As filed with the Securities and Exchange Commission on March 9,
2018
Registration Statement No. 333-______
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
CORMEDIX INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation or organization)
|
20-5894890
(I.R.S. Employer
Identification No.)
|
400 Connell Drive, Suite 5000
Berkeley Heights, New Jersey 07922
Telephone: (908) 517-9500
(Address, including zip code, and telephone number, including area
code, of registrant’s principal executive
offices)
Khoso Baluch
Chief Executive Officer
CorMedix Inc.
400 Connell Drive, Suite 5000
Berkeley Heights, New Jersey 07922
Telephone:
(908) 517-9500
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
Alexander M. Donaldson, Esq.
Wyrick Robbins Yates & Ponton LLP
4101 Lake Boone Trail, Suite 300
Raleigh, North Carolina 27607
Telephone: (919) 781-4000
Fax (919) 781-4865
Approximate date of
commencement of proposed sale to the public: From time to time
after the effective date of this Registration
Statement.
If the
only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check
the following box. ☐
If any
of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the
following box. ☒
If this
Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same
offering. ☐
If this
Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier
effective registration statement for the same offering.
☐
If this
Form is a registration statement pursuant to General Instruction
I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(c)
under the Securities Act, check the following box.
☐
If this
Form is a post-effective amendment filed pursuant to General
Instruction I.D. filed to register additional securities or
additional classes of securities pursuant to Rule 413(b) under the
Securities Act, check the following box. ☐
Indicate by check
mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting
company. See the definitions of “accelerated filer”,
“large accelerated filer” and “smaller reporting
company” (as defined in Rule 12b-2 of the Act) (Check
one):
Large
accelerated filer ☐
|
Accelerated filer
☐
|
Non-accelerated
filer ☐ (Do not check if smaller reporting
company)
|
Smaller reporting
company ☒
|
|
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 7(a)(2)(B) of the Securities Act.
☐
CALCULATION OF REGISTRATION FEE
Title of each
class of securities to be registered
|
|
Amount to be
registered
(1)
|
Proposed
maximum aggregate offering price per unit
(2)
|
Proposed
maximum
aggregate
offering price
|
Amount
of
registration
fee
|
Common stock,
$0.001 par value per share
|
|
--
|
$
--
|
$
--
|
$
--
|
Preferred stock,
$0.001 par value per share
|
|
--
|
--
|
--
|
--
|
Warrants
|
|
--
|
--
|
--
|
--
|
Debt
Securities
|
|
--
|
--
|
--
|
--
|
Units
|
|
--
|
--
|
--
|
--
|
Total
|
|
|
|
$
70,000,000
|
$
8,715.00
(3)
|
_______________
(1)
The Registrant is
registering such indeterminate number of shares of common stock and
preferred stock, such indeterminate principal amount of debt
securities, such indeterminate number of warrants to purchase
common stock, preferred stock or debt securities, and such
indeterminate number of units as shall have an aggregate initial
offering price not to exceed $70,000,000, less the aggregate dollar
amount of all securities previously issued hereunder. If any debt
securities are issued at an original issued discount, then the
offering price of such debt securities shall be in such greater
principal amount as shall result in an aggregate offering price not
to exceed $70,000,000, less the aggregate dollar amount of all
securities previously issued hereunder. Any securities registered
hereunder may be sold separately or as units with the other
securities registered hereunder. The proposed maximum offering
price per unit will be determined, from time to time, by the
Registrant in connection with the issuance by the Registrant of the
securities registered hereunder. The securities registered
hereunder also include such indeterminate number of shares of
common stock and preferred stock and amount of debt securities as
may be issued upon conversion of or exchange for preferred stock or
debt securities that provide for conversion or exchange, upon
exercise of warrants or pursuant to the antidilution provisions of
any of such securities. In addition, pursuant to Rule 416 under the
Securities Act, the shares being registered hereunder include such
indeterminate number of shares of common stock and preferred stock
as may be issuable with respect to the shares being registered
hereunder as a result of stock splits, stock dividends or similar
transaction.
(2)
The proposed
maximum offering price per unit will be determined from time to
time by the Registrant in connection with, and at the time of, the
issuance of the securities and is not specified as to each class of
security pursuant to General Instruction II.D. of Form S-3, as
amended.
(3)
Calculated pursuant
to Rule 457(o) under the Securities Act of 1933, as amended, based
on the proposed maximum aggregate offering price of all securities
listed.
EXPLANATORY NOTE
This
registration statement contains two prospectuses:
●
a base prospectus
which covers the offering, issuance and sale by us of up to $70.0
million of our common stock, preferred stock, warrants, debt
securities and/or units; and
●
a sales agreement
prospectus covering the offering and sale of our common stock that
may be issued and sold under a sales agreement between us and B.
Riley FBR, Inc. for shares of common stock having an aggregate
offering price of up to $14.1 million, which is an amount equal to
one-third of our public float as of March 8, 2018 (which was
approximately $42,399,750), as limited by General Instruction I.B.6
of Form S-3.
The
sales agreement prospectus immediately follows the base prospectus.
The $14.1 million of common stock that may be offered, issued and
sold under the sales agreement prospectus is included in the $70.0
million of securities that may be offered, issued and sold by us
under the base prospectus. Upon termination of the sales agreement
with B. Riley FBR, Inc., any portion of the $14.1 million included
in the sales agreement prospectus that is not sold pursuant to the
sales agreement will be available for sale in other offerings
pursuant to the base prospectus, and if no shares are sold under
the sales agreement, the full $70.0 million of securities may be
sold in other offerings pursuant to the base prospectus and a
corresponding prospectus supplement.
The
Registrant hereby amends this registration statement on such date
or dates as may be necessary to delay its effective date until the
Registrant shall file a further amendment which specifically states
that this registration statement shall thereafter become effective
in accordance with Section 8(a) of the Securities Act of 1933 or
until the registration statement shall become effective on such
date as the Commission, acting pursuant to said Section 8(a), may
determine.
The information in this prospectus is not complete and may be
changed. We may not sell these securities or accept an offer to buy
these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is
not an offer to sell these securities, and we are not soliciting an
offer to buy these securities in any state where the offer or sale
is not permitted.
Subject to completion, dated March 9, 2018
Prospectus
$70,000,000 of
Common Stock,
Preferred Stock,
Warrants,
Debt Securities and/or
Units
From
time to time, we may offer up to $70,000,000 of any combination of
the securities described in this prospectus, either individually or
in units, in one or more offerings in amounts, at prices and on the
terms that we will determine at the time of offering. We may also
offer common stock or preferred stock upon conversion of debt
securities, common stock upon conversion of preferred stock, or
common stock, preferred stock or debt securities upon the exercise
of warrants.
Each
time we sell securities, we will provide specific terms of the
securities offered in a supplement to this prospectus. The
prospectus supplement may also add, update or change information
contained in this prospectus. We will specify in any accompanying
prospectus supplement the terms of any offering. You should read
this prospectus and the applicable prospectus supplement, as well
as any documents incorporated by reference in this prospectus and
any prospectus supplement, carefully before you invest in any
securities.
This prospectus may not
be used by us to consummate a sale of securities unless accompanied
by the applicable prospectus supplement.
We will
sell these securities directly to our stockholders or to other
purchasers or through agents on our behalf or through underwriters
or dealers as designated from time to time. If any agents or
underwriters are involved in the sale of any of these securities,
the applicable prospectus supplement will provide the names of the
agents or underwriters and any applicable fees, commissions or
discounts.
Our
common stock trades on the NYSE American under the trading symbol
“CRMD.” On
March 6, 2018,
the
closing price of our common stock was $0.29 per share. We recommend
that you obtain current market quotations for our common stock
prior to making an investment decision.
As of
March 8, 2018, the aggregate market value of our outstanding common
stock held by non-affiliates, or the public float, was
approximately $42,399,750, which was calculated based on 74,385,540
shares of our outstanding common stock held by non-affiliates and
on a price of $0.57 per share, the last reported sale price for our
common stock on February 16, 2018. Pursuant to General Instruction
I.B.6 of Form S-3, in no event will we sell our common stock in a
public primary offering with a value exceeding one-third of our
public float in any 12-month period unless our public float
subsequently rises to $75.0 million or more. We have not offered
any securities pursuant to General Instruction I.B.6 of Form S-3
during the 12 calendar months prior to and including the date of
this prospectus.
You
should carefully read this prospectus, the prospectus supplement
relating to any specific offering of securities and all information
incorporated by reference herein and therein.
Investing in our securities involves a high degree of risk. These
risks are described under the caption “
Risk
Factors
” beginning on page 5 and
in the documents incorporated by reference into this
prospectus.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is ______, 2018
TABLE OF CONTENTS
About this Prospectus
|
1
|
Prospectus Summary
|
2
|
Risk Factors
|
5
|
Special Note Regarding Forward-Looking Statements
|
24
|
Use of Proceeds
|
25
|
Plan of Distribution
|
26
|
Description of Our Capital Stock
|
28
|
|
Common Stock
|
28
|
|
Issued and Outstanding Preferred Stock
|
28
|
|
Series C-2 and C-3 Non-Voting Convertible Preferred
Stock
|
29
|
|
Series D Non-Voting Convertible Preferred Stock
|
30
|
|
Series E Non-Voting Convertible Preferred Stock
|
31
|
|
Series F Non-Voting Convertible Preferred Stock
|
32
|
|
Transfer Agent and Registrar
|
34
|
|
Description of Preferred Stock That May be Offered
|
34
|
Description of Debt Securities
|
35
|
Description of Warrants
|
37
|
Description of Units
|
38
|
Certain Provisions of Delaware Law and of Our Amended and Restated
Certificate of Incorporation and Amended and Restated
Bylaws
|
39
|
Legal Matters
|
40
|
Experts
|
40
|
Where You Can Find Additional Information
|
40
|
Incorporation of Documents by Reference
|
40
|
ABOUT THIS PROSPECTUS
This prospectus is part of a registration
statement that we filed with the Securities and Exchange
Commission, or SEC, utilizing a “shelf” registration
process.
Under this shelf registration process, we may offer
shares of our common stock and preferred stock, various series of
debt securities and/or warrants to purchase any of such securities,
either individually or in units, in one or more offerings, of an
indeterminate amount.
This prospectus
provides you with a general description of the securities we may
offer. Each time we offer a type or series of securities under this
prospectus, we will provide a prospectus supplement that will
contain specific information about the terms of that
offering.
This
prospectus does not contain all of the information included in the
registration statement. For a more complete understanding of the
offering of the securities, you should refer to the registration
statement, including its exhibits. Prospectus supplements may also
add, update or change information contained or incorporated by
reference in this prospectus. However, no prospectus supplement
will fundamentally change the terms that are set forth in this
prospectus or offer a security that is not registered and described
in this prospectus at the time of its effectiveness. This
prospectus, together with the applicable prospectus supplements and
the documents incorporated by reference into this prospectus,
includes all material information relating to this offering. You
should carefully read this prospectus, the applicable prospectus
supplement, the information and documents incorporated herein by
reference and the additional information under the heading
“Where You Can Find More Information” before making an
investment decision.
You
should rely only on the information we
have provided or incorporated by reference in this prospectus or
any prospectus supplement. We have not authorized anyone to provide
you with information different from that contained or incorporated
by reference in this prospectus. No dealer, salesperson or other
person is authorized to give any information or to represent
anything not contained or incorporated by reference in this
prospectus. You must not rely on any unauthorized information or
representation. This prospectus is an offer to sell only the
securities offered hereby, but only under circumstances and in
jurisdictions where it is lawful to do so. You should assume that
the information in this prospectus or any prospectus supplement is
accurate only as of the date on the front of the document and that
any information we have incorporated herein by reference is
accurate only as of the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus or
any sale of a security.
To
the extent there are inconsistencies between any prospectus
supplement, this prospectus and any documents incorporated by
reference, the document with the most recent date will
control.
This prospectus may not be used to consummate sales of our
securities, unless it is accompanied by a prospectus
supplement.
Unless
the context otherwise requires, “CorMedix,” the
“company,” “we,” “us,”
“our” and similar names refer to CorMedix
Inc.
Neutrolin
®
is our registered trademark and the
CorMedix logo is our trademark. All other trade names, trademarks
and service marks appearing in this prospectus are the property of
their respective owners. We have assumed that the reader
understands that all such terms are source-indicating. Accordingly,
such terms, when first mentioned in this prospectus, appear with
the trade name, trademark or service mark notice and then
throughout the remainder of this prospectus without trade name,
trademark or service mark notices for convenience only and should
not be construed as being used in a descriptive or generic
sense.
PROSPECTUS SUMMARY
This summary highlights certain information about us, this offering
and selected information contained elsewhere in or incorporated by
reference into this prospectus. This summary is not complete and
does not contain all of the information that you should consider
before deciding whether to invest in our common stock. For a more
complete understanding of our company and this offering, we
encourage you to read and consider carefully the more detailed
information in this prospectus, including the information
incorporated by reference into this prospectus, and the information
referred to under the heading “Risk Factors” in this
prospectus beginning on page 5, and in the documents incorporated
by reference into this prospectus.
OUR COMPANY
Overview
We are
a
biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of infectious and inflammatory
diseases
.
Our
primary focus is to develop our lead product candidate,
Neutrolin
®
(also known as
CRMD003), for potential commercialization in the U.S. and other key
markets. We have in-licensed the worldwide rights to develop and
commercialize Neutrolin, which is a novel anti-infective solution
(a formulation of taurolidine, citrate and heparin 1000 u/ml) under
development in the U.S. for the reduction and prevention of
catheter-related infections and thrombosis in patients requiring
central venous catheters in clinical settings such as dialysis,
critical/intensive care, and oncology. Infection and thrombosis
represent key complications among critical care/ intensive care and
cancer patients with central venous catheters. These complications
can lead to treatment delays and increased costs to the healthcare
system when they occur due to hospitalizations, need for IV
antibiotic treatment, long-term anticoagulation therapy,
removal/replacement of the central venous catheter, related
treatment costs and increased mortality. We believe Neutrolin has
the potential to address a significant unmet medical need and
represents a potential large market opportunity.
In July
2013, we received CE Mark approval for Neutrolin. As a result, in
December 2013, we commercially launched Neutrolin in Germany
for the prevention of catheter-related bloodstream infections and
maintenance of catheter patency in hemodialysis patients using a
tunneled, cuffed central venous catheter for vascular
access. To date, Neutrolin is registered and may be sold
in certain European Union and Middle Eastern countries for such
treatment. I
n April 2017, we
entered into a commercial collaboration with Hemotech SAS covering
France and French overseas territories.
We
initiated one Phase 3 clinical trial in hemodialysis patients with
a central venous catheter (“LOCK-IT-100”) in December
2015. The FDA has indicated that two pivotal trials to demonstrate
safety and effectiveness of Neutrolin will be required by the U.S.
Food and Drug Administration (“FDA”) to secure
marketing approval in the United States.
In
April 2017, a safety review by an independent Data and Safety
Monitoring Board, or DSMB was completed. The DSMB unanimously
concluded that it is safe to continue the LOCK-IT-100 clinical
trial as designed based on its evaluation of data from the first
279 patients randomized on trial.
On
August 2, 2017, we announced that the FDA had agreed to key changes
to the LOCK-IT-100 clinical trial. We believe that the changes
endorsed by the FDA facilitate our ability to complete the ongoing
Phase 3 clinical trial in hemodialysis patients with central venous
catheters, as previously announced, by year-end 2018. We sought
guidance from the FDA to address, in part, the apparent overall
lower rate of catheter-related blood stream infection (CRBSI)
events as announced in April 2017. Changes made to the protocol
were 1) the utilization of a Clinical Adjudication Committee (CAC)
to assess suspected CRBSIs; 2) the use of the CAC to critically and
independently assess suspected CRBSIs in a blinded fashion based on
a single positive blood culture and supporting documentation,
rather than two positive blood cultures as previously required; 3)
the ability to capture cases occurring outside of dialysis centers
to facilitate more complete capture of CRBSI events in the study,
particularly when patients present with CRBSI events outside of the
dialysis center setting (emergency rooms or urgent care centers);
and 4) a revision of the design of the study to detect a treatment
effect of 55% or greater when comparing the Neutrolin and heparin
control arms. The FDA agreed that cases adjudicated by the CAC to
be CRBSI events and the per protocol definition of CRBSI events
will be included in the primary analysis of the primary efficacy
endpoint of the LOCK-IT-100 study. The amended study assumptions
including a reduction in statistical power have resulted in a
reduction in the total number of CRBSI events required from 161
events to 56 events to complete the study. We believe that these
changes have allowed the identification of more infections,
enabling a single interim analysis.
On
February 20, 2018, we announced that the CAC has reviewed potential
cases of CRBSI in the LOCK-IT 100 study that occurred through early
December 2017, and identified 28 such cases. As previously agreed
with FDA, an interim analysis will be performed when the first 28
CRBSIs case have been identified. The primary endpoint for the
study is the reduction of CRBSI by Neutrolin in comparison to a
heparin catheter lock solution. We are currently directing standard
procedures to ensure the accuracy and completeness of the data
required for conducting the interim analysis. This review includes
data for all subjects in the study needed to assess the two
secondary endpoints related to a reduction in catheter removal and
catheter blockage, as well as the primary endpoint and safety
information. Before the full dataset can be locked and the interim
analysis can proceed, a number of weeks will be required to
complete the quality assurance procedures appropriate for the
amount of data generated in the trial. The interim analysis will be
provided to the Data Safety Monitoring Board for its review and
recommendation upon completion. We anticipate that DSMB review will
occur in the second quarter of 2018.
We are
evaluating
opportunities for the
possible expansion of taurolidine as a platform compound for use in
certain medical devices. Patent applications have been filed in
wound closure, surgical meshes, wound management, and
osteoarthritis, including visco-supplementation. Based on initial
feasibility work, we are advancing preclinical studies for three
product candidates: surgical meshes, suture materials, and
hydrogels. We expect to develop and pursue FDA clearance for
these potential products by the 510(k) pathway and will seek to
establish development/commercial partnerships as these programs
advance.
We are also involved in a pre-clinical research
collaboration for the use of taurolidine as a possible combination
treatment for rare orphan pediatric tumors.
In February
2018, the FDA granted orphan drug designation to taurolidine for
the treatment of neuroblastoma.
Corporate History and Information
We were
organized as a Delaware corporation on July 28, 2006 under the name
“Picton Holding Company, Inc.” and we changed our
corporate name to “CorMedix Inc.” on January 18, 2007.
Our operations to date have been primarily limited to organizing
and staffing, licensing product candidates, developing clinical
trials for our product candidates, seeking regulatory approvals for
Neutrolin, establishing manufacturing for our product candidates
and maintaining and improving our patent portfolio and launching
Neutrolin in the E.U and other foreign countries.
Our
executive offices are located at 400 Connell Drive, Suite 5000,
Berkeley Heights, NJ 07922. Our telephone number is (908) 517-9500.
Our website address is www.cormedix.com. Information contained in,
or accessible through, our website does not constitute part of this
prospectus supplement.
Offerings Under This Prospectus
We may
offer shares of our common stock and preferred stock, various
series of debt securities and/or warrants to purchase any of such
securities, either individually or in units, up to an indeterminate
amount from time to time under this prospectus at prices and on
terms to be determined by market conditions at the time of any
offering. This prospectus provides you with a general description
of the securities we may offer. Each time we offer a type or series
of securities under this prospectus, we will provide a prospectus
supplement that will describe the specific amounts, prices and
other important terms of the securities.
The
prospectus supplement also may add, update or change information
contained in this prospectus or in documents we have incorporated
by reference into this prospectus. However, no prospectus
supplement will fundamentally change the terms that are set forth
in this prospectus or offer a security that is not registered and
described in this prospectus at the time of its
effectiveness.
This prospectus may not be used to consummate a sale of any
securities unless it is accompanied by a prospectus
supplement.
We may
sell the securities directly to investors or to or through agents,
underwriters or dealers. We, and our agents or underwriters,
reserve the right to accept or reject all or part of any proposed
purchase of securities. If we offer securities through agents or
underwriters, we will include in the applicable prospectus
supplement:
●
the
names of those agents or underwriters;
●
applicable
fees, discounts and commissions to be paid to them;
●
details
regarding over-allotment options, if any; and
●
the
net proceeds to us.
Common Stock
We may
issue shares of our common stock from time to time. The holders of
common stock are entitled to one vote per share on all matters to
be voted upon by stockholders. Subject to preferences that may be
applicable to any outstanding preferred stock, the holders of
common stock are entitled to receive ratably any dividends that may
be declared from time to time by our board of directors out of
funds legally available for that purpose. In the event of our
liquidation, dissolution or winding up, the holders of common stock
are entitled to share ratably in all assets remaining after payment
of liabilities, subject to prior distribution rights of any
preferred stock then outstanding.
Preferred Stock
We may
issue shares of our preferred stock from time to time, in one or
more series. Our board of directors will determine the rights,
preferences, privileges and restrictions of the preferred stock,
including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences, sinking fund terms and the
number of shares constituting any series or the designation of such
series, without any further vote or action by stockholders.
Convertible preferred stock will be convertible into our common
stock or exchangeable for our other securities. Conversion may be
mandatory or at your option or both and would be at prescribed
conversion rates.
If
we sell any series of preferred stock under this prospectus and
applicable prospectus supplements, we will fix the rights,
preferences, privileges and restrictions of the preferred stock of
such series in the certificate of designation relating to that
series. We will file as an exhibit to the registration statement of
which this prospectus is a part, or will incorporate by reference
from reports that we file with the SEC, the form of any certificate
of designation that describes the terms of the series of preferred
stock we are offering before the issuance of the related series of
preferred stock. We urge you to read the applicable prospectus
supplement related to the series of preferred stock being offered,
as well as the complete certificate of designation that contains
the terms of the applicable series of preferred stock.
Warrants
We
may issue warrants for the purchase of common stock, preferred
stock and/or debt securities in one or more series. We may issue
warrants independently or together with common stock, preferred
stock and/or debt securities, and the warrants may be attached to
or separate from these securities. We will evidence each series of
warrants by warrant certificates that we will issue under a
separate agreement. We may enter into warrant agreements with a
bank or trust company that we select to be our warrant agent. We
will indicate the name and address of the warrant agent in the
applicable prospectus supplement relating to a particular series of
warrants.
In
this prospectus, we have summarized certain general features of the
warrants. We urge you, however, to read the applicable prospectus
supplement related to the particular series of warrants being
offered, as well as the warrant agreements and warrant certificates
that contain the terms of the warrants. We will file as exhibits to
the registration statement of which this prospectus is a part, or
will incorporate by reference from reports that we file with the
SEC, the form of warrant agreement or warrant certificate
containing the terms of the warrants we are offering before the
issuance of the warrants.
Debt Securities
We
may offer debt securities from time to time, in one or more series,
as either senior or subordinated debt or as senior or subordinated
convertible debt. The senior debt securities will rank equally with
any other unsecured and unsubordinated debt. The subordinated debt
securities will be subordinate and junior in right of payment, to
the extent and in the manner described in the instrument governing
the debt, to all of our senior indebtedness. Convertible debt
securities will be convertible into or exchangeable for our common
stock or our other securities. Conversion may be mandatory or at
your option or both and would be at prescribed conversion
rates.
With
respect to any debt securities that we issue, we will issue such
debt securities under an indenture, which we would enter into with
the trustee named in the indenture. The form of indenture was filed
as an exhibit to the registration statement of which this
prospectus is a part and is incorporated herein by reference. Any
indenture would be qualified under the Trust Indenture Act of
1939.
Units
We
may issue units consisting of common stock, preferred stock, debt
securities and/or warrants for the purchase of common stock,
preferred stock and/or debt securities in one or more series. In
this prospectus, we have summarized certain general features of the
units. We urge you, however, to read the applicable prospectus
supplement related to the series of units being offered, as well as
the unit agreements that contain the terms of the units. We will
file as exhibits to the registration statement of which this
prospectus is a part, or will incorporate by reference reports that
we file with the SEC, the form of unit agreement and any
supplemental agreements that describe the terms of the series of
units we are offering before the issuance of the related series of
units.
RISK FACTORS
Investing in our securities involves risk. The prospectus
supplement applicable to each offering of our securities will
contain a discussion of the risks applicable to an investment in
our company. Prior to making a decision about investing in our
securities, you should carefully consider the specific factors
discussed below and under the heading “Risk Factors” in
the applicable prospectus supplement, together with all of the
other information contained or incorporated by reference in the
prospectus supplement or appearing or incorporated by reference in
this prospectus. You should also consider the risks, uncertainties
and assumptions discussed under the heading “Risk
Factors” included in our most recent annual report on
Form 10-K which is on file with the SEC and is incorporated
herein by reference, and which may be amended, supplemented or
superseded from time to time by other reports we file with the SEC
in the future.
Risks Related to Our Financial Position and Need for Additional
Capital
We have a history of operating losses, expect to incur additional
operating losses in the future and may never be
profitable.
Our prospects must be considered in light of the
uncertainties, risks, expenses, and difficulties frequently
encountered by companies in the early stages of operation. We
incurred net losses of approximately $24.6 million, $18.2 million
and $20.5 million for the years ended December 31, 2016, 2015 and
2014, respectively, and $7.6 million, $12.7 million and $22.7
million for the three months ended March 31, 2017, the six months
ended June 30, 2017, and the nine months ended September 30, 2017,
respectively. As of September 30, 2017, we had an accumulated
deficit of approximately $141.9 million. We expect to incur
substantial additional operating expenses over the next several
years as our research, development, pre-clinical testing, clinical
trial and commercialization activities increase as we develop and
commercialize Neutrolin. As a result, we expect to experience
negative cash flow as we fund our operating losses and capital
expenditures. The amount of future losses and when, if ever, we
will achieve profitability are uncertain. Neutrolin was launched in
December 2013 and is currently available for distribution in
certain European Union and Middle East countries. We have not
generated any significant commercial revenue and do not expect to
generate substantial revenues from Neutrolin until it is approved
by the FDA and launched in the U.S. market, and might never
generate significant revenues from the sale of Neutrolin or any
other products. Our ability to generate revenue and achieve
profitability will depend on, among other things, the following:
successfully marketing Neutrolin in Germany and other countries in
which it is approved for sale; obtaining necessary regulatory
approvals for Neutrolin from the other applicable European and
Middle East agencies, other foreign agencies and the FDA and
international regulatory agencies for any other products;
establishing manufacturing, sales, and marketing arrangements,
either alone or with third parties; and raising sufficient funds to
finance our activities. We might not succeed at any of these
undertakings. If we are unsuccessful at some or all of these
undertakings, our business, prospects, and results of operations
may be materially adversely affected.
We
have
received a
going concern opinion from our independent registered public
accounting firm.
Our
operations are subject to a number of factors that can affect our
operating results and financial condition. Such factors
include
, but are not limited
to: the results of clinical testing and trial activities of our
product candidates; the ability to obtain regulatory approval to
market our products; ability to manufacture successfully;
competition from products manufactured and sold or being developed
by other companies; the price of, and demand for, our products; our
ability to negotiate favorable licensing or other manufacturing and
marketing agreements for our products; and our ability to raise
capital to support our operations.
To
date, our commercial operations have not generated sufficient
revenues to enable profitability. As of September 30, 2017, we had
an accumulated deficit of approximately $141.9 million, and
incurred net losses from operations of $22.7 million for the nine
months then ended. Based on the current development plans for
Neutrolin in both the U.S. and foreign
markets
(including the ongoing hemodialysis
Phase 3 clinical trial in the U.S.) and our other operating
requirements, management believes that our existing cash and
short-term investments at September 30, 2017 will fund our
operations into the second quarter of 2018 after taking into
consideration the net proceeds received through February 2018 from
sales of common stock under our at the market common stock sales
program and the proceeds from the November 2017 financing with
Elliott Associates, L.P. and Elliott International, L.P. (together,
“Elliott”). These factors raise substantial doubt
regarding our ability to continue as a going concern. We will need
additional funding to complete the LOCK-IT 100 hemodialysis
clinical trial in the U.S. which commenced in December 2015 as well
as to initiate the anticipated second Phase 3 clinical trial that
is currently required in order to file an NDA with the
FDA.
As a
result of the above matters, our independent registered public
accounting firm indicated in its report on our December 31, 2016
financial statements that there is substantial doubt about our
ability to continue as a going concern and we expect to receive
such an opinion in their report for fiscal 2017. A “going
concern” opinion indicates that the financial statements have
been prepared assuming we will continue as a going concern and do
not include any adjustments to reflect the possible future effects
on the recoverability and
classification
of assets, or the amounts
and classification of liabilities that may result if we do not
continue as a going concern. Therefore, you should not rely on our
consolidated balance sheet as an indication of the amount of
proceeds that would be available to satisfy claims of our
creditors, and potentially be available for distribution to our
stockholders, in the event of liquidation.
Our
continued operations will ultimately depend on our ability to raise
additional capital through various potential sources, such as
equity and/or debt financings, strategic relationships, or
out-licensing of our products in order to complete our
ongoing
and planned Phase 3 clinical trials
and until we achieve profitability, if ever. We can provide no
assurances that such financing or strategic relationships will be
available on acceptable terms, or at all. Without this funding, we
could be required to delay, scale back or eliminate some or all of
our research and development programs which would likely have a
material adverse effect on our business.
We will need to finance our future cash needs through public or
private equity offerings, debt financings or corporate
collaboration and licensing arrangements. Any additional funds that
we obtain may not be on terms favorable to us or our stockholders
and may require us to relinquish valuable
rights.
We have launched Neutrolin in certain European
Union and Middle East countries, but to date have no other approved
product on the market and have not generated significant product
revenue from Neutrolin to date. Unless and until we receive
applicable regulatory approval for Neutrolin in the U.S., we cannot
sell Neutrolin in the U.S. Therefore, for the foreseeable future,
we will have to fund all of our operations and capital expenditures
from Neutrolin sales in Europe and other foreign markets, if
approved, cash on hand, additional financings, licensing fees and
grants.
We believe that our cash resources as of September
30, 2017, even after taking into consideration the net proceeds
received through February 2018 from sales of common stock under our
at the market common stock sales program and the proceeds from the
November 2017 financing with Elliott, will not be sufficient to
enable us to fund our projected operating requirements for at least
the next 12 months following the balance sheet
date. We will need additional funding thereafter
to complete our ongoing Phase 3
hemodialysis clinical trial
in the U.S. in oncology patients with catheters, as well initiate
as our anticipated second Phase 3 clinical trial in the U.S. If we
are unable to raise additional funds when needed, we may not be
able to complete our ongoing Phase 3 clinical trial, commence and
complete our planned Phase 3 clinical trial or commercialize
Neutrolin and we could be required to delay, scale back or
eliminate some or all of our research and development programs. We
can provide no assurances that any financing or strategic
relationships will be available to us on acceptable terms, or at
all. We expect to incur increases in our cash used in operations as
we conduct our ongoing Phase 3 clinical trial and prepare for our
anticipated second Phase 3 clinical trial in oncology patients,
seek FDA approval of Neutrolin in the U.S., commercialize Neutrolin
in Europe and other markets, pursue business development
activities, and incur additional legal costs to defend our
intellectual property.
To raise needed capital, we may sell additional
equity or debt securities, obtain a bank credit facility, or enter
into a corporate collaboration or licensing arrangement.
The sale of additional equity or debt
securities, if convertible, could result in dilution to our
stockholders. The incurrence of indebtedness would result in fixed
obligations and could also result in covenants that would restrict
our operations. Raising additional funds through collaboration or
licensing arrangements with third parties may require us to
relinquish valuable rights to our technologies, future revenue
streams, research programs or product candidates, or to grant
licenses on terms that may not be favorable to us or our
stockholders.
Until
the date that none of the shares of common stock or warrants that
we issued to Elliott Associates, L.P. and Elliott International,
L.P in November 2017 as part of the backstop financing are
outstanding, we are prohibited from issuing or selling any
securities convertible into common stock on terms more favorable
than the backstop financing terms and with a conversion, exchange
or exercise price that is based upon and/or varies with the trading
prices of or quotations for the shares of our common stock or that
is subject to being reset at some future date or upon the
occurrence of specified or contingent events directly or indirectly
related to our business (other than pursuant to a customary
“weighted average” anti-dilution provision) or the
market for our common stock or enter into any agreement to sell
securities at a future determined price (other than standard and
customary “preemptive” or “participation”
rights and other than pursuant to an at-the-market offering through
a registered broker-dealer). This restriction could make raising
capital through the sale of equity securities very difficult and
could have a material adverse impact on our business, financial
condition and prospects.
Risks Related to the Development and Commercialization of Our
Product Candidates
If we are unable to successfully complete our Phase 3 LOCK-IT-100
clinical trial, or if such clinical trial takes longer to complete
than we project, our ability to execute our current business
strategy will be adversely affected.
Whether or not and how quickly we complete the
Phase 3 LOCK-IT-100 clinical trial is dependent in part upon the
rate of enrollment of patients, the rate we collect, clean, lock
and analyze the clinical trial database, and the frequency with
which CRBSI events occur. Patient enrollment is a function of many
factors, including the size of the patient population, the
proximity of patients to clinical sites, the eligibility criteria
for the study, the existence of competitive clinical trials, and
whether existing or new products are approved for the indication we
are studying. In addition, the LOCK-IT-100 clinical trial is
designed to continue until a pre-determined number of events have
occurred in the patients enrolled. Event-driven trials such as
LOCK-IT-100 are subject to delays and other risks stemming from
patient withdrawal and from lower than expected event rates.
A lower event rate will require that
we enroll more patients than initially anticipated, which would
require us to incur additional costs and
extend the anticipated time for
completion of the trial
in order to achieve the desired number
of events. If we experience delays in patient enrollment in our
clinical trial, or if we experience other issues related to the
number of events or other trial results, we may incur additional
costs and delays in the trial, and may not be able to complete the
clinical trial in a cost-effective or timely manner, which would
have an adverse effect on our development program for Neutrolin as
a treatment for catheter related bloodstream
infections.
Our only product Neutrolin is only approved in Europe and is still
in development in the U. S.
Neutrolin currently and for at least the near
future is our only current product as well as our only late-stage
product candidate. Neutrolin has received CE Mark approval in
Europe, and we launched it in Germany in December 2013. We also are
pursuing development of Neutrolin in the U.S. Our product
commercialization and development efforts may not lead to
commercially viable products for any of several reasons. For
example, our product candidates may fail to be proven safe and
effective in clinical trials, or we may have inadequate financial
or other resources to pursue development efforts for our product
candidates. Even if approved, our products may not be accepted in
the marketplace. Neutrolin will require significant additional
development, clinical trials, regulatory clearances and/or
investment by us or our collaborators as we continue its
commercialization, as will any of our other products. Specifically,
we plan to expand marketing of Neutrolin in other foreign countries
and to develop Neutrolin for sale in the U.S., which will take time
and capital.
In
April 2017, we entered into a commercial collaboration with
Hemotech SAS covering France and certain overseas territories. We
have entered into agreements with a Saudi Arabian company to market
and sell Neutrolin in Saudi Arabia, and with a South Korean company
to market, sell and distribute Neutrolin in South Korea upon
receipt of regulatory approval in that country. We also have a
commercial presence in Germany and the United Arab Emirates.
Consequently, we will be dependent on these companies and
individuals for the success of sales in those countries and any
other countries in
which
we
receive regulatory approval and in which we contract with third
parties for the marketing, sale and/or distribution of Neutrolin.
If these companies or individuals do not perform for whatever
reason, our business, prospects and results of operations will be
materially adversely affected. Finding a suitable replacement
organization or individual for these or any other companies or
individuals with whom we might contract could be difficult, which
would further harm our business, prospects and results of
operations.
Successful development and commercialization of our products is
uncertain.
Our
development
and commercialization of current and future
product candidates is subject to the risks of failure and delay
inherent in the development of new pharmaceutical products,
including but not limited to the
following:
●
inability
to produce positive data in pre-clinical and clinical
trials;
●
delays in product
development
, pre-clinical and clinical testing, or
manufacturing;
●
unplanned expenditures in
product
development, clinical testing, or
manufacturing;
●
failure
to receive regulatory approvals;
●
emergence of superior or
equivalent
products;
●
inability to manufacture our
product
candidates on a commercial scale on
our own, or in collaboration with third parties;
and
●
failure to achieve market
acceptance
.
Because of these risks, our development efforts
may not result in any commercially viable products. If a
significant portion of these development efforts are not
successfully completed, required regulatory approvals are not
obtained or any approved products are not commercialized
successfully, our business, financial condition, and results of
operations will be materially harmed.
Clinical trials required for our product candidates are expensive
and time-consuming, and their outcome is
uncertain.
In order to obtain FDA or foreign approval to
market a new drug or device product, we must demonstrate proof of
safety and effectiveness in humans. Foreign regulations and
requirements are similar to those of the FDA. To meet FDA
requirements, we must conduct “adequate and
well-controlled” clinical trials. Conducting clinical trials
is a lengthy, time-consuming, and expensive process. The length of
time may vary substantially according to the type, complexity,
novelty, and intended use of the product candidate, and often can
be several years or more per trial. Delays associated with products
for which we are directly conducting clinical trials may cause us
to incur additional operating expenses. The commencement and rate
of completion of clinical trials may be delayed by many factors,
including, for example:
●
inability
to manufacture sufficient quantities of qualified materials under
the FDA’s cGMP requirements for use in clinical
trials;
●
slower than expected rates of
patient
recruitment;
●
failure to recruit a sufficient
number
of patients;
●
modification of clinical trial
protocols
;
●
changes in regulatory
requirements
for clinical
trials;
●
lack of effectiveness during
clinical
trials;
●
emergence of unforeseen
safety
issues;
●
delays, suspension, or
termination
of clinical trials due to the
institutional review board responsible for overseeing the study at
a particular study site; and
●
government or regulatory
delays
or “clinical holds”
requiring suspension or termination of the
trials.
The results from early pre-clinical and clinical
trials are not necessarily predictive of results to be obtained in
later clinical trials. Accordingly, even if we obtain positive
results from early pre-clinical or clinical trials, we may not
achieve the same success in later clinical
trials.
Our clinical trials may be conducted in patients
with serious or life-threatening diseases for whom conventional
treatments have been unsuccessful or for whom no conventional
treatment exists, and in some cases, our product is expected to be
used in combination with approved therapies that themselves have
significant adverse event profiles. During the course of treatment,
these patients could suffer adverse medical events or die for
reasons that may or may not be related to our products. We cannot
ensure that safety issues will not arise with respect to our
products in clinical development.
Clinical trials may not demonstrate statistically
significant safety and effectiveness to obtain the requisite
regulatory approvals for product candidates. The failure of
clinical trials to demonstrate safety and effectiveness for the
desired indications could harm the development of our product
candidates. Such a failure could cause us to abandon a product
candidate and could delay development of other product candidates.
Any delay in, or termination of, our clinical trials would delay
the filing of any NDA or any Premarket Approval Application, or
PMA, with the FDA and, ultimately, our ability to commercialize our
product candidates and generate product revenues. Any change in, or
termination of, our clinical trials could materially harm our
business, financial condition, and results of
operations.
If we fail to comply with international regulatory
requirements we could be subject to regulatory delays,
fines or other penalties.
Regulatory requirements in foreign countries for
international sales of medical devices often vary from country to
country. The occurrence and related impact of the following factors
would harm our business:
●
delays in receipt of, or failure to
receive,
foreign
regulatory
approvals or clearances;
●
the loss of previously obtained
approvals
or clearances; or
●
the failure to comply with existing or
future
regulatory
requirements.
