall be entitled to designate in writing one (1) Development Compound for further development and, on such selection, the relevant Compound shall become a Licensed Compound and shall cease to be a Development Compound. In making any selection of a Development Compound pursuant to this Section 3.4(a). Indivior shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights;

 

(b)                                 Addex shall then be entitled to designate in writing one (1) Development Compound for further development and, on such selection the relevant Compound shall become an Addex Retained Compound and cease to be a Development Compound. In making any selection of a Development Compound pursuant to this Section 3.4(b), Addex shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights; and

 

(c)                                  to the extent that there are any further Development Compounds that have not been selected by a Party, the process in Sections 3.4(a) and 3.4(b) shall be repeated until no further Development Compounds remain or until one Party decides that it does not wish to designate any further Development Compounds in which case (i) if it is Addex that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Licensed Compounds and (ii) if it is Indivior that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Addex Retained Compounds.

 

3.5                               Diligence.

 

(a)                                 Each Party shall use Commercially Reasonable Efforts to carry out its obligations under the Research Plan. Each Party shall provide the other with [***] reports detailing the progress of its activities under the Research Plan. Further, each Party shall promptly provide a summary report on significant results where the Research Plan identifies an outcome as requiring prompt disclosure.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

13


 

(b)                                 The Parties acknowledge and agree that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement.

 

3.6                               Authority. Indivior (by itself or through its Affiliates) shall have sole responsibility, including sole responsibility for all funding, resourcing and decision-making, for all further research and development with respect to Licensed Compounds and Products.

 

3.7                               Subcontracting. Each Party shall have the right to subcontract its obligations under this Agreement to subcontractors and Affiliates; provided that such subcontractors and Affiliates agree in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 3.5(a) and the confidentiality provisions of Article 13.

 

3.8                               Joint Research Committee.

 

(a)                                 Within [***] days after the Effective Date, the Parties shall establish a joint research committee (the “Joint Research Committee” or “JRC”). The JRC shall consist of [***] representatives with voting rights from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the Research Plan and each Party’s Research Activities, with each Party having one (1) vote. From time to time, each Party may substitute one (1) or more of its representatives to the JRC on written notice to the other Party. The chair and the co-chair of the JRC shall be one of the Indivior and Addex voting representatives on the JRC, respectively. From time to time, Indivior or Addex may change the representative who will serve as chairperson or co-chair, respectively, upon written notice to the other Party.

 

(b)                                 The JRC shall provide strategic direction for, and monitor, manage, coordinate and oversee the conduct of, the Research Activities by the Parties under the Research Plan. In particular, the JRC shall: (i) serve as a forum for discussing the proposed Research Activities and periodically review the Research Plan, and review and approve amendments thereto; (ii) oversee the Parties’ performance of the Research Plan; (iii) obtain and review each Party’s written reports detailing the progress of its activities under the Research Plan; and (iv) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

 

(c)                                  During the Research Term, the JRC shall meet [***], with the location of such meetings alternating between locations designated by Addex and locations designated by Indivior, provided that such meetings may be held via telephone conference upon mutual agreement of the Parties. The chairperson in collaboration with the co-chair of the JRC shall be responsible for calling meetings on no less than [***] days’ notice and the chairperson and co-chair shall collaborate to prepare an agenda for circulation in advance of each such meeting. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least [***] days in advance of the applicable meeting; provided, that under exigent circumstances requiring input by the JRC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

14


 

later addition of such agenda items or the absence of a specific agenda for such meeting. The chairperson and co-chair of the JRC shall prepare and circulate for review and approval of the Parties minutes of each meeting within [***] days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JRC.

 

(d)                                 The JRC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JRC shall exist whenever there is present at a meeting at least one (1) voting representative appointed by each Party. Representatives of the Parties on the JRC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by proxy shall be allowed. The JRC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JRC may attend meetings of the JRC; provided, that such attendees (i) shall not vote or otherwise participate in the decision-making process of the JRC, and (ii) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Article 13.

 

(e)                                  If the JRC cannot, or does not, reach consensus on any matter relating to Research Activities or the Research Plan within [***] days after such dispute or lack of consensus was raised at a JRC meeting, then such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The Parties acknowledge that, notwithstanding the creation of the JRC, each Party shall retain the rights, powers and discretion granted to it hereunder. The Parties further acknowledge that the JRC shall not have the power to amend this Agreement and that any amendments to this Agreement shall be subject to Section 14.10.

 

(f)                                   Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JRC.

 

3.9                               Records. Each Party shall, and shall ensure that its Affiliates subcontractors, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, which shall be complete and accurate and shall properly reflect all work done and results achieved in the performance of its obligations under the Research Plan, which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such records shall be retained by each Party and its Affiliates and subcontractors for at least [***] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, Addex shall provide, and shall procure that its Affiliates and subcontractors provide, copies of the records it has maintained pursuant to this Section 3.9 to Indivior.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

15


 

3.10                        Joint Research. This Agreement is intended by the Parties to be considered a “Joint Research Agreement” for the purposes of 35 U.S.C. 102(c), or any successor to that statute in the United States, or other statutes having similar effect in jurisdictions outside the United States. Each Party consents to the other Party disclosing the names of the Parties to this agreement and identifying this Agreement as a “Joint Research Agreement” in any patent application filed pursuant to this Agreement, including, for the avoidance of doubt, patents claiming Indivior Improvements.

 

4.                                      DEVELOPMENT ACTIVITIES

 

4.1                               Regulatory Matters. As between the Parties, on a Licensed Compound-by-Licensed Compound basis, Indivior shall have the sole right to prepare, obtain, and maintain any applications for Marketing Approval (including the setting of the overall regulatory strategy) other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Products (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities).

 

4.2                               Pharmacovigilance. Within [***] days after IND effectiveness of the first Licensed Compound, Product, Addex Retained Compound or Addex Product, the Parties shall determine if it is necessary to, and if so, enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed format in order to monitor the safety of the Licensed Compounds, Products, Addex Retained Compounds and Addex Products and to meet reporting requirements with any applicable Regulatory Authority.

 

4.3                               [***] Meetings. Each of the Parties shall keep the other informed about the status and results of its development activities with respect to the Licensed Compounds, Products, Addex Retained Compounds and Addex Products, as applicable. Promptly, and in any event within [***] days, after the Effective Date, each of the Parties shall designate an employee with sufficient knowledge such Party’s obligations hereunder (collectively, “Representatives”). From time to time, each Party may substitute one (1) or more of its Representatives on written notice to the other Party. From and after the Effective Date and until receipt of the first Marketing Approval, upon [***] days’ notice by either Party, the Representatives shall meet [***], to:

 

(a)                                 discuss the development plans for Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

 

(b)                                 review of regulatory strategies for obtaining and maintaining Marketing Approval for Products;

 

(c)                                  share safety and other relevant data related to the development of Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

 

(d)                                 inform Addex of material development/regulatory events and key Indivior decisions relating to the development activities for Licensed Compounds and Products; and

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

16


 

(e)                                  address safety issues relating to the development of Products and Addex Products.

 

Unless otherwise agreed by the Parties, at least one meeting per year required by this Section 4.3 will be in person [***] and all other meetings shall be by telephone conference.

 

4.4                               [***] Reports. Following receipt of Marketing Approval for a Product and continuing until such time as Marketing Approval has been obtained for Products under development in four additional Major Markets, Indivior shall provide to Addex, [***], unless agreed otherwise in writing by the Parties, a written report of the status of its efforts to develop such Products hereunder.

 

5.                                      DILIGENCE

 

5.1                               In General. Indivior shall have the sole right to develop and commercialize (and shall be solely responsible for, and shall control all aspects of, development and commercialization) Licensed Compounds and Products in the Field in the Territory at its own cost and expense (except as otherwise expressly set forth herein).

 

5.2                               Diligence. Indivior will use Commercially Reasonable Efforts to (a) develop one Product [***] and (b) commercialize one Product [***] following receipt of Marketing Approval [***]. Indivior shall undertake such development and commercialization in accordance with GMP, GCP and all Applicable Laws. If at any time Addex has a reasonable basis to believe that Indivior is in material breach of its material obligations under this Section 5.2, then Addex shall so notify Indivior, specifying the basis for its belief, and, without prejudice to any other rights that Addex may have under this Agreement, the Parties, within [***] days after such notice, shall meet, in person or via telephone conference, to discuss in good faith Addex’s concerns and Indivior’s development or commercialization plans, as applicable, with respect to any Products.

 

5.3                               Product Trademarks. Indivior shall have the sole right to determine and own the trademarks to be used with respect to the exploitation of the Products on a worldwide basis.

 

6.                                      PAYMENT

 

6.1                               Upfront License Fee. As partial consideration for the rights granted to Indivior herein, Indivior shall pay Addex an upfront license fee in the amount of $5,000,000 no later than [***] days after the Effective Date.

 

6.2                               Reserved.

 

6.3                               Development Milestone Payments. As additional consideration for the rights granted to Indivior herein, after the achievement by Indivior of any of the milestones set forth below, Indivior shall pay Addex the applicable milestone payment set forth next to such milestone below (“Development Milestone Payments”). For the avoidance of doubt, each Development Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone set forth in the table below.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

17


 

Development Milestone Event

 

Milestone Payment

1. [***]

 

[***]

2. [***]

 

[***]

3. [***]

 

[***]

4. [***]

 

[***]

5. [***]

 

[***]

6. [***]

 

[***]

7. [***]

 

[***]

8. [***]

 

[***]

9. [***]

 

[***]

10. [***]

 

[***]

Total

 

[***]

 

6.4                               Royalty.

 

(a)                                 As additional consideration for the rights granted to Indivior herein, during the Royalty Term (subject to Section 6.5(b)), Indivior shall pay to Addex, on a country-by-country basis, tiered royalty payments at the rates set out below on Net Sales of Products sold, on a country-by-country basis, by Indivior, its Affiliates and/or sublicensees (“Royalty”):

 

Annual Net Sales of Products in a Country

 

Royalty Rate

 

Portion of Annual Net Sales of Products in such country less than [***]

 

[***]

%

Portion of Annual Net Sales of Products in such country equal to or greater than [***] but less than [***]

 

[***]

%

Portion of Annual Net Sales of Products in such country equal to or greater than [***] but less than [***]

 

[***]

%

Portion of Annual Net Sales of Products in such country equal to or greater than [***]

 

[***]

%

 

(b)                                 Notwithstanding Section 6.4(a) above, with respect to [***], the Royalty payable with respect to each Product [***] shall be [***] once such Product [***].

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

18


 

6.5                               Royalty Term; Generic Competition.

 

(a)                                 Indivior’s obligation to pay a Royalty on Net Sales for each Product in a particular country shall terminate upon the expiration of the Royalty Term with respect to such Product, except as provided in Section 6.5(b) below.

 

(b)                                 Indivior’s obligation pursuant to Section 6.4 to pay a Royalty in respect of a particular Presentation of a Product (such Presentation being an “Affected Product”) in a country shall be reduced [***] in respect of a Quarter if, in respect of such Quarter, (i) a Generic Product [***] is marketed in such country and (ii) the Net Sales of such Affected Product in such country in the Quarter are less than [***] of the Net Sales generated by [***] such Product in such country in the Quarter immediately prior to the launch of [***] such Generic Product in such country.

 

6.6                               Sales Milestone Payments. As additional consideration for the rights granted to Indivior herein, Indivior shall pay to Addex a one-time milestone payment upon first achieving each of the Annual Net Sales thresholds set forth below (“Sales Milestone Payments”). For the avoidance of doubt, each Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone provided below.

 

Sales Milestone Event

 

Milestone Payment

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

First time Annual Net Sales exceed [***]

 

[***]

Total

 

[***]

 

6.7                               Payment/Reports.

 

(a)                                 All Development Milestone Payments shall be due and payable by Indivior within [***] days after completion of any of the milestones set forth in Section 6.3 above. Together with any such payment, Indivior shall deliver a written statement of completion and other pertinent and available information.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

19


 

(b)                                 All Royalty payments owed for each country shall be due and payable by Indivior on a Quarterly basis within [***] days after the last day of each calendar Quarter during the Royalty Term. Together with any such payment, Indivior shall deliver a report specifying, with respect to the applicable calendar Quarter: the (i) total gross invoiced amount from sales of Product in each country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from gross invoiced amounts to calculate Net Sales; (iii) Net Sales for such country; and (iv) the Royalty payment payable.

 

(c)                                  All Sales Milestone Payments shall be due and payable by Indivior within [***] days after the last day of the Quarter in which the relevant milestone event was achieved. Together with any such payment, Indivior shall deliver a report specifying, with respect to such 12-month period: the (i) total gross invoiced amount from sales of Product in such country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from such gross invoiced amounts to calculate Net Sales; (iii) Net Sales; and (iv) Sales Milestone Payment payable.

 

6.8                               Inspection of Records. Indivior shall keep records of its sales of Products reasonably necessary for the calculation of payment to be made to Addex hereunder. During the Term, and for a period of [***] thereafter, Addex shall have the right to have an independent certified public accountant, mutually agreed upon by Indivior, audit the records of Indivior. Addex, upon providing at least [***] days’ prior written notice to Indivior, may initiate such an audit no more than [***] during the Term and [***] thereafter. Any such audit shall be conducted during the normal business hours of Indivior, at a single location where Indivior shall make the records sought to be audited available, and in such a manner as shall not disrupt Indivior’s business operations. All personnel conducting the audit on behalf of the independent auditor shall enter into confidentiality agreements with Indivior. Each·such audit shall be conducted at the expense of Addex; provided that if the inspection and audit shows an underpayment of more than [***] of the amount due for the applicable period covered by the inspection, then Indivior shall reimburse Addex for all costs incurred in connection with such inspection within [***] days thereafter. Indivior shall pay to Addex the amount of any undisputed underpayment revealed by an examination and review. Any overpayment by Indivior revealed by an examination and review shall be deducted by Indivior from the next payment due to Addex.

 

6.9                               Payment Method.

 

(a)                                 All payments due under this Agreement shall be made by bank wire transfer in immediately available funds from the United Kingdom or the United States to an account in Switzerland, the United Kingdom or the United States designated by Addex in writing. In the event that Indivior pays from an account in a country other than the United States or the United Kingdom, then Indivior shall pay an amount such that, when any withholding or other deductions described in Section 6.9(c) have been applied, Addex receives the amount that it would have done had no deduction been made.

 

(b)                                 All payments hereunder shall be made in the legal currency of the United States of America, and all references to “$” or “Dollars” shall refer to United States dollars. For the purpose of converting any amount owed hereunder to $, such conversion shall be calculated using the average exchange rate for the conversion of foreign currency into United States Dollars,

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

20


 

quoted for current transactions for both buying and selling United States Dollars, as reported in The Wall Street Journal (Internet Edition) for the last business day of each month of the calendar Quarter to which such payment pertains. Without limiting any other remedy of Addex, if Indivior fails to make any payment that is due by the due date, Addex may charge interest in the amount overdue at the rate of [***]. Interest will be calculated on a daily basis.

 

(c)                                  Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use reasonable endeavors to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor shall remit such withholding or similar tax to the appropriate government authority, deduct the amount paid from the amount due to payee and secure and send to payee the best available evidence of the payment of such withholding or similar tax. If withholding or similar taxes are paid to a government authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes paid.

 

(d)                                 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within [***] days of receipt.

 

7.                                      INTELLECTUAL PROPERTY

 

7.1                               Ownership; Improvements.

 

(a)                                 As between the Parties, Addex shall remain the sole owner of all right, title and interest in and to the Licensed IP, subject to the rights and licenses granted to Indivior herein.

 

(b)                                 Indivior has the right when exercising its rights under the licenses granted in Section 2.1 hereunder to create Indivior Improvements and to file Indivior Improvement Patent Rights. All right, title and interest in any Indivior Improvements and Indivior Improvement Patent Rights shall remain the sole and exclusive property of Indivior and shall not be licensed to Addex. To the extent that Addex acquires rights in any Indivior Improvements or Indivior Improvement Patent Rights, Addex hereby irrevocably assigns, and shall cause to be assigned, to Indivior, such rights, and Indivior hereby accepts such assignment. Addex further acknowledges and agrees that

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

21


 

Indivior is the sole and exclusive owner of, all right, title and interest in and to such Indivior Improvements and Indivior Improvement Patent Rights. Addex shall take all action reasonably requested by Indivior to effect the foregoing, at Indivior’s expense. Indivior shall, in its own name and at its sole expense, take all actions which Indivior deems to be necessary or appropriate to protect and maintain the Indivior Improvements and Indivior Improvement Patent Rights. At Indivior’s request and expense, Addex shall cooperate with Indivior in taking any action reasonably necessary to protect and maintain Indivior Improvements and Indivior Improvement Patent Rights.

 

(c)                                  All right, title and interest in any Addex Improvements and all patents and patent applications directed to Addex Improvements shall remain the sole and exclusive property of Addex and shall be included in the scope of the Licensed IP. All such Addex Improvements and patents and patent applications directed to Addex Improvements that are made in connection with this Agreement shall constitute (i) Addex Development Patent Rights if they Cover Licensed Compounds but not Addex Retained Compounds, (ii) Addex Overlapping Patent Rights if they cover both Licensed Compounds and Addex Retained Compounds and (iii) Addex Retained Patent Rights if they Cover Addex Retained Compounds but not Licensed Compounds. To the extent that Indivior acquires rights, other than the licenses granted in this Agreement, in any Addex Improvements, Indivior hereby irrevocably assigns, and shall cause to be assigned, to Addex, such rights, and Addex hereby accepts such assignment. Indivior further acknowledges and agrees that Addex is the sole and exclusive owner of, all right, title and interest in and to such Addex Improvements. Indivior shall take all action reasonably requested by Addex to effect the foregoing, at Addex’s expense. Except as otherwise provided in this Article 7, Addex may, in its own name and at its sole expense and in consultation with Indivior, take all actions which Addex deems to be necessary or appropriate to protect and maintain the Addex Improvements. Except where otherwise provided in this Article 7, at Addex’s request and, in respect of Addex Improvements only, at Addex’s expense, Indivior shall cooperate with Addex in taking any action reasonably necessary to protect and maintain the Licensed IP and Addex Improvements.

 

(d)                                 In the event employees (or consultants) of both Parties (or their respective Affiliates) jointly develop any improvements, enhancements or modifications to the Licensed IP during the Term (“Joint Improvements”), such Joint Improvements shall be jointly owned by·both Parties; provided that Addex’s interest in such Joint Improvements shall be included in the scope of the Licensed IP. Each of Indivior and Addex shall promptly disclose to the other all inventions that it considers to be a Joint Improvement. Indivior shall have the right, but not the obligation, to file, prosecute and maintain any patent application directed to any such Joint Improvement in the name of Indivior and Addex jointly.

 

7.2                               Patent Prosecution and Maintenance.

 

(a)                                 Addex Existing Patent Rights. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Addex Existing Patent Rights. Indivior may conduct such activities in Addex’s name where reasonably necessary. If Indivior decides to abandon any Addex Existing Patent Rights, Indivior shall provide prior written notice sufficiently in advance of any abandonment to enable Addex to have the right, at its sole expense to, assume

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Existing Patent Rights in the applicable jurisdiction and Indivior shall transfer control of such prosecution in such jurisdiction to Addex. Upon delivery of such notice, such Addex Existing Patent Right shall cease to be an Addex Existing Patent Right and all of Indivior’s rights and licenses under and in respect of such Addex Existing Patent Right shall terminate. Except where Indivior abandons an Addex Existing Patent Right in accordance with this Section 7.2, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Existing Patent Rights in the Patent Filing Jurisdictions.

