UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 16, 2019
IMMUNIC, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36201 | 56-2358443 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
Am Klopferspitz 19
82152 Martinsried
Germany
(Address of principal executive offices)
Registrant’s telephone number, including area code: 49 89 250079460
Vital Therapies, Inc.
15222-B Avenue of Science
San Diego, CA 92128
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of exchange on which registered |
Common Stock, par value $0.0001 | IMUX | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☒ No ☐
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this Current Report on Form 8-K regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to development programs of Immunic, Inc. (“Immunic” or the “Company”) and the targeted diseases; the potential for IMU-838, IMU-935 and IMU-856 to safely and effectively target diseases; the nature, strategy and focus of the Company; the development and commercial potential of any product candidates of the Company; expectations regarding the capitalization, resources and ownership structure of the Company; and the executive and board structure of the Company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by intellectual property of Immunic, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. Immunic disclaims any obligation except as required by law to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
Item 1.01. Entry into a Material Definitive Agreement.
Sales Agreement
On July 17, 2019, Immunic entered into a Sales Agreement (the “Agreement”) with SVB Leerink LLC, as agent (“SVB Leerink”). Under the Agreement, the Company may offer and sell its common stock, par value $0.0001 per share, from time to time having an aggregate offering price of up to $40,000,000 (the “Shares”) during the term of the Agreement through SVB Leerink, acting as agent. The Company has filed a prospectus supplement relating to the offer and sale of the Shares pursuant to the Agreement. The Shares will be issued pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-225230), which was initially filed with the Securities and Exchange Commission on May 25, 2018, amended on June 8, 2018 and declared effective on June 13, 2018. The Company intends to use the net proceeds from the offering, if any, to continue to fund the ongoing clinical development of its product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
The Company is not obligated to sell any Shares pursuant to the Agreement. Subject to the terms and conditions of the Agreement, SVB Leerink will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Capital Market (“Nasdaq”), to sell Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose.
Under the Agreement, SVB Leerink may sell Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended, and the rules and regulations thereunder, including, without limitation, sales made directly on or through Nasdaq, on or through any other existing trading market for the Shares or to or through a market maker. If expressly authorized by the Company, SVB Leerink may also sell Shares in negotiated transactions.
The Agreement will terminate upon the earlier of (i) the issuance and sale of all of the Shares through SVB Leerink on the terms and subject to the conditions set forth in the Agreement or (ii) termination of the Agreement as otherwise permitted thereby. The Agreement may be terminated at any time by either party upon ten days’ prior notice, or by SVB Leerink at any time in certain circumstances, including the occurrence of a material adverse effect on the Company.
The Company has agreed to pay SVB Leerink a commission equal to 3.0% of the gross proceeds from the sales of Shares pursuant to the Agreement and has agreed to provide SVB Leerink with customary indemnification and contribution rights.
The foregoing summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated herein by reference. The Agreement contains representations and warranties that the parties made to, and solely for the benefit of, the other in the context of all of the terms and conditions of the Agreement and in the context of the specific relationship between the parties. The provisions of the Agreement, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to the Agreement and are not intended as a document for investors and the public to obtain factual information about the Company’s current state of affairs. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the SEC.
The opinion of the Company’s counsel regarding the validity of the Shares that may be issued pursuant to the Agreement is filed herewith as Exhibit 5.1.
This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy Shares, nor shall there be any sale of the Shares in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Item 5.03 | Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
On July 17, 2019, the Company filed an amended and restated certificate of incorporation (the “Certificate”) with the Secretary of State of the State of Delaware. The Certificate amended and restated the Company’s certificate of incorporation to, among other things: (i) eliminate the requirements that changes to the number of directors, the calling of a special meeting and affiliate transactions be approved by at least 75% of all directors, providing instead for majority approval; (ii) eliminate the requirements that removal of directors, changes to the bylaws, certain changes to the Certificate and certain transactions be approved by at least 75% of the voting power of outstanding common stock, providing instead for majority approval; and (iii) implement a number of clarifications, stylistic revisions and incorporation of prior amendments in order to improve the organization and clarity of the Certificate.
The foregoing description of the Certificate does not purport to be complete and is qualified in its entirety by reference to the Certificate, a copy of which is attached hereto as Exhibit 3.1 and is incorporated herein by reference.
On July 16, 2019, the Board of Directors of the Company (the “Board”) approved an amendment and restatement of the Company’s bylaws (the “Bylaws”). The Board amended and restated the Bylaws to, among other things: (i) reflect the Company’s name change from Vital Therapies, Inc. to Immunic, Inc.; (ii) eliminate the concept of a lead director; (iii) eliminate the requirement that Company officers give a bond or other security for performance of their duties; and (iv) implement a number of clarifications in order to improve the organization and clarity of the Bylaws.
The foregoing description of the Bylaws does not purport to be complete and is qualified in its entirety by reference to the Bylaws, a copy of which is attached hereto as Exhibit 3.2 and is incorporated herein by reference.
Item 8.01 | Other Events. |
Recent Developments
On April 12, 2019, the Company (formerly known as Vital Therapies, Inc.) completed an exchange transaction with Immunic AG in accordance with the terms of an Exchange Agreement, dated as of January 6, 2019 (the “Exchange Agreement”), between the Company, Immunic AG and the former shareholders of Immunic AG party thereto. Pursuant to the terms of the Exchange Agreement, the holders of ordinary shares of Immunic AG exchanged all of their shares for shares of our common stock (the “Exchange”), resulting in Immunic AG becoming the Company’s wholly-owned subsidiary. Immediately prior to the Exchange, the Company effected a 40-for-1 reverse split of its outstanding common stock (the “Reverse Stock Split”). Immediately following the Exchange, the Company changed its name to Immunic, Inc. and the business of Immunic AG became the Company’s business. In connection with the closing of the Exchange, the Company’s stock began trading on The Nasdaq Capital Market under the symbol “IMUX” on April 15, 2019.
Prior to and in connection with the Exchange, Immunic AG issued, in a private placement transaction, an aggregate of 129,744 ordinary shares to certain of its shareholders for aggregate consideration of approximately €26.7 million (approximately $30 million), pursuant to the terms of an Investment and Subscription Agreement, dated as of January 6, 2019, between Immunic AG and the shareholders and investors party thereto.
On May 12, 2015, the Company (then known as Vital Therapies, Inc.) entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co. (the “Prior Sales Agreement”), providing for the issuance and sale of up $75,000,000 of the Company’s common stock. On July 9, 2019, the Company terminated the Prior Sales Agreement, effective July 19, 2019.
Material Agreements
Daiichi Option and License Agreement
In November 2018, Immunic AG and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) in Tokyo, Japan, entered into an option and license agreement (the “Daiichi License Agreement”). Under the Daiichi License Agreement, Immunic AG has the right to commercialize IMU-856, a drug candidate targeting the intestinal barrier function (“IMU-856”), in all countries, and has the exclusive option to execute an exclusive worldwide license during an option period determined by reference to specified clinical milestones (the “Option Period”). Immunic AG is permitted to sublicense its rights under the Daiichi License Agreement, subject to Daiichi Sankyo’s approval. Daiichi Sankyo received an upfront payment in connection with the Daiichi License Agreement, and is also entitled to (i) certain option exercise payments, (ii) milestone payments contingent upon select regulatory developments, (iii) sales milestone payments upon the achievement of specified annual net sales thresholds, and (iv) a royalty on net sales of IMU-856.
Pursuant to the Daiichi License Agreement, Immunic AG and Daiichi Sankyo formed a joint steering committee to monitor and review the parties’ activities during the Option Period and review the development plan formulated by the parties.
The preceding summary does not purport to be complete and is qualified in its entirety by reference to the Daiichi License Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.
4SC AG Asset Purchase Agreement
In May 2016, Immunic AG entered into an asset purchase agreement (the “4SC Agreement”) with 4SC AG (“4SC”) pursuant to which Immunic AG acquired an option to purchase certain assets, including patents and patent applications, trademarks and know-how related to select compounds aimed at treating cancer and autoimmune diseases (the “4SC Assets”). 4SC is entitled to certain upfront payments, milestone payments and a royalty on net sales of select compounds under the 4SC Agreement. 4SC is also entitled to certain payments upon a change of control, merger or similar transaction by Immunic AG. In September 2016, Immunic AG exercised its option to purchase the 4SC Assets.
The preceding summary does not purport to be complete and is qualified in its entirety by reference to the 4SC Agreement, which is filed as Exhibit 10.3 to this Current Report on Form 8-K and is incorporated herein by reference.
Indemnification Agreements
Each of the Company’s directors and officers has entered into the Company’s standard form of indemnification agreement, which is attached as Exhibit 10.4 to this Current Report on Form 8-K and incorporated herein by reference.
Employment Agreements
Vitt Employment Agreement
In 2016, Immunic AG entered into an employment agreement with Dr. Daniel Vitt, the President and Chief Executive Officer of the Company (the “Vitt Employment Agreement”). The Vitt Employment Agreement has a three year term, subject to extension in Immunic AG’s discretion, and provides for (i) a fixed annual salary of €215,000, and (ii) additional compensation of up to €30,000, subject to achievement of certain performance targets. Both components of Dr. Vitt’s compensation are reviewed annually by Immunic AG and may be modified based on his performance and the performance of Immunic AG. Pursuant to the Vitt Employment Agreement, Dr. Vitt is also entitled to reimbursement of certain expenses, insurance coverage and certain other customary benefits.
Upon termination of his employment upon a change in control of Immunic AG, Dr. Vitt is entitled to severance in an amount equal the total compensation that he would have received until the expiration of the Vitt Employment Agreement, subject to certain exceptions and adjustments.
The preceding summary does not purport to be complete and is qualified in its entirety by reference to the Vitt Employment Agreement, which is filed as Exhibit 10.5 to this Current Report on Form 8-K and is incorporated herein by reference.
Gröppel Employment Agreement
In 2016, Immunic AG entered into an employment agreement with Dr. Manfred Gröppel, Chief Operating Officer of the Company (the “Gröppel Employment Agreement”). The Gröppel Employment Agreement has an initial term until August 31, 2019, subject to extension in Immunic AG’s discretion, and provides for (i) a fixed annual salary of €150,000, and (ii) additional compensation of up to €24,000, subject to achievement of certain performance targets. Both components of Dr. Gröppel’s compensation are reviewed annually by Immunic AG and may be modified based on his performance and the performance of Immunic AG. Pursuant to the Gröppel Employment Agreement, Dr. Gröppel is also entitled to reimbursement of certain expenses, insurance coverage and certain other customary benefits.
Upon termination of his employment upon a change in control of Immunic AG, Dr. Gröppel is entitled to severance in an amount equal the total compensation that he would have received until the expiration of the Gröppel Employment Agreement, subject to certain exceptions and adjustments.
The preceding summary does not purport to be complete and is qualified in its entirety by reference to the Gröppel Employment Agreement, which is filed as Exhibit 10.6 to this Current Report on Form 8-K and is incorporated herein by reference.
IMMUNIC BUSINESS
Overview
Immunic is a clinical-stage biopharmaceutical company focused on the development of selective oral therapies in immunology with the goal of becoming a leader in treatments for chronic inflammatory and autoimmune diseases. Immunic’s main operations are in Planegg-Martinsried near Munich, Germany. Immunic currently has 18 employees.
Strategy
Immunic is currently pursuing three development programs. These include the IMU-838 program, focused on the development of oral formulations of small molecule inhibitors of dihydroorotate dehydrogenase, or DHODH; the IMU-935 program focused on an inverse agonist of ROR g t, an immune cell-specific isoform of ROR g (retinoic acid receptor-related orphan nuclear receptor gamma), and the IMU-856 program, involving the development of a drug targeting the restoration of intestinal barrier function. These product candidates are being developed to address diseases such as relapsing-remitting multiple sclerosis, or RRMS, ulcerative colitis, or UC, Crohn’s disease, or CD, and psoriasis. In addition to these large markets, Immunic’s products are also being developed to address certain rare diseases with high unmet medical needs, such as primary sclerosing cholangitis, or PSC.
The following table summarizes the potential indications, clinical targets and clinical development status of Immunic’s three product candidates:
* | IST: Investigator-Sponsored Trial |
Immunic’s most advanced drug candidate, IMU-838, targets DHODH, a key enzyme in the intracellular metabolism of immune cells in the body. IMU-838’s lead indications are RRMS and inflammatory bowel disease, or IBD, where the drug candidate is currently being studied in Phase 2b trials, EMPhASIS and CALDOSE-1. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in PSC is ongoing at the Mayo Clinic. If approved, Immunic believes that IMU-838 has the potential to be a first-in-class DHODH inhibitor in IBD and a best-in-class DHODH inhibitor in RRMS. DHODH represents a proven target for drug development, with other DHODH inhibitors (e.g. Aubagio ® , Sanofi) available commercially for the treatment of conditions outside of IBD, such as multiple sclerosis, or MS. In addition, prior clinical data with IMU-838 in rheumatoid arthritis, or RA. has resulted in a good understanding of the safety profile of the drug at doses consistent with those currently under evaluation for the treatment of RRMS and IBD.
Immunic’s second drug candidate, IMU-935, is a highly potent and selective inverse agonist of a transcription factor called ROR g t with additional activity on DHODH. Immunic believes that the nuclear receptor ROR g t is the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. Immunic believes this target is an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17 itself. Immunic has observed strong cytokine inhibition targeting both Th1 and Th17 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and IBD. Preclinical experiments indicated that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. Based on these preclinical data, Immunic believes that IMU-935 has potential as a best-in-class therapy for various autoimmune diseases.
Immunic’s third program, IMU-856, is a small molecule inhibitor that targets a protein that serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, Immunic believes this compound represents a new and potentially disruptive approach for the treatment of gastrointestinal, or GI, disorders by potentially restoring the intestinal barrier function while maintaining immunocompetency.
Acquisition History
Immunic acquired IMU-838 and IMU-935 in September 2016 from 4SC AG, a publicly traded company based near Munich, Germany, through full asset acquisitions. Immunic’s rights to IMU-856 are secured pursuant to a license and option agreement with Daiichi Sankyo Company, Limited, or Daiichi Sankyo, in Tokyo, Japan. Immunic and Daiichi Sankyo are currently conducting Phase 1-enabling studies, including Good Laboratory Practice, or GLP, toxicology studies in rats and monkeys. Immunic has the exclusive option to execute an exclusive worldwide license to this development project at the time of starting Phase 1, in return for payment of an upfront licensing fee and further development, approval and sales milestone payments as well as royalties.
Commercialization Strategy
Immunic’s products are being developed with the aim of delivering proof-of-efficacy in state-of-the-art clinical trials with multiple compounds in multiple indications. Subsequent pivotal trials may be conducted by Immunic alone or with a potential future partner.
Immunic expects to continue to lead most of its research and development activities from its Planegg-Martinsried location, where a dedicated scientific, regulatory, clinical and medical team is available. Due to this team’s key relationships with local service providers, Immunic anticipates that this will result in timely, cost-effective execution of Immunic’s development programs. In addition, Immunic intends to use its subsidiary in Melbourne, Australia to expedite the early clinical trials for IMU-935 and IMU-856.
Immunic also conducts preclinical work in Halle/Saale, Germany through a collaboration with the Fraunhofer Institute.
Leadership
Immunic is led by a team of dedicated and committed experienced professionals with an entrepreneurial spirit and track record of successful licensing transactions in the healthcare industry worldwide (EU, the United States and Asia). The team brings together more than 70 years of leadership experience in the pharmaceutical industry with a strong scientific background and sound knowledge in drug discovery, product development, chemistry, manufacturing and controls processes, intellectual property, clinical trial design, health economics and market access, capital markets, regulatory affairs and project valuation. Immunic’s team members are inventors on project-related patents and have successfully published project-related scientific publications.
Product Candidates
IMU-838
IMU-838 is a small molecule investigational drug (vidofludimus calcium) under development as an oral tablet formulation for the treatment of RRMS, IBD and other chronic inflammatory and autoimmune diseases. By inhibiting DHODH, a key enzyme of pyrimidine de novo biosynthesis, metabolically activated T and B immune cells experience metabolic stress, and the release of Th1 and Th17 key cytokines including IL-17A, IL-17F and IFN g is inhibited, thereby reducing the inflammation associated with IBD. In preclinical studies of vidofludimus, the active ingredient of IMU-838, apoptosis (or programmed cell death) was induced in activated T cells, which Immunic believes may also play a crucial role in the activity of the drug in IBD by further dampening the inflammatory response. Immunic believes that a key advantage of DHODH inhibition in general is that the sensitivity of specific immune cells to DHODH inhibition correlates with their intracellular metabolic activation state, and therefore may not negatively impact “normal” bone marrow cells. In animal studies of IMU-838, animals treated with large doses of the active moiety of IMU-838 were shown to lack detrimental effects on bone marrow, supporting the lack of an unspecific anti-proliferative effect regularly seen with many traditional immunomodulators.
Based on the selectivity toward metabolically activated cells (with a high need for ribonucleic acid, or RNA, and deoxyribonucleic acid, or DNA, production), DHODH inhibition also leads to a direct antiviral effect, which has been demonstrated in various virus infected cells, such as influenza virus infections, cytomegalovirus infections and even hemorrhagic fever-causing viruses, such as Lassa virus. Treatment with IMU-838 may avoid virus reactivation, one of the major drawbacks of the long-term use of traditional immunomodulators in IBD patients.
Efficacy of vidofludimus, the active moiety and free acid form of IMU-838, has been demonstrated in several animal disease models for IBD, as well as systemic lupus erythematosus and transplant rejection.
Initial clinical trials were conducted by 4SC using a free acid formulation of the active moiety of IMU-838, vidofludimus, and an amorphous material. In total, 4SC’s clinical trial data encompasses more than 250 patients treated with the active moiety, helping generate a safety database to encourage further development of IMU-838. 4SC conducted a Phase 2 double-blinded, randomized, placebo-controlled study in patients with RA (the COMPONENT trial), where it was observed that there was no increased rate of infections in the vidofludimus arm versus the placebo arm. In addition, 4SC conducted a small single-arm, open-label, uncontrolled Phase 2a study in corticosteroid-dependent IBD patients. In this study, following steroid tapering during 12-week treatment with vidofludimus, approximately 50% of IBD patients were able to discontinue steroids completely and an additional approximately 35% of patients were able to significantly reduce their daily steroid dose below their previous personal threshold dose.
After the consummation of the asset acquisition from 4SC described above in “Overview—Acquisition History,” Immunic developed and patented a new specific polymorph of the calcium salt formulation of vidofludimus, IMU-838, which Immunic believes exhibits improved physicochemical and pharmacokinetic properties.
Immunic has used and continues to use its IMU-838 formulation in its drug development activities. In 2017, Immunic completed two Phase 1 studies of single or repeated once-daily doses of IMU-838 in healthy volunteers, where Immunic observed results supporting tolerability of repeated daily dosing of up to 50 mg of IMU-838. A Phase 2b study in patients with UC is currently ongoing, with enrollment initiated in April 2018. A second Phase 2b study in patients with RRMS is also ongoing, with enrollment initiated in February 2019. A third Phase 2b trial in patients with CD is expected to start in the second half of 2019.
Indication: Ulcerative Colitis
Diagnosis and Prevalence
UC is a chronic inflammatory disease characterized by diffuse inflammation of the mucosa of the colon and rectum. The hallmark clinical symptoms of UC are diarrhea and bloody stool, and its clinical course is marked by exacerbations and remissions, which may occur spontaneously or in response to treatment changes or intercurrent illnesses.
UC is most commonly diagnosed in late adolescence or early adulthood, but it can occur at any age. According to Burisch/Munkholm (2015), the occurrence of UC worldwide has increased over the past few years, particularly in Latin America, Asia and Eastern Europe. Recent estimates note that there are more than 700,000 patients affected by UC in the United States, as well as 1.5 million in Europe ( Understanding Ulcerative Colitis , available at https://www.crohnsandcolitis.com/ulcerative-colitis (last accessed July 16, 2019) ; Burisch, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis . (2013 May)) and more than 100,000 in Canada (Rocchi, et al. Inflammatory bowel disease: a Canadian burden of illness review. Can J Gastroenterol . (2012 Nov)). UC is almost equally distributed between genders (Kappelman, et al. The prevalence and geographic distribution of CD and UC in the United States. Clin Gastroenterol Hepatol. (2007)).
Current Treatment Options
The severity and extent of UC are characterized based on clinical and endoscopic findings. Treatment approach often depends on disease severity and typically follows a stepwise treatment regimen. Patients with mild disease may initially receive aminosalicylates or non-systemic steroids such as budesonide. Patients with moderate to severe disease activity may receive traditional immunomodulators (such as azathioprine or 6-mercaptopurine), steroids (such as prednisone) or selective immunomodulators (such as tofacitinib). If patients fail to respond to these therapies, treatment may be escalated to the use of biologics. The most common category of biologics used to treat UC includes anti-tumor necrosis factor-alpha (TNFα) antibody drugs, such as infliximab or adalimumab. New biologic options are alpha-4-beta-7 (α4ß7) integrin-specific antibodies, such as vedolizumab. All biologics currently used to treat UC are injectables. Biologics are usually the most expensive treatment option and reserved for patients who have failed other therapies.
Treatment of UC is differentiated between induction treatment (during periods of disease symptoms or following relapse) and maintenance treatment (often a long-term treatment to keep a patient relapse-free). Since many UC patients fail to respond to treatments, cease to respond to their treatments or develop unacceptable side effects, there is a need for safe and effective treatments for UC with novel mechanisms. Additionally, patients prefer the convenience of oral treatments over injections. For some of the currently available oral immunomodulators or those in clinical testing, a higher rate of infections (particularly virus re-activations) have been reported versus placebo control, which can be a medically significant event for patients.
IMU-838 is being developed to be a new treatment option for patients with moderate to severe UC who have failed current therapies and are now candidates for therapy with biologics.
Competition
The field of IBD, including UC, is highly competitive. Immunic’s competitors in the United States and elsewhere include major pharmaceutical, biotechnology and biosimilar manufacturers. Some of these competitors may have more extensive research and development, regulatory compliance, manufacturing, marketing and sales capabilities than Immunic. Many competitors also have significantly greater financial resources. These companies may succeed in developing products that are more effective or more economical than any of Immunic’s product candidates and may also be more successful than Immunic in manufacturing, developing and registering products. In addition, technological advances or different approaches developed by one or more of Immunic’s competitors may render Immunic’s products obsolete, less effective or uneconomical.
Currently there are several new oral treatment options for UC patients in advanced clinical development. Most of them fall into one of two categories: S1P agonists, such as ozanimod or etrasimod, or JAK inhibitors, such as upadacitinib or filgotinib. Some of these drug candidates may be approved by regulatory authorities for commercial use before IMU-838 may receive approval. However, depending on the results of future clinical trials, Immunic believes that IMU-838 has the potential to demonstrate medically important advantages compared with other treatments, particularly for long-term therapy in UC patients, due to the selectivity of DHODH targeting of metabolically activated lymphocytes, the absence of general detrimental effects on bone marrow and the direct antiviral activity.
Clinical Development Plan and Ongoing Studies
Immunic has prepared a clinical development plan for IBD, including UC, in collaboration with a group of well-known and experienced physicians from North America and Europe. Immunic also sought regulatory advice on its development program from the U.S. Food and Drug Administration, or FDA, and BfArM ( Bundesinstitut für Arzneimittel und Medizinprodukte , the drug regulatory agency in Germany), before commencing its development program. During a pre-investigational new drug application, or IND, meeting with the FDA in June 2017, Immunic and the FDA agreed on a development program for IMU-838 that started with a dose-finding trial in UC patients which consisted of a placebo group and three active dose groups, including a low dose to establish the lowest effective dose of IMU-838. At the request of Immunic, the FDA agreed that an interim dose-finding analysis of CALDOSE-1, the Phase 2b trial of IMU-838 in UC, could be performed in order to establish whether the lowest dose(s) were potentially ineffective. Based on this analysis, the potentially ineffective dose(s) may be discontinued, enabling the study to continue with fewer active dose groups, which may enable Immunic to complete enrollment in the trial more efficiently. A Phase 2 study of IMU-838 in CD could then begin following such interim dosing analysis of the UC study. Additionally, the FDA and Immunic agreed on safety monitoring, the definition of adverse events of special interest and study endpoints. Based on those discussions, Immunic initiated CALDOSE-1 in April 2018 and is currently ongoing.
Phase 2b Study in UC (CALDOSE-1)
The CALDOSE-1 study is a Phase 2b, dose-finding, multicenter, double-blind, placebo-controlled study including a blinded induction and maintenance phase, with double randomization (initial randomization for induction and second randomization for maintenance). The study also includes an option for an open-label treatment extension for patients discontinuing from or completing blinded treatment. The primary endpoint of the study consists of a patient-reported outcome and an endoscopy-assessed outcome, both assessed following 10 weeks of induction treatment comparing IMU-838 to placebo.
CALDOSE-1 is being conducted in approximately 85 study centers throughout nine countries (including the United States and countries in Western, Central and Eastern Europe). Immunic has an active IND for IMU-838 in UC from the FDA and the study is currently enrolling subjects in the United States and other countries.
Enrollment in the study also includes a central, blinded and independent assessment of endoscopy at screening to confirm patient eligibility. Immunic believes that it has taken prudent steps to ensure that the study is conducted in a manner that is consistent with the study protocol in all countries in which the study is being conducted, even though such countries have varying healthcare systems and practices.
A total of approximately 200 patients are planned to be randomized in CALDOSE-1. The first patient was enrolled in April 2018 and enrollment is anticipated to conclude during the second half of 2020. Immunic expects to receive unblinded top-line results in the first quarter of 2021.
As outlined above, an interim dosing analysis is scheduled to be performed in 2019 with the aim of potentially eliminating an ineffective dose group (such as the lowest active dose group) or a poorly-tolerated dose of IMU-838, and to continue the study in a more efficient manner using appropriate dose groups. This analysis will be done by an unblinded data review committee. Immunic will not receive general unblinded data. The interim dosing analysis is not designed to be a futility analysis nor will the primary endpoint of the study be tested statistically. The unblinded data review committee will be asked to make a targeted recommendation regarding the discontinuation of a dose group or dose groups.
Indication: Crohn’s Disease
Diagnosis and Prevalence
CD is an idiopathic chronic inflammatory disease of unknown etiology with genetic, immunologic and environmental influences. Like UC, it is one of the major diseases that are generally characterized as IBD. Both UC and CD are caused by chronic inflammation in the GI tract, but CD can involve the entire GI tract, from the mouth to the anus (but it most commonly involves both the large and small intestines), whereas UC is restricted to the colon and rectum. Distinguishing CD from UC can be challenging when inflammation is confined to the colon. CD typically involves all layers of the bowel wall, thereby causing complications such as abscesses, strictures and fistulas that regularly require surgical intervention.
Hallmark clinical symptoms of CD are chronic diarrhea and abdominal pain. However, the diagnosing physician needs to evaluate laboratory tests, endoscopy results, pathology findings and radiographic tests to arrive at a clinical diagnosis of CD. In general, it is the presence of chronic intestinal inflammation that leads to a diagnosis of CD.
CD is most commonly diagnosed in late adolescence or early adulthood, but it can manifest at any age. According to recent data and literature reviews on the incidence of CD (Kappelman 2007; Burisch 2013; Rocchi 2012; Understanding Crohn’s Disease, available at https://www.crohnsandcolitis.com/crohns (last accessed July 16, 2019), there are more than 600,000 patients affected by CD in the United States as well as 1.1 million in Europe and more than 125,000 in Canada. CD is slightly more prevalent in women than in men.
Current Treatment Options
Treatment of CD is similar to treatment of UC. However, some of the therapies available for UC (such as tofacitinib) have shown no or less activity in CD. Conversely, and based on the treatment needs of patients with CD, some drugs have been primarily developed for CD. One such example is the biologic ustekinumab, an antibody directed against interleukin 12 and interleukin 23. There are now also some approved treatments, such as alofisel, that target the specific structural complications of CD, including fistulas.
Competition
Most oral drugs currently in clinical development are traditionally developed for both UC and CD. Thus, the main competitive factors discussed above under “—Product Candidates—IMU-838—Indication: Ulcerative Colitis—Competition” also apply with respect to CD. Immunic considers CD to be a very competitive field.
Leflunomide is used off-label in patients with CD and has shown an initial suggestion of the value of DHODH inhibition in this patient population. In two small investigator trials of leflunomide in CD patients, investigators observed DHODH inhibitor activity in the treatment of moderate to severe CD in patients who have failed or are intolerant to traditional immunomodulator therapy. However, the side effect profile of leflunomide included diarrhea. The prescribing information for teriflunomide, a compound related to leflunomide and approved for patients with MS, lists a 15-18% rate of diarrhea, which makes it one of the most prevalent side effects of this DHODH inhibitor. Immunic believes that despite the findings of efficacy for leflunomide in the investigator trials in CD patients, the side effect profile makes it unlikely that this type of DHODH inhibitor can be developed in the indication of IBD, and particularly in CD.
Current Development Plan and Ongoing Studies
Immunic is also developing IMU-838 for the treatment of CD. During its discussions with the FDA, Immunic and the FDA reached agreement that the Phase 2b study of IMU-838 in CD could commence when the interim dosing analysis for the Phase 2b CALDOSE-1 study in UC had been completed. This would also allow Immunic to execute its Phase 2b study of IMU-838 in CD with the likely two remaining active dose groups from CALDOSE-1 and placebo, thereby potentially allowing more efficient recruitment into this trial. Immunic had also received additional written advice from the FDA regarding patient-reported outcomes to be used in this Phase 2b trial, called CALDOSE-2. CALDOSE-2 is expected to initiate during the second half of 2019.
Phase 2b Study in Crohn’s Disease (CALDOSE-2)
CALDOSE-2 is a Phase 2b, dose-finding, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial with randomization of CD patients into the active dosing arms that are determined based on the interim dosing analysis of the UC study, or placebo. The interim dosing analysis of the UC study is described under “—Product Candidates—IMU-838—Indication: Ulcerative Colitis—Clinical Development Plan and Ongoing Studies”. The blinded study period will include a 14-week induction treatment phase and an extended blinded treatment phase of an additional 24 weeks, with an option for an open-label treatment extension for patients discontinuing or completing blinded treatment. Approximately 260 patients are planned to be randomized for this study and approximately 75 to 95 centers in up to 13 countries are expected to participate. For operational and financial synergies, the service providers, systems and performing study centers from CALDOSE-1 study in UC patients will also be used in this trial.
This study will again include study sites in the United States and countries in Western, Central and Eastern Europe. Immunic plans to submit an IND to the FDA, as well as pursue comparable submissions in Europe to conduct the trial.
The primary endpoint of CALDOSE-2 is a patient-reported outcome endpoint of symptomatic remission and the key secondary endpoint is an endoscopy-based assessment, both evaluated after 14 weeks of treatment. Study enrollment also includes a central, blinded and independent assessment of endoscopy at screening to confirm patient eligibility.
Immunic expects patient enrollment to begin in the second half of 2019 and to last for approximately 20 months.
Indication: Multiple Sclerosis
Diagnosis and Prevalence
MS is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects the nerves, is attacked by immune cells and damaged. Thus, MS is considered an immune-mediated demyelinating disease of the central nervous system, or CNS. MS is a progressive disease which, without effective treatment, leads to severe disability. Immunic is developing IMU-838 for the treatment of RRMS, the most common form of MS. Approximately 85% of patients with MS are expected to develop RRMS, with some of these patients later developing other and more severe forms of the disease. RRMS is characterized by clearly defined attacks of new or increasing neurologic symptoms. These relapses are followed by periods of remissions, or partial or complete recovery. During remissions, all symptoms may disappear, or some symptoms may continue and become permanent.
MS is a disease with unpredictable symptoms that can vary widely. Common early signs of MS include vision problems, tingling and numbness or other unspecific neurological symptoms. Diagnosis of MS is confirmed via blood tests and a spinal tap, in which a small sample of fluid is removed from the spinal cord. However, most important for diagnosis are characteristic CNS lesions found using magnetic resonance imaging, or MRI.
According to Wallin et al. (2019), MS affects more than 700,000 people in the United States, and more than 2.2 million people worldwide. The disease has a large economic impact as it affects mainly young adults in the prime working age, although MS can occur in children and in adults. MS is at least two to three times more common in women than in men.
Current Treatment Options
There are currently two main types of treatment for RRMS. Some therapies, such as short-term corticosteroid medications, are used for treating relapses of MS symptoms. Other approaches are used as long-term treatments to reduce the number of relapses. The latter are referred to as disease-modifying therapies. Immunic intends to develop IMU-838 as a disease-modifying therapy for RRMS.
The main first-line treatment options for RRMS patients are beta interferons (either as interferon beta-1a or interferon beta-1b) or glatiramer acetate, all of which are given by injection. For patients requiring more advanced treatment options, there are now several oral medications (such as dimethyl fumarate, fingolimod and cladribine) and biologics (such as natalizumab and alemtuzumab) approved for commercial use in MS in various countries.
In 2012, teriflunomide, an orally available DHODH inhibitor, was approved by the FDA for the treatment of patients with RRMS. Teriflunomide had shown efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. Global sales of teriflunomide in 2017 and 2018 (Aubagio ® ) were approximately $1.8 billion each year.
Clinical data of teriflunomide indicates that the use of DHODH inhibition may be an effective treatment for RRMS. However, teriflunomide’s adverse effects include diarrhea in 13-14% of patients, hair loss (alopecia) in 10-13% of patients, and neutropenia in 4-6% of patients. Leflunomide (and its active metabolite, teriflunomide) is also known to show several off-target effects at therapeutically relevant concentrations, including inhibition of kinases such as epidermal growth factor receptor tyrosine kinase. In contrast, the active moiety of IMU-838 has not yet been shown to be an inhibitor of kinases at doses of up to 300 µM, a concentration largely exceeding the blood concentrations for doses of IMU-838 currently tested in Phase 2 studies. Immunic also has not observed any increased rates of diarrhea, alopecia or neutropenia in its clinical trials to date. The median blood half-life of teriflunomide in RRMS patients was estimated to be 18 and 19 days after repeated daily doses. This long half-life may lead to the need for accelerated elimination with cholestyramine when a patient requires quick drug discontinuation (for example, for change of therapies or when a patient becomes pregnant). In Phase 1 studies, IMU-838 had a blood half-life of 30-40 hours, allowing quick elimination of the drug at a required treatment discontinuation. Based on these differences between teriflunomide and IMU-838, and depending on the results of future clinical trials, Immunic believes that IMU-838 has the potential to demonstrate medically important advantages compares with teriflunomide, particularly for a drug class that is potentially intended for long-term therapy in RRMS patients.
Competition
Ozanimod is an investigational, oral, selective sphingosine 1-phosphate, or S1P, receptor modulator that has been tested by Celgene in two Phase 3 clinical trials in RRMS. Both trials evaluated the efficacy and safety of ozanimod versus interferon beta-1a in patients with RRMS and demonstrated an advantage in annualized relapse rate. In early 2018, Celgene received an FDA-issued Refusal to File letter regarding insufficient data for ozanimod. Celgene announced its intention to re-submit its NDA in 2019. Immunic expects that regulatory approval for ozanimod as an additional oral treatment option in RRMS patients may occur in 2020.
Many drugs approved for patients with RRMS have reported a rare and often lethal viral disease of the brain called progressive multifocal leukoencephalopathy, or PML. Many disease-modifying therapies alter how the immune system functions, including its ability to effectively fight viral infections. As a result, people who take these therapies are at higher risk for John Cunningham virus infection or re-activation, which is believed to be the cause of PML. To date, occurrences of PML have been reported in individuals with RRMS treated with natalizumab, dimethyl fumarate and fingolimod. No case of PML has yet been reported for the DHODH inhibitor teriflunomide, which has been one of the key differentiates teriflunomide from other disease-modifying therapies in RRMS. The active moiety of IMU-838 has also shown direct antiviral effects in several models of virus-infected cells, which Immunic believes is caused by DHODH inhibition. Subject to further clinical trials, Immunic believes that this “class effect” of the DHODH inhibitors can be an important potential differentiator against other drug classes in RRMS.
Current Development Plan and Ongoing Studies
Immunic is developing IMU-838 for use in RRMS. The Phase 2 clinical trial design in RRMS depends on well-established MRI endpoints (i.e., the difference between 45 mg/day IMU-838 and placebo in the cumulative number of combined unique active MRI lesions up to week 24). Additionally, Immunic, in consultation with experts, analyzed and incorporated the Phase 2 study results for teriflunomide in connection with its study design and statistical assumptions. Immunic has not yet obtained formal regulatory advice for the Phase 2 study of IMU-838 in RRMS.
Phase 2b Study of IMU-838 in RRMS (EMPhASIS)
EMPhASIS is a Phase 2 dose-finding, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of IMU-838 in patients with RRMS and evidence of active disease. The trial consists of a blinded 24-week main treatment period, during which five MRI examinations will be performed. The primary endpoint of this study is the cumulative number of combined unique active MRI lesions up to week 24. Patients discontinuing or completing the blinded treatment phase have an option to enroll in a long-term open-label extended treatment.
The study is being performed in approximately 200 patients at about 40 study centers in four countries in Central and Eastern Europe. Patient enrollment commenced in February 2019 and is planned to continue for approximately 18 months. Patient recruitment is expected to be completed in the first half of 2020 and Immunic expects to report unblinded top-line data in the third quarter of 2020.
Other Studies
Immunic is also exploring the use of IMU-838 in orphan diseases that may allow an accelerated path to the commercialization of IMU-838. Immunic is investigating such orphan diseases in conjunction with investigators that are interested in performing feasibility studies in certain rare conditions.
PSC is a rare liver disease in which the bile ducts in the liver become inflamed, narrow and prevent bile from flowing properly. According to Toy et al. (2011), PSC has a prevalence of approximately 4.15 per 100,000 in the United States. The exact cause and disease mechanism of PSC are still unknown, but an autoimmune mechanism may play a role. According to Singh et al. (2013), there is an association with IBD, most often with UC and less commonly with CD. Progressive biliary and hepatic damage results in portal hypertension and hepatic failure in a significant majority of patients over a 10–15 year period from initial diagnosis.
Treatment of PSC is supportive, with a focus on monitoring the progression of the disease and treating symptoms and complications as they arise. The only substantial treatment is liver transplantation, which may be an option when the disease progresses to cirrhosis and liver function is significantly affected.
When some of the larger bile ducts become blocked in patients with PSC, one potential is to open them with endoscopy-based methods, balloon dilatation or stent placement. No medication is currently approved to treat PSC, but medications may be used to control symptoms. Although many trials have failed to meet their endpoints in PSC, there are now a few studies for medications (such as obeticholic acid) that have shown limited activity in PSC.
Immunic has entered into a collaboration with investigators at Arizona State University and Mayo Clinic to explore the use of IMU-838 in PSC. The principal investigator of the trial, Keith Lindor, M.D., Senior Advisor to the Provost and Professor of Medicine, College of Health Solutions, Arizona State University, had applied for a grant from the National Institutes of Health and received a funding letter in the third quarter of 2018. The study is sponsored by Elizabeth Carey, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, who has received IND approval from the FDA and has been granted Institutional Review Board, or IRB, approval to conduct the study. Immunic supports this study by providing IMU-838 and reference to its active IND.
Investigator-Sponsored Proof-of-Concept Clinical Trial of IMU-838 in PSC
This is a single arm, open-label, exploratory study of IMU-838 enrolling a total of 30 patients with PSC, aged 18 to 75 years, who will receive 30 mg IMU-838 once daily for a period of six months. The primary endpoint is the change in serum alkaline phosphatase at six months compared to baseline. The study is being conducted at Mayo Clinic locations in Arizona and Minnesota, both of which are tertiary care centers for PSC patients. The first patient was screened in July 2019.
Registration Plan
All of Immunic’s drug development candidates require approval from the FDA and corresponding agencies in other countries before they can be marketed for sale. The activities required before drugs or biologics may be marketed in the United States include:
· | preclinical laboratory tests, in vitro and in vivo preclinical studies and formulation and stability studies; |
· | the submission to the FDA of an application for human clinical testing, which is known as an IND; |
· | adequate and well-controlled human clinical trials to demonstrate the safety and effectiveness of the drug; |
· | the submission of an NDA for a drug; and |
· | the approval by the FDA of an NDA or a biologics license application. |
The FDA reviews all available data relating to safety, efficacy and quality and assesses the risk/benefit profile of a product candidate before granting approval. The data assessed by the FDA in reviewing an NDA includes animal or preclinical testing data, chemistry, drug-drug interaction data, manufacturing controls data and clinical safety and efficacy data.
For marketing outside the United States, Immunic would be subject to foreign regulatory requirements governing human clinical testing and marketing approval for its products. These requirements vary by jurisdiction, differ from those in the United States and may require Immunic to perform additional preclinical or clinical testing regardless of whether FDA approval has been obtained. The amount of time required to obtain necessary approvals from foreign regulatory agencies may be longer or shorter than that required for FDA approval. In many countries outside of the United States, coverage, pricing and reimbursement approvals are also required.
Immunic currently plans to start or continue three different Phase 2b trials for IMU-838 in UC, CD RRMS, and one investigator-sponsored proof-of-concept study in PSC. If any of these studies meet their primary endpoint and demonstrate general safety and efficacy of IMU-838, Immunic intends to conduct pivotal trials to be initiated either by Immunic itself or by Immunic in collaboration with a potential future partner. For most indications listed above, marketing approval would require completion of two successful, well-controlled Phase 3 studies. Completing such studies would require substantial financial and resource investments and may take several years to complete. In parallel, additional preclinical and clinical investigations need to be conducted in preparation for filing applications for regulatory approval, including additional pharmacological studies in special populations or drug-drug interaction studies. There are also additional steps required to develop and validate large-scale manufacturing capabilities as well as manufacturing controls.
The FDA may grant accelerated approval for drugs that address life-threatening diseases without effective therapies, based on findings from surrogate endpoints reasonably expected to predict clinical outcomes. Additionally, the FDA may grant orphan status for drugs that address high unmet medical needs in rare diseases. Accordingly, due to its relatively low prevalence, PSC may have the potential for an accelerated path toward commercial approval. Based on the rarity of PSC, the life-threatening nature of the disease and the lack of effective therapies, the FDA and other regulatory agencies may agree to an abbreviated development plan, including the possibility of only one single open-label pivotal trial. However, any such development path needs to be discussed with regulatory agencies once proof-of-concept data in PSC are available for IMU-838. This approval may require Immunic to study dosing of IMU-838 in a liver impaired patient population.
Manufacturing and Formulation
IMU-838 is provided as a white, uncoated tablet. Dose strengths for clinical trials are 5 mg, 15 mg and 22.5 mg, compared with placebo. The tablets are packaged in 30 mL polyethylene bottles containing 85 tablets each. IMU-838 has been synthesized in batches up to 18 kg, or approximately 40,000 tablets.
Commercialization Strategy
UC and CD are prevalent in the Western population, and according to recent literature reviews on the incidence of IBD (Kappelman 2007; Burisch 2013; Rocchi 2012), almost 4.1 million patients suffer from IBD in the United States, Europe and Canada. Worldwide, according to GBD 2015 Lancet. 388 (10053): 1545–1602 (2016), around 11.2 million patients are affected by IBD. In total, the global market for IBD is estimated to be $7.6 billion in 2023, according to Global IBD Market Forecast 2018.
Immunic believes that there is an unmet need in IBD for oral, safe, steroid-sparing non-biologics with potential to induce and maintain remission. Immunic believes that current treatment options for IBD are inadequate to satisfy this need as:
· | first-line treatments (steroids) are effective for short-term induction treatment but may cause long-term systemic side effects (if steroids cannot be discontinued without recurrence); and |
· | second- and third-line options do not provide sufficient response in light of their risk profile (for example, azathioprine and anti-TNFs), and are expensive and inconvenient (for example, anti-TNFs and anti-integrins). |
Tofacitinib, marketed as Xeljanz by Pfizer and Takeda, is a first-in-class inhibitor of kinases called JAK kinases. Tofacitinib is particularly active on the isoform JAK3. Based on two Phase 3 trials, tofacitinib was approved in 2018 in the United States and Europe for the treatment of UC. The European Medicines Agency, or EMA, refused to grant approval for Xeljanz for the treatment of RA based on its side effect profile.
Since IBD is still a substantially underserved market, several innovative late-stage projects are currently in Phase 2 and Phase 3 testing in patients with UC and/or CD.
· | Filgotinib: A JAK1 inhibitor developed by Gilead and Galapagos delivered promising Phase 2 data in a clinical trial of UC. However, filgotinib led to a substantial number of herpes zoster virus reactivations in patients, which may have a negative impact on the number of patients treated with this drug, if it is approved in the future. |
· | Ozanimod: a potentially best-in-class S1P1 receptor agonist was developed by Receptos and was acquired by Celgene in a $7.2 billion USD acquisition. Ozanimod completed Phase 3 testing in RRMS and is currently being tested for UC and CD. |
· | Upadacitinib: A JAK1 kinase inhibitor developed by AbbVie delivered promising Phase 2 clinical data in patients with UC. In February of 2019, AbbVie initiated a Phase 3 study and is currently actively recruiting patients. As was the case with filgotinib, upadacitinib has also demonstrated reactivation of viruses such as herpes zoster in clinical trials. |
Further relevant immuno-modulators are in late stage development for UC and CD. These include S1P targeting drugs and JAK/TYK2 inhibitors. Immunic is not aware of other DHODH inhibitors currently in development for IBD. Immunic believes that the only approved DHODH inhibitor, Aubagio, and its predecessor molecule Arava, are unlikely to be successful for IBD due to its side effect profile, which includes diarrhea.
A recent unpublished report by the National Multiple Sclerosis Society suggests that the prevalence of MS in the United States is about 1 million. Even though the prevalence of MS in the United States is potentially higher, Wallin et al. (2019) state that the number of diagnosed patients remains at about 700,000 patients. Of the approximately 700,000 patients diagnosed with MS, about 85% are diagnosed with RRMS. MS affects twice as many women and men in certain age cohorts and is more common in areas inhabited by people of northern European ancestry, such as Europe, the United States, Canada, New Zealand and parts of Australia. MS symptoms typically appear during young adulthood, peaking around 30 years old.
According to a recent market study, Global Multiple Sclerosis Drugs Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2017 to 2025 . the global MS market in expected to be worth $27.4 billion by 2025. The United States holds the largest portion of the global market share for MS treatments, which is expected to continue to grow rapidly due to the increasing incidence of MS, technological advances, and rising drug costs in the United States. Unmet medical need remains high and is a main driver for new pipeline entrances. Oral, small molecules are seeing the fastest growth in the MS market due to their increased patient convenience.
Intellectual Property, Licenses and Royalties
IMU-838 is covered by four layers of patents and applications all either granted or filed in the United States, EU and other territories.
Immunic’s first layer of protection over IMU-838 is a granted patent claiming the composition of matter of IMU-838’s active moiety vidofludimus, the free acid form of IMU-838. This patent is granted in most major markets and expires in 2022 in most of these jurisdictions. A second layer of applications was filed to cover IMU-838’s active ingredient, the calcium salt of vidofludimus. These applications are granted in some jurisdictions and cover IMU-838 until 2031, and U.S. Patent Term Extension and/or European Supplementary Protection Certificates could provide prolonged protection from generic entry up to 2036, depending on NDA submission time and IND filing in the United States and analogous filings in the European Union. A third layer consists of patent applications filed in early 2018 and directed to a method of production of the clinical material for IMU-838, including a newly-identified, specific polymorph of IMU-838. Finally, a patent application covering a dosing schemes currently used with IMU-838 was filed in 2017, based on unexpected findings from Phase 1 and preclinical investigations. If issued, this patent could extend patent protection for IMU-838 to 2038.
IMU-838 and IMU-935 were acquired in a transaction with the originator 4SC in April 2016. As part of the transaction, 4SC is entitled to receive a royalty on net sales if products originating from this contract achieve market approval.
IMU-935 – Targeting RORγt and Th17
Mechanism of Action and Key Mechanistic Data
IMU-935 is a highly potent and selective inverse agonist of ROR g t with an IC50 (the concentration of drug that inhibits 50% of the activity of the target) of around 24 nM with additional activity on DHODH (IC50 of 240 nM). The target ROR g (RORC) is a key regulator of T cell differentiation to Th17 cells and is the crucial transcription factor for the genes encoding IL-17A and IL-17F. IMU-935 also is a moderate inhibitor of DHODH, which offers the opportunity to increase the therapeutic window of IMU-935 compared with pure RORC inhibitors. In preclinical testing, Immunic observed that IMU-935 is a potent inhibitor of IL-17A / IL-17F as well as an inhibitor of Th17 differentiation. Furthermore, IMU-935 inhibits inflammatory cytokines such as IFN g and TNFα. In several cellular test systems and in psoriasis IL-17F and IBD animal models, IMU-935 has demonstrated dose dependent activity.
Immunic believes that ROR g t is an attractive target in the field of autoimmune diseases since it is the key transcription factor and nuclear receptor for regulation of Th17 cell differentiation and production of the IL-17 family of cytokines. The imbalance between regulatory T cells and Th17 cells is a hallmark of autoimmune diseases, and by preventing differentiation toward Th17 cells and impairing their function, IMU-935 targets this imbalance in a beneficial manner. Therefore, Immunic believes that IMU-935 has the potential to target a high unmet need for safe and cost-effective oral treatments in psoriasis and other autoimmune disorders.
The preclinical effect of targeting ROR g t has been demonstrated in several preclinical trials of competing ROR g t modulators. Some molecules progressed to clinical stage, however, to date, only a limited number of products have reached Phase 2 clinical studies.
One of the potential risks of drugs targeting ROR g t arose from prior research suggesting that ROR g t could act as a biological link between IL-17 production and both thymocyte development and Th17 cell differentiation. More recent research published in Nature Immunology in 2017 suggests that these functions are mediated by different parts of the ROR g t protein. In light of these findings, IMU-935 was analyzed to study its effect on thymocyte maturation and Th17 differentiation. In this research, Immunic observed that IMU-935 inhibited Th17 differentiation without affecting thymocyte maturation. As a result, Immunic does not anticipate that treatment with IMU-935 will be associated with an increased risk of T cell malignancies.
Indication: Psoriasis
Diagnosis and Prevalence
Psoriasis is a chronic inflammatory disease of the skin with unknown etiology that leads to hyperproliferation of keratinocytes and endothelial cells. Most mechanistic data support the hypothesis that psoriasis is an autoimmune disease driven by activated T-lymphocytes which then release cytokines, chemokines and pro-inflammatory molecules into the dermis and epidermis.
Psoriasis is characterized clinically by development of red, scaly, itchy, symmetrical, dry plaques typically located on skin overlying the elbows, knees, lumbar area and scalp. Plaques vary from a few millimeters in diameter to several centimeters and can be localized to a specific area or extend over most of the body surface.
According to Di Meglio, P.; Villanova, F.; Nestle, F.O. Psoriasis. Cold Spring Harb. Perspect. Med. (2014), psoriasis is one of the most common chronic inflammatory skin diseases. The disease prevalence varies between geographic regions. Studies of psoriasis suggest an overall prevalence of 2% to 3% of the world’s population, with a higher prevalence in U.S. and Canadian populations (4.6% and 4.7%, respectively). Psoriasis is considered equally prevalent between genders and can occur at any age. However, there seems to be a bimodal distribution of the age of disease onset, with a first peak between 15 and 30 years, and a second peak between 50 and 60 years of age.
Current Treatment Options
Current treatments for patients with psoriasis include topical therapies, oral therapies and biologics. Topical therapies, such as corticosteroids and vitamin D3 analogues, reduce inflammation, which slows the proliferation of keratinocytes and reduces itching. Oral therapies such as methotrexate, cyclosporine, apremilast and tofacitinib target anti-inflammatory processes. Biologics block proteins produced by keratinocytes, dendritic cells, Th17 lymphocytes or other immune cells. Examples of biologics include anti-TNFα biologics such as infliximab, etanercept and adalimumab. More recently approved monoclonal antibodies, such as secukinumab, ixekizumab and brodalumab, have been developed to target the pro-inflammatory cytokine interleukin 17, or IL-17. IL-17 antibodies have largely revolutionized the treatment of patients with moderate to severe psoriasis as they have achieved highly successful skin clearance rates.
Immunic intends to develop IMU-935 as an oral and more convenient treatment option for patients with moderate to severe psoriasis with a mechanism of action and efficacy that approximates those of IL-17 antibodies.
Competitors
Currently, several ROR g t inverse agonists are in preclinical development for the treatment of psoriasis, but only a few are in clinical development. To Immunic’s knowledge, these are:
· | ABBV-157 in Phase 1 (AbbVie) |
· | BOS172767 / ARN-6039 in Phase 1 (Boston Pharmaceuticals, licensed from Arrien Pharmaceuticals) |
· | Molecule in Phase 1 (Bristol Myers Squibb) |
· | JTE-451 in Phase 2 (Japan Tobacco) |
Immunic believes that IMU-935 is a unique modulator of ROR g t as compared to previous and current competitors. IMU-935 is an inverse agonist (and not an antagonist) and is unable to completely block ROR g t activity, thereby allowing a basal remaining ROR g t activity to support normal T cell maturation. Immunic believes this mechanism of action may avoid unwanted side effects. In addition, because IMU-935 blocks two separate pathways relevant to the function of Th17 cells (ROR g t and DHODH), it was shown in preclinical studies to have single nanomolar activity of inhibition of cytokine release in human peripheral blood mononuclear cells. Given these properties, Immunic believes that IMU-935 may provide a reasonable therapeutic window between an effective dose and an intolerable dose.
Clinical Development Plan and Planned Studies
Immunic’s current development plan for IMU-935 focuses on two initial goals: (i) to rapidly obtain human safety data for IMU-935 in order to evaluate the safety profile of this development candidate, and (ii) to obtain preliminary clinical activity data using safe doses.
Immunic intends to perform early clinical trials in IMU-935, including single-dose and multiple-dose trials, through its Australian subsidiary. Immunic expects that this development approach will allow it to accelerate the initiation of first-in-man studies due to certain unique regulatory requirements and processes in Australia. Immunic has selected a clinical research organization, or CRO, in Australia and is currently preparing documents for submission to local ethics committees. Based on current timelines, Immunic expects to start first-in-man trials, as detailed below, in September 2019.
Phase 1 Single Ascending Dose Study
This would be a double-blind, placebo-controlled study with four or five ascending dose levels of IMU-935. A single dose of study drug would be investigated. Safety and pharmacokinetic properties would be assessed in healthy volunteers. One dose level would evaluate intra-individual differences between fast and fed conditions.
Phase 1 Multiple Ascending Dose Study
This would be a double-blind, placebo-controlled study with two ascending dose levels of IMU-935. The study drug would be given daily for 14 consecutive days. Safety, pharmacodynamic and pharmacokinetic properties would be assessed in healthy volunteers.
Phase 1b/2a Study in Psoriasis Patients
This would be a double-blind, placebo-controlled study with partial parallel group design. The study drug would be given daily over 28 consecutive days in patients with psoriasis, and safety and drug trough levels would be assessed. Immunic expects that this study would provide an early indication of potential activity of IMU-935 in psoriasis patients.
Other Studies (Orphan Indications)
Immunic believes that the mechanism of action of IMU-935 may also support its evaluation for the treatment of potential orphan indications. Immunic is currently investigating various options for developing IMU-935 in certain orphan indications. However, no decision has been made to date regarding the most appropriate orphan indication. Discussions with medical experts to identify targets are ongoing. An orphan indication would potentially offer an accelerated path to commercialization of IMU-935.
Manufacturing and Formulation
IMU-935 is a small molecular weight compound and was successfully synthesized in a kilogram scale. Single ascending dose and multiple ascending dose studies are expected to be supplied via a capsule formulation.
Commercialization Strategy
According to the World Health Organization, psoriasis affects 2-3% of the world’s population and according to the National Psoriasis Foundation over 8 million people in the United States have psoriasis.
Intellectual Property, Licenses and Royalties
Immunic filed a patent application covering composition of matter for IMU-935 and related molecules in September 2017 with the European Patent Office, and this application entered the international phase in September 2018. Assuming this patent issues with sufficient claim coverage, IMU-935 is expected to be under patent protection until 2037, with further extension possible.
All of Immunic’s rights to IMU-838 and IMU-935 were acquired in a transaction with 4SC in April 2016. As part of the transaction, Immunic is required to pay 4SC a royalty on net sales of relevant products.
IMU-856 – Targeting Intestinal Barrier Function
Mechanism of Action and Key Mechanistic Data
IMU-856 is a novel, highly innovative, orally available small molecule modulator targeting a protein that serves as a transcriptional regulator of the intestinal barrier function. Immunic has not yet disclosed the target for IMU-856. Based on preclinical data, this compound appears to represent a new and potentially disruptive treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function in patients suffering from diseases like IBD, irritable bowel syndrome with diarrhea, or IBS-D, immune checkpoint inhibitor, or ICI, induced colitis and other barrier function associated diseases. Immunic believes that because IMU-856 avoids suppression of the immune functions, it should therefore maintain immune surveillance for patients.
Importance of Targeting Bowel Permeability in Multiple Diseases
Bowel permeability is suspected to be involved in the initiation of many chronic inflammatory or autoimmune conditions, as the impaired intestinal barrier function may be one of the preconditions for antigens of the microbiome to be recognized by the body’s immune system. This is not true only for diseases of the bowel; the interaction of the immune system with components of the microbiome is suspected for many diseases throughout the body. To date, there are no good treatment strategies to ameliorate impaired bowel permeability.
IBD is a chronic, inflammatory disorder characterized by transmural inflammation of a part of the GI tract (UC) or the entire GI tract (CD). IBD is defined by relapsing and remitting episodes with progression over time to complications, including intestinal ulcers and bleeding. The current hypothesis regarding the onset of IBD involves an impaired bowel wall barrier function as the central element of the pathophysiology. In healthy bowel walls, bacteria cannot pass from the lumen to the lamina propria because tightness is maintained between the epithelial cells in what resembles an intact barrier function of the bowel wall. However, in response to environmental or genetic factors, bowel wall barrier function may be weakened, allowing bacteria to pass through and enter the bowel wall, where immune cells recognize the bacteria. This would trigger an initial inflammation event. It is hypothesized that in IBD patients, the initial inflammatory response is abnormally sustained from lack of efficient apoptosis of immune cells, but this mechanism is not yet fully understood. Ultimately, patients develop a chronic and systemic immune response. The presence of certain “bad bacteria”, which may contain certain epitopes in the microbiota, or the overall makeup of the microbiome, which lack “good bacteria”, are also known to contribute to the sustained and overshooting inflammation in IBD. Additionally, it has been shown that IBD patients in endoscopic remission still display IBD symptoms if bowel tightness is not normalized. Episodes of impaired bowel wall barrier function is also correlated with relapse weeks later.
Irritable bowel syndrome, or IBS, is a common GI disorder in which the underlying pathophysiology is poorly understood. However, increased intestinal permeability in IBS-D patients has been reported. Studies have shown that IBS-D patients have increased intestinal membrane permeability. This increased intestinal permeability may be due to a number of factors, including low-grade inflammation, which has been reported in mucosal biopsies of some diarrhea-predominant and post-infectious patients, but not constipation-predominant, or IBS-C, patients. It has been established that patients with inflammatory conditions such as celiac sprue and acute alcoholic gastroenteritis also have increased gut permeability. Acute symptoms usually coincide with the acute inflammation that leads to chronic abdominal pain, diarrhea and bloating.
ICIs have been one of the major advances of cancer care in recent years. ICIs are monoclonal antibodies that inactivate repressors of the anti-cancer immune response. However, immune-related adverse events affecting various organs, including the GI tract, and causing diarrhea and colitis, might occur due to the fact that the immune system becomes less suppressed. The median time to onset of diarrhea is within the first weeks or months of treatment. The exact mechanism of these immune-mediated side effects is currently unknown; however, one hypothesis is that impaired bowel barrier function due to ICI treatment may play a role in this condition.
Targeting the Disease-Causing and Sustaining Processes
Current treatments of many conditions of the bowel are aimed at inhibiting inflammation, but they do not target the impaired bowel wall barrier function. IMU-856 is designed to target pathways impacting the bowel wall barrier function and is aimed to normalize such function. Immunic believes that normalized bowel wall barrier function may avoid bacterial triggers, which may lead to the achievement and maintenance of remission without significantly influencing the immune competency of the patient.
Clinical Development Plan and Planned Studies
Immunic expects to perform early clinical trials of IMU-856, including single-dose and multiple-dose Phase 1 trials, through its Australian subsidiary. Immunic expects this development approach will allow it to accelerate the initiation of first-in-man studies due to certain unique regulatory requirements and processes in Australia. The development activities for IMU-856 are intended to largely follow established processes and service provider relationships established for the IMU-935 development program. This may lead to operational and financial synergies in study preparation and execution.
IMU-856 is currently in preclinical testing. Based on current project timelines, Immunic expects to initiate first-in-man in the first half of 2020. However, this depends on the progress of manufacturing required amounts of the active drug. Immunic plans to conduct the studies of IMU-856 summarized below.
Phase 1 Single Ascending Dose Study
This would be a double-blind, placebo-controlled study with four or five ascending dose levels of IMU-856. A single dose of study drug would be investigated. Safety and pharmacokinetic properties would be assessed in healthy volunteers. One dose level would evaluate intra-individual differences between fast and fed conditions.
Phase 1 Multiple Ascending Dose Study
This would be a double-blind, placebo-controlled study with two ascending dose levels of IMU-856. The study drug would be given daily for 14 consecutive days. Safety, pharmacodynamic and pharmacokinetic properties would be assessed in healthy volunteers.
Phase 2a Study in Patients with Conditions Involving Impaired Bowel Barrier Function
This would be a double-blind, placebo-controlled study with partial parallel group design. The study drug would be given daily over 28 consecutive days in patients with several conditions with impaired bowel barrier function that were screened for increased bowel permeability using oral dyes. The change in bowel permeability would be evaluated as change from baseline and comparing one or two active dose groups to placebo. Additionally, safety and drug trough levels would be assessed.
Immunic expects that this study would provide an early indication of improvement with IMU-856 by measuring barrier function surrogate markers in CD patients.
Manufacturing and Formulation
IMU-856 is a small molecular weight compound and is currently synthesized in kilogram scale.
Commercialization Strategy
Immunic believes that IMU-856 has the potential to be part of a new category of GI treatments focusing on normalizing bowel wall barrier function. The likely focus of product differentiation will be on safe long-term treatment to avoid disease relapse. Additionally, IMU-856 is designed to target the intestinal barrier function rather than directly targeting immune regulation, which may lead to a different safety profile from current immunomodulatory therapies.
Intellectual Property, Licenses and Royalties
On November 5, 2018, Daiichi Sankyo Co and Immunic AG entered into an option and licensing agreement that grants Immunic AG an exclusive global option to exclusively license IMU-856 and related molecules. This option includes exclusivity on a patent application filed by Daiichi Sankyo in early 2018, covering the composition of matter of IMU-856.
In addition to an option execution fee and smaller development milestone payments, Daiichi Sankyo will receive sales-based milestone payments and a royalty rate on net sales. See “Material Agreements—Daiichi Sankyo License Agreement” above for more information.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. Before deciding to invest in our company or deciding to maintain or increase your investment, you should consider carefully the risks and uncertainties described below. The risks and uncertainties described below and in our other filings with the Securities and Exchange Commission, or SEC, are not the only risks we face. If one or more of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. In that event, the market price for our common stock could decline, and you may lose your entire investment.
Risks Related to Immunic’s Business and Financial Condition
Immunic has a limited operating history with its current business plan, has incurred significant losses since 2016, anticipates that it will continue to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability. The absence of any commercial sales and Immunic’s limited operating history make it difficult to assess its future viability.
Immunic is a development-stage pharmaceutical company with a limited operating history with its current business plan. Immunic’s net losses were $41.5 million and $52.1 million for the years ended December 31, 2018 and 2017, respectively. As of March 31, 2019, Immunic had an accumulated deficit of $346.9 million. To date, Immunic has not generated any revenue from its current product candidates. Moreover, Immunic AG, the company’s operating subsidiary, has only a limited operating history upon which stockholders can evaluate its business and prospects, and is not profitable and has incurred losses in each year since its inception in 2016. In addition, Immunic has limited experience and has not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biotechnology industry.
Immunic has devoted substantially all of its financial resources to identify, acquire and develop its product candidates, including providing general and administrative support for its operations. Immunic expects losses to increase as it conducts clinical trials and continues to develop its lead product candidates. Immunic expects to invest significant funds into the research and development of its current product candidates to determine the potential to advance these product candidates to regulatory approval. To date, Immunic has financed its operations primarily through the sale of equity securities. The amount of its future net losses will depend, in part, on the rate of its future expenditures and its ability to obtain funding through equity or debt financings, strategic collaborations or grants.
Immunic does not expect to generate significant revenue unless and until it is able to obtain marketing approval for, and successfully commercialize, any current or future product candidate, however pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. In addition, if Immunic obtains regulatory approval to market a product candidate, its future revenue will depend upon the size of any markets in which its product candidates may receive regulatory approval, and its ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and adequate market share for its product candidates. Even if Immunic obtains adequate market share for its product candidates, to the extent they receive regulatory approval, because the potential markets in which its product candidates may ultimately receive approval could be very small, Immunic may never become profitable.
Immunic expects to continue to incur significant expenses and increasing operating losses for the foreseeable future, and its expenses will increase substantially if and as Immunic:
• | continues the clinical development of its product candidates; | |
• | continues efforts to discover, develop and/or acquire new product candidates; | |
• | undertakes the manufacturing of its product candidates for clinical development and, potentially, commercialization, or increases volumes manufactured by third parties; | |
• | advances its programs into larger, more expensive clinical trials; | |
• | initiates additional preclinical, clinical, or other trials or studies for its product candidates; | |
• | seeks regulatory and marketing approvals and reimbursement for its product candidates; | |
• | experiences any delays or encounters issues with the development and potential for regulatory approval of its product candidates such as safety issues, clinical trial accrual delays, longer follow-up for planned studies, additional major studies or supportive studies necessary to support marketing approval. | |
• | establishes a sales, marketing and distribution infrastructure to commercialize any products for which Immunic may obtain marketing approval and market for itself; | |
• | makes milestone, royalty or other payments under any third-party license agreements; | |
• | seeks to maintain, protect and expand its intellectual property portfolio; | |
• | seeks to retain current skilled personnel and attract additional personnel; and | |
• | adds operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts. |
Further, the net losses Immunic incurs may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of its results of operations may not be a good indication of its future performance. Failure to become and remain profitable would decrease the value of the company and could impair its ability to raise capital, expand its business, maintain its development efforts, expand its pipeline of product candidates or continue its operations.
Immunic currently has no source of product sales revenue and may never be profitable.
Immunic has not generated any revenues from commercial sales of any of its current product candidates. Immunic’s ability to generate product revenue depends upon its ability to successfully commercialize these product candidates or other product candidates that it may develop, in-license or acquire in the future. Immunic does not anticipate generating revenue from the sale of products for the foreseeable future. Immunic’s ability to generate revenue from its current or future product candidates also depends on a number of additional factors, including its ability to:
• | successfully complete research and clinical development of current and future product candidates; | |
• | establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of product candidates; | |
• | obtain regulatory approval from relevant regulatory authorities in jurisdictions where Immunic intends to market its product candidates; | |
• | launch and commercialize product candidates for which Immunic obtains marketing approval, if any, and if launched independently, successfully establish a sales force and marketing and distribution infrastructure; | |
• | obtain coverage and adequate product reimbursement from third-party payors, including government payors; | |
• | achieve market acceptance for its approved products, if any; | |
• | establish, maintain and protect its intellectual property rights; and | |
• | attract, hire and retain qualified personnel. |
In addition, because of the numerous risks and uncertainties associated with clinical product development, including that Immunic’s product candidates may not advance through development or achieve regulatory approval, Immunic is unable to predict the timing or amount of any potential future product sale revenues. Immunic’s expenses also could increase beyond expectations if Immunic decides to or is required by the U.S. Food and Drug Administration, or FDA, or comparable foreign regulatory authorities, to perform studies or trials in addition to those that Immunic currently anticipates. Even if Immunic completes the development and regulatory processes described above, Immunic anticipates incurring significant costs associated with launching and commercializing any product candidates that may be approved.
Immunic will require substantial additional funding, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Immunic to delay, limit, reduce or terminate its product development, other operations or future commercialization efforts.
Since the inception of Immunic AG, substantially all of its resources have been dedicated to the clinical development of its product candidates. Developing pharmaceutical products, including conducting preclinical and non-clinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. We have consumed substantial amounts of cash since our inception. For example, in the years ended December 31, 2018 and December 31, 2017, we used net cash of $9.7 million and $9.7 million, respectively, in our operating activities, substantially all of which related to development of our current product candidates. Immunic believes that it will continue to expend substantial resources for the foreseeable future on the completion of clinical development and regulatory preparedness of its product candidates, preparations for a commercial launch of its product candidates, if approved, and development of any other current or future product candidates it may choose to further develop. These expenditures will include costs associated with research and development, conducting preclinical studies and clinical trials, obtaining marketing approvals, and manufacturing and supply as well as marketing and selling any products approved for sale. In addition, other unanticipated costs may arise. Because the outcome of any drug development process is highly uncertain, Immunic cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of its current product candidates, if approved, or future product candidates, if any.