The CE Mark is a mandatory conformity mark for
products to be sold in the European Economic Area. Currently, 28
countries in Europe require products to bear CE Marking. To market
in Europe, a product must first obtain the certifications
necessary to affix the CE Mark. The CE Mark is an international
symbol of adherence to the Medical Device Directives and the
manufacturer’s declaration that the product complies with
essential requirements. Compliance with these requirements is
ascertained within a certified Quality Management System (QMS)
pursuant to ISO 13485. In order to obtain and to maintain a CE
Mark, a product must be in compliance with the applicable
quality assurance provisions of the aforementioned ISO and obtain
certification of its quality assurance systems by a recognized
European Union notified body. We received CE Mark approval for
Neutrolin on July 5, 2013. However, certain individual countries
within the European Union require further approval by their
national regulatory agencies. Failure to receive or
maintain these other requisite approvals could prohibit us
from marketing and selling Neutrolin in the entire
European Economic Area or elsewhere.
We do not have, and may never obtain, the regulatory approvals we
need to market our product candidates outside of the European
Union.
While we have received the CE Mark approval for
Neutrolin in Europe, certain individual countries within the
European Union require further approval by their national
regulatory agencies. Failure to receive or maintain these
other requisite approvals could prohibit us from marketing and
selling Neutrolin in the entire European Economic Area. In
addition, we will need regulatory approval to market and sell
Neutrolin in foreign countries outside of Europe. We have received
regulatory approval in Saudi Arabia, Kuwait and
Bahrain.
In the United States, we have no current
application for, and have not received the regulatory approvals
required for, the commercial sale of any of our products. We have
not submitted an NDA, PMA or 510(K) to the FDA for any product. We
have received approval from the FDA to proceed with our ongoing
Phase 3 clinical trial for Neutrolin in hemodialysis catheters as
the first of our required two Phase 3 studies. We are assessing the
structure of our anticipated second Phase 3 clinical trial to seek
efficiencies and improvements in its design and execution.
Financing will be required to complete our current Phase 3 trial
and to begin and execute our anticipated second Phase 3 trial.
However, we might not obtain any financing and may never start the
second Phase 3 trial.
It is possible that Neutrolin will not receive any
further approval or that any of our other product candidates will
be approved for marketing. Failure to obtain regulatory approvals,
or delays in obtaining regulatory approvals, would adversely affect
the successful commercialization of Neutrolin or any other drugs or
products that we or our partners develop, impose additional costs
on us or our collaborators, diminish any competitive advantages
that we or our partners may attain, and/or adversely affect our
cash flow.
Even if approved, our products will be subject to extensive
post-approval regulation.
Once a product is approved, numerous post-approval
requirements apply in the United States and abroad. Depending on
the circumstances, failure to meet these post-approval requirements
can result in criminal prosecution, fines, injunctions, recall or
seizure of products, total or partial suspension of production,
denial or withdrawal of pre-marketing product approvals, or refusal
to allow us to enter into supply contracts, including government
contracts. In addition, even if we comply with FDA, foreign and
other requirements, new information regarding the safety or
effectiveness of a product could lead the FDA or a foreign
regulatory body to modify or withdraw product
approval.
The successful commercialization of Neutrolin will depend on
obtaining coverage and reimbursement for use of Neutrolin from
third-party payors.
Sales of pharmaceutical products largely depend on
the reimbursement of patients’ medical expenses by government
health care programs and/or private health insurers, both in the
U.S. and abroad. Further, significant uncertainty exists as to the
reimbursement status of newly approved health care products.
We initially expect to sell Neutrolin directly to hospitals and key
dialysis center operators, but also plan to expand its usage into
intensive care, oncology and total parenteral nutrition
patients
needing catheters,
including Medicare patients. All of these potential customers are
healthcare providers who depend upon reimbursement by government
and commercial insurance payors for dialysis and other treatments.
Reimbursement is strictly governed by these insurance payors. We
believe that Neutrolin would be eligible for coverage under various
reimbursement programs, including hospital inpatient
diagnosis-related groups (DRGs), outpatient ambulatory payment
classification (APCs) and the End-Stage Renal Disease Prospective
Payment System (ESRD PPS) or under the Durable Medical Equipment,
Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule,
depending on the treatment setting. However, coverage by any of
these reimbursement programs is not assured, and even if coverage
is granted it could later be revoked or modified under future
regulations. Further, the U.S. Centers for Medicare & Medicaid
Services (CMS), which administers Medicare and works with states to
administer Medicaid, has adopted and will continue to adopt and/or
amend rules governing reimbursement for specific treatments,
including those we intend to address such as dialysis and ESRD PPS.
We anticipate that CMS and private insurers will increasingly
demand that manufacturers demonstrate the cost effectiveness of
their products as part of the reimbursement review and approval
process. Rising healthcare costs have also lead many European and
other foreign countries to adopt healthcare reform proposals and
medical cost containment measures. Any measures affecting the
reimbursement programs of these governmental and private insurance
payors, including any uncertainty in the medical community
regarding their nature and effect on reimbursement programs, could
have an adverse effect on purchasing decisions regarding Neutrolin,
as well as limit the prices we may charge for Neutrolin.
The failure to obtain or maintain
reimbursement coverage for Neutrolin or any other products could
materially harm our operations.
In
anticipation that CMS and private payers will demand that we
demonstrate the cost effectiveness of Neutrolin as part of the
reimbursement
review
and
approval process, we have incorporated health economic evaluations
into our ongoing clinical studies to support this review in the
context of the prospective use of Neutrolin in dialysis, the ICU
and oncology settings. However, our studies might not be
sufficient to support coverage or reimbursement at levels that
allow providers to use Neutrolin.
Physicians and patients may not accept and use our
products.
Even with
the
CE Mark approval of Neutrolin, and even if we
receive FDA or other foreign regulatory approval for Neutrolin or
other product candidates, physicians and patients may not accept
and use our products. Acceptance and use of our products will
depend upon a number of factors including the
following:
●
perceptions
by members of the health care community, including physicians,
about the safety and effectiveness of our drug or device
product;
●
cost-effectiveness
of our product relative to competing products;
●
availability of reimbursement for our
product
from government or other
healthcare payors; and
●
effectiveness of marketing and distribution
efforts
by us and our licensees and
distributors, if any.
Because we expect sales of Neutrolin to generate
substantially all of our product revenues for the foreseeable
future, the failure of Neutrolin to find market acceptance would
harm our business and would require us to seek additional
financing.
Risks Related to Our Business and Industry
Competition and technological change may make our product
candidates and technologies less attractive or
obsolete.
We compete with established pharmaceutical and
medical device companies that are pursuing other forms of
prevention or treatment for the same indications we are pursuing
and that have greater financial and other resources. Other
companies may succeed in developing products earlier than we do,
obtaining FDA or any other regulatory agency approval for products
more rapidly, or developing products that are more effective than
our product candidates. Research and development by others may
render our technology or product candidates obsolete or
noncompetitive, or result in processes, treatments or cures
superior to any therapy we develop. We face competition from
companies that internally develop competing technology or acquire
competing technology from universities and other research
institutions. As these companies develop their technologies, they
may develop competitive positions that may prevent, make futile, or
limit our product commercialization efforts, which would result in
a decrease in the revenue we would be able to derive from the sale
of any products.
There can be no assurance that Neutrolin or any
other product candidate will be accepted by the marketplace as
readily as these or other competing treatments. Furthermore, if our
competitors’ products are approved before ours, it could be
more difficult for us to obtain approval from the FDA or any other
regulatory agency. Even if our products are successfully developed
and approved for use by all governing regulatory bodies, there can
be no assurance that physicians and patients will accept any of our
products as a treatment of choice.
Furthermore, the pharmaceutical and medical device
industry is diverse, complex, and rapidly changing. By its nature,
the business risks associated with the industry are numerous and
significant. The effects of competition, intellectual property
disputes, market acceptance, and FDA or other regulatory agency
regulations preclude us from forecasting revenues or income with
certainty or even confidence.
We face the risk of product liability claims and the amount of
insurance coverage we hold now or in the future may not be adequate
to cover all liabilities we might incur.
Our business exposes us to the risk of product
liability claims that are inherent in the development of drugs. If
the use of one or more of our or our collaborators’ drugs or
devices harms people, we may be subject to costly and damaging
product liability claims brought against us by clinical trial
participants, consumers, health care providers, pharmaceutical
companies or others selling our products.
We currently carry product liability insurance
that covers our clinical trials. We cannot predict all of the
possible harms or side effects that may result and, therefore, the
amount of insurance coverage we hold may not be adequate to cover
all liabilities we might incur. Our insurance covers bodily injury
and property damage arising from our clinical trials, subject to
industry-standard terms, conditions and exclusions. This coverage
includes the sale of commercial products. We have expanded our
insurance coverage to include the sale of commercial products due
to the receipt of the CE Mark approval, but we may be unable to
maintain such coverage or obtain commercially reasonable product
liability insurance for any other products approved for
marketing.
If we are unable to obtain insurance at an
acceptable cost or otherwise protect against potential product
liability claims, we may be exposed to significant liabilities,
which may materially and adversely affect our business and
financial position. If we are sued for any injury allegedly caused
by our or our collaborators’ products and do not have
sufficient insurance coverage, our liability could exceed our total
assets and our ability to pay the liability. A successful product
liability claim or series of claims brought against us would
decrease our cash and could cause the value of our capital stock to
decrease.
We may be exposed to liability claims associated with the use of
hazardous materials and chemicals.
Our research, development and manufacturing
activities and/or those of our third-party contractors may involve
the controlled use of hazardous materials and chemicals. Although
we believe that our safety procedures for using, storing, handling
and disposing of these materials comply with federal, state and
local, as well as foreign, laws and regulations, we cannot
completely eliminate the risk of accidental injury or contamination
from these materials. In the event of such an accident, we could be
held liable for any resulting damages and any liability could
materially adversely affect our business, financial condition and
results of operations. In addition, the federal, state and local,
as well as foreign, laws and regulations governing the use,
manufacture, storage, handling and disposal of hazardous or
radioactive materials and waste products may require us to incur
substantial compliance costs that could materially adversely affect
our business, financial condition and results of
operations.
Healthcare policy changes, including reimbursement policies for
drugs and medical devices, may have an adverse effect on our
business, financial condition and results of
operations.
Market acceptance and sales of Neutrolin or any
other product candidates that we develop will depend on
reimbursement policies and may be affected by health care reform
measures in the United States and abroad. Government authorities
and other third-party payors, such as private health insurers and
health maintenance organizations, decide which drugs they will pay
for and establish reimbursement levels. We cannot be sure that
reimbursement will be available for Neutrolin or any other product
candidates that we develop. Also, we cannot be sure that the amount
of reimbursement available, if any, will not reduce the demand for,
or the price of, our products. If reimbursement is not available or
is available only at limited levels, we may not be able to
successfully commercialize Neutrolin or any other product
candidates that we develop.
In
the United States, there have been a number of legislative and
regulatory proposals to change the health care system in ways that
could affect our ability to sell our products profitably. The
Patient Protection and Affordable Care Act, as amended by the
Health Care and Education Reconciliation Act of 2010, or
collectively, the Healthcare Reform Act, substantially changes the
way healthcare is financed by both governmental and private
insurers, and significantly impacts the pharmaceutical industry.
The Healthcare Reform Act contains a number of provisions,
including those governing enrollment in federal healthcare
programs, reimbursement changes and fraud and abuse, which will
impact existing government healthcare programs and will result in
the development of new programs, including Medicare payment for
performance initiatives and improvements to the physician quality
reporting system and feedback program. We anticipate that if we
obtain approval for our products, some of our revenue may be
derived from U.S. government healthcare programs, including
Medicare.
Some of
the provisions of the Healthcare Reform Act have yet to be
implemented, and there have been judicial and Congressional
challenges to certain aspects of the Healthcare Reform Act. Since
January 2017, President Trump has signed two Executive Orders and
other directives designed to delay, circumvent or loosen the
implementation of certain provisions requirements mandated by the
Healthcare Reform Act or otherwise circumvent some of the
requirements for health insurance mandated by the Healthcare Reform
Act. Concurrently, Congress has considered legislation that would
repeal or repeal and replace all or part of the Healthcare Reform
Act. While Congress has not passed repeal legislation, the Tax Cuts
and Jobs Act of 2017 includes a provision repealing, effective
January 1, 2019, the tax-based shared responsibility payment
imposed by the Healthcare Reform Act on certain individuals who
fail to maintain qualifying health coverage for all or part of a
year that is commonly referred to as the “individual
mandate.” Additionally, on January 23, 2018, President
Trump signed a continuing resolution on appropriations for fiscal
year 2018 that delayed the implementation of certain Healthcare
Reform Act-mandated fees, including the so-called
“Cadillac” tax on certain high cost employer-sponsored
insurance plans. Congress may consider other legislation to repeal
or replace elements of the Healthcare Reform Act.
In addition to the Healthcare Reform Act, we
expect that there will continue to be proposals by legislators at
both the federal and state levels, regulators and third-party
payors to keep healthcare costs down while expanding individual
healthcare benefits. Certain of these changes could impose
limitations on the prices we will be able to charge for any
products that are approved or the amounts of reimbursement
available for these products from governmental agencies or other
third-party payors or may increase the tax requirements for life
sciences companies such as ours. While it is too early to predict
what effect the Healthcare Reform Act or any future legislation or
regulation will have on us, such laws could have an adverse effect
on our business, financial condition and results of
operations.
Health administration authorities in countries
other than the United States may not provide reimbursement for
Neutrolin or any of our other product candidates at rates
sufficient for us to achieve profitability, or at all. Like the
United States, these countries could adopt health care reform
proposals and could materially alter their government-sponsored
health care programs by reducing reimbursement
rates.
Any reduction in reimbursement rates under
Medicare or private insurers or foreign health care programs could
negatively affect the pricing of our products. If we are not able
to charge a sufficient amount for our products, then our margins
and our profitability will be adversely
affected.
If we lose key management or scientific personnel, cannot recruit
qualified employees, directors, officers, or other personnel or
experience increases in compensation costs, our business may
materially suffer.
We are highly dependent on the principal members
of our management and scientific staff, specifically, Khoso Baluch,
a director and our Chief Executive Officer, Robert Cook, our Chief
Financial Officer, and John Armstrong, our Executive Vice President
for Technical Operations. Our future success will depend in part on
our ability to identify, hire, and retain current and additional
personnel. We experience intense competition for qualified
personnel and may be unable to attract and retain the personnel
necessary for the development of our business. Moreover, our work
force is located in the New York metropolitan area, where
competition for personnel with the scientific and technical skills
that we seek is extremely high and is likely to remain high.
Because of this competition, our compensation costs may increase
significantly. In addition, we have only limited ability to prevent
former employees from competing with
us.
If we are unable to hire additional qualified personnel, our
ability to grow our business may be
harmed.
Over time, we expect to hire additional qualified
personnel with expertise in clinical testing, clinical research and
testing, government regulation, formulation and manufacturing, and
sales and marketing. We compete for qualified individuals with
numerous pharmaceutical companies, universities and other research
institutions. Competition for such individuals is intense, and we
cannot be certain that our search for such personnel will be
successful. Attracting and retaining such qualified personnel will
be critical to our success.
We may not successfully manage our
growth.
Our success will depend upon the expansion of our
operations to commercialize Neutrolin and the effective management
of any growth, which could place a significant strain on our
management and our administrative, operational and financial
resources. To manage this growth, we may need to expand our
facilities, augment our operational, financial and management
systems and hire and train additional qualified personnel. If we
are unable to manage our growth effectively, our business may be
materially harmed.
Risks Related to Our Intellectual Property
If we materially breach or default under any of our license
agreements, the licensor party to such agreement will have the
right to terminate the license agreement, which termination may
materially harm our business.
Our commercial success will depend in part on the
maintenance of our license agreements. Each of our license
agreements provides the licensor with a right to terminate the
license agreement for our material breach or default under the
agreement, including the failure to make any required milestone or
other payments. Should the licensor under any of our license
agreements exercise such a termination right, we would lose our
right to the intellectual property under the respective license
agreement, which loss may materially harm our
business.
If we and our licensors do not obtain protection for and
successfully defend our respective intellectual property rights,
our competitors may be able to take advantage of our research and
development efforts to develop competing
products.
Our commercial success will depend in part on
obtaining further patent protection for our products and other
technologies and successfully defending any patents that we
currently have or will obtain against third-party challenges. The
patents which we currently believe are most material to our
business are as follows:
●
U.S. Patent No. 8,541,393 (
expiring
in November 2024) (the “Prosl
Patent”) - use of Neutrolin for preventing infection and
maintenance of catheter patency in hemodialysis
catheters;
●
U.S.
Patent No. 6,166,007 (expiring May 2019) (the “Sodemann
Patent”) - a method of inhibiting or preventing infection and
blood coagulation at a medical prosthetic device; and
●
European Patent EP 1 814 562 B1 (
expiring
October 12, 2025) (the “Prosl
European Patent”) - a low heparin catheter lock solution for
maintaining and preventing infection in a hemodialysis
catheter.
We are currently seeking further patent protection
for our compounds and methods of treating diseases. However, the
patent process is subject to numerous risks and uncertainties, and
there can be no assurance that we will be successful in protecting
our products by obtaining and defending patents. These risks and
uncertainties include the
following:
●
patents
that may be issued or licensed may be challenged, invalidated, or
circumvented, or otherwise may not provide any competitive
advantage;
●
our competitors, many of which have
substantially
greater resources than
we have and many of which have made significant investments in
competing technologies, may seek, or may already have obtained,
patents that will limit, interfere with, or eliminate our ability
to make, use, and sell our potential products either in the United
States or in international markets;
●
there
may be significant pressure on the United States government and
other international governmental bodies to limit the scope of
patent protection both inside and outside the United States for
treatments that prove successful as a matter of public policy
regarding worldwide health concerns; and
●
countries other than the United States may
have
less restrictive patent laws than
those upheld by United States courts, allowing foreign competitors
the ability to exploit these laws to create, develop, and market
competing products.
In addition, the United States Patent and
Trademark Office, or PTO, and patent offices in other jurisdictions
have often required that patent applications concerning
pharmaceutical and/or biotechnology-related inventions be limited
or narrowed substantially to cover only the specific innovations
exemplified in the patent application, thereby limiting the scope
of protection against competitive challenges. Thus, even if we or
our licensors are able to obtain patents, the patents may be
substantially narrower than
anticipated.
The above mentioned patents and patent
applications are exclusively licensed to us. To support our patent
strategy, we have engaged in a review of patentability and certain
freedom to operate issues, including performing certain searches.
However, patentability and certain freedom to operate issues are
inherently complex, and we cannot provide assurances that a
relevant patent office and/or relevant court will agree with our
conclusions regarding patentability issues or with our conclusions
regarding freedom to operate issues, which can involve subtle
issues of claim interpretation and/or claim liability. Furthermore,
we may not be aware of all patents, published applications or
published literature that may affect our business either by
blocking our ability to commercialize our product candidates,
preventing the patentability of our product candidates to us or our
licensors, or covering the same or similar technologies that may
invalidate our patents, limit the scope of our future patent claims
or adversely affect our ability to market our product
candidates. Additionally, it is also possible that prior art
of which we are aware, but which we do not believe affects the
validity or enforceability of a claim, may, nonetheless, ultimately
be found by a court of law or an administration panel to affect the
validity or enforceability of a claim. If a third party were to
prevail on a legal assertion of invalidity and/or unenforceability,
we would lose at least part, and perhaps all, of the patent
protection on our product candidates. Such loss of patent
protection could have a material adverse impact on our
business.
In addition to patents, we also rely on trade
secrets and proprietary know-how. Although we take measures to
protect this information by entering into confidentiality and
inventions agreements with our employees and some, but not all, of
our scientific advisors, consultants, and collaborators. However,
we cannot provide any assurances that these agreements will not be
breached, that we will be able to protect ourselves from the
harmful effects of disclosure or dispute ownership if they are
breached, or that our trade secrets will not otherwise become known
or be independently discovered by competitors. If any of these
events occurs, or we otherwise lose protection for our trade
secrets or proprietary know-how, the value of our intellectual
property may be greatly
reduced.
Ongoing and future intellectual property disputes could require us
to spend time and money to address such disputes and could limit
our intellectual property rights.
The biotechnology and pharmaceutical industries
have been characterized by extensive litigation regarding patents
and other intellectual property rights, and companies have employed
intellectual property litigation to gain a competitive advantage.
We may initiate or become subject to infringement claims or
litigation arising out of patents and pending applications of our
competitors, or we may become subject to proceedings initiated by
our competitors or other third parties or the PTO or applicable
foreign bodies to reexamine the patentability of our licensed or
owned patents. In addition, litigation may be necessary to enforce
our issued patents, to protect our trade secrets and know-how, or
to determine the enforceability, scope, and validity of the
proprietary rights of others.
We initiated court proceedings in Germany for
patent infringement and unfair use of our proprietary information
related to Neutrolin (as described below). We also have had
opposition proceedings brought against the European Patent and the
German utility model patent which are the basis of our infringement
proceedings (as described below). The defense and prosecution of
these ongoing and any future intellectual property suits, PTO or
foreign proceedings, and related legal and administrative
proceedings are costly and time-consuming to pursue, and their
outcome is uncertain. An adverse determination in litigation or PTO
or foreign proceedings to which we may become a party could subject
us to significant liabilities, including damages, require us to
obtain licenses from third parties, restrict or prevent us from
selling our products in certain markets, or invalidate or render
unenforceable our licensed or owned patents. Although patent and
intellectual property disputes might be settled through licensing
or similar arrangements, the costs associated with such
arrangements may be substantial and could include our paying large
fixed payments and ongoing royalties. Furthermore, the necessary
licenses may not be available on satisfactory terms or at
all.
On
September 9, 2014, we filed in the District Court of Mannheim,
Germany a patent infringement action against TauroPharm GmbH and
Tauro-Implant GmbH as well as their respective CEOs (the
“Defendants”) claiming infringement of our European
Patent EP 1 814 562 B1, which was granted by the EPO on January 8,
2014 (the “Prosl European Patent”). The Prosl European
Patent covers a low dose heparin catheter lock solution for
maintaining patency and preventing infection in a hemodialysis
catheter. In this action, we claim that the Defendants
infringe on the Prosl European Patent by manufacturing and
distributing catheter locking solutions to the extent they are
covered by the claims of the Prosl European Patent. We
believe that our patent is sound, and are seeking injunctive relief
and raising claims for information, rendering of accounts, calling
back, destruction and damages. Separately, TauroPharm has filed an
opposition with the EPO against the Prosl European Patent alleging
that it lacks novelty and inventive step. We cannot
predict what other defenses the Defendants may raise, or the
ultimate outcome of either of these related
matters.
In the
same complaint against the same Defendants, we also alleged an
infringement (requesting the same remedies) of NDP’s utility
model DE 20 2005 022 124 U1 (the “Utility Model”),
which we believe is fundamentally identical to the Prosl European
Patent in its
main
aspects and
claims. The Court separated the two proceedings and the Prosl
European Patent and the Utility Model claims are now being tried
separately. TauroPharm has filed a cancellation action
against the Utility Model before the German Patent and Trademark
Office (the “German PTO”) based on the similar
arguments as those in the opposition against the Prosl European
Patent.
On
March 27, 2015, the District Court held a hearing to evaluate
whether the Utility Model has been infringed by TauroPharm in
connection with the manufacture, sale and distribution of its
TauroLock-HEP100TM and TauroLock-HEP500TM products. A
hearing
before the same court was held on
January 30, 2015 on the separate, but related, question of
infringement of the Prosl European Patent by
TauroPharm.
The
Court issued its decisions on May 8, 2015, staying both
proceedings. In its decisions, the Court found that the
commercialization by TauroPharm in Germany of its TauroLock
catheter lock solutions Hep100 and Hep500 infringes both the
Prosl European Patent and the Utility Model and further that there
is no prior use right that would allow TauroPharm to
continue
to make, use or sell its product
in Germany. However, the Court declined to issue an injunction in
favor of us that would preclude the continued commercialization by
TauroPharm based upon its finding that there is a sufficient
likelihood that the EPO, in the case of the Prosl European Patent,
or the German PTO, in the case of the Utility Model, may find that
such patent or utility model is invalid. Specifically, the Court
noted the possible publication of certain instructions for
product use that may be deemed to constitute prior art. As such,
the District Court determined that it will defer any consideration
of the request by us for injunctive and other relief until such
time as the EPO or the German PTO has ruled on the underlying
validity of the Prosl European Patent and the Utility
Model.
The
opposition proceeding against the Prosl European Patent before the
EPO is ongoing. In its preliminary consideration of the matter, the
EPO (and the German PTO) regarded the patent as not inventive or
novel due to publication of prior art. Oral proceedings
before the Opposition Division at the EPO were held on November 25,
2015, at which the three judge patent examiner panel considered
arguments related to the validity of the Prosl European Patent. The
hearing was adjourned due to the fact that the panel was of the
view that Claus Herdeis, one of the managing directors of
TauroPharm, has to be heard as a witness in a further hearing in
order to close some gaps in the documentation presented by
TauroPharm as regards the publication of prior art.
The
German PTO held a hearing in the validity proceedings relating to
the Utility Model on June 29, 2016, at which the panel affirmed its
preliminary finding that the Utility Model was invalid based upon
prior publication of a reference to the benefits that may be
associated with adding heparin to a taurolidine based solution. The
decision is subject to appeal and has only a
declaratory
effect, as the Utility Model
had expired in November 2015. Furthermore, it has no bearing on the
ongoing consideration of the validity and possible infringement of
the Prosl Patent by the EPO. We filed an appeal against the ruling
on September 7, 2016.
In
October 2016, TauroPharm submitted a further writ to the EPO
requesting a date for the hearing and bringing forward further
arguments, in particular in view of the June 2016 decision of the
German PTO on the invalidity of the utility model, which we have
appealed. On November 22, 2017, the EPO in Munich, Germany, held a
further oral hearing in this matter. At the hearing, the panel held
that the Prosl European Patent would be invalidated because it did
not meet the requirements of novelty based on a technical aspect of
the European intellectual property law. We disagree with this
decision and plan to appeal. Our appeal will be based, in part, on
the written opinion to be issued by the Opposition Division, which
is expected by the first quarter 2018. We continue to believe that
the Prosl European Patent is indeed novel and that its validity
should be maintained. There can be no assurance that we will
prevail in this matter.
In
addition, the ongoing Unfair Competition litigation against
TauroPharm is not affected and will continue.
On
January 16, 2015, we filed a complaint against TauroPharm GmbH and
its managing directors in the District Court of Cologne,
Germany. In the complaint, we allege violation of the
German Unfair Competition Act by TauroPharm for the unauthorized
use of its proprietary information obtained in confidence by
TauroPharm. We allege that TauroPharm is improperly and
unfairly
using its proprietary
information relating to the composition and manufacture of
Neutrolin, in the manufacture and sale of TauroPharm’s
products TauroLockTM, TauroLock-HEP100 and
TauroLock-HEP500. We seek a cease and desist order
against TauroPharm from continuing to manufacture and sell any
product containing taurolidine (the active pharmaceutical
ingredient (“API”) of Neutrolin) and citric acid in
addition to possible other components, damages for any sales in the
past and the removal of all such products from the market. An
initial hearing in the District Court of Cologne, Germany was held
on November 19, 2015 to consider our claims. The judge made no
decision on the merits of our complaint. On January 14, 2016,
the court issued an interim decision in the form of a court order
outlining several issues of concern that relate primarily to
court's interest in clarifying the facts and reviewing any and all
available documentation, in particular with regard to the question
which specific know-how was provided to TauroPharm by whom and
when. We have prepared the requested reply and produced the
respective documentation. TauroPharm has also filed another writ
within the same deadline and both parties have filed further writs
at the end of April setting out their respective argumentation in
more detail. A further oral hearing in this matter was held on
November 15, 2016. In this hearing, the court heard arguments from
us and TauroPharm concerning the allegations of unfair competition.
The court made no rulings from the bench, and indicated that it is
prepared to further examine the underlying facts of our
allegations. On March 7, 2017, the court issued another interim
decision in the form of a court order outlining again several
issues relating to the argumentation of both sides in the
proceedings. In particular the court requested us to further
specify our requests and to further substantiate in even more
detail which know know-how was provided by Biolink to TauroPharm by
whom and when. The court also raised the question whether the
know-how provided at the time to TauroPharm could still be
considered to be secret know-how or may have become public in the
meantime. The court granted both sides the opportunity to reply to
this court order and provide additional facts and evidence until
May 15, 2017. Both parties have submitted further writs in this
matter and the court had scheduled a further hearing for May 8,
2018.
After having been rescheduled
several times, the hearing is now scheduled to take place on
November 20, 2018.
We intend to continue to pursue this
matter, and to provide additional supplemental documentary and
other evidence as may be necessary to support our
claims.
If we infringe the rights of third parties we could be prevented
from selling products and forced to pay damages and defend against
litigation.
If our products, methods, processes and other
technologies infringe the proprietary rights of other parties, we
could incur
substantial
costs
and we may have to do one or more of the
following:
●
obtain licenses, which may not be
available
on commercially reasonable terms, if
at all;
●
abandon an infringing product
candidate
;
●
redesign
our products or processes to avoid infringement;
●
stop using the subject matter claimed
in
the patents held by
others;
●
defend litigation
or
administrative proceedings, which may be costly
whether we win or lose, and which could result in a substantial
diversion of our financial and management
resources.
Risks Related to Dependence on Third Parties
If we are not able to develop and maintain collaborative marketing
relationships with licensees or partners, or create an effective
sales, marketing, and distribution capability, we may be unable to
market our products or market them
successfully.
Our business strategy for Neutrolin relies on
collaborating with larger firms with experience in marketing and
selling medical devices and pharmaceutical products; for other
products we may also rely on such marketing collaborations or
out-licensing of our product candidates. Specifically, for
Neutrolin we have a distributor agreement with each of a Saudi
Arabian, an Emirati and a South Korean company for sales and
marketing (upon receipt of approval to market in South Korea). In
April 2017, we announced a commercial collaboration with Hemotech
SAS covering France and certain overseas territories. Assuming we
receive applicable regulatory approval for other markets, we plan
to enter into distribution agreements with one or more third
parties for the sale of Neutrolin in various European, Middle East
and other markets. However, there can be no assurance that we will
be able to successfully maintain those relationships or establish
and maintain additional marketing, sales, or distribution
relationships, nor can there be assurance that such relationships
will be successful, or that we will be successful in gaining market
acceptance for our products. To the extent that we enter into any
marketing, sales, or distribution arrangements with third parties,
our product revenues will be lower than if we marketed and sold our
products directly, and any revenues we receive will depend upon the
efforts of such third-parties.
If
we are unable to establish and maintain such third-party sales and
marketing relationships, or choose not to do so, we will have to
establish our own in-house capabilities. We currently have no
sales, marketing, or distribution infrastructure. To market any of
our products directly, we would need to develop a marketing, sales,
and distribution force that has both technical expertise and the
ability to support a distribution capability. The establishment of
a marketing, sales, and distribution capability would take time and
significantly increase our costs, possibly requiring substantial
additional capital. In addition, there is intense competition for
proficient sales and marketing personnel, and we may not be able to
attract individuals who have the qualifications necessary to
market, sell, and distribute our products. There can be no
assurance that we will be able to establish internal marketing,
sales, or distribution capabilities. If we are unable to, or choose
not to establish these capabilities, or if the capabilities we
establish are not sufficient to meet our needs, we will be required
to establish collaborative marketing, sales, or distribution
relationships with third parties, which we might not be able to do
on acceptable terms or at all.
We currently have no internal marketing and sales organization and
currently rely and intend to continue to rely on third parties to
market
and
sell Neutrolin.
If we are unable to enter into or maintain agreements with third
parties to market and sell Neutrolin or any other product after
approval or are unable to establish our own marketing and sales
capabilities, we may not be able to generate significant or any
product revenues.
We do
not have an internal sales organization. To date we have relied,
and intend to continue to rely, on third parties for the marketing,
sales and distribution of Neutrolin and any other product we might
develop. However, we may not be able to maintain current and future
arrangements or enter into new arrangements with third parties to
sell Neutrolin or any other product on favorable terms or at all.
In that event, we would have to develop our own marketing and sales
force. The establishment and development of our own sales force
would be expensive and time consuming and could delay any
product
launch, and we cannot
be certain that we would be able to successfully develop this
capability. In addition, the use of third parties to commercialize
our approved products reduces the revenues that we would receive if
we commercialized these products ourselves.
We have
entered into agreements with independent companies to market
Neutrolin in Saudi Arabia, the United Arab Emirates and France,
and, upon regulatory approval, South Korea. We may seek a sales
partner in the U.S. if Neutrolin receives FDA approval.
Consequently, we will be dependent on these firms and individuals
for the success of sales in these and any other countries in which
approval is granted. If these firms or individuals do not perform
for whatever reason, our business,
prospects
and results of operations may be
materially adversely affected. Finding a new or replacement
organization for sales and marketing could be difficult, which
would further harm our business, prospects and results of
operations.
If we or our collaborators are unable to manufacture our products
in sufficient quantities or are unable to obtain regulatory
approvals for a manufacturing facility, we may be unable to meet
demand for our products and we may lose potential
revenues.
Completion of our clinical trials and
commercialization of Neutrolin and any other product candidate
require access to, or development of, facilities to manufacture a
sufficient supply of our product candidates. All of our
manufacturing processes currently are, and we expect them to
continue to be, outsourced to third parties. Specifically, we will
rely on one or more manufacturers to supply us and/or our
distribution partners with commercial quantities of Neutrolin. If,
for any reason, we become unable to rely on our current sources for
the manufacture of Neutrolin or any other product candidates or for
active pharmaceutical ingredient, or API, either for clinical
trials or for commercial quantities, then we would need to identify
and contract with additional or replacement third-party
manufacturers to manufacture compounds for pre-clinical, clinical,
and commercial purposes. We may not be successful in identifying
such additional or replacement third-party manufacturers, or in
negotiating acceptable terms with any that we do identify. Such
third-party manufacturers must receive FDA or applicable foreign
approval before they can produce clinical material or commercial
product, and any that are identified may not receive such approval
or may fail to maintain such approval. In addition, we may be in
competition with other companies for access to these
manufacturers’ facilities and may be subject to delays in
manufacturing if the manufacturers give other clients higher
priority than they give to us. If we are unable to secure and
maintain third-party manufacturing capacity, the development and
sales of our products and our financial performance may be
materially affected.
Before we could begin to commercially manufacture
Neutrolin or any other product candidate on our own, we must obtain
regulatory approval of the manufacturing facility and process. The
manufacture of drugs for clinical and commercial purposes must
comply with cGMP and applicable non-U.S. regulatory requirements.
The cGMP requirements govern quality control and documentation
policies and procedures. Complying with cGMP and non-U.S.
regulatory requirements would require that we expend time, money,
and effort in production, recordkeeping, and quality control to
assure that the product meets applicable specifications and other
requirements. We would also have to pass a pre-approval inspection
prior to FDA or non-U.S. regulatory agency approval. Failure to
pass a pre-approval inspection may significantly delay regulatory
approval of our products. If we fail to comply with these
requirements, we would be subject to possible regulatory action and
may be limited in the jurisdictions in which we are permitted to
sell our products. As a result, our business, financial condition,
and results of operations could be materially adversely
affected.
Corporate and academic collaborators may take actions that delay,
prevent, or undermine the success of our
products.
Our operating and financial strategy for the
development, clinical testing, manufacture, and commercialization
of our product candidates is heavily dependent on our entering into
collaborations with corporations, academic institutions, licensors,
licensees, and other parties. Our current strategy assumes that we
will successfully establish and maintain these collaborations or
similar relationships. However, there can be no assurance that we
will be successful establishing or maintaining such collaborations.
Some of our existing collaborations, such as our licensing
agreements, are, and future collaborations may be, terminable at
the sole discretion of the collaborator in certain circumstances.
Replacement collaborators might not be available on attractive
terms, or at all.
In addition, the activities of any collaborator
will not be within our control and may not be within our power to
influence. There can be no assurance that any collaborator will
perform its obligations to our satisfaction or at all, that we will
derive any revenue or profits from such collaborations, or that any
collaborator will not compete with us. If any collaboration is not
pursued, we may require substantially greater capital to undertake
on our own the development and marketing of our product candidates
and may not be able to develop and market such products
successfully, if at all. In addition, a lack of development and
marketing collaborations may lead to significant delays in
introducing product candidates into certain markets and/or reduced
sales of products in such markets.
Data provided by collaborators and others upon which we rely that
has not been independently verified could turn out to be false,
misleading, or incomplete.
We rely on third-party vendors, scientists, and
collaborators to provide us with significant data and other
information related to our projects, clinical trials, and business.
If such third parties provide inaccurate, misleading, or incomplete
data, our business, prospects, and results of operations could be
materially adversely affected.
Risks Related to our Common Stock
Prior to fiscal 2015, we had identified a material weakness in our
internal control over financial reporting, and our current internal
control
over
financial
reporting and our disclosure controls and procedures may not
prevent all possible errors that could
occur.
In the
several years prior to fiscal 2015, we had identified a material
weakness in our internal control over financial reporting that was
related to our limited finance staff and the resulting ineffective
management review over financial reporting, coupled with
increasingly
complex
accounting
treatments associated with our financing activities and European
expansion. While we remediated this material weakness in 2015, we
cannot be certain that material weaknesses will not arise
again.
A
control system, no matter how well designed and operated, can
provide only reasonable, not absolute, assurance that the control
system’s objectives will be satisfied. Internal control over
financial reporting and disclosure controls and procedures are
designed to give a reasonable assurance that they are effective to
achieve their objectives. We cannot provide absolute assurance that
all of our possible future control issues will be detected. These
inherent limitations include the possibility that judgments in our
decision making can be faulty, and that isolated breakdowns can
occur because of simple
human
error or mistake. The design of our system of controls is based in
part upon assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed absolutely
in achieving our stated goals under all potential future or
unforeseeable conditions. Because of the inherent limitations in a
cost-effective control system, misstatements due to error could
occur and not be detected. This and any future failures could cause
investors to lose confidence in our reported financial information,
which could have a negative impact on our financial condition and
stock price.
Our common stock price has fluctuated considerably and is likely to
remain volatile, in part due to the limited market for our common
stock, and you could lose all or a part of your
investment.
During the period from the completion of our
initial public offering, or IPO, on March 30, 2010 through March 6,
2018, the high and low sales prices for our common stock were
$10.40 and $0.15, respectively. There is a limited public market
for our common stock and we cannot provide assurances that an
active trading market will develop or continue. As a result of low
trading volume in our common stock, the purchase or sale of a
relatively small number of shares could result in significant share
price fluctuations.
Additionally, the market price of our common stock
may continue to fluctuate significantly in response to a number of
factors, some of which are beyond our control, including the
following:
●
market acceptance of Neutrolin in those markets
in
which
it is approved for
sale;
●
our need for additional
capital
;
●
the
receipt of or failure to obtain additional regulatory approvals for
Neutrolin, including FDA approval in the U.S.;
●
results of clinical
trials
of our product candidates, including our ongoing
and planned Phase 3 trials for Neutrolin in the U.S., or those of
our competitors;
●
our entry into or the
loss
of a significant
collaboration;
●
regulatory
or legal developments in the United States and other countries,
including changes in the healthcare payment systems;
●
changes in
financial
estimates or investment recommendations by
securities analysts relating to our common
stock;
●
announcements
by our competitors of significant developments, strategic
partnerships, joint ventures or capital commitments;
●
changes in key
personnel
;
●
variations in our
financial
results or those of companies that are perceived
to be similar to us;
●
market conditions in the
pharmaceutical
and medical device sectors and
issuance of new or changed securities analysts’ reports or
recommendations;
●
general economic,
industry
and market conditions;
●
developments
or disputes concerning patents or other proprietary
rights;
●
future sales or
anticipated
sales of our securities by us or our stockholders;
and
●
any other factors
described
in this “Risk Factors”
section.
