Netherlands
|
| |
Not Applicable
|
(State or other jurisdiction of incorporation or organization)
|
| |
(I.R.S. Employer Identification Number)
|
Title of each class of securities to be registered
|
| |
Amount to be
registered(1) |
| |
Proposed maximum
aggregate price per unit(2) |
| |
Proposed maximum
aggregate offering price(3) |
| |
Amount of
registration fee(3) |
Common Shares, nominal value €0.12 per share(4)
|
| |
|
| |
|
| |
|
| |
(1)
|
Debt securities(4)
|
| |
|
| |
|
| |
|
| |
(1)
|
Warrants(4)
|
| |
|
| |
|
| |
|
| |
(1)
|
Purchase Contracts(4)
|
| |
|
| |
|
| |
|
| |
(1)
|
Units(4)
|
| |
|
| |
|
| |
|
| |
(1)
|
Total
|
| |
$200,000,000
|
| |
|
| |
$200,000,000
|
| |
$25,960
|
(1)
|
There are being registered hereunder such indeterminate number of the securities of each identified class being registered as may be sold by the registrant from time to time at indeterminate prices, with the maximum aggregate public offering price not to exceed $200,000,000. If any debt securities are issued at an original issue discount, then the offering price of such debt securities shall be in such greater principal amount as shall result in a maximum aggregate offering price not to exceed $200,000,000, less the aggregate dollar amount of all securities previously issued hereunder.
|
(2)
|
The proposed maximum aggregate price per unit of each class of securities will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of securities pursuant to the General Instruction II.C. of Form F-3 under the Securities Act of 1933, as amended, or the Securities Act.
|
(3)
|
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act with respect to the securities to be sold by the registrant. In no event will the aggregate offering price of all securities sold by the registrant from time to time pursuant to this registration statement exceed $200,000,000. Pursuant to Rule 415(a)(6) and Rule 457(p) under the Securities Act, the previously paid fees made to the Financial Industry Regulatory Authority in connection with the registrant's prior registration statement (File No. 333-230560) are available for offset.
|
(4)
|
Also includes such indeterminate number of ordinary shares of the registrant as may be issued upon exercise, conversion or exchange of these securities. Separate consideration may or may not be received for securities that are issuable upon exercise, conversion or exchange of other securities.
|
|
| |
Page
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| | ||
| | ||
| | ||
| |
•
|
the timing, progress and results of clinical trials of IFX-1 and any other product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally;
|
•
|
the timing and outcome of any discussions or submission of filings for regulatory approval of IFX-1 or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of IFX-1 for any indication;
|
•
|
our ability to leverage our proprietary anti-C5a technology to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases;
|
•
|
our ability to protect, maintain and enforce our intellectual property protection for IFX-1 and any other product candidates, and the scope of such protection;
|
•
|
whether the Food and Drug Administration, European Medicines Agency or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials;
|
•
|
the success of our future clinical trials for IFX-1 and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials;
|
•
|
our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of IFX-1 or any other product candidates, if approved for commercial use;
|
•
|
our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers for our planned future clinical trials;
|
•
|
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
|
•
|
our expectations regarding the scope of any approved indication for IFX-1;
|
•
|
our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales;
|
•
|
our ability to commercialize IFX-1 or our other product candidates;
|
•
|
if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview;
|
•
|
our ability to comply with enacted and future legislation in seeking marketing approval and commercialization;
|
•
|
our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel;
|
•
|
our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry;
|
•
|
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a foreign private issuer;
|
•
|
the recent outbreak of the COVID-19, which may cause business disruptions and could adversely impact our business, including our supply chain, clinical trials and commercialization of our product candidates; and
|
•
|
other risk factors discussed under “Risk Factors.”
|
|
IFX-1
|
| |
Placebo
|
| |||||||||
|
Minimal dose
|
| |
Low dose
|
| |
Medium dose
|
| |
High dose
|
| |
placebo Q2W
|
|
|
400mg every 4
weeks (Q4W) |
| |
800mg every 4
weeks (Q4W) |
| |
800mg every 2
weeks (Q2W) |
| |
1200mg every 2
weeks (Q2W) |
| |||
|
40.0%
|
| |
51.5%
|
| |
38.7%
|
| |
45.5%
|
| |
47.1%
|
|
•
|
70.6% of the Responder Group maintained their HiSCR response during the OLE, and
|
•
|
41.8% of the Non-responder Group became responders at week 40.
|
•
|
abscesses and inflammatory nodules (AN count) of -66.9% (mean) and -75.0% (median), and
|
•
|
draining fistula of -46.0% (mean) and -51.5% (median).
|
•
|
Rapid onset of action: IFX-1 has fast onset of action such that after its intravenous administration, IFX-1 inhibits C5a-induced signaling completely, providing immediate protection from C5a induced priming and activation of neutrophils in this disease. This may result in a faster response rate and a potentially quicker induction of remission when compared to the currently available treatment options.