 

(b)                                 Addex Development Patent Rights. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Addex Development Patent Rights. Indivior may conduct such activities in Addex’s name where reasonably necessary. If Indivior decides to abandon any Addex Development Patent Rights, Indivior shall provide prior written notice sufficiently in advance of any abandonment to enable Addex to have the right, at Addex’s sole expense, to assume control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Development Patent Rights in the applicable jurisdiction. In the case of such abandonment, Indivior shall transfer control of such prosecution in such jurisdiction to Addex, except where such abandonment is made as a part of a reasonable prosecution strategy, such as, for example, an abandonment made in favor of another Addex Patent Right covering the same Licensed Compound to improve its term or allowability. Except where Indivior elects not to file or abandons an Addex Development Patent Right in accordance with this Section 7.2, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Development Patent Rights in the Patent Filing Jurisdictions (including using reasonable endeavors to prosecute any Addex Development Patent Rights not yet granted in the Patent Filing Jurisdictions).

 

(c)                                  Addex Overlapping Patent Rights. Addex shall, at its cost, be responsible for and shall undertake the preparation, filing and prosecution of Addex Overlapping Patent Rights, and Indivior shall cooperate with Addex in connection therewith. The Parties shall use Commercially Reasonable Efforts to reach agreement on matters involving the preparation, filing, and prosecution of the Addex Overlapping Patent Rights in a manner that does not jeopardize the scope, allowability, validity or term of Addex Development Patent Rights or any claims Covering Addex Retained Compounds, or Licensed Compounds. Where it is reasonable to file separately or divide Addex Overlapping Patent Rights into separate Addex Development Patent Rights and an application or applications that Cover Addex Retained Compounds, and where such action shall not jeopardize the scope or term of such Addex Overlapping Patent Rights, then, at the request of either Party, such Addex Overlapping Patent Rights shall be so filed separately or divided. If Addex decides not to file a patent application reasonably requested by Indivior, or to abandon any Addex Overlapping Patent Rights in a Patent Filing Jurisdiction, Addex shall provide prior written notice sufficiently in advance of such abandonment to enable Indivior to, and Indivior shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such jurisdiction at its own expense (in Addex’s name) and Addex shall transfer such prosecution in such jurisdiction to Indivior and such patent application or patent shall be treated as an Addex Development Patent Right for the purposes of this Section 7.2. Unless Addex elects not to file or abandons an Addex Overlapping Patent Right

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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in accordance with this Section 7.2(c), the Parties shall be equally responsible for renewal fees and take reasonable actions to maintain such Addex Overlapping Patent Rights in the Patent Filing Jurisdictions. Addex shall use reasonable endeavors to prosecute any Addex Overlapping Patent Rights not yet granted to cover the Licensed Compounds and the Addex Retained Compounds.

 

(d)                                 Joint Patent Rights. Indivior shall at its cost be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Joint Patent Rights in the Patent Filing Jurisdictions (it being understood that filings may occur in additional jurisdictions, but that there shall be no obligation hereunder regarding filings in such jurisdictions). If Indivior decides not to file a patent application for a Joint Patent Right or decides to abandon a Joint Patent Right in any country in the Territory, Indivior shall provide prior written notice to Addex sufficiently in advance of any abandonment to enable Addex to, and Addex shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such country in the Parties’ joint names. In such case, Indivior shall transfer control of such prosecution in such country to Addex. Unless Indivior elects not to file or abandons a Joint Patent Right in accordance with this Section 7.2(d), Indivior shall pay renewal fees and use reasonable endeavors to maintain and prosecute such Joint Patent Right.

 

(e)                                  Sharing of Information. Any Party controlling filing and prosecution of Addex Patent Rights or Joint Patent Rights shall keep the other Party reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications), and shall discuss steps with regard to the preparation, filing, and strategy (including timing of filing, data to be included, and scope of claims of patent applications) with respect to such Patents and shall reasonably consider the other Parties’ comments in respect of the same. The Parties shall promptly provide copies of all substantive correspondence to and from patent offices and patent attorneys/agents, including any available translations. A Party controlling prosecution shall provide copies of proposed substantive filings or foreign patent agent instructions for such filings reasonably in advance of any due date, to allow comment by the other Party, and shall take reasonable steps to accommodate suggestions or requests of the other Party when received. The obligation hereunder for a Party to use reasonable efforts to pursue a patent application shall not extend to taking a judicial appeal of an administrative decision at its own expense. The obligation hereunder for a Party to pay for the other Party’s prosecution of a patent application shall not extend to payment for a judicial appeal of an administrative decision for such application. When reasonably requested by the Party controlling prosecution, the other Party shall provide reasonable assistance to the Party controlling prosecution, including signing or executing any necessary documents. If the Party controlling prosecution elects to abandon a patent application, or not to pursue a patent application in a particular jurisdiction, it shall provide reasonable advance notice to the other Party to enable the other Party to file such application or assume control of the prosecution, at its own expense, in the name of the original controlling Party if reasonably necessary.

 

(f)                                   Post-Grant Proceedings. With respect to this Article 7:

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(i)                                     the Party controlling prosecution of a patent or patent application (x) shall have the right to control any Post-Grant Proceeding related to such patent or patent application in the other Party’s name if reasonably necessary and (y) use reasonable endeavors to accommodate suggestions or requests made by the non-controlling Party;

 

(ii)                                  the Party that is not controlling a Post-Grant Proceeding shall cooperate with the other Party as reasonable requested;

 

(iii)                               the Party that is responsible for the cost of patent prosecution for the patent or patent application at issue in the Post-Grant Proceeding shall also bear the cost of the Post-Grant Proceeding;

 

(iv)                              the Party that is not obligated to prosecute (or pay) for the prosecution of a patent application shall not be obligated to pursue (or pay) for a Post-Grant Proceeding;

 

(v)                                 the obligation on a Party hereunder to use reasonable endeavors to conduct a Post-Grant Proceeding shall not extend to pursuing a judicial appeal of an administrative tribunal or agency decision; and

 

(vi)                              in the event that Party controlling a Post-Grant Proceeding elects not to participate in or continue such proceeding (including any appeal), such Party shall provide reasonable notice to the other Party to allow such other Party to conduct or assume control the Post-Grant Proceeding, which may be assumed in the controlling Party’s name, if necessary.

 

(g)                                  Disputes. In the event that the Parties have a dispute regarding any of their respective rights or obligations under this Article 7, such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The foregoing shall not limit either Party’s remedies at law or equity with respect to a breach by the other Party of this Article 7.

 

7.3                               Patent Term Extensions. Each Party agrees to cooperate with the other, and to do all such acts and provide and sign all documents or copies thereof which may be reasonably necessary or desirable, in connection with the filing or prosecution of any application for any Addex Patent Rights or any Joint Patent Rights.

 

7.4                               Enforcement Actions.

 

(a)                                 Indivior shall have the initial right, but not the obligation, using counsel of its choice and at its own cost to enforce the Addex Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, and/or Joint Patent Rights in the Field or defend any declaratory action with respect thereto, as well as any nullity, inventorship or other action brought in a judicial proceeding affecting the scope, validity, or enforceability of the Addex Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, or Joint Patent Rights. Indivior shall have sole control of any decisions or other aspects of such action, subject to Section 7.4(b), and Addex shall, upon request, give to Indivior such reasonable assistance as Indivior may reasonably request, including by signing or executing any necessary

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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documents and consenting to its name being used in the proceedings; provided that Indivior shall reimburse Addex for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Addex by reason of lending its name to the proceedings, where such costs order did not result from Addex wrongdoing or from conduct that would require Addex to indemnify Indivior under this Agreement. Indivior shall keep Addex reasonably informed of the progress of the action and shall consider the comments and observations of Addex in prosecuting the action. If Indivior does not, within [***] days of a notice from Addex requiring bringing or defending such action, institute or defend such an action, then Addex shall have the right, but not the obligation, at its own cost, to commence proceedings or assume the defense in the Territory regarding the action and, in such case, Addex shall, subject to Section 7.4(b), have sole control of any decisions or other aspects of the action, and Indivior shall, upon request, give to Addex such reasonable assistance as Addex may reasonably request; provided that Addex shall reimburse Indivior for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Indivior in connection therewith, where such costs order did not result from Indivior’s wrongdoing or from conduct that would require Indivior to indemnify Addex under this Agreement; provided further that nothing in this Section 7.4(a) shall oblige Indivior to lend its name to, or be joined in, any proceedings commenced by Addex pursuant to the foregoing.

 

(b)                                 In the event that Addex desires to bring an action based on Addex Overlapping Patent Rights in the Indivior Exclusive Field, or in the Shared Field if such action relates to Licensed Compounds or Products, Addex shall provide reasonable advance notice to Indivior, and Addex shall consider comments and observations of Indivior before undertaking such action. Addex shall keep Indivior reasonably informed of the progress of any such action, including any issues affecting the validity or enforceability of Addex Overlapping Patent Rights or the scope of the Addex Overlapping Patent Rights with respect to Licensed Compounds or Products. Addex shall not take any position negatively affecting the scope of the Addex Overlapping Patent Rights with respect to their coverage of Licensed Compounds or Products. To the extent an invalidity or unenforceability defense or counterclaim is raised in such action, where permitted by the law of the relevant jurisdiction, Indivior shall have the right to intervene or join in such action to protect its interests in the Addex Overlapping Patent Rights. Addex shall not, without Indivior’s prior written consent (which consent shall not be unreasonably withheld or delayed) bring an action for infringement of (i) Addex Existing Patent Rights or (ii) Addex Development Patent Rights outside of the Field.

 

(c)                                  Addex shall have the option, but not the duty, to enforce the Addex Retained Patent Rights against Third Party infringement in the Field. Addex shall bear the costs of such enforcement.

 

(d)                                 Indivior shall not, without the prior written consent of Addex, which shall not be unreasonably withheld, delayed or conditioned, make any admission or enter into a settlement, consent to judgement or other voluntary final disposition in connection with any such proceedings under this Section 7.4 that: (i) extends, or purports to exercise, Indivior’s rights under the Licensed IP beyond the rights granted pursuant to this Agreement, (ii) makes any admission regarding wrongdoing by Addex, or the invalidity, unenforceability or absence of infringement of any Patent Rights within the Licensed IP; (iii) subjects Addex to an injunction or other equitable

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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relief; or (iv) obligates Addex to make a monetary payment. Similarly, in no case may Addex enter into any settlement or consent judgment or other voluntary final disposition that: (a) limits Indivior’s rights under the Licensed IP or under this Agreement other than as expressly stated herein; (b) makes any admission regarding wrongdoing on the part of Indivior, an Affiliate or sublicensee, or the invalidity, unenforceability or absence of infringement of any Licensed IP or Addex Patent Rights; (c) subjects Indivior to an injunction or other equitable relief; or (d) obligates Indivior to make a monetary payment; in all cases without the prior written consent of Indivior, which consent shall not be unreasonably withheld, delayed or conditioned. In no case shall Addex grant or have the power to grant any license for Compounds or pharmaceutical products containing or comprising Compounds in the Indivior Exclusive Field under the Addex Patent Rights, Addex Retained Patent Rights or Licensed IP. In no case shall Addex grant or have the power to grant any license for Licensed Compounds or Products in the Shared Field under the Licensed IP.

 

(e)                                  Any damages or award (including any award of costs) made in the proceedings shall be used first to reimburse each Party for any costs or expenses that it may have incurred in connection with the infringement proceedings (including without limitation, any amounts paid by the Party bringing the action to the other Party as reimbursement for expenses related to assisting in the proceedings) and any remaining amounts shall be retained by the Party to which they were awarded, save that (i) any award [***] shall be [***] and (ii) any award [***] shall, following reimbursement of costs and expenses in accordance with the foregoing, be [***]; provided that any such award shall [***].

 

7.5                               Third Party Infringement Claims. If the production or use of any Licensed Compound or the production, sale or use any Product pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Indivior or Addex or their respective Affiliates or sublicensees, such Party shall promptly notify the other Party hereto in writing. Indivior shall have the right to direct and control the defense and settlement thereof; provided, however, that Addex may participate in (but not control) the defense of such action and employ counsel at its own expense.

 

8.                                      WARRANTIES

 

8.1                               General Warranties. Each Party warrants to the other that:

 

(a)                                 such Party is duly organized and validly existing under the laws of its·jurisdiction of organization, and has full power and authority to enter into this Agreement and to carry out the provisions hereof;

 

(b)                                 such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;

 

(c)                                  this Agreement has been duly executed and delivered by such Party and constitutes the legal, valid and binding obligation of such Party enforceable against such Party in accordance with its terms, except to the extent that the enforceability thereof may be limited by (i) applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors’ rights and (ii) general principles of equity;

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(d)                                 the execution, delivery and performance of this Agreement by such Party does not conflict with its organizational documents or any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any Governmental Authority having jurisdiction over it;

 

(e)                                  such Party is aware of no action, suit or inquiry or investigation instituted by any governmental agency that questions or threatens the validity of this Agreement; and

 

(f)                                   has the full power and authority and has obtained all Third Party consents, approvals, and/or other authorizations required to enter into this Agreement and to carry out its obligations hereunder.

 

8.2                               Addex Warranties. As at the Effective Date, Addex warrants to Indivior that:

 

(a)                                 Addex exclusively owns all right, title, and interest to the Addex Existing Patent Rights, free and clear of all liens, security interests and encumbrances. As of the Effective Date, there are no existing licenses with respect to the Licensed IP, except for the IP License granted to Indivior herein.

 

(b)                                 The Addex Patent Rights listed on Schedule 1.3 are, as of the Effective Date, the only patents or patent applications owned or controlled by Addex or its Affiliates that Cover Licensed Compounds.

 

(c)                                  Addex and/or its Affiliates have obtained and properly recorded previously executed assignments for the Licensed IP as necessary to fully perfect its rights and title therein in accordance with governing law and regulations in each applicable jurisdiction.

 

(d)                                 There are no actions, suits, investigations, lawsuits, claims or proceedings pending or, to Addex’s Knowledge, threatened, involving the Licensed IP.

 

(e)                                  No invention claimed or described in the Addex Existing Patent Rights was made with government funding in circumstances that could negatively affect Indivior’s rights to exclusivity under this Agreement.

 

(f)                                   None of the Addex Patent Rights has been declared abandoned, or been found invalid, unpatentable, or unenforceable for any reason including in a final decision in any administrative, arbitration, judicial, or other proceeding. Addex does not have Knowledge of existing facts and circumstances that would reasonably lead it to believe that any of the Addex Existing Patent Rights are invalid, unpatentable, or unenforceable for any reason. Addex does not have any Knowledge of existing facts and circumstances that would reasonably lead it to believe that material prior art was withheld from the United States Patent Office during the prosecution of Addex Existing Patent Rights.

 

(g)                                  Addex does not have Knowledge of existing facts and circumstances that·would reasonably lead it to believe that the development manufacture, sale or commercialization of the ADX 71441 Compound in the Field will infringe any rights of any Third Party.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(h)                                 Addex has not misappropriated trade secrets or misused the confidential information of any Third Party in developing the Licensed IP.

 

(i)                                     To Addex’s Knowledge, no Third Party is infringing the Addex Existing Patent Rights. Addex has taken reasonable measures to protect the confidentiality of the Addex Know How and, to Addex’s Knowledge, the Addex Know How remains a protected trade secret of Addex.

 

(j)                                    Neither Addex, nor to Addex’s Knowledge, any Third Party, owns or has rights to any Marketing Approvals for any Products.

 

(k)                                 Neither Addex nor any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement that will result in any Third Party obtaining any interest in, or that would give to any Third Party any right to assert any claim in or with respect to, any rights granted to Indivior under this Agreement.

 

(l)                                     [***] that would adversely affect the rights of Indivior hereunder.

 

8.3                               No Other Warranties. The representations and warranties provided in this Article 8 are in lieu of any other representations or warranties, express or implied, and nothing herein shall be construed as a representation or warranty by either Party of any kind, including without limitation, any implied warranty of fitness for a specific purpose or merchantable quality, all of which are expressly and specifically excluded. No director, officer, employee or agent of any Party or its Affiliates is authorized to make any further representation or warranty to the other Party which is not contained in this Agreement and, without limiting Section 11.1, each Party acknowledges that it has not relied on any such oral or written representations or warranties.

 

9.                                      CERTAIN COVENANTS AND AGREEMENTS

 

9.1                               Disclosure; Technology Transfer.

 

(a)                                 Promptly after the Effective Date and as applicable during the Term, Addex shall disclose to Indivior all Licensed IP that Addex reasonably considers would be necessary or useful, or that Indivior reasonably requests, for the development of Licensed Compounds or Products as the same shall become available to it. If and as requested by Indivior, Addex will use reasonable efforts to disclose to Indivior or any Regulatory Authority all relevant Licensed IP in its possession required for Indivior to register for sale or obtain Marketing Approval for the Products.

 

(b)                                 Promptly after the Effective Date, Addex will, [***], make available to Indivior all Addex Know-How that Addex, acting reasonably, considers necessary or useful for Indivior to develop and/or commercialize Products, and Addex Know-How that Indivior reasonably requests, including all research data, pharmacology data, preclinical data, and/or clinical data for the Licensed Compounds.

 

9.2                               No Third-Party Rights; Liens. During the Term, Addex shall not (a) grant any rights to any Third Party in or relating to Licensed IP or (b) encumber any portion of the Licensed IP

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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with liens, mortgages, security interests or another similar interest in any way that would have a negative effect on Indivior’s rights hereunder; provided that for the avoidance of doubt any such liens, mortgages, and security interests shall be expressly subordinate to Indivior’s rights hereunder; and provided further that Addex shall be entitled to grant licenses in respect of Addex Retained Compounds and Addex Products, in each case solely outside the Indivior Exclusive Field.

 

9.3                               [***]. Addex will [***] (which, for clarity, shall not require Addex to [***] other than [***]), to facilitate [***]. Addex has delivered to Indivior all [***] with respect to the Licensed Compounds as of the date hereof and, after the date hereof, Addex shall not [***] with respect to the Licensed Compounds without the prior written consent of Indivior.

 

9.4                               Compliance with Laws. Each Party shall comply with all Applicable Laws related to its performance of this Agreement.

 

9.5                               Restructuring. Promptly after the Effective Date, Indivior and Addex will discuss ways to protect Indivior’s rights herein in the event of insolvency of Addex and, in its sole discretion, Addex will take such protective steps as agreed upon by the Parties.

 

9.6                               Insolvency Notice. Addex will promptly notify Indivior if (a) to its Knowledge, Addex becomes subject to bankruptcy or similar proceedings or if a receiver or trustee is appointed to take possession of its assets, (b) Addex gives notice to any of its creditors that it has suspended payment of, or is unable to pay, its debts generally or (c) Addex takes or suffers any similar or analogous action in any jurisdiction in consequence of its insolvency.

 

9.7                               No Assignment. During the Term, Addex shall not transfer or assign the Licensed IP to any Person without the prior written consent of Indivior, except to an Affiliate of Addex or to an acquirer of all or substantially all of the business of Addex to which this Agreement relates who, in each case, has expressly agreed in writing to be bound by the terms hereof.

 

10.                               TERM; TERMINATION

 

10.1                        Term. The term of this Agreement shall commence on the Effective Date and continue in full force on a country-by-country or Product-by-Product basis until Indivior has no remaining payment obligations with respect to such country or Product, unless earlier terminated pursuant to Section 10.2 below (the “Term”). Upon expiration (but not an earlier termination) of this Agreement in a particular country or with respect to a particular Product, then the IP License with respect to such country or with respect to such Product to which the Term has expired, as applicable, shall become an exclusive, perpetual, fully paid-up, royalty-free, license of the scope described in Section 2.1 above.