Immunic’s operating plan may change as a result of factors currently unknown to Immunic, and it may need to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. Such financing may result in dilution to Immunic’s stockholders, imposition of debt covenants and repayment obligations, or other restrictions that may adversely affect its business. In addition, Immunic may seek additional capital due to favorable market conditions or strategic considerations even if Immunic believes it has sufficient funds for its current or future operating plans.
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2020. Our estimate as to how long we expect our existing cash and cash equivalents to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Immunic’s future capital requirements depend on many factors, including:
• | the scope, progress, results and costs of researching and developing Immunic’s current product candidates, future product candidates and related preclinical and clinical trials; | |
• | the cost of commercialization activities if Immunic’s current product candidates and future product candidates are approved for sale, including marketing, sales and distribution costs and preparedness of its corporate infrastructure; | |
• | the cost of manufacturing current product candidates and future product candidates that Immunic may obtain approval for and successfully commercialize; | |
• | Immunic’s ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; | |
• | the number and characteristics of any additional product candidates Immunic may develop or acquire; | |
• | any product liability or other lawsuits related to Immunic’s products or otherwise commenced against Immunic; | |
• | the expenses needed to attract and retain skilled personnel; | |
• | the costs associated with being a public company; | |
• | the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing Immunic’s intellectual property rights, including litigation costs and the outcome of such litigation, if any; and | |
• | the timing, receipt and amount of sales of, or royalties on, any future approved products, if any. |
Additional funds may not be available when Immunic needs them, on terms that are acceptable to Immunic, or at all. If adequate funds are not available to Immunic on a timely basis, Immunic may be required to:
• | delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for Immunic’s current product candidates or future product candidates, if any; | |
• | delay, limit, reduce or terminate its research and development activities; or | |
• | delay, limit, reduce or terminate its establishment of sales and marketing capabilities or other activities that may be necessary to commercialize its future product candidates. |
Raising additional capital may cause dilution to Immunic’s existing stockholders, restrict its operations or require Immunic to relinquish rights to its technologies or product candidates.
Immunic may seek additional capital through a combination of public and private equity offerings, debt financings, strategic collaborations and alliances and licensing arrangements. To the extent that Immunic raises additional capital through the sale of equity or convertible debt securities, the ownership interest of Immunic’s stockholders will be diluted, and the terms of such equity or convertible debt securities may include liquidation or other preferences that adversely affect the rights of Immunic’s stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on Immunic’s ability to incur additional debt, limitations on its ability to acquire or license intellectual property rights, limitations on redeeming stock or declaring dividends, and other operating restrictions that could adversely impact Immunic’s ability to conduct its business. If Immunic raises additional funds through strategic collaborations and alliances and licensing arrangements with third parties, Immunic may have to relinquish valuable rights to its technologies or product candidates, or grant licenses on terms unfavorable to Immunic.
Risks Related to the Clinical Development and Marketing Approval of Immunic’s Product Candidates
The marketing approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if Immunic is ultimately unable to obtain marketing approval for its product candidates, its business will be substantially harmed.
None of Immunic’s current product candidates have gained marketing approval for sale in the United States or any other country, and Immunic cannot guarantee that it will ever have marketable products. Immunic’s business is substantially dependent on its ability to complete the development of, obtain marketing approval for, and successfully commercialize its product candidates in a timely manner. Immunic cannot commercialize its product candidates in the United States without first obtaining approval from the FDA to market each product candidate. Similarly, Immunic cannot commercialize its product candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Immunic’s product candidates could fail to receive marketing approval for many reasons, including the following:
• | the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Immunic’s clinical trials; | |
• | the FDA or comparable foreign regulatory authorities may find the human subject protections for Immunic’s clinical trials inadequate and place a clinical hold on an investigational new drug application, or IND, at the time of its submission, precluding commencement of any trials, or a clinical hold on one or more clinical trials at any time during the conduct of Immunic’s clinical trials; | |
• | Immunic may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; | |
• | the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; | |
• | Immunic may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; | |
• | the FDA or comparable foreign regulatory authorities may disagree with Immunic’s interpretation of data from preclinical studies or clinical trials; | |
• | the data collected from clinical trials of Immunic’s product candidates may not be sufficient to support the submission of an application to obtain marketing approval in the United States or elsewhere; | |
• | the FDA or comparable foreign regulatory authorities may find inadequate the manufacturing processes or facilities of third-party manufacturers with which Immunic contracts for clinical and commercial supplies of Immunic’s product candidates; and | |
• | the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner that would delay marketing approval. |
Before obtaining marketing approval for the commercial sale of any drug product for a target indication, Immunic must demonstrate in preclinical studies and well-controlled clinical trials and, with respect to approval in the United States, to the satisfaction of the FDA, that the product is safe and effective for its intended use and that the manufacturing facilities, processes and controls are adequate to preserve the drug’s identity, strength, quality and purity. In the United States, it is necessary to submit and obtain approval of a new drug application, or NDA, from the FDA. An NDA must include extensive preclinical and clinical data and supporting information to establish the product safety and efficacy for each desired indication. The NDA must also include significant information regarding the chemistry, manufacturing and controls for the product. After the submission of an NDA, but before approval of the NDA, the manufacturing facilities used to manufacture a product candidate must be inspected by the FDA to ensure compliance with the applicable current good manufacturing practice, or cGMP, requirements. The FDA, the Competent Authorities of the Member States of the European Economic Area, and comparable foreign regulatory authorities may also inspect Immunic’s clinical trial sites and audit clinical study data to ensure that its studies are properly conducted in accordance with the IND regulations, human subject protection regulations, and current good clinical practice, or cGCP.
Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and approval may not be obtained. Upon submission of an NDA, the FDA must make an initial determination that the application is sufficiently complete to accept the submission for filing. Immunic cannot be certain that any submissions will be accepted for filing and reviewed by the FDA, or ultimately be approved. If an application is not accepted for review, the FDA may require that Immunic conduct additional clinical studies or preclinical testing, or take other actions before it will reconsider Immunic’s application. If the FDA requires additional studies or data, Immunic would incur increased costs and delays in the marketing approval process, which may require Immunic to expend more resources than Immunic has available. In addition, the FDA may not consider any additional information to be complete or sufficient to support the filing or approval of the NDA.
Regulatory authorities outside of the United States, such as in Europe and Japan and in emerging markets, also have requirements for approval of drugs for commercial sale with which Immunic must comply prior to marketing in those areas. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of Immunic’s product candidates into the relevant markets. Clinical trials conducted in one country may not be accepted or the results may not be found adequate by regulatory authorities in other countries, and obtaining regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. However, the failure to obtain regulatory approval in one jurisdiction could have a negative impact on Immunic’s ability to obtain approval in a different jurisdiction. Approval processes vary among countries and can involve additional product candidate testing and validation and additional administrative review periods. Seeking foreign regulatory approval could require additional non-clinical studies or clinical trials, which could be costly and time-consuming. Foreign regulatory approval may include all of the risks associated with obtaining FDA approval. For all of these reasons, Immunic may not obtain foreign regulatory approvals on a timely basis, if at all.
The process to develop, obtain marketing approval for, and commercialize product candidates is long, complex and costly both inside and outside of the United States, and approval is never guaranteed. The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary between jurisdictions. Even if Immunic’s product candidates were to successfully obtain approval from regulatory authorities, any such approval might significantly limit the approved indications for use, including more limited patient populations, require that precautions, warnings or contraindications be included on the product labeling, including “black box” warnings, require expensive and time-consuming post-approval clinical studies, risk evaluation and mitigation strategies, or REMS, or surveillance as conditions of approval, or, through the product label, the approval may limit the claims that it may make, which may impede the successful commercialization of Immunic’s product candidates. Following any approval for commercial sale of Immunic’s product candidates, certain changes to the product, such as changes in manufacturing processes and additional labeling claims, as well as new safety information, may require new studies and will be subject to additional FDA notification, or review and approval. Also, marketing approval for any of Immunic’s product candidates may be withdrawn. If Immunic is unable to obtain and maintain marketing approval for its product candidates in one or more jurisdictions, or any approval contains significant limitations, Immunic’s ability to market its product candidates to its full target market will be reduced and its ability to realize the full market potential of its product candidates will be impaired. Furthermore, Immunic may not be able to obtain sufficient funding or generate sufficient revenue and cash flows to continue or complete the development of any of its current or future product candidates.
Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether marketing approval will be obtained for Immunic’s product candidates. Even if Immunic believes the data collected from clinical trials of its current product candidates are promising, such data may not be sufficient to support approval by the FDA or comparable foreign authorities. Immunic’s future clinical trial results also may not be successful.
It is impossible to predict the extent to which the clinical trial process may be affected by existing or prospective legislative and regulatory developments. Due to these and other factors, Immunic’s current or future product candidates could take a significantly longer time to gain marketing approval than expected or may never gain marketing approval. This could delay or eliminate any potential product revenue by delaying or terminating the potential commercialization of Immunic’s current product candidates.
Preclinical trials must also be conducted in accordance with FDA and comparable foreign authorities’ legal requirements, regulations or guidelines, including Good Laboratory Practice, or GLP, an international standard meant to harmonize the conduct and quality of non-clinical studies and the archiving and reporting of findings. Preclinical studies including long-term toxicity studies and carcinogenicity studies in experimental animals may result in findings that may require further evaluation, which could affect the risk-benefit evaluation of clinical development, or which may even lead the regulatory agencies to delay, prohibit the initiation of or halt clinical trials or delay or deny marketing authorization applications. Failure to adhere to the applicable GLP standards or misconduct during the course of preclinical trials may invalidate the data and require one or more studies to be repeated or additional testing to be conducted.
Clinical trials must also be conducted in accordance with legal requirements, regulations or guidelines of the FDA and comparable foreign authorities, including human subject protection requirements and GCP. Clinical trials are subject to further oversight by these governmental agencies and IRBs at the medical institutions where the clinical trials are conducted. In addition, clinical trials must be conducted with supplies of Immunic’s current product candidates produced under cGMP and other requirements. Immunic’s clinical trials are conducted at multiple sites, including some sites in countries outside the United States and the European Union, which may subject Immunic to further delays and expenses as a result of increased shipment costs, additional regulatory requirements and the engagement of foreign and non-European Union clinical research organizations, as well as expose Immunic to risks associated with clinical investigators who are unknown to the FDA or European regulatory authorities, and with different standards of diagnosis, screening and medical care.
To date, Immunic has not completed all clinical trials required for the approval of its current product candidates. The commencement and completion of clinical trials for Immunic’s current product candidates may be delayed, suspended or terminated as a result of many factors, including but not limited to:
• | the delay or refusal of regulators or IRBs to authorize Immunic to commence a clinical trial at a prospective trial site; | |
• | changes in regulatory requirements, policies and guidelines; | |
• | the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of Immunic’s clinical trials; | |
• | failure to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; | |
• | delays in patient enrollment and variability in the number and types of patients available for clinical trials; | |
• | the inability to enroll a sufficient number of patients in trials to ensure adequate statistical power to detect statistically significant treatment effects; | |
• | lower than anticipated retention rates of patients and volunteers in clinical trials; | |
• | clinical sites deviating from trial protocols or dropping out of a trial; | |
• | adding new clinical trial sites; | |
• | negative or inconclusive results, which may require Immunic to conduct additional preclinical or clinical trials or to abandon projects that Immunic expects to be promising; | |
• | safety or tolerability concerns, which could cause Immunic to suspend or terminate a trial if it finds that the participants are being exposed to unacceptable health risks; | |
• | regulators or IRBs requiring that Immunic or its investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; | |
• | Immunic’s third-party research and manufacturing contractors failing to comply with regulatory requirements or meet their contractual obligations to Immunic in a timely manner, or at all; | |
• | difficulty in maintaining contact with patients after treatment, resulting in incomplete data; | |
• | delays in establishing the appropriate dosage levels; | |
• | the quality or stability of Immunic’s current product candidates falling below acceptable standards; | |
• | the inability to produce or obtain sufficient quantities of Immunic’s current product candidates to complete clinical trials; and | |
• | exceeding budgeted costs due to difficulty in predicting accurately the costs associated with clinical trials. |
Patient enrollment is a significant factor in the timing of clinical trials and is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, the design of the clinical trial, and competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications Immunic is investigating.
There are significant requirements imposed on Immunic and on clinical investigators who conduct clinical trials that Immunic sponsors. Although Immunic is responsible for selecting qualified clinical investigators, providing them with the information they need to conduct the clinical trial properly, ensuring proper monitoring of the clinical trial, and ensuring that the clinical trial is conducted in accordance with the general investigational plan and protocols contained in the IND, Immunic cannot ensure that clinical investigators will maintain compliance with all regulatory requirements at all times. The pharmaceutical industry has experienced cases where clinical investigators have been found to incorrectly record data, omit data, or even falsify data. Immunic cannot ensure that the clinical investigators in its trials will not make mistakes or otherwise compromise the integrity or validity of data, any of which would have a significant negative effect on Immunic’s ability to obtain marketing approval, Immunic’s business, and Immunic’s financial condition.
Immunic could encounter delays if a clinical trial is suspended or terminated by Immunic, by the IRBs or Ethics Committees of the institutions in which such trial is being conducted, by the independent Steering Committee, by the data safety monitoring board, or DSMB, for such trial, or by the FDA or comparable foreign regulatory authorities. Immunic or such authorities may impose a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Immunic’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using the drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If Immunic experiences delays in the completion of, or experiences termination of, any clinical trial of its current product candidates, the commercial prospects of its current product candidates will be harmed, and Immunic’s ability to generate product revenues from its product candidates will be delayed. In addition, any delays in completing Immunic’s clinical trials will increase its costs, slow its development and approval process and jeopardize its ability to commence product sales and generate revenues.
Moreover, clinical investigators for Immunic’s clinical trials may serve as scientific advisors or consultants to Immunic from time to time and receive compensation in connection with such services. Immunic is required to report certain financial relationships with clinical investigators to the FDA and, where applicable, take steps to minimize the potential for bias resulting from such financial relationships. The FDA will evaluate the reported information and may conclude that a financial relationship between Immunic and a clinical investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site, and the utility of the clinical trial itself may be jeopardized. This could result in a refusal to accept or a delay in approval of Immunic’s marketing applications by the FDA and may ultimately lead to the denial of marketing approval of one or more of its product candidates.
Any development candidate may also show in preclinical testing or clinical trials new and unexpected findings regarding safety and tolerability. Such findings may harm the ability to conduct further development of product candidates, may delay such development, may require additional expensive tests, may harm the ability of Immunic to partner these development candidates, or may delay or prevent marketing approval by regulatory agencies. It may also harm the ability to compete in the market with other products or to achieve certain pricing thresholds.
Any of these occurrences could materially adversely affect Immunic’s business, financial condition, results of operations, and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval of Immunic’s current product candidates. Significant clinical trial delays could also allow Immunic’s competitors to bring products to market before Immunic is able to do so, shorten any periods during which Immunic may have the exclusive right to commercialize its current product candidates, if approved, and impair its ability to commercialize its current product candidates, if approved, which may harm Immunic’s business, financial condition, results of operations, and prospects.
Use of patient-reported outcomes in Immunic’s clinical trials may delay the development of its product candidates or increase development costs.
Due to the difficulty of objectively measuring the efficacy of IMU-838, patient-reported outcomes, or PROs, may have an important role in the development and regulatory approval of Immunic’s IMU-838. PROs involve patients’ subjective assessments of efficacy, and this subjectivity increases the uncertainty in determining clinical endpoints. Such assessments can be influenced by factors outside of Immunic’s control, and can vary widely from day-to-day for a particular patient, and from patient-to-patient and site-to-site within a clinical trial. Furthermore, Immunic intends to use PROs in its Phase 3 trials of IMU-838 in inflammatory bowel disease, which may make the outcome of those trials more uncertain and may increase Immunic’s costs and time to finish regulatory approval trials.
Clinical failure can occur at any stage of clinical development. Because the results of earlier clinical trials are not necessarily predictive of future results, any product candidate Immunic advances through clinical trials may not have favorable results in later clinical trials or receive marketing approval.
Clinical failure can occur at any stage of Immunic’s clinical development. The results of preclinical studies and early clinical trials of Immunic’s product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Clinical trials may produce negative or inconclusive results, and Immunic may decide, or regulators may require Immunic, to conduct additional clinical or preclinical testing. Data obtained from tests are susceptible to varying interpretations, and regulators may not interpret Immunic’s data as favorably as Immunic does, which may delay, limit or prevent marketing approval of Immunic’s product candidates. In addition, the design of a clinical trial can determine whether its results will support approval of a product, or approval of a product for desired indications, and flaws or shortcomings in the design of a clinical trial may not become apparent until the clinical trial is well advanced. Immunic has limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval for Immunic’s desired indications. Further, clinical trials of product candidates often reveal that it is not practical or feasible to continue development efforts. If one of Immunic’s product candidates is found to be unsafe or lack efficacy, Immunic will not be able to obtain marketing approval for it and Immunic’s business would be harmed. For example, if the results of Immunic’s clinical trials of its product candidates do not achieve pre-specified endpoints, if Immunic is unable to provide primary or secondary endpoint measurements deemed acceptable by the FDA or comparable foreign regulators or if Immunic is unable to demonstrate an acceptable level of safety relative to the efficacy associated with its proposed indications, the prospects for approval of Immunic’s product candidates would be materially and adversely affected. A number of companies in the pharmaceutical industry, including those with greater resources and experience than Immunic, have suffered significant setbacks in Phase 2 and Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.
In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including differences in trial protocols and design, the size and type of the patient population, adherence to the dosing regimen and the rate of dropout among clinical trial participants. Immunic does not know whether any clinical trials it may conduct will demonstrate consistent and/or adequate efficacy and safety to obtain marketing approval for Immunic’s product candidates.
Marketing approval may be substantially delayed or may not be obtained for one or all of Immunic’s product candidates if regulatory authorities require additional or more time-consuming studies to assess the safety and efficacy of its product candidates.
Immunic may be unable to initiate or complete development of its product candidates on schedule, if at all. The timing for the completion of the studies for Immunic’s product candidates will require additional funding. In addition, if regulatory authorities require additional or more time-consuming studies to assess the safety or efficacy of Immunic’s product candidates, Immunic may not have or be able to obtain adequate funding to complete the necessary steps for approval for any or all of its product candidates. Additional delays may result if the FDA, an FDA Advisory Committee (if one is convened to review Immunic’s NDA) or other regulatory authority indicates that the product candidate should not be approved or there should be restrictions on approval, such as the requirement for a REMS, to ensure safe use of the drug. Delays in marketing approval or rejections of applications for marketing approval in the United States or other markets may result from many factors, including:
• | the FDA’s or comparable foreign regulatory authorities’ disagreement with the design or implementation of Immunic’s clinical trials; | |
• | regulatory requests for additional analyses, reports, data, non-clinical and preclinical studies and clinical trials; | |
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regulatory questions or disagreement by the FDA or comparable regulatory authorities regarding interpretations of data and results and the emergence of new information regarding Immunic’s current or future product candidates or the field of research;
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• | unfavorable or inconclusive results of clinical trials and supportive non-clinical studies, including unfavorable results regarding safety or efficacy of Immunic’s product candidates during clinical trials; | |
• | failure to meet the level of statistical significance required for approval; | |
• | inability to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; | |
• | lack of adequate funding to commence or continue Immunic’s clinical trials due to unforeseen costs or other business decisions; | |
• | regulatory authorities may find inadequate the manufacturing processes or facilities of the third-party manufacturers with which Immunic contracts for clinical and commercial supplies; | |
• | Immunic may have insufficient funds to pay the significant user fees required by the FDA upon the filing of an NDA; and | |
• | the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner that would delay marketing approval. |
The lengthy and unpredictable approval process, as well as the unpredictability of future clinical trial results, may result in Immunic’s failure to obtain marketing approval to market its product candidates, which would significantly harm Immunic’s business, results of operations and prospects.
Immunic’s product candidates may cause undesirable adverse effects or have other properties that could delay or prevent their marketing approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if obtained.
Undesirable side effects caused by Immunic’s product candidates could cause Immunic or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of marketing approval by the FDA or other comparable foreign authorities. If any of Immunic’s current product candidates or any future product candidate Immunic develops is associated with serious adverse, undesirable or unacceptable side effects, Immunic may need to abandon such candidate’s development or limit development to certain uses or sub-populations in which such side effects are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise in early-stage or clinical testing have later been found to cause side effects that prevented further development of the compound. Results of Immunic’s trials could reveal a high and unacceptable prevalence of these or other side effects. In such an event, Immunic’s trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order Immunic to cease further development of or deny approval of its product candidates for any or all targeted indications. Drug-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.
If Immunic’s product candidates receive marketing approval, and Immunic or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:
• | regulatory authorities may withdraw approvals of such products; | |
• | Immunic may be required to recall a product or change the way such product is administered to patients; | |
• | additional restrictions may be imposed on the marketing of the particular product or the manufacturing process for the product or any component thereof; | |
• | regulatory authorities may require the addition of labeling statements, such as a precaution, “black box” warning or other warnings or a contraindication; | |
• | Immunic or its collaborators may be required to implement a REMS or create a medication guide outlining the risks of such side effect for distribution to patients; | |
• | Immunic or its collaborators could be sued and held liable for harm caused to patients; | |
• | the product may become less competitive; and | |
• | Immunic’s reputation may suffer. |
Any of these events could prevent Immunic from achieving or maintaining market acceptance of its product candidates, if approved, and could materially adversely affect Immunic’s business, financial condition, results of operations and prospects.
Immunic is heavily dependent on the success of its product candidates, which are in the early stages of clinical development. Immunic cannot give any assurance that it will generate data for any of its product candidates sufficient to receive regulatory approval in its planned indications, which will be required before they can be commercialized.
Immunic has invested substantially all of its efforts and financial resources to identify, acquire and develop its portfolio of product candidates. Its future success is dependent on its ability to successfully further develop, obtain regulatory approval for, and commercialize one or more product candidates. Immunic currently generates no revenue from sales of any products, and Immunic may never be able to develop or commercialize a product candidate.
None of Immunic’s product candidates have advanced into a pivotal clinical trial for Immunic’s proposed indications. Immunic is not permitted to market or promote any of its product candidates before it receives regulatory approval from the FDA or comparable foreign regulatory authorities, and Immunic may never receive such regulatory approval for any of its product candidates. Immunic cannot be certain that any of its product candidates will be successful in clinical trials or receive regulatory approval. Further, its product candidates may not receive regulatory approval even if they are successful in clinical trials. If Immunic does not receive regulatory approvals for its product candidates, Immunic may not be able to continue its operations.
Immunic may use its financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
Because Immunic has limited financial and human resources, it may forego or delay pursuit of opportunities with some programs or product candidates or for indications that later prove to have greater commercial potential. Immunic’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or more profitable market opportunities. Immunic’s spending on current and future research and development programs and future product candidates for specific indications may not yield any commercially viable products. Immunic may also enter into additional strategic collaboration agreements to develop and commercialize some of its programs and potential product candidates in indications with potentially large commercial markets. If Immunic does not accurately evaluate the commercial potential or target market for a particular product candidate, it may relinquish valuable rights to that product candidate through strategic collaborations, licensing or other royalty arrangements in cases in which it would have been more advantageous for Immunic to retain sole development and commercialization rights to such product candidate, or Immunic may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a partnering arrangement.
Immunic may find it difficult to enroll patients in its clinical trials given the limited number of patients who have the diseases for which its product candidates are being studied. Difficulty in enrolling patients could delay or prevent clinical trials of its product candidates.
Identifying and qualifying patients to participate in clinical trials of Immunic’s product candidates is essential to its success. The timing of Immunic’s clinical trials depends in part on the rate at which Immunic can recruit patients to participate in clinical trials of its product candidates, and Immunic may experience delays in its clinical trials if Immunic encounters difficulties in enrollment.
The eligibility criteria of Immunic’s planned clinical trials may further limit the available eligible trial participants as Immunic expects to require that patients have specific characteristics that Immunic can measure or meet the criteria to assure their conditions are appropriate for inclusion in its clinical trials. Immunic may not be able to identify, recruit, and enroll a sufficient number of patients to complete its clinical trials in a timely manner because of the perceived risks and benefits of the product candidate under study, the availability and efficacy of competing therapies and clinical trials, and the willingness of physicians to participate in its planned clinical trials. If patients are unwilling to participate in Immunic’s clinical trials for any reason, the timeline for conducting trials and obtaining regulatory approval of its product candidates may be delayed.
If Immunic experiences delays in the completion of, or experiences termination of, any clinical trials of its product candidates, the commercial prospects of its product candidates could be harmed, and its ability to generate product revenue from any of these product candidates could be delayed or prevented. In addition, any delays in completing its clinical trials would likely increase its overall costs, impair product candidate development and jeopardize its ability to obtain regulatory approval relative to its current plans. Any of these occurrences may harm its business, financial condition, and prospects significantly.
Even if Immunic receives marketing approval for its product candidates, such approved products will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, Immunic’s product candidates, if approved, could be subject to labeling and other restrictions, and Immunic may be subject to penalties and legal sanctions if it fails to comply with regulatory requirements or experience unanticipated problems with its approved products.
If the FDA approves any of Immunic’s product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP regulations and GCP for any clinical trials that Immunic conducts post-approval. Any marketing approvals that Immunic receives for its product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor safety and efficacy.
Later discovery of previously unknown problems with an approved product, including adverse events of unanticipated severity or frequency, or with manufacturing operations or processes, or failure to comply with regulatory requirements, or evidence of acts that raise questions about the integrity of data supporting the product approval, may result in, among other things:
• | restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls; | |
• | fines, warning letters, untitled letters, or holds on clinical trials; | |
• | refusal by the FDA to approve pending applications or supplements to approved applications filed by Immunic, or suspension or revocation of product approvals; | |
• | product seizure or detention, or refusal to permit the import or export of products; and | |
• | injunctions or the imposition of civil or criminal penalties. |
The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval, manufacturing or commercialization of Immunic’s product candidates. Immunic cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Immunic is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or not able to maintain regulatory compliance, it may lose any marketing approval that may have been obtained and it may not achieve or sustain profitability, which would adversely affect Immunic’s business.
If Immunic fails to obtain regulatory approval in jurisdictions outside the United States, it will not be able to market its products in those jurisdictions.
Immunic intends to market its product candidates, if approved, in international markets, or in conjunction with collaborators. Such marketing will require separate regulatory approvals in each market and compliance with numerous and varying regulatory requirements. The approval procedures vary from country to country and may require testing in addition to what is required for a marketing application in the United States. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. In addition, in many countries outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that country. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. The failure to obtain approval in one jurisdiction may negatively impact Immunic’s ability to obtain approval in another jurisdiction. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval and additional or different risks. Immunic may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize its products in any market.
Agencies like the FDA and national competition regulators in European countries regulate the promotion and uses of drugs not consistent with approved product labeling requirements. If Immunic is found to have improperly promoted its current product candidates for uses beyond those that are approved, Immunic may become subject to significant liability.
Regulatory authorities like the FDA and national competition laws in Europe strictly regulate the promotional claims that may be made about prescription products, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or comparable foreign regulatory authorities as reflected in the product’s approved labeling, known as “off-label” use, nor may it be promoted prior to obtaining marketing approval. If Immunic receives marketing approval for its product candidates for Immunic’s proposed indications, physicians may nevertheless use Immunic’s products for their patients in a manner that is inconsistent with the approved label if the physicians personally believe in their professional medical judgment it could be used in such manner. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.
In addition, the FDA requires that promotional claims not be “false or misleading” as such terms are defined in the FDA’s regulations. For example, the FDA requires substantial evidence, which generally consists of two adequate and well-controlled head-to-head clinical trials, for a company to make a claim that its product is superior to another product in terms of safety or effectiveness. Generally, unless Immunic performs clinical trials meeting that standard comparing its product candidates to competitive products and these claims are approved in Immunic’s product labeling, Immunic will not be able promote its current product candidates as superior to other products. If Immunic is found to have made such claims it may become subject to significant liability. In the United States, the federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in improper promotion. The FDA has also requested that companies enter into consent decrees or corporate integrity agreements. The FDA could also seek permanent injunctions under which specified promotional conduct is monitored, changed or curtailed.
Immunic’s current and future relationships with healthcare professionals, investigators, consultants, collaborators, actual customers, potential customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose Immunic to sanctions.
Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any drug candidates for which Immunic obtains marketing approval. Immunic’s current and future arrangements with healthcare professionals, investigators, consultants, collaborators, actual customers, potential customers and third-party payors may expose Immunic to broadly applicable fraud and abuse and other healthcare laws, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, that may constrain the business or financial arrangements and relationships through which Immunic sells, markets and distributes any drug candidates for which it obtains marketing approval. In addition, Immunic may be subject to physician payment transparency laws and patient privacy and security regulation by the federal government and by the U.S. states and foreign jurisdictions in which Immunic conducts its business. The applicable federal, state and foreign healthcare laws that may affect Immunic’s ability to operate include the following:
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal and state healthcare programs such as Medicare and Medicaid; | |
• | federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; | |
• | the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent; | |
• | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; | |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; | |
• | the federal Open Payments program, created under Section 6002 of the Patient Protection and Affordable Care Act, or the Affordable Care Act, and its implementing regulations, which imposed new annual reporting requirements for manufacturers of drugs, devices, biologicals and medical supplies for certain payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit timely, accurately and completely the required information for all covered payments, transfers of value and ownership or investment interests may result in civil monetary penalties; and | |
• | analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
Further, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provided that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
Efforts to ensure that Immunic’s future business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities will conclude that Immunic’s business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws. If Immunic’s operations are found to be in violation of any of these laws or any other governmental regulations that may apply to it, Immunic may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of Immunic’s operations, which could significantly harm its business. If any of the physicians or other healthcare providers or entities with whom Immunic expects to do business, including its current and future collaborators, if any, are found not to be in compliance with applicable laws, those persons or entities may be subject to criminal, civil or administrative sanctions, including exclusion from participation in government healthcare programs, which could also affect Immunic’s business.
The impact of recent and future healthcare reform legislation and other changes in the healthcare industry and healthcare spending on Immunic is currently unknown, and may adversely affect its business model.
In the United States and some foreign jurisdictions, legislative and regulatory changes and proposed changes regarding the healthcare system could prevent or delay marketing approval of Immunic’s drug candidates, restrict or regulate post-approval activities and affect its ability to profitably sell any drug candidates for which Immunic obtains marketing approval.
Immunic’s revenue prospects could be affected by changes in healthcare spending and policy in the United States and abroad. Immunic operates in a highly regulated industry and new laws, regulations, judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, the method of delivery or payment for healthcare products and services could negatively impact Immunic’s business, financial condition, results of operations and prospects. There is significant interest in promoting health care reform, as evidenced by the enactment in the United States of the Affordable Care Act. Among other things, the Affordable Care Act contains provisions that may reduce the profitability of drug products, including, for example, revising the methodology by which rebates owed by manufacturers for covered outpatient drugs under the Medicaid Drug Rebate Program are calculated, extending the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans, imposing mandatory discounts for certain Medicare Part D beneficiaries, and subjecting drug manufacturers to payment of an annual fee.
In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. On August 2, 2011, the Budget Control Act of 2011 among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of 2% per fiscal year, which started in April 2013, and, due to subsequent legislative amendments, will remain in effect through 2024 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, also reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers.
Immunic expects that additional healthcare reform measures and drug pricing regulations that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that it receives for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Immunic from being able to generate revenue or commercialize Immunic’s drugs.
It is likely that federal and state legislatures within the United States and foreign governments will continue to consider changes to existing healthcare legislation. Immunic cannot predict the reform initiatives that may be adopted in the future or whether initiatives that have been adopted will be repealed or modified. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect:
• | the demand for any drug products for which Immunic may obtain marketing approval; | |
• | Immunic’s ability to set a price that Immunic believes is fair for its products; | |
• | Immunic’s ability to obtain coverage and reimbursement approval for a product; | |
• | Immunic’s ability to generate revenues and achieve or maintain profitability; and | |
• | the level of taxes that Immunic is required to pay. |
If Immunic fails to comply with environmental, health and safety laws and regulations, Immunic could become subject to fines or penalties or incur costs that could have a material adverse effect on its business, financial condition or results of operations.
Immunic’s research and development activities and its third-party manufacturers’ and suppliers’ activities involve the controlled storage, use, and disposal of hazardous materials, including the components of its product candidates and other hazardous compounds. Immunic and its manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling, and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at Immunic’s and its manufacturers’ facilities pending their use and disposal. Immunic cannot eliminate the risk of contamination, which could cause an interruption of its commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products. Although Immunic believes that the safety procedures utilized by it and its third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, Immunic cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, Immunic may be held liable for any resulting damages and such liability could exceed its resources and state or federal or other applicable authorities may curtail Immunic’s use of specified materials and/or interrupt its business operations. Furthermore, environmental laws and regulations are complex, change frequently, and have tended to become more stringent. Immunic cannot predict the impact of such changes and cannot be certain of its future compliance. Immunic does not currently carry biological or hazardous waste insurance coverage.
Other Risks Related to Immunic’s Business
Due to Immunic’s limited resources and access to capital, it must decide to prioritize development of its current product candidates for certain indications and at certain doses. These decisions may prove to have been wrong and may materially adversely affect Immunic’s business, financial condition, results of operations and prospects.
Because Immunic has limited resources and access to capital to fund its operations, it must decide which dosages and indications to pursue for the clinical development of its current product candidates and the amount of resources to allocate to each. Immunic’s decisions concerning the allocation of research, collaboration, management and financial resources toward dosages or therapeutic areas may not lead to the development of viable commercial products and may divert resources away from better opportunities. If Immunic makes incorrect determinations regarding the market potential of its current product candidates or misreads trends in the pharmaceutical industry, Immunic’s business, financial condition, results of operations and prospects could be materially adversely affected.
Immunic may not be able to win government, academic institution or non-profit contracts or grants.
From time to time, Immunic may apply for contracts or grants from government agencies, non-profit entities and academic institutions. Such contracts or grants can be highly attractive because they provide capital to fund the ongoing development of Immunic’s product candidates without diluting its stockholders. However, there is often significant competition for these contracts or grants. Entities offering contracts or grants may have requirements to apply for or to otherwise be eligible for certain contracts or grants that Immunic’s competitors may be able to satisfy that Immunic cannot. In addition, such entities may make arbitrary decisions as to whether to offer contracts or make grants, to whom the contracts or grants may or will be awarded and the size of the contracts or grants to each awardee. Even if Immunic is able to satisfy the award requirements, there is no guarantee that Immunic will be a successful awardee. Therefore, Immunic may not be able to win any contracts or grants in a timely manner, if at all.
If Immunic fails to attract and retain key management and scientific personnel, it may be unable to successfully develop or commercialize its product candidates.
Immunic’s success as a biotechnology company depends on its continued ability to attract, retain and motivate highly qualified management and scientific and clinical personnel. The loss of the services of any of Immunic’s senior management could delay or prevent obtaining marketing approval or commercialization of its product candidates.
Immunic may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for a limited number of qualified personnel among biotechnology businesses, and other pharmaceutical, biotechnology and other businesses. Immunic’s failure to attract, hire, integrate and retain qualified personnel could impair its ability to achieve its business objectives.
If a successful product liability claim or series of claims is brought against Immunic for uninsured liabilities or in excess of insured liabilities, Immunic could be forced to pay substantial damage awards.
The use of any of Immunic’s product candidates in clinical trials, and the sale of any approved products, may expose Immunic to product liability claims. Immunic currently maintains product liability insurance. Immunic intends to monitor the amount of coverage it maintains as the size and design of its clinical trials evolve and adjust the amount of coverage it maintains accordingly. However, there is no assurance that such insurance coverage will fully protect Immunic against some or all of the claims to which it might become subject. Immunic might not be able to maintain adequate insurance coverage at a reasonable cost or in sufficient amounts or scope to protect it against potential losses. In the event a claim is brought against Immunic, it might be required to pay legal and other expenses to defend the claim, as well as uncovered damages awards resulting from a claim brought successfully against Immunic.
Furthermore, whether or not Immunic is ultimately successful in defending any such claims, Immunic might be required to direct financial and managerial resources to such defense and adverse publicity could result, all of which could harm Immunic’s business.
Immunic’s employees, independent contractors, investigators, contract research organizations, consultants, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
Immunic is exposed to the risk that its employees and other third parties may engage in fraudulent conduct or other illegal activity. Misconduct by employees and other third parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to Immunic that violate FDA regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA, manufacturing standards, federal and state healthcare fraud and abuse laws and regulations, or laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to Immunic’s reputation. It is not always possible to identify and deter employee and other third-party misconduct, and the precautions Immunic takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Immunic from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against Immunic, and Immunic is not successful in defending itself or asserting its rights, those actions could have a significant impact on Immunic’s business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of Immunic’s operations, any of which could adversely affect Immunic’s ability to operate.
Immunic will need to expand its organization and Immunic may experience difficulties in managing this growth, which could disrupt its operations.
As of June 30, 2019, Immunic had eighteen (18) employees. As Immunic’s development and commercialization plans and strategies develop, Immunic expects to need additional managerial, operational, sales, marketing, financial, legal and other resources. Its management may need to divert a disproportionate amount of its attention away from its day-to-day activities and devote a substantial amount of time to managing these growth activities. As Immunic advances its product candidates through clinical trials, it will need to expand its development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for Immunic. As Immunic’s operations expand, Immunic expects that it will need to manage additional relationships with such third parties, as well as additional collaborators and suppliers.
Immunic may not be able to effectively manage the expansion of its operations, which may result in weaknesses in its infrastructure, operational mistakes, loss of business opportunities, loss of employees, and reduced productivity among remaining employees. Immunic’s expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If its management is unable to effectively manage its growth, its expenses may increase more than expected, its ability to generate and/or grow revenue could be reduced and Immunic may not be able to implement its business strategy. Immunic’s future financial performance and its ability to commercialize product candidates and compete effectively will depend, in part, on its ability to effectively manage any future growth.
Immunic’s internal computer systems, or those of its development collaborators, third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of Immunic’s product development programs.
Despite the implementation of security measures, Immunic’s internal computer systems and those of its current and any future CROs and other contractors, consultants and collaborators are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While Immunic has not experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in its operations, it could result in a material disruption of Immunic’s development programs and its business operations. For example, the loss of clinical trial data from ongoing, completed or future clinical trials could result in delays in Immunic’s marketing approval efforts and significantly increase its costs to recover or reproduce the data. Likewise, Immunic intends to rely on third parties to manufacture its product candidates and conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on Immunic’s business. To the extent that any disruption or security breach were to result in a loss of, or damage to, Immunic’s data or applications, or inappropriate disclosure of confidential or proprietary information, Immunic could incur liability and the further development and commercialization of its product candidates could be delayed.
Risks Related to Commercialization of Immunic’s Product Candidates
Even if Immunic obtains the required regulatory approvals in the United States and other territories, the commercial success of its product candidates will depend on market awareness and acceptance of its product candidates.
Even if Immunic obtains marketing approval for its current product candidates or any other product candidates that it may develop or acquire in the future, the products may not gain market acceptance among physicians, key opinion leaders, healthcare payors, patients and the medical community. Market acceptance of any approved products depends on a number of factors, including:
• | the timing of market introduction; | |
• | the efficacy and safety of the product, as demonstrated in clinical trials; | |
• | the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any precautions, warnings or contraindications that may be required on the label; | |
• | acceptance by physicians, key opinion leaders and patients of the product as a safe and effective treatment; | |
• | the cost, safety and efficacy of treatment in relation to alternative treatments; | |
• | the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities; | |
• | the number and clinical profile of competing products; | |
• | the growth of drug markets in Immunic’s various indications; | |
• | relative convenience and ease of administration; | |
• | marketing and distribution support; | |
• | the prevalence and severity of adverse side effects; and | |
• | the effectiveness of Immunic’s sales and marketing efforts. |
Market acceptance is critical to Immunic’s ability to generate revenue. Any product candidate, if approved and commercialized, may be accepted in only limited capacities or not at all. If any approved products are not accepted by the market to the extent that Immunic expects, Immunic may not be able to generate revenue and its business would suffer.
Immunic currently has limited marketing and sales experience. If Immunic is unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell its product candidates, Immunic may be unable to generate any revenue.
Immunic has never commercialized a product candidate, and Immunic currently has no marketing and sales organization. To the extent Immunic’s product candidates are approved for marketing, if Immunic is unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell its product candidates, Immunic may not be able to effectively market and sell its product candidates or generate product revenue.
In addition, Immunic currently does not have marketing, sales or distribution capabilities for its product candidates. In order to commercialize any of Immunic’s products that receive marketing approval, it would have to build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and Immunic may not be successful in doing so. In the event of successful development of Immunic’s product candidates, if Immunic elects to build a targeted specialty sales force, such an effort would be expensive and time consuming. Any failure or delay in the development of Immunic’s internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. Immunic may choose to collaborate with third parties that have their own sales forces and established distribution systems, in lieu of or to augment any sales force and distribution systems Immunic may create. If Immunic is unable to enter into collaborations with third parties for the commercialization of approved products, if any, on acceptable terms or at all, or if any such collaborator does not devote sufficient resources to the commercialization of Immunic’s product or otherwise fails in commercialization efforts, Immunic may not be able to successfully commercialize its product candidates if it receives marketing approval. If Immunic is not successful in commercializing its product candidates, either on its own or through collaborations with one or more third parties, its future revenue will be materially and adversely impacted.
If Immunic fails to enter into strategic relationships or collaborations, its business, financial condition, commercialization prospects and results of operations may be materially adversely affected.
Immunic’s product development programs and the potential commercialization of its current product candidates will require substantial additional cash to fund expenses. Therefore, in addition to financing the development of Immunic’s product candidates through additional equity financings or through debt financings, Immunic may decide to enter into collaborations with pharmaceutical or biopharmaceutical companies for the development and potential commercialization of its product candidates.
Immunic faces significant competition in seeking appropriate collaborators. Collaborations are complex and time-consuming to negotiate and document. Immunic may also be restricted under existing and future collaboration agreements from entering into agreements on certain terms with other potential collaborators. Immunic may not be able to negotiate collaborations on acceptable terms, or at all. If that were to occur, Immunic may have to curtail the development of a particular product, reduce or delay its development program or one or more of its other development programs, delay its potential commercialization or reduce the scope of its sales or marketing activities, or increase its expenditures and undertake development or commercialization activities at its own expense. If Immunic elects to increase its expenditures to fund development or commercialization activities on its own, Immunic may need to obtain additional capital, which may not be available to Immunic on acceptable terms or at all. If Immunic does not have sufficient funds, Immunic will not be able to bring its product candidates to market and generate product revenue. If Immunic does enter into a new collaboration agreement, it could be subject to the following risks, each of which may materially harm Immunic’s business, commercialization prospects and financial condition:
• | Immunic may not be able to control the amount or timing of resources that the collaborator devotes to the product development program; | |
• | the collaborator may experience financial difficulties and thus not commit sufficient financial resources to the product development program; | |
• | Immunic may be required to relinquish important rights such as marketing, distribution and intellectual property rights; | |
• | a collaborator could move forward with a competing product developed either independently or in collaboration with third parties, including Immunic’s competitors; or | |
• | business combinations or significant changes in a collaborator’s business strategy may adversely affect Immunic’s willingness to complete its obligations under any arrangement. |
Coverage and reimbursement may be limited or unavailable in certain market segments for Immunic’s product candidates, which could make it difficult for Immunic to sell its products profitably.
The pricing, coverage, and reimbursement of Immunic’s approved products, if any, must be sufficient to support its commercial efforts and other development programs, and the availability and adequacy of coverage and reimbursement by third-party payors, including governmental and private insurers, are essential for most patients to be able to afford expensive treatments. Sales of Immunic’s product candidates that may receive approval, if any, will depend substantially, both domestically and abroad, on the extent to which the costs of its approved products, if any, will be paid for or reimbursed by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or government payors and private payors. If coverage and reimbursement are not available, or are available only in limited amounts, Immunic may have to subsidize or provide products for free or Immunic may not be able to successfully commercialize its products.
In addition, there is significant uncertainty related to the insurance coverage and reimbursement for newly approved products. In the United States, the principal decisions about coverage and reimbursement for new drugs are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent a new drug will be covered and reimbursed under Medicare. Private payors tend to follow the coverage reimbursement policies established by CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement for novel product candidates such as Immunic’s and what reimbursement codes its product candidates may receive if approved.
Outside the United States, international operations are generally subject to extensive governmental price controls and other price-restrictive regulations, and Immunic believes the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of products. In many countries, the prices of products are subject to varying price control mechanisms as part of national health systems. Price controls or other changes in pricing regulation could restrict the amount that Immunic is able to charge for its products, if any. Accordingly, in markets outside the United States, the potential revenue may be insufficient to generate commercially reasonable revenue and profits.
Moreover, increasing efforts by governmental and private payors in the United States and abroad to limit or reduce healthcare costs may result in restrictions on coverage and the level of reimbursement for new products and, as a result, they may not cover or provide adequate payment for its products. Immunic expects to experience pricing pressures in connection with products due to the increasing trend toward managed healthcare, including the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, and prescription drugs in particular, has and is expected to continue to increase in the future. As a result, profitability of Immunic’s products, if any, may be more difficult to achieve even if they receive regulatory approval.
Immunic faces substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully, than Immunic does.
The development and commercialization of new drug products is highly competitive. Immunic faces competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, universities and other research institutions worldwide with respect to its product candidates that it may seek to develop or commercialize in the future.
Many of Immunic’s competitors have materially greater name recognition and financial, manufacturing, marketing, research and drug development resources than it does. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in its competitors. Large pharmaceutical companies in particular have extensive expertise in preclinical and clinical testing and in obtaining regulatory approvals for drugs. In addition, academic institutions, government agencies, and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products or technologies. These organizations may also establish exclusive collaborative or licensing relationships with Immunic’s competitors.
If Immunic’s competitors obtain marketing approval from the FDA or comparable foreign regulatory authorities for their product candidates more rapidly than Immunic does, it could result in Immunic’s competitors establishing a strong market position before Immunic is able to enter the market. Third-party payors, including governmental and private insurers, also may encourage the use of generic products. Failure of Immunic’s product candidates to effectively compete against established treatment options or in the future with new products currently in development would harm Immunic’s business, financial condition, results of operations and prospects.
Price controls may be imposed in foreign markets, which may adversely affect Immunic’s future profitability.
In some countries, particularly member states of the European Union, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European Union member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, Immunic may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of its product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of Immunic’s products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, Immunic’s business could be adversely affected.
Risks Related to Third Parties
Immunic relies on third-party suppliers and other third parties for production of its product candidates, and Immunic’s dependence on these third parties may impair the advancement of its research and development programs and the development of its product candidates.
Immunic does not currently own or operate manufacturing facilities for clinical or commercial production of its product candidates. Immunic lacks the resources and the capability to manufacture any of its product candidates on a clinical or commercial scale. Instead, Immunic relies on, and expects to continue to rely on, third parties for the supply of raw materials and manufacture of drug supplies necessary to conduct its preclinical studies and clinical trials. Immunic’s reliance on third parties may expose Immunic to more risk than if Immunic was to manufacture its current product candidates or other products itself. Delays in production by third parties could delay Immunic’s clinical trials or have an adverse impact on any commercial activities. In addition, the fact that Immunic is dependent on third parties for the manufacture of and formulation of its product candidates means that Immunic is subject to the risk that the products may have manufacturing defects that Immunic has limited ability to prevent or control. Although Immunic oversees these activities to ensure compliance with its quality standards, budgets and timelines, Immunic has had and will continue to have less control over the manufacturing of its product candidates than potentially would be the case if it was to manufacture its product candidates. Further, the third parties Immunic deals with could have staffing difficulties, might undergo changes in priorities or may become financially distressed, which would adversely affect the manufacturing and production of Immunic’s product candidates. In addition, a third party could be acquired by, or enter into an exclusive arrangement with, one of Immunic’s competitors, which would adversely affect Immunic’s ability to access the formulations it requires for the manufacturing of its product candidates.
The facilities used by Immunic’s current contract manufacturers and any future manufacturers to manufacture Immunic’s product candidates must be inspected by the FDA after Immunic submits its NDA. Immunic does not control the manufacturing process of, and is completely dependent on, its contract manufacturers for compliance with the regulatory requirements, known as cGMPs, for manufacture of both active drug substances and finished drug products. If Immunic’s contract manufacturers cannot successfully manufacture material that conforms to Immunic’s specifications and the strict regulatory requirements of the FDA or others, the FDA may refuse to approve Immunic’s NDA. If the FDA or a comparable foreign regulatory authority does not approve Immunic’s NDA because of concerns about the manufacture of its product candidates or if significant manufacturing issues arise in the future, Immunic may need to find alternative manufacturing facilities, which would significantly impact its ability to develop its product candidates, obtain marketing approval of its NDA or to continue to market its product candidates, if approved. Although Immunic is ultimately responsible for ensuring compliance with these regulatory requirements, Immunic does not have day-to-day control over a contract manufacturing organization, or CMO, or other third-party manufacturer’s compliance with applicable laws and regulations, including cGMPs and other laws and regulations, such as those related to environmental health and safety matters. Any failure to achieve and maintain compliance with these laws, regulations and standards could subject Immunic to the risk that Immunic may have to suspend the manufacturing of its product candidates or that obtained approvals could be revoked, which would adversely affect Immunic’s business and reputation. In addition, third-party contractors, such as Immunic’s CMOs, may elect not to continue to work with Immunic due to factors beyond Immunic’s control. They may also refuse to work with Immunic because of their own financial difficulties, business priorities or other reasons, at a time that is costly or otherwise inconvenient for Immunic. If Immunic was unable to find adequate replacement or another acceptable solution in time, Immunic’s clinical trials could be delayed or its commercial activities could be harmed.
Problems with the quality of the work of third parties may lead Immunic to seek to terminate its working relationships and use alternative service providers. However, making this change may be costly and may delay clinical trials. In addition, it may be very challenging, and in some cases impossible, to find replacement service providers that can develop and manufacture Immunic’s drug candidates in an acceptable manner and at an acceptable cost and on a timely basis. The sale of products containing any defects or any delays in the supply of necessary services could adversely affect Immunic’s business, financial condition, results of operations, and prospects.
Growth in the costs and expenses of components or raw materials may also adversely affect Immunic’s business, financial condition, results of operations, and prospects. Supply sources could be interrupted from time to time and, if interrupted, supplies may not be resumed (whether in part or in whole) within a reasonable timeframe and at an acceptable cost or at all.
Immunic plans to rely on third parties to conduct clinical trials for its product candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, it may cause delays in commencing and completing clinical trials of Immunic’s product candidates or Immunic may be unable to obtain marketing approval for or commercialize its product candidates.
Clinical trials must meet applicable FDA and foreign regulatory requirements. Immunic does not have the ability to independently conduct clinical trials for any of its product candidates. Immunic expects to rely on third parties, such as CROs, medical institutions, clinical investigators and contract laboratories, to conduct all of its clinical trials of its product candidates; however, Immunic remains responsible for ensuring that each of its clinical trials is conducted in accordance with its investigational plan and protocol. Moreover, the FDA and other foreign regulatory authorities require Immunic to comply with IND and human subject protection regulations and cGCPs for conducting, monitoring, recording, and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. Immunic’s reliance on third parties does not relieve Immunic of these responsibilities and requirements. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If Immunic or any of its third-party contractors fail to comply with applicable GCPs, the clinical data generated in Immunic’s clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Immunic to perform additional clinical trials before approving its marketing applications. There is no assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of Immunic’s clinical trials comply with GCPs. Immunic’s failure to comply with these regulations may require Immunic to repeat clinical trials, which would delay the marketing approval process.
There are significant requirements imposed on Immunic and on clinical investigators who conduct clinical trials that Immunic sponsors. Although Immunic is responsible for selecting qualified CROs or clinical investigators, providing them with the information they need to conduct the clinical trials properly, ensuring proper monitoring of the clinical trials, and ensuring that the clinical trials are conducted in accordance with the general investigational plan and protocols contained in the IND, Immunic cannot ensure that the CROs or clinical investigators will maintain compliance with all regulatory requirements at all times. The pharmaceutical industry has experienced cases where clinical investigators have been found to incorrectly record data, omit data, or even falsify data. Immunic cannot ensure that the CROs or clinical investigators in Immunic’s trials will not make mistakes or otherwise compromise the integrity or validity of data, any of which would have a significant negative effect on Immunic’s ability to obtain marketing approval, its business, and its financial condition.
Immunic or the third parties it relies on may encounter problems in clinical trials that may cause Immunic or the FDA or foreign regulatory agencies to delay, suspend or terminate Immunic’s clinical trials at any phase. These problems could include the possibility that Immunic may not be able to manufacture sufficient quantities of materials for use in its clinical trials, conduct clinical trials at its preferred sites, enroll a sufficient number of patients for its clinical trials at one or more sites, or begin or successfully complete clinical trials in a timely fashion, if at all. Furthermore, Immunic, the FDA or foreign regulatory agencies may suspend clinical trials of Immunic’s product candidates at any time if Immunic or they believe the subjects participating in the trials are being exposed to unacceptable health risks, whether as a result of adverse events occurring in Immunic’s trials or otherwise, or if Immunic or they find deficiencies in the clinical trial process or conduct of the investigation.
The FDA and foreign regulatory agencies could also require additional clinical trials before or after granting marketing approval for any products, which would result in increased costs and significant delays in the development and commercialization of such products and could result in the withdrawal of such products from the market after obtaining marketing approval. Immunic’s failure to adequately demonstrate the safety and efficacy of a product candidate in clinical development could delay or prevent obtaining marketing approval of the product candidate and, after obtaining marketing approval, data from post-approval studies could result in the product being withdrawn from the market, either of which would likely have a material adverse effect on Immunic’s business.
Immunic may be unable to realize the potential benefits of any collaboration.
Even if Immunic is successful in entering into a collaboration with respect to the development and/or commercialization of one or more product candidates, there is no guarantee that the collaboration will be successful. Collaborations may pose a number of risks, including:
• | collaborators often have significant discretion in determining the efforts and resources that they will apply to the collaboration, and may not commit sufficient resources to the development, marketing or commercialization of the product or products that are subject to the collaboration; | |
• | collaborators may not perform their obligations as expected; | |
• | any such collaboration may significantly limit Immunic’s share of potential future profits from the associated program, and may require it to relinquish potentially valuable rights to its current product candidates, potential products or proprietary technologies or grant licenses on terms that are not favorable to Immunic; | |
• | collaborators may cease to devote resources to the development or commercialization of Immunic’s product candidates if the collaborators view its product candidates as competitive with their own products or product candidates; | |
• | disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the course of development, might cause delays or termination of the development or commercialization of product candidates, and might result in legal proceedings, which would be time-consuming, distracting and expensive; | |
• | collaborators may be impacted by changes in their strategic focus or available funding, or business combinations involving them, which could cause them to divert resources away from the collaboration; | |
• | collaborators may infringe the intellectual property rights of third parties, which may expose Immunic to litigation and potential liability; | |
• | the collaborations may not result in Immunic achieving revenues to justify such transactions; and | |
• | collaborations may be terminated and, if terminated, may result in a need for Immunic to raise additional capital to pursue further development or commercialization of the applicable product candidate. |
As a result, a collaboration may not result in the successful development or commercialization of Immunic’s product candidates.
Immunic enters into various contracts in the normal course of its business in which Immunic indemnifies the other party to the contract. In the event Immunic has to perform under these indemnification provisions, it could have a material adverse effect on its business, financial condition and results of operations.
In the normal course of business, Immunic periodically enters into academic, commercial, service, collaboration, licensing, consulting and other agreements that contain indemnification provisions. With respect to Immunic’s academic and other research agreements, Immunic typically indemnifies the institution and related parties from losses arising from claims relating to the products, processes or services made, used, sold or performed pursuant to the agreements for which Immunic has secured licenses, and from claims arising from Immunic’s or its sublicensees’ exercise of rights under the agreements.
Should Immunic’s obligation under an indemnification provision exceed applicable insurance coverage or if Immunic were denied insurance coverage, Immunic’s business, financial condition and results of operations could be adversely affected. Similarly, if Immunic is relying on a collaborator to indemnify Immunic and the collaborator is denied insurance coverage or the indemnification obligation exceeds the applicable insurance coverage, and if the collaborator does not have other assets available to indemnify Immunic, its business, financial condition and results of operations could be adversely affected.
If Immunic’s contractors fail to comply with continuing regulations, Immunic or they may be subject to enforcement action that could adversely affect Immunic.
If any of Immunic’s contractors fails to comply with the requirements of the FDA and other applicable U.S. or foreign governmental or regulatory authorities or previously unknown problems with Immunic’s products, manufacturers or manufacturing processes are discovered, Immunic or the contractor could be subject to administrative or judicially imposed sanctions, including restrictions on the products, the manufacturers or manufacturing processes Immunic uses, warning letters, untitled letters, civil or criminal penalties, fines, injunctions, product seizures or detentions, import bans, voluntary or mandatory product recalls and publicity requirements, suspension or withdrawal of regulatory approvals, total or partial suspension of production, and refusal to approve pending applications for marketing approval of new products to approved applications.
Risks Related to Immunic’s Intellectual Property
Immunic’s proprietary rights may not adequately protect its technologies and product candidates.
Immunic’s commercial success will depend in part on its ability to obtain additional patents and protect its existing patent position as well as its ability to maintain adequate protection of other intellectual property for its technologies, product candidates, and any future products in the United States and other countries. If Immunic does not adequately protect its intellectual property, competitors may be able to use Immunic’s technologies and erode or negate any competitive advantage Immunic may have, which could harm Immunic’s business and ability to achieve profitability. The laws of some foreign countries do not protect Immunic’s proprietary rights to the same extent or in the same manner as U.S. laws, and Immunic may encounter significant problems in protecting and defending its proprietary rights in these countries. Immunic will be able to protect its proprietary rights from unauthorized use by third parties only to the extent that Immunic’s proprietary technologies, product candidates and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets.
Immunic applies for patents covering both its technologies and product candidates, as it deems appropriate. However, Immunic may fail to apply for patents on important technologies or product candidates in a timely fashion, or at all. Immunic’s existing patents and any future patents it obtains may not be sufficiently broad to prevent others from practicing its technologies or from developing competing products and technologies. Immunic cannot be certain that its patent applications will be approved or that any patents issued will adequately protect Immunic’s intellectual property.
Moreover, the patent positions of pharmaceutical companies are highly uncertain and involve complex legal and factual questions for which important legal principles are evolving and remain unresolved. As a result, the validity and enforceability of patents cannot be predicted with certainty. In addition, Immunic does not know whether:
• | Immunic or its licensors were the first to make the inventions covered by each of Immunic’s issued patents and pending patent applications; | |
• | Immunic or its licensors were the first to file patent applications for these inventions; | |
• | any of the patents that cover Immunic’s product candidates will be eligible to be listed in the FDA’s compendium of “Approved Drug Products with Therapeutic Equivalence Evaluations,” sometimes referred to as the FDA’s Orange Book; | |
• | others will independently develop similar or alternative technologies or duplicate any of Immunic’s technologies; | |
• | any of Immunic’s or its licensors’ pending patent applications will result in issued patents; | |
• | any of Immunic’s or its licensors’ patents will be valid or enforceable; | |
• | any patents issued to Immunic or its licensors and collaborators will provide Immunic with any competitive advantages, or will be challenged by third parties; | |
• | Immunic will develop additional proprietary technologies that are patentable; | |
• | the U.S. government will exercise any of its statutory rights to Immunic’s intellectual property that was developed with government funding; or | |
• | Immunic’s business may infringe the patents or other proprietary rights of others. |
The actual protection afforded by a patent varies based on products or processes, from country to country and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory related extensions, the availability of legal remedies in a particular country, the validity and enforceability of the patents and Immunic’s financial ability to enforce its patents and other intellectual property. Immunic’s ability to maintain and solidify its proprietary position for its product candidates and future products will depend on its success in obtaining effective claims and enforcing those claims once granted. Immunic’s issued patents and those that may issue in the future, or those licensed to Immunic, may be challenged, narrowed, invalidated or circumvented, and the rights granted under any issued patents may not provide Immunic with proprietary protection or competitive advantages against competitors with similar products. Due to the extensive amount of time required for the development, testing and regulatory review of a potential product, it is possible that, before any of Immunic’s product candidates can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby reducing any advantage of the patent.
Immunic may also rely on trade secrets to protect some of its technology, especially where Immunic does not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to maintain. While Immunic uses reasonable efforts to protect its trade secrets, Immunic’s or any of its collaborators’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose Immunic’s proprietary information to competitors and Immunic may not have adequate remedies in respect of that disclosure. Enforcement of claims that a third party has illegally obtained and is using trade secrets is expensive, time consuming and uncertain. In addition, foreign courts are sometimes less willing than U.S. courts to protect trade secrets. If Immunic’s competitors independently develop equivalent knowledge, methods and know-how, Immunic would not be able to assert its trade secrets against them and Immunic’s business could be harmed.
Immunic is a party to license agreements under which Immunic licenses intellectual property and receives commercialization rights relating to certain of its product candidates. If Immunic fails to comply with obligations in such agreements or otherwise experience disruptions to its business relationships with its licensors, Immunic could lose license rights that are important to its business; any termination of such agreements would adversely affect Immunic’s business.
Immunic is a party to license agreements that give Immunic various commercialization rights, the loss of which (whether due to Immunic’s actions or those of the respective counterparties) may adversely affect Immunic’s business. For instance, in November 2018, Immunic and Daiichi Sankyo Company, Limited entered into a license and option agreement that grants Immunic an exclusive global option to license IMU-856 and related molecules. Under this agreement, Immunic has the rights for commercialization of IMU-856 in all countries including the U.S., Europe and Japan.
The loss of the licenses granted to Immunic under its agreements with these licensors or the rights provided therein would prevent Immunic from developing, manufacturing or marketing products covered by the license or subject to supply commitments, and could materially harm Immunic’s business, financial condition, results of operations and prospects.
Immunic may not be able to protect its intellectual property rights throughout the world.
Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and Immunic’s intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Consequently, Immunic may not be able to prevent third parties from practicing Immunic’s inventions in all countries outside the United States, or from selling or importing products made using Immunic’s inventions in and into the United States or other jurisdictions. Competitors may use Immunic’s technologies in jurisdictions where Immunic has not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where Immunic has patent protection, but enforcement rights are not as strong as those in the United States. These products may compete with Immunic’s product candidates in jurisdictions where Immunic does not have any issued patents and Immunic’s patent claims or other intellectual rights may not be effective or sufficient to prevent them from so competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for Immunic to stop the infringement of its patents generally. Proceedings to enforce Immunic’s patent rights in foreign jurisdictions could result in substantial costs and divert Immunic’s efforts and attention from other aspects of its business, could put its patents at risk of being invalidated or interpreted narrowly and its patent applications at risk of not issuing and could provoke third parties to assert claims against Immunic. Immunic may not prevail in any lawsuits that it initiates and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Immunic’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that it develops or licenses.
If Immunic does not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for its product candidates, Immunic’s business may be materially harmed.
Depending on the timing, duration and specifics of FDA marketing approval of Immunic’s product candidates, if any, one of the U.S. patents covering each of such approved product(s) or the use thereof may be eligible for up to five years of patent term restoration under the Hatch-Waxman Act. The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA-approved product. Patent term extension or special protection certificates also may be available in certain foreign countries upon regulatory approval of Immunic’s product candidates. Nevertheless, Immunic may not be granted patent term extension either in the United States or in any foreign country because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or this being impossible or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than Immunic requests.
If Immunic is unable to obtain patent term extension or restoration, or the term of any such extension is less than Immunic or its collaborators request, the period during which Immunic will have the right to exclusively market its product will be shortened and Immunic’s competitors may obtain approval of competing products following Immunic’s patent expiration, and Immunic’s revenue could be reduced, possibly materially.
Immunic may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which may adversely affect Immunic’s ability to develop and market its product candidates.
Immunic cannot guarantee that any of its patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can Immunic be certain that Immunic has identified each and every patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of its product candidates in any jurisdiction.
The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Immunic’s interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact its ability to market its product candidates. Immunic may incorrectly determine that its product candidates are not covered by a third-party patent.
Many patents may cover a marketed product, including but not limited to patents covering the composition, methods of use, formulations, production processes and purification processes of or for the product. The identification of all patents and their expiration dates relevant to the production and sale of a therapeutic product is extraordinarily complex and requires sophisticated legal knowledge in the relevant jurisdiction. It may be impossible to identify all patents in all jurisdictions relevant to a marketed product. Immunic’s determination of the expiration date of any patent in the United States or abroad that it considers relevant may be incorrect, which may negatively impact its ability to develop and market its product candidates.
Obtaining and maintaining Immunic’s patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and Immunic’s patent protection could be reduced or eliminated for non-compliance with these requirements.
The United States Patent and Trademark Office, or USPTO, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent prosecution process. Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on any issued patent and/or pending patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of a patent or patent application. Immunic employs an outside firm and relies on its outside counsel to pay these fees. While an inadvertent lapse may sometimes be cured by payment of a late fee or by other means in accordance with the applicable rules, there are many situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If Immunic fails to maintain the patents and patent applications directed to its product candidates, Immunic’s competitors might be able to enter the market earlier than should otherwise have been the case, which would have a material adverse effect on Immunic’s business.
The patent protection for Immunic’s product candidates may expire before Immunic is able to maximize their commercial value, which may subject Immunic to increased competition and reduce or eliminate its opportunity to generate product revenue.
The patents for Immunic’s product candidates have varying expiration dates and, if these patents expire, Immunic may be subject to increased competition and Immunic may not be able to recover its development costs or market any of its approved products profitably. In some of the larger potential market territories, such as the United States and Europe, patent term extension or restoration may be available to compensate for time taken during aspects of the product’s development and regulatory review. However, Immunic cannot be certain that such an extension will be granted, or if granted, what the applicable time period or the scope of patent protection afforded during any extension period will be. In addition, even though some regulatory authorities may provide some other exclusivity for a product under their own laws and regulations, Immunic may not be able to qualify the product or obtain the exclusive time period. If Immunic is unable to obtain patent term extension/restoration or some other exclusivity, Immunic could be subject to increased competition and its opportunity to establish or maintain product revenue could be substantially reduced or eliminated. Furthermore, Immunic may not have sufficient time to recover its development costs prior to the expiration of its U.S. and foreign patents.
Immunic may become involved in lawsuits to protect its patents or other intellectual property rights, which could be expensive, time-consuming and ultimately unsuccessful.
Competitors may infringe Immunic’s patents or other intellectual property rights. To counter infringement or unauthorized use, Immunic may be required to file infringement claims, directly or through its licensors, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of Immunic’s licensor is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that Immunic’s patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of the patents Immunic licenses at risk of being invalidated or interpreted narrowly and could put Immunic’s licensors’ patent applications at risk of not issuing.
Interference proceedings brought by the USPTO may be necessary to determine the priority of inventions with respect to patents of Immunic’s licensors and patent applications or those of Immunic’s current or future collaborators. An unfavorable outcome could require Immunic to cease using the technology or to attempt to license rights to it from the prevailing party. Immunic’s business could be harmed if a prevailing party does not offer Immunic a license on terms that are acceptable to Immunic. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distraction of Immunic’s management and other employees. Immunic may not be able to prevent, alone or with its collaborators, misappropriation of its proprietary rights, particularly in countries where the laws may not protect those rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Immunic’s confidential and proprietary information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Immunic’s common stock.
Third-party claims of intellectual property infringement or misappropriation may adversely affect Immunic’s business and could prevent Immunic from developing or commercializing its product candidates.
Immunic’s commercial success depends in part on Immunic not infringing the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, ex-parte review, inter party review and post-grant review proceedings before the USPTO and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which Immunic is developing and may develop its product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that Immunic’s product candidates may be subject to claims of infringement of the patent rights of third parties. If a third party claims that Immunic infringes on their products or technology, Immunic could face a number of issues, including:
• | infringement and other intellectual property claims which, with or without merit, can be expensive and time-consuming to litigate and can divert management’s attention from Immunic’s core business; | |
• | substantial damages for past infringement, which Immunic may have to pay if a court decides that its product infringes on a competitor’s patent; | |
• | a court prohibiting Immunic from selling or licensing its product unless the patent holder licenses the patent to Immunic, which the patent holder would not be required to do; | |
• | if a license is available from a patent holder, Immunic may have to pay substantial royalties or grant cross licenses to Immunic’s patents; and | |
• | redesigning Immunic’s processes so they do not infringe, which may not be possible or could require substantial funds and time. |
Third parties may assert that Immunic is employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of Immunic’s product candidates, that Immunic failed to identify. For example, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until issued as patents. Except for the preceding exceptions, patent applications in the United States and elsewhere are generally published only after a waiting period of approximately 18 months after the earliest filing. Therefore, patent applications covering Immunic’s product candidates could have been filed by others without the knowledge of Immunic or its licensors. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover Immunic’s product candidates or the use or manufacture of its product candidates. Immunic may also face a claim of misappropriation if a third party believes that it inappropriately obtained and used trade secrets of such third party. If Immunic is found to have misappropriated a third party’s trade secrets, Immunic may be prevented from further using such trade secrets, limiting its ability to develop its product candidates, and Immunic may be required to pay damages.