|
•
|
Potential potency advantages (over receptor inhibition): IFX-1 blocks the upstream ligand C5a, which inhibits signaling through both receptors, C5aR and C5L2; C5a pro-inflammatory MoA through both C5aR and C5L2 has been shown to be important for ANCA-primed and C5a-induced neutrophil degranulation as key disease-driving mechanism in AAV (published by Hao and Wang et al 2013, PloS ONE).
|
•
|
Advance our lead program IFX-1 for HS.
|
•
|
Complete Phase II clinical development of IFX-1 for AAV, PG, oncological diseases and COVID-19 induced severe pneumonia and other complement-mediated autoimmune and inflammatory diseases.
|
•
|
Pursue the clinical development of IFX-2 and continue to expand the breadth of our anti-C5a technology.
|
•
|
Commercialize IFX-1, if approved, either independently or in collaboration with a partner.
|
•
|
Solidify our leadership position in the anti-C5a space by leveraging the full potential of our proprietary anti-C5a technology and expertise in complement and inflammation.
|
•
|
inclusion of only three years of audited financial statements with correspondingly reduced “Management’s discussion and analysis of financial condition and results of operations” disclosure in this prospectus;
|
•
|
an exception from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;
|
•
|
reduced disclosure about our executive compensation arrangements in our periodic reports and registration statements; and
|
•
|
exemptions from the requirements of holding non-binding advisory votes on executive compensation and golden parachute arrangements.
|
•
|
the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;
|
•
|
the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and
|
•
|
the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specific information, or current reports on Form 8-K, upon the occurrence of specified significant events.
|
•
|
to develop, license, manufacture and commercialize pharmaceutical products;
|
•
|
to develop and commercialize tests and analytical methods;
|
•
|
to participate in, to finance, to hold any other interest in and to conduct the management or supervision of other entities, companies, partnerships and businesses;
|
•
|
to acquire, administer, exploit, invest, encumber and dispose of assets and liabilities;
|
•
|
to furnish guarantees, to provide security, to warrant performance in any other way and to assume liability, whether jointly and severally or otherwise, in respect of obligations of group companies or other parties; and
|
•
|
to do anything which, in the widest sense, is connected with or may be conducive to the objectives described above.
|
•
|
Executive directors should be appointed for a maximum period of four years, without limiting the number of consecutive terms executive directors may serve.
|
•
|
Non-executive directors should be appointed for two consecutive periods of no more than four years.
|
1
|
NTD: Subject to ND review.
|
•
|
a director should report any potential conflict of interest in a transaction that is of material significance to the company and/or to such director to the other directors without delay, providing all relevant information in relation to the conflict;
|
•
|
the board of directors should then decide, outside the presence of the director concerned, whether there is a conflict of interest;
|
•
|
transactions in which there is a conflict of interest with a director should be agreed on arms’ length terms; and
|
•
|
a decision to enter into such a transaction in which there is a conflict of interest with a director that is of material significance to the company and/or to such director shall require the approval of the board of directors, and such transactions should be disclosed in the company’s annual board report.
|
•
|
the material facts as to the director’s relationship or interest are disclosed and a majority of disinterested directors consent;
|
•
|
the material facts are disclosed as to the director’s relationship or interest and a majority of shares entitled to vote thereon consent; or
|
•
|
the transaction is fair to the corporation at the time it is authorized by the board of directors, a committee of the board of directors or the stockholders.
|
•
|
options awarded to our executive directors as part of their compensation could (subject to the terms of the option awards) vest and become exercisable during the first three years after the date of grant;
|
•
|
our directors may generally sell our common shares held by them at any point in time, subject to applicable law, company policy and applicable lock-up arrangements;
|
•
|
our non-executive directors may be granted compensation in the form of shares, options and/or other equity-based compensation; and
|
•
|
our executive directors may be entitled to a severance payment in excess of their respective annual base salaries.
|
•
|
the authorization of a class of preferred shares that may be issued by our board of directors to the protective foundation, in such a manner as to dilute the interest of any potential acquirer;
|
•
|
the staggered multi-year terms of our directors (with subsequent terms as may be nominated by our board of directors and approved by our general meeting of shareholders), as a result of which only part of our directors may be subject to election or re-election in any one year;
|
•
|
a provision that our directors may only be removed at the general meeting of shareholders by a two-thirds majority of votes cast representing at least 50% of our outstanding share capital if such removal is not proposed by our board of directors;
|
•
|
our directors being appointed on the basis of a binding nomination by our board of directors, which can only be overruled by the general meeting of shareholders by a resolution adopted by at least a two-thirds majority of the votes cast, provided such majority represents more than half of the issued share capital (in which case the board of directors shall make a new nomination);
|
•
|
a provision allowing, among other matters, the former chairman of our board of directors or our former chief executive officer, as applicable, to manage our affairs if all of our directors are removed from office and to appoint others to be charged with the management and supervision of our affairs until new directors are appointed by the general meeting of shareholders on the basis of a binding nomination discussed above; and
|
•
|
requirements that certain matters, including an amendment of our Articles of Association, may only be brought to our shareholders for a vote upon a proposal by our board of directors.