 

10.2                        Termination.

 

(a)                                 Indivior may terminate this Agreement in its entirety or with respect to one or more countries or Products (i) if before Indivior’s receipt of Marketing Approval in the applicable country, upon ninety (90) days prior written notice to Addex and (ii) if after Indivior’s receipt of Marketing Approval in the applicable country, upon twelve (12) months prior written notice to Addex; or

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(b)                                 Prior to Indivior’s receipt of Marketing Approval in a specific Major Market (“Non-Approval Market”), Addex may terminate this Agreement solely with respect to such Non-Approval Market or in its entirety (subject to Section 10.2(c)) if Indivior commits a material breach of this Agreement and fails to cure such breach within 90 days of Addex’s written notification to Indivior, or, with respect to its payment obligations set forth in Article 3.1 or Article 6, fails to cure such breach within 30 days after receiving two separate notices of such payment breach from Addex at least 30 days apart; provided that, in the case of non-payment pursuant to Article 6, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

 

(c)                                  Without prejudice to Addex’s right to seek damages or injunctive relief, Addex’s right to terminate this Agreement in respect of a Major Market where Indivior has received Marketing Approval or in respect of all markets where Indivior has received Marketing Approval in five of the eight Major Markets shall be limited to termination on the following basis;

 

(i)                                     After Indivior’s receipt of Marketing Approval in a specific Major Market (“Approval Market”), Addex may terminate this Agreement solely with respect to such Approval Market or in its entirety if Indivior commits a material breach of its obligations set forth in Article 13 or Section 6.8 or its payment obligations set forth in Article 6, and with respect to Article 13, fails to cure such breach within 30 days of Addex’s written notification to Indivior or, with respect Section 6.8, fails to cure such breach within 90 days of Addex’s written notification to Indivior or, with respect to Article 6, fails to cure such breach within 30 days after receiving two separate notices of such payment breach from Addex at least 30 days apart; provided that, in the case of non-payment pursuant to Article 6, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

 

(ii)                                  This Section 10.2(c) sets out Addex’s sole right to terminate this Agreement in respect of a Major Market where Indivior has received Marketing Approval to the exclusion of any common law or statute based law and after receiving such Marketing Approval, subject to the right of termination set out in this Section 10.2(c), the exclusive licenses granted in Section 2.1 in respect of such Major Market shall become perpetual and irrevocable.

 

(iii)                               This Section 10.2(c) sets out Addex’s sole right to terminate this Agreement in respect of all markets where Indivior has received Marketing Approval in respect of at least five of the eight Major Markets to the exclusion of any common law or statute based law and after receiving such Marketing Approval, subject to the right of termination set out in this Section 10.2(c), the exclusive licenses granted in Section 2.1 in respect of all markets shall become perpetual and irrevocable.

 

(iv)                              For the avoidance of doubt, Addex’s right of termination under Section 10.2(c) is limited to circumstances in Indivior’s reasonable control and shall not include circumstances where the cause of the breach was outside Indivior’s reasonable control including, in the case of a breach of Section 6.8 because a sublicensee is not permitting an audit provided that Indivior has used its best efforts to secure the compliance of the sublicensee and in the case of

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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Article 13 where such breach was committed by a Person without Indivior’s prior knowledge or consent.

 

10.3                        Effects of Termination.

 

(a)                                 Termination of Rights. Except as otherwise expressly set forth herein, all of the rights of Indivior in respect of Licensed Compounds and Products in a country shall terminate upon the termination date in respect of such Licensed Compound and/or Products in such country pursuant to Section 10.2.

 

(b)                                 Supplies of Products After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to any Products or countries, Indivior and its Affiliates and permitted sublicensees shall have the right, for a period of up to six (6) months following such termination, to sell (in the Field) Indivior’s inventory of Licensed Compounds and Products to which such termination applies, subject to all applicable payment and other related obligations in this Agreement. Upon expiration of such six (6) month period, Indivior shall, at Addex’s request, sell to Addex at cost any and all remaining quantities of any Licensed Compound and Products subject to the termination that are in its possession or control.

 

(c)                                  Clinical Studies After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to a Product, Indivior shall be responsible for completing (in accordance with the established protocols and its customary business practices) any clinical studies on Licensed Compounds and/or Products that it commenced prior to the termination of this Agreement in its entirety or with respect to such terminated Products. The foregoing shall be at Indivior’s cost where this Agreement is terminated by Indivior pursuant to Section 10.2(a) or Addex pursuant to Section 10.2(b). Indivior shall not commence any clinical study of Products at any time after it has given or received a notice of termination with respect to such Products pursuant to Section 10.2.

 

(d)                                 Transfer of Marketing Approvals and Other Regulatory Approvals After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to any Products or countries pursuant to Section 10.2, Indivior shall, upon request by Addex, use reasonable endeavors to transfer to Addex or to its designee, all Marketing Approvals and any other regulatory approvals relating to any Licensed Compounds or Products subject to such termination, together with any applications for the foregoing (including Marketing Approval applications or other such applications, as well as all existing INDs and other similar regulatory filings for the conduct of clinical trials with respect to Licensed Compounds or Products), together with a copy of all Know-How of Indivior solely relating to such Licensed Compounds or Products. All such transfers shall be completed in accordance with Applicable Laws. In the event that such a transfer is not possible, Indivior shall use reasonable endeavors to provide Addex with the benefit of the existing Marketing Approvals and applications therefor for Products, including, without limitation, granting Addex and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Marketing Approvals to Addex.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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(e)                                  Return of Confidential Information After Termination. Upon termination of this Agreement in its entirety pursuant to Section 10.2, Indivior shall, at Addex’s option, either return to Addex all tangible Confidential Information disclosed to Indivior by or on behalf of Addex (including all copies thereof) or destroy such Confidential Information; provided that Indivior shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under Article 13. Upon termination by Addex or by Indivior, Indivior shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems (other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems). Upon termination, Addex shall, at Indivior’s option, either return to Indivior all tangible Confidential Information disclosed to Addex by or on behalf of Indivior (including all copies thereof) or destroy such Confidential Information; provided that Addex shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under Article 13. Addex shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems).

 

10.4                        Survival. Termination of this Agreement shall not impair or prejudice any cause of action or claim that one Party may have against the other Party for breach of this Agreement. Subject to the foregoing sentence, upon expiration of this Agreement, Articles 7, 11, 12, 13 and 14 and Sections 2.3, 2.4, 2.6, 3.9, 6.8, 10.3 and 10.4 and any other the provisions that expressly survive termination or expiration of the Term, shall be so performed and extended and shall continue to be subject to the terms and conditions of this Agreement.

 

11.                               INDEMNIFICATION

 

11.1                        Restriction on Limitation of Liability. Neither Party limits or excludes its liability for fraud, fraudulent concealment or fraudulent misrepresentation, nor for death or personal injury arising from its negligence.

 

11.2                        Indemnification by Indivior. Indivior shall defend, indemnify and hold harmless Addex, its Affiliates and their respective officers, directors, employees and agents (the “Addex Indemnified Parties”) against all claims, liabilities, losses, costs, expenses (including reasonable attorney’s fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Addex Indemnified Parties resulting or arising from (a) any breach by Indivior of its representations and warranties, covenants or other obligations hereunder, (b) the negligent acts or omissions or willful misconduct of Indivior or its representatives, and (c) Third Party claims or suits in connection with the marketing, sale or distribution of the Products, except to the extent such claim is indemnifiable by Addex pursuant to Section 11.3 below.

 

11.3                        Indemnification by Addex. Addex shall defend, indemnify and hold harmless Indivior, its Affiliates and their respective officers, directors, employees and agents (“Indivior Indemnified Parties”) against all claims, liabilities, losses, costs, expenses (including reasonable attorney’s fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Indivior Indemnified Parties resulting or arising from (a) any breach by Addex of its warranties, covenants or other obligations hereunder and (b) the negligent acts or omissions

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

33


 

or willful misconduct of Addex or its representatives except to the extent such claim is indemnifiable by Indivior pursuant to Sections 11.2(a)-(b) above.

 

11.4                        Procedure. Any Party seeking to be indemnified by virtue of this Article 11 (the “Indemnitee”) shall promptly notify the other Party (“Indemnifying Party”) in writing of any Third-Party claim, action, proceeding or liability in respect of which it intends to seek indemnification hereunder. The Indemnitor shall have the right to control the defense of, and enter into any settlement with respect to, any such action, claim or liability; provided, that such settlement (a) includes an unconditional release of the Indemnitee from any and all liability to any Third Party, (b) does not adversely affect the Indemnitee’s rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein in order for it to exercise such rights, (c) does not involve any injunctive or other equitable relief which would be imposed on Indemnitee, and (d) does not provide for any finding or admission of a violation of law or violation of the rights of any person or entity by the Indemnitee or any of its Affiliates. No such action, claim or liability shall be settled by the Indemnitee without the prior written consent of the Indemnitor, and the Indemnitor shall not be responsible for any fees or other costs incurred other than as provided herein. The Indemnitee, its employees, agents and Affiliates shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification. The Indemnitee shall have the right, but not the obligation to be represented by counsel of its own selection and at its own expense.

 

11.5                        Mitigation. Any Party making a claim under this Article 11 shall take reasonable steps to mitigate and/or minimize the losses or damages suffered.

 

11.6                        LIMITATION OF LIABILITY. NEITHER PARTY WILL HAVE ANY OBLIGATION OR LIABILITY (WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND NOTWITHSTANDING ANY FAULT, NEGLIGENCE (WHETHER ACTIVE, PASSIVE, OR IMPUTED), REPRESENTATION, STRICT LIABILITY, OR PRODUCT LIABILITY), OR FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, MULTIPLIED, PUNITIVE, SPECIAL, OR EXEMPLARY DAMAGES OR LOSS OF REVENUE, PROFIT, SAVINGS OR BUSINESS ARISING FROM OR OTHERWISE RELATED TO THIS AGREEMENT, EVEN IF A PARTY OR ITS REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT TO THE EXTENT THAT SUCH DAMAGES (A) ARISE FROM THE FRAUD OF SUCH PARTY, OR (B) ARE AWARDED TO A THIRD PARTY IN A CLAIM FOR WHICH SUCH PARTY IS RESPONSIBLE FOR INDEMNIFICATION HEREUNDER.

 

12.                               INSURANCE

 

12.1                        Each Party shall maintain at all times during the Term, and for [***] thereafter, comprehensive insurance coverage to cover its activities related to this Agreement, including, in the case of Indivior, products liability insurance and coverage for clinical trials, underwritten by insurers maintaining an AM Best rating of not less than “A-VII” for insurance coverage obligations. Indivior and Addex hereby agree to provide written notice to the other upon becoming aware of any material change, non-renewal or cancellation of insurance.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

34


 

13.                               CONFIDENTIALITY

 

13.1                        In carrying out the terms of this Agreement, either Party may disclose (the “Disclosing Party”) to the other Party (the “Recipient”) information regarding the Disclosing Party and/or its Affiliates which is of a proprietary and of confidential nature, including any and all information, information regarding its business, Know-How, methods, trade secrets, financial information, customers and technology (collectively, “Confidential Information”). Confidential Information also includes the terms of this Agreement. The Recipient shall not use the Disclosing Party’s Confidential Information for any purpose other than as permitted herein and shall not disclose the Confidential Information to any Third Party, except to its employees, directors and other representatives who have a need to know such information to fulfill the provisions and intent of this Agreement, and who are bound by written obligations of confidentiality with respect to such information. The Recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the Disclosing Party, as Recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care. The Recipient shall promptly notify the Disclosing Party of any unauthorized use or disclosure, or suspected unauthorized use or disclosure, of the Disclosing Party’s Confidential Information of which the Recipient becomes aware. Each Party shall be liable for any failure of its employees, directors or other representatives to comply with the terms of this Article 13.

 

13.2                        The confidentiality obligations set forth in this Article 13 shall not apply to confidential information which: (a) is or becomes publicly known through no wrongful act or inaction of the Recipient; (b) the Recipient can demonstrate by written records was lawfully received by it from a Third-Party that is not legally or contractually prohibited from disclosing such information; (c) the Recipient can demonstrate by written records was developed by or for such Recipient independently of, and without the use of, such information disclosed by the Disclosing Party, (d) the Recipient is required by legal order to disclose, provided that the Recipient shall, where permitted, give the Disclosing Party immediate written notice of any such request so that the Disclosing Party may seek a protective order or other reliable assurance that confidential treatment will be accorded to the information so disclosed or (e) Indivior discloses to Regulatory Authorities in connection with obtaining Marketing Approval or other communications relating to commercialization of the Products.

 

13.3                        Addex shall not, and shall not permit any of its Affiliates to, grant any license or other right or permission to any entity that, after the Effective Date, acquires control of Addex, to use any confidential or non-public information regarding Addex Know-How in the Indivior Exclusive Field. Addex shall not, and shall not permit any of its Affiliates to, disclose any Addex Know How related solely and exclusively to Licensed Compounds or Products to such an entity.

 

13.4                        The confidentiality obligations set forth in this Article 13 shall survive for [***] years after termination or expiration of this Agreement.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

35


 

14.                               MISCELLANEOUS

 

14.1                        Expenses. Except as otherwise expressly provided herein, each Party to this Agreement shall bear its respective expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated hereby, including without limitation all fees and expenses of agents, legal counsel, accountants, tax and financial advisors and other facilitators and advisors.

 

14.2                        Force Majeure. Notwithstanding anything to the contrary herein, neither Party shall be liable or in breach of any provision of this Agreement for any failure or delay on their·part to perform any obligation set out in this agreement because of a force majeure event caused by acts of nature, flood, fire, explosion, war, terrorism, civil unrest, national or regional emergency or any cause beyond the reasonable control of the Party affected; provided that such Party gives prompt written notice to the other Party promptly after such event occurs and shall use Commercially Reasonable Efforts to fulfill its commitments hereunder as soon as possible.

 

14.3                        Recordation. Indivior may, at its cost and discretion, record the license granted herein, including by use of a short form document, as permitted or required by Applicable Law or otherwise, including recording a security interest in those jurisdictions which permit a licensee to do so. Addex hereby irrevocably designates and appoints Indivior and its duly authorized officers and agents, as Addex’s agent and attorney-in-fact to execute such documents and to do all other acts necessary or useful to record the license granted herein. Addex shall, upon request and at Indivior’s cost, give to Indivior such reasonable assistance as Indivior may reasonably request in connection with recording the license.

 

14.4                        Publicity. The Parties agree that the terms and contents of this Agreement (including the Schedules hereto) shall be treated as Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in this Section 14.4. Neither Party shall make any press release or public announcement regarding the execution or terms of this Agreement or the transaction contemplated by this Agreement without the consent of the other Party in accordance with this Section 14.4.

 

(a)                                 Subject to the other Party’s prior written consent (which shall not be unreasonably withheld), each Party shall have the right to make a press release announcing the achievement of each milestone payment under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Major Markets as they occur. Indivior shall be given at least [***] Business Days to review such Addex announcements and may make specific, reasonable comments on such proposed press release; thereafter, Addex and Indivior may each disclose to Third Parties the information contained in such press release without the need for further approval by the other Party.

 

(b)                                 Except as set forth in Sections 14.4(a) and 14.4(c), neither Party shall make a public announcement concerning the existence, terms and/or contents of this Agreement, except in the case of a press release or governmental filing required by Applicable Law (where reasonably advised by the disclosing Party’s counsel), in which event the disclosing Party shall provide the other Party with such advance notice as it reasonably can and shall not be required to obtain approval therefor. A Party commenting on such a proposed press release shall provide its comments, if any, within [***] Business Days (or within [***] Business Days in the event that

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

36


 

such shorter period is required to comply with Applicable Law) after receiving the press release for review and the other Party shall give good faith consideration to same.

 

(c)                                  The Parties acknowledge that either or both Parties may be obligated to file under Applicable Law a copy of this Agreement with the SEC or other government authorities. Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of at least the financial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment not less than [***] Business Days prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), and shall reasonably consider the other Party’s comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed, and shall only disclose Confidential Information which it is advised by counsel or the applicable governmental authority is legally required to be disclosed. No such notice shall be required under this Section 14.4(c) if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by either Party hereunder or otherwise approved by the other Party.

 

14.5                        Independent Contractors. It is understood and agreed that nothing in this Agreement nor any agreement related hereto is intended to nor shall create a partnership between the Parties. The Parties are independent contractors and neither Party is to be considered the agent, partner, joint venturer or employee of the other Party for any purpose whatsoever and neither Party shall have any authority to enter into any contracts or assume any obligations for the other Party.

 

14.6                        Further Assurances. Each of the Parties shall take, or cause to be taken, all actions necessary, proper, or advisable under applicable laws to give effect to the provisions of this Agreement.

 

14.7                        Assignment; Binding Effect. Neither Party shall, without the prior written consent of the other Party, assign, novate, transfer or convey this Agreement (in whole or in part) or any of its rights and obligations hereunder to any Third Party except as set forth in Sections 2.2 and 3.7); provided always that either Party may assign or novate this Agreement (in whole or in part) without such consent to any Affiliate or to an acquirer of all or substantially all of the business of the assigning Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or otherwise, without such consent; subject only to that assigning or novating Party giving written notice to the non-assigning Party and the acquirer agreeing in writing to be bound by the terms hereof.

 

14.8                        Entire Agreement. This Agreement constitutes the entire contract between the Parties pertaining to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether written or oral, of the Parties; and there are no representations, warranties, or other agreements between the Parties in connection with the subject matter hereof except as specifically set forth herein.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

37


 

14.9                        Waiver. The waiver by either Party of any right hereunder, or the failure to exercise such right, shall not be deemed a waiver of exercising such right in the future or of any other right hereunder in case of breach or failure by the other Party whether of a similar nature or otherwise.

 

14.10                 Amendments. No amendment and/or modification to this Agreement shall be effective unless set forth in a writing signed by both Parties.

 

14.11                 Notice. Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given upon delivery in person, the next day after delivery by express courier service (signature required) or five (5) days after the date of mailing by registered or certified mail, return receipt requested (or its equivalent), as the address shown below or such other address as a Party provides in accordance with this Section 14.11.

 

Notices sent to Addex shall be addressed to:

 

Addex Pharma SA
12, Chemin des Aulx
CH1228 Plan-les-Ouates
Geneva, Switzerland
Attention: Chief Executive Officer

 

With a copy to:

 

Addex Pharma SA
12, Chemin des Aulx
CHI 228 Plan-les-Ouates
Geneva, Switzerland
Attention: Chief Financial Officer

 

and

 

Cooley (UK) LLP
Dashwood
69 Old Broad Street
London, EC2M 1QS
Attention: John Wilkinson

 

Notices sent to Indivior shall be addressed to:

 

Indivior UK Limited
103-105 Bath Road
Slough, Berkshire
SL1 3UH
Attention: Assistant General Counsel, EMEA

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

38


 

With a copy to:

 

Indivior Inc.
10710 Midlothian Turnpike
Suite 430
Richmond, VA 23235
Attention: Chief Legal Officer
Telephone: (804) 594-4442

 

and

 

K&L Gates LLP
599 Lexington Avenue
New York, NY 10022
Attn: Calvina Bostick
         Whitney J. Smith

 

Notwithstanding the foregoing, reports required to be delivered pursuant to Sections 3.8, 4.4 and 6.7 shall be in writing and shall be deemed to have been sufficiently delivered upon transmission by email in accordance with the below (provided that if such email is not sent during normal business hours, such notice or communication shall be deemed to have been sent the next business day:

 

Addex: [***]

 

Indivior: [***]

 

14.12                 Governing Law; Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of England and Wales, except that the construction or effect of a patent or patent application licensed under this Agreement shall be decided in accordance with the laws of the country in which the patent or patent application was granted or filed. Each Party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute arising out of or in connection with this Agreement.