In addition, the stock markets in general, and the
stock of pharmaceutical and medical device companies in particular,
have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating
performance of these companies. Broad market and industry factors
may negatively affect the market price of our common stock,
regardless of our actual operating
performance.
For these reasons and others, an investment in our
securities is risky and you should invest only if you can withstand
a significant loss and wide fluctuations in the value of your
investment.
A significant number of additional shares of our common stock may
be issued at a later date, and their sale could depress the market
price of our common stock.
As of December 31, 2017, we had outstanding the
following securities that are convertible into or exercisable for
shares of our common stock:
●
warrants
for 227,273 shares of common stock issued in July 2013 with an
exercise price of $1.50 that expire on July 30, 2018;
●
warrants
for 500,000 shares of common stock issued in May 2013 with an
exercise price of $0.65 per share that expire on May 30,
2019;
●
warrants for 125,000 shares
issued
to ND Partners in April 2013 in
connection with the amendment to the license and assignment
agreement with an exercise price of $1.50 per share that expire on
April 11, 2018;
●
options to purchase an aggregate of 120,000 shares
of our common stock issued to our officers, directors, employees
and non-employee consultants
under
our Amended and Restated 2006 Stock Incentive
Plan, or the 2006 Stock Plan, with a weighted average exercise
price of $1.44 per share;
●
options
to purchase an aggregate of 4,842,795 shares of our common stock
issued to our officers, directors and non-employee consultants
under our 2013 Stock Plan, with a weighted average exercise price
of $2.05 per share;
●
a warrant to
purchase
400,000 shares of our common stock issued on
February 19, 2013 with an exercise price of $1.50 that expire on
February 19, 2018;
●
warrants
for 750,000 shares of common stock with an exercise price of $0.90
that expire on October 22, 2019;
●
warrants for 725,000
shares
of common stock with an exercise price of $0.90
that expire on January 8, 2020;
●
150,000 shares of
Series C-2 Preferred Stock, which are convertible into 1,500,000
shares of common stock;
●
104,000 shares of
Series C-3 Preferred Stock, which are convertible into 1,040,000
shares of common stock;
●
73,962 shares of
Series D Preferred Stock, which are convertible into 1,479,240
shares of common stock;
●
89,623 shares of
Series E Preferred Stock, which are convertible into 1,959,759
shares of common stock;
●
2,000 shares of
Series F Preferred Stock, which are convertible into 3,157,562
shares of common stock, subject to adjustment;
●
warrants for
682,500 shares of common stock issued in March 2014 with an
exercise price of $2.50 per shares that expire on September 10,
2019;
●
warrants for
200,000 shares of common stock with an exercise price of $7.00 that
expire on March 3, 2020;
●
warrants for 83,400
shares of common stock with an exercise price of $7.00 that expire
on March 25, 2020;
●
Series A warrants
for 4,078,226 shares of common stock with an exercise price of
$0.75 that expire on September 10, 2018;
●
Series B warrants
for 13,964,476 shares of common stock with an exercise price of
$1.05 that expire on August 10, 2022;
●
underwriter
warrants for 1,117,158 shares of common stock with an exercise
price of $0.9375 that expire on August 10, 2022;
●
warrants for
564,858 shares of common stock with an exercise price of $0.001
that expire on November 16, 2020; and
●
restricted stock
units for 66,414 shares of common stock with an average grant date
fair value of $2.08 per share.
The possibility of the issuance of these shares,
as well as the actual sale of such shares, could substantially
reduce the market price for our common stock and impede our ability
to obtain future financing.
We will need additional financing to fund our activities in the
future, which likely will dilute our
stockholders.
To
date, our commercial operations have not generated sufficient
revenues to enable profitability. As of September 30, 2017, we had
an accumulated deficit of approximately $141.9 million, and
incurred net losses from operations of $22.7 million for the nine
months then
ended
. Based on the
current development plans for Neutrolin in both the U.S. and
foreign markets (including the ongoing hemodialysis Phase 3
clinical trial in the U.S.) and our other operating requirements,
management believes that our existing cash and short-term
investments at September 30, 2017 will fund our operations into the
second quarter of 2018 after taking into consideration the net
proceeds received through February 2018 from sales of common stock
under our at the market common stock sales program and the proceeds
from the November 2017 financing with Elliott. We will need
additional funding to complete the LOCK-IT-100 hemodialysis
clinical trial in the U.S. which commenced in December 2015 as well
as to initiate the second Phase 3 clinical trial that will be
required in order to file an NDA with the FDA.
Further, we anticipate that we will incur
operating losses for the foreseeable future. Additionally, we will
require substantial funds in the future to support our operations.
We expect to seek equity or debt financings in the future to fund
our operations. The issuance of additional equity securities, or
convertible debt or other derivative securities, likely will dilute
some if not all of our then existing stockholders, depending on the
financing terms.
Future sales and issuances of our equity securities or rights to
purchase our equity securities, including pursuant to equity
incentive plans, would result in additional dilution of the
percentage ownership of our stockholders and could cause our stock
price to fall.
To the extent we raise additional capital by
issuing equity securities, our stockholders may experience
substantial dilution. We may, as we have in the past, sell common
stock, convertible securities or other equity securities in
one
or
more transactions at
prices and in a manner we determine from time to time. If we sell
common stock, convertible securities or other equity securities in
more than one transaction, investors may be further diluted by
subsequent sales. Such sales may also result in material dilution
to our existing stockholders, and new investors could gain rights
superior to existing stockholders.
Pursuant to our 2013 Stock Plan, our Board of
Directors is authorized to award up to a total of 11,000,000 shares
of common stock or options to purchase shares of common stock to
our officers, directors, employees and non-employee consultants. As
of December 31, 2017, options to purchase 120,000 shares of common
stock issued under our 2006 Stock Plan at a weighted average
exercise price of $1.44 per share, and options to purchase
4,842,495 shares of common stock issued under our 2013 Stock Plan
at a weighted average exercise price of $2.05 per share were
outstanding. In addition, at December 31, 2017, there were
outstanding warrants to purchase an aggregate of 23,417,891 shares
of our common stock at prices ranging from $0.001 to $7.00, and
shares of our outstanding Series C-2, C-3, D, E and F preferred
stock convertible into an aggregate of 9,136,560 shares of our
common stock. Stockholders will experience dilution in the event
that additional shares of common stock are issued under our 2006
Stock Plan or 2013 Stock Plan, or options issued under our 2006
Stock Plan or 2013 Stock Plan are exercised, or any warrants are
exercised for, or preferred stock shares are converted to, common
stock.
Provisions in our corporate charter documents and under Delaware
law could make an acquisition of us, which may be beneficial to our
stockholders, more difficult.
Provisions in our Amended and Restated Certificate
of Incorporation, as amended, and our Amended and Restated Bylaws,
as well as provisions of the General Corporation Law of the State
of Delaware, or DGCL, may discourage, delay or prevent a merger,
acquisition or other change in control of our company, even if such
a change in control would be beneficial to our stockholders. These
provisions include the following:
●
authorizing
the issuance of “blank check” preferred stock, the
terms of which may be established and shares of which may be issued
without stockholder approval;
●
prohibiting our stockholders
from
fixing the number of our directors;
and
●
establishing advance notice
requirements
for stockholder proposals that can be
acted on at stockholder meetings and nominations to our Board of
Directors.
These provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace
members of our board of directors, which is responsible for
appointing the members of our management. In addition, we are
subject to Section 203 of the DGCL, which generally prohibits a
Delaware corporation from engaging in any of a broad range of
business combinations with an interested stockholder for a period
of three years following the date on which the stockholder became
an interested stockholder, unless such transactions are approved by
the board of directors. This provision could have the effect of
discouraging, delaying or preventing someone from acquiring us or
merging with us, whether or not it is desired by, or beneficial to,
our stockholders. Any provision of our Amended and Restated
Certificate of Incorporation, as amended, or Amended and Restated
Bylaws or Delaware law that has the effect of delaying or deterring
a change in control could limit the opportunity for our
stockholders to receive a premium for their shares of our common
stock and could also affect the price that some investors are
willing to pay for our common
stock.
If we fail to comply with the continued listing standards of the
NYSE American, it may result in a delisting of our common stock
from the exchange.
Our
common stock is currently listed for trading on the NYSE American,
and the continued listing of our common stock on the NYSE American
is subject to our compliance with a number of listing standards.
These listing standards include the requirement for avoiding
sustained
losses and
maintaining a minimum level of stockholders’
equity. In 2012 and 2014, we received notices from the
NYSE American that we did not meet continued listing standards of
the NYSE American as set forth in Part 10 of the Company
Guide. Specifically, we were not in compliance with
Section 1003(a)(i) and Section 1003(a)(ii) of the Company Guide
because we reported stockholders’ equity of less than the
required amounts. As a result, we became subject to the
procedures and requirements of Section 1009 of the Company Guide
and were subject to possible delisting. In March 2015, we regained
compliance with the NYSE American listing requirements due to our
market capitalization, pursuant to Section 1003(a) of the Company
Guide. However, there can be no assurance that we will continue to
meet the continued listing standards of the NYSE
American.
If our common stock were no longer listed on the
NYSE American, investors might only be able to trade on one of the
over-the-counter markets, including the OTC Bulletin Board
®
or in the Pink Sheets
®
(a
quotation medium operated by Pink Sheets LLC). This would impair
the liquidity of our common stock not only in the number of shares
that could be bought and sold at a given price, which might be
depressed by the relative illiquidity, but also through delays in
the timing of transactions and reduction in media
coverage.
Because the average daily trading volume of our common stock has
been low historically, the ability to sell our shares in the
secondary trading market may be limited.
Because the average daily trading volume of our
common stock on the NYSE American has been low historically, the
liquidity of our common stock may be impaired. As a result, prices
for shares of our common stock may be lower than might otherwise
prevail if the average daily trading volume of our common stock was
higher. The average daily trading volume of our common stock may be
low relative to the stocks of other exchange-listed companies,
which could limit investors’ ability to sell shares in the
secondary trading market.
Penny stock regulations may impose certain restrictions on
marketability of our securities.
The SEC has adopted regulations which generally
define a “penny stock” to be any equity security that
has a market price of less than $5.00 per share or an exercise
price of less than $5.00 per share, subject to certain exceptions.
A security listed on a national securities exchange is exempt from
the definition of a penny stock. Our common stock is listed on the
NYSE American and so is not considered a penny stock. However, if
we fail to maintain our common stock’s listing on the NYSE
American, our common stock would be considered a penny stock. In
that event, our common stock would be subject to rules that impose
additional sales practice requirements on broker-dealers who sell
such securities to persons other than established customers and
accredited investors (generally those with assets in excess of
$1,000,000 or annual income exceeding $200,000, or $300,000
together with their spouse). For transactions covered by such
rules, the broker-dealer must make a special suitability
determination for the purchase of such securities and have received
the purchaser’s written consent to the transaction prior to
the purchase. Additionally, for any transaction involving a penny
stock, unless exempt, the rules require the delivery, prior to the
transaction, of a risk disclosure document mandated by the SEC
relating to the penny stock market. The broker-dealer must also
disclose the commission payable to both the broker-dealer and the
registered representative, current quotations for the securities
and, if the broker-dealer is the sole market maker, the
broker-dealer must disclose this fact and the broker-dealer’s
presumed control over the market. Finally, monthly statements must
be sent disclosing recent price information for the penny stock
held in the account and information on the limited market in penny
stocks. Broker-dealers must wait two business days after providing
buyers with disclosure materials regarding a security before
effecting a transaction in such security. Consequently, the
“penny stock” rules restrict the ability of
broker-dealers to sell our securities and affect the ability of
investors to sell our securities in the secondary market and the
price at which such purchasers can sell any such securities,
thereby affecting the liquidity of the market for our common
stock.
Stockholders should be aware that, according to
the SEC, the market for penny stocks has suffered in recent years
from patterns of fraud and abuse. Such patterns
include:
●
control of the market for the security
by
one or more broker-dealers that are
often related to the promoter or issuer;
●
manipulation of prices through
prearranged
matching of purchases and sales and
false and misleading press releases;
●
“boiler room” practices
involving
high
pressure sales
tactics and unrealistic price projections by inexperienced sales
persons;
●
excessive and undisclosed bid-ask
differentials
and markups by selling
broker-dealers; and
●
the
wholesale dumping of the same securities by promoters and
broker-dealers after prices have been manipulated to a desired
level, along with the inevitable collapse of those prices with
consequent investor losses.
We do not intend to pay dividends on our common stock so any
returns on our common stock will be limited to the value of our
common stock.
We
have never declared dividends on our common stock, and currently do
not plan to declare dividends on shares of our common stock in the
foreseeable future. Pursuant to the terms of our Series D, E and F
Non-Voting Convertible Preferred Stock, we may not declare or pay
any dividends or make any distributions on any of our shares or
other equity securities as long as any of those preferred shares
remain outstanding. We currently expect to retain future earnings,
if any, for use in the operation and expansion of our business. The
payment of cash dividends in the future, if any, will be at the
discretion of our board of directors and will depend upon such
factors as earnings levels, capital requirements, our overall
financial condition and any other factors deemed relevant by our
board of directors. Any return to holders of our common stock will
be limited to the value of their common stock.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
SEC encourages companies to disclose forward-looking information so
that investors can better understand a company’s future
prospects and make informed investment decisions. This prospectus,
any applicable prospectus supplement and the documents we have
filed with the SEC that are incorporated herein and therein by
reference contain such “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995.
Words such as “may,”
“might,” “should,”
“anticipate,” “estimate,”
“expect,” “projects,”
“intends,” “plans,” “believes”
and words and terms of similar substance used in connection with
any discussion of future operating or financial performance,
identify forward-looking statements. Forward-looking statements
represent management’s current judgment regarding future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially from those
described in the forward-looking statements. These risks include,
but are not limited to:
the cost, timing and results of the
planned and ongoing Phase 3 trials for Neutrolin® in the U.S.,
including variances in the expected rate of catheter-related
bloodstream infection events and the resources needed to commence
and complete those trials; the risks and uncertainties associated
with CorMedix’s ability to manage its limited cash resources;
CorMedix’s ability to continue as a going concern;
CorMedix’s ability to obtain financing to support its
research and development and clinical activities and operations;
CorMedix’s ability to gain alignment with the FDA on proposed
protocol changes its LOCK-IT 100 trial; later developments with the
FDA that may be inconsistent with the FDA’s acceptance of
interim analyses of the LOCK-IT 100 trial; obtaining regulatory
approvals to conduct clinical trials and to commercialize
CorMedix’s product candidates, including the anticipated
second Phase 3 trial of Neutrolin and the marketing of Neutrolin in
countries other than Europe; the outcome of clinical trials of
CorMedix’s product candidates and whether they demonstrate
these candidates’ safety and effectiveness; the risks
associated with the launch of Neutrolin in new markets;
CorMedix’s ability to enter into, execute upon and maintain
collaborations with third parties for its development and marketing
programs; CorMedix’s dependence on its collaborations and its
license relationships; CorMedix’s ability to maintain its
listing on the NYSE American; achieving milestones under
CorMedix’s collaborations; CorMedix’s dependence on
preclinical and clinical investigators, preclinical and clinical
research organizations, manufacturers, sales and marketing
organizations, and consultants; and protecting the intellectual
property developed by or licensed to CorMedix.
Please also see the discussion of risks and
uncertainties under “Risk Factors” above and otherwise
incorporated by reference herein, and in our most recent annual
report on Form 10-K, as revised or supplemented by any of our
subsequently filed quarterly reports on Form 10-Q, as well as
any amendments thereto, as filed with the SEC and which are
incorporated herein by reference.
In
light of these assumptions, risks and uncertainties, the results
and events discussed in the forward-looking statements contained in
this prospectus, any applicable prospectus supplement or in any
document incorporated herein or therein by reference might not
occur. Investors are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the respective
dates of this prospectus or any applicable prospectus supplement or
the date of the document incorporated by reference in this
prospectus or any applicable prospectus supplement. We are not
under any obligation, and we expressly disclaim any obligation, to
update or alter any forward-looking statements, whether as a result
of new information, future events or otherwise. All subsequent
forward-looking statements attributable to us or to any person
acting on our behalf are expressly qualified in their entirety by
the cautionary statements contained or referred to in this
section.
USE OF PROCEEDS
We
cannot assure you that we will receive any proceeds in connection
with securities offered by us pursuant to this prospectus. Unless
otherwise provided in the applicable prospectus supplement, we
intend to use the net proceeds from the sale of our securities by
us under this prospectus for general corporate purposes, including
clinical trials, research and development expenses, and general and
administrative expenses. We will set forth in the applicable
prospectus supplement our intended use for the net proceeds
received from the sale of any securities by us. Pending the
application of the net proceeds, we intend to invest the net
proceeds generally in short-term, investment grade,
interest-bearing securities.
PLAN OF DISTRIBUTION
We may
sell the securities from time to time pursuant to underwritten
public offerings, negotiated transactions, block trades or a
combination of these methods. We may sell the securities to or
through underwriters or dealers, through agents, or directly to one
or more purchasers. We may distribute securities from time to time
in one or more transactions:
●
at a fixed price or
prices, which may be changed;
●
at market prices
prevailing at the time of sale;
●
at prices related
to such prevailing market prices; or
A
prospectus supplement or supplements (and any related free writing
prospectus that we may authorize to be provided to you) will
describe the terms of the offering of the securities, including, to
the extent applicable:
●
the name or names
of the underwriters, if any;
●
the purchase price
of the securities or other consideration therefor, and the
proceeds, if any, we will receive from the sale;
●
any over-allotment
options under which underwriters may purchase additional securities
from us;
●
any agency fees or
underwriting discounts and other items constituting agents’
or underwriters’ compensation;
●
any public offering
price;
●
any discounts or
concessions allowed or reallowed or paid to dealers;
and
●
any securities
exchange or market on which the securities may be
listed.
Only
underwriters named in the prospectus supplement will be
underwriters of the securities offered by the prospectus
supplement.
If
underwriters are used in the sale, they will acquire the securities
for their own account and may resell the securities from time to
time in one or more transactions at a fixed public offering price
or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through
underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. Subject to certain conditions,
the underwriters will be obligated to purchase all of the
securities offered by the prospectus supplement, other than
securities covered by any over-allotment option. Any public
offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may
use underwriters with whom we have a material relationship. We will
describe in the prospectus supplement, naming the underwriter, the
nature of any such relationship.
We may
sell securities directly or through agents we designate from time
to time. We will name any agent involved in the offering and sale
of securities and we will describe any commissions we will pay the
agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts
basis for the period of its appointment.
We may
authorize agents or underwriters to solicit offers by certain types
of institutional investors to purchase securities from us at the
public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and
delivery on a specified date in the future. We will describe the
conditions to these contracts and the commissions we must pay for
solicitation of these contracts in the prospectus
supplement.
We may
provide agents and underwriters with indemnification against civil
liabilities, including liabilities under the Securities Act, or
contribution with respect to payments that the agents or
underwriters may make with respect to these liabilities. Agents and
underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
All
securities we may offer, other than common stock, will be new
issues of securities with no established trading market. Any
underwriters may make a market in these securities, but will not be
obligated to do so and may discontinue any market making at any
time without notice. We cannot guarantee the liquidity of the
trading markets for any securities.
Any
underwriter may engage in over-allotment, stabilizing transactions,
short-covering transactions and penalty bids in accordance with
Regulation M under the Exchange Act. Over-allotment involves
sales in excess of the offering size, which create a short
position. Stabilizing transactions permit bids to purchase the
underlying security so long as the stabilizing bids do not exceed a
specified maximum price. Syndicate-covering or other short-covering
transactions involve purchases of the securities, either through
exercise of the over-allotment option or in the open market after
the distribution is completed, to cover short positions. Penalty
bids permit the underwriters to reclaim a selling concession from a
dealer when the securities originally sold by the dealer are
purchased in a stabilizing or covering transaction to cover short
positions. Those activities may cause the price of the securities
to be higher than it would otherwise be. If commenced, the
underwriters may discontinue any of the activities at any
time.
Any
underwriters that are qualified market makers on the NYSE American
may engage in passive market making transactions in the common
stock on the NYSE American in accordance with Regulation M
under the Exchange Act, during the business day prior to the
pricing of the offering, before the commencement of offers or sales
of the common stock. Passive market makers must comply with
applicable volume and price limitations and must be identified as
passive market makers. In general, a passive market maker must
display its bid at a price not in excess of the highest independent
bid for such security; if all independent bids are lowered below
the passive market maker’s bid, however, the passive market
maker’s bid must then be lowered when certain purchase limits
are exceeded. Passive market making may stabilize the market price
of the securities at a level above that which might otherwise
prevail in the open market and, if commenced, may be discontinued
at any time.
DESCRIPTION OF OUR CAPITAL STOCK
Common Stock
Pursuant to our Amended and Restated Certificate
of Incorporation, as amended, we are authorized to issue
160,000,000 shares of common stock, $0.001 par value per share. As
of December 31, 2017, we had
71,413,790
shares of common stock
outstanding.
The
following summary of certain provisions of our common stock does
not purport to be complete. You should refer to our Amended and
Restated Certificate of Incorporation, as amended, and our Amended
and Restated Bylaws. We filed our Amended and Restated Certificate
of Incorporation as an exhibit to our registration statement on
Form S-1/A filed with the SEC on March 1, 2010, and filed
amendments to the Amended and Restated Certificate of Incorporation
as exhibits to our registration statement on Form S-1/A filed with
the SEC on March 19, 2010, our annual report on Form 10-K filed
with the SEC on March 27, 2013, and our current report on Form 8-K
filed with the SEC on August 10, 2017. We filed an Amended and
Restated Certificate of Designation for each of our Series C-2,
C-3, D and E non-voting preferred stock as exhibits to our current
report on Form 8-K on September 16, 2014, and the Amended and
Restated Certificate of Designation for our Series F non-voting
preferred stock on December 11, 2017. We filed our Amended and
Restated Bylaws as an exhibit to our quarterly report on Form 10-Q
filed with the SEC on May 10, 2016. The summary below is also
qualified by provisions of applicable law.
The
holders of our common stock are entitled to one vote per share on
all matters to be voted on by the stockholders, and there are no
cumulative voting rights. Generally, all matters to be voted on by
stockholders must be approved by a majority (or, in the case of
election of directors, by a plurality) of the votes entitled to be
cast by all shares of common stock present in person or represented
by proxy, subject to any voting rights granted to holders of any
preferred stock.
The
holders of common stock are entitled to receive ratable dividends,
if any, payable in cash, in stock or otherwise if, as and when
declared from time to time by our board of directors out of funds
legally available for the payment of dividends, subject to any
preferential rights that may be applicable to any outstanding
preferred stock. In the event of a liquidation, dissolution, or
winding up of our company, after payment in full of all outstanding
debts and other liabilities, the holders of common stock are
entitled to share ratably in all remaining assets, subject to prior
distribution rights of preferred stock, if any, then outstanding.
No shares of common stock have preemptive rights or other
subscription rights to purchase additional shares of common stock.
There are no redemption or sinking fund provisions applicable to
the common stock. All outstanding shares of common stock are fully
paid and nonassessable, and the shares of common stock included in
this registration statement will be fully paid and nonassessable.
The rights, preferences and privileges of holders of our common
stock will be subject to, and might be adversely affected by, the
rights of holders of any preferred stock that we may issue in the
future. All shares of common stock that are acquired by us shall be
available for reissuance by us at any time.
Issued and Outstanding Preferred Stock
Under
the terms of our Amended and Restated Certificate of Incorporation,
as amended, our board of directors is authorized to issue up to
2,000,000 shares of preferred stock in one or more series without
stockholder approval. Our board of directors has the discretion to
determine the rights, preferences, privileges and restrictions,
including voting rights, dividend rights, conversion rights,
redemption privileges and liquidation preferences, of each series
of preferred stock. As of December 31, 2017, of the 2,000,000
shares of preferred stock authorized, our board of directors has
designated (all with par value of $0.001 per share): 150,000 shares
as Series C-2 Non-Voting Convertible Preferred Stock; 200,000
shares as Series C-3 Non-Voting Convertible Preferred Stock; 73,962
shares as Series D Non-Voting Convertible Preferred Stock; 92,440
shares as Series E Non-Voting Convertible Preferred Stock; and
5,000 shares as Series F Non-Voting Convertible Preferred Stock. At
December 31, 2017, we had outstanding: 150,000 shares as Series C-2
Non-Voting Convertible Preferred Stock; 104,000 shares as Series
C-3 Non-Voting Convertible Preferred Stock; 73,962 shares as Series
D Non-Voting Convertible Preferred Stock; 89,623 shares as Series E
Non-Voting Convertible Preferred Stock; and 2,000 shares as Series
F Non-Voting Convertible Preferred Stock. The Series A Non-Voting
Convertible Preferred Stock, Series B Non-Voting Convertible
Preferred Stock and Series C-1 Non-Voting Convertible Preferred
Stock that were previously designated have all been converted to
shares of common stock.
Series C-2 and C-3 Non-Voting Convertible Preferred
Stock
The
Series C-2 and C-3 Preferred Stock, referred to collectively as the
Series C Preferred Stock, have identical rights, privileges and
terms, as described below.
Rank
.
The Series C Preferred Stock will
rank:
●
senior
to our common stock;
●
senior
to any class or series of capital stock created
after the issuance of the Series C Preferred Stock
(subject
to the Company obtaining any consent, waiver or other authorization
from the holders of the Series C-3 Convertible Preferred Stock
necessary for the subordination of the Series C-3 Convertible
Preferred Stock to the Series F Preferred Stock)
; and
●
junior to the Series D Non-Voting Convertible
Preferred Stock, Series E Non-Voting Convertible Preferred Stock
and Series F Non-Voting Convertible Preferred Stock
(subject
to the Company obtaining any consent, waiver or other authorization
from the holders of the Series C-3 Convertible Preferred Stock
necessary for the subordination of the Series C-3 Convertible
Preferred Stock to the Series F Preferred Stock)
.
in
each case, as to dividends or distributions of assets upon our
liquidation, dissolution or winding up whether voluntarily or
involuntarily.
Conversion
.
Each share of Series C Preferred Stock
is convertible into 10 shares of our common stock (subject to
adjustment in the event of s
tock dividends and
distributions, stock splits, stock combinations, or
reclassifications affecting our common stock
) at a per share price of $1.00 at any time at the
option of the holder, except that a holder will be prohibited from
converting shares of Series C Preferred Stock into shares of common
stock if, as a result of such conversion, such holder, together
with its affiliates, would beneficially own more than 9.99% of the
total number of shares of our common stock then issued and
outstanding.
Liquidation
Preference
.
In the event of our liquidation, dissolution or
winding up, holders of Series C Preferred Stock will receive a
payment equal to $10.00 per share of Series C Preferred Stock
before any proceeds are distributed to the holders of our common
stock. After the payment of this preferential amount, and subject
to the rights of holders of any class or series of our capital
stock hereafter created specifically ranking by its terms senior to
the Series C Preferred Stock, holders of Series C Preferred Stock
will participate ratably in the distribution of any remaining
assets with the common stock and any other class or series of our
capital stock hereafter created that participates with the common
stock in such distributions.
Voting
Rights
.
Shares of Series C Preferred Stock will generally
have no voting rights, except as required by law and except that
the consent of holders of two thirds of the outstanding Series C-2
and Series C-3 Preferred Stock, respectively, will be required to
amend the terms of the Series C-2 and C-3 Preferred Stock or the
certificate of designation for the Series C-2 and C-3 Preferred
Stock, respectively.
Dividends
.
Holders of Series C Preferred Stock
are entitled to receive, and we are required to pay, dividends on
shares of the Series C Preferred Stock equal (on an
as-if-converted-to-common-stock basis) to and in the same form as
dividends (other than dividends in the form of common stock)
actually paid on shares of the common stock when, as and if such
dividends (other than dividends in the form of common stock) are
paid on shares of the common stock.
Redemption
.
We are not obligated to redeem or
repurchase any shares of Series C Preferred Stock. Shares of Series
C Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund
provisions.
Listing
.
There is no established public trading
market for the Series C Preferred Stock, and we do not expect a
market to develop. In addition, we do not intend to apply for
listing of the Series C Preferred Stock on any national securities
exchange or trading system.
Fundamental
Transactions
.
If, at any time that shares of Series C Preferred
Stock are outstanding, we effect a merger or other change of
control transaction, as described in the certificate of designation
and referred to as a fundamental transaction, then a holder will
have the right to receive, upon any subsequent conversion of a
share of Series C Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of
securities, cash or property as such holder would have been
entitled to receive upon the occurrence of such fundamental
transaction if such holder had been, immediately prior to such
fundamental transaction, the holder of a share of common
stock.
Debt
Restriction
.
As long as any the Series C-2 Preferred Stock is
outstanding, we cannot incur any indebtedness other than
indebtedness existing prior to September 15, 2014, trade payables
incurred in the ordinary course of business consistent with past
practice, and letters of credit incurred in an aggregate amount of
$3.0 million at any point in time.
Series D Non-Voting Convertible Preferred Stock
Rank
.
The Series D Preferred Stock will
rank:
●
junior
to the Series F Non-Voting Convertible Preferred
Stock;
●
senior
to our common stock;
●
senior
to any class or series of capital stock created after the issuance
of the Series D Preferred Stock;
●
senior
to the Series C-2 Non-Voting Convertible Preferred Stock and the
Series C-3 Non-Voting Convertible Preferred Stock; and
●
on
parity with the Series E Non-Voting Convertible Preferred
Stock.
in
each case, as to dividends or distributions of assets upon our
liquidation, dissolution or winding up whether voluntarily or
involuntarily.
Conversion
.
Each share of Series D Preferred Stock
is convertible into 20 shares of our common stock (subject to
adjustment in the event of s
tock dividends and
distributions, stock splits, stock combinations, or
reclassifications affecting our common stock
) at a per share price of $0.35 at any time at the
option of the holder, except that a holder will be prohibited from
converting shares of Series D Preferred Stock into shares of common
stock if, as a result of such conversion, such holder, together
with its affiliates, would beneficially own more than 9.99% of the
total number of shares of our common stock then issued and
outstanding.
Liquidation
Preference
.
In the event of our liquidation, dissolution or
winding up, holders of Series D Preferred Stock will receive a
payment equal to $21.00 per share of Series D Preferred Stock on
parity with the payment of the liquidation preference due the
Series E Preferred Stock, but before any proceeds are distributed
to the holders of common stock, the Series C-2 Non-Voting
Convertible Preferred Stock and the Series C-3 Non-Voting
Convertible Preferred Stock. After the payment of this preferential
amount, holders of Series D Preferred Stock will participate
ratably in the distribution of any remaining assets with the common
stock and any other class or series of our capital stock that
participates with the common stock in such
distributions.
Voting
Rights
.
Shares of Series D Preferred Stock will generally
have no voting rights, except as required by law and except that
the consent of holders of a majority of the outstanding Series D
Preferred Stock will be required to amend the terms of the Series D
Preferred Stock or the certificate of designation for the Series D
Preferred Stock.
Dividends
.
Holders of Series D Preferred Stock
are entitled to receive, and we are required to pay, dividends on
shares of the Series D Preferred Stock equal (on an
as-if-converted-to-common-stock basis) to and in the same form as
dividends (other than dividends in the form of common stock)
actually paid on shares of the common stock when, as and if such
dividends (other than dividends in the form of common stock) are
paid on shares of the common stock.
Redemption
.
We are not obligated to redeem or
repurchase any shares of Series D Preferred Stock. Shares of Series
D Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund
provisions.
Listing
.
There is no established public trading
market for the Series D Preferred Stock, and we do not expect a
market to develop. In addition, we do not intend to apply for
listing of the Series D Preferred Stock on any national securities
exchange or trading system.
Fundamental
Transactions
.
If, at any time that shares of Series D Preferred
Stock are outstanding, we effect a merger or other change of
control transaction, as described in the certificate of designation
and referred to as a fundamental transaction, then a holder will
have the right to receive, upon any subsequent conversion of a
share of Series D Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of
securities, cash or property as such holder would have been
entitled to receive upon the occurrence of such fundamental
transaction if such holder had been, immediately prior to such
fundamental transaction, the holder of a share of common
stock.
Debt
Restriction
.
As long as any the Series D Preferred Stock is
outstanding, we cannot incur any indebtedness other than
indebtedness existing prior to September 15, 2014, trade payables
incurred in the ordinary course of business consistent with past
practice, and letters of credit incurred in an aggregate amount of
$3.0 million at any point in time.
Series E Non-Voting Convertible Preferred Stock
Rank
.
The Series E Preferred Stock will
rank:
●
junior
to the Series F Non-Voting Convertible Preferred
Stock;
●
senior
to our common stock;
●
senior
to any class or series of capital stock created after the issuance
of the Series E Preferred Stock;
●
senior
to the Series C-2 Non-Voting Convertible Preferred Stock and the
Series C-3 Non-Voting Convertible Preferred Stock; and
●
on
parity with the Series D Non-Voting Convertible Preferred
Stock.
in
each case, as to dividends or distributions of assets upon our
liquidation, dissolution or winding up whether voluntarily or
involuntarily.
Conversion
.
Each share of Series E Preferred Stock
is convertible into 21.8667 shares of our common stock (subject to
adjustment as provided in the certificates of designation for the
Series E Preferred Stock) at a per share price of $0.75 at any time
at the option of the holder, except that a holder will be
prohibited from converting shares of Series E Preferred Stock into
shares of common stock if, as a result of such conversion, such
holder, together with its affiliates, would beneficially own more
than 9.99% of the total number of shares of our common stock then
issued and outstanding.
Liquidation
Preference
.
In the event of our liquidation, dissolution or
winding up, holders of Series E Preferred Stock will receive a
payment equal to $49.20 per share of Series E Preferred Stock on
parity with the payment of the liquidation preference due the
Series D Preferred Stock, but before any proceeds are distributed
to the holders of common stock, the Series C-2 Non-Voting
Convertible Preferred Stock and the Series C-3 Non-Voting
Convertible Preferred Stock. After the payment of this preferential
amount, holders of Series E Preferred Stock will participate
ratably in the distribution of any remaining assets with the common
stock and any other class or series of our capital stock that
participates with the common stock in such
distributions.
Voting
Rights
.
Shares of Series E Preferred Stock will generally
have no voting rights, except as required by law and except that
the consent of holders of a majority of the outstanding Series E
Preferred Stock will be required to amend the terms of the Series E
Preferred Stock or the certificate of designation for the Series E
Preferred Stock.
Dividends
.
Holders of Series E Preferred Stock
are entitled to receive, and we are required to pay, dividends on
shares of the Series E Preferred Stock equal (on an
as-if-converted-to-common-stock basis) to and in the same form as
dividends (other than dividends in the form of common stock)
actually paid on shares of the common stock when, as and if such
dividends (other than dividends in the form of common stock) are
paid on shares of the common stock.
Redemption
.
We are not obligated to redeem or
repurchase any shares of Series E Preferred Stock. Shares of Series
E Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund
provisions.
Listing
.
There is no established public trading
market for the Series E Preferred Stock, and we do not expect a
market to develop. In addition, we do not intend to apply for
listing of the Series E Preferred Stock on any national securities
exchange or trading system.
Fundamental
Transactions
.
If, at any time that shares of Series E Preferred
Stock are outstanding, we effect a merger or other change of
control transaction, as described in the certificate of designation
and referred to as a fundamental transaction, then a holder will
have the right to receive, upon any subsequent conversion of a
share of Series E Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of
securities, cash or property as such holder would have been
entitled to receive upon the occurrence of such fundamental
transaction if such holder had been, immediately prior to such
fundamental transaction, the holder of a share of common
stock.
Debt
Restriction
.
As long as any the Series E Preferred Stock is
outstanding, we cannot incur any indebtedness other than
indebtedness existing prior to September 15, 2014, trade payables
incurred in the ordinary course of business consistent with past
practice, and letters of credit incurred in an aggregate amount of
$3.0 million at any point in time.
Other
Covenants
.
In addition to the debt restrictions above, as
long as any the Series E Preferred Stock is outstanding
, we
cannot, among others things: create, incur, assume or suffer to
exist any encumbrances on any of our assets or property; redeem,
repurchase or pay any cash dividend or distribution on any of our
capital stock (other than as permitted, which includes the
dividends on the Series D Preferred Stock and the Series E
Preferred Stock); redeem, repurchase or prepay any indebtedness; or
engage in any material line of business substantially different
from our current lines of business.
Purchase
Rights
.
In the event
we issue any options, convertible securities or rights to purchase
stock or other securities pro rata to the holders of common stock,
then the a holder of Series E Preferred Stock will be entitled to
acquire, upon the same terms a pro rata amount of such stock or
securities as if the Series E Preferred Stock had been converted to
common stock.
Series F Non-Voting Convertible Preferred Stock
Rank
.
The Series F Preferred Stock will
rank:
●
senior
to our common stock;
●
senior
to any class or series of capital stock created after the issuance
of the Series F Preferred Stock; and
●
senior to the Series B Non-Voting Convertible
Preferred Stock, the Series C-2 Non-Voting Convertible Preferred
Stock, the Series C-3 Non-Voting Convertible Preferred Stock
(subject to the us obtaining any consent, waiver or other
authorization from the holders of the Series C-3 Convertible
Preferred Stock necessary for the subordination of the Series C-3
Convertible Preferred Stock to the Series F Preferred Stock), the
Series D
Non-Voting Convertible
Preferred Stock and
the Series E
Non-Voting Convertible Preferred
Stock;
in
each case, as to dividends or distributions of assets upon our
liquidation, dissolution or winding up whether voluntarily or
involuntarily.
Conversion
.
Each share of Series F Preferred Stock
is convertible into one share of our common stock at
a per
share price of $0.6334 per share
(subject to adjustment as provided in the
certificates of designation for the Series F Preferred Stock) at
any time at the option of the holder, except that a holder will be
prohibited from converting shares of Series F Preferred Stock into
shares of common stock if, as a result of such conversion, such
holder, together with its affiliates, would beneficially own more
than 9.99% of the total number of shares of our common stock then
issued and outstanding.
Liquidation
Preference
.
In the event of our liquidation, dissolution or
winding up, holders of Series F Preferred Stock will receive a
payment equal to $1,000.00 per share of Series F Preferred Stock,
but before any proceeds are distributed to the holders of common
stock, Series B Non-Voting Convertible Preferred Stock, the Series
C-2 Non-Voting Convertible Preferred Stock, the Series C-3
Non-Voting Convertible Preferred Stock, the Series D Non-Voting
Convertible Preferred Stock and the Series E Non-Voting Convertible
Preferred Stock. After the payment of this preferential amount,
holders of Series F Preferred Stock will participate ratably in the
distribution of any remaining assets with the common stock and any
other class or series of our capital stock that participates with
the common stock in such distributions.
Voting
Rights
.
Shares of Series F Preferred Stock will generally
have no voting rights, except as required by law and except that
the consent of holders of a majority of the outstanding Series F
Preferred Stock will be required to amend the terms of the Series F
Preferred Stock or the certificate of designation for the Series F
Preferred Stock.
Dividends
.
Holders of Series F Preferred Stock
are entitled to receive, and we are required to pay, dividends on
shares of the Series F Preferred Stock equal (on an
as-if-converted-to-common-stock basis) to and in the same form as
dividends (other than dividends in the form of common stock)
actually paid on shares of the common stock when, as and if such
dividends (other than dividends in the form of common stock) are
paid on shares of the common stock.
Redemption
.
We are not obligated to redeem or
repurchase any shares of Series F Preferred Stock. Shares of Series
F Preferred Stock are not otherwise entitled to any redemption
rights, or mandatory sinking fund or analogous fund
provisions.
Listing
.
There is no established public trading
market for the Series F Preferred Stock, and we do not expect a
market to develop. In addition, we do not intend to apply for
listing of the Series F Preferred Stock on any national securities
exchange or trading system.
Fundamental
Transactions
.