|
•
|
the transaction that will cause the person to become an interested stockholder is approved by the board of directors of the target prior to the transactions;
|
•
|
after the completion of the transaction in which the person becomes an interested stockholder, the interested stockholder holds at least 85% of the voting stock of the corporation not including shares owned by persons who are directors and officers of interested stockholders and shares owned by specified employee benefit plans; or
|
•
|
after the person becomes an interested stockholder, the business combination is approved by the board of directors of the corporation and holders of at least 66.67% of the outstanding voting stock, excluding shares held by the interested stockholder.
|
•
|
a transfer of the business or virtually the entire business to a third party;
|
•
|
the entry into or termination of a long-term cooperation of the company or a subsidiary with another legal entity or company or as a fully liable partner in a limited partnership or general partnership, if such cooperation or termination is of a far-reaching significance for the company; and
|
•
|
the acquisition or divestment by the company or a subsidiary of a participating interest in the capital of a company having a value of at least one-third of the amount of its assets according to its balance sheet and explanatory notes or, if the company prepares a consolidated balance sheet, according to its consolidated balance sheet and explanatory notes in the last adopted annual accounts of the company.
|
•
|
classification as senior or subordinated debt securities;
|
•
|
ranking of the specific series of debt securities relative to other outstanding indebtedness, including subsidiaries’ debt;
|
•
|
if the debt securities are subordinated, the aggregate amount of outstanding indebtedness, as of a recent date, that is senior to the subordinated securities, and any limitation on the issuance of additional senior indebtedness;
|
•
|
the designation, aggregate principal amount and authorized denominations;
|
•
|
the date or dates on which the principal of the debt securities may be payable;
|
•
|
the rate or rates (which may be fixed or variable) per annum at which the debt securities shall bear interest, if any;
|
•
|
the date or dates from which such interest shall accrue, on which such interest shall be payable, and on which a record shall be taken for the determination of holders of the debt securities to whom interest is payable;
|
•
|
the place or places where the principal and interest shall be payable;
|
•
|
our right, if any, to redeem the debt securities, in whole or in part, at our option and the period or periods within which, the price or prices at which and any terms and conditions upon which such debt securities may be so redeemed, pursuant to any sinking fund or otherwise;
|
•
|
our obligation, if any, of the Company to redeem, purchase or repay any debt securities pursuant to any mandatory redemption, sinking fund or other provisions or at the option of a holder of the debt securities;
|
•
|
if other than denominations of $2,000 and any higher integral multiple of $1,000, the denominations in which the debt securities will be issuable;
|
•
|
if other than the currency of the United States, the currency or currencies, in which payment of the principal and interest shall be payable;
|
•
|
whether the debt securities will be issued in the form of global securities;
|
•
|
provisions, if any, for the defeasance of the debt securities;
|
•
|
any U.S. federal income tax consequences; and
|
•
|
other specific terms, including any deletions from, modifications of or additions to the events of default or covenants described below or in the applicable indenture.
|
•
|
subject to Dutch law, any insolvency or bankruptcy proceedings, or any receivership, dissolution, winding up, total or partial liquidation, reorganization or other similar proceedings in respect of us or a substantial part of our property, whether voluntary or involuntary;
|
•
|
(i) a default having occurred with respect to the payment of principal or interest on or other monetary amounts due and payable with respect to any senior indebtedness or (ii) an event of default (other than a default described in clause (i) above) having occurred with respect to any senior indebtedness that permits the holder or holders of such senior indebtedness to accelerate the maturity of such senior indebtedness. Such a default or event of default must have continued beyond the period of grace, if any, provided in respect of such default or event of default, and such a default or event of default shall not have been cured or waived or shall not have ceased to exist; and
|
•
|
the principal of, and accrued interest on, any series of the subordinated debt securities having been declared due and payable upon an event of default pursuant to the subordinated indenture. This declaration must not have been rescinded and annulled as provided in the subordinated indenture.
|
(1)
|
default in the payment of the principal on the debt securities when it becomes due and payable at maturity or otherwise;
|
(2)
|
default in the payment of interest on the debt securities when it becomes due and payable, and such default continues for a period of 30 days;
|
(3)
|
default in the performance, or breach, of any covenant in the indenture (other than defaults specified in clauses (1) or (2) above) and the default or breach continues for a period of 90 consecutive days or more after written notice to us by the trustee or to us and the trustee by the holders of 25% or more in aggregate principal amount of the outstanding debt securities of all series affected thereby;
|
(4)
|
the occurrence of certain events of bankruptcy, insolvency, or similar proceedings with respect to us or any substantial part of our property; or
|
(5)
|
any other Events of Default that may be set forth in the applicable prospectus supplement.