If any third-party patents were held by a court of competent jurisdiction to cover aspects of Immunic’s materials, formulations, methods of manufacture or methods for treatment, the holders of any such patents would be able to block Immunic’s ability to develop and commercialize the applicable product candidate until such patent expired or unless Immunic obtains a license. These licenses may not be available on acceptable terms, if at all. Even if Immunic was able to obtain a license, the rights may be nonexclusive, which could result in Immunic’s competitors gaining access to the same intellectual property.
Ultimately, Immunic could be prevented from commercializing a product, or be forced to cease some aspect of its business operations, if, as a result of actual or threatened patent infringement claims, Immunic is unable to enter into licenses on acceptable terms. In addition, during the course of any patent or other intellectual property litigation, there could be public announcements of the results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of Immunic’s product candidates, programs, or intellectual property could be diminished. Accordingly, the market price of Immunic’s common stock may decline.
Parties making claims against Immunic may obtain injunctive or other equitable relief, which could effectively block Immunic’s ability to further develop and commercialize one or more of its product candidates. Defending against claims of patent infringement or misappropriation of trade secrets could be costly and time-consuming, regardless of the outcome. Thus, even if Immunic was to ultimately prevail, or to settle at an early stage, such litigation could burden Immunic with substantial unanticipated costs. In addition, litigation or threatened litigation could result in significant demands on the time and attention of Immunic’s management team, distracting them from the pursuit of other company business. In the event of a successful claim of infringement against Immunic, Immunic may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign its infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. In addition, the uncertainties associated with litigation could have a material adverse effect on Immunic’s ability to raise the funds necessary to continue its clinical trials, continue its research programs, license necessary technology from third parties, or enter into development collaborations that would help Immunic bring its product candidates to market.
Changes in U.S. patent law could diminish the value of patents in general, thereby impairing Immunic’s ability to protect its product candidates.
As is the case with other pharmaceutical companies, Immunic’s success is heavily dependent on intellectual property, particularly on obtaining and enforcing patents and patent rights. Obtaining and enforcing patents and patent rights in the biotechnology industry involves both technological and legal complexity, and therefore, is costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Further, several recent U.S. Supreme Court rulings have either narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Immunic’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents and patent rights, once obtained.
For Immunic’s U.S. patent applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law. In September 2011, the Leahy-Smith America Invents Act, or the AIA, was signed into law. The AIA includes a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted, reviewed after issuance, and may also affect patent litigation. The USPTO is currently developing regulations and procedures to govern administration of the AIA, and many of the substantive changes to patent law associated with the AIA. It is not clear what other, if any, impact the AIA will have on the operation of Immunic’s business. Moreover, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of patent rights, all of which could have a material adverse effect on Immunic’s business and financial condition.
An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-inventor-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before a licensor or Immunic could therefore be awarded a patent covering an invention of Immunic’s even if said licensor Immunic had made the invention before it was made by the third party. This will require Immunic to be cognizant going forward of the time from invention to filing of a patent application. Furthermore, Immunic’s ability to obtain and maintain valid and enforceable patent rights depends on whether the differences between the licensor’s or Immunic’s technology and the prior art allow Immunic’s technology to be patentable over the prior art. Since patent applications in the United States and most other countries are confidential for a period of time after filing, Immunic cannot be certain that a licensor or it was the first to either (a) file any patent application related to Immunic’s product candidates or (b) invent any of the inventions claimed in Immunic’s patents or patent applications.
Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent in the USPTO. This applies to all U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid as unpatentable even though the same evidence may be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate patent rights that would not have been invalidated if first challenged by the third party as a defendant in a district court action.
Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken Immunic’s ability to obtain new patents or to enforce its existing patents and patents that Immunic might obtain in the future.
Because of the expense and uncertainty of litigation, Immunic may not be in a position to enforce its intellectual property rights against third parties.
Because of the expense and uncertainty of litigation, Immunic may conclude that even if a third party is infringing the patents of Immunic’s licensors or Immunic or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of Immunic or its stockholders. In such cases, Immunic may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.
Intellectual property rights do not address all potential threats to Immunic’s competitive advantage.
The degree of future protection afforded by Immunic’s intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect Immunic’s business, or permit Immunic to maintain its competitive advantage. The following examples are illustrative:
• | Others may be able to make products that are similar to Immunic’s product candidates but that are not covered by the claims of the patents that Immunic licenses from others or may license or own in the future. | |
• | Others may independently develop similar or alternative technologies or otherwise circumvent any of Immunic’s technologies without infringing its intellectual property rights. | |
• | Any of Immunic’s collaborators might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that Immunic licenses or will, in the future, own or license. | |
• | Any of Immunic’s collaborators might not have been the first to file patent applications covering certain of the patents or patent applications that Immunic licenses or will, in the future, license. | |
• | Issued patents that have been licensed to Immunic may not provide Immunic with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by Immunic’s competitors. | |
• | Immunic’s competitors might conduct research and development activities in countries where Immunic does not have license rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in Immunic’s major commercial markets. | |
• | Ownership of patents or patent applications licensed to Immunic may be challenged by third parties. | |
• | The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on Immunic’s business. |
Some of Immunic’s intellectual property relies on trade secrets.
In addition to the protection afforded by patents, Immunic also relies on trade secret protection for certain aspects of its intellectual property. Immunic has not filed patents for or has publicly disclosed some of the important properties of its development candidates. Despite adequate efforts by Immunic, those trade secrets may become public knowledge, thereby potentially allowing competitors to develop similar products.
Confidentiality agreements with employees, consultants and others may not adequately prevent disclosure of trade secrets and protect other proprietary information.
Immunic considers proprietary trade secrets and/or confidential know-how and unpatented know-how to be important to its business. Immunic may rely on trade secrets and/or confidential know-how to protect its technology, especially where patent protection is believed by Immunic to be of limited value. However, trade secrets and/or confidential know-how can be difficult to maintain as confidential.
To protect this type of information against disclosure or appropriation by competitors, Immunic’s policy is to require its employees, consultants, contractors and advisors to enter into confidentiality agreements with Immunic. However, current or former employees, consultants, contractors and advisers may unintentionally or willfully disclose Immunic’s confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time-consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.
Failure to obtain or maintain trade secrets and/or confidential know-how trade protection could adversely affect Immunic’s competitive position. Moreover, Immunic’s competitors may independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in obtaining such patent protection, Immunic’s competitors could limit Immunic’s use of its trade secrets and/or confidential know-how.
Immunic may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
A third party may hold intellectual property, including patent rights that are important or necessary to the development or commercialization of Immunic’s product candidates. It may be necessary for Immunic to use the patented or proprietary technology of third parties to commercialize its product candidates, in which case Immunic would be required to obtain a license from such third parties. Such a license may not be available on commercially reasonable terms or at all, which could materially harm Immunic’s business.
Immunic may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
Immunic has received confidential and proprietary information from third parties. In addition, Immunic employs individuals who were previously employed at other biotechnology or pharmaceutical companies. Immunic may be subject to claims that Immunic or its employees, consultants or independent contractors have inadvertently or otherwise improperly used or disclosed confidential information of these third parties or Immunic’s employees’ former employers.
Further, Immunic may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing Immunic’s product candidates. Immunic may also be subject to claims that former employees, consultants, independent contractors, collaborators or other third parties have an ownership interest in Immunic’s patents or other intellectual property. Litigation may be necessary to defend against these and other claims challenging Immunic’s right to and use of confidential and proprietary information. If Immunic fails in defending any such claims, in addition to paying monetary damages, Immunic may lose its rights therein. Such an outcome could have a material adverse effect on Immunic’s business.
Even if Immunic is successful in defending against these claims, litigation could result in substantial cost and be a distraction to Immunic’s management and employees.
Immunic may be subject to claims challenging the inventorship or ownership of its patents and other intellectual property.
Immunic may also be subject to claims that former employees, collaborators or other third parties have an ownership interest in its patents and other intellectual property. Immunic may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing Immunic’s product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If Immunic fails in defending any such claims, in addition to paying monetary damages, Immunic may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on Immunic’s business. Even if Immunic is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
Immunic’s reliance on third parties requires Immunic to share its trade secrets, which increases the possibility that a competitor will discover them or that Immunic’s trade secrets will be misappropriated or disclosed.
Because Immunic relies on third parties to assist with research and development and to manufacture its product candidates, Immunic must, at times, share trade secrets with them. Immunic seeks to protect its proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with its advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose Immunic’s confidential information, including its trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by Immunic’s competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that Immunic’s proprietary position is based, in part, on its know-how and trade secrets, a competitor’s discovery of Immunic’s trade secrets or other unauthorized use or disclosure would impair Immunic’s competitive position and may have a material adverse effect on its business.
In addition, these agreements typically restrict the ability of Immunic’s advisors, employees, third-party contractors and consultants to publish data potentially relating to Immunic’s trade secrets, although Immunic’s agreements may contain certain limited publication rights. For example, any academic institution that Immunic may collaborate with in the future will usually expect to be granted rights to publish data arising out of such collaboration, provided that Immunic is notified in advance and given the opportunity to delay publication for a limited time period in order for Immunic to secure patent protection of intellectual property rights arising from the collaboration, in addition to the opportunity to remove confidential or trade secret information from any such publication. In the future Immunic may also conduct joint research and development programs that may require Immunic to share trade secrets under the terms of its research and development or similar agreements. Despite Immunic’s efforts to protect its trade secrets, Immunic’s competitors may discover its trade secrets, either through breach of Immunic’s agreements with third parties, independent development or publication of information by any of Immunic’s third-party collaborators. A competitor’s discovery of Immunic’s trade secrets would impair Immunic’s competitive position and have an adverse impact on its business.
If Immunic’s trademarks and trade names are not adequately protected, then Immunic may not be able to build name recognition in its markets of interest and its business may be adversely affected.
If Immunic’s trademarks and trade names are not adequately protected, then Immunic may not be able to build name recognition in its markets of interest and its business may be adversely affected. Immunic’s unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. Immunic may not be able to protect its rights to these trademarks and trade names, which Immunic needs to build name recognition among potential collaborators or customers in its markets of interest. At times, competitors may adopt trade names or trademarks similar to Immunic’s, thereby impeding Immunic’s ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of Immunic’s unregistered trademarks or trade names. Over the long term, if Immunic is unable to successfully register its trademarks and trade names and establish name recognition based on its trademarks and trade names, then Immunic may not be able to compete effectively and its business may be adversely affected. Immunic’s efforts to enforce or protect its proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact Immunic’s financial condition or results of operations.
Risks Related to Being a Public Company
Immunic incurs significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
Immunic incurs significant legal, accounting and other expenses that it would not incur as a private company, including costs associated with public company reporting requirements. Immunic also incurs costs associated with corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as new rules implemented by the SEC and The Nasdaq Stock Market, or Nasdaq. These rules and regulations increase the company’s legal and financial compliance costs and make some activities more time-consuming and costly. Not all members of Immunic’s management have previously managed and operated a public company. These executive officers and other personnel will need to devote substantial time to gaining expertise regarding operations as a public company and compliance with applicable laws and regulations. These rules and regulations may also make it difficult and expensive for the company to obtain directors’ and officers’ liability insurance. As a result, it may be more difficult for Immunic to attract and retain qualified individuals to serve on its board of directors or as executive officers of the company, which may adversely affect investor confidence in Immunic and could cause Immunic’s business or stock price to suffer.
If Immunic fails to maintain proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired.
Immunic is subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and Nasdaq rules and regulations. The Sarbanes-Oxley Act requires, among other things, that Immunic maintain effective disclosure controls and procedures and internal control over financial reporting. Effective internal control over financial reporting is necessary for Immunic to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud.
Immunic must perform system and process evaluation and testing of its internal control over financial reporting to allow management to report on the effectiveness of its internal controls over financial reporting in its Annual Report on Form 10-K for each year, as required by Section 404 of the Sarbanes-Oxley Act, or Section 404. Prior to the Exchange, Immunic AG was never required to test its internal controls within a specified period. This requires significant management efforts and requires Immunic to incur substantial professional fees and internal costs to expand its accounting and finance functions. Immunic may experience difficulty in meeting these reporting requirements in a timely manner. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause the company to fail to meet its reporting obligations. In addition, any testing by Immunic, as and when required, conducted in connection with Section 404, or any subsequent testing by the company’s independent registered public accounting firm, as and when required, may reveal deficiencies in the company’s internal control over financial reporting that are deemed to be significant deficiencies or material weaknesses or that may require prospective or retroactive changes to its financial statements or identify other areas for further attention or improvement.
In connection with the preparation of Immunic’s consolidated financial statements for the year ended December 31, 2018, Immunic concluded that there was a material weakness in its internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim consolidated financial statements will not be prevented or detected on a timely basis. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention by those responsible for oversight of the company’s financial reporting. The material weakness that Immunic identified related to a failure to identify a U.S. generally accepted accounting principles adjustment related to equity-based compensation accounting. As a result of the identification of this material weakness, Immunic plans to implement measures designed to improve its internal control over financial reporting, including the establishment of additional monitoring and oversight controls. Immunic cannot be certain that these efforts will be sufficient to remediate or prevent future material weaknesses or significant deficiencies from occurring.
While Immunic remains an emerging growth company, it will not be required to include an attestation report on internal control over financial reporting issued by its independent registered public accounting firm in its Annual Reports on Form 10-K as required by Section 404. There is a risk that neither Immunic, nor its independent registered public accounting firm once Immunic is required to obtain an attestation report on internal control over financial reporting from such firm, will be able to conclude within the prescribed timeframe that Immunic’s internal control over financial reporting is effective as required by Section 404.
If Immunic is not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if it is unable to maintain proper and effective internal controls, it may not be able to produce timely and accurate financial statements. If that were to happen, the market price of Immunic’s common stock could decline and it could be subject to sanctions or investigations by Nasdaq, the SEC, or other regulatory authorities.
Effective December 31, 2019, Immunic will no longer be an “emerging growth company,” and the reduced disclosure requirements applicable to “emerging growth companies” will no longer apply, which will increase Immunic’s costs as a public company and increase the demands on management.
Immunic will remain an “emerging growth company” until December 31, 2019, the fiscal year-end following the fifth anniversary of the completion of its initial public offering. After such time, Immunic will no longer be an “emerging growth company” as defined in the JOBS Act. As such, Immunic will incur significant additional expenses that it did not previously incur in complying with the Sarbanes-Oxley Act and rules implemented by the SEC. The cost of compliance with Section 404 has required and will continue to require Immunic to incur substantial accounting expense and expend significant management time on compliance-related issues as it implements additional corporate governance practices and complies with reporting requirements. Moreover, if Immunic or its independent registered public accounting firm identifies deficiencies in Immunic’s internal control over financial reporting that are deemed to be material weaknesses, the market price of Immunic’s stock could decline, and Immunic could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources. Furthermore, investor perceptions of Immunic may suffer if, in the future, material weaknesses are found, and this could cause a decline in the market price of Immunic’s stock. Irrespective of compliance with Section 404, any failure of Immunic’s internal control over financial reporting could have a material adverse effect on the company’s stated operating results and harm its reputation. If Immunic is unable to implement these changes effectively or efficiently, it could harm Immunic’s operations, financial reporting or financial results and could result in an adverse opinion on internal control from its independent registered public accounting firm.
In addition, Immunic will no longer be eligible for reduced disclosure requirements and exemptions requirements applicable to emerging growth companies regarding executive compensation and exemptions from the requirements of holding advisory say-on-pay votes on executive compensation and as such, Immunic will be required to hold a say-on-pay vote and a say-on-frequency vote at its 2020 annual meeting of stockholders. Immunic expects that the increased disclosure requirements will require additional attention from management and will result in increased costs to the company, which could include higher legal fees, accounting fees and fees associated with investor relations activities, among others.
Risks Related to Immunic’s Common Stock
The market price of Immunic’s common stock is volatile.
The market price of Immunic’s common stock can be subject to significant fluctuations. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of Immunic’s common stock to fluctuate include:
• | reports on or the perception of clinical progress, or the lack thereof; | |
• | the ability of Immunic to obtain regulatory approvals for its product candidates, and delays or failures to obtain such approvals; | |
• | failure of any of Immunic’s product candidates, if approved, to achieve commercial success; | |
• | failure to maintain its existing third-party license and supply agreements; | |
• | failure by Immunic or its licensors to prosecute, maintain, or enforce its intellectual property rights; | |
• | changes in laws or regulations applicable to its product candidates; | |
• | any inability to obtain adequate supply of its product candidates or the inability to do so at acceptable prices; | |
• | adverse regulatory authority decisions; | |
• | introduction of new products, services, or technologies by its competitors; | |
• | failure to meet or exceed financial and development projections that Immunic may provide to the public; | |
• | failure to meet or exceed the financial and development projections of the investment community; | |
• | the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; | |
• | announcements of significant acquisitions, strategic collaborations, joint ventures, or capital commitments by Immunic or its competitors; | |
• | disputes or other developments relating to proprietary rights, including patents, litigation matters, and its ability to obtain patent protection for its technologies; | |
• | additions or departures of key personnel; | |
• | significant lawsuits, including patent or stockholder litigation; | |
• | if securities or industry analysts do not publish research or reports about its business, or if they issue adverse or misleading opinions regarding its business and stock; | |
• | changes in the market valuations of similar companies; |
• | general market or macroeconomic conditions; | |
• | sales of common stock by the company or its stockholders in the future; | |
• | trading volume of its common stock; | |
• | announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships or capital commitments; | |
• | adverse publicity relating to the markets in which Immunic operates, including with respect to other products and potential products in such markets; | |
• | the introduction of technological innovations or new therapies that compete with potential products of Immunic; | |
• | changes in the structure of health care payment systems; and | |
• | period-to-period fluctuations in Immunic’s financial results. |
Moreover, stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Immunic’s common stock.
In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm Immunic’s profitability and reputation.
Additionally, a decrease in the stock price of Immunic may cause the company’s common stock to no longer satisfy the continued listing standards of The Nasdaq Capital Market. If the company is not able to maintain the requirements for listing on The Nasdaq Capital Market, it could be delisted, which could have a materially adverse effect on its ability to raise additional funds as well as the price and liquidity of its common stock.
Because the Exchange had the same effect as a “ reverse merger, ” Immunic may not be able to attract the attention of major brokerage firms.
Security analysts of major brokerage firms may not provide coverage of Immunic since, because it became public through a “reverse merger” type of transaction, there is no incentive to brokerage firms to recommend the purchase of its common stock. In addition, because of past abuses and fraud concerns stemming primarily from a lack of public information about newly public businesses, there are many people in the securities industry and business in general who view “reverse mergers” and similar transactions with suspicion. Without brokerage firm and analyst coverage, there may be fewer people aware of Immunic and its business, resulting in fewer potential buyers of its common stock, less liquidity and lower stock prices for its investors than would be the case if it had become a public reporting company in a more traditional manner. There is no assurance that brokerage firms will want to provide analyst coverage of Immunic’s capital stock or business in the future.
Anti-takeover provisions in Immunic’s organizational documents and Delaware law might discourage or delay acquisition attempts for the company that stockholders might consider favorable.
Immunic’s Amended and Restated Certificate of Incorporation, or the Certificate of Incorporation, and Amended and Restated Bylaws, or the Bylaws, contain provisions that may delay or prevent an acquisition or change in control of the company. Immunic’s certificate of incorporation and bylaws include provisions that:
• | authorize Immunic’s board of directors to issue without further action by the stockholders, up to 20,000,000 shares of undesignated preferred stock; | |
• | require that any action to be taken by Immunic’s stockholders be effected at a duly called annual or special meeting and not by written consent; | |
• | establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of Immunic’s stockholders, including proposed nominations of persons for election to Immunic’s board of directors; | |
• | provide that vacancies on Immunic’s board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and | |
• | establish that Immunic’s board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered terms. |
Further, as a Delaware corporation, Immunic is subject to provisions of Delaware law, which may impair a takeover attempt that Immunic’s stockholders may find beneficial. These anti-takeover provisions and other provisions under Delaware law could discourage, delay or prevent a transaction involving a change in control of Immunic, including actions that its stockholders may deem advantageous, or negatively affect the trading price of its common stock. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause Immunic to take other corporate actions they desire.
Immunic may experience adverse consequences because of required indemnification of officers and directors.
Provisions of Immunic’s Certificate of Incorporation and Bylaws provide that it will indemnify any director and officer as to liabilities incurred in their capacity as a director or officer and on those terms and conditions set forth therein to the fullest extent of Delaware law. Further, Immunic may purchase and maintain insurance on behalf of any such persons whether or not Immunic would have the power to indemnify such person against the liability insured against. The foregoing could result in substantial expenditures by Immunic and prevent any recovery from its officers, directors, agents and employees for losses incurred by the company as a result of their actions.
Immunic does not anticipate that it will pay any cash dividends in the foreseeable future.
The current expectation is that Immunic will retain its future earnings, if any, to fund the development and growth of its business. As a result, capital appreciation, if any, of the common stock of the company will be stockholders’ sole source of gain, if any, for the foreseeable future.
An active trading market for Immunic’s common stock may not be sustained and its stockholders may not be able to resell their shares of common stock for a profit, if at all.
An active trading market for Immunic’s shares of common stock may not be sustained. If an active market for Immunic’s common stock is not sustained, it may be difficult for stockholders to sell their shares at an attractive price or at all.
Future sales of shares by existing stockholders could cause Immunic’s stock price to decline.
If existing stockholders of Immunic sell, or indicate an intention to sell, substantial amounts of the company’s common stock in the public market after legal restrictions on resale lapse, the trading price of the common stock of the company could decline.
The ownership of Immunic’s common stock is highly concentrated, which may prevent stockholders from influencing significant corporate decisions and may result in conflicts of interest that could cause Immunic’s stock price to decline.
Executive officers and directors of Immunic and their affiliates and entities that are related to such officers and directors beneficially own or control approximately 61% of the outstanding shares of common stock of the company. Accordingly, these executive officers, directors and their affiliates, acting as a group, have substantial influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of Immunic’s assets or any other significant corporate transactions. These stockholders may also delay or prevent a change of control of Immunic, even if such a change of control would benefit the other stockholders of the company. The significant concentration of stock ownership may adversely affect the trading price of Immunic’s common stock due to investors’ perception that conflicts of interest may exist or arise, and may adversely affect the liquidity of Immunic’s common stock.
If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about Immunic, its business or its market, its stock price and trading volume could decline.
The trading market for Immunic’s common stock will be influenced by the research and reports that equity research analysts publish about it and its business. Equity research analysts may elect not to provide research coverage of Immunic’s common stock, and such lack of research coverage may adversely affect the market price of its common stock. In the event it does have equity research analyst coverage, Immunic will not have any control over the analysts or the content and opinions included in their reports. The price of the Immunic’s common stock could decline if one or more equity research analysts downgrade its stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of Immunic or fails to publish reports on it regularly, demand for its common stock could decrease, which in turn could cause its stock price or trading volume to decline.
If Immunic fails to retain accounting and finance staff with appropriate experience, its ability to maintain the financial controls required of a public company may adversely affect its business.
Immunic currently relies on third-party accounting professionals to assist it with its financial accounting and compliance obligations. Immunic is seeking financial professionals with appropriate experience to maintain its financial control and reporting obligations as a public company. If Immunic is unable to identify and retain such qualified and experienced personnel, its business may be adversely affected.
Director Biographies
Dr. Daniel Vitt . Dr. Daniel Vitt is Chief Executive Officer (CEO) and member of the board of directors of Immunic. He is also managing director of Immunic Research GmbH in Halle (Saale). He joined Immunic AG in January 2017 from 4SC AG, a publicly listed stock company based in Martinsried, Germany, which he co-founded in 1997. At 4SC, he served as Chief Scientific Officer (CSO) and Chief Development Officer (CDO). As a member of the executive board, he was responsible for all research and development activities at 4SC group including four clinical stage products. Dr. Vitt studied chemistry in Siegen and Würzburg, Germany from 1989 to 1994 and graduated from the University of Würzburg. During his doctoral studies, he focused on the molecular design of small molecule therapeutics. In 1998, he received his Ph.D. from the Institute of Organic Chemistry at the University of Würzburg.
Dr. Jörg Neermann . Dr. Jörg Neermann is the chairman of Immunic’s supervisory board. Dr. Neermann works for Life Sciences Partners (LSP) and is the managing director of LSP Services Deutschland GmbH, which provides management services for LSP V Coöperatieve U.A., one of Immunic’s current shareholders. He joined LSP in 2007. Dr. Neermann’s prime focus and responsibility within LSP is to invest in unlisted securities. Prior to joining LSP, Dr. Neermann was the managing director of Deutsche Venture Capital, a venture capital and private equity division of Deutsche Bank, where he ran its healthcare investment franchise. Previously, he worked at Atlas Ventures in Germany where he also invested in the healthcare sector. Dr. Neermann has a strong scientific background and hands-on finance and investment expertise and has served on the boards of numerous European biotech and life science companies. Dr. Neermann is currently a director at Probiodrug, a German biotech company that went public on Euronext Amsterdam in 2014 and is active in the development of novel, disease-modifying therapeutics against Alzheimer’s disease. Dr. Neermann studied biotechnology at the Technical University of Brunswick, Germany, and the MIT in Cambridge, USA, and holds a Master’s degree and a Ph.D. in biotechnology from the Technical University in Brunswick, Germany. He also studied economics at the Technical University in Brunswick, Germany, and Harvard Business School, U.S.
Dr. Vincent Ossipow . Dr. Vincent Ossipow is a member of Immunic’s supervisory board and is a Partner at Omega Funds. Dr. Ossipow joined Omega Funds, which manages Immunic’s current shareholder, Global Life Bioventure V S.à r.l., in 2014 and subsequently joined NeoMed in 2017. Previously, Dr. Ossipow worked with Sectoral Asset Management, a healthcare institutional investor, as a partner for private investments. From 2000 to 2006 he was a research fellow at the University of Geneva, studying the molecular basis of brain function, and acted as Sectoral Asset Management’s Chief Scientific Officer during this period. Previously, he worked at Pictet Bank as a research analyst for biotechnology equities and as a co-manager of the Pictet Biotech Fund, a biotech-equities listed investment vehicle. Dr. Ossipow trained as a postdoctoral fellow in Geneva (Hoffman-La-Roche and Human Frontier Science Program fellow) and at the National Cancer Institute in Bethesda, MD. He completed a Certificate in International Finance and Global Markets at the Georgetown University School of Business and holds an M.S. in computational sciences, an M.S. in molecular biology, and a Ph.D. in molecular biology, all from the University of Geneva. Dr. Ossipow holds a CFA designation (Chartered Financial Analyst) from the CFA Institute.
Jan Van den Bossche . Jan Van den Bossche is a member of Immunic’s supervisory board and is a partner at Immunic’s current shareholder, Fund+ N.V. He holds a master’s degree in applied economic sciences from the KULeuven, Belgium. He worked for more than 12 years as a biotech analyst at Petercam. He was involved in several public and private transactions of Belgian and Dutch Biotech companies, such as ThromoboGenics, Tigenix, UCB, AMT (Uniqure), IBA and MDxHealth. Before Mr. van den Bossche joined Fund+, he was for more than two years part of the investor relations team at the Dutch life sciences and materials sciences company DSM, Geleen, The Netherlands.
Dr. Duane Nash . Dr. Nash joined Immunic in 2012 prior to the stock-for-stock exchange transaction between the Company (then known as Vital Therapies, Inc.) and Immunic AG. He has held various leadership roles at Immunic, including Medical Director, Executive Vice President, Chief Business Officer, President, and Chief Executive Officer, a position he held until April 2019. Prior to joining Immunic, Dr. Nash held various positions at Wedbush PacGrow Life Sciences, an investment bank, where he was employed from March 2009 to March 2012, serving most recently as Senior Vice President in Equity Research. Before that, he was a research analyst at Pacific Growth Equities, an investment bank, from April 2008 through March 2009, which was subsequently acquired by Wedbush Securities, Inc. Dr. Nash also practiced as an attorney from November 2002 to February 2008, most recently at the law firm of Davis Polk, where he focused on intellectual property litigation and corporate matters. Dr. Nash served on the board of directors of Aerpio Pharmaceuticals, Inc. (Nasdaq: ARPO), from 2012 to 2017, and Akebia Therapeutics (Nasdaq: AKBA) from 2013 to 2018. Dr. Nash earned a B.A. in biology from Williams College, an M.D. from Dartmouth Medical School, a J.D. from the University of California, Berkeley, and a M.B.A. from the University of Oxford. Dr. Nash completed his internship in general surgery at the University of California at San Francisco.
Item 9.01. Financial Statements and Exhibits.
(b) Pro Forma Financial Information.
The Company is filing updated pro forma financial information required by Item 9.01(b) of Form 8-K, which updates and supersedes in its entirety the pro forma financial information filed as Exhibit 99.4 to the Form 8-K/A on June 21, 2019 and is attached as Exhibit 99.1 hereto.
(d) Exhibits.
+ Portions of this exhibit, marked by brackets, have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K under the Securities Act of 1933, as amended, because they are both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.
* Filed herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
Dated: July 17, 2019 | Immunic, Inc. | |
By: | /s/ Daniel Vitt | |
Daniel Vitt | ||
Chief Executive Officer |
Exhibit 3.1
AMENDED AND RESTATED
OF
IMMUNIC, INC.
ARTICLE One
The name of the corporation is Immunic, Inc. (the “ Corporation ”).
ARTICLE Two
The address of the Corporation’s registered office in the State of Delaware is Corporation Trust Center, 1209 Orange Street, City of Wilmington, County of New Castle, Delaware 19801. The name of the Corporation’s registered agent at such address is The Corporation Trust Company.
ARTICLE Three
The nature of the business of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware (the “ DGCL ”).
ARTICLE Four
PART A. AUTHORIZED SHARES
The total number of shares of all classes of capital stock which the Corporation shall have authority to issue is 150,000,000 shares, consisting of:
1. 20,000,000 shares of Preferred Stock, par value $0.0001 per share (the “ Preferred Stock ”); and
2. 130,000,000 shares of Common Stock, par value $0.0001 per share (the “ Common Stock ”).
Effective at 1:00 p.m. Eastern time on April 12, 2019 (the “ Effective Time ”), every 40 shares of the Corporation’s Common Stock, par value $0.0001 per share, issued and outstanding immediately prior to the Effective Time shall be combined into one share of common stock, par value $0.0001 per share, of the Corporation. Notwithstanding the immediately preceding sentence, no fractional shares shall be issued and, in lieu thereof, upon surrender after the Effective Time of a certificate or upon a change after the Effective Time in a book-entry which formerly represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time, any holder who would otherwise be entitled to a fractional share of Common Stock as a result of the combination, following the Effective Time (after taking into account all fractional shares of Common Stock otherwise issuable to such holder), shall be entitled to receive a cash payment equal to the fraction to which such holder would otherwise be entitled multiplied by the fair value of the Common Stock on the date of the Effective Time, as determined by the Board of Directors.
Each stock certificate or book-entry that, immediately prior to the Effective Time, represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall, from and after the Effective Time, automatically and without the necessity of presenting the same for exchange, represent that number of whole shares of Common Stock after the Effective Time into which the shares of Common Stock formerly represented by such certificate or book-entry shall have been combined (as well as the right to receive cash in lieu of fractional shares of Common Stock after the Effective Time), provided however, that each person of record holding a certificate that represented shares of Common Stock that were issued and outstanding immediately prior to the Effective Time shall receive, upon surrender of such certificate, a new certificate evidencing and representing the number of whole shares of Common Stock after the Effective Time into which the shares of Common Stock formerly represented by such certificate shall have been combined.
The Preferred Stock and the Common Stock shall have the rights, preferences and limitations set forth below.
PART B. PREFERRED STOCK
The Board of Directors is authorized, subject to limitations prescribed by law, to provide by resolution or resolutions for the issuance of shares of Preferred Stock in one or more series, to establish the number of shares to be included in each such series, and to fix the voting powers (if any), designations, powers, preferences, and relative, participating, optional or other rights, if any, of the shares of each such series, and any qualifications, limitations or restrictions thereof. Except as otherwise provided in any resolution or resolutions of the Board of Directors with respect to a series of Preferred Stock, the Board of Directors may increase or decrease (but not below the number of shares of any such series of Preferred Stock then outstanding) by resolution the number of shares of any such series of Preferred Stock. Except as otherwise provided in any resolution or resolutions of the Board of Directors with respect to a series of Preferred Stock, in the event that the number of shares of any series of Preferred Stock shall be decreased, the number of shares constituting such decrease shall resume the status of authorized but unissued shares of Preferred Stock undesignated as to series. The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of at least a majority in voting power of the outstanding shares of capital stock of the Corporation entitled to vote, without the separate vote of the holders of the Preferred Stock as a class irrespective of the provisions of Section 242(b)(2) of the DGCL (and any successor provision thereto) unless a vote of any such holders is required pursuant to the terms of any duly authorized certificate of designation relating to any series of Preferred Stock.
PART C. COMMON STOCK
Except as otherwise provided by the DGCL or this Amended and Restated Certificate of Incorporation (this “ Certificate of Incorporation ”) and subject to the rights of holders of any series of Preferred Stock, all of the voting power of the stockholders of the Corporation shall be vested in the holders of the Common Stock. Each share of Common Stock shall entitle the holder thereof to one vote for each share held by such holder on all matters voted upon by the stockholders of the Corporation; provided , however , that, except as otherwise required by law, holders of Common Stock, as such, shall not be entitled to vote on any amendment to this Certificate of Incorporation (including any duly authorized certificate of designation relating to any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to this Certificate of Incorporation (including any duly authorized certificate of designation relating to any series of Preferred Stock).
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ARTICLE Five
The Corporation is to have perpetual existence.
ARTICLE Six
6.1 Board of Directors . The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors. In addition to the powers and authority expressly conferred upon them by statute or by this Certificate of Incorporation or the Bylaws of the Corporation, the directors are hereby empowered to exercise all such powers and do all such acts and things as may be exercised or done by the Corporation. To the fullest extent permitted by law, to the extent any stockholder or investor rights agreement or similar agreement sets forth procedures governing the nomination of directors and/or any committees thereof or elections to leadership positions on the Board of Directors, the Corporation and the Board of Directors shall act in accordance with the provisions of any such agreement as to the matters set forth therein.
6.2 Number of Directors . Subject to the rights of the holders of any series of Preferred Stock then outstanding to elect additional directors under specified circumstances, the number of directors which shall constitute the Board of Directors shall be fixed exclusively from time to time by resolution adopted by the affirmative vote of a majority of the directors then in office; provided , however , the number of authorized directors as of any time may be increased by one, by resolution adopted by the affirmative vote of a majority of the directors then in office, if and only if (i) the Board of Directors shall have elected any person to serve as the Corporation’s Chief Executive Officer who is not then also serving as a member of the Board of Directors, and (ii) the Board of Directors causes the newly created directorship resulting from such increase in the authorized number of directors to be filled by such person elected to serve as the Corporation’s Chief Executive Officer.
6.3 Classes of Directors . The directors of the Corporation, other than those who may be elected by the holders of any series of Preferred Stock then outstanding under specified circumstances, shall be divided into three classes, hereby designated Class I, Class II and Class III.
6.4 Election and Term of Office . At all meetings of stockholders for the election of directors at which a quorum is present, the directors shall be elected by a plurality of the votes cast by the holders of shares present in person or represented by proxy at the meeting and entitled to vote on the election of directors. Unless otherwise provided in the resolution or resolutions of the Board of Directors with respect to any series of Preferred Stock, whenever the holders of any series of Preferred Stock are entitled to elect one or more directors, such directors shall be elected by a plurality of the votes of the shares of such series. At each annual meeting of stockholders, directors elected to replace those of a class whose terms expire at such annual meeting shall be elected to hold office until the third succeeding annual meeting after their election and until their respective successors shall have been duly elected and qualified. Each director shall hold office until the annual meeting of stockholders at which such director’s term expires and a successor is duly elected and qualified or until his or her earlier death, resignation or removal. Nothing in this Certificate of Incorporation shall preclude a director from serving consecutive terms. Elections of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide.
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6.5 Newly Created Directorships and Vacancies . Subject to the rights of the holders of any series of Preferred Stock then outstanding, newly created directorships resulting from any increase in the authorized number of directors or any vacancies in the Board of Directors resulting from death, resignation, disqualification, removal from office or any other cause may be filled solely by the Board of Directors (and not by stockholders), provided that a quorum is then in office and present, or by a majority of the directors then in office if less than a quorum is then in office, or by the sole remaining director. Notwithstanding the foregoing, any vacancy resulting from the death, resignation, disqualification, removal or any other cause of a director nominated pursuant to the provisions of any applicable stockholder or investor rights agreement or similar agreement that remains in effect at the time of such vacancy may be filled by the Board of Directors only with a director nominated in accordance with the provisions of any such agreement. A director elected to fill a newly-created directorship shall be assigned to a class of directors by the Board of Directors and shall hold office until the next annual meeting of stockholders at which the term of office of the directors assigned to such class expires and a successor is duly elected and qualified or until his or her earlier death, resignation or removal. A director elected to fill a vacancy (other than a newly-created directorship) shall be assigned to the same class of directors as his or her predecessor and shall hold office until the original term of office of such predecessor expires and a successor is duly elected and qualified or until his or her earlier death, resignation or removal. Any newly-created directorships and/or any decreases in the authorized number of directors shall be apportioned among the three classes of directors so as to make all such classes as nearly equal in number as is practicable. No decrease in the authorized number of directors shall shorten the term of any incumbent director.
6.6 Removal of Directors . Subject to the rights of the holders of any series of Preferred Stock then outstanding, any director or the entire Board of Directors may be removed, with or without cause, by the affirmative vote of the holders of at least a majority of the combined voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally on the election of directors, voting as a single class; provided , however , that subject to the rights of the holders of any series of Preferred Stock then outstanding, a director may be removed from office only for cause, at a meeting duly called for that purpose, by the affirmative vote of the holders of a majority of the combined voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally on the election of directors, voting together as a single class.
6.7 Rights of Holders of Preferred Stock . Notwithstanding the provisions of this ARTICLE SIX, whenever the holders of one or more series of Preferred Stock issued by the Corporation shall have the right, voting separately or together by series, to elect directors at an annual or special meeting of stockholders, the election, term of office, filling of vacancies and other features of such directorship shall be governed by the rights of such series of Preferred Stock as set forth in the certificate of designation governing such series.
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6.8 Bylaws . In furtherance and not in limitation of the powers conferred upon it by the laws of the State of Delaware, the Board of Directors shall have the power to adopt, amend, alter or repeal the Corporation’s Bylaws. The affirmative vote of a majority of the directors then in office shall be required to adopt, amend, alter or repeal the Corporation’s Bylaws. The Corporation’s Bylaws also may be adopted, amended, altered or repealed by the stockholders.
6.9 Advance Notice . Advance notice of stockholder nominations for the election of directors and of business to be brought by stockholders before any meeting of the stockholders of the Corporation shall be given in the manner provided in the Bylaws of the Corporation.
ARTICLE Seven
To the fullest extent permitted by the DGCL as it now exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader rights than permitted prior thereto), no director of the Corporation shall be liable to the Corporation or its stockholders for monetary damages arising from a breach of fiduciary duty owed to the Corporation or its stockholders. Any amendment, repeal or modification of the foregoing sentence shall not adversely affect any right or protection of a director of the Corporation existing at the time of such repeal or modification with respect to any act, omission or other matter occurring prior to such amendment, repeal or modification.
ARTICLE Eight
Subject to the rights of the holders of any series of Preferred Stock then outstanding, (i) the stockholders of the Corporation may not take any action by written consent in lieu of a meeting and must take all actions at duly called annual or special meetings of stockholders, and the power of stockholders to consent in writing without a meeting is specifically denied and (ii) special meetings of stockholders of the Corporation may be called only by a resolution adopted by the affirmative vote of a majority of the directors then in office, and may not be called by any other Person or Persons.
ARTICLE Nine
9.1 Section 203 of the DGCL . The Corporation expressly elects not to be governed by or subject to Section 203 of the DGCL.
9.2 Interested Stockholder Transactions . Notwithstanding any other provision in this Certificate of Incorporation to the contrary and in addition to any vote of the holders of any class or series of capital stock of the Corporation required by law, this Certificate of Incorporation (including any duly authorized certificate of designation relating to any series of Preferred Stock) or otherwise, the Corporation shall not engage in any Business Combination (as defined hereinafter) with any Interested Stockholder (as defined hereinafter) for a period of three years following the time that such stockholder became an Interested Stockholder, unless:
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(a) prior to such time the Board of Directors approved either the Business Combination or the transaction which resulted in such stockholder becoming an Interested Stockholder;
(b) upon consummation of the transaction which resulted in such stockholder becoming an Interested Stockholder, such Interested Stockholder Owned at least eighty-five percent (85%) of the Voting Stock (as defined hereinafter) of the Corporation outstanding at the time the transaction commenced, excluding for purposes of determining the Voting Stock outstanding (but not the outstanding Voting Stock Owned by the Interested Stockholder) those shares Owned (i) by Persons (as defined hereinafter) who are directors and also officers of the Corporation and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
(c) at or subsequent to such time the Business Combination is approved by the Board of Directors and authorized at an annual or special meeting of stockholders by the affirmative vote of a majority of the outstanding Voting Stock which is not Owned by the Interested Stockholder.
9.3 Exceptions to Prohibition on Interested Stockholder Transactions . The restrictions contained in this ARTICLE NINE shall not apply if:
(a) a stockholder becomes an Interested Stockholder inadvertently and (i) as soon as practicable divests itself of ownership of sufficient shares so that the stockholder ceases to be an Interested Stockholder; and (ii) would not, at any time within the three-year period immediately prior to a Business Combination between the Corporation and such stockholder, have been an Interested Stockholder but for the inadvertent acquisition of ownership; or
(b) the Business Combination is proposed prior to the consummation or abandonment of and subsequent to the earlier of the public announcement or the notice required hereunder of a proposed transaction which (i) constitutes one of the transactions described in the second sentence of this Section 3(b) of ARTICLE NINE; (ii) is with or by a Person who either was not an Interested Stockholder during the previous three years or who became an Interested Stockholder with the approval of the Board of Directors; and (iii) is approved or not opposed by at least a majority of the directors then in office (but not less than one) who were directors prior to any Person becoming an Interested Stockholder during the previous three years or were recommended for election or elected to succeed such directors by a majority of such directors. The proposed transactions referred to in the preceding sentence are limited to (x) a merger or consolidation of the Corporation (except for a merger in respect of which, pursuant to Section 251(f) of the DGCL, no vote of the stockholders of the Corporation is required); (y) a sale, lease, exchange, mortgage, pledge, transfer or other disposition (in one transaction or a series of transactions), whether as part of a dissolution or otherwise, of assets of the Corporation or of any direct or indirect majority-owned subsidiary of the Corporation (other than to any direct or indirect wholly-owned subsidiary or to the Corporation) having an aggregate market value equal to fifty percent (50%) or more of either that aggregate market value of all of the assets of the Corporation determined on a consolidated basis or the aggregate market value of all the outstanding Stock (as defined hereinafter) of the Corporation; or (z) a proposed tender or exchange offer for fifty percent (50%) or more of the outstanding Voting Stock of the Corporation. The Corporation shall give not less than 20 days’ notice to all Interested Stockholders prior to the consummation of any of the transactions described in clause (x) or (y) of the second sentence of this Section 3(b) of ARTICLE NINE.
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ARTICLE Ten
10.1 Section 251(h) of the DGCL . The Corporation shall not be subject to the provisions of Section 251(h) of the DGCL and, consequently, the vote of stockholders of the Corporation that, absent Section 251(h) of the DGCL, would be required to authorize a merger under the DGCL and this Certificate of Incorporation, shall be required to authorize a merger.
10.2 Affiliate Transactions . In addition to any vote of the holders of any class or series of capital stock of the Corporation required by law or by this Certificate of Incorporation (including any duly authorized certificate of designation relating to any series of Preferred Stock), the affirmative vote of a majority of the directors then in office shall be required prior to the consummation by the Corporation of any agreement, transaction, commitment or arrangement with a Majority Stockholder or any of its Affiliates or Associates.
ARTICLE Eleven
For purposes of this Certificate of Incorporation, the following capitalized terms shall have the meanings set forth below.
“ Affiliate ” means a Person that directly, or indirectly through one or more intermediaries, Controls, or is Controlled By, or is Under Common Control With, another Person.
“ Associate ,” when used to indicate a relationship with any Person, means: (i) any corporation, partnership, unincorporated association or other entity of which such Person is a director, officer or partner or is, directly or indirectly, the Owner of twenty percent (20%) or more of any class of Voting Stock; (ii) any trust or other estate in which such Person has at least a twenty percent (20%) beneficial interest or as to which such Person serves as trustee or in a similar fiduciary capacity; and (iii) any relative or spouse of such Person, or any relative of such spouse, who has the same residence as such Person.
“ Business Combination ” means:
(i) any merger or consolidation of the Corporation or any direct or indirect majority-owned subsidiary of the Corporation with (A) an Interested Stockholder, or (B) with any other corporation, partnership, unincorporated association or other entity if the merger or consolidation is caused by an Interested Stockholder and as a result of such merger or consolidation Section 2 of ARTICLE NINE is not applicable to the surviving entity;
(ii) any sale, lease, exchange, mortgage, pledge, transfer or other disposition (in one transaction or a series of transactions), except proportionately as a stockholder of the Corporation, to or with an Interested Stockholder, whether as part of a dissolution or otherwise, of assets of the Corporation or of any direct or indirect majority-owned subsidiary of the Corporation which assets have an aggregate market value equal to ten percent (10%) or more of either the aggregate market value of all the assets of the Corporation determined on a consolidated basis or the aggregate market value of all the outstanding Stock of the Corporation;
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(iii) any transaction which results in the issuance or transfer by the Corporation or by any direct or indirect majority-owned subsidiary of the Corporation of any Stock of the Corporation or of such subsidiary to an Interested Stockholder, except: (A) pursuant to the exercise, exchange or conversion of securities exercisable for, exchangeable for or convertible into Stock of the Corporation or any such subsidiary which securities were outstanding prior to the time that the Interested Stockholder became such; (B) pursuant to a merger under Section 251(g) of the DGCL; (C) pursuant to a dividend or distribution paid or made, or the exercise, exchange or conversion of securities exercisable for, exchangeable for or convertible into Stock of the Corporation or any such subsidiary which security is distributed, pro rata to all holders of a class or series of Stock of the Corporation subsequent to the time the Interested Stockholder became such; (D) pursuant to an exchange offer by the Corporation to purchase Stock made on the same terms to all holders of such Stock; or (E) any issuance or transfer of Stock by the Corporation; provided , however , that in no case under items (C)-(E) of this clause (iii) shall there be an increase in an Interested Stockholder’s proportionate share of the Stock of any class or series of the Corporation or of the Voting Stock of the Corporation;
(iv) any transaction involving the Corporation or any direct or indirect majority-owned subsidiary of the Corporation which has the effect, directly or indirectly, of increasing the proportionate share of the Stock of any class or series, or securities convertible into the Stock of any class or series, of the Corporation or of any such subsidiary which is Owned by an Interested Stockholder, except as a result of immaterial changes due to fractional share adjustments or as a result of any purchase or redemption of any shares of Stock not caused, directly or indirectly, by an Interested Stockholder; or
(v) any receipt by the Interested Stockholder of the benefit, directly or indirectly (except proportionately as a stockholder of the Corporation), of any loans, advances, guarantees, pledges or other financial benefits (other than those expressly permitted in clauses (i)-(iv) of this definition) provided by or through the Corporation or any direct or indirect majority-owned subsidiary of the Corporation.
“ Control ,” including the terms “ Controlled By ” and “ Under Common Control With ,” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of Voting Stock or other equity interests, by contract or otherwise. A Person who is the Owner of twenty percent (20%) or more of the outstanding Voting Stock of any corporation, partnership, unincorporated association or other entity shall be presumed to have control of such entity, in the absence of proof by a preponderance of the evidence to the contrary; notwithstanding the foregoing, a presumption of control shall not apply where such Person holds Voting Stock, in good faith and not for the purpose of circumventing ARTICLE NINE, as an agent, bank, broker, nominee, custodian or trustee for one or more Owners who do not individually or as a group have control of such entity.
“ Initial Public Offering ” means the Corporation’s initial public offering of its Common Stock pursuant to an effective registration statement under the Securities Act of 1933, as amended.
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“ Interested Stockholder ” means any Person (other than the Corporation and any direct or indirect majority-owned subsidiary of the Corporation) that (i) is the Owner of fifteen percent (15%) or more of the outstanding Voting Stock of the Corporation, or (ii) is an Affiliate or Associate of the Corporation and was the Owner of fifteen percent (15%) or more of the outstanding Voting Stock of the Corporation at any time within the three-year period immediately prior to the date on which it is sought to be determined whether such Person is an Interested Stockholder, and the Affiliates and Associates of such Person. Notwithstanding anything in ARTICLE NINE or this definition to the contrary, the term “ Interested Stockholder ” shall not include: (x) any Person that, individually or together with all of such Person’s Affiliates and/or Associates, is the Owner of fifteen percent (15%) or more of the outstanding Voting Stock of the Corporation immediately prior to the consummation of the Initial Public Offering or any of such Person’s Affiliates or Associates; (y) any Person who would otherwise be or become an Interested Stockholder either in connection with or because of a transfer, sale, assignment, conveyance, hypothecation, encumbrance, or other disposition of three percent (3%) or more of the outstanding Voting Stock of the Corporation (in one transaction or a series of transactions) by any Person described in the immediately preceding clause (x) to such Person; provided , however , that for purposes of this clause (y) such Person was not an Interested Stockholder prior to such transfer, sale, assignment, conveyance, hypothecation, encumbrance, or other disposition; or (z) any Person whose ownership of shares in excess of the fifteen percent (15%) limitation set forth herein is the result of action taken solely by the Corporation, provided that, for purposes of this clause (z), such Person shall be an Interested Stockholder if thereafter such Person acquires additional shares of Voting Stock of the Corporation, except as a result of further action by the Corporation not caused, directly or indirectly, by such Person.
“ Majority Stockholder ” means a Person that, individually or together with all of such Person’s Affiliates and/or Associates, Owns more than fifty percent (50%) of the combined voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally on the election of directors; provided , however , that a Majority Stockholder shall not include any Person that, individually or together with all of such Person’s Affiliates and/or Associates, is the Owner of fifteen percent (15%) or more of the outstanding Voting Stock of the Corporation immediately prior to the consummation of the Initial Public Offering or any of such Person’s Affiliates or Associates (even if such Person, individually or together with all of such Person’s Affiliates and/or Associates, Owns at the time of any determination more than fifty percent (50%) of the combined voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally on the election of directors).
“ Owner ,” including the terms “ Own ,” “ Owns ” and “ Owned ,” when used with respect to any Stock, means a Person that individually or with or through any of its Affiliates or Associates (1) beneficially owns such Stock, directly or indirectly (including for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder); (2) has (A) the right to acquire such Stock (whether such right is exercisable immediately or only after the passage of time) pursuant to any agreement, arrangement or understanding, or upon the exercise of conversion rights, exchange rights, warrants or options, or otherwise; provided , however , that a Person shall not be deemed the owner of Stock tendered pursuant to a tender or exchange offer made by such Person or any of such Person’s Affiliates or Associates until such tendered Stock is accepted for purchase or exchange; or (B) the right to vote such Stock pursuant to any agreement, arrangement or understanding; provided , however , that a Person shall not be deemed the owner of any Stock because of such Person’s right to vote such Stock if the agreement, arrangement or understanding to vote such Stock arises solely from a revocable proxy or consent given in response to a proxy or consent solicitation made to 10 or more Persons; or (3) has any agreement, arrangement or understanding for the purpose of acquiring, holding, voting (except voting pursuant to a revocable proxy or consent as described in the immediately preceding clause (2)(B) of this definition), or disposing of such Stock with any other Person that beneficially owns, or whose Affiliates or Associates beneficially own, directly or indirectly, such Stock; provided , that, for the purpose of determining whether a Person is an Interested Stockholder, the Voting Stock of the Corporation deemed to be outstanding shall include Stock deemed to be owned by the Person through application of this definition but shall not include any other unissued Stock of the Corporation which may be issuable pursuant to any agreement, arrangement or understanding, or upon exercise of conversion rights, warrants or options, or otherwise.
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“ Person ” means an individual, a partnership, a corporation, a limited liability company, a joint stock company, a trust, a joint venture, an unincorporated organization or association or other entity.
“ Stock ” means, with respect to any corporation, capital stock and, with respect to any other entity, any equity interest.
“ Voting Stock ” means, with respect to any corporation, Stock of any class or series entitled to vote generally in the election of directors and, with respect to any entity that is not a corporation, any equity interest entitled to vote generally in the election of the governing body of such entity. Every reference to a percentage of Voting Stock contained in ARTICLE NINE shall refer to such percentage of the votes of such Voting Stock.
ARTICLE Twelve
The Corporation reserves the right at any time, and from time to time, to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, and other provisions authorized by the laws of the State of Delaware at the time in force may be added or inserted, in the manner now or hereafter prescribed herein and by the laws of the State of Delaware, and all rights, preferences and privileges of any nature conferred upon stockholders, directors or any other persons pursuant to this Certificate of Incorporation in its present form or as hereafter amended are granted subject to this reservation. Notwithstanding any other provision of this Certificate of Incorporation or the Bylaws of the Corporation to the contrary, and notwithstanding the fact that a lesser percentage or separate class vote may be specified by law or otherwise, but in addition to any vote of the holders of any class or series of capital stock of the Corporation required by law, this Certificate of Incorporation (including any duly authorized certificate of designation relating to any series of Preferred Stock) or otherwise, the affirmative vote of the holders of a majority of the combined voting power of all of the then outstanding shares of capital stock of the Corporation entitled to vote generally on the election of directors, voting together as a single class, shall be required to adopt any provision inconsistent with, to amend, alter, change or repeal any provision of, or to adopt any bylaw inconsistent with, ARTICLE FOUR, PART A.1 (but only to the extent that such amendment would decrease the number of authorized shares of Preferred Stock) or PART B or ARTICLES SIX, SEVEN, EIGHT, NINE, TEN, ELEVEN or TWELVE of this Certificate of Incorporation, in each case whether by amendment, or by merger, consolidation or otherwise.
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ARTICLE Thirteen
Unless the Corporation, as authorized by the Board of Directors, consents in writing to the selection of one or more alternative forums, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for a stockholder (including a beneficial owner) to bring (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim against the Corporation arising pursuant to any provision of the DGCL or this Certificate of Incorporation or the Corporation’s Bylaws or (iv) any action asserting a claim against the Corporation, its directors, officers or employees governed by the internal affairs doctrine, except for, as to each of (i) through (iv), any claim as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation (including, without limitation, shares of Common Stock) shall, and shall be deemed to, have notice of and to have consented to the provisions of this ARTICLE THIRTEEN. If any provision or provisions of this ARTICLE THIRTEEN shall be held to be invalid, illegal or unenforceable as applied to any person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provisions in any other circumstance and of the remaining provisions of this ARTICLE THIRTEEN (including, without limitation, each portion of any sentence of this ARTICLE THIRTEEN containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable) and the application of such provision to other persons or entities and circumstances shall not in any way be affected or impaired thereby.
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Exhibit 3.2
THIRD AMENDED AND RESTATED BYLAWS
OF
IMMUNIC, INC.
A Delaware corporation
(Adopted as of July 16, 2019)
ARTICLE I
OFFICES
Section 1. Offices . Immunic, Inc. (the “ Corporation ”) may have an office or offices other than its registered office at such place or places, either within or outside the State of Delaware, as the Board of Directors of the Corporation (the “ Board of Directors ”) may from time to time determine or the business of the Corporation may require.
ARTICLE II
MEETINGS OF STOCKHOLDERS
Section 1. Place of Meetings . The Board of Directors may designate a place, if any, either within or outside the State of Delaware, as the place of meeting for any annual meeting or for any special meeting of stockholders.
Section 2. Annual Meeting . An annual meeting of the stockholders shall be held each year on such date and at such time as is specified by the Board of Directors. At the annual meeting, stockholders shall elect directors to succeed those whose terms expire and transact such other business as properly may be brought before the annual meeting pursuant to Section 11 of ARTICLE II of these Third Amended and Restated Bylaws (the “ Bylaws ”). The Board of Directors may postpone, reschedule or cancel any previously scheduled annual meeting.
Section 3. Special Meetings . Special meetings of the stockholders for any purpose or purposes may only be called in the manner provided in the Corporation’s certificate of incorporation as then in effect (the “ Certificate of Incorporation ”). Business transacted at any special meeting of stockholders shall be limited to the purposes stated in the notice. The Board of Directors may postpone, reschedule or cancel any previously scheduled special meeting.
Section 4. Notice of Meetings . Notice of the place, if any, date, and time of all meetings of the stockholders, the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the meeting and, in the case of a special meeting, the purpose or purposes for which the meeting is called, shall be given, not less than 10 nor more than 60 days before the date on which the meeting is to be held, to each stockholder entitled to vote at such meeting as of the record date for determining the stockholders entitled to notice of the meeting, except as otherwise provided herein or required by law (meaning, here and hereinafter, as required from time to time by the General Corporation Law of the State of Delaware (the “ DGCL ”) or the Certificate of Incorporation).
(a) Form of Notice. All such notices shall be delivered in writing or by a form of electronic transmission if receipt thereof has been consented to by the stockholder to whom the notice is given pursuant to applicable law. If mailed, such notice shall be deemed given when deposited in the United States mail, postage prepaid, addressed to the stockholder at his, her or its address as the same appears on the records of the Corporation. Subject to the limitations of Section 4(c) of this ARTICLE II, if given by electronic transmission, such notice shall be deemed to be delivered: (i) by electronic mail, when directed to an electronic mail address at which the stockholder has consented to receive notice; (ii) if by a posting on an electronic network together with separate notice to the stockholder of such specific posting, upon the later of (x) such posting and (y) the giving of such separate notice; and (iii) if by any other form of electronic transmission, when directed to the stockholder. An affidavit of the Secretary or an Assistant Secretary of the Corporation, the transfer agent of the Corporation or any other agent of the Corporation that the notice has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein.
(b) Waiver of Notice. Whenever notice is required to be given under any provisions of the DGCL, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or these Bylaws, a written waiver thereof, signed by the stockholder entitled to notice, or a waiver by electronic transmission by the person or entity entitled to notice, whether before or after the time stated therein, shall be deemed equivalent to notice. Neither the business to be transacted at, nor the purpose of, any meeting of the stockholders of the Corporation need be specified in any waiver of notice of such meeting. Attendance of a stockholder of the Corporation at a meeting of such stockholders shall constitute a waiver of notice of such meeting, except when the stockholder attends for the express purpose of objecting at the beginning of the meeting to the transaction of any business because the meeting is not lawfully called or convened.
(c) Notice by Electronic Delivery . Without limiting the manner by which notice otherwise may be given effectively to stockholders of the Corporation pursuant to the DGCL, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or these Bylaws, any notice to stockholders of the Corporation given by the Corporation under any provision of the DGCL, the Certificate of Incorporation or these Bylaws shall be effective if given by a form of electronic transmission consented to by the stockholder of the Corporation to whom the notice is given. Any such consent shall be revocable by the stockholder by written notice to the Corporation. Any such consent shall be deemed revoked if: (i) the Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such consent; and (ii) such inability becomes known to the Secretary or an Assistant Secretary of the Corporation or to the transfer agent or other person responsible for the giving of notice. However, the inadvertent failure to treat such inability as a revocation shall not invalidate any meeting or other action. For purposes of these Bylaws, except as otherwise limited by applicable law, the term “ electronic transmission ” means any form of communication not directly involving the physical transmission of paper that creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such recipient through an automated process.
Section 5. List of Stockholders . The officer who has charge of the stock ledger of the Corporation shall prepare and make available, at least 10 days before each meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting; provided, however, if the record date for determining the stockholders entitled to vote is less than 10 days before the meeting date, the list shall reflect the stockholders entitled to vote as of the 10th day before the meeting date, arranged in alphabetical order and showing the address of each such stockholder and the number of shares registered in his or her name. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during normal business hours, for a period of at least 10 days prior to the meeting: (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (b) during ordinary business hours, at the principal place of business of the Corporation. In the event the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation. If the meeting is to be held at a place, the list shall be produced and kept at the time and place, if any, of the meeting during the whole time thereof and may be inspected by any stockholder who is present. If the meeting is to be held solely by means of remote communication, then the list shall also be open to the examination of any stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information required to access such list shall be provided with the notice of the meeting. Except as otherwise provided by law, the stock ledger shall be the only evidence as to who are the stockholders entitled to examine the list of stockholders required by this Section 5 of ARTICLE II or to vote in person or by proxy at any meeting of stockholders.
Section 6. Quorum . The holders of a majority of the voting power of the outstanding capital stock entitled to vote at the meeting, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders, unless or except to the extent that the presence of a larger number may be required by the DGCL, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or the rules of any stock exchange upon which the Corporation’s securities are listed. If a quorum is not present, the chairman of the meeting or the holders of a majority of the voting power present in person or represented by proxy at the meeting and entitled to vote at the meeting may adjourn the meeting in the manner provided in Section 7 of ARTICLE II of these Bylaws until a quorum shall attend. When a specified item of business requires a separate vote by a class or series (if the Corporation shall then have outstanding shares of more than one class or series) voting as a class or series, the holders of a majority of the voting power of such class or series shall constitute a quorum (as to such class or series) for the transaction of such item of business.
Section 7. Adjourned Meetings . Any meeting of stockholders, annual or special, may be adjourned from time to time to reconvene at the same or some other place. When a meeting is adjourned to another time and place, notice need not be given of the adjourned meeting if the time and place, if any, thereof and the means of remote communication, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such adjourned meeting are announced at the meeting at which the adjournment is taken; provided, however, if the adjournment is for more than 30 days, a notice of the place, if any, date and time of the adjourned meeting and the means of remote communication, if any, by which stockholder and proxyholders may be deemed to be present in person and vote at such adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. A determination of stockholders of record entitled to notice of and to vote at any meeting shall apply to any adjournment of the meeting, provided that the Board of Directors may fix a new record date for notice of and to vote at such adjourned meeting. If a new record date for stockholders entitled to notice of and to vote at such adjourned meeting is fixed, such record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors and, except as otherwise required by law, shall not be more than 60 days nor less than 10 days before the date of such adjourned meeting. Notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at such adjourned meeting as of the record date fixed for notice of such adjourned meeting. At the adjourned meeting the Corporation may transact any business which might have been transacted at the original meeting.
Section 8. Vote Required . When a quorum is present, the affirmative vote of the holders of a majority of voting power of capital stock present in person or represented by proxy at the meeting and entitled to vote on the subject matter shall be the act of the stockholders, unless by express provisions of an applicable law, the rules of any stock exchange upon which the Corporation’s securities are listed, the Certificate of Incorporation or the certificate of designations relating to any series of preferred stock then outstanding, a different vote is required, in which case such express provision shall govern and control the decision of such question.
Section 9. Voting Rights . Except as otherwise provided by the DGCL, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or these Bylaws, every stockholder shall at every meeting of the stockholders be entitled to one vote for each share of capital stock held by such stockholder who has voting power regarding the matter in question.
Section 10. Proxies . Each stockholder entitled to vote at a meeting of stockholders may authorize another person or persons to act for him or her by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. A duly executed proxy shall be irrevocable if it states that it is irrevocable and if, and only as long as, it is coupled with an interest sufficient in law to support an irrevocable power. A proxy may be made irrevocable regardless of whether the interest with which it is coupled is an interest in the stock itself or an interest in the Corporation generally.
Section 11. Advance Notice of Stockholder Business and Director Nominations .
(a) Business at Annual Meetings of Stockholders .
(i) Only such business (other than nominations of persons for election to the Board of Directors, which must be made in compliance with and are governed exclusively by Section 11(b) of this ARTICLE II) shall be conducted at an annual meeting of the stockholders as shall have been brought before the meeting (A) as specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors, (B) by or at the direction of the Board of Directors or any committee thereof, or (C) by any stockholder of the Corporation who (1) was a stockholder of record at the time of giving of notice provided for in this Section 11(a) of ARTICLE II and at the time of the meeting, (2) is entitled to vote at the meeting and (3) complies with the notice procedures set forth in this Section 11(a) of ARTICLE II. For the avoidance of doubt, the foregoing clause (C) of this Section 11(a)(i) of ARTICLE II shall be the exclusive means for a stockholder to propose such business (other than business included in the Corporation’s annual meeting proxy materials pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”)) before an annual meeting of stockholders.
(ii) For any business (other than nominations of persons for election to the Board of Directors, which must be made in compliance with and are governed exclusively by Section 11(b) of this ARTICLE II) to be properly brought before an annual meeting by a stockholder, the stockholder must have given timely notice thereof in proper written form as described in Section 11(a)(iii) of this ARTICLE II to the Secretary; any such proposed business must be a proper matter for stockholder action and the stockholder and the Stockholder Associated Person (as defined in Section 11(e) of this ARTICLE II) must have acted in accordance with the representations set forth in the Solicitation Statement (as defined in Section 11(a)(iii) of this ARTICLE II) required by these Bylaws. To be timely, a stockholder’s notice for such business must be received by the Secretary at the principal executive offices of the Corporation in proper written form not less than 90 days and not more than 120 days prior to the first anniversary of the preceding year’s annual meeting of stockholders; provided, however, that if and only if the annual meeting is not scheduled to be held within a period that commences 30 days before such anniversary date and ends 30 days after such anniversary date, or if no annual meeting was held in the preceding year, such stockholder’s notice must be delivered by the later of (A) the tenth day following the day the Public Announcement (as defined in Section 11(e) of this ARTICLE II) of the date of the annual meeting is first made by the Corporation or (B) the date which is 90 days prior to the date of the annual meeting. In no event shall any adjournment, deferral or postponement of an annual meeting or the announcement thereof commence a new time period for the giving of a stockholder’s notice as described above. Notices delivered pursuant to Section 11(a) of this ARTICLE II will be deemed received on any given day if received prior to the close of business on such day (and otherwise on the next succeeding day).
(iii) To be in proper written form, a stockholder’s notice to the Secretary must set forth as to each matter of business the stockholder proposes to bring before the annual meeting (A) a brief description of the business desired to be brought before the annual meeting (including the specific text of any resolutions or actions proposed for consideration and if such business includes a proposal to amend these Bylaws, the specific language of the proposed amendment) and the reasons for conducting such business at the annual meeting, (B) the name and address of the stockholder proposing such business, as they appear on the Corporation’s books, the residence name and address (if different from the Corporation’s books) of such proposing stockholder, and the name and address of any Stockholder Associated Person covered by clauses (C), (D), (F) and (G) below, (C) the class or series and number of shares of stock of the Corporation which are directly or indirectly held of record or beneficially owned by such stockholder or by any Stockholder Associated Person, a description of any Derivative Positions (as defined in Section 11(e) of this ARTICLE II) directly or indirectly held or beneficially held by the stockholder or any Stockholder Associated Person, and whether and the extent to which a Hedging Transaction (as defined in Section 11(e) of this ARTICLE II) has been entered into by or on behalf of such stockholder or any Stockholder Associated Person, (D) a description of all arrangements or understandings between or among such stockholder or any Stockholder Associated Person and any other person or entity (including their names) in connection with the proposal of such business by such stockholder and any material interest of such stockholder, any Stockholder Associated Person or such other person or entity in such business, (E) a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting and that such stockholder intends to appear in person or by proxy at the annual meeting to bring such business before the meeting, (F) any other information related to such stockholder or any Stockholder Associated Person that would be required to be disclosed in a proxy statement or other filing required to be made in connection with the solicitation of proxies or consents (even if a solicitation is not involved) by such stockholder or Stockholder Associated Person in support of the business proposed to be brought before the meeting pursuant to Section 14 of the Exchange Act, and the rules, regulations and schedules promulgated thereunder and (G) a representation as to whether such stockholder or any Stockholder Associated Person intends to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve the proposal or otherwise to solicit proxies or votes from stockholders in support of the proposal (such representation, a “ Solicitation Statement ”). In addition, any stockholder who submits a notice pursuant to this Section 11(a) of ARTICLE II is required to update and supplement the information disclosed in such notice, if necessary, in accordance with Section 11(d) of this ARTICLE II.
(iv) Notwithstanding anything in these Bylaws to the contrary, no business (other than nominations of persons for election to the Board of Directors, which must be made in compliance with and are governed exclusively by Section 11(b) of this ARTICLE II) shall be conducted at an annual meeting except in accordance with the procedures set forth in this Section 11(a) of ARTICLE II.
(b) Nominations at Annual Meetings of Stockholders .
(i) Only persons who are nominated in accordance and compliance with the procedures set forth in Section 11(b) of ARTICLE II shall be eligible for election to the Board of Directors at an annual meeting of stockholders.