If, at any time that shares of Series F Preferred
Stock are outstanding, we effect a merger or other change of
control transaction, as described in the certificate of designation
and referred to as a fundamental transaction, then a holder will
have the right to receive, upon any subsequent conversion of a
share of Series F Preferred Stock (in lieu of conversion shares)
for each issuable conversion share, the same kind and amount of
securities, cash or property as such holder would have been
entitled to receive upon the occurrence of such fundamental
transaction if such holder had been, immediately prior to such
fundamental transaction, the holder of a share of common
stock.
Debt
Restriction
.
As long as any the Series F Preferred Stock is
outstanding, we cannot incur any indebtedness other than
indebtedness existing prior to November 9, 2017, trade payables
incurred in the ordinary course of business consistent with past
practice, and letters of credit incurred in an aggregate amount of
$3.0 million at any point in time.
Other
Covenants
.
In addition to the debt restrictions above, as
long as any the Series F Preferred Stock is outstanding
, we
cannot, among others things: create, incur, assume or suffer to
exist any encumbrances on any of our assets or property; redeem,
repurchase or pay any cash dividend or distribution on any of our
capital stock (other than as permitted, which includes the
dividends on the Series D Preferred Stock and the Series E
Preferred Stock); redeem, repurchase or prepay any indebtedness; or
engage in any material line of business substantially different
from our current lines of business.
Purchase
Rights
.
In the event
we issue any options, convertible securities or rights to purchase
stock or other securities pro rata to the holders of common stock,
then a holder of Series F Preferred Stock will be entitled to
acquire, upon the same terms a pro rata amount of such stock or
securities as if the Series F Preferred Stock had been converted to
common stock.
Transfer Agent and Registrar
The transfer agent and registrar for our common
stock is
VStock Transfer, LLC.
The transfer agent’s address is 18 Lafayette Place, Woodmere,
New York 11598 and its telephone number is (212)
828-8436.
We
act as our own transfer agent and registrar for the Series C-2,
C-3, D, E and F Preferred Stock.
Description of Preferred Stock That May Be Offered
Our
board of
directors has the authority,
without further action by the stockholders, to issue up to
2,000,000 shares of preferred stock in one or more series and to
fix the rights, preferences, privileges and restrictions thereof,
including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences, sinking fund terms and the
number of shares constituting any series or the designation of such
series, without any further vote or action by our stockholders. The
shares of preferred stock outstanding are described above. The
issuance of new or additional preferred stock could adversely
affect the voting power of holders of common stock and the
likelihood that such holders will receive dividend payments and
payments upon liquidation and could have the effect of delaying,
deferring or preventing a change in control of our
company.
We will fix the rights, preferences, privileges
and restrictions of any new series of preferred stock in the
certificate of designation relating to that series. We will file as
an exhibit to the registration statement of which this prospectus
is a part, or will incorporate by reference from reports that we
file with the SEC, the form of any certificate of designation that
describes the terms of the series of preferred stock we are
offering before the issuance of the related series of preferred
stock. This description will include any
or all of the
following, as required:
●
the title and
stated value;
●
the number of
shares we are offering;
●
the liquidation
preference per share;
●
the dividend rate,
period and payment date and method of calculation for
dividends;
●
whether dividends
will be cumulative or non-cumulative and, if cumulative, the date
from which dividends will accumulate;
●
the procedures for
any auction and remarketing, if any;
●
the provisions for
a sinking fund, if any;
●
the provisions for
redemption or repurchase, if applicable, and any restrictions on
our ability to exercise those redemption and repurchase
rights;
●
any listing of the
preferred stock on any securities exchange or market;
●
whether the
preferred stock will be convertible into our common stock, and, if
applicable, the conversion price, or how it will be calculated, and
the conversion period;
●
whether the
preferred stock will be exchangeable into debt securities, and, if
applicable, the exchange price, or how it will be calculated, and
the exchange period;
●
voting rights, if
any, of the preferred stock;
●
preemptive rights,
if any;
●
restrictions on
transfer, sale or other assignment, if any;
●
whether interests
in the preferred stock will be represented by depositary
shares;
●
a discussion of any
material or special United States federal income tax considerations
applicable to the preferred stock;
●
the relative
ranking and preferences of the preferred stock as to dividend
rights and rights if we liquidate, dissolve or wind up our
affairs;
●
any limitations on
issuance of any class or series of preferred stock ranking senior
to or on a parity with the series of preferred stock as to dividend
rights and rights if we liquidate, dissolve or wind up our affairs;
and
●
any other specific
terms, preferences, rights or limitations of, or restrictions on,
the preferred stock.
If we
issue shares of preferred stock under this prospectus, the shares
will be fully paid and non-assessable.
The
General Corporation Law of the State of Delaware, the state of our
incorporation, provides that the holders of preferred stock will
have the right to vote separately as a class on any proposal
involving fundamental changes in the rights of holders of that
preferred stock. This right is in addition to any voting rights
that may be provided for in the applicable certificate of
designation.
Our
board of directors may authorize the issuance of preferred stock
with voting or conversion rights that could adversely affect the
voting power or other rights of the holders of our common stock.
Preferred stock could be issued quickly with terms designed to
delay or prevent a change in control of our company or make removal
of management more difficult. Additionally, the issuance of
preferred stock may have the effect of decreasing the market price
of our common stock.
DESCRIPTION OF DEBT SECURITIES
The
following description, together with the additional information we
include in any applicable prospectus supplement, summarizes the
material terms and provisions of any debt securities that we may
offer under this prospectus. While the terms we have summarized
below will apply generally to any future debt securities we may
offer, we will describe the particular terms of any debt securities
that we may offer in more detail in the applicable prospectus
supplement. The terms of any debt securities we may offer under a
prospectus supplement may differ from the terms described below.
For any debt securities that we may offer, an indenture (and any
relevant supplemental indenture), if required, will contain
additional important terms and provisions, the form of which we
filed as an exhibit to the registration statement of which this
prospectus is a part and is incorporated therein by reference. We
will file any definitive indenture as an exhibit to reports that we
file with the SEC and incorporate by reference in this prospectus
and the applicable prospectus supplement. Any indenture would be
qualified under the Trust Indenture Act of 1939.
With
respect to any debt securities that we issue, we will describe in
each prospectus supplement the following terms relating to a series
of debt securities:
●
the
principal amount being offered, and if a series, the total amount
authorized and the total amount outstanding;
●
any
limit on the amount that may be issued;
●
whether
or not we will issue the series of debt securities in global form,
and if so, the terms and who the depository will be;
●
the
principal amount due at maturity;
●
whether
and under what circumstances, if any, we will pay additional
amounts on any debt securities held by a person who is not a United
States person for tax purposes, and whether we can redeem the debt
securities if we have to pay such additional amounts;
●
the
annual interest rate, which may be fixed or variable, or the method
for determining the rate and the date interest will begin to
accrue, the dates interest will be payable and the regular record
dates for interest payment dates or the method for determining such
dates;
●
whether
or not the debt securities will be convertible into shares of our
common stock or our preferred stock and, if so, the terms of such
conversion;
●
whether
or not the debt securities will be secured or unsecured by some or
all of our assets, and the terms of any secured debt;
●
the
terms of the subordination of any series of subordinated
debt;
●
the
place where payments will be payable;
●
r
estrictions on transfer, sale or other assignment,
if any;
●
our
right, if any, to defer payment or interest and the maximum length
of any such deferral period;
●
the
date, if any, after which and the conditions upon which, and the
price at which, we may, at our option, redeem the series of debt
securities pursuant to any optional or provisional redemption
provisions and the terms of those redemptions
provisions;
●
the
date, if any, on which, and the price at which we are obligated,
pursuant to any mandatory sinking fund or analogous fund provisions
or otherwise, to redeem, or at the holder’s option to
purchase, the series of debt securities and the currency or
currency unit in which the debt securities are
payable;
●
whether
the indenture will restrict our ability to pay dividends, or will
require us to maintain any asset ratios or reserves;
●
whether
we will be restricted from incurring any additional indebtedness,
issuing additional securities, or entering into a merger,
consolidation or sale of our business;
●
a
discussion of any material or special United States federal income
tax considerations applicable to the debt securities;
●
information
describing any book-entry features;
●
any
provisions for payment of additional amounts for
taxes;
●
whether
the debt securities are to be offered at a price such that they
will be deemed to be offered at an “original issue
discount” as defined in paragraph (a) of
Section 1273 of the Internal Revenue Code of 1986,
as amended;
●
the
denominations in which we will issue the series of debt securities,
if other than denominations of $1,000 and any integral multiple
thereof;
●
whether
we and/or the indenture trustee may change an indenture without the
consent of any holders;
●
the
form of debt security and how it may be exchanged and
transferred;
●
description
of the indenture trustee and paying agent, and the method of
payments; and
●
any
other specified terms, preferences, rights or limitations of, or
restrictions on, the debt securities and any terms that may be
required by us or advisable under applicable laws or
regulations.
We
summarize below the material terms of the form of indenture, if
required, or indicate which material terms will be described in the
applicable prospectus supplement. The indenture:
●
does not limit the
amount of debt securities that we may issue;
●
allows us to issue
debt securities in one or more series;
●
does not require us
to issue all of the debt securities of a series at the same
time;
●
allows us to reopen
a series to issue additional debt securities without the consent of
the holders of the debt securities of such series; and
●
provides that the
debt securities will be unsecured, except as may be set forth in
the applicable prospectus supplement.
DESCRIPTION OF WARRANTS
The
following description, together with the additional information we
may include in any applicable prospectus supplement, summarizes the
material terms and provisions of any warrants that we may offer
under this prospectus and the related warrant agreements and
warrant certificates. While the terms summarized below will apply
generally to any warrants that we may offer, we will describe the
particular terms of any series of warrants in more detail in the
applicable prospectus supplement. The terms of any warrants offered
under a prospectus supplement may differ from the terms described
below. With respect to any warrants that we offer, specific warrant
agreements will contain additional important terms and provisions
and will be incorporated by reference as an exhibit to the
registration statement that includes this prospectus or as an
exhibit to reports that we file with the SEC and incorporated by
reference in this prospectus:
●
the
specific designation and aggregate number of, and the price at
which we will issue, the warrants;
●
the
currency or currency units in which the offering price, if any, and
the exercise price are payable;
●
if
applicable, the exercise price for shares of our common stock or
preferred stock and the number of shares of common stock or
preferred stock to be received upon exercise of the
warrants;
●
in the case of
warrants to purchase debt securities, the principal amount of debt
securities purchasable upon exercise of one warrant and the price
at, and currency in which, this principal amount of debt securities
may be purchased upon such exercise;
●
the
date on which the right to exercise the warrants will begin and the
date on which that right will expire or, if you may not
continuously exercise the warrants throughout that period, the
specific date or dates on which you may exercise the
warrants;
●
w
hether the warrants will be issued in fully
registered form or bearer form, in definitive or global form or in
any combination of these forms, although, in any case, the form of
a warrant included in a unit will correspond to the form of the
unit and of any security included in that unit;
●
any
applicable material U.S. federal income tax
consequences;
●
the
identity of the warrant agent for the warrants and of any other
depositaries, execution or paying agents, transfer agents,
registrars or other agents;
●
the
proposed listing, if any, of the warrants or the common stock
issuable upon exercise of the warrants on any securities
exchange;
●
if
applicable, the date from and after which the warrants and the
common stock will be separately transferable;
●
if
applicable, the minimum or maximum amount of the warrants that may
be exercised at any one time;
●
information
with respect to book-entry procedures, if any;
●
the
anti-dilution provisions of the warrants, if any;
●
any
redemption or call provisions;
●
whether
the warrants are to be sold separately or with other securities as
parts of units; and
●
any
additional terms of the warrants, including terms, procedures and
limitations relating to the exchange and exercise of the
warrants.
Before
exercising their warrants, holders of warrants will not have any of
the rights of holders of the securities purchasable upon such
exercise, including:
●
in
the case of warrants to purchase debt securities, the right to
receive payments of principal of, or premium, if any, or interest
on, the debt securities purchasable upon exercise or to enforce
covenants in the applicable indenture; or
●
in the case of warrants to purchase common stock
or preferred stock, the right to receive dividends, if any, or,
payments
upon our liquidation, dissolution or winding up or
to exercise voting rights, if any.
Transfer Agent and Registrar
The
transfer agent and registrar for any warrants will be set forth in
the applicable prospectus supplement.
DESCRIPTION OF UNITS
We
might issue units composed of one or more debt securities, shares
of common stock, shares of preferred stock and warrants in any
combination. Each unit will be issued so that the holder of the
unit is also the holder of each security included in the unit.
Thus, the holder of a unit will have the rights and obligations of
a holder of each included security. The unit agreement under which
a unit is issued may provide that the securities included in the
unit may not be held or transferred separately, at any time or at
any time before a specified date. We will file as exhibits to the
registration statement of which this prospectus is a part, or will
incorporate by reference from reports that we file with the SEC,
the form of unit agreement, warrant and any supplemental agreements
that describe the terms of the series of units we are offering
before the issuance of the related series of units.
We
may choose to evidence each series of units by unit certificates
that we would issue under a separate agreement. If we choose to
evidence the units by unit certificates, we will enter into the
unit agreements with a unit agent and will indicate the name and
address of the unit agent in the applicable prospectus supplement
relating to the particular series of units.
CERTAIN PROVISIONS OF DELAWARE LAW AND OF OUR AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION AND AMENDED AND RESTATED
BYLAWS
Certain
provisions of DGCL and our Amended and Restated Certificate of
Incorporation, as amended, and our Amended and Restated Bylaws
discussed below may have the effect of making more difficult or
discouraging a tender offer, proxy contest or other takeover
attempt. These provisions are expected to encourage persons seeking
to acquire control of our company to first negotiate with our board
of directors. We believe that the benefits of increasing our
ability to negotiate with the proponent of an unfriendly or
unsolicited proposal to acquire or restructure our company outweigh
the disadvantages of discouraging these proposals because
negotiation of these proposals could result in an improvement of
their terms.
Delaware Anti-takeover Law
We are
subject to Section 203 of the DGCL, an anti-takeover law. In
general, Section 203 prohibits a publicly held Delaware corporation
from engaging in a “business combination” with an
“interested stockholder” for a period of three years
following the date the person became an interested stockholder,
unless:
●
the board of
directors approves the transaction in which the stockholder became
an interested stockholder prior to the date the interested
stockholder attained that status;
●
when the
stockholder became an interested stockholder, he or she owned at
least 85% of the voting stock of the corporation outstanding at the
time the transaction commenced, excluding shares owned by persons
who are directors and also officers and certain shares owned by
employee benefits plans; or
●
on or subsequent to
the date the business combination is approved by the board of
directors, the business combination is authorized by the
affirmative vote of at least 66 2/3% of the voting stock of the
corporation at an annual or special meeting of
stockholders.
Generally,
a “business combination” includes a merger, asset or
stock sale, or other transaction resulting in a financial benefit
to the interested stockholder. Generally, an “interested
stockholder” is a person who, together with affiliates and
associates, owns, or is an affiliate or associate of the
corporation and within three years prior to the determination of
interested stockholder status did own, 15% or more of a
corporation’s voting stock.
The
existence of Section 203 of the DGCL would be expected to have an
anti-takeover effect with respect to transactions not approved in
advance by our board of directors, including discouraging attempts
that might result in a premium over the market price for the shares
of our common stock.
Charter Documents
Our
Amended and Restated Certificate of Incorporation, as amended, and
Amended and Restated Bylaws include a number of provisions that may
have the effect of deterring hostile takeovers or delaying or
preventing changes in control or management of our company. First,
our Amended and Restated Bylaws limit who may call special meetings
of the stockholders, such meetings may only be called by the
chairman of the board, the chief executive officer, the board of
directors or holders of an aggregate of at least 15% of our
outstanding entitled to vote. Second, our Amended and Restated
Certificate of Incorporation does not include a provision for
cumulative voting for directors. Under cumulative voting, a
minority stockholder holding a sufficient percentage of a class of
shares may be able to ensure the election of one or more directors.
Third, our Amended and Restated Bylaws provide that the number of
directors on our board, which may range from five to nine
directors, shall be exclusively fixed by our board, which has set
the number of directors at seven. Fourth, newly created
directorships resulting from any increase in our authorized number
of directors and any vacancies in our board resulting from death,
resignation, retirement, disqualification or other cause (including
removal from office by a vote of the shareholders) will be filled
by a majority of our board then in office. Finally, our Amended and
Restated Bylaws establish procedures, including 90-day advance
notice requirement, with regard to the nomination of candidates for
election as directors and stockholder proposals. These and other
provisions of our Amended and Restated Certificate of Incorporation
and Amended and Restated Bylaws and Delaware law could discourage
potential acquisition proposals and could delay or prevent a change
in control or management of our company.
LEGAL MATTERS
The
validity of the securities being offered hereby will be passed upon
by Wyrick Robbins Yates & Ponton LLP, Raleigh, North
Carolina.
EXPERTS
The balance sheets of CorMedix Inc. as of December
31, 2016 and 2015 and the related consolidated statements of
operations and comprehensive income (loss), stockholders’
equity, and cash flows for each of the years in the three-year
period ended December 31, 2016,
and the effectiveness of
internal control over financial reporting as of December 31, 2016
(which is included in the Annual Report on Form 10-K for the year
ended December 31, 2016),
have been
incorporated herein by reference in reliance on the report of
Friedman LLP, independent registered public accounting firm, given
upon their authority as experts in accounting and
auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We are subject to the reporting requirements of the Exchange Act
and file annual, quarterly and current reports, proxy statements
and other information with the SEC. You may read and copy these
reports, proxy statements and other information at the SEC’s
public reference facilities at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can request copies of these documents
by writing to the SEC and paying a fee for the copying cost. Please
call the SEC at 1-800-SEC-0330 for more information about the
operation of the public reference facilities. SEC filings are also
available at the SEC’s web site at http://www.sec.gov. Our
common stock is listed on the NYSE American, and you can read and
inspect our filings at the offices of the NYSE American at 20 Broad
Street, New York, NY 10005.
This
prospectus is only part of a registration statement on Form S-3
that we have filed with the SEC under the Securities Act and
therefore omits certain information contained in the registration
statement. We have also filed exhibits and schedules with the
registration statement that are excluded from this prospectus, and
you should refer to the applicable exhibit or schedule for a
complete description of any statement referring to any contract or
other document. You may inspect a copy of the registration
statement, including the exhibits and schedules, without charge, at
the public reference room or obtain a copy from the SEC upon
payment of the fees prescribed by the SEC.
INCORPORATION OF DOCUMENTS BY REFERENCE
The
SEC allows us to “incorporate by reference” information
that we file with them. Incorporation by reference allows us to
disclose important information to you by referring you to those
other documents. The information incorporated by reference is an
important part of this prospectus and any applicable accompanying
prospectus, and information that we file later with the SEC will
automatically update and supersede this information. We filed a
registration statement on Form S-3 under the Securities Act of
1933, as amended, with the SEC with respect to the securities being
offered pursuant to this prospectus and any applicable accompanying
prospectus. This prospectus omits certain information contained in
the registration statement, as permitted by the SEC. You should
refer to the registration statement, including the exhibits, for
further information about us and the securities being offered
pursuant to this prospectus and any applicable accompanying
prospectus. Statements in this prospectus and any applicable
accompanying prospectus regarding the provisions of certain
documents filed with, or incorporated by reference in, the
registration statement are not necessarily complete and each
statement is qualified in all respects by that reference. Copies of
all or any part of the registration statement, including the
documents incorporated by reference or the exhibits, may be
obtained upon payment of the prescribed rates at the offices of the
SEC listed above in “Where You Can Find More
Information.” The documents we are incorporating by reference
into this prospectus are:
●
our
Annual Report on Form 10-K for the fiscal year ended
December 31, 2016, filed with the SEC pursuant to Section 13
of the Exchange Act on March 16, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017,
filed with the SEC pursuant to Section 13 of the Exchange Act on
May 10, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017,
filed with the SEC pursuant to Section 13 of the Exchange Act on
August 9, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2017, filed with the SEC pursuant to Section 13 of the Exchange Act
on November 9, 2017;
●
our
Current Reports on Form 8-K, filed with the SEC pursuant to
Section 13 of the Exchange Act on February 10, March 3, April 20,
April 28, May 3, June 13, June 27, July 12, August 1, August 2,
August 7, August 9 (Form 8-K/A), August 10, August 28, August 30,
September 1, September 5, November 13, November 20, December 4,
December 5, December 8 and December 11, 2017, and February 20,
February 26 and February 27, 2018;
●
our
definitive proxy statement on Schedule 14A for the 2017 annual
meeting of stockholders, filed with the SEC pursuant to Section 14
of the Exchange Act on April 24, 2017; and
●
all
of the filings pursuant to the Exchange Act after the date of the
filing of the registration statement and prior to the effectiveness
of the registration statement.
In
addition, all documents subsequently filed by us pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act before
the date our offering is terminated or completed are deemed to be
incorporated by reference into, and to be a part of, this
prospectus.
Any
statement contained in this prospectus and any applicable
prospectus supplement or in a document incorporated or deemed to be
incorporated by reference into this prospectus and any applicable
prospectus supplement will be deemed to be modified or superseded
for purposes of this prospectus and any prospectus supplement to
the extent that a statement contained in this prospectus and any
applicable prospectus supplement or any other subsequently filed
document that is deemed to be incorporated by reference into this
prospectus and any applicable prospectus supplement modifies or
supersedes the statement. Any statement so modified or superseded
will not be deemed, except as so modified or superseded, to
constitute a part of this prospectus and any applicable prospectus
supplement.
We
will furnish without charge to you, on written or oral request, a
copy of any or all of the documents incorporated by reference,
including exhibits to these documents. You should direct any
requests for documents to CorMedix, Inc., Attention: Secretary, 400
Connell Drive, Suite 5000, Berkeley Heights, New Jersey 07922,
(908) 517-9500.
You should rely only on information contained in,
or incorporated by reference into, this prospectus and any
applicable prospectus supplement. We have not authorized anyone to
provide you with information different from that contained in this
prospectus and any applicable prospectus supplement or incorporated
by reference in this prospectus and any applicable prospectus
supplement. We are not making offers to sell the securities in any
jurisdiction in which such an offer or solicitation is not
authorized or in which the person making such offer or solicitation
is not qualified to do so or to anyone to whom it is unlawful to
make such offer or solicitation
.
The information in this prospectus is not complete and may be
changed. We may not sell these securities or accept an offer to buy
these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is
not an offer to sell these securities, and we are not soliciting an
offer to buy these securities in any state where the offer or sale
is not permitted.
Subject to completion, dated March 9, 2018
Prospectus
$14,100,000
Common Stock
We have
entered into an At Market Issuance Sales Agreement, dated March 9,
2018, with B. Riley FBR, Inc., or B. Riley FBR, as sales agent. The
sales agreement relates to the sale of shares of our common stock
offered by this prospectus supplement. In accordance with the terms
of the sales agreement, under this prospectus supplement we may
offer and sell shares of our common stock, $0.001 par value per
share, having an aggregate offering price of up to $14,100,000 from
time to time through B. Riley FBR, acting as agent, which is an
amount equal to one-third of our public float as of March 8,
2018.
Our
common stock is traded on the NYSE American under the symbol
“CRMD.” The last reported sale price of our common
stock on March 6, 2018 was $0.29 per share.
Sales
of our common stock, if any, under this prospectus will be made by
any method permitted that is deemed an “at the market
offering” as defined in Rule 415 under the Securities Act of
1933, as amended, or the Securities Act. B. Riley FBR is not
required to sell any specific amount, but will act as our sales
agent using commercially reasonable efforts consistent with its
normal trading and sales practices. There is no arrangement for
funds to be received in any escrow, trust or similar
arrangement.
B.
Riley FBR will be entitled to compensation at a commission rate
equal to 3% of the gross sales price per share sold. In connection
with the sale of the common stock on our behalf, B. Riley FBR will
be deemed to be an “underwriter” within the meaning of
the Securities Act and the compensation of B. Riley FBR will be
deemed to be underwriting commissions or discounts. We have also
agreed to provide indemnification and contribution to B. Riley FBR
with respect to certain liabilities, including liabilities under
the Securities Act.
As of
March 8, 2018, the aggregate market value of our outstanding common
stock held by non-affiliates, or the public float, was
approximately $42,399,750, which was calculated based on 74,385,540
shares of our outstanding common stock held by non-affiliates and
on a price of $0.57 per share, the last reported sale price for our
common stock on February 16, 2018. Pursuant to General Instruction
I.B.6 of Form S-3, in no event will we sell our common stock in a
public primary offering with a value exceeding one-third of our
public float in any 12-month period unless our public float
subsequently rises to $75.0 million or more. We have not offered
any securities pursuant to General Instruction I.B.6 of Form S-3
during the 12 calendar months prior to and including the date of
this prospectus.
Investing
in our common stock involves a high degree of risk. Please read the
information contained in and incorporated by reference under the
heading “Risk Factors” beginning on page 6 of this
prospectus, the section captioned “Item 1A—Risk
Factors” in our most recently filed annual report on Form
10-K, which is incorporated by reference into this prospectus, and
under similar headings in the other documents that are filed after
the date hereof and incorporated by reference into this
prospectus.
Neither
the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
B. Riley FBR
The
date of this prospectus is ______, 2018.
TABLE OF CONTENTS
|
Page
|
About
this Prospectus
|
1
|
Prospectus
Summary
|
2
|
Risk
Factors
|
6
|
Special
Note Regarding Forward-Looking Statements
|
26
|
Use
of Proceeds
|
27
|
Dilution
|
28
|
Market
for Common Stock
|
30
|
Plan
of Distribution
|
31
|
Description
of our Common Stock
|
32
|
Certain
Provisions of Delaware Law and of Our Amended and Restated
Certificate of Incorporation and Amended and Restated
Bylaws
|
33
|
Legal
Matters
|
34
|
Experts
|
34
|
Where
You Can Find More Information
|
34
|
Incorporation
of Documents by Reference
|
34
|
ABOUT THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with
the Securities and Exchange Commission, or SEC, on Form S-3
utilizing a shelf registration process relating to the securities
described in this prospectus. Under this shelf registration
process, we may, from time to time, sell up to $70.0 million in the
aggregate of common stock, preferred stock, warrants, various
series of debt securities and/or warrants to purchase any of such
securities, either individually or in units, of which up to an
aggregate of $14.1 million may be sold in this offering in the form
of shares of common stock, which is an amount equal to one-third of
our public float as of March 8, 2018, as limited by General
Instruction I.B.6 of Form S-3.
This
prospectus relates to the offering of our common stock. Before
buying any of the common stock that we are offering, we urge you to
carefully read this prospectus, together with the information
incorporated by reference as described under the headings
“Where You Can Find More Information” and
“Incorporation of Certain Information by Reference” in
this prospectus. These documents contain important information that
you should consider when making your investment
decision.
This
prospectus describes the specific terms of the common stock we are
offering and also adds to, and updates information in any document
incorporated by reference into this prospectus. To the extent there
is a conflict between the information contained in this prospectus,
on the one hand, and the information contained any document
incorporated by reference into this prospectus that was filed with
the Securities and Exchange Commission, or SEC, before the date of
this prospectus, on the other hand, you should rely on the
information in this prospectus. If any statement in one of these
documents is inconsistent with a statement in another document
having a later date — for example, a document incorporated by
reference into this prospectus— the statement in the document
having the later date modifies or supersedes the earlier
statement.
You
should rely only on the information contained in, or incorporated
by reference into, this prospectus and in any free writing
prospectus that we may authorize for use in connection with this
offering. We have not, and B. Riley FBR has not, authorized any
other person to provide you with different information. If anyone
provides you with different or inconsistent information, you should
not rely on it. We are not, and B. Riley FBR is not, making an
offer to sell or soliciting an offer to buy our securities in any
jurisdiction in which an offer or solicitation is not authorized or
in which the person making that offer or solicitation is not
qualified to do so or to anyone to whom it is unlawful to make an
offer or solicitation. You should assume that the information
appearing into this prospectus, the documents incorporated by
reference into this prospectus, and in any free writing prospectus
that we may authorize for use in connection with this offering, is
accurate only as of the date of those respective documents. Our
business, financial condition, results of operations and prospects
may have changed since those dates. You should read this
prospectus, the documents incorporated by reference into this
prospectus, and any free writing prospectus that we may authorize
for use in connection with this offering, in their entirety before
making an investment decision. You should also read and consider
the information in the documents to which we have referred you in
the sections of this prospectus entitled “Where You Can Find
More Information” and “Incorporation of Certain
Information by Reference.”
We are
offering to sell, and seeking offers to buy, shares of common stock
only in jurisdictions where offers and sales are permitted. The
distribution of this prospectus and the offering of the common
stock in certain jurisdictions may be restricted by law. Persons
outside the United States who come into possession of this
prospectus must inform themselves about, and observe any
restrictions relating to, the offering of the common stock and the
distribution of this prospectus outside the United States. This
prospectus does not constitute, and may not be used in connection
with, an offer to sell, or a solicitation of an offer to buy, any
securities offered by this prospectus by any person in any
jurisdiction in which it is unlawful for such person to make such
an offer or solicitation.
Our primary executive offices are located at 400
Connell Drive, Suite 5000, Berkeley Heights, NJ 07922, and our
telephone number is (908) 517-9500. Our website address
is
www.cormedix.com
.
The
information contained on our website is not a part of, and should
not be construed as being incorporated by reference into, this
prospectus.
Unless
the context otherwise requires, “CorMedix,” the
“company,” “we,” “us,”
“our” and similar names refer to CorMedix
Inc.
Neutrolin
®
is our registered trademark and the
CorMedix logo is our trademark. All other trade names, trademarks
and service marks appearing in this prospectus are the property of
their respective owners. We have assumed that the reader
understands that all such terms are source-indicating. Accordingly,
such terms, when first mentioned in this prospectus, appear with
the trade name, trademark or service mark notice and then
throughout the remainder of this prospectus without trade name,
trademark or service mark notices for convenience only and should
not be construed as being used in a descriptive or generic
sense.
|
|
|
|
PROSPECTUS SUMMARY
This summary highlights certain information about us, this offering
and selected information contained elsewhere in or incorporated by
reference into this prospectus. This summary is not complete and
does not contain all of the information that you should consider
before deciding whether to invest in our common stock. For a more
complete understanding of our company and this offering, we
encourage you to read and consider carefully the more detailed
information in this prospectus, including the information
incorporated by reference into this prospectus, and the information
referred to under the heading “Risk Factors” in this
prospectus beginning on page 6, and in the documents incorporated
by reference into this prospectus.
OUR COMPANY
Overview
We are
a
biopharmaceutical company focused on
developing and commercializing therapeutic products for the
prevention and treatment of infectious and inflammatory
diseases
.
Our
primary focus is to develop our lead product candidate,
Neutrolin
®
(also known as
CRMD003), for potential commercialization in the U.S. and other key
markets. We have in-licensed the worldwide rights to develop and
commercialize Neutrolin, which is a novel anti-infective solution
(a formulation of taurolidine, citrate and heparin 1000 u/ml) under
development in the U.S. for the reduction and prevention of
catheter-related infections and thrombosis in patients requiring
central venous catheters in clinical settings such as dialysis,
critical/intensive care, and oncology. Infection and thrombosis
represent key complications among critical care/ intensive care and
cancer patients with central venous catheters. These complications
can lead to treatment delays and increased costs to the healthcare
system when they occur due to hospitalizations, need for IV
antibiotic treatment, long-term anticoagulation therapy,
removal/replacement of the central venous catheter, related
treatment costs and increased mortality. We believe Neutrolin has
the potential to address a significant unmet medical need and
represents a potential large market opportunity.
In July
2013, we received CE Mark approval for Neutrolin. As a result, in
December 2013, we commercially launched Neutrolin in Germany
for the prevention of catheter-related bloodstream infections and
maintenance of catheter patency in hemodialysis patients using a
tunneled, cuffed central venous catheter for vascular
access. To date, Neutrolin is registered and may be sold
in certain European Union and Middle Eastern countries for such
treatment. I
n April 2017, we
entered into a commercial collaboration with Hemotech SAS covering
France and French overseas territories.
We
initiated one Phase 3 clinical trial in hemodialysis patients with
a central venous catheter (“LOCK-IT-100”) in December
2015. The FDA has indicated that two pivotal trials to demonstrate
safety and effectiveness of Neutrolin will be required by the U.S.
Food and Drug Administration (“FDA”) to secure
marketing approval in the United States.
In
April 2017, a safety review by an independent Data and Safety
Monitoring Board, or DSMB was completed. The DSMB unanimously
concluded that it is safe to continue the LOCK-IT-100 clinical
trial as designed based on its evaluation of data from the first
279 patients randomized on trial.
On
August 2, 2017, we announced that the FDA had agreed to key changes
to the LOCK-IT-100 clinical trial. We believe that the changes
endorsed by the FDA facilitate our ability to complete the ongoing
Phase 3 clinical trial in hemodialysis patients with central venous
catheters, as previously announced, by year-end 2018. We sought
guidance from the FDA to address, in part, the apparent overall
lower rate of catheter-related blood stream infection (CRBSI)
events as announced in April 2017. Changes made to the protocol
were 1) the utilization of a Clinical Adjudication Committee (CAC)
to assess suspected CRBSIs; 2) the use of the CAC to critically and
independently assess suspected CRBSIs in a blinded fashion based on
a single positive blood culture and supporting documentation,
rather than two positive blood cultures as previously required; 3)
the ability to capture cases occurring outside of dialysis centers
to facilitate more complete capture of CRBSI events in the study,
particularly when patients present with CRBSI events outside of the
dialysis center setting (emergency rooms or urgent care centers);
and 4) a revision of the design of the study to detect a treatment
effect of 55% or greater when comparing the Neutrolin and heparin
control arms. The FDA agreed that cases adjudicated by the CAC to
be CRBSI events and the per protocol definition of CRBSI events
will be included in the primary analysis of the primary efficacy
endpoint of the LOCK-IT-100 study. The amended study assumptions
including a reduction in statistical power have resulted in a
reduction in the total number of CRBSI events required from 161
events to 56 events to complete the study. We believe that
these changes will allow the identification of more infections,
enabling a single interim analysis.
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On February 20, 2018, we announced that the CAC
has reviewed potential cases of CRBSI in the LOCK-IT 100 study that
occurred through early December 2017, and identified 28 such
cases.
As previously agreed with FDA, an interim analysis
will be performed when the first 28 CRBSIs case have been
identified. The primary endpoint for the study is the reduction of
CRBSI by Neutrolin in comparison to a heparin catheter lock
solution.
We are currently directing
standard procedures to ensure the accuracy and completeness of the
data required for conducting the interim analysis.
This
review includes data for all subjects in the study needed to assess
the two secondary endpoints related to a reduction in catheter
removal and catheter blockage, as well as the primary endpoint and
safety information. Before the full dataset can be locked and the
interim analysis can proceed, a number of weeks will be required to
complete the quality assurance procedures appropriate for the
amount of data generated in the trial. The interim analysis will be
provided to the Data Safety Monitoring Board for its review and
recommendation upon completion. We anticipate that DSMB review will
occur in the second quarter of 2018.
We are
evaluating
opportunities for the
possible expansion of taurolidine as a platform compound for use in
certain medical devices. Patent applications have been filed in
wound closure, surgical meshes, wound management, and
osteoarthritis, including visco-supplementation. Based on initial
feasibility work, we are advancing preclinical studies for three
product candidates: surgical meshes, suture materials, and
hydrogels. We expect to develop and pursue FDA clearance for
these potential products by the 510(k) pathway and will seek to
establish development/commercial partnerships as these programs
advance.
We are also involved in a pre-clinical research
collaboration for the use of taurolidine as a possible combination
treatment for rare orphan pediatric tumors.
In February
2018, the FDA granted orphan drug designation to taurolidine for
the treatment of neuroblastoma.
Corporate History and Information
We were
organized as a Delaware corporation on July 28, 2006 under the name
“Picton Holding Company, Inc.” and we changed our
corporate name to “CorMedix Inc.” on January 18, 2007.
Our operations to date have been primarily limited to organizing
and staffing, licensing product candidates, developing clinical
trials for our product candidates, seeking regulatory approvals for
Neutrolin, establishing manufacturing for our product candidates
and maintaining and improving our patent portfolio and launching
Neutrolin in the E.U and other foreign countries.
Our
executive offices are located at 400 Connell Drive, Suite 5000,
Berkeley Heights, NJ 07922. Our telephone number is (908) 517-9500.
Our website address is www.cormedix.com. Information contained in,
or accessible through, our website does not constitute part of this
prospectus supplement.
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THE
OFFERING
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Common stock
offered by us
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Shares having an
aggregate offering price of up to $14.10 million
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Common stock to be
outstanding after this offering
(1)
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Up to 48,620,689
shares, assuming sales at a price of $0.29 per share, which was the
closing price on the NYSE American on March 6, 2018. Actual number
of shares issued will vary depending on the sales price under this
offering.
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Manner of
offering
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“At the
market offering” that may be made from time to time through
our sales agent, B. Riley FBR. See “Plan of
Distribution” on page 31.
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Use of
proceeds
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We intend to use
the net proceeds from this offering, if any, for general corporate
purposes, including clinical trials, research and development
expenses and general and administrative expenses. See “Use of
Proceeds” on page 27.
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NYSE MKT
symbol
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“CRMD”
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Risk
factors
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Investing in our
common stock involves a high degree of risk. Please read the
information contained in and incorporated by reference under the
heading “Risk Factors” beginning on page 6, the section
captioned “Item 1A—Risk Factors” in our most
recently filed annual report on Form 10-K, which is incorporated by
reference into this prospectus, and under similar headings in the
other documents that are filed after the date hereof and
incorporated by reference into this prospectus.
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(1)
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The number of shares of our common stock that will
be outstanding immediately after this offering as shown above is
based on 71,413,790
shares
outstanding as of December 31, 2017. The number of shares
outstanding as of December 31, 2017, as used throughout this
prospectus, unless otherwise indicated,
excludes:
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●
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warrants
for 227,273 shares of common stock issued in July 2013 with an
exercise price of $1.50 that expire on July 30, 2018;
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warrants
for 500,000 shares of common stock issued in May 2013 with an
exercise price of $0.65 per share that expire on May 30,
2019;
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warrants
for 125,000 shares issued to ND Partners in April 2013 in
connection with the amendment to the license and assignment
agreement with an exercise price of $1.50 per share that expire on
April 11, 2018;
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options to purchase an aggregate of 120,000 shares
of our common stock issued to our officers, directors, employees
and non-employee consultants under our Amended and Restated 2006
Stock Incentive Plan, or the 2006 Stock Plan, with a weighted
average exercise price of $1.44 per share;
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options to purchase an aggregate of 4,842,495
shares of our common stock issued to our officers, directors and
non-employee consultants under our 2013 Stock Plan, with a weighted
average exercise price of $2.05 per share;
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a warrant to purchase 400,000 shares of our common
stock issued on February 19, 2013 with an exercise price of $1.50
that expire on February 19, 2018;
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warrants for 750,000 shares of common stock with
an exercise price of $0.90 that expire on October 22,
2019;
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warrants for 725,000 shares of common stock with
an exercise price of $0.90 that expire on January 8,
2020;
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Series C-2
Preferred Stock convertible into 1,500,000 shares of
common;
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Series C-3
Preferred Stock convertible into 1,040,000 shares of common
stock;
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Series D Preferred
Stock convertible into 1,479,240 shares of common
stock;
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Series E Preferred
Stock convertible into 1,959,759 shares of common
stock;
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Series F Preferred
Stock convertible into 3,157,562 shares of common stock, subject to
adjustment;
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warrants for
682,500 shares of common stock issued in March 2014 with an
exercise price of $2.50 per shares that expire on September 10,
2019;
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warrants for
200,000 shares of common stock with an exercise price of $7.00 that
expire on March 3, 2020;
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warrants for 83,400
shares of common stock with an exercise price of $7.00 that expire
on March 25, 2020. Series A warrants for 4,078,226 shares of common
stock with an exercise price of $0.75 that expire on September 10,
2018;
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Series A warrants
for 4,391,977 shares of common stock with an exercise price of
$0.75 that expire on September 10, 2018;
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Series B warrants
for 13,964,476 shares of common stock with an exercise price of
$1.05 that expire on August 10, 2022;
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underwriter
warrants for 1,117,158 shares of common stock with an exercise
price of $0.9375 that expire on August 10, 2022;
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warrants for
564,858 shares of common stock with an exercise price of $0.001
that expire on November 16, 2020; and
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restricted stock
units for 66,414 shares of common stock with an average grant date
fair value of $2.08 per share.