|
•
|
the rights of registration of transfer and exchange of debt securities, and our right of optional redemption, if any;
|
•
|
substitution of mutilated, defaced, destroyed, lost or stolen debt securities;
|
•
|
the rights of holders of the debt securities to receive payments of principal and interest;
|
•
|
the rights, obligations and immunities of the trustee; and
|
•
|
the rights of the holders of the debt securities as beneficiaries with respect to the property deposited with the trustee payable to them (as described below);
|
•
|
either:
|
•
|
all debt securities of any series issued that have been authenticated and delivered have been delivered by us to the trustee for cancellation; or
|
•
|
all the debt securities of any series issued that have not been delivered by us to the trustee for cancellation have become due and payable or will become due and payable within one year or are to be called for redemption within one year under arrangements satisfactory to the trustee for the giving of notice of redemption by such trustee in our name and at our expense, and we have irrevocably deposited or caused to be deposited with the trustee as trust funds the entire amount sufficient to pay at maturity or upon redemption all debt securities of such series not delivered to the trustee for cancellation, including principal and interest due or to become due on or prior to such date of maturity or redemption;
|
•
|
we have paid or caused to be paid all other sums then due and payable under such indenture; and
|
•
|
we have delivered to the trustee an officers’ certificate and an opinion of counsel, each stating that all conditions precedent under such indenture relating to the satisfaction and discharge of such indenture have been complied with.
|
•
|
we must irrevocably have deposited or caused to be deposited with the trustee as trust funds in trust for the purpose of making the following payments, specifically pledged as security for, and dedicated solely to the benefits of the holders of the debt securities of a series:
|
•
|
money in an amount;
|
•
|
U.S. government obligations; or
|
•
|
a combination of money and U.S. government obligations,
|
•
|
we have delivered to the trustee an opinion of counsel stating that, under then applicable U.S. federal income tax law, the holders of the debt securities of that series will not recognize gain or loss for U.S. federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur;
|
•
|
no default relating to bankruptcy or insolvency and, in the case of a covenant defeasance, no other default has occurred and is continuing at any time;
|
•
|
if at such time the debt securities of such series are listed on a national securities exchange, we have delivered to the trustee an opinion of counsel to the effect that the debt securities of such series will not be delisted as a result of such defeasance; and
|
•
|
we have delivered to the trustee an officers’ certificate and an opinion of counsel stating that all conditions precedent with respect to the defeasance have been complied with.
|
•
|
the title of the warrants;
|
•
|
the aggregate number of warrants offered;
|
•
|
the designation, number and terms of the debt securities, common shares or other securities purchasable upon exercise of the warrants and procedures by which those numbers may be adjusted;
|
•
|
the exercise price of the warrants;
|
•
|
the dates or periods during which the warrants are exercisable;
|
•
|
the designation and terms of any securities with which the warrants are issued;
|
•
|
if the warrants are issued as a unit with another security, the date on and after which the warrants and the other security will be separately transferable;
|
•
|
if the exercise price is not payable in U.S. dollars, the foreign currency, currency unit or composite currency in which the exercise price is denominated;
|
•
|
any minimum or maximum amount of warrants that may be exercised at any one time;
|
•
|
any terms relating to the modification of the warrants;
|
•
|
any terms, procedures and limitations relating to the transferability, exchange or exercise of the warrants; and
|
•
|
any other specific terms of the warrants.
|
•
|
the terms of the units and of the common shares, debt securities, warrants and/or purchase contracts comprising the units, including whether and under what circumstances the securities comprising the units may be traded separately;
|
•
|
a description of the terms of any unit agreement governing the units; and
|
•
|
a description of the provisions for the payment, settlement, transfer or exchange of the units.
|
•
|
through underwriters or dealers;
|
•
|
directly to a limited number of purchasers or to a single purchaser;
|
•
|
in “at-the-market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an existing trading market on an exchange or otherwise;
|
•
|
through agents; or
|
•
|
through any other method permitted by applicable law and described in the applicable prospectus supplement.
|
•
|
the name or names of any underwriters, dealers or agents;
|
•
|
the purchase price of such securities and the proceeds to be received by us, if any;
|
•
|
any underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation;
|
•
|
any initial public offering price;
|
•
|
any discounts or concessions allowed or reallowed or paid to dealers; and
|
•
|
any securities exchanges on which the securities may be listed.
|
•
|
negotiated transactions;
|
•
|
at a fixed public offering price or prices, which may be changed;
|
•
|
at market prices prevailing at the time of sale;
|
•
|
at prices related to prevailing market prices; or
|
•
|
at negotiated prices.