 

14.13                 Severability. If any provision in this Agreement is held to be invalid, void or unenforceable, then the remainder of this Agreement, or the application of such provision to the Parties or to the circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and shall be enforced to the fullest extent permitted by law. The Parties agree to renegotiate any such invalid, void or unenforceable provision in good faith in order to provide a reasonably acceptable alternative consistent with the basic purposes of this Agreement.

 

14.14                 Counterparts. This Agreement may be executed in one or more counterparts, none of which need contain the signatures of both Parties, each of which shall be deemed an·original, and all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or electronic signature, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered.

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

39


 

14.15                 Interpretation and Construction. Unless the context of this Agreement otherwise requires, (a) the terms “include,” “includes,” or “including” shall be deemed to be followed by the words “without limitation” unless otherwise indicated; (b) the terms “hereof,” “herein,” “hereby,” and derivative or similar words refer to this entire Agreement; and (c) the terms “Section” and “Schedule” refer to the specified Section and Schedule of this Agreement.

 

Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days. The headings and paragraph captions in this Agreement are for reference and convenience purposes only and shall not affect the meaning or interpretation of this Agreement. This Agreement shall not be interpreted or constructed in favor of or against either Party because of its effort in preparing it.

 

***

 

Certain confidential information contained in this document, marked by brackets and asterisks, has been omitted pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

40


 

This Agreement is signed by duly authorised representatives of the Parties:

 

 

Signed for an on behalf of

 

INDIVIOR UK LIMITED

 

 

 

 

By:

/s/ Richard Simkin

 

 

Name:

Richard Simkin

 

 

Title:

Chief Commercial Officer

 

 

 

 

Signed for an on behalf of

 

ADDEX PHARMA SA.

 

 

 

 

By:

/s/ Tim Dyer

 

 

Name:

Tim Dyer

 

 

Title:

Chief Executive Officer

 


 

SCHEDULE 1.3

 

ADDEX EXISTING PATENT RIGHTS

 

Reference

 

Country

 

Application Number

 

Patent Number

 

Grant Date

 

Expiry Date

 

Status

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 


 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 


 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 


 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 


 

 

 

[***]

 

 

 

[***]

 

 

 

[***]

 

[***]

 


(1)[***]

 


 

SCHEDULE 1.13

 

AGREED ASSAY

 

The details of the Agreed Assay are as follows:

 

[***]

 

OR

 

-                                            [***]

 




Exhibit 10.3

 

Execution Version

 

ADDEX THERAPEUTICS LTD.

REGISTRATION RIGHTS AGREEMENT

 


 

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

1.

Definitions

1

 

 

 

2.

Registration Rights

6

 

2.1

Demand Registration

6

 

2.2

Company Registration

11

 

2.3

Underwriting Requirements

11

 

2.4

Reserved

13

 

2.5

Obligations of the Company

13

 

2.6

Furnish Information

16

 

2.7

Expenses of Registration

16

 

2.8

Indemnification

17

 

2.9

Reports Under Exchange Act

19

 

2.10

Limitations on Subsequent Registration Rights

19

 

2.11

“Market Stand-off” Agreement

19

 

2.12

Termination of Registration Rights

20

 

 

 

 

3.

Additional Covenants

21

 

3.1

Successor Indemnification

21

 

3.2

Right to Conduct Activities

21

 

3.3

Termination of Covenants

21

 

 

 

 

4.

Miscellaneous

21

 

4.1

Successors and Assigns

21

 

4.2

Governing Law

22

 

4.3

Counterparts

22

 

4.4

Titles and Subtitles

22

 

4.5

Notices

22

 

4.6

Amendments and Waivers

22

 

4.7

Severability

23

 

4.8

Aggregation of Stock

23

 

4.9

Additional Investors

23

 

4.10

Entire Agreement

23

 

4.11

Dispute Resolution

23

 

4.12

Delays or Omissions

24

 

4.13

Acknowledgment

24

 

Schedule A

-

Schedule of Investors

Annex A

-

Plan of Distribution

 

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REGISTRATION RIGHTS AGREEMENT

 

THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), is made as of the 22 day of March 2018, by and among Addex Therapeutics Ltd., a corporation organized under the laws of Switzerland (the “Company”), and each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor.”

 

RECITALS

 

WHEREAS, the Company, Growth Equity Opportunities Fund IV, LLC (“NEA”) and New Leaf Biopharma Opportunities I, L.P. (“New Leaf”) are parties to the Investment Agreement dated February 14, 2018 (the “Investment Agreement”); and

 

WHEREAS, in order to induce the Company to enter into the Investment Agreement and to induce the Investors to invest funds in the Company pursuant to the Investment Agreement or a separate agreement, the Investors and the Company hereby agree that this Agreement shall govern the rights of the Investors to cause the Company to register shares of Common Stock issuable to the Investors, and shall govern certain other matters as set forth in this Agreement;

 

NOW, THEREFOREIN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and each of the Investors agree as follows:

 

1.                                      Definitions. Capitalized terms used and not otherwise defined herein that are defined in the Investment Agreement shall have the meanings given such terms in the Investment Agreement. As used in this Agreement, the following terms shall have the following meanings:

 

1.1                               ADR” means American Depository Receipts representing the Common Stock.

 

1.2                               Affiliate” means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common control with such Person, including without limitation any general partner, managing member, officer or director of such Person or any venture capital fund now or hereafter existing that is controlled by one or more general partners or managing members of, or shares the same management company with, such Person.

 

1.3                               Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

1.4                               Change of Control” means either: (a) any sale or transfer of all or substantially all of the assets of the Company to another Person; (b) the acquisition of the Company by another entity by means of any transaction or series of related transactions (including, without limitation, any reorganization, merger or consolidation or stock transfer, but excluding any such transaction effected primarily for the purpose of changing the domicile of the Company), unless such the Company’s stockholders of record immediately prior to such

 


 

transaction or series of related transactions hold, immediately after such transaction or series of related transactions, at least fifty percent (50%) of the voting power of the surviving or acquiring entity (provided that the sale by the Company of its securities for the purposes of raising additional funds shall not constitute a Change of Control hereunder); or (c) a disclosure that any person (as the term “person” is used in Section 13(d)(3) or Section 14(d)(2) of the Exchange Act) has become the beneficial owner (as the term “beneficial owner” is defined under Rule 13d-3 or any successor rule or regulation thereto under the Exchange Act) of securities representing fifty percent (50%) or more of the combined voting power of the then outstanding voting securities of the Company.

 

1.5                                    Commission” means the Securities and Exchange Commission.

 

1.6                                    Common Stock” means the registered common shares, nominal value CHF 1.00 per share, issued or issuable to the Investors pursuant to the Investment Agreement and any securities into which such common shares may hereinafter be reclassified.

 

1.7                                    Damages” means any loss, damage, claim or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability (or any action in respect thereof) arises out of or is based upon: (i) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company, including any preliminary Prospectus or final Prospectus contained therein or any amendments or supplements thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents or Affiliates) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities Act, the Exchange Act, or any state securities law.

 

1.8                                    Derivative Securities” means any securities or rights convertible into, or exercisable or exchangeable for (in each case, directly or indirectly), Common Stock, including options and warrants.

 

1.9                                    Effective Date” means the date that a Registration Statement filed pursuant to this Agreement is first declared effective by the Commission.

 

1.10                           Effectiveness Deadline” means, with respect to the Initial Registration Statement or the New Registration Statement, ninety (90) calendar days after the filing date of such Registration Statement (or, in the event the Commission reviews and has written comments to the Initial Registration Statement or the New Registration Statement, no later than one hundred eighty (180) calendar days from the filing date of such Registration Statement provided, however, that if the Company is notified by the Commission that the Initial Registration Statement or the New Registration Statement will not be reviewed or is no longer subject to further review and comments, the Effectiveness Deadline as to such Registration Statement shall be the tenth (10th) Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above; provided, further, that if the Effectiveness Deadline falls on a Saturday, Sunday or other day that the Commission is closed

 

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for business, the Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business.

 

1.11          “Event Date Investment Amount” means the number of Registrable Securities held by the applicable Holder on the Event Date.

 

1.12          “Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

1.13          “Excluded Registration” means (i) a registration relating to the sale of securities to employees of the Company or a subsidiary pursuant to a stock option, stock purchase, or similar plan (including equity incentives, such as equity sharing certificates, under Swiss law); (ii) a registration relating to an SEC Rule 145 transaction; (iii) a registration on any form that does not include substantially the same information as would be required to be included in a Registration Statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered.

 

1.14          “Form F-1” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.

 

1.15          “Form F-3” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities Act subsequently adopted by the SEC that permits incorporation of substantial information by reference to other documents filed by the Company with the SEC.

 

1.16          “Holder” means any holder of Registrable Securities who is a party to this Agreement.

 

1.17          “Immediate Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including, adoptive relationships, of a natural person referred to herein.

 

1.18          “Initiating Holders” means, collectively, Holders who properly initiate a registration request under this Agreement.

 

1.19          “Investment Agreement” has the meaning set forth in the Recitals.

 

1.20          “Investor” or “Investors” has the meaning set forth in the Preamble.

 

1.21          “IPO” means the Company’s first underwritten public offering of its Common Stock under the Securities Act.

 

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1.22          “NEA” means Growth Equity Opportunities Fund IV, LLC.

 

1.23          “New Leaf” means New Leaf Biopharma Opportunities I, L.P.

 

1.24          “NYSE” means the New York Stock Exchange, the NYSE Alternext and/or NYSE MKT (formerly the American Stock Exchange), as may be applicable.

 

1.25          “Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

 

1.26          “Principal Market” means the Trading Market on which the Shares are primarily listed on and quoted for trading, which, as of the Closing Date, shall be the SIX.

 

1.27          “Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective Registration Statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

 

1.28          “Registrable Securities” means (i) the Common Stock; (ii) any Common Stock issued or issuable upon exercise of the Warrants (disregarding for this purpose any and all limitations of any kind on exercise of any Warrants); (iii) ADRs, if any, and (iv) any Common Stock issued as (or issuable upon the conversion or exercise of any warrant, right, or other security that is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, the shares referenced in clauses (i) through (iii) above; excluding in all cases, however, any Registrable Securities sold by a Person in a transaction in which the applicable rights under this Agreement are not assigned pursuant to Subsection 4.1, and excluding for purposes of Section 2 any shares for which registration rights have terminated pursuant to Subsection 2.12 of this Agreement.

 

1.29          “Registrable Securities then outstanding” means the number of shares determined by adding the number of shares of outstanding Common Stock that are Registrable Securities and the number of shares of Common Stock issuable (directly or indirectly) pursuant to then exercisable and/or convertible securities that are Registrable Securities.

 

1.30          “Registration Expenses” means (i) all expenses incurred by the Company incident to the Company’s performance of and compliance with this Agreement, including, without limitation, all stock exchange, Commission, FINRA and, to the extent applicable, state securities registration, listing and filing fees, printing expenses, fees, expenses and disbursements of counsel for the Company and one counsel for all of the Investors, “blue sky” fees and expenses, and the expense of any special audits incident to or required by any such registration (but excluding the compensation of regular employees of the Company which shall

 

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be paid in any event by the Company) and (ii) the reasonable and documented fees and expenses of one legal counsel to the Investors, subject to an aggregate limit of fifty thousand dollars ($50,000).

 

1.31          “Registration Statements” means any one or more registration statements of the Company filed under the Securities Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement (including without limitation the Initial Registration Statement, the New Registration Statement, any Remainder Registration Statements and any Piggyback Registration), amendments and supplements to such Registration Statements, including post-effective amendments, all exhibits and all material incorporated by reference or deemed to be incorporated by reference in such Registration Statements.

 

1.32          “SEC” means the Securities and Exchange Commission.

 

1.33          “SEC Guidance” means (i) any publicly-available written or oral guidance, comments requirements or requests of the Commission staff and (ii) the Securities Act.

 

1.34          “SEC Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.

 

1.35          “SEC Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.

 

1.36          “SEC Rule 415” means Rule 415 promulgated by the SEC under the Securities Act.

 

1.37          “SEC Rule 424” means Rule 424 promulgated by the SEC under the Securities Act.

 

1.38          “Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

1.39          “Selling Expenses” means all underwriting discounts, selling commissions, and stock transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for any Holder, except for the fees and disbursements of the Selling Holder Counsel borne and paid by the Company as provided in Subsection 2.7.

 

1.40          “Selling Stockholder Questionnaire” means a questionnaire in the form attached as Annex B hereto, or such other form of questionnaire as may reasonably be adopted by the Company from time to time.

 

1.41          “SIX” means the SIX Swiss Exchange Ltd.

 

1.42          “Trading Day” means (i) a day on which the shares of Common Stock are listed or quoted and traded on its Principal Market (other than the OTC Bulletin Board), or (ii) if the shares of Common Stock are not listed on a Trading Market (other than the OTC Bulletin Board), a day on which the shares of Common Stock are traded in the over-the-

 

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counter market, as reported by the OTC Bulletin Board, or (iii) if the shares of Common Stock are not quoted on any Trading Market, a day on which the shares of Common Stock are quoted in the over-the-counter market as reported in the “pink sheets” by Pink Sheets LLC (or any similar organization or agency succeeding to its functions of reporting prices); provided, that in the event that the shares of Common Stock are not listed or quoted as set forth in (i), (ii) and (iii) hereof, then Trading Day shall mean a Business Day.

 

1.43          “Trading Market” means whichever of the SIX, NYSE, the NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market or OTC Bulletin Board on which the Shares are listed or quoted for trading on the date in question.

 

1.44          “U.S. Trading Market” means any of the NYSE, Nasdaq Global Market or Nasdaq Capital Market, as applicable.

 

1.45          “Warrants” means the warrants issued to the Investors pursuant to the Investment Agreement.

 

2.                                 Registration Rights. The Company covenants and agrees as follows:

 

2.1                               Demand Registration.

 

(a)                                 Form F-1 Demand. If (A) at any time after the earlier of (i) three (3) years after the date of this Agreement or (ii) one hundred eighty (180) days after the effective date of the Registration Statement for the IPO, the Company receives a request from Holders of at least ten percent (10%) of the Common Stock then outstanding that the Company effect an underwritten public offering (a “Demand Offering”) of Common Stock held by the Initiating Holders and any other participating Holders (the “Selling Holders”) (and, if the Company has not effected an IPO, of the Common Stock (or ADRs) of the Company in an IPO that includes the resale of the Common Stock of the Selling Holders) on a U.S. Trading Market and in connection therewith file a Form F-1 Registration Statement with the Commission with respect to at least thirty percent (30%) of the Registrable Securities then outstanding (or a lesser percent if the anticipated aggregate offering price, net of Selling Expenses, would exceed fifteen million ($15 million)), and (B) a major, “bulge bracket” U.S. investment bank selected by the Initiating Holder (and reasonably acceptable to the Company) is prepared to effect a firm commitment underwritten registered public offering of the Common Stock held by the Selling Holders on a U.S. Trading Market (the “U.S. Listing”), then the Company shall (x) within ten (10) days after the date such request is given, give notice thereof (the “Demand Notice”) to all Holders other than the Initiating Holders; and (y) as soon as practicable, and in any event within ninety (90) days after the date such request is given by the Initiating Holders, file a Form F-1 Registration Statement under the Securities Act covering all Registrable Securities that the Initiating Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given. The Company shall also exercise commercially reasonable efforts to take all actions necessary to register such class of securities under the Exchange Act, as well as (X) pay all Registration Expenses (exclusive of Selling Expenses), and (Y) to the extent applicable, to cause the

 

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registration of the issuance of such Common Stock or ADRs, if applicable, and obtain all required approvals for the listing of the Shares or ADRs representing the Shares with the applicable U.S. Trading Market. The Company shall also exercise commercially reasonable efforts to continue the U.S. Listing and trading of its Shares on the applicable U.S. Trading Market and, in accordance, therewith, will use commercially reasonable efforts to comply in all respects with the Company’s reporting, filing and other obligations applicable to issuers whose securities are listed on such U.S. Trading Market. The Company also agrees that the Investors shall have the rights set forth in this Agreement with respect to the registration for resale of the Registrable Securities of the Investors in the event of and immediately effective upon such U.S. Listing.

 

(b)                                      Shelf Registration. No later than the Lockup Termination Date of the earlier to occur of (i) an IPO of the Company, or (ii) a Demand Offering (and in the case of a Demand Offering, if no Company lock-up exists, then ninety (90) calendar days following the Effective Date of such Demand Offering) (such date, the “Filing Deadline”), the Company shall prepare and file with the Commission a Registration Statement covering the resale of all outstanding Registrable Securities not already covered by an effective Registration Statement for an offering to be made on a delayed or continuous basis pursuant to SEC Rule 415 or, if SEC Rule 415 is not available for offers and sales of the Registrable Securities, by such other means of distribution of the Registrable Securities as the Holders may reasonably specify (the “Initial Registration Statement”). The Initial Registration Statement shall be on Form F-3 (except if the Company is then ineligible to register for resale the Registrable Securities on Form F-3, in which case such registration shall be on Form F-1 or such other form available to register for resale the Registrable Securities as a secondary offering), subject to the provisions of Subsection 2.1(e), and shall contain (except if otherwise required pursuant to written comments received from the Commission upon a review of such Registration Statement) the “Plan of Distribution” section attached hereto as Annex A (which may be modified to respond to comments, if any, provided by the Commission). Notwithstanding the registration obligations set forth in this Section 2, in the event the Commission informs the Company that all of the Registrable Securities cannot, as a result of the application of SEC Rule 415, be registered for resale as a secondary offering on a single Registration Statement, the Company agrees to promptly (i) inform each of the Holders and use its commercially reasonable efforts to file amendments to the Initial Registration Statement as required by the Commission and/or (ii) withdraw the Initial Registration Statement and file a new Registration Statement (a “New Registration Statement”), in either case covering the maximum number of Registrable Securities permitted to be registered by the Commission, on Form F-3 or such other form available to register for resale the Registrable Securities as a secondary offering; provided, however, that prior to filing such amendment or New Registration Statement, the Company shall be obligated to use its commercially reasonable efforts to advocate with the Commission for the registration of all of the Registrable Securities in accordance with the SEC Guidance, including without limitation, the Manual of Publicly Available Telephone Interpretations D.29. Notwithstanding any other provision of this Agreement, if any SEC Guidance sets forth a limitation of the number of Registrable Securities permitted to be registered on a particular Registration Statement as a secondary offering (and notwithstanding that the Company used diligent efforts to advocate with the Commission for the registration of all or a greater number of Registrable Securities), unless otherwise directed in writing by a Holder as to its Registrable

 

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Securities, the number of Registrable Securities to be registered on such Registration Statement will first be reduced by Registrable Securities not acquired pursuant to the Investment Agreement (whether pursuant to registration rights or otherwise) and second by Registrable Securities represented by shares of Common Stock (applied, in the case that some shares of Common Stock may be registered, to the Holders on a pro rata basis based on the total number of unregistered shares of Common Stock held by such Holders, subject to a determination by the Commission that certain Holders must be reduced first based on the number of shares of Common Stock held by such Holders). In the event the Company amends the Initial Registration Statement or files a New Registration Statement, as the case may be, under clauses (i) or (ii) above, the Company will use its commercially reasonable efforts to file with the Commission, as promptly as allowed by Commission or SEC Guidance provided to the Company or to registrants of securities in general, one or more Registration Statements on Form F-3 or such other form available to register for resale those Registrable Securities that were not registered for resale on the Initial Registration Statement, as amended, or the New Registration Statement (the “Remainder Registration Statements”). The Company shall cause each Registration Statement required to be filed by the Filing Deadline and to be declared effective by the Commission no later than the Effectiveness Deadline (including filing with the Commission a request for acceleration of effectiveness in accordance with Rule 461 promulgated under the Securities Act), and shall use its reasonable best efforts to keep each Registration Statement continuously effective under the Securities Act for so long as Registrable Securities remain outstanding (the “Effectiveness Period”). The Company shall telephonically request effectiveness of a Registration Statement as of 5:00 P.M. New York City time on a Trading Day. The Company shall promptly notify the Holders via facsimile or electronic mail of a “.pdf” format data file of the effectiveness of a Registration Statement on the same Trading Day that the Company telephonically confirms effectiveness with the Commission, which date of confirmation shall initially be the date requested for effectiveness of such Registration Statement. The Company shall, by 9:30 A.M. New York City time on the first Trading Day after the Effective Date, file a final Prospectus with the Commission, as required by Rule 424(b). Failure to so notify the Holders on or before the second Trading Day after such notification or effectiveness or failure to file a final Prospectus as aforesaid shall be deemed an Event under Subsection 2.1(c).

