Switzerland
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| |
2834
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| |
Not Applicable
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(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification No.) |
Deanna L. Kirkpatrick
Yasin Keshvargar Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 (212) 450-4000 |
| |
Dieter Gericke
Benjamin Leisinger Homburger AG Hardstrasse 201 CH-8005 Zurich, Switzerland +41 43 222 10 00 |
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Jacques Iffland
Lenz & Staehelin Route de Chêne 30 CH-1211 Geneva 6, Switzerland +41 58 450 70 00 |
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Divakar Gupta
Richard C. Segal Alison A. Haggerty Cooley LLP 55 Hudson Yards New York, NY 10001 (212) 479-6000 |
Title of each class of securities to be registered
|
| |
Proposed maximum
aggregate offering price(1)(2) |
| |
Amount of registration fee(3)(4)
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Common shares, par value CHF 0.08 per share
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| |
$100,000,000
|
| |
$12,980.00
|
(1)
|
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
|
(2)
|
Includes common shares granted pursuant to the underwriters’ option to purchase additional common shares.
|
(3)
|
Calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended, based on an estimate of the proposed maximum aggregate offering price.
|
(4)
|
In accordance with Rule 457(p), $12,980.00, representing the full amount of the registration fee due in connection with this Registration Statement, has been offset by the registration fee previously paid with respect to the prior registration statement on Form F-1 (No. 333-233659) initially filed by ADC Therapeutics SA on September 6, 2019. Accordingly, no additional fee is due in connection with this filing.
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|
| |
PER SHARE
|
| |
TOTAL
|
Initial public offering price
|
| |
$
|
| |
$
|
Underwriting discounts and commissions(1)
|
| |
$
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| |
$
|
Proceeds, before expenses, to us
|
| |
$
|
| |
$
|
(1)
|
See “Underwriters” for a description of all compensation payable to the underwriters.
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MORGAN STANLEY
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BofA SECURITIES
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COWEN
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•
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Cytotoxic Potency. The PBD dimer warheads used in our ADCs have been shown preclinically to be approximately 100 times more potent than other warheads used in currently marketed ADCs, such as auristatin, maytansine and calicheamicin.
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•
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Activity in Tumors with Low-Expressing Targets. The high potency of our PBD-based warheads means that, compared to other warheads, fewer molecules of warhead should be needed to be internalized into the cancer cell to kill it. We believe that the potency of our PBD-based warheads may allow us to develop ADCs that target antigens with low expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
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•
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Durable Responses. Our PBD-based ADCs create interstrand cross-links in the target cells’ DNA. As PBD cross-links are non-distortive, they are designed to be able to evade the cells’ DNA repair mechanisms that result in limited clinical responses and relapses. We believe that this may contribute to the frequency and durability of responses in heavily pre-treated and primary refractory patients that we have observed in our clinical trials.
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•
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Bystander Effect. Since our PBD-based warheads are cell-permeable, they may be able to diffuse into adjacent cells and kill them in an antigen-independent manner. We believe that this may allow us to develop ADCs that target antigens with heterogeneous expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
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•
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Immunogenic Cell Death. PBD warheads have been observed to induce immunogenic cell death, whereby a cancer cell’s death expresses certain stress signals that induce the body’s anti-tumor immune response through the activation of T cells and antigen-presenting cells. This opens up the potential for combining our ADCs with other therapies, particularly with immuno-oncology therapies such as checkpoint inhibitors, that are specifically designed to activate the patient’s own immune system to combat cancer.
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•
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We retain exclusive worldwide development and commercialization rights to Lonca. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations in other geographies.
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•
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We intend to submit a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020. Concurrently, we intend to commence a post-marketing confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support a supplemental BLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL.
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•
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We completed enrollment of a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL, for which we anticipate reporting final data in the second quarter of 2020.
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○
|
As of October 2019, we observed a 45.5% interim ORR in 145 heavily pre-treated patients who have received a median of three prior lines of therapy. This interim ORR exceeded our target primary endpoint and the 41.4% ORR observed for DLBCL patients in our 183-patient Phase 1 clinical trial who were treated at the initial dose used in our pivotal Phase 2 clinical trial.
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○
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Lonca’s significant clinical activity was observed across a broad patient population in this clinical trial, including patients with primary refractory disease, bulky disease, double-hit or triple-hit disease and transformed disease, elderly patients and patients who did not respond to prior therapy.
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•
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Lonca is also being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and mantle cell lymphoma (“MCL”), for which we anticipate reporting safety and efficacy data from the Phase 1 part of this clinical trial in the fourth quarter of 2020.
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○
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As of April 21, 2020, at the dose that will be used in the pivotal Phase 2 part of the clinical trial, we observed a 76.9% ORR and a 61.5% complete response rate in heavily pre-treated evaluable DLBCL patients who have received a median of three prior lines of therapy.
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○
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We intend to advance Lonca into a potential pivotal Phase 2 stage of this clinical trial.
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•
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We also intend to commence an additional pivotal Phase 2 clinical trial of Lonca for the treatment of FL in the fourth quarter of 2020.
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○
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In the Phase 1 clinical trial of Lonca for the treatment of relapsed or refractory NHL, which included 14 patients with FL, we observed a 78.6% ORR in heavily pre-treated patients with relapsed or refractory FL who have received a median of four prior lines of therapy.
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•
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Favorable clinical activity across a broad patient population, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy and patients with bulky disease, double-hit and triple-hit disease and transformed disease;
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•
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Significant single-agent clinical activity while maintaining a manageable tolerability profile with a low incidence of febrile neutropenia;
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•
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Activity in heavily pretreated patients, including those who have received prior CD19 therapies and stem cell transplant (“SCT”);
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•
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Promising clinical activity observed in our combination clinical trial with ibrutinib, which we believe demonstrates the opportunity to advance Lonca into earlier lines of therapy in combination with other therapies such as ibrutinib and rituximab; and
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•
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Convenient 30-minute intravenous infusions once every three weeks in the out-patient setting.
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•
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Our successful recruitment of an experienced Chief Commercial Officer and senior commercial leadership team, including a Vice President of Sales, a Vice President of Marketing and a Vice President of Market Access, with broader organizational recruitment underway;
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Our successful recruitment of a Vice President of Medical Affairs, with a broader organizational recruitment underway to include field-based medical science liaisons;
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Investing resources to assess the competitive landscape, supporting our differentiated profile and accelerating our launch readiness efforts;
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•
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Increased scientific interactions with Key Opinion Leaders; and
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•
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Our plans to build a U.S. field sales organization comprising of approximately 40 to 60 sales representatives, which we believe will be sufficient to reach approximately 80% of the potential prescribing physicians for Lonca.
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•
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We retain worldwide development and commercialization rights to Cami, subject to our collaboration and license agreement with Genmab.
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•
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Cami is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL, for which we anticipate reporting top-line response rate data in the first half of 2021.
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○
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As of April 15, 2020, 47 patients have been enrolled in this pivotal Phase 2 clinical trial, which is currently subject to a partial clinical hold. See “Business—Camidanlumab Tesirine (ADCT-301): PBD-Based ADC Targeting CD25—Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Hodgkin Lymphoma.”
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•
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We are advancing Cami through clinical development to support a BLA submission for the treatment of relapsed or refractory HL.
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•
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Enrollment has been completed in a 133-patient Phase 1 clinical trial of Cami for the treatment of relapsed or refractory HL and NHL, including 77 patients with relapsed or refractory HL. In this clinical trial, Cami demonstrated significant clinical activity across a broad patient population, while maintaining a manageable tolerability profile. More specifically, as of April 2019, we observed:
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○
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At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR in heavily pre-treated patients with relapsed or refractory HL who have received a median of five prior lines of therapy, including patients who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant; and
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○
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A 44.0% ORR in heavily pre-treated patients with relapsed or refractory T-cell lymphoma who have received a median of four prior lines of therapy.
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•
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Cami is also being evaluated in a Phase 1b clinical trial for the treatment of selected advanced solid tumors by targeting CD25-expressing regulatory T cells (“Tregs”).
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○
|
In paired biopsies from three patients in the Phase 1b clinical trial, we have observed a significant increase in the ratio of T effector cells (“Teffs”) to Tregs.
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•
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At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR in heavily pre-treated patients with relapsed or refractory HL who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant;
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•
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Manageable tolerability profile;
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•
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The potential opportunity to advance Cami into earlier lines of therapy as a monotherapy or in combination with other therapies;
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•
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Novel immuno-oncology approach targeting Tregs for the treatment of various advanced solid tumors; and
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•
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Convenient 30-minute intravenous infusions once every three weeks in the out-patient setting.
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•
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Advance our lead product candidate, Lonca, to BLA submission in the second half of 2020.
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•
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Expand the potential market opportunity by advancing Lonca into earlier lines of therapy and for multiple indications.
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•
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Advance our second lead product candidate, Cami, to support BLA submission.
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•
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Advance our two clinical-stage solid tumor product candidates to address multiple indications in areas of high unmet medical need.
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•
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Continue to build a diverse and balanced portfolio of product candidates to address high unmet medical needs in oncology by leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy.
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•
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Maximize the commercial potential of our product candidates through both our own commercial organization and strategic collaborations.
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•
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We have incurred net losses during all fiscal periods since our inception, have no products approved for commercial sale and anticipate that we will continue to incur substantial net losses for the foreseeable future.
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•
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The Facility Agreement, our indebtedness and the associated restrictive covenants thereunder could adversely affect our financial condition and will restrict our ability to raise capital.
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•
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We have concentrated our research and development efforts on PBD-based ADCs, and our future success depends heavily on the successful development of this therapeutic approach.
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•
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Our current product candidates are in various stages of development, and it is possible that none of our product candidates will ever become commercial products.
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•
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Our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL is currently subject to a partial clinical hold. In addition, in the past, certain of our clinical trials have been subject to clinical holds prior to the dosing of the first patient and partial clinical holds after the dosing of the first patient. A clinical hold on any of our clinical trials will result in delays of our clinical development timeline.
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•
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Our product candidates may cause undesirable side effects or have other properties that may delay or prevent their development or regulatory approval or limit their commercial potential.
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•
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The regulatory review and approval processes of the FDA, the European Medicines Agency (“EMA”) and comparable regulatory authorities in other jurisdictions are lengthy, time-consuming and inherently unpredictable. If we are unable to obtain, or if there are delays in obtaining, regulatory approval for our product candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.
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•
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As a company, we have never commercialized a product. We currently have no active sales force and we are in the process of building our commercial infrastructure. We may lack the necessary expertise, personnel and resources to successfully commercialize our product candidates.
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•
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We face substantial competition, which may result in others discovering, developing or commercializing products, treatment methods and/or technologies before or more successfully than we do.
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•
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Our rights to Cami are subject to our collaboration and license agreement with Genmab, and there can be no assurance that we will maintain the rights to develop or commercialize Cami.
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•
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We rely on third parties for the manufacture, production, storage and distribution of our product candidates. Our dependence on these third parties may impair the clinical advancement and commercialization of our product candidates.
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•
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Issued patents covering one or more of our product candidates or technologies, including Lonca, Cami or the technology we use in our product candidates, could be found invalid or unenforceable if challenged in court.
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•
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If we fail to attract and retain senior management and key scientific personnel or fail to adequately plan for succession, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
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•
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Our business could be adversely affected by the effects of health epidemics, including the recent COVID-19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
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•
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We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and the price of our common shares.
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•
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a requirement to have only two years of audited financial statements in addition to any required interim financial statements and correspondingly reduced disclosure in the Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in the registration statement of which this prospectus forms a part;
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•
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an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); and
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•
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to the extent that we no longer qualify as a foreign private issuer, (i) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (ii) exemptions from the requirements of holding a non-binding advisory vote on executive compensation, including golden parachute compensation.
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•
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the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;
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•
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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
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•
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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.
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•
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1,020,434 common shares issuable upon the exercise of options outstanding under our 2019 Equity Incentive Plan as of December 31, 2019, at a weighted-average exercise price of $ per share, of which 7,857 common shares were forfeited in the first quarter of 2020;
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•
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245,126 common shares issuable upon the exercise of options outstanding under our 2019 Equity Incentive Plan granted after December 31, 2019, at a weighted-average exercise price of $ per share;
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•
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7,820,000 common shares reserved for future issuance under our 2019 Equity Incentive Plan, as amended and restated in connection with this offering;
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•
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common shares we hold in treasury, net of the delivery of an estimated common shares (subject to adjustments for final tax and social security deductions) that we expect to deliver to participants of our 2014 Incentive Plan to settle outstanding awards thereunder in connection with this offering; and
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•
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common shares issuable upon the conversion of our senior secured convertible notes to be issued under the Facility Agreement.
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•
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the Share Capital Reorganization;
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•
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the filing and effectiveness of our amended and restated articles of association, which will occur immediately prior to the completion of this offering;
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•
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no exercise of the option granted to the underwriters to purchase up to additional common shares in connection with this offering;
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•
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an initial public offering price of $ per common share, which is the midpoint of the price range set forth on the cover page of this prospectus;
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•
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no purchase of common shares in this offering by directors, officers or existing shareholders;
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•
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the delivery to participants of our 2014 Incentive Plan of an estimated common shares (subject to adjustments for final tax and social security deductions), which we currently hold in treasury, to settle outstanding awards under our 2014 Incentive Plan in connection with this offering; and
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•
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no exercise of outstanding options after December 31, 2019, other than the settlement of outstanding awards under our 2014 Incentive Plan in connection with this offering as contemplated above.
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Year Ended December 31,
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|||
|
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2019(3)
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2018
|
Consolidated Income Statement Data:
|
| |
(in USD thousands except for
share and per share data) |
|||
Contract revenue
|
| |
2,340
|
| |
1,140
|
Research and development expenses
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expenses
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
1,655
|
| |
—
|
Financial income
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expenses
|
| |
(582)
|
| |
(224)
|
Loss for the period
|
| |
(116,484)
|
| |
(123,096)
|
Basic and diluted loss per share(1)
|
| |
(2.36)
|
| |
(2.64)
|
Weighted-average number of shares used to compute basic and diluted loss per share(1)
|
| |
49,279,961
|
| |
46,600,000
|
Pro forma basic and diluted loss per share(2)
|
| |
|
| |
|
Weighted-average number of shares used to compute pro forma basic and diluted loss per share(2)
|
| |
|
| |
|
(1)
|
See Note 28 to our audited consolidated financial statements included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share. These figures have been retroactively adjusted to give effect to the Share Consolidation.
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(2)
|
The pro forma information gives effect to the following: (i) the delivery of 597,774 common shares by plan participants for the settlement of the 2013 Promissory Notes and the 2016 Promissory Notes; (ii) the delivery to participants of our 2014 Incentive Plan of an estimated common shares (subject to adjustments for final tax and social security deductions), which we currently hold in treasury, to settle outstanding awards under our 2014 Incentive Plan in connection with this offering and the related payment by us of an estimated $ million in tax and social security liabilities on behalf of participants of our 2014 Incentive Plan; (iii) the issuance of 4,778,035 common shares to the holders of our Class E preferred shares as described in “Related Party Transactions—Shareholders’ Agreement”; and (iv) the Conversion, as if each such event occurred on the first day of the period presented.
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(3)
|
On January 1, 2019, we adopted IFRS 16 “Leases,” the impact of which is described in Note 17 to our audited consolidated financial statements included elsewhere in this prospectus.
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As of December 31, 2019
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|
| |
Actual
|
| |
Pro Forma(1)
|
| |
Pro Forma
As Adjusted(2)(3) |
Consolidated Balance Sheet Data:
|
| |
(in USD thousands)
|
||||||
Cash and cash equivalents
|
| |
115,551
|
| |
|
| |
|
Total assets
|
| |
137,682
|
| |
|
| |
|
Long-term liabilities
|
| |
|
| |
|
| |
|
Lease liability
|
| |
3,899
|
| |
|
| |
|
Financial liability
|
| |
—
|
| |
|
| |
|
Share capital
|
| |
4,361
|
| |
|
| |
|
Share premium
|
| |
549,922
|
| |
|
| |
|
Treasury shares
|
| |
(100)
|
| |
|
| |
|
Other reserves
|
| |
5,473
|
| |
|
| |
|
Cumulative translation adjustments
|
| |
69
|
| |
|
| |
|
Accumulated losses
|
| |
(448,569)
|
| |
|
| |
|
Total equity
|
| |
111,156
|
| |
|
| |
|
(1)
|
The pro forma information gives effect to the following: (i) the delivery of 597,774 common shares by plan participants for the settlement of the 2013 Promissory Notes and the 2016 Promissory Notes; (ii) the delivery to participants of our 2014 Incentive Plan of an estimated common shares (subject to adjustments for final tax and social security deductions), which we currently hold in treasury, to settle outstanding awards under our 2014 Incentive Plan in connection with this offering and the related payment by us of an estimated $ million in tax and social security liabilities on behalf of participants of our 2014 Incentive Plan; (iii) the issuance of 4,778,035 common shares to the holders of our Class E preferred shares as described in “Related Party Transactions—Shareholders’ Agreement”; and (iv) the Conversion.
|
(2)
|
The pro forma as adjusted information gives effect to the pro forma adjustments described in footnote (1) above and to the following: (i) our issuance and sale of common shares in this offering at the assumed initial public offering price of $ per common share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and (ii) the receipt of the $65.0 million initial disbursement under the Facility Agreement, after deducting estimated fees and expenses payable by us, and our issuance of $65.0 million aggregate principal amount of senior secured convertible notes in connection therewith. For the purposes of the pro forma as adjusted information, the amount to be received under the Facility Agreement has been presented entirely under financial liability and has not been divided between the fair value of the embedded derivative conversion feature and the residual convertible loan.
|
(3)
|
The pro forma as adjusted information is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $ per common share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total equity by $ million, assuming that the number of common shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each 1,000,000 share increase or decrease in the number of common shares offered by us would increase or decrease the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total equity by $ million, assuming the assumed initial public offering price of $ per common share, the midpoint of the price range set forth on the cover page of this prospectus remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
•
|
conduct and complete the pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL;
|
•
|
commence and conduct a confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
commence and conduct a pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL;
|
•
|
conduct and complete the pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
conduct and complete the Phase 1/2 clinical trial of Lonca and the Phase 1b clinical trial of Cami for the treatment of other indications and Phase 1 clinical trials for our other product candidates, as well as any subsequent clinical trials;
|
•
|
commence and conduct any required post-marketing confirmatory clinical trials for any of our product candidates in anticipation of potential accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
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•
|
expand our research and development efforts for our preclinical product candidates and research pipeline;
|
•
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seek regulatory approval for our product candidates from applicable regulatory authorities;
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•
|
invest in our late-stage clinical development, manufacturing and commercialization activities, including launching commercial sales, marketing and distribution operations;
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•
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continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
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•
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add clinical, scientific, operational, financial and management information systems and personnel; and
|
•
|
operate as a public company.
|
•
|
the progress, results and costs of our pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL and our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
the progress, results and costs of our planned confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
the progress, results and costs of our clinical trials of Lonca and Cami for the treatment of other indications and for our other product candidates;
|
•
|
the progress, results and costs of any required post-marketing confirmatory clinical trials for any product candidates that receive accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
the scope, progress, results and costs of researching and developing product candidates in our research pipeline, including conducting preclinical studies and clinical trials of such product candidates;
|
•
|
the costs of outsourced manufacturing of our product candidates, which are complex biological molecules, for clinical trials and in preparation for regulatory approval and commercialization;
|
•
|
the outcome, timing and costs of obtaining regulatory approvals for our product candidates if the requisite clinical trials are successful;
|
•
|
the size of the markets for approved indications in territories in which we receive regulatory approval, if any;
|
•
|
the timing and costs of commercialization activities for our product candidates, if any are approved for sale, including establishing our sales and marketing capabilities and engaging in the marketing, sales and distribution of our product candidates;
|
•
|
the revenue, if any, received from the commercialization of our product candidates, if any are approved for sale;
|
•
|
our ability to maintain and establish collaboration, licensing or other arrangements and the financial terms of such agreements;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, protecting and enforcing our intellectual property rights and claims, including any litigation costs and the outcome of such litigation;
|
•
|
the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims;
|
•
|
the timing and amount of milestone payments we receive under our collaboration agreements;
|
•
|
the costs involved in maintaining and improving the technology we use in our product candidates;
|
•
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our efforts to enhance operational systems and hire additional personnel, including personnel to support the development of our product candidates and to satisfy our obligations as a public company;
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the effect of competing technological and market developments; and
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the types of available sources of private and/or public market financing.
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require us to dedicate a substantial portion of cash and cash equivalents to the payment of interest on, and principal of, the indebtedness, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;
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oblige us to negative covenants restricting our activities, including limitations on dispositions, mergers or acquisitions, encumbering our intellectual property, incurring indebtedness or liens, paying dividends, making investments and engaging in certain other business transactions;
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limit our flexibility in planning for, or reacting to, changes in our business and our industry;
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place us at a competitive disadvantage compared to our competitors who have less debt or competitors with comparable debt at more favorable interest rates; and
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limit our ability to borrow additional amounts for working capital, capital expenditures, research and development efforts, acquisitions, debt service requirements, execution of our business strategy and other purposes and otherwise restrict our financing options.
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negative preclinical data;
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delays in receiving the required regulatory clearance from the appropriate regulatory authorities to commence clinical trials or amend clinical trial protocols, including any objections to our INDs or protocol amendments from the FDA;
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delays in reaching, or a failure to reach, a consensus with regulatory authorities on study design;
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delays in reaching, or a failure to reach, an agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
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difficulties in obtaining required Institutional Review Board (“IRB”) or ethics committee approval at each clinical trial site;
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challenges in recruiting and enrolling suitable patients that meet the study criteria to participate in clinical trials;
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the inability to enroll a sufficient number of patients in clinical trials to ensure adequate statistical power to detect statistically significant treatment effects;
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imposition of a clinical hold by regulatory authorities or IRBs for any reason, including safety concerns and non-compliance with regulatory requirements;
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failure by CROs, other third parties or us to adhere to clinical trial requirements;
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failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other jurisdictions;
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the inability to manufacture adequate quantities of a product candidate or other materials necessary in accordance with current Good Manufacturing Practices (“cGMPs”) to conduct clinical trials, including, for example, quality issues and delays in the testing, validation, manufacturing delays or failures at our CROs and delivery of the product candidates to the clinical trial sites;
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lower than anticipated patient retention rates;
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difficulties in maintaining contact with patients after treatment, resulting in incomplete data;
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ambiguous or negative interim results;
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our CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a clinical trial;
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unforeseen safety issues, including occurrence of treatment emergent adverse events (“TEAEs”) associated with the product candidate that are viewed to outweigh the product candidate’s potential benefits;
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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
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lack of adequate funding to continue the clinical trial; or
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delays and disruptions as a result of the COVID-19 pandemic.
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the size and nature of the patient population;
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the severity of the disease under investigation;
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the eligibility criteria for the study in question, including any misjudgment of, and resultant adjustment to, the appropriate ranges applicable to the exclusion and inclusion criteria;
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the number of clinical trial sites and the proximity of prospective patients to those sites;
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the nature, severity and frequency of adverse side effects associated with our product candidates;
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the standard of care in the diseases under investigation;
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the commitment of our clinical investigators to identify eligible patients;
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competing studies or trials with similar eligibility criteria;
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the patient referral practices of physicians;
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clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including perception of ADCs generally and of PBD-based ADCs specifically; and
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disruptions as a result of the COVID-19 pandemic.
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we may encounter delays or difficulties in enrolling patients for our clinical trials due to a negative perception of our product candidates’ safety and tolerability profile;
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we and/or regulatory authorities may temporarily or permanently put our clinical trials on hold;
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we may be unable to obtain regulatory approval for our product candidates;
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regulatory authorities may withdraw or limit their approvals of our product candidates;
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regulatory authorities may require the addition of labeling statements, such as a contraindication, boxed warnings or additional warnings;
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the FDA may require development of a Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use as a condition of approval;
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we may decide to remove our product candidates from the marketplace;
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we may be subject to regulatory investigations and government enforcement actions;
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we could be sued and held liable for harm caused to patients, including as a result of hospital errors; and
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our reputation may suffer.
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may disagree with the number, design or implementation of our clinical trials;
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the population studied in the clinical trial may not be considered sufficiently broad or representative to assure safety in the full population for which we seek approval;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may disagree with our interpretation of data from preclinical studies or clinical trials;
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the data collected from clinical trials of our product candidates may not meet the level of statistical or clinical significance required by the FDA, EMA or comparable regulatory authorities in other jurisdictions or may otherwise not be sufficient to support the submission of a BLA, Marketing Authorization Application (“MAA”) or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may not accept data generated by our preclinical service providers and clinical trial sites;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may require us to conduct additional preclinical studies and clinical trials;
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we may be unable to demonstrate to the FDA, EMA or comparable regulatory authorities in other jurisdictions that a product candidate’s response rate, DoR or risk-benefit ratio for its proposed indication is acceptable;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may fail to approve the manufacturing processes, test procedures and specifications applicable to the manufacture of our product candidates, the facilities of third-party manufacturers with which we contract for clinical or commercial supplies may fail to maintain a compliance status acceptable to the FDA, EMA or comparable regulatory authorities or the EMA or comparable regulatory authorities may fail to approve facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
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we or any third-party service providers may be unable to demonstrate compliance with cGMPs to the satisfaction of the FDA, EMA or comparable regulatory authorities in other jurisdictions, which could result in delays in regulatory approval or require us to withdraw or recall products and interrupt commercial supply of our products;
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the approval policies or regulations of the FDA, EMA or comparable regulatory authorities in other jurisdictions may change in a manner rendering our clinical data insufficient for approval; or
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political factors surrounding the approval process, such as government shutdowns and political instability.
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the clinical trial(s) required to verify the predicted clinical benefit of a product candidate fails to verify such benefit or does not demonstrate sufficient clinical benefit to justify the risks associated with the product candidate;
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other evidence demonstrates that a product candidate is not shown to be safe or effective under the conditions of use;
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we fail to conduct any required post-marketing confirmatory clinical trial with due diligence; or
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we disseminate false or misleading promotional materials relating to the relevant product candidate.
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restrictions on the marketing or manufacturing of the product;
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withdrawal of the product from the market or voluntary or mandatory product recalls;
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fines, restitution or disgorgement of profits or revenues;
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warning or untitled letters;
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requirements to conduct post-marketing studies or clinical trials;
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holds on clinical trials;
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refusal by the FDA, EMA or comparable regulatory authorities in other jurisdictions to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;
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product seizure or detention;
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refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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the safety and efficacy of the product, as demonstrated in clinical trials;
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the indications for which the product is approved and the labeling approved by regulatory authorities for use with the product, including any warnings that may be required in the labeling;
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our ability to offer our products for sale at competitive prices;
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the perceptions of physicians, patients and patient advocacy groups of ADCs generally and PBD-based ADCs specifically;
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the treatment’s cost, safety, efficacy, convenience and ease of administration compared to that of alternative treatments;
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acceptance by physicians, patients and patient advocacy groups of the product as a safe and effective treatment;
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the availability of coverage and adequate reimbursement by third-party payors, including cost-sharing programs such as copays and deductibles;
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patients’ willingness to pay out-of-pocket in the absence of coverage and/or adequate reimbursement from third-party payors;
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the effectiveness of our and our competitors’ sales and marketing efforts;
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our ability to establish sales, marketing and commercial product distribution capabilities or to partner with third parties with such capabilities;
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the nature, severity and frequency of adverse side effects;
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any restrictions on the use of our products together with other medications;
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publication of any post-approval data on the safety and effectiveness of the product; and
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the success of randomized post-marketing commitment studies to confirm the benefit-risk ratio of the product.
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a covered benefit under its health plan;
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safe, effective and medically necessary;
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appropriate for the specific patient;
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cost-effective; and
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neither experimental nor investigational.
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increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program;
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established a branded prescription drug fee that pharmaceutical manufacturers of certain branded prescription drugs must pay to the federal government;
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expanded the list of covered entities eligible to participate in the 340B drug pricing program by adding new entities to the program;
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established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% 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;
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extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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expanded 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;
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created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
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established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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established a Center for Medicare and Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and
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created a licensure framework for follow-on biologic products.
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the demand for any products for which we may obtain regulatory approval;
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our ability to set a price that we believe is fair for our products;
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our ability to obtain coverage and reimbursement approval for a product;
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our ability to generate revenues and achieve or maintain profitability; and
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the level of taxes that we are required to pay.
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advance the technology we use in our product candidates;
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obtain, maintain, protect and enforce intellectual property protection for our technologies and product candidates;
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obtain required government and other public and private approvals on a timely basis;
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attract and retain key personnel;
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execute our research and development plans;
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commercialize effectively;
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obtain and maintain coverage and reimbursement for our products in approved indications;
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obtain adequate funding for our activities;
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comply with applicable laws, regulations and regulatory requirements and restrictions with respect to the commercialization of our products, including with respect to any changed or increased regulatory restrictions; and
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enter into additional strategic collaborations to advance the development and commercialization of our product candidates.
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have staffing difficulties;
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fail to comply with contractual obligations;
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experience regulatory compliance issues;
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undergo changes in priorities or become financially distressed; or
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form relationships with other entities, some of which may be our competitors.
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delays or stoppages in product shipments for our product candidates, including loss shipments and cross-border logistical complications, resulting in delayed and lost shipments;
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delays to the development timelines for our product candidates;
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an inability to commence or continue clinical trials of product candidates under development;
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interruption of supply resulting from modifications to a CMO’s operations;
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delays or stoppage in manufacturing or shipment due to a CMO’s bankruptcy, winding up, reorganization or similar corporate failures or financial distress;
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delays in product manufacturing or shipments resulting from uncorrected defects, reliability or stability issues, or a CMO’s variation in a component;
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a lack of long-term arrangements for key components;
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inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms;
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difficulty and cost associated with locating and qualifying alternative CMOs for our components or raw materials in a timely manner;
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production delays related to the evaluation and testing of components from alternative CMOs, and corresponding regulatory qualifications;
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delay in delivery due to our CMOs’ prioritizing other customer orders over ours;
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damage to our reputation caused by defective product candidates produced by our CMOs; and
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•
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potential price increases.
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the scope of rights granted under the license agreement and other interpretation-related issues;
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the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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the sublicensing of patent and other rights under our existing collaborative development relationships and any collaboration relationships we might enter into in the future;
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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our current and future licensors and us; and
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the priority of invention of patented technology.
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others may be able to make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future;
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we, or our license partners or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;
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we, or our license partners or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;
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it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents;
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issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;
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•
|
our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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we may not develop additional proprietary technologies that are patentable;
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the patents of others may harm our business; and
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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
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our available capital resources or capital constraints we experience;
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•
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the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;
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•
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our ability to identify and enroll patients who meet clinical trial eligibility criteria;
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•
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our receipt of approvals by the FDA, EMA and comparable regulatory authorities in other jurisdictions, and the timing thereof;
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•
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other actions, decisions or rules issued by regulators;
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•
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our ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates;
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•
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our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis;
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•
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the efforts of our collaborators with respect to the commercialization of our products; and
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•
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the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activities.
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The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.
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Federal civil and criminal false claims laws, such as the False Claims Act (“FCA”), which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. In addition, 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 FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.
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HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
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HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates that perform services for them that involve 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 U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
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Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
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The federal transparency requirements under the Physician Payments Sunshine Act, created under the Health Care Reform Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value provided to physicians, as defined by such law, and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members.
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State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers.
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State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
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decreased demand for our product candidates or products that we may develop;
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•
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injury to our reputation and significant negative media attention;
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•
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withdrawal of clinical trial sites and/or study participants;
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•
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significant costs to defend the related litigations;
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•
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a diversion of management’s time and our resources to pursue our business strategy;
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•
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substantial monetary awards to study participants or patients;
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•
|
product recalls, withdrawals or labeling, marketing or promotional restrictions;
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•
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loss of revenue;
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•
|
the inability to commercialize our product candidates that we may develop; and
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•
|
a decline in the price of our common shares.
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•
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high acquisition costs;
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•
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the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;
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•
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the potential disruption of our historical business and our activities under our collaboration agreements;
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•
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the strain on, and need to expand, our existing operational, technical, financial and administrative infrastructure;
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•
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our lack of experience in late-stage product development and commercialization;
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•
|
the difficulties in assimilating employees and corporate cultures;
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•
|
the difficulties in hiring qualified personnel and establishing necessary development and/or commercialization capabilities;
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•
|
the failure to retain key management and other personnel;
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•
|
the challenges in controlling additional costs and expenses in connection with and as a result of the acquisition;
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•
|
the need to write down assets or recognize impairment charges;
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•
|
the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and
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•
|
any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.
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•
|
economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;
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•
|
global trends towards pharmaceutical pricing;
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•
|
differing regulatory requirements for drug approvals in non-U.S. countries;
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•
|
differing reimbursement, pricing and insurance regimes;
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•
|
potentially reduced protection for, and complexities and difficulties in obtaining, maintaining, protecting and enforcing, intellectual property rights;
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•
|
difficulties in compliance with non-U.S. laws and regulations;
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•
|
changes in non-U.S. regulations and customs, tariffs and trade barriers;
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•
|
changes in non-U.S. currency exchange rates and currency controls;
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•
|
changes in a specific country’s or region’s political or economic environment;
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•
|
trade protection measures, economic sanctions and embargoes, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments;
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•
|
negative consequences from changes in tax laws;
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•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
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•
|
difficulties associated with staffing and managing international operations, including differing labor relations;
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•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
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•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and
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•
|
the impact of public health epidemics on employees and the global economy, such as the novel coronavirus.
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•
|
results and timing of preclinical studies and clinical trials of our product candidates;
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•
|
results of clinical trials of our competitors’ products;
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•
|
public concern relating to the commercial value or safety of any of our product candidates;
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•
|
our inability to adequately protect our proprietary rights, including patents, trademarks and trade secrets;
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•
|
our inability to raise additional capital and the terms on which we raise it;
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•
|
commencement or termination of any strategic collaboration or licensing arrangement;
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•
|
regulatory developments, including actions with respect to our products or our competitors’ products;
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•
|
actual or anticipated fluctuations in our financial condition and operating results;
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•
|
publication of research reports by securities analysts about us or our competitors or our industry;
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•
|
our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
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•
|
additions and departures of key personnel;
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•
|
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
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•
|
the passage of legislation or other regulatory developments affecting us or our industry;
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•
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
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•
|
sales of our common shares by us, our insiders or our other shareholders;
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•
|
speculation in the press or investment community;
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•
|
announcement or expectation of additional financing efforts;
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•
|
any default under the Facility Agreement or the timing of any conversion of the convertible notes issued thereunder into common shares;
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•
|
changes in market conditions for biopharmaceutical stocks; and
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•
|
changes in general market and economic conditions.
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•
|
variations in the level of expense related to the ongoing development of our product candidates or research pipeline;
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•
|
results of clinical trials, or the addition or termination of clinical trials or funding support by us, or existing or future collaborators or licensing partners;
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•
|
our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements, or the termination or modification of any such existing or future arrangements;
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•
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developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products;
|
•
|
any intellectual property infringement lawsuit or any opposition, interference, cancellation or other intellectual-property-related proceeding in which we may become involved;
|
•
|
additions and departures of key personnel;
|
•
|
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
|
•
|
if any of our product candidates receives regulatory approval, the terms of such approval and market acceptance and demand for such product candidates;
|
•
|
regulatory developments affecting our product candidates or those of our competitors; and
|
•
|
changes in general market and economic conditions.
|
•
|
the non-Swiss court had jurisdiction pursuant to the PILA;
|
•
|
the judgment of such non-Swiss court has become final and non-appealable;
|
•
|
the judgment does not contravene Swiss public policy;
|
•
|
the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
|
•
|
no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state, and this decision is recognizable in Switzerland.
|
•
|
in certain cases, allow our board of directors to place up to 32,000,000 common shares and rights to acquire an additional 32,000,000 common shares (in aggregate, % of the expected share capital after completion of this offering) with affiliates or third parties, without existing shareholders having statutory pre-emptive rights in relation to this share placement;
|
•
|
allow our board of directors not to record any acquirer of common shares, or several acquirers acting in concert, in our share register as a shareholder with voting rights with respect to more than 15% of our share capital as set forth in the commercial register;
|
•
|
limit the size of our board of directors to 11 members; and
|
•
|
require two-thirds of the votes represented at a shareholder meeting for amending or repealing the above-mentioned voting and recording restrictions, for amending the provision setting a maximum board size or providing for indemnification of our directors and members of our executive committee and for removing the chairman or any member of the board of directors before the end of his or her term of office.
|
•
|
the commencement, timing, progress and results of our research and development programs, preclinical studies and clinical trials;
|
•
|
the timing of IND, BLA, MAA and other regulatory submissions with the FDA, EMA or comparable regulatory authorities in other jurisdictions;
|
•
|
the proposed clinical development pathway for our lead product candidates, Lonca and Cami, and our other product candidates, and the acceptability of the results of clinical trials for regulatory approval of such product candidates by the FDA, EMA or comparable regulatory authorities in other jurisdictions;
|
•
|
assumptions relating to the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates;
|
•
|
the timing of and our ability to obtain and maintain regulatory approval for our product candidates;
|
•
|
our plan for the commercialization of Lonca and, subject to our collaboration and license agreement with Genmab, of Cami, if approved;
|
•
|
our expectations regarding the size of the patient populations amenable to treatment with our product candidates, if approved, as well as the treatment landscape of the indications that we are targeting with our product candidates;
|
•
|
assumptions relating to the rate and degree of market acceptance of any approved product candidates;
|
•
|
the pricing and reimbursement of our product candidates;
|
•
|
our ability to identify and develop additional product candidates;
|
•
|
the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do;
|
•
|
our competitive position and the development of and projections relating to our competitors or our industry;
|
•
|
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
|
•
|
our ability to raise capital when needed in order to continue our research and development programs or commercialization efforts;
|
•
|
our ability to identify and successfully enter into strategic collaborations in the future;
|
•
|
our ability to obtain, maintain, protect and enforce intellectual property protection for our product candidates, and the scope of such protection;
|
•
|
our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of third parties;
|
•
|
our expectations regarding the impact of the COVID-19 pandemic;
|
•
|
our ability to attract and retain qualified key management and technical personnel; and
|
•
|
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act and a foreign private issuer.
|
•
|
approximately $ million to advance Lonca through the completion of the ongoing pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL, to advance Lonca through the completion of the ongoing Phase 1/2 combination clinical trial with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL, to commence and advance a confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL and to commence and advance a pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL;
|
•
|
approximately $ million to advance Cami through the completion of the ongoing pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL, to advance Cami through the completion of the ongoing Phase 1b clinical trial for the treatment of selected advanced solid tumors and to commence and advance potential combination clinical trials for Cami in these and other indications;
|
•
|
approximately $ million to advance ADCT-602 through the completion of the ongoing Phase 1/2 clinical trial for the treatment of relapsed or refractory ALL;
|
•
|
approximately $ million to further advance the clinical development of ADCT-601;
|
•
|
approximately $ million to further build our commercial operations in the United States for Lonca and to fund our commercial-scale CMC plans for Lonca and Cami;
|
•
|
approximately $ million to fund the research and development of our preclinical product candidates and preclinical pipeline; and
|
•
|
the remainder for working capital and other general corporate purposes.
|
•
|
on an actual basis;
|
•
|
on a pro forma basis to give effect to the following adjustments: (i) the delivery of 597,774 common shares by plan participants for the settlement of the 2013 Promissory Notes and the 2016 Promissory Notes; (ii) the delivery to participants of our 2014 Incentive Plan of an estimated common shares (subject to adjustments for final tax and social security deductions), which we currently hold in treasury, to settle outstanding awards under our 2014 Incentive Plan in connection with this offering and the related payment by us of an estimated $ million in tax and social security liabilities on behalf of participants of our 2014 Incentive Plan; (iii) the issuance of 4,778,035 common shares to the holders of our Class E preferred shares as described in “Related Party Transactions—Shareholders’ Agreement”; and (iv) the Conversion; and
|
•
|
on a pro forma as adjusted basis to give effect to the pro forma adjustments described immediately above and to the following adjustment: (i) our issuance and sale of common shares in this offering at the assumed initial public offering price of $ per common share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us; and (ii) the receipt of the $65.0 million initial disbursement under the Facility Agreement, after deducting estimated fees and expenses payable by us, and our issuance of $65.0 million aggregate principal amount of senior secured convertible notes in connection therewith.
|
|
| |
As of December 31, 2019
|
||||||
|
| |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted(1)(2) |
|
| |
(in USD thousands except for share,
par value per share and per share data) |
||||||
Cash and cash equivalents
|
| |
115,551
|
| |
|
| |
|
Long-term liabilities
|
| |
|
| |
|
| |
|
Lease liability
|
| |
3,899
|
| |
|
| |
|
Financial liability
|
| |
—
|
| |
|
| |
|
Shareholders’ equity:
|
| |
|
| |
|
| |
|
Common shares, par value CHF 0.08 per share; 10,521,960 shares issued and outstanding, actual; shares issued and outstanding, pro forma; shares issued and outstanding, pro forma as adjusted(3)
|
| |
961
|
| |
|
| |
|
Preferred shares, par value CHF 0.08 per share; 41,575,000 shares issued and outstanding, actual; no shares issued and outstanding, pro forma; no shares issued and outstanding, pro forma as adjusted(3)
|
| |
3,400
|
| |
|
| |
|
Share premium
|
| |
549,922
|
| |
|
| |
|
Treasury shares
|
| |
(100)
|
| |
|
| |
|
Other reserves
|
| |
5,473
|
| |
|
| |
|
Cumulative translation adjustments
|
| |
69
|
| |
|
| |
|
Accumulated losses
|
| |
(448,569)
|
| |
|
| |
|
Total equity
|
| |
111,156
|
| |
|
| |
|
Total capitalization
|
| |
115,055
|
| |
|
| |
|
(1)
|
For the purposes of the pro forma as adjusted information, the amount to be received under the Facility Agreement has been presented entirely under financial liability and has not been divided between the fair value of the embedded derivative conversion feature and the residual convertible loan.
|
(2)
|
The pro forma as adjusted information is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $ per common share,
|
(3)
|
The number and par values of common shares and of preferred shares have been retroactively adjusted to give effect to the Share Consolidation.
|
Assumed initial public offering price per common share
|
| |
|
| |
$
|
Historical net tangible book value per share as of December 31, 2019
|
| |
$1.97
|
| |
|
Decrease in net tangible book value per share as of December 31, 2019 attributable to pro forma adjustments
|
| |
|
| |
|
Pro forma net tangible book value per common share as of December 31, 2019
|
| |
|
| |
|
Increase in pro forma net tangible book value per share attributable to new investors participating in this offering
|
| |
|
| |
|
Pro forma as adjusted net tangible book value per common share after giving effect to this offering
|
| |
|
| |
|
Dilution per common share to investors participating in this offering
|
| |
|
| |
$
|
|
| |
Year Ended December 31,
|
|||
|
| |
2019(3)
|
| |
2018
|
Consolidated Income Statement Data:
|
| |
(in USD thousands except for
share and per share data) |
|||
Contract revenue
|
| |
2,340
|
| |
1,140
|
Research and development expenses
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expenses
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
1,655
|
| |
—
|
Financial income
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expenses
|
| |
(582)
|
| |
(224)
|
Loss for the period
|
| |
(116,484)
|
| |
(123,096)
|
Basic and diluted loss per share(1)
|
| |
(2.36)
|
| |
(2.64)
|
Weighted-average number of shares used to compute basic and diluted loss per share(1)
|
| |
49,279,961
|
| |
46,600,000
|
Pro forma basic and diluted loss per share(2)
|
| |
|
| |
|
Weighted-average number of shares used to compute pro forma basic and diluted loss per share(2)
|
| |
|
| |
|
(1)
|
See Note 28 to our audited consolidated financial statements included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share. These figures have been retroactively adjusted to give effect to the Share Consolidation.
|
(2)
|
The pro forma information gives effect to the following: (i) the delivery of 597,774 common shares by plan participants for the settlement of the 2013 Promissory Notes and the 2016 Promissory Notes; (ii) the delivery to participants of our 2014 Incentive Plan of an estimated common shares (subject to adjustments for final tax and social security deductions), which we currently hold in treasury, to settle outstanding awards under our 2014 Incentive Plan in connection with this offering and the related payment by us of an estimated $ million in tax and social security liabilities on behalf of participants of our 2014 Incentive Plan; (iii) the issuance of 4,778,035 common shares to the holders of our Class E preferred shares as described in “Related Party Transactions—Shareholders’ Agreement”; and (iv) the Conversion, as if each such event occurred on the first day of the period presented.
|
(3)
|
On January 1, 2019, we adopted IFRS 16 “Leases,” the impact of which is described in Note 17 to our audited consolidated financial statements included elsewhere in this prospectus.
|
|
| |
As of December 31,
|
|||
|
| |
2019
|
| |
2018
|
Consolidated Balance Sheet Data:
|
| |
(in USD thousands)
|
|||
Cash and cash equivalents
|
| |
115,551
|
| |
138,807
|
Total assets
|
| |
137,682
|
| |
150,558
|
Share capital
|
| |
4,361
|
| |
401
|
Share premium
|
| |
549,922
|
| |
452,268
|
Treasury shares
|
| |
(100)
|
| |
—
|
Other reserves
|
| |
5,473
|
| |
5,702
|
Cumulative translation adjustments
|
| |
69
|
| |
(43)
|
Accumulated losses
|
| |
(448,569)
|
| |
(332,085)
|
Total equity
|
| |
111,156
|
| |
126,243
|
•
|
conduct and complete the pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL;
|
•
|
commence and conduct a confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
commence and conduct a pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL;
|
•
|
conduct and complete the pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
conduct and complete the Phase 1/2 clinical trial of Lonca and the Phase 1b clinical trial of Cami for the treatment of other indications and Phase 1 clinical trials for our other product candidates, as well as any subsequent clinical trials;
|
•
|
commence and conduct any required post-marketing confirmatory clinical trials for any of our product candidates in anticipation of potential accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
expand our research and development efforts for our preclinical product candidates and research pipeline;
|
•
|
seek regulatory approval for our product candidates from applicable regulatory authorities;
|
•
|
invest in our late-stage clinical development, manufacturing and commercialization activities, including launching commercial sales, marketing and distribution operations;
|
•
|
continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
|
•
|
add clinical, scientific, operational, financial and management information systems and personnel; and
|
•
|
operate as a public company.
|
•
|
salaries for research and development staff and related expenses, including share-based compensation expense;
|
•
|
costs for production of preclinical and clinical-stage product candidates by CMOs;
|
•
|
fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials;
|
•
|
costs of related facilities, materials and equipment;
|
•
|
costs associated with depreciation of right-of-use assets;
|
•
|
costs associated with obtaining and maintaining patents and other intellectual property; and
|
•
|
amortization and depreciation of tangible and intangible fixed assets used to develop our product candidates.
|
•
|
Lonca. Our pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL and our Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL.
|
•
|
Cami. Our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL and our Phase 1b clinical trial of Cami for the treatment of selected advanced solid tumors.
|
•
|
Other development programs. Our other research and development expenses related to our Phase 1/2 clinical trial of ADCT-602 for the treatment of relapsed or refractory ALL, ADCT-601 for the treatment of selected advanced solid tumors and our preclinical studies of ADCT-701 and ADCT-901 for the treatment of selected advanced solid tumors. The expenses mainly consist of salaries, costs for production of our product candidates and costs paid to contract research organizations in conjunction with clinical trials and preclinical studies.
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in thousands)
|
||||||
Lonca
|
| |
42,123
|
| |
45,701
|
| |
(3,578)
|
Cami
|
| |
31,839
|
| |
29,374
|
| |
2,465
|
ADCT-602
|
| |
3,374
|
| |
6,162
|
| |
(2,788)
|
ADCT-601
|
| |
7,183
|
| |
14,250
|
| |
(7,067)
|
MEDI3726
|
| |
915
|
| |
2,389
|
| |
(1,474)
|
Preclinical product candidates and research pipeline
|
| |
22,103
|
| |
20,437
|
| |
1,666
|
Total
|
| |
107,537
|
| |
118,313
|
| |
(10,776)
|
•
|
the scope, rate of progress, results and cost of our clinical trials, preclinical studies and other related activities;
|
•
|
the cost of manufacturing clinical supplies, and establishing commercial supplies, of any product candidates;
|
•
|
the number and characteristics of product candidates that we pursue;
|
•
|
the cost, timing and outcomes of regulatory approvals;
|
•
|
the cost and timing of establishing sales, marketing and distribution capabilities; and
|
•
|
the terms and timing of any collaboration, licensing or other arrangements that we may establish, including any required milestone and royalty payments thereunder.
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Contract revenue
|
| |
2,340
|
| |
1,140
|
| |
1,200
|
Research and development expenses
|
| |
(107,537)
|
| |
(118,313)
|
| |
10,776
|
General and administrative expenses
|
| |
(14,202)
|
| |
(8,768)
|
| |
(5,434)
|
Operating loss
|
| |
(119,399)
|
| |
(125,941)
|
| |
6,542
|
Other income
|
| |
1,655
|
| |
—
|
| |
1,655
|
Financial income
|
| |
2,253
|
| |
2,856
|
| |
(603)
|
Financial expense
|
| |
(156)
|
| |
—
|
| |
(156)
|
Exchange differences
|
| |
(255)
|
| |
213
|
| |
(468)
|
Loss before taxes
|
| |
(115,902)
|
| |
(122,872)
|
| |
6,970
|
Income tax expenses
|
| |
(582)
|
| |
(224)
|
| |
(358)
|
Loss for the year
|
| |
(116,484)
|
| |
(123,096)
|
| |
6,612
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
External costs
|
| |
81,363
|
| |
98,493
|
| |
(17,130)
|
Employee expenses
|
| |
24,916
|
| |
19,246
|
| |
5,670
|
Depreciation of property, plant and equipment
|
| |
407
|
| |
330
|
| |
77
|
Depreciation of right-of-use assets
|
| |
837
|
| |
—
|
| |
837
|
Amortization of intangible assets
|
| |
14
|
| |
17
|
| |
(3)
|
Impairment of intangible assets
|
| |
—
|
| |
227
|
| |
(227)
|
Research and development expenses
|
| |
107,537
|
| |
118,313
|
| |
(10,776)
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Employee expenses
|
| |
5,135
|
| |
4,936
|
| |
199
|
External costs
|
| |
8,668
|
| |
3,628
|
| |
5,040
|
General and administrative costs charged by related parties
|
| |
11
|
| |
38
|
| |
(27)
|
Depreciation of property, plant and equipment
|
| |
145
|
| |
158
|
| |
(13)
|
Depreciation of right-of-use assets
|
| |
227
|
| |
—
|
| |
227
|
Amortization of intangible assets
|
| |
16
|
| |
8
|
| |
8
|
General and administrative expenses
|
| |
14,202
|
| |
8,768
|
| |
5,434
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Net cash provided by (used in):
|
| |
|
| |
|
| |
|
Operating activities
|
| |
(121,581)
|
| |
(121,362)
|
| |
(219)
|
Investing activities
|
| |
(2,248)
|
| |
(2,506)
|
| |
258
|
Financing activities
|
| |
100,512
|
| |
(24)
|
| |
100,536
|
Net change in cash and cash equivalents
|
| |
(23,317)
|
| |
(123,892)
|
| |
100,575
|
•
|
the progress, results and costs of our pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL and our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
the progress, results and costs of our planned confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
the progress, results and costs of our clinical trials of Lonca and Cami for the treatment of other indications and for our other product candidates;
|
•
|
the progress, results and costs of any required post-marketing confirmatory clinical trials for any product candidates that receive accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
the scope, progress, results and costs of researching and developing product candidates in our research pipeline, including conducting preclinical studies and clinical trials of such product candidates;
|
•
|
the costs of outsourced manufacturing of our product candidates, which are complex biological molecules, for clinical trials and in preparation for regulatory approval and commercialization;
|
•
|
the outcome, timing and costs of obtaining regulatory approvals for our product candidates if the requisite clinical trials are successful;
|
•
|
the size of the markets for approved indications in territories in which we receive regulatory approval, if any;
|
•
|
the timing and costs of commercialization activities for our product candidates, if any are approved for sale, including establishing our sales and marketing capabilities and engaging in the marketing, sales and distribution of our product candidates;
|
•
|
the revenue, if any, received from the commercialization of our product candidates, if any are approved for sale;
|
•
|
our ability to maintain and establish collaboration, licensing or other arrangements and the financial terms of such agreements;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, protecting and enforcing our intellectual property rights and claims, including any litigation costs and the outcome of such litigation;
|
•
|
the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims;
|
•
|
the timing and amount of milestone payments we receive under our collaboration agreements;
|
•
|
the costs involved in maintaining and improving the technology we use in our product candidates;
|
•
|
our efforts to enhance operational systems and hire additional personnel, including personnel to support the development and commercialization of our product candidates and to satisfy our obligations as a public company;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the types of available sources of private and/or public market financing.
|
|
| |
Payments Due By Period(1)
|
||||||||||||
|
| |
Total
|
| |
Less than
1 year |
| |
1-3
years |
| |
3-5
years |
| |
More than
5 years |
|
| |
(in USD thousands)
|
||||||||||||
Trade accounts payable
|
| |
3,329
|
| |
3,329
|
| |
—
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
5,370
|
| |
1,246
|
| |
1,859
|
| |
1,204
|
| |
1,061
|
Total(2)
|
| |
8,699
|
| |
4,575
|
| |
1,859
|
| |
1,204
|
| |
1,061
|
(1)
|
The amounts of contractual obligations set forth in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
|
(2)
|
Excludes collaboration agreements described in the preceding paragraphs above.
|
•
|
including any market performance conditions;
|
•
|
excluding the impact of any service and non-market performance vesting conditions; and
|
•
|
including the impact of any non-vesting conditions.
|
|
| |
Year Ended
December 31, 2019 |
Weighted average share price (in USD)
|
| |
16.31
|
Strike price (in USD)
|
| |
18.75
|
Expected volatility (%)
|
| |
176.6
|
Award life (years)
|
| |
5.65
|
Expected dividend yield (%)
|
| |
—
|
Risk-free interest rate (%)
|
| |
1.67
|
|
| |
Year Ended December 31,
|
|||
|
| |
2019
|
| |
2018
|
Weighted average share price (in USD)
|
| |
0.51 to 16.31
|
| |
0.50 to 1.25
|
Strike price (in USD)
|
| |
2.50 to 2.56
|
| |
2.58 to 2.63
|
Expected volatility (%)
|
| |
176.6 to 233.1
|
| |
170.0 to 233.1
|
Award life (years)
|
| |
0.83 to 1.29
|
| |
0.83 to 1.33
|
Expected dividend yield (%)
|
| |
—
|
| |
—
|
Risk-free interest rate (%)
|
| |
1.55 to 2.60
|
| |
2.32 to 2.60
|
|
| |
Year Ended December 31,
|
|||
|
| |
2019
|
| |
2018
|
Weighted average share price (in USD)
|
| |
0.80 to 27.50
|
| |
0.79 to 1.91
|
Strike price (in USD)
|
| |
26.00 to 28.00
|
| |
25.94
|
Expected volatility (%)
|
| |
201.9 to 4,612.8
|
| |
146.4 to 201.9
|
Award life (years)
|
| |
0.08 to 1.02
|
| |
1.02 to 1.75
|
Expected dividend yield (%)
|
| |
—
|
| |
—
|
Risk-free interest rate (%)
|
| |
2.08 to 2.57
|
| |
1.84 to 2.57
|
•
|
the amount of the initial measurement of lease liability;
|
•
|
any lease payments made at or before the commencement date less any lease incentives received;
|
•
|
any initial direct costs; and
|
•
|
restoration costs.
|
•
|
The convertible loan’s initial fair value will be the residual amount of the consideration received, net of directly attributable costs, after separating out the fair value of the embedded conversion feature. The loan will be subsequently measured at its amortized cost in accordance with IFRS 9. It will be presented in the balance sheet as a financial liability.
|
•
|
The embedded derivative conversion feature will be initially measured at fair value and subsequently remeasured to fair value at each reporting date. This conversion feature will be presented in the balance sheet as a liability and classified as non-equity in accordance with IFRS 9. Changes in the fair value (gains or losses) of the conversion feature at the end of each period will be recorded in the consolidated income statement.
|
•
|
We are a pioneer in developing highly potent and targeted PBD-based ADCs. We believe that our team, with decades of experience in this field, is well positioned to develop and commercialize PBD-based ADCs for the benefit of patients with cancer.
|
•
|
Our two lead product candidates, Lonca and Cami, have consistently demonstrated robust single-agent clinical activity across a broad population of heavily pre-treated patients, while maintaining manageable tolerability profiles, and we are advancing the clinical development of Lonca to BLA submission in the second half of 2020 and of Cami to support BLA submission.
|
•
|
We are advancing a broad pipeline of four clinical-stage product candidates and two preclinical product candidates addressing multiple areas of unmet medical need across hematological malignancies and solid tumors, leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy.
|
•
|
We retain exclusive worldwide development and commercialization rights to all of our product candidates, other than Cami for which we have a collaboration and license agreement with Genmab. Our commercial organization has initiated pre-launch market activities and is leveraging our team’s deep industry experience to maximize the commercial potential of any approved products.
|
•
|
Our experienced CMC team is highly proficient in the manufacturing of PBD-based ADCs and has developed a validated commercial supply chain that has been able to consistently produce Lonca at commercial scale to support BLA submission.
|
•
|
Advance our lead product candidate, Lonca, to BLA submission in the second half of 2020. As of October 2019, we observed a 45.5% interim ORR in our 145-patient pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL. This interim ORR exceeded our target primary endpoint and the 41.4% ORR observed for DLBCL patients in our 183-patient Phase 1 clinical trial who were treated at the initial dose used in our pivotal Phase 2 clinical trial. We intend to submit a BLA to the FDA in the second half of 2020.