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RISK FACTORS
Investing in our common stock involves risk. Prior
to making a decision about investing in our common stock, you
should carefully consider the specific factors discussed below
together with all of the other information contained or
incorporated by reference in this prospectus. You should also
consider the risks, uncertainties and assumptions discussed under
the heading “Risk Factors” included in our most recent
annual report on Form 10-K which is on file with the SEC and
is incorporated herein by reference, and which may be amended,
supplemented or superseded from time to time by other reports we
have subsequently filed or may file with the SEC in the
future.
Risks Related to Our Financial Position and Need for Additional
Capital
We have a history of operating losses, expect to incur additional
operating losses in the future and may never be
profitable.
Our prospects must be considered in light of the
uncertainties, risks, expenses, and difficulties frequently
encountered by companies in the early stages of operation. We
incurred net losses of approximately $24.6 million, $18.2 million
and $20.5 million for the years ended December 31, 2016, 2015 and
2014, respectively, and $7.6 million, $12.7 million and $22.7
million for the three months ended March 31, 2017, the six months
ended June 30, 2017, and the nine months ended September 30, 2017,
respectively. As of September 30, 2017, we had an accumulated
deficit of approximately $141.9 million. We expect to incur
substantial additional operating expenses over the next several
years as our research, development, pre-clinical testing, clinical
trial and commercialization activities increase as we develop and
commercialize Neutrolin. As a result, we expect to experience
negative cash flow as we fund our operating losses and capital
expenditures. The amount of future losses and when, if ever, we
will achieve profitability are uncertain. Neutrolin was launched in
December 2013 and is currently available for distribution in
certain European Union and Middle East countries. We have not
generated any significant commercial revenue and do not expect to
generate substantial revenues from Neutrolin until it is approved
by the FDA and launched in the U.S. market, and might never
generate significant revenues from the sale of Neutrolin or any
other products. Our ability to generate revenue and achieve
profitability will depend on, among other things, the following:
successfully marketing Neutrolin in Germany and other countries in
which it is approved for sale; obtaining necessary regulatory
approvals for Neutrolin from the other applicable European and
Middle East agencies, other foreign agencies and the FDA and
international regulatory agencies for any other products;
establishing manufacturing, sales, and marketing arrangements,
either alone or with third parties; and raising sufficient funds to
finance our activities. We might not succeed at any of these
undertakings. If we are unsuccessful at some or all of these
undertakings, our business, prospects, and results of operations
may be materially adversely affected.
We
have
received a
going concern opinion from our independent registered public
accounting firm.
Our
operations are subject to a number of factors that can affect our
operating results and financial condition. Such factors
include
, but are not limited
to: the results of clinical testing and trial activities of our
product candidates; the ability to obtain regulatory approval to
market our products; ability to manufacture successfully;
competition from products manufactured and sold or being developed
by other companies; the price of, and demand for, our products; our
ability to negotiate favorable licensing or other manufacturing and
marketing agreements for our products; and our ability to raise
capital to support our operations.
To
date, our commercial operations have not generated sufficient
revenues to enable profitability. As of September 30, 2017, we had
an accumulated deficit of approximately $141.9 million, and
incurred net losses from operations of $22.7 million for the nine
months then ended. Based on the current development plans for
Neutrolin in both the U.S. and foreign
markets
(including the ongoing hemodialysis
Phase 3 clinical trial in the U.S.) and our other operating
requirements, management believes that our existing cash and
short-term investments at September 30, 2017 will fund our
operations into the second quarter of 2018 after taking into
consideration the net proceeds received through February 2018 from
sales of common stock under our at the market common stock sales
program and the proceeds from the November 2017 financing with
Elliott Associates, L.P. and Elliott International, L.P. (together,
“Elliott”). These factors raise substantial doubt
regarding our ability to continue as a going concern. We will need
additional funding to complete the LOCK-IT 100 hemodialysis
clinical trial in the U.S. which commenced in December 2015 as well
as to initiate the anticipated second Phase 3 clinical trial that
is currently required in order to file an NDA with the
FDA.
As a
result of the above matters, our independent registered public
accounting firm indicated in its report on our December 31, 2016
financial statements that there is substantial doubt about our
ability to continue as a going concern and we expect to receive
such an opinion in their report for fiscal 2017. A “going
concern” opinion indicates that the financial statements have
been prepared assuming we will continue as a going concern and do
not include any adjustments to reflect the possible future effects
on the recoverability and
classification
of assets, or the amounts
and classification of liabilities that may result if we do not
continue as a going concern. Therefore, you should not rely on our
consolidated balance sheet as an indication of the amount of
proceeds that would be available to satisfy claims of our
creditors, and potentially be available for distribution to our
stockholders, in the event of liquidation.
Our
continued operations will ultimately depend on our ability to raise
additional capital through various potential sources, such as
equity and/or debt financings, strategic relationships, or
out-licensing of our products in order to complete our
ongoing
and planned Phase 3 clinical trials
and until we achieve profitability, if ever. We can provide no
assurances that such financing or strategic relationships will be
available on acceptable terms, or at all. Without this funding, we
could be required to delay, scale back or eliminate some or all of
our research and development programs which would likely have a
material adverse effect on our business.
We will need to finance our future cash needs through public or
private equity offerings, debt financings or corporate
collaboration and licensing arrangements. Any additional funds that
we obtain may not be on terms favorable to us or our stockholders
and may require us to relinquish valuable
rights.
We have launched Neutrolin in certain European
Union and Middle East countries, but to date have no other approved
product on the market and have not generated significant product
revenue from Neutrolin to date. Unless and until we receive
applicable regulatory approval for Neutrolin in the U.S., we cannot
sell Neutrolin in the U.S. Therefore, for the foreseeable future,
we will have to fund all of our operations and capital expenditures
from Neutrolin sales in Europe and other foreign markets, if
approved, cash on hand, additional financings, licensing fees and
grants.
We believe that our cash resources as of September
30, 2017, even after taking into consideration the net proceeds
received through February 2018 from sales of common stock under our
at the market common stock sales program and the proceeds from the
November 2017 financing with Elliott, will not be sufficient to
enable us to fund our projected operating requirements for at least
the next 12 months following the balance sheet
date. We will need additional funding thereafter
to complete our ongoing Phase 3
hemodialysis clinical trial
in the U.S. in oncology patients with catheters, as well initiate
as our anticipated second Phase 3 clinical trial in the U.S. If we
are unable to raise additional funds when needed, we may not be
able to complete our ongoing Phase 3 clinical trial, commence and
complete our planned Phase 3 clinical trial or commercialize
Neutrolin and we could be required to delay, scale back or
eliminate some or all of our research and development programs. We
can provide no assurances that any financing or strategic
relationships will be available to us on acceptable terms, or at
all. We expect to incur increases in our cash used in operations as
we conduct our ongoing Phase 3 clinical trial and prepare for our
anticipated second Phase 3 clinical trial in oncology patients,
seek FDA approval of Neutrolin in the U.S., commercialize Neutrolin
in Europe and other markets, pursue business development
activities, and incur additional legal costs to defend our
intellectual property.
To raise needed capital, we may sell additional
equity or debt securities, obtain a bank credit facility, or enter
into a corporate collaboration or licensing arrangement.
The sale of additional equity or debt
securities, if convertible, could result in dilution to our
stockholders. The incurrence of indebtedness would result in fixed
obligations and could also result in covenants that would restrict
our operations. Raising additional funds through collaboration or
licensing arrangements with third parties may require us to
relinquish valuable rights to our technologies, future revenue
streams, research programs or product candidates, or to grant
licenses on terms that may not be favorable to us or our
stockholders.
Until
the date that none of the shares of common stock or warrants that
we issued to Elliott Associates, L.P. and Elliott International,
L.P in November 2017 as part of the backstop financing are
outstanding, we are prohibited from issuing or selling any
securities convertible into common stock on terms more favorable
than the backstop financing terms and with a conversion, exchange
or exercise price that is based upon and/or varies with the trading
prices of or quotations for the shares of our common stock or that
is subject to being reset at some future date or upon the
occurrence of specified or contingent events directly or indirectly
related to our business (other than pursuant to a customary
“weighted average” anti-dilution provision) or the
market for our common stock or enter into any agreement to sell
securities at a future determined price (other than standard and
customary “preemptive” or “participation”
rights and other than pursuant to an at-the-market offering through
a registered broker-dealer). This restriction could make raising
capital through the sale of equity securities very difficult and
could have a material adverse impact on our business, financial
condition and prospects.
Risks Related to the Development and Commercialization of Our
Product Candidates
If we are unable to successfully complete our Phase 3 LOCK-IT-100
clinical trial, or if such clinical trial takes longer to complete
than we project, our ability to execute our current business
strategy will be adversely affected.
Whether or not and how quickly we complete the
Phase 3 LOCK-IT-100 clinical trial is dependent in part upon the
rate of enrollment of patients, the rate we collect, clean, lock
and analyze the clinical trial database, and the frequency with
which CRBSI events occur. Patient enrollment is a function of many
factors, including the size of the patient population, the
proximity of patients to clinical sites, the eligibility criteria
for the study, the existence of competitive clinical trials, and
whether existing or new products are approved for the indication we
are studying. In addition, the LOCK-IT-100 clinical trial is
designed to continue until a pre-determined number of events have
occurred in the patients enrolled. Event-driven trials such as
LOCK-IT-100 are subject to delays and other risks stemming from
patient withdrawal and from lower than expected event rates.
A lower event rate will require that
we enroll more patients than initially anticipated, which would
require us to incur additional costs and
extend the anticipated time for
completion of the trial
in order to achieve the desired number
of events. If we experience delays in patient enrollment in our
clinical trial, or if we experience other issues related to the
number of events or other trial results, we may incur additional
costs and delays in the trial, and may not be able to complete the
clinical trial in a cost-effective or timely manner, which would
have an adverse effect on our development program for Neutrolin as
a treatment for catheter related bloodstream
infections.
Our only product Neutrolin is only approved in Europe and is still
in development in the U. S.
Neutrolin currently and for at least the near
future is our only current product as well as our only late-stage
product candidate. Neutrolin has received CE Mark approval in
Europe, and we launched it in Germany in December 2013. We also are
pursuing development of Neutrolin in the U.S. Our product
commercialization and development efforts may not lead to
commercially viable products for any of several reasons. For
example, our product candidates may fail to be proven safe and
effective in clinical trials, or we may have inadequate financial
or other resources to pursue development efforts for our product
candidates. Even if approved, our products may not be accepted in
the marketplace. Neutrolin will require significant additional
development, clinical trials, regulatory clearances and/or
investment by us or our collaborators as we continue its
commercialization, as will any of our other products. Specifically,
we plan to expand marketing of Neutrolin in other foreign countries
and to develop Neutrolin for sale in the U.S., which will take time
and capital.
In
April 2017, we entered into a commercial collaboration with
Hemotech SAS covering France and certain overseas territories. We
have entered into agreements with a Saudi Arabian company to market
and sell Neutrolin in Saudi Arabia, and with a South Korean company
to market, sell and distribute Neutrolin in South Korea upon
receipt of regulatory approval in that country. We also have a
commercial presence in Germany and the United Arab Emirates.
Consequently, we will be dependent on these companies and
individuals for the success of sales in those countries and any
other countries in
which
we
receive regulatory approval and in which we contract with third
parties for the marketing, sale and/or distribution of Neutrolin.
If these companies or individuals do not perform for whatever
reason, our business, prospects and results of operations will be
materially adversely affected. Finding a suitable replacement
organization or individual for these or any other companies or
individuals with whom we might contract could be difficult, which
would further harm our business, prospects and results of
operations.
Successful development and commercialization of our products is
uncertain.
Our
development
and commercialization of current and future
product candidates is subject to the risks of failure and delay
inherent in the development of new pharmaceutical products,
including but not limited to the
following:
●
inability
to produce positive data in pre-clinical and clinical
trials;
●
delays in product
development
, pre-clinical and clinical testing, or
manufacturing;
●
unplanned expenditures in
product
development, clinical testing, or
manufacturing;
●
failure
to receive regulatory approvals;
●
emergence of superior or
equivalent
products;
●
inability to manufacture our
product
candidates on a commercial scale on
our own, or in collaboration with third parties;
and
●
failure to achieve market
acceptance
.
Because of these risks, our development efforts
may not result in any commercially viable products. If a
significant portion of these development efforts are not
successfully completed, required regulatory approvals are not
obtained or any approved products are not commercialized
successfully, our business, financial condition, and results of
operations will be materially harmed.
Clinical trials required for our product candidates are expensive
and time-consuming, and their outcome is
uncertain.
In order to obtain FDA or foreign approval to
market a new drug or device product, we must demonstrate proof of
safety and effectiveness in humans. Foreign regulations and
requirements are similar to those of the FDA. To meet FDA
requirements, we must conduct “adequate and
well-controlled” clinical trials. Conducting clinical trials
is a lengthy, time-consuming, and expensive process. The length of
time may vary substantially according to the type, complexity,
novelty, and intended use of the product candidate, and often can
be several years or more per trial. Delays associated with products
for which we are directly conducting clinical trials may cause us
to incur additional operating expenses. The commencement and rate
of completion of clinical trials may be delayed by many factors,
including, for example:
●
inability
to manufacture sufficient quantities of qualified materials under
the FDA’s cGMP requirements for use in clinical
trials;
●
slower than expected rates of
patient
recruitment;
●
failure to recruit a sufficient
number
of patients;
●
modification of clinical trial
protocols
;
●
changes in regulatory
requirements
for clinical
trials;
●
lack of effectiveness during
clinical
trials;
●
emergence of unforeseen
safety
issues;
●
delays, suspension, or
termination
of clinical trials due to the
institutional review board responsible for overseeing the study at
a particular study site; and
●
government or regulatory
delays
or “clinical holds”
requiring suspension or termination of the
trials.
The results from early pre-clinical and clinical
trials are not necessarily predictive of results to be obtained in
later clinical trials. Accordingly, even if we obtain positive
results from early pre-clinical or clinical trials, we may not
achieve the same success in later clinical
trials.
Our clinical trials may be conducted in patients
with serious or life-threatening diseases for whom conventional
treatments have been unsuccessful or for whom no conventional
treatment exists, and in some cases, our product is expected to be
used in combination with approved therapies that themselves have
significant adverse event profiles. During the course of treatment,
these patients could suffer adverse medical events or die for
reasons that may or may not be related to our products. We cannot
ensure that safety issues will not arise with respect to our
products in clinical development.
Clinical trials may not demonstrate statistically
significant safety and effectiveness to obtain the requisite
regulatory approvals for product candidates. The failure of
clinical trials to demonstrate safety and effectiveness for the
desired indications could harm the development of our product
candidates. Such a failure could cause us to abandon a product
candidate and could delay development of other product candidates.
Any delay in, or termination of, our clinical trials would delay
the filing of any NDA or any Premarket Approval Application, or
PMA, with the FDA and, ultimately, our ability to commercialize our
product candidates and generate product revenues. Any change in, or
termination of, our clinical trials could materially harm our
business, financial condition, and results of
operations.
If we fail to comply with international regulatory
requirements we could be subject to regulatory delays,
fines or other penalties.
Regulatory requirements in foreign countries for
international sales of medical devices often vary from country to
country. The occurrence and related impact of the following factors
would harm our business:
●
delays in receipt of, or failure to
receive,
foreign
regulatory
approvals or clearances;
●
the loss of previously obtained
approvals
or clearances; or
●
the failure to comply with existing or
future
regulatory
requirements.
The CE Mark is a mandatory conformity mark for
products to be sold in the European Economic Area. Currently, 28
countries in Europe require products to bear CE Marking. To market
in Europe, a product must first obtain the certifications
necessary to affix the CE Mark. The CE Mark is an international
symbol of adherence to the Medical Device Directives and the
manufacturer’s declaration that the product complies with
essential requirements. Compliance with these requirements is
ascertained within a certified Quality Management System (QMS)
pursuant to ISO 13485. In order to obtain and to maintain a CE
Mark, a product must be in compliance with the applicable
quality assurance provisions of the aforementioned ISO and obtain
certification of its quality assurance systems by a recognized
European Union notified body. We received CE Mark approval for
Neutrolin on July 5, 2013. However, certain individual countries
within the European Union require further approval by their
national regulatory agencies. Failure to receive or
maintain these other requisite approvals could prohibit us
from marketing and selling Neutrolin in the entire
European Economic Area or elsewhere.
We do not have, and may never obtain, the regulatory approvals we
need to market our product candidates outside of the European
Union.
While we have received the CE Mark approval for
Neutrolin in Europe, certain individual countries within the
European Union require further approval by their national
regulatory agencies. Failure to receive or maintain these
other requisite approvals could prohibit us from marketing and
selling Neutrolin in the entire European Economic Area. In
addition, we will need regulatory approval to market and sell
Neutrolin in foreign countries outside of Europe. We have received
regulatory approval in Saudi Arabia, Kuwait and
Bahrain.
In the United States, we have no current
application for, and have not received the regulatory approvals
required for, the commercial sale of any of our products. We have
not submitted an NDA, PMA or 510(K) to the FDA for any product. We
have received approval from the FDA to proceed with our ongoing
Phase 3 clinical trial for Neutrolin in hemodialysis catheters as
the first of our required two Phase 3 studies. We are assessing the
structure of our anticipated second Phase 3 clinical trial to seek
efficiencies and improvements in its design and execution.
Financing will be required to complete our current Phase 3 trial
and to begin and execute our anticipated second Phase 3 trial.
However, we might not obtain any financing and may never start the
second Phase 3 trial.
It is possible that Neutrolin will not receive any
further approval or that any of our other product candidates will
be approved for marketing. Failure to obtain regulatory approvals,
or delays in obtaining regulatory approvals, would adversely affect
the successful commercialization of Neutrolin or any other drugs or
products that we or our partners develop, impose additional costs
on us or our collaborators, diminish any competitive advantages
that we or our partners may attain, and/or adversely affect our
cash flow.
Even if approved, our products will be subject to extensive
post-approval regulation.
Once a product is approved, numerous post-approval
requirements apply in the United States and abroad. Depending on
the circumstances, failure to meet these post-approval requirements
can result in criminal prosecution, fines, injunctions, recall or
seizure of products, total or partial suspension of production,
denial or withdrawal of pre-marketing product approvals, or refusal
to allow us to enter into supply contracts, including government
contracts. In addition, even if we comply with FDA, foreign and
other requirements, new information regarding the safety or
effectiveness of a product could lead the FDA or a foreign
regulatory body to modify or withdraw product
approval.
The successful commercialization of Neutrolin will depend on
obtaining coverage and reimbursement for use of Neutrolin from
third-party payors.
Sales of pharmaceutical products largely depend on
the reimbursement of patients’ medical expenses by government
health care programs and/or private health insurers, both in the
U.S. and abroad. Further, significant uncertainty exists as to the
reimbursement status of newly approved health care products.
We initially expect to sell Neutrolin directly to hospitals and key
dialysis center operators, but also plan to expand its usage into
intensive care, oncology and total parenteral nutrition
patients
needing catheters,
including Medicare patients. All of these potential customers are
healthcare providers who depend upon reimbursement by government
and commercial insurance payors for dialysis and other treatments.
Reimbursement is strictly governed by these insurance payors. We
believe that Neutrolin would be eligible for coverage under various
reimbursement programs, including hospital inpatient
diagnosis-related groups (DRGs), outpatient ambulatory payment
classification (APCs) and the End-Stage Renal Disease Prospective
Payment System (ESRD PPS) or under the Durable Medical Equipment,
Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule,
depending on the treatment setting. However, coverage by any of
these reimbursement programs is not assured, and even if coverage
is granted it could later be revoked or modified under future
regulations. Further, the U.S. Centers for Medicare & Medicaid
Services (CMS), which administers Medicare and works with states to
administer Medicaid, has adopted and will continue to adopt and/or
amend rules governing reimbursement for specific treatments,
including those we intend to address such as dialysis and ESRD PPS.
We anticipate that CMS and private insurers will increasingly
demand that manufacturers demonstrate the cost effectiveness of
their products as part of the reimbursement review and approval
process. Rising healthcare costs have also lead many European and
other foreign countries to adopt healthcare reform proposals and
medical cost containment measures. Any measures affecting the
reimbursement programs of these governmental and private insurance
payors, including any uncertainty in the medical community
regarding their nature and effect on reimbursement programs, could
have an adverse effect on purchasing decisions regarding Neutrolin,
as well as limit the prices we may charge for Neutrolin.
The failure to obtain or maintain
reimbursement coverage for Neutrolin or any other products could
materially harm our operations.
In
anticipation that the CMS and private payers will demand that we
demonstrate the cost effectiveness of Neutrolin as part of the
reimbursement
review
and
approval process, we have incorporated health economic evaluations
into our ongoing clinical studies to support this review in the
context of the prospective use of Neutrolin in dialysis, the ICU
and oncology settings. However, our studies might not be
sufficient to support coverage or reimbursement at levels that
allow providers to use Neutrolin.
Physicians and patients may not accept and use our
products.
Even with
the
CE Mark approval of Neutrolin, and even if we
receive FDA or other foreign regulatory approval for Neutrolin or
other product candidates, physicians and patients may not accept
and use our products. Acceptance and use of our products will
depend upon a number of factors including the
following:
●
perceptions
by members of the health care community, including physicians,
about the safety and effectiveness of our drug or device
product;
●
cost-effectiveness
of our product relative to competing products;
●
availability of reimbursement for our
product
from government or other
healthcare payors; and
●
effectiveness of marketing and distribution
efforts
by us and our licensees and
distributors, if any.
Because we expect sales of Neutrolin to generate
substantially all of our product revenues for the foreseeable
future, the failure of Neutrolin to find market acceptance would
harm our business and would require us to seek additional
financing.
Risks Related to Our Business and Industry
Competition and technological change may make our product
candidates and technologies less attractive or
obsolete.
We compete with established pharmaceutical and
medical device companies that are pursuing other forms of
prevention or treatment for the same indications we are pursuing
and that have greater financial and other resources. Other
companies may succeed in developing products earlier than we do,
obtaining FDA or any other regulatory agency approval for products
more rapidly, or developing products that are more effective than
our product candidates. Research and development by others may
render our technology or product candidates obsolete or
noncompetitive, or result in processes, treatments or cures
superior to any therapy we develop. We face competition from
companies that internally develop competing technology or acquire
competing technology from universities and other research
institutions. As these companies develop their technologies, they
may develop competitive positions that may prevent, make futile, or
limit our product commercialization efforts, which would result in
a decrease in the revenue we would be able to derive from the sale
of any products.
There can be no assurance that Neutrolin or any
other product candidate will be accepted by the marketplace as
readily as these or other competing treatments. Furthermore, if our
competitors’ products are approved before ours, it could be
more difficult for us to obtain approval from the FDA or any other
regulatory agency. Even if our products are successfully developed
and approved for use by all governing regulatory bodies, there can
be no assurance that physicians and patients will accept any of our
products as a treatment of choice.
Furthermore, the pharmaceutical and medical device
industry is diverse, complex, and rapidly changing. By its nature,
the business risks associated with the industry are numerous and
significant. The effects of competition, intellectual property
disputes, market acceptance, and FDA or other regulatory agency
regulations preclude us from forecasting revenues or income with
certainty or even confidence.
We face the risk of product liability claims and the amount of
insurance coverage we hold now or in the future may not be adequate
to cover all liabilities we might incur.
Our business exposes us to the risk of product
liability claims that are inherent in the development of drugs. If
the use of one or more of our or our collaborators’ drugs or
devices harms people, we may be subject to costly and damaging
product liability claims brought against us by clinical trial
participants, consumers, health care providers, pharmaceutical
companies or others selling our products.
We currently carry product liability insurance
that covers our clinical trials. We cannot predict all of the
possible harms or side effects that may result and, therefore, the
amount of insurance coverage we hold may not be adequate to cover
all liabilities we might incur. Our insurance covers bodily injury
and property damage arising from our clinical trials, subject to
industry-standard terms, conditions and exclusions. This coverage
includes the sale of commercial products. We have expanded our
insurance coverage to include the sale of commercial products due
to the receipt of the CE Mark approval, but we may be unable to
maintain such coverage or obtain commercially reasonable product
liability insurance for any other products approved for
marketing.
If we are unable to obtain insurance at an
acceptable cost or otherwise protect against potential product
liability claims, we may be exposed to significant liabilities,
which may materially and adversely affect our business and
financial position. If we are sued for any injury allegedly caused
by our or our collaborators’ products and do not have
sufficient insurance coverage, our liability could exceed our total
assets and our ability to pay the liability. A successful product
liability claim or series of claims brought against us would
decrease our cash and could cause the value of our capital stock to
decrease.
We may be exposed to liability claims associated with the use of
hazardous materials and chemicals.
Our research, development and manufacturing
activities and/or those of our third-party contractors may involve
the controlled use of hazardous materials and chemicals. Although
we believe that our safety procedures for using, storing, handling
and disposing of these materials comply with federal, state and
local, as well as foreign, laws and regulations, we cannot
completely eliminate the risk of accidental injury or contamination
from these materials. In the event of such an accident, we could be
held liable for any resulting damages and any liability could
materially adversely affect our business, financial condition and
results of operations. In addition, the federal, state and local,
as well as foreign, laws and regulations governing the use,
manufacture, storage, handling and disposal of hazardous or
radioactive materials and waste products may require us to incur
substantial compliance costs that could materially adversely affect
our business, financial condition and results of
operations.
Healthcare policy changes, including reimbursement policies for
drugs and medical devices, may have an adverse effect on our
business, financial condition and results of
operations.
Market acceptance and sales of Neutrolin or any
other product candidates that we develop will depend on
reimbursement policies and may be affected by health care reform
measures in the United States and abroad. Government authorities
and other third-party payors, such as private health insurers and
health maintenance organizations, decide which drugs they will pay
for and establish reimbursement levels. We cannot be sure that
reimbursement will be available for Neutrolin or any other product
candidates that we develop. Also, we cannot be sure that the amount
of reimbursement available, if any, will not reduce the demand for,
or the price of, our products. If reimbursement is not available or
is available only at limited levels, we may not be able to
successfully commercialize Neutrolin or any other product
candidates that we develop.
In
the United States, there have been a number of legislative and
regulatory proposals to change the health care system in ways that
could affect our ability to sell our products profitably. The
Patient Protection and Affordable Care Act, as amended by the
Health Care and Education Reconciliation Act of 2010, or
collectively, the Healthcare Reform Act, substantially changes the
way healthcare is financed by both governmental and private
insurers, and significantly impacts the pharmaceutical industry.
The Healthcare Reform Act contains a number of provisions,
including those governing enrollment in federal healthcare
programs, reimbursement changes and fraud and abuse, which will
impact existing government healthcare programs and will result in
the development of new programs, including Medicare payment for
performance initiatives and improvements to the physician quality
reporting system and feedback program. We anticipate that if we
obtain approval for our products, some of our revenue may be
derived from U.S. government healthcare programs, including
Medicare.
Some of
the provisions of the Healthcare Reform Act have yet to be
implemented, and there have been judicial and Congressional
challenges to certain aspects of the Healthcare Reform Act. Since
January 2017, President Trump has signed two Executive Orders and
other directives designed to delay, circumvent or loosen the
implementation of certain provisions requirements mandated by the
Healthcare Reform Act or otherwise circumvent some of the
requirements for health insurance mandated by the Healthcare Reform
Act. Concurrently, Congress has considered legislation that would
repeal or repeal and replace all or part of the Healthcare Reform
Act. While Congress has not passed repeal legislation, the Tax Cuts
and Jobs Act of 2017 includes a provision repealing, effective
January 1, 2019, the tax-based shared responsibility payment
imposed by the Healthcare Reform Act on certain individuals who
fail to maintain qualifying health coverage for all or part of a
year that is commonly referred to as the “individual
mandate.” Additionally, on January 23, 2018, President
Trump signed a continuing resolution on appropriations for fiscal
year 2018 that delayed the implementation of certain Healthcare
Reform Act-mandated fees, including the so-called
“Cadillac” tax on certain high cost employer-sponsored
insurance plans. Congress may consider other legislation to repeal
or replace elements of the Healthcare Reform Act.
In addition to the Healthcare Reform Act, we
expect that there will continue to be proposals by legislators at
both the federal and state levels, regulators and third-party
payors to keep healthcare costs down while expanding individual
healthcare benefits. Certain of these changes could impose
limitations on the prices we will be able to charge for any
products that are approved or the amounts of reimbursement
available for these products from governmental agencies or other
third-party payors or may increase the tax requirements for life
sciences companies such as ours. While it is too early to predict
what effect the Healthcare Reform Act or any future legislation or
regulation will have on us, such laws could have an adverse effect
on our business, financial condition and results of
operations.
Health administration authorities in countries
other than the United States may not provide reimbursement for
Neutrolin or any of our other product candidates at rates
sufficient for us to achieve profitability, or at all. Like the
United States, these countries could adopt health care reform
proposals and could materially alter their government-sponsored
health care programs by reducing reimbursement
rates.
Any reduction in reimbursement rates under
Medicare or private insurers or foreign health care programs could
negatively affect the pricing of our products. If we are not able
to charge a sufficient amount for our products, then our margins
and our profitability will be adversely
affected.
If we lose key management or scientific personnel, cannot recruit
qualified employees, directors, officers, or other personnel or
experience increases in compensation costs, our business may
materially suffer.
We are highly dependent on the principal members
of our management and scientific staff, specifically, Khoso Baluch,
a director and our Chief Executive Officer, Robert Cook, our Chief
Financial Officer, and John Armstrong, our Executive Vice President
for Technical Operations. Our future success will depend in part on
our ability to identify, hire, and retain current and additional
personnel. We experience intense competition for qualified
personnel and may be unable to attract and retain the personnel
necessary for the development of our business. Moreover, our work
force is located in the New York metropolitan area, where
competition for personnel with the scientific and technical skills
that we seek is extremely high and is likely to remain high.
Because of this competition, our compensation costs may increase
significantly. In addition, we have only limited ability to prevent
former employees from competing with
us.
If we are unable to hire additional qualified personnel, our
ability to grow our business may be
harmed.
Over time, we expect to hire additional qualified
personnel with expertise in clinical testing, clinical research and
testing, government regulation, formulation and manufacturing, and
sales and marketing. We compete for qualified individuals with
numerous pharmaceutical companies, universities and other research
institutions. Competition for such individuals is intense, and we
cannot be certain that our search for such personnel will be
successful. Attracting and retaining such qualified personnel will
be critical to our success.
We may not successfully manage our
growth.
Our success will depend upon the expansion of our
operations to commercialize Neutrolin and the effective management
of any growth, which could place a significant strain on our
management and our administrative, operational and financial
resources. To manage this growth, we may need to expand our
facilities, augment our operational, financial and management
systems and hire and train additional qualified personnel. If we
are unable to manage our growth effectively, our business may be
materially harmed.
Risks Related to Our Intellectual Property
If we materially breach or default under any of our license
agreements, the licensor party to such agreement will have the
right to terminate the license agreement, which termination may
materially harm our business.
Our commercial success will depend in part on the
maintenance of our license agreements. Each of our license
agreements provides the licensor with a right to terminate the
license agreement for our material breach or default under the
agreement, including the failure to make any required milestone or
other payments. Should the licensor under any of our license
agreements exercise such a termination right, we would lose our
right to the intellectual property under the respective license
agreement, which loss may materially harm our
business.
If we and our licensors do not obtain protection for and
successfully defend our respective intellectual property rights,
our competitors may be able to take advantage of our research and
development efforts to develop competing
products.
Our commercial success will depend in part on
obtaining further patent protection for our products and other
technologies and successfully defending any patents that we
currently have or will obtain against third-party challenges. The
patents which we currently believe are most material to our
business are as follows:
●
U.S. Patent No. 8,541,393 (
expiring
in November 2024) (the “Prosl
Patent”) - use of Neutrolin for preventing infection and
maintenance of catheter patency in hemodialysis catheters (for
CRMD003);
●
U.S.
Patent No. 6,166,007 (expiring May 2019) (the “Sodemann
Patent”) - a method of inhibiting or preventing infection and
blood coagulation at a medical prosthetic device (for CRMD003);
and
●
European Patent EP 1 814 562 B1 (
expiring
October 12, 2025) (the “Prosl
European Patent”) - a low heparin catheter lock solution for
maintaining and preventing infection in a hemodialysis
catheter.
We are currently seeking further patent protection
for our compounds and methods of treating diseases. However, the
patent process is subject to numerous risks and uncertainties, and
there can be no assurance that we will be successful in protecting
our products by obtaining and defending patents. These risks and
uncertainties include the
following:
●
patents
that may be issued or licensed may be challenged, invalidated, or
circumvented, or otherwise may not provide any competitive
advantage;
●
our competitors, many of which have
substantially
greater resources than
we have and many of which have made significant investments in
competing technologies, may seek, or may already have obtained,
patents that will limit, interfere with, or eliminate our ability
to make, use, and sell our potential products either in the United
States or in international markets;
●
there
may be significant pressure on the United States government and
other international governmental bodies to limit the scope of
patent protection both inside and outside the United States for
treatments that prove successful as a matter of public policy
regarding worldwide health concerns; and
●
countries other than the United States may
have
less restrictive patent laws than
those upheld by United States courts, allowing foreign competitors
the ability to exploit these laws to create, develop, and market
competing products.
In addition, the United States Patent and
Trademark Office, or PTO, and patent offices in other jurisdictions
have often required that patent applications concerning
pharmaceutical and/or biotechnology-related inventions be limited
or narrowed substantially to cover only the specific innovations
exemplified in the patent application, thereby limiting the scope
of protection against competitive challenges. Thus, even if we or
our licensors are able to obtain patents, the patents may be
substantially narrower than
anticipated.
The above mentioned patents and patent
applications are exclusively licensed to us. To support our patent
strategy, we have engaged in a review of patentability and certain
freedom to operate issues, including performing certain searches.
However, patentability and certain freedom to operate issues are
inherently complex, and we cannot provide assurances that a
relevant patent office and/or relevant court will agree with our
conclusions regarding patentability issues or with our conclusions
regarding freedom to operate issues, which can involve subtle
issues of claim interpretation and/or claim liability. Furthermore,
we may not be aware of all patents, published applications or
published literature that may affect our business either by
blocking our ability to commercialize our product candidates,
preventing the patentability of our product candidates to us or our
licensors, or covering the same or similar technologies that may
invalidate our patents, limit the scope of our future patent claims
or adversely affect our ability to market our product
candidates. Additionally, it is also possible that prior art
of which we are aware, but which we do not believe affects the
validity or enforceability of a claim, may, nonetheless, ultimately
be found by a court of law or an administration panel to affect the
validity or enforceability of a claim. If a third party were to
prevail on a legal assertion of invalidity and/or unenforceability,
we would lose at least part, and perhaps all, of the patent
protection on our product candidates. Such loss of patent
protection could have a material adverse impact on our
business.
In addition to patents, we also rely on trade
secrets and proprietary know-how. Although we take measures to
protect this information by entering into confidentiality and
inventions agreements with our employees and some, but not all, of
our scientific advisors, consultants, and collaborators. However,
we cannot provide any assurances that these agreements will not be
breached, that we will be able to protect ourselves from the
harmful effects of disclosure or dispute ownership if they are
breached, or that our trade secrets will not otherwise become known
or be independently discovered by competitors. If any of these
events occurs, or we otherwise lose protection for our trade
secrets or proprietary know-how, the value of our intellectual
property may be greatly
reduced.
Ongoing and future intellectual property disputes could require us
to spend time and money to address such disputes and could limit
our intellectual property rights.
The biotechnology and pharmaceutical industries
have been characterized by extensive litigation regarding patents
and other intellectual property rights, and companies have employed
intellectual property litigation to gain a competitive advantage.
We may initiate or become subject to infringement claims or
litigation arising out of patents and pending applications of our
competitors, or we may become subject to proceedings initiated by
our competitors or other third parties or the PTO or applicable
foreign bodies to reexamine the patentability of our licensed or
owned patents. In addition, litigation may be necessary to enforce
our issued patents, to protect our trade secrets and know-how, or
to determine the enforceability, scope, and validity of the
proprietary rights of others.
We initiated court proceedings in Germany for
patent infringement and unfair use of our proprietary information
related to Neutrolin (as described below). We also have had
opposition proceedings brought against the European Patent and the
German utility model patent which are the basis of our infringement
proceedings (as described below). The defense and prosecution of
these ongoing and any future intellectual property suits, PTO or
foreign proceedings, and related legal and administrative
proceedings are costly and time-consuming to pursue, and their
outcome is uncertain. An adverse determination in litigation or PTO
or foreign proceedings to which we may become a party could subject
us to significant liabilities, including damages, require us to
obtain licenses from third parties, restrict or prevent us from
selling our products in certain markets, or invalidate or render
unenforceable our licensed or owned patents. Although patent and
intellectual property disputes might be settled through licensing
or similar arrangements, the costs associated with such
arrangements may be substantial and could include our paying large
fixed payments and ongoing royalties. Furthermore, the necessary
licenses may not be available on satisfactory terms or at
all.
On
September 9, 2014, we filed in the District Court of Mannheim,
Germany a patent infringement action against TauroPharm GmbH and
Tauro-Implant GmbH as well as their respective CEOs (the
“Defendants”) claiming infringement of our European
Patent EP 1 814 562 B1, which was granted by the EPO on January 8,
2014 (the “Prosl European Patent”). The Prosl European
Patent covers a low dose heparin catheter lock solution for
maintaining patency and preventing infection in a hemodialysis
catheter. In this action, we claim that the Defendants
infringe on the Prosl European Patent by manufacturing and
distributing catheter locking solutions to the extent they are
covered by the claims of the Prosl European Patent. We
believe that our patent is sound, and are seeking injunctive relief
and raising claims for information, rendering of accounts, calling
back, destruction and damages. Separately, TauroPharm has filed an
opposition with the EPO against the Prosl European Patent alleging
that it lacks novelty and inventive step. We cannot
predict what other defenses the Defendants may raise, or the
ultimate outcome of either of these related
matters.
In the
same complaint against the same Defendants, we also alleged an
infringement (requesting the same remedies) of NDP’s utility
model DE 20 2005 022 124 U1 (the “Utility Model”),
which we believe is fundamentally identical to the Prosl European
Patent in its
main
aspects and
claims. The Court separated the two proceedings and the Prosl
European Patent and the Utility Model claims are now being tried
separately. TauroPharm has filed a cancellation action
against the Utility Model before the German Patent and Trademark
Office (the “German PTO”) based on the similar
arguments as those in the opposition against the Prosl European
Patent.
On
March 27, 2015, the District Court held a hearing to evaluate
whether the Utility Model has been infringed by TauroPharm in
connection with the manufacture, sale and distribution of its
TauroLock-HEP100TM and TauroLock-HEP500TM products. A
hearing
before the same court was held on
January 30, 2015 on the separate, but related, question of
infringement of the Prosl European Patent by
TauroPharm.