 

(c)                                       If: in respect of any Registration Statement filed pursuant to Subsection 2.1(b), (i) the Initial Registration Statement is not filed with the Commission on or prior to the Filing Deadline, (ii) the Initial Registration Statement or the New Registration Statement, as applicable, is not declared effective by the Commission (or otherwise does not become effective) on or prior to the Effectiveness Deadline or (iii) after its Effective Date, (A) such Registration Statement ceases (including without limitation by reason of a stop order, or the Company’s failure to update the Registration Statement), to remain continuously effective as to all Registrable Securities included in such Registration Statement or (B) the Holders are not permitted to utilize the Prospectus therein to resell such Registrable Securities for any reason for more than an aggregate of either thirty (30) consecutive calendar days or sixty (60) calendar days in the aggregate (which need not be consecutive days) during any twelve (12) month period, or (iv) the Company fails to satisfy the current public information requirement pursuant to Rule 144(c)(1) as a result of which the Holders who are not affiliates are unable to sell Registrable Securities without restriction under Rule 144 (or any successor thereto), (any such

 

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failure or breach in clauses (i) through (iv) above being referred to as an “Event,” and, for purposes of clauses (i), (ii) or (iv), the date on which such Event occurs, or for purposes of clause (iii), the date on which either such thirty (30) or sixty (60) calendar day period is exceeded, being referred to as an “Event Date”), then in addition to any other rights the Holders may have hereunder or under applicable law, on each such Event Date and on each additional thirty (30) consecutive day or sixty (60) day aggregate period, as may be applicable, following such Event Date until the applicable Event is cured, the Company shall pay to each Holder an amount in cash, as partial liquidated damages and not as a penalty (“Liquidated Damages”), equal to four tenths of one percent (0.4%) of the aggregate purchase price paid by such Holder pursuant to the Investment Agreement for any unregistered Registrable Securities then held by such Holder (the “Liquidated Damages Amount”). The parties agree that notwithstanding anything to the contrary herein or in the Investment Agreement, (1) no Liquidated Damages shall be payable with respect to any period after the expiration of the Effectiveness Period (except in respect of an Event described in Subsection 2.1(c)(iv) hereof), (it being understood that this sentence shall not relieve the Company of any Liquidated Damages accruing prior to the Effectiveness Deadline), (2) the Liquidated Damages Amount for any Holder in any twelve (12) month period following an Event Date shall not exceed a cap of four and eight tenths percent (4.8%) of the Event Date Investment Amount (e.g., for purposes of illustration and to avoid ambiguity, assuming twenty-five million dollars ($25,000,000) of unregistered Registrable Securities are outstanding on an Event Date, the applicable cap on the Liquidated Damages Amount would be one million two hundred thousand dollars ($1,200,000) in any twelve (12) month period assuming continuous, uncured breach during such period), and (3) no Liquidated Damages shall accrue during any period covered by the exercise of the Company’s rights in accordance with Subsection 2.1(e) hereof. The Liquidated Damages pursuant to the terms hereof shall apply on a daily pro-rata basis for any portion of an applicable period prior to the cure of an Event, except in the case of the first Event Date. The Company shall not be liable for Liquidated Damages under this Agreement as to any Registrable Securities which are not permitted by the Commission to be included in a Registration Statement due solely to SEC Guidance from the time that it is determined that such Registrable Securities are not permitted to be registered until such time as the provisions of this Agreement as to the Remainder Registration Statements required to be filed hereunder are triggered, in which case the provisions of this Subsection 2.1(c) shall once again apply, if applicable. In such case, the Liquidated Damages shall be calculated to only apply to the percentage of Registrable Securities which are permitted in accordance with SEC Guidance to be included in such Registration Statement. The Effectiveness Deadline for a Registration Statement shall be extended without default or Liquidated Damages hereunder in the event that the Company’s failure to obtain the effectiveness of the Registration Statement on a timely basis results from the failure of an Investor to timely provide the Company with information requested by the Company and necessary to complete the Registration Statement in accordance with the requirements of the Securities Act (in which the Effectiveness Deadline would be extended with respect to Registrable Securities held by such Investor).

 

(d)                                      In the event that Form F-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on another appropriate form reasonably acceptable to the Holders and (ii) undertake to register the Registrable Securities on Form F-3 promptly after such

 

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form becomes available to the Company, provided, that the Company shall maintain the effectiveness of the Registration Statement then in effect until such time as a Registration Statement on Form F-3 covering the resale of the Registrable Securities has been declared effective by the Commission.

 

(e)                                  Notwithstanding the foregoing obligations, if the Company furnishes to Holders requesting a registration pursuant to this Subsection 2.1 a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Company’s Board of Directors it would be materially detrimental to the Company and its stockholders for such Registration Statement to either become effective or remain effective for as long as such Registration Statement otherwise would be required to remain effective, because such action would (i) materially interfere with a significant acquisition, corporate reorganization, or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, then the Company shall have the right to defer taking action with respect to such filing or suspend the right of Holder to use a Prospectus in connection with the resale of Common Stock pursuant to Subsection 2.1(e) hereof, as may be applicable, and any time periods with respect to filing or effectiveness thereof shall be tolled correspondingly, for a period of not more than ninety (90) days after the request of the Initiating Holders is given or the date the Company notifies Holders of the suspension of a Registration Statement filed under Subsection 2.1(b), as may be applicable (such period, the “Blackout Period”); provided, however, that the Company may not invoke this right more than once in any twelve (12) month period; and provided further that the Company shall not register any securities for its own account or that of any other stockholder during such ninety (90) day period other than an Excluded Registration. Neither the delivery of a certificate described herein nor the passage of such ninety (90) day period shall be considered an Event and neither shall trigger the Company’s obligations to pay to the Holders Liquidated Damages hereunder. Notwithstanding any of the foregoing to the contrary, the Company shall not be entitled to exercise its rights pursuant to this Subsection 2.1(e) for the period of ninety (90) days immediately following the Lockup Termination Date if (x) the basis for such exercise is the Company’s intent to effect a registered public offering (a “Secondary Offering”) for the account of the Company and/or other stockholders of the Company and (y) the Company has not included all of the shares of Common Stock requested by the Holders for resale in the IPO, unless the Company includes all shares of Common Stock requested by the Holders for registration in such Secondary Offering.

 

(f)                                   The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(a) during the period that is sixty (60) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is one hundred eighty (180) days after the effective date of, a Company-initiated registration, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such Registration Statement to become effective; (ii) after the Company has effected two registrations pursuant to Subsection 2.1(a); or (iii) if the Initiating Holders propose to dispose of shares of Registrable Securities that may be immediately registered on Form F-3 pursuant to the obligations of Subsection 2.1(b). The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(b) during the period

 

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that is thirty (30) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is ninety (90) days after the effective date of, a Company-initiated IPO, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such Registration Statement to become effective in connection to such IPO. A registration shall not be counted as “effected” for purposes of this Subsection 2.1(f) until such time as the applicable Registration Statement has been declared effective by the SEC, unless the Initiating Holders withdraw their request for such registration, elect not to pay the registration expenses therefor, and forfeit their right to one demand Registration Statement pursuant to Subsection 2.7, in which case such withdrawn Registration Statement shall be counted as “effected” for purposes of this Subsection 2.1(f).

 

2.2                            Company Registration. If the Company proposes to register (including, for this purpose, a registration effected by the Company for stockholders other than the Holders) any of its Common Stock under the Securities Act in connection with the public offering of such securities solely for cash (other than in an Excluded Registration) (a “Piggyback Registration”), the Company shall, at such time, promptly give each Holder notice of such registration. Upon the request of each Holder given within twenty (20) days after such notice is given by the Company, the Company shall, subject to the provisions of Subsection 2.3, cause to be registered all of the Registrable Securities that each such Holder has requested to be included in such registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Subsection 2.2 before the effective date of such registration, whether or not any Holder has elected to include Registrable Securities in such registration. The expenses (other than Selling Expenses) of such withdrawn registration shall be borne by the Company in accordance with Subsection 2.7. Notwithstanding the foregoing, assuming a Requesting Investor has given notice of its desire to participate in such registration, if, at any time after giving a Notice of Piggyback Registration and prior to the effective date of the Registration Statement filed in connection with such registration, the Company shall determine for any reason not to register or to delay registration of such securities, the Company may, at its election, give written notice of such determination to such Requesting Investor and, thereupon, (a) in the case of a determination not to register the Company’s securities for its own account, shall be relieved of its obligation to register any Registrable Securities in connection with such registration, and (b) in the case of a determination to delay registering the Company’s securities for its own account, shall be permitted to delay registering any Registrable Securities for the same period as the delay in registering such other securities to be sold for the account of the Company. No registration effected under this Subsection 2.2 shall (i) relieve the Company of its obligations to effect any Registration under Subsections 2.1(a) or 2.1(b) herein, or (ii) entitle the Company to treat Registrable Securities differently in any such decision not to register or to delay pursuant to this Subsection 2.2(a). Subject to Subsection 2.1(e), the failure to register or to delay registration of securities under this Subsection 2.2 shall not obligate the Company to pay any Liquidated Damages pursuant to Subsection 2.1(c).

 

2.3                            Underwriting Requirements.

 

(a)                            If, pursuant to Subsection 2.1, the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to Subsection 2.1, and

 

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the Company shall include such information in the Demand Notice. The underwriter(s) will be selected by the Company and shall be reasonably acceptable to a majority in interest of the Initiating Holders; provided; however, in the event of a Demand Offering (other than an IPO) the underwriter(s) shall be selected by the Initiating Holders and shall be reasonably acceptable to the Company. In such event, the right of any Holder to include such Holder’s Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in Subsection 2.5(e)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting. Notwithstanding any other provision of this Subsection 2.3, if the managing underwriter(s) advise(s) the Initiating Holders in writing that marketing factors require a limitation on the number of shares to be underwritten, then the Initiating Holders shall so advise all Holders of Registrable Securities that otherwise would be underwritten pursuant hereto, and the number of Registrable Securities that may be included in the underwriting shall be allocated among such Holders of Registrable Securities, including the Initiating Holders, in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Holder or in such other proportion as shall mutually be agreed to by all such selling Holders; provided, however, that the number of Registrable Securities held by the Holders to be included in such underwriting shall not be reduced unless all other securities are first entirely excluded from the underwriting. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Holder to the nearest one hundred (100) shares.

 

(b)                                      In connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Subsection 2.2, the Company shall not be required to include any of the Holders’ Registrable Securities in such underwriting unless the Holders accept the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company. If the total number of securities, including Registrable Securities, requested by stockholders to be included in such offering exceeds the number of securities to be sold (other than by the Company) that the underwriters in their reasonable discretion determine is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, which the underwriters and the Company in their sole discretion determine will not jeopardize the success of the offering. If the underwriters determine that less than all of the Registrable Securities requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering shall be allocated among the selling Holders in proportion (as nearly as practicable to) the number of Registrable Securities owned by each selling Holder or in such other proportions as shall mutually be agreed to by all such selling Holders. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Holder to the nearest one hundred (100) shares. Notwithstanding the foregoing, in no event shall (i) the number of Registrable Securities included in the offering be reduced unless all other securities (other than securities to be sold by the Company) are first entirely excluded from the offering, (ii) subject to Subsection 2.1(e), the number of Registrable Securities included in the

 

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offering be reduced below thirty percent (30%) of the total number of securities included in such offering, unless such offering is the IPO, in which case the selling Holders may be excluded further if the underwriters make the determination described above and no other stockholder’s securities are included in such offering, and (iii) notwithstanding (ii) above, in the event that an Event has occurred and so long as such Event shall continue without being cured by the Company, the Company shall include in the Registration Statement all Registrable Securities which have been requested to be included by the Holders. For purposes of the provision in this Subsection 2.3(b) concerning apportionment, for any selling Holder that is a partnership, limited liability company, or corporation, the partners, members, retired partners, retired members, stockholders, and Affiliates of such Holder, or the estates and Immediate Family Members of any such partners, retired partners, members, and retired members and any trusts for the benefit of any of the foregoing Persons, shall be deemed to be a single “selling Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate number of Registrable Securities owned by all Persons included in such “selling Holder,” as defined in this sentence.

 

(c)                             For purposes of Subsection 2.1, a registration shall not be counted as “effected” if, as a result of an exercise of the underwriter’s cutback provisions in Subsection 2.3(a), fewer than fifty percent (50%) of the total number of Registrable Securities that Holders have requested to be included in such Registration Statement are actually included.

 

2.4                            Reserved.

 

2.5                            Obligations of the Company. Whenever required under this Section 2 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:

 

(a)                            prepare and file with the SEC a Registration Statement with respect to such Registrable Securities and use its commercially reasonable efforts to cause such Registration Statement to become effective and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such Registration Statement effective for a period of up to one hundred twenty (120) days or, if earlier, until the distribution contemplated in the Registration Statement has been completed; provided, however, that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Holder refrains, at the request of an underwriter of Common Stock (or other securities) of the Company, from selling any securities included in such registration, and (ii) in the case of any registration of Registrable Securities covered by a Registration Statement filed pursuant to Subsection 2.1(b) hereof that are intended to be offered on a continuous or delayed basis, subject to compliance with applicable SEC rules, such one hundred twenty (120) day period shall be extended indefinitely, if necessary, to keep the Registration Statement effective until all such Registrable Securities are sold and use commercially reasonable efforts to avoid the issuance of, or, if issued, obtain the withdrawal of (x) any order suspending the effectiveness of a Registration Statement, or (y) any suspension of the qualification (or exemption from qualification) of any of the Registrable Securities for sale in any jurisdiction, as soon as practicable;

 

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(b)                                 (i) prepare and file with the SEC such amendments and supplements to such Registration Statement, and the Prospectus used in connection with such Registration Statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities covered by such Registration Statement, (ii) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement (subject to the terms of this Agreement), and, as so supplemented or amended, to be filed pursuant to SEC Rule 424, (iii) respond as promptly as reasonably practicable to any comments received from the Commission with respect to each Registration Statement or any amendment thereto and, as promptly as reasonably possible, provide the Holders true and complete copies of all correspondence from and to the Commission relating to such Registration Statement that pertains to the Holders as “Selling Stockholders” but not any comments that would result in the disclosure to the Holders of material and non-public information concerning the Company, and (iv) comply with the provisions of the Securities Act and the Exchange Act with respect to the disposition of all Registrable Securities covered by a Registration Statement until such time as all of such Registrable Securities shall have been disposed of (subject to the terms of this Agreement) in accordance with the intended methods of disposition by the Holders thereof as set forth in such Registration Statement as so amended or in such Prospectus as so supplemented; provided, however, that each Investor shall be responsible for the delivery of the Prospectus to the Persons to whom such Investor sells any of the shares of Common Stock (including in accordance with Rule 172 under the Securities Act), and each Investor agrees to dispose of Registrable Securities in compliance with the “Plan of Distribution” described in the Registration Statement and otherwise in compliance with applicable federal and state securities laws;

 

(c)                                  furnish to the selling Holders such numbers of copies of such Registration Statements and a Prospectus, including a preliminary Prospectus, amendments or supplements, and all exhibits and attachments thereto, as required by the Securities Act, and such other documents as the Holders may reasonably request in order to facilitate their disposition of their Registrable Securities;

 

(d)                                 use its commercially reasonable efforts to register and qualify the securities covered by such Registration Statement under such other securities or blue-sky laws of such jurisdictions as shall be reasonably requested by the selling Holders and keep such registration and qualification effective until all such Registrable Securities are sold; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;

 

(e)                                  in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering;

 

(f)                                   use its commercially reasonable efforts to cause all such Registrable Securities covered by such Registration Statement to be listed on a national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities issued by the Company are then listed;

 

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(g)                                  provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;

 

(h)                                 promptly make available for inspection by the selling Holders, any managing underwriter(s) participating in any disposition pursuant to such Registration Statement, and any attorney or accountant or other agent retained by any such underwriter or selected by the selling Holders, all financial and other records, pertinent corporate documents, and properties of the Company, and cause the Company’s officers, directors, employees, and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant, or agent, in each case, as necessary or advisable to verify the accuracy of the information in such Registration Statement and to conduct appropriate due diligence in connection therewith;

 

(i)                                     notify each selling Holder, promptly after the Company receives notice thereof, (1) of the time when such Registration Statement has been declared effective or a supplement to any Prospectus forming a part of such Registration Statement has been filed, (2) of any request by the Commission or any other federal or state governmental authority for amendments or supplements to a Registration Statement or Prospectus or for additional information that pertains to the Holders as “Selling Stockholders” or the “Plan of Distribution”, (3) of the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement covering any or all of the Registrable Securities or the initiation of any Proceedings for that purpose, (4) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, (5) of the occurrence of any event or passage of time that makes the financial statements included in a Registration Statement ineligible for inclusion therein or any statement made in such Registration Statement or Prospectus or any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires any revisions to such Registration Statement, Prospectus or other documents so that, in the case of such Registration Statement or the Prospectus, as the case may be, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or supplement thereto, in light of the circumstances under which they were made), not misleading and (6) of the occurrence or existence of any pending corporate development with respect to the Company that the Company believes may be material and that, in the determination of the Company, makes it not in the best interest of the Company to allow continued availability of a Registration Statement or Prospectus, provided that, any and all such information shall remain confidential to each Holder until such information otherwise becomes public, unless disclosure by a Holder is required by law; and provided, further, that notwithstanding each Holder’s agreement to keep such information confidential, each such Holder makes no acknowledgement that any such information is material, non-public information. In the event of an occurrence of any event contemplated by this Subsection 2.5(i), as promptly as reasonably practicable (taking into account the Company’s good faith assessment of any adverse consequences to the Company and its stockholders of the premature disclosure of such event), the Company shall prepare a

 

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supplement or amendment, including a post-effective amendment, to the affected Registration Statements or a supplement to the related Prospectus or any document incorporated or deemed to be incorporated therein by reference, and file any other required document so that, as thereafter delivered, no Registration Statement nor any Prospectus will contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or supplement thereto, in light of the circumstances under which they were made), not misleading. Subject to Subsection 2.1(e), the Company will use its commercially reasonable efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable. The Company shall be entitled to exercise its right under this Subsection 2.5(i), and if applicable, under Subsection 2.1(e), to suspend the availability of a Registration Statement and Prospectus, and shall be liable for the payment of Liquidated Damages only in accordance with the provisions and time periods of Subsections 2.1(c)(iii)(A) and (B), except no such Liquidated Damages shall accrue during any Blackout Period permitted under Subsection 2.1(e); and

 

(j)                               after such Registration Statement becomes effective, notify each selling Holder of any request by the SEC that the Company amend or supplement such Registration Statement or Prospectus.