|
•
|
Expand the potential market opportunity by advancing Lonca into earlier lines of therapy and for multiple indications. Based on the significant single-agent clinical activity and promising combination data with ibrutinib observed in clinical trials to date, we believe that Lonca has the opportunity to advance into earlier lines of therapy in combination with other therapies, including into first-line therapy. Concurrently with our BLA submission in the second half of 2020, we intend to commence a post-marketing confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support a supplemental BLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL. In addition, to further expand Lonca’s potential market opportunity, we are conducting a Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL and intend to commence a pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL in the fourth quarter of 2020.
|
•
|
Advance our second lead product candidate, Cami, to support BLA submission. Based on promising results from our 133-patient Phase 1 clinical trial, we are currently evaluating Cami in a pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL that, if successful, we believe will form the basis for a BLA submission.
|
•
|
Advance our two clinical-stage solid tumor product candidates to address multiple indications in areas of high unmet medical need. Our PBD-based ADCs have multiple mechanisms of action that we believe make them suitable for targeting solid tumors. We are therefore evaluating Cami, which targets
|
•
|
Continue to build a diverse and balanced portfolio of product candidates to address high unmet medical needs in oncology by leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy. In addition to the lead indications that we are pursuing for Lonca and Cami, we are also evaluating these two product candidates in various other disease settings, such as MCL and FL and, in the case of Cami, multiple solid tumors, both as monotherapies and when used in combination with other therapies. Furthermore, we are advancing our other product candidates, including ADCT-601 and ADCT-602, and research programs through preclinical and clinical development. To strike an optimized risk-reward balance, we intend to address both hematological malignancies and solid tumors, across both clinically validated and novel cancer targets.
|
•
|
Maximize the commercial potential of our product candidates through both our own commercial organization and strategic collaborations.. We currently hold exclusive worldwide development and commercialization rights to all of our product candidates, other than Cami for which we have a collaboration and license agreement with Genmab. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations in other geographies. We have an experienced team with substantial expertise in the commercialization of oncology products to support our commercialization efforts for Lonca, if approved, which will also serve as the foundation of our U.S. commercialization efforts for our other product candidates in our hematology franchise.
|
•
|
Selective Targeting. Traditional chemotherapies are unable to distinguish between healthy cells and tumor cells. As a result, these therapies typically have a narrow therapeutic window (i.e., the dose range that can treat disease effectively without causing unacceptable toxic side effects). In contrast, ADCs, through their use of antigen-specific antibodies, target tumor cells or other cells in the tumor microenvironment with greater selectivity than do traditional chemotherapies. This selective targeting allows ADCs to use potent cytotoxins at dose levels that otherwise would not be tolerable. As a result, ADCs can represent a highly effective treatment approach while maintaining manageable side effects.
|
•
|
Wide Addressable Patient Population. ADCs represent a treatment approach that expands the treatment options available to cancer patients. Many therapies are not appropriate for certain patient populations. For example, surgery is not used when the cancer is widespread, chemotherapy may not be appropriate when the patient is too sick to tolerate or does not respond to available chemotherapeutics, stem cell transplant may not be appropriate when the patient is frail, and some novel targeted therapies such as CAR-T (i.e., a type of treatment in which a patient’s T cells are modified in the laboratory so they will attack cancer cells) may not be appropriate when there is significant comorbidity. As a result of these limitations, there remains a significant unmet medical need for patients for whom other treatment options are inappropriate or ineffective.
|
•
|
Potential in Relapsed or Refractory Patients. Traditional therapies typically have limited effectiveness for patients who exhibit relapsed (i.e., the cancer returns after an initial positive response to treatment) or refractory (i.e., the cancer is resistant to treatment) cancers. In contrast, some ADCs have proven efficacious in such patient populations while maintaining a manageable tolerability profile. Therefore, ADCs represent an important part of the cancer treatment paradigm, expanding the treatment options available to patients suffering from relapsed or refractory cancers.
|
•
|
Cytotoxic Potency. The PBD dimer warheads used in our ADCs have been shown preclinically to be approximately 100 times more potent than warheads used in currently marketed ADCs, such as auristatin, maytansine and calicheamicin. The figure below shows the relative in vitro cytotoxic potency of various ADC warheads and common chemotherapeutics in comparison to a PBD dimer. Despite their potency, however, the PBD dimer warheads used in our ADCs have demonstrated a manageable tolerability profile in our preclinical studies and clinical trials to date.
|
•
|
Activity in Tumors with Low-Expressing Targets. Tumor cells typically require a threshold number of warhead molecules to be internalized for efficient cell killing. The high potency of our PBD-based warheads means that, compared to other warheads, fewer molecules of warhead should be needed to be internalized into the cancer cell to kill it. In cancer cells with low levels of antigen expression, ADCs with less potent warheads cannot bind in sufficient quantities to be effective. We believe that the potency of our PBD-based warheads may allow us to develop ADCs that target antigens with low expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
|
•
|
Durable Responses. Cross-links in DNA occur when an agent reacts with two nucleotides of DNA, forming a covalent linkage between them. The cross-links can occur in the same strand (i.e., intrastrand) or between opposite strands of DNA (i.e., interstrand). Our PBD-based ADCs create interstrand cross-links in the target cells’ DNA. These interstrand cross-links persist in target cells and can lie dormant, potentially for weeks. We believe that this allows our ADCs to target slowly proliferating cancer cells, including cancer stem cells. The persistence of the interstrand cross-links is explained by the fact that these cross-links do not distort the DNA helix. Cells have natural DNA repair mechanisms that detect structural changes to DNA, including those caused by cytotoxic warheads, and repair the DNA back to its original state. Warheads that create intrastrand cross-links, and even some warheads that create interstrand cross-links such as calicheamicin, distort the DNA helix, triggering the cells’ DNA repair mechanisms, thereby reducing their efficacy and leading to drug resistance. As PBD cross-links are non-distortive, they are designed to be able to evade the cells’ DNA repair mechanisms. In addition, tumor cells also induce the expression of certain transporter proteins (i.e., proteins that are able to transport warheads across the membrane outside the tumor cell) or the activation of detoxifying mechanisms that lead to inactive toxins. These potential resistance mechanisms limit traditional ADCs’
|
•
|
Bystander Effect. The bystander effect occurs when a released warhead is able to diffuse into and kill neighboring cells in the tumor microenvironment, irrespective of those cells’ antigen expression. Upon binding to the target antigen and internalization of our ADCs into the tumor cell, the warhead is designed to induce apoptosis. This is followed by the release of free PBD dimers into the tumor microenvironment. Since our PBD-based warheads are cell-permeable, they may be able to diffuse into adjacent cells and kill them in an antigen-independent manner. We believe that this may allow us to develop ADCs that target antigens with heterogeneous expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs. Once the PBD is released into circulation outside the tumor microenvironment, it is rapidly excreted with a short half-life, thus limiting overall systemic toxicity. We believe that this results in our ADCs’ bystander effect being controlled and generally limited to tumor cells.
|
•
|
Immunogenic Cell Death. PBD warheads have been observed to induce immunogenic cell death, whereby a cancer cell’s death expresses certain stress signals that induce the body’s anti-tumor immune response through the activation of T cells and antigen-presenting cells. This opens up the potential for combining our ADCs with other therapies, particularly with immuno-oncology therapies such as checkpoint inhibitors, that are specifically designed to activate the patient’s own immune system to combat cancer.
|
•
|
analysis of the relative overexpression of the target antigen on the membrane of cancer cells (as compared to healthy cells) and other target characteristics, such as internalization (i.e., how rapidly the antigen migrates from the membrane to the inside of the cell), recycling (i.e., whether or not the antigen recycles back to the membrane once internalized) and shedding (i.e., whether the antigen is cleaved off from the membrane to form a soluble antigen sink in the extracellular space and/or circulation) properties;
|
•
|
review of whether an ADC that targets the antigen has the potential to address a clear unmet medical need and whether there is an established development path with the potential for accelerated regulatory approval;
|
•
|
extensive in-house research and development focused on identifying preclinical in vivo activity and on- and off-target toxicity to determine the therapeutic index of a PBD-based ADC aimed at the antigen target; and
|
•
|
determination of the potential product candidate’s placement in the overall risk-reward profile of our portfolio.
|
•
|
selecting the clinical product candidate that represents the optimal combination of antibody, linker and PBD dimer. We compare multiple candidates with different combinations of the target-specific antibodies, linkers and linker positions, conjugation chemistry and the PBD warhead. Our objective is to nominate product candidates that exhibit the optimal balance between efficacy and safety in preclinical models.
|
•
|
advancing our product candidates through IND-enabling preclinical studies, focusing on rapid execution of required pharmacology studies, non-clinical toxicology and pharmacokinetic studies and cGMP manufacturing of Phase 1 clinical material. Our efficient approach to preclinical development is evidenced by the following:
|
○
|
We have consistently completed IND-enabling preclinical studies in 13 to 22 months following selection of the clinical product candidate.
|
○
|
Since 2015, we have submitted five INDs and worked with our collaborators to submit two additional INDs for our product candidates.
|
•
|
designing clinical trials to efficiently advance our product candidates towards regulatory submission and potential approval. Our clinical trials have the following features:
|
○
|
Our Phase 1 clinical trials enroll patients with different cancers that express the target antigen on the tumor cells or other cells in the tumor microenvironment. This allows us to conduct small dose-expansion studies simultaneously with dose-escalation studies, enabling signal searching and dose selection prior to concluding Phase 1 clinical trials. We have successfully used this method in our Phase 1 clinical trials for Lonca and Cami, which resulted in the early identification of DLBCL and HL as the initial indications to pursue in our pivotal Phase 2 clinical trials, respectively.
|
○
|
Our approach allows us to identify opportunities that may expand the market opportunity for our product candidates. For example, while we are pursuing DLBCL as the lead indication for Lonca, we believe that the data generated from the Phase 1 clinical trial may allow us to more efficiently advance evaluations of Lonca for the treatment of other indications, such as MCL and FL, in pivotal clinical trials.
|
○
|
Our Phase 1 clinical trials involve a wide range of dosing regimens. Because the PBD cross-links persist in tumor cells, it is important to find the dose levels and intervals that result in optimal tumor shrinkage while minimizing cumulative toxicities due to accumulation of the cross-links between doses. The wide range of dosing regimens in our Phase 1 clinical trials enables us to select the dose level to be used in pivotal clinical trials without the need for separate dose-range finding studies.
|
○
|
Our clinical trials are designed to balance risk and reward by enrolling patients with both cancers that are difficult to treat and those that are more responsive to treatment.
|
•
|
encouraging close collaboration between our preclinical and clinical teams. For example, when our clinical team provides emerging pharmacokinetic data to our preclinical team, this strengthens the predictive value of our preclinical animal models when switching between indications, such as from hematological tumors to solid tumors with Cami. Our preclinical team also analyze biomarkers that correlate with patient outcomes taken by our clinical team to monitor their pharmacodynamics effects and to inform patient selection and dosing strategies.
|
Patient Characteristics
|
| |
Polatuzumab vedotin (Polivy®)
in combination with rituximab plus bendamustine |
| |
Tafasitamab (MOR208)
in combination with lenalidomide** |
Median Number of Prior Lines of Therapy
|
| |
2
|
| |
2
|
SCT eligible
|
| |
Excluded
|
| |
Excluded
|
Primary refractory disease
|
| |
Excluded***
|
| |
*
|
Double-hit and triple-hit DLBCL
|
| |
Excluded
|
| |
Excluded
|
Transformed disease
|
| |
*
|
| |
Excluded
|
Bulky disease
|
| |
*
|
| |
Included
|
Prior treatment with CAR-T
|
| |
Excluded
|
| |
*
|
Prior treatment with SCT
|
| |
Included
|
| |
Included
|
Best Overall Response (%)
|
| |
Polatuzumab vedotin
(Polivy®)** |
| |
Tafasitamab
(MOR208)** |
| |
Polatuzumab vedotin
(Polivy®) in combination with rituximab plus bendamustine |
| |
Tafasitamab (MOR208)
in combination with lenalidomide** |
Complete response (CR)
|
| |
15%
|
| |
6%
|
| |
50%
|
| |
43%
|
Partial response (PR)
|
| |
37%
|
| |
20%
|
| |
13%
|
| |
18%
|
Overall response rate (CR + PR)
|
| |
52%
|
| |
26%
|
| |
63%
|
| |
60%
|
Common Grade ≥3
TEAEs (%) |
| |
Polatuzumab vedotin
(Polivy®)** |
| |
Tafasitamab
(MOR208)** |
| |
Polatuzumab vedotin
(Polivy®) in combination with rituximab plus bendamustine |
| |
Tafasitamab (MOR208)
in combination with lenalidomide** |
Neutropenia
|
| |
40%
|
| |
17%
|
| |
61%
|
| |
48%
|
Anemia
|
| |
11%
|
| |
9%
|
| |
24%
|
| |
*
|
Peripheral sensory neuropathy
|
| |
9%
|
| |
26%
|
| |
*
|
| |
*
|
Thrombocytopenia
|
| |
*
|
| |
6%
|
| |
31%
|
| |
17%
|
Lymphopenia
|
| |
*
|
| |
*
|
| |
13%
|
| |
*
|
Febrile neutropenia
|
| |
*
|
| |
*
|
| |
11%
|
| |
12%
|
Pneumonia
|
| |
*
|
| |
*
|
| |
16%
|
| |
6%
|
TEAEs leading to treatment discontinuation
|
| |
*
|
| |
*
|
| |
31%
|
| |
12%
|
|
| |
Duvelisib
(Copiktra®) |
| |
Copanlisib
(Aliqopa®) |
| |
Idelalisib (Zydelig®)
|
| |
Obinutuzumab
(Gazyva®) in combination with bendamustine |
| |
Lenalidomide
(Revlimid®) in combination with rituximab |
Complete response (CR)
|
| |
1.2%
|
| |
14.4%
|
| |
8.3%
|
| |
15.5%
|
| |
35%-46%
|
Partial response (PR)
|
| |
41.0%
|
| |
44.2%
|
| |
45.8%
|
| |
63.2%
|
| |
28%-46%
|
Overall response rate (CR + PR)
|
| |
42.2%
|
| |
58.7%
|
| |
54.2%
|
| |
78.7%
|
| |
74%-80%
|
Median duration of response
|
| |
*
|
| |
12.2 months
|
| |
not reached
|
| |
not reached
|
| |
36.6 months -
not reached |
•
|
We retain exclusive worldwide development and commercialization rights to Lonca. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations in other geographies.
|
•
|
We intend to submit a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020. Concurrently, we intend to commence a post-marketing confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support a supplemental BLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL.
|
•
|
We completed enrollment of a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL, for which we anticipate reporting final data in the second quarter of 2020.
|
○
|
As of October 2019, we observed a 45.5% interim ORR in 145 heavily pre-treated patients who have received a median of three prior lines of therapy. This interim ORR exceeded our target primary endpoint and the 41.4% ORR observed for DLBCL patients in our 183-patient Phase 1 clinical trial who were treated at the initial dose used in our pivotal Phase 2 clinical trial.
|
○
|
Lonca’s significant clinical activity was observed across a broad patient population in this clinical trial, including patients with primary refractory disease, bulky disease, double-hit or triple-hit disease and transformed disease, elderly patients and patients who did not respond to prior therapy.
|
•
|
Lonca is also being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL, for which we anticipate reporting safety and efficacy data from the Phase 1 part of this clinical trial in the fourth quarter of 2020.
|
○
|
As of April 21, 2020, at the dose that will be used in the pivotal Phase 2 part of the clinical trial, we observed a 76.9% ORR and a 61.5% complete response rate in heavily pre-treated evaluable DLBCL patients who have received a median of three prior lines of therapy.
|
○
|
We intend to advance Lonca into a potential pivotal Phase 2 stage of this clinical trial.
|
•
|
We also intend to commence an additional pivotal Phase 2 clinical trial of Lonca for the treatment of FL in the fourth quarter of 2020.
|
○
|
In the Phase 1 clinical trial of Lonca for the treatment of relapsed or refractory NHL, which included 14 patients with FL, we observed a 78.6% ORR in heavily pre-treated patients with relapsed or refractory FL who have received a median of four prior lines of therapy.
|
•
|
Favorable clinical activity across a broad patient population, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy and patients with bulky disease, double-hit and triple-hit disease and transformed disease;
|
•
|
Significant single-agent clinical activity while maintaining a manageable tolerability profile with a low incidence of febrile neutropenia;
|
•
|
Activity in heavily pretreated patients, including those who have received prior CD19 therapies and SCT;
|
•
|
Promising clinical activity observed in our combination clinical trial with ibrutinib, which we believe demonstrates the opportunity to advance Lonca into earlier lines of therapy in combination with other therapies such as ibrutinib and rituximab; and
|
•
|
Convenient 30-minute intravenous infusions once every three weeks in the out-patient setting.
|
•
|
Our successful recruitment of an experienced Chief Commercial Officer and senior commercial leadership team, including a Vice President of Sales, a Vice President of Marketing and a Vice President of Market Access, with broader organizational recruitment underway;
|
•
|
Our successful recruitment of a Vice President of Medical Affairs, with a broader organizational recruitment underway to include field-based medical science liaisons;
|
•
|
Investing resources to assess the competitive landscape, supporting our differentiated profile and accelerating our launch readiness efforts;
|
•
|
Increased scientific interactions with Key Opinion Leaders; and
|
•
|
Our plans to build a U.S. field sales organization comprising of approximately 40 to 60 sales representatives, which we believe will be sufficient to reach approximately 80% of the potential prescribing physicians for Lonca.
|
•
|
CD19 is a clinically validated target for the treatment of B cell malignancies.
|
•
|
CD19 is expressed in B cell lineage at an earlier stage compared to CD20, which is another well-known target for the treatment of hematological malignancies.
|
•
|
The CD19 antigen is rapidly internalized by the cell. Therefore, it is an effective target for ADC therapy since ADCs bind only to antigens on the cell surface and the ADCs must be internalized to release the warhead inside the cell.
|
•
|
The CD19 antigen does not shed into the circulation. Therefore, there are no, or very low, levels of soluble CD19 to compete for binding of the ADC.
|
Patient Characteristics
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
63
|
| |
(20, 87)
|
|||
Number of previous chemotherapies received, median (minimum, maximum)
|
| |
3
|
| |
(1, 13)
|
|||
Response to first-line chemotherapy, n (%)
|
| |
Relapsed
|
| |
115
|
| |
(62.8)
|
|
| |
Refractory
|
| |
43
|
| |
(23.5)
|
Response to last-line chemotherapy, n (%)
|
| |
Relapsed
|
| |
66
|
| |
(36.1)
|
|
| |
Refractory
|
| |
109
|
| |
(59.6)
|
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
42
|
| |
(23.0)
|
|
| |
No
|
| |
141
|
| |
(77.0)
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 108 patients, or 77.7% of patients. The table below presents the most common Grade ≥3 TEAEs that were reported in more than 5% of patients.
|
Grade ≥3 TEAEs*, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤90 µg/kg
(n=10) |
| |
120 µg/kg
(n=32) |
| |
150 µg/kg
(n=70) |
| |
200 µg/kg
(n=27) |
| |
All Doses
(n=139) |
||
Neutrophil count decreased**
|
| |
2 (20.0)
|
| |
10 (31.2)
|
| |
26 (37.1)
|
| |
15 (55.6)
|
| |
53 (38.1)
|
Platelet count decreased**
|
| |
1 (10.0)
|
| |
7 (21.9)
|
| |
18 (25.7)
|
| |
11 (40.7)
|
| |
37 (26.6)
|
Gamma-glutamyltransferase increased
|
| |
1 (10.0)
|
| |
7 (21.9)
|
| |
12 (17.1)
|
| |
7 (25.9)
|
| |
27 (19.4)
|
Anemia
|
| |
2 (20.0)
|
| |
3 (9.4)
|
| |
11 (15.7)
|
| |
3 (11.1)
|
| |
19 (13.7)
|
Disease progression
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
8 (11.4)
|
| |
0 (0.0)
|
| |
10 (7.2)
|
Hypokalemia
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
8 (11.4)
|
| |
1 (3.7)
|
| |
9 (6.5)
|
Alkaline phosphatase increased
|
| |
1 (10.0)
|
| |
3 (9.4)
|
| |
3 (4.3)
|
| |
1 (3.7)
|
| |
8 (5.8)
|
Lymphocyte count decreased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
4 (5.7)
|
| |
2 (7.4)
|
| |
8 (5.8)
|
Alanine aminotransferase increased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
3 (4.3)
|
| |
2 (7.4)
|
| |
7 (5.0)
|
Fatigue
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
2 (2.9)
|
| |
3 (11.1)
|
| |
7 (5.0)
|
White blood cell count decreased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
3 (4.3)
|
| |
2 (7.4)
|
| |
7 (5.0)
|
Patients with any Grade ≥3 TEAEs
|
| |
4 (40.0)
|
| |
24 (75.0)
|
| |
56 (80.0)
|
| |
24 (88.9)
|
| |
108 (77.7)
|
•
|
TEAEs in 26 patients, or 18.7% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, 32 patients, or 23.4% of patients, achieved a complete response and another 26 patients, or 19.0% of patients, achieved a partial response, resulting in a 42.3% ORR. At dose levels ≥120 μg/kg, 31 patients, or 24.4% of patients, achieved a complete response and another 25 patients, or 19.7% of patients, achieved a partial response, resulting in a 44.1% ORR. The table below shows the response rate data from this clinical trial.
|
Best Overall Response, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤90 µg/kg
(n=10) |
| |
120 µg/kg
(n=32) |
| |
150 µg/kg
(n=70) |
| |
200 µg/kg
(n=25) |
| |
All Doses
(n=137) |
||
Complete response (CR)
|
| |
1 (10.0)
|
| |
6 (18.8)
|
| |
15 (21.4)
|
| |
10 (40.0)
|
| |
32 (23.4)
|
Partial response (PR)
|
| |
1 (10.0)
|
| |
8 (25.0)
|
| |
14 (20.0)
|
| |
3 (12.0)
|
| |
26 (19.0)
|
Stable disease
|
| |
2 (20.0)
|
| |
7 (21.9)
|
| |
12 (17.1)
|
| |
2 (8.0)
|
| |
23 (16.8)
|
Progressive disease
|
| |
6 (60.0)
|
| |
10 (31.3)
|
| |
28 (40.0)
|
| |
10 (40.0)
|
| |
54 (39.4)
|
Not evaluable
|
| |
0 (0.0)
|
| |
1 (3.1)
|
| |
1 (1.4)
|
| |
0 (0.0)
|
| |
2 (1.5)
|
Overall response rate (CR + PR)
|
| |
2 (20.0)
|
| |
14 (43.8)
|
| |
29 (41.4)
|
| |
13 (52.0)
|
| |
58 (42.3)
|
•
|
In our post-hoc subset analysis that excluded patients with double-hit or triple-hit disease and patients with primary refractory and early relapsed disease, at dose levels ≥120 μg/kg, 18 patients, or 45.0% of patients, achieved a complete response and another eight patients, or 20.0% of patients, achieved a partial response, resulting in a 65.0% ORR.
|
•
|
Lonca’s favorable clinical activity was observed across a broad patient population in this clinical trial, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy and patients with bulky disease, double-hit and triple-hit disease and transformed disease. The tables below show the effect of tumor characteristics, age and response to prior therapy on response rate data at dose levels ≥120 µg/kg.
|
Tumor Characteristics
|
| |
Overall Response Rate,
responders/total (%) |
|||
Bulky disease*
|
| |
Absent
|
| |
52/109 (47.7)
|
|
| |
Present
|
| |
4/18 (22.2), including 2/18 (11.1) CR
|
Double-hit or triple-hit disease**
|
| |
Absent
|
| |
51/105 (48.6)
|
|
| |
Present
|
| |
5/22 (22.7), including 3/22 (13.6) CR
|
Transformed disease***
|
| |
No
|
| |
40/96 (41.7)
|
|
| |
Yes
|
| |
16/31 (51.6), including 9/31 (29.0) CR
|
Age
|
| |
Overall Response Rate,
responders/total (%) |
Less than 65
|
| |
25/69 (36.2), including 16/69 (23.2) CR
|
65-74
|
| |
18/36 (50.0), including 11/36 (30.6) CR
|
More than 74
|
| |
13/22 (59.1), including 4/22 (18.2) CR
|
Response to Prior Therapy
|
| |
Overall Response Rate,
responders/total (%) |
|||
Response to first-line therapy
|
| |
Complete response
|
| |
32/49 (65.3)
|
|
| |
Partial response
|
| |
12/33 (36.4)
|
|
| |
Any response
|
| |
44/82 (53.7)
|
|
| |
No response
|
| |
12/44 (27.3)
|
Response to most recent therapy
|
| |
Complete response
|
| |
16/21 (76.2)
|
|
| |
Partial response
|
| |
9/24 (37.5)
|
|
| |
Any response
|
| |
25/45 (55.6)
|
|
| |
No response
|
| |
31/82 (37.8)
|
•
|
Across all dose levels, the median DoR was not reached for patients who achieved a complete response (indicating that more than half of the patients continued to show a complete response as of their most recent assessment) and 2.86 months for patients who achieved a partial response, for an overall DoR of 4.47 months. At dose levels ≥120 µg/kg, the median DoR was not reached for patients who achieved a complete response (indicating that more than half of the patients continued to show a complete response as of their most recent assessment) and was 2.69 months for patients who achieved a partial response, for an overall DoR of 4.17 months. The figure below shows the DoR by response at dose levels ≥120 µg/kg.
|
•
|
In our post-hoc subset analysis that excluded patients with double-hit or triple-hit disease and patients with primary refractory and early relapsed disease, at dose levels ≥120 μg/kg, the median DoR was 10.6 months for patients who achieved a complete response and was 2.1 months for patients who achieved a partial response, for an overall DoR of 4.1 months.
|
•
|
Across all dose levels, five patients, or 33.3% of patients, achieved a complete response and another two patients, or 13.3% of patients, achieved a partial response, resulting in a 46.7% ORR.
|
•
|
The median DoR was not reached (indicating that more than half of the patients continued to show a complete response as of their most recent assessment).
|
•
|
Across all dose levels, nine patients, or 64.3% of patients, achieved a complete response and another two patients, or 14.3% of patients, achieved a partial response, resulting in a 78.6% ORR.
|
•
|
The median DoR was not reached (indicating that more than half of the patients continued to show a complete response as of their most recent assessment).
|
Patient Characteristics
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
66
|
| |
(23, 94)
|
|||
Cancer characteristic, n (%)
|
| |
Double-hit or triple-hit disease*
|
| |
13
|
| |
(9.0)
|
|
| |
Transformed disease**
|
| |
26
|
| |
(17.9)
|
Number of previous chemotherapies received, median (minimum, maximum)
|
| |
3
|
| |
(2, 7)
|
|||
Response to first-line chemotherapy, n (%)
|
| |
Relapsed
|
| |
99
|
| |
(68.3)
|
|
| |
Refractory
|
| |
29
|
| |
(20.0)
|
Response to last-line chemotherapy, n (%)
|
| |
Relapsed
|
| |
43
|
| |
(29.7)
|
|
| |
Refractory
|
| |
82
|
| |
(56.6)
|
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
24
|
| |
(16.6)
|
|
| |
No
|
| |
121
|
| |
(83.4)
|
•
|
With respect to the 145-patient interim analysis population, Grade ≥3 TEAEs were reported in 92 patients, or 63.4% of patients. The table below presents the most common Grade ≥3 TEAEs that were reported in more than 5% of patients.
|
Grade ≥3 TEAEs*, n (%)
|
| |
52-Patient Futility
Analysis Cohort (n=52) |
| |
145-Patient Interim
Analysis Population (n=145) |
||||||
Neutrophil count decreased**
|
| |
17
|
| |
(32.7)
|
| |
34
|
| |
(23.4)
|
Gamma-glutamyltransferase increased
|
| |
13
|
| |
(25.0)
|
| |
20
|
| |
(13.8)
|
Platelet count decreased**
|
| |
11
|
| |
(21.2)
|
| |
20
|
| |
(13.8)
|
Anemia
|
| |
6
|
| |
(11.5)
|
| |
14
|
| |
(9.7)
|
Hypercalcemia
|
| |
4
|
| |
(7.7)
|
| |
***
|
|||
Alanine aminotransferase increased
|
| |
3
|
| |
(5.8)
|
| |
***
|
|||
Hypokalemia
|
| |
3
|
| |
(5.8)
|
| |
***
|
|||
Leukopenia
|
| |
3
|
| |
(5.8)
|
| |
***
|
|||
Lymphocyte count decreased
|
| |
3
|
| |
(5.8)
|
| |
8
|
| |
(5.5)
|
White blood cell count decreased
|
| |
3
|
| |
(5.8)
|
| |
8
|
| |
(5.5)
|
Patients with any Grade ≥3 TEAEs
|
| |
41
|
| |
(78.8)
|
| |
92
|
| |
(63.4)
|
•
|
With respect to the 52-patient futility analysis cohort, TEAEs in 13 patients, or 25.0% of patients, led to treatment discontinuation, treatment-related adverse events in seven patients, or 13.5% of patients, led to treatment discontinuation and adverse events led to dose reductions in two patients, or 3.8% of patients. With respect to the 145-patient interim analysis population, TEAEs in 24 patients, or 16.6% of patients, led to treatment discontinuation, treatment-related adverse events in 13 patients, or 9.0% of patients, led to treatment discontinuation and adverse events led to dose reductions in 10 patients, or 6.9% of patients.
|
•
|
As of April 2020, 14 patients, or 21.2% of patients, who displayed a response have each tolerated ten or more cycles of treatment.
|
•
|
With respect to the 145-patient interim analysis population, 29 patients, or 20.0% of patients, achieved a complete response and another 37 patients, or 25.5% of patients, achieved a partial response, resulting in a 45.5% ORR. Six of the ten patients in the 52-patient futility analysis cohort who achieved a complete response later received stem cell transplant. The table below shows the response rate data.
|
Best Overall Response, n (%)
|
| |
52-Patient Futility
Analysis Cohort (n=52) |
| |
145-Patient Interim
Analysis Population (n=145) |
Complete response (CR)
|
| |
10 (19.2)
|
| |
29 (20.0)
|
Partial response (PR)
|
| |
14 (26.9)
|
| |
37 (25.5)
|
Stable disease
|
| |
10 (19.2)
|
| |
22 (15.2)
|
Progressive disease
|
| |
10 (19.2)
|
| |
29 (20.0)
|
Not evaluable
|
| |
8 (15.4)
|
| |
28 (19.3)
|
Overall response rate (CR + PR)
|
| |
24 (46.2)
|
| |
66 (45.5)
|
•
|
Lonca’s favorable clinical activity was observed across a broad patient population in this clinical trial, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy, patients with bulky disease, double-hit and triple-hit disease and transformed disease and patients who have received prior CD19 therapies and SCT. The tables below show the effect of tumor characteristics, age, response to prior therapy and prior therapy (i.e., stem cell transplant or CAR-T) on response rate data.
|
Tumor Characteristics
|
| |
Overall Response Rate,
responders/total (%) |
|||
Bulky disease*
|
| |
Absent
|
| |
64/136 (47.1)
|
|
| |
Present
|
| |
2/9 (22.2), including 1/9 (11.1) CR
|
Double-hit or triple-hit disease**
|
| |
Absent
|
| |
63/132 (47.7)
|
|
| |
Present
|
| |
3/13 (23.1), including 3/13 (23.1) CR
|
Transformed disease***
|
| |
No
|
| |
54/119 (45.4)
|
|
| |
Yes
|
| |
12/26 (46.2), including 6/26 (23.1) CR
|
Age
|
| |
Overall Response Rate,
responders/total (%) |
Less than 65
|
| |
32/65 (49.2), including 10/65 (15.4) CR
|
More than or equal to 65
|
| |
34/80 (42.5), including 19/80 (23.8) CR
|
Response to Prior Therapy
|
| |
Overall Response Rate,
responders/total (%) |
|||
Response to first-line therapy
|
| |
Refractory
|
| |
11/29 (37.9), including 3/29 (10.3) CR
|
|
| |
Relapsed
|
| |
49/99 (49.5), including 22/99 (22.2) CR
|
Response to most recent therapy
|
| |
Refractory
|
| |
28/82 (34.1), including 6/82 (7.3) CR
|
|
| |
Relapsed
|
| |
28/43 (65.1), including 17/43 (39.5) CR
|
Response to any prior line therapy
|
| |
Refractory
|
| |
8/22 (36.4), including 2/22 (9.1) CR
|
|
| |
Relapsed
|
| |
57/117 (48.7), including 26/117 (22.2) CR
|
Prior Therapy
|
| |
Overall Response Rate,
responders/total (%) |
|||
Stem cell transplant
|
| |
Yes
|
| |
14/24 (58.3), including 7/24 (29.2) CR
|
|
| |
No
|
| |
52/121 (43.0), including 22/121 (18.2) CR
|
CAR-T
|
| |
Yes
|
| |
6/13 (46.2), including 2/13 (15.4) CR
|
|
| |
No
|
| |
60/132 (45.5), including 27/132 (20.5) CR
|
•
|
For the 52-patient futility analysis cohort, the median DoR was not reached for patients who achieved a complete response (indicating that more than half of the patients continued to show a complete response as of their most recent assessment) and was 5.68 months for patients who achieved a partial response, for an overall DoR of 6.87 months. The figure below shows the DoR by response for the 52-patient futility analysis cohort.
|
•
|
We retain worldwide development and commercialization rights to Cami, subject to our collaboration and license agreement with Genmab.
|
•
|
Cami is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL, for which we anticipate reporting top-line response rate data in the first half of 2021.
|
○
|
As of April 15, 2020, 47 patients have been enrolled in this pivotal Phase 2 clinical trial, which is currently subject to a partial clinical hold. See “Business—Camidanlumab Tesirine (ADCT-301): PBD-Based ADC Targeting CD25—Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Hodgkin Lymphoma.”
|
•
|
We are advancing Cami through clinical development to support a BLA submission for the treatment of relapsed or refractory HL.
|
•
|
Enrollment has been completed in a 133-patient Phase 1 clinical trial of Cami for the treatment of relapsed or refractory HL and NHL, including 77 patients with relapsed or refractory HL. In this clinical trial, Cami demonstrated significant clinical activity across a broad patient population, while maintaining a manageable tolerability profile. More specifically, as of April 2019, we observed:
|
○
|
At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR in heavily pre-treated patients with relapsed or refractory HL who have received a median of five prior lines of therapy, including patients who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant; and
|
○
|
A 44.0% ORR in heavily pre-treated patients with relapsed or refractory T-cell lymphoma who have received a median of four prior lines of therapy.
|
•
|
Cami is also being evaluated in a Phase 1b clinical trial for the treatment of selected advanced solid tumors by targeting Tregs.
|
○
|
In paired biopsies from three patients in the Phase 1b clinical trial, we have observed a significant increase in the ratio of T effector cells (“Teffs”) to Tregs.
|
•
|
At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR in heavily pre-treated patients with relapsed or refractory HL who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant;
|
•
|
Manageable tolerability profile;
|
•
|
The potential opportunity to advance Cami into earlier lines of therapy as a monotherapy or in combination with other therapies;
|
•
|
Novel immuno-oncology approach targeting Tregs for the treatment of various advanced solid tumors; and
|
•
|
Convenient 30-minute intravenous infusions once every three weeks in the out-patient setting.
|
•
|
CD25 expression in healthy human tissue is mainly limited to activated T cells and activated B cells.
|
•
|
CD25 is expressed in a wide range of hematological malignancies.
|
•
|
The importance of CD25 overexpression as a prognosticator in hematological malignancies has been shown in multiple indications, including DLBCL.
|
•
|
CD25 positive Treg cells have been shown to play a role in undermining anti-tumor immune functions.
|
•
|
The safety profiles of monoclonal antibodies directed against CD25 have been well characterized.
|
•
|
Clinical proof of concept for treatment of CD25 positive malignancies has been established using radio-immunoconjugates and immunotoxins incorporating the anti-CD25 antibodies.
|
Patient Characteristics
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
52
|
| |
(19, 88)
|
|||
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
5
|
| |
(1, 15)
|
|||
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
57
|
| |
(44.5)
|
|
| |
No
|
| |
71
|
| |
(55.5)
|
Patient Characteristics of HL Patients
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
38
|
| |
(19, 80)
|
|||
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
5
|
| |
(2, 15)
|
|||
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
47
|
| |
(61.0)
|
|
| |
Autologous stem cell transplant
|
| |
39
|
| |
(50.6)
|
|
| |
Allogeneic stem cell transplant
|
| |
3
|
| |
(3.9)
|
|
| |
Both autologous and allogeneic stem cell transplant
|
| |
5
|
| |
(6.5)
|
|
| |
No
|
| |
30
|
| |
(39.0)
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 51 patients, or 66.2% of patients. The table below presents the most common Grade ≥3 TEAEs that are reported in more than 5% of patients.
|
Grade ≥3 TEAEs, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤20 µg/kg
(n=3) |
| |
30 µg/kg
(n=20) |
| |
45 µg/kg
(n=37) |
| |
≥60 µg/kg
(n=17) |
| |
All Doses
(n=77) |
||
Gamma-glutamyltransferase increased
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
3 (8.1)
|
| |
7 (41.2)
|
| |
13 (16.9)
|
Maculopapular rash
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
8 (21.6)
|
| |
2 (11.8)
|
| |
13 (16.9)
|
Alanine aminotransferase increased
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (8.1)
|
| |
4 (23.5)
|
| |
7 (9.1)
|
Anemia
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
3 (8.1)
|
| |
0 (0.0)
|
| |
6 (7.8)
|
Aspartate aminotransferase increased
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
1 (2.7)
|
| |
4 (23.5)
|
| |
5 (6.5)
|
Guillain–Barré syndrome
|
| |
0 (0.0)
|
| |
1 (5.0)
|
| |
2 (5.4)
|
| |
1 (5.9)
|
| |
4 (5.2)
|
Lipase increased
|
| |
0 (0.0)
|
| |
1 (5.0)
|
| |
3 (8.1)
|
| |
0 (0.0)
|
| |
4 (5.2)
|
Patients with any Grade ≥3 TEAEs
|
| |
2 (66.7)
|
| |
12 (60.0)
|
| |
25 (67.6)
|
| |
12 (70.6)
|
| |
51 (66.2)
|
•
|
TEAEs in 20 patients, or 26.0% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, 30 patients, or 40.0% of patients, achieved a complete response and another 23 patients, or 30.7% of patients, achieved a partial response, resulting in a 70.7% ORR. At the 45 µg/kg dose level, 18 patients, or 48.6% of patients, achieved a complete response and another 14 patients, or 37.8% of patients achieved a partial response, resulting in an 86.5% ORR. The table below shows the response rate data from this clinical trial.
|
Best Overall Response, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤20 µg/kg
(n=3) |
| |
30 µg/kg
(n=18) |
| |
45 µg/kg
(n=37) |
| |
≥60 µg/kg
(n=17) |
| |
All Doses
(n=75) |
||
Complete response (CR)
|
| |
0 (0.0)
|
| |
5 (27.8)
|
| |
18 (48.6)
|
| |
7 (41.1)
|
| |
30 (40.0)
|
Partial response (PR)
|
| |
1 (33.3)
|
| |
4 (22.2)
|
| |
14 (37.8)
|
| |
4 (23.5)
|
| |
23 (30.7)
|
Stable disease
|
| |
1 (33.3)
|
| |
6 (33.3)
|
| |
0 (0.0)
|
| |
1 (5.9)
|
| |
8 (10.7)
|
Progressive disease
|
| |
0 (0.0)
|
| |
2 (11.1)
|
| |
5 (13.5)
|
| |
4 (23.5)
|
| |
11 (14.7)
|
Not evaluable
|
| |
1 (33.3)
|
| |
1 (5.6)
|
| |
0 (0.0)
|
| |
1 (5.9)
|
| |
3 (4.0)
|
Overall response rate (CR + PR)
|
| |
1 (33.3)
|
| |
9 (50.0)
|
| |
32 (86.5)
|
| |
11 (64.7)
|
| |
53 (70.7)
|
•
|
Cami’s favorable clinical activity was observed across a broad patient population in this clinical trial, including elderly patients and patients who have failed SCT. The table below shows the effect of age, prior therapy and response to prior therapy on response rate data at the 45 µg/kg dose level.
|
Age
|
| |
Overall Response Rate,
responders/total (%) |
Less than or equal to 55
|
| |
25/28 (89.3), including 14/28 (50.0) CR
|
More than 55
|
| |
7/9 (77.8), including 4/9 (44.4) CR
|
Prior Therapy
|
| |
Overall Response Rate,
responders/total (%) |
Brentuximab vedotin
|
| |
32/37 (86.5)
|
Brentuximab vedotin and checkpoint inhibitor
|
| |
23/26 (88.5)
|
Stem cell transplant
|
| |
16/18 (88.9)
|
Brentuximab vedotin, checkpoint inhibitor and stem cell transplant
|
| |
13/14 (92.9)
|
Response to Prior Therapy
|
| |
|
| |
Overall Response Rate,
responders/total (%) |
Response to first-line therapy
|
| |
Refractory
|
| |
11/13 (84.6), including 6/13 (46.2) CR
|
|
| |
Relapsed
|
| |
21/24 (87.5), including 12/24 (50.0) CR
|
Response to most recent therapy
|
| |
Refractory
|
| |
22/25 (88.0), including 11/25 (44.0) CR
|
|
| |
Relapsed
|
| |
8/10 (80.0), including 6/10 (60.0) CR
|
•
|
Across all dose levels, the median DoR was 8.1 months for patients who achieved a complete response and 5.1 months for patients who achieved a partial response, for an overall DoR of 6.4 months. At the 45 µg/kg dose level, the median DoR was 7.2 months for patients who achieved a complete response and 5.6 months for patients who achieved a partial response, for an overall DoR of 6.6 months. The figure below shows the DoR by response at the 45 µg/kg dose level.
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 23 patients, or 79.3% of patients. The most common Grade ≥3 TEAEs, reported in more than 5% of patients, included hypercalcemia (10.3%), acute kidney injury (6.9%), back pain (6.9%), dehydration (6.9%), gamma-glutamyltransferase increased (6.9%), lung infection (6.9%), platelet count decreased (6.9%), pyrexia (6.9%), rash (6.9%) and maculopapular rash (6.9%).
|
•
|
TEAEs in two patients, or 6.9% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, two patients, or 8.0% of patients, achieved a complete response and another nine patients, or 36.0% of patients, achieved a partial response, resulting in a 44.0% ORR.
|
•
|
The CD22 antigen is rapidly internalized by the cell.
|
•
|
An increasing number of reports describe the outgrowth of CD19-negative tumor cells in patients who initially respond to CD19-targeted therapy. We believe that given CD22’s broad and favorable expression profile, it may be a viable alternative B cell marker to CD19 for the targeted delivery of highly potent cytotoxic drugs.
|
|
| |
n (%)
|
|||||||||
Response
|
| |
ADCT-602
0.3 mg/kg (n=10) |
| |
ADCT-602
1 mg/kg (n=10) |
| |
Non-Targeted ADC
1 mg/kg (n=10) |
| |
Vehicle Control
(n=10) |
Complete response
|
| |
0 (0.0)
|
| |
10 (100.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
9 (90.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
•
|
Sur301 exhibited strong and durable anti-tumor activity that is superior to that achieved by an anti-PD1 antibody;
|
•
|
Sur301 exhibited strong synergistic effects when tested at a low dose level in combination with an anti-PD1 regimen;
|
•
|
Sur301’s observed anti-tumor activity was dependent on CD8 Teffs, and a statistically significant increase in the ratio of intratumoral CD8+ Teffs to Tregs was observed after administration of Sur301; and
|
•
|
Sur301 was associated with immunological memory in our re-challenge of tumor-free survivors.
|
•
|
ADCT-601 uses GlycoconnectTM site-specific conjugation technology, which allows for fast and stable conjugation of the warhead to the antibody.
|
•
|
The PBD payload of ADCT-601 contains a unique spacer, HydraspaceTM, which we have shown to provide an additional improvement in therapeutic index in preclinical models.
|
•
|
AXL is highly overexpressed or ectopically expressed in a multitude of solid tumors, including in lung, breast, prostate, pancreas, glioma and esophageal cancers. Its overexpression is maintained in both primary tumors and metastasis.
|
•
|
AXL expression in healthy tissues is significantly lower than that in tumor cells.
|
•
|
AXL is expressed on M2 macrophages, which are part of the immunosuppressive tumor microenvironment.
|
•
|
Expression and activation of AXL is associated with poor clinical prognosis in many tumor indications and several studies suggest that expression of AXL is induced by both targeted and chemotherapy drugs. Therefore, AXL-based therapies may be efficacious even where traditional therapies have failed.
|
•
|
AXL is prevalent in tumors resistant to anti-PD1 therapy, and pre-clinical data have shown the benefit of combining AXL-targeted therapies with immunotherapies.
|
•
|
The extracellular portion of AXL can be cleaved off from the membrane to generate soluble AXL (“sAXL”), which can be detected in serum. Recent studies suggest that sAXL can be a potential circulating biomarker in certain tumors, representing a potentially attractive biomarker for clinical use.
|
Response
|
| |
n (%)
|
||||||
|
ADCT-601
1 mg/kg (n=10) |
| |
Non-Targeted ADC
1 mg/kg (n=10) |
| |
Vehicle Control
(n=10) |
||
Complete response
|
| |
4 (40.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
5 (50.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
4 (40.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Response
|
| |
n (%)
|
||||||
|
ADCT-601
1 mg/kg (n=8) |
| |
Non-Targeted ADC
1 mg/kg (n=8) |
| |
Vehicle Control
(n=8) |
||
Complete response
|
| |
2 (25.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
5 (62.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
2 (25.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
|||||||||||||||
Response
|
| |
ADCT-601
0.075 mg/kg (n=8) |
| |
ADCT-601
0.15 mg/kg (n=8) |
| |
ADCT-601
0.3 mg/kg (n=8) |
| |
AXL-107-MMAE
0.3 mg/kg (n=8) |
| |
AXL-107-MMAE
4 mg/kg (n=8) |
| |
Vehicle Control
(n=8) |
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (37.5)
|
| |
0 (0.0)
|
| |
8 (100.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
1 (12.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (37.5)
|
| |
0 (0.0)
|
| |
8 (100.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
||||||
Response
|
| |
ADCT-901
1 mg/kg (n=8) |
| |
Non-Targeted ADC
1 mg/kg (n=8) |
| |
Vehicle Control
(n=8) |
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
7 (87.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
||||||||||||
Response
|
| |
ADCT-701
0.1 mg/kg (n=8) |
| |
ADCT-701
0.3 mg/kg (n=8) |
| |
ADCT-701
1 mg/kg (n=8) |
| |
Non-Targeted ADC
1 mg/kg (n=8) |
| |
Vehicle Control
(n=8) |
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
2 (37.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (62.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
•
|
completion of extensive preclinical laboratory and animal studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements;
|
•
|
submission to the FDA of an IND, which must become effective before human clinical trials may begin;
|
•
|
approval by an IRB or independent ethics committee at each clinical trial site before each clinical trial may be commenced;
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;
|
•
|
submission to the FDA of a BLA;
|
•
|
a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review;
|
•
|
satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic, or components thereof, will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity;
|
•
|
satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCPs and integrity of the clinical data;
|
•
|
payment of any user fees for FDA review of the BLA;
|
•
|
FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee; and
|
•
|
compliance with any post-approval requirements, including REMS, where applicable, and post-approval studies required by the FDA as a condition of approval.
|
•
|
Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacokinetics, pharmacologic action, side effect tolerability, safety of the product candidate, and, if possible, early evidence of effectiveness. Phase 1 clinical trials may be designated as Phase 1a, which may involve dose escalation to determine the maximum tolerated dose, or Phase 1b, which may involve dose expansion at one or more dose levels to determine the recommended dose level for Phase 2 clinical trials.
|
•
|
Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.
|
•
|
Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product, and provide an adequate basis for product labeling. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the biologic.
|
•
|
restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls;
|
•
|
fines, warning or other enforcement-related letters or holds on post-approval clinical studies;
|
•
|
refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product license 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.
|
•
|
preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations;
|
•
|
submission to the relevant national authorities of a clinical trial application (“CTA”) for each trial in humans, which must be approved before the trial may begin in each country where patient enrollment is planned;
|
•
|
performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;
|
•
|
submission to the relevant competent authorities of a MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling;
|
•
|
satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMP;
|
•
|
potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and
|
•
|
review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
|
•
|
The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.
|
•
|
Federal civil and criminal false claims laws, such as the FCA, which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. In addition, 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 FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.
|
•
|
HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
|
•
|
HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates that perform services for them that involve 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 U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
|
•
|
Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
|
•
|
The federal transparency requirements under the Physician Payments Sunshine Act, created under the Health Care Reform Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health
|
•
|
State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers.
|
•
|
State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
|
•
|
increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program;
|
•
|
established a branded prescription drug fee that pharmaceutical manufacturers of certain branded prescription drugs must pay to the federal government;
|
•
|
expanded the list of covered entities eligible to participate in the 340B drug pricing program by adding new entities to the program;
|
•
|
established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% 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;
|
•
|
extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
•
|
expanded 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;
|
•
|
created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
|
•
|
established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
established a Center for Medicare and Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and
|
•
|
created a licensure framework for follow-on biologic products.
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
Location
|
| |
Primary Function
|
| |
Approximate Size
|
Biopôle
Route de la Corniche 3B 1066 Epalinges Switzerland |
| |
Office
|
| |
518 m2
|
|
| |
|
| |
|
430 Mountain Avenue, 4th Floor
Murray Hill, New Jersey 07974 United States |
| |
Office
|
| |
1038 m2
|
|
| |
|
| |
|
42 New Road
London, E1 2AX United Kingdom |
| |
Office and laboratory
|
| |
284 m2
|
|
| |
|
| |
|
1510 Fashion Island Boulevard, Suite 205
San Mateo, California 94404 United States |
| |
Office
|
| |
390 m2
|
Name
|
| |
Position(s)
|
| |
Age
|
Executive Officers and Directors
|
| |
|
| |
|
Christopher Martin
|
| |
Chief Executive Officer and Director
|
| |
61
|
Michael Forer
|
| |
Executive Vice President, Chief Financial Officer and Vice Chairman of the Board of Directors(1)
|
| |
54
|
Jay Feingold
|
| |
Senior Vice President, Chief Medical Officer & Head of Oncology
|
| |
63
|
Jennifer Herron
|
| |
Senior Vice President, Chief Commercial Officer
|
| |
50
|
Patrick van Berkel
|
| |
Senior Vice President, Research and Development
|
| |
51
|
Richard Onyett
|
| |
Vice President, Business Development
|
| |
72
|
Dominique Graz
|
| |
General Counsel and Company Secretary
|
| |
59
|
Peter Greaney
|
| |
Head of Corporate Development
|
| |
40
|
Stéphane Henchoz
|
| |
Director of Finance
|
| |
52
|
Susan Romanus
|
| |
Chief Compliance Officer
|
| |
54
|
Jennifer Creel
|
| |
Chief Financial Officer Nominee(1)
|
| |
49
|
Non-Executive Directors
|
| |
|
| |
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Ron Squarer
|
| |
Chairman of the Board of Directors
|
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53
|
Peter B. Corr
|
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Director
|
| |
71
|
Stephen Evans-Freke
|
| |
Director
|
| |
68
|
Peter Hug
|
| |
Director
|
| |
61
|
Thomas Pfisterer
|
| |
Director
|
| |
38
|
Thomas M. Rinderknecht
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| |
Director
|
| |
66
|
Tyrell J. Rivers
|
| |
Director
|
| |
47
|
Victor Sandor
|
| |
Director
|
| |
53
|
Jacques Theurillat
|
| |
Director
|
| |
60
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(1)
|
We intend for Ms. Creel to become our Chief Financial Officer upon the consummation of this offering or on May 18, 2020, whichever is earlier, after which time, Mr. Forer will remain our Executive Vice President and Vice Chairman of our board of directors.
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•
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pre-approve the audit services and non-audit services (including the fees and terms thereof) to be provided by the independent auditor pursuant to pre-approval policies and procedures;
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•
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evaluate the independent auditor’s qualifications, performance and independence, and present its conclusions with respect to the independent auditor to the board of directors on at least an annual basis;
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•
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confirm and evaluate the rotation of the audit partners on the audit engagement team as required by law;
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•
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at least annually, review management’s plans with respect to the responsibilities, budget and staffing of the internal audit function and its plans for the implementation of the internal audit function, if any;
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•
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review and discuss with management and the independent auditor the annual audited consolidated and stand-alone financial statements and unaudited quarterly financial statements;
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•
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review with management, personnel responsible for the design and implementation of the internal audit function and the independent auditor (i) any analyses or other written communications prepared by management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the financial statements, (ii) the Company’s critical accounting policies and practices, (iii) the effect of regulatory and accounting initiatives, as well as off-balance sheet transactions and structures, on the Company’s financial statements and (iv) any major issues regarding accounting principles and financial statement presentations;
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•
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review the type and presentation of information included in the earnings press releases, as well as financial information and earnings guidance provided to analysts and rating agencies, and may review earnings press releases prior to public dissemination;
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•
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in conjunction with the chief executive officer and chief financial officer, review disclosure controls and procedures and internal control over financial reporting;
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•
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review policies and practices with respect to risk assessment and risk management; and
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•
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review any major litigation or investigations against the Company that may have a material impact on the Company’s financial statements.
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•
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regularly review and make recommendations to the board of directors regarding our compensation and benefits strategy and guidelines;
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•
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prepare the proposals to the shareholders’ meeting regarding the compensation of the members of the board of directors and the executive committee;
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•
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regularly review and make recommendations to the board of directors regarding the compensation of the members of the board of directors and of the executive committee;
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•
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review and approve the recommendation of our chief executive officer regarding the fixed and variable compensation, including incentive plan participation and benefits, of the members of the management team other than members of the executive committee;
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•
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review and make recommendations to the board of directors regarding our compensation and benefits plans (cash and/or equity-based plans) and, where appropriate or required, make recommendations to adopt, amend and terminate such plans;
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•
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to the extent not delegated by the compensation committee to a different body or a third party, administer our compensation and benefits plans (other than equity-based plans); and
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•
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review and assess risks arising from our employee compensation policies and practices and whether any such risks are reasonably likely to have a material adverse effect on us.
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•
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determine selection criteria for the succession of the members of the board of directors and board committees, our chief executive officer, our chief financial officer and our executive vice president, and establish such succession planning (including for the event of the incapacitation, retirement or removal of such individuals) by making recommendations to the board of directors;
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•
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oversee searches and identify qualified individuals for membership on the board of directors and for the position of chief executive officer;
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•
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recommend individuals for membership on the board of directors and board committees and for the position of chief executive officer;
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•
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at least annually, prepare the board of directors’ assessment of the performance of the board of directors and board committees and of our chief executive officer and review the recommendations of the other board committees based on their evaluation of their own performance;
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•
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review the recommendations of the other board committees based on their self-evaluations and discuss its self-evaluation with the board of directors;
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•
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monitor and assess developments and trends in corporate governance to the extent that these do not have an impact on the activities and tasks of the audit and finance committee or the compensation committee;
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•
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review proposals to be made to the board of directors for the amendment of our amended and restated articles of association, our organizational regulations, any other rules or regulations and the Code of Conduct;
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•
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periodically review and reassess the adequacy of the Code of Conduct and recommend any proposed changes to the board of directors;
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•
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periodically review and assess the adequacy of the charter of the nomination and corporate governance committee and recommend any proposed changes to the board of directors for approval;
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•
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if it deems advisable, develop and recommend to the board of directors corporate governance guidelines for the Company, and, if such guidelines are adopted, periodically review and reassess the adequacy of such guidelines, consider any requests for waivers of such guidelines and make recommendations to the board of directors regarding amendments and requests for waivers; and
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•
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oversee compliance with the Code of Conduct and report on such compliance to the board of directors.
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•
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Exemption from the requirement that a majority of the board of directors be comprised of independent directors and that there be regularly scheduled meetings with only the independent directors present. Swiss law does not have such a requirement.
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•
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Exemption from the requirements that the compensation committee and the nomination and corporate governance committee be comprised of independent directors. Swiss law does not have such requirements.
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•
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Exemption from quorum requirements applicable to meetings of shareholders. Swiss law does not require such quorum requirements.
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•
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Exemption from the requirement that independent directors meet at regularly scheduled executive sessions. Swiss law does not have such a requirement.
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•
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Exemption from the requirement that listed companies adopt and disclose corporate governance guidelines that cover certain minimum specified subjects related to director qualifications and responsibilities. Swiss law does not require the adoption or disclosure of such guidelines.
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•
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Exemption from the requirement to disclose within four business days of any determination to grant a waiver of the Code of Conduct to directors and executive officers. Although we will require approval by our board of directors for any such waiver, we may choose not to disclose the waiver in the manner set forth in the NYSE listing standards.
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•
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Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans. Our amended and restated articles of association will provide that our board of directors is authorized, in certain instances, to issue a certain number of common shares without re-approval by our shareholders.
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•
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each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding common shares;
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•
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each of our executive officers and directors and persons nominated to serve in such positions; and
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•
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all executive officers and directors and persons nominated to serve in such positions as a group.