|
•
|
our 2019 Annual Report on Form 20-F for the fiscal year ended December 31, 2019, or the Annual Report;
|
•
|
•
|
the description of our common shares contained in our registration statement on Form 8-A filed with the SEC on November 7, 2017, as updated by the description of our common shares filed as Exhibit 2.4 to the Annual Report, including any amendments or supplements thereto.
|
|
| |
Amount To Be
Paid |
SEC registration fee
|
| |
$25,960
|
FINRA filing fee
|
| |
$225,500**
|
Transfer agent’s fees
|
| |
*
|
Printing and engraving expenses
|
| |
*
|
Legal fees and expenses
|
| |
*
|
Accounting fees and expenses
|
| |
*
|
Miscellaneous
|
| |
*
|
Total
|
| |
$25,960
|
*
|
To be provided by a prospectus supplement or a Report on Form 6–K that is incorporated by reference into this prospectus.
|
**
|
Previously paid in connection with the filing of the Registration Statement.
|
(a)
|
any financial losses or damages incurred by such indemnified person;
|
(b)
|
any expense reasonably paid or incurred by such indemnified person in connection with any threatened, pending or completed suit, claim, action or legal proceedings of a civil, criminal, administrative or other nature, formal or informal, in which he becomes involved:
|
(a)
|
if a competent court or arbitral tribunal has established that the acts or omissions of such indemnified person that led to the financial losses, damages, expenses, suit, claim, action or legal proceedings as described above are of an unlawful nature (including acts or omissions which are considered to constitute malice, gross negligence, intentional recklessness and/or serious culpability attributable to such indemnified person);
|
(b)
|
to the extent that his financial losses, damages and expenses are covered under an insurance and the relevant insurer has settled, or has provided reimbursement for, these financial losses, damages and expenses (or has irrevocably undertaken to do so); or
|
(c)
|
in relation to proceedings brought by such indemnified person against the company, except for proceedings brought to enforce indemnification to which he is entitled pursuant to the Articles of Association, pursuant to an agreement between such indemnified person and the company which has been approved by the board of directors or pursuant to an insurance taken out by the company for the benefit of such indemnified person.
|
1.1*
|
| |
Form of Underwriting Agreement
|
| |
Articles of Association of InflaRx N.V. (incorporated herein by reference to Exhibit 3.2 to the post-effective amendment to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on November 9, 2017)
|
|
| |
Form of Senior Indenture (incorporated herein by reference to Exhibit 4.2 to the Company’s Registration Statement on Form F-3 (File No. 333-230560) filed with the SEC on March 28, 2019)
|
|
| |
Form of Subordinated Indenture (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form F-3 (File No. 333-230560) filed with the SEC on March 28, 2019)
|
|
4.4*
|
| |
Form of Senior Note
|
4.5*
|
| |
Form of Subordinated Note
|
4.6*
|
| |
Form of Warrant Agreement
|
4.7*
|
| |
Form of Purchase Contract
|
4.8*
|
| |
Form of Unit Agreement
|
| |
Opinion of NautaDutilh N.V.
|
|
| |
Opinion of Kirkland & Ellis LLP
|
|
| |
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft, independent registered public accounting firm
|
|
| |
Consent of NautaDutilh N.V. (included in Exhibit 5.1)
|
|
| |
Consent of Kirkland & Ellis LLP (included in Exhibit 5.2)
|
|
| |
Powers of Attorney (included on signature page to the registration statement)
|
|
25.1*
|
| |
Statement of Eligibility on Form T-1 for Senior Indenture
|
25.2*
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| |
Statement of Eligibility on Form T-1 for Subordinated Indenture
|
*
|
To be filed, if necessary, by amendment.
|
(a)
|
The undersigned registrant hereby undertakes:
|
(1)
|
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
(i)
|
To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii)
|
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) (§ 230.424(b) of this chapter) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
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(iii)
|
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
|
(A)
|
Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the registration statement is on Form S-1(§ 239.11 of this chapter), Form S-3 (§ 239.13 of this chapter), Form SF-3 (§ 239.45 of this chapter) or Form F-3 (§ 239.33 of this chapter) and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) (§ 230.424(b) of this chapter) that is part of the registration statement.
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(2)
|
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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(3)
|
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
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(4)
|
To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A of Form 20–F (§ 249.220f of this chapter) at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act (15 U.S.C. 77j(a)(3)) need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (a)(4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with respect to registration statements on Form F–3 (§ 239.33 of this chapter), a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Act or Item 8.A of Form 20–F if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F–3.