 

In addition, the Company shall ensure that, at all times after any Registration Statement covering a public offering of securities of the Company under the Securities Act shall have become effective, its insider trading policy shall provide that the Company’s directors may implement a trading program under Rule 10b5-1 of the Exchange Act.

 

2.6                            Furnish Information. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 2 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably required to effect the registration of such Holder’s Registrable Securities.

 

2.7                            Expenses of Registration. All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to this Section 2, including all registration, filing, and qualification fees; printers’ and accounting fees; fees and disbursements of counsel for the Company; and the reasonable fees and disbursements, not to exceed fifty thousand dollars ($50,000), of one counsel for the selling Holders (“Selling Holder Counsel”), shall be borne and paid by the Company; provided, however, that the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Subsection 2.1 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all selling Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn registration), unless the Holders of a majority of the Registrable Securities agree to forfeit their right to one registration pursuant to Subsection 2.1(a); provided further that if, at the time of such withdrawal, the Holders shall have learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Holders at the time of their request and have withdrawn the request with reasonable

 

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promptness after learning of such information then the Holders shall not be required to pay any of such expenses and shall not forfeit their right to one registration pursuant to Subsection 2.1(a). All Selling Expenses relating to Registrable Securities registered pursuant to this Section 2 shall be borne and paid by the Holders pro rata on the basis of the number of Registrable Securities registered on their behalf.

 

2.8                               Indemnification. If any Registrable Securities are included in a Registration Statement under this Section 2:

 

(a)                                 To the extent permitted by law, the Company will indemnify and hold harmless each selling Holder, and the partners, members, officers, directors, and stockholders of each such Holder; legal counsel and accountants for each such Holder; any underwriter (as defined in the Securities Act) for each such Holder; and each Person, if any, who controls such Holder or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to each such Holder, underwriter, controlling Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Subsection 2.8(a) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably withheld, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of any such Holder, underwriter, controlling Person, or other aforementioned Person expressly for use in connection with such registration.

 

(b)                                 To the extent permitted by law, each selling Holder, severally and not jointly, will indemnify and hold harmless the Company, and each of its directors, each of its officers who has signed the Registration Statement, each Person (if any), who controls the Company within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities Act), any other Holder selling securities in such Registration Statement, and any controlling Person of any such underwriter or other Holder, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of such selling Holder expressly for use in connection with such registration; and each such selling Holder will pay to the Company and each other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Subsection 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld; and provided further that in no event shall the aggregate amounts payable by any Holder by way of indemnity or contribution under Subsections 2.8(b) and 2.8(d) exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of fraud or willful misconduct by such Holder.

 

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(c)                                  Promptly after receipt by an indemnified party under this Subsection 2.8 of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Subsection 2.8, give the indemnifying party notice of the commencement thereof. The indemnifying party shall have the right to participate in such action and, to the extent the indemnifying party so desires, participate jointly with any other indemnifying party to which notice has been given, and to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such action.

 

(d)                                 To provide for just and equitable contribution to joint liability under the Securities Act in any case in which either: (i) any party otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Subsection 2.8 but it is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding the fact that this Subsection 2.8 provides for indemnification in such case, or (ii) contribution under the Securities Act may be required on the part of any party hereto for which indemnification is provided under this Subsection 2.8, then, and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided, however, that, in any such case (x) no Holder will be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by such Holder pursuant to such Registration Statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation; and provided further that in no event shall a Holder’s liability pursuant to this Subsection 2.8(d), when combined with the amounts paid or payable by such Holder pursuant to Subsection 2.8(b), exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of willful misconduct or fraud by such Holder.

 

(e)                                  Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered

 

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into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control.

 

(f)                              Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations of the Company and Holders under this Subsection 2.8 shall survive the completion of any offering of Registrable Securities in a registration under this Section 2, and otherwise shall survive the termination of this Agreement.

 

2.9                               Reports Under Exchange Act. With a view to making available to the Holders the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form F-3, the Company shall:

 

(a)                                 make and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144, at all times after the effective date of the Registration Statement filed by the Company for the IPO;

 

(b)                                 use commercially reasonable efforts to file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act (at any time after the Company has become subject to such reporting requirements); and

 

(c)                                  furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days after the effective date of the Registration Statement filed by the Company for the IPO), the Securities Act, and the Exchange Act (at any time after the Company has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form F-3 (at any time after the Company so qualifies); and (ii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC that permits the selling of any such securities without registration (at any time after the Company has become subject to the reporting requirements under the Exchange Act) or pursuant to Form F-3 (at any time after the Company so qualifies to use such form).

 

2.10          Limitations on Subsequent Registration Rights. From and after the date of this Agreement, the Company shall not, without the prior written consent of the Holders of a majority of the Registrable Securities then outstanding, enter into any agreement with any holder or prospective holder of any securities of the Company that would provide to such holder the right to include securities in any registration on other than either a pro rata basis with respect to the Registrable Securities or on a subordinate basis after all Holders have had the opportunity to include in the registration and offering all shares of Registrable Securities that they wish to so include; provided that this limitation shall not apply to any additional Investor who becomes a party to this Agreement in accordance with Subsection 4.9.

 

2.11          “Market Stand-off” Agreement. Each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period

 

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commencing on the date of the final Prospectus relating to the registration by the Company for its own behalf of shares of its Common Stock or any other equity securities under the Securities Act on a Registration Statement on Form F-1 or Form F-3, and ending on the date specified by the Company and the managing underwriter (such period not to exceed one hundred eighty (180) days in the case of the IPO, or such other period as may be requested by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research reports, and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto), or such other period as may be requested by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research reports and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto) (the applicable termination date of each such period, the “Lockup Termination Date”), (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable (directly or indirectly) for Common Stock (whether such shares or any such securities are then owned by the Holder or are thereafter acquired) or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or other securities, in cash, or otherwise. The foregoing provisions of this Subsection 2.11 shall apply only to an IPO, shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, or the transfer of any shares to any trust for the direct or indirect benefit of the Holder or the immediate family of the Holder, provided that the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided further that any such transfer shall not involve a disposition for value, and shall be applicable to the Holders only if all officers and directors are subject to the same restrictions and the Company uses commercially reasonable efforts to obtain a similar agreement from all stockholders individually owning more than one percent (1%) of the Company’s outstanding Common Stock. The underwriters in connection with such registration are intended third-party beneficiaries of this Subsection 2.11 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Holder further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Subsection 2.11 or that are necessary to give further effect thereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all Holders subject to such agreements, based on the number of shares subject to such agreements.

 

2.12          Termination of Registration Rights. The rights of any Holder to request registration or inclusion of Registrable Securities in any registration pursuant to Subsections 2.1 or 2.2 shall terminate only at such time as SEC Rule 144 or other similar exemption under the Securities Act is available for the sale of all of such Holder’s shares without any restriction including volume or any other limitations.

 

20


 

3.                                      Additional Covenants.

 

3.1          Successor Indemnification. If the Company or any of its successors or assignees consolidates with or merges into any other Person and is not the continuing or surviving corporation or entity of such consolidation or merger, then to the extent necessary, proper provision shall be made so that the successors and assignees of the Company assume the obligations of the Company with respect to indemnification of members of the Board of Directors as in effect immediately before such transaction, whether such obligations are contained in the Company’s Bylaws, its Certificate of Incorporation, or elsewhere, as the case may be.

 

3.2          Right to Conduct Activities. The Company hereby agrees and acknowledges that NEA and New Leaf (together with their respective affiliates) are a professional investment funds, and as such invests in numerous portfolio companies, some of which may be deemed competitive with the Company’s business (as currently conducted or as currently propose to be conducted). The Company hereby agrees that, to the extent permitted under applicable law, NEA and New Leaf shall not be liable to the Company for any claim arising out of, or based upon, (i) the investment by NEA or New Leaf in any entity competitive with the Company, or (ii) actions taken by any partner, officer or other representative of NEA and New Leaf to assist any such competitive company, whether or not such action was taken as a member of the board of directors of such competitive company or otherwise, and whether or not such action has a detrimental effect on the Company; provided, however, that the foregoing shall not relieve (x) any of the Investors from liability associated with the unauthorized disclosure of the Company’s confidential information obtained pursuant to this Agreement, or (y) any director or officer of the Company from any liability associated with his or her fiduciary duties to the Company.

 

3.3          Termination of Covenants. The covenants set forth in this Section 3, except for Subsection 3.1, shall terminate and be of no further force or effect (i) immediately before the consummation of the IPO or (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, or (iii) upon a Change of Control.

 

4.             Miscellaneous.

 

4.1          Successors and Assigns. The rights under this Agreement may be assigned (but only with all related obligations) by a Holder to a transferee of Registrable Securities that (i) is an Affiliate of a Holder; (ii) is a Holder’s Immediate Family Member or trust for the benefit of an individual Holder or one or more of such Holder’s Immediate Family Members; or (iii) after such transfer, holds at least ten percent (10%) of the Registrable Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations, and other recapitalizations); provided, however, that (x) the Company is, within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee and the Registrable Securities with respect to which such rights are being transferred; and (y) such transferee agrees in a written instrument delivered to the Company to be bound by and subject to the terms and conditions of this Agreement, including the provisions of Subsection 2.11. For the purposes of determining the number of shares of Registrable Securities held by a transferee, the holdings of a transferee (1) that is an Affiliate or stockholder of a Holder; (2) who is a Holder’s

 

21


 

Immediate Family Member; or (3) that is a trust for the benefit of an individual Holder or such Holder’s Immediate Family Member shall be aggregated together and with those of the transferring Holder; provided further that all transferees who would not qualify individually for assignment of rights shall have a single attorney-in-fact for the purpose of exercising any rights, receiving notices, or taking any action under this Agreement. The terms and conditions of this Agreement inure to the benefit of and are binding upon the respective successors and permitted assignees of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and permitted assignees any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided herein.

 

4.2          Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be determined in accordance with the internal law of the State of Delaware.

 

4.3          Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

4.4          Titles and Subtitles. The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing or interpreting this Agreement.

 

4.5          Notices. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given upon the earlier of actual receipt or (i) personal delivery to the party to be notified; (ii) when sent, if sent by electronic mail or facsimile during the recipient’s normal business hours, and if not sent during normal business hours, then on the recipient’s next business day; (iii) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (iv) one (1) business day after the business day of deposit with a nationally recognized overnight courier, freight prepaid, specifying next-day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their addresses as set forth on Schedule A hereto, or to the principal office of the Company and to the attention of the Chief Executive Officer, in the case of the Company, or to such email address, facsimile number, or address as subsequently modified by written notice given in accordance with this Subsection 4.5. If notice is given to the Company, a copy shall also be sent to Dr.iur. Frank Gerhard, LL.M., Homburger AG, Prime Tower, Hardstrasse 201, CH-8005 Zurich, Switzerland.

 

4.6          Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent of the Company and the holders of a majority of the Registrable Securities then outstanding; provided that any provision hereof may be waived by any waiving party on such party’s own

 

22


 

behalf, without the consent of any other party. Notwithstanding the foregoing, this Agreement may not be amended or terminated and the observance of any term hereof may not be waived with respect to any Investor without the written consent of such Investor, unless such amendment, termination, or waiver applies to all Investors in the same fashion. The Company shall give prompt notice of any amendment or termination hereof or waiver hereunder to any party hereto that did not consent in writing to such amendment, termination, or waiver. Any amendment, termination, or waiver effected in accordance with this Subsection 4.6 shall be binding on all parties hereto, regardless of whether any such party has consented thereto. No waivers of or exceptions to any term, condition, or provision of this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.

 

4.7          Severability. In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to the maximum extent permitted by law.

 

4.8          Aggregation of Stock. All shares of Registrable Securities held or acquired by Affiliates shall be aggregated together for the purpose of determining the availability of any rights under this Agreement and such Affiliated persons may apportion such rights as among themselves in any manner they deem appropriate.

 

4.9          Additional Investors. Notwithstanding anything to the contrary contained herein, if the Company issues additional shares of the Company’s Common Stock after the date hereof, pursuant to the Investment Agreement, any purchaser of such shares of Common Stock may become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement, and thereafter shall be deemed an “Investor” for all purposes hereunder. No action or consent by the Investors shall be required for such joinder to this Agreement by such additional Investor, so long as such additional Investor has agreed in writing to be bound by all of the obligations as an “Investor” hereunder.

 

4.10          Entire Agreement. This Agreement (including any Schedules and Exhibits hereto) constitutes the full and entire understanding and agreement among the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties is expressly canceled.

 

4.11          Dispute Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of Delaware and to the jurisdiction of the United States District Court for the District of Delaware for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the state courts of Delaware or the United States District Court for the District of Delaware, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that

 

23


 

the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.

 

WAIVER OF JURY TRIAL: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, THE INVESTMENT AGREEMENT, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL.

 

4.12          Delays or Omissions. No delay or omission to exercise any right, power, or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power, or remedy of such nonbreaching or nondefaulting party, nor shall it be construed to be a waiver of or acquiescence to any such breach or default, or to any similar breach or default thereafter occurring, nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. All remedies, whether under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

 

4.13          Acknowledgment. The Company acknowledges that the Investors are in the business of venture capital investing and therefore review the business plans and related proprietary information of many enterprises, including enterprises which may have products or services which compete directly or indirectly with those of the Company. Nothing in this Agreement shall preclude or in any way restrict the Investors from investing or participating in any particular enterprise whether or not such enterprise has products or services which compete with those of the Company.

 

[Remainder of Page Intentionally Left Blank]

 

24


 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.

 

 

ADDEX THERAPEUTICS LTD.

 

 

 

 

By:

/s/ T.M. Dyer

 

Name:

T.M. Dyer

 

Title:

CEO

 

 

 

 

INVESTORS:

 

 

 

 

Growth Equity Opportunities Fund IV, LLC

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

 

 

 

New Leaf Biopharma Opportunities I, L.P.

 

 

 

 

By:New Leaf BPO Associates I, L.P.

 

Its: General Partner

 

 

 

 

By:New Leaf Venture Management III, L.L.C.

 

Its: General Partner

 

 

 

 

By:

/s/ Craig L. Slutzkin

 

 

Craig L. Slutzkin

 

 

Chief Financial Officer

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 


 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.

 

 

ADDEX THERAPEUTICS LTD.

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

 

 

 

INVESTORS:

 

 

 

 

Growth Equity Opportunities Fund IV, LLC

 

 

 

 

By:

/s/ Louis s. Citron

 

Name:

Louis s. Citron

 

Title:

Chief legal officer

 

 

 

 

New Leaf Biopharma Opportunities I, L.P.

 

 

 

 

By:New Leaf BPO Associates I, L.P.

 

Its: General Partner

 

 

 

By:New Leaf Venture Management III, L.L.C.

 

Its: General Partner

 

 

 

 

By:

 

 

 

Craig L. Slutzkin

 

 

Chief Financial Officer

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 


 

 

CDK Associates. L.L.C

 

 

 

 

By:

/s/ Karen Cross

 

Name:

Karen Cross

 

Title:

Treasurer

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 


 

SCHEDULE A

 

Investors

 

1)             Growth Equity Opportunities Fund IV, LLC

c/o New Enterprise Associates 16, L.P.

Attn.: Louis S. Citron

1954 Greenspring Drive, Suite 600

Timonium, MD 21093

Email: LCitron@NEA.com

Fax: +1 410 842 4115

 

With copy, which copy shall not constitute notice, to:

 

Greenberg Traurig, LLP
Attn.: Trevor Chaplick
2101 L St. NW, Suite 1000
Washington, DC 20037
Email:

Fax:

 

2)             New Leaf Biopharma Opportunities I, L.P.

Attn: Craig L. Slutzkin

7 Times Square, Suite 3502

New York, NY 10036

Email:

Fax:

 

3)             CDK Associates. L.L.C

Attn: Heath N. Weisberg

CAM Capital

731 Alexander Road

Bldg. 2, Suite 500

Princeton, NJ 08540

Email:

Fax:

 


 

ANNEX A

 

PLAN OF DISTRIBUTION

 

We are registering the shares of Common Stock issued to the selling stockholders and issuable upon the exercise of the warrants issued to the selling stockholders to permit the resale of these shares of Common Stock by the holders of the shares of Common Stock and warrants from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the selling stockholders of the shares of Common Stock. We will bear all fees and expenses incident to our obligation to register the shares of Common Stock.

 

The selling stockholders may sell all or a portion of the shares of Common Stock beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the shares of Common Stock are sold through underwriters or broker-dealers, the selling stockholders will be responsible for underwriting discounts or commissions or agent’s commissions. The shares of Common Stock may be sold on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale, in the over-the-counter market or in transactions otherwise than on these exchanges or systems or in the over-the-counter market and in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions. The selling stockholders may use any one or more of the following methods when selling shares:

 

·                  ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

·                  block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

 

·                  purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

·                  an exchange distribution in accordance with the rules of the applicable exchange;

 

·                  privately negotiated transactions;

 

·                  settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;

 

·                  broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

 

·                  through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise;

 

·                  a combination of any such methods of sale; and

 

·                  any other method permitted pursuant to applicable law.

 

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(1) under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conform to the requirements of those provisions.

 

Broker-dealers engaged by the selling stockholders may arrange for other broker-dealers to participate in sales. If the selling stockholders effect such transactions by selling shares of Common Stock to or through underwriters, broker-dealers or agents, such underwriters, broker-

 


 

dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling stockholders or commissions from purchasers of the shares of Common Stock for whom they may act as agent or to whom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

 

In connection with sales of the shares of Common Stock or otherwise, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares of Common Stock in the course of hedging in positions they assume. The selling stockholders may also sell shares of Common Stock short and if such short sale shall take place after the date that this Registration Statement is declared effective by the Commission, the selling stockholders may deliver shares of Common Stock covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling stockholders may also loan or pledge shares of Common Stock to broker-dealers that in turn may sell such shares, to the extent permitted by applicable law. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the selling stockholders have been advised that they may not use shares registered on this registration statement to cover short sales of our shares of Common Stock made prior to the date the registration statement, of which this prospectus forms a part, has been declared effective by the SEC.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of Common Stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act of 1933, as amended, amending, if necessary, the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer and donate the shares of Common Stock in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

The selling stockholders and any broker-dealer or agents participating in the distribution of the shares of Common Stock may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agent and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Selling Stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

Each selling stockholder has informed the Company that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the shares of Common Stock. Upon the Company being notified in writing by a selling stockholder that any material arrangement has been entered into with a broker-dealer for the sale of shares of Common Stock through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of each such selling stockholder and of the participating broker-dealer(s),

 


 

(ii) the number of shares involved, (iii) the price at which such the shares of Common Stock were sold, (iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In no event shall any broker-dealer receive fees, commissions and markups, which, in the aggregate, would exceed eight percent (8.0%).

 

Under the securities laws of some states, the shares of Common Stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the shares of Common Stock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

 

There can be no assurance that any selling stockholder will sell any or all of the shares of Common Stock registered pursuant to the shelf registration statement, of which this prospectus forms a part.