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|
| |
Shares Beneficially Owned Before This Offering
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| |
Shares Beneficially Owned After This Offering
|
||||||
Principal Shareholders
|
| |
Number
|
| |
Percent
|
| |
Number
|
| |
Percent
|
5% Shareholders
|
| |
|
| |
|
| |
|
| |
|
Entities affiliated with Auven Therapeutics GP Ltd.(1)
|
| |
22,030,479
|
| |
42.8%
|
| |
|
| |
|
AstraZeneca UK Limited(2)
|
| |
3,675,000
|
| |
7.1%
|
| |
|
| |
|
HPWH TH AG(3)
|
| |
6,000,000
|
| |
11.7%
|
| |
|
| |
|
Executive Officers and Directors
|
| |
|
| |
|
| |
|
| |
|
Peter B. Corr(4)
|
| |
22,030,419
|
| |
42.8%
|
| |
|
| |
|
Jennifer Creel
|
| |
*
|
| |
*
|
| |
|
| |
|
Stephen Evans-Freke(4)
|
| |
22,030,419
|
| |
42.8%
|
| |
|
| |
|
Jay Feingold
|
| |
*
|
| |
*
|
| |
|
| |
|
Michael Forer(5)
|
| |
858,392.8
|
| |
1.7%
|
| |
|
| |
|
Dominique Graz
|
| |
*
|
| |
*
|
| |
|
| |
|
Peter Greaney
|
| |
*
|
| |
*
|
| |
|
| |
|
Stéphane Henchoz
|
| |
*
|
| |
*
|
| |
|
| |
|
Jennifer Herron
|
| |
*
|
| |
*
|
| |
|
| |
|
Peter Hug
|
| |
*
|
| |
*
|
| |
|
| |
|
Christopher Martin(6)
|
| |
1,131,744.8
|
| |
2.2%
|
| |
|
| |
|
Richard Onyett
|
| |
*
|
| |
*
|
| |
|
| |
|
Thomas Pfisterer
|
| |
*
|
| |
*
|
| |
|
| |
|
Thomas M. Rinderknecht
|
| |
*
|
| |
*
|
| |
|
| |
|
Tyrell J. Rivers(7)
|
| |
*
|
| |
*
|
| |
|
| |
|
Susan Romanus
|
| |
*
|
| |
*
|
| |
|
| |
|
Victor Sandor
|
| |
*
|
| |
*
|
| |
|
| |
|
Ron Squarer
|
| |
*
|
| |
*
|
| |
|
| |
|
Jacques Theurillat
|
| |
*
|
| |
*
|
| |
|
| |
|
Patrick van Berkel(8)
|
| |
*
|
| |
*
|
| |
|
| |
|
Barrie Ward
|
| |
*
|
| |
*
|
| |
|
| |
|
All executive officers and directors as a group
(20 persons)(9) |
| |
|
| |
|
| |
|
| |
|
*
|
Less than 1% of our total outstanding common shares.
|
(1)
|
Consists of (i) 17,003,125.0 common shares held of record by A.T. Holdings II Sàrl (“A.T. Holdings”), a Swiss limited liability company (société à responsabilité limitée) and (ii) 5,027,294.2 common shares held of record by ADC Products Switzerland Sàrl (“ADC Products”), a Swiss limited liability company (société à responsabilité limitée). A.T. Holdings is a wholly-owned subsidiary of C.T. Phinco Sàrl, a Swiss limited liability company (société à responsabilité limitée). C.T. Phinco Sàrl is a wholly-owned subsidiary of Auven Therapeutics Holdings L.P. (“Auven Therapeutics”). Auven Therapeutics GP Ltd. is the general partner of Auven Therapeutics General L.P. Auven Therapeutics General L.P. is the general partner of Auven Therapeutics. Auven Therapeutics holds a 73.8% ownership interest in ADC Products. As the sole shareholders of Auven Therapeutics GP Ltd., Mr. Corr and Mr. Evans-Freke may be deemed to have shared voting and investment power with respect to the common shares of ADCT. Although the managing directors of A.T. Holdings and ADC Products have voting rights with respect to the common shares held of record, the managing directors disclaim beneficial ownership over 22,030,419.2 of the common shares of ADCT. The number of common shares above includes 60 common shares held of record by A.T. Holdings as nominee on behalf of investors, for which A.T. Holdings does not take into account the wishes of investors when exercising voting rights. The number of common shares above does not reflect 3,999,186.4 common shares held of record by A.T. Holdings as nominee on behalf of equity incentive plan participants, for which A.T. Holdings takes into account the wishes of the equity incentive plan participants when exercising voting rights. 22,027,293.6 common shares of ADCT held of record by A.T. Holdings and ADC Products have been pledged pursuant to lending arrangements. The business address for Auven Therapeutics GP Ltd. is 171 Main Street, Road Town, Tortola, British Virgin Islands VG1110.
|
(2)
|
Consists of 3,675,000 common shares held of record by AstraZeneca UK Limited (“AstraZeneca”), a private limited company organized in the United Kingdom. AstraZeneca is a wholly-owned subsidiary of AstraZeneca PLC, a public limited company organized under the laws of the United Kingdom, which may be deemed to have sole voting and investment power. The registered office address of AstraZeneca is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, United Kingdom, CB2 0AA.
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(3)
|
Consists of 6,000,000 common shares held of record by HPWH TH AG (“HPWH”), a Swiss stock corporation. Dr. Hans-Peter Wild and Mr. Pfisterer are members of HPWH board of directors, and may be deemed to have shared voting and investment power with respect to such shares held of record by HPWH through a shareholders agreement. Mr. Pfisterer disclaims beneficial ownership over 5,687,500 common shares held of record by HPWH. The business address of HPWH is Neugasse 22, 6300 Zug, Switzerland.
|
(4)
|
Consists of (i) 17,003,125.0 common shares held of record by A.T. Holdings, a company controlled by Auven Therapeutics and (ii) 5,027,294.2 common shares held of record by ADC Products. Auven Therapeutics holds a 73.8% ownership interest in ADC Products. As described in footnote (1), the sole shareholders of Auven Therapeutics GP Ltd., Mr. Corr and Mr. Evans-Freke, may be deemed to have shared voting and investment power with respect to the common shares of ADCT.
|
(5)
|
Does not include 336,259.2 common shares held by Dune Capital Inc., a company which is wholly-owned by a trust whose beneficiaries include Mr. Forer and his family. Mr. Forer does not exercise investment or voting control over the trust, and therefore such shares do not appear in the table above.
|
(6)
|
Does not include 493,444.6 common shares held of record by Tuula Martin, spouse of Christopher Martin. Mr. Martin does not exercise investment or voting control over such shares, and therefore such shares do not appear in the table above.
|
(7)
|
Mr. Rivers, an executive director within AstraZeneca’s corporate development group, disclaims beneficial ownership with respect to the 3,675,000 common shares held of record by AstraZeneca. See footnote (2).
|
(8)
|
Consists of 229,805.6 common shares held by Betulamab B.V., a Dutch private limited liability company of which Dr. van Berkel is beneficial owner. The registered office address of Betulamab B.V. is Neerdyck 3, 3601 CZ Maarssen, The Netherlands.
|
(9)
|
Includes 1,415,200.2 common shares held by directors and executive officers who beneficially own less than 1.0% of shares and an estimated common shares (subject to adjustments for final tax and social security deductions) subject to options that are immediately exercisable or exercisable within 60 days of the completion of this offering, which represent the common shares that will be issued to settle outstanding awards under our 2014 Incentive Plan in connection with this offering.
|
Name of Shareholders
|
| |
Number of Class E Preferred
Shares (Number of Common Shares After Giving Effect to the Share Capital Reorganization and the Share Split) Purchased(1) |
|||
A.T. Holdings II Sàrl
|
| |
105.0000
|
| |
(1,312,500.0000)
|
ADC Products Switzerland Sàrl
|
| |
56.0000
|
| |
(700,000.0000)
|
Michael Forer
|
| |
0.7709
|
| |
(9,636.2500)
|
Tuula Martin(2)
|
| |
1.5418
|
| |
(19,272.5000)
|
Thomas Rinderknecht
|
| |
3.3421
|
| |
(41,776.2500)
|
Jacques Theurillat
|
| |
1.5815
|
| |
(19,768.7500)
|
Barrie Ward(3)
|
| |
0.4667
|
| |
(5,833.7500)
|
(1)
|
Includes shares and fractional shares held by nominees on behalf of the shareholders set out in the table.
|
(2)
|
Tuula Martin is the spouse of Christopher Martin, who is a member of our board of directors and CEO.
|
(3)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
Name of Shareholders
|
| |
Number of Class E Preferred Shares
(Number of Common Shares After Giving Effect to the Share Capital Reorganization and the Share Split) Purchased(1) |
|||
A.T. Holdings II Sàrl(2)
|
| |
62.0000
|
| |
(775,000.0000)
|
Michael Forer
|
| |
0.4286
|
| |
(5,357.5000)
|
Dominique Graz
|
| |
0.5700
|
| |
(7,125.0000)
|
Stéphane Henchoz
|
| |
0.1000
|
| |
(1,250.0000)
|
Thomas Rinderknecht
|
| |
1.0000
|
| |
(12,500.0000)
|
Jacques Theurillat
|
| |
0.1800
|
| |
(2,250.0000)
|
Tuula Martin(3)
|
| |
0.4300
|
| |
(5,375.0000)
|
Barrie Ward(4)
|
| |
0.0200
|
| |
(250.0000)
|
(1)
|
Includes shares and fractional shares held by nominees on behalf of the shareholders set out in the table.
|
(2)
|
Includes 29.0000 Class E preferred shares (which is equal to 362,500.0000 common shares after giving effect to the Share Capital Reorganization and the Share Split) originally acquired by ADC Products Switzerland Sàrl and later transferred to A.T. Holdings II Sàrl.
|
(3)
|
Tuula Martin is the spouse of Christopher Martin, who is a member of our board of directors and CEO.
|
(4)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
Name of Director or Executive Officer
|
| |
Interest Rate as of
April 15, 2020 |
| |
Largest Amount
Previously Outstanding Immediately Prior to Repayment (in USD thousands) |
Michael Forer
|
| |
2.25%
|
| |
3,307
|
Dominique Graz
|
| |
2.25%
|
| |
207
|
Peter Greaney
|
| |
2.25%
|
| |
71
|
Stéphane Henchoz
|
| |
2.25%
|
| |
336
|
Peter Hug
|
| |
2.25%
|
| |
229
|
Christopher Martin
|
| |
2.25%
|
| |
4,148
|
Thomas Pfisterer
|
| |
2.25%
|
| |
341
|
Thomas M. Rinderknecht
|
| |
2.25%
|
| |
472
|
Jacques Theurillat
|
| |
2.25%
|
| |
472
|
Patrick van Berkel
|
| |
2.25%
|
| |
472
|
Barrie Ward(1)
|
| |
2.25%
|
| |
385
|
(1)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
•
|
On October 11, 2017, our share capital as registered with the Commercial Register on October 12, 2017, was increased by issuing 588 Class E preferred shares;
|
•
|
On October 24, 2017, our share capital as registered with the Commercial Register on October 30, 2017, was increased by issuing 22 Class E preferred shares;
|
•
|
On November 10, 2017, our share capital as registered with the Commercial Register on November 16, 2017, was increased by issuing 7 Class E preferred shares;
|
•
|
On June 19, 2018, our share capital as registered with the Commercial Register on June 29, 2018, was increased by issuing 3 Class A common shares;
|
•
|
On December 10, 2018, our share capital as registered with the Commercial Register on December 14, 2018, was increased by issuing 33 Class A common shares;
|
•
|
On January 30, 2019, our share capital as registered with the Commercial Register on February 6, 2019, was increased by issuing 6 Class A common shares;
|
•
|
On June 4, 2019, our share capital as registered with the Commercial Register on June 7, 2019, was increased by issuing 216 Class E preferred shares;
|
•
|
On June 7, 2019, our share capital as registered with the Commercial Register on June 14, 2019, was increased by issuing 2 Class E preferred shares;
|
•
|
On June 28, 2019, our share capital as registered with the Commercial Register on July 5, 2019, was increased by issuing 77 Class E preferred shares;
|
•
|
On August 22, 2019, our share capital as registered with the Commercial Register on August 28, 2019, was increased by an aggregate amount of CHF 3,714,300 through an increase of the par value of each of our Class A common shares and Class B, C, D and E preferred shares from CHF 100 to CHF 1,000;
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•
|
On September 19, 2019, our share capital as registered with the Commercial Register on September 19, 2019, was increased by issuing 140 Class A common shares;
|
•
|
In the one-to-15,625 share split of all issued shares effected on September 19, 2019, each of our issued shares was split into 15,625 shares of the same class with a par value of CHF 0.064 per share; and
|
•
|
In the five-to-four reverse share split of all issued shares effected on April 24, 2020, each of our issued shares was consolidated into 0.8 shares of the same class with a par value of CHF 0.08 per share, and an aggregate of 44 common shares were converted into 6 Class C preferred shares, 12 Class D preferred shares and 26 Class E preferred shares, each with a par value of CHF 0.08.
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•
|
conditional share capital (capital-actions conditionnel) for the purpose of issuing shares in connection with, among other things, (i) option and conversion rights granted in connection with warrants and convertible bonds of the Company or one of our subsidiaries or (ii) grants of rights to employees, members of our board of directors or consultants or to our subsidiaries or other persons providing services to the Company or a subsidiary to subscribe for new shares (conversion or option rights); or
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•
|
authorized share capital (capital-actions autorisé) to be utilized by the board of directors within a period determined by the shareholders but not exceeding two years from the date of the shareholder approval.
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•
|
if the issue price of the new registered shares is determined by reference to the market price;
|
•
|
for raising of capital (including private placements) in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable conditions, without the exclusion of the statutory pre-emptive subscription rights of the existing shareholders;
|
•
|
for the acquisition of an enterprise, parts of an enterprise or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares;
|
•
|
for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners, or in connection with the listing of new shares on domestic or foreign stock exchanges;
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•
|
for purposes of granting an over-allotment option or an option to purchase additional shares in a placement or sale of shares to the respective initial purchaser(s) or underwriter(s);
|
•
|
for the participation of members of the board of directors, members of the executive committee, employees, contractors, consultants or other persons performing services for the benefit of the Company or any of its group companies;
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•
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following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of our share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors;
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•
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for the defense of an actual, threatened or potential takeover bid, that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders acceptance on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest; or
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•
|
for other valid grounds in the sense of Article 652b para. 2 of the CO.
|
•
|
for the purpose of financing or refinancing, or the payment for, the acquisition of enterprises, parts of enterprises, participations, intellectual property rights, licenses or investments;
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•
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if the issuance occurs in domestic or international capital markets, including private placements;
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•
|
following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of the share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors; or
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•
|
for the defense of an actual, threatened or potential takeover bid that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders to accept on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest.
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•
|
adopting and amending the articles of association, including the change of a company’s purpose or domicile;
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•
|
electing 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 proxy;
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•
|
approving the business report, the annual statutory and consolidated financial statements, and deciding on the allocation of profits as shown on the balance sheet, in particular with regard to dividends;
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•
|
approving the aggregate amount of compensation of members of the board of directors and the executive committee;
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•
|
discharging the members of the board of directors and the executive committee from liability with respect to their conduct of business;
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•
|
dissolving a company with or without liquidation; and
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•
|
deciding matters reserved to the general meeting of shareholders by law or the articles of association or submitted to it by the board of directors.
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•
|
amending the Company’s corporate purpose;
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•
|
creating shares with preference rights;
|
•
|
cancelling or amending the transfer restrictions of shares;
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•
|
creating authorized or conditional share capital;
|
•
|
increasing share capital out of equity, against contributions in-kind or for the purpose of acquiring specific assets and granting specific benefits;
|
•
|
limiting or withdrawing shareholder’s pre-emptive subscription rights;
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•
|
changing a company’s domicile;
|
•
|
amending or repealing the voting and recording restrictions, the provision setting a maximum board size or the indemnification provision for the board of directors and the executive committee set forth in our articles of association;
|
•
|
converting registered shares into bearer shares;
|
•
|
removing the chairman or any member of the board of directors before the end of his or her term of office; and
|
•
|
dissolving or liquidating the Company.
|
•
|
a brief description of the business desired to be brought before the general meeting of shareholders and the reasons for conducting such business at the general meeting of shareholders;
|
•
|
the motions regarding the agenda item;
|
•
|
the name and address, as they appear in the share register, of the shareholder proposing such business;
|
•
|
the number of shares which are beneficially owned by such shareholder (including documentary support of such beneficial ownership);
|
•
|
the dates upon which the shareholder acquired such shares;
|
•
|
any material interest of the proposing shareholder in the proposed business;
|
•
|
a statement in support of the matter; and
|
•
|
all other information required under the applicable laws and stock exchange rules.
|
•
|
a core part of our business is sold without which it is economically impracticable or unreasonable to continue to operate the remaining business;
|
•
|
our assets, after the divestment, are not invested in accordance with our corporate purpose as set forth in the articles of association; and
|
•
|
the proceeds of the divestment are not earmarked for reinvestment in accordance with our corporate purpose but, instead, are intended for distribution to our shareholders or for financial investments unrelated to our corporate purpose.
|
•
|
the ultimate direction of the business of the Company and issuing of the relevant directives;
|
•
|
laying down the organization of the Company;
|
•
|
formulating accounting procedures, financial controls and financial planning;
|
•
|
nominating and removing persons entrusted with the management and representation of the Company and regulating the power to sign for the Company;
|
•
|
the ultimate supervision of those persons entrusted with management of the Company, with particular regard to adherence to law, our articles of association, and regulations and directives of the Company;
|
•
|
issuing the business report and the compensation report, and preparing for the general meeting of shareholders and carrying out its resolutions; and
|
•
|
informing the court in case of over-indebtedness.
|
•
|
severance payments (compensation due until the termination of a contractual relationship does not qualify as severance payment);
|
•
|
advance compensation;
|
•
|
incentive fees for the acquisition or transfer of companies, or parts thereof, by the Company or by companies being, directly or indirectly, controlled by us;
|
•
|
loans, other forms of indebtedness, pension benefits not based on occupational pension schemes and performance-based compensation not provided for in the articles of association; and
|
•
|
equity-based compensation not provided for in the articles of association.
|
•
|
the maximum aggregate amount of compensation of the board of directors for the term of office until the next annual general meeting of shareholders; and
|
•
|
the maximum aggregate amount of fixed compensation of the executive committee for the following financial year; and
|
•
|
the maximum aggregate amount of variable compensation of the executive committee for the current financial year.
|
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 demerger 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 voting rights represented at the respective general meeting of shareholders as well as the absolute majority of the par value of shares represented at such general meeting of shareholders. A shareholder of a Swiss corporation participating in a statutory merger or demerger pursuant to the Swiss Merger Act (Loi sur la fusion) can file a lawsuit against the surviving company. 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 if the merger agreement provides only for a compensation payment, at least 90.0% of all members in the transferring legal entity, who are entitled to vote, shall approve the merger agreement.
|
|
| |
|
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 have a similar effect. A shareholder is entitled to bring suit against directors for breach of their duties and claim the payment of the company’s losses or damages to the corporation and, in some cases, to the individual shareholder. Likewise, an appraisal lawsuit won by a shareholder may indirectly compensate all shareholders. In addition, to the extent that U.S. laws and regulations provide a basis for liability and U.S. courts have jurisdiction, a class action may be available.
|
|
| |
|
|
| |
Under Swiss law, the winning party is generally entitled to recover a limited amount of attorneys’ fees incurred in connection with such action. The court has discretion to permit the shareholder who lost the lawsuit to recover attorneys’ fees incurred to the extent that he acted in good faith.
|
|
| |
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
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. 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. |
| |
Also, a corporation may enter into and pay for directors’ and officers’ liability insurance, which may cover negligent acts as well.
|
|
| |
|
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 or herself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction. |
| |
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 committee 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; |
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
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.
|
| |
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:
• shareholders together representing at least 10% of the share capital may demand that a general meeting of shareholders be called for specific agenda items and specific proposals; and • shareholders together representing shares with a par value of at least CHF 1.0 million or 10% of the share capital, whichever is lower, may demand that an agenda item including a specific proposal be put on the agenda for a scheduled general meeting of shareholders, provided such request is made with appropriate lead time. 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 (i) request information from the board of directors on the affairs of the company (note, however, that the right to obtain such information is limited), (ii) request information from the auditors on the methods and results of their audit, (iii) request that the general meeting of shareholders resolve to convene an extraordinary general meeting, or (iv) request that the general meeting of shareholders resolve to appoint an examiner to carry out a special examination (“contrôle spécial”). |
|
| |
|
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 (i) all members of the board of directors, (ii) the chairperson of the board of directors, (iii) the members of the compensation committee, (iv) the election of the independent proxy for a term of office of one year (i.e., until the following annual general meeting of shareholders), as well as the vote on the aggregate amount of compensation of the members of the board of directors, of the executive committee and of the members of any advisory board, is mandatory for listed companies. Re-election is permitted.
|
|
| |
|
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 a majority of the shares represented at a general meeting of shareholders, 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, the introduction of authorized and conditional capital and the introduction of shares with preferential voting rights that require the approval by two-thirds of the votes and an absolute majority of the nominal value of the shares represented at such general meeting of shareholders. The articles of association may increase these 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. The information may be refused where providing it would jeopardize the corporation’s trade secrets or other interests warranting protection. A shareholder is only entitled to receive information to the extent required to exercise his or her rights as a shareholder, subject to the interests of the corporation. A shareholder’s right to inspect the share register is limited to the right to inspect his or her 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 and/or the preceding fiscal year. Shareholder approval is required to authorize capital stock in excess of that provided in the charter. Directors may issue authorized shares without shareholder 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 a corporation’s share capital (in other words, the aggregate nominal value of the corporation’s registered share capital) in the form of dividends are not allowed and may be made only by way of a share capital reduction. Dividends may be paid only from the profits of the previous business year or brought forward from previous business years or if the corporation has distributable reserves, each as evidenced by the corporation’s audited stand-alone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and the articles of association have been deducted. |
|
| |
|
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.
|
•
|
1% of the number of our common shares then outstanding, which will equal approximately common shares immediately after this offering, assuming no exercise of the underwriters’ option to purchase additional common shares; or
|
•
|
the average weekly trading volume of our common shares on the NYSE during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale;
|
•
|
certain banks, insurance companies and other financial institutions;
|
•
|
brokers, dealers or traders in securities who use a mark-to-market method of tax accounting;
|
•
|
persons holding common shares as part of a hedging transaction, straddle, wash sale, conversion transaction or other integrated transaction or persons entering into a constructive sale with respect to the common shares;
|
•
|
persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar;
|
•
|
entities or arrangements classified as partnerships or S corporations for U.S. federal income tax purposes;
|
•
|
tax-exempt entities, including an “individual retirement account” or “Roth IRA” or governmental entities;
|
•
|
real estate investment trusts or regulated investment companies;
|
•
|
former U.S. citizens or long-term residents of the United States;
|
•
|
persons subject to Section 451(b) of the Code;
|
•
|
persons that own or are deemed to own 10% or more of the voting power or value of our shares; or
|
•
|
persons holding common shares in connection with a trade or business conducted outside of the United States or in connection with a permanent establishment or other fixed place of business outside of the United States.
|
•
|
a citizen or individual resident of the United States;
|
•
|
a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia; or
|
•
|
an estate or trust the income of which is subject to U.S. federal income taxation regardless of its source.
|
Underwriter
|
| |
Number of Common
Shares |
Morgan Stanley & Co. LLC
|
| |
|
BofA Securities, Inc.
|
| |
|
Cowen and Company, LLC
|
| |
|
Total
|
| |
|
|
| |
|
| |
Total
|
|||
|
| |
Per Share
|
| |
No Exercise
|
| |
Full Exercise
|
Public offering price
|
| |
$
|
| |
$
|
| |
$
|
Underwriting discounts and commissions
|
| |
$
|
| |
$
|
| |
$
|
Proceeds, before expenses, to us
|
| |
$
|
| |
$
|
| |
$
|
•
|
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, lend or otherwise transfer or dispose of, directly or indirectly, any common shares or any securities convertible into or exercisable or exchangeable for common shares;
|
•
|
file any registration statement with the SEC relating to the offering of any common shares or any securities convertible into or exercisable or exchangeable for common shares; or
|
•
|
enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common shares,
|
(i)
|
transactions relating to common shares or any security convertible into common shares acquired in the offering (other than any issuer-directed common shares purchased in the offering by our officers or directors) or in open market transactions after the completion of the offering;
|
(ii)
|
transfers or distributions as a bona fide gift or for bona fide estate planning purposes or to a charitable organization or educational institution;
|
(iii)
|
transfers or distributions to any immediate family member of such person, affiliate or any trust or trustee or beneficiary thereof for the direct or indirect benefit of such person or the immediate family of such person (for this purpose, “immediate family” means any relationship by blood, marriage, domestic partnership or adoption, not more remote than first cousin);
|
(iv)
|
transfers or distributions to any corporation, partnership, limited liability company or other entity or affiliate of such person or the immediate family of such person;
|
(v)
|
transfers or distributions (a) by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate family of such person upon the death of such person; (b) by operation of law pursuant to a domestic order or negotiated divorce settlement;
|
(vi)
|
transfers or distributions to another corporation, member, partnership, limited liability company, trust or other entity that is a direct or indirect affiliate (as defined under Rule 12b-2 of the Exchange Act), or to an investment fund or other entity that controls or manages, or is under common control with, such person, or distributions to partners, members, shareholders, beneficiaries or other equity holders of such person;
|
(vii)
|
transfers or distributions to us (a) in connection with the repurchase of such securities with respect to the termination of such person’s employment with us or (b) pursuant to contractual arrangements described in this prospectus;
|
(viii)
|
transfers or distributions to us in connection with the repayment (including any adjustments) of any loans or promissory notes of such as described in this prospectus;
|
(ix)
|
transfers or distributions (including through a “cashless” exercise or on a “net exercise basis”) to us in connection with the conversion of any convertible security into, or the exercise of any option or warrant for, common shares (including to satisfy withholding obligations or the payment of taxes in
|
(x)
|
transfers or distributions prior to the date of the public filing of the registration statement of which this prospectus forms a part and pursuant to our shareholders’ agreement;
|
(xi)
|
transfers or distributions to a nominee or custodian of a person or entity to whom a disposition or transfer would be permissible under clauses (i) through (x) above, provided that any common shares shall be subject to the terms of the lock-up agreement;
|
(xii)
|
any pledge or transfer by such person (or any permitted transferee) of common shares or any security convertible into common shares pursuant to agreements governing indebtedness or commitments relating to indebtedness of such person (or any permitted transferee) or its affiliates (other than us and our subsidiaries) in effect on the date thereof (and any refinancing or replacement thereof) and described in this prospectus and any transfer upon foreclosure, provided that any required filing under Section 16(a) of the Exchange Act (or its foreign equivalent) reporting a reduction in beneficial ownership by such person or any party (pledgor or pledgee) shall indicate by footnote disclosure or otherwise the nature of the transfer and if any filing is required to be made under Section 16(a) of the Exchange Act (or its foreign equivalent) during the restricted period, and such person shall provide the representatives prior written notice informing them of such report;
|
(xiii)
|
the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act (or its foreign equivalent) for the transfer of common shares, provided that (a) such plan does not provide for the transfer of common shares during the restricted period and (b) to the extent a public announcement or filing under the Exchange Act (or its foreign equivalent), if any, is required of or voluntarily made by or on behalf of such person or us regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common shares may be made under such plan during the restricted period;
|
(xiv)
|
transfers or dispositions pursuant to a bona fide tender offer for our capital shares, merger, consolidation or other similar transaction made to all holders of our securities involving a change of control of us (including without limitation, the entering into of any lock-up, voting or similar agreement pursuant to which such person may agree to transfer, sell, tender or otherwise dispose of common shares or any security convertible into common shares in connection with such transaction) that has been approved by our board of directors; provided that, in the event that such change of control transaction is not consummated, this paragraph shall not be applicable and such person’s shares and other securities shall remain subject to the lock-up agreement (for this purpose, “change of control” means the transfer whether by tender offer, merger, consolidation or other similar transaction), in one transactions or a series of related transactions, to a person or group of affiliated persons (other than the underwriters pursuant to this offering), of our voting securities if, after such transfer, such person or group of affiliated persons would hold greater than 50% of our outstanding voting securities); or
|
(xv)
|
the conversion, exercise or exchange of our preferred shares, options to purchase common shares, warrants or any security convertible into common shares pursuant to any reorganization, conversion or share split, as such terms are described in this prospectus; provided that any such securities shall remain subject to the lock-up agreement,
|
(i)
|
the common shares to be sold in this offering;
|
(ii)
|
the issuance by us of shares of common shares upon the exercise of an option or warrant or the conversion of a security outstanding on the date of this prospectus of which the underwriters have been advised in writing;
|
(iii)
|
the grant of any options to purchase common shares, restricted shares or restricted units under an incentive compensation plan in effect or approved by our board of directors on the date of this prospectus and described in this prospectus;
|
(iv)
|
our filing of any registration statement on Form S-8 or a successor form relating to the common shares granted pursuant to or reserved for issuance under an incentive compensation plan described in this prospectus;
|
(v)
|
offers to acquire, transfers, issuances or repurchases pursuant to loan settlement agreements, including the transfer of common shares to us in connection therewith, as described in this prospectus;
|
(vi)
|
the offer or issuance of common shares in connection with an acquisition, joint venture, commercial or collaborative relationship, or an acquisition or license by us of assets of another person or entity or pursuant to an employee benefit plan assumed by us in connection with any such acquisition, provided that (1) the aggregate number of shares issued does not exceed 5% of the total number of outstanding shares of our common shares immediately following the closing of this offering and (2) the recipient of any such shares during the restricted period enters into a lock-up agreement; or
|
(vii)
|
facilitating the establishment of a trading plan on behalf of one of our shareholders, officers or directors pursuant to Rule 10b5-1 under the Exchange Act for the transfer of common shares, provided that such plan does not provide for the transfer of common shares during the restricted period and, to the extent a public announcement or filing under the Exchange Act is required of or voluntarily made by us regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common shares may be made under such plan during the restricted period.
|
(a)
|
to any legal entity which is a qualified investor as defined in the Prospectus Regulation;
|
(b)
|
to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or
|
(c)
|
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
|
(a)
|
a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or
|
(b)
|
a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor,
|
(a)
|
to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;
|
(b)
|
where no consideration is or will be given for the transfer;
|
(c)
|
where the transfer is by operation of law;
|
(d)
|
as specified in Section 276(7) of the SFA; or
|
(e)
|
as specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018 of Singapore.
|
(a)
|
it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000 (“FSMA”) received by it in connection with the issue or sale of our common shares in circumstances in which Section 21(1) of the FSMA does not apply to us; and
|
(b)
|
it has complied and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to our common shares in, from or otherwise involving the United Kingdom.
|
Expenses
|
| |
Amount
|
SEC registration fee
|
| |
$ *
|
NYSE listing fees and expenses
|
| |
*
|
FINRA filing fee
|
| |
*
|
Printing and engraving expenses
|
| |
*
|
Legal fees and expenses
|
| |
*
|
Accounting fees and expenses
|
| |
*
|
Miscellaneous costs
|
| |
*
|
Total
|
| |
$ *
|
*
|
To be provided by amendment.
|
•
|
the non-Swiss court had jurisdiction pursuant to the PILA;
|
•
|
the judgment of such non-Swiss court has become final and non-appealable;
|
•
|
the judgment does not contravene Swiss public policy;
|
•
|
the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
|
•
|
no proceeding involving the same position and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state and this decision is recognizable in Switzerland.
|
| | ||
|
| |
|
| | ||
|
| |
|
Consolidated Financial Statements
|
| |
|
| | ||
| | ||
| | ||
| | ||
| | ||
| |
|
| |
Note
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Contract revenue
|
| |
7
|
| |
2,340
|
| |
1,140
|
Research and development expenses
|
| |
9/11
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expenses
|
| |
11
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
8
|
| |
1,655
|
| |
—
|
Financial income
|
| |
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expenses
|
| |
12
|
| |
(582)
|
| |
(224)
|
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| |
|
Attributable to:
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| |
|
Loss per share
|
| |
|
| |
|
| |
|
Basic and diluted loss per share (in USD)
|
| |
28
|
| |
(2.36)
|
| |
(2.64)
|
|
| |
Note
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| ||
Other comprehensive (loss) / profit:
|
| |
|
| |
|
| |
|
Items that will not be reclassified to profit or loss
|
| |
|
| |
|
| |
|
Remeasurements of defined benefit plan
|
| |
22
|
| |
(1,346)
|
| |
(193)
|
Total items that will not be reclassified to profit or loss
|
| |
|
| |
(1,346)
|
| |
(193)
|
Items that may be reclassified subsequently to profit or loss
|
| |
|
| |
|
| |
|
Currency translation differences
|
| |
|
| |
112
|
| |
(79)
|
Total items that may be reclassified subsequently to profit or loss
|
| |
|
| |
112
|
| |
(79)
|
|
| |
|
| |
|
| |
|
Other comprehensive loss for the year
|
| |
|
| |
(1,234)
|
| |
(272)
|
|
| |
|
| |
|
| |
|
Total comprehensive loss for the year
|
| |
|
| |
(117,718)
|
| |
(123,368)
|
|
| |
|
| |
|
| |
|
Attributable to:
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
|
| |
(117,718)
|
| |
(123,368)
|
|
| |
Note
|
| |
December 31,
2019 |
| |
December 31,
2018 |
ASSETS
|
| |
|
| |
|
| |
|
Current assets
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
19
|
| |
115,551
|
| |
138,807
|
Trade accounts receivable
|
| |
13/19/27
|
| |
—
|
| |
192
|
Other current assets
|
| |
14
|
| |
7,055
|
| |
3,081
|
Total current assets
|
| |
|
| |
122,606
|
| |
142,080
|
Non-current assets
|
| |
|
| |
|
| |
|
Property, plant and equipment
|
| |
16
|
| |
1,376
|
| |
1,540
|
Right-of-use assets
|
| |
4/17
|
| |
4,898
|
| |
—
|
Intangible assets
|
| |
18
|
| |
8,434
|
| |
6,674
|
Other long-term assets
|
| |
|
| |
368
|
| |
264
|
Total non-current assets
|
| |
|
| |
15,076
|
| |
8,478
|
|
| |
|
| |
|
| |
|
Total assets
|
| |
|
| |
137,682
|
| |
150,558
|
|
| |
|
| |
|
| |
|
LIABILITIES AND EQUITY
|
| |
|
| |
|
| |
|
Current liabilities
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
19a/27
|
| |
3,329
|
| |
6,750
|
Accrued liabilities and other payables
|
| |
21
|
| |
15,430
|
| |
13,650
|
Contract liability (short-term)
|
| |
7
|
| |
—
|
| |
1,765
|
Lease liabilities (short-term)
|
| |
4/17
|
| |
1,132
|
| |
—
|
Current income tax payable
|
| |
|
| |
52
|
| |
189
|
Total current liabilities
|
| |
|
| |
19,943
|
| |
22,354
|
Non-current liabilities
|
| |
|
| |
|
| |
|
Contract liability (long-term)
|
| |
7
|
| |
—
|
| |
575
|
Lease liabilities (long-term)
|
| |
4/17
|
| |
3,899
|
| |
—
|
Defined benefit pension liabilities
|
| |
22
|
| |
2,684
|
| |
1,386
|
Total non-current liabilities
|
| |
|
| |
6,583
|
| |
1,961
|
|
| |
|
| |
|
| |
|
Total liabilities
|
| |
|
| |
26,526
|
| |
24,315
|
|
| |
|
| |
|
| |
|
Equity attributable to owners of the parent
|
| |
|
| |
|
| |
|
Share capital
|
| |
24
|
| |
4,361
|
| |
401
|
Share premium
|
| |
24
|
| |
549,922
|
| |
452,268
|
Treasury shares
|
| |
24
|
| |
(100)
|
| |
—
|
Other reserves
|
| |
22/23
|
| |
5,473
|
| |
5,702
|
Cumulative translation adjustments
|
| |
|
| |
69
|
| |
(43)
|
Accumulated losses
|
| |
|
| |
(448,569)
|
| |
(332,085)
|
Total equity
|
| |
|
| |
111,156
|
| |
126,243
|
|
| |
|
| |
|
| |
|
Total liabilities and equity
|
| |
|
| |
137,682
|
| |
150,558
|
|
| |
|
| |
Attributable to owners of the parent
|
||||||||||||||||||
|
| |
Note
|
| |
Share
capital |
| |
Share
premium |
| |
Other
reserves |
| |
Treasury
shares |
| |
Cumulative
translation adjustment |
| |
Accumulated
losses |
| |
Total
|
January 1, 2018
|
| |
|
| |
397
|
| |
452,296
|
| |
5,426
|
| |
—
|
| |
36
|
| |
(208,989)
|
| |
249,166
|
Loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(123,096)
|
| |
(123,096)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(79)
|
| |
—
|
| |
(79)
|
Remeasurements of defined benefit pension
|
| |
22
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
—
|
| |
—
|
| |
(193)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
(79)
|
| |
—
|
| |
(272)
|
Total comprehensive loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
(79)
|
| |
(123,096)
|
| |
(123,368)
|
Issue of share capital
|
| |
24
|
| |
4
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
4
|
Transaction costs
|
| |
24
|
| |
—
|
| |
(28)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(28)
|
Share-based compensation expense
|
| |
23
|
| |
—
|
| |
—
|
| |
469
|
| |
—
|
| |
—
|
| |
—
|
| |
469
|
Total transactions with owners
|
| |
|
| |
4
|
| |
(28)
|
| |
469
|
| |
—
|
| |
—
|
| |
—
|
| |
445
|
December 31, 2018
|
| |
|
| |
401
|
| |
452,268
|
| |
5,702
|
| |
—
|
| |
(43)
|
| |
(332,085)
|
| |
126,243
|
Loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(116,484)
|
| |
(116,484)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
112
|
| |
—
|
| |
112
|
Remeasurements of defined benefit pension
|
| |
22
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,346)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
112
|
| |
—
|
| |
(1,234)
|
Total comprehensive loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
112
|
| |
(116,484)
|
| |
(117,718)
|
Issue of share capital / capital contributions
|
| |
24
|
| |
171
|
| |
103,221
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
103,392
|
Transaction costs
|
| |
24
|
| |
—
|
| |
(1,778)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,778)
|
Transfer from share premium for par value increase
|
| |
24
|
| |
3,789
|
| |
(3,789)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Purchase of treasury shares
|
| |
24
|
| |
—
|
| |
—
|
| |
—
|
| |
(141)
|
| |
—
|
| |
—
|
| |
(141)
|
Sale of treasury shares
|
| |
24
|
| |
—
|
| |
—
|
| |
—
|
| |
41
|
| |
—
|
| |
—
|
| |
41
|
Share-based compensation expense
|
| |
23
|
| |
—
|
| |
—
|
| |
1,117
|
| |
—
|
| |
—
|
| |
—
|
| |
1,117
|
Total transactions with owners
|
| |
|
| |
3,960
|
| |
97,654
|
| |
1,117
|
| |
(100)
|
| |
—
|
| |
—
|
| |
102,631
|
December 31, 2019
|
| |
|
| |
4,361
|
| |
549,922
|
| |
5,473
|
| |
(100)
|
| |
69
|
| |
(448,569)
|
| |
111,156
|
|
| |
Note
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Cash used in operating activities
|
| |
|
| |
|
| |
|
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
Adjustments for non-monetary items:
|
| |
|
| |
|
| |
|
Share-based compensation expense
|
| |
23
|
| |
1,117
|
| |
469
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
552
|
| |
488
|
Depreciation of right-of-use assets
|
| |
17
|
| |
1,064
|
| |
—
|
Amortization and impairment of intangible assets
|
| |
18
|
| |
30
|
| |
252
|
Change in defined benefit pension liabilities
|
| |
22
|
| |
(53)
|
| |
119
|
Change in fair value measurement
|
| |
|
| |
557
|
| |
1,009
|
Accrued withholding tax
|
| |
|
| |
626
|
| |
711
|
Accrued R&D credit
|
| |
|
| |
(437)
|
| |
—
|
Financial income
|
| |
|
| |
(2,253)
|
| |
(2,856)
|
Financial expense (including interest on lease obligations)
|
| |
|
| |
156
|
| |
—
|
Exchange differences
|
| |
|
| |
128
|
| |
(29)
|
Income taxes
|
| |
12
|
| |
582
|
| |
224
|
Operating loss before working capital changes
|
| |
|
| |
(114,415)
|
| |
(122,709)
|
Decrease in trade accounts receivable
|
| |
|
| |
192
|
| |
895
|
(Increase) in other current assets
|
| |
|
| |
(4,030)
|
| |
(1,678)
|
(Decrease) in contract liability (short and long term)
|
| |
|
| |
(2,340)
|
| |
(1,140)
|
(Decrease) in trade accounts payable
|
| |
|
| |
(3,425)
|
| |
(858)
|
Increase in accrued liabilities and other payables
|
| |
|
| |
1,720
|
| |
3,262
|
Cash used in operating activities
|
| |
|
| |
(122,298)
|
| |
(122,228)
|
|
| |
|
| |
|
| |
|
Interest received
|
| |
|
| |
1,164
|
| |
1,051
|
Interest paid
|
| |
|
| |
(157)
|
| |
—
|
Tax paid
|
| |
|
| |
(290)
|
| |
(185)
|
Net cash used in operating activities
|
| |
|
| |
(121,581)
|
| |
(121,362)
|
|
| |
|
| |
|
| |
|
Cash used in investing activities
|
| |
|
| |
|
| |
|
Payment for purchases of property, plant and equipment
|
| |
16
|
| |
(358)
|
| |
(944)
|
Payment for purchases of intangible assets
|
| |
18
|
| |
(1,790)
|
| |
(1,526)
|
Payment for rent deposits
|
| |
|
| |
(100)
|
| |
(36)
|
Net cash used in investing activities
|
| |
|
| |
(2,248)
|
| |
(2,506)
|
|
| |
|
| |
|
| |
|
Cash from / (used in) financing activities
|
| |
|
| |
|
| |
|
Proceeds from capital contributions, net of transaction costs
|
| |
24
|
| |
101,614
|
| |
(24)
|
Acquisition of treasury shares
|
| |
24
|
| |
(141)
|
| |
—
|
Sale of treasury shares
|
| |
24
|
| |
41
|
| |
—
|
Principal portion of lease obligations payments
|
| |
17
|
| |
(1,002)
|
| |
—
|
Net cash from / (used in) financing activities
|
| |
|
| |
100,512
|
| |
(24)
|
|
| |
|
| |
|
| |
|
Net decrease in cash and cash equivalents
|
| |
|
| |
(23,317)
|
| |
(123,892)
|
Exchange gains / (losses) on cash and cash equivalents
|
| |
|
| |
61
|
| |
(53)
|
Cash and cash equivalents at beginning of year
|
| |
|
| |
138,807
|
| |
262,752
|
Cash and cash equivalents at end of year
|
| |
|
| |
115,551
|
| |
138,807
|
Corporate information
|
2.
|
Basis of preparation
|
-
|
establish and maintain a strong patent position and protection;
|
-
|
enter into collaborations with partners in the pharmaceutical industry;
|
-
|
acquire and retain key personnel; and
|
-
|
acquire additional funding to support its operations.
|
3.
|
Significant accounting policies
|
3.1
|
Consolidation
|
3.2
|
Foreign currency translation
|
(i)
|
assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet;
|
(ii)
|
income and expenses for each income statement are translated at monthly average exchange rates; and
|
(iii)
|
all resulting exchange differences are recognized in other comprehensive income, under “Cumulative translation adjustments”.
|
3.3
|
Cash and cash equivalents
|
3.4
|
Property, plant and equipment
|
Leasehold improvements
|
| |
3 to 10 years
|
Laboratory equipment
|
| |
5 years
|
Office equipment
|
| |
5 years
|
Hardware
|
| |
3 years
|
3.5
|
Intangible assets
|
3.6
|
Impairment of non-financial assets
|
3.7
|
Employee benefits
|
-
|
including any market performance conditions;
|
-
|
excluding the impact of any service and non-market performance vesting conditions; and
|
-
|
including the impact of any non-vesting conditions.
|
3.8
|
Share capital and share premium
|
3.9
|
Treasury shares
|
3.10
|
Leases
|
-
|
the amount of the initial measurement of lease liability;
|
-
|
any lease payments made at or before the commencement date less any lease incentives received;
|
-
|
any initial direct costs, and
|
-
|
restoration costs.
|
-
|
periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option; and
|
-
|
periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option.
|
3.11
|
Revenue recognition
|
3.12
|
Research and development expenses
|
3.13
|
Current, deferred income tax and tax credit
|
3.14
|
Segment reporting
|
3.15
|
Loss per share
|
4.
|
New and amended IFRS standards
|
(in KUSD)
|
| |
December 31,
2019 |
| |
January 1,
2019 |
Properties (offices)
|
| |
4,820
|
| |
5,399
|
Vehicles
|
| |
78
|
| |
24
|
(in KUSD)
|
| |
December 31,
2019 |
| |
January 1,
2019 |
Total right-of-use assets
|
| |
4,898
|
| |
5,423
|
5.
|
Financial risk management
|
5.1
|
Financial risk factors
|
-
|
forecast costs denominated in a currency other than the entity’s functional currency;
|
-
|
recognized assets and liabilities denominated in a currency other than the entity's functional currency; and
|
-
|
net investments in foreign operations.
|
December 31
|
| |
2019
in KL/C(1) |
| |
2019
in KUSD |
| |
2018
in KL/C(1) |
| |
2018
in KUSD |
In USD
|
| |
109,939
|
| |
109,939
|
| |
135,451
|
| |
135,451
|
In CHF
|
| |
457
|
| |
472
|
| |
1,143
|
| |
1,160
|
In GBP
|
| |
3,529
|
| |
4,654
|
| |
929
|
| |
1,179
|
In EUR
|
| |
433
|
| |
486
|
| |
889
|
| |
1,017
|
|
| |
|
| |
115,551
|
| |
|
| |
138,807
|
(1)
|
Thousands Local Currencies
|
(in KUSD)
|
| |
Note
|
| |
Less than
3 months |
| |
Between 3
months and 1 year |
| |
Between 1
year and 3 years |
| |
More than
3 years |
Trade accounts payable
|
| |
|
| |
3,266
|
| |
63
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
17
|
| |
311
|
| |
935
|
| |
1,859
|
| |
2,265
|
At December 31, 2019
|
| |
|
| |
3,577
|
| |
998
|
| |
1,859
|
| |
2,265
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
|
| |
6,597
|
| |
153
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At December 31, 2018
|
| |
|
| |
6,597
|
| |
153
|
| |
—
|
| |
—
|
5.2
|
Capital management
|
5.3
|
Fair value estimation
|
-
|
Cash and cash equivalents
|
-
|
Trade accounts receivable
|
-
|
Trade accounts payable
|
6
|
Critical accounting estimates and judgements
|
7.
|
Contract revenue and contract liability
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
2,340
|
| |
3,480
|
Recognized as contract revenue
|
| |
(2,340)
|
| |
(1,140)
|
December 31
|
| |
—
|
| |
2,340
|
|
| |
|
| |
|
of which:
|
| |
|
| |
|
Contract liability (short term)
|
| |
—
|
| |
1,765
|
Contract liability (long term)
|
| |
—
|
| |
575
|
Contract liability (total)
|
| |
—
|
| |
2,340
|
8.
|
Other Income
|
(in KUSD):
|
| |
|
| |
|
Years
|
| |
December 31,
2019 |
| |
December 31,
2018 |
2016
|
| |
296
|
| |
—
|
2017
|
| |
350
|
| |
—
|
2018
|
| |
477
|
| |
—
|
2019
|
| |
532
|
| |
—
|
|
| |
1,655
|
| |
—
|
9.
|
Research and development expenses
|
10
|
Employee expenses
|
(in KUSD)
|
| |
Note
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
|
| |
|
| |
|
| |
|
Wages, salaries and other costs
|
| |
|
| |
24,061
|
| |
19,245
|
Social security costs
|
| |
|
| |
3,871
|
| |
3,452
|
Share-based compensation expense
|
| |
23
|
| |
1,117
|
| |
469
|
Defined benefit plan - pension costs
|
| |
22
|
| |
462
|
| |
535
|
Defined contribution plan - pension costs
|
| |
|
| |
540
|
| |
481
|
Employee expenses
|
| |
|
| |
30,051
|
| |
24,182
|
11
|
Expenses by nature
|
(in KUSD)
|
| |
Note
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
R&D
|
| |
|
| |
|
| |
|
External costs
|
| |
|
| |
81,363
|
| |
98,493
|
Employee expenses
|
| |
10
|
| |
24,916
|
| |
19,246
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
407
|
| |
330
|
Depreciation of right-of-use assets
|
| |
17
|
| |
837
|
| |
—
|
Amortization of intangible assets
|
| |
18
|
| |
14
|
| |
17
|
Impairment of intangible assets
|
| |
18
|
| |
—
|
| |
227
|
Research and development expenses
|
| |
|
| |
107,537
|
| |
118,313
|
|
| |
|
| |
|
| |
|
G&A
|
| |
|
| |
|
| |
|
External costs
|
| |
|
| |
8,668
|
| |
3,628
|
Employee expenses
|
| |
10
|
| |
5,135
|
| |
4,936
|
General and administrative costs charged by related parties
|
| |
27
|
| |
11
|
| |
38
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
145
|
| |
158
|
Depreciation of right-of-use assets
|
| |
17
|
| |
227
|
| |
—
|
Amortization of intangible assets
|
| |
18
|
| |
16
|
| |
8
|
General and administrative expenses
|
| |
|
| |
14,202
|
| |
8,768
|
Total expenses by nature
|
| |
|
| |
121,739
|
| |
127,081
|
12
|
Income tax expenses
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Current income taxes for the year
|
| |
572
|
| |
218
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Current income taxes related to prior years
|
| |
10
|
| |
6
|
Income tax expenses
|
| |
582
|
| |
224
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Loss before taxes
|
| |
115,902
|
| |
122,872
|
Tax calculated at tax domestic rates applicable to profits in the respective countries
|
| |
(12,332)
|
| |
(13,321)
|
|
| |
|
| |
|
Tax effects of:
|
| |
|
| |
|
- Tax losses for which no deferred income tax asset was recognized
|
| |
13,187
|
| |
13,766
|
- Utilization of R&D tax credit (USA)
|
| |
(436)
|
| |
(310)
|
- Income not subject to tax / (expenses not deductible for tax purposes)
|
| |
156
|
| |
83
|
- Tax relating to prior years
|
| |
10
|
| |
6
|
- Other
|
| |
(3)
|
| |
—
|
Income tax expenses
|
| |
582
|
| |
224
|
13.
|
Trade accounts receivable
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Trade accounts receivable
|
| |
—
|
| |
192
|
Less: Allowance for doubtful accounts
|
| |
—
|
| |
—
|
Trade accounts receivable, net
|
| |
—
|
| |
192
|
14.
|
Other current assets
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
VAT receivable, net
|
| |
471
|
| |
549
|
Withholding tax receivable
|
| |
626
|
| |
968
|
Prepaid expenses
|
| |
4,215
|
| |
1,384
|
UK R&D expenditure credits
|
| |
891
|
| |
—
|
Other
|
| |
852
|
| |
180
|
|
| |
7,055
|
| |
3,081
|
15.
|
Non-current assets by geographic area
|
(in KUSD):
|
| |
|
| |
|
Country
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Switzerland
|
| |
10,903
|
| |
7,112
|
United Kingdom
|
| |
2,032
|
| |
885
|
United States
|
| |
1,773
|
| |
217
|
|
| |
14,708
|
| |
8,214
|
16.
|
Property, plant and equipment
|
(in KUSD)
|
| |
Leasehold
improve- ments |
| |
Laboratory
equipment |
| |
Office
equipment |
| |
Hardware
|
| |
Total
|
Cost
|
| |
|
| |
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
291
|
| |
671
|
| |
340
|
| |
388
|
| |
1,690
|
Additions
|
| |
226
|
| |
327
|
| |
277
|
| |
114
|
| |
944
|
Disposals and scrapping
|
| |
—
|
| |
—
|
| |
(7)
|
| |
—
|
| |
(7)
|
Exchange difference
|
| |
(3)
|
| |
(59)
|
| |
(13)
|
| |
(5)
|
| |
(80)
|
December 31, 2018
|
| |
514
|
| |
939
|
| |
597
|
| |
497
|
| |
2,547
|
Additions
|
| |
17
|
| |
131
|
| |
93
|
| |
118
|
| |
359
|
Exchange difference
|
| |
2
|
| |
41
|
| |
8
|
| |
3
|
| |
54
|
December 31, 2019
|
| |
533
|
| |
1,111
|
| |
698
|
| |
618
|
| |
2,960
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Accumulated depreciation
|
| |
|
| |
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
(70)
|
| |
(168)
|
| |
(136)
|
| |
(174)
|
| |
(548)
|
Depreciation charge
|
| |
(57)
|
| |
(159)
|
| |
(118)
|
| |
(154)
|
| |
(488)
|
Disposals and scrapping
|
| |
—
|
| |
—
|
| |
7
|
| |
—
|
| |
7
|
Exchange difference
|
| |
1
|
| |
17
|
| |
2
|
| |
2
|
| |
22
|
December 31, 2018
|
| |
(126)
|
| |
(310)
|
| |
(245)
|
| |
(326)
|
| |
(1,007)
|
Depreciation charge
|
| |
(82)
|
| |
(204)
|
| |
(149)
|
| |
(117)
|
| |
(552)
|
Exchange difference
|
| |
(1)
|
| |
(19)
|
| |
(3)
|
| |
(2)
|
| |
(25)
|
December 31, 2019
|
| |
(209)
|
| |
(533)
|
| |
(397)
|
| |
(445)
|
| |
(1,584)
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Net book amount
|
| |
|
| |
|
| |
|
| |
|
| |
|
December 31, 2018
|
| |
388
|
| |
629
|
| |
352
|
| |
171
|
| |
1,540
|
December 31, 2019
|
| |
324
|
| |
578
|
| |
301
|
| |
173
|
| |
1,376
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Research and development expenses
|
| |
407
|
| |
330
|
General and administrative expenses
|
| |
145
|
| |
158
|
|
| |
552
|
| |
488
|
17.
|
Leases
|
(in KUSD)
|
| |
December 31,
2019 |
| |
January 1,
2019 |
Properties (offices)
|
| |
4,820
|
| |
5,399
|
Vehicles
|
| |
78
|
| |
24
|
Total right-of-use assets
|
| |
4,898
|
| |
5,423
|
Lease liabilities (short-term)
|
| |
1,132
|
| |
924
|
Lease liabilities (long-term)
|
| |
3,899
|
| |
4,499
|
Total lease liabilities
|
| |
5,031
|
| |
5,423
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Research and development expenses
|
| |
837
|
| |
—
|
General and administrative expenses
|
| |
227
|
| |
—
|
|
| |
1,064
|
| |
—
|
(in KUSD)
|
| |
|
| |
|
| |
|
Lease liabilities
|
| |
Offices
|
| |
Vehicles
|
| |
Total
|
January 1, 2019
|
| |
5,399
|
| |
24
|
| |
5,423
|
Additions
|
| |
466
|
| |
78
|
| |
544
|
Disposals
|
| |
—
|
| |
(12)
|
| |
(12)
|
Cash outflow (including interest)
|
| |
(1,130)
|
| |
(13)
|
| |
(1,143)
|
Interest
|
| |
140
|
| |
1
|
| |
141
|
Exchange difference
|
| |
78
|
| |
—
|
| |
78
|
December 31, 2019
|
| |
4,953
|
| |
78
|
| |
5,031
|
|
| |
|
| |
|
| |
|
Lease liabilities (short-term)
|
| |
1,114
|
| |
18
|
| |
1,132
|
Lease liabilities (long-term)
|
| |
3,839
|
| |
60
|
| |
3,899
|
Total lease liabilities
|
| |
4,953
|
| |
78
|
| |
5,031
|
18.
|
Intangible assets
|
(in KUSD)
|
| |
Licenses
|
| |
Software
|
| |
Total
|
Cost
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
6,009
|
| |
44
|
| |
6,053
|
Additions
|
| |
1,481
|
| |
45
|
| |
1,526
|
Exchange difference
|
| |
—
|
| |
(2)
|
| |
(2)
|
December 31, 2018
|
| |
7,490
|
| |
87
|
| |
7,577
|
Additions
|
| |
1,731
|
| |
59
|
| |
1,790
|
Exchange difference
|
| |
—
|
| |
1
|
| |
1
|
December 31, 2019
|
| |
9,221
|
| |
147
|
| |
9,368
|
Accumulated amortization
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
(626)
|
| |
(26)
|
| |
(652)
|
Amortization charge
|
| |
—
|
| |
(25)
|
| |
(25)
|
Impairment loss
|
| |
(227)
|
| |
—
|
| |
(227)
|
Exchange difference
|
| |
—
|
| |
1
|
| |
1
|
December 31, 2018
|
| |
(853)
|
| |
(50)
|
| |
(903)
|
Amortization charge
|
| |
—
|
| |
(30)
|
| |
(30)
|
Exchange difference
|
| |
—
|
| |
(1)
|
| |
(1)
|
December 31, 2019
|
| |
(853)
|
| |
(81)
|
| |
(934)
|
|
| |
|
| |
|
| |
|
Net book amount
|
| |
|
| |
|
| |
|
December 31, 2018
|
| |
6,637
|
| |
37
|
| |
6,674
|
December 31, 2019
|
| |
8,368
|
| |
66
|
| |
8,434
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Research and development expenses
|
| |
14
|
| |
17
|
General and administrative expenses
|
| |
16
|
| |
8
|
|
| |
30
|
| |
25
|
-
|
An amount of KUSD 1,000 relating to a license agreement with a third party to acquire an antibody to be used in pre-clinical formalization, clinical testing, manufacturing and commercialization was capitalized as intangible assets.
|
-
|
An amount of KUSD 500 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 231 relating to a license agreement with a third party to use their technology for the production of antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 231 relating to a license agreement with a third party to use their technology for the production of antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 750 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 250 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 250 relating to a license agreement with a third party to acquire an antibody to be used in pre-clinical formalization, clinical testing, manufacturing and commercialization was capitalized as intangible assets.
|
-
|
Historical expenditure on clinical trials, future contractual commitments and internal budgets approved by the Board of Directors for ongoing and future trials;
|
-
|
Consideration of the progress of clinical trials, including obtaining primary endpoint readout data, discussions with regulatory authorities for new trials and enrollment status for ongoing clinical trials;
|
-
|
Consideration of market potential, supported where available by external market studies, and assessments of competitor products and product candidates.
|
19a.