(ii) Nominations of persons for election to the Board of Directors of the Corporation may be made at an annual meeting of stockholders only (A) by or at the direction of the Board of Directors or any committee thereof or (B) by any stockholder of the Corporation who (1) was a stockholder of record at the time of giving of notice provided for in Section 11(b) of ARTICLE II and at the time of the meeting, (2) is entitled to vote at the meeting and (3) complies with the notice procedures set forth in Section 11(b) of ARTICLE II. For the avoidance of doubt, clause (B) of this Section 11(b)(ii) of ARTICLE II shall be the exclusive means for a stockholder to make nominations of persons for election to the Board of Directors at an annual meeting of stockholders. For nominations to be properly brought by a stockholder at an annual meeting of stockholders, the stockholder must have given timely notice thereof in proper written form as described in Section 11(b)(iii) of ARTICLE II to the President and the stockholder and the Stockholder Associated Person must have acted in accordance with the representations set forth in the Nomination Solicitation Statement (as defined in Section 11(b)(iii) of ARTICLE II) required by these Bylaws. To be timely, a stockholder’s notice for the nomination of persons for election to the Board of Directors must be delivered to the President at the principal executive offices of the Corporation in proper written form not less than 90 days and not more than 120 days prior to the first anniversary of the preceding year’s annual meeting of stockholders; provided, however, that if and only if the annual meeting is not scheduled to be held within a period that commences 30 days before such anniversary date and ends 30 days after such anniversary date, or if no annual meeting was held in the preceding year, such stockholder’s notice must be delivered by the later of the tenth day following the day the Public Announcement of the date of the annual meeting is first made by the Corporation and the date which is 90 days prior to the date of the annual meeting. In no event shall any adjournment, deferral or postponement of an annual meeting or the announcement thereof commence a new time period for the giving of a stockholder’s notice as described above. Notices delivered pursuant to Section 11(b) of ARTICLE II will be deemed received on any given day if received prior to the close of business on such day (and otherwise on the next succeeding day).
(iii) To be in proper written form, a stockholder’s notice to the President shall set forth (A) as to each person whom the stockholder proposes to nominate for election or re-election as a director of the Corporation, (1) the name, age, business address and residence address of the person, (2) the principal occupation or employment of the person, (3) the class or series and number of shares of capital stock of the Corporation which are directly or indirectly owned beneficially or of record by the person, (4) the date such shares were acquired and the investment intent of such acquisition and (5) any other information relating to the person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with the solicitation of proxies or consents for a contested election of directors (even if an election contest or proxy solicitation is not involved), or is otherwise required, pursuant to Section 14 of the Exchange Act, and the rules, regulations and schedules promulgated thereunder (including such person’s written consent to being named in the proxy statement as a nominee, if applicable, and to serving if elected), (B) as to the stockholder giving the notice, the name and address of such stockholder, as they appear on the Corporation’s books, the residence name and address (if different from the Corporation’s books) of such proposing stockholder, and the name and address of any Stockholder Associated Person covered by clauses (C), (D), (F) and (G) below, (C) the class or series and number of shares of stock of the Corporation which are directly or indirectly held of record or beneficially owned by such stockholder or by any Stockholder Associated Person with respect to the Corporation’s securities, a description of any Derivative Positions directly or indirectly held or beneficially held by the stockholder or any Stockholder Associated Person, and whether and the extent to which a Hedging Transaction has been entered into by or on behalf of such stockholder or any Stockholder Associated Person, (D) a description of all arrangements or understandings (including financial transactions and direct or indirect compensation) between or among such stockholder or any Stockholder Associated Person and each proposed nominee and any other person or entity (including their names) pursuant to which the nomination(s) are to be made by such stockholder, (E) a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting and that such stockholder intends to appear in person or by proxy at the meeting to nominate the persons named in its notice, (F) any other information relating to such stockholder or any Stockholder Associated Person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with the solicitation of proxies or consents for a contested election of directors (even if an election contest or proxy solicitation is not involved), or otherwise required, pursuant to Section 14 of the Exchange Act, and the rules, regulations and schedules promulgated thereunder, and (G) a representation as to whether such stockholder or any Stockholder Associated Person intends to deliver a proxy statement and/or form of proxy to the holders of a sufficient number of the Corporation’s outstanding shares reasonably believed by the stockholder or any Stockholder Associated Person, as the case may be, to elect each proposed nominee or otherwise to solicit proxies or votes from stockholders in support of the nomination (such representation, a “ Nomination Solicitation Statement ”). In addition, any stockholder who submits a notice pursuant to this Section 11(b) of ARTICLE II is required to update and supplement the information disclosed in such notice, if necessary, in accordance with Section 11(d) of ARTICLE II and shall comply with Section 11(f) of ARTICLE II.
(iv) Notwithstanding anything in Section 11(b)(ii) of ARTICLE II to the contrary, if the number of directors to be elected to the Board of Directors at the annual meeting is increased effective after the time period for which nominations would otherwise be due under Section 11(b)(ii) of this ARTICLE II and there is no Public Announcement naming all of the nominees for director or specifying the size of the increased Board of Directors made by the Corporation at least 10 days prior to the last day a stockholder may deliver a notice of nomination in accordance with Section 11(b)(ii), a stockholder’s notice required by Section 11(b)(ii) of ARTICLE II shall also be considered timely, but only with respect to nominees for any new positions created by such increase, if it shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the tenth day following the day on which such Public Announcement is first made by the Corporation.
(c) Special Meetings of Stockholders . Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the notice of meeting. Only persons who are nominated in accordance and compliance with the procedures set forth in this Section 11(c) of ARTICLE II shall be eligible for election to the Board of Directors at a special meeting of stockholders at which directors are to be elected. Nominations of persons for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be elected pursuant to the notice of meeting only (i) by or at the direction of the Board of Directors or any committee thereof or (ii) provided that the Board of Directors has determined that directors are to be elected at such special meeting, by any stockholder of the Corporation who (A) was a stockholder of record at the time of giving of notice provided for in this Section 11(c) of ARTICLE II and at the time of the special meeting, (B) is entitled to vote at the meeting and (C) complies with the notice procedures provided for in this Section 11(c) of ARTICLE II. For the avoidance of doubt, the foregoing clause (ii) of this Section 11(c) of ARTICLE II shall be the exclusive means for a stockholder to propose nominations of persons for election to the Board of Directors at a special meeting of stockholders at which directors are to be elected. For nominations to be properly brought by a stockholder at a special meeting of stockholders, the stockholder must have given timely notice thereof in proper written form as described in this Section 11(c) of ARTICLE II to the Secretary. To be timely, a stockholder’s notice for the nomination of persons for election to the Board of Directors must be received by the Secretary at the principal executive offices of the Corporation not earlier than the 120th day prior to such special meeting and not later than the close of business on the later of the 90th day prior to such special meeting or the tenth day following the day on which a Public Announcement is first made by the Corporation of the date of the special meeting and of the nominees proposed by the Board of Directors to be elected at such meeting. In no event shall any adjournment, deferral or postponement of a special meeting or the announcement thereof commence a new time period for the giving of a stockholder’s notice as described above. Notices delivered pursuant to Section 11(c) of ARTICLE II will be deemed received on any given day if received prior to the close of business on such day. To be in proper written form, such stockholder’s notice shall set forth all of the information required by, and otherwise be in compliance with, Section 11(b)(iii) of ARTICLE II. In addition, any stockholder who submits a notice pursuant to this Section 11(c) of ARTICLE II is required to update and supplement the information disclosed in such notice, if necessary, in accordance with Section 11(d) of ARTICLE II and shall comply with Section 11(f) of ARTICLE II.
(d) Update and Supplement of Stockholder’s Notice . Any stockholder who submits a notice of proposal for business or nomination for election pursuant to this Section 11 of ARTICLE II is required to update and supplement the information disclosed in such notice, if necessary, so that the information provided or required to be provided in such notice shall be true and correct as of the record date for determining the stockholders entitled to notice of the meeting of stockholders and as of the date that is 10 business days prior to such meeting of the stockholders or any adjournment or postponement thereof, and such update and supplement shall be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the fifth business day after the record date for the meeting of stockholders (in the case of the update and supplement required to be made as of the record date), and not later than the close of business on the eighth business day prior to the date for the meeting of stockholders or any adjournment or postponement thereof (in the case of the update and supplement required to be made as of 10 business days prior to the meeting of stockholders or any adjournment or postponement thereof).
(e) Definitions . For purposes of this Section 11 of ARTICLE II, the term:
(i) “ Derivative Positions ” means, with respect to a stockholder or any Stockholder Associated Person, any derivative positions including, without limitation, any short position, profits interest, option, warrant, convertible security, stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any class or series of shares of the Corporation or with a value derived in whole or in part from the value of any class or series of shares of the Corporation, whether or not such instrument or right shall be subject to settlement in the underlying class or series of capital stock of the Corporation or otherwise and any performance-related fees to which such stockholder or any Stockholder Associated Person is entitled based, directly or indirectly, on any increase or decrease in the value of shares of capital stock of the Corporation;
(ii) “ Hedging Transaction ” means, with respect to a stockholder or any Stockholder Associated Person, any hedging or other transaction (such as borrowed or loaned shares) or series of transactions, or any other agreement, arrangement or understanding, the effect or intent of which is to increase or decrease the voting power or economic or pecuniary interest of such stockholder or any Stockholder Associated Person with respect to the Corporation’s securities;
(iii) “ Public Announcement ” means disclosure in a press release reported by the Dow Jones News Service, Associated Press, Business Wire, PR Newswire or comparable news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Exchange Act; and
(iv) “ Stockholder Associated Person ” of any stockholder means (A) any person controlling, directly or indirectly, or acting in concert with, such stockholder, (B) any beneficial owner of shares of stock of the Corporation owned of record or beneficially by such stockholder or (C) any person directly or indirectly controlling, controlled by or under common control with such Stockholder Associated Person.
(f) Submission of Questionnaire, Representation and Agreement . To be qualified to be a nominee for election or re-election as a director of the Corporation, a person must deliver (in the case of a person nominated by a stockholder in accordance with Section 11(b) or 11(c) of this ARTICLE II, in accordance with the time periods prescribed for delivery of notice under such sections) to the Secretary at the principal executive offices of the Corporation a written questionnaire with respect to the background and qualification of such person and the background of any other person or entity on whose behalf the nomination is being made (which questionnaire shall be provided by the Secretary upon written request) and a written representation and agreement (in the form provided by the Secretary upon written request) that such person (i) is not and will not become a party to (A) any agreement, arrangement or understanding with, and has not given any commitment or assurance to, any person or entity as to how such person, if elected as a director of the Corporation, will act or vote on any issue or question (a “ Voting Commitment ”) that has not been disclosed to the Corporation or (B) any Voting Commitment that could limit or interfere with such person’s ability to comply, if elected as a director of the Corporation, with such person’s fiduciary duties under applicable law, (ii) is not and will not become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect to any direct or indirect compensation, reimbursement or indemnification in connection with service or action as a director that has not been disclosed therein and (iii) would be in compliance, and if elected as a director of the Corporation will comply, with all applicable publicly disclosed corporate governance, conflict of interest, confidentiality and stock ownership and trading policies and guidelines of the Corporation. The Corporation may also require any proposed nominee to furnish such other information as may reasonably be required by the Corporation to determine the eligibility of such proposed nominee to serve either as a director of the Corporation or as an independent director of the Corporation under applicable Securities and Exchange Commission and stock exchange rules and the Corporation’s publicly disclosed corporate governance guidelines, or that could be material to a reasonable stockholder’s understanding of the qualifications and/or independence, or lack thereof, of such nominee.
(g) Authority of Chairman of Meeting . Except as otherwise provided by applicable law, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or these Bylaws, the chairman of the meeting shall have the power and duty to determine whether any nomination or other business proposed to be brought before the meeting was made or brought in accordance with the procedures set forth in these Bylaws (including whether the stockholder (or Stockholder Associated Person, if any) on whose behalf the nomination or proposal is made solicited (or was part of a group that solicited) or did not so solicit, as the case may be, proxies or votes in support of such nominee or proposal in compliance with such stockholder’s Solicitation Statement or Nomination Solicitation Statement, as applicable) and, if any nomination or other business is not made or brought in compliance with these Bylaws, to declare that such nomination or proposal of other business be disregarded and not acted upon. Notwithstanding the foregoing provisions of this Section 11 of ARTICLE II, unless otherwise required by law, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual or special meeting of stockholders of the Corporation to present a nomination or proposed business, such nomination shall be disregarded and such proposed business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 11 of Article II, to be considered a qualified representative of the stockholder, a person must be a duly authorized officer, manager or partner of such stockholder or must be authorized by a writing executed by such stockholder or an electronic transmission delivered by such stockholder to act for such stockholder as proxy at the meeting of stockholders and such person must produce such writing or electronic transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
(h) Compliance with Exchange Act . Notwithstanding the foregoing provisions of these Bylaws, a stockholder shall also comply with all applicable requirements of the Exchange Act and the rules and regulations promulgated thereunder with respect to the matters set forth in these Bylaws; provided, however, that any references in these Bylaws to the Exchange Act or the rules and regulations promulgated thereunder are not intended to and shall not limit the requirements applicable to any nomination or other business to be considered pursuant to this Section 11 of ARTICLE II.
(i) Effect on Other Rights . Nothing in these Bylaws shall be deemed to affect any rights of the stockholders to request inclusion of proposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act or of the holders of any series of preferred stock to elect directors pursuant to any applicable provisions of the Certificate of Incorporation or the certificate of designations relating to any series of preferred stock then outstanding. Notwithstanding the foregoing, the restrictions, requirements and limitations in this Section 11 shall not apply to any nominations to be brought before an annual or special meeting of stockholders as directed or requested pursuant to any stockholders, investors’ rights or similar agreement in effect on the date hereof.
Section 12. Fixing a Record Date for Stockholder Meetings . In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, the Board of Directors may fix, in advance, a record date, which record date shall, unless otherwise required by law, not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date shall not be more than 60 days nor less than 10 days before the date of such meeting. If the Board of Directors so fixes a date, such date shall also be the record date for determining the stockholders entitled to vote at such meeting unless the Board of Directors determines, at the time it fixes such record date, that a later date on or before the date of the meeting shall be the date for making such determination. If no record date is fixed by the Board of Directors, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be the close of business on the day next preceding the day on which notice is first given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting; and in such case shall also fix as the record date for stockholders entitled to notice of such adjourned meeting the same or an earlier date as that fixed for determination of stockholders entitled to vote in accordance with the foregoing provisions of this Section 12 at the adjourned meeting.
Section 13. Conduct of Meetings .
(a) Generally. Meetings of stockholders shall be presided over by the Chairman (or a Co-Chairman designated by the Board of Directors), or in his or her absence, such other chairman designated by the Board of Directors from among the Chief Executive Officer, Chief Medical Officer, Chief Science Officer and Chief Financial Officer, or in the absence of such designation, by a chairman chosen at the meeting. The Secretary shall act as secretary of the meeting, but in the Secretary’s absence the chairman of the meeting may appoint any person to act as secretary of the meeting.
(b) Rules, Regulations and Procedures. The Board of Directors may adopt by resolution such rules, regulations and procedures for the conduct of any meeting of stockholders of the Corporation as it shall deem appropriate, including, without limitation, such guidelines and procedures as it may deem appropriate regarding the participation by means of remote communication of stockholders and proxyholders not physically present at a meeting. Except to the extent inconsistent with such rules, regulations and procedures as adopted by the Board of Directors, the chairman of any meeting of stockholders shall have the right and authority to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board of Directors or prescribed by the chairman of the meeting, may include, without limitation, the following: (i) the establishment of an agenda or order of business for the meeting; (ii) rules and procedures for maintaining order at the meeting and the safety of those present; (iii) limitations on attendance at or participation in the meeting to stockholders of record of the Corporation, their duly authorized and constituted proxies or such other persons as shall be determined; (iv) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (v) limitations on the time allotted to questions or comments by participants. The chairman of the meeting, in addition to making any other determinations that may be appropriate to the conduct of the meeting, shall, if the facts warrant, determine and declare to the meeting that a matter or business was not properly brought before the meeting and if such chairman should so determine, such chairman shall so declare to the meeting and any such matter or business not properly brought before the meeting shall not be transacted or considered. Unless and to the extent determined by the Board of Directors or the chairman of the meeting, meetings of stockholders shall not be required to be held in accordance with the rules of parliamentary procedure. The chairman of the meeting shall announce at the meeting when the polls for each matter to be voted upon at the meeting will be opened and closed. After the polls close, no ballots, proxies or votes or any revocations or changes thereto may be accepted. The chairman of the meeting shall have the power, right and authority to convene and (for any or no reason) to recess and/or adjourn the meeting.
(c) Inspectors of Elections . The Corporation may, and to the extent required by law shall, in advance of any meeting of stockholders, appoint one or more inspectors of election to act at the meeting or any adjournment thereof and make a written report thereof. One or more other persons may be designated as alternate inspectors to replace any inspector who fails to act. If no inspector or alternate is able to act at a meeting of stockholders, the chairman of the meeting shall appoint one or more inspectors to act at the meeting. Unless otherwise required by law, inspectors may be officers, employees or agents of the Corporation. Each inspector, before entering upon the discharge of such inspector’s duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of such inspector’s ability. The inspector shall have the duties prescribed by law and, when the vote is completed, shall make a certificate of the result of the vote taken and of such other facts as may be required by law.
ARTICLE III
DIRECTORS
Section 1. General Powers . The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors. In addition to such powers as are herein and in the Certificate of Incorporation expressly conferred upon it, the Board of Directors shall have and may exercise all the powers of the Corporation, subject to the provisions of the laws of the State of Delaware, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding and these Bylaws.
Section 2. Nomination and Election . Members of the Board of Directors shall be elected in accordance with the terms of the Certificate of Incorporation. Notwithstanding anything to the contrary contained in these Bylaws, to the extent any stockholders, investors’ rights or similar agreement sets forth procedures governing the nomination of members to the Board of Directors and/or any committees thereof, the Corporation and the Board of Directors must act in accordance with the provisions of any such agreement in complying with the provisions of this ARTICLE III. Elections of directors need not be by written ballot.
Section 3. Annual Meetings . Except as otherwise may be determined by the Board of Directors, the annual meeting of the Board of Directors shall be held without other notice than this Bylaw immediately after the annual meeting of stockholders. In the event the annual meeting of stockholders takes place telephonically or through any other means by which the stockholders do not convene in any one location, the annual meeting of the Board of Directors shall be held immediately after the annual meeting of stockholders at such place, if any, either within or outside the State of Delaware, as may be designated by the Board of Directors.
Section 4. Regular Meetings and Special Meetings . Regular meetings, other than the annual meeting, of the Board of Directors may be held, within or outside the State of Delaware, without notice at such time and at such place as shall from time to time be determined by resolution of the Board of Directors and publicized among all directors. Special meetings of the Board of Directors may be called by the Chairman or upon the written request of at least a majority of the directors then in office.
Section 5. Notice of Meetings . Notice of the annual or any regular meetings of the Board of Directors need not be given except as otherwise required by law or these Bylaws. Notice of each special meeting of the Board of Directors, and of each regular and annual meeting of the Board of Directors for which notice shall be required, shall be given by the Secretary as hereinafter provided in this Section 5, in which notice shall be stated the time and place of the meeting. Notice of any special meeting, and of any regular or annual meeting for which notice is required, shall be given to each director at least (a) forty-eight (48) hours before the meeting if by telephone or by being personally delivered or sent by telex, telecopy, facsimile, email or similar means or (b) five (5) days before the meeting if delivered by mail to the director’s residence or usual place of business. Such notice shall be deemed to be delivered when deposited in the United States mail so addressed, with postage prepaid, or when transmitted if sent by telex, telecopy, facsimile, email or similar means. Neither the business to be transacted at, nor the purpose of, any special meeting of the Board of Directors need be specified in the notice or waiver of notice of such meeting.
Section 6. Waiver of Notice . Any director may waive notice of any meeting by a writing signed by the director or by electronic transmission from the director entitled to the notice and filed with the minutes or corporate records. Any member of the Board of Directors or any committee thereof who is present at a meeting shall be conclusively presumed to have waived notice of such meeting except when such member attends for the express purpose of objecting at the beginning of the meeting to the transaction of any business because the meeting is not lawfully called or convened.
Section 7. [Reserved]
Section 8. Chairman and Co-Chairmen of the Board . Subject to the provisions of any applicable stockholders, investors’ rights or similar agreement then in effect, (a) the Board of Directors may elect or remove, by the affirmative vote of a majority of the directors then in office, a Chairman, or if there shall be more than one at any time, a Co-Chairman (provided that no more than two Co-Chairmen shall be in office at any time), and (b) the Chairman (or Co-Chairmen, as applicable) shall be elected annually by the Board of Directors at the first meeting of the Board of Directors held after each annual meeting of stockholders or as soon thereafter as is convenient; provided , however , that the individuals serving from time to time as Chief Executive Officer shall also serve as a Co-Chairman of the Board of Directors unless otherwise determined by the affirmative vote of at least seventy-five percent (75%) of the directors then in office. Any Chairman or Co-Chairman must be a director of the Corporation and may also be an officer of the Corporation, but in no event shall any Chairman or Co-Chairman be deemed to be an officer or employee of the Corporation solely by virtue of his or her service as Chairman or Co-Chairman. The Chairman (or a Co-Chairman designated by the Board of Directors) shall preside at all meetings of the Board of Directors and at all meetings of the stockholders and, subject to the provisions of these Bylaws and the direction of the Board of Directors, the Chairman (or each Co-Chairman, as applicable) shall have such powers and perform such duties that are commonly incident to the position of chairman of the board or as may be prescribed from time to time by the Board of Directors or provided in these Bylaws. The initial Chairman shall be the Chief Executive Officer.
Section 9. Quorum, Required Vote and Adjournment . A majority of the directors then in office shall constitute a quorum for the transaction of business at all meetings of the Board of Directors. Unless otherwise provided by applicable law, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding or these Bylaws a different vote is required, the affirmative vote of a majority of directors present at a meeting at which a quorum is present shall be the act of the Board of Directors. If a quorum shall not be present at any meeting of the Board of Directors, the directors present thereat may, to the fullest extent permitted by law, adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present. At any meeting of the Board of Directors, business shall be transacted in such order and manner as the chairman of the meeting may from time to time determine.
Section 10. Committees . The Board of Directors (a) may designate one or more committees, including an executive committee, consisting of one or more of the directors of the Corporation and (b) shall during such period of time as any securities of the Corporation are listed on any exchange designate all committees required by the rules and regulations of such exchange. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. To the extent permitted by applicable law and to the extent provided in the resolution of the Board of Directors, each such committee shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation. Each such committee shall serve at the pleasure of the Board of Directors as may be determined from time to time by resolution adopted by the Board of Directors or as required by the rules and regulations of such exchange, if applicable. Each committee shall keep regular minutes of its meetings and report the same to the Board of Directors upon request.
Section 11. Committee Rules . Each committee of the Board of Directors may fix its own rules of procedure and shall hold its meetings as provided by such rules, except as may otherwise be provided by a resolution of the Board of Directors designating such committee or as otherwise provided herein. Unless otherwise provided in such a resolution, the presence of at least a majority of the members of the committee shall be necessary to constitute a quorum. All matters shall be determined by a majority vote of the members present at a meeting at which a quorum is present. Unless otherwise provided in such a resolution, in the event that a member and that member’s alternate, if alternates are designated by the Board of Directors, of such committee is or are absent or disqualified, the member or members thereof present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in place of any such absent or disqualified member.
Section 12. Action by Written Consent . Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken without a meeting if all members of the Board of Directors or such committee, as the case may be, consent thereto in writing or by electronic transmission, and the writing or writings or electronic transmission or transmissions are filed with the minutes of proceedings of the board or committee. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form.
Section 13. Compensation . The Board of Directors shall have the authority to fix the compensation, including fees and reimbursement of expenses, of directors for services to the Corporation in any capacity, including participation on any committees.
Section 14. Reliance on Books and Records . A member of the Board of Directors, or a member of any committee designated by the Board of Directors, shall, in the performance of such person’s duties, be fully protected in relying in good faith upon records of the Corporation and upon such information, opinions, reports or statements presented to the Corporation by any of the Corporation’s officers or employees, or committees of the Board of Directors, or by any other person as to matters the member reasonably believes are within such other person’s professional or expert competence and who has been selected with reasonable care by or on behalf of the Corporation.
Section 15. Telephonic and Other Meetings . Unless restricted by the Certificate of Incorporation or the certificate of designations relating to any series of preferred stock then outstanding, any one or more members of the Board of Directors or any committee thereof may participate in a meeting of the Board of Directors or such committee by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other. Participation by such means shall constitute presence in person at a meeting.
ARTICLE IV
OFFICERS
Section 1. Number . The officers of the Corporation shall be elected by the Board of Directors and shall consist of a Chief Executive Officer and President, a Chief Medical Officer, a Chief Science Officer, a Chief Financial Officer, one or more Vice Presidents, a Secretary, a Treasurer and such other officers and assistant officers as may be deemed necessary or desirable by the Board of Directors. Any number of offices may be held by the same person. In its discretion, the Board of Directors may choose not to fill any office for any period as it may deem advisable, except that the offices of President and Secretary shall be filled as expeditiously as possible.
Section 2. Election and Term of Office . The officers of the Corporation shall be elected annually by the Board of Directors at its first meeting held after each annual meeting of stockholders or as soon thereafter as is convenient. Each officer shall hold office until a successor is duly elected and qualified or until his or her earlier death, resignation or removal as hereinafter provided.
Section 3. Removal . Any officer elected by the Board of Directors may be removed by the Board of Directors at its discretion, with or without cause, but such removal shall be without prejudice to the contract rights, if any, of the person so removed.
Section 4. Vacancies . Any vacancy occurring in any office because of death, resignation, removal, disqualification or otherwise may be filled by the Board of Directors.
Section 5. Compensation . Compensation of all executive officers shall be approved by the Board of Directors, a duly authorized committee thereof or such officers as may be designated by resolution of the Board of Directors, and no officer shall be prevented from receiving such compensation by virtue of his or her also being a director of the Corporation.
Section 6. Chief Executive Officer . The Chief Executive Officer shall be the chief executive officer of the Corporation and shall have the powers and perform the duties incident to that position. Subject to the powers of the Board of Directors and the Chairman (or any Co-Chairman, as applicable), the Chief Executive Officer shall be in the general and active charge of the entire business and affairs of the Corporation and shall be its chief policy making officer. In the absence of the Chairman, the Chief Executive Officer shall preside at all meetings of the Board of Directors and at all meetings of the stockholders and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board of Directors or provided in these Bylaws. The Chief Executive Officer shall execute bonds, mortgages and other contracts requiring a seal, under the seal of the Corporation, except where required or permitted by law to be otherwise signed and executed and except where the signing and execution thereof shall be expressly delegated by the Board of Directors to some other officer or agent of the Corporation. For all purposes of the DGCL, the Chief Executive Officer shall be deemed to be the president of the Corporation at all times.
Section 7. Chief Science Officer . Subject to the powers of the Board of Directors, the Chairman (or any Co-Chairman, as applicable) and the Chief Executive Officer, the Chief Science Officer shall be in the general and active charge of the scientific affairs of the Company and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable) or the Chief Executive Officer or as may be provided in these Bylaws.
Section 8. Chief Medical Officer . Subject to the powers of the Board of Directors, the Chairman (or any Co-Chairman, as applicable) and the Chief Executive Officer, the Chief Medical Officer shall be in the general and active charge of the medical affairs of the Company and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable) or the Chief Executive Officer or as may be provided in these Bylaws.
Section 9. The Chief Financial Officer . Subject to the powers of the Board of Directors, the Chairman (or any Co-Chairman, as applicable) and the Chief Executive Officer, the Chief Financial Officer shall be in the general and active charge of all financial and accounting matters and for the direction of the offices of treasurer and controller and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable) or the Chief Executive Officer or as may be provided in these Bylaws.
Section 10. Vice Presidents . The Vice President, or if there shall be more than one, the Vice Presidents in the order determined by the Board of Directors or the Chief Executive Officer, shall have such powers and perform other duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable) or the Chief Executive Officer or as may be provided in these Bylaws. Any Vice President may also be designated as an Executive Vice Presidents or Senior Vice President as determined by the Board of Directors from time to time.
Section 11. The Secretary and Assistant Secretaries . The Secretary shall attend all meetings of the Board of Directors (other than executive sessions thereof), all meetings of the stockholders and all meetings of all committees of the Board of Directors and record all the proceedings of the meetings in a book or books to be kept for that purpose or shall ensure that his or her designee attends each such meeting to act in such capacity. Under the Board of Directors’ supervision, the Secretary shall give, or cause to be given, all notices required to be given by these Bylaws or by law; shall have such powers and perform such duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable) or the Chief Executive Officer or as may be provided in these Bylaws; and shall have custody of the corporate seal of the Corporation. The Secretary, or an Assistant Secretary, shall have authority to affix the corporate seal to any instrument requiring it and when so affixed, it may be attested by his or her signature or by the signature of such Assistant Secretary. The Board of Directors may give general authority to any other officer to affix the seal of the Corporation and to attest the affixing by his or her signature. The Assistant Secretary, or if there be more than one, the Assistant Secretaries in the order determined by the Board of Directors or the Chief Executive Officer, shall in the absence of the Secretary, perform the duties and exercise the powers of the Secretary and shall have such powers and perform such duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable), the Chief Executive Officer or the Secretary or as may be provided in these Bylaws.
Section 12. Treasurer and Assistant Treasurer . The Treasurer shall have the custody of the corporate funds and securities; shall keep full and accurate accounts of receipts and disbursements in books belonging to the corporation; shall deposit all monies and other valuable effects in the name and to the credit of the corporation as may be ordered by the Board of Directors; shall cause the funds of the corporation to be disbursed when such disbursements have been duly authorized, taking proper vouchers for such disbursements; and shall render to the Chief Executive Officer and the Board of Directors, at its regular meeting or when the board of directors so requires, an account of the corporation; and shall have such powers and perform such duties as may be prescribed from time to time by the Board of Directors, the Chief Executive Officer or the Secretary or as may be provided in these Bylaws. The Assistant Treasurer, or if there be more than one, the Assistant Treasurers in the order determined by the Board of Directors or the Chief Executive Officer, shall in the absence of the Treasurer, perform the duties and exercise the powers of the Treasurer and shall have such powers and perform such duties as may be prescribed from time to time by the Board of Directors, the Chairman (or any Co-Chairman, as applicable), the Chief Executive Officer or the Treasurer or as may be provided in these Bylaws.
Section 13. Other Officers, Assistant Officers and Agents . Officers, assistant officers and agents, if any, other than those whose duties are provided for in these Bylaws, shall have such authority and perform such duties as may from time to time be prescribed by resolution of the Board of Directors.
Section 14. Delegation of Authority . The Board of Directors may by resolution delegate the powers and duties of such officer to any other officer or to any director, or to any other person whom it may select.
ARTICLE V
CERTIFICATES OF STOCK
Section 1. Form . The shares of stock of the Corporation shall be represented by certificates provided that the Board of Directors may provide by resolution that some or all of any or all classes or series of its stock shall be uncertificated shares. If shares are represented by certificates, the certificates shall be in such form as required by applicable law and as determined by the Board of Directors. Each certificate shall certify the number of shares owned by such holder in the Corporation and shall be signed by, or in the name of the Corporation by the Chairman of the Board, the Chief Executive Officer or a Vice-President and by the Treasurer or an Assistant Treasurer or the Secretary or an Assistant Secretary. Any or all signatures on the certificate may be a facsimile. In case any officer or officers who have signed, or whose facsimile signature or signatures have been used on, any such certificate or certificates shall cease to be such officer or officers of the Corporation whether because of death, resignation or otherwise before such certificate or certificates have been issued by the Corporation, such certificate or certificates may nevertheless be issued as though the person or persons who signed such certificate or certificates or whose facsimile signature or signatures have been used thereon had not ceased to be such officer or officers of the Corporation. All certificates for shares shall be consecutively numbered or otherwise identified. The Board of Directors may appoint a bank or trust company organized under the laws of the United States or any state thereof to act as its transfer agent or registrar, or both, in connection with the transfer of any class or series of securities of the Corporation. The Corporation, or its designated transfer agent or other agent, shall keep a book or set of books to be known as the stock transfer books of the Corporation, containing the name of each holder of record, together with such holder’s address and the number and class or series of shares held by such holder and the date of issue. When shares are represented by certificates, the Corporation shall issue and deliver to each holder to whom such shares have been issued or transferred, certificates representing the shares owned by such holder, and shares of stock of the Corporation shall only be transferred on the books of the Corporation by the holder of record thereof or by such holder’s attorney duly authorized in writing, upon surrender to the Corporation or its designated transfer agent or other agent of the certificate or certificates for such shares endorsed by the appropriate person or persons, with such evidence of the authenticity of such endorsement, transfer, authorization and other matters as the Corporation may reasonably require, and accompanied by all necessary stock transfer stamps. In that event, it shall be the duty of the Corporation to issue a new certificate to the person entitled thereto, cancel the old certificate or certificates and record the transaction on its books. When shares are not represented by certificates, shares of stock of the Corporation shall only be transferred on the books of the Corporation by the holder of record thereof or by such holder’s attorney duly authorized in writing, with such evidence of the authenticity of such transfer, authorization and other matters as the Corporation may reasonably require, and accompanied by all necessary stock transfer stamps, and within a reasonable time after the issuance or transfer of such shares, the Corporation shall send the holder to whom such shares have been issued or transferred a written statement of the information required by applicable law. Unless otherwise provided by applicable law, the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding, these Bylaws or any other instrument, the rights and obligations of stockholders are identical, whether or not their shares are represented by certificates.
Section 2. Lost Certificates . The Corporation may issue or direct a new certificate or certificates or uncertificated shares to be issued in place of any certificate or certificates previously issued by the Corporation alleged to have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate of stock to be lost, stolen or destroyed. When authorizing such issue of a new certificate or certificates or uncertificated shares, the Corporation may, in its discretion and as a condition precedent to the issuance thereof, require the owner of such lost, stolen or destroyed certificate or certificates, or his or her legal representative, to give the Corporation a bond in such sum as it may direct, sufficient to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of any such certificate or the issuance of such new certificate or uncertificated shares.
Section 3. Registered Stockholders . The Corporation shall be entitled to recognize the exclusive right of a person registered on its records as the owner of shares of stock to receive dividends, to vote, to receive notifications and otherwise to exercise all the rights and powers of an owner. The Corporation shall not be bound to recognize any equitable or other claim to or interest in such share or shares of stock on the part of any other person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of the State of Delaware.
Section 4. Fixing a Record Date for Purposes Other Than Stockholder Meetings . In order that the Corporation may determine the stockholders entitled to receive payment of any dividend or other distribution or allotment or any rights or the stockholders entitled to exercise any rights in respect of any change, conversion or exchange of stock, or for the purposes of any other lawful action (other than stockholder meetings which is expressly governed by Section 12 of ARTICLE II), the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted, and which record date shall be not more than 60 days prior to such action. If no record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.
ARTICLE VI
GENERAL PROVISIONS
Section 1. Dividends . Subject to and in accordance with applicable law, the Certificate of Incorporation and the certificate of designations relating to any series of preferred stock then outstanding, dividends upon the shares of capital stock of the Corporation may be declared by the Board of Directors. Dividends may be paid in cash, in property or in shares of the capital stock, subject to the provisions of applicable law, the Certificate of Incorporation and the certificate of designations relating to any series of preferred stock then outstanding. Before payment of any dividend, there may be set aside out of any funds of the Corporation available for dividends such sum or sums as the Board of Directors from time to time, in its absolute discretion, thinks proper as a reserve or reserves to meet contingencies, or for equalizing dividends, or for repairing or maintaining any property of the Corporation or for such other purpose as the Board of Directors may think conducive to the interests of the Corporation. The Board of Directors may modify or abolish any such reserves in the manner in which they were created.
Section 2. Checks, Notes, Drafts, Etc . All checks, notes, drafts or other orders for the payment of money of the Corporation shall be signed, endorsed or accepted in the name of the Corporation by such officer, officers, person or persons as from time to time may be designated by the Board of Directors or by an officer or officers authorized by the Board of Directors to make such designation.
Section 3. Contracts . In addition to the powers otherwise granted to officers pursuant to ARTICLE IV, the Board of Directors may authorize any officer or officers, or any agent or agents, in the name and on behalf of the Corporation to enter into or execute and deliver any and all deeds, bonds, mortgages, contracts and other obligations or instruments, and such authority may be general or confined to specific instances.
Section 4. Loans . Subject to compliance with applicable law (including Section 13(k) of the Exchange Act), the Corporation may lend money to, or guarantee any obligation of, or otherwise assist any officer or other employee of the Corporation or of its subsidiaries, including any officer or employee who is a director of the Corporation or its subsidiaries, whenever, in the judgment of the directors, such loan, guaranty or assistance may reasonably be expected to benefit the Corporation. The loan, guaranty or other assistance may be with or without interest, and may be unsecured, or secured in such manner as the Board of Directors shall approve, including, without limitation, a pledge of shares of stock of the Corporation. Nothing in this section shall be deemed to deny, limit or restrict the powers of guaranty or warranty of the Corporation at common law or under any statute.
Section 5. Fiscal Year . The fiscal year of the Corporation shall be fixed by resolution of the Board of Directors.
Section 6. Corporate Seal . The Board of Directors may provide a corporate seal which shall be in the form of a circle and shall have inscribed thereon the name of the Corporation and the words “Corporate Seal, Delaware.” The seal may be used by causing it or a facsimile thereof to be impressed or affixed or reproduced or otherwise. Notwithstanding the foregoing, no seal shall be required by virtue of this Section 6 of ARTICLE VI.
Section 7. Voting Securities Owned By Corporation . The Chairman (or any Co-Chairman, as applicable), if any, the Chief Executive Officer, the Chief Operating Officer or the Chief Financial Officer, unless the Board of Directors specifically confers authority to vote with respect thereto, shall have power to vote and otherwise act on behalf of the Corporation, in person or by proxy, at any meeting of stockholders of or with respect to any action of stockholders of any other corporation in which this Corporation may hold securities and otherwise to exercise any and all rights and powers which this Corporation may possess by reason of its ownership of securities in such other corporation, unless the Board of Directors specifically confers authority to vote or act with respect thereto, which authority may be general or confined to specific instances, upon some other person or officer. Any person authorized to vote securities shall have the power to appoint proxies, with general power of substitution.
Section 8. Inspection of Books and Records . Subject to applicable law, the Board of Directors shall have power from time to time to determine to what extent and at what times and places and under what conditions and regulations the accounts and books of the Corporation, or any of them, shall be open to the inspection of the stockholders; and no stockholder shall have any right to inspect any account or book or document of the Corporation, except as conferred by the laws of the State of Delaware, unless and until authorized so to do by resolution of the Board of Directors.
Section 9. Section Headings . Section headings in these Bylaws are for convenience of reference only and shall not be given any substantive effect in limiting or otherwise construing any provision herein.
Section 10. Inconsistent Provisions . In the event that any provision of these Bylaws is or becomes inconsistent with any provision of the Certificate of Incorporation, the certificate of designations relating to any series of preferred stock then outstanding, the DGCL or any other applicable law, or any stockholders, investors’ rights or similar agreement, the provision of these Bylaws shall not be given any effect to the extent of such inconsistency but shall otherwise be given full force and effect.
ARTICLE VII
INDEMNIFICATION
Section 1. Right to Indemnification and Advancement . Each person who was or is made a party or is threatened to be made a party to or is otherwise involved (including involvement, without limitation, as a witness) in any actual or threatened action, suit or proceeding, whether civil, criminal, administrative or investigative (a “ proceeding ”), by reason of the fact that he or she is or was a director or officer of the Corporation or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as an employee or agent of the Corporation or as a director, officer, partner, member, trustee, administrator, employee or agent of another corporation or of a partnership, joint venture, limited liability company, trust or other enterprise, including service with respect to an employee benefit plan (an “ indemnitee ”), whether the basis of such proceeding is alleged action in an official capacity as a director or officer or in any other capacity while serving as a director or officer, shall be indemnified and held harmless by the Corporation to the fullest extent authorized by the DGCL, as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than permitted prior thereto), against all expense, liability and loss (including attorneys’ fees and related disbursements, judgments, fines, excise taxes, penalties and amounts paid or to be paid in settlement) reasonably incurred or suffered by such indemnitee in connection therewith and such indemnification shall continue as to an indemnitee who has ceased to be a director, officer, partner, member, trustee, administrator, employee or agent and shall inure to the benefit of the indemnitee’s heirs, executors and administrators; provided, however, that, except as provided in Section 2 of this ARTICLE VII with respect to proceedings to enforce rights to indemnification, the Corporation shall indemnify any such indemnitee in connection with a proceeding (or part thereof) initiated by such indemnitee only if such proceeding (or part thereof) was authorized by the Board of Directors of the Corporation. The right to indemnification conferred in this Section 1 of this ARTICLE VII shall be a contract right. In addition to the right to indemnification conferred herein, an indemnitee shall also have the right, to the fullest extent not prohibited by law, to be paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition (an “ advance of expenses ”); provided, however, that if and to the extent that the DGCL requires, an advance of expenses incurred by an indemnitee shall be made only upon delivery to the Corporation of an undertaking (an “ undertaking ”), by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal that such indemnitee is not entitled to be indemnified for such expenses under this Section 1 or otherwise. The Corporation may also, by action of its Board of Directors, provide indemnification and advancement of expenses to employees and agents of the Corporation.
Section 2. Procedure for Indemnification . Any indemnification of a director or officer of the Corporation or advance of expenses (including attorneys’ fees, costs and charges) under this Section 2 of ARTICLE VII shall be made promptly. If a claim for indemnification pursuant to this ARTICLE VII is not paid in full within 60 days after the Corporation has received a written request for indemnity, or a claim for the advancement of expenses is not paid in full within 30 days after the Corporation has received a statement or statements requesting such amounts to be advanced, the indemnitee shall thereupon (but not before) be entitled to file suit to recover the unpaid amount of such claim. Such person’s costs and expenses incurred in connection with successfully establishing his or her right to indemnification or advancement of expense, in whole or in part, in any such action shall also be paid by the Corporation to the fullest extent permitted by Delaware law. It shall be a defense to any such action (other than an action brought to enforce a claim for the advance of expenses where the undertaking required pursuant to Section 1 of this ARTICLE VII, if any, has been tendered to the Corporation) that the claimant has not met the standards of conduct which make it permissible under the DGCL for the Corporation to indemnify the claimant for the amount claimed, but the burden of such defense shall be on the Corporation to the fullest extent permitted by law. Neither the failure of the Corporation (including its Board of Directors, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he or she has met the applicable standard of conduct set forth in the DGCL, nor an actual determination by the Corporation (including its Board of Directors, independent legal counsel or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that the claimant has not met the applicable standard of conduct. The procedure for indemnification of other employees and agents for whom indemnification and advancement of expenses is provided pursuant to Section 1 of this ARTICLE VII shall be the same procedure set forth in this Section 2 of ARTICLE VII for directors or officers, unless otherwise set forth in the action of the Board of Directors providing indemnification and advancement of expenses for such employee or agent.
Section 3. Insurance . The Corporation may purchase and maintain insurance on its own behalf and on behalf of any person who is or was a director, officer, employee or agent of the Corporation or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, limited liability company, trust or other enterprise against any expense, liability or loss asserted against him or her and incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the Corporation would have the power to indemnify such person against such expenses, liability or loss under the DGCL.
Section 4. Service for Subsidiaries . Any person serving as a director, officer, employee or agent of another corporation or of a partnership, joint venture, limited liability company, trust or other enterprise, at least 50% of whose equity interests are owned by the Corporation (a “subsidiary” for this ARTICLE VII) shall be conclusively presumed to be serving in such capacity at the request of the Corporation.
Section 5. Reliance . Persons who after the date of the adoption of this provision become or remain directors or officers of the Corporation or who, while a director or officer of the Corporation, become or remain a director, officer, employee or agent of a subsidiary, shall be conclusively presumed to have relied on the rights to indemnity, advance of expenses and other rights contained in this ARTICLE VII in entering into or continuing such service.
Section 6. Non-Exclusivity of Rights; Continuation of Rights to Indemnification . The rights to indemnification and to the advance of expenses conferred in this ARTICLE VII shall not be exclusive of any other right which any person may have or hereafter acquire under the Certificate of Incorporation or under any statute, bylaw, agreement, vote of stockholders or disinterested directors or otherwise. All rights to indemnification under this ARTICLE VII shall be deemed to be a contract between the Corporation and each director or officer of the Corporation who serves or served in such capacity at any time while this ARTICLE VII is in effect. Any repeal or modification of this ARTICLE VII or any repeal or modification of relevant provisions of the Delaware General Corporation Law or any other applicable laws shall not in any way diminish any rights to indemnification and advancement of expenses of such director or officer or the obligations of the Corporation arising hereunder with respect to any proceeding arising out of, or relating to, any actions, transactions or facts occurring prior to the final adoption of such repeal or modification.
Section 7. Merger or Consolidation . For purposes of this ARTICLE VII, references to the “Corporation” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would have had power and authority to indemnify its directors, officers and employees or agents, so that any person who is or was a director, officer, employee or agent of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, shall stand in the same position under this ARTICLE VII with respect to the resulting or surviving corporation as he or she would have with respect to such constituent corporation if its separate existence had continued.
Section 8. Savings Clause . If this ARTICLE VII or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify and advance expenses to each person entitled to indemnification under Section 1 of ARTICLE VII as to all expense, liability and loss (including attorneys’ fees and related disbursements, judgments, fines, ERISA excise taxes and penalties, penalties and amounts paid or to be paid in settlement) actually and reasonably incurred or suffered by such person and for which indemnification or advancement of expenses is available to such person pursuant to this ARTICLE VII to the fullest extent permitted by any applicable portion of this ARTICLE VII that shall not have been invalidated and to the fullest extent permitted by applicable law.
ARTICLE VIII
AMENDMENTS
These Bylaws may be amended, altered, changed or repealed or new Bylaws adopted only in accordance with the Certificate of Incorporation.
Exhibit 5.1
Dentons US LLP
1221 Avenue of the Americas New York, NY 10020-1089 United States |
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大成 Salans FMC SNR Denton McKenna Long dentons.com |
July 17, 2019
Immunic, Inc.
Am Klopferspitz 19
82152 Martinsried, Germany
Re: Immunic, Inc., Registration Statement on Form S-3 (File No. 333-225230)
Ladies and Gentlemen:
In our capacity as counsel to Immunic, Inc., a corporation organized under the laws of the State of Delaware (the “ Company ”), we have been asked to render this opinion in connection with a registration statement on Form S-3 (File No. 333-225230) (the “ Registration Statement ”), which Registration Statement the Company initially filed with the Securities and Exchange Commission (the “ Commission ”) under the Securities Act of 1933, as amended (the “ Act ”), and the prospectus supplement filed pursuant to Rule 424(b) under the Act, dated July 17, 2019 (the “ Prospectus Supplement ”), under which up to $40,000,000 of shares (the “ Shares ”) of Company common stock, par value $0.0001 per share, have been registered, to be sold from time to time by the Company pursuant to the Sales Agreement, dated July 17, 2019, between the Company and SVB Leerink LLC.
We are delivering this opinion to you at your request in accordance with the requirements of Item 16 of Form S-3 and Item 601(b)(5) of Regulation S-K under the Act.
In connection with rendering this opinion, we have examined originals, certified copies or copies otherwise identified as being true copies of the following: (i) the Company’s articles of incorporation, as amended, (ii) the Company’s by-laws, as amended, (iii) the Registration Statement, including the prospectus contained therein (the “ Base Prospectus ”), (iv) the Prospectus Supplement (the Base Prospectus and the Prospectus Supplement are collectively referred to herein as the “ Prospectus ”), (v) corporate proceedings of the Company relating to the Shares and (vi) such other instruments and documents as we have deemed relevant under the circumstances.
In making the aforesaid examinations, we have assumed the genuineness and authenticity of all documents examined by us and all signatures thereon, and the conformity to originals of all copies of all documents examined by us.
Based on the foregoing, and in reliance thereon, and subject to the qualifications, limitations and exceptions stated herein, we are of the opinion that the Shares have been duly authorized and, when issued and delivered by the Company against due payment therefor in accordance with the terms set forth in the Registration Statement and the Prospectus, will be validly issued, fully paid and non-assessable.
The foregoing opinion is limited to the laws of the State of Delaware (excluding local laws) and the federal law of the United States of America.
We hereby consent to the use of our opinion as an exhibit to the Registration Statement and to the reference to this firm and this opinion under the heading “Legal Matters” in the Prospectus comprising a part of the Registration Statement and any amendment thereto. In giving such consent, we do not hereby admit that we come within the category of persons whose consent is required under Section 7 of the Act, or the rules and regulations of the Commission thereunder.
Very truly yours, | |
/s/ Dentons US LLP | |
Dentons US LLP |
Exhibit 10.1
EXECUTION COPY
IMMUNIC, INC.
Shares of Common Stock
($0.0001 par value per share)
SALES AGREEMENT
July 17, 2019
SVB LEERINK LLC
1301 Avenue of the Americas, 12 th Floor
New York, New York 10019
Ladies and Gentlemen:
IMMUNIC, INC. (formerly known as Vital Therapies, Inc. (“ Vital Therapies ”)), a Delaware corporation (the “ Company ,” with all references in this agreement to the “Company” also referring to Vital Therapies prior to the date on which, pursuant to the terms of the Exchange Agreement, dated as of January 6, 2019, among Vital Therapies, Immunic AG (“ Former Immunic ”) and the former shareholders of Former Immunic, the shareholders of Former Immunic exchanged all of their shares for shares of common stock of Vital Therapies, resulting in Former Immunic becoming a wholly-owned subsidiary of Vital Therapies; and in connection therewith, Vital Therapies changed its name to Immunic, Inc.), confirms its agreement (this “ Agreement ”) with SVB Leerink LLC (the “ Agent ”), as follows:
1. Issuance and Sale of Shares . The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the conditions set forth herein, it may issue and sell through the Agent up to $40,000,000 of shares of common stock, $0.0001 par value per share, of the Company (the “ Common Stock ”), subject to the limitations set forth in Section 5(c) (the “ Placement Shares ”). Notwithstanding anything to the contrary contained herein, the parties hereto agree that compliance with the limitation set forth in this Section 1 on the aggregate gross sales price of Placement Shares that may be issued and sold under this Agreement from time to time shall be the sole responsibility of the Company, and that the Agent shall have no obligation in connection with such compliance. The issuance and sale of Placement Shares through the Agent will be effected pursuant to the Registration Statement (as defined below) filed by the Company with the Securities and Exchange Commission (the “ Commission ”) on May 25, 2018, as amended on June 8, 2018, and declared effective by the Commission on June 13, 2018, although nothing in this Agreement shall be construed as requiring the Company to issue any Placement Shares.
The Company has prepared and filed, in accordance with the provisions of the Securities Act of 1933, as amended, and the rules and regulations thereunder (collectively, the “ Securities Act ”), with the Commission a registration statement on Form S-3 (File No. 333-225230), including a base prospectus, relating to certain securities, including the Common Stock, to be issued from time to time by the Company, and which incorporates by reference documents that the Company has filed or will file in accordance with the provisions of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder (collectively, the “ Exchange Act ”). The Company has prepared a prospectus supplement to the base prospectus included as part of such registration statement at the time the registration statement became effective, which prospectus supplement specifically relates to the Placement Shares to be issued from time to time pursuant to this Agreement (the “ Prospectus Supplement ”). The Company will furnish to the Agent, for use by the Agent, copies of the base prospectus included as part of such registration statement at the time it became effective, as supplemented by the Prospectus Supplement. Except where the context otherwise requires, such registration statement, including all documents filed as part thereof or incorporated by reference therein, and including any information contained in a Prospectus (as defined below) subsequently filed with the Commission pursuant to Rule 424(b) under the Securities Act or deemed to be a part of such registration statement pursuant to Rule 430B or Rule 462(b) under the Securities Act, is herein called the “ Registration Statement .” The base prospectus, including all documents incorporated therein by reference, included in the Registration Statement, as it may be supplemented by the Prospectus Supplement, in the form in which such prospectus and/or Prospectus Supplement have most recently been filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act, together with any “issuer free writing prospectus” (as used herein, as defined in Rule 433 under the Securities Act (“ Rule 433 ”)), relating to the Placement Shares that (i) is required to be filed with the Commission by the Company or (ii) is exempt from filing pursuant to Rule 433(d)(5)(i), in each case, in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g), is herein called the “ Prospectus .”
Any reference herein to the Registration Statement, the Prospectus Supplement, the Prospectus or any issuer free writing prospectus shall be deemed to refer to and include the documents, if any, that are or are deemed to be incorporated by reference therein (the “ Incorporated Documents ”), including, unless the context otherwise requires, the documents, if any, filed as exhibits to such Incorporated Documents. Any reference herein to the terms “amend,” “amendment” or “supplement” with respect to the Registration Statement, the Prospectus Supplement, the Prospectus or any issuer free writing prospectus shall be deemed to refer to and include the filing of any document under the Exchange Act on or after the most-recent effective date of the Registration Statement, or the respective dates of the Prospectus Supplement, Prospectus or such issuer free writing prospectus, as the case may be, and incorporated therein by reference. For purposes of this Agreement, all references to the Registration Statement, the Prospectus or any amendment or supplement thereto shall be deemed to include the most recent copy filed with the Commission pursuant to its Electronic Data Gathering Analysis and Retrieval System or, if applicable, the Interactive Data Electronic Application system when used by the Commission (collectively, “ EDGAR ”).
2. Placements . Each time that the Company wishes to issue and sell any Placement Shares through the Agent hereunder (each, a “ Placement ”), it will notify the Agent by email notice (or other method mutually agreed to in writing by the parties) (each such notice, a “ Placement Notice ”) containing the parameters in accordance with which it desires such Placement Shares to be sold, which at a minimum shall include the maximum number or amount of Placement Shares to be sold, the time period during which sales are requested to be made, any limitation on the number or amount of Placement Shares that may be sold in any one Trading Day (as defined in Section 3) and any minimum price below which sales may not be made, a form of which containing such minimum sales parameters is attached hereto as Schedule 1 . The Placement Notice must originate from one of the individuals authorized to act on behalf of the Company and set forth on Schedule 2 (with a copy to each of the other individuals from the Company listed on such Schedule 2 ), and shall be addressed to each of the individuals from the Agent set forth on Schedule 2 , as such Schedule 2 may be updated by either party from time to time by sending a written notice containing a revised Schedule 2 to the other party in the manner provided in Section 12 (including by email correspondence to each of the individuals of the Company set forth on Schedule 2 , if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply). The Placement Notice shall be effective upon receipt by the Agent unless and until (i) in accordance with the notice requirements set forth in Section 4, the Agent declines to accept the terms contained therein for any reason, in its sole discretion, within two Trading Days of the date the Agent receives the Placement Notice, (ii) in accordance with the notice requirements set forth in Section 4, the Agent suspends sales under the Placement Notice for any reason in its sole discretion, (iii) the entire amount of the Placement Shares has been sold pursuant to this Agreement, (iv) in accordance with the notice requirements set forth in Section 4, the Company suspends sales under or terminates the Placement Notice for any reason in its sole discretion, (v) the Company issues a subsequent Placement Notice and explicitly indicates that its parameters supersede those contained in the earlier dated Placement Notice or (vi) this Agreement has been terminated pursuant to the provisions of Section 11. The amount of any discount, commission or other compensation to be paid by the Company to the Agent in connection with the sale of the Placement Shares effected through the Agent shall be calculated in accordance with the terms set forth in Schedule 3 . It is expressly acknowledged and agreed that neither the Company nor the Agent will have any obligation whatsoever with respect to a Placement or any Placement Shares unless and until the Company delivers a Placement Notice to the Agent and the Agent does not decline such Placement Notice pursuant to the terms set forth above, and then only upon the terms specified therein and herein. In the event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the Placement Notice will control with respect to the matters covered thereby.
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3. Sale of Placement Shares by the Agent . On the basis of the representations and warranties herein contained and subject to the terms and conditions herein set forth, including Section 5(c), upon the effectiveness of a Placement Notice as provided in Section 2, and unless the sale of the Placement Shares described therein has been declined, suspended or otherwise terminated in accordance with the terms of this Agreement, the Agent, for the period specified in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Nasdaq Capital Market (“ Nasdaq ”) to sell such Placement Shares up to the number or amount specified in, and otherwise in accordance with the terms of, such Placement Notice. The Agent will provide written confirmation to the Company (including by email correspondence to each of the individuals of the Company set forth on Schedule 2 , if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) no later than the opening of the Trading Day (as defined below) immediately following the Trading Day on which it has made sales of Placement Shares hereunder setting forth the number or amount of Placement Shares sold on such Trading Day, the volume-weighted average price of the Placement Shares sold, the Net Proceeds (as defined below) payable to the Company and an itemization of the deductions made by the Agent from the gross proceeds that it receives from such sales. Unless otherwise specified by the Company in a Placement Notice, the Agent may sell Placement Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act, including sales made directly on or through Nasdaq, on or through any other existing trading market for the Common Stock or to or through a market maker. If expressly authorized by the Company (including in a Placement Notice), the Agent may also sell Placement Shares in negotiated transactions. Notwithstanding the provisions of Section 6(tt), except as may be otherwise agreed by the Company and the Agent, the Agent shall not purchase Placement Shares on a principal basis pursuant to this Agreement unless the Company and the Agent enter into a separate written agreement setting forth the terms of such sale. The Company acknowledges and agrees that (i) there can be no assurance that the Agent will be successful in selling Placement Shares, (ii) the Agent will incur no liability or obligation to the Company or any other person or entity if it does not sell Placement Shares for any reason other than a failure by the Agent to use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of Nasdaq to sell such Placement Shares as required under this Agreement and (iii) the Agent shall be under no obligation to purchase Placement Shares on a principal basis pursuant to this Agreement unless the Company and the Agent enter into a separate written agreement setting forth the terms of such sale. For the purposes hereof, “ Trading Day ” means any day on which the Common Stock is purchased and sold on Nasdaq.
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4. Suspension of Sales .
(a) The Company or the Agent may, upon notice to the other party in writing (including by email correspondence to each of the individuals of the other party set forth on Schedule 2 , if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by email correspondence to each of the individuals of the other party set forth on Schedule 2 ), suspend any sale of Placement Shares; provided , however , that such suspension shall not affect or impair either party’s obligations with respect to any Placement Shares sold hereunder prior to the receipt of such notice. Each of the parties agrees that no such notice under this Section 4 shall be effective against the other party unless notice is sent by one of the individuals named on Schedule 2 hereto to the other party in writing (including by email correspondence to each of the individuals of the other party set forth on Schedule 2 , if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply).
(b) Notwithstanding any other provision of this Agreement, during any period in which the Company is, or could be deemed to be, in possession of material non-public information, the Company and the Agent agree that (i) no sale of Placement Shares will take place, (ii) the Company shall not request the sale of any Placement Shares and shall cancel any effective Placement Notices instructing the Agent to make any sales and (iii) the Agent shall not be obligated to sell or offer to sell any Placement Shares.
(c) While a suspension is in effect pursuant to this Section 4 , any obligation under Sections 7(m) , 7(n) , 7(o) and 7(p) with respect to the delivery of certificates, opinions or comfort letters to the Agent, shall be waived.
5. Settlement and Delivery of the Placement Shares .
(a) Settlement of Placement Shares . Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares will occur on the second Trading Day (or such earlier day as is industry practice or as is required for regular-way trading) following the date on which such sales are made (each, a “ Settlement Date ”). The amount of proceeds to be delivered to the Company on a Settlement Date against receipt of the Placement Shares sold (the “ Net Proceeds ”) will be equal to the aggregate gross sales price received by the Agent at which such Placement Shares were sold, after deduction of (i) the Agent’s commission, discount or other compensation for such sales payable by the Company pursuant to Section 2 hereof, (ii) any other amounts due and payable by the Company to the Agent hereunder pursuant to Section 7(g) hereof and (iii) any transaction fees imposed by any governmental or self-regulatory organization in respect of such sales.
(b) Delivery of Placement Shares . On or before each Settlement Date, the Company will issue the Placement Shares being sold on such date and will, or will cause its transfer agent to, electronically transfer such Placement Shares by crediting the Agent’s or its designee’s account ( provided the Agent shall have given the Company written notice of such designee prior to the Settlement Date) at The Depository Trust Company through its Deposit and Withdrawal at Custodian System (“ DWAC ”) or by such other means of delivery as may be mutually agreed upon by the parties hereto, which in all cases shall be duly authorized, freely tradeable, transferable, registered shares of Common Stock in good deliverable form. On each Settlement Date, the Agent will deliver the related Net Proceeds in same day funds to an account designated by the Company on or prior to the Settlement Date. The Agent shall be responsible for providing DWAC instructions or other instructions for delivery by other means with regard to the transfer of the Placement Shares being sold. In addition to and in no way limiting the rights and obligations set forth in Section 9(a) hereto, the Company agrees that if the Company or its transfer agent (if applicable), defaults in its obligation to deliver duly authorized, freely tradeable, transferable, registered Placement Shares in good deliverable form by 2:30 P.M., New York City time, on a Settlement Date (other than as a result of a failure by the Agent to provide instructions for delivery), and as a result the Agent cancels such trade, the Company will (i) take all necessary action to cause the full amount of any Net Proceeds that were delivered to the Company’s account with respect to such settlement, together with any costs incurred by the Agent and/or its clearing firm in connection with recovering such Net Proceeds, to be immediately returned to the Agent or its clearing firm no later than 5:00 P.M., New York City time, on such Settlement Date, by wire transfer of immediately available funds to an account designated by the Agent or its clearing firm, (ii) indemnify and hold the Agent and its clearing firm harmless against any reasonably incurred out-of-pocket loss, claim, damage, or expense (including reasonable legal fees and expenses), as incurred, arising out of or in connection with such default by the Company or its transfer agent (if applicable) and (iii) pay to the Agent any commission, discount or other compensation to which it would otherwise have been entitled absent such default. Certificates for the Placement Shares, if any, shall be in such denominations and registered in such names as the Agent may request in writing one Business Day (as defined below) before the applicable Settlement Date. Certificates for the Placement Shares, if any, will be made available by the Company for examination and packaging by the Agent in New York City not later than 12:00 P.M., New York City time, on the Business Day prior to the applicable Settlement Date.
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(c) Limitations on Offering Size . Under no circumstances shall the Company cause or request the offer or sale of any Placement Shares if, after giving effect to the sale of such Placement Shares, the aggregate number or gross sales proceeds of Placement Shares sold pursuant to this Agreement would exceed the lesser of: (i) the number or dollar amount of shares of Common Stock registered pursuant to, and available for offer and sale under, the Registration Statement pursuant to which the offering of Placement Shares is being made, (ii) the number of authorized but unissued shares of Common Stock of the Company (less shares of Common Stock issuable upon exercise, conversion or exchange of any outstanding securities of the Company or otherwise reserved from the Company’s authorized capital stock), (iii) the number or dollar amount of shares of Common Stock permitted to be offered and sold by the Company under Form S-3 (including General Instruction I.B.6. thereof, if such instruction is applicable), (iv) the number or dollar amount of shares of Common Stock that the Company’s board of directors or a duly authorized committee thereof is authorized to issue and sell from time to time, and notified to the Agent in writing, or (v) the dollar amount of shares of Common Stock for which the Company has filed the Prospectus Supplement. Under no circumstances shall the Company cause or request the offer or sale of any Placement Shares pursuant to this Agreement at a price lower than the minimum price authorized from time to time by the Company’s board of directors or a duly authorized committee thereof, and notified to the Agent in writing. Notwithstanding anything to the contrary contained herein, the parties hereto acknowledge and agree that compliance with the limitations set forth in this Section 5(c) on the number or dollar amount of Placement Shares that may be issued and sold under this Agreement from time to time shall be the sole responsibility of the Company, and that the Agent shall have no obligation in connection with such compliance.
6. Representations and Warranties of the Company . The Company represents and warrants to, and agrees with, the Agent that, except as set forth in the Registration Statement or the Prospectus, as of the date of this Agreement, and as of (i) each Representation Date (as defined in Section 7(m)), (ii) each date on which a Placement Notice is given, (iii) the date and time of each sale of any Placement Shares pursuant to this Agreement and (iv) each Settlement Date (each such time or date referred to in clauses (i) through (iv), an “ Applicable Time ”):
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(a) The Company and the transactions contemplated by this Agreement meet the requirements for and comply with the conditions for the use of Form S-3 (including General Instructions I.A and I.B.1.) under the Securities Act. The Registration Statement has been filed with the Commission and has been declared effective by the Commission under the Securities Act prior to the issuance of any Placement Notices by the Company. At the time the Registration Statement originally became effective and at the time the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, was filed with the Commission, the Company met the then-applicable requirements for use of Form S-3 (including General Instructions I.A and I.B.1.) under the Securities Act. The Registration Statement meets, and the offering and sale of Placement Shares as contemplated hereby comply in all material respects with, the requirements of Rule 415(a)(1)(x) under the Securities Act. The Agent is named as the agent engaged by the Company in the section entitled “Plan of Distribution” in the Prospectus Supplement. The Company has not received, and has no notice from the Commission of, any notice pursuant to Rule 401(g)(1) under the Securities Act objecting to the use of the shelf registration statement form. No stop order of the Commission preventing or suspending the use of the base prospectus, the Prospectus Supplement or the Prospectus, or the effectiveness of the Registration Statement, has been issued, and no proceedings for such purpose are pending before or, to the knowledge of the Company, threatened by the Commission. At the time of the initial filing of the Registration Statement, the Company paid the required Commission filing fees relating to the securities covered by the Registration Statement, including the Shares that may be sold pursuant to this Agreement, in accordance with Rule 457(o) under the Securities Act. Copies of the Registration Statement, the Prospectus, any such amendments or supplements to any of the foregoing and all Incorporated Documents that were filed with the Commission on or prior to the date of this Agreement have been delivered, or are available through EDGAR, to the Agent and its counsel.
(b) Each of the Registration Statement and any post-effective amendment thereto, at the time it became or becomes effective, at each deemed effective date with respect to the Agent pursuant to Rule 430B(f)(2) under the Securities Act and as of each Applicable Time, complied, complies and will comply in all material respects with the requirements of the Securities Act and did not, does not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, except that the representations and warranties set forth in this sentence do not apply to the Agent’s Information (as defined below). The Prospectus and any amendment or supplement thereto, when so filed with the Commission under Rule 424(b) under the Securities Act, complied, complies and as of each Applicable Time will comply in all material respects with the requirements of the Securities Act, and each Prospectus Supplement, Prospectus or issuer free writing prospectus (or any amendments or supplements to any of the foregoing) furnished to the Agent for use in connection with the offering of the Placement Shares was identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T. Neither the Prospectus nor any amendment or supplement thereto, as of its date and as of each Applicable Time, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading, except that the representations and warranties set forth in this sentence do not apply to the Agent’s Information. Each Incorporated Document heretofore filed, when it was filed (or, if any amendment with respect to any such document was filed, when such amendment was filed), conformed in all material respects with the requirements of the Exchange Act and were filed on a timely basis with the Commission, and any further Incorporated Documents so filed and incorporated after the date of this Agreement will be filed on a timely basis and, when so filed, will conform in all material respects with the requirements of the Exchange Act; no such Incorporated Document when it was filed (or, if an amendment with respect to any such document was filed, when such amendment was filed), contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and no such Incorporated Document, when it is filed, will contain an untrue statement of a material fact or will omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The foregoing shall not apply to statements in, or omissions from, any such document made in reliance upon, and in conformity with, information furnished to the Company by the Agent specifically for use in the preparation thereof.
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(c) (i) At the time of filing the Registration Statement and (ii) at the time of the execution of this Agreement (with such date being used as the determination date for purposes of this clause ii)), the Company was not and is not an “ineligible issuer” (as defined in Rule 405), without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary that the Company be considered an ineligible issuer.
(d) The Company is, and since April 23, 2014 has been, an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “ Emerging Growth Company ”).
(e) Each issuer free writing prospectus, as of its issue date and as of each Applicable Time, did not, does not and will not include any information that conflicted, conflicts or will conflict with the information contained in the Registration Statement or the Prospectus, including any Incorporated Document deemed to be a part thereof that has not been superseded or modified. Each issuer free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433 or that was prepared by or on behalf of or used by the Company complies or will comply in all material respects with the requirements of the Securities Act.
(f) The Company has not distributed and, prior to the later to occur of each Settlement Date and completion of the Agent’s distribution of the Placement Shares under this Agreement, will not distribute any offering material in connection with the offering and sale of the Placement Shares other than the Registration Statement, the Prospectus or any Permitted Free Writing Prospectus (as defined below).
(g) The interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement and the Prospectus fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto.
(h) The Company is subject to and in compliance in all material respects with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act. The Common Stock is registered pursuant to Section 12(b) of the Exchange Act and is listed on Nasdaq, and the Company has taken no action designed to, or reasonably likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act or delisting the Common Stock from Nasdaq, nor has the Company received any notification that the Commission or Nasdaq is contemplating terminating such registration or listing. The Company is in compliance with the current listing standards of Nasdaq. The Company has filed a Notification of Listing of Additional Shares with Nasdaq with respect to the Placement Shares.
(i) No person (as such term is defined in Rule 1-02 of Regulation S-X promulgated under the Securities Act) has the right to act as an underwriter or as a financial advisor to the Company in connection with the offer and sale of the Placement Shares hereunder, whether as a result of the filing or effectiveness of the Registration Statement or the sale of the Placement Shares as contemplated hereby or otherwise. Except for the Agent, there is no broker, finder or other party that is entitled to receive from the Company or any of its Subsidiaries (as defined below) any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(j) The Company has been duly organized and is validly existing as a corporation in good standing under the laws of the State of Delaware, with full corporate power and authority to acquire, own, lease and operate its properties, and to lease the same to others, and to conduct its business as described in the Registration Statement and the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified to transact business as a foreign corporation and is in good standing in the State of California and under the laws of each other jurisdiction that requires such qualification, whether by reason of the ownership or leasing of property or the conduct of business, except to the extent that the failure to be so qualified or in good standing could not reasonably be expected, individually or in the aggregate, to have a material adverse effect on the condition (financial or otherwise), earnings, results of operations, business, properties, operations, assets, liabilities or prospects of the Company and its Subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business (a “ Material Adverse Effect ”).