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(5)
|
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
(A)
|
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
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(B)
|
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date; or
|
(6)
|
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:
|
(i)
|
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
|
(ii)
|
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
|
(iii)
|
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
|
(iv)
|
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
(b)
|
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
(c)
|
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
|
(d)
|
The undersigned registrant hereby undertakes that:
|
(1)
|
For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
|
(2)
|
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
(e)
|
The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations prescribed by the Commission under Section 305(b)(2) of the Act.
|
|
| |
INFLARX N.V.
|
|||
|
| |
|
| |
|
|
| |
By:
|
| |
/s/ Niels Riedemann
|
|
| |
|
| |
Name: Niels Riedemann
|
|
| |
|
| |
Title: Chief Executive Officer
|
NAME
|
| |
TITLE
|
|
| |
|
/s/ Niels Riedemann
|
| |
Chief Executive Officer and Director
(principal executive officer) |
Niels Riedemann
|
| ||
|
| |
|
/s/ Arnd Christ
|
| |
Chief Financial Officer (principal financial
and accounting officer) |
Arnd Christ
|
| ||
|
| |
|
/s/ Nicolas Fulpius
|
| |
Chairman and Director
|
Nicolas Fulpius
|
| ||
|
| |
|
/s/ Renfeng Guo
|
| |
Director and Authorized Representative
in the United States |
Renfeng Guo
|
| ||
|
| |
|
/s/ Katrin Uschmann
|
| |
Director
|
Katrin Uschmann
|
| ||
|
| |
|
/s/ Lina Ma
|
| |
Director
|
Lina Ma
|
| ||
|
| |
|
/s/ Mark Kubler
|
| |
Director
|
Mark Kubler
|
| ||
|
| |
|
/s/ Richard Brudnick
|
| |
Director
|
Richard Brudnick
|
|
ATTORNEYS • CIVIL LAW NOTARIES • TAX ADVISERS
|
||
P.O. Box 7113
1007 JC Amsterdam
Beethovenstraat 400
1082 PR Amsterdam
T +31 20 71 71 000
F +31 20 71 71 111
|
Amsterdam, July 8.
To the Company
|
Ladies and Gentlemen:
|
|
We have acted as legal counsel as to Dutch law to the Company in connection with the filing of the Registration Statement with the SEC. This opinion letter is
rendered to you in order to be filed with the SEC as an exhibit to the Registration Statement.
|
|
Capitalised terms used in this opinion letter have the meanings set forth in Exhibit A to this opinion letter. The section headings used in this opinion letter are
for convenience of reference only and are not to affect its construction or to be taken into consideration in its interpretation.
|
|
This opinion letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in
it. Nothing in this opinion letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in any document reviewed by us in connection with this opinion letter.
|
|
In rendering the opinions expressed in this opinion letter, we have reviewed and relied upon a draft of the Registration Statement and pdf copies of the Corporate
Documents and we have assumed that any issuance of Registered Securities shall be effected for bona fide commercial reasons. We have not investigated or verified any factual matter disclosed to us in the course of our review.
|
|
This opinion letter sets out our opinion on certain matters of the laws with general applicability of the Netherlands, and, insofar as they are directly applicable
in the Netherlands, of the European Union, as at today’s date and as presently interpreted under published authoritative case law of the Dutch courts, the General Court and the Court of Justice of the European Union. We do not express any
opinion on Dutch or European competition law, data protection law, tax law or regulatory law. No undertaking is assumed on our part to revise, update or amend this opinion letter in connection with or to notify or inform you of, any
developments and/or changes of Dutch law subsequent to today’s date. We do not purport to opine on the consequences of amendments to the Registration Statement or the Corporate Documents subsequent to the date of this opinion letter.
|
|
This communication is confidential and may be subject to professional privilege. All legal relationships are subject to NautaDutilh N.V.'s general terms and conditions (see https://www.nautadutilh.com/terms),
which apply mutatis mutandis to our relationship with third parties relying on statements of NautaDutilh N.V., include a limitation of liability clause, have been filed with the Rotterdam District Court and will be provided free of charge
upon request. NautaDutilh N.V.; corporate seat Rotterdam; trade register no. 24338323.
|
|
|
2
|
The opinions expressed in this opinion letter are to be construed and interpreted in accordance with Dutch law. The competent courts at Amsterdam, the Netherlands,
have exclusive jurisdiction to settle any issues of interpretation or liability arising out of or in connection with this opinion letter. Any legal relationship arising out of or in connection with this opinion letter (whether contractual or
non-contractual), including the above submission to jurisdiction, is governed by Dutch law and shall be subject to the general terms and conditions of NautaDutilh. Any liability arising out of or in connection with this opinion letter shall
be limited to the amount which is paid out under NautaDutilh’s insurance policy in the matter concerned. No person other than NautaDutilh may be held liable in connection with this opinion letter.
|
||
In this opinion letter, legal concepts are expressed in English terms. The Dutch legal concepts concerned may not be identical in meaning to the concepts described
by the English terms as they exist under the law of other jurisdictions. In the event of a conflict or inconsistency, the relevant expression shall be deemed to refer only to the Dutch legal concepts described by the English terms.
|
||
For the purposes of this opinion letter, we have assumed that:
|
||
a.
|
each copy of a document conforms to the original, each original is authentic, and each signature is the genuine signature of the individual purported to have placed
that signature;
|
|
b.