|
Financial instruments by class and by category
|
(in KUSD)
|
| |
Note
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Financial assets - financial assets at amortized cost
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
|
| |
115,551
|
| |
138,807
|
Trade accounts receivable
|
| |
13
|
| |
—
|
| |
192
|
Other current assets (excluding prepaid expenses)
|
| |
14
|
| |
2,840
|
| |
1,697
|
Other long-term assets
|
| |
|
| |
368
|
| |
264
|
Total financial assets
|
| |
|
| |
118,759
|
| |
140,960
|
|
| |
|
| |
|
| |
|
Financial liabilities - financial liabilities at amortized cost
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
|
| |
3,329
|
| |
6,750
|
Accrued liabilities and other payables
|
| |
21
|
| |
15,430
|
| |
13,650
|
Lease liabilities
|
| |
17
|
| |
5,031
|
| |
—
|
Total financial liabilities
|
| |
|
| |
23,790
|
| |
20,400
|
|
| |
|
| |
|
| |
|
Net financial position
|
| |
|
| |
94,969
|
| |
120,560
|
19b.
|
Credit quality of financial assets
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Cash and cash equivalents
|
| |
|
| |
|
A+ UBS
|
| |
51,983
|
| |
71,493
|
A+ Credit Suisse
|
| |
62,652
|
| |
66,066
|
A+ JP Morgan Chase
|
| |
916
|
| |
1,248
|
|
| |
115,551
|
| |
138,807
|
20.
|
Deferred income taxes and tax credit
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Deductible temporary differences, unused tax losses and unused tax credits for which no deferred tax assets have been recognized are attributable to the following:
|
| |
|
| |
|
Taxes losses
|
| |
437,013
|
| |
329,254
|
Unused tax credit
|
| |
10,765
|
| |
6,009
|
Deductible temporary differences related to the retirement benefit plan
|
| |
2,684
|
| |
1,386
|
Deductible temporary differences related to IFRS 16
|
| |
(39)
|
| |
—
|
Offset of recognized temporary differences related to intangible assets
|
| |
(2,364)
|
| |
(2,364)
|
Total
|
| |
448,059
|
| |
334,285
|
Years of expiry
|
| |
December 31,
2019 |
| |
December 31,
2018 |
2019
|
| |
—
|
| |
6,209
|
2020
|
| |
14,735
|
| |
14,966
|
2021
|
| |
19,889
|
| |
20,200
|
2022
|
| |
31,128
|
| |
31,615
|
2023
|
| |
38,441
|
| |
39,042
|
Beyond 2024
|
| |
332,820
|
| |
217,222
|
|
| |
437,013
|
| |
329,254
|
Years of expiry
|
| |
December 31,
2019 |
| |
December 31,
2018 |
2036
|
| |
783
|
| |
783
|
2037
|
| |
1,839
|
| |
1,839
|
2038
|
| |
3,387
|
| |
3,387
|
2039
|
| |
4,756
|
| |
—
|
|
| |
10,765
|
| |
6,009
|
21.
|
Accrued liabilities and other payables
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Payroll and social charges
|
| |
5,726
|
| |
4,939
|
Research and development costs
|
| |
8,922
|
| |
8,124
|
Other
|
| |
782
|
| |
587
|
|
| |
15,430
|
| |
13,650
|
22.
|
Pension obligations
|
(in KUSD)
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Present value of defined benefit obligation for funded plan
|
| |
7,880
|
| |
4,372
|
Fair value of plan assets
|
| |
(5,196)
|
| |
(2,986)
|
Deficit of funded plan: liability on the balance sheet
|
| |
2,684
|
| |
1,386
|
(in KUSD)
|
| |
Present value
of obligation |
| |
Fair value of
plan assets |
| |
Total
|
January 1, 2018
|
| |
3,070
|
| |
(1,994)
|
| |
1,076
|
Defined benefit plan - pension costs:
|
| |
|
| |
|
| |
|
Current service cost
|
| |
527
|
| |
—
|
| |
527
|
Interest cost / (income)
|
| |
23
|
| |
(15)
|
| |
8
|
Defined benefit plan - pension costs
|
| |
550
|
| |
(15)
|
| |
535
|
Employee contributions
|
| |
208
|
| |
(208)
|
| |
—
|
Employer contributions
|
| |
—
|
| |
(416)
|
| |
(416)
|
Transfers from joiners' previous plans
|
| |
382
|
| |
(382)
|
| |
—
|
|
| |
590
|
| |
(1,006)
|
| |
(416)
|
Exchange differences
|
| |
(12)
|
| |
10
|
| |
(2)
|
Remeasurements:
|
| |
|
| |
|
| |
|
Change in financial assumptions
|
| |
(99)
|
| |
—
|
| |
(99)
|
Other actuarial losses
|
| |
295
|
| |
—
|
| |
295
|
Plan asset losses
|
| |
—
|
| |
5
|
| |
5
|
Exchange differences
|
| |
(22)
|
| |
14
|
| |
(8)
|
Remeasurements
|
| |
174
|
| |
19
|
| |
193
|
December 31, 2018
|
| |
4,372
|
| |
(2,986)
|
| |
1,386
|
Defined benefit plan - pension costs:
|
| |
|
| |
|
| |
|
Current service cost
|
| |
769
|
| |
—
|
| |
769
|
Impact of plan changes
|
| |
(319)
|
| |
—
|
| |
(319)
|
Interest cost / (income)
|
| |
37
|
| |
(25)
|
| |
12
|
Defined benefit plan - pension costs
|
| |
487
|
| |
(25)
|
| |
462
|
Employee contributions
|
| |
257
|
| |
(257)
|
| |
—
|
Employer contributions
|
| |
—
|
| |
(515)
|
| |
(515)
|
Transfers from joiners' previous plans
|
| |
1,302
|
| |
(1,302)
|
| |
—
|
|
| |
1,559
|
| |
(2,074)
|
| |
(515)
|
Exchange differences
|
| |
74
|
| |
(69)
|
| |
5
|
(in KUSD)
|
| |
Present value
of obligation |
| |
Fair value of
plan assets |
| |
Total
|
Remeasurements:
|
| |
|
| |
|
| |
|
Change in financial assumptions
|
| |
686
|
| |
—
|
| |
686
|
Other actuarial losses
|
| |
609
|
| |
—
|
| |
609
|
Plan asset gains
|
| |
—
|
| |
(2)
|
| |
(2)
|
Exchange differences
|
| |
93
|
| |
(40)
|
| |
53
|
Remeasurements
|
| |
1,388
|
| |
(42)
|
| |
1,346
|
December 31, 2019
|
| |
7,880
|
| |
(5,196)
|
| |
2,684
|
|
| |
2019
|
| |
2018
|
Discount rate
|
| |
0.20%
|
| |
0.85%
|
Interest credited on savings accounts
|
| |
0.20%
|
| |
1.00%
|
Future salary increases
|
| |
1.50%
|
| |
1.50%
|
Future pension increases
|
| |
0.00%
|
| |
0.00%
|
|
| |
2019
|
| |
2018
|
Male
|
| |
22.61
|
| |
22.50
|
Female
|
| |
25.64
|
| |
25.53
|
2019
|
| |
Increase in
assumption |
| |
Impact on
defined benefit obligation and service cost |
| |
Decrease in
assumption |
| |
Impact on
defined benefit obligation and service cost |
Discount rate
|
| |
0.25%
|
| |
(5.40%)
|
| |
(0.25%)
|
| |
5.90%
|
Future salary increases
|
| |
0.50%
|
| |
0.90%
|
| |
(0.50%)
|
| |
(0.90%)
|
Interest credited on savings accounts
|
| |
0.50%
|
| |
3.20%
|
| |
(0.50%)
|
| |
(3.00%)
|
Future pension increases
|
| |
0.50%
|
| |
7.00%
|
| |
(0.50%)
|
| |
(6.30%)
|
2018
|
| |
Increase in
assumption |
| |
Impact on
defined benefit obligation and service cost |
| |
Decrease in
assumption |
| |
Impact on
defined benefit obligation and service cost |
Discount rate
|
| |
0.25%
|
| |
(5.40%)
|
| |
(0.25%)
|
| |
5.90%
|
Future salary increases
|
| |
0.50%
|
| |
1.00%
|
| |
(0.50%)
|
| |
(1.00%)
|
Interest credited on savings accounts
|
| |
0.50%
|
| |
3.20%
|
| |
(0.50%)
|
| |
(3.10%)
|
Future pension increases
|
| |
0.50%
|
| |
6.20%
|
| |
(0.50%)
|
| |
(5.60%)
|
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Cash
|
| |
155
|
| |
65
|
Bonds
|
| |
3,065
|
| |
1,919
|
Shares
|
| |
329
|
| |
147
|
Real estates and mortgages
|
| |
1,303
|
| |
720
|
Alternative investments
|
| |
344
|
| |
135
|
|
| |
5,196
|
| |
2,986
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
(1,043)
|
| |
(850)
|
Remeasurements of defined benefit pension plan
|
| |
(1,346)
|
| |
(193)
|
December 31
|
| |
(2,389)
|
| |
(1,043)
|
23.
|
Share-based compensation expense
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike price in USD per share |
| |
Number of
awards |
| |
Average
strike price in USD per share |
| |
Number of
awards |
At the beginning of the year
|
| |
12.5
|
| |
1,982,375
|
| |
11.8
|
| |
1,882,125
|
Granted
|
| |
26.6
|
| |
226,666
|
| |
25.9
|
| |
100,250
|
Forfeited
|
| |
9.8
|
| |
(183,509)
|
| |
—
|
| |
—
|
At the end of the year
|
| |
14.3
|
| |
2,025,532
|
| |
12.5
|
| |
1,982,375
|
Grant date
|
| |
Expiry date
|
| |
Strike
price in USD |
| |
Awards
December 31, 2019 |
| |
Awards
December 31, 2018 |
Feb - Sep 2014
|
| |
2024
|
| |
9.3
|
| |
602,375
|
| |
602,375
|
Mar - Jul 2015
|
| |
2025
|
| |
9.3
|
| |
144,875
|
| |
144,875
|
Oct - Nov 2015
|
| |
2025
|
| |
11.2
|
| |
11,875
|
| |
11,875
|
Jan - Jul 2016
|
| |
2026
|
| |
11.2
|
| |
151,375
|
| |
151,375
|
Jan - Oct 2017
|
| |
2027
|
| |
13.4
|
| |
938,250
|
| |
938,250
|
Nov - Dec 2017
|
| |
2027
|
| |
25.9
|
| |
33,375
|
| |
33,375
|
Jan - Dec 2018
|
| |
2028
|
| |
25.9
|
| |
100,250
|
| |
100,250
|
Jan - Apr 2019
|
| |
2029
|
| |
25.9
|
| |
155,062
|
| |
|
Jul - Sep 2019
|
| |
2029
|
| |
28.0
|
| |
71,604
|
| |
|
Jul 2019 forfeited
|
| |
|
| |
|
| |
(183,509)
|
| |
|
Total
|
| |
|
| |
|
| |
2,025,532
|
| |
1,982,375
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
6.64 years
|
| |
7.17 years
|
|
| |
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
a) weighted average share price
|
| |
in USD
|
| |
0.80 to 27.50
|
| |
0.79 to 1.91
|
b) strike price
|
| |
in USD
|
| |
26.00 to 28.00
|
| |
25.94
|
c) expected volatility
|
| |
in %
|
| |
201.9 to 4,612.8
|
| |
146.4 to 201.9
|
d) award life
|
| |
in # of years
|
| |
0.08 to 1.02
|
| |
1.02 to 1.75
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
0
|
f) risk-free interest rate
|
| |
in %
|
| |
2.08 to 2.57
|
| |
1.84 to 2.57
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike price in USD per share |
| |
Number of
awards |
| |
Average
strike price in USD per share |
| |
Number of
awards |
At the beginning of the year
|
| |
2.7
|
| |
2,762,500
|
| |
2.7
|
| |
2,312,500
|
Granted
|
| |
2.5
|
| |
584,460
|
| |
2.6
|
| |
450,000
|
Forfeited
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
2.6
|
| |
3,346,960
|
| |
2.7
|
| |
2,762,500
|
Grant date
|
| |
Expiry date
|
| |
Strike
price in USD |
| |
Awards
December 31, 2019 |
| |
Awards
December 31, 2018 |
May 2014
|
| |
2024
|
| |
2.8
|
| |
63,750
|
| |
63,750
|
Sep 2014
|
| |
2024
|
| |
2.8
|
| |
102,500
|
| |
102,500
|
May 2015
|
| |
2025
|
| |
2.7
|
| |
1,047,375
|
| |
1,047,375
|
Sep 2015
|
| |
2025
|
| |
2.7
|
| |
160,500
|
| |
160,500
|
May 2016
|
| |
2026
|
| |
2.7
|
| |
101,125
|
| |
101,125
|
May 2016
|
| |
2026
|
| |
2.7
|
| |
160,500
|
| |
160,500
|
Oct 2016
|
| |
2026
|
| |
2.6
|
| |
112,500
|
| |
112,500
|
Dec 2016
|
| |
2026
|
| |
2.6
|
| |
564,250
|
| |
564,250
|
Jun 2018
|
| |
2028
|
| |
2.6
|
| |
37,500
|
| |
37,500
|
Dec 2018
|
| |
2028
|
| |
2.6
|
| |
412,500
|
| |
412,500
|
Jan 2019
|
| |
2029
|
| |
2.6
|
| |
75,000
|
| |
|
Dec 2019
|
| |
2029
|
| |
2.5
|
| |
509,460
|
| |
|
Total
|
| |
|
| |
|
| |
3,346,960
|
| |
2,762,500
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
6.97 years
|
| |
7.37 years
|
|
| |
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
a) weighted average share price
|
| |
in USD
|
| |
0.51 to 16.31
|
| |
0.50 to 1.25
|
b) strike price
|
| |
in USD
|
| |
2.50 to 2.56
|
| |
2.58 to 2.63
|
c) expected volatility
|
| |
in %
|
| |
176.6 to 233.1
|
| |
170.0 to 233.1
|
d) award life
|
| |
in # of years
|
| |
0.83 to 1.29
|
| |
0.83 to 1.33
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
0
|
f) risk-free interest rate
|
| |
in %
|
| |
1.55 to 2.60
|
| |
2.32 to 2.60
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike price in USD per share |
| |
Number of
awards |
| |
Average
strike price in USD per share |
| |
Number of
awards |
At the beginning of the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Granted
|
| |
18.8
|
| |
1,020,434
|
| |
—
|
| |
—
|
Forfeited
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
18.8
|
| |
1,020,434
|
| |
—
|
| |
—
|
Grant date
|
| |
Expiry date
|
| |
Strike price
in USD |
| |
Awards
December 31, 2019 |
| |
Awards
December 31, 2018 |
Dec 2019
|
| |
2029
|
| |
18.8
|
| |
1,020,434
|
| |
|
Total
|
| |
|
| |
|
| |
1,020,434
|
| |
—
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
9.96 years
|
| |
—
|
|
| |
|
| |
Year
ended December 31, 2019 |
| |
Year
ended December 31, 2018 |
a) weighted average share price
|
| |
in USD
|
| |
16.31
|
| |
—
|
b) strike price
|
| |
in USD
|
| |
18.75
|
| |
—
|
c) expected volatility
|
| |
in %
|
| |
176.6
|
| |
—
|
d) award life
|
| |
in # of years
|
| |
5.65
|
| |
—
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
—
|
f) risk-free interest rate
|
| |
in %
|
| |
1.67
|
| |
—
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
6,745
|
| |
6,276
|
Share Purchase Plan 2013
|
| |
—
|
| |
—
|
Incentive Plan 2014
|
| |
437
|
| |
108
|
Share Purchase Plan 2016
|
| |
332
|
| |
361
|
Equity Incentive Plan 2019
|
| |
348
|
| |
—
|
December 31
|
| |
7,862
|
| |
6,745
|
24.
|
Share capital
|
|
| |
Number of
shares issued Common |
| |
Number of
shares issued Class B |
| |
Number of
shares issued Class C |
| |
Number of
shares issued Class D |
| |
Number of
shares issued Class E |
| |
Number of
shares issued Total |
January 1, 2018
|
| |
9,487,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
| |
47,375,000
|
Issuance of share capital / capital contributions
|
| |
450,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
450,000
|
December 31, 2018
|
| |
9,937,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
| |
47,825,000
|
Issuance of share capital / capital contributions
|
| |
1,825,000
|
| |
—
|
| |
—
|
| |
—
|
| |
3,687,500
|
| |
5,512,500
|
December 31, 2019
|
| |
11,762,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
11,400,000
|
| |
53,337,500
|
of which, treasury shares:
|
| |
1,240,540
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
Share
capital (in KUSD) |
| |
Share
premium (in KUSD) |
| |
Treasury
shares (in KUSD) |
| |
Total
(in KUSD) |
January 1, 2018
|
| |
397
|
| |
452,296
|
| |
—
|
| |
452,693
|
Issuance of share capital /capital contributions
|
| |
4
|
| |
(28)
|
| |
—
|
| |
(24)
|
December 31, 2018
|
| |
401
|
| |
452,268
|
| |
—
|
| |
452,669
|
Issuance of share capital /capital contributions
|
| |
171
|
| |
101,443
|
| |
—
|
| |
101,614
|
Change in par value
|
| |
3,789
|
| |
(3,789)
|
| |
|
| |
—
|
Treasury shares - additions
|
| |
—
|
| |
—
|
| |
(141)
|
| |
(141)
|
Treasury shares - disposals
|
| |
—
|
| |
—
|
| |
41
|
| |
41
|
December 31, 2019
|
| |
4,361
|
| |
549,922
|
| |
(100)
|
| |
554,183
|
1.
|
First, to the Class E shareholders, an amount equal to the total price paid for the Class E shares, plus an 8% per annum return;
|
2.
|
Second, to the Class D shareholders, an amount equal to the total price paid for the Class D shares, plus an 8% per annum return;
|
3.
|
Third, to the Class C shareholders, an amount equal to the total price paid for the Class C shares;
|
4.
|
Fourth, pari passu, to the Class B shareholders, an amount equal to the total price paid for the Class B shares, plus an 8% per annum return, and, to the Class C shareholders, an 8% per annum return on the total price paid for the Class C shares; and
|
5.
|
Thereafter, to all shareholders, the remaining proceeds in proportion to the nominal value of their shares.
|
|
| |
2019
|
| |
2018
|
||||||||||||
|
| |
Price
(in USD) |
| |
Number of
treasury shares |
| |
Value
(in KUSD) |
| |
Price
(in USD) |
| |
Number of
treasury shares |
| |
Value
(in KUSD) |
At the beginning of the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Additions
|
| |
0.08
|
| |
1,750,000
|
| |
141
|
| |
—
|
| |
—
|
| |
—
|
Disposals
|
| |
0.08
|
| |
(509,460)
|
| |
(41)
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
0.08
|
| |
1,240,540
|
| |
100
|
| |
—
|
| |
—
|
| |
—
|
25.
|
Commitments
|
(in KUSD):
|
| |
|
| |
|
R&D Phase
|
| |
December 31,
2019 |
| |
December 31,
2018 |
Pre-clinical
|
| |
192,290
|
| |
275,602
|
Phase I
|
| |
116,115
|
| |
49,959
|
Phase II
|
| |
15,568
|
| |
5,569
|
|
| |
323,973
|
| |
331,130
|
(in KUSD)
|
| |
December 31,
2018 |
Not later than 1 year
|
| |
1,084
|
Later than 1 year and not later than 5 years
|
| |
3,163
|
More than 5 years
|
| |
131
|
|
| |
4,378
|
26.
|
Contingent liabilities
|
27.
|
Related parties
|
(in KUSD)
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Salaries and other short-term employee benefits
|
| |
5,364
|
| |
4,512
|
Pension costs
|
| |
407
|
| |
299
|
Share-based compensation expenses
|
| |
396
|
| |
341
|
Other compensation
|
| |
73
|
| |
183
|
|
| |
6,240
|
| |
5,335
|
28.
|
Loss per share
|
Year Ended December 31, 2019
|
| |
Common
Shares |
| |
Class B
Preferred Shares |
| |
Class C
Preferred Shares |
| |
Class D
Preferred Shares |
| |
Class E
Preferred Shares |
Net loss attributable to shareholders (in KUSD)
|
| |
(22,137)
|
| |
(33,713)
|
| |
(19,087)
|
| |
(18,526)
|
| |
(23,021)
|
Weighted average number of shares in issue
|
| |
9,365,406
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
9,739,555
|
Basic and diluted loss per share (in USD)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
Year Ended December 31, 2018
|
| |
Common
Shares |
| |
Class B
Preferred Shares |
| |
Class C
Preferred Shares |
| |
Class D
Preferred Shares |
| |
Class E
Preferred Shares |
Net loss attributable to shareholders (in KUSD)
|
| |
(23,014)
|
| |
(37,676)
|
| |
(21,330)
|
| |
(20,703)
|
| |
(20,373)
|
Year Ended December 31, 2018
|
| |
Common
Shares |
| |
Class B
Preferred Shares |
| |
Class C
Preferred Shares |
| |
Class D
Preferred Shares |
| |
Class E
Preferred Shares |
Weighted average number of shares in issue
|
| |
8,712,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
Basic and diluted loss per share (in USD)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
29.
|
Foreign currency exchange rate
|
USD / GBP
|
| |
|
| |
Year ended
December 31, 2019 |
| |
Year ended
December 31, 2018 |
Closing rate, GBP 1
|
| |
USD
|
| |
1.31858
|
| |
1.26902
|
Weighted average exchange rate, GBP 1
|
| |
USD
|
| |
1.27468
|
| |
1.35009
|
Events after the reporting date
|
Item 6.
|
Indemnification of Directors and Officers
|
Item 7.
|
Recent Sales of Unregistered Securities
|
Name or Class of Purchasers
|
| |
Date of Issuance
|
| |
Title of Securities
|
| |
Number of
Securities |
| |
Consideration
(in USD thousands) |
Directors, officers, employees and consultants
|
| |
December 16, 2019
|
| |
Common shares
|
| |
636,825
|
| |
1,274
|
|
| |
|
| |
|
| |
|
| |
|
A.T. Holdings II Sàrl (for the creation of treasury shares to settle share grants and equity-linked instruments for directors, officers employees and consultants)
|
| |
September 19, 2019
|
| |
Class A common shares
|
| |
140
|
| |
141
|
|
| |
|
| |
|
| |
|
| |
|
Various private equity investment funds, institutional investors and other persons
|
| |
June 7, 2019
June 14, 2019 July 5, 2019 |
| |
Class E preferred shares
|
| |
295
|
| |
103,250
|
|
| |
|
| |
|
| |
|
| |
|
Name or Class of Purchasers
|
| |
Date of Issuance
|
| |
Title of Securities
|
| |
Number of
Securities |
| |
Consideration
(in USD thousands) |
Directors and officers
|
| |
June 29, 2018
December 14, 2018 February 6, 2019 |
| |
Class A common shares
|
| |
42
|
| |
1,314
|
|
| |||||||||||
Various private equity investment funds, institutional investors and other persons
|
| |
October 12, 2017
October 30, 2017 November 16, 2017 |
| |
Class E preferred shares
|
| |
617
|
| |
200,088
|
Item 8.
|
Exhibits and Financial Statement Schedules
|
Item 9.
|
Undertakings
|
(a)
|
for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this 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 this registration statement as of the time it was declared effective;
|
(b)
|
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;
|
(c)
|
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 SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, 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 of 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; and
|
(d)
|
to provide to the underwriters at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
|
1.1*
|
| |
Form of Underwriting Agreement
|
| |
Form of Amended and Restated Articles of Association of ADC Therapeutics SA, to be in effect immediately prior to the consummation of this offering
|
|
4.1*
|
| |
Form of Registration Rights Agreement between ADC Therapeutics SA and Deerfield Partners, L.P. and Deerfield Private Design Fund IV, L.P., to be entered into in connection with this offering
|
5.1*
|
| |
Opinion of Homburger AG, Swiss counsel of ADC Therapeutics SA, as to the validity of the common shares
|
| |
Second Amended and Restated License Agreement among ADC Products (UK) Limited, ADC Therapeutics SA and MedImmune Limited, dated May 9, 2016
|
|
| |
Amendment #1 to the Second Amended and Restated License Agreement among ADC Products (UK) Limited, ADC Therapeutics SA and MedImmune Limited, dated September 19, 2018
|
|
| |
Collaboration and License Agreement between ADC Therapeutics Sarl and Genmab A/S, dated June 14, 2013
|
|
| |
Amendment to the Collaboration and License Agreement between ADC Therapeutics Sarl and Genmab A/S, dated November 20, 2013
|
|
| |
Second Amendment to the Collaboration and License Agreement between ADC Therapeutics SA and Genmab A/S, dated April 16, 2020
|
|
| |
Lease Relating to Suite 5, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated September 14, 2017
|
|
| |
Lease Relating to Lab 11b, Suite 11 Write Up Space and Suite 12, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated December 20, 2017
|
|
| |
Counterpart Lease Relating to Suite 8, First Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 9, 2018
|
|
| |
Deed of Variation Relating to Lease of Suite 5, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019
|
|
| |
Deed of Variation Relating to Lease of Lab 11b, Suite 11 Write Up Space and Suite 12, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019
|
|
| |
Deed of Variation Relating to Lease of Suite 8, First Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019
|
|
| |
Form of Indemnity Agreement with directors and officers entered into in connection with this offering
|
|
| |
Form of Purchase and Shareholders Agreement relating to the 2013 Share Purchase Plan (including form of promissory note included in Schedule A thereto)
|
|
| |
ADC Therapeutics Incentive Plan, between ADC Therapeutics SA and the parties named therein, dated May 1, 2014 as amended and restated as of October 1, 2015
|
|
| |
2016 Share Purchase Plan, between ADC Therapeutics Ltd and the parties named therein, dated November 18, 2016 (including form of promissory note including in Annex 3A thereto)
|
|
| |
Form of 2019 Equity Incentive Plan, as amended and restated in connection with this offering
|
|
10.17*
|
| |
Facility Agreement among ADC Therapeutics SA, the other Loan Parties party thereto, the Lenders and Deerfield Partners, L.P., as agent for itself and the Secured Parties thereto, dated April 24, 2020
|
10.18*
|
| |
Form of Senior Secured Convertible Note
|
| |
List of subsidiaries
|
|
| |
Consent of PricewaterhouseCoopers SA
|
|
23.2*
|
| |
Consent of Homburger AG, Swiss counsel of ADC Therapeutics SA (included in Exhibit 5.1)
|
| |
Powers of attorney (included on signature page to the registration statement)
|
|
| |
Consent of Jennifer Creel to be named as Chief Financial Officer nominee
|
*
|
To be filed by amendment.
|
#
|
Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
|
|
| |
ADC THERAPEUTICS SA
|
||||||
|
| |
|
| |
|
| |
|
|
| |
By:
|
| |
/s/ Christopher Martin
|
|||
|
| |
|
| |
Name:
|
| |
Christopher Martin
|
|
| |
|
| |
Title:
|
| |
Chief Executive Officer
|
Name
|
| |
|
| |
Title
|
|
| |
|
| |
|
/s/ Christopher Martin
|
| |
|
| |
Chief Executive Officer and Director
(principal executive officer) |
Christopher Martin
|
| |
|
| ||
|
| |
|
| |
|
/s/ Michael Forer
|
| |
|
| |
Chief Financial Officer and Vice Chairman of the Board of Directors
(principal financial officer and principal accounting officer) |
Michael Forer
|
| |
|
| ||
|
| |
|
| ||
/s/ Ron Squarer
|
| |
|
| |
Chairman of the Board of Directors
|
Ron Squarer
|
| |
|
| ||
|
| |
|
| |
|
/s/ Peter B. Corr
|
| |
|
| |
Director
|
Peter B. Corr
|
| |
|
| ||
|
| |
|
| |
|
/s/ Stephen Evans-Freke
|
| |
|
| |
Director
|
Stephen Evans-Freke
|
| |
|
| ||
|
| |
|
| |
|
/s/ Peter Hug
|
| |
|
| |
Director
|
Peter Hug
|
| |
|
| ||
|
| |
|
| |
|
/s/ Thomas Pfisterer
|
| |
|
| |
Director
|
Thomas Pfisterer
|
| |
|
| ||
|
| |
|
| |
|
/s/ Thomas M. Rinderknecht
|
| |
|
| |
Director
|
Thomas M. Rinderknecht
|
| |
|
| ||
|
| |
|
| |
|
/s/ Tyrell J. Rivers
|
| |
|
| |
Director
|
Tyrell J. Rivers
|
| |
|
| ||
|
| |
|
| |
|
/s/ Victor Sandor
|
| |
|
| |
Director
|
Victor Sandor
|
| |
|
| ||
|
| |
|
| |
|
/s/ Jacques Theurillat
|
| |
|
| |
Director
|
Jacques Theurillat
|
| |
|
| ||
|
| |
|
| |
|
/s/ Jay Feingold
|
| |
|
| |
Authorized Representative in the United States
|
Jay Feingold
|
| |||||
ADC Therapeutics America, Inc.
|
| |
|
|
Section 1
Name, Registered Office, Purpose and Duration of the Company
|
Section 1
Raison sociale, siège, but de la société, durée
|
|||
Article 1
|
Article 1
|
|||
Name, Place of In-
corporation
|
Under the name ADC Therapeutics SA (ADC Therapeutics AG) (ADC Therapeutics Ltd) (the Company) shall exist a corporation with its registered office in Epalinges, canton of Vaud.
|
Raison sociale,
siège
|
Sous la raison sociale ADC Therapeutics SA (ADC Therapeutics AG), (ADC Therapeutics Ltd) (la Société) existe une société anonyme avec siège à Epalinges,
canton de Vaud.
|
|
Article 2
|
Article 2
|
|||
Purpose
|
1 The Company's purpose is to research, develop, produce and sell products in the fields of biotechnology, pharmaceutics, medical technology, diagnosis and
therapy as well as to purchase, sell and use patents and licenses in these fields. The Company may engage in all types of transactions that appear appropriate to promote the purpose of the Company or that are related thereto.
|
But
|
1 La Société a pour but la recherche, le développement, la production et la vente de produits dans les domaines de la biotechnologie, de la pharmaceutique, de
la technologie médicale, du diagnostic et de la thérapie ainsi que l’acquisition, la vente et l'utilisation de brevets et de licences dans ces domaines. La Société peut exercer toutes activités aptes à favoriser son but ou en rapport avec ce
dernier.
|
|
2 The Company may open branch offices and subsidiaries in Switzerland and abroad. It may also acquire participations or otherwise invest in other companies in
Switzerland and abroad.
|
2 La Société peut constituer des succursales et des filiales en Suisse et à l'étranger et participer à ou investir autrement dans d'autres entreprises en
Suisse et à l'étranger.
|
|||
3 The Company may acquire, hold, manage, mortgage, exploit and sell real estate and intellectual property rights in Switzerland and abroad and may also
finance other companies.
|
3 La Société peut acquérir, détenir, gérer, gager, mettre en valeur et aliéner des immeubles et des droits de propriété intellectuelle en Suisse et à
l'étranger, ainsi que financer d'autres sociétés.
|
|||
Article 3
|
Article 3
|
|||
Duration
|
The duration of the Company shall be unlimited.
|
|
Durée
|
La durée de la Société est illimitée.
|
Section 2
Share Capital, Shares, Restrictions of Transferability
|
Section 2
Capital-actions, actions et restrictions à la transmissibilité
|
|||
Article 4
|
Article 4
|
|||
Share Capital
|
The share capital of the Company is CHF [■] and is divided into [■] fully
paid in registered shares with a par value of CHF 0.08 each.
|
|
Capital-actions
|
Le capital-actions de la Société s'élève à CHF [■] et est divisé en [■]
actions nominatives entièrement libérées d'une valeur nominale de CHF 0.08 chacune.
|
Article 4a
|
Article 4a
|
|||
Authorized Share
Capital
|
1 The Board of Directors shall be authorized to increase the share capital at any time, including in connection with an intended takeover, until April 23,
2022 by a maximum amount of CHF 32,000,000 by issuing a maximum of 2,560,000 fully paid in registered shares with a par value of CHF 0.08 each. Increases in partial amounts shall be permissible.
|
Capital-actions auto-risé
|
1 Le Conseil d'administration est autorisé à augmenter le capital-actions d'un montant maximum de CHF 2'560'000, en tout temps, y inclus en lien avec une
future offre publique d'acquisition, mais jusqu'au 23 avril 2022 au plus tard, par l'émission d'un maximum de 32'000'000 actions nominatives d'une valeur nominale de CHF 0.08 chacune, qui doivent être intégralement libérées. Des augmentations
par montants partiels sont autorisées.
|
|
2 The subscription and acquisition of the new shares as well as any subsequent transfer of the shares shall be subject to the restrictions pursuant to Article
6 of these articles of association.
|
2 La souscription et l'acquisition des nouvelles actions ainsi que tout transfert ultérieur des actions sont assujettis aux restrictions à la transmissibilité
conformément à l'article 6 des présents statuts.
|
|||
3 The Board of Directors shall determine the issue price, the type of contribution, the date of issue, 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 financial institution, a syndicate of financial institutions or another third party and a
subsequent offer of these shares to the existing shareholders or third parties (if the pre-emptive rights of the existing shareholders have been withdrawn or have not been duly exercised). The Board of Directors is entitled to permit, to
restrict or to exclude the trading of pre-emptive rights. It may permit the expiration of pre-emptive rights that have not been exercised, or it may place such rights or shares as to which pre-emptive rights have been granted, but not
exercised, at market conditions or may use them otherwise in the interest of the Company.
|
3 Le Conseil d'administration détermine le prix d'émission, la nature des apports, le moment de l'émission, les conditions de l'exercice du droit de
souscription préférentiel et le moment à partir duquel les actions donneront droit à des dividendes. A cet effet, le Conseil d'administration peut émettre des nouvelles actions par voie de prise ferme par un établissement financier, un
consortium bancaire ou un tiers et d'offre subséquente de ces actions aux actionnaires actuels ou à des tiers (si les droits de souscription préférentiels des actionnaires actuels ont été supprimés ou qu'ils n'ont pas été valablement
exercés). Le Conseil d'administration est en droit d'autoriser, de limiter ou d'exclure le négoce des droits de souscription préférentiels. Le Conseil d'administration peut laisser s'éteindre les droits de souscription préférentiels non
exercés; il peut aussi aliéner ceux-ci, respectivement les actions pour lesquelles des droits de souscription ont été accordés sans toutefois être exercés, aux conditions du marché ou les utiliser autrement dans l'intérêt de la Société.
|
4 The Board of Directors is further authorized to withdraw or restrict pre-emptive rights of existing shareholders and to allocate such rights to third
parties, the Company or any of its group companies:
|
4 Le Conseil d'administration peut aussi exclure ou limiter les droits de souscription préférentiels des actionnaires actuels et les attribuer à des tiers, à
la Société ou à une des sociétés du groupe:
|
|||
(a) if the issue price of the new shares is determined by reference to the market price; or
|
(a) si le prix d'émission des nouvelles actions est déterminé en fonction du prix du marché; ou
|
|||
(b) for raising capital in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable
conditions, without the exclusion of the pre-emptive rights of existing shareholders; or
|
(b) pour créer des fonds de manière rapide et flexible, ce qui ne serait pas possible ou possible qu'avec difficulté ou tardivement ou à des conditions nettement plus défavorables sans
l'exclusion des droits de souscription préférentiels des actionnaires actuels; ou
|
|||
(c) for the acquisition of companies, part(s) of companies or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the
Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares; or
|
(c) pour l'acquisition de sociétés, de partie(s) de sociétés ou de participations, pour l'acquisition de produits, de droits de propriété intellectuelle, ou licences par ou pour des
projets d'investissement de la Société ou de l'une des sociétés du groupe, ou pour le financement ou le refinancement de telles transactions par le placement d'actions; ou
|
|||
(d) for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners,
or in connection with the listing of new shares on domestic or foreign stock exchanges; or
|
(d) pour élargir le cercle des actionnaires de la Société dans certains marchés géographiques, financiers ou d'investisseurs, pour permettre la participation de
partenaires stratégiques, ou en relation avec la cotation de nouvelles actions sur des bourses nationales ou étrangères; ou
|
(e) for purposes of granting an over-allotment option (Greenshoe) or an option to subscribe for additional shares in a placement or sale of
shares to the respective initial purchaser(s) or underwriter(s); or
|
(e) pour octroyer une option de surallocation (Greenshoe) ou une option de souscription d'actions supplémentaires lors d'un placement ou de la
vente d'actions à un ou plusieurs acheteurs initiaux ou souscripteurs; ou
|
|||
(f) for the participation of members of the Board of Directors, members of the executive management, employees, contractors, consultants or other persons performing services for the
benefit of the Company or any of its group companies; or
|
(f) pour la participation de membres du Conseil d'administration, de membres de la direction, d'employés, de co-contractants, de consultants ou d'autres personnes exerçant des services
au bénéfice de la Société ou de l'une des sociétés du groupe; ou
|
|||
(g) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of the share capital registered in the commercial register
without having submitted to all other shareholders a takeover offer recommended by the Board of Directors; or
|
(g) si un actionnaire ou un groupe d'actionnaires agissant de concert a acquis ou réuni une participation de plus de 20% du capital-actions inscrit au registre du commerce sans avoir
présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil d'administration; ou
|
|||
(h) for the defense of an actual, threatened or potential takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not
recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find such takeover bid to be financially fair to the shareholders or not to be in the Company's interest.
|
(h) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'administration,
après consultation d'un conseiller financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'administration estime que l'offre publique d'achat n'est pas équitable d'un point de vue financier vis-à-vis des actionnaires ou n'est
pas dans l'intérêt de la Société.
|
Article 4b
|
Article 4b
|
|||
Conditional Share
Capital for Em
ployee Participation
|
1 The share capital may be increased in an amount not to exceed CHF 936,000 through the issuance of up to 11,700,000 fully paid in registered shares with a
par value of CHF 0.08 per share through the direct or indirect issuance of shares, options or related subscription rights to members of the Board of Directors, members of the executive management, employees, contractors or consultants of the
Company or its group companies, or other persons providing services to the Company or its group companies.
|
Capital-actions
conditionnel pour
la participation
des employés
|
1 Le capital-actions peut être augmenté d'un montant maximum de CHF 936'000 par l'émission de 11'700'000 actions nominatives au plus, d'une valeur nominale
de CHF 0.08 chacune, qui doivent être intégralement libérées, par l'émission directe ou indirecte d'actions, d'options ou de droits de souscription y relatifs, octroyés aux membres du Conseil d'administration, aux membres de la direction, ou
aux employés, co-contractants ou consultants de la Société ou de l'une des sociétés du groupe, ou d'autres personnes exerçant des services au bénéfice de la Société ou de l'une des sociétés du groupe.
|
|
2 The pre-emptive rights and advance subscription rights of the shareholders of the Company shall be excluded in connection with the issuance of any shares,
options, other rights to receive shares, or subscription rights therefor. Shares, options, other rights to receive shares, or subscription rights therefor shall be issued pursuant to one or more regulations to be issued by the Board of
Directors or, to the extent delegated to it, the Compensation Committee, and to the extent applicable, taking into account the compensation principles pursuant to Article 28 of these articles of association. Shares,
options, other rights to receive shares, or subscription rights therefor may be issued at a price or with an exercise price lower than the market price.
|
2 Le droit de souscription préférentiel ainsi que le droit de souscription préalable des actionnaires de la Société sont exclus en relation avec l'émission de
toutes actions, options, autres droits à recevoir des actions ou des droits de souscription qui y sont attachés. L'émission d'actions, d'options, d'autres droits à recevoir des actions ou des droits de souscription qui y sont attachés est
faite selon un ou plusieurs règlements adoptés par le Conseil d'administration ou le Comité de rémunération, dans la mesure où cette compétence lui a été déléguée, et le cas échéant en tenant compte des principes de rémunération selon
l'article 28 des présents statuts. L'émission d'actions, d'options, d'autres droits à recevoir des actions ou des droits de souscription qui y sont attachés peut se faire à un prix ou avec un prix d'exercice en-dessous du prix du marché.
|
|||
3 The direct or indirect acquisition of the new shares by persons listed in paragraph 1 in connection with an employee participation program and any
subsequent transfer of such shares shall be subject to the restrictions of Article 6 of these articles of association.
|
3 L'acquisition directe ou indirecte de nouvelles actions par des personnes mentionnées à l'alinéa 1 dans le cadre d'un programme de participation des
collaborateurs ainsi que le transfert subséquent de ces actions sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des présents statuts.
|
Article 4c
|
Article 4c
|
|||
Conditional Share
Capital for Financing,
Acquisitions and other
Purposes
|
1 The share capital may be increased including in connection with an intended takeover in an amount not to exceed CHF 1,624,000 through the issuance of up to
20,300,000 fully paid in registered shares with a par value of CHF 0.08 per share through the exercise or mandatory exercise of conversion, exchange, option, warrant or similar rights or obligations for the subscription of shares granted to
shareholders or third parties on a stand-alone basis or in connection with bonds, notes, options, warrants or other securities or contractual obligations of the Company or any of its group companies, including without limitation a convertible
debenture to be entered into by the Company, as may be amended or novated from time to time (hereinafter collectively, the Financial Instruments).
|
Capital-actions
conditionnel aux
fins de financement,
acquisitions ou
d'autres buts
|
1 Le capital-actions peut être augmenté, y compris en lien avec une future offre publique d'acquisition, d'un montant maximum de CHF 1'624'000 par l'émission
de 20'300'000 actions nominatives au plus, d'une valeur nominale de CHF 0.08 chacune, qui doivent être intégralement libérées par l'exercice ou l'exercice obligatoire de droits de conversion, d'échange, d'option, de warrant ou d'autres droits
ou obligations similaires pour la souscription d'actions octroyés aux actionnaires ou à des tiers de manière autonome ou en rapport avec des obligations, effets, options, warrants ou autres instruments financiers ou obligations contractuelles
de la Société ou de l'une des sociétés du groupe, y compris, mais sans s'y limiter, une débenture convertible de la société, laquelle peut être amenée à être modifiée ou actualisée (ci-après désignés collectivement les Instruments Financiers).
|
|
2 The pre-emptive rights of shareholders shall be excluded for the exercise of any Financial Instruments in connection with the issuance of shares. The
then-current owners of such Financial Instruments shall be entitled to acquire the new shares issued upon conversion, exchange or exercise of any Financial Instruments. The key conditions of the Financial Instruments shall be determined by
the Board of Directors.
|
2 Le droit de souscription préférentiel des actionnaires est exclu en relation avec l'émission d'actions à l'occasion de l'exercice d'Instruments Financiers.
Les personnes qui détiendront alors de tels Instruments Financiers seront en droit d'acquérir les nouvelles actions émises à l'occasion de la conversion, de l'échange ou de l'exercice d'Instruments Financiers. Le Conseil d'administration
détermine les principales conditions des Instruments Financiers.
|
3 The Board of Directors shall be authorized to restrict or withdraw advance subscription rights of shareholders in connection with the issuance of Financial
Instruments by the Company or one of its group companies (1) if the issuance is for purposes of financing or refinancing, or the payment for, the acquisition of companies, parts of a company, participations, intellectual property rights,
licenses or investments, (2) if the issuance occurs in domestic or international capital markets or through a private placement, (3) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in
excess of 20% of the share capital registered in the commercial register without having submitted to all other shareholders a takeover offer recommended by the Board of Directors, or (4) for the defense of an actual, threatened or potential
takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find
such takeover bid to be financially fair to the shareholders or not in the Company's interest. If the advance subscription rights are neither granted directly nor indirectly by the Board of Directors, the following shall apply:
|
3 Le Conseil d'administration est autorisé à limiter ou retirer le droit de souscription préalable des actionnaires en relation avec l'émission d'Instruments
Financiers par la Société ou une des sociétés du groupe (1) si l'émission a pour but le financement, le refinancement ou le paiement de l'acquisition d'entreprises, de parties d'une entreprise, de participations, de droits de propriété
intellectuelle, de licences ou d'investissements, (2) si l'émission a lieu sur les marchés de capitaux nationaux ou internationaux ou par le biais d'un placement privé, (3) si un actionnaire ou un groupe d'actionnaires agissant de concert a
acquis ou réuni une participation de plus de 20% du capital-actions inscrit au registre du commerce sans avoir présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil
d'administration, ou (4) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'administration, après consultation d'un conseiller
financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'administration estime que l'offre publique d'achat n'est pas équitable d'un point de vue financier vis-à-vis des actionnaires ou n'est pas dans l'intérêt de la Société.
Si le droit de souscription préalable n'est pas accordé, de manière directe ou indirecte, par le Conseil d'administration, les règles suivantes s'appliquent:
|
|||
(a) the Financial Instruments shall be issued or entered into at market conditions;
|
(a) les Instruments Financiers sont émis ou conclus aux conditions du marché;
|
|||
(b) the Financial Instruments may be converted, exchanged or exercised during a maximum period of 10 years from the date of issuance or contract conclusion; and
|
(b) les Instruments Financiers peuvent être convertis, échangés ou exercés durant une période maximale de 10 ans suivant la date de l'émission ou de la conclusion du contrat; et
|
|||
(c) the conversion, exchange or exercise price of the Financial Instruments shall be set with reference to, and/or shall be subject to change
based upon, the valuation of the Company's equity and/or market conditions.
|
(c) le prix de conversion, d'échange ou d'exercice des Instruments Financiers est fixé en prenant en compte, et/ou peut être modifié en fonction, de la valorisation des fonds propres de
la société et/ou des conditions du marché.
|
|||
4 The direct or indirect acquisition of the new shares acquired through the exercise of Financial Instruments and any subsequent transfer of such shares
shall be subject to the restrictions of Article 6 of these articles of association.
|
4 L'acquisition de nouvelles actions acquises directement ou indirectement par l'exercice d'Instruments Financiers ainsi que le transfert subséquent de ces
actions sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des présents statuts.
|
Article 5
|
Article 5
|
|||
Share Certificates and Intermediated Securities
|
1 The Company may issue its registered shares in the form of single certificates, global certificates and uncertificated securities. Subject to applicable
law, the Company may convert its registered shares from one form into another form at any time and without the approval of the shareholders. The Company shall bear the cost associated with any such conversion.
|
|
Certificats d'actions et titres intermédiés
|
1 La Société émet ses actions nominatives sous forme de certificats individuels, de certificats globaux ou de droits-valeurs. La Société est libre, dans les
limites du droit applicable, en tout temps et sans l'approbation des actionnaires, de convertir ses actions nominatives émises sous l'une des formes ci-dessus, en une autre forme. La Société supporte les coûts d'une telle conversion.
|
2 A shareholder has no right to request a conversion of the registered shares issued in one form into another form. Each shareholder may, however, at any time
request from the Company a written confirmation of the registered shares held by such shareholder, as reflected in the share register.
|
2 Un actionnaire n'a pas le droit de réclamer la conversion d'actions nominatives émises sous une certaine forme en une autre forme. Chaque actionnaire peut
toutefois exiger en tout temps que la Société établisse une attestation relative aux actions nominatives qu'il détient selon le registre des actions.
|
|||
3 Intermediated securities based on registered shares of the Company cannot be transferred by way of assignment. A security interest in any such intermediated
securities also cannot be granted by way of assignment.
|
3 Les titres intermédiés fondés sur des actions nominatives de la Société ne peuvent pas être transférés par cession. Il ne peut pas non plus être constitué
de sûretés par cession sur ces titres intermédiés.
|
|||
Article 6
|
Article 6
|
|||
Share Register, Re
strictions on Regis
tration, Nominees
|
1 The Company shall maintain, itself or through a third party, a share register for the registered shares that lists the surname and name (the name of the
company in case of a legal entity), the address and domicile (the registered office in case of a legal entity) of the shareholders or usufructuaries. A person registered in the share register shall notify the share registrar of any change of
address. Until such notification has occurred, all written communications from the Company to persons registered in the share register shall be deemed to have validly been made if sent to the address previously recorded in the share register.
|
|
Registre des ac
tions, limitations à
l'inscription, Nomin
ees
|
1 La Société ou un tiers mandaté par elle tient un registre des actions qui mentionne le nom et le prénom (la raison sociale pour les personnes morales),
l'adresse et le domicile (le siège pour les personnes morales) des propriétaires et des usufruitiers. Si une personne inscrite au registre des actions change d'adresse, elle doit le communiquer à la personne en charge de la tenue du registre.
Aussi longtemps que cette communication n'a pas eu lieu, toutes les communications écrites de la Société aux personnes inscrites au registre des actions seront valablement envoyées à l'adresse inscrite au registre des actions.
|
2 Persons acquiring shares shall be registered in the share register as shareholders with voting rights upon their request if they expressly declare to have
acquired these shares in their own name and for their own account. Subject to paragraph 4 of this Article 6 and article 685d para. 3 of the Swiss Code of Obligations, no person or entity shall be
registered in the share register as a shareholder with voting rights for, and no person or entity may directly or indirectly, formally, constructively or beneficially own, or otherwise control alone or together with third parties voting
rights (whether exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register as a shareholder with voting rights. This restriction shall also apply to persons or entities who hold some or all
of their shares through Nominees (as defined in paragraph 4 of this Article 6).
|
2 Les personnes qui acquièrent des actions sont inscrites dans le registre des actions, à leur demande, comme actionnaires avec droit de vote, pour autant
qu'ils déclarent expressément avoir acquis les actions en leur nom et pour leur propre compte. Sous réserve de l'alinéa 4 du présent article 6 et de l'article 685d al. 3 du Code des obligations, aucune personne physique ou morale ne peut être
inscrite au registre des actions comme actionnaire avec droit de vote et aucune personne physique ou morale ne peut détenir, directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôler autrement, seul ou
avec des tiers, des droits de vote (exerçables ou non), par rapport à plus de 15% du capital-actions inscrit au registre du commerce en tant qu'actionnaire avec droit de vote. Cette restriction s'applique également aux personnes ou entités
qui détiennent tout ou partie de leurs actions par l'intermédiaire de Nominees (tels que définis à l'alinéa 4 du présent article 6).
|
|||
3 Subject to Art. 652b para. 3 of the Swiss Code of Obligations, this transfer restriction also applies in the case of the acquisition of shares by the
exercise of subscription, option and conversion rights. The transfer restriction does not apply to acquisitions by inheritance, division of an estate or matrimonial property law.
|
3 Sous réserve de l'art. 652b al. 3 CO, les restrictions au transfert s'appliquent également lors de l'acquisition d'actions dans le cadre de l'exercice d'un
droit de souscription, d'option ou de conversion. Les restrictions au transfert ne s'appliquent pas lors d'acquisitions par succession, partage successoral ou en vertu du droit matrimonial.
|
|||
4 The Board of Directors may, in its own discretion, register persons who declare in the registration application that they hold the shares as nominees (each
a Nominee) on behalf of third party beneficiaries (each a Beneficial Owner) in the share register as shareholders with voting rights. If, however, any
Beneficial Owner should as a result of such registration being made or upheld, directly or indirectly, formally, constructively or beneficially own, or otherwise control or direct, alone or together with third parties, voting rights (whether
exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register, the Board of Directors may cancel the registration of the Nominee holding shares for the account of such Beneficial Owner with
respect to any shares in excess of such limit. The Board of Directors may make the registration with voting rights of the shares held by a Nominee subject to conditions, limitations and reporting requirements or may impose or adjust such
conditions, limitations and requirements once registered.
|
4 Le Conseil d'administration peut, à son entière discretion inscrire les personnes qui déclarent dans leur requête d'inscription qu'elles détiennent les
actions en tant que nominees (chacun un Nominee) pour le compte de tiers ayants droit économiques (chacun un Ayant Droit Economique) en tant qu'actionnaires
avec droit de vote. Toutefois, si suite à l'inscription ou à la confirmation de l'inscription, un Ayant Droit Economique détient directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôle ou dirige
autrement, seul ou avec des tiers, des droits de votes (exerçables ou non) par rapport à plus de 15% du capital-actions inscrit au registre du commerce, le Conseil d'administration peut annuler l'inscription du Nominee détenant les actions
pour le compte d'un tel Ayant Droit Economique pour les actions dépassant cette limite. Le Conseil d'administration peut soumettre l'inscription avec droit de vote des actions détenues par un Nominee à des conditions, limitations, exigences
de rapports ou peut imposer de telles conditions, limitiations ou exigences suite à l'inscription.
|
5 Legal entities and partnerships or other groups of persons or joint owners who are interrelated to one another through capital ownership, voting rights,
uniform management or are otherwise linked, as well as individuals or legal entities or partnerships who act in concert or otherwise act in a coordinated manner or acquire shares indirectly, thereby circumventing the restrictions or limits
pursuant to paragraph 2 or 4 of this article 6 shall be treated as one single person, entity, Nominee or as a person acquiring shares, as applicable, for purposes of paragraphs 2 and 4 of this article 6.
|
5 Les personnes morales et communautés de personnes ou autres groupes de personnes ou de copropriétaires qui sont liés par le capital, les droits de vote, la
gestion commune ou de toute autre manière, de même que les personnes physiques ou morales ou communautés de personnes qui agissent de concert ou de manière coordonnée ou acquièrent indirectement des actions, et contournent ainsi les
restrictions ou limites visées aux alinéas 2 ou 4 du présent article 6 sont traités comme une seule personne, personne morale, Nominee ou comme une personne acquérant des actions, selon le cas, aux fins des alinéas 2 et 4 du présent article
6.
|
|||
6 The Board of Directors may grant exceptions from the restrictions or limits pursuant to paragraph 2 or 4 of this article 6 for justified reasons with the
majority vote of two thirds of all its members. A justified reason may include the situation where a person extends an offer to purchase with respect to all other shares of the Company, which the Board of Directors, after having consulted an
independent financial advisor, recommends to the shareholders. Shareholders, other than Nominees, already being registered directly or through a Nominee with more than 15% at the time that this article takes effect remain registered with
voting rights for such shares.
|
6 Le Conseil d'administration peut octroyer des dérogations aux restrictions et limites mentionnées aux alinéas 2 ou 4 du présent article 6 pour des raisons
justifiées, à la majorité des deux tiers de l'ensemble de ses membres. Peut aussi être considérée comme une raison justifiée le fait qu'une personne étende une offre d'achat par rapport à l'ensemble des autres actions de la Société et que le
Conseil d'administration, après avoir consulté un conseiller financier indépendant, recommande aux actionnaires d'accepter cette offre. Les actionnaires autres que les Nominees déjà inscrits directement ou par l'intermédiaire d'un Nominee
pour plus de 15% au moment où le présent article entre en vigueur demeurent enregistrés avec droit de vote pour ces actions.
|
7 After hearing the registered shareholder or Nominee, the Board of Directors may cancel such person's registration in the share register with retroactive
effect as of the date of registration if such registration was made based on false or misleading information or if such information becomes untrue or misleading. The relevant shareholder or Nominee shall be promptly informed of the
cancellation.
|
7 Le Conseil d'administration peut, après avoir entendu l'actionnaire ou le Nominee, radier du registre des actions l'inscription qui a été faite sur la base
d'informations fausses ou trompeuses données par l'acquéreur, ou si les informations deviennent fausses ou trompeuses. L'actionnaire ou le Nominee doit être informé immédiatement de la radiation.
|
|||
8 The Board of Directors shall regulate all details and issue the instructions necessary to ensure compliance with the preceding provisions. The Board of
Directors may delegate its duties.
|
8 Le Conseil d'administration règle les détails et prend les mesures nécessaires au respect des dispositions ci-dessus. Le Conseil d'administration peut
déléguer ses tâches.
|
|||
Article 7
|
Article 7
|
|||
Exercise of Rights
|
1 The Company shall only accept one representative per share.
|
|
Exercice des droits
|
1 La Société ne reconnaît qu'un représentant par action.
|
2 The voting right and the rights associated therewith may be exercised vis-à-vis the Company by a shareholder, usufructuary or Nominee only to the extent
that such person is registered in the share register with voting rights.
|
2 Le droit de vote et les droits y relatifs ne peuvent être exercés à l'égard de la Société que par un actionnaire, un usufruitier ou un Nominee uniquement
dans la mesure où celui-ci est inscrit avec droit de vote au registre des actions.
|
Section 3
Corporate Bodies
|
Section 3
Organes
|
|||
A. The General Meeting of Shareholders
|
A. L'Assemblée générale
|
|||
Article 8
|
Article 8
|
|||
|
1 The General Meeting of Shareholders is the supreme corporate body of the Company.
|
|
|
1 L'Assemblée générale est l'organe suprême de la Société.
|
Powers of the Gen
eral Meeting of
Shareholders
|
2 The General Meeting of Shareholders shall have the following inalienable powers:
|
Pouvoirs de
l'Assemblée géné
rale
|
2 L'Assemblée générale a le droit inaliénable:
|
|
1. the adoption and amendment of these articles of association;
|
1. d'adopter et de modifier les présents statuts;
|
|||
2. the election of the members of the Board of Directors, the Chairman of the Board of Directors and the members of the Compensation Committee;
|
2. de nommer les membres du Conseil d'administration, le président du Conseil d'administration et les membres du Comité de rémunération;
|
|||
3. the election of the Auditors;
|
3. de nommer l'organe de révision;
|
|||
4. the election of the independent voting rights representative;
|
4. de nommer le représentant indépendant;
|
|||
5. the approval of the annual management report and the consolidated financial statements;
|
5. d’approuver le rapport annuel et les comptes consolidés;
|
|||
6. the approval of the annual financial statements as well as the resolution on the allocation of profit shown on the balance sheet, in particular the determination of dividends;
|
6. d'approuver les comptes annuels et de déterminer l'emploi du bénéfice résultant du bilan, en particulier de fixer le dividende;
|
|||
7. the discharge from liability of the members of the Board of Directors and the persons entrusted with management;
|
7. de donner décharge aux membres du Conseil d'administration et aux personnes chargées de la gestion;
|
|||
8. the approval of the compensation of the Board of Directors and of the Executive Committee pursuant to Article 26 of these articles of association; and
|
8. d'approuver la rémunération du Conseil d'administration et de la Direction exécutive selon l'article 26 des présents statuts; et
|
|||
9. the adoption of resolutions on matters that are reserved to the General Meeting of Shareholders by law or these articles of association or that are, subject to article 716a CO,
submitted to the General Meeting of Shareholders by the Board of Directors.
|
9. de prendre toutes les décisions qui lui sont réservées par la loi ou les présents statuts ou qui lui sont soumises par le Conseil d’administration, sous réserve de l’article 716a CO.
|
|||
Article 9
|
Article 9
|
|||
Ordinary and Ex
traordinary General
Meetings of Share
holders
|
1 The Ordinary General Meeting of Shareholders shall be held each year within six months of the close of the financial year of the Company.
|
Assemblées géné
rales ordinaires et
extraordinaires
|
1 L'Assemblée générale ordinaire a lieu chaque année dans les six mois qui suivent la clôture de l'exercice de la Société.
|
|
2 Extraordinary General Meetings of Shareholders shall be held if
|
2 Des Assemblées générales extraordinaires ont lieu lorsque
|
|||
(a) the Board of Directors or the Auditors deem it necessary;
|
(a) le Conseil d'administration ou l'organe de révision l'estime nécessaire;
|
|||
(b) so resolved by a General Meeting of Shareholders; or
|
(b) une Assemblée générale le décide; ou
|
|||
(c) shareholders who hold, alone or together, shares representing at least 10% of the share capital so request in writing, indicating the matters to be discussed and the corresponding
proposals and, in case of elections, the names of the nominated candidates.
|
(c) des actionnaires représentant seuls ou ensemble 10% au moins du capital-actions le requièrent par écrit en indiquant les objets de discussion et les propositions, et en cas
d'élections, les noms des candidats proposés.
|
|||
Article 10
|
Article 10
|
|||
Notice
|
1 Notice of a General Meeting of Shareholders shall be given by the Board of Directors or, if necessary, by the Auditors, no later than 20 calendar days
prior to the date of the meeting. Liquidators and representatives of bond-holders are also entitled to call a General Meeting of Shareholders.
|
|
Convocation
|
1 L'Assemblée générale est convoquée par le Conseil d'administration ou, si nécessaire, par l'organe de révision au plus tard 20 jours calendaires avant le
jour de l'assemblée. Les liquidateurs et les représentants de détenteurs d'obligations ont également le droit de convoquer l'Assemblée générale.