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(k) Each of the Company’s “subsidiaries” (for purposes of this Agreement, as defined in Rule 405 under the Securities Act) (each, a “ Subsidiary ” and collectively, the “ Subsidiaries ”) has been duly organized and is validly existing in good standing (where such concept exists) under the laws of the jurisdiction of its organization and has full power and authority to acquire, own, lease and operate its properties, and to conduct its business as described in the Registration Statement and the Prospectus. Each Subsidiary is duly qualified to transact business and is in good standing (where such concept exists) under the laws of each jurisdiction that requires such qualification, whether by reason of the ownership or leasing of property or the conduct of business, except to the extent that the failure to be so qualified or in good standing could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. All of the issued and outstanding share capital or other equity or ownership interests of each Subsidiary has been duly authorized and validly issued, is fully paid and nonassessable, has been issued in compliance with federal state and securities laws and is owned by the Company, directly or through other wholly-owned Subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse claim. The Company does not own or control, directly or indirectly, any corporation, association or other entity, other than the Subsidiaries listed on Exhibit 21.1 to the Company’s most recent Annual Report on Form 10-K filed with the Commission and Former Immunic. No Subsidiary is prohibited or restricted, directly or indirectly, from paying dividends to the Company, from making any other distribution with respect to such Subsidiary’s equity securities, from repaying to the Company or any other Subsidiary any amounts that may from time to time become due under any loans or advances to such Subsidiary from the Company or from transferring any property or assets to the Company or to any other Subsidiary.
(l) The Company has the authorized and outstanding capitalization as set forth in the Company’s quarterly report on Form 10-Q for the most recent fiscal quarter, as of the dates referred to therein (subject, in each case, to the issuance of Placement Shares under this Agreement, the issuance of shares of Common Stock upon exercise of share options and warrants disclosed as outstanding as of the date hereof in the Registration Statement and the Prospectus and the grant of options under existing share option plans described in the Registration Statement and the Prospectus). The Common Stock conforms in all material respects to the description thereof contained in the Registration Statement and the Prospectus, including under the heading “Description of Capital Stock.” All of the issued and outstanding share capital or other equity or ownership interest of the Company (including the Common Stock) has been duly authorized and validly issued and is fully paid and nonassessable, has been issued in compliance with all federal, state and local securities laws and is free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse claim. None of the outstanding shares of capital stock of the Company were issued in violation of any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. There are no authorized or outstanding options, warrants, preemptive rights, rights of first refusal or other rights to purchase or subscribe for, or equity or debt securities convertible into or exchangeable or exercisable for, any share capital of the Company or any of its Subsidiaries or to which the Company or any of its Subsidiaries is a party or by which any of them may be bound. The descriptions of the Company’s equity incentive plan, stock option plans and other stock plans or arrangements described in the Prospectus and in effect as of the date hereof (collectively, the “ Stock Plans ”) and the options or other rights granted thereunder, set forth in the Registration Statement and the Prospectus accurately and fairly present the information required to be shown with respect to such Stock Plans and the options or other rights granted thereunder.
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(m) The Placement Shares have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued, fully paid and nonassessable and will conform in all material respects to the description thereof contained in the Prospectus. The issuance and sale of the Placement Shares as contemplated hereby shall not be subject to any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase the Placement Shares. When issued and delivered by the Company against payment therefor pursuant to this Agreement, the purchasers of the Placement Shares issued and sold hereunder will acquire good, marketable and valid title to such Placement Shares, free and clear of all pledges, liens, security interests, charges, claims or encumbrances. The issuance and sale of the Placement Shares as contemplated hereby will not cause any holder of any share capital, securities convertible into or exchangeable or exercisable for share capital or options, warrants or other rights to purchase share capital or any other securities of the Company to have any right to acquire any preferred shares of the Company. There are no restrictions upon the voting or transfer of the Common Stock under the Company’s amended and restated certificate of incorporation or amended and restated bylaws or any agreement or other instrument to which the Company is a party or otherwise filed as an exhibit to the Registration Statement.
(n) There is no statute, regulation, contract, agreement or other document required to be described in the Registration Statement, Prospectus or in any Incorporated Document, or to be filed as an exhibit to the Registration Statement or any Incorporated Document which is not described or filed as required. The statements set forth or incorporated by reference in the Prospectus, insofar as they purport to constitute summaries of the terms of the statutes, regulations, contracts, agreements or other documents described and filed, constitute accurate summaries of the terms thereof in all material respects. The statements set forth or incorporated by reference in the Prospectus under the headings “Risk Factors,” “Business—Intellectual Property,” “Business—Government Regulation” and “Description of Capital Stock,” insofar as such statements summarize legal matters, agreements, documents or proceedings discussed therein, are accurate and fair summaries of such legal matters, agreements, documents or proceedings. Neither the Company nor any of its Subsidiaries has sent or received any communication regarding termination of, or intent not to renew or render performance under, any of the contracts or agreements referred to or described in the Prospectus or any free writing prospectus, or referred to or described in, or filed as an exhibit to, the Registration Statement, or any Incorporated Document, and no such termination or non-renewal has been threatened by the Company or any of its Subsidiaries or, to the Company’s knowledge, any other party to any such contract or agreement, which threat of termination or non-renewal has not been rescinded as of the date hereof.
(o) This Agreement has been duly and validly authorized, executed and delivered by the Company and constitutes a valid and legally binding obligation of the Company, enforceable against the Company in accordance with its terms, except as enforceability, including rights of indemnification, may be limited by bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting creditors’ rights generally and by general principles of equity. This Agreement conforms in all material respects to the descriptions thereof in the Registration Statement and the Prospectus.
(p) The Company is not and, after giving effect to the offering and sale of the Placement Shares and the application of the proceeds thereof as described in the Prospectus, will not be an “investment company” as defined in the Investment Company Act of 1940, as amended.
(q) No consent, approval, license, permit, qualification, authorization or other order or decree of, or registration or filing with, any court or other governmental, taxing or regulatory authority or agency, is required for the Company’s execution, delivery and performance of this Agreement or consummation of the transactions contemplated hereby or by the Registration Statement and the Prospectus (including the issuance and sale of the Placement Shares hereunder), except such as have been already obtained or made or as may be required under the Securities Act, applicable state securities or Blue Sky laws, applicable rules of Nasdaq, or applicable rules of the Financial Industry Regulatory Authority, Inc. (“ FINRA ”).
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(r) Neither the execution and delivery by the Company of, nor the performance of the Company of its obligations under, this Agreement will conflict with, result in a breach or violation of, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company or any of its Subsidiaries pursuant to: (i) the certificate or articles of incorporation, charter, bylaws, articles of association, limited liability company agreement, certificate or agreement of limited or general partnership or other similar organizational documents, as the case may be, of such entity, (ii) the terms of any indenture, contract, license, lease, mortgage, deed of trust, note agreement, agreement or other instrument, obligation, condition, covenant or instrument to which it is a party or bound or to which its property or assets is subject or (iii) any statute, law, rule, regulation, judgment, order or decree applicable to the Company or any of its Subsidiaries of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company, any of its Subsidiaries or any of their respective properties or assets, as applicable, except, in the case of clauses (ii) and (iii) above, for any such conflict, breach, violation or default that would not, individually or in the aggregate, have a Material Adverse Effect.
(s) Subsequent to the respective dates as of which information is given in the Registration Statement and the Prospectus: (i) there has been no material adverse change, or any development that could reasonably be expected to result in a material adverse change, in the condition (financial or otherwise), earnings, results of operations, business, properties, operations, assets, liabilities or prospects of the Company and its Subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business; (ii) neither the Company nor its Subsidiaries has (A) incurred any material liability or obligation, indirect, direct or contingent, including without limitation any losses or interference with its business from fire, explosion, flood, earthquakes, accident or other calamity, whether or not covered by insurance, or from any strike, labor dispute or court or governmental action, order or decree, that are material, individually or in the aggregate, to the Company and its Subsidiaries, considered as one entity, (B) entered into any material transactions not in the ordinary course of business or (C) issued or granted any shares of the Company’s capital stock or securities convertible into or exchangeable or exercisable for or that represent the right to receive shares of the Company’s capital stock other than under the Stock Plans; and (iii) there has not been any material decrease in the share capital or any material increase in any short-term or long-term indebtedness of the Company or any of its Subsidiaries and there has been no dividend or distribution of any kind declared, paid or made by the Company or, except for dividends paid to the Company or another Subsidiary, by any Subsidiary on any class of shares, or any repurchase or redemption by the Company or any of its Subsidiaries of any class of shares.
(t) There are no persons (as such term is defined in Rule 1-02 of Regulation S-X promulgated under the Securities Act) with registration or other similar rights to have any equity or debt securities of the Company registered for sale under the Registration Statement or included in the offering contemplated by this Agreement, except for such rights as have been duly waived in a writing previously furnished to the Agent.
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(u) The financial statements of the Company and Former Immunic included or incorporated by reference in the Registration Statement and the Prospectus, together with the related notes and schedules, present fairly the consolidated financial position of the Company and the Subsidiaries and Former Immunic and its subsidiaries, respectively, as of the dates indicated and the consolidated results of operations, cash flows and changes in stockholders’ equity of the Company and the Subsidiaries and Former Immunic and its subsidiaries, respectively, for the periods specified and have been prepared in compliance in all material respects with the requirements of the Securities Act and Exchange Act and in conformity with United States generally accepted accounting principles (“ GAAP ”) applied on a consistent basis during the periods involved. To the extent applicable, any pro forma financial statements, information or data included or incorporated by reference in the Registration Statement and the Prospectus comply with the requirements of Regulation S-X of the Securities Act, including, without limitation, Article 11 thereof, fairly present the information set forth therein, and the assumptions used in the preparation of such pro forma financial statements and data are reasonable, the pro forma adjustments used therein are appropriate to give effect to the circumstances referred to therein and the pro forma adjustments have been properly applied to the historical amounts in the compilation of those statements and data. The other financial data set forth or incorporated by reference in the Registration Statement and the Prospectus is accurately and fairly presented in all material respects and prepared on a basis consistent with the financial statements and books and records of the Company and Former Immunic. There are no financial statements (historical or pro forma) that are required to be included or incorporated by reference in the Registration Statement or the Prospectus that are not included or incorporated by reference therein as required. The Company and the Subsidiaries do not have any material liabilities or obligations, direct or contingent (including any off-balance sheet obligations or any “variable interest entities” as that term is used in Accounting Standards Codification Paragraph 810-10-25-20), not disclosed in the Registration Statement and the Prospectus. All disclosures contained in the Registration Statement or the Prospectus that contain “non-GAAP financial measures” (as such term is defined by the rules and regulations of the Commission) comply, in all material respects, with Regulation G under the Exchange Act and Item 10 of Regulation S-K under the Securities Act, to the extent applicable. The statistical, industry-related and market-related data included or incorporated by reference in the Registration Statement and the Prospectus were obtained or derived from sources which the Company reasonably and in good faith believes are reliable and accurate, such data agree with the sources from which they are derived, and the Company has obtained the written consent to the use of such data from such sources to the extent required. To the Company’s knowledge, no person who has been suspended or barred from being associated with a registered public accounting firm, or who has failed to comply with any sanction pursuant to Rule 5300 promulgated by the Public Company Accounting Oversight Board (“ PCAOB ”), has participated in or otherwise aided the preparation of, or audited, the financial statements, supporting schedules or other financial data filed with the Commission as a part of the Registration Statement and the Prospectus.
(v) There are no actions, suits, claims, investigations or proceedings pending or, to the Company’s knowledge, threatened to which the Company or any of the Subsidiaries is or would be a party, or of which any of the respective properties or assets of the Company and the Subsidiaries is or would be subject, at law or in equity, before any court or arbitral body or by or before any federal, state, local or foreign governmental or regulatory commission, board, body, authority or agency, that (i) are required to be described in the Registration Statement or the Prospectus and are not so described, (ii) could reasonably be expected to have a material adverse effect on the ability of the Company to perform its obligations under this Agreement or on the consummation of any of the transactions contemplated hereby or (iii) could reasonably be expected to have a Material Adverse Effect. The aggregate of all pending legal or governmental proceedings to which the Company or any of its Subsidiaries is a party or of which any of their respective properties or assets is the subject which are not described in the Prospectus, including ordinary routine litigation incidental to the Company’s business, could not reasonably be expected to (A) result in a Material Adverse Effect or (B) have a material adverse effect on the ability of the Company to perform its obligations under this Agreement or the consummation of any of the transactions contemplated hereby.
(w) The Company owns or leases all such real properties as are necessary to the conduct of its operations as presently conducted in all material respects.
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(x) Neither the Company nor any Subsidiary is in violation or default of (i) any provision of its certificate or articles of incorporation, charter, bylaws, articles of association, limited liability company agreement, certificate or agreement of limited or general partnership, or other similar organizational documents, as the case may be, of such entity; (ii) the terms of any indenture, contract, lease, mortgage, deed of trust, note agreement, loan agreement or other agreement, obligation, condition, covenant or instrument to which it is a party or bound or to which its property or assets is subject; or (iii) any statute, law, rule, regulation, judgment, order or decree of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company, any of its Subsidiaries or any of their respective properties or assets, as applicable, except, in the case of clauses (ii) and (iii) above, for any such default or violation that would not, individually or in the aggregate, have a Material Adverse Effect.
(y) Baker Tilly Virchow Krause LLP (“ Baker Tilly ”), whose report on the consolidated financial statements of Former Immunic is filed with the Commission as part of the Company’s Current Report on Form 8-K/A filed with the Commission on June 21, 2019 and incorporated by reference in the Registration Statement and the Prospectus, is (i) an independent registered public accounting firm as required by the Securities Act, the Exchange Act and the rules of the PCAOB, (ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X under the Securities Act and (iii) a registered public accounting firm as defined by the PCAOB whose registration has not been suspended or revoked and who has not requested such registration to be withdrawn. Baker Tilly has not been engaged by the Company to perform any “prohibited activities” or provided to the Company any “non-audit services” (as defined in Section 10A of the Exchange Act). PricewaterhouseCoopers LLP (“ PwC ”), whose report on the consolidated financial statements of Vital Therapies is filed with the Commission as part of the Company’s most recent annual report on Form 10-K filed with the Commission and incorporated by reference in the Registration Statement and the Prospectus, is (i) an independent registered public accounting firm as required by the Securities Act, the Exchange Act and the rules of the PCAOB, (ii) in compliance with the applicable requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X under the Securities Act and (iii) a registered public accounting firm as defined by the PCAOB whose registration has not been suspended or revoked and who has not requested such registration to be withdrawn. PwC has not been engaged by the Company to perform any “prohibited activities” or provided to the Company any “non-audit services” (as defined in Section 10A of the Exchange Act).
(z) There are no transfer taxes or other similar fees or charges under federal law, the laws of any state, any foreign law, or any political subdivision thereof, required to be paid in connection with the execution and delivery of this Agreement or the issuance by the Company or sale by the Company of the Placement Shares.
(aa) All United States federal income tax returns of the Company and its Subsidiaries required by law to be filed have been filed or extensions thereof have been requested, and all taxes shown by such returns or otherwise assessed, which are due and payable, have been paid, except assessments that are being contested in good faith and as to which adequate reserves have been provided under GAAP. The Company has no knowledge of any material tax deficiency which has been or is likely to be threatened or asserted against the Company or its Subsidiaries. Each of the Company and its Subsidiaries has filed all foreign, state, provincial, local or other tax returns that are required to have been filed pursuant to applicable foreign, state, provincial, local or other law except insofar as the failure to file such returns would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, and paid all taxes due pursuant to such returns or pursuant to any assessment received by the Company and its Subsidiaries, except for such taxes, if any, as are being contested in good faith and as to which adequate reserves have been provided and except for such taxes or assessments the nonpayment of which would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The charges, accruals and reserves on the books of the Company and its Subsidiaries in respect of any income or other tax liability for any years not finally determined are adequate to meet any assessments or re-assessments for additional tax for any years not finally determined, except to the extent of any inadequacy that would not reasonably be expected to result in a Material Adverse Effect. All material taxes which the Company and its Subsidiaries are required by law to withhold or to collect for payment have been duly withheld and collected and have been paid to the appropriate governmental authority or agency or have been accrued, reserved against and entered on the books of the Company and its Subsidiaries.
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(bb) No labor dispute with the employees of the Company or any of its Subsidiaries exists or, to the Company’s knowledge, is threatened or imminent, and the Company is not aware of any existing, threatened or imminent labor disturbance by the employees of any of its or any of its Subsidiaries’ principal suppliers, manufacturers, contractors or customers, in each case that would have a Material Adverse Effect. None of the employees of the Company or any of its Subsidiaries is represented by a union and, to the knowledge of the Company, no union organizing activities are taking place. Neither the Company nor any of its Subsidiaries has violated (or received notice of any violation of) any federal, state or local law or foreign law relating to the discrimination in hiring, promotion or pay of employees, nor any applicable wage or hour laws, or the rules and regulations thereunder, or analogous foreign laws and regulations, which would, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
(cc) Each of the Company and its Subsidiaries are insured by recognized and reputable institutions with policies in such amounts and with such deductibles and covering such risks as are generally deemed adequate and customary for their businesses including, but not limited to, policies covering real and personal property owned or leased by the Company and its Subsidiaries against theft, damage, destruction, acts of vandalism and earthquakes and policies covering the Company and its Subsidiaries for clinical trial liability claims. The Company has no reason to believe that it or any of its Subsidiaries will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that could not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has been denied any material insurance coverage which it has sought or for which it has applied.
(dd) The Company and each of its Subsidiaries has good and marketable title in fee simple to all real property owned by them and good and marketable title to all personal property owned by them that is material to their business (except with respect to intellectual property, which is addressed exclusively in Section 6(pp) and Section 6(ggg) below), in each case free and clear of all liens, encumbrances and defects except such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company or any Subsidiary; and any real property and buildings held under lease by the Company or any of its Subsidiaries are held by them under valid, subsisting and enforceable leases (subject to the effects of (A) bankruptcy, insolvency, fraudulent conveyance, fraudulent transfer, reorganization, moratorium or other similar laws relating to or affecting the rights or remedies of creditors generally; (B) the application of general principles of equity (including, without limitation, concepts of materiality, reasonableness, good faith and fair dealing, regardless of whether enforcement is considered in proceedings at law or in equity); and (C) applicable law and public policy with respect to rights to indemnity and contribution) with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company or such Subsidiary.
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(ee) The Company and its Subsidiaries possess and are operating in compliance in all material respects with such valid and current material certificates, authorizations or permits required by United States federal, state or foreign regulatory agencies or bodies to conduct their respective businesses as currently conducted and as described in the Registration Statement and the Prospectus (collectively, “ Permits ”). Neither the Company nor any of its Subsidiaries is in violation of, or in default under, any of the Permits or has received any written notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate, authorization or permit, which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Effect.
(ff) The Company and each of its Subsidiaries make and keep accurate books and records and maintain a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and (v) the interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement and the Prospectus fairly presents the information called for in all material respects and is prepared in accordance with the Commission’s rules and guidelines applicable thereto.
(gg) The Company and each of its Subsidiaries have established and maintain disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed to ensure that material information relating to the Company, including its consolidated Subsidiaries, is made known to the Company’s principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to perform the functions for which they were established. Since the end of the Company’s most recent audited fiscal year, there has been no material weakness in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting, including any corrective actions with regard to significant deficiencies or material weaknesses. The Company is not aware of any change in its internal control over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
(hh) Neither the Company, nor any of its Subsidiaries, nor to the knowledge of the Company, any of its or their respective directors, officers or controlling persons has taken, directly or indirectly, without giving effect to any actions taken by the Agent, (i) any action designed to or that might constitute or reasonably be expected to cause or result in, under the Exchange Act or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Placement Shares or (ii) any action designed to or that might constitute or reasonably be expected to cause or result in a violation of Regulation M under the Exchange Act.
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(ii) Except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect: (i) neither the Company nor any of its Subsidiaries is in violation of any United States federal, state or local, or any foreign, statute, law, rule, regulation, ordinance, code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations relating to the emissions, discharges, release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum or petroleum products (collectively, “ Hazardous Materials ”) or otherwise related to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “ Environmental Laws ”), which violation includes, but is not limited to, noncompliance with any permits or other governmental authorizations required for the operation of the business of the Company or any of its Subsidiaries under applicable Environmental Laws, or noncompliance with the terms and conditions thereof, nor has the Company or any of its Subsidiaries received any written communication, whether from a governmental authority, citizens group, employee or otherwise, that alleges that the Company or any of its Subsidiaries is in violation of any Environmental Law; (ii) the Company and its Subsidiaries have all material permits, authorizations and approvals required under any applicable Environmental Laws and are in compliance with their requirements; (iii) there are no pending or, to the Company’s knowledge, threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating to any Environmental Law against the Company or any of its Subsidiaries, or any investigation with respect to which the Company or any of its Subsidiaries has received written notice or any written notice by any person or entity alleging potential liability for investigatory costs, cleanup costs, governmental responses costs, natural resources damages, property damages, personal injuries, attorneys’ fees or penalties arising out of, based on or resulting from the presence, or release into the environment, of any Hazardous Materials at any location owned, leased or operated by the Company or any of its Subsidiaries, now or in the past; and (iv) to the Company’s knowledge, there are no past or present actions, activities, events, conditions, incidents or circumstances that might reasonably be expected to result in a violation of any Environmental Law or form the basis of an order for clean-up or remediation, or an action, suit, investigation or proceeding by any private party or governmental body or agency, against or affecting the Company or any of its Subsidiaries relating to Hazardous Materials or any Environmental Laws.
(jj) The Company and any “employee benefit plan” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ ERISA ”)) established or maintained by the Company, or its “ERISA Affiliates” (as defined below) are in compliance in all material respects with ERISA. “ERISA Affiliates” means, with respect to the Company, any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations thereunder (the “ Code ”) of which the Company is a member. No “reportable event” (as defined under ERISA) has occurred or is reasonably expected to occur with respect to any “employee benefit plan” established or maintained by the Company, or any of its ERISA Affiliates. No “employee benefit plan” established or maintained by the Company or any of its ERISA Affiliates, if such “employee benefit plan” were terminated, would have any “amount of unfunded benefit liabilities” (as defined under ERISA). Neither the Company nor any of its ERISA Affiliates has incurred or reasonably expects to incur any liability under (i) Title IV of ERISA with respect to termination of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each “employee benefit plan” established or maintained by the Company or any of its ERISA Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification.
(kk) The Company is in compliance with, and there is and has been no failure on the part of the Company and, to the Company’s knowledge, any of the Company’s directors or officers, in their capacities as such, to comply with, any applicable provision of the Sarbanes-Oxley Act of 2002 and all rules and regulations promulgated thereunder or implementing the provisions thereof (the “ Sarbanes-Oxley Act ”) and the rules and regulations promulgated in connection therewith, including Section 402 relating to loans.
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(ll) Neither the Company, any of its Subsidiaries, nor, to the knowledge of the Company, any of their respective directors, officers, agents, employees or affiliates, has taken or will take any action in furtherance of an offer, payment, promise to pay, or authorization or approval of the unlawful payment or giving of money, property, gifts or anything else of value, directly or indirectly, to any “government official” (including any officer or employee of a government or government-owned or controlled entity or of a public international organization, or any person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official or candidate for political office) to influence official action or secure an improper advantage; and the Company, each of its Subsidiaries and, to the Company’s knowledge, each of their respective affiliates have conducted their businesses in compliance with applicable anti-corruption laws.
(mm) None of the Company, any Subsidiary, affiliate, director, officer or employee thereof or, to the best of the Company’s knowledge, any agent, representative or other person acting on behalf of the Company or any of its Subsidiaries or affiliates, is aware of or has taken any action, directly or indirectly, that would result in a violation by such persons of any applicable anti-corruption laws, including the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “ FCPA ”), including, without limitation, making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office or otherwise took any action (or failed to fully disclose any action) in contravention of the FCPA; and the Company, its Subsidiaries and each of their respective affiliates have conducted their businesses in compliance with the FCPA and have instituted and maintain, and will continue to maintain, policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith.
(nn) The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance in all material respects with applicable financial recordkeeping and reporting requirements and the money laundering statutes and the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “ Money Laundering Laws ”) and no action, suit, investigation or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its Subsidiaries with respect to the Money Laundering Laws is pending or, to the best of the Company’s knowledge, threatened.
(oo) Neither the Company nor any of its Subsidiaries, nor any director or officer thereof, nor, to the Company’s knowledge, any employee, agent, affiliate or representative of the Company or any of its Subsidiaries, is currently or is owned or controlled by an individual or entity that is subject to any sanctions administered or enforced by the United States government (including, without limitation, the Office of Foreign Assets Control of the United States Department of the Treasury), the United Nations Security Council, the European Union, Her Majesty’s Treasury or other relevant sanctions authority (collectively, “ Sanctions ”) or is located, organized or resident in a country or territory that is the subject or target of Sanctions; and the Company will not directly or indirectly use the proceeds of the sale of the Placement Shares, or lend, contribute or otherwise make available such proceeds to any Subsidiary, or any joint venture partner or other person or entity, for the purpose of financing or facilitating the activities of or business of any person or entity, or in any country or territory, that currently or at the time of such financing or facilitation is the subject of any Sanctions or in any other manner that will result in a violation by any person or entity (including any person participating in the transactions contemplated by this Agreement) of any Sanctions. For the past five years, the Company and its Subsidiaries have not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person or entity, or in any country or territory, that at the time of the dealing or transaction is or was the subject of Sanctions.
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(pp) The Company and its Subsidiaries own or possess the right to use all inventions, patent applications, patents, trademarks, trade names, service names, domain names, copyrights, trade secrets, know-how and other intellectual property (collectively, “ Intellectual Property ”) as are (i) necessary or material for the conduct of their respective businesses as currently conducted or as currently proposed to be conducted and as described in the Registration Statement and the Prospectus and (ii) necessary or material for the commercialization of the products described in the Registration Statement and the Prospectus as being under development. There is no pending or, to the Company’s knowledge, threatened (i) action, suit, proceeding, or claim by others challenging the rights of the Company or any of its Subsidiaries in or to any such Intellectual Property that, if decided adversely to the Company or such Subsidiary would, individually or in the aggregate, have a Material Adverse Effect, and the Company is unaware of any facts which would form a reasonable basis for any such claim; (ii) action, suit, proceeding, or claim by others that the Company or any of its Subsidiaries infringes, misappropriates, or otherwise violates any Intellectual Property of others that, if decided adversely to the Company or such Subsidiary would, individually or in the aggregate, have a Material Adverse Effect, and the Company is unaware of any facts which would form a reasonable basis for any such claim; or (iii) action, suit, proceeding, or claim by others challenging the validity, scope, or enforceability of any such Intellectual Property owned or licensed by the Company or its Subsidiaries and the Company is unaware of any facts which would form a reasonable basis for any such claim. To the best of the Company’s knowledge, the operation of the business of the Company and its Subsidiaries as now conducted, and as described in the Prospectus, and in connection with the development and commercialization of the products described in the Prospectus does not infringe, misappropriate, conflict with or otherwise violate any claim of any patent or published patent application of any other person or entity. There is no prior art of which the Company or any of its Subsidiaries is aware that may render any patent owned or licensed by the Company or its Subsidiaries invalid or any patent application owned or licensed by the Company or its Subsidiaries unpatentable which has not been disclosed to the applicable government patent office. The Company’s granted or issued patents, registered trademarks and registered copyrights have been duly maintained and are in full force and effect, and none of the patents, trademarks and copyrights have been adjudged invalid or unenforceable in whole or in part. The Company knows of no infringement, misappropriation or violation by others of any Intellectual Property owned or licensed by the Company or its Subsidiaries which would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is a party to or bound by any options, licenses or agreements with respect to the Intellectual Property of any other person or entity that are required to be set forth in the Prospectus and that are not described therein in all material respects. The Company and its Subsidiaries have taken all reasonable steps necessary to secure their interests in the Intellectual Property of the Company and its Subsidiaries from their employees and contractors and to protect the confidentiality of all of their confidential information and trade secrets. None of the technology or intellectual property used by the Company and its Subsidiaries in its business has been obtained or is being used by the Company or its Subsidiaries in violation of any contractual obligation binding on the Company or its Subsidiaries, or, to the Company’s knowledge, any of its officers, directors or employees or otherwise in violation of the rights of any persons. No third party has been granted by the Company or its Subsidiaries rights to the Intellectual Property of the Company or its Subsidiaries, including any rights that, if exercised, could enable such party to develop products competitive to those of the Company as described in the Registration Statement and the Prospectus. All Intellectual Property owned or exclusively licensed by the Company or its Subsidiaries are free and clear of all liens, encumbrances, defects or other restrictions (other than non-exclusive licenses granted in the ordinary course of business), except those that could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. The Company and its Subsidiaries are not subject to any judgment, order, writ, injunction or decree of any court or any federal, state, local, foreign or other governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, or any arbitrator, nor has it entered into or is it a party to any agreement made in settlement of any pending or threatened litigation, which materially restricts or impairs their use of any Intellectual Property.
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(qq) The Company and each of its Subsidiaries (i) are and have at all times been in material compliance with all laws, statutes, rules, regulations or guidance applicable to the Company and its Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any pharmaceuticals or biohazardous substances, materials or any other products developed, manufactured or distributed by the Company (including, without limitation, from the United States Food and Drug Administration (“ FDA ”), European Medicines Agency (“ EMA ”) and any local or other governmental or regulatory authority performing functions similar to those performed by the FDA or EMA) (collectively, “ Applicable Laws ”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, (ii) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company, any of its Subsidiaries or their activities alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (collectively, the “ Governmental Permits ”), (iii) have made all filings with, the appropriate local, or other governmental or regulatory agencies or bodies that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Registration Statement and the Prospectus, except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Effect, (iv) possess all material Governmental Permits necessary to conduct their respective businesses as described in the Registration Statement and the Prospectus, and such Governmental Permits are valid and in full force and effect and are not in violation of any term of any such Governmental Permits, (v) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Governmental Permits and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission), and (vi) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental authority. All Governmental Permits are valid and in full force and effect, except where the validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any Subsidiary has received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed. Neither the Company, any of its Subsidiaries nor, to the Company’s knowledge, any of their respective directors, officers, employees or agents has been convicted of any crime under any Applicable Laws or has been the subject of an FDA debarment proceeding. Neither the Company nor any of its Subsidiaries has been nor is now subject to the FDA’s Application Integrity Policy. To the Company’s knowledge, neither the Company, any of its Subsidiaries nor any of its directors, officers, employees or agents has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental authority.
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(rr) There is no legal or governmental proceeding to which the Company or any of its Subsidiaries is a party or of which any property or assets of the Company or any of its Subsidiaries is the subject, including any proceeding before the FDA, the EMA or any foreign, local, national or other governmental agency with jurisdiction over the types of products being developed by the Company that is required to be described in the Registration Statement or the Prospectus and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company or any of its Subsidiaries, could reasonably be expected to have a Material Adverse Effect; and no such proceedings are threatened or contemplated by governmental or regulatory authorities or threatened by others. The Company and its Subsidiaries (i) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Governmental Permits and have no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding and (ii) have not received notice that any governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Governmental Permits and the Company has no knowledge that any such governmental authority is considering such action.
(ss) The research, non-clinical pre-clinical studies and clinical studies and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical trials directed or sponsored by the Company’s collaborators (collectively, the “ Studies ”) that are described in, or the results of which are referred to in, the Registration Statement and the Prospectus were and, if still pending, are being conducted with reasonable care and in all material respects in accordance with the protocols, procedures and controls pursuant to all Applicable Laws and Governmental Permits and with standard medical and scientific research procedures; each description of the results of such Studies is accurate and complete in all material respects and fairly presents the data derived from such Studies, and the Company and its Subsidiaries have no knowledge of any other research, non-clinical studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement and the Prospectus; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the EMA, the FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the types of products being developed by the Company; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any governmental authority requiring the termination, suspension or modification of any Study; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of all governmental authorities. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all Applicable Laws and Governmental Permits.
(tt) The Company acknowledges and agrees that the Agent has informed the Company that the Agent may, to the extent permitted under the Securities Act and the Exchange Act, purchase and sell shares of Common Stock for its own account while this Agreement is in effect; provided , that (i) no such purchase or sales shall take place while a Placement Notice is in effect (except to the extent the Agent may engage in sales of Placement Shares purchased or deemed purchased from the Company as a “riskless principal” or in a similar capacity) and (ii) the Company shall not be deemed to have authorized or consented to any such purchases or sales by the Agent, except as may be otherwise agreed by the Company and the Agent.
(uu) The Company is not a party to any agreement with an agent or underwriter for any other “at the market” or continuous equity transaction.
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(vv) The Company is not required to register as a “broker” or “dealer” in accordance with the provisions of the Exchange Act and does not, directly or indirectly through one or more intermediaries, control or have any other association with (within the meaning of Article I of the By-laws of FINRA) any member firm of FINRA. No relationship, direct or indirect, exists between or among the Company, on the one hand, and the directors, officers or shareholders of the Company, on the other hand, which is required by the rules of FINRA to be described in the Registration Statement and the Prospectus, which is not so described. All of the information (including, but not limited to, information regarding affiliations, security ownership and trading activity) provided to the Agent or its counsel by the Company, its officers and directors and the holders of any securities (debt or equity) or warrants, options or rights to acquire any securities of the Company in connection with the filing to be made and other supplemental information to be provided to FINRA pursuant to FINRA Rule 5110 in connection with the transactions contemplated by this Agreement is true, complete and correct.
(ww) As of the close of trading on Nasdaq on June 24, 2019, the aggregate market value of the outstanding voting and non-voting common equity (as defined in Rule 405) of the Company held by persons other than affiliates of the Company (pursuant to Rule 144 of the Securities Act, those that directly, or indirectly through one or more intermediaries, control, or are controlled by, or are under common control with, the Company) (the “ Non-Affiliate Shares ”), was approximately $78,575,114.25 (calculated by multiplying (x) the price at which the common equity of the Company was last sold on Nasdaq on June 24, 2019 by (y) the number of Non-Affiliate Shares outstanding on June 24, 2019). The Company is not a shell company (as defined in Rule 405) and has not been a shell company for at least 12 calendar months previously.
(xx) Neither the issuance, sale and delivery of the Placement Shares nor the application of the proceeds thereof by the Company as described in the Registration Statement and the Prospectus will violate Regulation T, U or X of the Board of Governors of the Federal Reserve System or any other regulation of such Board of Governors.
(yy) Each of the independent directors (or independent director nominees, once appointed, if applicable) named in the Registration Statement and Prospectus satisfies the independence standards established by Nasdaq and, with respect to members of the Company’s audit committee, the enhanced independence standards contained in Rule 10A-3(b)(1) promulgated by the Commission under the Exchange Act.
(zz) Neither the Company nor, to the Company’s knowledge, any of its affiliates (within the meaning of Rule 144 under the Securities Act) has, prior to the date hereof, made any offer or sale of any securities which could be “integrated” (within the meaning of the Securities Act) with the offer and sale of the Placement Shares hereunder.
(aaa) Neither the Company nor any of its Subsidiaries has (i) failed to pay any dividend or sinking fund installment on preferred stock or (ii) defaulted on any installment or payment due on indebtedness for borrowed money or on any rental on one or more long-term leases, which defaults, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect.
(bbb) Each financial or operational projection or other “forward-looking statement” (as defined by Section 27A of the Securities Act or Section 21E of the Exchange Act) contained in the Registration Statement or the Prospectus (i) was so included by the Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions, estimates and other applicable facts and circumstances and (ii) as required, is accompanied by meaningful cautionary statements identifying those factors that could cause actual results to differ materially from those in such forward-looking statement. No such statement was made with the knowledge of a director or senior manager of the Company that was false or misleading.
(ccc) There are no relationships, direct or indirect, or related party transactions involving the Company or any of its Subsidiaries or any other person (including any director, officer, stockholder, customer or supplier of the Company or any of its Subsidiaries) required to be described in the Registration Statement or the Prospectus that have not been described as required. There are no material outstanding loans, advances (except normal advances for business expenses in the ordinary course of business) or guarantees of indebtedness by the Company or any of its Subsidiaries to or for the benefit of any of the officers or directors of the Company or any of its Subsidiaries, or any of the family members of any of such persons.
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(ddd) The Company is not in or subject to a bankruptcy or insolvency proceeding in any jurisdiction.
(eee) The Company and its Subsidiaries (i) are in compliance, in all material respects, with any and all applicable foreign, federal, state and local laws, rules, regulations, treaties, statutes and codes promulgated by any and all governmental authorities (including pursuant to the Occupational Health and Safety Act) relating to the protection of human health and safety the workplace (“ Occupational Laws ”); (ii) have received all material permits, licenses or other approvals required of it under applicable Occupational Laws to conduct their respective businesses as currently conducted; and (iii) are in compliance, in all material respects, with all terms and conditions of such permit, license or approval. No action, proceeding, revocation proceeding, writ, injunction or claim is pending or, to the Company’s knowledge, threatened against the Company or any of its Subsidiaries relating to Occupational Laws, and the Company does not have knowledge of any facts, circumstances or developments relating to its operations or cost accounting practices that could reasonably be expected to form the basis for or give rise to such actions, suits, investigations or proceedings.
(fff) No director or officer of the Company or any of its Subsidiaries is subject to any non-competition agreement or non-solicitation agreement with any employer or prior employer which could materially affect each director’s or officer’s ability to be and act in the capacity of a director or officer of the Company or a Subsidiary.
(ggg) The Company has duly and properly filed or caused to be filed with the U.S. Patent and Trademark Office (the “ PTO ”) and applicable foreign and international patent and trademark authorities all patents, trademarks, copyrights and applications relating to the same owned by the Company and its Subsidiaries (the “ Company Patent and Trademark Applications ”). To the knowledge of the Company, the Company has complied with the PTO’s duty of candor and disclosure for the Company Patent and Trademark Applications and has made no material misrepresentation in the Company Patent and Trademark Applications. To the Company’s knowledge, the Company Patent and Trademark Applications disclose patentable subject matter. The Company has not been notified of any inventorship challenges nor has any interference been declared or provoked nor is any material fact known by the Company that would preclude the issuance of patents with respect to the Company Patent and Trademark Applications or would render such patents, if issued, invalid or unenforceable. Except as would not have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has breached and is currently in breach of any provision of any license, contract or other agreement governing the use by the Company or its Subsidiaries of Intellectual Property owned by third parties (collectively, the “ Licenses ”) and no third party has alleged any such breach and the Company is unaware of any facts that would form a reasonable basis for such a claim. To the Company’s knowledge, no other party to the Licenses has breached or is currently in breach of any provision of the Licenses. Each of the Licenses is in full force and effect and constitutes a valid and binding agreement between the parties thereto, enforceable in accordance with its terms, and there has not occurred any breach or default under any such Licenses or any event that, with the giving of notice or lapse of time, would constitute a breach or default thereunder. Except as would not have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has been and is currently involved in any disputes regarding the Licenses. To the Company’s knowledge, all patents licensed to the Company pursuant to the Licenses are valid, enforceable and being duly maintained. To the Company’s knowledge, all patent applications licensed to the Company pursuant to the Licenses are being duly prosecuted.
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Any certificate signed by any officer of the Company and delivered to the Agent or its counsel in connection with the offering of the Placement Shares shall be deemed a representation and warranty by the Company, as to matters covered thereby, to the Agent.
7. Covenants of the Company . The Company covenants and agrees with the Agent that:
(a) Registration Statement Amendments . After the date of this Agreement and during any period in which the Prospectus relating to any Placement Shares is required to be delivered by the Agent under the Securities Act (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act or a similar rule); (i) the Company will notify the Agent promptly of the time when any subsequent amendment to the Registration Statement, other than Incorporated Documents, has been filed with the Commission and/or has become effective or any subsequent supplement to the Prospectus, other than Incorporated Documents, has been filed and of any request by the Commission for any amendment or supplement to the Registration Statement or Prospectus or for additional information; (ii) the Company will prepare and file with the Commission, promptly upon the Agent’s request, any amendments or supplements to the Registration Statement or Prospectus that, in the Agent’s reasonable opinion, may be necessary or advisable in connection with the distribution of the Placement Shares by the Agent ( provided , however , that the failure of the Agent to make such request shall not relieve the Company of any obligation or liability hereunder, or affect the Agent’s right to rely on the representations and warranties made by the Company in this Agreement and provided , further , that the only remedy the Agent shall have with respect to the failure by the Company to make such filing (but without limiting the Agent’s rights under Section 9 hereof) will be to cease making sales under this Agreement until such amendment or supplement is filed); (iii) the Company will not file any amendment or supplement to the Registration Statement or Prospectus, other than Incorporated Documents, relating to the Placement Shares or a security convertible into or exchangeable or exercisable for the Placement Shares unless a copy thereof has been submitted to the Agent within a reasonable period of time before the filing and the Agent has not reasonably objected thereto ( provided , however , that the failure of the Agent to make such objection shall not relieve the Company of any obligation or liability hereunder, or affect the Agent’s right to rely on the representations and warranties made by the Company in this Agreement and provided , further , that the only remedy the Agent shall have with respect to the Company’s making such filing notwithstanding the Agent’s objection (but without limiting the Agent’s rights under Section 9 hereof) will be to cease making sales under this Agreement) and the Company will furnish to the Agent at the time of filing thereof a copy of any Incorporated Document, except for those documents available via EDGAR; and (iv) the Company will cause each amendment or supplement to the Prospectus, other than Incorporated Documents, to be filed with the Commission as required pursuant to the applicable paragraph of Rule 424(b) of the Securities Act and, in the case of any Incorporated Document, to be filed with the Commission as required pursuant to the Exchange Act, within the time period prescribed.
(b) Notice of Commission Stop Orders . The Company will advise the Agent, promptly after it receives notice or obtains knowledge thereof, of the issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement, of the suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction or of the initiation or threatening of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop order or to obtain its withdrawal if such a stop order should be issued. The Company will advise the Agent promptly after it receives any request by the Commission for any amendments to the Registration Statement or any amendment or supplements to the Prospectus or for additional information related to the offering of the Placement Shares or for additional information related to the Registration Statement or the Prospectus.
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(c) Delivery of Prospectus; Subsequent Changes . During any period in which the Prospectus relating to the Placement Shares is required to be delivered by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act or a similar rule), the Company will comply in all material respects with all requirements imposed upon it by the Securities Act, as from time to time in force, and will file on or before their respective due dates (taking into account any extensions available under the Exchange Act) all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange Act. If during such period any event occurs as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration Statement or Prospectus to comply with the Securities Act, the Company will promptly notify the Agent to suspend the offering of Placement Shares during such period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of the Company) so as to correct such statement or omission or effect such compliance. If the Company has omitted any information from the Registration Statement pursuant to Rule 430B under the Securities Act, it will use its best efforts to comply with the provisions thereof and make all requisite filings with the Commission pursuant to said Rule 430B and to notify the Agent promptly of all such filings if not available on EDGAR.
(d) Listing of Placement Shares . During any period in which the Prospectus relating to the Placement Shares is required to be delivered by the Agent under the Securities Act with respect to the offer and sale of the Placement Shares (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act or a similar rule), the Company will use its commercially reasonable efforts to cause the Placement Shares to be listed on Nasdaq. The Company will timely file with Nasdaq all material documents and notices required by Nasdaq of companies that have or will issue securities that are traded on Nasdaq.
(e) Delivery of Registration Statement and Prospectus . The Company will furnish to the Agent and its counsel (at the expense of the Company) copies of the Registration Statement, the Prospectus (including all Incorporated Documents) and all amendments and supplements to the Registration Statement or Prospectus that are filed with the Commission during any period in which the Prospectus relating to the Placement Shares is required to be delivered under the Securities Act (including all Incorporated Documents filed with the Commission during such period), in each case as soon as reasonably practicable and in such quantities as the Agent may from time to time reasonably request and, at the Agent’s request, will also furnish copies of the Prospectus to each exchange or market on which sales of the Placement Shares may be made; provided , however , that the Company shall not be required to furnish any document (other than the Prospectus) to the Agent to the extent such document is available on EDGAR.
(f) Earnings Statement . The Company will make generally available to its security holders and to the Agent as soon as practicable, but in any event not later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month period that satisfies the provisions of Section 11(a) of and Rule 158 under the Securities Act.
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(g) Expenses . The Company will pay all expenses incident to the performance of its obligations hereunder, including expenses relating to (i) the preparation, printing and filing of the Registration Statement and each amendment and supplement thereto, of the Prospectus and of each amendment and supplement thereto and of this Agreement and such other documents as may be required in connection with the offering, purchase, sale, issuance or delivery of the Placement Shares, (ii) the preparation, issuance, sale and delivery of the Placement Shares and any taxes due or payable in connection therewith, (iii) the qualification of the Placement Shares under securities laws in accordance with the provisions of Section 7(w) of this Agreement, including filing fees ( provided , however , that any fees or disbursements of counsel for the Agent in connection therewith shall be paid by the Agent except as set forth in clauses (vii) and (viii) below), (iv) the printing and delivery to the Agent and its counsel of copies of the Prospectus and any amendments or supplements thereto, and of this Agreement, (v) the fees and expenses incurred in connection with the listing or qualification of the Placement Shares for trading on Nasdaq, (vi) the filing fees and expenses, if any, owed to the Commission or FINRA and the fees and expenses of any transfer agent or registrar for the Shares, (vii) the fees and associated expenses of the Agent’s outside legal counsel for filings with the FINRA Corporate Financing Department in an amount not to exceed $15,000 (excluding FINRA filing fees referred to in clause (vi) above and in addition to the fees and disbursements referred to in clause (viii) below), and (viii) the reasonable fees and disbursements of the Agent’s outside legal counsel in an amount not to exceed $50,000 (in addition to the fees and associated expenses referred to in clause (vii) above).
(h) Use of Proceeds . The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.”
(i) Notice of Other Sales . Without the prior written consent of the Agent, the Company will not, directly or indirectly, offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose of any shares of Common Stock (other than the Placement Shares offered pursuant to this Agreement) or securities convertible into or exchangeable or exercisable for shares of Common Stock, warrants or any rights to purchase or acquire shares of Common Stock during the period beginning on the fifth Trading Day immediately prior to the date on which any Placement Notice is delivered to Agent hereunder and ending on the second Trading Day immediately following the final Settlement Date with respect to Placement Shares sold pursuant to such Placement Notice (or, if the Placement Notice has been terminated or suspended prior to the sale of all Placement Shares covered by a Placement Notice, the date of such suspension or termination); and will not directly or indirectly in any other “at the market offering” or continuous equity transaction offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose of any shares of Common Stock (other than the Placement Shares offered pursuant to this Agreement) or securities convertible into or exchangeable or exercisable for shares of Common Stock, warrants or any rights to purchase or acquire, shares of Common Stock prior to the later of the termination of this Agreement and the sixtieth day immediately following the final Settlement Date with respect to Placement Shares sold pursuant to such Placement Notice; provided , however , that such restrictions will not be required in connection with the Company’s issuance or sale of (i) shares of Common Stock, options to purchase shares of Common Stock, other securities under the Company’s existing equity incentive plans, or shares of Common Stock issuable upon the exercise of options or vesting of other securities, pursuant to any employee or director stock option or benefits plan, stock ownership plan or dividend reinvestment plan (but not shares of Common Stock subject to a waiver to exceed plan limits in its dividend reinvestment plan) of the Company whether now in effect or hereafter implemented, (ii) shares of Common Stock issuable upon conversion of securities or the exercise of warrants, options or other rights in effect or outstanding, and disclosed in filings by the Company available on EDGAR or otherwise in writing to the Agent and (iii) shares of Common Stock or securities convertible into or exchangeable for shares of Common Stock as consideration for mergers, acquisitions, other business combinations or strategic alliances occurring after the date of this Agreement which are not issued for capital raising purposes.
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(j) Change of Circumstances . The Company will, at any time during a fiscal quarter in which the Company intends to tender a Placement Notice or sell Placement Shares, advise the Agent promptly after it shall have received notice or obtained knowledge of any information or fact that would alter or affect in any material respect any opinion, certificate, letter or other document provided or required to be provided to the Agent pursuant to this Agreement.
(k) Due Diligence Cooperation . During the term of this Agreement, the Company will cooperate with any reasonable due diligence review conducted by the Agent, its affiliates agents and counsel from time to time in connection with the transactions contemplated hereby, including providing information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices, as the Agent may reasonably request.
(l) Required Filings Relating to Placement of Placement Shares . The Company agrees that on or prior to such dates as the Securities Act shall require, the Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities Act, which prospectus supplement will set forth, within the relevant period, the number or amount of Placement Shares sold through the Agent, the Net Proceeds to the Company and the compensation payable by the Company to the Agent with respect to such Placement Shares, and (ii) deliver such number of copies of each such prospectus supplement to each exchange or market on which such sales were effected as may be required by the rules or regulations of such exchange or market; provided , that, unless a prospectus supplement containing such information is required to be filed under the Securities Act, the requirement of this Section 7(l) may be satisfied by Company’s inclusion in the Company’s Form 10-K or Form 10-Q, as applicable, of the number or amount of Placement Shares sold through the Agent, the Net Proceeds to the Company and the compensation payable by the Company to the Agent with respect to such Placement Shares during the relevant period.
(m) Representation Dates; Certificate . On or prior to the date on which the Company first delivers a Placement Notice pursuant to this agreement (the “ First Placement Notice Date ”) and each time the Company:
(i) amends or supplements the Registration Statement or the Prospectus relating to the Placement Shares (other than a prospectus supplement filed in accordance with Section 7(l) of this Agreement) by means of a post-effective amendment, sticker or supplement but not by means of incorporation of document(s) by reference into the Registration Statement or the Prospectus relating to the Placement Shares;
(ii) files an annual report on Form 10-K under the Exchange Act (including any Form 10-K/A containing amended financial information or a material amendment to the previously filed Form 10-K);
(iii) files a quarterly report on Form 10-Q under the Exchange Act; or
(iv) files a current report on Form 8-K containing amended financial information (other than an earnings release that is “furnished” pursuant to Item 2.02 or Item 7.01 of Form 8-K) under the Exchange Act (each date of filing of one or more of the documents referred to in clauses (i) through (iv) shall be a “ Representation Date ”),
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the Company shall furnish the Agent (but in the case of clause (iv) above only if (1) a Placement Notice is pending or in effect and (2) the Agent requests such certificate within three Business Days after the filing of such Form 8-K with the Commission) with a certificate, in the form attached hereto as Exhibit 7(m) (modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented), within two Trading Days of any Representation Date. The requirement to provide a certificate under this Section 7(m) shall be waived for any Representation Date occurring at a time at which no Placement Notice is pending or in effect, which waiver shall continue until the earlier to occur of (1) the date the Company delivers a Placement Notice hereunder (which for such calendar quarter shall be considered a Representation Date) and (2) the next occurring Representation Date. Notwithstanding the foregoing, if the Company subsequently decides to sell Placement Shares following a Representation Date on which the Company relied on the waiver referred to in the previous sentence and did not provide the Agent with a certificate under this Section 7(m), then before the Company delivers a Placement Notice or the Agent sells any Placement Shares pursuant thereto, the Company shall provide the Agent with a certificate, in the form attached hereto as Exhibit 7(m) , dated the date of such Placement Notice. Within two Trading Days of each Representation Date, the Company shall have furnished to the Agent such further information, certificates and documents as the Agent may reasonably request.
(n) Legal Opinions . On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate pursuant to Section 7(m) for which no waiver is applicable, the Company shall cause to be furnished to the Agent the written opinion and negative assurance letter of each of Dentons US LLP (“ U.S. Company Counsel ”) and Dentons Europe LLP (“ German Company Counsel ”), each counsel to the Company, or such other counsel satisfactory to the Agent, each in form and substance satisfactory to the Agent and its counsel, dated the date that each such opinion and negative assurance letter are required to be delivered, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented; provided , however , that the Company shall be required to furnish to the Agent no more than one opinion from each of U.S. Company Counsel and German Company Counsel in connection with each Annual Report on Form 10-K and Quarterly Report on Form 10-Q filing; and provided further , that in lieu of such opinion and negative assurance letter for subsequent Representation Dates, each of U.S. Company Counsel and German Company Counsel may furnish the Agent with a letter to the effect that the Agent may rely on a prior opinion or negative assurance letter delivered by such counsel under this Section 7(n) to the same extent as if it were dated the date of such letter (except that statements in such prior opinion or negative assurance letter shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented at such Representation Date).
(o) Intellectual Property Opinion . On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate pursuant to Section 7(m) for which no waiver is applicable, the Company shall cause to be furnished to the Agent the written opinion of Boehmert & Boehmert, counsel for the Company with respect to intellectual property matters, or such other intellectual property counsel reasonably satisfactory to the Agent (“ Intellectual Property Counsel ”), in form and substance reasonably satisfactory to the Agent and its counsel, dated the date that the opinion letter is required to be delivered, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented; provided , however , that in lieu of such written opinion for subsequent Representation Dates, Intellectual Property Counsel may furnish the Agent with a letter to the effect that the Agent may rely on a prior opinion letter delivered by such counsel under this Section 7(o) to the same extent as if it were dated the date of such opinion letter (except that statements in such prior opinion letter shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented at such Representation Date).
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(p) Comfort Letter . On or prior to the First Placement Notice Date and on any date which the Company is obligated to deliver a certificate pursuant to Section 7(m) for which no waiver is applicable, the Company shall cause Baker Tilly to furnish the Agent a letter (the “ Comfort Letter ”), dated the date the Comfort Letter is delivered, which shall meet the requirements set forth in this Section 7(p); provided , that if requested by the Agent, the Company shall cause a Comfort Letter to be furnished to the Agent within 10 Trading Days of the occurrence of any material transaction or event that necessitates the filing of additional, pro forma, amended or revised financial statements (including any restatement of previously issued financial statements). Each Comfort Letter from Baker Tilly shall be in form and substance reasonably satisfactory to the Agent and each Comfort Letter from Baker Tilly shall (i) confirm that they are an independent registered public accounting firm within the meaning of the Securities Act and the PCAOB, (ii) state, as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily covered by accountants’ “comfort letters” to underwriters in connection with registered public offerings (the first such letter, the “ Initial Comfort Letter ”) and (iii) update the Initial Comfort Letter with any information that would have been included in the Initial Comfort Letter had it been given on such date and modified as necessary to relate to the Registration Statement and the Prospectus, as amended and supplemented to the date of such letter. In addition, on or prior to the First Placement Notice Date, the Company shall cause PwC to furnish the Agent a Comfort Letter, dated the date the Comfort Letter is delivered, which shall meet the requirements set forth in this Section 7(p). The Company shall also be required to furnish a Comfort Letter from PwC in connection with the filing of each of the Company’s annual reports on Form 10-K if such reports include financial information audited by PwC. Each Comfort Letter from PwC shall be in form and substance reasonably satisfactory to the Agent and each Comfort Letter from PwC shall (A) confirm that they are an independent registered public accounting firm within the meaning of the Securities Act and the PCAOB and (B) state, as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily covered by accountants’ “comfort letters” to underwriters in connection with registered public offerings.
(q) Market Activities . The Company will not, directly or indirectly, and will cause its officers, directors and Subsidiaries not to (i) take any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of shares of Common Stock or (ii) sell, bid for, or purchase shares of Common Stock in violation of Regulation M, or pay anyone any compensation for soliciting purchases of the Placement Shares other than the Agent; provided , however , that the Company may bid for and purchase shares of Common Stock in accordance with Rule 10b-18 under the Exchange Act.
(r) Investment Company Act . The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor any of its Subsidiaries will be or become, at any time prior to the termination of this Agreement, an “investment company,” as such term is defined in the Investment Company Act.
(s) Securities Act and Exchange Act . The Company will use its best efforts to comply with all requirements imposed upon it by the Securities Act and the Exchange Act as from time to time in force, so far as necessary to permit the sales of, or dealings in, the Placement Shares as contemplated by the provisions hereof and the Prospectus.
(t) No Offer to Sell . Other than a free writing prospectus (as defined in Rule 405 under the Securities Act) approved in advance by the Company and the Agent, neither the Agent nor the Company (including its agents and representatives, other than the Agent in its capacity as agent) will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under the Securities Act), required to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Placement Shares hereunder.
(u) Blue Sky and Other Qualifications . The Company will use its commercially reasonable efforts, in cooperation with the Agent, to qualify the Placement Shares for offering and sale, or to obtain an exemption for the Placement Shares to be offered and sold, under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Agent may designate and to maintain such qualifications and exemptions in effect for so long as required for the distribution of the Placement Shares (but in no event for less than one year from the date of this Agreement); provided , however , that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject. In each jurisdiction in which the Placement Shares have been so qualified or exempt, the Company will file such statements and reports as may be required by the laws of such jurisdiction to continue such qualification or exemption, as the case may be, in effect for so long as required for the distribution of the Placement Shares (but in no event for less than one year from the date of this Agreement).
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(v) Sarbanes-Oxley Act . The Company will maintain and keep accurate books and records reflecting its assets and maintain internal accounting controls in a manner designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP and including those policies and procedures that (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company, (ii) provide reasonable assurance that transactions are recorded as necessary to permit the preparation of the Company’s financial statements in accordance with GAAP, (iii) that receipts and expenditures of the Company are being made only in accordance with management’s and the Company’s directors’ authorization, and (iv) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on its financial statements. The Company will maintain such controls and other procedures, including, to the extent applicable to the Company, those required by Sections 302 and 906 of the Sarbanes-Oxley Act, and the applicable regulations thereunder that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms, including, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure and to ensure that material information relating to the Company is made known to it by others within the Company, particularly during the period in which such periodic reports are being prepared.
(w) Emerging Growth Company . The Company will promptly notify the Agent if the company ceases to be an Emerging Growth Company at any time prior to the completion of the Agent’s distribution of the Placement Shares pursuant to this Agreement.
(x) Renewal of Registration Statement . If, immediately prior to the third anniversary of the initial effective date of the Registration Statement (the “ Renewal Date ”), any of the Placement Shares remain unsold and this Agreement has not been terminated, the Company will, prior to the Renewal Date, file a new shelf registration statement or, if applicable, an automatic shelf registration statement relating to the Common Stock that may be offered and sold pursuant to this Agreement (which shall include a prospectus reflecting the number or amount of Placement Shares that may be offered and sold pursuant to this Agreement), in a form reasonably satisfactory to the Agent and its counsel, and, if such registration statement is not an automatic shelf registration statement, will use its best efforts to cause such registration statement to be declared effective within 180 days after the Renewal Date. The Company will take all other reasonable actions necessary or appropriate to permit the public offer and sale of the Placement Shares to continue as contemplated in the expired registration statement and this Agreement. From and after the effective date thereof, references herein to the “Registration Statement” shall include such new shelf registration statement or such new automatic shelf registration statement, as the case may be.
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(y) Form S-3 . If, from and after the date of this Agreement, the Company is no longer eligible to use Form S-3 pursuant to General Instruction I.B.1. at the time it files with the Commission an annual report on Form 10-K or any post-effective amendment to the Registration Statement, then it shall promptly notify the Agent and, within two Business Days prior to the date of filing of such annual report on Form 10-K or amendment to the Registration Statement, the Company shall, if still eligible to use Form S-3 pursuant to General Instruction I.B.6., file a new prospectus supplement with the Commission reflecting the number of shares of Common Stock available to be offered and sold by the Company under this Agreement pursuant to General Instruction I.B.6. of Form S-3; provided , however , that the Company may delay the filing of any such prospectus supplement for up to 30 days if, in the reasonable judgment of the Company, it is in the best interest of the Company to do so, provided that no Placement Notice is in effect or pending during such time. Until such time as the Company shall have corrected such misstatement or omission or effected such compliance, the Company shall not notify the Agent to resume the offering of Placement Shares.
(z) Tax Indemnity . The Company will indemnify and hold harmless the Agent against any documentary, stamp or similar issue tax, including any interest and penalties, on the issue and sale of the Placement Shares.
(aa) Transfer Agent . The Company has engaged and will maintain, at its sole expense, a transfer agent and registrar for the Common Stock.
8. Conditions to the Agent’s Obligations . The obligations of the Agent hereunder with respect to a Placement will be subject to the continuing accuracy and completeness of the representations and warranties made by the Company herein, to the due performance in all material respects by the Company of its obligations hereunder, to the completion by the Agent of a due diligence review satisfactory to the Agent in its reasonable judgment, and to the continuing satisfaction (or waiver by the Agent in its sole discretion) in all material respects of the following additional conditions:
(a) Registration Statement Effective . The Registration Statement shall be effective and shall be available for all offers and sales of Placement Shares (i) that have been issued pursuant to all prior Placement Notices and (ii) that will be issued pursuant to any Placement Notice.
(b) Prospectus Supplement . The Company shall have filed with the Commission the Prospectus Supplement pursuant to Rule 424(b) under the Securities Act not later than the Commission’s close of business on the second Business Day following the date of this Agreement.
(c) No Material Notices . None of the following events shall have occurred and be continuing: (i) receipt by the Company or any of its Subsidiaries of any request for additional information from the Commission or any other federal or state governmental authority during the period of effectiveness of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration Statement or the Prospectus; (ii) the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company or any of its Subsidiaries of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Placement Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event that makes any material statement made in the Registration Statement or the Prospectus or any material Incorporated Document untrue in any material respect or that requires the making of any material changes in the Registration Statement, the Prospectus or Incorporated Documents so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading and, in the case of the Prospectus, so that it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.
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(d) No Misstatement or Material Omission . The Agent shall not have advised the Company that the Registration Statement or Prospectus, or any amendment or supplement thereto, contains an untrue statement of fact that in the Agent’s reasonable opinion is material, or omits to state a fact that in the Agent’s reasonable opinion is material and is required to be stated therein or is necessary to make the statements therein not misleading.
(e) Material Changes . Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall not have been any material adverse change, on a consolidated basis, in the authorized capital stock of the Company or any Material Adverse Effect or any development that could reasonably be expected to result in a Material Adverse Effect, or any downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities), if any, by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating of any of the Company’s securities (other than asset backed securities), if any, the effect of which, in the judgment of the Agent (without relieving the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of the Placement Shares on the terms and in the manner contemplated in the Prospectus.
(f) Company Counsel Legal Opinions . The Agent shall have received the opinions and negative assurance letters, as applicable, of U.S. Company Counsel, German Company Counsel and Intellectual Property Counsel required to be delivered pursuant to Section 7(n) and Section 7(o), as applicable, on or before the date on which such delivery of such opinions and negative assurance letters are required pursuant to Section 7(n) and Section 7(o), as applicable.
(g) Agent’s Counsel Legal Opinion . The Agent shall have received from Covington & Burling LLP, counsel for the Agent, such opinion or opinions, on or before the date on which the delivery of the legal opinions of U.S. Company Counsel and German Company Counsel is required pursuant to Section 7(n), with respect to such matters as the Agent may reasonably require, and the Company shall have furnished to such counsel such documents as they may request to enable them to pass upon such matters.
(h) Comfort Letters . The Agent shall have received the Comfort Letters required to be delivered pursuant to Section 7(p) on or before the date on which such delivery of such Comfort Letters is required pursuant to Section 7(p).
(i) Representation Certificate . The Agent shall have received the certificate required to be delivered pursuant to Section 7(m) on or before the date on which delivery of such certificate is required pursuant to Section 7(m).
(j) Secretary’s Certificate . On or prior to the First Placement Notice Date, the Agent shall have received a certificate, signed on behalf of the Company by the Secretary of the Company and attested to by an executive officer of the Company, dated as of such date and in form and substance satisfactory to the Agent and its counsel, certifying as to (i) the amended and restated certificate of incorporation of the Company, (ii) the amended and restated bylaws of the Company, (iii) the resolutions of the board of directors of the Company or duly authorized committee thereof authorizing the execution, delivery and performance of this Agreement and the issuance and sale of the Placement Shares and (iv) the incumbency of the officers of the Company duly authorized to execute this Agreement and the other documents contemplated by this Agreement (including each of the officers set forth on Schedule 2 ).
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(k) No Suspension . The Common Stock shall be duly listed, and admitted and authorized for trading, subject to official notice of issuance, on Nasdaq. Trading in the Common Stock shall not have been suspended on, and the Common Stock shall not have been delisted from, Nasdaq.
(l) Other Materials . On each date on which the Company is required to deliver a certificate pursuant to Section 7(m), the Company shall have furnished to the Agent such appropriate further information, opinions, certificates, letters and other documents as the Agent may have reasonably requested. All such information, opinions, certificates, letters and other documents shall have been in compliance with the provisions hereof. The Company shall have furnished the Agent with conformed copies of such opinions, certificates, letters and other documents as the Agent may have reasonably requested.
(m) Securities Act Filings Made . All filings with the Commission required by Rule 424(b) or Rule 433 under the Securities Act to have been filed prior to the issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing by Rule 424(b) (without reliance on Rule 424(b)(8) of the Securities Act) or Rule 433, as applicable.
(n) Approval for Listing . Either (i) the Placement Shares shall have been approved for listing on Nasdaq, subject only to notice of issuance, or (ii) the Company shall have filed an application for listing of the Placement Shares on Nasdaq at, or prior to, the First Placement Notice Date and Nasdaq shall have reviewed such application and not provided any objections thereto.
(o) FINRA . FINRA shall have raised no objection to the terms of the offering contemplated hereby and the amount of compensation allowable or payable to the Agent as described in the Prospectus.
(p) No Termination Event . There shall not have occurred any event that would permit the Agent to terminate this Agreement pursuant to Section 11(a).
9. Indemnification and Contribution .
(a) Company Indemnification . The Company agrees to indemnify and hold harmless the Agent, its affiliates and their respective partners, members, directors, officers, employees and agents, and each person, if any, who (i) controls the Agent within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the Agent, in each case from and against any and all losses, claims, liabilities, expenses and damages (including any and all investigative, legal and other expenses) reasonably incurred in connection with, and any and all amounts paid in settlement (in accordance with this Section 9) of, any action, suit, investigation or proceeding between any of the indemnified parties and any indemnifying parties or between any indemnified party and any third party (including any governmental or self-regulatory authority, or otherwise, or any claim asserted or threatened), as and when incurred, to which the Agent, or any such other person may become subject under the Securities Act, the Exchange Act or other federal or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, liabilities, expenses or damages arise out of or are based, directly or indirectly, on (x) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement or the Prospectus (or any amendment or supplement to the Registration Statement or the Prospectus) or in any free writing prospectus or in any application or other document executed by or on behalf of the Company or based on written information furnished by or on behalf of the Company filed in any jurisdiction in order to qualify the Common Stock under the securities laws thereof or filed with the Commission, (y) the omission or alleged omission to state in any such document a material fact required to be stated therein or necessary to make the statements therein (solely with respect to the Prospectus, in light of the circumstances under which they were made) not misleading or (z) any breach by any of the indemnifying parties of any of their respective representations, warranties or agreements contained in this Agreement; provided , however , that this indemnity agreement shall not apply to the extent that such loss, claim, liability, expense or damage arises from the sale of the Placement Shares pursuant to this Agreement and is caused, directly or indirectly, by an untrue statement or omission, or alleged untrue statement or omission, made in reliance upon and in conformity with the Agent’s Information. This indemnity agreement will be in addition to any liability that the Company might otherwise have.
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(b) Agent Indemnification . The Agent agrees to indemnify and hold harmless the Company and its directors and each officer of the Company that signed the Registration Statement, and each person, if any, who (i) controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the Company against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 9(a), as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions, made in the Registration Statement (or any amendments thereto) or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Agent’s Information.
(c) Procedure . Any party that proposes to assert the right to be indemnified under this Section 9 will, promptly after receipt of notice of commencement of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under this Section 9, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served, but the omission so to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might have to any indemnified party otherwise than under this Section 9 and (ii) any liability that it may have to any indemnified party under the foregoing provision of this Section 9 unless, and only to the extent that, such omission results in the forfeiture of substantive rights or defenses by the indemnifying party. If any such action is brought against any indemnified party and it notifies the indemnifying party of its commencement, the indemnifying party will be entitled to participate in and, to the extent that it elects by delivering written notice to the indemnified party promptly after receiving notice of the commencement of the action from the indemnified party, jointly with any other indemnifying party similarly notified, to assume the defense of the action, with counsel reasonably satisfactory to the indemnified party, and after notice from the indemnifying party to the indemnified party of its election to assume the defense, the indemnifying party will not be liable to the indemnified party for any other legal expenses except as provided below and except for the reasonable costs of investigation subsequently incurred by the indemnified party in connection with the defense. The indemnified party will have the right to employ its own counsel in any such action, but the fees, expenses and other charges of such counsel will be at the expense of such indemnified party unless (1) the employment of counsel by the indemnified party has been authorized in writing by the indemnifying party, (2) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (3) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified party) or (4) the indemnifying party has not in fact employed counsel reasonably satisfactory to the indemnified party to assume the defense of such action within a reasonable time after receiving notice of the commencement of the action, in each of which cases the reasonable fees, disbursements and other charges of counsel will be at the expense of the indemnifying party or parties. It is understood that the indemnifying party or parties shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees, disbursements and other charges of more than one separate firm (plus local counsel) admitted to practice in such jurisdiction at any one time for all such indemnified party or parties. All such fees, disbursements and other charges will be reimbursed by the indemnifying party promptly after the indemnifying party receives a written invoice relating to such fees, disbursements and other charges in reasonable detail. An indemnifying party will not, in any event, be liable for any settlement of any action or claim effected without its written consent. No indemnifying party shall, without the prior written consent of each indemnified party, settle or compromise or consent to the entry of any judgment in any pending or threatened claim, action or proceeding relating to the matters contemplated by this Section 9 (whether or not any indemnified party is a party thereto), unless such settlement, compromise or consent (1) includes an unconditional release of each indemnified party, in form and substance reasonably satisfactory to such indemnified party, from all liability arising out of such claim, action or proceeding and (2) does not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party.