The
Court issued its decisions on May 8, 2015, staying both
proceedings. In its decisions, the Court found that the
commercialization by TauroPharm in Germany of its TauroLock
catheter lock solutions Hep100 and Hep500 infringes both the
Prosl European Patent and the Utility Model and further that there
is no prior use right that would allow TauroPharm to
continue
to make, use or sell its product
in Germany. However, the Court declined to issue an injunction in
favor of us that would preclude the continued commercialization by
TauroPharm based upon its finding that there is a sufficient
likelihood that the EPO, in the case of the Prosl European Patent,
or the German PTO, in the case of the Utility Model, may find that
such patent or utility model is invalid. Specifically, the Court
noted the possible publication of certain instructions for
product use that may be deemed to constitute prior art. As such,
the District Court determined that it will defer any consideration
of the request by us for injunctive and other relief until such
time as the EPO or the German PTO has ruled on the underlying
validity of the Prosl European Patent and the Utility
Model.
The
opposition proceeding against the Prosl European Patent before the
EPO is ongoing. In its preliminary consideration of the matter, the
EPO (and the German PTO) regarded the patent as not inventive or
novel due to publication of prior art. Oral proceedings
before the Opposition Division at the EPO were held on November 25,
2015, at which the three judge patent examiner panel considered
arguments related to the validity of the Prosl European Patent. The
hearing was adjourned due to the fact that the panel was of the
view that Claus Herdeis, one of the managing directors of
TauroPharm, has to be heard as a witness in a further hearing in
order to close some gaps in the documentation presented by
TauroPharm as regards the publication of prior art.
The
German PTO held a hearing in the validity proceedings relating to
the Utility Model on June 29, 2016, at which the panel affirmed its
preliminary finding that the Utility Model was invalid based upon
prior publication of a reference to the benefits that may be
associated with adding heparin to a taurolidine based solution. The
decision is subject to appeal and has only a
declaratory
effect, as the Utility Model
had expired in November 2015. Furthermore, it has no bearing on the
ongoing consideration of the validity and possible infringement of
the Prosl Patent by the EPO. We filed an appeal against the ruling
on September 7, 2016.
In
October 2016, TauroPharm submitted a further writ to the EPO
requesting a date for the hearing and bringing forward further
arguments, in particular in view of the June 2016 decision of the
German PTO on the invalidity of the utility model, which we have
appealed. On November 22, 2017, the EPO in Munich, Germany, held a
further oral hearing in this matter. At the hearing, the panel held
that the Prosl European Patent would be invalidated because it did
not meet the requirements of novelty based on a technical aspect of
the European intellectual property law. We disagree with this
decision and plan to appeal. Our appeal will be based, in part, on
the written opinion to be issued by the Opposition Division, which
is expected by the first quarter 2018. We continue to believe that
the Prosl European Patent is indeed novel and that its validity
should be maintained. There can be no assurance that we will
prevail in this matter.
In addition,
the ongoing Unfair Competition litigation against TauroPharm is not
affected and will continue.
On
January 16, 2015, we filed a complaint against TauroPharm GmbH and
its managing directors in the District Court of Cologne,
Germany. In the complaint, we allege violation of the
German Unfair Competition Act by TauroPharm for the unauthorized
use of its proprietary information obtained in confidence by
TauroPharm. We allege that TauroPharm is improperly and
unfairly
using its proprietary
information relating to the composition and manufacture of
Neutrolin, in the manufacture and sale of TauroPharm’s
products TauroLockTM, TauroLock-HEP100 and
TauroLock-HEP500. We seek a cease and desist order
against TauroPharm from continuing to manufacture and sell any
product containing taurolidine (the active pharmaceutical
ingredient (“API”) of Neutrolin) and citric acid in
addition to possible other components, damages for any sales in the
past and the removal of all such products from the market. An
initial hearing in the District Court of Cologne, Germany was held
on November 19, 2015 to consider our claims. The judge made no
decision on the merits of our complaint. On January 14, 2016,
the court issued an interim decision in the form of a court order
outlining several issues of concern that relate primarily to
court's interest in clarifying the facts and reviewing any and all
available documentation, in particular with regard to the question
which specific know-how was provided to TauroPharm by whom and
when. We have prepared the requested reply and produced the
respective documentation. TauroPharm has also filed another writ
within the same deadline and both parties have filed further writs
at the end of April setting out their respective argumentation in
more detail. A further oral hearing in this matter was held on
November 15, 2016. In this hearing, the court heard arguments from
us and TauroPharm concerning the allegations of unfair competition.
The court made no rulings from the bench, and indicated that it is
prepared to further examine the underlying facts of our
allegations. On March 7, 2017, the court issued another interim
decision in the form of a court order outlining again several
issues relating to the argumentation of both sides in the
proceedings. In particular the court requested us to further
specify our requests and to further substantiate in even more
detail which know know-how was provided by Biolink to TauroPharm by
whom and when. The court also raised the question whether the
know-how provided at the time to TauroPharm could still be
considered to be secret know-how or may have become public in the
meantime. The court granted both sides the opportunity to reply to
this court order and provide additional facts and evidence until
May 15, 2017. Both parties have submitted further writs in this
matter and the court had scheduled a further hearing for May 8,
2018.
After having been rescheduled
several times, the hearing is now scheduled to take place on
November 20, 2018.
We intend to continue to pursue this
matter, and to provide additional supplemental documentary and
other evidence as may be necessary to support our
claims.
If we infringe the rights of third parties we could be prevented
from selling products and forced to pay damages and defend against
litigation.
If our products, methods, processes and other
technologies infringe the proprietary rights of other parties, we
could incur
substantial
costs
and we may have to do one or more of the
following:
●
obtain licenses, which may not be
available
on commercially reasonable terms, if
at all;
●
abandon an infringing product
candidate
;
●
redesign
our products or processes to avoid infringement;
●
stop using the subject matter claimed
in
the patents held by
others;
●
defend litigation
or
administrative proceedings, which may be costly
whether we win or lose, and which could result in a substantial
diversion of our financial and management
resources.
Risks Related to Dependence on Third Parties
If we are not able to develop and maintain collaborative marketing
relationships with licensees or partners, or create an effective
sales, marketing, and distribution capability, we may be unable to
market our products or market them
successfully.
Our business strategy for Neutrolin relies on
collaborating with larger firms with experience in marketing and
selling medical devices and pharmaceutical products; for other
products we may also rely on such marketing collaborations or
out-licensing of our product candidates. Specifically, for
Neutrolin we have a distributor agreement with each of a Saudi
Arabian, an Emirati and a South Korean company for sales and
marketing (upon receipt of approval to market in South Korea). In
April 2017, we announced a commercial collaboration with Hemotech
SAS covering France and certain overseas territories. Assuming we
receive applicable regulatory approval for other markets, we plan
to enter into distribution agreements with one or more third
parties for the sale of Neutrolin in various European, Middle East
and other markets. However, there can be no assurance that we will
be able to successfully maintain those relationships or establish
and maintain additional marketing, sales, or distribution
relationships, nor can there be assurance that such relationships
will be successful, or that we will be successful in gaining market
acceptance for our products. To the extent that we enter into any
marketing, sales, or distribution arrangements with third parties,
our product revenues will be lower than if we marketed and sold our
products directly, and any revenues we receive will depend upon the
efforts of such third-parties.
If
we are unable to establish and maintain such third-party sales and
marketing relationships, or choose not to do so, we will have to
establish our own in-house capabilities. We currently have no
sales, marketing, or distribution infrastructure. To market any of
our products directly, we would need to develop a marketing, sales,
and distribution force that has both technical expertise and the
ability to support a distribution capability. The establishment of
a marketing, sales, and distribution capability would take time and
significantly increase our costs, possibly requiring substantial
additional capital. In addition, there is intense competition for
proficient sales and marketing personnel, and we may not be able to
attract individuals who have the qualifications necessary to
market, sell, and distribute our products. There can be no
assurance that we will be able to establish internal marketing,
sales, or distribution capabilities. If we are unable to, or choose
not to establish these capabilities, or if the capabilities we
establish are not sufficient to meet our needs, we will be required
to establish collaborative marketing, sales, or distribution
relationships with third parties, which we might not be able to do
on acceptable terms or at all.
We currently have no internal marketing and sales organization and
currently rely and intend to continue to rely on third parties to
market
and
sell Neutrolin.
If we are unable to enter into or maintain agreements with third
parties to market and sell Neutrolin or any other product after
approval or are unable to establish our own marketing and sales
capabilities, we may not be able to generate significant or any
product revenues.
We do
not have an internal sales organization. To date we have relied,
and intend to continue to rely, on third parties for the marketing,
sales and distribution of Neutrolin and any other product we might
develop. However, we may not be able to maintain current and future
arrangements or enter into new arrangements with third parties to
sell Neutrolin or any other product on favorable terms or at all.
In that event, we would have to develop our own marketing and sales
force. The establishment and development of our own sales force
would be expensive and time consuming and could delay any
product
launch, and we cannot
be certain that we would be able to successfully develop this
capability. In addition, the use of third parties to commercialize
our approved products reduces the revenues that we would receive if
we commercialized these products ourselves.
We have
entered into agreements with independent companies to market
Neutrolin in Saudi Arabia, the United Arab Emirates and France,
and, upon regulatory approval, South Korea. We may seek a sales
partner in the U.S. if Neutrolin receives FDA approval.
Consequently, we will be dependent on these firms and individuals
for the success of sales in these and any other countries in which
approval is granted. If these firms or individuals do not perform
for whatever reason, our business,
prospects
and results of operations may be
materially adversely affected. Finding a new or replacement
organization for sales and marketing could be difficult, which
would further harm our business, prospects and results of
operations.
If we or our collaborators are unable to manufacture our products
in sufficient quantities or are unable to obtain regulatory
approvals for a manufacturing facility, we may be unable to meet
demand for our products and we may lose potential
revenues.
Completion of our clinical trials and
commercialization of Neutrolin and any other product candidate
require access to, or development of, facilities to manufacture a
sufficient supply of our product candidates. All of our
manufacturing processes currently are, and we expect them to
continue to be, outsourced to third parties. Specifically, we will
rely on one or more manufacturers to supply us and/or our
distribution partners with commercial quantities of Neutrolin. If,
for any reason, we become unable to rely on our current sources for
the manufacture of Neutrolin or any other product candidates or for
active pharmaceutical ingredient, or API, either for clinical
trials or for commercial quantities, then we would need to identify
and contract with additional or replacement third-party
manufacturers to manufacture compounds for pre-clinical, clinical,
and commercial purposes. We may not be successful in identifying
such additional or replacement third-party manufacturers, or in
negotiating acceptable terms with any that we do identify. Such
third-party manufacturers must receive FDA or applicable foreign
approval before they can produce clinical material or commercial
product, and any that are identified may not receive such approval
or may fail to maintain such approval. In addition, we may be in
competition with other companies for access to these
manufacturers’ facilities and may be subject to delays in
manufacturing if the manufacturers give other clients higher
priority than they give to us. If we are unable to secure and
maintain third-party manufacturing capacity, the development and
sales of our products and our financial performance may be
materially affected.
Before we could begin to commercially manufacture
Neutrolin or any other product candidate on our own, we must obtain
regulatory approval of the manufacturing facility and process. The
manufacture of drugs for clinical and commercial purposes must
comply with cGMP and applicable non-U.S. regulatory requirements.
The cGMP requirements govern quality control and documentation
policies and procedures. Complying with cGMP and non-U.S.
regulatory requirements would require that we expend time, money,
and effort in production, recordkeeping, and quality control to
assure that the product meets applicable specifications and other
requirements. We would also have to pass a pre-approval inspection
prior to FDA or non-U.S. regulatory agency approval. Failure to
pass a pre-approval inspection may significantly delay regulatory
approval of our products. If we fail to comply with these
requirements, we would be subject to possible regulatory action and
may be limited in the jurisdictions in which we are permitted to
sell our products. As a result, our business, financial condition,
and results of operations could be materially adversely
affected.
Corporate and academic collaborators may take actions that delay,
prevent, or undermine the success of our
products.
Our operating and financial strategy for the
development, clinical testing, manufacture, and commercialization
of our product candidates is heavily dependent on our entering into
collaborations with corporations, academic institutions, licensors,
licensees, and other parties. Our current strategy assumes that we
will successfully establish and maintain these collaborations or
similar relationships. However, there can be no assurance that we
will be successful establishing or maintaining such collaborations.
Some of our existing collaborations, such as our licensing
agreements, are, and future collaborations may be, terminable at
the sole discretion of the collaborator in certain circumstances.
Replacement collaborators might not be available on attractive
terms, or at all.
In addition, the activities of any collaborator
will not be within our control and may not be within our power to
influence. There can be no assurance that any collaborator will
perform its obligations to our satisfaction or at all, that we will
derive any revenue or profits from such collaborations, or that any
collaborator will not compete with us. If any collaboration is not
pursued, we may require substantially greater capital to undertake
on our own the development and marketing of our product candidates
and may not be able to develop and market such products
successfully, if at all. In addition, a lack of development and
marketing collaborations may lead to significant delays in
introducing product candidates into certain markets and/or reduced
sales of products in such markets.
Data provided by collaborators and others upon which we rely that
has not been independently verified could turn out to be false,
misleading, or incomplete.
We rely on third-party vendors, scientists, and
collaborators to provide us with significant data and other
information related to our projects, clinical trials, and business.
If such third parties provide inaccurate, misleading, or incomplete
data, our business, prospects, and results of operations could be
materially adversely affected.
Risks Related to our Common Stock
Prior to fiscal 2015, we had identified a material weakness in our
internal control over financial reporting, and our current internal
control
over
financial
reporting and our disclosure controls and procedures may not
prevent all possible errors that could
occur.
In the
several years prior to fiscal 2015, we had identified a material
weakness in our internal control over financial reporting that was
related to our limited finance staff and the resulting ineffective
management review over financial reporting, coupled with
increasingly
complex
accounting
treatments associated with our financing activities and European
expansion. While we remediated this material weakness in 2015, we
cannot be certain that material weaknesses will not arise
again.
A
control system, no matter how well designed and operated, can
provide only reasonable, not absolute, assurance that the control
system’s objectives will be satisfied. Internal control over
financial reporting and disclosure controls and procedures are
designed to give a reasonable assurance that they are effective to
achieve their objectives. We cannot provide absolute assurance that
all of our possible future control issues will be detected. These
inherent limitations include the possibility that judgments in our
decision making can be faulty, and that isolated breakdowns can
occur because of simple
human
error or mistake. The design of our system of controls is based in
part upon assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed absolutely
in achieving our stated goals under all potential future or
unforeseeable conditions. Because of the inherent limitations in a
cost-effective control system, misstatements due to error could
occur and not be detected. This and any future failures could cause
investors to lose confidence in our reported financial information,
which could have a negative impact on our financial condition and
stock price.
Our common stock price has fluctuated considerably and is likely to
remain volatile, in part due to the limited market for our common
stock, and you could lose all or a part of your
investment.
During the period from the completion of our
initial public offering, or IPO, on March 30, 2010 through March 6,
2018, the high and low sales prices for our common stock were
$10.40 and $0.15, respectively. There is a limited public market
for our common stock and we cannot provide assurances that an
active trading market will develop or continue. As a result of low
trading volume in our common stock, the purchase or sale of a
relatively small number of shares could result in significant share
price fluctuations.
Additionally, the market price of our common stock
may continue to fluctuate significantly in response to a number of
factors, some of which are beyond our control, including the
following:
●
market acceptance of Neutrolin in those markets
in
which
it is approved for
sale;
●
our need for additional
capital
;
●
the
receipt of or failure to obtain additional regulatory approvals for
Neutrolin, including FDA approval in the U.S.;
●
results of clinical
trials
of our product candidates, including our ongoing
and planned Phase 3 trials for Neutrolin in the U.S., or those of
our competitors;
●
our entry into or the
loss
of a significant
collaboration;
●
regulatory
or legal developments in the United States and other countries,
including changes in the healthcare payment systems;
●
changes in
financial
estimates or investment recommendations by
securities analysts relating to our common
stock;
●
announcements
by our competitors of significant developments, strategic
partnerships, joint ventures or capital commitments;
●
changes in key
personnel
;
●
variations in our
financial
results or those of companies that are perceived
to be similar to us;
●
market conditions in the
pharmaceutical
and medical device sectors and
issuance of new or changed securities analysts’ reports or
recommendations;
●
general economic,
industry
and market conditions;
●
developments
or disputes concerning patents or other proprietary
rights;
●
future sales or
anticipated
sales of our securities by us or our stockholders;
and
●
any other factors
described
in this “Risk Factors”
section.
In addition, the stock markets in general, and the
stock of pharmaceutical and medical device companies in particular,
have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating
performance of these companies. Broad market and industry factors
may negatively affect the market price of our common stock,
regardless of our actual operating
performance.
For these reasons and others, an investment in our
securities is risky and you should invest only if you can withstand
a significant loss and wide fluctuations in the value of your
investment.
A significant number of additional shares of our common stock may
be issued at a later date, and their sale could depress the market
price of our common stock.
As of December 31, 2017, we had outstanding the
following securities that are convertible into or exercisable for
shares of our common stock:
●
warrants
for 227,273 shares of common stock issued in July 2013 with an
exercise price of $1.50 that expire on July 30, 2018;
●
warrants
for 500,000 shares of common stock issued in May 2013 with an
exercise price of $0.65 per share that expire on May 30,
2019;
●
warrants for 125,000 shares
issued
to ND Partners in April 2013 in
connection with the amendment to the license and assignment
agreement with an exercise price of $1.50 per share that expire on
April 11, 2018;
●
options to purchase an aggregate of 120,000 shares
of our common stock issued to our officers, directors, employees
and non-employee consultants
under
our Amended and Restated 2006 Stock Incentive
Plan, or the 2006 Stock Plan, with a weighted average exercise
price of $1.44 per share;
●
options
to purchase an aggregate of 4,842,795 shares of our common stock
issued to our officers, directors and non-employee consultants
under our 2013 Stock Plan, with a weighted average exercise price
of $2.05 per share;
●
a warrant to
purchase
400,000 shares of our common stock issued on
February 19, 2013 with an exercise price of $1.50 that expire on
February 19, 2018;
●
warrants
for 750,000 shares of common stock with an exercise price of $0.90
that expire on October 22, 2019;
●
warrants for 725,000
shares
of common stock with an exercise price of $0.90
that expire on January 8, 2020;
●
150,000 shares of
Series C-2 Preferred Stock, which are convertible into 1,500,000
shares of common stock;
●
104,000 shares of
Series C-3 Preferred Stock, which are convertible into 1,040,000
shares of common stock;
●
73,962 shares of
Series D Preferred Stock, which are convertible into 1,479,240
shares of common stock;
●
89,623 shares of
Series E Preferred Stock, which are convertible into 1,959,759
shares of common stock;
●
2,000 shares of
Series F Preferred Stock, which are convertible into 3,157,562
shares of common stock, subject to adjustment;
●
warrants for
682,500 shares of common stock issued in March 2014 with an
exercise price of $2.50 per shares that expire on September 10,
2019;
●
warrants for
200,000 shares of common stock with an exercise price of $7.00 that
expire on March 3, 2020;
●
warrants for 83,400
shares of common stock with an exercise price of $7.00 that expire
on March 25, 2020;
●
Series A warrants
for 4,078,226 shares of common stock with an exercise price of
$0.75 that expire on September 10, 2018;
●
Series B warrants
for 13,964,476 shares of common stock with an exercise price of
$1.05 that expire on August 10, 2022;
●
underwriter
warrants for 1,117,158 shares of common stock with an exercise
price of $0.9375 that expire on August 10, 2022;
●
warrants for
564,858 shares of common stock with an exercise price of $0.001
that expire on November 16, 2020; and
●
restricted stock
units for 66,414 shares of common stock with an average grant date
fair value of $2.08 per share.
The possibility of the issuance of these shares,
as well as the actual sale of such shares, could substantially
reduce the market price for our common stock and impede our ability
to obtain future financing.
We will need additional financing to fund our activities in the
future, which likely will dilute our
stockholders.
To
date, our commercial operations have not generated sufficient
revenues to enable profitability. As of September 30, 2017, we had
an accumulated deficit of approximately $141.9 million, and
incurred net losses from operations of $22.7 million for the nine
months then
ended
. Based on the
current development plans for Neutrolin in both the U.S. and
foreign markets (including the ongoing hemodialysis Phase 3
clinical trial in the U.S.) and our other operating requirements,
management believes that our existing cash and short-term
investments at September 30, 2017 will fund our operations into the
second quarter of 2018 after taking into consideration the net
proceeds received through February 2018 from sales of common stock
under our at the market common stock sales program and the proceeds
from the November 2017 financing with Elliott. We will need
additional funding to complete the LOCK-IT-100 hemodialysis
clinical trial in the U.S. which commenced in December 2015 as well
as to initiate the second Phase 3 clinical trial that will be
required in order to file an NDA with the FDA.
Further, we anticipate that we will incur
operating losses for the foreseeable future. Additionally, we will
require substantial funds in the future to support our operations.
We expect to seek equity or debt financings in the future to fund
our operations. The issuance of additional equity securities, or
convertible debt or other derivative securities, likely will dilute
some if not all of our then existing stockholders, depending on the
financing terms.
Future sales and issuances of our equity securities or rights to
purchase our equity securities, including pursuant to equity
incentive plans, would result in additional dilution of the
percentage ownership of our stockholders and could cause our stock
price to fall.
To the extent we raise additional capital by
issuing equity securities, our stockholders may experience
substantial dilution. We may, as we have in the past, sell common
stock, convertible securities or other equity securities in
one
or
more transactions at
prices and in a manner we determine from time to time. If we sell
common stock, convertible securities or other equity securities in
more than one transaction, investors may be further diluted by
subsequent sales. Such sales may also result in material dilution
to our existing stockholders, and new investors could gain rights
superior to existing stockholders.
Pursuant to our 2013 Stock Plan, our Board of
Directors is authorized to award up to a total of 11,000,000 shares
of common stock or options to purchase shares of common stock to
our officers, directors, employees and non-employee consultants. As
of December 31, 2017, options to purchase 120,000 shares of common
stock issued under our 2006 Stock Plan at a weighted average
exercise price of $1.44 per share, and options to purchase
4,842,495 shares of common stock issued under our 2013 Stock Plan
at a weighted average exercise price of $2.05 per share were
outstanding. In addition, at December 31, 2017, there were
outstanding warrants to purchase an aggregate of 23,417,891 shares
of our common stock at prices ranging from $0.001 to $7.00, and
shares of our outstanding Series C-2, C-3, D, E and F preferred
stock convertible into an aggregate of 9,136,560 shares of our
common stock. Stockholders will experience dilution in the event
that additional shares of common stock are issued under our 2006
Stock Plan or 2013 Stock Plan, or options issued under our 2006
Stock Plan or 2013 Stock Plan are exercised, or any warrants are
exercised for, or preferred stock shares are converted to, common
stock.
Provisions in our corporate charter documents and under Delaware
law could make an acquisition of us, which may be beneficial to our
stockholders, more difficult.
Provisions in our Amended and Restated Certificate
of Incorporation, as amended, and our Amended and Restated Bylaws,
as well as provisions of the General Corporation Law of the State
of Delaware, or DGCL, may discourage, delay or prevent a merger,
acquisition or other change in control of our company, even if such
a change in control would be beneficial to our stockholders. These
provisions include the following:
●
authorizing
the issuance of “blank check” preferred stock, the
terms of which may be established and shares of which may be issued
without stockholder approval;
●
prohibiting our stockholders
from
fixing the number of our directors;
and
●
establishing advance notice
requirements
for stockholder proposals that can be
acted on at stockholder meetings and nominations to our Board of
Directors.
These provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace
members of our board of directors, which is responsible for
appointing the members of our management. In addition, we are
subject to Section 203 of the DGCL, which generally prohibits a
Delaware corporation from engaging in any of a broad range of
business combinations with an interested stockholder for a period
of three years following the date on which the stockholder became
an interested stockholder, unless such transactions are approved by
the board of directors. This provision could have the effect of
discouraging, delaying or preventing someone from acquiring us or
merging with us, whether or not it is desired by, or beneficial to,
our stockholders. Any provision of our Amended and Restated
Certificate of Incorporation, as amended, or Amended and Restated
Bylaws or Delaware law that has the effect of delaying or deterring
a change in control could limit the opportunity for our
stockholders to receive a premium for their shares of our common
stock and could also affect the price that some investors are
willing to pay for our common
stock.
If we fail to comply with the continued listing standards of the
NYSE American, it may result in a delisting of our common stock
from the exchange.
Our
common stock is currently listed for trading on the NYSE American,
and the continued listing of our common stock on the NYSE American
is subject to our compliance with a number of listing standards.
These listing standards include the requirement for avoiding
sustained
losses and
maintaining a minimum level of stockholders’
equity. In 2012 and 2014, we received notices from the
NYSE American that we did not meet continued listing standards of
the NYSE American as set forth in Part 10 of the Company
Guide. Specifically, we were not in compliance with
Section 1003(a)(i) and Section 1003(a)(ii) of the Company Guide
because we reported stockholders’ equity of less than the
required amounts. As a result, we became subject to the
procedures and requirements of Section 1009 of the Company Guide
and were subject to possible delisting. In March 2015, we regained
compliance with the NYSE American listing requirements due to our
market capitalization, pursuant to Section 1003(a) of the Company
Guide. However, there can be no assurance that we will continue to
meet the continued listing standards of the NYSE
American.
If our common stock were no longer listed on the
NYSE American, investors might only be able to trade on one of the
over-the-counter markets, including the OTC Bulletin Board
®
or in the Pink Sheets
®
(a
quotation medium operated by Pink Sheets LLC). This would impair
the liquidity of our common stock not only in the number of shares
that could be bought and sold at a given price, which might be
depressed by the relative illiquidity, but also through delays in
the timing of transactions and reduction in media
coverage.
Because the average daily trading volume of our common stock has
been low historically, the ability to sell our shares in the
secondary trading market may be limited.
Because the average daily trading volume of our
common stock on the NYSE American has been low historically, the
liquidity of our common stock may be impaired. As a result, prices
for shares of our common stock may be lower than might otherwise
prevail if the average daily trading volume of our common stock was
higher. The average daily trading volume of our common stock may be
low relative to the stocks of other exchange-listed companies,
which could limit investors’ ability to sell shares in the
secondary trading market.
Penny stock regulations may impose certain restrictions on
marketability of our securities.
The SEC has adopted regulations which generally
define a “penny stock” to be any equity security that
has a market price of less than $5.00 per share or an exercise
price of less than $5.00 per share, subject to certain exceptions.
A security listed on a national securities exchange is exempt from
the definition of a penny stock. Our common stock is listed on the
NYSE American and so is not considered a penny stock. However, if
we fail to maintain our common stock’s listing on the NYSE
American, our common stock would be considered a penny stock. In
that event, our common stock would be subject to rules that impose
additional sales practice requirements on broker-dealers who sell
such securities to persons other than established customers and
accredited investors (generally those with assets in excess of
$1,000,000 or annual income exceeding $200,000, or $300,000
together with their spouse). For transactions covered by such
rules, the broker-dealer must make a special suitability
determination for the purchase of such securities and have received
the purchaser’s written consent to the transaction prior to
the purchase. Additionally, for any transaction involving a penny
stock, unless exempt, the rules require the delivery, prior to the
transaction, of a risk disclosure document mandated by the SEC
relating to the penny stock market. The broker-dealer must also
disclose the commission payable to both the broker-dealer and the
registered representative, current quotations for the securities
and, if the broker-dealer is the sole market maker, the
broker-dealer must disclose this fact and the broker-dealer’s
presumed control over the market. Finally, monthly statements must
be sent disclosing recent price information for the penny stock
held in the account and information on the limited market in penny
stocks. Broker-dealers must wait two business days after providing
buyers with disclosure materials regarding a security before
effecting a transaction in such security. Consequently, the
“penny stock” rules restrict the ability of
broker-dealers to sell our securities and affect the ability of
investors to sell our securities in the secondary market and the
price at which such purchasers can sell any such securities,
thereby affecting the liquidity of the market for our common
stock.
Stockholders should be aware that, according to
the SEC, the market for penny stocks has suffered in recent years
from patterns of fraud and abuse. Such patterns
include:
●
control of the market for the security
by
one or more broker-dealers that are
often related to the promoter or issuer;
●
manipulation of prices through
prearranged
matching of purchases and sales and
false and misleading press releases;
●
“boiler room” practices
involving
high
pressure sales
tactics and unrealistic price projections by inexperienced sales
persons;
●
excessive and undisclosed bid-ask
differentials
and markups by selling
broker-dealers; and
●
the
wholesale dumping of the same securities by promoters and
broker-dealers after prices have been manipulated to a desired
level, along with the inevitable collapse of those prices with
consequent investor losses.
We do not intend to pay dividends on our common stock so any
returns on our common stock will be limited to the value of our
common stock.
We
have never declared dividends on our common stock, and currently do
not plan to declare dividends on shares of our common stock in the
foreseeable future. Pursuant to the terms of our Series D, E and F
Non-Voting Convertible Preferred Stock, we may not declare or pay
any dividends or make any distributions on any of our shares or
other equity securities as long as any of those preferred shares
remain outstanding. We currently expect to retain future earnings,
if any, for use in the operation and expansion of our business. The
payment of cash dividends in the future, if any, will be at the
discretion of our board of directors and will depend upon such
factors as earnings levels, capital requirements, our overall
financial condition and any other factors deemed relevant by our
board of directors. Any return to holders of our common stock will
be limited to the value of their common stock.
Additional Risks Related to This Offering
Management will have broad discretion as to the use of the proceeds
from this offering, and may not use the proceeds
effectively.
Because
we have not designated the amount of net proceeds from this
offering to be used for any particular purpose, our management will
have broad discretion as to the application of the net proceeds
from this offering and could use them for purposes other than those
contemplated at the time of the offering. Our management may use
the net proceeds for corporate purposes that may not improve our
financial condition or market value. The failure by management to
apply these funds effectively could result in financial losses that
could have a material adverse effect on our business, cause the
price of our common stock to decline and delay the development and
commercialization of our product candidates.
You may experience immediate and substantial dilution.
The
offering price per share in this offering may exceed the net
tangible book value per share of our common stock outstanding prior
to this offering. Assuming that an aggregate of 48,620,689
shares of our common stock are sold during the term of the sales
agreement with B. Riley FBR at a price of $0.29 per share, the last
reported sale price of our common stock on the NYSE American on
March 6, 2018, for aggregate gross proceeds of $14.1 million, after
deducting commissions and estimated aggregate offering expenses
payable by us, you will experience immediate dilution of $0.0799
per share, representing the
difference between our as-adjusted net tangible book value per
share as of September 30, 2017, after giving effect to this
offering and the assumed offering price. The exercise of
outstanding stock options and warrants may result in further
dilution of your investment. See the section entitled
“Dilution” below for a more detailed illustration of
the dilution you would incur if you participate in this
offering.
You may experience future dilution as a result of future equity
offerings.
We will
need significant additional funds to complete the U.S development
of Neutrolin. In order to raise additional capital, we plan to
offer in the future additional shares of our common stock or other
securities convertible into or exchangeable for our common stock at
prices that may not be the same as the price per share in this
offering. We may sell shares or other securities in any other
offering at a price per share that is less than the price per share
paid by investors in this offering, and investors purchasing shares
or other securities in the future could have rights superior to
existing stockholders. The price per share at which we sell
additional shares of our common stock, or securities convertible or
exchangeable into common stock, in future transactions may be
higher or lower than the price per share paid by investors in this
offering.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The
SEC encourages companies to disclose forward-looking information so
that investors can better understand a company’s future
prospects and make informed investment decisions. This prospectus,
any applicable prospectus supplement and the documents we have
filed with the SEC that are incorporated herein and therein by
reference contain such “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995.
Words such as “may,”
“might,” “should,”
“anticipate,” “estimate,”
“expect,” “projects,”
“intends,” “plans,” “believes”
and words and terms of similar substance used in connection with
any discussion of future operating or financial performance,
identify forward-looking statements. Forward-looking statements
represent management’s current judgment regarding future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially from those
described in the forward-looking statements. These risks include,
but are not limited to:
the cost, timing and results of the
planned and ongoing Phase 3 trials for Neutrolin® in the U.S.,
including variances in the expected rate of catheter-related
bloodstream infection events and the resources needed to commence
and complete those trials; the risks and uncertainties associated
with CorMedix’s ability to manage its limited cash resources;
CorMedix’s ability to continue as a going concern;
CorMedix’s ability to obtain financing to support its
research and development and clinical activities and operations;
CorMedix’s ability to gain alignment with the FDA on proposed
protocol changes its LOCK-IT 100 trial; later developments with the
FDA that may be inconsistent with the FDA’s acceptance of
interim analyses of the LOCK-IT 100 trial; obtaining regulatory
approvals to conduct clinical trials and to commercialize
CorMedix’s product candidates, including the planned second
Phase 3 trial of Neutrolin and the marketing of Neutrolin in
countries other than Europe; the outcome of clinical trials of
CorMedix’s product candidates and whether they demonstrate
these candidates’ safety and effectiveness; the risks
associated with the launch of Neutrolin in new markets;
CorMedix’s ability to enter into, execute upon and maintain
collaborations with third parties for its development and marketing
programs; CorMedix’s dependence on its collaborations and its
license relationships; CorMedix’s ability to maintain its
listing on the NYSE American; achieving milestones under
CorMedix’s collaborations; CorMedix’s dependence on
preclinical and clinical investigators, preclinical and clinical
research organizations, manufacturers, sales and marketing
organizations, and consultants; and protecting the intellectual
property developed by or licensed to CorMedix.
Please also see the discussion of risks and
uncertainties under “Risk Factors” above and otherwise
incorporated by reference herein, and in our most recent annual
report on Form 10-K, as revised or supplemented by any of our
subsequently filed quarterly reports on Form 10-Q, as well as
any amendments thereto, as filed with the SEC and which are
incorporated herein by reference.
In
light of these assumptions, risks and uncertainties, the results
and events discussed in the forward-looking statements contained in
this prospectus, any applicable prospectus supplement or in any
document incorporated herein or therein by reference might not
occur. Investors are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the respective
dates of this prospectus or any applicable prospectus supplement or
the date of the document incorporated by reference in this
prospectus or any applicable prospectus supplement. We are not
under any obligation, and we expressly disclaim any obligation, to
update or alter any forward-looking statements, whether as a result
of new information, future events or otherwise. All subsequent
forward-looking statements attributable to us or to any person
acting on our behalf are expressly qualified in their entirety by
the cautionary statements contained or referred to in this
section.
USE OF PROCEEDS
We
currently intend to use the net proceeds from this offering, if
any, for general corporate purposes, including clinical trials,
research and development expenses, and general and administrative
expenses.
The
amounts and timing of our use of the net proceeds from this
offering will depend on a number of factors, such as the timing and
progress of our research and development efforts, the timing and
progress of any collaborative or strategic partnering efforts, and
the competitive environment for our planned products. As of the
date of this prospectus, we cannot specify with certainty all of
the particular uses for the net proceeds to us from this offering.
Accordingly, our management will have broad discretion in the
timing and application of these proceeds. Pending application of
the net proceeds as described above, we intend to temporarily
invest the proceeds in short-term, interest-bearing
instruments.
DILUTION
Our net tangible book value as of September 30,
2017 was approximately $9,767,292, or $0.1561
per share of common stock. Net tangible book value
per share is calculated by subtracting our total liabilities from
our total tangible assets, which is total assets less intangible
assets, and dividing this amount by the number of shares of common
stock outstanding. After giving effect to the sale by us of the
full $14.1 million of common stock that may be offered in this
offering at an assumed offering price of $0.29 per share, which was
the closing price of our common stock on the NYSE American on March
6, 2018, and after deducting estimated offering commissions and
expenses payable by us, our as-adjusted net tangible book value as
of September 30, 2017 would have been approximately $23,241,292, or
$0.2101
per share of common stock. This represents an
immediate increase in the net tangible book value of $0.054 per
share to our existing stockholders and an immediate and substantial
dilution in net tangible book value of $0.0799
per share to new investors. The following table
illustrates this hypothetical per share
dilution:
Assumed public
offering price per share
|
|
$
0.29
|
Net tangible book
value per share as of September 30, 2017
|
$
0.1561
|
|
Increase in net
tangible book value per share attributable to this
offering
|
$
0.054
|
|
As adjusted net
tangible book value per share as of September 30, 2017, after
giving effect to this offering
|
|
$
0.2101
|
Dilution per share
to new investors purchasing shares in this offering
|
|
$
0.0799
|
The table above assumes for illustrative purposes
that an aggregate of 48,620,689 shares of our common stock are sold
at a price of $0.29
per share, the last reported sale price of our
common stock on the NYSE American on March 6, 2018, for aggregate
gross proceeds of $14.1 million. The shares sold in this offering,
if any, will be sold from time to time at various prices. An
increase of $0.07
per share in the price at which the shares are
sold from the assumed offering price of $0.29 per share shown in
the table above, assuming all of our common stock in the aggregate
amount of $14.1 million
is sold at that price, would increase our adjusted
net tangible book value per share after the offering to $0.2304 per
share and would increase the dilution in net tangible book value
per share to new investors in this offering to $
0.1321
per share, after deducting
commissions and estimated aggregate offering expenses payable by
us. A decrease of $0.07 per share in the price at which the shares
are sold from the assumed offering price of $0.29 per share shown
in the table above, assuming all of our common stock in the
aggregate amount of $14.1 million is sold at that price, would
decrease our adjusted net tangible book value per share after the
offering to $0.1833
per share and would decrease the dilution in net
tangible book value per share to new investors in this offering to
$0.0342 per share, after deducting commissions and estimated
aggregate offering expenses payable by us. This information is
supplied for illustrative purposes only.
To
the extent that any outstanding options or warrants are exercised,
new options are issued under our 2006 Stock Incentive Plan or our
2013 Stock Incentive Plan or we otherwise issue additional shares
of common stock in the future, there will be further dilution to
new investors.
The
above discussion and table are based on 61,978,609 shares of our
common stock outstanding as of September 30, 2017 and excludes the
following securities outstanding on September 30,
2017:
●
warrants
for 227,273 shares of common stock issued in July 2013 with an
exercise price of $1.50 that expire on July 30, 2018;
●
warrants
for 500,000 shares of common stock issued in May 2013 with an
exercise price of $0.65 per share that expire on May 30,
2019;
●
warrants
for 125,000 shares issued to ND Partners in April 2013 in
connection with the amendment to the license and assignment
agreement with an exercise price of $1.50 per share that expire on
April 11, 2018;
●
options
to purchase an aggregate of 120,000 shares of our common stock
issued to our officers, directors, employees and non-employee
consultants under our Amended and Restated 2006 Stock Incentive
Plan, or the 2006 Stock Plan, with a weighted average exercise
price of $1.44 per share;
●
options
to purchase an aggregate of 4,826,429 shares of our common stock
issued to our officers, directors and non-employee consultants
under our 2013 Stock Plan, with a weighted average exercise price
of $2.07 per share;
●
a
warrant to purchase 400,000 shares of our common stock issued on
February 19, 2013 with an exercise price of $1.50 that expire on
February 19, 2018;
●
warrants
for 750,000 shares of common stock with an exercise price of $0.90
that expire on October 22, 2019;
●
warrants
for 725,000 shares of common stock with an exercise price of $0.90
that expire on January 8, 2020;
●
Series C-2
Preferred Stock convertible into 1,500,000 shares of
common;
●
Series C-3
Preferred Stock convertible into 1,365,000 shares of common
stock;
●
Series D Preferred
Stock convertible 1,479,240 shares of common stock;
●
Series E Preferred
Stock convertible 1,959,759 shares of common stock;
●
warrants for
682,500 shares of common stock issued in March 2014 with an
exercise price of $2.50 per shares that expire on September 10,
2019;
●
warrants for
200,000 shares of common stock with an exercise price of $7.00 that
expire on March 3, 2020;
●
warrants for 83,400
shares of common stock with an exercise price of $7.00 that expire
on March 25, 2020;
●
Series A warrants
for 13,964,476 shares of common stock with an exercise price of
$0.75 that expire on September10, 2018 (decreased to 4,414,476
shares at September 30, 2017);
●
Series B warrants
for 13,964,476 shares of common stock with an exercise price of
$1.05 that expire on August 10, 2022;
●
underwriter
warrants for 1,117,158 shares of common stock with an exercise
price of $0.9375 that expire on August 10, 2022; and
●
restricted stock
units for 66,414 shares of common stock with an average grant date
fair value of $2.22 per share.