|
the Registration Statement will have become effective by the SEC in the form reviewed by us;
|
|
c.
|
the Current Articles are the Articles of Association currently in force;
|
|
d.
|
the authorized share capital (maatschappelijk kapitaal) of the Company allows for the issuance of the Registered Shares;
|
|
e.
|
any Registered Securities shall be issued, and any pre-emption rights in connection therewith shall have been excluded, pursuant to resolutions validly passed by
the corporate body (orgaan) of the Company duly authorized to do so;
|
|
f.
|
the issue price for any Registered Shares shall at least equal the aggregate nominal value thereof, any conversion, exchange or exercise price of other Registered
Securities shall at least equal the aggregate nominal value of the underlying Registered Shares, and any such issue, conversion, exchange or exercise price shall have been satisfied in cash and shall have been received and accepted by the
Company ultimately upon the issuance of the relevant Registered Shares and, where relevant, the Company shall have consented to payment in a currency other than Euro;
|
|
|
3
|
g.
|
any Registered Shares issued in connection with the conversion, exchange or exercise of other Registered Securities shall be issued pursuant to a valid conversion,
exchange or exercise of such Registered Securities in accordance with their respective terms; and
|
|
h.
|
no Registered Securities shall be offered to the public (aanbieden aan het publiek) in the Netherlands other than in
conformity with the Prospectus Regulation, the DFSA and the rules promulgated thereunder.
|
|
Based upon and subject to the foregoing and subject to the qualifications set forth in this opinion letter and to any matters, documents or events not disclosed to
us, we express the following opinions:
|
||
Corporate Status
|
||
1.
|
The Company has been duly incorporated as a besloten vennootschap met beperkte aansprakelijkheid and is validly existing
as a naamloze vennootschap.
|
|
Registered Shares
|
||
2.
|
The Registered Shares, when issued by the Company and accepted by the acquiror(s) of such Registered Shares, shall be validly issued, fully paid and non-assessable.
|
|
The opinions expressed above are subject to the following qualifications:
|
||
A.
|
Opinion 1 must not be read to imply that the Company cannot be dissolved (ontbonden). A company such as the Company may be
dissolved, inter alia by the competent court at the request of the company’s board of directors, any interested party (belanghebbende) or the public prosecution office in certain circumstances, such as
when there are certain defects in the incorporation of the company. Any such dissolution will not have retro-active effect.
|
|
|
4
|
B.
|
Pursuant to Section 2:7 DCC, any transaction entered into by a legal entity may be nullified by the legal entity itself or its liquidator in bankruptcy proceedings
(curator) if the objects of that entity were transgressed by the transaction and the other party to the transaction knew or should have known this without independent investigation (wist of zonder eigen onderzoek moest weten). The Dutch Supreme Court (Hoge Raad der Nederlanden) has ruled that in determining whether the objects of a legal entity
are transgressed, not only the description of the objects in that legal entity’s articles of association (statuten) is decisive, but all (relevant) circumstances must be taken into account, in
particular whether the interests of the legal entity were served by the transaction. Based on the objects clause contained in the Current Articles, we have no reason to believe that, by issuing Registered Securities, the Company would
transgress the description of the objects contained in its Articles of Association. However, we cannot assess whether there are other relevant circumstances that must be taken into account, in particular whether the interests of the Company
are served by issuing Registered Securities since this is a matter of fact.
|
||
C.
|
Pursuant to Section 2:98c DCC, a naamloze vennootschap may grant loans (leningen
verstrekken) only in accordance with the restrictions set out in Section 2:98c DCC, and may not provide security (zekerheid stellen), give a price guarantee (koersgarantie
geven) or otherwise bind itself, whether jointly and severally or otherwise with or for third parties (zich op andere wijze sterk maken of zich hoofdelijk of anderszins naast of voor anderen
verbinden) with a view to (met het oog op) the subscription or acquisition by third parties of shares in its share capital or depository receipts. This prohibition also applies to its
subsidiaries (dochtervennootschappen). It is generally assumed that a transaction entered into in violation of Section 2:98c DCC is null and void (nietig).
|
||
D.
|
The opinions expressed in this opinion letter may be limited or affected by:
|
||
a.
|
any applicable bankruptcy, insolvency, reorganisation, moratorium or other similar laws or procedures now or hereafter in effect, relating to or affecting the
enforcement or protection of creditors’ rights generally;
|
||
b.
|
the provisions of fraudulent preference and fraudulent conveyance (Actio Pauliana) and similar rights available in other
jurisdictions to insolvency practitioners and insolvency office holders in bankruptcy proceedings or creditors;
|
|
|
5
|
c.
|
claims based on tort (onrechtmatige daad);
|
||
d.
|
sanctions and measures, including but not limited to those concerning export control, pursuant to European Union regulations, under the Sanctions Act 1977 (Sanctiewet 1977) or other legislation;
|
||
e.