 

Each selling stockholder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the shares of Common Stock by the selling stockholder and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the shares of Common Stock to engage in market-making activities with respect to the shares of Common Stock. All of the foregoing may affect the marketability of the shares of Common Stock and the ability of any person or entity to engage in market-making activities with respect to the shares of Common Stock.

 

We will pay all expenses of the registration of the shares of Common Stock pursuant to the registration rights agreement, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, that each selling stockholder will pay all underwriting discounts and selling commissions, if any and any related legal expenses incurred by it. We will indemnify the selling stockholders against certain liabilities, including some liabilities under the Securities Act, in accordance with the registration rights agreement, or the selling stockholders will be entitled to contribution. We may be indemnified by the selling stockholders against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by the selling stockholders specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled to contribution.

 




Exhibit 10.4

 

ADDEX THERAPEUTICS LTD

SHARE OPTION PLAN

 

Effective date: [DATE]

 

1


 

TABLE OF CONTENTS

 

INTRODUCTION

3

General Information

3

THE PLAN

3

A.

General Terms and Definitions

3

Article 1 Purpose

3

Article 2 Definitions

3

Article 3 Shares subject to the Plan

5

B.

Administration

5

Article 4 Board of Directors

6

C.

Grant of Options

6

Article 5 Eligibility and Conditions of Participation

6

Article 6 Procedure

6

Article 7 Option Agreement

7

Article 8 Vesting period

7

Article 9 Exercise Period

8

Article 10 Exercise of Options

8

D.

Limitations on transfer

8

Article 11 Transferability of Options and Shares

8

E.

Forfeiture of Rights

9

Article 12 Termination of Employment/Breaches

9

Article 13 Transfer / Leave of Absence

10

F.

General Provisions

10

Article 14 No (Continued) Employment or Contractual Relationship

10

Article 15 No Segregation of Cash or Shares

11

Article 16 Adjustment due to Corporate Events

11

Article 17 Amendment and Termination

11

Article 18 Indemnification

11

Article 19 Taxes Indemnification

12

Article 20 Applicable law and arbitration

12

Article 21 Effective Date

13

 

2


 

INTRODUCTION

 

GENERAL INFORMATION

 

Addex Therapeutics Ltd is a Swiss corporation (“société anonyme” / “Aktiengesellschaft”) pursuant to Articles 620 et seq. of the Swiss Code of Obligations with unlimited duration and seat in Plan-les-Ouates, Canton of Geneva, Switzerland.

 

THE PLAN

 

A.                          GENERAL TERMS AND DEFINITIONS

 

Article 1
PURPOSE

 

1.1                              The purpose of the Plan is to provide certain Employees, Directors and Consultants with an opportunity to obtain Options on Shares, thus providing an increased incentive for these Employees, Directors and Consultants to contribute to the future success and long-term business value of the Group, enhancing the value of the Shares and increasing the ability of the Company and its Subsidiaries to attract and retain individuals of exceptional skills.

 

1.2                              The Plan rules the conditions and modalities of the purchase and disposal of such Options.

 

Article 2
DEFINITIONS

 

2.1                              In the Plan, the following terms shall have the meanings set forth below:

 

“Articles of Association”

 

shall mean the articles of association of the Company.

 

 

 

“Board of Directors”

 

shall mean the board of directors of the Company.

 

 

 

“Change of Control”

 

shall mean (i) an event which triggers a mandatory offer on the Shares under the rules applying to SIX Swiss Exchange listed companies or any other applicable rules, the event being deemed a qualifying event if any one set of such rules considers it an event triggering a mandatory offer or (ii) the acquisition by any person or entity, alone or jointly, of more than 50% of the Shares or of the voting rights of the Company.

 

 

 

“Company”

 

shall mean Addex Therapeutics Ltd, c/o Addex Pharma SA, 12, chemin des Aulx, 1228 Plan-les-Ouates,

 

3


 

 

 

Switzerland.

 

 

 

“Compensation Committee”

 

shall mean the compensation committee appointed by the general meeting of Shareholders with the rights and duties as defined in the Organizational Rules of the Company.

 

 

 

“Consultant”

 

shall mean any person who is engaged by the Company or a Subsidiary to render consulting or advisory services and is compensated for such services.

 

 

 

“Continuous Service”

 

shall mean that the Participant’s service with the Company or a Subsidiary, whether as an Employee, Director or Consultant, is not interrupted or terminated and Participant remains in such service as defined in the Plan.

 

 

 

“Director”

 

shall mean a member of the board of directors of the Company or of the board of directors of a Subsidiary.

 

 

 

“Disability”

 

shall mean the inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or that has lasted or can be expected to last for a continuous period of not less than twelve (12) months, and will be determined by the Board of Directors on the basis of such medical evidence as the Board of Directors deems warranted under the circumstances.

 

 

 

“Employee”

 

shall mean any executive or employee of the Company or of a Subsidiary.

 

 

 

“Exercise Period”

 

shall mean the period during which Options can be exercised, such period starting on the Grant Date and ending on the Option Term.

 

 

 

“Grant Date”

 

shall mean the date on which Options are granted.

 

 

 

“Group”

 

shall mean the Company and its Subsidiaries.

 

 

 

“Option”

 

shall mean a share option, that is a right to acquire Shares pursuant to the Plan, in accordance with any Option Agreement or as the Board of Directors shall otherwise determine.

 

 

 

“Option Agreement”

 

shall mean the agreement specifying the terms and conditions of the granting of Options and executed by the Company and a Participant in substantially the form attached as Appendix I hereto.

 

 

 

“Option Exercise Notice”

 

shall mean the notice that needs to be given by a Participant when Options are exercised in substantially the form attached as Appendix II hereto or any other form decided by the Board of Directors.

 

 

 

“Options Grant”

 

shall mean the number of Options granted to a Participant

 

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pursuant to an Option Agreement.

 

 

 

“Option Term”

 

shall mean the term of an Option.

 

 

 

“Participant”

 

shall mean an Employee, a Director or a Consultant to whom Options are granted hereunder.

 

 

 

“Plan”

 

shall mean this share option plan in its present form or as amended from time to time.

 

 

 

“Shareholders”

 

shall mean the holders of any Shares of the Company.

 

 

 

“Shares”

 

shall mean the registered shares with a par value of CHF 1 issued by the Company.

 

 

 

“Share Option Plan Administrator”

 

shall mean the person or company appointed by the Board of Directors responsible for receiving and executing Option Exercise Notices.

 

 

 

“Strike Price”

 

shall mean the price at which Shares may be purchased by exercising Options.

 

 

 

“Subsidiary”

 

shall mean a corporation, whether now or hereafter existing, in an unbroken chain of corporations beginning with the Company, if each corporation other than the Company owns shares possessing 50% or more of the total combined voting power of all classes of shares in one of the other corporations in such chain.

 

 

 

“Vested Option”

 

shall mean an Option that has vested in accordance with the rules set forth hereunder.

 

 

 

“Vesting Date”

 

shall mean the date upon which an Option vests in accordance with the rules set forth hereunder.

 

2.2                              References to any statutory provision are to that provision as amended or re-enacted from time to time and, unless the context otherwise requires, words or expressions denoting the singular shall include the plural (and vice versa) and words and expressions denoting the masculine shall include the feminine (and vice versa).

 

2.3                              The Plan is valid for the Participants in its entirety only. No statement made in any part of the Plan shall be construed without reference to the Plan as a whole.

 

Article 3
SHARES SUBJECT TO THE PLAN

 

Shares may be made available from an increase of the share capital of the Company, whether such increase is based on ordinary, authorized or conditional share capital, or from Shares otherwise owned by, or made available to, the Company.

 

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B.                          ADMINISTRATION

 

Article 4
BOARD OF DIRECTORS

 

4.1                              Unless otherwise provided in the Plan, the Board of Directors administers and has full power to construe and interpret the Plan, establish and amend rules and regulations for the administration of the Plan, and perform all other actions relating to the Plan, including the delegation of administrative responsibilities. The Board of Directors may in particular delegate the administration of the Plan to the Compensation Committee or any other duly authorized committee of the Board of Directors, in which case references to the Board of Directors in the Plan shall be construed as referring to the Compensation Committee or to the relevant committee of the Board of Directors. The Board of Directors shall also appoint a Share Option Plan Administrator who shall be responsible for giving, receiving and executing the notices set forth in the Plan.

 

4.2                              All decisions made by the Board of Directors pursuant to the provisions of the Plan and related orders or resolutions of the Board of Directors shall be final, conclusive and binding on all persons, including the Company, Shareholders, Participants, Employees, Directors and Consultants.

 

4.3                              The costs of introducing and administrating the Plan shall be borne by the Company.

 

C.                          GRANT OF OPTIONS

 

Article 5
ELIGIBILITY AND CONDITIONS OF PARTICIPATION

 

5.1                              Those eligible to be granted Options under the Plan are Employees, Directors and Consultants.

 

5.2                              The Board of Directors shall, at its absolute discretion, select from Employees, Directors and Consultants those eligible to be granted Options, the Options Grant, the Strike Price, the Grant Date, the Exercise Date and any other conditions and/or constraints related to the Options.

 

5.3                              When exercising its discretionary power, the Board of Directors shall follow market practice and Options shall be granted to the Participant free of charge, all individual taxes, such as income taxes, and the Participant’s part, if any, of any social security contributions, shall be borne by the Participant.

 

5.4                              Neither the establishment of the Plan, nor the granting of Options, nor the payment of any benefits, nor any action of the Company or of the Board of Directors shall be held or construed to confer upon any Employee, Director or Consultants any legal right to further receive Options. Participation to the Plan in any given year gives no right to participate in any subsequent year.

 

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Article 6
PROCEDURE

 

6.1                              The Board of Directors may adopt any procedures as it thinks fit for the granting of Options.

 

6.2                              The Board of Directors may, among others: (i) require a Participant to make such declarations or take such other action as may be required for the purpose of any securities, exchange control, taxation laws, regulations, practice or other laws of any territory which may be applicable to him at the Grant Date, the Exercise Date or on exercise; (ii) determine that any Option under the Plan shall be subject to additional and/or modified terms and conditions with respect to the granting and terms of exercise as may be necessary to comply with or take account of any securities, exchange control or taxation laws, regulations or practice of any territory which may have application to the relevant Employees, Directors, Consultants, Participants, Company or Subsidiary; (iii) adopt any supplemental rules or procedures governing the grant or exercise of Options as may be required for the purpose of any securities, tax or other laws of any territory which may be applicable to an Employee, a Director, a Consultant or a Participant.

 

Article 7
OPTION AGREEMENT

 

7.1                              The contemplated granting of Option(s) hereunder and the terms thereof shall be subject to the execution of an Option Agreement between the Company and the Participant in substantially the form attached as Appendix I hereto, or in such form as the Board of Directors shall from time to time determine.

 

7.2                              Each Option granted by an Option Agreement shall entitle the Participant to purchase one Share at the Strike Price subject to the conditions specified in such Option Agreement, pursuant to the Plan.

 

7.3                              The Option Agreement shall include the vesting provisions of individual Options, such as details of the Options Grant, the Strike Price, the Grant Date, the Exercise Date and any other conditions.

 

Article 8
VESTING PERIOD

 

8.1                              Subject in particular to the limitations which may be determined from time to time by the Board of Directors, an Options Grant shall vest gradually on a straight line basis over a period of 4 years from the Grant Date until exhaustion of such Options Grant, provided however that the Participant may not exercise any Options of such Options Grant during the first year starting from the Grant Date where the Grant Date falls within the first year of employment or contractual relationship of the Participant with the Company or any of its Subsidiaries.

 

8.2                              Notwithstanding the above, in the event of a Change of Control, all Options held by Participants shall vest immediately.

 

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Article 9
EXERCISE PERIOD

 

9.1                              Without prejudice to Article 8.2, Vested Options may be exercised at any time within the Exercise Period subject to limitations of applicable securities law provisions and subject to the limitations which may be determined by the Board of Directors from time to time.

 

9.2                              Subject to Article 12, the Option Term shall be the tenth anniversary of the Grant Date of such Option or such shorter period specified in the Option Agreement.

 

9.3                              Past the Option Term, all unexercised Options shall expire without value.

 

Article 10
EXERCISE OF OPTIONS

 

10.1                       During the Exercise Period and subject to the provisions of the Plan, notably Article 12, and of any Option Agreement, the Participant may exercise Vested Options in whole or in part, and at one or more times.

 

10.2                       The exercising Participant shall receive within 5 business days after receipt by the Share Option Plan Administrator of an Option Exercise Notice, the number of Shares for which Options are exercised.

 

10.3                       The Company shall not deliver any Shares, respectively register the acquisition of Shares pursuant to the exercise of Options, until full payment of the Strike Price by the Participant.

 

D.                          LIMITATIONS ON TRANSFER

 

Article 11
TRANSFERABILITY OF OPTIONS AND SHARES

 

11.1                       A Participant may only transfer an Option if permitted by the Board of Directors or a duly authorized officer of the Company at the time of the transfer. The Board may only permit transfer of the Option in a manner that is permitted by the Plan. The Board of Directors, in its sole discretion, may impose such limitations on the transferability of Options as the Board of Directors will determine. In the absence of such a determination by the Board of Directors to the contrary, the following restrictions on the transferability of Options will apply:

 

i)                               An Option will not be transferable except by will or by the laws of descent and distribution and will be exercisable during the lifetime of the Participant only by the Participant. An Option may not be transferred for consideration.

 

ii)                            Subject to the approval of the Board of Directors or a duly authorized officer of the Company, a Participant may, by delivering written notice to the Company, in a form approved by the Company, designate a third party who, on the death of the Participant, will thereafter be entitled to exercise the Option and receive the Shares or other consideration resulting from such exercise. In the absence of such a designation, upon the death of

 

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the Participant, the executor or administrator of the Participant’s estate will be entitled to exercise the Option and receive the Shares or other consideration resulting from such exercise. However, the Company may prohibit designation of a beneficiary at any time, including due to any conclusion by the Company that such designation would be inconsistent with the provisions of applicable laws.

 

11.2                       Any purported sale, assignment or transfer of such Options in violation of this provision shall be void.

 

11.3                       Shares purchased upon exercise of Options may be subject to sales restrictions according to applicable securities law provisions and according to the limitations which may be determined by the Board of Directors from time to time with reference to the Company’s Securities Trading Policies, provided however that all such limitations by the Board of Directors shall automatically be lifted in the case of a Change of Control.

 

E.                          FORFEITURE OF RIGHTS

 

Article 12
TERMINATION OF EMPLOYMENT/BREACHES

 

12.1                       Unless otherwise agreed upon by the Board of Directors and the Participant:

 

i)                               Upon termination of employment or contractual relationship by the Company or any of its Subsidiaries for cause (e.g., in the case of employment, according to Article 337 of the Swiss Code of Obligations or similar grounds) or in case of termination by the Participant of a contractual relationship (other than an employment relationship) at an improper time; or

 

ii)                            Upon breach by the Participant of any material obligations set out in any agreement dealing with the Participant’s contractual relationship with the Company or any of its Subsidiaries, as entered into or amended from time to time and/or any provisions of the laws of Switzerland as a consequence of which the Company may not be expected in good faith to continue the existing contractual relationship with the Participant,

 

all Options (including, for the avoidance of doubt, Vested Options) held by the Participant shall be immediately forfeited without value.

 

12.2                       Upon termination of the employment or contractual relationship with the Company or any of its Subsidiaries as a result of a Participant’s Disability, all Options that are not Vested Options held by such Participant shall be immediately forfeited without value, while Vested Options may be exercised by the Participant pursuant to the Plan during the Option Term, after which they shall be forfeited without value.

 

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12.3                       Upon the death of a Participant, all Options that are not Vested Options held by such Participant shall be immediately forfeited without value, while Vested Options may be exercised by the Participant’s estate, or by a person who acquired the right to exercise the Option(s) by bequest or inheritance, pursuant to the Plan during the Option Term, after which they shall be forfeited without value.

 

12.4                       Upon termination of the employment or contractual relationship by the Company or any of its Subsidiaries or by a Participant prior to the first anniversary of entering the employment or contractual relationship, all Options shall be immediately forfeited without value.

 

12.5                       Upon termination of the employment or contractual relationship by the Company or any of its Subsidiaries or by a Participant for any reason other than as aforesaid, all Options that are not Vested Options held by the Participant shall be immediately forfeited without value, while Vested Options may be exercised by the Participant pursuant to the Plan during the Option Term, after which they shall be forfeited without value.

 

Article 13
TRANSFER / LEAVE OF ABSENCE

 

13.1                       A change in the capacity in which the Participant renders service to the Company or a Subsidiary as an Employee, Director or Consultant or a change in the entity for which the Participant renders such service, will not cause the Participant to cease to be an eligible participant provided that there is no interruption or termination of the Participant’s service with the Company or a Subsidiary. To the extent permitted by law, the Board of Directors, in its sole discretion, may determine whether Continuous Service will be considered interrupted in the case of any leave of absence approved by the Board of Directors, including sick leave, military leave or any other personal leave.

 

13.2                       If employment is terminated prior to the reemployment of the Employee, the provisions of Article 12 shall be applicable.

 

F.                           GENERAL PROVISIONS

 

Article 14
NO (CONTINUED) EMPLOYMENT OR CONTRACTUAL RELATIONSHIP

 

14.1                       Neither the establishment of the Plan, nor the granting of Options, nor the payment of any benefits, nor any action of the Company, the Board of Directors or a Subsidiary shall be held or construed to confer upon any Participant any legal right to continue to be employed by the Company or any of its Subsidiaries or to remain in a contractual relationship with said, each of which expressly reserves the right to discharge any Employee or Director whenever the interest of any such company in its sole discretion may so require without liability to such company or to the Board of Directors, except as to any rights which may be expressly conferred upon such Participant under the Plan.

 

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14.2                       The mere fact of participating to the Plan shall in no circumstances whatsoever be construed as an employment agreement, or any similar agreement, between the Participant and the Company.

 

Article 15
NO SEGREGATION OF CASH OR SHARES

 

The Company shall not be required to segregate any cash or Shares in order to fulfill its obligations hereunder.

 

Article 16
ADJUSTMENT DUE TO CORPORATE EVENTS

 

In events such as stock dividend, extraordinary cash dividend, recapitalization, reorganization, merger, consolidation, split-up, spin-off, combination, exchange of shares, options or rights offering to purchase Shares at a price substantially below fair market value, or other similar corporate event, affects the Shares underlying the Options such that an adjustment is required in order to preserve the benefits intended to be made available under this Plan, then the Option shall be adjusted and/or, if deemed appropriate, a cash payment to Participants or persons having outstanding Options shall be made. Such adjustment shall take into consideration the acquired rights of the Participants and the objectives of the Plan, and it shall be final and binding.

 

Article 17
AMENDMENT AND TERMINATION

 

17.1                       Subject, as the case may be, to the prior approval of the Shareholders (as provided for by the law, or in the Articles of Association), the Board of Directors may amend, suspend or discontinue the Plan.

 

17.2                       The Options granted hereunder shall be subject to such further rules and regulations as the Company may adopt with respect to its equity incentive plans, and the Participant agrees to enter into such further documents, not inconsistent with the terms hereof, as the Company may require. The Company may also require the Participant to enter into such further documents with respect to the holding and transfer of any Shares subject to the Options described herein as may be necessary or appropriate in the sole discretion of the Company to ensure compliance with applicable law with respect to such holding and transfer.

 

17.3                       Amendment, suspension or discontinuity of the Plan shall be communicated by the Board of Directors to all Participants.