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(d) Settlement Without Consent if Failure to Reimburse . If an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for reasonable fees and expenses of counsel for which it is entitled to be reimbursed under this Section 9, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by Section 9(a) effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request, (ii) such indemnifying party shall have received notice of the terms of such settlement at least 30 days prior to such settlement being entered into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.
(e) Contribution . In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing paragraphs of this Section 9 is applicable in accordance with its terms but for any reason is held to be unavailable or insufficient from the Company or the Agent, the Company and the Agent will contribute to the total losses, claims, liabilities, expenses and damages (including any investigative, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any action, suit, investigation or proceeding or any claim asserted, but after deducting any contribution received by the Company from persons other than the Agent, such as persons who control the Company within the meaning of the Securities Act, officers of the Company who signed the Registration Statement and directors of the Company, who also may be liable for contribution) to which the Company and the Agent may be subject in such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and the Agent on the other hand. The relative benefits received by the Company on the one hand and the Agent on the other hand shall be deemed to be in the same proportion as the total Net Proceeds from the sale of the Placement Shares (before deducting expenses) received by the Company bear to the total compensation received by the Agent from the sale of Placement Shares on behalf of the Company. If, but only if, the allocation provided by the foregoing sentence is not permitted by applicable law, the allocation of contribution shall be made in such proportion as is appropriate to reflect not only the relative benefits referred to in the foregoing sentence but also the relative fault of the Company, on the one hand, and the Agent, on the other hand, with respect to the statements or omission that resulted in such loss, claim, liability, expense or damage, or action, suit, investigation or proceeding in respect thereof, as well as any other relevant equitable considerations with respect to such offering. Such relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or the Agent, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Agent agree that it would not be just and equitable if contributions pursuant to this Section 9(e) were to be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, liability, expense or damage, or action, suit, investigation or proceeding in respect thereof, referred to above in this Section 9(e) shall be deemed to include, for the purpose of this Section 9(e), any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action, suit, investigation, proceeding or claim to the extent consistent with this Section 9. Notwithstanding the foregoing provisions of this Section 9(e), the Agent shall not be required to contribute any amount in excess of the commissions received by it under this Agreement and no person found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 9(e), any person who controls a party to this Agreement within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, any affiliates of the Agent, any partners, members, directors, officers, employees and agents of the Agent and each person that is controlled by or under common control with the Agent will have the same rights to contribution as that party, and each officer of the Company who signed the Registration Statement will have the same rights to contribution as the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after receipt of notice of commencement of any action against such party in respect of which a claim for contribution may be made under this Section 9(e), will notify any such party or parties from whom contribution may be sought, but the omission to so notify will not relieve that party or parties from whom contribution may be sought from any other obligation it or they may have under this Section 9(e) except to the extent that the failure to so notify such other party materially prejudiced the substantive rights or defenses of the party from whom contribution is sought. Except for a settlement entered into pursuant to the last sentence of Section 9(c) hereof or pursuant to Section 9(d) hereof, no party will be liable for contribution with respect to any action or claim settled without its written consent if such consent is required pursuant to Section 9(c) hereof.
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10. Representations and Agreements to Survive Delivery . The indemnity and contribution agreements contained in Section 9 of this Agreement and all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective dates, regardless of (i) any investigation made by or on behalf of the Agent, any controlling persons, or the Company (or any of their respective officers, directors, employees or controlling persons), (ii) delivery and acceptance of the Placement Shares and payment therefor or (iii) any termination of this Agreement.
11. Termination .
(a) The Agent shall have the right, by giving notice as hereinafter specified, at any time to terminate this Agreement if (i) any Material Adverse Effect, or any development that could reasonably be expected to result in a Material Adverse Effect, has occurred that, in the judgment of the Agent, may materially impair the ability of the Agent to sell the Placement Shares hereunder, (ii) the Company shall have failed, refused or been unable to perform any agreement on its part to be performed hereunder; provided , however , in the case of any failure of the Company to deliver (or cause another person to deliver) any certification, opinion or letter required under Section 7(m), Section 7(n), Section 7(o) or Section 7(p), the Agent’s right to terminate shall not arise unless such failure to deliver (or cause to be delivered) continues for more than 15 calendar days from the date such delivery was required, (iii) any other condition of the Agent’s obligations hereunder is not fulfilled, (iv) any suspension or limitation of trading in the Placement Shares or in securities generally on Nasdaq shall have occurred, (v) a general banking moratorium shall have been declared by any of United States federal or New York authorities, or (vi) there shall have occurred any outbreak or escalation of national or international hostilities or any crisis or calamity, or any change in the United States or international financial markets, or any substantial change or development involving a prospective substantial change in United States or international political, financial or economic conditions that, in the judgment of the Agent, may materially impair the ability of the Agent to sell the Placement Shares hereunder or to enforce contracts for the sale of securities. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination. If the Agent elects to terminate this Agreement as provided in this Section 11(a), the Agent shall provide the required notice as specified in Section 12.
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(b) The Company shall have the right, by giving 10 days’ prior notice as hereinafter specified, to terminate this Agreement in its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
(c) The Agent shall have the right, by giving 10 days’ prior notice as hereinafter specified, to terminate this Agreement in its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
(d) Unless earlier terminated pursuant to this Section 11, this Agreement shall automatically terminate upon the issuance and sale of all of the Placement Shares through the Agent on the terms and subject to the conditions set forth herein; provided that the provisions of Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
(e) This Agreement shall remain in full force and effect unless terminated pursuant to Sections 11(a), (b), (c), or (d) above or otherwise by mutual agreement of the parties; provided , however , that any such termination by mutual agreement shall in all cases be deemed to provide that Section 7(g), Section 9, Section 10, Section 11(f), Section 16 and Section 17 shall remain in full force and effect.
(f) Any termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however , that such termination shall not be effective until the close of business on the date of receipt of such notice by the Agent or the Company, as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares shall settle in accordance with the provisions of this Agreement. Upon termination of this Agreement, the Company shall not be required to pay to the Agent any discount or commission with respect to any Placement Shares not otherwise sold by the Agent under this Agreement; provided , however , that the Company shall remain obligated to reimburse the Agent’s expenses pursuant to Section 7(g).
12. Notices . All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement shall be in writing, unless otherwise specified in this Agreement, and if sent to the Agent, shall be delivered to:
SVB Leerink LLC
1301 Avenue of the Americas, 12 th Floor
New York, New York 10019
Attention: Gabriel Cavazos
E-mail: gabriel.cavazos@leerink.com
with a copy (which shall not constitute notice) to:
SVB Leerink LLC
1301 Avenue of the Americas, 12 th Floor
New York, New York 10019
Attention: Stuart R. Nayman, Esq.
E-mail: stuart.nayman@svbleerink.com
35
and
Covington & Burling LLP
620 8 th Avenue
New York, New York 10018
Attention: Brian K. Rosenzweig
E-mail: brosenzweig@cov.com
and if to the Company, shall be delivered to:
Immunic, Inc.
11440 West Bernardo Court, Suite 300
San Diego, California 92127
Attention: Dr. Daniel Vitt
E-mail: daniel.vitt@immunic.de
with copies (which shall not constitute notice) to:
Dentons US LLP
1221 Avenue of the Americas
New York, New York 10020
Attention: Ilan Katz
E-mail: ilan.katz@dentons.com
Each party to this Agreement may change such address for notices by sending to the parties to this Agreement written notice of a new address for such purpose. Each such notice or other communication shall be deemed given (i) when delivered personally on or before 4:30 P.M., New York City time, on a Business Day, or, if such day is not a Business Day, on the next succeeding Business Day, (ii) by Electronic Notice as set forth in the next paragraph, (iii) on the next Business Day after timely delivery to a nationally-recognized overnight courier or (iv) on the Business Day actually received if deposited in the U.S. mail (certified or registered mail, return receipt requested, postage prepaid). For purposes of this Agreement, “ Business Day ” shall mean any day on which the Nasdaq and commercial banks in the City of New York are open for business.
An electronic communication (“ Electronic Notice ”) shall be deemed written notice for purposes of this Section 12 if sent to the electronic mail address specified by the receiving party in Section 12. Electronic Notice shall be deemed received at the time the party sending Electronic Notice receives actual acknowledgment of receipt from the person whom the notice is sent, other than via auto-reply. Any party receiving Electronic Notice may request and shall be entitled to receive the notice on paper, in a nonelectronic form (“ Nonelectronic Notice ”), which shall be sent to the requesting party within 10 days of receipt of the written request for Nonelectronic Notice.
13. Successors and Assigns . This Agreement shall inure to the benefit of and be binding upon the Company and the Agent and their respective successors and the affiliates, controlling persons, officers, directors and other persons referred to in Section 9 hereof. References to any of the parties contained in this Agreement shall be deemed to include the successors and permitted assigns of each such party. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto, the persons referred to in the preceding sentence and their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights or obligations under this Agreement without the prior written consent of the other party; provided , however , that the Agent may assign its rights and obligations hereunder to an affiliate of the Agent without obtaining the Company’s consent, so long as such affiliate is a registered broker-dealer.
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14. Adjustments for Share Splits . The parties acknowledge and agree that all share-related numbers contained in this Agreement shall be adjusted to take into account any share split, share dividend or similar event effected with respect to the Common Stock.
15. Entire Agreement; Amendment; Severability; Waiver . This Agreement (including all schedules (as amended pursuant to this Agreement) and exhibits attached hereto and Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement nor any term hereof may be amended except pursuant to a written instrument executed by the Company and the Agent; provided , however , that Schedule 2 of this Agreement may be amended by either party from time to time by sending a notice containing a revised Schedule 2 to the other party in the manner provided in Section 12 and, upon such amendment, all references herein to Schedule 2 shall automatically be deemed to refer to such amended Schedule 2 . In the event that any one or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable as written by a court of competent jurisdiction, then such provision shall be given full force and effect to the fullest possible extent that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Agreement. No implied waiver by a party shall arise in the absence of a waiver in writing signed by such party. No failure or delay in exercising any right, power, or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any right, power, or privilege hereunder.
16. GOVERNING LAW AND TIME; WAIVER OF JURY TRIAL . THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAWS. SPECIFIED TIMES OF DAY REFER TO NEW YORK CITY TIME. EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
17. Consent to Jurisdiction . Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan, for the adjudication of any dispute hereunder or in connection with any of the transactions contemplated hereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum, or that the venue of such suit, action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy (certified or registered mail, return receipt requested) to such party at the address in effect for notices under Section 12 of this Agreement and agrees that such service shall constitute good and sufficient notice of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law.
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18. Construction .
(a) The section and exhibit headings herein are for convenience only and shall not affect the construction hereof.
(b) Words defined in the singular shall have a comparable meaning when used in the plural, and vice versa.
(c) The words “hereof,” “hereto,” “herein” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
(d) Wherever the word “include,” “includes” or “including” is used in this Agreement, it shall be deemed to be followed by the words “without limitation.”
(e) References herein to any gender shall include each other gender.
(f) References herein to any law, statute, ordinance, code, regulation, rule or other requirement of any governmental authority shall be deemed to refer to such law, statute, ordinance, code, regulation, rule or other requirement of any governmental authority as amended, reenacted, supplemented or superseded in whole or in part and in effect from time to time and also to all rules and regulations promulgated thereunder.
19. Permitted Free Writing Prospectuses . Each of the Company and the Agent represents, warrants and agrees that, unless it obtains the prior written consent of the other party, which consent shall not be unreasonably withheld, conditioned or delayed, it has not made and will not make any offer relating to the Placement Shares that would constitute an issuer free writing prospectus, or that would otherwise constitute a free writing prospectus (as defined in Rule 405), required to be filed with the Commission. Any such free writing prospectus consented to by the Agent or by the Company, as the case may be, is hereinafter referred to as a “ Permitted Free Writing Prospectus .” The Company represents and warrants that it has treated and agrees that it will treat each Permitted Free Writing Prospectus as an issuer free writing prospectus, and that it has complied and will comply with the requirements of Rule 433 applicable to any Permitted Free Writing Prospectus, including timely filing with the Commission where required, legending and record keeping.
20. Absence of Fiduciary Relationship . The Company acknowledges and agrees that:
(a) the Agent has been retained to act as sales agent in connection with the sale of the Placement Shares, the Agent has acted at arms’ length and no fiduciary or advisory relationship between the Company or any of its respective affiliates, stockholders (or other equity holders), creditors or employees or any other party, on the one hand, and the Agent, on the other hand, has been or will be created in respect of any of the transactions contemplated by this Agreement, irrespective of whether the Agent has advised or is advising the Company on other matters and the Agent has no duties or obligations to the Company with respect to the transactions contemplated by this Agreement except the obligations expressly set forth herein;
(b) the Company is capable of evaluating, and understanding and understands and accepts, the terms, risks and conditions of the transactions contemplated by this Agreement;
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(c) neither the Agent nor its affiliates have provided any legal, accounting, regulatory or tax advice with respect to the transactions contemplated by this Agreement and it has consulted its own legal, accounting, regulatory and tax advisors to the extent it has deemed appropriate;
(d) the Company has been advised and is aware that the Agent and its affiliates are engaged in a broad range of transactions which may involve interests that differ from those of the Company and that the Agent and its affiliates have no obligation to disclose such interests and transactions to the Company by virtue of any fiduciary, advisory or agency relationship or otherwise; and
(e) the Company waives, to the fullest extent permitted by law, any claims it may have against the Agent or its affiliates for breach of fiduciary duty or alleged breach of fiduciary duty in connection with the transactions contemplated by this Agreement and agrees that the Agent and its affiliates shall have no liability (whether direct or indirect) to the Company in respect of such a fiduciary claim or to any person asserting a fiduciary duty claim on behalf of or in right of the Company, including stockholders (or other equity holders), creditors or employees of the Company.
21. Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed Agreement by one party to the other may be made by facsimile or electronic transmission.
22. Use of Information . The Agent may not provide any information gained in connection with this Agreement and the transactions contemplated by this Agreement, including due diligence, to any third party other than its legal counsel advising it on this Agreement and the transactions contemplated by this Agreement unless expressly approved by the Company in writing.
23. Agent’s Information . As used in this Agreement, “ Agent’s Information ” means solely the following information in the Registration Statement and the Prospectus: the tenth paragraph under the heading “Plan of Distribution” in the Prospectus Supplement.
All references in this Agreement to the Registration Statement, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include the copy filed with the Commission pursuant to EDGAR. All references in this Agreement to financial statements and schedules and other information that is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information that is incorporated by reference in the Registration Statement or the Prospectus, as the case may be.
All references in this Agreement to “supplements” to the Prospectus shall include any supplements, “wrappers” or similar materials prepared in connection with any offering, sale or private placement of any Placement Shares by the Agent outside of the United States.
[Remainder of Page Intentionally Blank]
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If the foregoing correctly sets forth the understanding between the Company and the Agent, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between the Company and the Agent.
Very truly yours, | |||
IMMUNIC, INC. | |||
By: | /s/ Dr. Daniel Vitt | ||
Name: | Dr. Daniel Vitt | ||
Title: | Chief Executive Officer | ||
ACCEPTED as of the date | |||
first-above written: | |||
SVB LEERINK LLC | |||
By: | /s/ Gabriel P. Cavazos | ||
Name: | Gabriel P. Cavazos | ||
Title: | Managing Director |
SCHEDULE 1
FORM OF PLACEMENT NOTICE
From: | [ ] |
[TITLE] | |
Immunic, Inc. | |
Cc: | [ ] |
To: | SVB Leerink LLC |
Subject: | SVB Leerink—At the Market Offering—Placement Notice |
Ladies and Gentlemen:
Pursuant to the terms and subject to the conditions contained in the Sales Agreement, dated July 17, 2019 (the “ Agreement ”), by and between Immunic Inc., a Delaware corporation (the “ Company ”), and SVB Leerink LLC (“ SVB Leerink ”), I hereby request on behalf of the Company that SVB Leerink sell up to [ ] shares of common stock, $0.0001 par value per share, of the Company (the “ Shares ”), at a minimum market price of $ per share[; provided that no more than [ ] Shares shall be sold in any one Trading Day (as such term is defined in Section 3 of the Agreement)]. Sales should begin [on the date of this Placement Notice] and end on [DATE] [until all Shares that are the subject of this Placement Notice are sold].
SCHEDULE 2
The Company
Daniel Vitt
Manfred Groeppel
SVB Leerink
Gabriel Cavazos
Brian Swanson
Oren Karsen
Rahul Chaudhary
Patrick Morley
Sam Spector
Stuart Nayman
Eric Olson
SCHEDULE 3
Compensation
The Company shall pay SVB Leerink compensation in cash equal to 3.0% of the gross proceeds from the sales of Placement Shares pursuant to the terms of the Sales Agreement of which this Schedule 3 forms a part.
Exhibit 7(m)
OFFICERS’ CERTIFICATE
Each of Daniel Vitt, the duly qualified and elected Chief Executive Officer of Immunic, Inc., a Delaware corporation (the “ Company ”), and Sanjay S. Patel, the duly qualified and elected Chief Financial Officer of the Company, does hereby certify in his or her respective capacity and on behalf of the Company, pursuant to Section 7(m) of the Sales Agreement, dated July 17, 2019 (the “ Sales Agreement ”), by and between the Company and SVB Leerink LLC, that, after due inquiry, to the best of the knowledge of the undersigned:
(i) The representations and warranties of the Company in Section 6 of the Sales Agreement (A) to the extent such representations and warranties are subject to qualifications and exceptions contained therein relating to materiality or Material Adverse Effect, are true and correct on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof, and (B) to the extent such representations and warranties are not subject to any qualifications or exceptions relating to materiality or Material Adverse Effect, are true and correct in all material respects as of the date hereof as if made on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof.
(ii) The Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied pursuant to the Sales Agreement at or prior to the date hereof.
(iii) As of the date hereof, (A) the Registration Statement complies in all material respects with the requirements of the Securities Act and does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein not misleading, (B) the Prospectus complies in all material respects with the requirements of the Securities Act does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading and (C) no event has occurred as a result of which it is necessary to amend or supplement the Registration Statement or the Prospectus in order to make the statements therein not untrue or misleading or for clauses (A) and (B) above, to be true and correct.
(iv) There has been no material adverse change, or any development that could reasonably be expected to result in a material adverse change, in the condition (financial or otherwise), earnings, results of operations, business, properties, operations, assets, liabilities or prospects of the Company and its Subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, since the date as of which information is given in the Prospectus, as amended or supplemented to the date hereof.
(v) The Company does not possess any material non-public information.
(vi) The maximum amount of Placement Shares that may be sold pursuant to the Sales Agreement has been duly authorized by the Company’s board of directors or a duly authorized committee thereof pursuant to a resolution or unanimous written consent in accordance with the Company’s amended and restated articles of incorporation, amended and restated bylaws and applicable law.
Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Sales Agreement.
IN WITNESS WHEREOF, each of the undersigned, in such individual’s respective capacity as Chief Executive Officer or Chief Financial Officer of the Company, has executed this Officers’ Certificate on behalf of the Company.
By: | ||
Name: Daniel Vitt | ||
Title: Chief Executive Officer | ||
Date: | ||
By: | ||
Name: Sanjay S. Patel | ||
Title: Chief Financial Officer | ||
Date: |
[ Company Signature Page to Officers’ Certificate ]
Exhibit 10.2
REDACTED | |
Certain identified information, indicated by [***], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. |
OPTION AND LICENSE AGREEMENT
FOR THE LICENSING AND DEVELOPMENT
OF
[***]
INHIBITORS
This LICENSE AND OPTION AGREEMENT FOR THE LICENSING AND DEVELOPMENT OF [***] INHIBITORS (the “ Agreement ”) is effective as of this day of October 2018 (the “ Effective Date ”) by and between Immunic AG, a stock corporation organized under the laws of Germany, having a place of business at Am Klopferspitz 19, 82152 Martinsried, Germany (“ Immunic ”), and Daiichi Sankyo Co., Ltd., a Japanese corporation organized under the laws of Japan, having a place of business at 1-2-58 Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan (“DS)”; Immunic and DS are sometimes hereinafter individually referred to as a “ Party ” and collectively as the “ Parties ”).
RECITALS
(1) DS has developed and owns certain technology relating to small molecules that inhibit the biological activity of [***] , as listed [***] ; and
(2) DS is the owner or otherwise controls certain proprietary technology, including the patent applications filed or to be filed by DS claiming the Subject Compounds, as listed in [***] , and any issued patents or pending patent applications resulting therefrom, all such patent rights and technology as necessary or useful to make, use or sell Licensed Product(s) (as defined below), and related chemical, biological, and non-clinical data and relevant information, as listed and summarized in [***] ; and
(3) Immunic is interested in, either by itself or by an Affiliate, developing the Subject Compounds to appropriate form(s), method(s) of use, mode(s) of administration or dosage(s) of one or more pharmaceutical composition(s) of the Subject Compounds to be used in the therapy, prognosis, diagnosis and prevention of any human diseases; and
(4) Immunic and DS have discussed (under a “Bilateral Confidential Disclosure Agreement” dated November 9, 2017) and on July 11, 2018 agreed upon an Outline of Terms, binding only to the extent as set forth therein, according to which DS grants Immunic an exclusive option to enter into a full licensing agreement, both the option and the license in accordance with the terms and conditions set forth herein;
Based on the foregoing considerations, the Parties hereto agree as follows:
ARTICLE
1
INTERPRETATION AND DEFINITIONS
1.1. Interpretation Principles . As used in this Agreement, the capitalized terms listed in Section 1.2 shall have the meanings set forth therein or in the specific Section of this Agreement, to which the respective definition refers. Unless the context of this Agreement otherwise requires: (a) words of any gender include the other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and derivative or similar words refer to this entire Agreement; and (d) the term “including” means “including without limitation”.
- 1 -
1.2. Definitions .
“ Affiliate ” means any person or entity that controls, is controlled by, or is under common control with a Party. For purposes of this definition, the term “control” means (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether such control is obtained through ownership of voting securities, by contract or otherwise, or (ii) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of an entity. A person or entity shall only be considered an Affiliate for so long as such control exists.
“ BCDA ” means the Bilateral Confidential Disclosure Agreement effective between the Parties as of November 9, 2017.
“ Business Day(s) ” means a day which is neither a Saturday nor a Sunday or a bank holiday in Martinsried, Germany or Tokyo, Japan.
“ Combination Product ” means a product that contains a Subject Compound as an active pharmaceutical ingredient together with one or more other compounds that are active pharmaceutical ingredient(s).
“ Commercially Reasonable Efforts ” means those efforts, activities and measures, with respect to the efforts to be expended by the respective Party which, with respect to any objective, are reasonable, diligent, good-faith efforts to accomplish such objective as a similarly situated (with respect to size, stage of research and other aspects) pharmaceutical company would use to accomplish a similar objective under similar circumstances exercising reasonable business judgement and considering the scientific, medical and commercial potential and characteristics of the Subject Compound and Licensed Product as well as the associated risks in the development, obtaining of Regulatory Approvals and governmental pricing and reimbursement approvals, and commercialization.
“ Control ” or “ Controlled ” means with respect to any (i) item of information, including, without limitation, Know-how, or (ii) intellectual property right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party of the ability to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement or other arrangements with any Third Party.
“ CTA ” means a clinical trial application to any Regulatory Authority.
“ DS Patent Rights ” means any of the following: (a) any issued and unexpired patent, including substitutions, extensions, re-registrations, reissues, renewals, or similar governmental grants of exclusive rights to practice an invention; (b) any patent application, including continuation, continuation-in-part, divisional, and provisional applications that claim priority to, or common priority with a previously filed patent application or issued patent; (c) any foreign counterparts to any of the foregoing, in each case that are necessary for Immunic to research, develop, manufacture, use, or sell the Subject Compounds and Licensed Products for use in the Field in the Territory. The DS Patent Rights shall include the patent rights owned or controlled by DS identified in [***] .
“ DS Technology ” means Know-how that is owned by DS or its Affiliates during the Term that is necessary or useful for Immunic to research, develop, manufacture, seek Regulatory Approval for, and distribute the Subject Compounds and Licensed Products for use in the Field in the Territory. The DS Technology shall include the regulatory documentation, and Know-how identified in [***] .
“ Field ” means the treatment, diagnosis, prognosis, or prevention of any disease in humans.
“ First Commercial Sale ” means, with respect to any Licensed Product and any country of the world, the first sale by Immunic or any of its Affiliates, sub-licensees of any Licensed Product for use in the Field in that country, after such Licensed Product has been granted Regulatory Approval by the competent Regulatory Authorities.
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“ IND ” means an Investigational New Drug application submitted to the United States Food and Drug Administration (the “FDA”).
“ Know-how ” means any confidential technical information, techniques, processes, methods, data, assays, substances and materials, and other information in a Party’s possession that is not generally available to the public.
“ Licensed Product(s) ” means any pharmaceutical product that contains a Subject Compound as an active pharmaceutical ingredient.
“ Net Sales ” means [***] using generally accepted accounting standards:
[***]
Notwithstanding the foregoing, Net Sales shall not include any consideration received by lmmunic, or any of its Affiliates or sub-licensees in respect of the sale, use or other disposition of a Licensed Product (i) solely between the foregoing parties, or (ii) in a country as part of a clinical trial prior to the receipt of all Regulatory Approvals required to commence commercial sales of such Licensed Product in such country.
“ Regulatory Approval ” means and includes all licenses, permits, authorizations and approvals of, and all registrations, filings and other notifications to, any Regulatory Authority, necessary for the manufacture, production, distribution, marketing, sale and/or use of any Licensed Product within the Field and in a particular country or region of the Territory.
“ Regulatory Authority ” means any national, supra-national, regional, state or local regulatory agency, department, or other governmental entity in a country in the Territory, including the United States Food and Drug Administration or any successor thereto (FDA), and the European Medicines Agency or any successor thereto (EMA), that is responsible for regulating the manufacture, production, distribution, marketing, sale and/or use of any Licensed Product within the Field and in a particular country or region of the Territory.
“ Representative ” means any officer, director, employee, agent, advisor and representative.
“ [***] ” means [***] .
“ Subject Compound(s) ” means the compounds identified and described by their respective chemical compound names in [***] .
“ Term ” means the period between the Effective Date, and: (i) Immunic’s payment of royalties accruing from its last obligation to pay royalties to DS under Section 6.6, or (ii) this Agreement is terminated earlier under Article 11.
“ Territory ” means worldwide.
“ Third Party ” means any entity or person other than the Parties and their respective Affiliates.
“ Trademarks ” means all registered or unregistered trademarks, service marks, trade dress, trade names, logos, insignias, domain names, symbols, designs, artwork, and combinations thereof, and other indicia of origin, including all applications for registration and registrations of any such marks and renewals for any of the foregoing.
“ Valid Claim ” means a claim of (i) any unexpired issued Patent Right that shall not have been dedicated to the public, disclaimed, nor held invalid or unenforceable by a court or government agency of competent jurisdiction in an unappealed or unappealable decision, or (ii) of any patent application filed in good faith being part of the DS Patent Rights that has not been cancelled, withdrawn or abandoned.
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ARTICLE
2
OPTION
2.1. Option Right . DS hereby grants to Immunic an exclusive option to obtain an exclusive, worldwide, royalty-bearing license under the DS Patent Rights and DS Technology to research, develop, make, have made, use, import, offer for sale, distribute and sell the Subject Compounds and Licensed Product(s) (the “ Option Right ”).
2.2. Term of Option Right . The term of the Option Right granted under Article 2.1 shall commence on the Effective Date and shall expire [***] (the “Option Period”). Immunic may exercise its Option Right at any time during the Option Period by giving written notice to DS. If Immunic does not notify DS that it has exercised the Option Right before the expiration of the Option Period, such Option Right will expire, as provided in this Section 2.2, without the need for further action by DS.
ARTICLE
3
RESEARCH AND DEVELOPMENT INITIATED DURING THE OPTION PERIOD
3.1. Duties of the Parties . Following the Effective Date, the Parties shall without undue delay perform the studies listed in Exhibit D as follows:
(a) lmmunic shall use Commercially Reasonable Efforts to:
(i) at its own cost and expense, perform the studies listed in Part 1 of Exhibit D to analyze the mode of action of the Subject Compounds, and
(ii) at DS’s cost and expense, not to exceed [***] , perform the agreed upon studies listed in Part 2 of Exhibit D that are necessary for obtaining an IND or CTA, respectively. If Immunic reasonably anticipates that the total cost for the studies to be performed under this Section 3.1(a)(ii) will exceed [***] , it will promptly notify DS, and the Parties will discuss in good faith whether to increase the funding for such studies. Promptly after the receipt of an invoice issued by a contract research organization or contract manufacturing organization to Immunic for any study to be performed by Immunic under this Section 3.1(a)(ii), Immunic shall issue a corresponding invoice for all agreed upon costs and expenses to DS. DS shall reimburse Immunic for all such costs and expenses within [***] of receiving such invoice.
(b) DS shall use Commercially Reasonable Efforts to conduct, at its own cost and expense, the studies listed in Part 3 of Exhibit D, including [***] ; and
(c) DS shall reasonably support and assist Immunic in its due diligence efforts with respect to evaluating the Subject Compounds and the DS Technology to determine whether to execute its Option Right.
3.2. During the Option Period, lmmunic shall have the right under the DS Patent Rights and DS Technology to carry out all activities necessary and/or useful for the tasks assigned to Immunic pursuant to Section 3.1(a).
3.3. Any results generated by either Party or both Parties during the Option Period, including any intellectual property generated solely by or on behalf of a Party in performing the activities described in Section 3.1(a) and Section 3.1(b) shall, subject to the licenses granted pursuant to Articles 4 and 12, be solely owned by such Party. If and to the extent both Parties contributed to such results, such results shall, subject to the licenses granted pursuant to Articles 4 and 12, be jointly owned by both Parties, and the Parties shall in good faith discuss and agree upon any patent prosecution, enforcement, and defense of such jointly owned intellectual property. In the case of results generated during the Option Period that are solely owned by one Party, if such Party does not wish to obtain or maintain applicable intellectual property rights, it shall provide the other Party a reasonable opportunity to obtain and/or maintain such rights.
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3.4. Technology Transfer . During the Option Period, DS shall make the DS Technology available to Immunic through an electronic data room or other method agreed to by the Parties. Immunic shall not use any of the DS Patent Rights or DS Technology furnished under this Agreement for any purpose other than as specifically authorized in this Agreement, or as otherwise specifically authorized in writing by DS. DS shall use its reasonable endeavors to answer all questions received from Immunic regarding the DS Patent Rights and DS Technology as soon as reasonably possible after receipt.
3.5. During the Option Period, DS shall take reasonable steps to ensure that the existence and/or the scope of the DS Patent Rights and the DS Technology are not impaired, and shall refrain from acts that could reasonably be foreseen to impair the existence or scope of the DS Patent Rights or the DS Technology.
3.6. If Immunic does not exercise the Option Right before the Option Period expires, the rights granted to Immunic under Section 3.2 of this Agreement shall terminate automatically upon expiration of the Option Period and Immunic shall: (a) upon a request from DS, return or destroy all Confidential Information disclosed by DS, (b) grant, free of charge, an exclusive, royalty-free, worldwide license to any intellectual property generated by Immunic pursuant to this Agreement, whether solely or jointly with DS, during the Option Period to DS. with the right to grant sub-licenses, as necessary or useful to continue the development and commercialization of products containing the Subject Compound(s), and (c) transfer all data and results related to the Subject Compound(s) generated by Immunic during the Option Period. Thereafter, DS shall be free to further develop the Subject Compound(s) by itself or in cooperation with any Third Party, or to license the Subject Compound(s) and/or the DS Technology to any Third Party for further development and/or commercialization.
ARTICLE
4
LICENSE
4.1. License Grant . Effective as of, and subject to Immunic exercising the Option Right in accordance with Section 2.2 of this Agreement, DS hereby grants to Immunic, and Immunic hereby accepts, an exclusive license in the Field to use the DS Patent Rights and DS Technology to develop, have developed, make, have made, manufacture, have manufactured, register, have registered, use, have used, import, have imported, export, have exported, distribute, have distributed, market, have marketed, offer and have offered for sale, sell and have sold, and commercialize the Subject Compounds and/or Licensed Product(s) in the Territory, in accordance with the terms and conditions of this Agreement.
4.2. Sub-licensing .
4.2.1. Right to Sublicense . Immunic shall be entitled to sub-license (including the right to grant further sub-sublicenses, including sub-licenses in multiple layers) all or any of its rights in the Field under this Agreement to any Affiliate or Third Party. Any sublicense granted by Immunic shall be subject to the sub-licensing agreement containing terms and conditions that are not less restrictive in favor of DS than, and not inconsistent with those contained in this Agreement. Notwithstanding any sub-license it may grant, Immunic shall remain responsible for the performance of all of its duties and obligations under this Agreement, and shall be liable to DS for any breach of the terms of this Agreement by a sublicensee.
4.2.2. Approval of Sublicensees . Following Immunic’s execution of this Agreement, and on the anniversary of the date of the execution by lmmunic each year of the Term thereafter, Immunic shall provide DS with a list of proposed sub-licensees for review and approval. DS shall review the list and notify Immunic of any potential sub-licensees that are not approved. If DS does not notify Immunic that it has denied approval of a specific sub-licensee within thirty (30) days of receiving the list from Immunic, such sub-licensee shall be deemed approved. If Immunic wishes to engage a sub-licensee that is not on the then-current list of approved sub-licensees, it may request approval of such sub-licensee by submitting a written request to DS at any time. If DS does not notify Immunic that it does not approve of such sub-licensee within fifteen (15) days, such sub-licensee shall be deemed approved. Any denial of approval by DS shall be made in good faith based on reasonable concerns related to the particular sub-licensee, and if requested, DS shall discuss its reasons with Immunic. For clarity, approval of a sub-licensee by DS under this Section 4.2.2 does not relieve Immunic of any liability or responsibility for the acts or omissions of its sub-licensees as otherwise provided in this Agreement.
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4.3. Documents and Declarations . DS shall execute all documents, give all required declarations required to give effect to the licenses granted hereunder, and shall reasonably cooperate with Immunic to the extent such documents, declarations and/or cooperation are required to record or register the licenses granted hereunder at the various patent offices in the Territory for the benefit of Immunic.
ARTICLE
5
FURTHER DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS
5.1. Commercially Reasonable Efforts of Immunic . Immunic shall, following the exercise of its Option Right, use Commercially Reasonable Efforts to, [***] , develop, manufacture, register and market Licensed Products where commercially reasonable throughout the Territory.
5.2. Manufacturing . Following the exercise of its Option Right, lmmunic shall be solely responsible for manufacturing the Subject Compound and/or Licensed Product(s) for all clinical trials and for commercialization purposes.
5.3. Steering Committee .
5.3.1. Formation, Meetings, Procedures . The Parties shall form a joint steering committee (the “ Steering Committee ”) to monitor and review their respective activities during the Option Period. The Steering Committee shall be comprised of four (4) professionally and technically qualified representatives, two (2) from each Party. The Steering Committee shall meet for the first time within [***] after the Effective Date, and thereafter [***] , until lmmunic exercises its Option Right, or the Option Period expires. The meeting place of the in person meeting shall alternate between the offices of DS in Tokyo, or at another place designated by DS, and the offices of lmmunic in Martinsried, or at another place designated by lmmunic, or as otherwise agreed to by the Steering Committee. Steering Committee meetings may also be conducted by telephone, or by videoconference. Each Party shall provide the other Party with written notice of its Representatives for the Steering Committee within ten (10) Business Days after the Effective Date, and, thereafter, without undue delay upon any replacement. Each Party may invite guests to the meetings, in order to discuss special technical or commercial topics. At least [***] prior to each meeting of the Steering Committee, the Parties will exchange written copies of all materials, development documentation, and data and other information, as far as reasonably required to support the activities of the Steering Committee.
5.3.2. Activities of the Steering Committee . The activities of the Steering Committee shall include: (i) the review and discussion of the Development Plan and the progress being made in relation to the various topics listed therein, (ii) the monitoring of DS’s, lmmunic’s, or any of its sub-licensee’s development activities regarding the Subject Compounds and any Licensed Products, (iii) the exchange of development and safety information, (iv) sharing information by each of the Parties about improvements to the DS Technology, and (v) coordination of activities relating to the DS Patent Rights and other IP applications regarding joint inventions.
5.3.3. Minutes . The Steering Committee shall keep accurate and complete minutes of its meetings. The responsibility for preparing the minutes setting forth decisions made at each Steering Committee meeting shall alternate between the Parties with the Immunic Representatives preparing the minutes of the first Steering Committee meeting. The minutes of each meeting of the Steering Committee shall be prepared within [***] of its completion, and will only become official when agreed upon by all Steering Committee members. If no issue is taken with any set of minutes within [***] of their receipt by all Steering Committee members, they shall be deemed to have been accepted. All records of the Steering Committee shall be available at all times to each Party.
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5.3.4. Decisions . All decisions of the Steering Committee shall be made in good faith in the best interest of the successful and responsible development and commercialization of the Subject Compounds and the Licensed Products according to this Agreement. The Parties shall use reasonable efforts to take decisions unanimously. In the event that the Steering Committee is unable to agree on any matter after good faith attempts to resolve such any disagreement in a mutually acceptable fashion, then the vote of [***] shall be decisive.
5.3.5. Joint Project Team . If Immunic exercises its Option Right, the Steering Committee shall be reconstituted as a Joint Project Team to facilitate information sharing between the Parties. The role of the DS personnel on the Joint Project Team shall be solely that of observers to monitor the development and commercialization of the Subject Compounds and Licensed Product(s), and to answer questions from Immunic about the DS Technology. Meetings of the Joint Project Team can be called by either Party on an ad hoc basis, but in no case more than once in each calendar quarter. Such meeting may be held by teleconference or videoconference. DS personnel on the Joint Project Team may fully participate in all discussions during the meeting, but will have no authority to make decisions related to the development or commercialization of the Subject Compounds or Licensed Products. All information disclosed to DS personnel on the Joint Project Team shall be treated as Confidential Information under this Agreement.
5.4. Use of Names . Except as otherwise provided herein, no Party has any right, express or implied, to use in any manner the name or other designation of the other Party, or any other trade name, trademark or logos of the other Party for any purpose in connection with the performance of this Agreement, or otherwise. In particular, DS does not grant Immunic any license to use any of DS’s trademarks to designate any Subject Compound or Licensed Product. Immunic shall have the sole right to select the Trademarks used in connection with the Subject Compounds and Licensed Products, and shall own and retain all right, title and interest in and to such Trademarks, and all goodwill associated with or attached to such Trademarks arising out of the use thereof by Immunic, its Affiliates and any sub-licensees shall inure to the benefit of Immunic. Only Immunic will be authorized to initiate, at its own discretion, legal proceedings against any infringement or threatened infringement of such Trademarks.
5.5. Covenant not to Compete . During the Option Period, neither Party may develop or commercialize any compound or product that derives its intended therapeutic effect from [***] other than the Subject Compounds. If Immunic exercises its Option Right, during the Term Immunic shall not develop or commercialize any compound that derives its intended therapeutic effect from [***] other than the Subject Compounds and competes with any of the Licensed Products, either on its own or with a Third Party.
ARTICLE
6
CONSIDERATION
6.1. Up-front Payment . In consideration for DS granting the license and rights pursuant to this Agreement, Immunic shall, subject to its exercise of the Option Right, pay to DS a one-time-only, non-refundable, non-creditable lump sum amount of [***] payable within [***] after the date of its exercise of the Option Right.
6.2. Development Milestone Payments . Immunic shall make the following additional one-time-only payments to DS, each upon the achievement of the following events by Immunic, its Affiliate, or its Third Party sub-licensee:
[***]
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6.3. Sales Milestone Payments . Immunic shall, in addition to the payments specified in Sections 6.1 and 6.2, pay DS the following one time sales milestone payments on the aggregated annual Net Sales of the Licensed Products in the Territory:
[***]
For the avoidance of doubt, the term “aggregated annual Net Sales of the Licensed Products in the Territory”, as used in this Agreement, shall mean [***] .
6.4. Royalties . Immunic shall pay to DS, as further consideration for the rights and licenses granted by it under this Agreement, royalties on Net Sales of the Licensed Products in the Territory equal to [***] of annual Net Sales. Such royalty payments shall be determined irrespective of whether such Net Sales result from the commercialization of the Licensed Products by Immunic or its Affiliates, or by any Third Party sub-licensees; annual Net Sales of the relevant Licensed Product shall mean the total of all Net Sales of a particular Licensed Product anywhere in the Territory in any single calendar year.
6.5. Royalties for Combination Product . If a Licensed Product is sold as part of a Combination Product for a single invoiced amount (in each case, a “Combination Sale”), the Net Sales amount for the Licensed Product sold in such a Combination Sale shall be that portion of the gross amount invoiced for such Combination Sale (less all permitted deductions) reasonably attributable (in terms of value) to the Licensed Product included in the Combination Sale, based on the relative prices of the separate components of the Combination Sale when sold separately in the country where such Combination Sale occurs (if such components are sold separately in such country) or (if such components are not sold separately in such country) on such other objective and reasonable factors agreed to by the Parties after good faith discussions.
6.6. Royalty Payment Term . Immunic’s obligation to make royalty payments terminates on a country-by-country and Licensed Product-by-Licensed Product basis by the later of (i) the Licensed Product is no longer covered by a Valid Claim in an issued patent within the DS Patent Rights in the relevant country, or (ii) [***] after the First Commercial Sale of the respective Licensed Product in the relevant country; provided, however, that if the Licensed Product:
(a) is no longer covered by a Valid Claim in an issued patent within the DS Patent Rights in the relevant country,
(b) no longer enjoys market exclusivity from legal or regulatory protections (e.g. data exclusivity) obtained by the original holder of the Regulatory Approval in the relevant country, and
(c) one or more generic competitors enter the market in the relevant country and as a result, the prescription volume of the Licensed Product declines by [***] or more in such country. For the purposes of this Section 6.6(c), the decline in prescription volume shall be measured by comparing the total number of units sold by Immunic, its Affiliates, and sub-licensees during the applicable calendar quarter against the average of the total number of units sold by Immunic, its Affiliates, and sub-licensees during the [***] immediately before the first sale of a product by the first generic competitor in such country, then the royalty rate shall be reduced to [***] for Net Sales of such Licensed Product in the relevant country.
6.7. Third-Party License Payments .
6.7.1. Notification . If Immunic, its Affiliates, or its sub-licensees reasonably believe that one or more of them is/are required to obtain and maintain a license to Third Party patent rights, or a license of other proprietary rights owned or controlled by a Third Party in order to research, develop, manufacture, use, import, offer for sale, distribute or sell a Licensed Product in the Field, Immunic shall notify DS of such circumstance before executing any license agreement with the Third Party. The Parties shall meet promptly and discuss the necessity of obtaining the proposed license and the terms of proposed Third Party license agreement. Immunic shall have the final decision making authority regarding whether to execute the Third Party license agreement, but shall consider in good faith the comments, concerns, and objections raised by DS.
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6.7.2. Payment Offset . Immunic shall be entitled to offset [***] of the amounts paid to all Third Party licensor(s) under the applicable license(s) from the amounts to be paid to DS under this Agreement. The amounts paid to all Third Party licensors in a particular country during [***] may be offset against the royalties otherwise payable to DS for Net Sales of Licensed Products in that country for [***] . [***] .
6.7.3. Minimum Royalty Payment . During any calendar quarter in which royalties are due to DS and a payment offset under Section 6.7.2 of this Agreement is claimed by Immunic, the aggregated amount of the offset for all Third Party license payments in a country shall not reduce the royalties paid to DS below [***] .
6.8. Payments to DS .
6.8.1. Payment Method . All payments due to DS under this Agreement will be made in US Dollars by bank wire transfer in immediately available funds to an account designated by DS. Immunic shall be responsible for paying all transfer and other fees related to completing all bank wire transfers required under this Agreement. Within [***] , DS will provide Immunic all information necessary to make such bank wire transfers. Thereafter, any change to such bank wire transfer information will be transmitted to Immunic by a notice in accordance with Section 13.3.
6.8.2. Currency Exchange . In the event that any Net Sales subject to royalty payments according to this Agreement are calculated in any currency other than US Dollars, for purposes of calculating payments payable by Immunic under Section 6.5, and Section 6.6 of this Agreement, such Net Sales shall be converted into US Dollars at the rate of exchange between the currency in which such Net Sales and licensing payments were received and the US Dollar prevailing at Federal Reserve Bank of New York, at noon on the last banking day of the calendar quarter in which such Net Sales have been effected.
6.8.3. Payments for Milestone Events . Immunic shall inform DS of the occurrence of a milestone event without undue delay, however, no later than within [***] following [***] . Milestone payments are payable within [***] after Immunic’s receipt of an invoice issued by DS for such milestone payment.
6.8.4. Royalty Payments . Payment of royalties under Section 6.5, and Section 6.6 of this Agreement shall be paid on a [***] basis. Each payment by Immunic under Section 6.5, and Section 6.6 shall be paid within [***] . Within [***] , Immunic will deliver a report specifying in the aggregate and on a country-by-country basis the following information for such calendar quarter: (a) total gross invoiced amount from sales of each Product by Immunic, its Affiliates, and its Sublicensees; (b) amounts deducted by category (e.g., normal and customary trade, cash and other discounts, allowances and credits actually allowed and taken directly with respect to sales of the Product) from gross invoiced amounts to calculate Net Sales; [***] .
6.8.5. Taxes . All payments by Immunic to DS are exclusive of value added tax, which shall, if applicable, be invoiced separately. The Parties shall use reasonable efforts to obtain any available exemptions from withholding taxes and to assist each other in that regard. Any tax paid or required to be withheld by Immunic on behalf of DS on account of any upfront, milestone, royalty or other payments payable to DS under this Agreement will be deducted from the amount of such payments otherwise due. To the extent that Immunic is able to do so, Immunic will secure and send to DS proof of any such taxes withheld and paid by Immunic on behalf of DS, and will, at DS’s request, provide reasonable assistance to DS in recovering or crediting, as applicable, such taxes. Immunic shall use Commercially Reasonable Efforts to enable DS to take advantage of any applicable legal provision or tax treaty with the object of paying the sums due to DS without imposing or withholding any tax.
6.8.6. Late Payments . In the event of any delay in effecting any payment due to DS under this Agreement by the due date, Immunic shall pay DS, in addition to the overdue amount, interest calculated on a daily basis on the overdue payment, from the day after such payment was due to the date of actual payment, at a rate of [***] as applicable from time to time.
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6.9. Book Keeping and Auditing . For the Term and for [***] , Immunic shall maintain complete and accurate books and records of account, in accordance with generally accepted account principles, of all transactions and other business activities conducted pursuant to this Agreement that are necessary to confirm the accuracy of all payments by Immunic to DS under this Article 6. Upon reasonable written notice to Immunic, DS, or a certified public accountant designated by DS and reasonably acceptable to Immunic, shall have the right to audit such books and records of account of Immunic (provided always that in the case of review by a certified public accountant, the relevant public accountant enters into an appropriate confidentiality agreement with Immunic), in order to confirm the accuracy and completeness of all such payments. DS shall bear all costs and expenses incurred in connection with any such audit; provided, however, that if any such audit reveals an inaccuracy of [***] or more based on the amount of payments actually due during the audited period, then, in addition to paying the full amount of such underpayment, plus accrued interest, Immunic shall reimburse DS all such reasonable costs and expenses incurred with the audit.
ARTICLE
7
DS PATENT RIGHTS
7.1. Ownership . Immunic hereby acknowledges that DS is, as of the Effective Date, the owner of all of the DS Patent Rights, and Immunic shall acquire no rights, title or interest whatsoever in or to any of the DS Patent Rights other than the licenses granted to it under this Agreement. Immunic shall not utilize any of the DS Patent Rights for any purpose whatsoever, except as specifically authorized in this Agreement. Immunic shall not in its own name register, or attempt to register, any of the DS Patent Rights, or otherwise assert any ownership rights with respect to any of the DS Patent Rights, in any country within the Territory.
7.2. Obligation to Prosecute and Maintain . During the Option Period, DS shall, at its sole expense, be responsible for prosecuting and maintaining the patents and the patent applications comprised within the DS Patent Rights. If Immunic exercises its Option Right, then thereafter Immunic shall be responsible, at its sole expense and using counsel of its choice, for prosecuting and maintaining the DS Patent Rights claiming the Subject Compounds. DS shall take all steps, and execute all documents and authorizations that are necessary to transfer such responsibility to Immunic and DS shall reasonably support Immunic in the prosecution and maintaining of such DS Patent Rights. DS shall remain responsible for prosecuting and maintaining the other patent rights claiming DS Technology that are licensed to Immunic.
7.3. Information and Consultation . During the Option Period, DS shall keep Immunic reasonably informed of and shall consult with Immunic on an ongoing basis regarding the prosecution and maintenance of the DS Patent Rights containing claims that cover the Subject Compounds, and of any actions that are required to be taken in relation thereto. In particular, DS shall provide Immunic with a copy of material communications from any patent authority in the Territory regarding the DS Patent Rights, and shall, to the extent reasonably practical, provide Immunic with drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses.
7.4. Abandonment of Patent Rights . In the event that DS elects not to continue prosecuting or maintaining any of the DS Patent Rights, DS shall notify Immunic in writing [***] before any relevant deadline relating to or any public disclosure of the relevant DS Patent Rights. Upon receipt of a notice from DS indicating that it intends to cease prosecuting or maintaining any of the DS Patent Rights, Immunic shall have the right to continue, at its own expense, prosecution or maintenance (as the case may be) of the relevant DS Patent Rights and DS shall at the request and cost of Immunic do all such acts and execute all such documents as may be necessary to (i) transfer title to the relevant DS Patent Rights to Immunic and (ii) assist Immunic with the prosecution and maintenance of the relevant DS Patent Rights until such times as Immunic’s title as proprietor of the relevant DS Patent Rights has been registered at all of the appropriate patent offices.
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7.5. Third Party Infringement of DS Patent Rights .
7.5.1. Notification . If either Immunic or DS becomes aware of any activity that it believes represents an infringement of any of the DS Patent Rights, the Party obtaining such knowledge shall promptly advise, to the extent that such information is available to the respective Party, the other of all relevant facts and circumstances relevant to the potential infringement. Immunic and DS shall thereafter consult and cooperate fully to determine a course of action, including but not limited to the commencement of legal action to enjoin any infringement of the relevant DS Patent Rights. However, Immunic shall have the first right, but not the obligation, to bring, defend, or maintain any suit or action, in its own name, against any actual, threatened, or suspected infringement of any of the DS Patent Rights in the Territory.
7.5.2. Controlling Party . If Immunic decides to exercise such right and so to bring, defend or maintain any such suit or action in its own name and at its own expense, Immunic shall be responsible for taking all actions, in the courts, administrative agencies, or otherwise, including a settlement, to prevent or enjoin any and all such infringements and other unauthorized uses of the DS Patent Rights, and DS shall take no action with respect to any such infringement or unauthorized use of the Patent Rights, without the prior written authorization of Immunic; provided, however, that Immunic shall not take any action or agree to any settlement that impairs, diminishes, limits, or forfeits any DS Patent Rights without written consent from DS, such consent not to be unreasonably withheld or delayed. DS shall provide, at the request and cost of Immunic, such assistance as Immunic shall reasonably request in connection with any action to prevent or enjoin any such infringement or unauthorized use of any of the DS Patent Rights.
7.5.3. Damage Awards . Any damage award or settlement payments, made in connection with any action relating to infringement of the DS Patent Rights in the Territory, whether obtained by judgment, settlement or otherwise shall be allocated (i) first, to the Parties to recover their respective reasonable costs and expenses incurred in connection with the action, and (ii) second, the amount of any recovery remaining shall then be allocated between DS and Immunic depending on the economic effect of the infringement action on the commercialization of the Subject Compounds and/or the Licensed Products by Immunic or its sub-licensees under the license granted to Immunic.
7.6. Transfer of Title to DS Patent Rights . If Immunic desires to transfer, all or a substantial part of the DS Patents Rights licensed to Immunic under this Agreement to a Third Party, and the proposed Third Party transferee requires that Immunic hold title to the DS Patents as a condition to consummating the proposed transaction, Immunic may request discussions with DS to determine the feasibility of transferring title to the DS Patent Rights from DS to Immunic. Any request from Immunic shall include a detailed description of the circumstances underlying the request and a timeline for DS to make its decision. After making such request, Immunic shall promptly provide all information and answer any questions reasonably requested by DS. DS shall have the sole discretion to decide whether to transfer title to any DS Patent Rights to Immunic, and if undertaken, the scope of the transfer, and any conditions that must be satisfied before such transfer of title is completed. All decisions by DS regarding whether to transfer title, the scope of the transfer, and the conditions for the transfer are final and undisputable, and therefore not subject to the dispute resolution procedure provided in Section 13.5 of this Agreement, or as provided under any other laws or regulations.
ARTICLE
8
CONFIDENTIALITY
8.1. Confidentiality Obligations . All information disclosed by one Party to the other Party pursuant to this Agreement and all information disclosed pursuant to the BCDA shall be “ Confidential Information ” of the disclosing Party for all purposes hereunder. Each Party agrees that, for the Term and for [***] thereafter, such Party shall, and shall ensure that its, its Affiliates’, and its sub-licensees’ Representatives shall, keep completely confidential (using at least the same standard of care as it uses to protect proprietary or confidential information of its own, but in no event less than reasonable care) and not publish or otherwise disclose, and not use for any purpose except as expressly permitted hereunder, any Confidential Information of the other Party. The foregoing obligations shall not apply to any information disclosed by a Party hereunder to the extent that the receiving Party can demonstrate with competent evidence that such information:
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(i) was already known to the receiving Party or its Affiliates, other than under an obligation of confidentiality, at the time of disclosure;
(ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
(iii) became generally available to the public or otherwise part of the public domain after its disclosure to the receiving Party other than through any act or omission of the receiving Party, its Affiliates, or its sub-licensees in breach of this Agreement or the BCDA;
(iv) was subsequently lawfully disclosed on a non-confidential basis to the receiving Party or its Affiliates by a Third Party other than in contravention of a confidentiality obligation of such Third Party to the disclosing Party; or
(v) was independently developed by the receiving Party without use of the Confidential Information of the disclosing Party, as established by contemporaneous written records of the receiving Party.
Notwithstanding the definition of “Confidential Information” above and any licenses granted to such information, all results generated by either Party pursuant to Article 3 shall be deemed Confidential Information of such Party.
8.2. Authorized Disclosure . A Party may disclose the Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances:
(i) Filing or prosecuting or maintaining Patent Rights as expressly permitted under this Agreement;
(ii) Submissions to a Regulatory Authority and request for Regulatory Approvals relating to the Licensed Products as provided for in the Development Plan or otherwise permitted under this Agreement;
(iii) Prosecuting or defending litigation or arbitration as permitted under this Agreement;
(iv) Disclosure, in connection with the performance of this Agreement, to Affiliates, Representatives, sub-licensees, research collaborators, or subcontractors, each of whom prior to such disclosure must be bound by obligations of confidentiality and nonuse equivalent or greater in scope to those set forth in this Article 8.
Further, a Party may disclose the other Party’s Confidential Information to the extent such disclosure is required by valid court order or legal process, provided that, to the extent consistent with such order or process, such Party gives the other Party advance notice of such required disclosure, limits the disclosure to that actually required, and cooperates in the other Party’s attempts to obtain a protective order or confidential treatment of the information required to be disclosed.
8.3. Confidentiality of Agreement Terms . Each Party acknowledges that the terms of this Agreement shall be treated as Confidential Information of the other Party. Notwithstanding the foregoing, such terms may be disclosed by a Party to investment bankers, investors, and potential investors or acquirers, solely in the context of a potential transaction and for the limited purpose of evaluating such potential transaction. In addition, a copy of this Agreement and any ad hoc announcement pertaining hereto may be filed by a Party with the Securities and Exchange Commission and/or any applicable securities exchange as required by applicable laws or stock exchange regulations. In connection with any such filing, such Party shall provide the other Party a reasonable opportunity to review the proposed filing to identify and request the removal of sensitive financial and trade secret information, and shall endeavor to obtain confidential treatment of economic and trade secret information, if included. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information except as permitted hereunder.
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ARTICLE
9
WARRANTIES AND LIABILITIES
9.1. Mutual Representations and Warranties . The Parties represent and warrant that they have the full right and authority to enter into this Agreement and that they have no obligations or commitments inconsistent with this Agreement.
9.2. Warranties of DS . DS warrants and represents that:
(i) as of the Effective Date, it owns the right, title and interest in the DS Patent Rights and owns or has the right to license the DS Technology;
(ii) as of the Effective Date, it does not own or otherwise control any patent rights other than the DS Patent Rights which are necessary or reasonably useful for or directed to the development, manufacture or commercialization of the Subject Compounds;
(iii) it has the right to grant the licenses contained herein;
(iv) as of the Effective Date, it is not aware of any claim or threatened claim that any of the DS Patent Rights is invalid or that the development of the Subject Compounds would infringe any intellectual property rights of any Third Party;
(v) as of the Effective Date, it is not aware of any Third Party having any right, title or interest in or to any of the DS Patent Rights or the DS Technology.
9.3. Disclaimer . DS makes no representation or warranty and specifically disclaims any guarantee that the development of the Subject Compound(s) and/or Licensed Products will be successful, in whole or in part. DS expressly disclaims any warranties or conditions, express, implied, statutory or otherwise with respect to any of the DS Patent Rights or DS Technology, except as set forth in Section 9.2, including any warranty of merchantability or fitness for a particular purpose.
9.4. Limitation of Liability . The Parties’ liability in case of simple negligence shall be excluded. Except in case of gross negligence or willful misconduct, neither Party shall be liable to the other Party for any indirect, punitive or consequential damages or loss of profits, whether based on contract or tort, or arising under applicable law or otherwise.
ARTICLE
10
INDEMNIFICATION AND INSURANCE
10.1. DS’s Indemnification Obligations . DS shall defend, indemnify and hold Immunic harmless against [***] .
DS indemnification obligation under this Section 10.1 shall be subject to each of the following conditions: (i) Immunic shall furnish DS with written notice of any such Claims and Liabilites for which it will seek indemnification within [***] of the date on which Immunic receives notice thereof; (ii) subject to DS confirming in writing that its indemnification obligation will apply to the relevant Claims and Liabilities, DS shall thereafter be solely responsible for investigating, defending, settling and discharging such Claims and Liabilities, provided that DS shall not settle or discharge any Claims and Liabilities in a manner that admits fault or liability by Immunic without first obtaining consent from Immunic; and (iii) Immunic shall at DS’s costs furnish DS with all assistance reasonably requested by DS or its counsel. Immunic’s failure to comply with its obligations pursuant to this Section 10.1 shall not constitute a breach of this Agreement nor relieve DS of its indemnification obligations pursuant to this Section 10.1, except to the extent, if any, that DS’s defense of the claim, action or proceeding was materially impaired thereby.
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10.2. Immunic’s Indemnification Obligations. Immunic shall defend, indemnify and hold DS harmless against [***]
Immunic’s indemnification obligation under this Section 10.2 shall be subject to each of the following conditions: (i) DS shall provide Immunic with written notice of any such Claims and Liabilities for which it seeks indemnification within [***] after DS receives notice thereof; (ii) subject to Immunic confirming in writing that its indemnification obligation will apply to such Claims and Liabilities, Immunic shall be solely responsible for investigating, defending, settling and discharging such Claims and Liabilities, provided that Immunic shall not settle or discharge any Claims and Liabilities in a manner that admits fault or liability by DS or materially affects the scope of the DS Patent Rights without first obtaining consent from DS; and (iii) DS shall at Immunic’s cost provide Immunic with all assistance reasonably requested by Immunic or its counsel. DS’s failure to comply with its obligations pursuant to this Section 10.2 shall not constitute a breach of this Agreement nor relieve Immunic of its indemnification obligations, except to the extent, if any, that Immunic’s defense of the claim, action or proceeding was materially impaired thereby.
10.3. Insurance . Both Parties shall, at their sole cost and expense, obtain and maintain in full force and effect during the continuance of this Agreement and thereafter in accordance with Section 10.5 of this Agreement, a policy of commercial general liability insurance with coverage adequate in relation to the risks attached to the activities conducted by the respective Party. The Parties hereby specifically acknowledge and agree that the insurance coverage limits set forth in this Section 10.4 shall not be construed to create any limit on each Party’s liability hereunder and/or indemnification obligation under Sections 10.1 and 10.3 of this Agreement.
10.4. Survival . DS’s indemnification obligation under Section 10.1, Immunic’s indemnification obligation under Section 10.2, and the Parties’ obligation to maintain general liability insurance under Section 10.3 shall survive for fifteen (15) years after the expiration or termination of this Agreement.
ARTICLE
11
TERM AND TERMINATION
11.1. Expiration . This Agreement shall expire at the end of the Term without the need for further action by either Party. Thereafter, Immunic shall retain an irrevocable, fully paid-up and royalty free right to use the DS Technology in the Field. For clarity, termination under Section 11.2 through 11.4 of this Agreement shall not be considered an “expiration”, and the foregoing right to use DS Technology thereafter shall not apply.
11.2. Termination by Immunic for Convenience . Immunic may terminate this Agreement at any time before it pays the first development milestone payment for Regulatory Approval in the United States, the European Union, or Japan, as provided in Section 6.2(iii) — (v), by giving written notice to DS not less than [***] before the date on which the termination is to become effective. After paying the first development milestone payment for Regulatory Approval in the United States, the European Union, or Japan, Immunic may terminate this Agreement, as a whole or on a country-by-country basis, at any time by giving written notice to DS not less than [***] before the date on which the termination is to become effective. Any written notice by Immunic to DS to the effect that Immunic decided to finally discontinue the development and/or commercialization of the Licensed Products in all countries in the Territory shall be deemed to constitute notice of termination according to the foregoing sentence of this Section 11.2.
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11.3. Termination for Breach . In the event that either Party (the “ Breaching Party ”) commits a material breach or default of any of its obligations hereunder, the other Party (the “ Non-Breaching Party ”) may give the Breaching Party written notice of such material breach or default, and request that such material breach or default be cured as soon as reasonably practicable. If the Breaching Party fails to cure such breach or default within ninety (90) calendar days after the date of the Non-Breaching Party’s notice or, if such breach or default is not capable to be cured within such ninety (90) day period, fails to make good faith efforts to cure such breach or default within a reasonable period of time after such ninety (90) day period, the Non-Breaching Party may terminate this Agreement by giving written notice of termination to the Breaching Party. If it is not possible for the Breaching Party to cure the alleged breach, despite good faith efforts, this Agreement may be terminated by the Non-Breaching Party effective immediately upon giving written notice to the Breaching Party. Termination of this Agreement in accordance with this Section 11.3 shall not affect or impair the Non-Breaching Party’s right to pursue any remedy, in law or in equity, including seeking injunctive relief and the right to recover damages, for harm suffered or incurred by the Non-Breaching Party as a result of such breach or default.
11.4. Termination in Case of Insolvency . If a Party files a voluntary petition, or if an involuntary petition is granted against such Party and appeal proceedings are not commenced within a period of ten (10) Business Days from the date of such petition under the bankruptcy provisions of applicable law, or if such Party is declared insolvent, undergoes voluntary or involuntary dissolution, or makes an assignment for the benefit of its creditors, or fails or is unable to pay its debts as they come due, or suffers the appointment of a receiver or trustee over all, or substantially all, of its assets or properties, and whether or not any of the aforesaid acts be the outcome of a voluntary act of that Party, such Party shall provide the other Party with prompt written notice and the Parties shall mutually discuss in good faith the effects of any of the foregoing on this Agreement and any reasonable consequences such as amendments to or a termination of this Agreement.
ARTICLE
12
CONSEQUENCES OF TERMINATION
12.1. Sell Off . Except as set forth in Sections 12.3 and 12.4 hereof, immediately upon the termination of this Agreement for any reason, Immunic shall cease all manufacturing, producing, distributing, marketing and selling all Licensed Products, provided, however, that, if this Agreement is terminated for any reason other than a breach by Immunic, Immunic shall have the right to distribute and sell its existing inventory of Licensed Products for not more than one (1) year after the date of expiration or termination, subject to lmmunic’s continuing obligation to make all payments required under Article 6 of this Agreement that accrue as a result of the sale of such existing inventory.
12.2. Accrued Payment Claims . Termination or expiration of this Agreement shall not relieve Immunic of its obligations to pay all royalties and other amounts payable to DS which have accrued prior to, but remain unpaid as of, the date of expiration or termination, or that accrue thereafter.
12.3. Continued Rights and Obligations of DS . Except as otherwise specifically provided in this Agreement, upon expiration or termination of this Agreement for any reason whatsoever, DS shall have no further obligations to Immunic.
12.4. Continued Rights and Obligations of Immunic . Except as otherwise specifically provided in this Agreement, upon expiration or termination of this Agreement for any reason whatsoever, Immunic shall have no further obligations to DS.
12.5. Substitution of Sub-licenses . Upon termination of this Agreement for any reason, all sub-licensees that are granted sublicenses by Immunic pursuant to this Agreement, and are not in material breach of the terms of such sublicense shall have the right to obtain equivalent licenses directly from DS, unless the respective sublicense agreement contains terms which are reasonably unacceptable to DS. Further, if this Agreement is terminated by Immunic pursuant to Section 11.2 or by DS pursuant to Section 11.3 or Section 11.4, DS shall not have any obligation to negotiate or execute a substitute license with an existing Immunic sub-licensee, but any negotiations undertaken by DS shall be conducted in good faith with the intention of agreeing upon commercially reasonable terms and conditions. DS shall not be required to negotiate a substitute license agreement if the sub-licensee is in material breach under the sublicense Agreement.
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12.6. Termination by Immunic for Convenience or by DS for Immunic’s Breach or Insolvency . If this Agreement is terminated by Immunic in its entirety (i.e. not only on a country-by-country basis) pursuant to Section 11.2 or by DS pursuant to Section 11.3, or Section 11.4, Immunic shall, upon a request from DS (to be exercised by written notice within ninety (90) calendar days after the effective date of termination), and at no cost to DS, deliver to DS or its designee: (a) all development data and any other relevant information controlled by Immunic regarding the Subject Compounds and Licensed Products, and (b) all Regulatory Approvals granted to Immunic prior to the effective date of termination. DS shall be entitled to use such development data and Regulatory Approvals to continue development and commercialization of the Subject Compounds and/or Licensed Products solely in the Field. If Immunic terminates this Agreement for convenience pursuant to Section 11.2 or DS terminates this Agreement for Immunic’s insolvency pursuant to Section 11.4, DS’ right to use such development data and Regulatory Approvals shall be without further obligation to Immunic.
ARTICLE
13
GENERAL PROVISIONS
13.1. Assignment . Subject to the other terms of this Agreement, neither Party shall have the right or the power to assign this Agreement or any of its rights or obligations under this Agreement, without the prior written authorization of the other Party, such written authorization not to be unreasonably withheld or delayed; provided, however, that the prior written authorization of the other Party shall not be required for a Party to assign this Agreement or any of its rights or obligations hereunder to an Affiliate. Any permitted assignment hereunder by either Party, whether to an Affiliate pursuant to this Section 13.1, or pursuant to the prior written authorization of the other Party, shall not relieve such Party of any of its obligations under this Agreement, including, but not limited to, Immunic’s obligation to make upfront, milestone and royalty payments pursuant to Sections 6.1 through 6.6 with respect to any and all Net Sales derived by any of the Immunic’s assignees or sub-licensees from the distribution, marketing and sale of any of the Licensed Products.
13.2. Force Majeure . Neither Party shall be liable for any failure to perform, or any delay in the performance of, any of its obligations under this Agreement to the extent that such Party’s performance is prevented by the occurrence of an event of force majeure. For purposes of this Section 13.2, an event of force majeure shall mean and include, war, civil war, insurrection, rebellion, civil unrest, fire, flood, earthquake, adverse weather conditions, strike, lockout, labor unrest, unavailability of supplies, materials or transportation, acts of the public enemy, and, in general, any other cause or condition beyond the reasonable control of the Party whose performance is affected thereby. In the event that a Party’s performance is affected by the occurrence of any event of force majeure, that Party shall furnish immediate written notice thereof to the other Party. If the affected Party reasonably believes that the event of force majeure will continue for more than one hundred eighty (180) calendar days, the Parties shall discuss in good faith actions that may be taken to mitigate or relieve its effects.
13.3. Notices . All notices, reports and other communications between the Parties under this Agreement shall be sent by registered mail, postage prepaid and return receipt requested, or by facsimile, with a confirmation copy sent by registered mail or courier, addressed as follows:
To: DS
Daiichi Sankyo Co., Ltd.