Also
excluded from the discussion and table above are the following
securities issued after September 30, 2017:
●
warrants
for 564,858 shares of common stock issued on November 16, 2017 with
an exercise price of $0.001;
●
84,061 shares of
common stock issued upon the exchange of 336,251
warrants;
●
5,041,185 shares of
common stock issued in sales under the at the market common stock
sales program;
●
2,000 shares of
Series F Preferred Stock, which are convertible into 3,157,562
shares of common stock, subject to adjustment; and
●
624,246 shares of
common stock sold to all of our directors and executive officers
and to certain of our employees in November 2017.
MARKET FOR COMMON STOCK
Our
common stock trades on the NYSE American under the symbol
“CRMD.” The following table sets forth the high and low
sales prices for our common stock for the periods indicated as
reported by NYSE American:
Fiscal
Year ending 2018
|
|
|
First Quarter
(through March 6, 2018)
|
$
0.59
|
$
0.28
|
Fiscal
Year 2017
|
|
|
First
Quarter
|
$
2.48
|
$
1.44
|
Second
Quarter
|
$
1.64
|
$
0.36
|
Third
Quarter
|
$
0.54
|
$
0.32
|
Fourth
Quarter
|
$
0.77
|
$
0.45
|
Fiscal
Year 2016
|
|
|
First
Quarter
|
$
2.88
|
$
1.15
|
Second
Quarter
|
$
4.54
|
$
1.83
|
Third
Quarter
|
$
3.12
|
$
1.35
|
Fourth
Quarter
|
$
3.26
|
$
1.46
|
Based
upon information furnished by our transfer agent, at February 28,
2018, we had 61 holders of record of our common stock.
We have
never declared dividends on our equity securities, and currently do
not plan to declare dividends on shares of our common stock in the
foreseeable future. We expect to retain our future earnings, if
any, for use in the operation and expansion of our business.
Further, pursuant to the terms of our
Series D, Series E and Series F Non-Voting Convertible Preferred
Stock, we may not declare or pay any dividends or make any
distributions on any of our shares of common stock or other equity
securities as long as any of those preferred shares remain
outstanding.
Subject to the foregoing, the payment of cash
dividends in the future, if any, will be at the discretion of our
Board of Directors and will depend upon such factors as earnings
levels, capital requirements, our overall financial condition and
any other factors deemed relevant by our Board of
Directors.
PLAN OF DISTRIBUTION
We have
entered into an At Market Issuance Sales Agreement, referred to as
the sales agreement, with B. Riley FBR, Inc., or. B. Riley FBR.
Pursuant to the sales agreement, we may issue and sell up to
$14,100,000 of our common stock from time to time through B. Riley
FBR acting as agent, subject to certain limitations, including the
number
or dollar amount
of
shares registered under the registration statement to which the
offering relates. The form of the sales agreement was filed as an
exhibit to
the registration statement
of which this prospectus is a part
and is incorporated by
reference in this prospectus. The sales, if any, of shares made
under the sales agreement will be made by any method that is deemed
an “at the market offering” as defined in Rule 415
promulgated under the Securities Act. We may instruct B. Riley FBR
not to sell common stock if the sales cannot be effected at or
above the price designated by us from time to time. We or B. Riley
FBR may suspend the offering of common stock upon notice and
subject to other conditions.
Each
time we wish to issue and sell common stock under the sales
agreement, we will notify B. Riley FBR of the number or dollar
value of shares to be issued, the dates on which such sales are
anticipated to be made, any minimum price below which sales may not
be made and other sales parameters as we deem appropriate. Once we
have so instructed B. Riley FBR, unless B. Riley FBR declines to
accept the terms of the notice, B. Riley FBR has agreed to use its
commercially reasonable efforts consistent with its normal trading
and sales practices to sell such shares up to the amount specified
on such terms. The obligations of B. Riley FBR under the sales
agreement to sell our common stock is subject to a number of
conditions that we must meet.
We will
pay B. Riley FBR commissions for its services in acting as agent in
the sale of common stock. B. Riley FBR will be entitled to a
commission equal to 3% of the gross proceeds from the sale of
common stock offered hereby. In addition, we have agreed to
reimburse certain expenses of B. Riley FBR in an amount not to
exceed $25,000. We estimate that the total expenses for the
offering, excluding compensation payable to B. Riley FBR under the
terms of the sales agreement, will be approximately
$100,000.
Settlement for
sales of common stock will generally occur on the second business
day following the date on which any sales are made, or on some
other date that is agreed upon by us and B. Riley FBR in connection
with a particular transaction, in return for payment of the net
proceeds to us. There is no arrangement for funds to be received in
an escrow, trust or similar arrangement.
In
connection with the sale of the common stock on our behalf, B.
Riley FBR will be deemed to be an “underwriter” within
the meaning of the Securities Act and the compensation of B. Riley
FBR will be deemed to be underwriting commissions or discounts. We
have agreed to provide indemnification and contribution to B. Riley
FBR against certain civil liabilities, including liabilities under
the Securities Act. We have also agreed to reimburse B. Riley FBR
for certain other specified expenses.
The
offering of our common stock pursuant to the sales agreement will
terminate upon the earlier of (i) the sale of all of our common
stock provided for in this prospectus or (ii) termination of the
sales agreement as provided therein.
B.
Riley FBR and its affiliates may in the future provide various
investment banking and other financial services for us and our
affiliates, for which services they may in the future receive
customary fees. To the extent required by Regulation M, B. Riley
FBR will not engage in any market making activities involving our
common stock while the offering is ongoing under this
prospectus.
The
$14,100,000 equals one-third of our public float as of March 8,
2018 (which was approximately $42,399,750), as limited by General
Instruction I.B.6 of Form S-3.
DESCRIPTION OF OUR COMMON STOCK
Pursuant
to our Amended and Restated Certificate of Incorporation, as
amended, we are authorized to issue 160,000,000 shares of common
stock, $0.001 par value per share. As of December 31, 2017, we had
71,413,790 shares of common stock outstanding.
The
following summary of certain provisions of our common stock does
not purport to be complete. You should refer to our Amended and
Restated Certificate of Incorporation, as amended, and our Amended
and Restated Bylaws. We filed our Amended and Restated Certificate
of Incorporation as an exhibit to our registration statement on
Form S-1/A filed with the SEC on March 1, 2010, and filed
amendments to the Amended and Restated Certificate of Incorporation
as exhibits to our registration statement on Form S-1/A filed with
the SEC on March 19, 2010, our annual report on Form 10-K filed
with the SEC on March 27, 2013, and our current report on Form 8-K
filed with the SEC on August 10, 2017. We filed an Amended and
Restated Certificate of Designation for each of our Series C-2,
C-3, D and E non-voting preferred stock as exhibits to our current
report on Form 8-K on September 16, 2014, and the Amended and
Restated Certificate of Designation for our Series F non-voting
preferred stock on December 11, 2017. We filed our Amended and
Restated Bylaws as an exhibit to our quarterly report on Form 10-Q
filed with the SEC on May 10, 2016. The summary below is also
qualified by provisions of applicable law.
The
holders of our common stock are entitled to one vote per share on
all matters to be voted on by the stockholders, and there are no
cumulative voting rights. Generally, all matters to be voted on by
stockholders must be approved by a majority (or, in the case of
election of directors, by a plurality) of the votes entitled to be
cast by all shares of common stock present in person or represented
by proxy, subject to any voting rights granted to holders of any
preferred stock.
The
holders of common stock are entitled to receive ratable dividends,
if any, payable in cash, in stock or otherwise if, as and when
declared from time to time by our board of directors out of funds
legally available for the payment of dividends, subject to any
preferential rights that may be applicable to any outstanding
preferred stock. In the event of a liquidation, dissolution, or
winding up of our company, after payment in full of all outstanding
debts and other liabilities, the holders of common stock are
entitled to share ratably in all remaining assets, subject to prior
distribution rights of preferred stock, if any, then outstanding.
No shares of common stock have preemptive rights or other
subscription rights to purchase additional shares of common stock.
There are no redemption or sinking fund provisions applicable to
the common stock. All outstanding shares of common stock are fully
paid and nonassessable, and the shares of common stock included in
this registration statement will be fully paid and nonassessable.
The rights, preferences and privileges of holders of our common
stock will be subject to, and might be adversely affected by, the
rights of holders of any preferred stock that we may issue in the
future. All shares of common stock that are acquired by us shall be
available for reissuance by us at any time.
Transfer Agent and Registrar
The
transfer agent and registrar for our common stock is VStock
Transfer, LLC. The transfer agent’s address is 18 Lafayette
Place, Woodmere, New York 11598 and its telephone number is (212)
828-8436.
CERTAIN PROVISIONS OF DELAWARE LAW AND OF OUR AMENDED AND
RESTATED
CERTIFICATE OF INCORPORATION AND AMENDED AND RESTATED
BYLAWS
Certain
provisions of DGCL and our Amended and Restated Certificate of
Incorporation, as amended, and our Amended and Restated Bylaws
discussed below may have the effect of making more difficult or
discouraging a tender offer, proxy contest or other takeover
attempt. These provisions are expected to encourage persons seeking
to acquire control of our company to first negotiate with our board
of directors. We believe that the benefits of increasing our
ability to negotiate with the proponent of an unfriendly or
unsolicited proposal to acquire or restructure our company outweigh
the disadvantages of discouraging these proposals because
negotiation of these proposals could result in an improvement of
their terms.
Delaware Anti-takeover Law
We are
subject to Section 203 of the DGCL, an anti-takeover law. In
general, Section 203 prohibits a publicly held Delaware corporation
from engaging in a “business combination” with an
“interested stockholder” for a period of three years
following the date the person became an interested stockholder,
unless:
●
the board of
directors approves the transaction in which the stockholder became
an interested stockholder prior to the date the interested
stockholder attained that status;
●
when the
stockholder became an interested stockholder, he or she owned at
least 85% of the voting stock of the corporation outstanding at the
time the transaction commenced, excluding shares owned by persons
who are directors and also officers and certain shares owned by
employee benefits plans; or
●
on or subsequent to
the date the business combination is approved by the board of
directors, the business combination is authorized by the
affirmative vote of at least 66 2/3% of the voting stock of the
corporation at an annual or special meeting of
stockholders.
Generally,
a “business combination” includes a merger, asset or
stock sale, or other transaction resulting in a financial benefit
to the interested stockholder. Generally, an “interested
stockholder” is a person who, together with affiliates and
associates, owns, or is an affiliate or associate of the
corporation and within three years prior to the determination of
interested stockholder status did own, 15% or more of a
corporation’s voting stock.
The
existence of Section 203 of the DGCL would be expected to have an
anti-takeover effect with respect to transactions not approved in
advance by our board of directors, including discouraging attempts
that might result in a premium over the market price for the shares
of our common stock.
Charter Documents
Our
Amended and Restated Certificate of Incorporation, as amended, and
Amended and Restated Bylaws include a number of provisions that may
have the effect of deterring hostile takeovers or delaying or
preventing changes in control or management of our company. First,
our Amended and Restated Bylaws limit who may call special meetings
of the stockholders, such meetings may only be called by the
chairman of the board, the chief executive officer, the board of
directors or holders of an aggregate of at least 15% of our
outstanding entitled to vote. Second, our Amended and Restated
Certificate of Incorporation does not include a provision for
cumulative voting for directors. Under cumulative voting, a
minority stockholder holding a sufficient percentage of a class of
shares may be able to ensure the election of one or more directors.
Third, our Amended and Restated Bylaws provide that the number of
directors on our board, which may range from five to nine
directors, shall be exclusively fixed by our board, which has set
the number of directors at seven. Fourth, newly created
directorships resulting from any increase in our authorized number
of directors and any vacancies in our board resulting from death,
resignation, retirement, disqualification or other cause (including
removal from office by a vote of the shareholders) will be filled
by a majority of our board then in office. Finally, our Amended and
Restated Bylaws establish procedures, including 90-day advance
notice requirement, with regard to the nomination of candidates for
election as directors and stockholder proposals. These and other
provisions of our Amended and Restated Certificate of Incorporation
and Amended and Restated Bylaws and Delaware law could discourage
potential acquisition proposals and could delay or prevent a change
in control or management of our company.
LEGAL MATTERS
Wyrick
Robbins Yates & Ponton LLP, Raleigh, North Carolina, will pass
upon the validity of the common stock offered by this prospectus.
B. Riley FBR is being represented in connection with this offering
by Duane Morris LLP, Newark, New Jersey.
EXPERTS
The balance sheets of CorMedix Inc. as of December
31, 2016 and 2015 and the related consolidated statements of
operations and comprehensive income (loss), stockholders’
equity, and cash flows for each of the years in the three-year
period ended December 31, 2016,
and the effectiveness of
internal control over financial reporting as of December 31, 2016
(which is included in the Annual Report on Form 10-K for the year
ended December 31, 2016),
have been
incorporated herein by reference in reliance on the report of
Friedman LLP, independent registered public accounting firm, given
upon their authority as experts in accounting and
auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
This
prospectus is part of the registration statement on Form S-3 we
filed with the SEC under the Securities Act and does not contain
all the information set forth in the registration statement.
Whenever a reference is made in this prospectus to any of our
contracts, agreements or other documents, the reference may not be
complete and you should refer to the exhibits that are a part of
the registration statement or the exhibits to the reports or other
documents incorporated by reference into this prospectus for a copy
of such contract, agreement or other document. Because we are
subject to the information and reporting requirements of the
Exchange Act, we file annual, quarterly and current reports, proxy
statements and other information with the SEC. Our SEC filings are
available to the public over the Internet at the SEC’s
website at http://www.sec.gov. You may also read and copy any
document we file at the SEC’s Public Reference Room at 100 F
Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the operation of the
Public Reference Room.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC
allows us to “incorporate by reference” information
from other documents that we file with it, which means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is considered
to be part of this prospectus. Information in this prospectus
supersedes information incorporated by reference that we filed with
the SEC prior to the date of this prospectus, while information
that we file later with the SEC will automatically update and
supersede the information in this prospectus. The
documents we are incorporating by reference are:
●
our
Annual Report on Form 10-K for the fiscal year ended
December 31, 2016, filed with the SEC pursuant to Section 13
of the Exchange Act on March 16, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017,
filed with the SEC pursuant to Section 13 of the Exchange Act on
May 10, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2017,
filed with the SEC pursuant to Section 13 of the Exchange Act on
August 9, 2017;
●
our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2017, filed with the SEC pursuant to Section 13 of the Exchange Act
on November 9, 2017;
●
our
Current Reports on Form 8-K, filed with the SEC pursuant to
Section 13 of the Exchange Act on February 10, March 3, April 20,
April 28, May 3, June 13, June 27, July 12, August 1, August 2,
August 7, August 9 (Form 8-K/A), August 10, August 28, August 30,
September 1, September 5, November 13, November 20, December 4,
December 5, December 8 and December 11, 2017, and February 20,
February 26 and February 27, 2018;
●
our
definitive proxy statement on Schedule 14A for the 2017 annual
meeting filed with the SEC pursuant to Section 14 of the Exchange
Act on April 24, 2017; and
●
all
of the filings pursuant to the Securities Exchange Act of 1934, as
amended, after the date of the filing of the registration statement
and prior to the effectiveness of the registration
statement.
We also
incorporate by reference any future filings (other than current
reports furnished under Item 2.02 or Item 7.01 of Form
8-K and exhibits filed on such form that are related to such items
unless such Form 8-K expressly provides to the contrary) made with
the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the
Exchange Act, including those made after the date of the initial
filing of the registration statement of which this prospectus is a
part and prior to effectiveness of such registration statement,
until we file a post-effective amendment that indicates the
termination of the offering of the common stock made by this
prospectus and will become a part of this prospectus from the date
that such documents are filed with the SEC. Information in such
future filings updates and the information provided in this
prospectus.
Any
statements in any such future filings will automatically be deemed
to modify and supersede any information in any document we
previously filed with the SEC that is incorporated or deemed to be
incorporated herein by reference to the extent that statements in
the later filed document modify or replace such earlier
statements.
The information relating to us contained in this prospectus should
be read together with the documents incorporated herein by
reference.
Upon
oral or written request and at no cost to the requester, we will
provide to any person, including a beneficial owner, to whom a
prospectus is delivered, a copy of any or all of the information
that has been incorporated by reference in this prospectus but not
delivered with this prospectus. All requests should be made
to: CorMedix Inc., Attention: Secretary, 400 Connell
Drive, Suite 5000, Berkeley Heights, NJ 07922, (908)
517-9500.
You
should rely only on the information incorporated by reference or
provided in this prospectus. We have not authorized anyone to
provide you with different information. You should not assume that
the information in this prospectus or the documents incorporated
herein by reference is accurate as of any date other than the date
on the front of this prospectus or those documents.
$14,100,000
Common
Stock
PROSPECTUS
B. Riley FBR
__________, 2018
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14.
Other
Expenses of Issuance and Distribution.
We
estimate that expenses payable by us in connection with the
offering described in this registration statement will be as
follows:
SEC registration
fee
|
$
8,715
|
FINRA
fee
|
$
11,000
|
Legal fees and
expenses
|
50,000
*
|
Accounting fees and
expenses
|
20,000
*
|
Printing
expenses
|
10,000
*
|
Miscellaneous
|
12,285
*
|
Total
|
112,000
*
|
*
Estimated as
permitted under Rule 511 of Regulation S-K.
Item 15.
Indemnification
of Directors and Officers.
Section
145 of the DGCL permits a corporation, under specified
circumstances, to indemnify its directors, officers, employees or
agents against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlements actually and
reasonably incurred by them in connection with any action, suit or
proceeding brought by third parties by reason of the fact that they
were or are directors, officers, employees or agents of the
corporation, if such directors, officers, employees or agents acted
in good faith and in a manner they reasonably believed to be in or
not opposed to the best interests of the corporation and, with
respect to any criminal action or proceeding, had no reason to
believe their conduct was unlawful. In a derivative action, that is
one by or in the right of the corporation, indemnification may be
made only for expenses actually and reasonably incurred by
directors, officers, employees or agents in connection with the
defense or settlement of an action or suit, and only with respect
to a matter as to which they will have acted in good faith and in a
manner they reasonably believed to be in or not opposed to the best
interests of the corporation, except that no indemnification will
be made if such person will have been adjudged liable to the
corporation, unless and only to the extent that the court in which
the action or suit was brought will determine upon application that
the defendant directors, officers, employees or agents are fairly
and reasonably entitled to indemnity for such expenses despite such
adjudication of liability.
Pursuant to the
DGCL, our Amended and Restated Certificate of Incorporation, as
amended provides that no director will be personally liable to our
company or our stockholders for monetary damages for breach of
fiduciary duty as a director, except for liability (i) for any
breach of the director’s duty of loyalty to our company or
our stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law,
(iii) under Section 174 of the DGCL, or (iv) for any transaction
from which the director derived any improper personal benefit. Our
Amended and Restated Bylaws provide that we will generally
indemnify our directors, officers, employees or agents to the
fullest extent permitted by the law against all losses, claims,
damages or similar events. We have obtained liability insurance for
each director and officer for certain losses arising from claims or
charges made against them while acting in their capacities as
directors or officers of our Company.
Item 16. Exhibits.
(a) The
following exhibits are filed as part of this Registration
Statement:
Exhibit
Number
|
|
Description of
Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
S-1/A
|
|
3/01/2010
|
|
3.3
|
|
|
|
|
|
|
S-1/A
|
|
3/19/2010
|
|
3.5
|
|
|
|
|
|
|
10-Q
|
|
5/10/2016
|
|
3.1
|
|
|
|
|
|
|
10-K
|
|
3/27/2013
|
|
3.3
|
|
|
|
|
|
|
8-K
|
|
8/10/2017
|
|
3.1
|
|
|
|
|
|
|
8-K
|
|
2/19/2013
|
|
3.3
|
|
|
|
|
|
|
8-K
|
|
7/26/2013
|
|
3.4
|
|
|
|
|
|
|
8-K
|
|
10/23/2013
|
|
3.5
|
|
|
|
|
|
|
8-K
|
|
9/16/2014
|
|
3.15
|
|
|
|
|
|
|
8-K
|
|
9/16/2014
|
|
3.16
|
|
|
|
|
|
|
8-K
|
|
9/16/2014
|
|
3.17
|
|
|
|
|
|
|
8-K
|
|
9/16/2014
|
|
3.18
|
|
|
|
|
|
|
8-K
|
|
12/11/2017
|
|
3.1
|
|
|
Exhibit
Number
|
|
Description of
Document
|
|
Registrant's
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
S-1/A
|
|
3/19/2010
|
|
4.1
|
|
|
|
|
|
|
8-K
|
|
2/19/2013
|
|
4.13
|
|
|
|
|
|
|
10-K
|
|
5/15/2013
|
|
4.18
|
|
|
|
|
|
|
8-K
|
|
7/26/2013
|
|
4.21
|
|
|
|
|
|
|
8-K
|
|
1/09/2014
|
|
4.23
|
|
|
4.6
|
|
Form of
Warrant issued on January 8, 2014.
|
|
|
|
|
|
|
|
|
|
|
|
|
8-K
|
|
03/05/2014
|
|
4.24
|
|
|
|
|
|
|
8-K
|
|
03/04/2015
|
|
4.1
|
|
|
|
|
|
|
8-K
|
|
03/04/2015
|
|
4.2
|
|
|
|
|
|
|
8-K
|
|
03/04/2015
|
|
4.3
|
|
|
|
|
|
|
8-K
|
|
03/04/2015
|
|
4.5
|
|
|
|
|
|
|
8-K
|
|
5/03/2017
|
|
4.1
|
|
|
|
|
|
|
8-K
|
|
5/03/2017
|
|
4.2
|
|
|
|
|
|
|
8-K
|
|
5/03/2017
|
|
4.3
|
|
|
|
|
|
|
8-K
|
|
11/13/2017
|
|
4.15
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
4.17*
|
|
Form
of Note.
|
|
|
|
|
|
|
|
|
4.18*
|
|
Form of
Common Stock Warrant Agreement and Warrant
Certificate.
|
|
|
|
|
|
|
|
|
4.19*
|
|
Form of
Preferred Stock Warrant Agreement and Warrant
Certificate.
|
|
|
|
|
|
|
|
|
4.20*
|
|
Form of
Debt Securities Warrant Agreement and Warrant
Certificate.
|
|
|
|
|
|
|
|
|
4.21*
|
|
Form of
Unit Agreement.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
25.1*
|
|
Statement
of Eligibility of Trustee
|
|
|
|
|
|
|
|
|
*
To be filed by
amendment or as an exhibit to a Current Report on Form 8-K and
incorporated herein by reference, if applicable.
(b) Financial
statement schedule.
None.
Item 17. Undertakings
(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;
(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 SEC pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a
20% change in the maximum aggregate offering price set forth in the
“Calculation of Registration Fee” table in the
effective registration statement;
(iii) To
include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement;
provided, however,
that paragraphs (1)(i), (1)(ii) and
(1)(iii) above do not apply if 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
Registrant pursuant to Section 13 and 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) that is part of the
registration statement.
(2) That,
for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
(3) To
remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the
termination of the offering.
(4) That,
for the purpose of determining liability under the Securities Act
of 1933 to any purchaser:
(i) 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
(ii)
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.
(5) 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:
The
undersigned Registrant undertakes that in a primary offering of
securities of the undersigned Registrant pursuant to this
Registration Statement, regardless of the underwriting method used
to sell the securities to the purchaser, if the securities are
offered or sold to such purchaser by means of any of the following
communications, the undersigned Registrant will be a seller to the
purchaser and will be considered to offer or sell such securities
to such purchaser:
(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;
and
(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.
SIGNATURES
Pursuant to the
requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly
caused this Registration Statement on Form S-3 to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City
of Berkeley Heights, State of New Jersey, on March 9,
2018.
|
CORMEDIX
INC.
|
|
|
|
|
|
|
By:
|
/s/
Khoso
Baluch
|
|
|
|
Khoso
Baluch
|
|
|
|
Chief
Executive Officer
|
|
We, the
undersigned officers and directors of CorMedix Inc., do hereby
constitute and appoint Khoso Baluch and Robert Cook, or either of
them, our true and lawful attorneys-in-fact and agents, each with
full power of substitution and resubstitution, for him and in his
name, place and stead, in any and all capacities, to sign any and
all amendments to this Registration Statement, and to file the
same, with exhibits thereto, and other documents in connection
therewith, with the SEC, granting unto said attorneys-in-fact and
agents, and each of them, full power and authority to do and
perform each and every act and thing requisite are necessary to be
done in and about the premises, as fully to all intents and
purposes as he or she might or could do in person, hereby ratifying
and confirming all that each of said attorney-in-fact and agents,
or his or her substitute or substitutes, may lawfully do or cause
to be done by virtue hereof.
Pursuant to the
requirements of the Securities Act, this Registration Statement on
Form S-3 has been signed by the following persons in the capacities
and on the dates indicated.
Signature
|
|
Capacity
|
|
Date
|
/s/
Khoso Baluch
|
|
Director
and Chief Executive Officer (Principal Executive
Officer)
|
|
March
9, 2018
|
Khoso
Baluch
|
|
|
|
|
/s/
Robert Cook
|
|
Chief
Financial Officer (Principal Financial Officer and Principal
Accounting Officer)
|
|
March
9, 2018
|
Robert
Cook
|
|
|
|
|
/s/
Janet Dillione
|
|
|
|
|
Janet
Dillione
|
|
Director
|
|
March
9, 2018
|
/s/
Gary Gelbfish
|
|
|
|
|
Gary
Gelbfish
|
|
Director
|
|
March
9, 2018
|
/s/
Myron Kaplan
|
|
|
|
|
Myron
Kaplan
|
|
Director
|
|
March
9, 2018
|
/s/
Mehmood Khan
|
|
|
|
|
Mehmood
Khan
|
|
Director
|
|
March
9, 2018
|
/s/
Steven Lefkowitz
|
|
|
|
|
Steven
Lefkowitz
|
|
Director
|
|
March
9, 2018
|
Exhibit 1.1
CORMEDIX INC.
Common
Stock
(par
value $0.001 per share)
At
Market Issuance Sales Agreement
March
9, 2018
B.
Riley FBR, Inc.
299
Park Avenue, 7
th
Floor
New
York, NY 10171
Ladies
and Gentlemen:
CorMedix Inc., a
Delaware corporation (the “
Company
”), confirms its
agreement (this “
Agreement
”), with B.
Riley FBR, Inc. (“
B.
Riley FBR
”), 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 B. Riley FBR, shares (the
“
Placement
Shares
”) of the Company’s common stock, par
value $0.001 per share (the “
Common Stock
”),
provided however,
that in
no event shall the Company issue or sell through B. Riley FBR such
number of Placement Shares that (a) exceeds the number of shares or
dollar amount of Common Stock registered on the effective
Registration Statement (as defined below) pursuant to which the
offering is being made, (b) exceeds the number of shares or dollar
amount registered on the Prospectus Supplement or (c) exceeds the
number of authorized but unissued shares of Common Stock (the
lesser of (a), (b) and (c), the “
Maximum Amount
”).
Notwithstanding anything to the contrary contained herein, the
parties hereto agree that compliance with the limitations set forth
in this
Section 1
on the number of Placement Shares issued and sold under this
Agreement shall be the sole responsibility of the Company and that
B. Riley FBR shall have no obligation in connection with such
compliance. The issuance and sale of Placement Shares through B.
Riley FBR will be effected pursuant to the Registration Statement
(as defined below), although nothing in this Agreement shall be
construed as requiring the Company to use the Registration
Statement to issue any Placement Shares.
The
Company shall file, in accordance with the provisions of the
Securities Act of 1933, as amended, and the rules and regulations
thereunder (the “
Securities Act
”), with
the Securities and Exchange Commission (the “
Commission
”), a
registration statement on Form S-3, including a prospectus relating
to the Placement Shares 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 (the “
Exchange Act
”). The
Company will, if necessary, prepare a prospectus supplement to the
prospectus included as part of such registration statement
specifically relating to the Placement Shares (the
“
Prospectus
Supplement
”). The Company will furnish to B. Riley
FBR, for use by B. Riley FBR, copies of the prospectus included as
part of such registration statement, as supplemented, if at all, by
the Prospectus Supplement, relating to the Placement Shares. Except
where the context otherwise requires, such registration statement,
and any post-effective amendment thereto, 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 of the Securities Act,
is herein called the “
Registration Statement
.”
The prospectus relating to the Placement Shares, including all
documents incorporated or deemed incorporated therein by reference
to the extent such information has not been superseded or modified
in accordance with Rule 412 under the Securities Act (as qualified
by Rule 430B(g) of the Securities Act), 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, is
herein called the “
Prospectus
.” Any
reference herein to the Registration Statement, the Prospectus or
any amendment or supplement thereto shall be deemed to refer to and
include the documents incorporated or deemed incorporated by
reference therein, and any reference herein to the terms
“amend,” “amendment” or
“supplement” with respect to the Registration Statement
or the Prospectus shall be deemed to refer to and include the
filing after the execution hereof of any document with the
Commission deemed to be incorporated by reference therein (the
“
Incorporated
Documents
”).
For
purposes of this Agreement, all references to the Registration
Statement, the Prospectus or to 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 Placement Shares
hereunder (each, a “
Placement
”), it will
notify B. Riley FBR by email notice (or other method mutually
agreed to in writing by the Parties) of the number of Placement
Shares, the time period during which sales are requested to be
made, any limitation on the number of Placement Shares that may be
sold in any one day and any minimum price below which sales may not
be made (a “
Placement Notice
”), the
form of which is attached hereto as
Schedule 1.
The Placement
Notice shall originate from any of the individuals from the Company
set forth on
Schedule
3
(with a copy to each of the other individuals from the
Company listed on such schedule), and shall be addressed to each of
the individuals from B. Riley FBR set forth on
Schedule 3,
as such
Schedule 3
may be
amended from time to time. Provided that the Company is otherwise
in compliance with the terms of this Agreement, the Placement
Notice shall be effective immediately upon receipt by B. Riley FBR
unless and until (i) B. Riley FBR declines to accept the terms
contained therein for any reason, in its sole discretion, (ii) the
entire amount of the Placement Shares thereunder has been sold,
(iii) the Company suspends or terminates the Placement Notice or
(iv) this Agreement has been terminated under the provisions of
Section 13
. The
amount of any discount, commission or other compensation to be paid
by the Company to B. Riley FBR in connection with the sale of the
Placement Shares shall be calculated in accordance with the terms
set forth in
Schedule
2
. It is expressly acknowledged and agreed that neither the
Company nor B. Riley FBR will have any obligation whatsoever with
respect to a Placement or any Placement Shares unless and until the
Company delivers a Placement Notice to B. Riley FBR and B. Riley
FBR 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
Sections 2
or
3
of this Agreement
and the terms of a Placement Notice, the terms of the Placement
Notice will control.
3.
Sale of Placement Shares
by B. Riley FBR.
a.
Subject
to the terms and conditions of this Agreement, for the period
specified in a Placement Notice, B. Riley FBR 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 NYSE American (the
“
Exchange
”), to sell the
Placement Shares up to the amount specified in, and otherwise in
accordance with the terms of, such Placement Notice. B. Riley FBR
will provide written confirmation to the Company 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 of Placement Shares sold on such
day, the compensation payable by the Company to B. Riley FBR
pursuant to
Section
2
with respect to such sales, and the Net Proceeds (as
defined below) payable to the Company, with an itemization of the
deductions made by B. Riley FBR (as set forth in
Section 5(b)
) from the gross
proceeds that it receives from such sales. Subject to the terms of
a Placement Notice, B. Riley FBR 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.
“
Trading
Day
” means any day on which Common Stock is purchased
and sold on the Exchange.
b.
During
the term of this Agreement, neither B. Riley FBR nor any of its
affiliates or subsidiaries shall engage in (i) any short sale of
any security of the Company or (ii) any sale of any security of the
Company that B. Riley FBR does not own or any sale which is
consummated by the delivery of a security of the Company borrowed
by, or for the account of, B. Riley FBR. Neither B. Riley FBR nor
any of its affiliates or subsidiaries shall engage in any
proprietary trading or trading for B. Riley FBR’s (or its
affiliates’ or subsidiaries’) own account.
4.
Suspension of
Sales.
The Company or B. Riley FBR 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 3
, 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 verifiable facsimile
transmission or email correspondence to each of the individuals of
the other party set forth on
Schedule
3), suspend any sale
of Placement Shares;
provided,
however
, that such suspension shall not affect or impair any
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 any other party unless it is made to one of the individuals
named on
Schedule 3
hereto, as such Schedule may be amended from time to
time.
5.
Sale and Delivery to B.
Riley FBR; Settlement.
a.
Sale
of Placement Shares.
On the basis of the representations and
warranties herein contained and subject to the terms and conditions
herein set forth, upon B. Riley FBR’s acceptance of the terms
of a Placement Notice, 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, B. Riley
FBR, for the period specified in the Placement Notice, will use its
commercially reasonable efforts consistent with its normal trading
and sales practices to sell such Placement Shares up to the amount
specified in, and otherwise in accordance with the terms of, such
Placement Notice. The Company acknowledges and agrees that (i)
there can be no assurance that B. Riley FBR will be successful in
selling Placement Shares, (ii) B. Riley FBR 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 B. Riley FBR to use its commercially reasonable efforts
consistent with its normal trading and sales practices and
applicable law and regulations to sell such Placement Shares as
required under this Agreement and (iii) B. Riley FBR shall be under
no obligation to purchase Placement Shares on a principal basis
pursuant to this Agreement, except as otherwise agreed by B. Riley
FBR and the Company.
b.
Settlement
of Placement Shares.
Unless otherwise specified in the
applicable Placement Notice, settlement for sales of Placement
Shares will occur on the second (2
nd
) Trading Day (or
such earlier day as is industry practice 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 sales price received by B. Riley FBR, after
deduction for (i) B. Riley FBR’s commission, discount or
other compensation for such sales payable by the Company pursuant
to
Section 2
hereof, and (ii) any transaction fees imposed by any governmental
or self-regulatory organization in respect of such
sales.
c.
Delivery
of Placement Shares.
On or before each Settlement Date, the
Company will, or will cause its transfer agent to, electronically
transfer the Placement Shares being sold by crediting B. Riley
FBR’s or its designee’s account (provided B. Riley FBR
shall have given the Company written notice of such designee at
least one Trading Day prior to the Settlement Date) at The
Depository Trust Company through its Deposit and Withdrawal at
Custodian System or by such other means of delivery as may be
mutually agreed upon by the parties hereto which in all cases shall
be freely tradable, transferable, registered shares in good
deliverable form. On each Settlement Date, B. Riley FBR 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
Company agrees that if the Company, or its transfer agent (if
applicable), defaults in its obligation to deliver Placement Shares
on a Settlement Date, then in addition to and in no way limiting
the rights and obligations set forth in
Section 11(a)
hereto, it will
(i) hold B. Riley FBR harmless against any loss, claim, damage, or
reasonable, documented expense (including reasonable and documented
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 (ii) pay to B. Riley FBR (without duplication)
any commission, discount, or other compensation to which it would
otherwise have been entitled absent such default.
d.
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
of Placement Shares sold pursuant to this Agreement would exceed
the lesser of (A) together with all sales of Placement Shares under
this Agreement, the Maximum Amount, (B) the amount available for
offer and sale under the currently effective Registration Statement
and (C) the amount authorized from time to time to be issued and
sold under this Agreement by the Company’s board of
directors, a duly authorized committee thereof or a duly authorized
executive committee, and notified to B. Riley FBR in writing. 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, a duly authorized committee
thereof or a duly authorized executive committee, and notified to
B. Riley FBR in writing. Further, under no circumstances shall the
Company cause or permit the aggregate offering amount of Placement
Shares sold pursuant to this Agreement to exceed the Maximum
Amount.
6.
Representations
and Warranties of the Company.
Except as disclosed in the
Registration Statement or Prospectus (including the Incorporated
Documents), the Company represents and warrants to, and agrees with
B. Riley FBR that as of the date of this Agreement and as of each
Applicable Time (as defined below), unless such representation,
warranty or agreement specifies a different date or
time:
a.
Registration
Statement and Prospectus.
The Company and, assuming no act
or omission on the part of B. Riley FBR that would make such
statement untrue, the transactions contemplated by this Agreement
meet the requirements for and comply with the conditions for the
use of Form S-3 under the Securities Act. The Registration
Statement has been filed with the Commission and has been declared
effective under the Securities Act. The Prospectus Supplement will
name B. Riley FBR as the agent in the section entitled “Plan
of Distribution.” The Company has not received, and has no
notice of, any order of the Commission preventing or suspending the
use of the Registration Statement, or threatening or instituting
proceedings for that purpose. The Registration Statement and the
offer and sale of Placement Shares as contemplated hereby meet the
requirements of Rule 415 under the Securities Act and comply in all
material respects with said Rule. Any statutes, regulations,
contracts or other documents that are required to be described in
the Registration Statement or the Prospectus or to be filed as
exhibits to the Registration Statement have been so described or
filed. Copies of the Registration Statement, the Prospectus, and
any such amendments or supplements and all documents incorporated
by reference therein that were filed with the Commission on or
prior to the date of this Agreement have been delivered, or are
available through EDGAR, to B. Riley FBR and its counsel. The
Company has not distributed and, prior to the later to occur of
each Settlement Date and completion of the distribution of the
Placement Shares, will not distribute any offering material in
connection with the offering or sale of the Placement Shares other
than the Registration Statement and the Prospectus and any Issuer
Free Writing Prospectus (as defined below) to which B. Riley FBR
has consented. The Common Stock is currently quoted on the
Exchange. The Company has not, in the 12 months preceding the date
hereof, received notice from the Exchange to the effect that the
Company is not in compliance with the listing or maintenance
requirements of the Exchange. The Company has no reason to believe
that it will not in the foreseeable future continue to be in
compliance with all such listing and maintenance
requirements.
b.
No
Misstatement or Omission.
The Registration Statement, when
it became or becomes effective, and the Prospectus, and any
amendment or supplement thereto, on the date of such Prospectus or
amendment or supplement, conformed and will conform in all material
respects with the requirements of the Securities Act. At each
Settlement Date, the Registration Statement and the Prospectus, as
of such date, will conform in all material respects with the
requirements of the Securities Act. The Registration Statement,
when it became or becomes effective, did not, and will not, contain
an untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the
statements therein not misleading. The Prospectus and any amendment
and supplement thereto, on the date thereof and at each Applicable
Time (defined below), did not or will not include an untrue
statement of a material fact or omit to state a material fact
necessary to make the statements therein, in light of the
circumstances under which they were made, not misleading. The
documents incorporated by reference in the Prospectus or any
Prospectus Supplement did not, and any further documents filed and
incorporated by reference therein will not, when filed with the
Commission, contain an untrue statement of a material fact or omit
to state a material fact required to be stated in such document or
necessary to make the statements in such document, 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 B. Riley FBR specifically
for use in the preparation thereof.
c.
Conformity
with Securities Act and Exchange Act.
The Registration
Statement, the Prospectus, any Issuer Free Writing Prospectus or
any amendment or supplement thereto, and the Incorporated
Documents, when such documents were or are filed with the
Commission under the Securities Act or the Exchange Act or became
or become effective under the Securities Act, as the case may be,
conformed or will conform in all material respects with the
requirements of the Securities Act and the Exchange Act, as
applicable.
d.