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2 Notice of the General Meeting of Shareholders shall be given by way of a single announcement in the official means of publication of the Company pursuant to
Article 36 of these articles of association. Registered shareholders may in addition be notified in writing.
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2 La convocation à l'Assemblée générale a lieu par une annonce unique dans l'organe de publication de la Société selon l'article 36 des présents statuts. La convocation peut également être envoyée par écrit aux actionnaires inscrits.
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3 The annual report, the compensation report and the Auditors' reports shall be made available for inspection by the shareholders at the registered office of
the Company no later than 20 calendar days prior to the Ordinary General Meeting of Shareholders. Registered shareholders shall be informed in writing in the notice.
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3 Le rapport de gestion, le rapport de rémunération et les rapports de révision sont mis à la disposition des actionnaires au siège de la Société au plus
tard 20 jours calendaires avant l'Assemblée générale ordinaire. Les actionnaires inscrits doivent en être informés par écrit dans la convocation.
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4 The notice shall specify the items on the agenda as well as the proposals of the Board of Directors and the shareholder(s) who requested that a General
Meeting of Shareholders be held or an item be included on the agenda and, in the event of elections, the names of the proposed candidates.
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4 La convocation mentionne les objets portés à l'ordre du jour ainsi que les propositions du Conseil d'administration et du ou des actionnaires qui ont
demandé la convocation de l'Assemblée générale ou l'inscription d'un objet à l'ordre du jour et, en cas d'élections, les noms des candidats proposés.
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Article 11
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Article 11
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Agenda
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1 Shareholders who, alone or together, either hold shares with a par value of at least CHF 1,000,000 or who represent at least 10% of the share capital may
request that an item be included on the agenda. Such request must be made in writing and be received at the registered office of the Company at least 45 calendar days prior to the General Meeting of
Shareholders, specifying the agenda item and the proposals of the shareholders.
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Objets à l'ordre du
jour
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1 Des actionnaires qui représentent seuls ou ensemble des actions totalisant une valeur nominale d'au moins CHF 1'000'000 ou qui représentent au moins 10% du
capital-actions peuvent requérir l'inscription d'un objet à l'ordre du jour. La demande doit être faite par écrit et reçue au siège de la Société au moins 45 jours calendaires avant l'Assemblée générale avec indication des objets à l'ordre du
jour et des propositions des actionnaires.
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2 No resolutions may be passed at a General Meeting of Shareholders on proposals concerning agenda items for which proper notice was not given. This provision
shall not apply, however, to proposals made during a General Meeting of Shareholders to convene an Extraordinary General Meeting of Shareholders or to initiate a special audit. Each request for inclusion of an item on the agenda shall include
(i) a brief description of the agenda item and the reason for which it is to be discussed at the meeting; (ii) the motions regarding the agenda item; (iii) the name and address, as they appear on the Company’s register of shareholders, of the
shareholder proposing such business; (iv) the number of shares of the Company which are beneficially owned by such shareholder; (v) the dates upon which the shareholder acquired such shares; (vi) documentary support for any claim of
beneficial ownership; (vii) any material interest of such shareholder in including the item in the agenda; (viii) a statement in support of the matter; and (ix) all other information required under applicable law and stock exchange rules.
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2 Aucune décision ne peut être prise par l'Assemblée générale sur des objets qui n'ont pas été dûment portés à l'ordre du jour, à l'exception des propositions
de convoquer une Assemblée générale extraordinaire et d'instituer un contrôle spécial. Toute requête visant l'inscription d'un objet à l'ordre du jour doit inclure (i) une brève description de cet objet et la raison pour laquelle il doit être
discuté lors de l'Asemblée générale; (ii) les propositions relatives à cet objet; (iii) le nom et l'adresse, tels qu'ils apparaissent dans le registre des actions, de l'actionnaire proposant un tel objet; (iv) le nombre d'actions de la
Société dont cet actionnaire est ayant droit économique; (v) les dates auxquelles l'actionnaire a acquis ces actions; (vi) les pièces justificatives démontrant le statut d'ayant droit économique; (vii) l'intérêt important de l'actionnaire à
l'inscription de l'objet à l'ordre du jour; (viii) une déclaration à l'appui de la requête; et (ix) toute autre information requise par la loi ou les règles boursières applicables.
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3 No prior notice is required to bring motions related to items already on the agenda or for the discussion of matters on which no resolution is to be taken.
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3 En revanche, il n'est pas nécessaire d'annoncer à l'avance les propositions entrant dans le cadre des objets portés à l'ordre du jour ni les délibérations
qui ne doivent pas être suivies d'un vote.
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Article 12
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Article 12
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Chairman, Vote
Counters, Minutes
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1 The Chairman of the Board of Directors shall chair the General Meeting of Shareholders. In his absence, the Vice-Chairman of the Board of Directors,
another member or a person designated by the Board of Directors shall chair the General Meeting of Shareholders. If no member of the Board of Directors is available and no other person has been designated by the Board of Directors, the acting
chair shall be elected by the General Meeting of Shareholders.
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Présidence, scruta
teurs, procès-verbal
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1 Le président du Conseil d'administration préside l'Assemblée générale. En son absence, le vice-président du Conseil d'administration, un autre membre ou
une personne désignée par le Conseil d'administration préside l'Assemblée générale. Si aucun membre du Conseil d'administration n'est disponible et aucune personne n'a été désignée par le Conseil d'administration, l'Assemblée générale élit
son président.
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2 The acting chair of the General Meeting of Shareholders shall appoint the secretary and the vote counter(s), none of whom need be shareholders. The minutes
shall be signed by the acting chair of the General Meeting of Shareholders and the secretary.
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2 Le président de l'Assemblée générale désigne un rédacteur du procès-verbal et le ou les scrutateurs, qui ne doivent pas nécessairement être des
actionnaires. Le procès-verbal doit être signé par le président de l'Assemblée générale et le secrétaire.
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3 The acting chair of the General Meeting of Shareholders shall have all powers and authority necessary and appropriate to ensure the orderly conduct of the
General Meeting of Shareholders.
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3 Le président de l'Assemblée générale a tous les pouvoirs nécessaires et appropriés pour s'assurer de la conduite régulière de l'Assemblée générale.
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Article 13
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Article 13
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Voting Rights, Rep
resentation
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1 Each share shall convey the right to one vote. The voting rights are subject to the conditions of Articles 6 and 7 of these articles of association.
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Droit de vote, repré
sentation |
1 Chaque action donne droit à une voix. Les droits de vote sont soumis aux conditions des articles 6 et 7 des
présents statuts.
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2 The Board of Directors shall issue the rules regarding the participation in and representation at the General Meeting of Shareholders and determine the
requirements as to proxies and instructions. A shareholder may only be represented at the General Meeting of Shareholders by the independent voting rights representative, its legal representative or, by means of a written proxy, by another
shareholder with the right to vote. All shares held by a shareholder may only be represented by one person.
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2 Le Conseil d'administration prend les dispositions relatives à la participation et à la représentation à l'Assemblée générale et détermine les exigences
applicables aux procurations et instructions. Un actionnaire ne peut être représenté à l'Assemblée générale que par le représentant indépendant, par son représentant légal ou, au moyen d'une procuration écrite, par un autre actionnaire ayant
droit de vote. Toutes les actions détenues par un actionnaire ne peuvent être représentées que par une seule personne.
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3 The General Meeting of Shareholders shall elect the independent voting rights representative for a term of office until completion of the next Ordinary
General Meeting of Shareholders. Re-election is possible.
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3 L'Assemblée générale nomme le représentant indépendant pour une durée de fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La
réélection est possible.
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4 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.
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4 Dans le cas où la Société n'a pas de représentant indépendant, le Conseil d'administration nommera le représentant indépendant pour l'Assemblée générale
suivante.
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Article 14
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Article 14
|
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Resolutions, Elec
tions
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1 The General Meeting of Shareholders shall pass its resolutions and decide its elections by the absolute majority of the votes attached to the shares
represented, unless required otherwise by law or these articles of association. In the event of a tie, the resolution shall be deemed refused.
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Décisions, élections
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1 Les décisions de l'Assemblée générale sont prises à la majorité absolue des voix attribuées aux actions représentées, à moins que la loi ou les présents
statuts n'en disposent autrement. En cas d'égalité de voix, la décision est refusée.
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2 Two thirds of the votes represented and the absolute majority of the par value of shares represented shall be required for the General Meeting of
Shareholders to adopt resolutions on the following matters:
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2 Une décision de l'Assemblée générale recueillant au moins les deux tiers des voix attribuées aux actions représentées et la majorité absolue des valeurs
nominales représentées est nécessaire pour:
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1. the amendment of the purpose of the Company;
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1. la modification du but social de la Société;
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2. the creation of shares with privileged voting rights;
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2. l'introduction d'actions à droit de vote privilégié;
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3. the restriction on the transferability of registered shares or their registration with voting rights and the cancelation of such a restriction;
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3. la restriction de la transmissibilité des actions nominatives ou leur inscription avec droit de vote ainsi que la suppression d'une telle restriction;
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4. an authorized or conditional increase in share capital;
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4. l'augmentation autorisée ou conditionnelle du capital-actions;
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5. an increase in share capital through the conversion of equity surplus, against contributions in kind or for purposes of an acquisition of assets, or the granting of special benefits;
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5. l'augmentation du capital-actions au moyen de la conversion de fonds propres, contre apport en nature ou en vue d'une reprise de biens et l'octroi d'avantages particuliers;
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6. the limitation or withdrawal of pre-emptive rights;
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6. la limitation ou la suppression du droit de souscription préférentiel;
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7. the relocation of the registered office of the Company;
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7. le transfert du siège de la Société;
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8. the dissolution of the Company;
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8. la dissolution de la Société;
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9. mergers, demergers and conversions pursuant to the Merger Act;
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9. une fusion, scission ou transformation conformément à la Loi sur la fusion;
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10. the conversion of registered shares into bearer shares;
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10. la conversion d'actions nominatives en actions au porteur;
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11. the removal of any member of the Board of Directors or of its Chairman before the end of his or her term of office; and
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11. la révocation de tout membre du Conseil d'administration ou de son président avant la fin de son mandat; et
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12. the amendment or repeal of the following provisions of these articles of association, with the exception of editorial amendments that do not effectively change their content:
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12. la modification ou la suppression des dispositions suivantes des présents statuts, à l'exception des modifications rédactionnelles qui ne modifient pas effectivement leur contenu:
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(i) article 6;
(ii) article 14;
(iii) article 15; and
(iv) article 18.
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(i) article 6;
(ii) article 14;
(iii) article 15; et
(iv) article 18.
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3 Resolutions and elections shall be decided by open ballot, unless the acting chair of the General Meeting of Shareholders decides that a secret ballot be
held or that it be voted by electronic means. The acting chair may at any time order that a resolution or election be repeated if he considers the vote to be in doubt. The resolution or election previously held shall then be deemed not to
have taken place.
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3 Les décisions et élections ont lieu à main levée, à moins qu'un vote à bulletins secrets ou électronique ne soit ordonné par le président de l'Assemblée
générale. Le président peut en tout temps ordonner qu'une décision ou élection soit répétée s'il estime qu'il existe des doutes sur le résultat. Dans ce cas, la décision ou l'élection précédente est réputée ne pas avoir eu lieu.
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B. The Board of Directors
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B. Le Conseil d'administration
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Article 15
|
Article 15
|
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Number of Directors
|
The Board of Directors shall consist of not less than 3 and no more than 11 members.
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Nombre de membres
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Le Conseil d'administration se compose de 3 membres au moins et de 11 membres au plus.
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Article 16
|
Article 16
|
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Election and Term
of Office
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1 The General Meeting of Shareholders shall elect the members of the Board of Directors and the Chairman of the Board of Directors individually and for a
term of office until the completion of the next Ordinary General Meeting of Shareholders. Re-election is possible.
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Élection et durée
des fonctions
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1 Les membres du Conseil d’administration et le président du Conseil d’administration sont élus individuellement par l’Assemblée générale pour une durée de
fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La réélection est possible.
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2 If the office of the Chairman of the Board of Directors is 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.
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2 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 l’Assemblée générale ordinaire suivante.
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Article 17
|
Article 17
|
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Organization of the
Board of Directors
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1 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 constitute itself. The Board of Directors may elect one or several Vice-Chairmen. The Board of Directors shall further appoint a secretary who need not be member of the Board of Directors.
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Organisation du
Conseil d'adminis
tration
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1 A l'exception de l'élection par l'Assemblée générale du président du Conseil d'administration et des membres du Comité de rémunération, le Conseil
d'administration se constitue lui-même. Il peut désigner au besoin, un ou plusieurs vice-présidents. Le Conseil d'administration désigne en outre un secrétaire, qui ne doit pas nécessairement être membre du Conseil d'administration.
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2 Subject to these articles of association, the Board of Directors shall regulate its organization and the adoption of resolutions in the organizational
regulations.
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2 Le Conseil d'administration règle en outre son organisation et la manière de prendre des décisions dans un règlement d'organisation, sous réserve des
présents statuts.
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Article 18
|
Article 18
|
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Reimbursement of
Expenses, Indemni
fication
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1 The members of the Board of Directors shall be entitled to the reimbursement of all expenses incurred in the interest of the Company.
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Remboursement
des frais, indemni
sation
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1 Les membres du Conseil d'administration ont droit au remboursement de tous les frais engagés dans l'intérêt de la Société.
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2 To the extent not included in insurance coverage or paid by third parties, the Company shall indemnify and hold harmless, to the extent permitted by law,
the existing and former members of the Board of Directors and Executive Committee, and their heirs, executors and administrators, out of the assets of the Company from and against all threatened, pending or completed actions, suits or
proceedings – whether civil, criminal, administrative or investigative – and all costs, charges, losses, damages, and expenses which they or any of them, their heirs, executors or administrators, shall or may incur or sustain by or by reason
of any actual or alleged actions, consents or omissions in or about the execution of their duty, or alleged duty, or by reason of the fact that he is or was a member of the Board of Directors or Executive Committee of the Company or one of
its subsidiaries, or, while serving as a member of the Board of Directors or Executive Committee of the Company, is or was serving at the request of the Company as a director, member of the executive management, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise; provided, however, that this indemnity shall not extend to any matter in which any of said persons is found, in a final judgment or decree of a court or governmental or
administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory duties as a member of the Board of Directors or Executive Committee.
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2 Dans la mesure où la loi le permet, la Société indemnisera, à concurrence de la portion non couverte par une assurance ou payée par un tiers, sur ses
propres biens les membres actuels et passés du Conseil d'administration et de la Direction exécutive ainsi que leurs héritiers, masse en faillite ou masse successorale contre toutes actions, procès ou poursuites, menaçants, en cours ou
terminés, de nature civile, pénale, administrative ou autre, et tous les coûts, dépenses, pertes, dommages et frais qu'ils (ou leurs héritiers, masse en faillite ou masse successorale) subiraient ou pourraient subir en raison d'actions,
consentements ou omissions, effectifs ou présumés, en relation avec l'exercice de leurs fonctions, leurs fonctions supposées ou en raison du fait d'être ou d'avoir été membres du Conseil d'administration ou de la Direction exécutive de la
Société ou de l'une de ses filiales ou, sur instruction de la Société en tant que membres du Conseil d'administration ou de la Direction exécutive, en raison du fait d'être ou d'avoir été administrateur, membre de la direction, employé ou
mandataire d'une autre société, entreprise, coentreprise, personne morale dénuée de la personnalité ou trust. L'obligation d'indemnisation s'éteint dès qu'un jugement définitif et exécutoire d'un tribunal ou d'une autorité compétente a décidé
que la personne en question a violé, volontairement ou par grave négligence, ses devoirs de membre du Conseil d'administration ou de la Direction exécutive.
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3 Without limiting the foregoing paragraph 2 of this Article 18, the Company shall advance costs and expenses idemnifiable thereunder to the existing and
former members of the Board of Directors and Executive Committee to the extent not included in insurance coverage or advanced by third parties. The Company may however recover such advanced costs if any of said persons is found, in a final
judgment or decree of a court or governmental or administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory duties as a member of the Board of
Directors or Executive Committee.
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3 Sans préjudice de l'alinéa 2 du présent article 18, la Société avancera les frais et les coûts indemnisables en vertu de la disposition précitée aux
membres actuels et passés du Conseil d'administration et de la Direction exécutive, à concurrence de la portion non couverte par une assurance ou payée par un tiers. La Société peut cependant recouvrer ces avances de frais si l'une de ces
personnes a été reconnue coupable de violation intentionnelle ou par négligence grave de ses devoirs de membre du Conseil d'administration ou de la Direction exécutive par un jugement ou une décision final et exécutoire d'un tribunal ou d'une
autorité gouvernementale ou administrative compétente.
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Article 19
|
Article 19
|
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Convening of Meet
ings, Resolutions,
Minutes
|
1 The Board of Directors shall meet at the invitation of its Chairman or, if not available, of the Vice-Chairman or of another member of the Board of
Directors as often as the business of the Company shall require or if a member requests it in writing or via telefax, e-mail or another form of electronic communication, indicating the reasons.
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Convocation, déci
sions, procès-verbal
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1 Le Conseil d'administration est convoqué par son président ou, en cas d'empêchement de ce dernier, par son vice-président ou par un autre membre du Conseil
d'administration, aussi souvent que cela apparaît nécessaire ou lorsqu'un membre du Conseil d'administration le demande par écrit, par télécopie, courriel ou par un autre moyen de communication électronique, avec indication des motifs.
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2 Unless the organizational regulations adopted by the Board of Directors or a board resolution taken with the applicable attendance quorum provide otherwise,
the Board of Directors shall only have a quorum if a majority of the members of the Board of Directors is present. No attendance quorum shall be required for resolutions of the Board of Directors providing for the amendment and ascertainment
of a capital increase.
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2 A moins que le contraire ne résulte d'une disposition du règlement d'organisation adopté par le Conseil d'administration ou d'une décision du Conseil
d'administration prise conformément aux dispositions applicables au quorum de présence, la majorité des membres du Conseil d'administration doivent être présents afin de pouvoir prendre une décision. Ce quorum de présence n'est pas nécessaire
pour les décisions de modification et de constatation du Conseil d'administration en lien avec les augmentations du capital-actions.
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3 The Board of Directors shall adopt its resolutions by a majority of votes cast. In the case of a tie, the Chairman of the Board of Directors shall have the
casting vote.
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3 Les décisions du Conseil d'administration sont prises à la majorité des voix exprimées. En cas d'égalité des voix, la voix du président du Conseil
d'administration prévaut.
|
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4 Resolutions may also be adopted by way of written consent or by approval via telefax, e-mail or another form of electronic communication, unless a member
requests discussion thereof.
|
4 Les décisions du Conseil d'administration peuvent également être prises par voie de circulation ou être adoptées par télécopie, courriel ou par un autre
moyen de communication électronique, à moins qu'une discussion ne soit requise par l'un des membres du Conseil d'administration.
|
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5 The decisions of the Board of Directors shall be recorded in minutes to be signed by the acting chair and the secretary.
|
5 Les décisions du Conseil d'administration sont consignées dans un procès-verbal signé par le président et par le secrétaire.
|
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Article 20
|
Article 20
|
|||
Powers of the Board
of Directors
|
1 The Board of Directors may pass resolutions with respect to all matters which are not delegated to another corporate body of the Company by law, by these
articles of association or by regulations.
|
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Attributions du Con
seil d'administration
|
1 Le Conseil d'administration peut prendre des décisions sur toutes les affaires qui ne sont pas attribuées à un autre organe de la Société par la loi, les
présents statuts ou un règlement.
|
2 It shall have the following non-transferable and inalienable duties:
|
2 Il a les attributions intransmissibles et inaliénables suivantes:
|
1. the ultimate management of the Company and the issuance of necessary instructions;
|
1. exercer la haute direction de la Société et établir les instructions nécessaires;
|
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2. the determination of the organization of the Company;
|
2. fixer l'organisation de la Société;
|
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3. the structuring of the accounting system, of the financial controls and of the financial planning;
|
3. fixer les principes de la comptabilité et du contrôle financier ainsi que le plan financier;
|
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4. the appointment and dismissal of the persons entrusted with management and representation of the Company, and issuance of rules on the signature authority;
|
4. nommer et révoquer les personnes chargées de la gestion et de la représentation de la Société et réglementer le droit de signature;
|
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5. the ultimate supervision of the persons entrusted with management, in particular in view of compliance with the law, these articles of association, regulations and directives;
|
5. exercer la haute surveillance sur les personnes chargées de la gestion pour s'assurer notamment qu'elles observent la loi, les présents statuts, les règlements et les instructions
données;
|
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6. the preparation of the annual report and the compensation report;
|
6. établir le rapport de gestion et le rapport de rémunération;
|
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7. the preparation of the General Meeting of Shareholders and the implementation of its resolutions;
|
7. préparer l'Assemblée générale et exécuter ses décisions;
|
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8. the adoption of resolutions on the increase of the share capital to the extent that such power is vested in the Board of Directors, the ascertainment of capital increases, the
preparation of the report on the capital increase, and the respective amendments of the articles of association (including deletions);
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8. prendre les décisions relatives aux augmentations du capital-actions, dans la mesure où elles sont de la compétence du Conseil d'administration, ainsi que les décisions relatives à
la constatation d'augmentations de capital, à l'établissement du rapport d'augmentation du capital-actions et aux modifications des statuts qui en résultent (radiation comprise);
|
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9. the non-transferable and inalienable duties and powers of the Board of Directors pursuant to the Merger Act;
|
9. les attributions et compétences intransmissibles et inaliénables du Conseil d'administration selon la Loi sur la fusion;
|
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10. the notification of the judge if liabilities exceed assets; and
|
10. informer le juge en cas de surendettement; et
|
Article 23
|
Article 23
|
|||
Organization of the
Compensation
Committee
|
1 The Compensation Committee shall constitute itself. Unless the organizational regulations provide otherwise, the Board of Directors shall elect a chairman
from among the Compensation Committee's members.
|
|
Organisation du Co
mité de rémunéra
tion
|
1 Le Comité de rémunération se constitue lui-même. A moins que le règlement d'organisation n'en dispose autrement, le Conseil d'administration élit le
Président du Comité de rémunération parmi les membres du Comité de rémunération.
|
2 The Board of Directors shall issue regulations establishing the organization and decision-making process of the Compensation Committee, which may be part of
the organizational regulations.
|
2 Le Conseil d'administration établit un règlement concernant l'organisation et le processus de décision du Comité de rémunération, qui peut être intégré au
règlement d'organisation.
|
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Article 24
|
Article 24
|
|||
Duties and Powers
|
1 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 the Executive Committee. It may submit proposals to the Board of Directors in other compensation-related issues.
|
Attributions
|
1 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 préparation des propositions à soumettre à l'Assemblée générale concernant la rémunération du Conseil d'administration et de la Direction exécutive. Il peut soumettre au Conseil d'administration des propositions en toutes autres
matières relatives à la rémunération.
|
|
2 The Board of Directors shall determine in regulations for which positions of the Board of Directors, the Executive Committee and other member of management
(if any) the Compensation Committee shall submit proposals for the performance metrics, target values and/or the compensation of the members of the Board of Directors and the Executive Committee, and
for which positions it shall itself determine, in accordance with these articles of association and the compensation guidelines established by the Board of Directors, such performance metrics, target values and/or the compensation.
|
2 Le Conseil d'administration détermine dans un règlement pour quelles fonctions du Conseil d'administration, de la Direction exécutive et d'autres membres
de la direction (si applicable) le Comité de rémunération proposera au Conseil d'administration les mesures de performances, les valeurs cibles et/ou la rémunération des membres du Conseil d'administration et de la Direction exécutive, et
pour quelles fonctions il aura la 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/ou la
rémunération.
|
3 The Board of Directors may delegate further tasks to the Compensation Committee.
|
3 Le Conseil d’administration peut déléguer d'autres tâches au Comité de rémunération.
|
|||
D. The Auditors
|
D. L'organe de révision
|
|||
Article 25
|
Article 25
|
|||
1 The General Meeting of Shareholders shall elect the Auditors for a term of office until the completion of the next Ordinary General Meeting of
Shareholders. Re-election is possible.
|
1 L'Assemblée générale élit l'organe de révision pour une durée de fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La réélection
est possible.
|
|||
2 The Auditors shall have the powers and duties vested in them by law.
|
2 L'organe de révision a les pouvoirs et obligations que lui confère la loi.
|
|||
3 The Board of Directors may mandate the Auditors at any time to perform special investigations, in particular interim audits, and to prepare a report on
their findings.
|
3 Le Conseil d'administration peut en tout temps charger l'organe de révision de procéder à des contrôles spéciaux, notamment des révisions intermédiaires,
et de lui en soumettre un rapport.
|
|||
Section 4
Compensation of the Members of the Board of Directors and the Executive Committee and Related Matters
|
Section 4
Rémunération des membres du Conseil d'administration et de la Direction exécutive et affaires connexes
|
|||
Article 26
|
Article 26
|
|||
Approval of the
Compensation by
the General Meeting
of Shareholders
|
1 The General Meeting of Shareholders shall approve the proposals of the Board of Directors in relation to the aggregate amounts of:
|
Approbation de la
rémunération par
l'Assemblée géné
rale
|
1 L'Assemblée générale approuve les propositions du Conseil d'administration en relation avec les montants maximaux suivants:
|
|
1. the maximum compensation of the Board of Directors until the completion of the next Ordinary General Meeting of Shareholders;
|
1. la rémunération maximale du Conseil d'administration jusqu'à la fin de l'Assemblée générale ordinaire des actionnaires suivante;
|
2. the maximum fixed compensation of the Executive Committee for the following financial year; and
|
2. la rémunération fixe maximale de la Direction exécutive pour l'année comptable suivante; et
|
|||
3. the maximum variable compensation of the Executive Committee for the current financial year.
|
3. la rémunération variable maximale de la Direction exécutive pour l'exercice en cours.
|
|||
2 The Board of Directors may submit for approval by the General Meeting of Shareholders deviating, additional or conditional proposals relating to the
maximum aggregate amount or maximum partial amounts for the same or different periods and/or specific compensation components and/or in relation to additional amounts for specific compensation components.
|
2 Le Conseil d'administration peut soumettre à l'approbation de l'Assemblée générale des propositions divergentes, supplémentaires ou conditionnelles
concernant le montant maximal total ou les montants maximaux partiels pour les mêmes périodes ou des périodes différentes et/ou des éléments de rémunération spécifiques et/ou en relation avec des montants additionnels pour des éléments de
rémunération spécifiques.
|
|||
3 In the event that the General Meeting of Shareholders does not approve a proposal of the Board of Directors, the Board of Directors shall determine, taking
into account all relevant factors, the respective (maximum) aggregate amount or (maximum) partial amounts, and submit the amount(s) so determined for approval by a General Meeting of Shareholders.
|
3 Si l'Assemblée générale n'approuve pas une proposition du Conseil d'administration, le Conseil d'administration détermine, 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 d'une Assemblée générale.
|
|||
4 The Company or companies controlled by it may pay or grant compensation prior to approval by the General Meeting of Shareholders, subject to subsequent
approval.
|
4 La rémunération peut être versée ou octroyée par la Société ou les sociétés qu'elle contrôle avant l'approbation de l'Assemblée générale, sous réserve
d'une approbation ultérieure.
|
|||
Article 27
|
Article 27
|
|||
Supplementary
Amount for
Changes to the Ex
ecutive Committee
|
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 Committee or are being
promoted within the Executive Committee after the General Meeting of Shareholders has approved the compensation of the Executive Committee for the relevant period, then the Company or companies controlled by it shall be authorized to pay such
member(s) a supplementary amount during the compensation period(s) already approved. The supplementary amount per compensation period per member shall not exceed 100% of the aggregate amount of (maximum) compensation of the Executive
Committee last approved.
|
Montant complé
mentaire en cas de
changements au
sein de la Direction
exécutive
|
Si le montant global maximal de la rémunération déjà approuvé par l'Assemblée générale n'est pas suffisant pour couvrir également la rémunération d'une ou plusieurs personnes devenant membre(s) de la Direction exécutive ou étant promue(s)
au sein de la Direction exécutive après que l'Assemblée générale a approuvé la rémunération de la Direction exécutive pour la période visée, la Société ou toute autre société qu'elle contrôle est alors autorisée à verser à ce(s) membre(s) un
montant complémentaire au cours de la (ou les) période(s) de rémunération déjà approuvée(s). Le montant complémentaire par période de compensation par membre ne doit pas dépasser 100% du montant global
de la rémunération (maximale) de la Direction exécutive approuvée en dernier.
|
Article 28
|
Article 28
|
|||
General Compensa
tion Principles
|
1 The compensation of the non-executive members of the Board of Directors may consist of fixed and variable compensation elements. Total compensation shall
take into account the position and level of responsibility of the recipient.
|
Principes généraux
de rémunération
|
1 La rémunération des membres non-exécutifs du Conseil d'administration peut être constituée d'éléments de rémunérations fixes et variables. La rémunération
totale prend en compte la position et le niveau de responsabilité du bénéficiaire.
|
|
2 The compensation of the members of the Executive Committee may consist of fixed and variable compensation elements. Fixed compensation comprises the base
salary and may consist of other compensation elements. Variable compensation may take into account the achievement of specific performance targets. Total compensation shall take into account the position and level of responsibility of the
recipient.
|
2 La rémunération des membres de la Direction exécutive peut être constituée d'éléments de rémunération fixes et variables. La rémunération fixe comprend le
salaire de base et peut être constituée d'autres éléments de rémunération. La rémunération variable peut prendre en compte l'accomplissement d'objectifs de performance spécifiques. La rémunération totale prend en compte la position et le
niveau de responsabilité du bénéficiaire.
|
|||
3 The performance targets may include individual targets, targets of the Company, group or parts thereof or targets in relation to the market, other
companies or comparable benchmarks, taking into account the position and level of responsibility of the recipient. The Board of Directors or, to the extent delegated to it, the Compensation Committee shall determine the relative weight of the
performance targets and the respective target values.
|
3 Les objectifs de performance peuvent comprendre des objectifs personnels, des objectifs liés à la performance de la Société ou de tout ou partie du groupe
ou des buts en relation avec le marché, d'autres sociétés ou d'autres repères comparables, prenant en compte la position et le niveau de responsabilité du bénéficiaire. Le Conseil d'administration ou le Comité de rémunération, dans la mesure
où cette compétence lui est déléguée, détermine le poids relatif des objectifs de performance et les valeurs cibles respectives.
|
4 Compensation may be paid in the form of cash, shares, options or other 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 determine grant, vesting, exercise, restriction and forfeiture conditions and periods. In particular, they may provide for continuation, acceleration or
removal of vesting, exercise, restriction and forfeiture conditions and periods, for payment or grant of compensation based upon assumed target achievement, or for forfeiture, in each case in the event of pre-determined events such as a
change of control or termination of an employment or mandate agreement. The Company may procure the required shares or other securities through purchases in the market, from treasury shares or by using conditional or authorized share capital.
|
4 La rémunération peut être versée en espèces, sous forme d'actions, d'options ou d'instruments ou unités sur base d'actions ou d'autres types de
prestations. Le Conseil d'administration ou le Comité de rémunération, dans la mesure où cette compétence lui a été déléguée, détermine les conditions et périodes d'octroi, d'acquisition (vesting),
d'exercice, de restriction et de péremption. Ils peuvent en particulier prévoir la continuation, l'accélération ou la suppression des conditions ou périodes d'acquisition (vesting), d'exercice, de
restriction et de péremption, le versement ou l'octroi d'une rémunération supposant l'atteinte des objectifs ou encore la déchéance des droits, dans chaque cas lors d'événements prédéterminés 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 ou autres instruments des marchés financiers requis par le biais d'achats sur le marché ou d'actions propres, ou en utilisant son capital-actions
conditionnel ou autorisé.
|
|||
5 Compensation may be paid by the Company or companies controlled by it.
|
5 La rémunération peut être versée par la Société ou tout autre société qu'elle contrôle.
|
|||
Article 29
|
Article 29
|
|||
Agreements with
Members of the
Board of Directors
and the Executive
Committee
|
1 The Company or companies controlled by it may enter into agreements with non-executive members of the Board of Directors relating to their compensation for
a fixed term or for an indefinite term. The duration and termination are subject to the term of office and the law.
|
Contrats avec les
membres du Con
seil d'administration
et de la Direction
exécutive
|
1 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de durée déterminée ou indéterminée avec les membres non-exécutifs du Conseil
d'administration en relation avec leur rémunération. La durée et la résiliation doivent être conformes avec la durée des fonctions ainsi qu'avec les dispositions légales applicables.
|
|
2 The Company or companies controlled by it may enter into employment agreements with executive members of the Board of Directors and other members of the
Executive Committee for a fixed term or for an indefinite term. Fixed term agreements may have a maximum duration of one year; renewal is possible. Agreements for an indefinite term may have a notice period of maximum twelve months.
|
2 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de travail de durée déterminée ou indéterminée avec les membres exécutifs du
conseil d'administration et les autres membres de la Direction exécutive. Les contrats de durée déterminée peuvent avoir une durée maximale d'une année; le renouvellement est possible. Les contrats de durée indéterminée peuvent prévoir un
délai de congé d'au maximum douze mois.
|
3 The Company or companies controlled by it may enter into non-compete agreements with members of the Executive Committee for the time after termination of
employment. Their duration shall not exceed two years, and consideration paid per year for such non-compete undertaking shall not exceed the sum of the total annual compensation of such member last paid or payable for the first time.
|
3 La Société, ou toute société qu'elle contrôle, peut conclure des accords de non-concurrence avec les membres de la Direction exécutive pour la période
suivant la fin des rapports de travail. Leur durée ne peut excéder deux ans, et l'indemnisation par an versée en contrepartie d'un tel accord de non concurrence ne peut excéder la somme de la dernière rémunération annuelle totale versée ou à
verser pour la première fois au membre concerné.
|
|||
Article 30
|
Article 30
|
|||
Mandates Outside
of the Group
|
1 The number of mandates on the board of directors or the executive committee of legal entities that have to be registered in a Swiss commercial register or a
similar foreign register outside the group is limited:
|
Mandats en dehors
du groupe
|
1 Le nombre de mandats d'administrateur et/ou au sein de la Direction exécutive d'entités juridiques tenues d'être inscrites au registre du commerce suisse
ou dans un registre similaire étranger est limité:
|
|
(a) for members of the Executive Committee, to seven mandates, of which no more than two in a listed company; and
|
(a) pour les membres de la Direction exécutive, à sept mandats, dont pas plus de deux au sein de sociétés cotées; et
|
|||
(b) for members of the Board of Directors, to fifteen mandates, of which no more than five in listed companies.
|
(b) pour les membres du Conseil d'administration à quinze mandats, dont pas plus de cinq au sein de sociétés cotées.
|
|||
2 Mandates in different legal entities being part of the same group or for the same group are deemed to be one mandate.
|
2 Les mandats dans différentes entités juridiques appartenant au même groupe ou assumés pour le même groupe sont considérés comme un mandat.
|
|||
3 Mandates in associations, charitable organizations, family trusts and foundations relating to post-retirement benefits are not subject to the above
limitations. No member of the Board of Directors or the Executive Committee shall hold more than 10 such mandates.
|
3 Les mandats dans des associations, organisations caritatives, fondations de famille et fondations de prévoyance professionnelle ne sont pas soumis aux
limites mentionnées ci-dessus. Aucun membre du Conseil d'administration ou de la Direction exécutive ne peut exercer plus de 10 mandats de ce genre.
|
Article 31
|
Article 31
|
|||
Post-Retirement
Benefits
|
The Company or companies controlled by it may grant to members of the Board of Directors and the Executive Committee post-retirement benefits beyond the occupational benefit schemes which do not exceed the annual compensation of the
respective member of the Board of Directors or the Executive Committee last paid or payable for the first time.
|
Prestations de re
traite
|
La Société ou toute société qu'elle contrôle peut octroyer aux membres du Conseil d'administration et de la Direction exécutive des prestations de retraite allant au-delà du régime de prévoyance professionnelle n'excédant pas la
rémunération annuelle du membre du Conseil d'administration ou de la Direction exécutive concerné versée ou à verser pour la première fois.
|
|
Section 5
Financial Year, Profit Allocation
|
Section 5
Exercice, répartition du bénéfice
|
|||
Article 32
|
Article 32
|
|||
Financial Year, An
nual and Compen
sation Report
|
1 The Company's financial year shall be determined by the Board of Directors.
|
Exercice social, rap
port de gestion et de
rémunération
|
1 L'exercice est fixé par le Conseil d'administration.
|
|
2 The Board of Directors shall prepare an annual report for each financial year, comprising the annual financial statements, if required, the management
report and the consolidated financial statements, as well as a compensation report.
|
2 Le Conseil d'administration établit pour chaque exercice un rapport de gestion, qui se compose des comptes annuels et, cas échéant, du rapport annuel et des
comptes de groupe, ainsi qu'un rapport de rémunération.
|
|||
Article 33
|
Article 33
|
|||
Allocation of Profit
Shown on the Bal
ance Sheet, Re
serves
|
1 The General Meeting of Shareholders shall resolve on the allocation of the profit as shown on the balance sheet in accordance with applicable law. The
Board of Directors shall submit its proposals to the General Meeting of Shareholders.
|
Utilisation du béné
fice résultant du
bilan, réserves
|
1 L'Assemblée générale détermine l'emploi du bénéfice résultant du bilan, sous réserve des prescriptions légales concernant la répartition du bénéfice. Le
Conseil d'administration lui soumet ses propositions.
|
|
2 In addition to the reserves required by law, the General Meeting of Shareholders may create other reserves.
|
2 En sus des réserves légales, l'Assemblée générale peut constituer des réserves supplémentaires.
|
3 Dividends that have not been collected within five years after their payment date shall inure to the Company and be allocated to the general statutory
reserves.
|
3 Les dividendes qui n'ont pas été perçus dans un délai de cinq ans après leur date de paiement sont prescrits et sont alloués aux réserves statutaires de la
Société.
|
|||
Section 6
Dissolution, Liquidation
|
Section 6
Dissolution, liquidation
|
|||
Article 34
|
Article 34
|
|||
Dissolution, Liquida
tion
|
1 The General Meeting of Shareholders may at any time resolve to dissolve and liquidate the Company in accordance with the law and the provisions set forth
in these articles of association.
|
Dissolution, liquida
tion
|
1 L'Assemblée générale peut décider en tout temps de la dissolution et de la liquidation de la Société en conformité avec les prescriptions légales et
statutaires.
|
|
2 The liquidation shall be effected by the Board of Directors, unless the General Meeting of Shareholders appoints other persons as liquidators.
|
2 La liquidation a lieu par les soins du Conseil d'administration, à moins que l'Assemblée générale ne désigne d'autres liquidateurs.
|
|||
3 The liquidation of the Company shall be effected pursuant to applicable law. The liquidators shall be entitled to sell assets (real estate included) in
private transactions.
|
3 La liquidation de la Société s'effectue conformément au droit applicable. Les liquidateurs sont autorisés à vendre des actifs (immeubles y compris) de gré
à gré.
|
|||
4 Upon discharge of all liabilities of the Company, the assets shall be distributed to the shareholders in proportion to the share capital, unless these
articles of association provide otherwise.
|
4 Après paiement des dettes de la Société, l'actif est réparti entre les actionnaires au prorata du capital-actions, à moins que les présents statuts n'en
disposent autrement.
|
Section 7
Notices, Communications
|
Section 7
Communications, organe de publication
|
|||
Article 35
|
Article 35
|
|||
Notices, Communi
cations
|
1 The official means of publication of the Company shall be the Swiss Official Gazette of Commerce.
|
Communications,
organe de publica
tion
|
1 L'organe de publication de la Société est la Feuille officielle suisse du commerce.
|
|
2 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. Written communications by the Company to its shareholders shall be sent by ordinary mail to the last address of the shareholder or authorized recipient entered in the share register. If neither these articles of
association nor the law mandatorily require a communication to be in written form, the Company can validly send communications to the shareholders to the last e-mail address of the shareholder or authorized recipient communicated to the
Company, through the banking system, electronically, by publication in the Swiss Official Gazette of Commerce or in any other way. To comply with a written form, a facsimile or electronic copy of a signature shall be sufficient.
|
2 Dans la mesure où la loi n’exige pas de notification personnelle, toutes les communications aux actionnaires publiées dans la Feuille officielle suisse du
commerce seront réputées valides. Les communications écrites adressées par la Société à ses actionnaires seront envoyées par courrier ordinaire à la dernière adresse de l’actionnaire ou de son bénéficiaire autorisé qui figure sur le registre
des actions. Si ni la loi ni les présents statuts n'imposent qu'une communication revête la forme écrite, la Société peut valablement envoyer une telle communication aux actionnaires par courriel, à la dernière adresse e-mail de l’actionnaire
ou de son bénéficiaire autorisé communiquée à la Société, par l'intermédiraire du système bancaire, électroniquement, par publication dans la Feuille officielle suisse du commerce ou de toute autre manière. Un téléfax ou une copie
électronique de la signature suffisent pour se conformer à la forme écrite.
|
|||
Section 8
Authoritative Language
|
Section 8
Langue faisant foi
|
|||
Article 36
|
Article 36
|
|||
Authoritative Lan
guage
|
In the event of discrepancies between the French and English version of these articles of association, the French version shall prevail.
|
Langue faisant foi
|
En cas de désaccord entre la version française et la version anglaise, la version française des présents statuts prévaut.
|
1. |
ADC Products (UK) Limited, a company
incorporated and registered in England & Wales with company number 03925411 whose registered office is at 4th Floor, Reading Bridge House, George
Street, Reading, Berkshire RG1 8LS, United Kingdom (“ADCP”) (formerly Spirogen Ltd, having its principal place of business at 79 George Street, Ryde, Isle of Wight PO33 2JF, United Kingdom (“Spirogen Ltd”)),
|
2. |
ADC Therapeutics SA, a Swiss
corporation, having its principal place of business at Rue Saint-Pierrre 2, 1003 Lausanne, Switzerland (“ADCT”, also known as “Licensee”) [(formerly ADC
Therapeutics Sàrl)];
|
3. |
MedImmune Limited, a company
registered in England and Wales with company number 2451177 and registered office at Milstein Building, Granta Park, Cambridge CB21 6GH (“MedImmune”) (successor in interest to Spirogen Sarl, of
Rue Saint-Pierre 2, 1003 Lausanne, Switzerland (“Spirogen Sarl”)).
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
2 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
3 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
4 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
5 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
6 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
7 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
8 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
9 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
10 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
11 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
12 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
13 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
14 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
15 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
16 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
17 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
18 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
19 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
20 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
21 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
If to Licensee:
|
ADC Therapeutics SA
|
|
[**]
|
||
With copy to
|
||
[**]
|
||
If to ADCP:
|
ADC Products (UK) Limited
|
|
[**]
|
||
If to MedImmune:
|
MedImmune Limited
|
|
[**]
|
||
With a Copy to:
|
||
[**]
|
22 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
23 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
ADC PRODUCT LIMITED
|
|||
By:
|
/s/ Michael Forer
|
||
Name:
|
Michael Forer
|
||
Title:
|
Director
|
MEDIMMUNE LTD
|
|||
By:
|
/s/ Christopher S. Winter
|
||
Name:
|
Christopher S. Winter
|
||
Title:
|
European Patent Counsel
|
ADC THERAPEUTICS SA
|
|||
By:
|
/s/ Chris Martin
|
||
Name:
|
Chris Martin
|
||
Title:
|
CEO
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
25 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
[**]
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26 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
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27 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
[**]
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28 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
29 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
[**]
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30 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
CONFIDENTIAL
|
|
Certain confidential information contained in this document, marked by [**], has been omitted because ADC
Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive
harm to ADC Therapeutics SA (ADCT) if publicly disclosed.
|
1. |
The Parties agree to cancel, delete and replace Section 2.3.3. of the License Agreement with the following new Section 2.3.3:
|
2. |
Unless they are defined in this Amendment #1, all terms used with a capital and not defined herein shall have the meaning set forth in the License Agreement.
|
3. |
All other terms and conditions of the License Agreement shall remain in full force and effect. In the event of any conflict between this Amendment #1 and the License Agreement, this
Amendment #1 shall prevail.
|
4. |
This Amendment #1 shall enter into force on the Amendment Effective Date set forth above and shall be governed by English law.
|
ADC PRODUCTS (UK) LTD.
|
ADC THERAPEUTICS SA
|
|||
By:
|
/s/ Michael Forer
|
By:
|
/s/ Chris Martin
|
|
Name:
|
Michael Forer
|
Name:
|
Chris Martin
|
|
Title:
|
Director
|
Title:
|
CEO
|
MEDIMMUNE LTD.
|
||||
By:
|
/s/ C S Winter
|
|||
Name:
|
Christopher S. Winter
|
|||
Title:
|
Authorised Signatory
|
2
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
3
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
4
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
5
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
6
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
7
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
8
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
9
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
10
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
11
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
12
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
13
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
14
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
15
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
16
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
17
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
18
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
19
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
20
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
21
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
22
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
|
9.6.1 |
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9.6.2 |
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9.6.3 |
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9.6.4 |
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9.6.5 |
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9.6.7 |
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9.6.8 |
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9.6.9 |
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23
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Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
24
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
25
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
26
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
27
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
28
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
29
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
30
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
31
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
32
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
33
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
34
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
35
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
36
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
37
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
38
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
ADC Therapeutics Sarl
|
||
By:
|
/s/ Michael Forer
|
|
Name:
|
Michael Forer | |
Title:
|
Chief Executive Officer |
Genmab A/S
|
||
By:
|
/s/ [**]
|
|
Name:
|
[**] | |
Title:
|
[**] |
39
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 1
|
page 1 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 1
|
page 2 |
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 2
|
page 1
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 3
|
page 1
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 4
|
page 1
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 5
|
page 1
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Schedule 6
|
page 1
|
Certain confidential information contained in this document, marked by [**], has been omitted because
ADC Therapeutics SA (ADCT) has determined that the information (i) is not material and (ii) would likely cause competitive harm to ADC Therapeutics SA (ADCT) if publicly disclosed. |
Genmab A/S
[**]
[**] [**] |
ADC Therapeutics Sarl
Rue Saint-Pierre 2
Lausanne, 1003
Switzerland
|
|||
Signature:
|
/s/ [**]
|
Signature:
|
/s/ Michael Forer
|
|
Print Name:
|
[**]
|
Print Name:
|
Michael Forer
|
|
Title:
|
[**]
|
Title:
|
CEO
|
ADC Therapeutics SA
|
||
By:
|
/s/ Michael Forer
|
|
Name: |
Michael Forer
|
|
Title: |
Vice Chairman & EVP
|
|
Genmab A/S | ||
By:
|
/s/ Birgitte Stephensen
|
|
Name: |
Birgitte Stephensen
|
|
Title: |
SVP, IPR & Legal
|
|
Exhibit 10.6
www.bonddickinson.com
14 September 2017
Lease relating to
Suite 5, 1st floor, The Queen Mary BioEnterprises Innovation Centre
Whitechapel 42 New Road London E 1 2AX
Queen Mary Bioenterprises Limited (1)
and
ADC Therapeutics (UK) Limited (2)
Bond Dickinson LLP
Tel +44(0)345 415 0000
www.bonddickinson.com
Clause | Page | |
1. | PARTICULARS | 1 |
2. | DEFINITIONS | 2 |
3. | INTERPRETATION | 3 |
4. | GRANT | 3 |
5. | TENANT’S COVENANTS | 3 |
6. | LANDLORD’S COVENANTS | 9 |
7. | PROVISO | 10 |
8. | MUTUAL OPTION TO BREAK | 12 |
9. | RENT REVIEW | 12 |
10. | EXCLUSION OF SECURITY OF TENURE | 14 |
SCHEDULE 1
|
15
|
|
Rights Granted
|
15
|
|
SCHEDULE 2
|
16
|
|
Rights Reserved
|
16
|
|
SCHEDULE 3
|
17
|
|
Subjections
|
17
|
|
SCHEDULE 4
|
18
|
|
Services
|
18
|
|
SCHEDULE 5
|
20
|
|
Services
|
20
|
|
SCHEDULE 6
|
22
|
|
Plan
|
22
|
|
SCHEDULE 7
|
23
|
|
Rent
|
23
|
DATE
PARTIES
(1) | Queen Mary Bioenterprises Limited (No. 04324033) whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS. |
(2) | ADC Therapeutics (UK) Limited (No. 09353055) whose registered office is at 4th Floor Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS. |
AGREED TERMS | |||
1. | PARTICULARS | ||
Business Day | a day on which banks are open for business in London which is not a Saturday or Sunday or bank holiday. | ||
Building | the Queen Mary Bioenterprises Innovation Centre 42 New Road Whitechapel E1 2AX being all the land comprised in Title Number EGL520546. | ||
Group Company | a company that is a member of the same group as the Tenant within the meaning of Section 42 of the Landlord and Tenant Act 1954 (as amended). | ||
Premises | Suite 5, First Floor of The Queen Mary Bioenterprises Innovation Centre 42 New Road Whitechapel E1 2AX shown edged yellow on the Plan which forms Schedule 6 hereto which includes: | ||
(a) | all additions and improvements to the Premises; | ||
(b) | all Landlord’s fixtures and fittings and all other fixtures of every kind which shall from time to time be in or upon the Premises (whether originally affixed or fastened to or upon the Premises or otherwise) except any trade fixtures installed by the Tenant which can be removed from the Premises without causing any material damage to the Premises; | ||
(c) | the internal faces (including the plaster paint and other decorative finishes but not any other part) of the walls which enclose the Premises and of the walls within the Premises; | ||
(d) | the screed and finish (but not any other part) of the floors within the Premises; | ||
(e) | the suspended ceiling and the internal faces including the tiles plaster paint and other decorative finishes of it and all light fittings therein; | ||
(f) | all doors door furniture door frames and glass in such door within premises; | ||
But excluding: | |||
(a) | the windows in the exterior walls and their frames and fittings; | ||
the whole of the interior structural load bearing walls and columns within that part of the Building other than their plasterwork and other than the doors and windows and their frames and fittings within such walls; |
Superior Landlord | Queen Mary and Westfield College, University of London. | |
Superior Lease | a lease dated 15 March 2007 and made between (1) the Superior Landlord and (2) Queen Mary Innovation Limited. | |
VAT | Value Added Tax or any other such imposition or levy of a like nature which may extend or replace Value Added Tax. |
3. | INTERPRETATION |
3.1 | The expressions the Superior Landlord the Landlord and the Tenant wherever the context so admits include their respective successors in title. |
3.2 | Words importing the one gender include all other genders and words importing the singular include the plural and vice versa. |
3.3 | References to any right of the Landlord to have access to the Premises shall be construed as extending to all persons reasonably authorised by the Landlord and also the Superior Landlord. |
3.4 | Any covenant by the Ten ant not to do an act or thing shall be deemed to include an obligation not to permit such act or thing to be done. |
3.5 | Any reference to a specific statute includes any statutory extension or modification or reenactment of such statute and any regulations or orders made there under and any general reference to ‘statute’ or ‘statutes’ includes any regulations or orders made there under. |
4. | GRANT |
4.1 | The Landlord lets the Premises to the Tenant for the Term with full title guarantee. |
4.2 | The grant is made together with the rights specified in Schedule 1 excepting and reserving to the Landlord the rights specified in Schedule 2 and subject to the matters referred to in Schedule 3. |
4.3 | The grant 2019 is made with the Tenant paying the following as rent to the Landlord: |
4.3.1 | the Rent and all VAT in respect of it; |
4.3.2 | all interest payable under this Lease; and |
4.3.3 | all other sums due under this Lease. |
5. | TENANT’S COVENANTS |
The Tenant covenants with the Landlord:
5.1 | Rents |
To pay the Rent and any VAT in respect of it (whether formally demanded or not) without any deduction or set off by twelve (12) equal monthly instalments in advance on or before the Rent Payment Dates. The payments shall be made by electronic means and the first such payment shall be made on the date of this Lease and shall be a proportionate sum in respect of the period from and including the Rent Commencement Date to and including the day before the Rent Payment Date next following.
5.2 | Security Deposit |
5.2.1 | On or before the date of this Lease the Tenant shall pay the Deposit to the Landlord. The Deposit shall belong to the Tenant subject to the terms of this Lease; |
5.2.2 | The Tenant shall pay to the Landlord such sum or sums necessary to ensure that the Deposit is not less than the Minimum Amount within 10 Business Days of the date upon which each and every review of Rent is settled in accordance with the terms of this Lease (and the Landlord shall provide the Tenant with a written demand for such payment); |
5.2.3 | If: |
(a) | an event of default by the Tenant (as set out in clause 7.1) exists under this Lease at any time or; |
(b) | the Tenant fails to comply with the yielding up requirements of clause 5.11 on or following the expiry of the Term (however so determined); |
the Landlord shall forthwith give notice thereof to the Tenant in writing and may use or apply or retain the whole or any part of the Deposit to the extent necessary to cure the event of default;
5.2.4 | If at any time during or following the Term of this Lease the Landlord applies all or a portion of the Deposit to cure the Tenant’s event of default the Tenant shall repay to the Landlord within ten (10) Business Days after written demand by the Landlord any amount necessary to restore the Deposit to the Minimum Amount; |
5.2.5 | At the end of the Term (howsoever determined) the Tenant shall at its own cost appoint an independent consultant (such appointment to be approved by the Landlord such approval not to be unreasonably withheld or delayed) to inspect the Premises, the ceiling void air supply and extract ductwork, the ceiling void ductwork connected to the Tenant’s ducted fume hoods and dueled equipment and provide a certificate of decontamination to confirm that the Premises are free from contamination by radioactive or other toxic substances and that there has been no spread of any contamination into the ceiling void ductwork or otherwise. In the event that a satisfactory decontamination certificate is not produced within five (5) Business Days after the end of the Term (howsoever determined) the Landlord may: |
(a) | require the Tenant to remove at its own cost and within a period of fifteen (15) Business Days after the end of the Term the fume hoods (such works to be carried out to the satisfaction of the Landlord); and or |
(b) | implement its own decontamination processes on the Premises and ceiling void ductwork using an independent consultant (and using reasonable endeavours to complete these processes within twelve months after the end of the Term) and if at any time the costs incurred by the Landlord in carrying out its decontamination processes exceed the Deposit the Tenant shall pay the balance sum to the Landlord within ten (10) Business Days of written demand. |
5.2.6 | If the Tenant has provided a certificate of decontamination in accordance with clause 5.2.4 the Deposit or the balance of it (if any) shall be returned to the Tenant within three (3) months of the end of the Term; |
5.2.7 | If the Landlord requires the Tenant to remove the fume hoods as detailed in clause 5.2.4 (a) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the removal works have been completed to the satisfaction of the Landlord or within 3 months of the date on which the Landlord’s decontamination process has been concluded, whichever is the latest; |
5.2.8 | If the Landlord implements its own decontamination processes as detailed in clause 5.2.4 (b) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the Landlord’s decontamination processes have been concluded or within 3 months of the date on which the fume hood removal works have been completed to the satisfaction of the Landlord, whichever is the latest. |
5.3 | Operating Expenses |
The Tenant agrees to pay to the Landlord within twenty (20) Business Days of written demand any and all operating expenses expressly set out below:
5.3.1 | Sub-metered chargeable electrical usage for the Premises as evidenced by the Landlord (see Schedule 5 of this Lease); |
5.3.2 | Use of other fee-for-use services such as usage of the telecoms lines and meeting room usage; |
5.3.3 | Electricity charges as evidenced by the Landlord covering the air handling systems connected to any Tenant’s ducted equipment e.g. fume hoods (every three (3) months payable within twenty (20) Business Days of written demand). |
5.4 | Outgoings |
To pay and indemnify the Landlord against all rates taxes assessments duties charges impositions and outgoings which are now or during the Term shall be charged assessed or imposed on the Premises or upon the owner or occupier of them excluding any payable by the Landlord which in the absence of a direct assessment shall be reasonably determined by the Landlord.