[***]
To: IMMUNIC
Immunic AG
[***]
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13.4. Governing Law . This Agreement shall be governed by, and interpreted in accordance with the laws of the Federal Republic of Germany without reference to conflicts of laws principles. The validity of the intellectual property rights shall be subject to an evaluation under the law of the country in which the intellectual property rights were applied for or have been issued.
13.5. Dispute Resolution . Any dispute relating to the validity, performance, construction or interpretation of this Agreement, which cannot be resolved amicably between the Parties, shall be submitted to arbitration in accordance with the Rules of the International Chamber of Commerce (ICC). Unless otherwise agreed to by the Parties, each Party shall appoint one (1) neutral arbitrator, and the two appointed arbitrators shall mutually agree upon the appointment of a third arbitrator to serve as the chairperson of the arbitration panel. The decision of the arbitrators shall be final and binding upon the Parties and enforceable in any court of competent jurisdiction. All arbitration proceedings initiated under this Section 13.5 shall be conducted in the English language in Zurich, Switzerland. Each Party shall have the right to seek preliminary and permanent injunctive relief in any court of competent jurisdiction, in order to prevent or enjoin any misappropriation, misuse, unauthorized disclosure or infringement of any of the patent rights and/or the Confidential Information of either Party.
13.6. Independent Contractors . The Parties each acknowledge and agree that their relationship under this Agreement is that of independent contractors. Nothing contained in this Agreement is intended implicitly or explicitly, nor is to be construed, as creating or constituting a partnership, joint venture, employment, or any form of agency relationship between them. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.
13.7. Headings . The captions to the several Sections and Articles of this Agreement are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation.
13.8. Counterparts . This Agreement may be executed in any number of identical counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.
13.9. Severability . If any provision of this Agreement is determined by any court or administrative tribunal of competent jurisdiction to be invalid or unenforceable, the Parties shall negotiate in good faith a replacement provision that, to the maximum extent permitted by applicable law, is equivalent in effect to such invalid or unenforceable provision. Unless otherwise provided in this Agreement the invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of the other provisions of this Agreement.
13.10. Entire Agreement and Amendments . This Agreement, including all Exhibits attached hereto, constitutes the entire Agreement between the Parties, and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof, including the BCDA which shall remain in force until the Effective Date and then terminate with effect ex nunc. No modification or amendment of this Agreement shall be binding upon the Parties unless in writing and executed by the duly authorized representative of each of the Parties; this shall also apply to any change of this clause.
13.11. No Waiver . The failure by either Party to assert any of its rights, including, the right to terminate this Agreement due to a breach or default by the other Party, shall not be deemed to constitute a waiver by that Party of its right to enforce each and every provision of this Agreement at a later time.
13.12. Press Releases . Each Party shall give notice to the other Party prior to issuing any press release relating to this Agreement within due time to allow for reasonable consideration. The Party issuing the press release shall give due consideration and weight to any comments or concerns raised by the other Party and shall, if requested, remove any information that the other Party deems to be its Confidential Information. Notwithstanding the foregoing, neither Party shall issue a press release announcing the execution of this Agreement outside of a joint press release prepared jointly by the Parties. A draft of a joint press release shall be provided by Immunic.
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In Witness whereof, this Agreement has been signed by the Parties hereto on September 27, 2018 at 1-2-58 Hriomachi, Shinagawa-ku, Tokyo 140-8710, Japan and on October ____, 2018 at Am Klopferspitz 19, 82152 Martinsried, Germany, in two (2) originals, each Party acknowledging receipt of one original.
Daiichi Sankyo Co., Ltd. | |
By: | /s/ Takashi Fukuoka |
Name: | Takashi Fukuoka |
Title: | Vice President, Venture Science Laboratories |
Immunic AG | |
By: | /s/ Dr. Daniel Vitt |
Name: | Dr. Daniel Vitt |
Title: | CEO |
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Exhibit 10.3
REDACTED | |
Certain identified information, indicated by [***], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. |
ASSET PURCHASE AGREEMENT
by and between
1. | 4SC AG , with registered seat at Am Klopferspitz 19a, 82152 Martinsried, Germany, registered in the commercial register of the local court of Munich under HRB 132917, represented by its management board [and supervisory board] |
- “ 4SC ” or “ Seller ” -
and
2. | Immunic AG (currently Blitz 16-571 AG) , with registered seat at Am Klopferspitz 19, 82152 Planegg-Martinsried, Germany, registered in commercial register of the local court of Munich under HRB 223333, represented by its management board [and supervisory board] |
- “ Immunic ” or “ Purchaser ” -
- 4SC and Immunic hereinafter also referred to as “ Parties ” and each as “ Party ” -
Table of Content
RECITALS | 3 | |
Section 1 | Option to the Sale and Transfer of Assets | 3 |
Section 2 | Sale and Transfer of Panoptes Agreements | 6 |
Section 3 | Option Right of Purchaser | 6 |
Section 4 | Excluded Assets and Agreements; No Transfer of Employment Relationships and No Transfer of Insurance Agreements | 7 |
Section 5 | Purchase Price | 7 |
Section 6 | Warranties | 13 |
Section 7 | Additional Provisions on Transfer of Sold Assets and Sold Agreements | 15 |
Section 8 | Non-Compete, Non-Solicitation, Confidentiality | 15 |
Section 9 | Miscellaneous | 16 |
RECITALS
WHEREAS, 4SC is an innovative biotech company with a strong focus on research and development listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
WHEREAS, 4SC discovers and develops targeted small molecule drugs for the treatment of cancer and autoimmune diseases in indications with a high unmet medical need and major economic potential. 4SC’s product pipeline comprises promising drug programs at various stages of clinical development, as well as early-stage research projects. Certain results of those research projects are the products [***] (collectively “ Sold Projects ”) which comprise a number of patents, patent applications, know-how and project related materials.
WHEREAS, 4SC (through the Seller’s 100% subsidiary 4SC Discovery GmbH) has entered into a Patent and Know How Assignment Agreement as well as a separate Patent License Agreement with Panoptes Pharma GmbH, each on July 2, 2013, in regards to certain know-how and patent rights relating to developing and commercializing the chemical compound [***] (collectively “ Panoptes Agreements ”). The Panoptes Agreements are attached hereto as Annex R .
WHEREAS, Immunic intends to acquire from 4SC and 4SC intends to sell to Immunic certain assets, in particular the Sold Projects, and related rights in accordance with the terms and conditions of this asset purchase agreement (hereinafter “ APA ”).
NOW THEREFORE, the Parties agree as follows:
Section 1
Option to the Sale and Transfer of Assets
1. | The Seller hereby sells to the Purchaser, with economic effect as from the date of payment of Tranche 1 (as defined in Section 5 below) (the “ Effective Date ”), the assets described in this Section para. 1 lit. (a) through lit. (c) irrespective of how they are shown in the balance sheets of the Seller and whether or not they have to be shown in such balance sheets (together the “ Sold Assets ”), if and to the extent the respective Sold Asset is owned by the Seller: |
(a) | The (i) rights to all patent applications and patents listed in Annex 1 hereto, and any and all reissues, substitutions, continuations, divisions, continuations-in-part applications, as well as patents granted on the aforementioned patent applications and/or patents and (ii) the right to apply for and register trademarks on the Sold Projects and/or Sold Assets (altogether “ Sold IP ”). |
(b) | Any and all know-how pertaining or relating exclusively to the Sold Projects as listed in Annex 2 hereto (altogether “ Sold Know-How ”). The term “know-how” includes but is not limited to all specifications, results and reports of preclinical and clinical studies and all other documentation containing any data relating to the application for regulatory approval and registrations dossiers. It shall further include secret and confidential information in tangible form, contained in documents, materials, correspondence and other records (whether in hardcopy or in electronic format), including process descriptions and operating instructions, all written research documents, tabulations, experimental reports, specimen, drawings and plans, as well as to all intangible information pertaining or relating exclusively to the Sold Projects. In case the tangible or intangible information does not pertain to the Sold Projects exclusively and cannot be easily separated, i.e. in case of laboratory notebook ( Laborjournale ), such information shall not be part of the Sold Know-How, but the Seller shall undertake all reasonable efforts to provide Purchaser with copies of the relevant information in the laboratory notebook relating to the Sold Projects to the extent that the Purchaser requires such information for the reasonable defense against third party claims or the reasonable enforcement of Sold-IP and/or Sold Know-How against third parties. The historic clinical studies, where, for the avoidance of doubt, the Seller remains official sponsor, shall also not be part of the Sold Know-How and solely para. 9 below shall apply to such studies and the information contained therein (collectively: the “ Historic Clinical Studies ”). |
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(c) | A copy of the existing quality management reports relating to the Sold Assets and Sold Projects as listed in Annex 3 . |
2. | Subject to Section 1 para. 6 below, the Seller hereby transfers to the Purchaser the ownership of all Sold Assets. To the extent the Seller only has an expectancy right ( Anwartschaftsrecht ) to the Sold Assets, the Seller hereby transfers to the Purchaser such expectancy rights to the Sold Assets. This transfer is particularly performed as follows: |
(a) | The Seller shall transfer to the Purchaser its possession of the tangible Sold Assets. To the extent that such Sold Assets are located on real estate or in buildings that are in the Seller’s possession, transfer of possession shall take place by performing such possession on behalf of Purchaser and by granting the Purchaser access to the respective real estate or buildings ( Besitzmittlungsverhältnis ) . |
(b) | All documents, materials and information which form part of the Sold Know-How shall be transferred to the Purchaser in the same way as described under lit. (a) above. The delivery of each of the documents shall be noted in a report that is established for this purpose and signed by both Parties. |
(c) | Seller shall procure that within 6 months after the Purchaser has exercised its option right set forth in Section 3 below, the intangible Sold Know-How is transferred to Purchaser as follows: Within such period, the Seller undertakes to introduce the Purchaser’s employees into the Sold Know-How. This introduction shall be provided in the form of meetings, taking place at the offices of Purchaser in Martinsried or any other venue agreed by the Parties, and shall be free of cost for Purchaser, to the extent that it does not exceed 24 man-days. For the avoidance of doubt, this introduction relates solely to data created prior to the Effective Date; any forward looking support or other services with respect to the future usage or development of the Sold Assets, except for the processing of the COMPONENT study data related to the Sold Projects to prepare an audit and inspection ready trial master file in accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) GCP (good clinical practice) guidelines, will be invoiced on the basis of service and/or development agreements yet to be concluded. The Parties acknowledge that Dr. Manfred Gröppel as main possessor of the intangible Sold Know-How is likely to join the Purchaser. |
3. | To the extent that Sold Assets are in possession of third parties, the Seller (i) hereby transfers to the Purchaser the Seller’s repossession claims, and (ii) if Seller’s repossession claim against any third party is not transferable, hereby undertakes to instruct the third party at issue in writing to hold possession of the relevant Sold Asset in its possession to the benefit of the Purchaser and to hand it over to the Purchaser upon the latter’s request. |
4. | If and to the extent further declarations have to be made or actions have to be taken to transfer any Sold Assets to the Purchaser, the Seller shall, to the extent reasonably required, make such declarations or take such actions without undue delay upon request of the Purchaser. Any and all costs and expenses in connection with the transfer of the Sold Assets to the Purchaser, in particular without limitation any and all fees and expenses of the patent offices, shall be borne by the Purchaser with the exception of (i) internal administration costs of the Seller and (ii) payments to be rendered under or in connection with the German Inventing Employee Act ( Gesetz über Arbeitnehmererfindungen ) with respect solely to the Sold Assets. |
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5. | Unless explicitly specified otherwise in this APA, the Parties assume that none of the Sold Assets is in the possession by anybody else than the Seller. If it turns out that such assumption is wrong, the Seller shall be obliged to transfer upon Purchaser’s request the possession of any such assets, rights or claims or to procure the transfer of the possession of any such assets, rights or claims to the Purchaser without undue delay and at no additional costs to the Purchaser. |
6. | The transfer of the Sold Assets to the Purchaser pursuant to paras. 2 to 5 above shall be subject to the condition precedent ( aufschiebende Bedingung ) of the payment of [***] . |
7. | The Purchaser shall, on a product-by-product basis, in case of a development of the Sold Projects [***] , for the registration of the transfer of the Sold IP regarding such product with the respective official registries (“IP Registration”). In the event that a third party takes legal action against, or relating to, the Sold IP, or Purchaser intends to take legal action against a third party based on the Sold IP, the Purchaser shall [***] apply for IP Registration of the Sold IP to the extent affected by such legal action, and shall use best efforts to procure that such third party acknowledges the Purchaser as party (as the case may be plaintiff or defendant) in a court of law or proceedings before a patent office. Should such third party not acknowledge the Purchaser as such party, Seller agrees to support Purchaser in such legal action as reasonably required, and Purchaser shall reimburse Seller [***] . In the event of a disposal of the Sold Assets in whole or in part (and individually or as part of a disposal of more than [***] of all assets of Purchaser), the Purchaser shall procure that the respective acquirer applies as soon as practicable, but in any event not later than six months after such disposal, for IP Registration of the Sold IP (in case of a partial disposal, to the extent that the Sold IP is disposed of). The Purchaser shall prepare and deliver all reasonably requested documentation and Seller shall give all reasonably requested declarations and make all necessary signatures that the Purchaser reasonably requires for the IP Registration, and Purchaser and Seller agree to promptly after the Effective Date transfer formal ownership in sold IP directly to Purchaser by separate agreements as in Annex X, as well as by preparation of forms and declarations which may be required by the respective official registries. The Purchaser shall bear all costs related to such registration. |
8. | The Purchaser undertakes to use commercially reasonable efforts to develop and commercialize, by itself or via licensees, the Sold Projects until market approval for at least one Product (as defined hereafter) in the European Union and the US, provided that, in the event of a disposal of the Sold Assets in whole or in part (and individually or as part of a disposal of more than [***] of all assets of Purchaser), the Purchaser shall use best efforts to procure that the respective acquirer agrees to assume the obligation in this para. 8 as well. |
9. | With effect as from the Effective Date and subject to the condition precedent ( aufschiebende Bedingung ) of the payment of [***] , the Seller hereby grants (i) a non-exclusive license for the use of the Historic Clinical Studies to the extent that they solely relate to the Sold Projects and (ii) a right of possession ( Besitzrecht ) of such studies (to the extent that such studies are in tangible form), both with the proviso that the Purchaser shall undertake all reasonable efforts to provide the Seller with copies of the relevant Historic Clinical Studies, and provide Seller access to the originals thereof, to the extent that the Seller requires such studies for (a) the reasonable defense against third party claims or (b) for any correspondence with public authorities (notably regulatory authorities), in particular to comply with information requests from such authorities. If Purchaser does not comply with its obligations under the preceding sentence, the Seller shall be entitled to terminate the aforementioned license for the use and the right of possession of the Historic Clinical Studies and request return of the Historic Clinical Studies. For the avoidance of doubt, the Seller retains ownership of any and all Historic Clinical Studies. |
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Section 2
Sale and Transfer of Panoptes Agreements
1. | The Seller hereby sells to the Purchaser the rights and obligations of the Seller arising out of the Patent License Agreement with Panoptes Pharma GmbH dated July 2, 2013 (the “ Sold Agreement ”) by way of assumption of contract with full discharge of the Seller ( Vertragsübernahme mit schuldbefreiender Wirkung ), to the extent that the Seller’s 100% subsidiary 4SC Discovery GmbH (“ 4SC Discovery ”) is counterparty to the Sold Agreement, with effect as from the Effective Date. For the avoidance of doubt, the rights and obligations arising out of the Patent and Know How Assignment Agreement with Panoptes Pharma GmbH dated July 2, 2013 are not sold and shall remain with the Seller / 4SC Discovery. |
2. | The sale pursuant to Section 2.1 extends to all present and future rights and obligations of the Seller under the Sold Agreement as from the Effective Date. |
3. | Subject to the condition precedent ( aufschiebende Bedingung ) of the payment of [***] , the Seller hereby transfers to the Purchaser, and the Purchaser hereby accepts the transfer of, the Sold Agreement in accordance with the provisions set forth above by way of an assumption of contract with full discharge of the Seller. The Purchaser acknowledges and agrees that the transfer of the Sold Agreement may require the consent of the respective contractual partners or of other third parties in order to become effective, and that the Seller does not guarantee in any way that such consents will be given. Section 7 below remains unaffected. |
4. | The Purchaser hereby assumes the Sold Agreement with the effect of fully discharging the Seller’s obligations ( Vertragsübernahme mit schuldbefreiender Wirkung ) subject to the condition precedent ( aufschiebende Bedingung ) of the payment of [***] , and, if required, any third party consent as set out in Section 7 below, and shall indemnify and hold harmless the Seller from and against [***] . |
5. | With effect as from the Effective Date, the Purchaser hereby assumes, and agrees to pay, perform and discharge when due, all liabilities and obligations arising from or under the Sold Agreement (whether actual or contingent, known or unknown). These liabilities are hereby assumed by the Purchaser with full discharge of the Seller ( mit schuldbefreiender Wirkung ) subject to the condition precedent ( aufschiebende Bedingung ) of the payment of [***] , and, if required, any third party consent as set out in Section 7 below; pending such consent, the Purchaser assumes these liabilities as direct debtor ( Schuldbeitritt ) . |
Section 3
Option Right of Purchaser
1. | The’ Purchaser shall be entitled to accept the sale and transfer of the Sold Assets and the Sold Agreement as set forth in Section 1 and Section 2 above by written declaration to be addressed to Seller by fax ((+49-89-700763-2600) or email (kathleen.masch-wiest@4sc.com ) until no later than [***] (“ Option Term ”). |
2. | In case the Purchaser does not fully accept the sale and transfer of the Sold Assets and the Sold Agreement as set forth in Section 1 and Section 2 within the Option Term, this APA in total shall become null and void, with the exception of Section 7 para. 4 sentence 2, Section 8 para. 2 and Section 9 below which shall survive any termination of this APA. |
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Section 4
Excluded Assets and Agreements; No Transfer of
Employment Relationships and No Transfer of Insurance Agreements
1. | The Seller does not sell and the Purchaser does not acquire any assets, agreements or offers that are not expressly referred to in Sections 1 and 2 above. |
2. | The Purchaser does not assume any obligations from the Seller unless these (i) are expressly referred to in this APA, (ii) result from the Sold Agreement or (iii) are directly attached to any Sold Asset. |
3. | The Parties assume that no obligations (of whatever nature) from the Seller vis-a-vis public authorities, administrative entities and other public entities, no matter in which jurisdiction, from or in connection with taxes or violations of legal provisions, will be transferred to the Purchaser by operation of law following the consummation of the transactions contemplated herein. If, contrary to the Parties’ assumption, any such obligation should be transferred to the Purchaser, the Seller shall indemnify and hold harmless the Purchaser from any such obligation and related costs incurred by the Purchaser. |
4. | The Parties assume that no employment relationships will be transferred to the Purchaser by operation of law following the consummation of the transactions contemplated herein. If, contrary to the Parties’ assumption, any employment relationship should be transferred to the Purchaser, the Seller shall indemnify and hold harmless the Purchaser from any costs, losses, expenses and/or other negative consequences resulting from such transfer of the respective employment relationships or the obligations towards any transferred employee unless the Purchaser explicitly agrees to assume such transferred employment relationship and continues to employ such transferred employee. However, given that Dr. Manfred Gröppel is considering joining the Purchaser in the course of, or following the consummation of the transactions contemplated herein, the Purchaser acknowledges that no liability of the Seller whatsoever shall result from the transfer of Dr. Manfred Gröppel’s employment relationship to the Purchaser. |
5. | The Parties assume that no insurance agreements will be transferred to the Purchaser by operation of law following the consummation of the transactions contemplated herein. If, contrary to the Parties’ assumption, any insurance agreements should be transferred to the Purchaser, the Seller shall indemnify and hold harmless the Purchaser from any costs, losses, expenses and/or other negative consequences resulting from such transfer or the obligations of the Purchaser towards the relevant insurance company unless the Purchaser is legally compelled to enter into such insurance or otherwise agrees to assume such transferred insurance agreements and continues such insurance agreements. |
Section 5
Purchase Price
1. | Subject to the condition precedent ( aufschiebende Bedingung ) that Purchaser accepts the sale and transfer of the Sold Assets and the Sold Agreement as set forth in Section 1 and Section 2 above in accordance with Section 3 above (the date of such acceptance the “ Exercise Date ”), Purchaser shall pay to Seller a purchase price consisting of the following components: |
(a) | [***] (“ Tranche 1 ”); |
(b) | [***] (“ Tranche 2 ”); |
(c) | an amount equal to [***] for a period ending upon [***] ; provided that the aforementioned percentage of the aggregate Net Sales is, on a country-by-country and product-by-product basis, reduced from [***] (“ Tranche 3 ”); and |
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(d) | a further amount equal to [***] . |
2. | “ Net Sales ” shall mean with respect to any substance and/or product that has been developed using Sold Assets or is covered by the Sold IP and/or Sold Know-How or is otherwise stemming from the Sold Projects (“ Product ”) for any period, the total (gross) amount billed or invoiced on sales of such Product during such period by (i) the Purchaser; (ii) its affiliates within the meaning of §§ 15 et seq. of the German Stock Corporation Act ( AktG ) (“ Affiliates ”) or (iii) licensees of the Purchaser and/or its Affiliates worldwide to third parties (including wholesalers) in bona fide arm’s length transactions, less the following deductions, in each case related specifically to the Product and actually allowed and taken by such third parties and not otherwise recovered by or reimbursed to the Purchaser, its Affiliates or their respective licensees: |
(i) | trade, cash and quantity discounts (other than price discounts granted at the time of invoicing which have been already included in the gross amount invoiced); |
(ii) | taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced (but not including taxes assessed against the income derived from such sale); |
(iii) | amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
(iv) | freight, insurance, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Product; |
(v) | cost of collections or for commissions paid to independent sales agencies of Purchaser, its Affiliates or their respective licensees; |
(vi) | deductions to gross invoice price of Product imposed by Regulatory Authorities or other governmental entities (where such deductions are imposed based on published and independently verifiable regulatory standards); and |
(vii) | standard inventory costs of devices or delivery systems sold as unit with the Product and used for dispensing or administering or delivering the Product, provided that they are directly related to the respective sold product. |
No deductions shall be made for the cost of collections or for commissions paid to regular employees of Purchaser, its Affiliates or their respective licensees.
If a Product is sold in form of a combination product, then Net Sales for such combination product shall be determined on a country-by-country basis by mutual agreement of the Parties in good faith taking into account the perceived relative value contributions of the Product and the other ingredient or component in the combination product, as reflected in their respective market prices. In case of disagreement, an independent expert agreed upon by both Parties within thirty (30) days following the first commercial sale in the specific country or, failing such agreement, an independent expert designated by the Industrie- und Handelskammer für München und Oberbayern at its earliest convenience, shall determine such relative value contributions and such determination shall be final and binding upon the Parties.
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If a Product is sold as part of a bundled transaction (i.e. a scenario in which a number of transactions for an assortment of goods, services, and intangibles are combined), the amount to be included in Net Sales shall be determined based on the pro rata allocation of the amount invoiced for all products included in such bundled transaction, based on the average per unit net sales price (calculated for the calendar quarter being reported) for such Product and the average per unit net sales price (calculated for the calendar quarter being reported) for every other product included in such bundled transaction and the number of units of Product and every other product included in such bundled transaction.
Net Sales shall not include transfers or dispositions for no profit, for charitable, promotional, evaluation, pre-clinical, clinical, regulatory, or governmental purposes or as commercial samples to the extent such transfers and dispositions are in line with international standards and applicable form. Net Sales shall include the amount or fair market value of all other consideration received by the Purchaser or its Affiliates or their respective licensees in respect of the Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among the Purchaser, its Affiliates, or their respective licensees. Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of the Purchaser, its Affiliates, or their respective licensees, which must be in accordance with IFRS or the generally accepted accounting principles as practiced in the United States (US-GAAP).
3. | “ Exit ” shall mean (i) any sale of more than [***] of all shares in the Purchaser in a single transaction or a series of related transactions to one or more third parties; (ii) the disposal (including by way of licenses) of in aggregate more than [***] of all assets of Purchaser to one or more third parties (according to their fair value and irrespective of whether such assets may be shown in the Purchaser’s financial statements under applicable generally accepted accounting principles); (iii) a share swap, contribution, merger, other transformation or take-over of Purchaser, if the shareholding in the new entity by the current shareholders of the Purchaser following the merger is less than 50 %; (iv) the liquidation of the Purchaser; or (v) the direct or indirect (via a holding company) listing of the Purchaser and/or the Purchaser’s shares and/or the public offering of the Purchaser’s shares or a secondary offering of the Purchaser’s shares on a stock exchange (the “ IPO ”); provided, however, that in the event that not all shares in or assets of the Purchaser are included in the Exit, then each subsequent sale, disposal, share swap, contribution, merger, other transformation or take-over of shares in or assets of the Purchaser not included in the initial Exit shall also be considered to be an “ Exit ” and the Seller shall be entitled [***] . The following shall be considered the “ Proceeds ”: (i) In case of a sale of shares in the Purchaser: The total purchase price received by the shareholders of the Purchaser as consideration for the relevant shares in the Purchaser; (ii) in case of a disposal of assets of the Purchaser: The total purchase price or other consideration (including upfront, milestone, earn-out and royalty payments) received by the Purchaser as consideration for the relevant assets of the Purchaser; (iii) in case of a share swap, contribution, merger, other transformation or take-over: The total number of shares of the receiving or surviving legal entity received by the shareholders of the Purchaser as consideration for the relevant shares in the Purchaser; (iv) in case of a liquidation: The cash proceeds resulting from the liquidation ( Liquidationserlös ) remaining after satisfaction of all liabilities of the Purchaser; and (v) in case of an IPO: The fully-diluted pre-money valuation of the Purchaser in such IPO. If and to the extent that the Proceeds do not consist of cash, but rather of a consideration in kind (e.g. shares), the Seller shall receive [***] in such consideration in kind and (in case of a mixed consideration, e.g. cash and shares) in the same ratio as the shareholders of the Purchaser, provided that [***] . With respect to the amount of any substituting payment in cash as well as in all other cases in which the value of a consideration in kind is relevant, to the extent that the consideration in kind consists of shares in companies listed on a stock exchange, the share price fixed at the stock exchange at the time and date that the transfer of the consideration in kind to the shareholders of the Purchaser takes effect shall be conclusive, and in all other cases, the fair market value of such consideration in kind at the time and date of the consummation of the Exit shall be conclusive, which shall be determined with binding effect on both Parties by the Purchaser’s auditor in accordance with the IDW-guidelines. In case of an !PO, the Seller shall receive [***] . |
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4. | The Tranches set forth in para. 1 above shall be due and payable as follows: |
(a) | Tranche 1 within [***] . |
(b) | Tranche 2 within [***] . |
(c) | Tranche 3 shall be paid [***] . |
(d) | Tranche 4 within [***] . |
5. | Each payment on Tranche 3 or Tranche 4 shall be accompanied by a statement from the Purchaser in sufficient detail to allow for the calculation of the payments due hereunder, [***] . |
6. | Each of the Tranches set forth in para. 1 above shall be transferred to the following account of Seller: [***] |
7. | Any payments to be made under this APA shall be made in EUR free of costs and charges by irrevocable wire transfer of immediately available funds. |
8. | Unless otherwise provided herein, each of the Parties shall pay interest on any amounts becoming due and payable to the other Party under this APA as from [***] . |
9. | No Party shall be entitled to |
(a) | set-off any rights and claims it may have against the other Party, against any rights or claims which the other Party may have under or in connection with this APA, or |
(b) | refuse to perform any obligation it may have under or in connection with this APA on the grounds that it has a right of retention, |
except as (i) explicitly permitted herein or (ii) except for claims undisputed by the respective other Party or (iii) in respect of claims resulting from a final and non-appealable court judgement or court settlement or by a final arbitral award obtained in accordance with this APA.
10. | Until [***] , the Purchaser shall, and the Purchaser shall procure that its Affiliates and their respective licensees, maintain complete and accurate books and records of account, in accordance with generally accepted accounting principles, of all transactions and other business activities relevant for the payments under this APA, sufficient to confirm the accuracy of all reports and payments furnished by Purchaser to Seller under this Section 5. Upon Seller’s written notice to Purchaser, during normal business hours and not more than once every calendar year, a certified public accountant designated by Seller and reasonably acceptable to Purchaser shall have the right to audit such books and records of account of the Purchaser, its Affiliates and their respective licensees (provided always that such certified public accountant enters into an appropriate confidentiality agreement with Purchaser and its Affiliates), in order to confirm the accuracy and completeness of all such reports and all such payments. Such certified public accountant may disclose to Seller only whether such reports and payments are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Seller. Seller shall bear all costs and expenses incurred by it in connection with any such audit; [***] . |
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11. | In the event of a disposal of the Sold Assets by the Purchaser to a third party in whole or in part (and individually or as part of a disposal of more than [***] of all assets of Purchaser), the Purchaser shall procure that the acquirer assumes all of the obligations of Purchaser under this APA, in particular without limitation the obligations to pay the purchase price under this Section 5 and the book keeping and auditing obligations under para. 10 above, it being understood that for the obligations of the Purchaser under Section 1 para. 8, only Section 1 para. 8 shall be relevant; following such disposal of the Sold Assets, any reference to the Purchaser, its Affiliates and their respective licensees in this Section 5, in particular without limitation in the definition of Net Sales, shall henceforth refer to such acquirer, its Affiliates and their respective licensees mutatis mutandis. The same shall apply in the event of a universal transaction ( Gesamtrechtsnachfolge ) . |
12. | In addition to the purchase price, the Purchaser shall reimburse the Seller for [***] . The relevant costs and expenses up to the date hereof are set forth in Annex 4 hereto, and the further costs and expenseS incurred after the date hereof up until the Effective Date shall be agreed upon by the Purchaser in advance and documented by the Seller in the same format and submitted to the Purchaser as of the Effective Date. Such reimbursement shall be due and payable concurrently with Tranche 1, i.e. the Purchaser shall not be obligated to reimburse the Seller in case it does not accept the sale and transfer of the Sold Assets and Sold Projects pursuant to Section 3. |
13. | All payments due to the terms of this APA are expressed to be exclusive of VAT or similar indirect taxes (e.g. goods and service tax). VAT/indirect taxes shall be added to the payments due to the terms of this APA if legally applicable. Withholding taxes, if any, shall be borne by Seller. |
Section
6
Warranties
1. | The Seller hereby represents and warrants in the form of independent undertakings pursuant to § 311 para. 1 German Civil Code ( selbständiges Garantieversprechen gem. § 311 Abs. 1 BGB ) to the Purchaser that the statements set forth in this Section 6 para. 1 (collectively “ Warranties ” and each a “ Warranty ”) are true and correct as of the date hereof: |
(a) | The Seller does validly exist under the law of the Federal Republic of Germany. The execution and performance by the Seller of this APA are within the Seller’s power and authority, do not violate the articles of association or |
by-laws of the Seller and have been duly authorized by all necessary corporate and other actions and required approvals on the part of the Seller.
(b) | The execution and performance of this APA by the Seller require no approval or consent by any governmental authority and do not violate any applicable law or decision by any court or governmental authority binding on the Seller. |
(c) | The Seller is the lawful owner of the Sold Assets. The Seller is fully entitled to transfer the Sold Assets which are free and clear of any liens, encumbrances or any other third party rights, in particular the assets are not subject to any pledges or other security rights of any third party and have not been subject to any execution proceedings ( Zwangsvollstreckung ), unless explicitly disclosed in Section 1 para. 1. The Seller has not granted any license with regard to the Sold Assets to any third party. |
(d) | To the knowledge of the Seller, none of the Sold IP is subject to any judgment, injunction, order or decree which materially restricts the use thereof and no third party has challenged or threatened to challenge any Sold IP. The Seller does not know of, or of any basis for, any claim for revocation, amendment, opposition or rectification or any challenge to ownership or entitlement in respect of any of the Sold IP. The Seller has not licensed any intellectual property rights necessary for the exploitation of the Sold Projects from any third parties. The Seller explicitly does not provide any representation and warranty as to the patentability or validity of any of the Sold IP, for the commercial exploitability or the fitness for any purpose of any of the Sold IP and for the non-infringement of any third party right by any of the Sold IP or its use. |
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(e) | To the knowledge of the Seller, Seller has undertaken all appropriate means to keep the Sold Know-How secret, in particular by concluding appropriate confidentiality agreements and by limiting the access to the Sold Know-How to the personal/third party contractors to the extent reasonably required. |
(f) | Seller is not aware of any circumstances that have infringed the confidentiality of the Sold Know-How. |
(g) | The Seller explicitly does not provide any representation and warranty as to the confidentiality of the Sold Know-How, for the commercial exploitability or the fitness for any purpose of any of the Sold Know-How and for the non-infringement of any third party right by the use of the Sold Know-How. |
2. | If and to the extent that any of the Warranties is incorrect, the Seller shall be liable to put the Purchaser into the same position the Purchaser would be in, had the respective Warranty been correct or had the respective breach not occurred ( Naturalrestitution ) . If and to the extent that the Seller fails to put the Purchaser into the position it would be in without such breach of Warranty within one month from notification of such breach, the Purchaser shall be entitled to claim monetary damages in cash ( Schadensersatz in Geld ) . |
3. | Any claims of the Purchaser pursuant to the afore-mentioned para. 2 (the “ Warranty Claims ”) shall be limited as follows: |
(a) | Warranty Claims arising from a breach of Warranty pursuant to para. 1 lit. (a) through lit. (c) (including) above (collectively “ Title Warranties ”) shall become time-barred under the statute of limitations ( verjähren ) three years after the Exercise Date. The limitation period ( Verjährungsfrist ) for all other Warranty Claims shall be 18 months after the Exercise Date. |
(b) | The Seller shall not be liable for any Warranty Claims unless and until the amount of the individual Warranty Claim exceeds [***] (the “ De Minimis Amount ”) and unless and until the aggregate amount of all Warranty Claims which individually exceed the De Minimis Amount exceeds [***] , in which event all of such Warranty Claims which individually exceed the De Minimis Amount shall be recoverable under this APA. |
(c) | The total liability of the Seller for any and all Warranty Claims shall in the aggregate be limited to an amount equal to [***] of the amounts actually received by the Seller as purchase price under Section 5 above, except for any and all Warranty Claims related to the breach of any of the Title Warranties that shall be limited to an amount of [***] of the amounts actually received by the Seller as purchase price under Section 5 above. |
(d) | The Purchaser may not assert Warranty Claims if and to the extent that it had knowledge of the facts or circumstances on which the claim is based when this APA was concluded. § 442 (1) sentence 2 German Civil Code ( BGB ) and § 377 German Commercial Code ( HGB ) shall not apply. A possible knowledge of Dr. Manfred Gröppel shall neither be attributed ( zugerechnet ) to the Purchaser nor to the Seller within this Section 6. |
(e) | Warranty Claims may only be asserted against the Seller once for one and the same loss, even if this arises from a breach of more than one Warranty. |
(f) | Moreover, the Seller shall not be liable to the extent that (i) the Purchaser failed to fulfil its duty to avoid or mitigate the loss pursuant to § 254 German Civil Code ( BGB ), or (ii) the Warranty Claim is attributable to an amendment to legal provisions which was made after this APA was signed. |
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4. | The Parties agree that the rights and remedies which the Purchaser may have in relation to Warranty Claims are limited to the rights and remedies expressly provided for in this APA which shall apply in lieu of all other rights and remedies that would be available to the Purchaser under statutory law in relation to Warranty Claims. Except as expressly provided for otherwise in this APA, any and all other rights and remedies of any legal nature which the Purchaser may have against the Seller with respect to Warranty Claims shall be hereby expressly waived and excluded, in particular, without limitation, any statutory rights and remedies based on a breach of a representation and warranty as well as claims based on a frustration of contract ( Störung der Geschäftsgrundlage , § 313 German Civil Code ( BGB )), voidance of the APA ( Anfechtung ), rescission of the APA ( Rücktritt ), reduction of the purchase price ( Minderung ), supplementary performance ( Nacherftüllung ) and other claims for defects according to § 437 German Civil Code ( BGB ), compensation for expenses ( Aufwendungsersatz ), culpa in contrahendo ( Verschulden bei Vertragsverhandlungen , § 311 German Civil Code ( BGB )), breach of contract (§§ 280 to 282 German Civil Code ( BGB )) and rights and remedies based on tort (§§ 823 et seq. German Civil Code ( BGB )) . For the avoidance of doubt, the Seller’s liability is not excluded or limited with respect to claims for willful misconduct ( Vorsatz ) and willful deceit ( arglistige Täuschung ). |
5. | Except as expressly provided for otherwise in this APA, the Warranties shall be exhaustive and the Seller does not assume any express or implied guarantees, representations, warranties, indemnities or similar instruments of any kind in addition to the Warranties. |
Section 7
Additional Provisions on Transfer of Sold Assets and Sold Agreements
1. | If the transfer of any Sold Assets or the Sold Agreement (including obligations) hereunder depends on the consent of a third party, the Parties shall cooperate in good faith and jointly endeavor to obtain such consent without undue delay; in this context the Parties shall disclose to the third party the scope according to which the Purchaser assumes the rights and obligations of the Seller. |
2. | Until the required consent pursuant to para. 1 above has been obtained in relation to any Sold Asset or the Sold Agreement, the Parties shall, to the extent legally permissible, treat each other with effect from the Effective Date as if the transfer of the Sold Asset or Sold Agreement hereunder had already become effective as of the Effective Date. Consequently, until such consent is given, the Seller shall, via its 100% subsidiary 4SC Discovery, act vis-à-vis third parties ( im Auβenverhältnis ) as owner of the relevant asset, party to the relevant agreement or offer, or debtor of the relevant obligation, as the case may be, but shall, to the extent legally permissible, in the internal relationship with the Purchaser ( im Innenverhältnis ) act for the Purchaser’s account, but only in accordance with and on the prior written instruction of Purchaser. Consequently, with effect as from the Effective Date, the Purchaser shall indemnify and hold harmless the Seller from and against any and all costs, losses, proceedings, claims, demands and expenses resulting from or relating to the relevant Sold Agreement as the Seller may reasonably require. |
3. | The Purchaser acknowledges that Panoptes Pharma GmbH has signaled that it will not grant its consent to the transfer to the Sold Agreement, that therefore a transfer of the Sold Agreement will probably not be possible, and that the Sold Agreement does not encompasses the possibility to grant a sub-license or to otherwise transfer the license granted thereunder to a third party. |
4. | The Seller shall procure that its 100% subsidiary 4SC Discovery does not terminate the Sold Agreement unless there is good cause ( wichtiger Grund ), and furthermore that a potential acquirer of 4SC Discovery also assumes the Seller’s obligations under this APA if and to the extent that they relate solely to 4SC Discovery. |
5. | Until the expiry of the Option Term, Seller shall reasonably participate in and support the due diligence process of Purchaser and its advisors in regard to the Sold Assets or Sold Agreement and any and all rights and obligations pertaining to them in order to facilitate a financing of Purchaser. Any reasonable out-of-pocket expenses, in particular travel expenses, of the Seller resulting therefrom shall be reimbursed by the Purchaser, provided that Purchaser has granted its prior approval to such expenses. |
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Section 8
Non-Compete, Non-Solicitation, Confidentiality
1. | For a period of [***] following the Effective Date the Seller shall refrain, and shall procure that its Affiliates refrain, from engaging, itself or through Affiliates, in research and/or development activities as well as service activities in the field of [***] (any of such business activities a “ Competing Activity ”), provided that any other research and/or development activities as well as service activities, in particular, without limitation, the service activities performed by the Seller or any of its Affiliates at the date of this APA, shall not be deemed a Competing Activity, and further provided that, for the avoidance of doubt, Panoptes Pharma GmbH shall not be considered an Affiliate for the purposes of this Section 8 and any activities conducted by Panoptes Pharma GmbH shall not be a Competing Activity; |
2. | In the case of a breach by the Seller of the obligations set forth in para. 1 above, the damages and losses of the Purchaser for which the Seller shall be liable as a result thereof shall include any damages suffered by Purchaser or any of its Affiliates. In addition to any other remedies available to the Purchaser under this APA or applicable law, the Seller, as the case may be, shall pay to the Purchaser irrespective of fault a penalty of [***] for each individual breach by the Seller, as the case may be, of any of its obligations set out in para. 1 above. If a breach continues for more than ten business days, such continuation shall be regarded as a new and separate breach within the meaning of this para. 2. The Purchaser shall not be deemed to have waived the requirement of the Seller, and the Seller shall not be deemed to be relieved of its obligation, to comply with the obligations of para. 1 above by the Purchaser accepting payment of such penalty or seeking any other remedy available to which the Purchaser may be entitled under this APA or applicable law. |
3. | For a period of [***] the Seller shall refrain, and shall procure that its Affiliates refrain, from soliciting or attempting to solicit the employment of [***] as future director, officer or key employee of Purchaser, it being understood that the Seller’s right to enter into service agreements with [***] as (external) advisor or consultant shall remain unaffected. |
4. | The Seller shall keep the Sold Know-How confidential during the Option Term and after the Exercise Date, unless otherwise provided in this APA. The Seller undertakes to exercise all reasonable efforts to ensure that the duty of confidentiality regarding the Sold Know-How laid down in this APA is observed by all its Affiliates and all its employees. |
5. | Each Party undertakes to maintain secrecy of the confidential information and the confidential know-how disclosed by the other Party before the Effective Date and shall only use this information for the purpose of this APA. Each Party shall be allowed to disclose confidential information of the other Party to its employees, senior executives or advisers and its subsidiaries only if and to the extent to which these employees, senior executives, advisers and subsidiaries need to know this information for the purpose of this APA. The Parties undertake to exercise all necessary efforts to ensure that the duty of confidentiality laid down in this APA are observed by such employees, senior executives, advisers or subsidiaries. |
6. | The Parties understand and agree that in the case of a breach by the Seller of its obligations in this Section 8, the remedies available to the Purchaser under this APA may not be sufficient to indemnify the Purchaser fully against all damage, and that therefore the Purchaser shall be entitled to enforce any claims for specific performance ( Unterlassungs- and Beseitigungsansprüche ) by injunctive relief ( einstweiliger Rechtsschutz ) . |
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Section 9
Miscellaneous
1. | The Parties are aware and agree that the transfer of the Sold Assets is subject to German law. This APA shall be interpreted exclusively consistent with German law and usage of terminology. This includes, without limitation, the legal concepts and terms contained in this APA, the English translations of which may not be identical with the original German terms in their respective legal understanding. |
2. | Should any provision of this APA, or any provision incorporated into this APA in the future, be or become invalid or unenforceable, the validity or enforceability of the other provisions of this APA shall not be affected thereby. The invalid or unenforceable provision shall be deemed to be substituted by a suitable and equitable provision which, to the extent legally permissible, comes as close as possible to the intent and purpose of the invalid or unenforceable provision. The same shall apply if (i) the Parties have unintentionally failed to address a certain matter in this APA ( Regelungslücke ); in this case a suitable and equitable provision shall be deemed to have been agreed upon which comes as close as possible to that the Parties, in light of the intent and purpose of this APA, would have agreed upon if they had considered the matter; or (ii) any provision of this APA is invalid because of the scope of any time period or performance stipulated herein; in this case the Parties shall be deemed to have agreed upon a legally permissible time period or performance which comes as close as possible to the stipulated time period or performance. |
Planegg-Martinsried, this __May 15, 2016
/s/ Enno Spillner Vorstand | /s/ Manfried Groeppel |
4SC AG CEO |
Immunic AG COO |
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Exhibit 10.4
IMMUNIC, INC.
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (“ Agreement ”) is made as of [______], by and between Immunic, Inc., a Delaware corporation (the “ Company ”), and [______] (“ Indemnitee ”). This Agreement supersedes and replaces any and all previous Agreements between the Company and Indemnitee covering the subject matter of this Agreement.
WHEREAS , the Company and Indemnitee recognize the significant cost of directors’ and officers’ liability insurance and the general reductions in the coverage of such insurance;
WHEREAS , the Company and Indemnitee further recognize the substantial increase in corporate litigation in general, subjecting officers and directors to expensive litigation risks at the same time as the coverage of liability insurance has been severely limited;
WHEREAS , the Company desires to attract and retain the services of highly qualified individuals, such as Indemnitee, to serve as officers and directors of the Company and to indemnify its officers and directors so as to provide them with the maximum protection permitted by law;
WHEREAS , it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, qualified individuals such as Indemnitee to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified;
WHEREAS , this Agreement is a supplement to and in furtherance of the Bylaws and Certificate of Incorporation of the Company and any resolutions adopted pursuant thereto, and shall not be deemed to substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder; and
WHEREAS , Indemnitee does not regard the protection available under the Bylaws and Certificate of Incorporation of the Company and insurance as adequate in the present circumstances, and may not be willing to serve as an officer or director without adequate protection, and the Company desires Indemnitee to serve in such capacity. Indemnitee is willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that he be so indemnified.
NOW, THEREFORE , in consideration for Indemnitee’s services as an officer or director of the Company, the Company and Indemnitee hereby agree as follows:
1. Definitions.
(a) A “ Change in Control ” shall be deemed to occur upon the earliest to occur after the date of this Agreement of any of the following events:
(i) Acquisition of Stock by Third Party. Any Person (as defined below becomes the Beneficial Owner (as defined below), directly or indirectly, of securities of the Company representing fifteen percent (15%) or more of the combined voting power of the Company’s then outstanding securities unless the change in relative Beneficial Ownership of the Company’s securities by any Person results solely from a reduction in the aggregate number of outstanding securities entitled to vote generally in the election of directors;
(ii) Change in Board Composition. During any period of two consecutive years (not including any period prior to the execution of this Agreement), individuals who at the beginning of such period constitute the Company’s board of directors, and any new directors (other than a director designated by a person who has entered into an agreement with the Company to effect a transaction described in Sections 1(a)(i), 1(a)(iii) or 1(a)(iv)) whose election by the board of directors or nomination for election by the Company’s stockholders was approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved, cease for any reason to constitute at least a majority of the members of the Company’s board of directors;
(iii) Corporate Transactions. The effective date of a merger or consolidation of the Company with any other entity, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than 50% of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation and with the power to elect at least a majority of the board of directors or other governing body of such surviving entity;
(iv) Liquidation. The approval by the stockholders of the Company of a complete liquidation of the Company or an agreement for the sale or disposition by the Company of all or substantially all of the Company’s assets; and
(v) Other Events. Any other event of a nature that would be required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or in response to any similar item on any similar schedule or form) promulgated under the Securities Exchange Act of 1934, as amended, whether or not the Company is then subject to such reporting requirement.
For purposes of this Section 1(a), the following terms shall have the following meanings:
(1) “ Person ” shall have the meaning as set forth in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended; provided, however, that “ Person ” shall exclude (i) the Company, (ii) any trustee or other fiduciary holding securities under an employee benefit plan of the Company, and (iii) any corporation owned, directly or indirectly, by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company.
(2) “ Beneficial Owner ” shall have the meaning given to such term in Rule 13d-3 under the Securities Exchange Act of 1934, as amended; provided, however, that “ Beneficial Owner ” shall exclude any Person otherwise becoming a Beneficial Owner by reason of (i) the stockholders of the Company approving a merger of the Company with another entity or (ii) the Company’s board of directors approving a sale of securities by the Company to such Person.
(b) “ Corporate Status ” describes the status of a person who is or was a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise.
(c) “ DGCL ” means the General Corporation Law of the State of Delaware.
(d) “ Disinterested Director ” means a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee.
(e) “ Enterprise ” means the Company and any other corporation, partnership, limited liability company, joint venture, trust, employee benefit plan or other enterprise of which Indemnitee is or was serving at the request of the Company as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary.
(f) “ Expenses ” include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees and costs of experts and other professionals, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and federal, state, local or foreign taxes imposed on Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement, ERISA excise taxes and penalties, and all other disbursements or expenses of the types customarily incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, being or preparing to be a witness in, or otherwise participating in, a Proceeding. Expenses also include (i) Expenses incurred in connection with any appeal resulting from any Proceeding, including without limitation the premium, security for, and other costs relating to any cost bond, supersedeas bond or other appeal bond or their equivalent, and (ii) for purposes of Section 12(d), Expenses incurred by Indemnitee in connection with the interpretation, enforcement or defense of Indemnitee’s rights under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company. The parties agree that for the purposes of any advancement of Expenses for which Indemnitee has made written demand to the Company in accordance with this Agreement, all Expenses included in such demand that are certified by affidavit of Indemnitee’s counsel as being reasonable shall be presumed conclusively to be reasonable. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of judgments or fines against Indemnitee.
(g) “ Independent Counsel ” means a law firm, or a partner or member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five years has been, retained to represent (i) the Company or Indemnitee in any matter material to either such party (other than as Independent Counsel with respect to matters concerning Indemnitee under this Agreement, or other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the foregoing, the term “ Independent Counsel ” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the reasonable fees and expenses of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
(h) “ Proceeding ” means any threatened, pending or completed action, suit, claim, counterclaim, cross claim, arbitration, mediation, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether brought in the right of the Company or otherwise and whether of a civil, criminal, administrative, legislative or investigative (formal or informal) nature, including any appeal therefrom and including without limitation any such Proceeding pending as of the date of this Agreement, in which Indemnitee was, is or will be involved as a party, a potential party, a non-party witness or otherwise by reason of (i) the fact that Indemnitee is or was a director or officer of the Company, (ii) any action taken by Indemnitee or any action or inaction on Indemnitee’s part while acting as a director or officer of the Company, or (iii) the fact that he or she is or was serving at the request of the Company as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, in each case whether or not serving in such capacity at the time any liability or Expense is incurred for which indemnification or advancement of expenses can be provided under this Agreement. If the Indemnitee believes in good faith that a given situation may lead to or culminate in the institution of a Proceeding, this shall be considered a Proceeding under this paragraph.
(i) Reference to “ other enterprises ” shall include employee benefit plans; references to “ fines ” shall include any excise taxes assessed on a person with respect to any employee benefit plan; references to “ serving at the request of the Company ” shall include any service as a director, officer, employee or agent of the Company which imposes duties on, or involves services by, such director, officer, employee or agent with respect to an employee benefit plan, its participants or beneficiaries; and a person who acted in good faith and in a manner he or she reasonably believed to be in the best interests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “ not opposed to the best interests of the Company ” as referred to in this Agreement.
2. Indemnity in Third-Party Proceedings. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 2 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding, other than a Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 2, Indemnitee shall be indemnified to the fullest extent permitted by applicable law against all Expenses, judgments, fines and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses, judgments, fines and amounts paid in settlement) actually and reasonably incurred by Indemnitee or on his or her behalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Company and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was unlawful. The parties hereto intend that this Agreement shall provide to the fullest extent permitted by law for indemnification in excess of that expressly permitted by statute, including, without limitation, any indemnification provided by the Certificate of Incorporation, the Bylaws, vote of its stockholders or disinterested directors or applicable law.
3. Indemnity in Proceedings by or in the Right of the Company. The Company shall indemnify Indemnitee in accordance with the provisions of this Section 3 if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding by or in the right of the Company to procure a judgment in its favor. Pursuant to this Section 3, Indemnitee shall be indemnified to the fullest extent permitted by applicable law against all Expenses and, to the fullest extent permitted by law, amounts paid in settlement actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection with such Proceeding or any claim, issue or matter therein, if Indemnitee acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Company. No indemnification shall be made under this Section 3 in respect of any claim, issue or matter as to which Indemnitee shall have been adjudged by a court of competent jurisdiction to be liable to the Company, unless and only to the extent that the Delaware Court of Chancery or any court in which the Proceeding was brought shall determine upon application that, despite the adjudication of liability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnification for such expenses as the Delaware Court of Chancery or such other court shall deem proper.
4. Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any other provisions of this Agreement, to the fullest extent permitted by applicable law and to the extent that Indemnitee is a party to or a participant in and is successful (on the merits or otherwise) in defense of any Proceeding or any claim, issue or matter therein, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith. To the extent permitted by applicable law, if Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, in defense of one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf, to the fullest extent permitted by law, in connection with (a) each successfully resolved claim, issue or matter and (b) any claim, issue or matter related to any such successfully resolved claim, issuer or matter. For purposes of this section, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
5. Indemnification for Expenses of a Witness. Notwithstanding any other provisions of this Agreement, to the fullest extent permitted by applicable law and to the extent that Indemnitee is, by reason of his or her Corporate Status, a witness or otherwise asked to participate in any Proceeding to which Indemnitee is not a party, Indemnitee shall be indemnified to the extent permitted by applicable law against all Expenses actually and reasonably incurred by Indemnitee or on Indemnitee’s behalf in connection therewith.
6. Additional Indemnification.
(a) Notwithstanding any limitation in Sections 2, 3 or 4, the Company shall indemnify Indemnitee to the fullest extent permitted by applicable law if Indemnitee is, or is threatened to be made, a party to or a participant in any Proceeding (including a Proceeding by or in the right of the Company to procure a judgment in its favor) against all Expenses, judgments, fines and amounts paid in settlement (including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses, judgments, fines and amounts paid in settlement) actually and reasonably incurred by Indemnitee or on his or her behalf in connection with the Proceeding or any claim, issue or matter therein.
(b) For purposes of Section 6(a), the meaning of the phrase “ to the fullest extent permitted by applicable law ” shall include, but not be limited to:
(i) the fullest extent permitted by the provision of the DGCL that authorizes or contemplates additional indemnification by agreement, or the corresponding provision of any amendment to or replacement of the DGCL; and
(ii) the fullest extent authorized or permitted by any amendments to or replacements of the DGCL adopted after the date of this Agreement that increase the extent to which a corporation may indemnify its officers and directors.
7. Exclusions. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnity in connection with any Proceeding (or any part of any Proceeding):
(a) for which payment has actually been made to or on behalf of Indemnitee under any statute, insurance policy, indemnity provision, vote or otherwise, except with respect to any excess beyond the amount paid under any insurance policy or other indemnity provision;
(b) for an accounting or disgorgement of profits pursuant to Section 16(b) of the Securities Exchange Act of 1934, as amended, or similar provisions of federal, state or local statutory law or common law, if Indemnitee is held liable therefor (including pursuant to any settlement arrangements);
(c) for any reimbursement of the Company by Indemnitee of any bonus or other incentive-based or equity-based compensation or of any profits realized by Indemnitee from the sale of securities of the Company, as required in each case under the Securities Exchange Act of 1934, as amended (including any such reimbursements that arise from an accounting restatement of the Company pursuant to Section 304 of the Sarbanes-Oxley Act of 2002 (the “ Sarbanes-Oxley Act ”), or the payment to the Company of profits arising from the purchase and sale by Indemnitee of securities in violation of Section 306 of the Sarbanes-Oxley Act), if Indemnitee is held liable therefor (including pursuant to any settlement arrangements);
(d) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company or its directors, officers, employees, agents or other indemnitees, unless (i) the Company’s board of directors authorized the Proceeding (or the relevant part of the Proceeding) prior to its initiation, (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law, (iii) otherwise authorized in Section 12(d) or (iv) otherwise required by applicable law; or
(e) if prohibited by applicable law.
8. Advances of Expenses. The Company shall advance, the Expenses incurred by Indemnitee in connection with any Proceeding (or any part of any Proceeding), and such advancement shall be made as soon as reasonably practicable, but in any event no later than 30 days, after the receipt by the Company of a written statement or statements requesting such advances from time to time, whether prior to or after final disposition of any Proceeding (which (a) shall include invoices received by Indemnitee in connection with such Expenses but, in the case of invoices in connection with legal services, any references to legal work performed or to expenditure made that would cause Indemnitee to waive any privilege accorded by applicable law shall not be included with the invoice, and (b) contain the affirmation required by Section 9(a)). Advances shall be unsecured and interest free and made without regard to Indemnitee’s ability to repay such advances and without regard to Indemnitee’s ultimate entitlement to indemnification under the other provisions of this Agreement. Indemnitee hereby undertakes to repay any advance to the extent that it is ultimately determined that Indemnitee is not entitled to be indemnified by the Company. No other form of undertaking shall be required other than the execution of this Agreement. This Section 8 shall not apply to the extent advancement is prohibited by law and shall not apply to any Proceeding for which indemnity is not permitted under this Agreement, but shall apply to any Proceeding referenced in Section 7(b) or 7(c) prior to a determination that Indemnitee is not entitled to be indemnified by the Company.
9. Procedures for Notification and Defense of Claim.
(a) Indemnitee shall notify the Company in writing of any matter with respect to which Indemnitee intends to seek indemnification or advancement of Expenses as soon as reasonably practicable following the receipt by Indemnitee of notice thereof. The written notification to the Company shall include, a description of the nature of the Proceeding and the facts underlying the Proceeding. The failure by Indemnitee to notify the Company will not relieve the Company from any liability which it may have to Indemnitee hereunder or otherwise than under this Agreement, and any delay in so notifying the Company shall not constitute a waiver by Indemnitee of any rights.
(b) If, at the time of the receipt of a notice of a Proceeding pursuant to the terms hereof, the Company has directors’ and officers’ liability insurance in effect, the Company shall give prompt notice of the commencement of the Proceeding to the insurers in accordance with the procedures set forth in the applicable policies. The Company shall thereafter take all necessary and desirable action to cause such insurers to pay, on behalf of Indemnitee, all amounts payable as a result of such Proceeding in accordance with the terms of such policies.
10. Procedures upon Application for Indemnification.
(a) To obtain indemnification, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and as is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification following the final disposition of the Proceeding. The Company shall, as soon as reasonably practicable after receipt of such a request for indemnification, advise the board of directors that Indemnitee has requested indemnification. Any delay in providing the request will not relieve the Company from its obligations under this Agreement.
(b) Upon written request by Indemnitee for indemnification pursuant to Section 10(a), a determination, if required by applicable law, with respect to Indemnitee’s entitlement thereto shall be made in the specific case (i) if a Change in Control shall have occurred, by Independent Counsel in a written opinion to the Company’s board of directors, a copy of which shall be delivered to Indemnitee or (ii) if a Change in Control shall not have occurred, (A) by a majority vote of the Disinterested Directors, even though less than a quorum of the Company’s board of directors, (B) by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors, even though less than a quorum of the Company’s board of directors, (C) if there are no such Disinterested Directors or, if such Disinterested Directors so direct, by Independent Counsel in a written opinion to the Company’s board of directors, a copy of which shall be delivered to Indemnitee or (D) if so directed by the Company’s board of directors, by the stockholders of the Company. If it is determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made within ten days after such determination. Indemnitee shall cooperate with the person, persons or entity making the determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information that is not privileged or otherwise protected from disclosure and that is reasonably available to Indemnitee and reasonably necessary to such determination. Any costs or expenses (including attorneys’ fees and disbursements) reasonably incurred by Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom. The Company promptly will advise Indemnitee in writing with respect to any determination that Indemnitee is or is not entitled to indemnification, including a description of any reason or basis for which indemnification has been denied.
(c) In the event the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 10(b), the Independent Counsel shall be selected as provided in this Section 10(c). If a Change in Control shall not have occurred, the Independent Counsel shall be selected by the Company’s board of directors, and the Company shall give written notice to Indemnitee advising him or her of the identity of the Independent Counsel so selected. If a Change in Control shall have occurred, the Independent Counsel shall be selected by Indemnitee (unless Indemnitee shall request that such selection be made by the Company’s board of directors, in which event the preceding sentence shall apply), and Indemnitee shall give written notice to the Company advising it of the identity of the Independent Counsel so selected. In either event, Indemnitee or the Company, as the case may be, may, within ten days after such written notice of selection shall have been given, deliver to the Company or to Indemnitee, as the case may be, a written objection to such selection; provided , however , that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 1 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If such written objection is so made and substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court has determined that such objection is without merit. If, within 20 days after the later of (i) submission by Indemnitee of a written request for indemnification pursuant to Section 10(a) hereof and (ii) the final disposition of the Proceeding, the parties have not agreed upon an Independent Counsel, either the Company or Indemnitee may petition a court of competent jurisdiction for resolution of any objection which shall have been made by the Company or Indemnitee to the other’s selection of Independent Counsel and for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel under Section 10(b) hereof. Upon the due commencement of any judicial proceeding or arbitration pursuant to Section 12(a) of this Agreement, the Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing).
(d) The Company agrees to pay the reasonable fees and expenses of any Independent Counsel and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
11. Presumptions and Effect of Certain Proceedings.
(a) In making a determination with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall, to the fullest extent not prohibited by law, presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee has submitted a request for indemnification in accordance with Section 10(a) of this Agreement, and the Company shall, to the fullest extent not prohibited by law, have the burden of proof to overcome that presumption in connection with the making by such person, persons or entity of any determination contrary to that presumption. Neither the failure of the Company (including by its directors or Independent Counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including by its directors or Independent Counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
(b) Subject to Section 12(e), if the person, persons or entity empowered or selected under Section 10 of this Agreement to determine whether Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of the request therefor, the requisite determination of entitlement to indemnification shall, to the fullest extent not prohibited by law, be deemed to have been made and Indemnitee shall be entitled to such indemnification, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making the determination with respect to entitlement to indemnification in good faith requires such additional time for the obtaining or evaluating of documentation and/or information relating thereto; and provided, further, that the foregoing provisions of this Section 11(b) shall not apply (i) if the determination of entitlement to indemnification is to be made by the stockholders pursuant to Section 10(b) of this Agreement and if (A) within fifteen (15) days after receipt by the Company of the request for such determination the Board has resolved to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (B) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat, or (ii) if the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 10(b) of this Agreement.
(c) The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his or her conduct was unlawful.
(d) For purposes of any determination of good faith, Indemnitee shall be deemed to have acted in good faith to the extent Indemnitee relied in good faith on (i) the records or books of account of the Enterprise, including financial statements, (ii) information supplied to Indemnitee by the directors or officers of the Enterprise in the course of their duties, (iii) the advice of legal counsel for the Enterprise or its board of directors or counsel selected by any committee of the board of directors or (iv) information or records given or reports made to the Enterprise by an independent certified public accountant, an appraiser, investment banker or other expert selected with reasonable care by the Enterprise or its board of directors or any committee of the board of directors. The provisions of this Section 11(d) shall not be deemed to be exclusive or to limit in any way the other circumstances in which Indemnitee may be deemed to have met the applicable standard of conduct set forth in this Agreement.
(e) Neither the knowledge, actions nor failure to act of any other director, officer, trustee, partner, managing member, fiduciary, agent or employee of the Enterprise shall be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.
12. Remedies of Indemnitee.
(a) Subject to Section 12(e), in the event that (i) a determination is made pursuant to Section 10 of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 8 or 12(d) of this Agreement, (iii) no determination of entitlement to indemnification shall have been made pursuant to Section 10 of this Agreement within 90 days after the later of the receipt by the Company of the request for indemnification or the final disposition of the Proceeding, (iv) payment of indemnification pursuant to this Agreement is not made (A) within ten days after a determination has been made that Indemnitee is entitled to indemnification or (B) with respect to indemnification pursuant to Sections 4, 5 and 12(d) of this Agreement, within 30 days after receipt by the Company of a written request therefor, or (v) the Company or any other person or entity takes or threatens to take any action to declare this Agreement void or unenforceable, or institutes any litigation or other action or proceeding designed to deny, or to recover from, Indemnitee the benefits provided or intended to be provided to Indemnitee hereunder, Indemnitee shall be entitled to an adjudication by a court of competent jurisdiction of his or her entitlement to such indemnification or advancement of Expenses. Indemnitee shall commence such proceeding seeking an adjudication within 180 days following the date on which Indemnitee first has the right to commence such proceeding pursuant to this Section 12(a); provided, however, that the foregoing clause shall not apply in respect of a proceeding brought by Indemnitee to enforce his or her rights under Section 4 of this Agreement. The Company shall not oppose Indemnitee’s right to seek any such adjudication in accordance with this Agreement.
(b) Neither (i) the failure of the Company, its board of directors, any committee or subgroup of the board of directors, Independent Counsel or stockholders to have made a determination that indemnification of Indemnitee is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor (ii) an actual determination by the Company, its board of directors, any committee or subgroup of the board of directors, Independent Counsel or stockholders that Indemnitee has not met the applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has or has not met the applicable standard of conduct. In the event that a determination shall have been made pursuant to Section 10 of this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding commenced pursuant to this Section 12 shall be conducted in all respects as a de novo trial, on the merits, and Indemnitee shall not be prejudiced by reason of that adverse determination. In any judicial proceeding commenced pursuant to this Section 12, the Company shall, to the fullest extent not prohibited by law, have the burden of proving Indemnitee is not entitled to indemnification or advancement of Expenses, as the case may be.
(c) To the fullest extent not prohibited by law, the Company shall be precluded from asserting in any judicial proceeding commenced pursuant to this Section 12 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court that the Company is bound by all the provisions of this Agreement. If a determination shall have been made pursuant to Section 10 of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding commenced pursuant to this Section 12, absent (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statements not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law. It is the intent of the Company that, to the fullest extent permitted by law, the Indemnitee not be required to incur legal fees or other Expenses associated with the interpretation, enforcement or defense of Indemnitee’s rights under this Agreement by litigation or otherwise because the cost and expense thereof would substantially detract from the benefits intended to be extended to the Indemnitee hereunder.
(d) To the extent not prohibited by law, the Company shall indemnify Indemnitee against all Expenses that are incurred by Indemnitee in connection with any action for indemnification or advancement of Expenses from the Company under this Agreement unless as a part of such action, the court of competent jurisdiction determines that each of the material assertions made by Indemnitee as a basis for such action were not made in good faith or were frivolous or to the extent Indemnitee is successful in such action, and, if requested by Indemnitee, shall (as soon as reasonably practicable, but in any event no later than 30 days, after receipt by the Company of a written request therefor) advance such Expenses to Indemnitee, subject to the provisions of Section 8.
(e) Notwithstanding anything in this Agreement to the contrary, no determination as to entitlement to indemnification shall be required to be made prior to the final disposition of the Proceeding.
13. Contribution. To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amounts incurred by Indemnitee, whether for Expenses, judgments, fines or amounts paid or to be paid in settlement, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the events and transactions giving rise to such Proceeding; and (ii) the relative fault of Indemnitee and the Company (and its other directors, officers, employees and agents) in connection with such events and transactions.
14. Non-exclusivity. The rights of indemnification and to receive advancement of Expenses as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the Company’s certificate of incorporation or bylaws, any agreement, a vote of stockholders or a resolution of directors, or otherwise. To the extent that a change in Delaware law, whether by statute or judicial decision, permits greater indemnification or advancement of Expenses than would be afforded currently under the Company’s certificate of incorporation and bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. Except as expressly set forth herein, no right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. Except as expressly set forth herein, the assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.
15. Primary Responsibility. The Company acknowledges that Indemnitee has or may have certain rights to indemnification and advancement of expenses provided by other entities and/or organizations (collectively, the “ Secondary Indemnitors ”). The Company hereby agrees (i) that it is the indemnitor of first resort (i.e., its obligations to Indemnitee are primary and any obligation of the Secondary Indemnitors to advance Expenses or to provide indemnification for the same Expenses or liabilities incurred by Indemnitee in connection with a Proceeding are secondary), (ii) that it shall be required to advance the full amount of Expenses incurred by Indemnitee and shall be liable for the full amount of all Expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this Agreement and the certificate of incorporation or bylaws of the Company (or any other agreement between the Company and Indemnitee), without regard to any rights Indemnitee may have against the Secondary Indemnitors, and (iii) that, to the extent not in contravention of any insurance policy or policies providing liability or other insurance for the Company or any director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, it irrevocably waives, relinquishes and releases the Secondary Indemnitors from any and all claims against the Secondary Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof. The Company further agrees that no advancement or payment by the Secondary Indemnitors on behalf of Indemnitee with respect to any claim for which indemnification is required under the terms of this Agreement shall affect the foregoing and the Secondary Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Indemnitee against the Company. The Company and Indemnitee agree that the Secondary Indemnitors are express third party beneficiaries of the terms of this Section 15.
16. No Duplication of Payments. The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder (or for which advancement is provided hereunder) if and to the extent that Indemnitee has otherwise actually received payment for such amounts under any insurance policy, contract, agreement or otherwise.
17. Insurance. The Company shall, from time to time, make the good faith determination whether or not it is practicable for the Company to obtain and maintain a policy or policies of insurance with reputable insurance companies providing the officers and directors of the Company with coverage for losses from wrongful acts, or to ensure the Company’s performance of its indemnification obligations under this Agreement. Among other considerations, the Company will weigh the costs of obtaining such insurance coverage against the protection afforded by such coverage. In all policies of director and officer liability insurance, Indemnitee shall be named as an insured in such a manner as to provide Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s directors, if Indemnitee is a director; or of the Company’s officers, if Indemnitee is not a director of the Company but is an officer. Notwithstanding the foregoing, the Company shall have no obligation to obtain or maintain such insurance if the Company determines in good faith that such insurance is not reasonably available, if the premium costs for such insurance are disproportionate to the amount of coverage provided, if the coverage provided by such insurance is limited by exclusions so as to provide an insufficient benefit, or if Indemnitee is covered by similar insurance maintained by a subsidiary or parent of the Company.