|
the Anti-Boycott Regulation and related legislation; and
|
||
f.
|
the rules of force majeure (niet toerekenbare tekortkoming), reasonableness and fairness (redelijkheid
en billijkheid), suspension (opschorting), dissolution (ontbinding), unforeseen circumstances (onvoorziene
omstandigheden) and vitiated consent (i.e., duress (bedreiging), fraud (bedrog), abuse of circumstances (misbruik
van omstandigheden) and error (dwaling)) or a difference of intention (wil) and declaration (verklaring).
|
||
E.
|
The term “non-assessable” has no equivalent in the Dutch language and for purposes of this opinion letter such term should be interpreted to mean that a holder of a Registered
Share shall not by reason of merely being such a holder be subject to assessment or calls by the Company or its creditors for further payment on such Registered Share.
|
||
F.
|
This opinion letter does not purport to express any opinion or view on the operational rules and procedures of any clearing or settlement system or agency.
|
||
We consent to the filing of this opinion letter as an exhibit to the Registration Statement and also consent to the reference to NautaDutilh in the Registration
Statement under the caption “Legal Matters”. In giving this consent we do not admit or imply that we are a person whose consent is required under Section 7 of the United States Securities Act of 1933, as amended, or any rules and regulations
promulgated thereunder.
|
|||
Sincerely yours,
|
|||
/s/ NautaDutilh N.V. | |||
NautaDutilh N.V. |
|
|
6
|
EXHIBIT A | |||
LIST OF DEFINITIONS | |||
“Anti-Boycott Regulation”
|
The Council Regulation (EC) No 2271/96 of 22 November 1996 on protecting against the effects of the extra-territorial application of legislation adopted by a third
country, and actions based thereon or resulting therefrom.
|
||
“Articles of Association”
|
The Company’s articles of association (statuten) as they read from time to time.
|
||
“Commercial Register”
|
The Dutch Commercial Register (handelsregister).
|
||
“Common Shares”
|
Common shares in the Company’s capital, with a nominal value of EUR 0.12 each.
|
||
“Company”
|
InflaRx N.V., registered with the Commercial Register under number 68904312.
|
||
“Corporate Documents”
|
The Deed of Incorporation, the Deed of Conversion and the Current Articles.
|
||
“Current Articles”
|
The Articles of Association as they read after the execution of the Deed of Conversion.
|
||
“DCC”
|
The Dutch Civil Code (Burgerlijk Wetboek).
|
||
“Debt Securities”
|
One or more series of debt securities issuable by the Company and registered pursuant to the Registration Statement.
|
||
“Deed of Conversion”
|
The deed of conversion and amendment to the Articles of Association dated November 8, 2017.
|
||
“Deed of Incorporation”
|
The Company’s deed of incorporation (akte van oprichting) dated June 6, 2017.
|
||
“DFSA”
|
The Dutch Financial Supervision Act (Wet op het financieel toezicht).
|
||
“NautaDutilh”
|
NautaDutilh N.V.
|
|
|
7
|
“the Netherlands”
|
The European territory of the Kingdom of the Netherlands.
|
||
“Prospectus Regulation”
|
Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public
or admitted to trading on a regulated market, and repealing Directive 2003/71/EC.
|
||
“Purchase Contracts”
|
One or more series of purchase contracts issuable by the Company and registered pursuant to the Registration Statement for the purchase or sale of debt or equity
securities issued by us or securities of third parties, a basket of such securities, an index or indices of such securities or any combination of such securities as specified in the applicable prospectus supplement.
|
||
“Registered Securities”
|
The Debt Securities, Purchase Contracts, Registered Shares, Units and Warrants.
|
||
“Registered Shares”
|
The following Common Shares:
|
||
a. | the Common Shares registered pursuant to the Registration Statement; and | ||
b.
|
the Common Shares issuable pursuant to the conversion, exchange or exercise of other Registered Securities.
|
||
“Registration Statement”
|
The Company’s registration statement on Form F-3 filed or to be filed with the SEC in the form reviewed by us.
|
||
“Relevant Moment”
|
Each time when one or more Registered Securities are issued by the Company.
|
||
“SEC”
|
The United States Securities and Exchange Commission.
|
||
“Units”
|
One or more series of units issuable by the Company and registered pursuant to the Registration Statement consisting of one or more Registered Shares, Debt
Securities, Warrants, Purchase Contracts, or any combination of such securities as specified in the applicable prospectus supplement.
|
||
“Warrants”
|
One or more series of warrants issuable by the Company and registered pursuant to the Registration Statement for the purchase of Debt Securities, Common Shares or
other securities as specified in the applicable prospectus supplement.
|
|
||
601 Lexington Avenue
New York, NY 10022
United States
+1 212 446 4800
www.kirkland.com
|
|
Yours very truly, |
|
|
|
/s/ KIRKLAND & ELLIS LLP |
|
|
|
KIRKLAND & ELLIS LLP |