5.5 | Repair |
To keep the Premises in good repair and decorative order and in a clean and tidy state and condition at all times, but in no better condition than as evidenced by the photographic schedule of condition attached hereto.
5.6 | Alterations and Additions |
5.6.1 | Structural alterations external alterations and additions are not permitted; |
5.6.2 | Not to make any internal non-structural alterations or additions (including partitioning) to the whole or any part of the Premises without the Landlord’s prior written consent (such consent not to be unreasonably withheld or delayed) and approval (such approval not to be unreasonably withheld or delayed) of previously submitted drawings and/or specification in a form reasonably required by the Landlord and if such consent is granted to comply with the Planning Acts in the carrying out of such alterations or additions; |
5.6.3 | For the avoidance of doubt, if the Landlord gives consent to the carrying out by the Tenant of any alterations to the Premises pursuant to clause 5.6.2 above, unless the Superior Landlord agrees to insure any such works from the date on which they are completed, they will at all times be at the sole risk of the Tenant. |
5.7 | Use |
5.7.1 | Not to use the Premises for any purpose other than the Permitted Use; |
5.7.2 | The Tenant covenants not under any circumstances to introduce Schedule 5 Pathogens into the Premises. Schedule 5 Pathogens are defined within the U.K. government’s Act entitled ‘The Schedule 5 to the Anti-Terrorism, Crime and Security Act 2001 (Modification) Order 2007’ and any subsequent modifying Statutory Instruments; |
5.7.3 | The Tenant covenants not under any circumstances to introduce human pathogens within hazard group categories 2, 3 and 4, as defined by the U.K. Government’s Health & Safety Executive Advisory Committee on Dangerous Pathogens, in their document entitled ‘The Approved List of Biological Agents’, dated 15 August 2013; |
5.7.4 | The Tenant covenants to indemnify the Landlord against all expenses costs claims damage and loss arising directly or indirectly from any breach of the provisions of clause 5.7. |
5.8 | Access of Landlord and Notice to Repair |
5.8.1 | Subject to the proviso in paragraph 3 of Schedule 2 to permit the Landlord at all reasonable times and upon prior reasonable notice (save in an emergency); |
(a) | to enter upon the Premises for the purpose of ascertaining that the covenants and conditions of this Lease have been observed and performed or for any other reasonable purpose; |
(b) | to view the state of repair and condition of the Premises; |
5.8.2 | If within one (1) month (or sooner in emergency) of the service of a notice by the Landlord on the Tenant to carry out specified repairs to the Premises which the Tenant has failed to carry out under the terms of this Lease the Tenant has not commenced or is not proceeding diligently with the work referred to in such notice or if the Tenant fails to complete the work within three (3) months (or sooner in emergency) the Tenant shall permit the Landlord to enter the Premises to execute the outstanding work and must pay to the Landlord the proper cost of so doing and all reasonable expenses properly incurred by the Landlord (including legal costs and surveyor’s fees) within seven (7)Business Days of a written demand. |
5.9 | Alienation |
5.9.1 | Save as permitted by clause 5.9.2 or clause 5.9.3, not to assign underlet charge or part with or share possession or occupation of the whole or any part of the Premises or hold the whole or any part of the Premises on trust for another. |
5.9.2 | The Tenant may assign the whole of this Lease with the prior consent of the Landlord provided that it is agreed that the Landlord shall not be under any obligation not to unreasonably withhold or delay the giving of consent to any request for consent to assign submitted in accordance with this clause. |
5.9.3 | The Tenant may share occupation of the Premises with any company that is a member of the same group (within the meaning of section 42 of the LTA 1954) as the Tenant for as long as that company remains within that group and provided that no relationship of landlord and tenant is established by that arrangement. |
5.10 | Nuisance and Residential Restrictions |
5.10.1 | Not to do or permit to be done or suffer to remain upon the Premises anything which in the reasonable opinion of the Landlord may be or become or cause a nuisance annoyance injury or damage to the Landlord or its tenants or the occupiers of adjacent or neighbouring premises and not to obstruct others who are lawfully using any adjoining parts of the Premises; |
5.10.2 | Not to use the Premises for any dangerous noxious noisy or offensive trade or business nor for any illegal or immoral act or purpose and not to sleep or allow any person to sleep in the Premises; |
5.10.3 | Without prejudice to the generality of clauses 5.10.1 and 5.22 of this Lease, unless the lights are switched off, the Tenant must ensure that all blinds and curtains at the windows of the Premises are pulled down at dusk and remain down during all hours of darkness so that no disturbance, nuisance or inconvenience is caused to any neighbouring properties; |
5.11 | Yield Up |
5.11.1 | At the expiry of the Term to yield up the Premises with vacant possession and in accordance with the Tenant’s covenants in this Lease and to give up all keys (if any) of the Premises to the Landlord reinstate any alterations or additions if required by the Landlord and remove all signage erected by the Tenant in upon or near the Premises and forthwith to make good damage caused by such removal or reinstatement at the Tenant’s expense; |
5.11.2 | At the expiry of the Term the Premises should be delivered in a clean and tidy condition and laboratories will be decommissioned and inspected by a qualified independent consultant at tenant’s cost (who shall be first approved by the Landlord) at or before the expiration of the Term and the Tenant shall upon termination of this Lease remove from the Premises all the Tenant’s personal property and any and all owned or leased fixtures and equipment save as provided in clause 5.2 hereof. |
5.12 | Interest on Arrears |
The Tenant must pay Interest on any of the Rent or other sums due under this Lease that are not paid within seven (7) Business Days of the date due whether formally demanded or not. Nothing in this clause entitles the Tenant to withhold or delay any payment of the Rent or any other sum due under this Lease or affects the rights of the Landlord in relation to any non-payment.
5.13 | Costs |
5.13.1 | The Tenant shall pay the costs and expenses of the Landlord including any solicitors’ or other professionals’ costs and expenses incurred (both during and after the end of the Term) in connection with or in contemplation of any of the following: |
(a) | the enforcement of the tenant covenants of this Lease; |
(b) | serving any notice in connection with this Lease under section 146 or 147 of the Law of Property Act 1925 or taking any proceedings under either of those sections, notwithstanding that forfeiture is avoided otherwise than by relief granted by the court; |
(c) | serving any notice in connection with this Lease under section 17 of the Landlord and Tenant (Covenants) Act 1995; |
(d) | the preparation and service of a schedule of dilapidations in connection with this Lease; or |
(e) | any consent or approval applied for under this Lease, whether or not it is granted (unless the consent or approval is unreasonably withheld by the Landlord in circumstances where the Landlord is not unreasonably to withhold it). |
5.13.2 | Where the Tenant is obliged to pay or indemnify the Landlord against any solicitors’ or other professionals’ costs and expenses (whether under this or any other clause of this Lease) that obligation extends to those costs and expenses assessed on a full indemnity basis; |
5.14 | Keyholders |
The Tenant must ensure that at all times the Landlord has written notice of the name home address and home telephone number and mobile telephone number of at least two (2) codeholders or keyholders (as appropriate) of the Premises.
5.15 | Notices |
To pass to the Landlord within ten (10) Business Days of receipt any notices or communications received from any public authority affecting the Premises.
5.16 | Defective Premises |
The Tenant must give notice to the Landlord of any defect in the Premises which might give rise to an obligation on the Landlord to do or refrain from doing any act or thing in order to comply with the provisions of this Lease or the duty of care imposed on the Landlord pursuant to the Defective Premises Act 1972 or otherwise and at all times to display and maintain all notices which the Landlord may from time to time reasonably require to display at the Premises.
5.17 | Signs |
Not to place any sign or advertisement outside the Premises or lettering upon the windows or any other part of the Premises without the prior written consent of the Landlord such consent not to be unreasonably withheld.
5.18 | Insurance |
5.18.1 | Not to do or suffer to be done on the Premises anything whereby any policy of insurance effected by the Superior Landlord or the Landlord may become void or voidable or whereby the premiums payable in respect thereof may be increased; |
5.18.2 | To indemnify the Landlord against any loss or damage suffered due to the Tenant’s failure to comply with clause 5.18.1; |
5.18.3 | To insure its own fixtures and fittings and effects including personal property insurance and public liability insurance in respect of its directors and staff and visitors and any other persons at the Premises and to provide the Landlord on demand with evidence of a valid certificate of insurance. |
5.19 | Regulations |
The Tenant shall comply with the Superior Landlord’s and the Landlord’s reasonable regulations from time to time relating to the Building including the disposal of refuse.
5.20 | Indemnity |
To be responsible for and to keep the Landlord fully indemnified against all costs expenses claims and liabilities arising directly out of any act omission or negligence of the Tenant or any persons at the Premises or in the Building expressly or impliedly with the Tenant’s authority or any breach or non-observance by the Tenant of the covenants conditions or other provisions of this Lease.
5.21 | Pollution |
Not to permit to be discharged into any pipes or conduits serving the Premises or the Building any oil or grease or any deleterious objectionable dangerous poisonous or explosive matter or substance and to take all reasonable measures to ensure that any effluent so discharged will not be corrosive or otherwise harmful to the said pipes or conduits or cause obstruction or deposit in them.
5.22 | Compliance with Statute |
To comply with all legal requirements statutes regulations and orders and all directly applicable EC Law for the time being in force and any requirements or directions of any competent authority relating to the Premises.
5.23 | VAT |
To pay to the Landlord VAT chargeable in respect of Rent or any other payment made by the Tenant under any of the provisions of or in connection with this Lease or paid by the Landlord or any payment made by the Landlord where the Tenant agrees in this Lease to reimburse the Landlord for such payment and the Landlord is not entitled to recover the same by way of set off from H M Revenue and Customs.
5.24 | Superior Lease |
To observe and perform the tenant covenants in the Superior Lease in so far as they relate to the Premises except for the covenant to pay rent.
5.25 | Compliance with Queen Mary Bioenterprises Management processes |
5.25.1 | If appropriate upon request to complete sign and date the ‘Queen Mary Bioenterprises Lab Questionnaire’ on or prior to completion a signed and dated copy of which is annexed to this Lease and to review and assess annually; |
5.25.2 | To provide the Landlord with information relating to jobs brought to the Landlord and any jobs or employment created within the Term to enable the Landlord to provide quarterly reports to the London Development Agency (the LDA) or its successor; |
5.25.3 | To reasonably assist the management of the Landlord prior to the occupation of the space in carrying out credit-worthiness checks of the Tenant which may include: a standard commercial credit check; checking that the company directors are not disqualified; copies of the current balance sheet and business plan (including cash flow forecast); |
5.25.4 | To provide every half year interim accounts and a written directors’ report outlining the development plans of the business with regards to the occupied space; |
5.25.5 | To provide half yearly job forecasts due to grant reporting demands by the Landlord’s funders; |
5.25.6 | Upon request to complete sign and date the ‘Queen Mary Bioenterprises Health & Safety Policy’ on or prior to completion of signing this Lease. |
6. | LANDLORD’S COVENANTS |
The Landlord covenants with the Tenant:
6.1 | Quiet Enjoyment |
To permit the Tenant peaceably and quietly to hold and enjoy the Premises without any lawful interruption or disturbance from or by the Landlord or any person claiming under or in trust for the Landlord or by title paramount.
6.2 | Superior Lease |
The Landlord shall observe and perform the tenant covenants in the Superior Lease including to pay the rent save where they are the responsibility of the Tenant or another occupier of all or any part of the Building and shall procure so far as possible the Superior Landlord’s compliance with the landlord covenants in the Superior Lease.
6.3 | Services |
Subject to payment by the Tenant of the Rent the Landlord shall provide those services listed in Schedule 4 (the Services) PROVIDED THAT:
6.3.1 | the Landlord shall not be liable for any temporary delay or interruption in or disruption to the provisions of any of the Services ; |
6.3.2 | the Landlord shall not be liable for any delay or interruption in or disruption to the provisions of any of the Services for any reason that is outside the reasonable control of the Landlord; |
6.3.3 | the Landlord shall not be liable for any defect or want of repair affecting the Premises unless the Landlord has received notice in writing thereof from the Tenant. |
6.4 | Option to Terminate |
If the whole or a substantial part of the Premises shall be damaged or destroyed by any of the Insured Risks such that reinstatement of the Premises is impracticable either party may determine this Lease by giving three (3) months’ notice to the other after such damage or destruction and if so determined the Landlord shall not be under any obligation to reinstate the Premises and such determination shall be without prejudice to any antecedent breaches and the insurance monies shall belong to the Landlord (but not monies received by the Tenant under its own policy for loss of its own equipment and effects).
6.5 | Confidentiality |
To keep confidential all commercial and financial information provided by the Tenant in compliance with clause 5.25.1 (but for the avoidance of doubt the Landlord shall not be required to keep the information provided in accordance with clauses 5.24.2 and 5.24.5 confidential but the Landlord shall only share such information with the LDA or its successor).
7. | PROVISO |
7.1 | Re-entry |
If at any time during the Term:
7.1.1 | the Rent (or any part thereof) is outstanding for twenty one (21) calendar days after becoming due (whether formally demanded or not); or |
7.1.2 | the Tenant breaches any of the covenants and conditions contained in this Lease; or |
7.1.3 | the Tenant (being an individual) becomes bankrupt or (being a company) enters into liquidation whether compulsory or voluntary (save for the purpose of amalgamation or reconstruction of a solvent company) or has a receiver appointed or (in either case) enters into an arrangement or composition for the benefit of its creditors |
the Landlord may at any time (and notwithstanding the waiver of any previous right of re-entry) re-enter the Premises or any part of them in the name of the whole and thereupon the Term shall absolutely cease and determine but without prejudice to any rights or remedies which may have accrued to the Landlord against the Tenant in respect of any antecedent breach of any of the covenants and conditions contained in this Lease (including the breach in relation to which re-entry is made).
7.2 | Representations |
The Tenant acknowledges that this Lease has not been entered into in reliance wholly or partly on any statement or representation made by or on behalf of the Landlord except any such statement or representation that is expressly set out in this Lease.
7.3 | Suspension of Rent |
If the Premises or the access there to is destroyed or damaged by any of the Insured Risks as listed in the Superior Lease so as to make the Premises or access thereto unfit for beneficial occupation or use or reasonable access to the Premises unavailable and the insurance effected by the Landlord has not been vitiated or payment of the policy monies wholly or partly withheld or refused by reason of any act neglect or default or omission of the Tenant or any person deriving title under the Tenant or their respective servants agents licensees or invitees the Rent or a fair proportion thereof according to the nature and extent of the damage shall not be payable until the Premises are again rendered fit for beneficial use and (as the case may be) occupation and any dispute shall be referred to the award of a single arbitrator to be appointed in default of agreement upon the application of the Landlord by the President for the time being of the Royal Institute of Chartered Surveyors in accordance with the provisions of the Arbitration Act 1996.
7.4 | Lien |
The Landlord shall be entitled to sell any goods on which it may have a lien pursuant to this Lease which have been left at the Premises for more than ten (10) Business Days after the end of the Term (howsoever determined) at such price and upon such terms as the Landlord in its discretion may think fit and the net proceeds of any such sale shall be applied firstly towards payment of any such sums due by the Tenant to the Landlord and any balance shall be paid to the Tenant after deduction of all reasonable costs and expenses incurred by the Landlord.
7.5 | No Implied Easements |
Nothing in this Lease shall operate expressly or impliedly to confer upon or grant to the Tenant any easement right or privilege other than those expressly hereby granted.
7.6 | No Warranty as to Use |
Nothing in this Lease or in any consent granted by the Landlord under this Lease is to imply or warrant either the state or condition of the Premises or that the Premises may be lawfully used under the Planning Acts for the Permitted Use.
7.7 | Landlord’s Obligations |
Nothing in the Lease shall by implication or otherwise render the Landlord obliged to do anything that the Landlord has not specifically covenanted to do.
7.8 | Jurisdiction |
Disputes and differences between the parties arising out of or in relation to this Lease shall be referred to the exclusive jurisdiction of the English Courts This Lease shall be governed by and construed in accordance with English Law.
7.9 | Contracts (Rights of Third Parties) Act |
The parties hereby confirm that notwithstanding any other provision of this Lease this Lease shall not and shall not purport to confer on any third party any right to enforce any term of this agreement for the purposes of the Contracts (Rights of Third Parties) Act 1999.
8. | TENANT OPTION TO BREAK |
8.1 | The Tenant may terminate this lease by serving a Break Notice on the Landlord at least six months before the relevant Break Date. |
8.2 | A Break Notice served by the Tenant shall be of no effect if, at the Break Date stated in the Break Notice: |
8.2.1 | the Tenant has not paid any part of the Rent, or any VAT in respect of it, which was due to have been paid; or |
8.2.2 | there is a subsisting material breach of any of the tenant covenants of this lease. |
8.3 | Subject to Clause 8.2, following service of a Break Notice this lease shall terminate on the relevant Break Date. |
8.4 | Termination of this lease on a Break Date shall not affect any other right or remedy that either party may have in relation to any earlier breach of this lease. |
8.5 | If this lease terminates in accordance with Clause 8.1 then, within 30 Business Days after the relevant Break Date, the Landlord shall refund to the Tenant the proportion of the Rent, and any VAT paid in respect of it, for the period from and excluding the relevant Break Date up to and excluding the next Rent Payment Date, calculated on a daily basis. |
9. | RENT REVIEW |
9.1 | In this clause the “President” is the President for the time being of the Royal Institution of Chartered Surveyors or a person acting on his behalf, and the “Surveyor” is the independent valuer appointed pursuant to clause 9.8. |
9.2 | The amount of Rent shall be reviewed on the Review Date to equal: |
9.2.1 | the Rent payable immediately before the Review Date (or which would then be payable but for any abatement or suspension of the Rent or restriction on the right to collect it) or, if greater; |
9.2.2 | the open market rent agreed or determined pursuant to this clause (the New Rent). |
9.3 | The New Rent may be agreed between the Landlord and the Tenant at any time before it is determined by the Surveyor. |
9.4 | If the Landlord and the Tenant have not agreed the New Rent, either of them may, not earlier than three months before the Review Date or at any time, after the Review Date, require the market rent to be determined by the Surveyor. |
9.5 | The open market rent shall be the amount that the Surveyor determines is the annual rent (exclusive of any VAT) at which the Premises could reasonably be expected to be let: |
9.5.1 | in the open market; |
9.5.2 | at the Review Date; |
9.5.3 | on the assumptions listed in clause 9.6; and |
9.5.4 | disregarding the matters listed in clause 9.7. |
9.6 | The assumptions are: |
9.6.1 | the Premises are available to let in the open market: |
(a) | by a willing lessor to a willing lessee; |
(b) | as a whole; |
(c) | with vacant possession; |
(d) | without a fine or a premium; |
(e) | for a term equal to the unexpired residue of the Term at the Review Date or a term of two years commencing on the Review Date, if longer; and |
(f) | otherwise on the terms of this Lease other than as to: |
(i) | the amount of the Rent; |
(ii) | the inclusion of clause 8 (Tenant’s option to determine); and |
(iii) | the inclusion of provisions for review of the Rent. |
9.6.2 | the willing lessee has had the benefit of any rent-free or other concession or contribution which would be offered in the open market at the Review Date in relation to fitting out works at the Premises; |
9.6.3 | the Premises may lawfully be used and occupied, and are in a physical state to enable them to be lawfully used any occupied, by the willing lessee (or any potential undertenant or assignee of the willing lessee) for any purpose permitted by this Lease; |
9.6.4 | the Tenant has fully complied with their obligations in this Lease; |
9.6.5 | if the Premises or any means of access to them have been destroyed or damaged, they have been fully restored; |
9.6.6 | no work has been carried out on the Premises that has diminished their rental value; |
9.6.7 | any fixtures, fittings, machinery or equipment supplied to the Premises by the Landlord that have been removed by or at the request of the Tenant or its predecessors in title (otherwise than to comply with any law) remain at the Premises; and |
9.7 | The matters to be disregarded are: |
9.7.1 | any effect on rent of the fact that the Tenant or any of their predecessors in business have been in occupation of the Premises; |
9.7.2 | any goodwill attached to the Premises by reason of any business carried out there by the Tenant or by any of their predecessors in business; |
9.7.3 | any effect on rent attributable to any physical improvement to the Premises carried out after the date of the Previous Lease, by or at the expense of the Tenant or any of their predecessors in business with all necessary consents, approvals and authorisations and not pursuant to an obligation to the Landlord (other than an obligation to comply with any law); |
9.7.4 | any effect on rent of any obligation on the Tenant to fit out the Premises; |
9.7.5 | any statutory restriction on rents or the right to recover them. |
9.8 | The Surveyor shall be an independent valuer who is a Member or Fellow of the Royal Institution of Chartered Surveyors. The Landlord and the Tenant may, by agreement, appoint the Surveyor at any time before either of them applies to the President for the Surveyor to be appointed. |
9.9 | The Surveyor shall act as an expert and not as an arbitrator. The Surveyor shall determine the open market rent. The Surveyor’s decision shall be given in writing, and the Surveyor shall provide reasons for any determination. The Surveyor’s written decision on the matters referred to him shall be final and binding in the absence of manifest error or fraud. |
9.10 | The Surveyor shall give the Landlord and the Tenant an opportunity to make written representations to the Surveyor and to make written counter-representations commenting on the representations of the other party to the Surveyor. The parties will provide (or procure that others provide) the Surveyor with such assistance and documents as the Surveyor reasonably requires for the purpose of reaching a decision. |
9.11 | If the Surveyor dies, or becomes unwilling or incapable of acting, or unreasonably delays in making any determination, then either the Landlord or the Tenant may apply to the President to discharge the Surveyor and clause 9.8 shall then apply in relation to the appointment of a replacement. |
9.12 | The fees and expenses of the Surveyor and the cost of the Surveyor’s appointment and any counsel’s fees, or other fees, reasonably incurred by the Surveyor shall be payable by the Landlord and the Tenant in the proportions that the Surveyor directs (or if the Surveyor makes no direction, then equally). The Landlord and the Tenant shall otherwise each bear their own costs in connection with the rent review. |
9.13 | Time shall not be of the essence for the purposes of this clause. |
9.14 | If at any time there is a guarantor, the guarantor shall not have any right to participate in the review of the Rent. |
10. | EXCLUSION OF SECURITY OF TENURE |
The Landlord has served on the Tenant a notice on the form set out in schedule 1 to the Regulatory Reform (Business Tenancies) (England and Wales) Order 2003 (the Order) and the Tenant has made a statutory declaration in the form set out in paragraph 8 of schedule 2 to the Order and the parties agree that the provisions of sections 24-28 (inclusive) of the Landlord and Tenant Act 1954 shall not apply to this Lease.
This document has been executed as a deed and is delivered and takes effect on the date stated at the beginning of it.
Executed as a deed by ADC Therapeutics (UK)
Limited acting by a director in the presence of:
/s/ Michael Forer | |
Michael Forer, Director |
Signature | /s/ CHRISTINE WAITE |
Witness Name | CHRISTINE WAITE |
Address | CHEMIN PRESLES BO15 56, 7066 EPALINGES, SWITZERLAND |
Occupation | OFFICE MANAGER |
Executed as a deed by
Queen Mary Bioenterprises Limited acting by a director in |
/s/ George Edward Webster
|
|
the presence of: | ||
Director |
Witness Signature: | /s/ R. Richmond |
Witness Name: | R. RICHMOND |
Address: | 42 NEW ROAD, c/o QMB, WHITE CHAPEL, LONDON E1 2AX |
Occupation: | COMMERCIAL OFFICER OF UNIVERSITY |
16
Exhibit 10.7
womblebonddickinson.com |
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20 December 2017
Lease
relating to
Lab 11b, Suite 11 Write Up Space and Suite 12, 1st Floor, The Queen Mary BioEnterprises Innovation Centre, Whitechapel, 42 New Road,
London, E1 2AX
Queen Mary Bioenterprises Limited (1) and
ADC Therapeutics (UK) Limited (2)
I, Nicola Louise Guss | |
certify that this is a true and complete copy of the original document |
Signed | /s/ Nicola Louise Guss | |
Solicitor/Legal Executive |
Dated | 21 December 2017 | |
Womble Bond Dickinson (UK) LLP | ||
112 Quayside St Ann’s Wharf, | ||
Newcastle-upon-Tyne, NE1 3DX | ||
Womble Bond Dickinson (UK) LLP
Tel +44(0)345 415 0000
www.womblebonddickinson.com
CONTENTS | ||
Clause | Page | |
1. | PARTICULARS | 1 |
2. | DEFINITIONS | 2 |
3. | INTERPRETATION | 3 |
4. | GRANT | 3 |
5. | TENANT’S COVENANTS | 3 |
6. | LANDLORD’S COVENANTS | 9 |
7. | PROVISO | 10 |
8. | TENANT OPTION TO BREAK | 12 |
9. | RENT REVIEW | 12 |
10. | EXCLUSION OF SECURITY OF TENURE | 14 |
SCHEDULE 1
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15
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Rights Granted
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15
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SCHEDULE 2
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16
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Rights Reserved
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16
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SCHEDULE 3
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17
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Subjections
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17
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SCHEDULE 4
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18
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Services
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18
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SCHEDULE 5
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20
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Services
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20
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SCHEDULE 6
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22
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Plan
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22
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SCHEDULE 7
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23
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Rent
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23
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SCHEDULE 8
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24
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Reinstatement Specification
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24
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DATE
PARTIES
(1) | Queen Mary Bioenterprises Limited (No. 04324033) whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS. |
(2) | ADC Therapeutics (UK) Limited (No. 09353055) whose registered office is at 4th Floor Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS. |
AGREED TERMS
1. | PARTICULARS | |
Business Day | a day on which banks are open for business in London which is not a Saturday or Sunday or bank holiday. | |
Building | the Queen Mary Bioenterprises Innovation Centre 42 New Road Whitechapel E1 2AX being all the land comprised in Title Number EGL520546. | |
Group Company | a company that is a member of the same group as the Tenant within the meaning of Section 42 of the Landlord and Tenant Act 1954 (as amended). | |
Premises |
Lab 11b, Suite 11 write up space and Suite 12, First Floor of The Queen Mary Bioenterprises Innovation Centre 42 New Road Whitechapel E1 2AX shown edged yellow on the Plan which forms Schedule 6 hereto which includes: |
(a) | all additions and improvements to the Premises; | |
(b) | all Landlord’s fixtures and fittings and all other fixtures of every kind which shall from time to time be in or upon the Premises (whether originally affixed or fastened to or upon the Premises or otherwise) except any trade fixtures installed by the Tenant which can be removed from the Premises without causing any material damage to the Premises; |
(c) | the internal faces (including the plaster paint and other decorative finishes but not any other part) of the walls which enclose the Premises and of the walls within the Premises; |
(d) | the screed and finish (but not any other part) of the floors within the Premises; |
(e) | the suspended ceiling and the internal faces including the tiles plaster paint and other decorative finishes of it and all light fittings therein; |
(f) | all doors door furniture door frames and glass in such door within premises; |
But excluding: |
(a) | the windows in the exterior walls and their frames and fittings; |
the whole of the interior structural load bearing walls and columns within that part of the Building other than their plasterwork and other than the doors and windows and their frames and fittings within such walls; |
all service media within that part of the Building which do not exclusively serve that part of the Building; and | ||
the void between the suspended ceiling and the concrete slab separating the first floor of the Building from the second floor of the Building. | ||
Term | a term commencing on 1 January 2018 and expiring on 31 December 2023. | |
Rent | initial rent of £150,444.75 plus VAT per annum subject to review in accordance with clause 9 of this Lease. The Rent is inclusive of charges for the provision of Landlord services relating to facilities infrastructure building fabric as set out in Schedule 4 but excludes business rates or any additional charges payable by the Tenant as itemised in Schedule 5. | |
Rent Commencement
Date |
1 January 2018. | |
Rent Payment Dates | the 1st day in any calendar month. | |
Review Date | 1 January 2020 and 1 January 2022. | |
Permitted Use | research and development within Use Class B1 of the Schedule to the Town & Country Planning (Use Classes) Order 1987. | |
2. | DEFINITIONS | |
Break Date | 1 January 2020 and 1 January 2022. | |
Break Notice | written notice to terminate this lease on the Break Date specifying the relevant Break Date and serve in accordance with Clause 8. | |
Deposit | a sum equal to two months’ annual Rent plus a sum equal to VAT on that amount. | |
Insured Risk | such risks as are specified in the Superior Lease. | |
Interest | interest during the period from the date on which the payment is due to the date of payment both before and after any judgment at the Interest Rate or should the base rate referred to in clause 2.4 cease to exist such other rate of interest as is most closely comparable with the Interest Rate to be determined by the Landlord. | |
Interest Rate | three per cent (3%) above the base rate of the Bank of England. | |
Minimum Amount | the sum equal to 2 months’ annual Rent plus a sum equal to VAT on that amount. | |
Planning Acts | the Town and County Planning Act 1990 the Planning (Listed Building and Conservation Areas) Act 1990 the Planning (Consequential Provisions) Act 1990 the Planning (Hazardous Substances) Act 1990 the Planning and Compensation Act 1991 the Planning Act 2008 and all statutes regulations and orders included by virtue of clause 3.5. |
Previous Leases | the lease of Suite 11 dated 9 March 2015 (as varied by a Deed of Surrender and Variation dated 1 August 2017) and the lease of Suite 12 dated 22 January 2015 | |
Reinstatement Specification Index | the plans, photographs and specifications indexed and annexed in Schedule 8 | |
Superior Landlord | Queen Mary and Westfield College, University of London. | |
Superior Lease | a lease dated 15 March 2007 and made between (1) the Superior Landlord and (2) Queen Mary Innovation Limited. | |
VAT | Value Added Tax or any other such imposition or levy of a like nature which may extend or replace Value Added Tax. |
3. | INTERPRETATION |
3.1 | The expressions the Superior Landlord the Landlord and the Tenant wherever the context so admits include their respective successors in title. |
3.2 | Words importing the one gender include all other genders and words importing the singular include the plural and vice versa. |
3.3 | References to any right of the Landlord to have access to the Premises shall be construed as extending to all persons reasonably authorised by the Landlord and also the Superior Landlord. |
3.4 | Any covenant by the Tenant not to do an act or thing shall be deemed to include an obligation not to permit such act or thing to be done. |
3.5 | Any reference to a specific statute includes any statutory extension or modification or re-enactment of such statute and any regulations or orders made there under and any general reference to ‘statute’ or ‘statutes’ includes any regulations or orders made there under. |
4. | GRANT |
4.1 | The Landlord lets the Premises to the Tenant for the Term with full title guarantee. |
4.2 | The grant is made together with the rights specified in Schedule 1 excepting and reserving to the Landlord the rights specified in Schedule 2 and subject to the matters referred to in Schedule 3. |
4.3 | The grant is made with the Tenant paying the following as rent to the Landlord: |
4.3.1 | the Rent and all VAT in respect of it; |
4.3.2 | all interest payable under this Lease; and |
4.3.3 | all other sums due under this Lease. |
5. | TENANT’S COVENANTS |
The Tenant covenants with the Landlord: | |
5.1 | Rents |
To pay the Rent and any VAT in respect of it (whether formally demanded or not) without any deduction or set off by twelve (12) equal monthly instalments in advance on or before the Rent Payment Dates. The payments shall be made by electronic means and the first such payment shall be made on the date of this Lease and shall be a proportionate sum in respect of the period from and including the Rent Commencement Date to and including the day before the Rent Payment Date next following. |
5.2 | Security Deposit |
5.2.1 | On or before the date of this Lease the Tenant shall pay the Deposit to the Landlord. The Deposit shall belong to the Tenant subject to the terms of this Lease; |
5.2.2 | The Tenant shall pay to the Landlord such sum or sums necessary to ensure that the Deposit is not less than the Minimum Amount within 10 Business Days of the date upon which each and every review of Rent is settled in accordance with the terms of this Lease (and the Landlord shall provide the Tenant with a written demand for such payment); |
5.2.3 | If: |
(a) | an event of default by the Tenant (as set out in clause 7.1) exists under this Lease at any time or; |
(b) | the Tenant fails to comply with the yielding up requirements of clause 5.11 on or following the expiry of the Term (however so determined); |
the Landlord shall forthwith give notice thereof to the Tenant in writing and may use or apply or retain the whole or any part of the Deposit to the extent necessary to cure the event of default;
5.2.4 | If at any time during or following the Term of this Lease the Landlord applies all or a portion of the Deposit to cure the Tenant’s event of default the Tenant shall repay to the Landlord within ten (10) Business Days after written demand by the Landlord any amount necessary to restore the Deposit to the Minimum Amount; |
5.2.5 | At the end of the Term (howsoever determined) the Tenant shall at its own cost appoint an independent consultant (such appointment to be approved by the Landlord such approval not to be unreasonably withheld or delayed) to inspect the Premises, the ceiling void air supply and extract ductwork, the ceiling void ductwork connected to the Tenant’s ducted fume hoods and ducted equipment and provide a certificate of decontamination to confirm that the Premises are free from contamination by radioactive or other toxic substances and that there has been no spread of any contamination into the ceiling void ductwork or otherwise. In the event that a satisfactory decontamination certificate is not produced within five (5) Business Days after the end of the Term (howsoever determined) the Landlord may: |
(a) | require the Tenant to remove at its own cost and within a period of fifteen (15) Business Days after the end of the Term the fume hoods (such works to be carried out to the satisfaction of the Landlord); and or |
(b) | implement its own decontamination processes on the Premises and ceiling void ductwork using an independent consultant (and using reasonable endeavours to complete these processes within twelve months after the end of the Term) and if at any time the costs incurred by the Landlord in carrying out its decontamination processes exceed the Deposit the Tenant shall pay the balance sum to the Landlord within ten (10) Business Days of written demand. |
5.2.6 | If the Tenant has provided a certificate of decontamination in accordance with clause 5.2.4 the Deposit or the balance of it (if any) shall be returned to the Tenant within three (3) months of the end of the Term; |
5.2.7 | If the Landlord requires the Tenant to remove the fume hoods as detailed in clause 5.2.4 (a) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the removal works have been completed to the satisfaction of the Landlord or within 3 months of the date on which the Landlord’s decontamination process has been concluded, whichever is the latest; |
5.2.8 | If the Landlord implements its own decontamination processes as detailed in clause 5.2.4 (b) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the Landlord’s decontamination processes have been concluded or within 3 months of the date on which the fume hood removal works have been completed to the satisfaction of the Landlord, whichever is the latest. |
5.3 | Operating Expenses |
The Tenant agrees to pay to the Landlord within twenty (20) Business Days of written demand any and all operating expenses expressly set out below:
5.3.1 | Sub-metered chargeable electrical usage for the Premises as evidenced by the Landlord (see Schedule 5 of this Lease); |
5.3.2 | Use of other fee-for-use services such as usage of the telecoms lines and meeting room usage; |
5.3.3 | Electricity charges as evidenced by the Landlord covering the air handling systems connected to any Tenant’s ducted equipment e.g. fume hoods (every three (3) months payable within twenty (20) Business Days of written demand). |
5.4 | Outgoings |
To pay and indemnify the Landlord against all rates taxes assessments duties charges impositions and outgoings which are now or during the Term shall be charged assessed or imposed on the Premises or upon the owner or occupier of them excluding any payable by the Landlord which in the absence of a direct assessment shall be reasonably determined by the Landlord.
5.5 | Repair |
To keep the Premises in good repair and decorative order and in a clean and tidy state and condition at all times.
5.6 | Alterations and Additions |
5.6.1 | Structural alterations external alterations and additions are not permitted; |
5.6.2 | Not to make any internal non-structural alterations or additions (including partitioning) to the whole or any part of the Premises without the Landlord’s prior written consent (such consent not to be unreasonably withheld or delayed) and approval (such approval not to be unreasonably withheld or delayed) of previously submitted drawings and/or specification in a form reasonably required by the Landlord and if such consent is granted to comply with the Planning Acts in the carrying out of such alterations or additions; |
5.6.3 | For the avoidance of doubt, if the Landlord gives consent to the carrying out by the Tenant of any alterations to the Premises pursuant to clause 5.6.2 above, unless the Superior Landlord agrees to insure any such works from the date on which they are completed, they will at all times be at the sole risk of the Tenant. |
5.7 | Use |
5.7.1 | Not to use the Premises for any purpose other than the Permitted Use; |
5.7.2 | The Tenant covenants not under any circumstances to introduce Schedule 5 Pathogens into the Premises. Schedule 5 Pathogens are defined within the U.K. government’s Act entitled ‘The Schedule 5 to the Anti-Terrorism, Crime and Security Act 2001 (Modification) Order 2007’ and any subsequent modifying Statutory Instruments; |
5.7.3 | The Tenant covenants not under any circumstances to introduce human pathogens within hazard group categories 2, 3 and 4, as defined by the U.K. Government’s Health & Safety Executive Advisory Committee on Dangerous Pathogens, in their document entitled ‘The Approved List of Biological Agents’, dated 15 August 2013; |
5.7.4 | The Tenant covenants to indemnify the Landlord against all expenses costs claims damage and loss arising directly or indirectly from any breach of the provisions of clause 5.7. |
5.8 | Access of Landlord and Notice to Repair |
5.8.1 | Subject to the proviso in paragraph 3 of Schedule 2 to permit the Landlord at all reasonable times and upon prior reasonable notice (save in an emergency); |
(a) | to enter upon the Premises for the purpose of ascertaining that the covenants and conditions of this Lease have been observed and performed or for any other reasonable purpose; |
(b) | to view the state of repair and condition of the Premises; |
5.8.2 | If within one (1) month (or sooner in emergency) of the service of a notice by the Landlord on the Tenant to carry out specified repairs to the Premises which the Tenant has failed to carry out under the terms of this Lease the Tenant has not commenced or is not proceeding diligently with the work referred to in such notice or if the Tenant fails to complete the work within three (3) months (or sooner in emergency) the Tenant shall permit the Landlord to enter the Premises to execute the outstanding work and must pay to the Landlord the proper cost of so doing and all reasonable expenses properly incurred by the Landlord (including legal costs and surveyor’s fees) within seven (7)Business Days of a written demand. |
5.9 | Alienation |
5.9.1 | Save as permitted by clause 5.9.2 or clause 5.9.3, not to assign underlet charge or part with or share possession or occupation of the whole or any part of the Premises or hold the whole or any part of the Premises on trust for another. |
5.9.2 | The Tenant may assign the whole of this Lease with the prior consent of the Landlord. The Tenant acknowledges and agrees that the Landlord shall not be required to act reasonably when considering any application for consent to assign submitted by the Tenant pursuant to this clause, nor shall it be required to consider any such application within any specified period of time. |
5.9.3 | The Tenant may share occupation of the Premises with any company that is a member of the same group (within the meaning of section 42 of the LTA 1954) as the Tenant for as long as that company remains within that group and provided that no relationship of landlord and tenant is established by that arrangement. |
5.10 | Nuisance and Residential Restrictions |
5.10.1 | Not to do or permit to be done or suffer to remain upon the Premises anything which in the reasonable opinion of the Landlord may be or become or cause a nuisance annoyance injury or damage to the Landlord or its tenants or the occupiers of adjacent or neighbouring premises and not to obstruct others who are lawfully using any adjoining parts of the Premises; |
5.10.2 | Not to use the Premises for any dangerous noxious noisy or offensive trade or business nor for any illegal or immoral act or purpose and not to sleep or allow any person to sleep in the Premises; |
5.10.3 | Without prejudice to the generality of clauses 5.10.1 and 5.22 of this Lease, unless the lights are switched off, the Tenant must ensure that all blinds and curtains at the windows of the Premises are pulled down at dusk and remain down during all hours of darkness so that no disturbance, nuisance or inconvenience is caused to any neighbouring properties; |
5.11 Yield Up
5.11.1 | At the expiry of the Term to yield up the Premises with vacant possession and in accordance with the Tenant’s covenants in this Lease and to give up all keys (if any) of the Premises to the Landlord and remove all signage erected by the Tenant in upon or near the Premises and forthwith make good damage caused by such removal at the Tenant’s expense; |
5.11.2 | At the expiry of the Term the Premises should be delivered in a clean and tidy condition and laboratories will be decommissioned and inspected by a qualified independent consultant at the tenant’s cost (who shall be first approved by the Landlord) at or before the expiration of the Term and the Tenant shall upon termination of this Lease remove from the Premises all the Tenant’s personal property and any and all owned or leased fixtures and equipment save as provided in clause 5.2 hereof. |
5.11.3 | If required by the Landlord the Tenant shall prior to the expiry of the Term (however so determined) reinstate the Premises to the specification detailed in the Reinstatement Specification. The Tenant will make good any damage caused by such reinstatement at its own expense and to the reasonable satisfaction of the Landlord. |
5.12 Interest on Arrears
The Tenant must pay Interest on any of the Rent or other sums due under this Lease that are not paid within seven (7) Business Days of the date due whether formally demanded or not. Nothing in this clause entitles the Tenant to withhold or delay any payment of the Rent or any other sum due under this Lease or affects the rights of the Landlord in relation to any non-payment.
5.13 Costs
5.13.1 | The Tenant shall pay the costs and expenses of the Landlord including any solicitors’ or other professionals’ costs and expenses incurred (both during and after the end of the Term) in connection with or in contemplation of any of the following: |
(a) | the enforcement of the tenant covenants of this Lease; |
(b) | serving any notice in connection with this Lease under section 146 or 147 of the Law of Property Act 1925 or taking any proceedings under either of those sections, notwithstanding that forfeiture is avoided otherwise than by relief granted by the court; |
(c) | serving any notice in connection with this Lease under section 17 of the Landlord and Tenant (Covenants) Act 1995; |
(d) | the preparation and service of a schedule of dilapidations in connection with this Lease; or |
(e) | any consent or approval applied for under this Lease, whether or not it is granted (unless the consent or approval is unreasonably withheld by the Landlord in circumstances where the Landlord is not unreasonably to withhold it). |
5.13.2 | Where the Tenant is obliged to pay or indemnify the Landlord against any solicitors’ or other professionals’ costs and expenses (whether under this or any other clause of this Lease) that obligation extends to those costs and expenses assessed on a full indemnity basis; |
5.14 Keyholders
The Tenant must ensure that at all times the Landlord has written notice of the name home address and home telephone number and mobile telephone number of at least two (2) codeholders or keyholders (as appropriate) of the Premises.
5.15 Notices
To pass to the Landlord within ten (10) Business Days of receipt any notices or communications received from any public authority affecting the Premises.
5.16 Defective Premises
The Tenant must give notice to the Landlord of any defect in the Premises which might give rise to an obligation on the Landlord to do or refrain from doing any act or thing in order to comply with the provisions of this Lease or the duty of care imposed on the Landlord pursuant to the Defective Premises Act 1972 or otherwise and at all times to display and maintain all notices which the Landlord may from time to time reasonably require to display at the Premises.
5.17 Signs
Not to place any sign or advertisement outside the Premises or lettering upon the windows or any other part of the Premises without the prior written consent of the Landlord such consent not to be unreasonably withheld.
5.18 Insurance
5.18.1 | Not to do or suffer to be done on the Premises anything whereby any policy of insurance effected by the Superior Landlord or the Landlord may become void or voidable or whereby the premiums payable in respect thereof may be increased; |
5.18.2 | To indemnify the Landlord against any loss or damage suffered due to the Tenant’s failure to comply with clause 5.18.1; |
5.18.3 | To insure its own fixtures and fittings and effects including personal property insurance and public liability insurance in respect of its directors and staff and visitors and any other persons at the Premises and to provide the Landlord on demand with evidence of a valid certificate of insurance. |
5.19 Regulations
The Tenant shall comply with the Superior Landlord’s and the Landlord’s reasonable regulations from time to time relating to the Building including the disposal of refuse.
5.20 Indemnity
To be responsible for and to keep the Landlord fully indemnified against all costs expenses claims and liabilities arising directly out of any act omission or negligence of the Tenant or any persons at the Premises or in the Building expressly or impliedly with the Tenant’s authority or any breach or non-observance by the Tenant of the covenants conditions or other provisions of this Lease.
5.21 Pollution
Not to permit to be discharged into any pipes or conduits serving the Premises or the Building any oil or grease or any deleterious objectionable dangerous poisonous or explosive matter or substance and to take all reasonable measures to ensure that any effluent so discharged will not be corrosive or otherwise harmful to the said pipes or conduits or cause obstruction or deposit in them.
5.22 Compliance with Statute
To comply with all legal requirements statutes regulations and orders and all directly applicable EC Law for the time being in force and any requirements or directions of any competent authority relating to the Premises.
5.23 VAT
To pay to the Landlord VAT chargeable in respect of Rent or any other payment made by the Tenant under any of the provisions of or in connection with this Lease or paid by the Landlord or any payment made by the Landlord where the Tenant agrees in this Lease to reimburse the Landlord for such payment and the Landlord is not entitled to recover the same by way of set off from H M Revenue and Customs.
5.24 Superior Lease
To observe and perform the tenant covenants in the Superior Lease in so far as they relate to the Premises except for the covenant to pay rent.
5.25 Compliance with Queen Mary Bioenterprises Management processes
5.25.1 | If appropriate upon request to complete sign and date the ‘Queen Mary Bioenterprises Lab Questionnaire’ on or prior to completion a signed and dated copy of which is annexed to this Lease and to review and assess annually; |
5.25.2 | To provide the Landlord with information relating to jobs brought to the Landlord and any jobs or employment created within the Term to enable the Landlord to provide quarterly reports to the London Development Agency (the LDA) or its successor; |
5.25.3 | To reasonably assist the management of the Landlord prior to the occupation of the space in carrying out credit-worthiness checks of the Tenant which may include: a standard commercial credit check; checking that the company directors are not disqualified; copies of the current balance sheet and business plan (including cash flow forecast); |
5.25.4 | To provide every half year interim accounts and a written directors’ report outlining the development plans of the business with regards to the occupied space; |
5.25.5 | To provide half yearly job forecasts due to grant reporting demands by the Landlord’s funders; |
5.25.6 | Upon request to complete sign and date the ‘Queen Mary Bioenterprises Health & Safety Policy’ on or prior to completion of signing this Lease. |
6. | LANDLORD’S COVENANTS |
The Landlord covenants with the Tenant:
6.1 Quiet Enjoyment
To permit the Tenant peaceably and quietly to hold and enjoy the Premises without any lawful interruption or disturbance from or by the Landlord or any person claiming under or in trust for the Landlord or by title paramount.
6.2 Superior Lease
The Landlord shall observe and perform the tenant covenants in the Superior Lease including to pay the rent save where they are the responsibility of the Tenant or another occupier of all or any part of the Building and shall procure so far as possible the Superior Landlord’s compliance with the landlord covenants in the Superior Lease.
6.3 Services
Subject to payment by the Tenant of the Rent the Landlord shall provide those services listed in Schedule 4 (the Services) PROVIDED THAT:
6.3.1 | the Landlord shall not be liable for any temporary delay or interruption in or disruption to the provisions of any of the Services ; |
6.3.2 | the Landlord shall not be liable for any delay or interruption in or disruption to the provisions of any of the Services for any reason that is outside the reasonable control of the Landlord; |
6.3.3 | the Landlord shall not be liable for any defect or want of repair affecting the Premises unless the Landlord has received notice in writing thereof from the Tenant. |
6.4 Option to Terminate
If the whole or a substantial part of the Premises shall be damaged or destroyed by any of the Insured Risks such that reinstatement of the Premises is impracticable either party may determine this Lease by giving three (3) months’ notice to the other after such damage or destruction and if so determined the Landlord shall not be under any obligation to reinstate the Premises and such determination shall be without prejudice to any antecedent breaches and the insurance monies shall belong to the Landlord (but not monies received by the Tenant under its own policy for loss of its own equipment and effects).
6.5 Confidentiality
To keep confidential all commercial and financial information provided by the Tenant in compliance with clause 5.25.1 (but for the avoidance of doubt the Landlord shall not be required to keep the information provided in accordance with clauses 5.24.2 and 5.24.5 confidential but the Landlord shall only share such information with the LDA or its successor).
7. | PROVISO |
7.1 Re-entry
If at any time during the Term:
7.1.1 | the Rent (or any part thereof) is outstanding for twenty one (21) calendar days after becoming due (whether formally demanded or not); or | |
7.1.2 |
the Tenant breaches any of the covenants and conditions contained in this Lease; or |
7.1.3 | the Tenant (being an individual) becomes bankrupt or (being a company) enters into liquidation whether compulsory or voluntary (save for the purpose of amalgamation or reconstruction of a solvent company) or has a receiver appointed or (in either case) enters into an arrangement or composition for the benefit of its creditors the Landlord may at any time (and notwithstanding the waiver of any previous right of re-entry) re-enter the Premises or any part of them in the name of the whole and thereupon the Term shall absolutely cease and determine but without prejudice to any rights or remedies which may have accrued to the Landlord against the Tenant in respect of any antecedent breach of any of the covenants and conditions contained in this Lease (including the breach in relation to which re-entry is made). |
7.2 Representations
The Tenant acknowledges that this Lease has not been entered into in reliance wholly or partly on any statement or representation made by or on behalf of the Landlord except any such statement or representation that is expressly set out in this Lease.
7.3 Suspension of Rent
If the Premises or the access there to is destroyed or damaged by any of the Insured Risks as listed in the Superior Lease so as to make the Premises or access thereto unfit for beneficial occupation or use or reasonable access to the Premises unavailable and the insurance effected by the Landlord has not been vitiated or payment of the policy monies wholly or partly withheld or refused by reason of any act neglect or default or omission of the Tenant or any person deriving title under the Tenant or their respective servants agents licensees or invitees the Rent or a fair proportion thereof according to the nature and extent of the damage shall not be payable until the Premises are again rendered fit for beneficial use and (as the case may be) occupation and any dispute shall be referred to the award of a single arbitrator to be appointed in default of agreement upon the application of the Landlord by the President for the time being of the Royal Institute of Chartered Surveyors in accordance with the provisions of the Arbitration Act 1996.
7.4 Lien
The Landlord shall be entitled to sell any goods on which it may have a lien pursuant to this Lease which have been left at the Premises for more than ten (10) Business Days after the end of the Term (howsoever determined) at such price and upon such terms as the Landlord in its discretion may think fit and the net proceeds of any such sale shall be applied firstly towards payment of any such sums due by the Tenant to the Landlord and any balance shall be paid to the Tenant after deduction of all reasonable costs and expenses incurred by the Landlord.
7.5 No Implied Easements
Nothing in this Lease shall operate expressly or impliedly to confer upon or grant to the Tenant any easement right or privilege other than those expressly hereby granted.
7.6 No Warranty as to Use
Nothing in this Lease or in any consent granted by the Landlord under this Lease is to imply or warrant either the state or condition of the Premises or that the Premises may be lawfully used under the Planning Acts for the Permitted Use.
7.7 Landlord’s Obligations
Nothing in the Lease shall by implication or otherwise render the Landlord obliged to do anything that the Landlord has not specifically covenanted to do.
7.8 Jurisdiction
Disputes and differences between the parties arising out of or in relation to this Lease shall be referred to the exclusive jurisdiction of the English Courts This Lease shall be governed by and construed in accordance with English Law.
7.9 |
Contracts (Rights of Third Parties) Act |
The parties hereby confirm that notwithstanding any other provision of this Lease this Lease shall not and shall not purport to confer on any third party any right to enforce any term of this agreement for the purposes of the Contracts (Rights of Third Parties) Act 1999.
8. | TENANT OPTION TO BREAK |
8.1 |
The Tenant may terminate this lease by serving a Break Notice on the Landlord at least six months before the relevant Break Date.
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8.2 |
A Break Notice served by the Tenant shall be of no effect if, at the Break Date stated in the Break Notice:
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8.2.1 |
the Tenant has not paid any part of the Rent, or any VAT in respect of it, which was due to have been paid; or
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8.2.2 |
there is a subsisting material breach of any of the tenant covenants of this lease.
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8.3 |
Subject to Clause 8.2, following service of a Break Notice this lease shall terminate on the relevant Break Date.
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8.4 |
Termination of this lease on a Break Date shall not affect any other right or remedy that either party may have in relation to any earlier breach of this lease.
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8.5
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If this lease terminates in accordance with Clause 8.1 then, within 30 Business Days after the relevant Break Date, the Landlord shall refund to the Tenant the proportion of the Rent, and any
VAT paid in respect of it, for the period from and excluding the relevant Break Date up to and excluding the next Rent Payment Date, calculated on a daily basis.
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9.
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RENT REVIEW
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9.1 |
In this clause the “President” is the President for the time being of the Royal Institution of Chartered Surveyors or a person acting on his behalf, and the “Surveyor”
is the independent valuer appointed pursuant to clause 9.8.
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9.2 |
The amount of Rent shall be reviewed on the Review Date to equal:
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9.2.1 |
the Rent payable immediately before the Review Date (or which would then be payable but for any abatement or suspension of the Rent or restriction on the right to collect it) or, if greater;
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9.2.2 |
the open market rent agreed or determined pursuant to this clause (the New Rent).
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9.3 |
The New Rent may be agreed between the Landlord and the Tenant at any time before it is determined by the Surveyor.
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9.4 |
If the Landlord and the Tenant have not agreed the New Rent, either of them may, not earlier than three months before the Review Date or at any time, after the Review Date, require the market rent to be determined by the Surveyor.
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9.5 |
The open market rent shall be the amount that the Surveyor determines is the annual rent (exclusive of any VAT) at which the Premises could reasonably be expected to be let:
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9.5.1 |
in the open market;
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9.5.2 |
at the Review Date;
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9.5.3 |
on the assumptions listed in clause 9.6; and
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9.5.4 |
disregarding the matters listed in clause 9.7.
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9.6 |
The assumptions are:
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9.6.1
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the Premises are available to let in the open market:
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(a) |
by a willing lessor to a willing lessee;
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(b) |
as a whole;
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(c) |
with vacant possession;
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(d) |
without a fine or a premium;
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(e) |
for a term equal to the unexpired residue of the Term at the Review Date or a term of two years commencing on the Review Date, if longer; and
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(f) |
otherwise on the terms of this Lease other than as to:
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(i) |
the amount of the Rent;
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(ii) |
the inclusion of clause 8 (Tenant’s option to determine); and
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(iii) |
the inclusion of provisions for review of the Rent.
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9.6.2 | the willing lessee has had the benefit of any rent-free or other concession or contribution which would be offered in the open market at the Review Date in relation to fitting out works at the Premises; |
9.6.3 | the Premises may lawfully be used and occupied, and are in a physical state to enable them to be lawfully used any occupied, by the willing lessee (or any potential undertenant or assignee of the willing lessee) for any purpose permitted by this Lease; |
9.6.4 | the Tenant has fully complied with their obligations in this Lease; |
9.6.5 | if the Premises or any means of access to them have been destroyed or damaged, they have been fully restored; |
9.6.6 | no work has been carried out on the Premises that has diminished their rental value; |
9.6.7 | any fixtures, fittings, machinery or equipment supplied to the Premises by the Landlord that have been removed by or at the request of the Tenant or its predecessors in title (otherwise than to comply with any law) remain at the Premises; and |
9.7 | The matters to be disregarded are: |
9.7.1 | any effect on rent of the fact that the Tenant or any of their predecessors in business have been in occupation of the Premises; |
9.7.2 | any goodwill attached to the Premises by reason of any business carried out there by the Tenant or by any of their predecessors in business; |
9.7.3 | any effect on rent attributable to any physical improvement to the Premises carried out after the date of the Previous Leases, by or at the expense of the Tenant or any of their predecessors in business with all necessary consents, approvals and authorisations and not pursuant to an obligation to the Landlord (other than an obligation to comply with any law); |
9.7.4 | any effect on rent of any obligation on the Tenant to fit out the Premises; |
9.7.5 | any statutory restriction on rents or the right to recover them. |
9.8 | The Surveyor shall be an independent valuer who is a Member or Fellow of the Royal Institution of Chartered Surveyors. The Landlord and the Tenant may, by agreement, appoint the Surveyor at any time before either of them applies to the President for the Surveyor to be appointed. |
9.9 | The Surveyor shall act as an expert and not as an arbitrator. The Surveyor shall determine the open market rent. The Surveyor’s decision shall be given in writing, and the Surveyor shall provide reasons for any determination. The Surveyor’s written decision on the matters referred to him shall be final and binding in the absence of manifest error or fraud. |
9.10 | The Surveyor shall give the Landlord and the Tenant an opportunity to make written representations to the Surveyor and to make written counter-representations commenting on the representations of the other party to the Surveyor. The parties will provide (or procure that others provide) the Surveyor with such assistance and documents as the Surveyor reasonably requires for the purpose of reaching a decision. |
9.11 | If the Surveyor dies, or becomes unwilling or incapable of acting, or unreasonably delays in making any determination, then either the Landlord or the Tenant may apply to the President to discharge the Surveyor and clause 9.8 shall then apply in relation to the appointment of a replacement. |
9.12 | The fees and expenses of the Surveyor and the cost of the Surveyor’s appointment and any counsel’s fees, or other fees, reasonably incurred by the Surveyor shall be payable by the Landlord and the Tenant in the proportions that the Surveyor directs (or if the Surveyor makes no direction, then equally). The Landlord and the Tenant shall otherwise each bear their own costs in connection with the rent review. |
9.13 | Time shall not be of the essence for the purposes of this clause. |
9.14 | If at any time there is a guarantor, the guarantor shall not have any right to participate in the review of the Rent. |
10. | EXCLUSION OF SECURITY OF TENURE |
The Landlord has served on the Tenant a notice on the form set out in schedule 1 to the Regulatory Reform (Business Tenancies) (England and Wales) Order 2003 (the Order) and the Tenant has made a statutory declaration in the form set out in paragraph 8 of schedule 2 to the Order and the parties agree that the provisions of sections 24-28 (inclusive) of the Landlord and Tenant Act 1954 shall not apply to this Lease.
This document has been executed as a deed and is delivered and takes effect on the date stated at the beginning of it.