18. Subrogation. In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
19. Services to the Company. Indemnitee agrees to serve as a director or officer of the Company or, at the request of the Company, as a director, trustee, general partner, managing member, officer, employee, agent or fiduciary of another Enterprise, for so long as Indemnitee is duly elected or appointed or until Indemnitee tenders his or her resignation or is removed from such position. Indemnitee may at any time and for any reason resign from such position (subject to any other contractual obligation or any obligation imposed by operation of law), in which event the Company shall have no obligation under this Agreement to continue Indemnitee in such position.
This Agreement shall not be deemed an employment contract between the Company (or any of its subsidiaries or any Enterprise) and Indemnitee. Indemnitee specifically acknowledges that any employment with the Company (or any of its subsidiaries or any Enterprise) is at will, and Indemnitee may be discharged at any time for any reason, with or without cause, with or without notice, except as may be otherwise expressly provided in any executed, written employment contract between Indemnitee and the Company (or any of its subsidiaries or any Enterprise), any existing formal severance policies adopted by the Company’s board of directors or, with respect to service as a director or officer of the Company, the Company’s certificate of incorporation or bylaws or the DGCL. No such document shall be subject to any oral modification thereof. The foregoing notwithstanding, this Agreement shall continue in force after Indemnitee has ceased to serve as a director, as provided in Section 29 hereof.
20. Successors. This Agreement shall be binding upon and be enforceable by the parties hereto and their respective successors and assigns, including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company, shall continue as to an Indemnitee who has ceased to be a director, officer, employee or agent of the Company or of any other Enterprise, and shall inure to the benefit of Indemnitee and his or her spouse, assigns, heirs, executors, administrators and other legal representatives. The Company shall require and cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company, by written agreement, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.
21. Severability. Nothing in this Agreement is intended to require or shall be construed as requiring the Company to do or fail to do any act in violation of applicable law. The Company’s inability, pursuant to court order or other applicable law, to perform its obligations under this Agreement shall not constitute a breach of this Agreement. If any provision or provisions of this Agreement shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (i) the validity, legality and enforceability of the remaining provisions of this Agreement (including without limitation, each portion of any section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law; (ii) such provision or provisions shall be deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (iii) to the fullest extent possible, the provisions of this Agreement (including, without limitation, each portion of any section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested thereby.
22. Enforcement. The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligations imposed on it hereby in order to induce Indemnitee to serve as a director or officer of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as a director or officer of the Company.
23. Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof; provided , however , that this Agreement is a supplement to and in furtherance of the Company’s certificate of incorporation and bylaws and applicable law.
24. Modification and Waiver. No supplement, modification or amendment to this Agreement shall be binding unless executed in writing by the parties hereto. No amendment, alteration or repeal of this Agreement shall adversely affect any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in his or her Corporate Status prior to such amendment, alteration or repeal. No waiver of any of the provisions of this Agreement shall constitute or be deemed a waiver of any other provision of this Agreement nor shall any waiver constitute a continuing waiver.
25. Notices. All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, postage prepaid, sent by facsimile or electronic mail or otherwise delivered by hand, messenger or courier service addressed:
(a) if to Indemnitee, to Indemnitee’s address, facsimile number or electronic mail address as shown on the signature page of this Agreement or in the Company’s records, as may be updated in accordance with the provisions hereof; or
(b) if to the Company, to the attention of the Chief Executive Officer or Chief Financial Officer of the Company at Am Klopferspitz 19, 82152 Martinsried, or at such other current address as the Company shall have furnished to Indemnitee, with a copy (which shall not constitute notice) to Ilan Katz, Dentons US LLP, 101 John F Kennedy Parkway, Short Hills, NJ 07078.
Each such notice or other communication shall for all purposes of this Agreement be treated as effective or having been given (i) if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, one business day after deposit with the courier), or (ii) if sent via mail, at the earlier of its receipt or three days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via facsimile, upon confirmation of facsimile transfer or, if sent via electronic mail, upon confirmation of delivery when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next business day.
26. Applicable Law and Consent to Jurisdiction. This Agreement and the legal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict of laws rules. The Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement shall be brought only in the Delaware Court of Chancery, and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Delaware Court of Chancery for purposes of any action or proceeding arising out of or in connection with this Agreement, (iii) appoint, to the extent such party is not otherwise subject to service of process in the State of Delaware, The Corporation Trust Company, Wilmington, New Castle County, Delaware as its agent in the State of Delaware as such party’s agent for acceptance of legal process in connection with any such action or proceeding against such party with the same legal force and validity as if served upon such party personally within the State of Delaware, (iv) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court of Chancery, and (v) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court of Chancery has been brought in an improper or inconvenient forum.
27. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signature and in counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. Only one such counterpart signed by the party against whom enforceability is sought needs to be produced to evidence the existence of this Agreement.
28. Captions. The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.
29. Duration of Agreement. This Agreement shall continue until and terminate upon the later of: (a) ten (10) years after the date that Indemnitee shall have ceased to serve as a director of the Company or (b) one (1) year after the final termination of any Proceeding then pending in respect of which Indemnitee is granted rights of indemnification hereunder or advancement of Expenses hereunder and of any Proceeding commenced by Indemnitee pursuant to Section 12 of this Agreement relating thereto. The indemnification and advancement of Expenses rights provided by or granted pursuant to this Agreement shall be binding upon and be enforceable by the parties hereto and their respective successors and assigns (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business or assets of the Company), shall continue as to an Indemnitee who has ceased to be a director, officer, employee or agent of the Company or of any other Enterprise, and shall inure to the benefit of Indemnitee and his or her spouse, assigns, heirs, devisees, executors and administrators and other legal representatives.
( signature page follows )
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
IMMUNIC, INC. | |
Signature of Authorized Signatory | |
Print Name | |
Title |
Address: |
Am Klopferspitz 19 82152 Martinsried Germany |
AGREED TO AND ACCEPTED:
INDEMNITEE: | |
Signature | |
Print Name | |
Title |
Address: | ||
Exhibit 10.5
CONTRACT OF EMPLOYMENT
between
Immunic AG,
represented by the Chairman of the Supervisory Board
- hereinafter referred to as the "Company“ -
and
Mr. Daniel Vitt,
- hereinafter referred to as the "Management Board“ -
§ 1
Scope and duties
1. | Mr. Daniel Vitt is to be appointed as a full member of the Management Board of the Company. He shall be appointed as chairman of the Management Board (CEO) of the Company and shall represent the Company together with a member of the Management Board or an authorized signatory. The Supervisory Board may grant the Management Board exemption from Section 181 of the German Civil Code (BGB). |
2. | The Management Board conducts the Company's business in accordance with the law, the Articles of Association, the rules of procedure for the Management Board and this contract of employment. In particular, the Management Board shall obtain the approval of the Supervisory Board for the transactions and actions specified in section 7 of the rules of procedure of the Management Board. |
3. | The Management Board shall in particular be responsible for those tasks that fall within the scope of the distribution-of-business plan ( Annex 1 ) of the executive member of the Management Board (CEO). |
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4. | The place of employment shall be Munich/Planegg-Martinsried. |
§ 2
Nebentatigkeiten
1. | The Management Board will allocate all its manpower, professional knowledge and experience to the company. The assumption of a remunerated secondary activity as well as of Supervisory Board, Advisory Board or similar mandates requires the prior consent of the Chairman of the Supervisory Board. |
The Supervisory Board is aware that the Management Board holds the mandates listed in Annex 2 at the time of signing this agreement and gives its approval to their continuation.
2. | The non-competition clause of Section 88 of the German Stock Corporation Act applies to the Management Board. During the term of this contract, the Management Board will also not acquire shares in companies that compete with the Company or have business relations with the Company, unless the Supervisory Board has given its prior written consent. |
The non-competition clause does not apply to investments in companies in the form of securities traded on stock exchanges and acquired for the purpose of capital investment.
§ 3
Remuneration and bonus
1. | The management board receives for its work |
a) | a fixed annual salary ("basic remuneration") in the amount of EUR 215,000.00 gross, which is paid in 12 equal monthly payments at the end of each month. If this agreement does not exist for the duration of an entire calendar year, the fixed annual salary shall be paid pro rata temporis. |
b) | an annual variable remuneration, which amounts to a maximum of EUR 30,000.00 gross if the defined annual targets are achieved by 100 percent. The details, in particular the procedure for setting targets, determining the achievement of targets and the due date, are set out in the framework agreement on the target agreement in its current version. The nature of the objectives, the requirements for their achievement and their weighting in relation to each other shall be laid down in a separate definition of objectives for the respective financial year. |
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2. | The basic remuneration and the variable remuneration are reviewed annually by the Supervisory Board. The Company's economic development and the personal performance of the Management Board must be taken into account. |
3. | In addition, the Supervisory Board may reduce the total remuneration of the Management Board to the reasonable amount if the situation of the Company deteriorates to such an extent that it would be inequitable for the Company to continue to grant such remuneration; retirement pension, surviving dependants' pensions and payments of a related kind may only be reduced in the first three years after leaving the Company (Section 87 (2) of the German Stock Corporation Act ). In this case, the Management Board may terminate this contract of employment extraordinarily with six weeks' notice to the end of the next calendar quarter after declaration of the reduction (Section 87 (2) sentence 3 of the German Stock Corporation Act ). The reduction shall be reversed if the Company's situation is no longer deteriorated. |
§ 4
Insurance and fringe benefits
1. | Although there is no statutory insurance obligation, the Company pays to the Management Board member monthly subsidies for health and nursing care insurance of the Management Board member. The amount of the individual subsidies corresponds to half of the contributions paid by the member of the Management Board, but not more than the maximum amount of the employer's contribution to the statutory health and nursing care insurance scheme legally owed in each case, taking into account the applicable income thresholds. The subsidies owed by the Company are paid to the Management Board member at the end of each calendar month. Any income tax payable on these payments is borne by the member of the Management Board. |
2. | The Management Board shall be reimbursed to an appropriate extent for the expenses required in the Company's interest. Any travel expenses required will be reimbursed upon individual proof. The daily and overnight allowances contained therein may also be settled as a lump sum within the limits of the amounts permissible for tax purposes. |
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3. | The Company may, at its discretion, insure the Management Board for the duration of this contract of employment under a term life insurance policy in the amount of EUR 500,000.00 for the event of death and under an accident insurance policy in the amount of EUR 700,000.00 for the event of disability or continue an existing insurance policy. The Management Board has the right to determine the beneficiary(s). |
4. | In case of the assumption of an existing direct insurance, this can be continued according to section 40 b of the German Income Tax Act in its valid version. In this case, the lump-sum taxation shall be borne by the Company. |
5. | The Company offers the Management Board the opportunity to participate in a pension fund, support fund or similar company pension scheme (CPS) or to take over an existing CPS. In this context, the Management Board may convert part of its salary entitlements into a company pension commitment. The basic remuneration paid to the Management Board pursuant to section 3 (1) lit. a) shall be reduced by a gross monthly amount with effect from the beginning of a company pension commitment in order to be converted into a company pension commitment of equal value. The Management Board's entitlement to payment of the basic remuneration is reduced by this amount. If the Board of Management subsequently cancels or suspends the pension commitment completely or partially, the corresponding entitlement to remuneration is revived. |
6. | The Company shall conclude a directors' and officers' liability insurance (D&O) for the Management Board in the event that a third party or the Company brings a claim against the Management Board for financial loss due to a breach of duty committed in the performance of its duties by virtue of statutory liability provisions under private law. The Management Board bears a deductible in the amount of the minimum value pursuant to section 93 (2) of the German Stock Corporation Act (AktG) (currently 10% of the loss per claim, but no more than 11/2 times the basic remuneration per year (annual maximum limit). If several loss events occur in one year, the annual maximum limit applies to all loss events combined. The deductible is automatically adjusted in the event of a change in the basic remuneration (or in the event of a change in section 93 (2) of the German Stock Corporation Act); the Board of Management is obliged to arrange for the corresponding changes to be made to the deductible in the D&O insurance contract and/or to make all declarations required in this connection. The reference year for the deductible to be applied is the year of the breach of duty. |
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§ 5
Vacation
1. | The Management Board is entitled to an annual leave of 30 working days. Working days are all calendar days except Saturdays, Sundays and public holidays at the registered office of the Company. If the employment commences or ends during the year, the annual leave in this calendar year is granted pro rata temporis. |
2. | The vacation period shall be coordinated with the other members of the Board of Management, taking into account the business situation. |
§ 6
Remuneration in the event of illness, incapacity for work or death
1. | In the event of an impediment to service (e.g. due to illness), the member of the Management Board is obliged to inform the Chairman of the Supervisory Board of the Company immediately of the reason for and the duration of the impediment to service and to point out tasks to be performed urgently. If the disability lasts longer than one week, the Management Board member must submit a medical certificate in the event of illness or a written declaration in the event of any other disability, stating the reason for the disability and its expected duration. The Management Board member hereby assigns to the Company any (compensation) claims in the amount of the payments made or to be made by the Company in accordance with this provision to which he is entitled vis-à-vis third parties due to the impediment to work. The Management Board member is obliged to provide the Company without delay with all information necessary for the assertion of such (compensation) claims and to provide the necessary documents. |
2. | In the event of a temporary illness-related or other non-culpable incapacity to work of the Management Board, the basic remuneration pursuant to section 3 (1) lit. a) shall continue to be paid during the period of the incapacity to work up to a duration of six months, but at the latest until the termination of this contract of employment. If the incapacity to work lasts longer than three months without interruption, the Supervisory Board may reduce the variable remuneration in accordance with Annex 4 by a reasonable amount, taking into account the duration of the incapacity to work. |
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3. | In the event of a permanent incapacity to work of the Management Board, the employment contract shall end at the end of the quarter in which the permanent incapacity to work was determined. |
If the Management Board is unable to perform its duties for more than six months, the Supervisory Board may request that the existence of a permanent incapacity to work be reviewed by a doctor of its choice at the Company's expense. If the Management Board fails to meet the deadline despite two requests by the Supervisory Board, the Management Board shall be deemed to be permanently incapacitated for work. The requests must be made at one-week time intervals.
No severance payment shall be made in the event of termination of the contract of employment due to permanent incapacity to work.
4. | If the Management Board dies during the term of the contract of employment, the basic remuneration pursuant to section 3 (1) lit. a) shall be payable for the month of death and for the following two months. |
The bonuses pursuant to section 3 (1) lit. b) shall be determined by the Supervisory Board in accordance with Annex 4 No. 3 and be paid to the spouse or, in their absence, to the dependent children of the Management Board (the latter as joint creditors) or their heirs.
§ 6
Special benefits and extraordinary right of termination in the event of a change of control
1. | If, after the signing of this Agreement, control is acquired in the sense of a share purchase of more than 50% by a shareholder, third party or persons acting in concert, or if an economically comparable transaction (e.g. (e.g. sale of the business operations or a substantial part thereof by the Company, sale of substantial associated companies of the Company, merger into another company, sale of more than 50% of the shares of the Company following a delisting of the Company, etc) and if the Company intends in this regard or as a result thereof to terminate the contract with the Management Board prematurely without having an material reason within the meaning of section 626 of the German Civil Code (BGB), the Management Board shall receive, in addition to the remuneration and all benefits to which it is entitled up to the time of such termination, a severance payment. The amount of the severance payment corresponds to the sum of the total remuneration (basic remuneration, variable remuneration and fringe benefits) which the Management Board had received under this contract until expiry of the term defined in section 10 (1) if the contract had not been terminated prematurely but had been fulfilled until the end of the full term of office. For the purpose of calculating the severance payment pursuant to this paragraph (1), it is assumed that the maximum bonus pursuant to Annex 4 (if applicable pro rata temporis until the end of the contract term) would have been paid to the Management Board. If the ordinary term of this contract pursuant to section 10 (1) is less than 15 months at the time the termination pursuant to this paragraph (1) takes effect, the severance payment to be paid shall be calculated on the basis of a notional remaining term of 15 months, i.e. the severance payment shall be calculated on the basis of an assumed remaining term of at least 15 months. Any increases in the remuneration pursuant to section 3 (1) that take place during the term of the contract shall be taken into account in the calculations described. |
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2. | The severance payment shall be payable in full together with the salary for the month at the end of which the termination of the contract pursuant to paragraph (1) takes effect. |
3. | In the event of this paragraph (1), the Management Board shall be granted an extraordinary termination right to this contract of employment. The extraordinary termination right may be exercised within six weeks of the Management Board becoming aware of the legally effective execution of the change of control within the meaning of paragraph (1) with a notice period of three months to the end of the month. In addition, the Management Board has an extraordinary termination right even if the Management Board is dismissed within one year after completion of the change of control. In this case, the special notice period shall be two weeks. The termination can be declared within four weeks after the dismissal by the Management Board. |
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§ 8
Service inventions and industrial property rights
1. | Service inventions of the Management Board as well as its technical or organizational suggestions for improvement shall be treated in accordance with the applicable provisions of the Act on Employee Inventions of 25 July 1957 with the following proviso: The Management Board shall immediately notify the Company of service inventions, free inventions and technical and organizational suggestions for improvement and offer them to the Company for exclusive, limited or unlimited use. The company must declare the claim within four months of notification. The Company has the right, but not the obligation, to apply for industrial property rights in Germany and abroad. In the event of a service invention or a technical or organizational suggestion for improvement, the parties agree that any remuneration for a service invention claimed by the Company shall be paid in full upon payment of the basic remuneration pursuant to section 3 (1) lit. a) of this Agreement. In the case of a free invention, the member of the Management Board shall be paid a remuneration in line with market conditions. |
2. | The Management Board shall transfer to the Company exclusively the rights of use and exploitation, which are unlimited in terms of time, place and content, for any and all results of activities which may be protected under copyright law and which the Management Board member produces during the term of his contract of employment during his working hours or, insofar as they relate to his duties under the contract of employment, also outside his working hours. The transfer of the rights of use and exploitation under copyright law shall also include any types of use still unknown at the time of conclusion of the contract. The transfer of the rights of use and exploitation includes in particular the permission for processing and licensing to third parties. The member of the Management Board expressly waives any other rights to the results of his activities to which he may be entitled as the originator, in particular the right to name, edit and make available the work. |
3. | Insofar as the results of activities which the Management Board produces during the term of its service contract during its working hours or, insofar as they relate to its duties under the service contract, also outside its working hours, have not already been transferred in accordance to paragraphs (1) and (2) above, the Management Board shall transfer to the Company all rights to such results of activities, in particular trademark and other proprietary rights as well as registered designs. |
4. | The parties agree that the granting of these rights and the waiver of rights under this provision shall be fully compensated by the payment of the basic remuneration pursuant to section 3 (1) lit. a) of this Agreement, unless otherwise provided by mandatory statutory provisions. The Management Board is obliged to immediately notify the Company, represented by the Supervisory Board, of any results of its activities that are eligible for protection and to support the Company to the necessary extent, even after termination of this contract of employment, in obtaining protection rights. Insofar as the Executive Board fulfils its duties to cooperate after termination of this service contract, the Management Board shall receive an appropriate daily rate for this purpose as well as reimbursement of all expenses incurred as a result of its cooperation. |
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§ 9
Confidentiality and return of documents, conflicts of interest
1. | The Management Board undertakes to inform the Supervisory Board about all business and operational matters that come to its attention within the scope of its activities or otherwise. To maintain the strictest confidentiality with respect to the affairs of the Company and all Affiliates, including the contents of this Agreement and the contract negotiations underlying the conclusion of this Agreement. The Management Board further undertakes not to use such information for its own benefit or for the benefit of others and to maintain all such business and operational records of the Company and Affiliates confidential. For the purposes of this provision, business and operational matters shall mean, in particular, trade and business secrets and all information and data relating to confidential matters and business-related know-how, all information about all business plans and strategies, processes, pricing or market strategies and product, service or development plans relating to the existing or future business of the Company and its Affiliates, planned company acquisitions or disposals, all business figures and details of the organizational structures as well as the essential ideas and principles underlying these strategies and plans, and all information that can reasonably be expected to lead to such strategies or plans and that has been conceived, invented, revised, discovered, developed, assessed, tested or applied by the Company, its affiliates or the member of the Management Board during the term of this contract of employment. |
2. | The obligation to maintain confidentiality pursuant to paragraph (1) above shall continue even after termination of the contract of employment. Within the scope of a professional or entrepreneurial activity carried out by the Management Board after termination of this contract of employment, he may use the knowledge he has acquired as a Management Board member, provided that the statutory restrictions - in particular in accordance with sections 3, 17 of the Unfair Competition Act (UWG), section 823 (1) and (2) of the German Civil Code (BGB) in conjunction with sections 3, 17 of the German Civil Code (BGB) - are complied with UWG, section 826 BGB and the data protection regulations - as well as the restrictions arising from the post-contractual non-competition clause pursuant to section 16 of this Agreement. |
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3. | In cases of doubt, the Management Board is obliged to clarify the scope of the confidentiality obligation pursuant to paragraphs (1) and (2) above with the Supervisory Board of the Company. |
4. | The Management Board undertakes, at the request of the Company at any time and at the latest at the end of its appointment as a governing body and without separate request, to return to the Company without delay and in full all documents in its possession of the Company or affiliated companies, in particular all notes, memorandums, records, minutes and reports, files and all other similar documents (including copies, photocopies, copies or other reproductions) in connection with its activities. A right of retention is excluded. This provision shall apply mutatis mutandis to electronically stored data and the respective data or program carriers. |
5. | The obligation to surrender also applies to other property owned by the Company or its affiliates or leased by the Company or its affiliates. In particular, this obligation to surrender also applies to a mobile telephone, laptop or other data processing devices entrusted to the Management Board, at the end of its mandate as a governing body even if private use was permitted in this respect. |
6. | The Management Board shall disclose possible and actual conflicts of interest to the Supervisory Board without delay and inform the other members of the Management Board thereof. |
§ 10
Term of a contract
1. | The contract is subject to the condition precedent that (A) (i) the Management Board is appointed to the Management Board of the Company and (ii) Tranche I pursuant to Sec. 4 (2) of the Investment Agreement of 10 August is paid in full to the Company and (B) the condition precedent that the option under the Asset Purchase Agreement between the Company and 4SC AG is not exercised by 30 September 2016. |
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2. | This contract shall be concluded with effect from the earliest possible date, but not later than 1 April 2017. It shall expire at the end of three years. |
3. | The right of extraordinary termination remains unaffected. |
4. | In the event of revocation of the appointment, resignation from office by a member of the Management Board or any other termination of the appointment to an executive body, this contract of employment shall end at the end of one year after the end of the term of office, at the latest, however, at the end of the term of office in accordance with paragraph (1). Any earlier termination due to paragraph (2) of this Agreement shall remain unaffected. |
5. | The Chairman of the Supervisory Board shall inform the Executive Board in writing not later than nine months prior to the expiry of this contract whether and under what conditions the Supervisory Board will reappoint the Management Board as a member of the Management Board and whether he is prepared to extend the contract of employment in accordance with the duration of the new appointment or to conclude a new contract of employment with the Management Board on at least the same terms. Within two months of receipt of the offer of the Chairman of the Supervisory Board, the Management Board will declare whether it accepts the new appointment and is prepared to agree to the terms and conditions offered for the continuation or renewal of the service contract. |
6. | The Company shall be entitled after revocation of its appointment pursuant to section 84 (3) of the AktG or in connection with termination of the service contract, in particular after termination or following conclusion of a termination agreement, to release the Executive Board in whole or in part from its obligation to provide services with continued payment of the basic remuneration pursuant to section 3 (1) a) revocably or irrevocably. In the case of irrevocable release, outstanding vacation and other time off compensation claims shall be credited and settled. The remaining provisions of the service agreement shall not be affected by the indemnity; in this respect, the obligation to maintain confidentiality and the contractual non-competition clause shall continue to apply until the end of the service agreement. Other earnings during the exemption period shall be credited in accordance with section 615 sentence 2 of the German Civil Code (BGB). No credit shall be made if and to the extent that the other earnings originate from an approved secondary activity ( section 2 (1) of this service contract). |
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7. | The service contract shall end at the latest at the end of the calendar year in which the member of the Management Board reaches the age of 65, provided that this service contract has not already ended before this date in accordance with paragraphs (1) to (2) of this contract. |
8. | In the event of premature termination of a Management Board member's contract without good cause, payments to the Management Board, including fringe benefits, shall not exceed the value of two years' compensation (severance payment cap) and shall not exceed the total compensation (basic compensation, variable compensation and fringe benefits) for the remaining term of the contract. In the case of an acquisition of control pursuant to section 7, a severance payment cap of a maximum of three annual remunerations applies. |
§ 11
Cut-off periods
1. | Claims of the Company and the Management Board arising from or in connection with the employment relationship shall lapse, irrespective of their legal basis, if the claimant does not assert the claim within a period of six months, calculated from the due date and the knowledge or grossly negligent ignorance of the claimant of the circumstances giving rise to the claim, by means of a written declaration to the respective other contracting party. For the assessment of the timeliness of the assertion, the date of receipt of the written declaration shall be decisive. This does not apply to the assertion of claims due to injury to life, limb or health as well as to intentional breaches of duty. Failure to comply with the preclusive period shall result in the loss of the claim. |
2. | Any claims of the Company pursuant to section 93 (2) and (3) of the German Stock Corporation Act (AktG) against the Management Board member shall remain unaffected by the above paragraph (1) pursuant to section 93 (4) sentence 3 of the German Stock Corporation Act (AktG). |
§ 11
Final provisions
1. | This contract contains the entire agreement between the parties. Agreements already made between the parties are hereby expressly cancelled. |
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2. | Amendments or supplements to this contract, including this written form clause, must be made in writing in order to be effective. |
3. | This contract is subject to the law of the Federal Republic of Germany. |
4. | Place of performance shall be the registered office of the Company. The place of jurisdiction for disputes arising from this contract shall be the registered office of the Company. |
5. | Should any provision of this contract be or become invalid or unenforceable in whole or in part, the validity of the remaining provisions of this contract shall not be affected. Rather, the invalid or unenforceable provision, in whole or in part, shall be replaced by a provision which achieves as far as possible the economic purpose intended by the invalid provision. The same shall apply in the event of loopholes in this contract. |
Martinsried 23 March 2016 | Martinsried 23 March 2016 | |
/s/ Dr. Daniel Vitt | /s/ Dr. Jörg Neermann | |
Immunic AG, represented by the Chairman of the supervisory board |
Annexes directory
Annex 1: AR resolution
Annex 2: Current business distribution plan
Annex 3: Approved secondary activities of the Management Board
Exhibit 10.6
CONTRACT OF EMPLOYMENT
between
Immunic AG,
represented by the Chairman of the Supervisory Board
- hereinafter referred to as the "Company“ -
and
Mr. Manfred Gröppel,
- hereinafter referred to as the "Management Board“ -
§ 1
Scope and duties
1. | Mr. Manfred Gröppel has been appointed as a full member of the Management Board of the Company for one year by resolution of the Supervisory Board of the Company dated 23 March 2016 (Annex 1). This appointment is to be extended until the end of 31 August 2019. He is appointed to the Management Board as COO of the Company and represents the Company together with a member of the Management Board or an authorized signatory. The Supervisory Board may grant the Management Board sole power of representation as well as the right to exclude the restrictions of section 181 alt. 2 of the German Civil Code (BGB). |
2. | The Management Board shall conduct the Company's business in accordance with the law, the Articles of Association, the rules of procedure for the Management Board and this contract of employment. In particular, the Management Board shall obtain the approval of the Supervisory Board for transactions and measures subject to approval in accordance with the rules of procedure of the Management Board. |
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3. | The Management Board shall in particular be responsible for the business areas of the operating Business Segment (COO) within the meaning of the respective distribution-of-business plan. |
4. | The place of employment shall be Munich/Planegg-Martinsried. |
§ 2
Secondary employment
1. | The Management Board will allocate all its manpower, professional knowledge and experience to the company. The assumption of a remunerated secondary activity as well as of Supervisory Board, Advisory Board or similar mandates requires the prior consent of the Chairman of the Supervisory Board. |
The Supervisory Board is aware that the Management Board holds the mandates listed in Annex 2 at the time of signing this agreement and gives its approval to their continuation.
2. | The non-competition clause of Section 88 of the German Stock Corporation Act applies to the Management Board. During the term of this contract, the Management Board will also not acquire shares in companies that compete with the Company or have business relations with the Company, unless the Supervisory Board has given its prior written consent. |
The non-competition clause does not apply to investments in companies in the form of securities traded on stock exchanges and acquired for the purpose of capital investment.
§ 3
Remuneration and bonus
1. | The management board receives for its work |
a) | a fixed annual salary ("basic remuneration") in the amount of EUR 150,000.00 gross, which is paid in 12 equal monthly payments at the end of each month. If this agreement does not exist for the duration of an entire calendar year, the fixed annual salary shall be paid pro rata temporis. |
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b) | an annual variable remuneration, which amounts to a maximum of EUR 24,000.00 gross if the defined annual targets are achieved by 100 percent. The details, in particular the procedure for setting targets, determining the achievement of targets and the due date, are set out in the framework agreement on the target agreement in its current version. The nature of the objectives, the requirements for their achievement and their weighting in relation to each other shall be laid down in a separate definition of objectives for the respective financial year. |
2. | The basic remuneration and the variable remuneration are reviewed annually by the Supervisory Board. The Company's economic development and the personal performance of the Management Board must be taken into account. |
3. | In addition, the Supervisory Board may reduce the total remuneration of the Management Board to the reasonable amount if the situation of the Company deteriorates to such an extent that it would be inequitable for the Company to continue to grant such remuneration; retirement pension, surviving dependants' pensions and payments of a related kind may only be reduced in the first three years after leaving the Company (Section 87 (2) of the German Stock Corporation Act ). In this case, the Management Board may terminate this contract of employment extraordinarily with six weeks' notice to the end of the next calendar quarter after declaration of the reduction (Section 87 (2) sentence 3 of the German Stock Corporation Act ). The reduction shall be reversed if the Company's situation is no longer deteriorated. |
§ 4
Insurance and fringe benefits
1. | Although there is no statutory insurance obligation, the Company pays to the Management Board member monthly subsidies for health and nursing care insurance of the Management Board member. The amount of the individual subsidies corresponds to half of the contributions paid by the member of the Management Board, but not more than the maximum amount of the employer's contribution to the statutory health and nursing care insurance scheme legally owed in each case, taking into account the applicable income thresholds. The subsidies owed by the Company are paid to the Management Board member at the end of each calendar month. Any income tax payable on these payments is borne by the member of the Management Board. |
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2. | The Management Board shall be reimbursed to an appropriate extent for the expenses required in the Company's interest. Any travel expenses required will be reimbursed upon individual proof. The daily and overnight allowances contained therein may also be settled as a lump sum within the limits of the amounts permissible for tax purposes. |
3. | The Company may, at its discretion, insure the Management Board for the duration of this contract of employment under a term life insurance policy in the amount of EUR 500,000.00 for the event of death and under an accident insurance policy in the amount of EUR 700,000.00 for the event of disability or continue an existing insurance policy. The Management Board has the right to determine the beneficiary(s). |
4. | In case of the assumption of an existing direct insurance, this can be continued according to section 40 b of the German Income Tax Act in its valid version. In this case, the lump-sum taxation shall be borne by the Company. |
5. | The Company offers the Management Board the opportunity to participate in a pension fund, support fund or similar company pension scheme (CPS) or to take over an existing CPS. In this context, the Management Board may convert part of its salary entitlements into a company pension commitment. The basic remuneration paid to the Management Board pursuant to section 3 (1) lit. a) shall be reduced by a gross monthly amount with effect from the beginning of a company pension commitment in order to be converted into a company pension commitment of equal value. The Management Board's entitlement to payment of the basic remuneration is reduced by this amount. If the Board of Management subsequently cancels or suspends the pension commitment completely or partially, the corresponding entitlement to remuneration is revived. |
6. | The Company shall conclude a directors' and officers' liability insurance (D&O) for the Management Board in the event that a third party or the Company brings a claim against the Management Board for financial loss due to a breach of duty committed in the performance of its duties by virtue of statutory liability provisions under private law. The Management Board bears a deductible in the amount of the minimum value pursuant to section 93 (2) of the German Stock Corporation Act (AktG) (currently 10% of the loss per claim, but no more than 1 times the basic remuneration per year (annual maximum limit). If several loss events occur in one year, the annual maximum limit applies to all loss events combined. The deductible is automatically adjusted in the event of a change in the basic remuneration (or in the event of a change in section 93 (2) of the German Stock Corporation Act); the Board of Management is obliged to arrange for the corresponding changes to be made to the deductible in the D&O insurance contract and/or to make all declarations required in this connection. The reference year for the deductible to be applied is the year of the breach of duty. |
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§ 5
Vacation
1. | The Management Board is entitled to an annual leave of 30 working days. Working days are all calendar days except Saturdays, Sundays and public holidays at the registered office of the Company. If the employment commences or ends during the year, the annual leave in this calendar year is granted pro rata temporis. |
2. | The vacation period shall be coordinated with the other members of the Board of Management, taking into account the business situation. |
§ 6
Remuneration in the event of illness, incapacity for work or death
1. | In the event of an impediment to service (e.g. due to illness), the member of the Management Board is obliged to inform the Chairman of the Supervisory Board of the Company immediately of the reason for and the duration of the impediment to service and to point out tasks to be performed urgently. If the disability lasts longer than one week, the Management Board member must submit a medical certificate in the event of illness or a written declaration in the event of any other disability, stating the reason for the disability and its expected duration. The Management Board member hereby assigns to the Company any (compensation) claims in the amount of the payments made or to be made by the Company in accordance with this provision to which he is entitled vis-à-vis third parties due to the impediment to work. The Management Board member is obliged to provide the Company without delay with all information necessary for the assertion of such (compensation) claims and to provide the necessary documents. |
2. | In the event of a temporary illness-related or other non-culpable incapacity to work of the Management Board, the basic remuneration pursuant to section 3 (1) lit. a) shall continue to be paid during the period of the incapacity to work up to a duration of six months, but at the latest until the termination of this contract of employment. If the incapacity to work lasts longer than three months without interruption, the Supervisory Board may reduce the variable remuneration in accordance with Annex 4 by a reasonable amount, taking into account the duration of the incapacity to work. |
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3. | In the event of a permanent incapacity to work of the Management Board, the employment contract shall end at the end of the quarter in which the permanent incapacity to work was determined. |
If the Management Board is unable to perform its duties for more than six months, the Supervisory Board may request that the existence of a permanent incapacity to work be reviewed by a doctor of its choice at the Company's expense. If the Management Board fails to meet the deadline despite two requests by the Supervisory Board, the Management Board shall be deemed to be permanently incapacitated for work. The requests must be made at one-week time intervals.
No severance payment shall be made in the event of termination of the contract of employment due to permanent incapacity to work.
4. | If the Management Board dies during the term of the contract of employment, the basic remuneration pursuant to section 3 (1) lit. a) shall be payable for the month of death and for the following two months. |
The bonuses pursuant to section 3 (1) lit. b) shall be determined by the Supervisory Board in accordance with Annex 4 No. 3 and be paid to the spouse or, in their absence, to the dependent children of the Management Board (the latter as joint creditors) or their heirs.
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§ 7
Special benefits and extraordinary right of termination in the event of a change of control
1. | If, after the signing of this Agreement, control is acquired in the sense of a share purchase of more than 50% by a shareholder, third party or persons acting in concert, or if an economically comparable transaction (e.g. sale of the business operations or a substantial part thereof by the Company, sale of substantial associated companies of the Company, merger into another company, sale of more than 50% of the shares of the Company following a delisting of the Company, etc) and if the Company intends in this regard or as a result thereof to terminate the contract with the Management Board prematurely without having an material reason within the meaning of section 626 of the German Civil Code (BGB), the Management Board shall receive, in addition to the remuneration and all benefits to which it is entitled up to the time of such termination, a severance payment. The amount of the severance payment corresponds to the sum of the total remuneration (basic remuneration, variable remuneration and fringe benefits) which the Management Board had received under this contract until expiry of the term defined in section 10 (1) if the contract had not been terminated prematurely but had been fulfilled until the end of the full term of office. For the purpose of calculating the severance payment pursuant to this paragraph (1), it is assumed that the maximum bonus pursuant to Annex 4 (if applicable pro rata temporis until the end of the contract term) would have been paid to the Management Board. If the ordinary term of this contract pursuant to section 10 (1) is less than 15 months at the time the termination pursuant to this paragraph (1) takes effect, the severance payment to be paid shall be calculated on the basis of a notional remaining term of 15 months, i.e. the severance payment shall be calculated on the basis of an assumed remaining term of at least 15 months. Any increases in the remuneration pursuant to section 3 (1) that take place during the term of the contract shall be taken into account in the calculations described. |
2. | The severance payment shall be payable in full together with the salary for the month at the end of which the termination of the contract pursuant to paragraph (1) takes effect. |
3. | In the event of this paragraph (1), the Management Board shall be granted an extraordinary termination right to this contract of employment. The extraordinary termination right may be exercised within six weeks of the Management Board becoming aware of the legally effective execution of the change of control within the meaning of paragraph (1) with a notice period of three months to the end of the month. In addition, the Management Board has an extraordinary termination right even if the Management Board is dismissed within one year after completion of the change of control. In this case, the special notice period shall be two weeks. The termination can be declared within four weeks after the dismissal by the Management Board. |
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§ 8
Service inventions and industrial property rights
1. | Service inventions of the Management Board as well as its technical or organizational suggestions for improvement shall be treated in accordance with the applicable provisions of the Act on Employee Inventions of 25 July 1957 with the following proviso: The Management Board shall immediately notify the Company of service inventions, free inventions and technical and organizational suggestions for improvement and offer them to the Company for exclusive, limited or unlimited use. The company must declare the claim within four months of notification. The Company has the right, but not the obligation, to apply for industrial property rights in Germany and abroad. In the event of a service invention or a technical or organizational suggestion for improvement, the parties agree that any remuneration for a service invention claimed by the Company shall be paid in full upon payment of the basic remuneration pursuant to section 3 (1) lit. a) of this Agreement. In the case of a free invention, the member of the Management Board shall be paid a remuneration in line with market conditions. |
2. | The Management Board shall transfer to the Company exclusively the rights of use and exploitation, which are unlimited in terms of time, place and content, for any and all results of activities which may be protected under copyright law and which the Management Board member produces during the term of his contract of employment during his working hours or, insofar as they relate to his duties under the contract of employment, also outside his working hours. The transfer of the rights of use and exploitation under copyright law shall also include any types of use still unknown at the time of conclusion of the contract. The transfer of the rights of use and exploitation includes in particular the permission for processing and licensing to third parties. The member of the Management Board expressly waives any other rights to the results of his activities to which he may be entitled as the originator, in particular the right to name, edit and make available the work. |
3. | Insofar as the results of activities which the Management Board produces during the term of its service contract during its working hours or, insofar as they relate to its duties under the service contract, also outside its working hours, have not already been transferred in accordance to paragraphs (1) and (2) above, the Management Board shall transfer to the Company all rights to such results of activities, in particular trademark and other proprietary rights as well as registered designs. |
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4. | The parties agree that the granting of these rights and the waiver of rights under this provision shall be fully compensated by the payment of the basic remuneration pursuant to section 3 (1) lit. a) of this Agreement, unless otherwise provided by mandatory statutory provisions. The Management Board is obliged to immediately notify the Company, represented by the Supervisory Board, of any results of its activities that are eligible for protection and to support the Company to the necessary extent, even after termination of this contract of employment, in obtaining protection rights. Insofar as the Executive Board fulfils its duties to cooperate after termination of this service contract, the Management Board shall receive an appropriate daily rate for this purpose as well as reimbursement of all expenses incurred as a result of its cooperation. |
§ 9
Confidentiality and return of documents, conflicts of interest
1. | The Management Board undertakes to inform the Supervisory Board about all business and operational matters that come to its attention within the scope of its activities or otherwise. To maintain the strictest confidentiality with respect to the affairs of the Company and all Affiliates, including the contents of this Agreement and the contract negotiations underlying the conclusion of this Agreement. The Management Board further undertakes not to use such information for its own benefit or for the benefit of others and to maintain all such business and operational records of the Company and Affiliates confidential. For the purposes of this provision, business and operational matters shall mean, in particular, trade and business secrets and all information and data relating to confidential matters and business-related know-how, all information about all business plans and strategies, processes, pricing or market strategies and product, service or development plans relating to the existing or future business of the Company and its Affiliates, planned company acquisitions or disposals, all business figures and details of the organizational structures as well as the essential ideas and principles underlying these strategies and plans, and all information that can reasonably be expected to lead to such strategies or plans and that has been conceived, invented, revised, discovered, developed, assessed, tested or applied by the Company, its affiliates or the member of the Management Board during the term of this contract of employment. |
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2. | The obligation to maintain confidentiality pursuant to paragraph (1) above shall continue even after termination of the contract of employment. Within the scope of a professional or entrepreneurial activity carried out by the Management Board after termination of this contract of employment, he may use the knowledge he has acquired as a Management Board member, provided that the statutory restrictions - in particular in accordance with sections 3, 17 of the Unfair Competition Act (UWG), section 823 (1) and (2) of the German Civil Code (BGB) in conjunction with sections 3, 17 of the German Civil Code (BGB) - are complied with UWG, section 826 BGB and the data protection regulations - as well as the restrictions arising from the post-contractual non-competition clause pursuant to section 16 of this Agreement. |
3. | In cases of doubt, the Management Board is obliged to clarify the scope of the confidentiality obligation pursuant to paragraphs (1) and (2) above with the Supervisory Board of the Company. |
4. | The Management Board undertakes, at the request of the Company at any time and at the latest at the end of its appointment as a governing body and without separate request, to return to the Company without delay and in full all documents in its possession of the Company or affiliated companies, in particular all notes, memorandums, records, minutes and reports, files and all other similar documents (including copies, photocopies, copies or other reproductions) in connection with its activities. A right of retention is excluded. This provision shall apply mutatis mutandis to electronically stored data and the respective data or program carriers. |
5. | The obligation to surrender also applies to other property owned by the Company or its affiliates or leased by the Company or its affiliates. In particular, this obligation to surrender also applies to a mobile telephone, laptop or other data processing devices entrusted to the Management Board, at the end of its mandate as a governing body even if private use was permitted in this respect. |
6. | The Management Board shall disclose possible and actual conflicts of interest to the Supervisory Board without delay and inform the other members of the Management Board thereof. |
§ 10
Term of a contract
1. | This agreement shall be concluded with effect from 1 September 2016. The contract expires at the end of 31 August 2019. |
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2. | The right of extraordinary termination remains unaffected. |
3. | In the event of revocation of the appointment, resignation from office by the member of the Management Board or other termination of the Board position, this contract of employment shall end one year after the end of the term of office, at the latest, however, at the end of the term pursuant to paragraph (1). Any earlier termination due to paragraph (2) of this Agreement shall remain unaffected. |
4. | The Chairman of the Supervisory Board shall inform the Executive Board in writing not later than nine months prior to the expiry of this contract, i.e. by 30 November 2018, whether and under what conditions the Supervisory Board will reappoint the Management Board as a member of the Management Board and whether he is prepared to extend the contract of employment in accordance with the duration of the new appointment or to conclude a new contract of employment with the Management Board on at least the same terms. Within two months of receipt of the offer of the Chairman of the Supervisory Board, the Management Board will declare whether it accepts the new appointment and is prepared to agree to the terms and conditions offered for the continuation or renewal of the service contract. |
5. | The Company shall be entitled after revocation of its appointment pursuant to section 84 (3) of the AktG or in connection with termination of the service contract, in particular after termination or following conclusion of a termination agreement, to release the Executive Board in whole or in part from its obligation to provide services with continued payment of the basic remuneration pursuant to section 3 (1) a) revocably or irrevocably. In the case of irrevocable release, outstanding vacation and other time off compensation claims shall be credited and settled. The remaining provisions of the service agreement shall not be affected by the indemnity; in this respect, the obligation to maintain confidentiality and the contractual non-competition clause shall continue to apply until the end of the service agreement. Other earnings during the exemption period shall be credited in accordance with section 615 sentence 2 of the German Civil Code (BGB). No credit shall be made if and to the extent that the other earnings originate from an approved secondary activity ( section 2 (1) of this service contract). |
6. | The contract of employment shall end at the latest at the end of the calendar year in which the member of the Management Board reaches the age of 65, provided that this service contract has not already ended before this date in accordance with paragraphs (1) to (2) of this contract. |
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7. | In the event of premature termination of a Management Board member's contract without good cause, payments to the Management Board, including fringe benefits, shall not exceed the value of two years' compensation (severance payment cap) and shall not exceed the total compensation (basic compensation, variable compensation and fringe benefits) for the remaining term of the contract. In the case of an acquisition of control pursuant to section 7, a severance payment cap of a maximum of three annual remunerations applies. |
§ 11
Cut-off periods
1. | Claims of the Company and the Management Board arising from or in connection with the employment relationship shall lapse, irrespective of their legal basis, if the claimant does not assert the claim within a period of six months, calculated from the due date and the knowledge or grossly negligent ignorance of the claimant of the circumstances giving rise to the claim, by means of a written declaration to the respective other contracting party. For the assessment of the timeliness of the assertion, the date of receipt of the written declaration shall be decisive. This does not apply to the assertion of claims due to injury to life, limb or health as well as to intentional breaches of duty. Failure to comply with the preclusive period shall result in the loss of the claim. |
2. | Any claims of the Company pursuant to section 93 (2) and (3) of the German Stock Corporation Act (AktG) against the Management Board member shall remain unaffected by the above paragraph (1) pursuant to section 93 (4) sentence 3 of the German Stock Corporation Act (AktG). |
§ 12
Final provisions
1. | This contract contains the entire agreement between the parties. Agreements already made between the parties are hereby expressly cancelled. |
2. | Amendments or supplements to this contract, including this written form clause, must be made in writing in order to be effective. |
3. | This contract is subject to the law of the Federal Republic of Germany. |
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4. | Place of performance shall be the registered office of the Company. The place of jurisdiction for disputes arising from this contract shall be the registered office of the Company. |
5. | Should any provision of this contract be or become invalid or unenforceable in whole or in part, the validity of the remaining provisions of this contract shall not be affected. Rather, the invalid or unenforceable provision, in whole or in part, shall be replaced by a provision which achieves as far as possible the economic purpose intended by the invalid provision. The same shall apply in the event of loopholes in this contract. |
Martinsried 29 August 2016 | Martinsried 29 August 2016 | |
/s/ Dr. Jörg Neermann | /s/ Dr. Manfred Gröppel | |
Immunic AG, | Dr. Manfred Gröppel | |
represented by the | ||
Chairman of the supervisory board | ||
Dr. Jörg Neermann |
Annexes directory
Annex 1: Supervisory Board resolution of 23.03.2016
Annex 2: Approved secondary activities of the Management Board
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Annex 1: Supervisory Board resolution of 23.03.2016
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Annex 2: Approved secondary activities of the Management Board
· | Advisory activity for 4SC AG until 31.12.2016 with an average maximum expenditure of 3 hours per week |
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Minutes of the meeting of the Supervisory Board of
Immunic AG
The members of the Supervisory Board of the Company appointed in accordance with the minutes of the Annual General Meeting of 23 March 2016 meet after acceptance of their appointment and pass the following resolutions unanimously with all votes:
1. | Dr. Jörg Neermann is elected as Chairman of the Supervisory Board and Dr. Gerhard Ries as Deputy Chairman. Both of them declare their acceptance of their election. |
2. | Members of the Management Board of the Company are appointed for a period of 1 year: |
a. | Dr. Manfred Gröppel, born 06.08.1968, resident in Munich |
b. | Dr. Andreas Mühler, born 21.05.1963, resident in Grünwald |
Dr. Manfred Gröppel is appointed as Chairman of the Management Board. Each member of the Management Board is entitled to represent the Company alone. Each member of the Management Board is exempted from the prohibition of multiple representation (§ 181 Alt. 2 of the German Civil Code (BGB)).
Dr. Gröppel and Dr. Mühler were subsequently consulted to the meeting. They declare:
We accept the appointment to the Management Board.
Munich, 23 March 2016
Dr. Jörg Neermann
(chairman of the supervisory board)
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements on Form S-3 (File No. 333-225230) and related Prospectus of Immunic, Inc. of our report dated June 20, 2019, relating to the consolidated financial statements of Immunic AG, which appears in Form 8-K/A for the year ended December 31, 2018, and to the reference to our Firm under the caption "Experts."
/s/ Baker Tilly Virchow Krause, LLP
Minneapolis, Minnesota
July 17, 2019
Exhibit 99.1
UPDATED UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
On January 6, 2019, Vital Therapies, Inc., or Vital Therapies, a Delaware corporation, and Immunic AG, or Immunic, a stock corporation formed under the laws of Germany focused on developing novel oral therapies for chronic inflammatory and autoimmune diseases, entered into a definitive agreement, or the Exchange Agreement, pursuant to which and subject to, among other things, the satisfaction or waiver of the conditions set forth in the Exchange Agreement, Vital Therapies acquired all of the outstanding shares of Immunic in exchange for newly-issued shares of Vital Therapies in an all-stock transaction, or the Transaction. The exchange, or the Merger, constituted a transaction qualifying for federal income tax purposes as a tax-free exchange under the provisions of Section 351(a) of the Internal Revenue Code of 1986, as amended. The Merger closed on April 12, 2019.
Subject to the terms and conditions of the Exchange Agreement, at the effective time of the exchange, or the Effective Time, (a) each holder of Immunic’s outstanding shares contributed and transferred by assignment all of the Immunic shares held by such holder in exchange for Vital Therapies’ common stock based on the exchange ratio described below. Immediately following the exchange, Immunic AG is a wholly-owned subsidiary of Vital Therapies and the name of Vital Therapies changed from “Vital Therapies, Inc.” to “Immunic, Inc.”
Under the exchange ratio provided in the Exchange Agreement, as of and immediately after the Merger, the Immunic security holders own 88.25% of the aggregate number of shares of Immunic Inc.'s common stock issued and outstanding plus any common stock equivalent outstanding on the Effective Date, or the Post-Closing Shares, and the stockholders of Vital Therapies own 11.75% of the aggregate number of Post-Closing Shares, as of the Effective Date. The aggregate consideration issuable in the Transaction, after giving effect to the reverse stock split, was 8,927,130 shares of Vital Therapies common stock.
Concurrent with Immunic’s entry into the Exchange Agreement, certain of Immunic’s existing security holders entered into an Investment and Subscription Agreement to purchase shares of Immunic’s common stock in a private financing prior to consummation of the Transaction for an aggregate purchase price of $30.0 million, referred to as the Pre-Closing Financing.
The following unaudited pro forma condensed combined financial information gives effect to the exchange of all of the outstanding shares of Immunic AG for newly-issued shares of Vital Therapies in the Transaction, pursuant to the Exchange Agreement between the companies, and were prepared in accordance with the regulations of the Securities and Exchange Commission, or the SEC. Immunic was determined to be the accounting acquirer based upon the terms of the Transaction and other factors including:
(i) Immunic’s security holders own over 80% of the company, (ii) Immunic directors hold a majority of the board seats in the company, and (iii) Immunic management hold all key positions in the management of the combined company, immediately following the closing of the Transaction.
In the unaudited pro forma condensed combined financial statements, the Transaction is recorded as a business combination using the acquisition method of accounting under accounting principles generally accepted in the United States, or “U.S. GAAP”. The Transaction is accounted for as a reverse acquisition under the accounting guidance and Immunic, as the accounting acquirer, recorded the assets acquired and liabilities assumed of Vital Therapies in the Transaction at their fair values as of the acquisition date. Vital Therapies and Immunic have determined a purchase price calculated as described in Note 3 to the unaudited pro forma condensed combined financial statements.
The unaudited pro forma condensed combined balance sheet as of March 31, 2019 gives effect to the Transaction as if it took place on March 31, 2019 and combines the historical balance sheets of Vital Therapies and Immunic as of such date. The unaudited pro forma condensed combined statements of operations for the three months ended March 31, 2019 and for the year ended December 31, 2018 gives effect to the Transaction as if it took place on January 1, 2019, and 2018, respectively, and combines the historical results of Vital Therapies and Immunic for each period. The historical financial statements of Vital Therapies and Immunic have been adjusted to give pro forma effect to events that are (i) directly attributable to the Transaction, (ii) factually supportable, and (iii) with respect to the unaudited pro forma condensed combined statements of operations, at the date hereof are expected to have a continuing impact on the combined companies’ results.
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Immunic has not completed the detailed valuations necessary to estimate the fair value of the assets acquired and the liabilities assumed from Vital Therapies and the related allocations of purchase price. Additionally, a final determination of the fair value of assets acquired and liabilities assumed from Vital Therapies will be based on the actual net tangible and intangible assets and liabilities of Vital Therapies that existed as of the closing date. Accordingly, the pro forma purchase price adjustments presented herein are preliminary. Immunic estimated the fair value of Vital Therapies' assets and liabilities based on discussions with Vital Therapies' management, due diligence and preliminary work performed by third-party valuation specialists. As the final valuations are being performed, increases or decreases in the fair value of relevant balance sheet amounts will result in adjustments, which may result in material differences from the information presented herein.
The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies, if any. The unaudited pro forma condensed combined financial information is preliminary and has been prepared for informational purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that actually would have been realized had Vital Therapies and Immunic been a combined company during the specified periods.
This Updated Unaudited Pro Forma Condensed Combined Financial Information should be read in conjunction with our audited consolidated financial statements as of and for the years ended December 31, 2018 and 2017 and our unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2019 and 2018 filed in our Current Report on Form 8-K filed on June 21, 2019.
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IMMUNIC AG
Unaudited Pro Forma Condensed Combined Balance Sheet March 31, 2019
(in thousands)
Vital Therapies |
Immunic U.S. GAAP Adjusted |
Pro Forma Adjustments |
Note |
Pro Forma Combined |
||||||||||||||||
Assets | ||||||||||||||||||||
Current assets | ||||||||||||||||||||
Cash and cash equivalents | $ | 9,595 | $ | 7,593 | $ | 30,026 | A | $ | 47,214 | |||||||||||
Restricted cash | — | 20,426 | (20,426 | ) | A | — | ||||||||||||||
Prepaid expenses and other current assets | 393 | 502 | 914 | B | 1,809 | |||||||||||||||
Total current assets | 9,988 | 28,521 | 10,514 | 49,023 | ||||||||||||||||
Property and equipment, net | 482 | 41 | (146 | ) | I | 377 | ||||||||||||||
Other assets | 12 | 74 | (12 | ) | H | 74 | ||||||||||||||
Intangible assets, net | — | — | — | — | ||||||||||||||||
In process research and development | — | — | 764 | C | 764 | |||||||||||||||
Goodwill | — | — | 33,103 | D | 33,103 | |||||||||||||||
Total assets | $ | 10,482 | 28,636 | $ | 44,223 | 83,341 | ||||||||||||||
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||||||||||||||
Current liabilities: | ||||||||||||||||||||
Accounts payable | $ | 184 | 511 | $ | — | $ | 695 | |||||||||||||
Accrued expenses and other current liabilities | 1,249 | 655 | 5,812 | E | 7,716 | |||||||||||||||
Total current liabilities | 1,433 | 1,166 | 5,812 | 8,411 | ||||||||||||||||
Long term liabilities | — | 48 | — | 48 | ||||||||||||||||
Series A-2 Convertible preferred stock, €1.00 par value, 299,456 shares authorized, issued and outstanding at March 31, 2019 and December 31, 2018, Liquidation Preference €47,465 ($53,237) as of March 31, 2019 | — | 34,313 | (34,313 | ) | A | — | ||||||||||||||
Series A-1 Convertible preferred stock, €1.00 par value,13,541 authorized, issued and outstanding at March 31, 2019 and December 31, 2018, Liquidation Preference €4,438 ($4,978) at March 31, 2019 | — | 2,879 | (2,879 | ) | A | — | ||||||||||||||
Stockholders’ equity (deficit): | ||||||||||||||||||||
Common Stock | 4 | 56 | (56 | ) | G | — | ||||||||||||||
(4 | ) | G | — | |||||||||||||||||
Additional paid-in capital | 355,874 | — | 30,026 | A | 115,527 | |||||||||||||||
34,313 | A | |||||||||||||||||||
2,879 | A | |||||||||||||||||||
8,853 | F | |||||||||||||||||||
(316,418 | ) | G | ||||||||||||||||||
Stock subscription not yet issued | — | 20,531 | (20,531 | ) | A | — | ||||||||||||||
Accumulated other comprehensive income | 80 | (1,066 | ) | (80 | ) | G | (961 | ) | ||||||||||||
105 | A | |||||||||||||||||||
Accumulated deficit | (346,909 | ) | (29,291 | ) | (1,540 | ) | E | (39,684 | ) | |||||||||||
(8,853 | ) | F | ||||||||||||||||||
346,909 | G | |||||||||||||||||||
Total stockholders’ equity (deficit) | 9,049 | (9,770 | ) | 75,603 | 74,882 | |||||||||||||||
Total liabilities, preferred stock and stockholders’ equity (deficit) | $ | 10,482 | $ | 28,636 | $ | 44,223 | $ | 83,341 |
See accompanying notes to the unaudited pro forma condensed combined financial statements.
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IMMUNIC AG
Unaudited Pro Forma Condensed Combined Statement of Operations For the Three Months Ended March 31, 2019
(in thousands, except share and per share amounts)
Vital Therapies |
Immunic
Adjusted |
Pro Forma Adjustments |
Note |
Pro Forma Combined |
Note | |||||||||||||||||
Operating Expenses: | ||||||||||||||||||||||
Research and development | $ | 494 | $ | 3,355 | $ | — | $ | 3,849 | ||||||||||||||
General and administrative | 2,690 | 1,307 | — | 3,997 | ||||||||||||||||||
Severance costs | 6,369 | — | — | 6,369 | ||||||||||||||||||
Total operating expenses | 9,553 | 4,662 | — | 14,215 | ||||||||||||||||||
Loss from operations | (9,553 | ) | (4,662 | ) | — | (14,215 | ) | |||||||||||||||
Other income (expense): | ||||||||||||||||||||||
Interest income (expense), net | 62 | — | — | 62 | ||||||||||||||||||
Other income (expense), net | (2 | ) | 349 | — | 347 | |||||||||||||||||
Total other income (expense) | 60 | 349 | — | 409 | ||||||||||||||||||
Net loss | $ | (9,493 | ) | $ | (4,313 | ) | $ | — | $ | (13,806 | ) | |||||||||||
Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (86.26 | ) | $ | — | $ | (1.38 | ) | |||||||||||
Weighted-average common shares outstanding, basic and diluted |
43,714,626 | 50,000 | (390,772,012 | ) | 10,019,795 | J |
See accompanying notes to the unaudited pro forma condensed combined financial statements.
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IMMUNIC AG
Unaudited Pro Forma Condensed Combined Statement of Operations For the Year Ended December 31, 2018
(in thousands, except share and per share amounts)
Vital Therapies |
Immunic U.S. GAAP Adjusted |
Pro Forma Adjustments |
Note |
Pro Forma Combined |
Note | |||||||||||||||||
Operating Expenses: | ||||||||||||||||||||||
Research and development | $ | 24,825 | $ | 9,595 | $ | (1,000 | ) | B | $ | 33,420 | ||||||||||||
General and administrative | 13,585 | 2,402 | — | 15,987 | ||||||||||||||||||
Severance costs | 2,395 | — | — | 2,395 | ||||||||||||||||||
Impairment loss | 1,219 | — | — | 1,219 | ||||||||||||||||||
Total operating expenses | 42,024 | 11,997 | (1,000 | ) | 53,021 | |||||||||||||||||
Loss from operations | (42,024 | ) | (11,997 | ) | 1,000 | (53,021 | ) | |||||||||||||||
Other income (expense): | ||||||||||||||||||||||
Interest income (expense), net | 521 | (1 | ) | — | 520 | |||||||||||||||||
Other income (expense), net | 28 | 456 | — | 484 | ||||||||||||||||||
Total other income (expense) | 549 | 455 | — | 1,004 | ||||||||||||||||||
Net loss | $ | (41,475 | ) | $ | (11,542 | ) | $ | 1,000 | $ | (52,017 | ) | |||||||||||
Net loss per share, basic and diluted | $ | (0.98 | ) | $ | (230.84 | ) | $ | — | $ | (5.21 | ) | |||||||||||
Weighted-average common shares | ||||||||||||||||||||||
outstanding, basic and diluted | 42,369,245 | 50,000 | (389,460,265 | ) | 9,986,161 |
See accompanying notes to the unaudited pro forma condensed combined financial statements.
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Notes to the Unaudited Pro Forma Condensed Combined Financial Information
1. | Description of the Transaction |
On January 6, 2019, Vital Therapies, Inc., a Delaware corporation, and Immunic AG, a stock corporation formed under the laws of Germany focused on developing novel oral therapies for chronic inflammatory and autoimmune diseases, entered into a definitive agreement, or the Exchange Agreement, pursuant to which and subject to, among other things, the satisfaction or waiver of the conditions set forth in the Exchange Agreement, Vital Therapies acquired all of the outstanding shares of Immunic in exchange for newly-issued shares of Vital Therapies in an all-stock transaction, or the Transaction. The exchange constituted a transaction qualifying for federal income tax purposes as a tax-free exchange under the provisions of Section 351(a) of the Internal Revenue Code of 1986, as amended. The Merger closed on April 12, 2019.
Subject to the terms and conditions of the Exchange Agreement, at the effective time of the exchange, or the Effective Time, (a) each holder of Immunic’s outstanding shares contributed and transferred by assignment all of the Immunic shares held by such holder in exchange for Vital Therapies’ common stock based on the exchange ratio described below. Immediately following the exchange, Immunic AG is a wholly-owned subsidiary of Vital Therapies and the name of Vital Therapies changed from “Vital Therapies, Inc.” to “Immunic, Inc.”
Under the exchange ratio provided in the Exchange Agreement, as of and immediately after the merger, the Immunic security holders own 88.25% of the aggregate number of shares of the company’s common stock issued and outstanding plus any common stock equivalent outstanding on the Effective Date, or the Post-Closing Shares, and the stockholders of Vital Therapies own 11.75% of the aggregate number of Post-Closing Shares, as of the Effective Date.
Concurrent with Immunic’s entry into the Exchange Agreement, certain of Immunic’s existing security holders entered into an Investment and Subscription Agreement to purchase shares of Immunic’s common stock in a private financing prior to consummation of the Transaction for an aggregate purchase price of $30.0 million.
In addition to other customary conditions, the Transaction required Vital Therapies’ stockholders to approve the issuance of shares to the Immunic security holders, and the amendment of Vital Therapies’ certificate of incorporation effected a reverse split of its shares and changed its name to Immunic, Inc.
2. | Basis of Presentation |
The accompanying unaudited pro forma condensed combined financial information was prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, and pursuant to Article 11 of SEC Regulation S-X. The condensed combined pro forma financial position and results of operations of the combined companies is based upon the separate historical data of Vital Therapies and Immunic. Immunic’s historical financial statements were prepared under International Financial Reporting Standards as issued by the International Accounting Standards Board and converted to U.S. GAAP.
The accompanying unaudited pro forma condensed combined balance sheet as of March 31, 2019 is presented as if the Transaction had been completed on March 31, 2019. The unaudited pro forma condensed combined statement of operations for the three months ended March 31, 2019 and for the year ended December 31, 2018 gives effect to the Transaction as if it took place as of January 1, 2019, and 2018, respectively, and were prepared using the historical results of Vital Therapies and Immunic for the three months ended March 31, 2019, and for the year ended December 31, 2018, respectively.
Accounting Policies
During the preparation of the accompanying unaudited pro forma condensed combined financial information, management did not identify any material differences between Vital Therapies’ accounting policies and the accounting policies of Immunic.
3. | Accounting for the Transaction |
The management of Vital Therapies and Immunic have concluded that the Transaction represents a business combination pursuant to Financial Accounting Standards Board Accounting Standards Codification Topic 805, Business Combinations , or ASC 805. For accounting purposes, Immunic has been determined (i) to be the accounting acquirer based upon the terms of the Transaction and other factors including: (x) Immunic’s security holders own over 80% of the company immediately following the closing of the Transaction, (y) Immunic directors hold a majority board seats in the company, and (z) Immunic management hold all key positions in the management of the combined company, and (ii) that the Transaction was accounted for as a reverse acquisition using the acquisition method of accounting for business combinations under the guidance of ASC 805. Accordingly, Immunic recorded the acquired assets and liabilities at their fair value as of the Transaction closing date.
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A purchase price allocation has been used to prepare the pro forma adjustments in the unaudited pro forma condensed combined balance sheet. The final purchase price allocation will be determined when the final assets and liabilities and any asset sales are known, and detailed valuations and any other studies and calculations deemed necessary have been completed. The final purchase price allocation could differ materially from the preliminary purchase price allocation used to prepare the pro forma adjustments resulting from changes to assets and liabilities.
The purchase price, or the proportional value to be retained by the Vital Therapies stockholders and the holders of its common stock equivalents, has been based on the last reported sale price of Vital Therapies common stock on The Nasdaq Global Market on April 12, 2019. This preliminary purchase price is based on the aggregate number of shares of Vital Therapies’ common stock and common stock equivalents expected to be outstanding at the closing of the Transaction as summarized below (amounts in thousands, except share and per share amounts):
Estimated number of shares to be owned by Vital Therapies stockholders | 47,469,694 | |||
Multiplied by the fair value per share of Vital Therapies commons stock | $ | 0.83 | ||
Estimated purchase price | $ | 39,400 |
Any excess of the purchase price over the estimated fair value of the net assets acquired will be recorded as goodwill on the balance sheet. Any excess of the estimated fair value of the net assets acquired over the purchase price paid will be recorded as a bargain purchase gain in the statement of operations.
The net tangible and intangible assets acquired and liabilities assumed in connection with the Transaction are recorded at their acquisition date fair values with the excess going to goodwill. The following summarizes an allocation of the purchase price as if the Transaction was completed on March 31, 2019:
Cash and cash equivalents | $ | 9,595 | ||
Prepaid expenses and other assets | 1,307 | |||
Property and equipment | 336 | |||
In-process research and development | 764 | |||
Accounts payable, accrued expenses and other liabilities | (5,705 | ) | ||
Net assets acquired | 6,297 | |||
Less: preliminary purchase price | 39,400 | |||
Goodwill | $ | 33,103 |
4. | Pro forma adjustments |
The pro forma adjustments, based on preliminary estimates that may change significantly as additional information is obtained, are as follows:
A. | Adjustments to reflect an estimated $30.0 million in net proceeds from the sale of equity capital to be raised by Immunic as part of the Pre-Closing Financing prior to consummation of the Transaction, the issuance of Immunic shares in conjunction with such financing and the simultaneous conversion of Series A-2 and A-1 preferred shares into common shares. |
B. | Reflects the estimated fair value of inventory, supplies and prepaid expenses on hand at April 12, 2019 that had been expensed by Vital Therapies in accordance with U.S. GAAP |
C. | To reflect the estimated fair value of indefinite-lived intangible assets associated with Vital Therapies’ ELAD System. These intangible assets would only be amortized over their respective estimated useful lives after approval, if any, by the FDA or other regulatory agencies. |
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D. | Represents an adjustment to record goodwill resulting from the Transaction. Goodwill represents the excess of the preliminary estimated purchase price over the estimated fair value of Vital Therapies identified net assets. |
E. | To reflect the accrued liabilities that are transaction costs to be incurred by Immunic of $1.0 million for investment banking services and $0.5 million in legal and other expenses as well as by Vital Therapies of $1,7 million in severance, benefits and taxes, $1.0 million in investment banking services, $1.3 million in director and officer liability insurance and $0.3 million in legal and other expenses. These pro forma transaction costs are not reflected in the unaudited pro forma condensed combined statements of operations as these amounts are not expected to have a continuing effect on the operating results of the combined company. |
F. | Adjustment to reflect the acceleration of restricted stock units held by Vital Therapies officers on termination, the issuance of shares to Immunic officers as a transaction bonus and issuance of shares to 4SC AG in connection with agreement executed in April 2019 upon closing of Transaction. |
G. | To reflect (1) the elimination of Vital Therapies’ historical stockholders’ equity and (2) the issuance of Vital Therapies common shares in exchange for Immunic’s common and preferred shares to finance the acquisition. |
H. | Adjustment to reflect the fair value of other assets relating to Vital Therapies right-of-use asset in regard to its existing lease. |
I. | Adjustment to reflect the fair value of property and equipment of Vital Therapies |
J. | Reflects the pro forma weighted average shares outstanding, including the issuance of common shares to finance the Transaction after giving effect to the reverse stock split. See Note 5 below. |
5. | Earnings Per Share |
Pro forma loss per share, basic and diluted, including pro forma impacts of the Merger, is calculated as follows:
For the Three Months Ended March 31, 2019 | For the Year Ended December 31, 2018 | |||||||
Basic and Diluted | ||||||||
Net loss, as originally reported | $ | (9,493 | ) | $ | (41,475 | ) | ||
Pro forma net loss | (13,806 | ) | (52,017 | ) | ||||
Weighted average outstanding shares for the year, as originally reported | 43,714,626 | 42,369,245 | ||||||
Pro forma adjustment - common shares issued to finance the transaction | 357,077,181 | 357,077,181 | ||||||
Effect of 1 to 40 reverse stock split | (390,772,012 | ) | (389,460,265 | ) | ||||
Pro forma weighted average outstanding shares for the year | 10,019,795 | 9,986,161 | ||||||
Basic and diluted loss per share, as originally reported | $ | (0.22 | ) | $ | (0.98 | ) | ||
Pro forma basic and diluted loss per share | $ | (1.38 | ) | $ | (5.21 | ) |
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