 

Article 18
INDEMNIFICATION

 

In addition to other rights of indemnification available to them, the members of the Board of Directors shall be indemnified by the Company against all costs and expenses reasonably

 

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incurred by them in connection with any action, suit or proceeding to which they or any of them may be party by reason of any action taken or failure to act under or in connection with the Plan or any Options granted thereunder, and against all amounts paid by them in settlement thereof (provided such settlement is approved by independent legal counsel selected by the Company) or paid by them in satisfaction of a judgement in any such action, suit or proceeding, except a judgement based upon the finding of bad faith, provided that upon the institution of any such action, suit or proceeding, members of the Board of Directors shall, in writing, give the Company notice thereof and an opportunity, at its own expense, to handle and defend the same before such member of the Board of Directors undertakes to handle and defend it on such member’s own behalf.

 

Article 19
TAXES INDEMNIFICATION

 

19.1                       The Participant shall indemnify the Company against any tax, including employment and social security taxes, arising in respect of the granting or the exercise of Options which is a liability of the Participant but for which the Company is required to account under the laws of any relevant territory.

 

19.2                       The Company may recover the tax from the Participant in such manner as the Board of Directors thinks fit including (but without prejudice to the generality of the foregoing): (i) withholding portion of the Options and selling the same; (ii) deducting the necessary amount from the Participant’s remuneration; or (iii) requiring the Participant to account directly to the Company for such tax.

 

Article 20
APPLICABLE LAW AND ARBITRATION

 

20.1                       The Plan and any related document shall be governed by and construed in accordance with Swiss law, excluding principles of conflict of laws.

 

20.2                       Any dispute, controversy or claim arising out of or in relation with the Plan including the validity, invalidity, breach or termination thereof, shall be finally decided by three arbitrators in accordance with the Swiss Rules of International Arbitration of the Swiss Chambers of Commerce in force on the date when the notice of arbitration is submitted in accordance with said rules. The seat of the arbitration shall be Geneva, Switzerland. The language of arbitration shall be English.

 

20.3                       The acceptance of any Option or any related right implies the consent to the choice of law and jurisdiction set in this Article.

 

20.4                       By executing an Option Agreement, the Participant expressly acknowledges and accepts the terms and conditions of the Plan and all its related documents, as well as the powers of the Board of Directors to complete, interpret and implement it through further documents which it may from time to time determine necessary or relevant. Any disagreement regarding the interpretation shall be resolved by the Company, whose determination shall be binding.

 

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Article 21
EFFECTIVE DATE

 

The Plan shall be effective on [DATE] and applicable to all outstanding Option grants.

 

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APPENDIX I

 

FORM OF OPTION AGREEMENT

 

ADDEX THERAPEUTICS LTD SHARE OPTION PLAN

 

This OPTION AGREEMENT is made on [date], by and between Addex Therapeutics Ltd, a Swiss corporation, with its seat in Plan-les-Ouates, Switzerland (the “Company”) and                     (the “Participant”).

 

In consideration of the mutual covenants and agreements herein contained and pursuant to the Company’s Share Option Plan of 1 January 2019 (the “Plan”), the Company and the Participant agree as follows:

 

The Company grants to the Participant the following number of Options according to the terms and conditions contained in the Plan and in this Option Agreement:

 

Number of Options:

 

 

 

 

 

Strike Price:

 

 

 

 

 

Grant Date:

 

 

 

 

 

Vesting Date:

In accordance with Article 8 of the Plan and the table below

 

 

 

Exercise Period:

Ten years from the Grant Date

 

 

 

 

Special Conditions:

 

 

 

The signature of this Option Agreement by the Participant implies his express and complete acceptance of the terms set forth in the Plan, in this Option Agreement or in any other document related hereto. Furthermore, the Participant hereby accepts the powers of the Board of Directors to administer the Plan at its absolute discretion, to complete, interpret and implement the documents herein referred through further documentation to the extent necessary or relevant and to decide on all issues in absolute discretion. The Participant agrees to be bound by the decisions of the Board of Directors.

 

All notices to the Company shall be delivered to Addex Therapeutics Ltd, c/o Addex Pharma, 14, chemin des Aulx, Plan-les-Ouates, Switzerland, attn Share Option Plan Administrator, and all notices to the Participant may be given to the Participant personally or may be mailed to the Participant c/o Addex Therapeutics Ltd or at such other address as the Participant may designate by written notice to the Company.

 

This Option Agreement and any related document shall be governed by Swiss law, excluding principles of conflict of laws.

 

Any dispute, controversy or claim arising out of or in relation with the Plan including the validity, invalidity, breach or termination thereof, shall be finally decided by three arbitrators in accordance with the Swiss Rules of International Arbitration of the Swiss

 

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Chambers of Commerce in force on the date when the notice of arbitration is submitted in accordance with said rules. The seat of the arbitration shall be Geneva, Switzerland. The language of arbitration shall be English.

 

IN WITNESS THEREOF, the parties have executed this Option Agreement in duplicate as of the time and place first above written.

 

 

 

 

Addex Therapeutics Ltd

 

Participant

 

 

 

 

 

 

 

 

 

Date

 

Date

 

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APPENDIX II

 

FORM OF OPTION EXERCISE NOTICE

 

ADDEX THERAPEUTICS LTD SHARE OPTION PLAN

 


[date of notice]

 

Share Option Plan Administrator

[address]

 

Reference: [Name of Participant]: Share Option Plan.

 

I hereby exercise my Option(s) according to and under the terms and conditions of the Addex Therapeutics Ltd Share Option Plan    [DATE]      (the “Plan”) and the Option Agreement of              , as follows:

 

Grant Date of the Options:

 

 

 

 

 

Number of Options exercised:

 

 

 

 

 

 

 

 

[Participant]

 

 

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Addex Therapeutics Ltd
Stock Option Plan

 

ADDENDUM FOR U.S. PARTICIPANTS

 

1.                                      Purpose and Applicability.

 

(a)                                 This Addendum for U.S. Participants (the “U.S. Addendum”) applies to participants in the Plan who are either U.S. residents or U.S. taxpayers (each such participant, a “U.S. Participant”). The purpose of the U.S. Addendum is to facilitate compliance with U.S. tax, securities and other applicable laws, and to permit the Company to issue Options to eligible U.S. Participants.

 

(b)                                 Except as otherwise provided by the U.S. Addendum, all Option grants made to U.S. Participants will be governed by the terms of the Plan, when read together with the U.S. Addendum. In any case of an irreconcilable contradiction (as determined by the Board of Directors) between the provisions of the U.S. Addendum and the Plan, the provisions of the U.S. Addendum will govern.

 

(c)                                  This Addendum is effective as of [     ], 2019 (the “Effective Date”).

 

2.                                      Definitions.

 

Capitalized terms contained herein have the same meanings given to them in the Plan, unless otherwise provided by the U.S. Addendum. In the U.S. Addendum, the following words will have the meaning as defined below:

 

Code” means the U.S. Internal Revenue Code of 1986, as amended.

 

Fair Market Value” means as of any date, the value of the Shares determined by the Board of Directors in compliance with Section 409A of the Code and, in the case of an Incentive Stock Option, in compliance with Section 422 of the Code.

 

Incentive Stock Option” or “ISO” means a stock option that is intended to be, and qualifies as, an incentive stock option within the meaning of Section 422 of the Code.

 

Nonstatutory Stock Option” or “NSO” means a stock option that does not qualify as an Incentive Stock Option.

 

Plan” means Addex Therapeutics Ltd Share Option Plan.

 

Securities Act” means the U.S. Securities Act of 1933, as amended.

 

U.S.” means the United States of America.

 

3.                                      Additional Terms and Conditions Applicable to All Options Granted to U.S. Participants.

 

(a)                                 Form of Grant Notice. The Grant Notice for U.S. Participants shall be in substantially the form attached as Schedule 1 to the U.S. Addendum, as may be amended from time to time by the Board of Directors. The Grant Notice shall indicate if all or a portion of the Option is designated as an Incentive Stock Option.

 

(b)                                 Exercise Price. Subject to the provisions of Section 4(d) below regarding Incentive Stock Options granted to certain major stockholders, the exercise price of each Option will be not less than one hundred percent (100%) of the Fair Market Value of the Shares subject to the Option on the date the Option is granted.

 

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(c)                                  Domestic Relations Orders.  Subject to the approval of the Board of Directors or a duly authorized officer of the Company, an Option may be transferred pursuant to the terms of a domestic relations order, official marital settlement agreement or other divorce or separation instrument as permitted by Treasury Regulations Section 1.421-1(b)(2).  If an Option is an Incentive Stock Option, such Option will be deemed to be a Nonstatutory Stock Option as a result of such transfer.

 

4.                                      Provisions Applicable to Incentive Stock Options.

 

(a)                                 Eligible Recipients of ISOs.  Incentive Stock Options may be granted only to Employees.

 

(b)                                 Designation of ISO Status.  The Board of Directors action approving the grant of an Option to a U.S. Participant, and the Grant Notice, must specify that the Option is intended to be an Incentive Stock Option. If an Option is not specifically designated as an Incentive Stock Option, or if an Option is designated as an Incentive Stock Option but some portion or all of the Option fails to qualify as an Incentive Stock Option under the applicable rules, then the Option (or portion thereof) will be a Nonstatutory Stock Option.

 

(c)                                  Maximum Shares Issuable On Exercise of ISOs. Subject to the adjustment provisions of Section 16 of the Plan, the maximum aggregate number of Shares that may be issued upon the exercise of Incentive Stock Options is [         ] Shares.

 

(d)                                 Limits for 10% Stockholders.  A person who owns (or is deemed to own pursuant to Section 424(d) of the Code) stock possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Company or any affiliate, will not be granted an Incentive Stock Option unless the exercise price of such Option is at least one hundred ten percent (110%) of the Fair Market Value on the date of grant and the Option is not exercisable after the expiration of five (5) years from the date of grant.

 

(e)                                  No Transfer.  As provided by Section 422(b)(5) of the Code, an Incentive Stock Option will not be transferable except by will or by the laws of descent and distribution, and will be exercisable during the lifetime of the U.S. Participant only by the U.S. Participant.  If the Board of Directors elects to allow the transfer of an Option by a U.S. Participant that is designated as an Incentive Stock Option, such transferred Option will automatically become a Nonstatutory Stock Option.

 

(f)                                   US $100,000 Limit.  As provided by Section 422(d) of the Code and applicable regulations thereunder, to the extent that the aggregate Fair Market Value (determined at the time of grant) of Shares with respect to which Incentive Stock Options are exercisable for the first time by any U.S. Participant during any calendar year (under all plans of the Company and any Subsidiary) exceeds US$100,000 (or such other limit established in the Code) or otherwise does not comply with the rules governing Incentive Stock Options, the Options or portions thereof that exceed such limit (according to the order in which they were granted) or otherwise do not comply with such rules will be treated as Nonstatutory Stock Options, notwithstanding any contrary provision of the applicable Grant Agreement(s).

 

(g)                                  Post-Termination Exercise Period.  To obtain the U.S. federal income tax advantages associated with an Incentive Stock Option, the U.S. Internal Revenue Code requires that at all times beginning on the date of grant and ending on the day three (3) months before the date of exercise of the Option, the U.S. Participant must be an employee of the Company or a Subsidiary (except in the event of the U.S. Participant’s death or Disability, in which case a 12-month period applies)). The Company cannot guarantee that the Option will be treated as an Incentive Stock Option if the U.S. Participant continues to provide services to the Company or a Subsidiary after such U.S. Participant’s

 

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employment terminates or if the U.S. Participant otherwise exercises the Option more than three (3) months (or twelve (12) months, as the case may be) after the date his or her employment terminates, or the Option otherwise fails to qualify as an Incentive Stock Option.

 

5.                                      Tax Matters

 

(a)                                 Tax Withholding Requirement. Prior to the delivery of any Shares pursuant to the exercise of an Option, the Company will have the power and the right to deduct or withhold, or require a U.S. Participant to remit to the Company, an amount sufficient to satisfy U.S. federal, state, local, foreign or other taxes (including the U.S. Participant’s FICA obligation) required to be withheld with respect to such Option.

 

(b)                                 Withholding Arrangements.  The Company may, in its sole discretion, satisfy any U.S. federal, state, local, foreign or other tax withholding obligation relating to an Option by any of the following means or by a combination of such means: (i) causing the U.S. Participant to tender a cash payment; (ii) withholding Shares issued or otherwise issuable to the U.S. Participant in connection with the Option; provided, however, that no Shares are withheld with a value exceeding the minimum amount of tax required to be withheld by law (or such lesser amount as may be necessary to avoid classification of the Option as a liability for financial accounting purposes); or (iii) withholding payment from any amounts otherwise payable to the U.S. Participant.

 

(c)                                  No Obligation to Notify or Minimize Taxes.  The Company will have no duty or obligation to the U.S. Participant to advise such holder as to the time or manner of exercising the Option.  Furthermore, the Company will have no duty or obligation to warn or otherwise advise such holder of a pending termination or expiration of an Option or a possible period in which the Option may not be exercised.  The Company has no duty or obligation to minimize the tax consequences of an Option to the U.S. Participant.

 

(d)                                 Section 409A of the Code. Unless otherwise expressly provided for in an Grant Agreement, the terms applicable to Options granted under the U.S. Addendum will be interpreted to the greatest extent possible in a manner that makes the Options exempt from Section 409A of the Code, and, to the extent not so exempt, that brings the Options into compliance with Section 409A of the Code. Notwithstanding anything to the contrary in the Plan (and unless the Grant Agreement or other written contract with the U.S. Participant specifically provides otherwise), if the Shares are publicly traded, and if a U.S. Participant of an Option that constitutes “deferred compensation” under Section 409A of the Code is a “specified employee” under Section 409A of the Code, no distribution or payment of any amount that is due because of a “separation from service” (as defined in Section 409A of the Code without regard to alternative definitions thereunder) will be issued or paid before the date that is six (6) months following the date of such U.S. Participant’s “separation from service” or, if earlier, the date of the U.S. Participant’s death, unless such distribution or payment can be made in a manner that complies with Section 409A of the Code, and any amounts so deferred will be paid in a lump sum on the day after such six (6) month period elapses, with the balance paid thereafter on the original schedule.

 

6.                                      Term, Amendment and Termination of the U.S. Addendum.

 

(a)                                 The Board of Directors may amend, suspend or terminate this U.S. Addendum at any time. Unless terminated sooner by the Board of Directors, the U.S. Addendum will terminate automatically upon the earlier of (i) 10 years after the Effective Date and (ii) the termination of the Plan. No Options may be granted under the U.S. Addendum while either the Plan or the U.S. Addendum is suspended or after the Plan or the U.S. Addendum is terminated.

 

(b)                                 If this U.S. Addendum is terminated, the provisions of this U.S. Addendum and any administrative guidelines, and other rules adopted by the Board of Directors and in force at the time of

 

3


 

suspension or termination of this U.S. Addendum, will continue to apply to any outstanding Options as long as an Option issued pursuant to the U.S. Addendum remain outstanding.

 

(c)                                  No amendment, suspension or termination of the U.S. Addendum may materially adversely affect any Options granted previously to any U.S. Participant without the consent of the U.S. Participant.

 

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SCHEDULE 1

 

STOCK OPTION GRANT NOTICE
(for U.S. Participants)

 

Addex Therapeutics Ltd (the “Company”), pursuant to its Incentive Plan (the “Plan”), hereby grants to the U.S. Participant options to purchase the number of Shares set forth below (the “Options”).  The Options are subject to all of the terms and conditions as set forth in this stock option grant notice (the “Grant Notice”), the attached U.S. Addendum and the Plan, all of which are attached hereto and incorporated herein in their entirety.  Capitalized terms not explicitly defined herein but defined in the Plan or the U.S. Addendum will have the same definitions as in the Plan or the U.S. Addendum.  If there is any conflict between the terms herein, the U.S. Addendum and the Plan, the terms of the U.S. Addendum, and then the terms of the Plan, will control.

 

U.S. Participant:

 

 

 

Date of Grant:

 

 

 

Vesting Commencement Date:

 

 

 

Number of Shares Subject to Options:

 

 

 

Exercise Price (Per Share):

 

 

 

Total Exercise Price:

 

 

 

Expiration Date:

 

 

 

Purchase Price per Option:

 

 

 

Total Purchase Price for the Options:

 

 

Type of Grant:

o Incentive Stock Options(1)              o  Nonstatutory Stock Options

 

 

Vesting Schedule:

The Options will vest and become exercisable as to [one third (1/3) of the original number of Options on each of the first three anniversaries of the Vesting Commencement Date](2), subject to the U.S. Participant’s Continuous Service on each applicable vesting date.

 

 

Payment:

By cash, check, bank draft or money order payable to the Company

 

Additional Terms/Acknowledgements:  The U.S. Participant acknowledges receipt of, and understands and agrees to, this Grant Notice, the U.S. Addendum and the Plan. The U.S. Participant acknowledges

 


(1)  If this is an Incentive Stock Option, it (plus other outstanding Incentive Stock Options) cannot be first exercisable for more than $100,000 in value (measured by exercise price) in any calendar year.  Any excess over $100,000 is a Nonstatutory Stock Option.

(2)  Note to client — the vesting schedule can be customized; this typical provision is a placeholder.

 


 

and agrees that this Grant Notice, the U.S. Addendum and the Plan may not be modified, amended or revised except as provided in the Plan. The U.S. Participant further acknowledges that as of the Date of Grant, this Grant Notice, the U.S. Addendum and the Plan set forth the entire understanding between the U.S. Participant and the Company regarding the Options and supersede all prior oral and written agreements, promises and/or representations on that subject with the exception of (i) options previously granted and delivered to the U.S. Participant, (ii) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law and (iii) any written employment or severance arrangement that would provide for vesting acceleration of the Options upon the terms and conditions set forth therein.

 

By accepting the Options, the U.S. Participant consents to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

In addition, by accepting the Options, the U.S. Participant consents that the Company does not have a duty to design or administer the Plan or its other compensation programs in a manner that minimizes the U.S. Participant’s tax liabilities.  The U.S. Participant agrees that the U.S. Participant will not make any claim against the Company, or any of its officers, directors, employees or affiliates related to tax liabilities arising from the Option or other compensation. In particular, the U.S. Participant acknowledges that the Option is exempt from Section 409A of the Code only if the exercise price per share specified in this Grant Notice is at least equal to the “fair market value” per Share on the Date of Grant and there is no other impermissible deferral of compensation associated with the Option. Because the Shares are not traded on an established securities market, the Fair Market Value is determined by the Board of Directors. The U.S. Participant acknowledges that there is no guarantee that the Internal Revenue Service will agree with the valuation as determined by the Board.

 

ADDEX THERAPEUTICS LTD

 

U.S. PARTICIPANT:

 

 

 

 

 

By:

 

 

 

Signature

 

Signature

Title:

 

 

Date:

 

 

 

 

 

 

Date:

 

 

 

 

 

ATTACHMENTS:

 

1.              U.S. Addendum

2.              Rules of the Addex Therapeutics Ltd Share Option Plan

 




Exhibit 21.1

 

Subsidiaries of Addex Therapeutics Ltd.

 

Name of Subsidiary

 

Jurisdiction of Organization

Addex Pharmaceuticals, Inc.

 

Delaware

Addex Pharma SA

 

Switzerland

Addex Pharmaceuticals France sas

 

France

 




Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We hereby consent to the use in this Registration Statement on Form F-1 of Addex Therapeutics Ltd of our report dated September 23, 2019 relating to the financial statements of Addex Therapeutics Ltd, which appears in this Registration Statement. We also consent to the reference to us under the heading “Experts” in such Registration Statement.

 

/s/ PricewaterhouseCoopers SA

Geneva, Switzerland
December 17, 2019