Executed as a deed
by ADC Therapeutics (UK)
Limited acting by a director in the presence of:
/s/ Michael Forer | |
Michael Forer, Director |
Signature | /s/ CHRISTINE WAITE | |
Witness Name | CHRISTINE WAITE | |
Address | CHEMIN PRES LES BOIS 56, 1066 EPALINGES | |
Occupation | OFFICE & ADMINISTRATION MANAGER |
Signed as a deed by
QUEEN MARY BIOENTERPRISES LIMITED |
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/s/ Thomas T MacDonald
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acting by one director and the
company secretary or by two directors |
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Director
/s/ R. Richmond
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Director/Secretary
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Exhibit 10.8
womblebonddickinson.com |
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9 July, 2018
Counterpart Lease
relating to
Suite 8, First Floor, The Queen Mary BioEnterprises Innovation Centre,
Whitechapel, 42 New Road, London, E1 2AX
Queen Mary BioEnterprises Limited (1) and
ADC Therapeutics (UK) Limited (2)
Womble Bond Dickinson (UK) LLP
Tel +44(0)345 415 0000
www.womblebonddickinson.com
CONTENTS
Clause | Page | |
1. | PARTICULARS | 1 |
2. | DEFINITIONS | 2 |
3. | INTERPRETATION | 3 |
4. | GRANT | 3 |
5. | TENANT’S COVENANTS | 3 |
6. | LANDLORD’S COVENANTS | 9 |
7. | PROVISO | 10 |
8. | TENANT OPTION TO BREAK | 12 |
9. | RENT REVIEW | 12 |
10. | EXCLUSION OF SECURITY OF TENURE | 14 |
SCHEDULE 1
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15
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SCHEDULE 2
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16
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SCHEDULE 3
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17
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SCHEDULE 4
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18
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SCHEDULE 5
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20
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SCHEDULE 6
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22
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SCHEDULE 7
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23
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DATE | 9 July, 2018 |
PARTIES
(1) | Queen Mary BioEnterprises Limited (No. 04324033) whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS. |
(2) | ADC Therapeutics (UK) Limited (No. 09353055) whose registered office is at 4th Floor Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS. |
AGREED TERMS
1. | PARTICULARS | |||
Business Day | a day on which banks are open for business in London which is not a Saturday or Sunday or bank holiday. | |||
Building | the Queen Mary BioEnterprises Innovation Centre 42 New Road Whitechapel E1 2AX being all the land comprised in Title Number EGL520546. | |||
Group Company | a company that is a member of the same group as the Tenant within the meaning of Section 42 of the Landlord and Tenant Act 1954 (as amended). | |||
Premises | Suite 8, First Floor of The Queen Mary Bioenterprises Innovation Centre 42 New Road Whitechapel E1 2AX shown edged yellow on the Plan which forms Schedule 6 hereto which includes: | |||
(a) | all additions and improvements to the Premises; | |||
(b) | all Landlord’s fixtures and fittings and all other fixtures of every kind which shall from time to time be in or upon the Premises (whether originally affixed or fastened to or upon the Premises or otherwise) except any trade fixtures installed by the Tenant which can be removed from the Premises without causing any material damage to the Premises; | |||
(c) | the internal faces (including the plaster paint and other decorative finishes but not any other part) of the walls which enclose the Premises and of the walls within the Premises; | |||
(d) | the screed and finish (but not any other part) of the floors within the Premises; | |||
(e) | the suspended ceiling and the internal faces including the tiles plaster paint and other decorative finishes of it and all light fittings therein; | |||
(f) | all doors door furniture door frames and glass in such door within premises; | |||
(g) | But excluding: | |||
(h) | the windows in the exterior walls and their frames and fittings; | |||
(i) | the whole of the interior structural load bearing walls and columns within that part of the Building other than their plasterwork and other than the doors and windows and their frames and fittings within such walls; |
(j) | all service media within that part of the Building which do not exclusively serve that part of the Building; and | |||
(k) | the void between the suspended ceiling and the concrete slab separating the first floor of the Building from the second floor of the Building. |
Term | a term commencing on 9 July 2018 and expiring on 31 December 2023. | ||
Rent | in respect of the period commencing on and including the Rent Commencement Date the sum of £41,325.00 plus VAT per annum and then as revised in accordance with clause 9 of this Lease. The Rent is inclusive of charges for the provision of Landlord services relating to facilities infrastructure building fabric as set out in Schedule 4 but excludes business rates or any additional charges payable by the Tenant as itemised in Schedule 5. | ||
Rent Commencement Date | 9 July 2018. | ||
Rent Payment Dates | the 1st day in any calendar month. | ||
Review Date | 1 January 2020 and 1 January 2022. | ||
Permitted Use | research and development within Use Class B1 of the Schedule to the Town & Country Planning (Use Classes) Order 1987. | ||
2. | DEFINITIONS | ||
Break Date | 1 January 2020 and 1 January 2022. | ||
Break Notice | written notice to terminate this lease on the Break Date specifying the relevant Break Date and serve in accordance with Clause 8. | ||
Deposit | a sum equal to two months’ annual Rent plus a sum equal to VAT on that amount. | ||
Insured Risk | such risks as are specified in the Superior Lease. | ||
Interest | interest during the period from the date on which the payment is due to the date of payment both before and after any judgment at the Interest Rate or should the base rate referred to in clause 2.4 cease to exist such other rate of interest as is most closely comparable with the Interest Rate to be determined by the Landlord. | ||
Interest Rate | three per cent (3%) above the base rate of the Bank of England. | ||
Minimum Amount | the sum equal to 2 months’ annual Rent plus a sum equal to VAT on that amount. | ||
Planning Acts | the Town and County Planning Act 1990 the Planning (Listed Building and Conservation Areas) Act 1990 the Planning (Consequential Provisions) Act 1990 the Planning (Hazardous Substances) Act 1990 the Planning and Compensation Act 1991 the Planning Act 2008 and all statutes regulations and orders included by virtue of clause 3.5. |
Superior Landlord | Queen Mary University of London. | ||
Superior Lease | a lease dated 15 March 2007 and made between (1) the Superior Landlord and (2) Queen Mary Innovation Limited. | ||
VAT | Value Added Tax or any other such imposition or levy of a like nature which may extend or replace Value Added Tax. |
3. | INTERPRETATION |
3.1 | The expressions the Superior Landlord the Landlord and the Tenant wherever the context so admits include their respective successors in title. |
3.2 | Words importing the one gender include all other genders and words importing the singular include the plural and vice versa. |
3.3 | References to any right of the Landlord to have access to the Premises shall be construed as extending to all persons reasonably authorised by the Landlord and also the Superior Landlord. |
3.4 | Any covenant by the Tenant not to do an act or thing shall be deemed to include an obligation not to permit such act or thing to be done. |
3.5 | Any reference to a specific statute includes any statutory extension or modification or re-enactment of such statute and any regulations or orders made there under and any general reference to ‘statute’ or ‘statutes’ includes any regulations or orders made there under. |
4. | GRANT |
4.1 | The Landlord lets the Premises to the Tenant for the Term with full title guarantee. |
4.2 | The grant is made together with the rights specified in Schedule 1 excepting and reserving to the Landlord the rights specified in Schedule 2 and subject to the matters referred to in Schedule 3. |
4.3 | The grant is made with the Tenant paying the following as rent to the Landlord: |
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4.3.1 | the Rent and all VAT in respect of it; |
4.3.2 | all interest payable under this Lease; and |
4.3.3 | all other sums due under this Lease. |
5. | TENANT’S COVENANTS |
The Tenant covenants with the Landlord: |
5.1 | Rents |
To pay the Rent and any VAT in respect of it (whether formally demanded or not) without any deduction or set off by twelve (12) equal monthly instalments in advance on or before the Rent Payment Dates. The payments shall be made by electronic means and the first such payment shall be made on the date of this Lease and shall be a proportionate sum in respect of the period from and including the Rent Commencement Date to and including the day before the Rent Payment Date next following. |
5.2 | Security Deposit | ||
5.2.1 | On or before the date of this Lease the Tenant shall pay the Deposit to the Landlord. The Deposit shall belong to the Tenant subject to the terms of this Lease; | ||
5.2.2 | The Tenant shall pay to the Landlord such sum or sums necessary to ensure that the Deposit is not less than the Minimum Amount within 10 Business Days of the date upon which each and every review of Rent is settled in accordance with the terms of this Lease (and the Landlord shall provide the Tenant with a written demand for such payment); | ||
5.2.3 | If: | ||
(a) | an event of default by the Tenant (as set out in clause 7.1) exists under this Lease at any time or; | ||
(b) | the Tenant fails to comply with the yielding up requirements of clause 5.11 on or following the expiry of the Term (however so determined); | ||
the Landlord shall forthwith give notice thereof to the Tenant in writing and may use or apply or retain the whole or any part of the Deposit to the extent necessary to cure the event of default; | |||
5.2.4 | If at any time during or following the Term of this Lease the Landlord applies all or a portion of the Deposit to cure the Tenant’s event of default the Tenant shall repay to the Landlord within ten (10) Business Days after written demand by the Landlord any amount necessary to restore the Deposit to the Minimum Amount; | ||
5.2.5 | At the end of the Term (howsoever determined) the Tenant shall at its own cost appoint an independent consultant (such appointment to be approved by the Landlord such approval not to be unreasonably withheld or delayed) to inspect the Premises, the ceiling void air supply and extract ductwork, the ceiling void ductwork connected to the Tenant’s ducted fume hoods and ducted equipment and provide a certificate of decontamination to confirm that the Premises are free from contamination by radioactive or other toxic substances and that there has been no spread of any contamination into the ceiling void ductwork or otherwise. In the event that a satisfactory decontamination certificate is not produced within five (5) Business Days after the end of the Term (howsoever determined) the Landlord may: | ||
(a) | require the Tenant to remove at its own cost and within a period of fifteen (15) Business Days after the end of the Term the fume hoods (such works to be carried out to the satisfaction of the Landlord); and or | ||
(b) | implement its own decontamination processes on the Premises and ceiling void ductwork using an independent consultant (and using reasonable endeavours to complete these processes within twelve months after the end of the Term) and if at any time the costs incurred by the Landlord in carrying out its decontamination processes exceed the Deposit the Ten ant shall pay the balance sum to the Landlord within ten (10) Business Days of written demand. | ||
5.2.6 | If the Tenant has provided a certificate of decontamination in accordance with clause 5.2.4 the Deposit or the balance of it (if any) shall be returned to the Tenant within three (3) months of the end of the Term; | ||
5.2.7 | If the Landlord requires the Tenant to remove the fume hoods as detailed in clause 5.2.4 (a) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the removal works have been completed to the satisfaction of the Landlord or within 3 months of the date on which the Landlord’s decontamination process has been concluded, whichever is the latest; |
5.2.8 | If the Landlord implements its own decontamination processes as detailed in clause 5.2.4 (b) the Deposit or the balance of it (if any) shall be returned to the Tenant within 3 months of the date on which the Landlord’s decontamination processes have been concluded or within 3 months of the date on which the fume hood removal works have been completed to the satisfaction of the Landlord, whichever is the latest. | |
5.3 | Operating Expenses | |
The Tenant agrees to pay to the Landlord within twenty (20) Business Days of written demand any and all operating expenses expressly set out below: | ||
5.3.1 | Sub-metered chargeable electrical usage for the Premises as evidenced by the Landlord (see Schedule 5 of this Lease); | |
5.3.2 | Use of other fee-for-use services such as usage of the telecoms lines and meeting room usage; | |
5.3.3 | Electricity charges as evidenced by the Landlord covering the air handling systems connected to any Tenant’s ducted equipment e.g. fume hoods (every three (3) months payable within twenty (20) Business Days of written demand). | |
5.4 | Outgoings | |
To pay and indemnify the Landlord against all rates taxes assessments duties charges impositions and outgoings which are now or during the Term shall be charged assessed or imposed on the Premises or upon the owner or occupier of them excluding any payable by the Landlord which in the absence of a direct assessment shall be reasonably determined by the Landlord. | ||
5.5 | Repair | |
To keep the Premises in good repair and decorative order and in a clean and tidy state and condition at all times, but in no better condition than as evidenced by the photographic schedule of condition attached hereto. | ||
5.6 | Alterations and Additions | |
5.6.1 | Structural alterations external alterations and additions are not permitted; | |
5.6.2 | Not to make any internal non-structural alterations or additions (including partitioning) to the whole or any part of the Premises without the Landlord’s prior written consent (such consent not to be unreasonably withheld or delayed) and approval (such approval not to be unreasonably withheld or delayed) of previously submitted drawings and/or specification in a form reasonably required by the Landlord and if such consent is granted to comply with the Planning Acts in the carrying out of such alterations or additions; | |
5.6.3 | For the avoidance of doubt, if the Landlord gives consent to the carrying out by the Tenant of any alterations to the Premises pursuant to clause 5.6.2 above, unless the Superior Landlord agrees to insure any such works from the date on which they are completed, they will at all times be at the sole risk of the Tenant. | |
5.7 | Use | |
5.7.1 | Not to use the Premises for any purpose other than the Permitted Use; | |
5.7.2 | The Tenant covenants not under any circumstances to introduce Schedule 5 Pathogens into the Premises. Schedule 5 Pathogens are defined within the U.K. government’s Act entitled ‘The Schedule 5 to the Anti-Terrorism, Crime and Security Act 2001 (Modification) Order 2007’ and any subsequent modifying Statutory Instruments; |
5.10.2 | Not to use the Premises for any dangerous noxious noisy or offensive trade or business nor for any illegal or immoral act or purpose and not to sleep or allow any person to sleep in the Premises; | ||
5.10.3 | Without prejudice to the generality of clauses 5.10.1 and 5.22 of this Lease, unless the lights are switched off, the Tenant must ensure that all blinds and curtains at the windows of the Premises are pulled down at dusk and remain down during all hours of darkness so that no disturbance, nuisance or inconvenience is caused to any neighbouring properties; | ||
5.11 | Yield Up | ||
5.11.1 | At the expiry of the Term to yield up the Premises with vacant possession and in accordance with the Tenant’s covenants in this Lease and to give up all keys (if any) of the Premises to the Landlord reinstate any alterations or additions if required by the Landlord and remove all signage erected by the Tenant in upon or near the Premises and forthwith to make good damage caused by such removal or reinstatement at the Tenant’s expense; | ||
5.11.2 | At the expiry of the Term the Premises should be delivered in a clean and tidy condition and laboratories will be decommissioned and inspected by a qualified independent consultant at the tenant’s cost (who shall be first approved by the Landlord) at or before the expiration of the Term and the Tenant shall upon termination of this Lease remove from the Premises all the Tenant’s personal property and any and all owned or leased fixtures and equipment save as provided in clause 5.2 hereof. | ||
5.12 | Interest on Arrears | ||
The Tenant must pay Interest on any of the Rent or other sums due under this Lease that are not paid within seven (7) Business Days of the date due whether formally demanded or not. Nothing in this clause entitles the Tenant to withhold or delay any payment of the Rent or any other sum due under this Lease or affects the rights of the Landlord in relation to any non-payment. | |||
5.13 | Costs | ||
5.13.1 | The Tenant shall pay the costs and expenses of the Landlord including any solicitors’ or other professionals’ costs and expenses incurred (both during and after the end of the Term) in connection with or in contemplation of any of the following: | ||
(a) | the enforcement of the tenant covenants of this Lease; | ||
(b) | serving any notice in connection with this Lease under section 146 or 147 of the Law of Property Act 1925 or taking any proceedings under either of those sections, notwithstanding that forfeiture is avoided otherwise than by relief granted by the court; | ||
(c) | serving any notice in connection with this Lease under section 17 of the Landlord and Tenant (Covenants) Act 1995; | ||
(d) | the preparation and service of a schedule of dilapidations in connection with this Lease; or | ||
(e) | any consent or approval applied for under this Lease, whether or not it is granted (unless the consent or approval is unreasonably withheld by the Landlord in circumstances where the Landlord is not unreasonably to withhold it). | ||
5.13.2 | Where the Tenant is obliged to pay or indemnify the Landlord against any solicitors’ or other professionals’ costs and expenses (whether under this or any other clause of this Lease) that obligation extends to those costs and expenses assessed on a full indemnity basis; |
5.22 | Compliance with Statute | ||
5.22.1 | The Tenant shall comply with all laws relating to: | ||
(a) | the Premises and the occupation and use of the Premises by the Tenant; | ||
(b) | the use or operation of all conduits and machinery and equipment in the Premises; | ||
(c) | any works carried out at the Premises; and | ||
(d) | all materials kept at or disposed of from the Premises. | ||
5.23 | VAT | ||
To pay to the Landlord VAT chargeable in respect of Rent or any other payment made by the Ten ant under any of the provisions of or in connection with this Lease or paid by the Landlord or any payment made by the Landlord where the Tenant agrees in this Lease to reimburse the Landlord for such payment and the Landlord is not entitled to recover the same by way of set off from H M Revenue and Customs. | |||
5.24 | Superior Lease | ||
To observe and perform the tenant covenants in the Superior Lease in so far as they relate to the Premises except for the covenant to pay rent. | |||
5.25 | Compliance with Queen Mary Bioenterprises Management processes | ||
5.25.1 | If appropriate upon request to complete sign and date the ‘Queen Mary Bioenterprises Lab Questionnaire’ on or prior to completion a signed and dated copy of which is annexed to this Lease and to review and assess annually; | ||
5.25.2 | To provide the Landlord with information relating to jobs brought to the Landlord and any jobs or employment created within the Term to enable the Landlord to provide quarterly reports to the London Development Agency (the LDA) or its successor; | ||
5.25.3 | To reasonably assist the management of the Landlord prior to the occupation of the space in carrying out credit-worthiness checks of the Tenant which may include: a standard commercial credit check; checking that the company directors are not disqualified; copies of the current balance sheet and business plan (including cash flow forecast); | ||
5.25.4 | To provide every half year interim accounts and a written directors’ report outlining the development plans of the business with regards to the occupied space; | ||
5.25.5 | To provide half yearly job forecasts due to grant reporting demands by the Landlord’s funders; | ||
5.25.6 | Upon request to complete sign and date the ‘Queen Mary Bioenterprises Health & Safety Policy’ on or prior to completion of signing this Lease. | ||
6. | LANDLORD’S COVENANTS | ||
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The Landlord covenants with the Tenant: |
6.1 | Quiet Enjoyment | |
To permit the Tenant peaceably and quietly to hold and enjoy the Premises without any lawful interruption or disturbance from or by the Landlord or any person claiming under or in trust for the Landlord or by title paramount. | ||
6.2 | Superior Lease | |
The Landlord shall observe and perform the tenant covenants in the Superior Lease including to pay the rent save where they are the responsibility of the Tenant or another occupier of all or any part of the Building and shall procure so far as possible the Superior Landlord’s compliance with the landlord covenants in the Superior Lease. | ||
6.3 | Services | |
Subject to payment by the Tenant of the Rent the Landlord shall provide those services listed in Schedule 4 (the Services) PROVIDED THAT: | ||
6.3.1 | the Landlord shall not be liable for any temporary delay or interruption in or disruption to the provisions of any of the Services; | |
6.3.2 | the Landlord shall not be liable for any delay or interruption in or disruption to the provisions of any of the Services for any reason that is outside the reasonable control of the Landlord; | |
6.3.3 | the Landlord shall not be liable for any defect or want of repair affecting the Premises unless the Landlord has received notice in writing thereof from the Tenant. | |
6.4 | Option to Terminate | |
If the whole or a substantial part of the Premises shall be damaged or destroyed by any of the Insured Risks such that reinstatement of the Premises is impracticable either party may determine this Lease by giving three (3) months’ notice to the other after such damage or destruction and if so determined the Landlord shall not be under any obligation to reinstate the Premises and such determination shall be without prejudice to any antecedent breaches and the insurance monies shall belong to the Landlord (but not monies received by the Tenant under its own policy for loss of its own equipment and effects). | ||
6.5 | Confidentiality | |
To keep confidential all commercial and financial information provided by the Tenant in compliance with clause 5.25.1 (but for the avoidance of doubt the Landlord shall not be required to keep the information provided in accordance with clauses 5.24.2 and 5.24.5 confidential but the Landlord shall only share such information with the LDA or its successor). | ||
7. | PROVISO | |
7.1 | Re-entry | |
If at any time during the Term: | ||
7.1.1 | the Rent (or any part thereof) is outstanding for twenty one (21) calendar days after becoming due (whether formally demanded or not); or | |
7.1.2 | the Tenant breaches any of the covenants and conditions contained in this Lease; or | |
7.1.3 | the Tenant (being an individual) becomes bankrupt or (being a company) enters into liquidation whether compulsory or voluntary (save for the purpose of amalgamation or reconstruction of a solvent company) or has a receiver appointed or (in either case) enters into an arrangement or composition for the benefit of its creditors the Landlord may at any time (and notwithstanding the waiver of any previous right of re-entry) re-enter the Premises or any part of them in the name of the whole and thereupon the Term shall absolutely cease and determine but without prejudice to any rights or remedies which may have accrued to the Landlord against the Tenant in respect of any antecedent breach of any of the covenants and conditions contained in this Lease (including the breach in relation to which re-entry is made). |
7.2 | Representations |
The Tenant acknowledges that this Lease has not been entered into in reliance wholly or partly on any statement or representation made by or on behalf of the Landlord except any such statement or representation that is expressly set out in this Lease. | |
7.3 | Suspension of Rent |
If the Premises or the access there to is destroyed or damaged by any of the Insured Risks as listed in the Superior Lease so as to make the Premises or access thereto unfit for beneficial occupation or use or reasonable access to the Premises unavailable and the insurance effected by the Landlord has not been vitiated or payment of the policy monies wholly or partly withheld or refused by reason of any act neglect or default or omission of the Tenant or any person deriving title under the Ten ant or their respective servants agents licensees or invitees the Rent or a fair proportion thereof according to the nature and extent of the damage shall not be payable until the Premises are again rendered fit for beneficial use and (as the case may be) occupation and any dispute shall be referred to the award of a single arbitrator to be appointed in default of agreement upon the application of the Landlord by the President for the time being of the Royal Institute of Chartered Surveyors in accordance with the provisions of the Arbitration Act 1996. | |
7.4 | Lien |
The Landlord shall be entitled to sell any goods on which it may have a lien pursuant to this Lease which have been left at the Premises for more than ten (10) Business Days after the end of the Term (howsoever determined) at such price and upon such terms as the Landlord in its discretion may think fit and the net proceeds of any such sale shall be applied firstly towards payment of any such sums due by the Tenant to the Landlord and any balance shall be paid to the Tenant after deduction of all reasonable costs and expenses incurred by the Landlord. | |
7.5 | No Implied Easements |
Nothing in this Lease shall operate expressly or impliedly to confer upon or grant to the Tenant any easement right or privilege other than those expressly hereby granted. | |
7.6 | No Warranty as to Use |
Nothing in this Lease or in any consent granted by the Landlord under this Lease is to imply or warrant either the state or condition of the Premises or that the Premises may be lawfully used under the Planning Acts for the Permitted Use. | |
7.7 | Landlord’s Obligations |
Nothing in the Lease shall by implication or otherwise render the Landlord obliged to do anything that the Landlord has not specifically covenanted to do. | |
7.8 | Jurisdiction |
Disputes and differences between the parties arising out of or in relation to this Lease shall be referred to the exclusive jurisdiction of the English Courts This Lease shall be governed by and construed in accordance with English Law. |
9.5.4 | disregarding the matters listed in clause 9.7. | |||
9.6 | The assumptions are: | |||
9.6.1 | the Premises are available to let in the open market: | |||
(a) | by a willing lessor to a willing lessee; | |||
(b) | as a whole; | |||
(c) | with vacant possession; | |||
(d) | without a fine or a premium; | |||
(e) | for a term equal to the unexpired residue of the Term at the Review Date or a term of two years commencing on the Review Date, if longer; and | |||
(f) | otherwise on the terms of this Lease other than as to: | |||
(i) | the amount of the Rent; | |||
(ii) | the inclusion of clause 8 (Tenant’s option to determine); and | |||
(iii) | the inclusion of provisions for review of the Rent. | |||
9.6.2 | the willing lessee has had the benefit of any rent-free or other concession or contribution which would be offered in the open market at the Review Date in relation to fitting out works at the Premises; | |||
9.6.3 | the Premises may lawfully be used and occupied, and are in a physical state to enable them to be lawfully used any occupied, by the willing lessee (or any potential undertenant or assignee of the willing lessee) for any purpose permitted by this Lease; | |||
9.6.4 | the Tenant has fully complied with their obligations in this Lease; | |||
9.6.5 | if the Premises or any means of access to them have been destroyed or damaged, they have been fully restored; | |||
9.6.6 | no work has been carried out on the Premises that has diminished their rental value; | |||
9.6.7 | any fixtures, fittings, machinery or equipment supplied to the Premises by the Landlord that have been removed by or at the request of the Ten ant or its predecessors in title (otherwise than to comply with any law) remain at the Premises; and | |||
9.7 | The matters to be disregarded are: | |||
9.7.1 | any effect on rent of the fact that the Tenant or any of their predecessors in business have been in occupation of the Premises; | |||
9.7.2 | any goodwill attached to the Premises by reason of any business carried out there by the Tenant or by any of their predecessors in business; | |||
9.7.3 | any effect on rent attributable to any physical improvement to the Premises carried out after the date of this Lease, by or at the expense of the Tenant or any of their predecessors in business with all necessary consents, approvals and authorisations and not pursuant to an obligation to the Landlord (other than an obligation to comply with any law); | |||
9.7.4 | any effect on rent of any obligation on the Ten ant to fit out the Premises; |
9.7.5 | any statutory restriction on rents or the right to recover them. | |
9.8 | The Surveyor shall be an independent valuer who is a Member or Fellow of the Royal Institution of Chartered Surveyors. The Landlord and the Tenant may, by agreement, appoint the Surveyor at any time before either of them applies to the President for the Surveyor to be appointed. | |
9.9 | The Surveyor shall act as an expert and not as an arbitrator. The Surveyor shall determine the open market rent. The Surveyor’s decision shall be given in writing, and the Surveyor shall provide reasons for any determination. The Surveyor’s written decision on the matters referred to him shall be final and binding in the absence of manifest error or fraud. | |
9.10 | The Surveyor shall give the Landlord and the Tenant an opportunity to make written representations to the Surveyor and to make written counter-representations commenting on the representations of the other party to the Surveyor. The parties will provide (or procure that others provide) the Surveyor with such assistance and documents as the Surveyor reasonably requires for the purpose of reaching a decision. | |
9.11 | If the Surveyor dies, or becomes unwilling or incapable of acting, or unreasonably delays in making any determination, then either the Landlord or the Tenant may apply to the President to discharge the Surveyor and clause 9.8 shall then apply in relation to the appointment of a replacement. | |
9.12 | The fees and expenses of the Surveyor and the cost of the Surveyor’s appointment and any counsel’s fees, or other fees, reasonably incurred by the Surveyor shall be payable by the Landlord and the Tenant in the proportions that the Surveyor directs (or if the Surveyor makes no direction, then equally). The Landlord and the Tenant shall otherwise each bear their own costs in connection with the rent review. | |
9.13 | Time shall not be of the essence for the purposes of this clause. | |
9.14 | If at any time there is a guarantor, the guarantor shall not have any right to participate in the review of the Rent. | |
10. | EXCLUSION OF SECURITY OF TENURE | |
The Landlord has served on the Tenant a notice on the form set out in schedule 1 to the Regulatory Reform (Business Tenancies) (England and Wales) Order 2003 (the Order) and the Ten ant has made a statutory declaration in the form set out in paragraph 8 of schedule 2 to the Order and the parties agree that the provisions of sections 24-28 (inclusive) of the Landlord and Ten ant Act 1954 shall not apply to this Lease. | ||
This document has been executed as a deed and is delivered and takes effect on the date stated at the beginning of it. |
Executed as a deed by ADC Therapeutics (UK)
|
/s/ Michael Forer
|
|
Limited acting by a director in the presence of:
|
Michael Forer
Director
|
Exhibit 10.9
womblebonddickinson.com |
|
1 July 2019
Deed Of Variation
Relating To
Lease of Suite 5, First Floor, The Queen Mary Bioenterprises Innovation
Centre, 42 New Road, London
Queen Mary Bioenterprises Limited (1) and
ADC Therapeutics (UK) Limited (2)
Womble Bond Dickinson (UK) LLP
Tel +44(0)345 415 0000
www.womblebonddickinson.com
CONTENTS
Clause | Page | |
1. | INTERPRETATION | 1 |
2. | VARIATIONS TO THE LEASE | 2 |
3. | TENANT’S COVENANT | 2 |
4. | ENDORSEMENT | 2 |
5. | GOVERNING LAW | 2 |
6. | JURISDICTION | 2 |
7. | THIRD PARTY RIGHTS | 2 |
SCHEDULE 1 | 3 | |
Variations to the Lease | 3 |
PARTIES
(1) | Queen Mary Bioenterprises Limited incorporated and registered in England and Wales with company number 04324033 whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS (Landlord). |
(2) | ADC Therapeutics (UK) Limited incorporated and registered in England and Wales with company number 09353055 whose registered office is at 4th Floor, Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS (Tenant). |
BACKGROUND
(A) | This deed is supplemental and collateral to the Lease. |
(B) | The Landlord and the Tenant have agreed to vary the Lease on the terms set out in this deed. |
(C) | The Landlord is entitled to the immediate reversion to the Lease. |
(D) | The residue of the term granted by the Lease is vested in the Tenant. |
AGREED TERMS
1. | INTERPRETATION |
The following definitions and rules of interpretation apply in this deed.
1.1 | Definitions: |
Lease | a lease of the Property dated 14 September 2017 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited. | |
Property | Suite 5, First Floor of the Queen Mary Bioenterprises Innovation Centre as more particularly described in and demised by the Lease. |
1.2 | References to the Landlord include a reference to the person entitled for the time being to the immediate reversion to the Lease. References to the Tenant include a reference to its respective successors in title and assigns. |
1.3 | A reference to the Lease includes any deed, licence, consent, approval or other instrument supplemental to it. |
1.4 | A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.5 | A reference to a statute or statutory provision shall include all subordinate legislation made from time to time under that statute or statutory provision. |
1.6 | A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.7 | The expression tenant covenant has the meaning given to it by the Landlord and Tenant (Covenants) Act 1995. |
1.8 | Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.9 | Unless the context otherwise requires, a reference to the Property is to the whole and any part of it. |
1.10 | Except where a contrary intention appears, references to clauses and Schedules are to the clauses and Schedules of this deed and references to paragraphs are to paragraphs of the relevant Schedule. |
1.11 | Clause, Schedule and paragraph headings shall not affect the interpretation of this deed. |
1.12 | Except to the extent that they are inconsistent with the definitions and interpretations in Clause 1 of this deed, the definitions and interpretations in clause 1 of the Lease shall apply to this deed. |
2. | VARIATIONS TO THE LEASE |
2.1 | Variations made |
From and including the date of this deed, the Lease shall be read and construed as varied by the provisions set out in the Schedule. |
2.2 | Lease remains in force |
The Lease shall remain fully effective as varied by this deed and the terms of the Lease shall have effect as though the provisions contained in this deed had been originally contained in the Lease. |
3. | TENANT’S COVENANT |
The Tenant covenants to observe and perform the tenant’s covenants in the Lease as varied by this deed.
4. | ENDORSEMENT |
Promptly following completion of this deed both the Landlord and the Tenant shall each endorse a memorandum of variation upon the Lease and its counterpart in the following terms:
“This Lease has been varied by a Deed of Variation dated [ ] 2019 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited.
5. | GOVERNING LAW |
This deed and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
6. | JURISDICTION |
Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this deed or its subject matter or formation (including non-contractual disputes or claims).
7. | THIRD PARTY RIGHTS |
A person who is not a party to this deed shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this deed. This does not affect any right or remedy of a third party which exists or is available apart from that Act.
This Deed has been entered into on the date stated at the beginning of it.
Executed as a deed by Queen Mary Bioenterprises
|
|
Limited acting by a director and its secretary
|
Director /s/ [Illegible]
|
|
|
Director/Secretary /s/ R. Richmond
|
Executed as a deed by ADC Therapeutics (UK)
|
|
Limited acting by a director and its secretary
|
Director /s/ Michael Forer
|
|
|
Director/Secretary
|
Exhibit 10.10
womblebonddickinson.com |
|
1 July 2019
Deed Of Variation
Relating To
Lease of Lab 11b, Suite 11 Write Up Space and Suite 12, First Floor, The
Queen Mary Bioenterprises Innovation Centre, 42 New Road, London
Queen Mary Bioenterprises Limited (1) and
ADC Therapeutics (UK) Limited (2)
Womble Bond Dickinson (UK) LLP
Tel +44(0)345 415 0000
www.womblebonddickinson.com
CONTENTS
Clause | Page | |
1. | INTERPRETATION | 1 |
2. | VARIATIONS TO THE LEASE | 2 |
3. | TENANT’S COVENANT | 2 |
4. | ENDORSEMENT | 2 |
5. | GOVERNING LAW | 2 |
6. | JURISDICTION | 2 |
7. | THIRD PARTY RIGHTS | 2 |
SCHEDULE 1 | 3 | |
Variations to the Lease | 3 |
PARTIES
(1) | Queen Mary Bioenterprises Limited incorporated and registered in England and Wales with company number 04324033 whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS (Landlord). |
(2) | ADC Therapeutics (UK) Limited incorporated and registered in England and Wales with company number 09353055 whose registered office is at 4th Floor, Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS (Tenant). |
BACKGROUND
(A) | This deed is supplemental and collateral to the Lease. |
(B) | The Landlord and the Tenant have agreed to vary the Lease on the terms set out in this deed. |
(C) | The Landlord is entitled to the immediate reversion to the Lease. |
(D) | The residue of the term granted by the Lease is vested in the Tenant. |
AGREED TERMS
1. | INTERPRETATION |
The following definitions and rules of interpretation apply in this deed.
1.1 | Definitions: |
Lease | a lease of the Property dated 20 December 2017 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited. | |
Property | Lab 11b , Suite 11 Write Up Space and Suite 12, First Floor, The Queen Mary Bioenterprises Innovation Centre as more particularly described in and demised by the Lease. |
1.2 | References to the Landlord include a reference to the person entitled for the time being to the immediate reversion to the Lease. References to the Tenant include a reference to its respective successors in title and assigns. |
1.3 | A reference to the Lease includes any deed, licence, consent, approval or other instrument supplemental to it. |
1.4 | A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.5 | A reference to a statute or statutory provision shall include all subordinate legislation made from time to time under that statute or statutory provision. |
1.6 | A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.7 | The expression tenant covenant has the meaning given to it by the Landlord and Tenant (Covenants) Act 1995. |
1.8 | Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.9 | Unless the context otherwise requires, a reference to the Property is to the whole and any part of it. |
1.10 | Except where a contrary intention appears, references to clauses and Schedules are to the clauses and Schedules of this deed and references to paragraphs are to paragraphs of the relevant Schedule. |
1.11 | Clause, Schedule and paragraph headings shall not affect the interpretation of this deed. |
1.12 | Except to the extent that they are inconsistent with the definitions and interpretations in Clause 1 of this deed, the definitions and interpretations in clause 1 of the Lease shall apply to this deed. |
2. | VARIATIONS TO THE LEASE |
2.1 | Variations made |
From and including the date of this deed, the Lease shall be read and construed as varied by the provisions set out in the Schedule. |
2.2 | Lease remains in force |
The Lease shall remain fully effective as varied by this deed and the terms of the Lease shall have effect as though the provisions contained in this deed had been originally contained in the Lease. |
3. | TENANT’S COVENANT |
The Tenant covenants to observe and perform the tenant’s covenants in the Lease as varied by this deed.
4. | ENDORSEMENT |
Promptly following completion of this deed both the Landlord and the Tenant shall each endorse a memorandum of variation upon the Lease and its counterpart in the following terms:
“This Lease has been varied by a Deed of Variation dated [ ] 2019 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited.
5. | GOVERNING LAW |
This deed and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
6. | JURISDICTION |
Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this deed or its subject matter or formation (including non-contractual disputes or claims).
7. | THIRD PARTY RIGHTS |
A person who is not a party to this deed shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this deed. This does not affect any right or remedy of a third party which exists or is available apart from that Act.
This Deed has been entered into on the date stated at the beginning of it.
Executed as a deed by Queen Mary Bioenterprises
|
|
Limited acting by a director and its secretary
|
Director /s/ [Illegible]
|
|
|
Director/Secretary /s/ R. Richmond
|
Executed as a deed by ADC Therapeutics (UK)
|
|
Limited acting by a director and its secretary
|
Director /s/ Michael Forer
|
|
|
Director/Secretary
|
Exhibit 10.11
womblebonddickinson.com |
|
1 July 2019
Deed Of Variation
Relating To
Lease of Suite 8, First Floor, The Queen Mary Bioenterprises Innovation
Centre, 42 New Road, London
Queen Mary Bioenterprises Limited (1) and
ADC Therapeutics (UK) Limited (2)
Womble Bond Dickinson (UK) LLP
Tel+44(0)345 415 0000
www.womblebonddickinson.com
CONTENTS
Clause | Page | |
1. | INTERPRETATION | 1 |
2. | VARIATIONS TO THE LEASE | 2 |
3. | TENANT’S COVENANT | 2 |
4. | ENDORSEMENT | 2 |
5. | GOVERNING LAW | 2 |
6. | JURISDICTION | 2 |
7. | THIRD PARTY RIGHTS | 2 |
SCHEDULE 1 | 3 | |
Variations to the Lease | 3 |
PARTIES
(1) | Queen Mary Bioenterprises Limited incorporated and registered in England and Wales with company number 04324033 whose registered office is at Queen Mary University of London, 327 Mile End Road, London, E1 4NS (Landlord). |
(2) | ADC Therapeutics (UK) Limited incorporated and registered in England and Wales with company number 09353055 whose registered office is at 4th Floor, Reading Bridge House, George Street, Reading, Berkshire, RG1 8LS (Tenant). |
BACKGROUND
(A) | This deed is supplemental and collateral to the Lease. |
(B) | The Landlord and the Tenant have agreed to vary the Lease on the terms set out in this deed. |
(C) | The Landlord is entitled to the immediate reversion to the Lease. |
(D) | The residue of the term granted by the Lease is vested in the Tenant. |
AGREED TERMS
1. | INTERPRETATION |
The following definitions and rules of interpretation apply in this deed.
1.1 | Definitions: |
Lease | a lease of the Property dated 9 July 2018 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited. | |
Property | Suite 8, First Floor of the Queen Mary Bioenterprises Innovation Centre as more particularly described in and demised by the Lease. |
1.2 | References to the Landlord include a reference to the person entitled for the time being to the immediate reversion to the Lease. References to the Tenant include a reference to its respective successors in title and assigns. |
1.3 | A reference to the Lease includes any deed, licence, consent, approval or other instrument supplemental to it. |
1.4 | A reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time. |
1.5 | A reference to a statute or statutory provision shall include all subordinate legislation made from time to time under that statute or statutory provision. |
1.6 | A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). |
1.7 | The expression tenant covenant has the meaning given to it by the Landlord and Tenant (Covenants) Act 1995. |
1.8 | Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular. |
1.9 | Unless the context otherwise requires, a reference to the Property is to the whole and any part of it. |
1.10 | Except where a contrary intention appears, references to clauses and Schedules are to the clauses and Schedules of this deed and references to paragraphs are to paragraphs of the relevant Schedule. |
1.11 | Clause, Schedule and paragraph headings shall not affect the interpretation of this deed. |
1.12 | Except to the extent that they are inconsistent with the definitions and interpretations in Clause 1 of this deed, the definitions and interpretations in clause 1 of the Lease shall apply to this deed. |
2. | VARIATIONS TO THE LEASE |
2.1 | Variations made |
From and including the date of this deed, the Lease shall be read and construed as varied by the provisions set out in the Schedule. |
2.2 | Lease remains in force |
The Lease shall remain fully effective as varied by this deed and the terms of the Lease shall have effect as though the provisions contained in this deed had been originally contained in the Lease. |
3. | TENANT’S COVENANT |
The Tenant covenants to observe and perform the tenant’s covenants in the Lease as varied by this deed.
4. | ENDORSEMENT |
Promptly following completion of this deed both the Landlord and the Tenant shall each endorse a memorandum of variation upon the Lease and its counterpart in the following terms:
“This Lease has been varied by a Deed of Variation dated [ ] 2019 and made between (1) Queen Mary Bioenterprises Limited and (2) ADC Therapeutics (UK) Limited.
5. | GOVERNING LAW |
This deed and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
6. | JURISDICTION |
Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this deed or its subject matter or formation (including non-contractual disputes or claims).
7. | THIRD PARTY RIGHTS |
A person who is not a party to this deed shall not have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this deed. This does not affect any right or remedy of a third party which exists or is available apart from that Act.
This Deed has been entered into on the date stated at the beginning of it.
Executed as a deed by Queen Mary Bioenterprises
|
|
Limited acting by a director and its secretary
|
Director /s/ [Illegible]
|
|
|
Director/Secretary /s/ R. Richmond
|
Executed as a deed by ADC Therapeutics (UK)
|
|
Limited acting by a director and its secretary
|
Director /s/ Michael Forer
|
|
|
Director/Secretary
|
A.
|
The Covered Person has been elected as a member of the Board of Directors (a “Director”) or appointed as member of the management (an “Officer”) of ADC Therapeutics SA, a company constituted under the laws of Switzerland, having its corporate seat in Epalinges. For the avoidance of doubt, for purposes of this agreement, the functions
and activities or omissions of the Covered Person as a member of a committee of the Board of Directors shall also be deemed functions, activities or omissions of such Covered Person as a Director.
|
B.
|
ADC Therapeutics SA is a biotechnology company, and its shares are listed on the New York Stock Exchange in the United States.
|
C.
|
The Covered Person is exposed to litigation risks arising from claims that may be brought against him or her in connection with his or her function as a Director or Officer.
|
D.
|
The articles of association of the Company (“Articles of Association”) provide that the Company shall indemnify and advance expenses to all
Directors and Officers in the manner set forth therein and to the fullest extent permitted by applicable law.
|
E.
|
It is reasonable, prudent and necessary for the Company, in due consideration of the risks related to its activity and its position as a US stock-exchange listed company, to enter
into this indemnity agreement (the “Agreement”) to contractually indemnify persons serving as Directors or Officers to the fullest extent permitted by the Articles of Association of the Company and
the applicable law so that they will serve, or continue to serve, in such capacity free from undue concern that they will not be so indemnified.
|
1.
|
THIRD PARTY PROCEEDINGS
|
1.1
|
In connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal or administrative, to which he or she was, is or is threatened to be made
a party, or is otherwise involved, whether conducted by the Company or any other party, whether civil, criminal, administrative, investigative or other and whether formal or informal except for one initiated by the Covered Person to
enforce the Covered Person’s rights under the Agreement (a “Proceeding”) involving the Covered Person, the Company shall indemnify the Covered Person if:
|
a)
|
he or she was or is a party or is threatened to be made a party to any Proceeding by reason of the fact that he or she is or was a Director or an Officer or a member of the Board of
Directors or management of a direct or indirect subsidiary of the Company (an “Affiliate”); and
|
b)
|
he or she is a party or is threatened to be made a party to any Proceeding by reason of the fact that he or she is or was an employee, agent or consultant of the Company or an
Affiliate, or is or was serving at the request of the Company as a Director or Officer,
|
1.2
|
Any indemnification under this Agreement, other than advance payments (unless ordered by a court), shall be made by the Company only as authorized in the specific case upon a
determination that indemnification of the Covered Person is not excluded pursuant to Section 3.
|
2.
|
PROCEEDING IN THE RIGHT OF THE COMPANY
|
2.1
|
The Company shall indemnify the Covered Person against any Expenses if the Covered Person was or is a party or is threatened to be made a party to any Proceeding by or in the right
of the Company to procure a judgment in favor of the Company by reason of the fact that the Covered Person is or was a Director, Officer, employee, consultant or agent of the Company or its Affiliates or is or was serving at the request
of the Company as a Director, Officer, employee, consultant or agent of, or participant in, another corporation, partnership, joint venture, trust, or other enterprise.
|
2.2
|
As far as is permissible under applicable law, Expenses incurred in defending any Proceeding for which indemnification is permitted pursuant to this Agreement shall be paid by the
Company in advance of the final disposition of such proceeding upon receipt by the Board of Directors of an undertaking by or on behalf of the Covered Person to repay such amount if it shall ultimately be determined that he or she is not
entitled to be indemnified by the Company under this Agreement.
|
3.
|
NO INDEMNIFICATION
|
3.1
|
Section 1 and 2 above shall not apply, and any advanced Expenses shall be reimbursed by the Covered Person to the Company if:
|
a)
|
a competent court holds the Covered Person to be liable and concludes that the relevant actions or omissions giving rise to the Proceeding constitute fraud, dishonesty or an
intentional or grossly negligent breach of the duties of the Covered Person under applicable law or under his terms of office or agreements with the Company including the obligation to act honestly and in good faith with a view to the
best interests of the Company; or
|
b)
|
absent a judgment by a competent court as set forth under Section 3.1(a) above, it is prima facie apparent that the relevant actions or omissions giving rise to the Proceeding
constitute fraud, dishonesty or an intentional or grossly negligent breach of the duties of the Covered Person under applicable law or under his terms of office or agreements with the Company.
|
3.2
|
Any determination shall be made, with respect to a Covered Person:
|
a)
|
by a majority vote of the members of the Board of Directors who are not parties to such proceeding, even though less than a quorum; or
|
b)
|
by a committee of members of the Board of Directors designated by a majority vote of the members of the Board of Directors who are not parties to such proceeding, even though less
than a quorum; or
|
c)
|
if there are no such member of the Board of Directors, or if such member of the Board of Directors so direct, by independent legal counsel in a written opinion; or
|
d)
|
by the General Meeting of Shareholders.
|
3.3
|
Notwithstanding the preceding sentence, this section shall not extend to any person holding the office of auditor or special auditor of the Company.
|
4.
|
NON-EXCLUSIVITY
|
4.1
|
The Agreement shall supplement the Covered Person’s terms of office and/or employment agreement with the Company as separately agreed with the Company.
|
4.2
|
The Agreement shall not limit the Covered Person’s reimbursement rights provided under statutory law and the Articles of Association.
|
5.
|
INDEMNIFICATION PROCEDURE
|
5.1
|
Should the Covered Person become aware of any Proceeding which could give rise to any entitlements under the Agreement, the Covered Person shall:
|
a)
|
as promptly as practicable (but in no event later than 20 business days of becoming so aware), notify the Company in writing of the existence of such a Proceeding, giving, as
reasonably available at the time of such notice, reasonable details relating to the Proceeding, including the person(s) making (or threatening to make) the respective Proceeding, the circumstances leading to such a Proceeding, the cause
of action for the Proceeding and the possible costs associated with the Proceeding;
|
b)
|
give to the Company and its professional advisers information and access to documents and records as the Company may reasonably request, except where such access would result in a
loss of privilege, or would be adverse to the Covered Person’s interests or where the Covered Person is prevented by law from providing such access. In this connection, the Company shall be entitled to require the Covered Person to take
such actions and give such information and assistance in order to avoid, mitigate, settle or defend the Proceeding as the Company may reasonably request;
|
c)
|
allow the Company upon its request, and following regular consultation with the Covered Person, to conduct such actions as the Company may deem appropriate in connection with any
such Proceeding (including assuming the defense of such Proceeding). In this connection, the Covered Person shall give to the Company all assistance as the Company may reasonably require in the conduct of such actions (except in cases
where taking such action is adverse to his legitimate and personal interests);
|
d)
|
make no admission of liability or enter into settlement discussions with any person in relation to any Proceeding without the prior written consent of the Company (which shall not
be unreasonably withheld); and
|
e)
|
take all reasonable actions to mitigate any potential loss which may incur as a result of a Proceeding.
|
5.2
|
The Company shall be entitled to settle any Proceeding at its sole discretion and without the Covered Person’s prior written consent, except where the terms of the settlement would
(i) impose any costs, expense, loss liability, damage, penalty or limitation on the Covered Person or (ii) cause damage to the Covered Person’s image or reputation. In each case of (i) and (ii) above, the Company may settle such
Proceeding, provided that the Company obtains the Covered Person’s prior written consent, which the Covered Person shall not unreasonably delay or withhold. In all cases, the Company shall not settle any Proceeding before notifying the
Covered Person of its intention and consulting with the Covered Person as to the terms of the proposed settlement. The Covered Person and the Company shall take all actions as may be necessary or advisable to effect such a settlement.
|
5.3
|
Notwithstanding the foregoing, the Covered Person and the Company shall take all actions as may be required to comply with the terms of any policy of a directors’ and officers’
liability insurance pursuant to Section 6.
|
5.4
|
Notwithstanding any provision of the Agreement to the contrary, and subject to reimbursement pursuant to Section 3, the Company shall advance to the Covered Person or pay directly,
at the Company’s sole discretion, any Expenses actually and reasonably incurred by the Covered Person in connection with any Proceeding pursuant to Section 1 and 2 of the Agreement within 30 calendar days after the receipt by the Company
of each statement requesting such advance from time to time, whether prior to or after final disposition of any Proceeding. Advances shall be unsecured and interest free.
|
6.
|
LIABILITY INSURANCE
|
6.1
|
To the extent the Company maintains an insurance policy or policies providing directors’ and officers’ liability insurance, the Covered Person shall be covered by such policy or
policies in accordance with its or their terms to the maximum extent of the coverage in place for any Director or Officer.
|
6.2
|
If, at the time the Company receives notice from any source of a Proceeding to which the Covered Person is a party or a participant (as a witness or otherwise), the Company has
director and officer liability insurance in effect, the Company shall give prompt notice of such proceeding to the insurers in accordance with the procedures set forth in the respective policies. The Company shall thereafter take all
necessary or desirable action to cause such insurers to pay, on behalf of the Covered Person, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.
|
6.3
|
The Company shall indemnify the Covered Person for Expenses incurred by Covered Person in connection with any reasonable action brought by Covered Person for recovery under any
insurance policy referred to in this Section 6 and shall advance to the Covered Person any Expenses actually and reasonably incurred by the Covered Person in connection with such action.
|
7.
|
SUBROGATION
|
7.1
|
In the event of payment under the Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of the Covered Person, who shall execute
all papers required and shall do everything that may be necessary to secure such rights, including the execution of such documents necessary to enable the Company effectively to bring suit to enforce such rights.
|
8.1
|
The Company shall not be liable under the Agreement to make any payment in connection with any Proceeding made against the Covered Person to the extent the Covered Person has
otherwise actually received payment (under an insurance policy or otherwise) of the amounts otherwise indemnifiable hereunder.
|
9.
|
EFFECT OF TERMINATION OF SERVICE
|
9.1
|
The indemnification provided by this Agreement shall continue for any person who has ceased to be a Covered Person.
|
10.
|
BINDING EFFECT
|
10.1
|
The Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto and their respective successors, assigns, including any direct or indirect
successor by purchase, merger, amalgamation, consolidation or otherwise to all or substantially all of the business or assets of the Company, spouse, heirs, and personal and legal representatives. The Agreement shall continue in effect
regardless of whether Covered Person continues to serve as a Director or Officer of the Company or of any other legal entity at the Board of Directors’ request.
|
10.2
|
The obligations of the Company under this Agreement are subject to applicable laws and the Articles of Association.
|
11.
|
AMENDMENTS
|
11.1
|
The Agreement may only be modified or amended by a document signed by all Parties. Any provision contained in the Agreement may only be waived by a document signed by the party
waiving such provision.
|
12.
|
SEVERABILITY
|
12.1
|
If any part or provision of the Agreement or the application of any such part or provision to any person or circumstance shall be held to be invalid, illegal or unenforceable on any
respect by any competent arbitral tribunal, court, governmental or administrative authority, (a) such invalidity, illegality or unenforceability shall not affect any other part or provision of the Agreement or the application of such part
or provision to any other person or circumstances, and (b) the Parties shall endeavor to negotiate a substitute provision that best reflects the economic intentions of the Parties without being invalid, illegal or unenforceable, and shall
execute all agreements and documents required in this connection.
|
13.
|
APPLICABLE LAW AND JURISDICTION
|
13.1
|
The Agreement shall be governed by and construed in accordance with the substantive laws of Switzerland, excluding the provisions on conflict-of-laws.
|
13.2
|
All disputes arising out of or in connection with the Agreement, including disputes on its conclusion, binding effect, amendment and termination, shall be resolved exclusively by
the courts at the domicile of the Company.
|
ADC Therapeutics SA
|
||
By:
|
||
Name:
|
||
Title:
|
[Covered Person]
|
||
By:
|
||
Name:
|
||
Title:
|
FORM OF PURCHASE AND SHAREHOLDERS AGREEMENT
|
Page | ||
1.
|
DEFINITIONS AND INTERPRETATION
|
1
|
2.
|
PURCHASE
|
2
|
3.
|
COMPLETION
|
2
|
4.
|
NOMINEE
|
2
|
5.
|
DEALINGS IN SHARES
|
3
|
6.
|
ADHERENCE
|
3
|
7.
|
LEAVER PROVISIONS
|
3
|
8.
|
ASSIGNMENT
|
4
|
9.
|
THIRD PARTY RIGHTS
|
4
|
10.
|
STATUS OF THIS AGREEMENT
|
5
|
11.
|
ACKNOWLEDGMENT
|
5
|
12.
|
SEVERANCE
|
5
|
13.
|
VARIATION
|
5
|
14.
|
COSTS
|
6
|
15.
|
WHOLE AGREEMENT
|
6
|
16.
|
FURTHER ASSURANCE
|
6
|
17.
|
COUNTERPARTS
|
6
|
18.
|
GOVERNING LAW AND JURISDICTION
|
6
|
(1) |
[●] (the “Shareholder”);
|
(2) |
A.T. DEVELOPMENT SWITZERLAND SARL a company registered in Switzerland with its registered office at Rue Saint Pierre 2, Lausanne, 1003, Switzerland (“ATDS”);
and
|
(3) |
ADC THERAPEUTICS SARL a company registered in Switzerland with its registered office at Rue Saint Pierre 2, Lausanne, 1003, Switzerland (“Company”).
|
1.1 |
In this agreement unless the context otherwise requires:
|
Anniversary Date
|
means [●]
|
|
Articles
|
the articles of association of the Company as amended, modified, supplemented or restated from time to time;
|
|
Bad Leaver
|
means a Leaver who is not a Good Leaver;
|
|
Completion
|
completion of this agreement in accordance with clause 2 and clause 3;
|
|
Employment
|
means, for the purposes of this agreement, acting as an employee, officer, manager, director, advisor, consultant, partner, agent, representative or the like to the Company or any member of
the Company’s group;
|
|
Good Leaver
|
means a person who is a Leaver (i) as a result of his death or serious ill health; or (ii) who has otherwise been determined by the Company’s board of directors acting reasonably to be a
Good Leaver;
|
|
Leaver
|
means an individual who was previously in the Employment of the Company or any member of the Company’s group and who ceases to be in such Employment;
|
|
Parties
|
the parties to this agreement; and
|
|
Promissory Note
|
a promissory note from the Shareholder to ATDS substantially in the form attached at Schedule A.
|
|
1.2.1 |
a reference to writing or written includes faxes and email;
|
|
1.2.2 |
any reference to the singular includes a reference to the plural and vice versa; and any reference to the masculine includes a reference to the feminine and vice versa; and
|
|
1.2.3 |
references to times of day are, unless the context requires otherwise, to London time and references to a date are to a period of 24 hours running from midnight on the previous day.
|
|
1.2.4 |
headings and titles are used for ease of reference only and do not affect the interpretation of this agreement.
|
2.1 |
ATDS hereby agrees to sell and the Shareholder hereby agrees to purchase [●] Class A shares in the capital of the Company (the “Shares”) subject to the terms of this agreement. The
consideration for such subscription shall be satisfied by the payment of the sum of [●] (the “Purchase Price”) in accordance with clause 3.2.
|
2.2 |
The Shares shall be sold with full title guarantee free from all encumbrances and shall rank in full for all dividends or other distributions declared, made or paid in respect of ordinary shares on or after Completion, and shall have
the rights, preferences and priorities as set forth in the Articles.
|
2.3 |
The Parties acknowledge that the Company is not party to, and has no interest in, the sale and purchase of the Shares and is entering into this Agreement solely for the purposes of safeguarding the interests of the Company and the
rights of other shareholders in the Company by ensuring that the Shareholder is subject inter alia to the Leaver provisions in clause 7 of this agreement.
|
|
3.2.1 |
the sum of CHF 100.00 per Share in cash representing the nominal value of the Shares;
|
|
3.2.2 |
an executed counterpart of the Promissory Note for the balance of the Purchase Price.
|
4.1 |
The Parties acknowledge that, as a matter of Swiss law the Company may not issue fractional interests in its shares. Therefore, the Shareholder acknowledges and agrees that ATDS shall continue to hold the legal interest in the Shares
as nominee for the Shareholder. ATDS shall act in its name for the account of the Shareholder and at the risk of the Shareholder.
|
4.2 |
The Shareholder irrevocably instructs and authorises ATDS to take all actions in respect of the Shares as ATDS may see fit including, without limitation:
|
|
4.2.1 |
to receive notice of and to attend, take part and vote in all meetings of the Company and/or any relevant class meetings of its shareholders and sign all consents to short notice, proxies and other instruments (including without
limitation, proposed resolutions) for the purpose of such meetings;
|
|
4.2.2 |
to pass any resolutions and/or to sign written resolutions of the shareholders or the holders of any class of shares of the Company;
|
|
4.2.3 |
to give a good receipt for any dividend or other distribution made in respect of our shareholding; and
|
|
4.2.4 |
to exercise all other rights and privileges and perform all duties which attach to our shares.
|
4.3 |
The Shareholder undertakes to ratify whatever ATDS may lawfully do or purport to do or cause to be done by virtue of the powers granted by this clause 4.
|
4.4 |
ATDS undertakes to deliver to the Shareholder copies of any and all Company communications within a reasonable period following receipt by ATDS of the same.
|
|
The Shareholder undertakes to each of the Company and ATDS that he will not, at any time, transfer, dispose, assign, grant security over, pledge or otherwise deal in or grant any interest over any interest in the Shares to any person
without the prior consent in writing of ATDS or the Company.
|
|
The Shareholder undertakes to the Company (for itself and on behalf of each other party to the Shareholders’ Agreement) that he will, with effect from the date hereof assume, perform and comply with each of the obligations as a
Shareholder under the Shareholders’ Agreement as if he had been a party to the Shareholders’ Agreement at the date of its execution.
|
7.1 |
If the Shareholder’s Employment with the Company or any member of the Company’s group terminates for any reason, ATDS, the Company (or its designee) shall have the right, but not the obligation, to repurchase all or any portion of the
Shareholder’s Shares at the applicable repurchase price, within thirty (30) days of the event, as follows:
|
|
7.1.1 |
Good Leaver. If the Shareholder’s Employment is terminated and the Shareholder is a Good Leaver, ATDS, the Company (or its designee) shall have the option, but not the obligation, to repurchase such portion of the Shareholder’s
Shares as is determined in accordance with the table below at a price per Share equal to the purchase price of such Share (calculated by dividing the Purchase Price for all Shares by the number of Shares being acquired pursuant to this
clause) as of the date such Shareholder is provided with a written notice requiring the repurchase of his Shares. Such consideration may at the election of the Company be satisfied by a waiver of all or part of the Shareholder’s
outstanding obligations under the Promissory Note.
|
Date on which the Shareholder’s Employment terminates if he is a Good Leaver
|
% of Shareholder’s Shares ATDS, the Company (or its designee) may repurchase
|
On or before the first anniversary of the Anniversary Date
|
100%
|
After the first anniversary of the Anniversary Date but on or before the second anniversary of the Anniversary Date
|
75%
|
After the second anniversary of the Anniversary Date but on or before the third anniversary of the Anniversary Date
|
50%
|
After the third anniversary of the Anniversary Date but on or before the fourth anniversary of the Anniversary Date
|
25%
|
After the fourth anniversary of the Anniversary Date
|
0%
|
|
7.1.2 |
Bad Leaver. If the Shareholder’s Employment is terminated and the Shareholder is a Bad Leaver, ATDS, the Company (or its designee) shall have the option, but not the obligation, to repurchase all or any portion of such
Shareholder’s Shares at a price per Share equal to the lower of (i) the Purchase Price of such Shares; and (ii) the amount understanding under the Promissory Note at the time such shareholder’s employment is terminated. Such consideration
may at the election of the Company be satisfied by a waiver of all or part of the Shareholder’s outstanding obligations under the Promissory Note.
|
7.2 |
The Company shall not terminate the Employment of the Shareholder solely for the purposes of causing the Shareholder not to enjoy the economic benefits of this Purchase and Shareholder Agreement.
|
|
The Shareholder may not assign its rights under this agreement without the prior written consent of ATDS.
|
|
This agreement does not confer any rights on any person that is not a party to this agreement pursuant to the Contracts (Rights of Third Parties) Act 1999.
|
10.1 |
Each of the Parties shall use its respective best endeavours to procure (so far as is possible) that, at all times during the term of this agreement, the provisions of this agreement are promptly observed and given full force and
effect according to its spirit and intention.
|
10.2 |
If, at any time, any provisions of the Articles conflict with any provision of this agreement, ATDS and the Company shall, so far as they are each able, take such steps as are necessary to ensure that the provisions of this agreement
shall prevail and that such modifications as are necessary are made to the Articles.
|
11.1 |
Each Party acknowledges that damages may not be an adequate remedy for any breach of the obligations of that Party in this Agreement and that any other Party may be entitled (in addition to damages) to the remedies of injunction,
specific performance, and other equitable remedy for any threatened or actual breach of any such obligations.
|
12.1 |
If any provision of this agreement (or part of a provision) is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions shall remain in force.
|
12.2 |
If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted or modified, that provision shall apply with whatever modification is necessary to give effect to the commercial
intention of the Parties.
|
13.1 |
A variation of this agreement shall be in writing and signed by or on behalf of each Party.
|
13.2 |
Any waiver of any right under this agreement is only effective if it is in writing and signed by the waiving or consenting Party and it applies only in the circumstances for which it is given and shall not prevent the Party who has
given the waiver or consent from subsequently relying on the provision it has waived.
|
13.3 |
No single or partial exercise of any right or remedy under this agreement shall preclude or restrict the further exercise of any such right or remedy.
|
13.4 |
Unless specifically provided otherwise, rights arising under this agreement are cumulative and do not exclude rights provided by law.
|
13.5 |
Save as specified in this agreement, no failure on the part of any Party to exercise or no delay in exercising any right or remedy provided under this agreement or by law constitutes a waiver of such right or remedy or shall prevent
any future exercise in whole or in part of any such right or remedy.
|
|
Unless otherwise provided, all costs and expenses in connection with the negotiation, preparation, execution and performance of this agreement, and any documents referred to in it,
shall be borne by the Party that incurred the costs.
|
15.1 |
This agreement, and any documents referred to in it constitute the whole agreement between the Parties and supersede any previous arrangement, understanding or agreement between them relating to the subject matter they cover.
|
15.2 |
Nothing in this clause 15 operates to limit or exclude any liability for fraud.
|
|
Each Party shall promptly execute and deliver all such documents, and do all such things, as any other Party may from time to time reasonably require for the
purpose of giving full force and effect to the provisions of this agreement.
|
|
This agreement may be executed in separate counterparts (including by facsimile or other electronic transmission), each of which is an
original and which, when executed and delivered, shall be an original and which together shall have the same effect as if each Party had executed and delivered the same document.
|
18.1 |
This agreement and any dispute or claim arising out of or in connection with it or its subject matter (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
|
18.2 |
The Parties agree that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this agreement or its subject matter (including non-contractual disputes
or claims).
|
Amount:
|
[●] (the “Facility”)
|
Number of shares to be Purchased:
|
[●] (the “Shares”)
|
Interest Rate:
|
[●]%
|
Term:
|
[●] years
|
1. |
We hereby loan the Facility to you to be repaid along with accrued interest (if any) on the earlier of:
|
1.1 |
the date [●] ([●]) years from the date hereof;
|
1.2 |
the occurrence of a Repayment Event as defined in paragraph 3 below.
|
2. |
The Facility may only be used for the purchase of the Shares (“Authorised Purpose”).
|
3. |
“Repayment Event” means any of:
|
3.1 |
you are a Leaver and ATDS or the Company (or its designee) elects to repurchase your Shares in accordance with the terms of the Purchase and Shareholder Agreement entered into between you, ATDS and the Company;
|
3.2 |
the Company is the subject of a change of control or a sale of all or substantially all of its assets; or
|
3.3 |
you deliver the Shares back to ATDS or the Company.
|
4. |
The Facility will be immediately repayable and you hereby undertake to repay, and to take all necessary action to repay, the Facility in full, or any part of it that has not been repaid, on the occurrence of a Repayment Event.
|
5. |
You may repay the Facility, or any part of it, early along with accrued interest but may not re-borrow any amount so repaid.
|
6. |
The principal amount of the Facility outstanding from time to time will be interest free
|
7. |
You will make all payments under or in respect of this Facility without set-off or counterclaim and free and clear of any withholding or deduction for or on account of tax, save as may be required by law.
|
8. |
You will pay, on demand and on a full indemnity basis, all costs and expenses (including VAT) which we may from time to time incur in connection with any breach by you of your obligations under this letter and/or in relation to the
Facility.
|
9. |
Any demand or notice in respect of this letter and/or the Facility will be in writing and (without prejudice to any other effective means of serving it) may be served on you personally or by post to your residential address as it
appears at the head of this letter.
|
10. |
Time shall be of the essence in respect of your obligations under or in respect of this Facility but no failure by us to exercise or delay by us in exercising any right or remedy under or in respect of this Facility shall operate as a
waiver of it, nor shall any single partial or defective exercise by us of any such right or remedy preclude any other or further exercise of that or any other right or remedy.
|
11. |
You may not assign or transfer any of your rights or obligations under this letter agreement without our prior written consent.
|
12. |
This letter is an agreement governed by English law.
|
Exhibit 10.14
THE ADC THERAPEUTICS INCENTIVE PLAN DATED MAY 1, 2014
AMENDED AND RESTATED AS OF 1st DAY OF OCTOBER, 2015
RULES
Adopted as of the 1st day of October, 2015 by:
ADC Therapeutics Sàrl (upon conversion on October 13, 2015: ADC Therapeutics SA)
ADC Therapeutics (UK) Limited
ADC Therapeutics America, Inc.
CONTENTS
WHEREAS | 1 | |
1. | DEFINITIONS AND INTERPRETATION | 2 |
2. | GRANT OF AWARDS | 5 |
3. | DOCUMENTATION OF AWARDS | 6 |
4. | NO DEALING IN AWARDS | 6 |
5. | PAYMENT AND LAPSE OF AWARDS | 7 |
6. | LIQUIDITY EVENT | 7 |
7. | VARIATION OF CAPITAL | 8 |
8. | PARTICIPATION SEPARATE FROM EMPLOYMENT OR SERVICE | 9 |
9. | TAX AND SOCIAL SECURITY | 9 |
10. | ADMINISTRATION, AMENDMENT AND TERMINATION | 10 |
THE ADC THERAPEUTICS INCENTIVE PLAN
RULES
WHEREAS
A) | On May 1, 2014, A.T. Development Switzerland Sàrl, ADC Therapeutics Services (UK) Limited and the Company’s Bermuda branch entered into this Plan. |
B) | Further to an internal reorganization of the Company’s activities, the Participants to the Plan formerly employed by A.T. Development Switzerland Sàrl and ADC Therapeutics Services (UK) Limited were transferred to the Company and ADC Therapeutics (UK) Limited, respectively, and the Participants having been granted an Award by the Company’s Bermuda branch were transferred from C.T. Development America, Inc. to ADC Therapeutics America, Inc. |
C) | The Company, ADC Therapeutics (UK) Limited and ADC Therapeutics America, Inc. wish to ensure continuity of the Awards to the benefit of the Participants as of the Date of Grant and amend the Plan as further stated herein. |
D) | The purpose of this Plan is to incentivize selected employees or service providers of the Company, ADC Therapeutics (UK) Limited and ADC Therapeutics America, Inc. to accept employment or service, foster retention of such employees or service providers and encourage them to contribute maximum efforts to the success of the Company’s and its affiliates’ business. |
E) | Pursuant to an amended and restated shareholders’ agreement dated as of August 10, 2015, the shareholders of the Company approved the implementation of an incentive plan comprised of up to 12% of the Company’s issued share capital at any time. |
F) | Within the share capital limitation set forth above, this Plan will be implemented individually by each of the Company, ADC Therapeutics (UK) Limited and ADC Therapeutics America, Inc. to fulfil their respective obligations to employees and/or service providers designated by them from time to time to receive Awards under this Plan. |
G) | Each Administrator may from time to time consult with the board of directors of the Company and, where necessary for consistency or compliance with the governance obligations of the Company pursuant to its amended and restated shareholders agreement or other organizational documents, seek the prior consent of the board of directors of the Company. |
H) | This Plan shall apply to (i) any Awards granted under this Plan prior to October 1, 2015, and (ii) any Awards to be granted as of October 1, 2015. For the avoidance of doubt, it is further understood that: |
- | the Awards granted by A.T. Development Switzerland Sàrl under this Plan before October 1, 2015 shall be assigned to and assumed by the Company; |
- | the Awards granted by ADC Therapeutics Services (UK) Limited under this Plan before October 1, 2015 shall be assigned to and assumed by ADC Therapeutics (UK) Limited; and |
- | Awards granted by the Company’s Bermuda branch to its Service Providers under this Plan before October 1, 2015 shall continue with the Company under the terms of such Awards. |
1. | DEFINITIONS AND INTERPRETATION |
1.1 | In this Plan (unless the context otherwise requires): |
“Administrator” means, unless otherwise specified in the applicable Country Annex, the Service Recipient of the Participant;
“Asset Sale” means the sale by the Company of all or substantially all (but, for the avoidance of doubt, no less than 90% of the fair market value) of its business and assets to a person who is not a Member of the Group;
“Award” means, unless otherwise specified in the applicable Country Annex, a right (for the time being subsisting) which following a Liquidity Event will entitle the holder to receive such number of Shares as indicated in the Award Letter or the Cashout Amount;
“Award Letter” means the letter issued by the Administrator with the contents set forth in Rule 3.
“Cashout Amount” shall mean an amount payable to a Participant in relation to an Award in accordance with Rule 6;
“Cause” means a Participant’s (i) material breach of any agreement (including any agreement containing restrictive covenants) entered into with the Company or the Service Recipient (or any affiliate thereof, as applicable), (ii) misappropriation of the Company’s property or of the Service Recipient’s property, fraud, embezzlement, breach of a fiduciary duty, offering or acceptance of any bribe or other unlawful inducement, other acts of dishonesty against the Company or the Service Recipient (or any affiliate thereof), (iii) commission of, or plea of guilty or no contest to, any felony or any crime involving moral turpitude, (iv) material violation of the Company’s or the Service Recipient’s code of conduct or ethics, or applicable law that results or could reasonably be expected to result in harm to the Company or the Service Recipient (or any affiliate thereof); (v) failure to follow the lawful directives reasonably set forth by the Company or the Service Recipient; (vi) gross negligence, wilful misconduct or disloyalty in the performance (or non-performance) of his duties and responsibilities to the Company or the Service Recipient (and any affiliate thereof, as applicable), and (vii) any act amounting to gross misconduct in relation to the Participant’s employment or service relationship;
“Closing Value” means the value of a Share as determined by the Administrator by reference to the Liquidity Event which has given rise to exercisability of an Award (for the avoidance of doubt, the value of a Share for this purpose will be adjusted for any transaction costs incurred in connection with a Liquidity Event);
“Company” means ADC Therapeutics Sàrl or, as of October 13, 2015, ADC Therapeutics SA (or its successor);
“Country Annex” means each Annex appended to this Plan, as amended from time to time, the terms of which form a part of the Plan and supersede any contrary provision in the Plan with respect to the applicable Participant;
“Date of Grant” means the date on which an Award is granted under Rule 2 as further stated in the Award Letter;
“Fund” means Auven Therapeutics Holdings L.P.;
“Group” means the Company and any other company in which the Fund holds a direct or indirect controlling interest now and in the future, and “Member of the Group” shall be construed accordingly;
“IPO” means an initial public offering raising at least US$60 million by means of listing and admission to trading on an internationally recognized stock exchange;
“Liquidity Event” means the first to occur of a Sale, a Merger, an Asset Sale and an IPO;
“Merger” means the merger of the Company with another entity, following the completion of which less than 50 percent of the share capital (by votes and value) in the merged, continuing or successor entity is owned directly or indirectly by the Fund;
“Notional Share” means a Share that is notionally (rather than actually) the subject of an Award;
“Participant” means an individual selected by the Administrator pursuant to Rule 3 and who holds an Award, or (where the context admits) his personal representatives;
“Personal Data” means any personal data that could identify the Participant, including details of the Award itself;
“Plan” means this Plan constituted by the Rules and the Country Annexes;
“Relevant Liability” means, in relation to any Cashout Amount or other settlement of an Award, an amount equal to any sums which the Service Recipient or any other Member of the Group are be obliged to deduct by law including (without limitation) the amount of income tax and social security (including national insurance) contributions for which such company has or is required to account to the taxation authorities in any jurisdiction as a consequence of a payment to the Participant of the Cashout Amount or other settlement of an Award;
“Rules” means these rules as from time to time amended;
“Sale” means a person or group of persons acting in concert (including AstraZeneca UK Limited, any affiliate thereof or any company it controls, but excluding the Fund or any Member of the Group) obtains more than 50% of the Shares;
“Service Recipient” means, as applicable, the Company, ADC Therapeutics (UK) Limited or ADC Therapeutics America, Inc., each in its capacity as the entity by which the Participant is employed or, in case of a service or consulting agreement, to which a Participant provides direct services;
“Share” means a common Class A share with a par value CHF 100 of the Company (or its successor);
“Strike Price” means the value per Share as reasonably determined by the Administrator on the Date of Grant and as indicated in the Award Letter;
“Vested” shall mean, in relation to an Award, that one or more tranches thereof has become vested according to the vesting schedule specified in Rule 3.3, and “Vesting” shall be construed accordingly.
“Vested Award” means an Award that has Vested.
1.2 | Words denoting the singular shall include the plural and vice versa. |
1.3 | Words denoting the masculine gender shall include the feminine gender. |
1.4 | References in these Rules to a rule, clause, sub-clause, paragraph or subparagraph are, unless otherwise stated, references to a rule, clause, sub-clause, paragraph or subparagraph of these Rules. |
1.5 | Rule headings are inserted for convenience only and are to be ignored in construing these Rules. |
1.6 | References in this Plan to any statute, regulation or enactment shall be deemed to include references to such statute, regulation or enactment as extended, re-enacted or amended. |
1.7 | Unless me Administrator otherwise determines, all sums shall be calculated and paid in US dollars. |
2. | GRANT OF AWARDS |
The Administrator may by resolution grant Awards to one or more employees or service providers selected by the Administrator in its discretion, provided that:
2.1 | no employee or service provider shall be entitled as of right to the grant of an Award; |
2.2 | no Award may be granted under this Plan after the tenth anniversary of the date of the adoption of the Plan by the Administrator; and |
2.3 | the total number of Notional Shares or Shares, as applicable, to which all Awards refer shall not, at any time, exceed 12% of the Company’s issued share capital at any time. |
For the avoidance of doubt, Rule 2.3 above may only be amended by the board of directors of the Company.
3. | DOCUMENTATION OF AWARDS |
As soon as reasonably practicable after each Award is granted, the Administrator shall issue to each Participant an Award Letter, which shall specify:
3.1 | the number of Notional Shares or Shares, as applicable, to which the Award relates; |
3.2 | the Date of Grant; |
3.3 | the vesting schedule for the Award, which shall unless otherwise determined by the Administrator in the Award Letter be as follows: 25% of the Notional Shares or Shares, as applicable, subject to an Award, shall Vest on each of the first, second, third and fourth anniversaries of the Date of Grant, in each case subject to Rule 5.2; |
3.4 | the Strike Price; and |
3.5 | such other terms and conditions as the Administrator shall determine (including terms and conditions to address any local legal and tax considerations). |
4. | NO DEALING IN AWARDS |
Except as otherwise specifically provided in an Award Letter or as agreed subsequently, an Award shall be personal to the Participant and may not be transferred, assigned, charged, pledged or otherwise disposed of or dealt with, other than Awards which may be transferred by will or the laws of descent and distribution or under matrimonial laws. Any purported transfer, assignment, charge, pledge or other disposal or dealing with the Award shall cause the Award to lapse forthwith.
5. | PAYMENT AND LAPSE OF AWARDS |
5.1 | Except as provided in the Country Annexes, an Award shall be settled and paid out only in accordance with Rule 6. |
5.2 | Where a Participant ceases to be an employee or service provider at any time: |
5.2.1 | by reason of termination for Cause, all Awards held by him (whether or not Vested) shall lapse forthwith without consideration therefor, |
5.2.2 | for any other reason, any Awards shall to the extent not already Vested lapse forthwith, without consideration therefor, while the Vested proportion shall continue in effect subject to these Rules, and shall be settled and paid on a Liquidity Event in accordance with Rule 6. |
5.3 | Where an Award continues to be in effect under Rule 5.2.2, an Award shall lapse and cease to be exercisable forthwith, without consideration therefor, if the Administrator reasonably determines that the Participant is in material breach of the terms of any settlement agreement relating to the termination of his employment or any other agreement with any Service Recipient (or any affiliate thereof), or has otherwise breached express or implied duties of confidentiality owed to the Company (or any of its affiliates) or the Service Recipient. |
5.4 | An Award shall automatically lapse, without consideration therefor, upon the earliest occurrence of any of the following events: |
5.4.1 | the tenth anniversary of the Date of Grant; |
5.4.2 | the Cashout Amount determined under Rule 6.2 being negative. |
6. | LIQUIDITY EVENT |
6.1 | In the event of a Liquidity Event, any non-Vested Awards (other than those held by Participants who have ceased to be employees or service providers prior to the date of the Liquidity Event) shall automatically Vest in full. |
|
6.2 |
Subject to Rules 6.3 and 6.4 and the Country Annexes, within 30 days following the Liquidity Event, each Participant shall be entitled to be paid by the Service Recipient a Cashout Amount calculated as follows: |
Cashout Amount = Z x (Closing Value less Strike Price)
where Z is the number of Notional Shares or Shares in relation to which the Award has Vested. Any Relevant Liabilities arising thereon shall be deducted prior to payment.
6.3 | Where the Liquidity Event takes the form of an IPO, the Administrator may in its discretion determine that Awards or parts thereof shall following Vesting be satisfied by transferring or procuring the issue to the Participant of Shares (or, if applicable, common shares of the public company that is the successor to the Company) with a fair market value equivalent to the Cashout Amount, less any Relevant Liabilities, provided that such Shares (or, if applicable, such common shares of the public company that is the successor to the Company) may be subject to limitations and transfer restrictions as the Administrator may in its discretion determine. In connection with an IPO, the Administrator may also determine to continue the Awards on such terms and conditions as it reasonably determines and in a manner consistent with applicable law. |
6.4 | Where the consideration on a Liquidity Event is deferred or contingent (which shall include an IPO where only part of the Fund’s holding is disposed of), the Administrator may in its discretion apply either or both of the following methods of payment: |
6.4.1 | determine a value of the Company based on the implied value of such deferred and/or contingent consideration, and make payments immediately on the basis that such value is included in the Closing Value for the purposes of Rule 6.2; or |
6.4.2 | make an initial payment under Rule 6.2 based on sums initially paid, followed by additional payments in the event that the deferred and/or contingent consideration is subsequently paid. |
7. | VARIATION OF CAPITAL |
7.1 | In the event of any variation of the share capital of the Company (whenever effected) by way of capital increases or reductions, or share splits, payment of a special or extraordinary dividend, or otherwise, by the Company, the Strike Price and the number of Notional Shares or Shares, as applicable, in respect of which any Award granted under the Plan shall Vest may be adjusted by the Administrator in such manner as it sees fit. |
7.2 | In the event of a group reorganization (including, without limitation, the formation of a new parent company), the Administrator may determine that the Notional Shares or Shares, as applicable, in which any Award granted under the Plan shall Vest, shall relate to the same or an adjusted number of shares of another company, provided that such shares have substantially an equivalent fair market value. |
7.3 | As soon as reasonably practicable after making any adjustment under Rules 7.1 or 7.2 above, the Administrator shall give notice in writing thereof to each Participant. |
8. | PARTICIPATION SEPARATE FROM EMPLOYMENT OR SERVICE |
It shall be a condition of participation in the Plan that in the event of a Participant ceasing to be an employee or service provider (for whatever reason), he shall not, subject to any provision of applicable law to the contrary, be entitled to any compensation whatsoever by reason of any termination or alteration of rights or expectations under the Plan whether such compensation is claimed by way of damages for wrongful dismissal or breach of contract or for loss of office or otherwise howsoever. Participation in this Plan by a Participant is a matter entirely separate from any pension right or entitlement he may have and from his terms or conditions of employment or service and participation in this Plan shall in no respect whatever affect in any way a Participant’s pension rights or entitlement or terms or conditions of employment or service. As a condition to participation, each Participant acknowledges and agrees that the grant of an Award hereunder is in full satisfaction of the Service Recipient’s (or any affiliate of the Service Recipient) commitment to grant an equity-based award under an offer letter or other terms of employment or service. Any amounts paid or payable hereunder shall not constitute salary, wages or other remuneration or compensation, for purposes of any other benefit plan of any Service Recipient (or its affiliates).
9. | TAX AND SOCIAL SECURITY |
9.1 | The Participant is responsible for reporting the receipt of any income under the Plan, however made, to the appropriate tax authority in accordance with applicable law. |
Payments made under this plan to Participants other than employees shall be deemed to be inclusive of VAT, if any.
The grant, vesting or other relevant event of an Award will be subject to any withholding that may be necessary of or on account of a Participant’s tax liability and employee social security contribution liability in respect of that Award. The Company and the Service Recipient will be entitled to deduct or withhold a sufficient portion of the value otherwise due to be released to the Participant to satisfy any withholding liability. Without limitation, where withholding is required, withholding arrangements may include the sale of any Shares subject to an Award on behalf of a Participant and/or deductions from salary and/or bonus payments and/or fees, or require a payment from the Participant before settlement of the Award. If required in order to comply with any applicable laws, the Participant may be required to personally pay such sums as may be required for purposes of meeting the withholding obligations of the Company or the Service Recipient.
The Company and the Service Recipient shall have the right to notify the tax authorities of the grant and payment of an Award and submit the tax authorities all documents in connection with the grant and payment of an Award, if so required by law.
9.2 | The Company and the Service Recipient will be entitled to block or prohibit the release of a sufficient number of Shares otherwise due to be released or to offset any claims towards the Participant if the Participant has any outstanding obligations (whether in connection with the Plan or otherwise arising in the course of the Participant’s employment or service contract), until the Participant has satisfied such outstanding obligations. |
10. | ADMINISTRATION, AMENDMENT AND TERMINATION |
10.1 | The Plan shall be interpreted and administered by the Administrator whose decision on all matters of interpretation and administration shall be final and binding on all parties. |
10.2 | There is no obligation for uniformity of treatment of Participants by the Administrators (either individually or collectively). |
10.3 | Except with respect to Rules 2.3 and 2.4, the Administrator may from time to time make amendments to these Rules and the accompanying Country Annexes, provided that: |
10.3.1 | no amendment may detrimentally and materially affect a Participant as regards any Award held by him on the date of the amendment unless being made with the Participant’s consent, provided, however, that the foregoing restriction in this clause 10.3.1 shall not apply to any amendment required to comply with any applicable statute, regulation or enactment; and |
10.3.2 | written notice of any material alteration made in accordance with this Rule 10 shall be given to all affected Participants. |
10.4 | The Administrator may at any time resolve to terminate this Plan, in which event no further Awards shall be granted but the provisions of this Plan shall continue in force in relation to Awards subsisting prior to that date. |
10.5 | The Plan is intended to constitute an “unfunded” plan for incentive compensation. With respect to any payments not yet made to a Participant by the Service Recipient, nothing contained herein shall give any such Participant any rights that are greater than those of a general unsecured creditor of the Service Recipient. No trust fund shall be established for the payment or provision of benefits hereunder. The obligation to make payments under the Plan shall be contractual only and all such payments shall be made from the general assets of the Service Recipient. |
10.6 | Any notice to be given pursuant to the terms of these Rules must be given in writing to the party due to receive such notice at (in the case of the Company) its registered office address from time to time or (in the case of an individual) his address (including email address) as notified to the Company from time to time. Notice must be delivered personally or sent by post or electronic transmission and shall be deemed to be given in the case of personal delivery on delivery and in the case of posting (in the absence of evidence of earlier receipt) within 48 hours after posting (six days if sent by air mail) and in the case of electronic transmission two hours after sending. |
10.7 | By accepting an Award, a Participant consents to the collection, holding, processing and transfer of the Participant’s Personal Data by any company in the Group for all purposes connected with the Awards, including |
10.7.1 | the transfer of the Participant’s Personal Data to the Company’s registrars or brokers or any administrators of the Company’s share incentive arrangements; and |
10.7.2 |
the transfer of the Participant’s Personal Data to a prospective buyer of the Company or of any company in the Group or business unit which employs the
Participant, and the prospective buyer’s professional advisers, provided that those persons irrevocably agree to use the Participant’s Personal Data only in connection with the proposed transaction and in accordance with the data protection
principles set out in the relevant data protection legislation
|
and, for the avoidance of doubt, any such permitted transfers shall include transfers of Personal Data to recipients located outside the EEA.
10.8 | The Plan and its terms may be disclosed to (potential) investors in the Company or acquirers of the Company or all or parts of its assets, to underwriting banks, and in any prospectuses or other disclosure materials. |
10.9 | Except as otherwise provided in the Country Annex, the Rules and the Plan shall in all respects be governed by the laws of Switzerland. |
[Country Annexes Follow]
COUNTRY ANNEX FOR ADC THERAPEUTICS (UK) LIMITED
(“UK COMPANY”)
The Rules governing awards to employees and service providers of the UK Company shall be as per the Plan, with the following differences:
1. Unless the Administrator determines otherwise in its discretion, Awards granted by the UK Company shall be granted over Notional Shares only, albeit that they may be satisfied in Shares on an IPO in accordance with Rule 6.3. The Plan, including in particular the definition of “Award” and Rule 3 shall be read accordingly.
2. The Administrator of the Plan shall be the UK Company. Under no circumstances shall payments be made under the Plan to UK-resident employees of the UK Company by any person other than the UK Company.
COUNTRY ANNEX FOR ADC THERAPEUTICS AMERICA, INC.
AND ANY U.S. TAXPAYER PARTICIPANTS
The Rules governing awards to employees and service providers who are U.S. taxpayers subject to Section 409A of the U.S. Internal Revenue Code of 1986, as amended (together with regulations and published guidance thereunder, the “Code”) shall be as per the Plan, with the following differences:
1. | Awards hereunder are intended to constitute non-qualified stock options having a Strike Price no less than fair market value of a Share on the date of grant as determined under Code Section 409A, and those Awards shall be, subject to the terms of the Plan and this Annex, exercisable for Shares of the Company. All interpretations and determinations hereunder shall be made on a basis consistent with such intent. Any adjustment to an Award under Rule 7 shall be made in a manner intending to comply with Code Section 409A. |
2. | The definition of “Award” means a right (for the time being subsisting) which following exercise (as applicable) and satisfaction of any strike price or, if earlier, a Liquidity Event will entitle the holder to receive Shares or a cash amount equal to the difference (if positive) between the Closing Value and the Strike Price, multiplied by the number of Vested Notional Shares or Shares subject to an Award. |
3. | The Plan is amended to add the following clause 6.4.3: |
6.4.3 | In each case above, no such payment shall be made to a Participant if such payment would result in adverse tax treatment under applicable law (including, without limitation, U.S. Internal Revenue Code Section 409A) or a material modification of such Award. Any such payment shall be made in a manner consistent with the intent that such Awards are intended to avoid such adverse tax treatment. |
4. | This Plan is not a retirement or welfare benefit plan, and is not intended and shall not be construed to be a retirement or welfare benefit plan. Further, this Plan is not intended to defer the receipt of payments to the termination of a Participant’s employment or beyond, and shall not be governed by or subject to the federal Employee Retirement Income Security Act of 1974, as amended (“ERISA”). All interpretations and determinations hereunder shall be made on a basis consistent with the Plan’s status as not an employee benefit plan subject to ERISA. |
5. | Notwithstanding any other provision of this Plan, this Plan is intended to be exempt from Section 409A and Section 457A of the Code, and shall at all times be interpreted in accordance with such intent. In no event will the Company or its affiliates, or their members or affiliates, or their respective employees, directors, officers, agents, representatives, attorneys, equityholders, principals, members, managers or affiliates have any liability for any failure of the Plan to satisfy the requirements of, or be exempt from, Code Section 409A and/or Code Section 457A, and such parties do not guarantee that the Plan complies with, or is exempt from, Code Section 409A and/or Code Section 457A. No Participant shall have a binding right to distributions made to it in error. Each payment payable hereunder is and shall be deemed a payment in a series of separate payments for all purposes of Code Section 409A. All references to termination of service (and similar terms) shall mean a “separation from service” within the meaning of Treasury Regulation 1.409A-l(h). |
6. | The terms of participation of any U.S. taxpayer in respect of his Award under the Plan will be set forth in an Award Letter, the terms of which shall control in the event of any inconsistency with the terms of the Plan. |
7. | The right of a U.S. taxpayer Participant to exercise his Award and receive Shares shall be subject to the satisfaction of all requirements of applicable law concerning the Company, including, without limitation, obtaining board and shareholder approval to issue such Shares. In the event the Participant cannot, under applicable law, receive Shares upon exercise, then the Company can either (i) defer the Participant’s exercise to a time when delivery of Shares would not violate applicable law, or (ii) settle such Award in cash. |
8. | Any Shares delivered to a U.S. taxpayer Participant prior to a Liquidity Event shall be subject to a right of repurchase by the Company (or its affiliates), which may be assigned, as more fully set forth in an Award Letter. |
9. | As a condition to the receipt of Shares following exercise of any option awarded under the Plan, a U.S. taxpayer Participant agrees to execute such documents as the Administrator shall, in its reasonable discretion, determine, including without limitation any lock-up agreement or shareholders’ agreement. |
10. | In the event that any payment or benefit provided under the Plan would, based on the determination of counsel or the accountants for the Company, not be deemed to be deductible in whole or in part in the calculation of federal income tax of the Company, or any other person making such payment, by reason of Section 280G of the Code or result in the imposition of taxes under Code Section 4999 to the Participant, the aggregate payments, coverages or benefits provided under the Plan and any other arrangement on account of a “change in control” shall be reduced to one dollar less than the “safe harbor” level under Section 280G so that the entire amount that is paid or provided to the Participant shall be deductible notwithstanding the provisions of Section 280G of the Code; provided, however, that the Company agrees to use commercially reasonable efforts to obtain shareholder approval of any payments or benefits in excess of the safe harbor level in accordance with Q&A #7 of Section 280G of the Code so that there will be no such loss of deductibility under Section 280G or imposition of tax under Section 4999, and in connection with such efforts to obtain shareholder approval, Plan Participants agree to waive any amounts in excess of such safe harbor level. All determinations regarding the manner of cutback shall be reasonably determined by the Plan Administrator in a manner that does not violate Section 409A of the Code, as applicable. |
Exhibit 10.15
ADC Therapeutics Ltd
2016 Share Purchase Plan
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 2 | 7 |
Table of Contents | |||
1. | Purpose | 3 | |
2. | Eligibility and Participation | 3 | |
3. | Offer to Purchase Shares | 3 | |
4. | Purchase Price and Promissory Note | 3 | |
5. | Completion | 4 | |
6. | Leaver Provisions | 5 | |
7. | Dealing in Shares | 5 | |
8. |
Adherence to Shareholders’ Agreement |
6
|
|
9. | Additional Provisions | 6 | |
9.1 | No Right of Continued Contractual Relationship | 6 | |
9.2 | Taxes and Social Security Contributions | 6 | |
9.3 | Amendment, Administration and Termination | 6 | |
9.4 | Data Protection | 7 | |
9.5 | Severability | 7 | |
9.6 | Applicable Law and Jurisdiction | 7 | |
10. | Approval and Date of Effect of the Plan | 7 |
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 3 | 7 |
1. | Purpose |
The purpose of this 2016 Stock Purchase Plan (such plan, as amended from time to time, the Plan) is to provide select employees, members of the board of directors or independent contractors of ADC Therapeutics Ltd (the Company) or its subsidiaries (each an Eligible Person) with an opportunity to participate in the future long term success and growth of the Company and its subisidiaries and to align their interest with those of the shareholders of the Company. It is intended that the Plan will motivate and retain such individuals as well as foster entrepreneurial behavior and thus enhance the value of the Company for the benefit of its shareholders.
2. | Eligibility and Participation |
(a) | In general, Eligible Persons are select employees, members of the board of directors and independent contractors of the Company or of a subsidiary of the Company. Being an Eligible Person as such does not provide any right or claim to actually participate in the Plan (and thus become a Participant) at any time. The board of directors of the Company (the BoD) in its sole discretion and from time to time determines the Eligible Persons to whom participation in the Plan shall actually be offered. |
(b) | The BoD may invite Eligible Persons from time to time to participate in the plan by entering into an individual Share Purchase Agreement substantially in the form as set out in Annex A (each a Share Purchase Agreement). By executing the Share Purchase Agreement, a Participant accepts and acknowledges the terms and conditions of the Plan as well as the details contained in the Share Purchase Agreement and, thus, becomes a Participant to the extent set out in the Share Purchase Agreement. |
(c) | The right to participate in the Plan is personal and not transferable, except that, subject to the BOD’s prior approval and the transferee’s assumption of all obligations of the Participant under the Plan, such right may be transferred to family members and family trusts before the Shares are listed on an internationally recognized securities exchange. |
(d) | Neither the establishment of or participation in the Plan, nor the payment of any benefits and transfer of Shares, nor any action of the Company or its subsidiaries or of the BoD shall be held or construed to confer upon any Participant or Eligible Person any right to participate in the Plan in the future. |
3. | Offer to Purchase Shares |
The BoD in its sole discretion may offer a defined number (including fractions) of class A common shares in the Company (including fractions of a share, the Shares) to select Eligible Persons for direct or indirect purchase in accordance with the provisions of this Plan and subject to the execution of a Share Purchase Agreement.
4. | Purchase Price and Promissory Note |
(a) | The purchase price for the Shares (the Purchase Price) shall be determined by the BoD in accordance with rulings obtained from the competent tax authorities (if any) from time to time. |
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 4 | 7 |
(b) | The Participant shall pay the Purchase Price, directly or indirectly, as follows: |
(i) | the nominal value of the Shares shall be paid in cash; and |
(ii) | the balance between the Purchase Price and the nominal value of the Shares shall be paid at the election of the Participant in cash or in the form a promissory note from the Participant to the Company substantially in the form as attached to the form of the Share Purchase Agreement (the Promissory Note) or partly in cash and partly in the form of a Promissory Note. |
(c) | The Promissory Note shall provide for full recourse, be repayable within five years (subject to early repayment in certain events) and shall bear interest at the minimum interest rate pursuant to the guidelines for related party transactions as periodically published by the Swiss Federal Tax Authority (AFC). |
5. | Completion |
(a) | Given that, as a matter of corporate law, the Company may not issue fractional shares, the Shares shall be issued to A.T. Holdings II Sari, Epalinges, or any other affiliate of the Company (ATH II). The legal interest in the Shares shall be held by ATH II as a nominee on behalf and for the account of each Participant. |
(b) | On a date mutually agreed by ATH II and the Participant (the Completion Date), but no later than 10 business days from the date of execution of the respective Share Purchase Agreement, the Participant shall deliver, or procure the delivery, to ATH II: |
(i) | a cash amount representing the nominal value of the Shares; and |
(ii) | as elected by the Participant, a cash amount and/or an executed counterpart of the Promissory Note for the balance between the Purchase Price and the nominal value of the Shares. |
(c) | On the Completion Date, ATH II and the Company shall enter into a subscription agreement (the Subscription Agreement), pursuant to which ATH II will subscribe for a sufficient number of Shares to ensure the delivery to the Participant of the Shares purchased by the Participant, pay the nominal value of the Shares in cash and deliver to the Company the Promissory Note in lieu of paying the share premium. |
(d) | On or before the Completion Date, the Participant and ATH II shall enter into a Nominee Agreement substantially in the form as attached to the form of the Share Purchase Agreement (the Nominee Agreement). |
(e) | As soon as practicable after the Completion Date, but no earlier than the date of receipt of the provisional commercial register excerpt (Tagebuchauszug) evidencing the issuance of the Shares to ATH II, the Company shall register ATH II as a shareholder with voting rights and nominee for the Participant with regard to the Shares. |
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 5 | 7 |
6. | Leaver Provisions |
(a) | If the Participant’s employment relationship with the Company or any subsidiary of the Company (the Employment) is terminated for whatever reason, the Company (and|or its designee) shall have the right, but not the obligation, to repurchase within thirty (30) calendar days of such termination such portion of the Participant’s Shares as is determined in accordance with the table below at a price per Share equal to the purchase price of such Share (calculated by dividing the applicable Purchase Price for all Shares by the number of Shares being acquired under the relevant Share Purchase Agreement) as of the date the Participant is provided with a written notice requiring the repurchase of his Shares. |
Date of termination of the Employment: | % of Participant’s Shares that Company (and|or its designee) may repurchase |
prior to or on the first anniversary of the Reference Date (as defined below) | 100% |
after the first anniversary but on or before the second anniversary of the Reference Date | 75% |
after the second anniversary but on or before the third anniversary of the Reference Date | 50% |
after the third anniversary but on or before the fourth anniversary of the Reference Date | 25% |
after the fourth anniversary of the Reference Date | 0% |
(b) | The Reference Date with respect to each Share Purchase Agreement shall be the date of such Share Purchase Agreement or any other date as determined by the BoD and stated in such Share Purchase Agreement. |
(c) | The consideration for such repurchase may at the election of the Company be satisfied by a waiver of all or part of the Participant’s outstanding obligations under the relevant Promissory Note (if any). |
(d) | The Company shall not terminate the Employment solely for the purposes of causing the Participant not to enjoy the economic benefits of this Agreement. |
7. | Dealing in Shares |
The Participant shall not, before the Shares or any shares substituted for the Shares are listed on an internationally recognized securities exchange (but subject, however, to any lock-up arrangement in connection with such listing), transfer, dispose, assign, grant security over, pledge or otherwise deal in or grant any interest over any interest in the Shares (or the Participant’s rights and entitlements thereto or under the Nominee Agreement) to any person without prior written consent of the Company.
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 6 | 7 |
8. | Adherence to Shareholders’ Agreement |
The Participant shall undertake to the Company (for itself and on behalf of each other party to the Amended and Restated Shareholders Agreement relating to the shares in the Company dated November 19, 2015, as amended or replaced from time to time (the Shareholders’ Agreement)), with respect to the Shares or any rights and entitlements thereto and to the Nominee Agreement and with effect from the date of the relevant Share Purchase Agreement, to assume, perform and comply with each of the obligations as a Shareholder under the and as defined in the Shareholders’ Agreement, as if the Participant had been a party thereto at the date of its execution. To the extent the Shareholders’ Agreement refers to the Shares, it shall also refer to any rights and entitlements of the Participant thereto or under the Nominee Agreement.
9. | Additional Provisions |
9.1 | Participants’ Contractual Relationships |
(a) | Neither the establishment of the Plan, nor the participation in the Plan, nor the payment of any benefits and transfer of Shares, nor any action by the Company or its subsidiaries or the BoD relating to the Plan shall be held or construed to confer upon any Participant any legal right for continuance of the contractual relationship with the Company or its relevant subsidiary (as applicable). |
(b) | The Company and its subsidiaries expressly reserve the right to terminate the contractual relationship of any Participant whenever the interest of the Company or its subsidiaries may require so, without any liability of the Company and its subsidiaries, except as to any rights which may be expressly conferred upon such Participant under the Plan or the Participant’s contractual agreement. |
(c) | Nothing in the Plan shall be construed as being considered as part of the salary or compensation for the purposes of calculating any resignation, redundancy or other termination payments, vacation, bonuses, long-term service awards, indemnification, pension or retirement benefits, or any other payments, benefits or rights of any similar kind. |
9.2 | Taxes and Social Security Contributions |
(a) | Every Participant is responsible for the correct tax and social security declarations and payments according to the applicable law. |
(b) | Any arising wage tax, income tax, capital gains tax, social security contributions or any other taxes or contributions payable by the Participant, must be borne by the Participant in accordance with applicable law. |
(c) | The Participant’s employer has the right to make withholdings from a Participant’s salary or retain Shares to meet payroll withholding obligations or request payment from the Participant unless the funds are provided otherwise to the employer. |
9.3 | Amendment, Administration and Termination |
(a) | The Plan is administered by the BoD. The BoD in its sole discretion may at any time and from time to time appoint a person or entity to administer the Plan (the Plan Administrator). |
ADC Therapeutics Ltd – 2016 Share Purchase Plan | 7 | 7 |
(b) | The BoD may terminate, suspend or amend this Plan at any time, at its sole discretion with regard to all or some future or past purchases of Shares under this Plan. Any adverse economic effects of such termination, suspension or amendment on purchases already made pursuant to a Share Purchase Agreement shall be fairly compensated in cash, by replacement by other benefits, or otherwise. |
(c) | Unless otherwise provided in the Plan, the BoD has full power to construe and interpret the Plan, establish and amend regulations and perform all other acts relating to the Plan, including the delegation of administrative tasks to third parties, to the extent that it deems reasonable and adequate. |
(d) | All decisions made by the BoD pursuant to the provisions of the Plan and related resolutions of the BoD shall be final, conclusive and binding for the Company, ATH II and the Participants. |
9.4 | Data Protection |
The Participant consents to the collection and processing of personal data relating to the Participant by the BoD, the Plan Administrator, the Company’s subsidiaries and any other person the Company may find appropriate for the administration of the Plan. The data will be used by the aforementioned parties to fulfill their obligations and exercise their rights under the Plan, enter into agreements (if any), issue statements and communication relating to the Plan, and generally administer and manage the Plan, including keeping records of participation levels. The data processing may be performed within or outside of Switzerland.
9.5 | Severability |
Should any of the provisions of the Plan become, or be held to be, in whole or in part, obsolete, invalid or unenforceable, all other regulations shall remain in force and shall continue to apply. Any obsolete, invalid or unenforceable provision shall be deemed to be automatically amended and replaced by valid, effective and enforceable provisions, which accomplish as far as possible the purpose and intent of this Plan with respect to the obsolete, invalid or unenforceable provision.
9.6 | Applicable Law and Jurisdiction |
(a) | This Plan shall be exclusively governed by and construed in accordance with the substantive laws of Switzerland, excluding its conflict of laws principles. |
(b) | The exclusive place of jurisdiction for any dispute, claim or controversy arising under, out ofor in connection with or related to this Plan (or subsequent amendments thereof), including, without limitation, disputes, claims or controversies regarding its existence, validity, interpretation, performance, breach or termination, shall be Epalinges, Switzerland. |
10. | Approval and Date of Effect of the Plan |
(a) | This Plan has been approved by the BoD and shall become effective on 18 November, 2016. |
(b) | The Participants accept the terms and regulations of this Plan by signing the respective Share Purchase Agreement. |
Annex A: Form of Share Purchase Agreement
Final_17 March 2016 | |
Confidential | |
Share Purchase Agreement | |
dated [Month] [Day], 2016 | |
by and between | |
[Name of employee]
[Address of employee]
|
(hereinafter the Participant) |
and | |
A.T. Holdings II Sàrl | (hereinafter ATH II) |
Biopôle | |
route de la Corniche 3 B | |
1066 Epalinges | |
Switzerland | |
and | |
ADC Therapeutics Ltd | (hereinafter the Company, |
route de la Corniche 3 B | together with the Participant and |
1066 Epalinges | ATH II the Parties) |
Switzerland |
regarding the purchase of shares under the 2016 Share Purchase Plan of the Company
Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 2 | 4 |
Whereas
A. | The Participant wishes to purchase from ATH II, and ATH II wishes to sell to the Participant, ■ [number of shares allocated to the employee] Class A common shares in the Company subject to and in accordance with the terms of this Agreement and the 2016 Share Purchase Plan of the Company attached hereto as Annex A (the Plan). |
Now, therefore, the Parties agree as follows:
1. | Definitions |
Unless otherwise defined herein, capitalized terms shall have the meaning ascribed to them in the Plan.
2. | Purchase |
(a) | ATH II hereby agrees to sell and the Participant hereby agrees to purchase ■ ([number in words]) Shares subject to the terms of this agreement and the Plan. |
(b) | The Purchase Price shall be the aggregate sum of CHF ■ and shall be satisfied as follows: |
(i) | CHF ■ shall be paid in cash (the Cash Amount); and |
(ii) | the balance between the Purchase Price and the Cash Amount shall be paid in the form of a Promissory Note. |
(c) | The Shares shall be sold with full title guarantee free from all encumbrances and shall have the rights, preferences and priorities as set forth in the articles of association of the Company. |
3. | Completion |
(a) | The Completion Date shall be ■ 2016. |
(b) | The form of the Promissory Note to be executed by the Completion Date (if any) is attached hereto as Annex 3(b). |
(c) | The form of the Nominee Agreement to be entered into by the Completion Date is attached hereto as Annex 3(c). |
Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 3 | 4 |
4. | Adherence to Shareholders’ Agreement |
The Participant hereby adheres to the Shareholders’ Agreement with effect as from the date hereof and in accordance with Article 8 of the Plan.
5. | Leaver Provisions – Reference Date |
The Reference Date for purposes of Article 6 of the Plan shall be [the date of this Agreement | ■].
6. | Governing Law and Jurisdiction |
(a) | This Agreement shall be exclusively governed by and construed in accordance with the substantive laws of Switzerland, excluding its conflict of laws principles. |
(b) | The exclusive place of jurisdiction for any dispute, claim or controversy arising under, out ofor in connection with or related to this Agreement (or subsequent amendments thereof), including, without limitation, disputes, claims or controversies regarding its existence, validity, interpretation, performance, breach or termination, shall be Epalinges, Switzerland. |
[Next page is signature page]
Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 4 | 4 |
The Participant | ||
[Name] | ||
A.T. Holdings II Sàrl | ||
[Name] | [Name] | |
[Function] | [Function] | |
ADC Therapeutics Ltd | ||
[Name] | [Name] | |
[Function] | [Function] |
Annex A of the Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 1 | 1 |
Annex A: 2016 Share Purchase Plan
Annex 3(a) of the Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 1 | 1 |
Annex 3(a): Form of Promissory Note
Final_17 March 2016
Confidential
Promissory Note
dated as of________________ 2016
The undersigned, [name and address] (the Borrower), hereby unconditionally promises to pay to ADC Therapeutics Ltd, Epalinges, Switzerland (CHE-461.408.645) (the Lender), the amount of USD [include amount] ([amount in words] U.S. Dollars) (the Principal Amount), in immediately available funds, pursuant to the following terms and provisions:
1. | The Borrower hereby promises to pay to the Lender any outstanding balance of the Principal Amount, and any accrued interest, in full, by no later than [the tenth anniversary of the date hereof]. |
2. | In the event of an Early Repayment Event (as defined below), the Borrower hereby promises to pay to the Lender any outstanding balance of the Principal Amount, and any accrued interest, in full within 30 calendar days following such Early Repayment Event. |
An Early Repayment Event is defined as a (i) change of control wherein a person, or group of persons acting in concert (including AstraZeneca UK Limited, any affiliate thereof or any company it controls, but excluding Auven Therapeutics Holdings L.P. and any other company in which Auven Therapeutics Holdings L.P. holds a direct or indirect controlling interest) obtains more than 50% of the voting rights in the Lender; or (ii) a sale of all or substantially (i.e., no less than 90% of the fair market value) all of the assets of the Lender; provided that, without prejudice to Clause 1, in the event that the Early Repayment Event does not deliver to the Borrower sufficient net upfront proceeds to satisfy the outstanding Principal Amount at that time, then the Borrower and the Lender shall enter into good faith negotiations regarding the appropriate and reasonable repayment terms.
3. | In the event of an IPO (as defined in the Amended and Restated Shareholders Agreement relating to the shares in the Lender dated November 19, 2015) of the Lender, the Borrower and the Lender shall, without prejudice to Clause 1, enter into good faith negotiations regarding the appropriate repayment schedule in the event the Borrower disposes of shares in the Lender such that the Borrower is repaying the Principal Amount proportionately to sales of shares. |
4. | The Borrower hereby promises to pay to the Lender interest on the unpaid Principal Amount for the period from and including the date hereof to but excluding the date the Principal Amount be paid in full, at the minimum interest rate pursuant to the guidelines for related party transactions as periodically published by the Swiss Federal Tax Authority (AFC). Interest on this Promissory Note shall be computed on the basis of a year of 360 days and actual days elapsed (including the first day but excluding the last day) occurring in the period for which payable. The current interest rate prescribed by the AFC is 0.25% per annum. |
2 | 4
5. | The Borrower may prepay the Principal Amount, or any part thereof, at any time, along with accrued interest, but may not re-borrow any amount so prepaid. |
6. | The Borrower may repay the Principal Amount, or any part thereof, at any time by delivering all or part of the shares in the Lender purchased by the Borrower under the Share Purchase Agreement dated ■, 2016, between the Borrower, the Lender and A.T. Holdings II Sàrl back to the Lender in full or partial satisfaction of the Principal Amount. For the purposes of this Clause 6, the value of the shares so delivered back to the Lender shall be determined in accordance with internationally recognized valuation principles. |
7. | Upon the occurrence of any of the following events, each of which shall constitute a default under this Promissory Note, the Principal Amount and accrued interest shall thereupon or thereafter, at the option of Lender, without notice or demand, become immediately due and payable: (a) failure of the Borrower to pay in full any amounts due under this Promissory Note; (b) the death of the Borrower; (c) the entry of a judgment against the Borrower, or the issuing of any attachments or garnishment or the filing of any lien against any property of the Borrower, which is not satisfied within thirty (30) days of the date thereof; and (d) the taking of possession of any substantial part of the property of the Borrower at the instance of any governmental authority. |
8. | The Borrower shall make all payments under or in respect of this Promissory Note without set-off or counterclaim and free and clear of any withholding or deduction for or on account of tax, save as may be required by law. |
9. | The Borrower shall pay, on demand and on a full indemnity basis, all costs and expenses (including VAT) which from time to time may be incurred by the Lender in connection with any breach by the Borrower of its obligations under or in relation to the Promissory Note. |
10. | Any demand or notice in respect of this Promissory Note shall be in writing and (without prejudice to any other effective means of serving it) may be served on the Borrower personally or by mail to the address indicated on page 1 hereof or any other address notified to the Lender in writing from time to time. |
11. | No failure by the Lender to exercise or delay by the Lender in exercising any right or remedy under or in respect of this Promissory Note shall operate as a waiver of it, nor shall any single partial or defective exercise by the Lender of any such right or remedy preclude any other or further exercise of that or any other right or remedy. |
12. | The Borrower may not assign or transfer any of its rights or obligations under this Promissory Note without the Lender’s prior written consent. |
13. | This Promissory Note shall be exclusively governed by and construed in accordance with the substantive laws of Switzerland, excluding its conflict of laws principles. |
14. | The exclusive place of jurisdiction for any dispute, claim or controversy arising under, out ofor in connection with or related to this Promissory Note (or subsequent amendments thereof), including, without limitation, disputes, claims or controversies regarding its existence, validity, interpretation, performance, breach or termination, shall be Epalinges, Switzerland. |
3 | 4
[Next page is signature page]
4 | 4
The Borrower | ||
[Name] | ||
Agreed and accepted by the Lender: | ||
ADC Therapeutics Ltd | ||
[Name] | [Name] | |
[Function] | [Function] |
Annex 2(c) of the Share Purchase Agreement between ■ and A.T. Holdings II Sàrl and ADC Therapeutics Ltd. | 1 | 1 |
Annex 2(c): Form of Nominee Agreement
Final_17 March 2016
Confidential
Whereas
A. | On ■, 2016, the Participant, ATH II and ADC Therapeutics SA (the Company) entered into a Share Purchase Agreement regarding the purchase by the Participant of Class A common shares in the Company. |
B. | On or around the date hereof, the Participant will purchase ■ Class A shares in the Company (the Shares) from ATH II, such Shares to be held by ATH II as nominee. |
C. | The Participant wishes to appoint ATH II as nominee in relation to the Shares and ATH II wishes to act as nominee for the Participant subject to and in accordance with the terms of this Agreement. |
Now, therefore, the Parties agree as follows:
1. | Appointment of Nominee |
(a) | The Participant hereby appoints and designates ATH II as nominee of the Shares for the Participant upon the terms and conditions of this Agreement. |
Nominee Agreement between ■ and ■ | 2 | 4 |
(b) | The Nominee shall hold the Shares not in its own name but on behalf and for the account of the Participant until either Party terminates this Agreement, it being understood and agreed that the Participant may only terminate the Agreement after the Company has completed a share split which results in the Participant no longer being the holder of fractional shares in the Company but only of a whole number of shares. |
(c) | This Agreement shall automatically terminate upon the Participant’s due registration as a shareholder of the Company. The Nominee hereby assigns such shares in the Company as it will hold as nominee for the Participant under this Agreement, and transfer all voting and shareholder rights associated therewith, upon such automatic termination. |
2. | Voting and Shareholder Rights |
(a) | Any shareholder rights under and in connection with the Shares shall be exercised by the Nominee. |
(b) | The Nominee may exercise the voting rights relating to the Shares at the general shareholders’ meetings of the Company, taking into account the wishes of the Participant, both acting reasonably, and in compliance with the Amended and Restated Shareholders Agreement relating to the shares in the Company dated November 19, 2015, or any subsequent shareholders’ agreement (such agreement as in force at any time the Shareholders’ Agreement). |
(c) | The Parties agree that the Participant shall be entitled to any dividends or other distributions made with respect to the Shares. The Nominee shall be entitled to set off any claims for indemnity pursuant to Article 3 of this Agreement against such dividends or other distributions. |
(d) | The Nominee undertakes to deliver to the Participant copies of any and all shareholder communications of the Company within a reasonable period following receipt by the Nominee of the same. |
3. | Indemnity |
Any and all risks and consequences that may result for the Nominee out of this Agreement shall be borne by the Participant. The Participant agrees to indemnify, defend and hold harmless the Nominee from and against any and all losses, liabilities, damages, taxes, costs and expenses actually and reasonably incurred by the Nominee in connection with this Agreement, unless caused by gross negligence, willful default or fraud on the part of the Nominee.
4. | Governing Law and Jurisdiction |
(a) | This Agreement shall be exclusively governed by and construed in accordance with the substantive laws of Switzerland, excluding its conflict of laws principles. |
Nominee Agreement between ■ and ■ | 3 | 4 |
(b) | The exclusive place of jurisdiction for any dispute, claim or controversy arising under, out ofor in connection with or related to this Agreement (or subsequent amendments thereof), including, without limitation, disputes, claims or controversies regarding its existence, validity, interpretation, performance, breach or termination, shall be Epalinges, Switzerland. |
[Next page is signature page]
Nominee Agreement between ■ and ■ | 4 | 4 |
The Participant | ||
[Name] | ||
A.T. Holdings II Sàrl | ||
[Name] | [Name] | |
[Function] | [Function] | |
Name of Subsidiary
|
Jurisdiction of Organization
|
ADC Therapeutics America, Inc.
|
United States
|
ADC Therapeutics (UK) Limited
|
England
|
By:
|
/s/ Jennifer Creel
|
|
Name:
|
Jennifer Creel
|
|
Date:
|
April 24, 2020
|