Financial
Information.
The consolidated financial statements of the
Company included or incorporated by reference in the Registration
Statement and the Prospectus, together with the related notes and
schedules, present fairly, in all material respects, the
consolidated financial position of the Company and the Subsidiaries
(as defined below) as of the dates indicated and the consolidated
results of operations, cash flows and changes in
stockholders’ equity of the Company for the periods specified
and have been prepared in compliance with the requirements of the
Securities Act and Exchange Act, as applicable, and in conformity
with generally accepted accounting principles in the United States
(“
GAAP
”) applied on a
consistent basis (except for such adjustments to accounting
standards and practices as are noted therein) during the periods
involved; the other financial and statistical data with respect to
the Company and the Subsidiaries contained or incorporated by
reference in the Registration Statement and the Prospectus, are
accurately and fairly presented and prepared on a basis consistent
with the financial statements and books and records of the Company;
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 as required; the Company and the
Subsidiaries do not have any material liabilities or obligations,
direct or contingent (including any off balance sheet obligations),
not described in the Registration Statement, and the Prospectus
which are required to be described in the Registration Statement or
Prospectus; and all disclosures contained or incorporated by
reference in the Registration Statement and the Prospectus, if any,
regarding “non-GAAP financial measures” (as such term
is defined by the rules and regulations of the Commission) comply
with Regulation G of the Exchange Act and Item 10 of Regulation S-K
under the Securities Act, to the extent applicable.
e.
Conformity
with EDGAR Filing.
The Prospectus delivered to B. Riley FBR
for use in connection with the sale of the Placement Shares
pursuant to this Agreement will be identical to the versions of the
Prospectus created to be transmitted to the Commission for filing
via EDGAR, except to the extent permitted by Regulation
S-T.
f.
Organization.
The Company and any subsidiary that is a significant subsidiary (as
such term is defined in Rule 1-02 of Regulation S-X promulgated by
the Commission) (each, a “
Subsidiary
”,
collectively, the “
Subsidiaries
”), are, and
will be, duly organized, validly existing as a corporation and in
good standing under the laws of their respective jurisdictions of
organization. The Company and the Subsidiaries are, and will be,
duly licensed or qualified as a foreign corporation for transaction
of business and in good standing under the laws of each other
jurisdiction in which their respective ownership or lease of
property or the conduct of their respective businesses requires
such license or qualification, and have all corporate power and
authority necessary to own or hold their respective properties and
to conduct their respective businesses as described in the
Registration Statement and the Prospectus, except where the failure
to be so qualified or in good standing or have such power or
authority would not, individually or in the aggregate, have a
material adverse effect or would reasonably be expected to have a
material adverse effect on the assets, business, operations,
earnings, properties, condition (financial or otherwise),
prospects, stockholders’ equity or results of operations of
the Company and the Subsidiaries taken as a whole, or prevent the
consummation of the transactions contemplated hereby (a
“
Material Adverse
Effect
”).
g.
Subsidiaries.
As of the date hereof, the Company’s only Subsidiaries are
set forth on
Schedule
6(g)
. The Company owns directly or indirectly, all of the
equity interests of the Subsidiaries free and clear of any lien,
charge, security interest, encumbrance, right of first refusal or
other restriction, and all the equity interests of the Subsidiaries
are validly issued and are fully paid, nonassessable and free of
preemptive and similar rights.
h.
No Violation or
Default.
Neither the Company nor any Subsidiary is (i) in
violation of its charter or by-laws or similar organizational
documents; (ii) in default, and no event has occurred that, with
notice or lapse of time or both, would constitute such a default,
in the due performance or observance of any term, covenant or
condition contained in any indenture, mortgage, deed of trust, loan
agreement or other agreement or instrument to which the Company or
any Subsidiary is a party or by which the Company or any Subsidiary
is bound or to which any of the property or assets of the Company
or any Subsidiary is subject; or (iii) in violation of any law or
statute or any judgment, order, rule or regulation of any court or
arbitrator or governmental or regulatory authority, except, in the
case of each of clauses (ii) and (iii) above, for any such
violation or default that would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect. To the Company’s knowledge, no other party under any
material contract or other agreement to which it or any Subsidiary
is a party is in default in any respect thereunder where such
default would reasonably be expected to have a Material Adverse
Effect.
i.
No
Material Adverse Effect.
Since the date of the most recent
financial statements of the Company included or incorporated by
reference in the Registration Statement and Prospectus, there has
not been (i) any Material Adverse Effect, or any development
involving a prospective Material Adverse Effect, in or affecting
the business, properties, management, condition (financial or
otherwise), results of operations, or prospects of the Company and
the Subsidiaries taken as a whole, (ii) any transaction which is
material to the Company and the Subsidiaries taken as a whole,
(iii) any obligation or liability, direct or contingent (including
any off-balance sheet obligations), incurred by the Company or the
Subsidiaries, which is material to the Company and the Subsidiaries
taken as a whole, (iv) any material change in the capital stock
(other than (A) the grant of additional options under the
Company’s existing stock option plans, (B) changes in the
number of outstanding Common Stock of the Company due to the
issuance of shares upon the exercise or conversion of securities
exercisable for, or convertible into, Common Stock outstanding on
the date hereof, (C) as a result of the issuance of Placement
Shares, (D) any repurchases of capital stock of the Company, (E) as
described in a proxy statement filed on Schedule 14A or a
Registration Statement on Form S-4, or (F) otherwise publicly
announced) or outstanding long-term indebtedness of the Company or
the Subsidiaries or (v) any dividend or distribution of any kind
declared, paid or made on the capital stock of the Company or any
Subsidiary, other than in each case above
in the
ordinary course of business or as otherwise disclosed in the
Registration Statement or Prospectus.
j.
Capitalization.
The issued and outstanding shares of capital stock of the Company
have been validly issued, are fully paid and non-assessable and,
other than as disclosed in the Registration Statement or the
Prospectus, are not subject to any preemptive rights, rights of
first refusal or similar rights. The Company has an authorized,
issued and outstanding capitalization as set forth in the
Registration Statement and the Prospectus as of the dates referred
to therein (other than (i) the grant of additional options under
the Company’s existing stock option plans, (ii) changes in
the number of outstanding Common Stock of the Company due to the
issuance of shares upon the exercise or conversion of securities
exercisable for, or convertible into, Common Stock outstanding on
the date hereof, (iii) as a result of the issuance of Placement
Shares, or (iv) any repurchases of capital stock of the Company)
and such authorized capital stock conforms to the description
thereof set forth in the Registration Statement and the Prospectus.
The description of the Common Stock in the Registration Statement
and the Prospectus is complete and accurate in all material
respects. As of the date referred to therein, the Company did not
have outstanding any options to purchase, or any rights or warrants
to subscribe for, or any securities or obligations convertible
into, or exchangeable for, or any contracts or commitments to issue
or sell, any shares of capital stock or other
securities.
k.
S-3 Eligibility
. At
the time the Registration Statement was or will be declared
effective, and at the time the Company’s most recent Annual
Report on Form 10-K was filed with the Commission, the Company met
or will meet the then applicable requirements for the use of Form
S-3 under the Securities Act, including, but not limited to,
General Instruction I.B.6 of Form S-3, if applicable. As of
the close of trading on the Exchange on February 16, 2018, 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 $42,399,750 (calculated by
multiplying (x) the price at which the common equity of the Company
was last sold on the Exchange on February 16, 2018 times (y) the
number of Non-Affiliate Shares). The Company is not a shell company
(as defined in Rule 405 under the Securities Act) and has not been
a shell company for at least 12 calendar months previously and if
it has been a shell company at any time previously, has filed
current Form 10 information (as defined in General Instruction
I.B.6 of Form S-3) with the Commission at least 12 calendar months
previously reflecting its status as an entity that is not a shell
company.
l.
Authorization;
Enforceability.
The Company has full legal right, power and
authority to enter into this Agreement and perform the transactions
contemplated hereby. This Agreement has been duly authorized,
executed and delivered by the Company and is a legal, valid and
binding agreement of the Company enforceable against the Company in
accordance with its terms, except to the extent that (i)
enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting
creditors’ rights generally and by general equitable
principles and (ii) the indemnification and contribution provisions
of
Section 11
hereof may be limited by federal or state securities laws and
public policy considerations in respect thereof.
m.
Authorization of Placement
Shares.
The Placement Shares, when issued and delivered
pursuant to the terms approved by the board of directors of the
Company or a duly authorized committee thereof, or a duly
authorized executive committee, against payment therefor as
provided herein, will be duly and validly authorized and issued and
fully paid and nonassessable, free and clear of any pledge, lien,
encumbrance, security interest or other claim (other than any
pledge, lien, encumbrance, security interest or other claim arising
from an act or omission of B. Riley FBR or a purchaser), including
any statutory or contractual preemptive rights, resale rights,
rights of first refusal or other similar rights, and will be
registered pursuant to Section 12 of the Exchange Act. The
Placement Shares, when issued, will conform in all material
respects to the description thereof set forth in or incorporated
into the Prospectus.
n.
No
Consents Required.
No consent, approval, authorization,
order, registration or qualification of or with any court or
arbitrator or any governmental or regulatory authority is required
for the execution, delivery and performance by the Company of this
Agreement, and the issuance and sale by the Company of the
Placement Shares as contemplated hereby, except for such consents,
approvals, authorizations, orders and registrations or
qualifications as may be required under applicable state securities
laws or by the by-laws and rules of the Financial Industry
Regulatory Authority (“
FINRA
”) or the Exchange,
including any notices that may be required by Exchange, in
connection with the sale of the Placement Shares by B. Riley
FBR.
o.
No
Preferential Rights.
(i) No person, as such term is defined
in Rule 1-02 of Regulation S-X promulgated under the Securities Act
(each, a “
Person
”), has the right,
contractual or otherwise, to cause the Company to issue or sell to
such Person any Common Stock or shares of any other capital stock
or other securities of the Company (other than upon the exercise of
options or warrants to purchase Common Stock or upon the exercise
of options that may be granted from time to time under the
Company’s stock option plans), (ii) no Person has any
preemptive rights, rights of first refusal, or any other rights
(whether pursuant to a “poison pill” provision or
otherwise) to purchase any Common Stock or shares of any other
capital stock or other securities of the Company from the Company
which have not been duly waived with respect to the offering
contemplated hereby, (iii) no Person 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 Common Stock, and (iv) no Person has
the right, contractual or otherwise, to require the Company to
register under the Securities Act any Common Stock or shares of any
other capital stock or other securities of the Company, or to
include any such shares or other securities in the Registration
Statement or the offering contemplated thereby, whether as a result
of the filing or effectiveness of the Registration Statement or the
sale of the Placement Shares as contemplated thereby or
otherwise.
p.
Independent
Public Accountant.
Friedman LLP (the “
Accountant
”), whose
reports on the consolidated financial statements of the Company are
filed with the Commission as part of the Company’s most
recent Annual Report on Form 10-K filed with the Commission and
incorporated into the Registration Statement, are and, during the
periods covered by their report, were independent public
accountants within the meaning of the Securities Act and the Public
Company Accounting Oversight Board (United States). To the
Company’s knowledge, with due inquiry, the Accountant is not
in violation of the auditor independence requirements of the
Sarbanes-Oxley Act of 2002 (the “
Sarbanes-Oxley Act
”) with
respect to the Company.
q.
Enforceability
of Agreements.
All agreements between the Company and third
parties expressly referenced in the Prospectus, other than such
agreements that have expired by their terms or whose termination is
disclosed in documents filed by the Company on EDGAR, are legal,
valid and binding obligations of the Company enforceable in
accordance with their respective terms, except to the extent that
(i) enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting
creditors’ rights generally and by general equitable
principles and (ii) the indemnification provisions of certain
agreements may be limited by federal or state securities laws or
public policy considerations in respect thereof, and except for any
unenforceability that, individually or in the aggregate, would not
unreasonably be expected to have a Material Adverse
Effect.
r.
No
Litigation.
There are no legal, governmental or regulatory
actions, suits or proceedings pending, nor, to the Company’s
knowledge, any legal, governmental or regulatory investigations, to
which the Company or a Subsidiary is a party or to which any
property of the Company or any Subsidiary is the subject that,
individually or in the aggregate, if determined adversely to the
Company or any Subsidiary, would reasonably be expected to have a
Material Adverse Effect or materially and adversely affect the
ability of the Company to perform its obligations under this
Agreement; to the Company’s knowledge, no such actions, suits
or proceedings are threatened or contemplated by any governmental
or regulatory authority or threatened by others that, individually
or in the aggregate, if determined adversely to the Company or any
Subsidiary, would reasonably be expected to have a Material Adverse
Effect; and (i) there are no current or pending legal, governmental
or regulatory investigations, actions, suits or proceedings that
are required under the Securities Act to be described in the
Prospectus that are not described in the Prospectus including any
Incorporated Document; and (ii) there are no contracts or other
documents that are required under the Securities Act to be filed as
exhibits to the Registration Statement that are not so
filed.
s.
Licenses and
Permits.
The Company and the Subsidiaries possess or have
obtained, all licenses, certificates, consents, orders, approvals,
permits and other authorizations issued by, and have made all
declarations and filings with, the appropriate federal, state,
local or foreign governmental or regulatory authorities 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 (the “
Permits
”), except where
the failure to possess, obtain or make the same would not,
individually or in the aggregate, reasonably be expected to have a
Material Adverse Effect. Neither the Company nor any Subsidiary
have received written notice of any proceeding relating to
revocation or modification of any such Permit or has any reason to
believe that such Permit will not be renewed in the ordinary
course, except where the failure to obtain any such renewal would
not, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect.
t.
No
Material Defaults.
Neither the Company nor any Subsidiary
has defaulted on any installment 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
have a Material Adverse Effect. The Company has not filed a report
pursuant to Section 13(a) or 15(d) of the Exchange Act since the
filing of its last Annual Report on Form 10-K, indicating that it
(i) has failed to pay any dividend or sinking fund installment on
preferred stock or (ii) has defaulted on any installment on
indebtedness for borrowed money or on any rental on one or more
long-term leases, which defaults, individually or in the aggregate,
would reasonably be expected to have a Material Adverse
Effect.
u.
Certain Market
Activities.
Neither the Company, nor any Subsidiary, nor any
of their respective directors, officers or controlling persons has
taken, directly or indirectly, any action designed, or that has
constituted or would reasonably be expected to cause or result in,
under the Exchange Act or otherwise, the stabilization or
manipulation of the price of any security of the Company to
facilitate the sale or resale of the Placement Shares.
v.
Broker/Dealer
Relationships.
Neither the Company nor any Subsidiary or any
related entities (i) is required to register as a
“broker” or “dealer” in accordance with the
provisions of the Exchange Act or (ii) directly or indirectly
through one or more intermediaries, controls or is a “person
associated with a member” or “associated person of a
member” (within the meaning set forth in the FINRA
Manual).
w.
No Reliance.
The
Company has not relied upon B. Riley FBR or legal counsel for B.
Riley FBR for any legal, tax or accounting advice in connection
with the offering and sale of the Placement Shares.
x.
Taxes.
The Company and the Subsidiaries have filed all federal, state,
local and foreign tax returns which have been required to be filed
and paid all taxes shown thereon through the date hereof, to the
extent that such taxes have become due and are not being contested
in good faith, except where the failure to do so would not
reasonably be expected to have a Material Adverse Effect. Except as
otherwise disclosed in or contemplated by the Registration
Statement or the Prospectus, no tax deficiency has been determined
adversely to the Company or any Subsidiary which has had, or would
reasonably be expected to have, individually or in the aggregate, a
Material Adverse Effect. The Company has no knowledge of any
federal, state or other governmental tax deficiency, penalty or
assessment which has been or might be asserted or threatened
against it which could have a Material Adverse Effect.
y.
Title
to Real and Personal Property.
The Company and the
Subsidiaries have good and valid title in fee simple to all items
of real property and good and valid title to all personal property
described in the Registration Statement or Prospectus as being
owned by them that are material to the businesses of the Company or
such Subsidiary, in each case free and clear of all liens,
encumbrances and claims, except those that (i) do not materially
interfere with the use made and proposed to be made of such
property by the Company and the Subsidiaries or (ii) would not
reasonably be expected, individually or in the aggregate, to have a
Material Adverse Effect. Any real property described in the
Registration Statement or Prospectus as being leased by the Company
and the Subsidiaries is held by them under valid, existing and
enforceable leases, except those that (A) do not materially
interfere with the use made or proposed to be made of such property
by the Company or the Subsidiaries or (B) would not be reasonably
expected, individually or in the aggregate, to have a Material
Adverse Effect.
z.
Intellectual
Property.
The Company and the Subsidiaries own or possess
adequate enforceable rights to use all patents, patent
applications, trademarks (both registered and unregistered),
service marks, trade names, trademark registrations, service mark
registrations, copyrights, licenses and know-how (including trade
secrets and other unpatented and/or unpatentable proprietary or
confidential information, systems or procedures) (collectively, the
“
Intellectual
Property
”)
,
necessary for the conduct of
their respective businesses as conducted as of the date hereof,
except to the extent that the failure to own or possess adequate
rights to use such Intellectual Property would not, individually or
in the aggregate, reasonably be expected to have a Material Adverse
Effect; the Company and the Subsidiaries have not received any
written notice of any claim of infringement or conflict which
asserted Intellectual Property rights of others, which infringement
or conflict, if the subject of an unfavorable decision, would
result in a Material Adverse Effect; there are no pending, or to
the Company’s knowledge, threatened judicial proceedings or
interference proceedings against the Company or its Subsidiaries
challenging the Company’s or any of its Subsidiary’s
rights in or to or the validity of the scope of any of the
Company’s or any Subsidiary’s patents, patent
applications or proprietary information; no other entity or
individual has any right or claim in any of the Company’s or
any of its Subsidiary’s patents, patent applications or any
patent to be issued therefrom by virtue of any contract, license or
other agreement entered into between such entity or individual and
the Company or any Subsidiary or by any non-contractual obligation,
other than by written licenses granted by the Company or any
Subsidiary; the Company and the Subsidiaries have not received any
written notice of any claim challenging the rights of the Company
or its Subsidiaries in or to any Intellectual Property owned,
licensed or optioned by the Company or any Subsidiary which claim,
if the subject of an unfavorable decision would result in a
Material Adverse Effect.
aa.
Environmental
Laws.
The Company and the Subsidiaries (i) are in compliance
with any and all applicable federal, state, local and foreign laws,
rules, regulations, decisions and orders relating to the protection
of human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants or contaminants (collectively,
“
Environmental
Laws
”); (ii) have received and are in compliance with
all permits, licenses or other approvals required of them under
applicable Environmental Laws to conduct their respective
businesses as described in the Registration Statement and the
Prospectus; and (iii) have not received notice of any actual or
potential liability for the investigation or remediation of any
disposal or release of hazardous or toxic substances or wastes,
pollutants or contaminants, except, in the case of any of clauses
(i), (ii) or (iii) above, for any such failure to comply or failure
to receive required permits, licenses, other approvals or liability
as would not, individually or in the aggregate, reasonably be
expected to have a Material Adverse Effect.
bb.
Disclosure
Controls.
The Company maintains systems of internal
accounting controls designed to provide reasonable assurance that
(i) transactions are executed in accordance with management’s
general or specific authorizations; (ii) transactions are recorded
as necessary to permit preparation of financial statements in
conformity with GAAP and to maintain asset accountability; (iii)
access to assets is permitted only in accordance with
management’s general or specific authorization; and (iv) the
recorded accountability for assets is compared with the existing
assets at reasonable intervals and appropriate action is taken with
respect to any differences. The Company is not aware of any
material weaknesses in its internal control over financial
reporting. Since the date of the latest audited financial
statements of the Company included in the Prospectus, there has
been no change in the Company’s internal control over
financial reporting that has materially affected, or is reasonably
likely to materially affect, the Company’s internal control
over financial reporting. The Company has established disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15
and 15d-15) for the Company and designed such disclosure controls
and procedures to ensure that material information relating to the
Company and the Subsidiaries is made known to the certifying
officers by others within those entities, particularly during the
period in which the Company’s Annual Report on Form 10-K or
Quarterly Report on Form 10-Q, as the case may be, is being
prepared. The Company’s certifying officers have evaluated
the effectiveness of the Company’s controls and procedures as
of a date within 90 days prior to the filing date of the Form 10-K
for the fiscal year most recently ended (such date, the
“
Evaluation
Date
”). The Company presented in its Form 10-K for the
fiscal year most recently ended the conclusions of the certifying
officers about the effectiveness of the disclosure controls and
procedures based on their evaluations as of the most recent
Evaluation Date. Since the most recent Evaluation Date, there have
been no significant changes in the Company’s internal
controls (as such term is defined in Item 307(b) of Regulation S-K
under the Securities Act) or, to the Company’s knowledge, in
other factors that could significantly affect the Company’s
internal controls. To the knowledge of the Company, the
Company’s “internal controls over financial
reporting” and “disclosure controls and
procedures” are effective.
cc.
Sarbanes-Oxley
Act.
There is and has been no failure on the part of the
Company or, to the knowledge of the Company, any of the
Company’s directors or officers, in their capacities as such,
to comply with any applicable provisions of the Sarbanes-Oxley Act
and the rules and regulations promulgated thereunder. Each of the
principal executive officer and the principal financial officer of
the Company (or each former principal executive officer of the
Company and each former principal financial officer of the Company
as applicable) has made all certifications required by Sections 302
and 906 of the Sarbanes-Oxley Act with respect to all reports,
schedules, forms, statements and other documents required to be
filed by it or furnished by it to the Commission during the past 12
months. For purposes of the preceding sentence, “principal
executive officer” and “principal financial
officer” shall have the meanings given to such terms in the
Exchange Act Rules 13a-15 and 15d-15.
dd.
Finder’s
Fees.
Neither the Company nor any Subsidiary has incurred
any liability for any finder’s fees, brokerage commissions or
similar payments in connection with the transactions herein
contemplated, except as may otherwise exist with respect to B.
Riley FBR pursuant to this Agreement.
ee.
Labor
Disputes.
No labor disturbance by or dispute with employees
of the Company or any Subsidiary exists or, to the knowledge of the
Company, is threatened which would reasonably be expected to result
in a Material Adverse Effect.
ff.
Investment
Company Act.
Neither the Company nor any Subsidiary is or,
after giving effect to the offering and sale of the Placement
Shares, will be an “investment company” or an entity
“controlled” by an “investment company,” as
such terms are defined in the Investment Company Act of 1940, as
amended (the “
Investment Company
Act
”).
gg.
Operations.
The
operations of the Company and the Subsidiaries are and have been
conducted at all times in compliance with applicable financial
record keeping and reporting requirements of the Currency and
Foreign Transactions Reporting Act of 1970, as amended, the money
laundering statutes of all jurisdictions to which the Company or
the Subsidiaries are subject, 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
”),
except as would not reasonably be expected to result in a Material
Adverse Effect; and no action, suit or proceeding by or before any
court or governmental agency, authority or body or any arbitrator
involving the Company or any Subsidiary with respect to the Money
Laundering Laws is pending or, to the knowledge of the Company,
threatened.
hh.
Off-Balance
Sheet Arrangements.
There are no transactions, arrangements
and other relationships between and/or among the Company, and/or,
to the knowledge of the Company, any of its affiliates and any
unconsolidated entity, including, but not limited to, any
structured finance, special purpose or limited purpose entity
(each, an “
Off
Balance Sheet Transaction
”) that could reasonably be
expected to affect materially the Company’s liquidity or the
availability of or requirements for its capital resources,
including those Off Balance Sheet Transactions described in the
Commission’s Statement about Management’s Discussion
and Analysis of Financial Conditions and Results of Operations
(Release Nos. 33-8056; 34-45321; FR-61), required to be described
in the Registration Statement or the Prospectus which have not been
described as required.
ii.
Underwriter
Agreements.
The Company is not a party to any agreement with
an agent or underwriter for any other “at the market”
or continuous equity transaction.
jj.
ERISA.
To the
knowledge of the Company, each material employee benefit plan,
within the meaning of Section 3(3) of the Employee Retirement
Income Security Act of 1974, as amended (“
ERISA
”), that is
maintained, administered or contributed to by the Company or any of
its affiliates for employees or former employees of the Company and
the Subsidiaries has been maintained in material compliance with
its terms and the requirements of any applicable statutes, orders,
rules and regulations, including but not limited to ERISA and the
Internal Revenue Code of 1986, as amended (the “
Code
”); no prohibited
transaction, within the meaning of Section 406 of ERISA or Section
4975 of the Code, has occurred which would result in a material
liability to the Company with respect to any such plan excluding
transactions effected pursuant to a statutory or administrative
exemption; and for each such plan that is subject to the funding
rules of Section 412 of the Code or Section 302 of ERISA, no
“accumulated funding deficiency” as defined in Section
412 of the Code has been incurred, whether or not waived, and the
fair market value of the assets of each such plan (excluding for
these purposes accrued but unpaid contributions) exceeds the
present value of all benefits accrued under such plan determined
using reasonable actuarial assumptions.
kk.
Forward-Looking
Statements.
No forward-looking statement (within the meaning
of Section 27A of the Securities Act and Section 21E of the
Exchange Act) (a “
Forward-Looking
Statement
”) contained in the Registration Statement
and the Prospectus has been made or reaffirmed without a reasonable
basis or has been disclosed other than in good faith. The
Forward-Looking Statements incorporated by reference in the
Registration Statement and the Prospectus from the Company’s
Annual Report on Form 10-K for the fiscal year most recently ended
(i) except for any Forward-Looking Statement included in any
financial statements and notes thereto, are within the coverage of
the safe harbor for forward looking statements set forth in Section
27A of the Securities Act, Rule 175(b) under the Securities Act or
Rule 3b-6 under the Exchange Act, as applicable, (ii) were made by
the Company with a reasonable basis and in good faith and reflect
the Company’s good faith commercially reasonable best
estimate of the matters described therein as of the respective
dates on which such statements were made, and (iii) have been
prepared in accordance with Item 10 of Regulation S-K under the
Securities Act.
ll.
Margin
Rules
. 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.
mm.
Insurance.
The
Company and the Subsidiaries carry, or are covered by, insurance in
such amounts and covering such risks as the Company and the
Subsidiaries reasonably believe are adequate for the conduct of
their business and as is customary for companies of similar size
engaged in similar businesses in similar industries.
nn.
No Improper
Practices.
(i) Neither the Company nor, to the
Company’s knowledge, the Subsidiaries, nor to the
Company’s knowledge, any of their respective executive
officers has, in the past five years, made any unlawful
contributions to any candidate for any political office (or failed
fully to disclose any contribution in violation of law) or made any
contribution or other payment to any official of, or candidate for,
any federal, state, municipal, or foreign office or other person
charged with similar public or quasi-public duty in violation of
any law or of the character required to be disclosed in the
Prospectus; (ii) no relationship, direct or indirect, exists
between or among the Company or, to the Company’s knowledge,
the Subsidiaries or any affiliate of any of them, on the one hand,
and the directors, officers and stockholders of the Company or, to
the Company’s knowledge, the Subsidiaries, on the other hand,
that is required by the Securities Act to be described in the
Registration Statement and the Prospectus that is not so described;
(iii) no relationship, direct or indirect, exists between or among
the Company or the Subsidiaries or any affiliate of them, on the
one hand, and the directors, officers, stockholders or directors of
the Company or, to the Company’s knowledge, the Subsidiaries,
on the other hand, that is required by the rules of FINRA to be
described in the Registration Statement and the Prospectus that is
not so described; (iv) there are no material outstanding loans or
advances or material guarantees of indebtedness by the Company or,
to the Company’s knowledge, the Subsidiaries to or for the
benefit of any of their respective officers or directors or any of
the members of the families of any of them; and (v) the Company has
not offered, or caused any placement agent to offer, Common Stock
to any person with the intent to influence unlawfully (A) a
customer or supplier of the Company or the Subsidiaries to alter
the customer’s or supplier’s level or type of business
with the Company or the Subsidiaries or (B) a trade journalist or
publication to write or publish favorable information about the
Company or the Subsidiaries or any of their respective products or
services, and, (vi) neither the Company nor the Subsidiaries nor,
to the Company’s knowledge, any employee or agent of the
Company or the Subsidiaries has made any payment of funds of the
Company or the Subsidiaries or received or retained any funds in
violation of any law, rule or regulation (including, without
limitation, the Foreign Corrupt Practices Act of 1977), which
payment, receipt or retention of funds is of a character required
to be disclosed in the Registration Statement or the
Prospectus.
oo.
Status Under the
Securities Act.
The Company was not and is not an ineligible
issuer as defined in Rule 405 at the times specified in Rules 164
and 433 under the Securities Act in connection with the offering of
the Placement Shares.
pp.
No Misstatement or
Omission in an Issuer Free Writing Prospectus.
Each Issuer
Free Writing Prospectus, as of its issue date and as of each
Applicable Time (as defined in
Section 25
below), 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. The foregoing sentence does not apply to
statements in or omissions from any Issuer Free Writing Prospectus
based upon and in conformity with written information furnished to
the Company by B. Riley FBR specifically for use
therein.
qq.
No Conflicts.
Neither the execution of this Agreement, nor the issuance, offering
or sale of the Placement Shares, nor the consummation of any of the
transactions contemplated herein, nor the compliance by the Company
with the terms and provisions hereof will conflict with, or will
result in a breach of, any of the terms and provisions of, or has
constituted or will constitute a default under, or has resulted in
or will result in the creation or imposition of any lien, charge or
encumbrance upon any property or assets of the Company pursuant to
the terms of any contract or other agreement to which the Company
may be bound or to which any of the property or assets of the
Company is subject, except (i) such conflicts, breaches or defaults
as may have been waived and (ii) such conflicts, breaches and
defaults that would not reasonably be expected to have a Material
Adverse Effect; nor will such action result (x) in any violation of
the provisions of the organizational or governing documents of the
Company, or (y) in any material violation of the provisions of any
statute or any order, rule or regulation applicable to the Company
or of any court or of any federal, state or other regulatory
authority or other government body having jurisdiction over the
Company, except where such violation would not reasonably be
expected to have a Material Adverse Effect.
rr.
Compliance with Applicable
Laws
. The Company and the Subsidiaries: (A) are and at all
times have been in material compliance with all statutes, rules and
regulations applicable to the ownership, testing, development,
manufacture, packaging, processing, use, distribution, marketing,
labeling, promotion, sale, offer for sale, storage, import, export
or disposal of any product under development, manufactured or
distributed by the Company or the Subsidiaries (“
Applicable Laws
”), (b)
have not received any Form 483 from the FDA, notice of adverse
finding, warning letter, or other written correspondence or notice
from the FDA, the European Medicines Agency (the
“
EMA
”),
or any other federal, state, local or foreign governmental or
regulatory authority alleging or asserting material noncompliance
with any Applicable Laws or any licenses, certificates, approvals,
clearances, authorizations, permits and supplements or amendments
thereto required by any such Applicable Laws (“
Authorizations
”), which
would, individually or in the aggregate, result in a Material
Adverse Effect; (C) possess all material Authorizations and such
Authorizations are valid and in full force and effect and neither
the Company nor the Subsidiaries is in material violation of any
term of any such Authorizations; (D) have not received written
notice of any claim, action, suit, proceeding, hearing,
enforcement, investigation, arbitration or other action from the
FDA, the EMA, or any other federal, state, local or foreign
governmental or regulatory authority or third party alleging that
any Company product, operation or activity is in material violation
of any Applicable Laws or Authorizations and has no knowledge that
the FDA, the EMA, or any other federal, state, local or foreign
governmental or regulatory authority or third party is considering
any such claim, litigation, arbitration, action, suit,
investigation or proceeding against the Company; (E) have not
received notice that the FDA, EMA, or any other federal, state,
local or foreign governmental or regulatory authority has taken, is
taking or intends to take action to limit, suspend, modify or
revoke any material Authorizations and has no knowledge that the
FDA, EMA, or any other federal, state, local or foreign
governmental or regulatory authority is considering such action;
and (F) have filed, obtained, maintained or submitted all reports,
documents, forms, notices, applications, records, claims,
submissions and supplements or amendments as required by any
Applicable Laws or Authorizations except where the failure to file
such reports, documents, forms, notices, applications, records,
claims, submissions and supplements or amendments would not result
in a Material Adverse Effect, and that all such reports, documents,
forms, notices, applications, records, claims, submissions and
supplements or amendments were materially complete and correct on
the date filed (or were corrected or supplemented by a subsequent
submission).
ss.
Clinical Studies
.
All animal and other preclinical studies and clinical trials
conducted by the Company or on behalf of the Company were, and, if
still pending are, to the Company’s knowledge, being
conducted in all material respects in compliance with all
Applicable Laws and in accordance with experimental protocols,
procedures and controls generally used by qualified experts in the
preclinical study and clinical trials of new drugs and biologics as
applied to comparable products to those being developed by the
Company; the descriptions of the results of such preclinical
studies and clinical trials contained in the Registration Statement
and the Prospectus are accurate in all material respects, and,
except as set forth in the Registration Statement and the
Prospectus, the Company has no knowledge of any other clinical
trials or preclinical studies, the results of which reasonably call
into question the clinical trial or preclinical study results
described or referred to in the Registration Statement and the
Prospectus when viewed in the context in which such results are
described; and the Company has not received any written notices or
correspondence from the FDA, the EMA, or any other domestic or
foreign governmental agency requiring the termination or suspension
of any preclinical studies or clinical trials conducted by or on
behalf of the Company that are described in the Registration
Statement and the Prospectus or the results of which are referred
to in the Registration Statement and the Prospectus.
tt.
Compliance Program.
The Company has established and administers a compliance program
applicable to the Company, to assist the Company and the directors,
officers and employees of the Company in complying with applicable
regulatory guidelines (including, without limitation, those
administered by the FDA, the EMA, and any other foreign, federal,
state or local governmental or regulatory authority performing
functions similar to those performed by the FDA or EMA), except
where such noncompliance would not reasonably be expected to have a
Material Adverse Effect.
uu.
OFAC.
(i)
The Company represents that, neither the Company nor any Subsidiary
(collectively, the “
Entity
”) or any director,
officer, employee, agent, affiliate or representative of the
Entity, is a government, individual, or entity (in this paragraph
(uu), “
Person
”) that is, or is
owned or controlled by a Person that is:
(a)
the
subject of any sanctions administered or enforced by the U.S.
Department of Treasury’s Office of Foreign Assets Control
(“
OFAC
”), the United
Nations Security Council (“
UNSC
”), the European
Union (“
EU
”), Her Majesty’s
Treasury (“
HMT
”), or other relevant
sanctions authority (collectively, “
Sanctions
”),
nor
(b)
located,
organized or resident in a country or territory that is the subject
of Sanctions.
(ii)
The Entity represents and covenants that it will not, directly or
indirectly, knowingly use the proceeds of the offering, or lend,
contribute or otherwise make available such proceeds to any
subsidiary, joint venture partner or other Person:
(a)
to
fund or facilitate any activities or business of or with any Person
or in any country or territory that, at the time of such funding or
facilitation, is the subject of Sanctions; or
(b)
in
any other manner that will result in a violation of Sanctions by
any Person (including any Person participating in the offering,
whether as underwriter, advisor, investor or
otherwise).
(iii)
The Entity represents and covenants that, except as detailed in the
Prospectus, for the past 5 years, it has not knowingly engaged in,
is not now knowingly engaged in, and will not engage in, any
dealings or transactions with any Person, or in any country or
territory, that at the time of the dealing or transaction is or was
the subject of Sanctions.
vv.
Stock
Transfer Taxes.
On each Settlement Date, all stock transfer
or other taxes (other than income taxes) which are required to be
paid in connection with the sale and transfer of the Placement
Shares to be sold hereunder will be, or will have been, fully paid
or provided for by the Company and all laws imposing such taxes
will be or will have been fully complied with by the
Company.
Any
certificate signed by an officer of the Company and delivered to B.
Riley FBR or to counsel for B. Riley FBR pursuant to or in
connection with this Agreement shall be deemed to be a
representation and warranty by the Company, as applicable, to B.
Riley FBR as to the matters set forth therein.
7.
Covenants
of the Company
. The Company covenants and agrees with B.
Riley FBR that:
a.
Registration
Statement Amendments.
After the date of this Agreement and
during any period in which a prospectus relating to any Placement
Shares is required to be delivered by B. Riley FBR under the
Securities Act (including in circumstances where such requirement
may be satisfied pursuant to Rule 172 under the Securities Act)
(the
“Prospectus
Delivery Period
”) (i) the Company will notify B. Riley
FBR promptly of the time when any subsequent amendment to the
Registration Statement, other than documents incorporated by
reference or amendments not related to any Placement, has been
filed with the Commission and/or has become effective or any
subsequent supplement to the Prospectus has been filed and of any
request by the Commission for any amendment or supplement to the
Registration Statement or Prospectus related to the Placement or
for additional information related to the Placement, (ii) the
Company will prepare and file with the Commission, promptly upon B.
Riley FBR’s request, any amendments or supplements to the
Registration Statement or Prospectus that, in B. Riley FBR’s
reasonable opinion, may be necessary or advisable in connection
with the distribution of the Placement Shares by B. Riley FBR
(
provided, however
, that
the failure of B. Riley FBR to make such request shall not relieve
the Company of any obligation or liability hereunder, or affect B.
Riley FBR’s right to rely on the representations and
warranties made by the Company in this Agreement and provided,
further, that the only remedy B. Riley FBR shall have with respect
to the failure to make such filing shall 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 relating to the Placement
Shares or a security convertible into the Placement Shares unless a
copy thereof has been submitted to B. Riley FBR within a reasonable
period of time before the filing and B. Riley FBR has not
reasonably objected thereto (
provided, however
, that (A) the failure
of B. Riley FBR to make such objection shall not relieve the
Company of any obligation or liability hereunder, or affect B.
Riley FBR’s right to rely on the representations and
warranties made by the Company in this Agreement and (B) the
Company has no obligation to provide B. Riley FBR any advance copy
of such filing or to provide B. Riley FBR an opportunity to object
to such filing if the filing does not name B. Riley FBR or does not
relate to the transaction herein provided; and provided, further,
that the only remedy B. Riley FBR shall have with respect to the
failure by the Company to obtain such consent shall be to cease
making sales under this Agreement) and the Company will furnish to
B. Riley FBR at the time of filing thereof a copy of any document
that upon filing is deemed to be incorporated by reference into the
Registration Statement or Prospectus, except for those documents
available via EDGAR; and (iv) the Company will cause each amendment
or supplement to the Prospectus to be filed with the Commission as
required pursuant to the applicable paragraph of Rule 424(b) of the
Securities Act or, in the case of any document to be incorporated
therein by reference, to be filed with the Commission as required
pursuant to the Exchange Act, within the time period prescribed
(the determination to file or not file any amendment or supplement
with the Commission under this
Section 7(a)
, based on the
Company’s reasonable opinion or reasonable objections, shall
be made exclusively by the Company).
b.
Notice
of Commission Stop Orders.
The Company will advise B. Riley
FBR, 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 B.
Riley FBR 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 any Issuer Free Writing
Prospectus or for additional information related to the offering of
the Placement Shares or for additional information related to the
Registration Statement, the Prospectus or any Issuer Free Writing
Prospectus.
c.
Delivery
of Prospectus; Subsequent Changes.
During the Prospectus
Delivery Period, the Company will comply with all requirements
imposed upon it by the Securities Act, as from time to time in
force, and to file on or before their respective due dates 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 the Company has omitted any information from the
Registration Statement pursuant to Rule 430A under the Securities
Act, it will use its commercially reasonable efforts to comply with
the provisions of and make all requisite filings with the
Commission pursuant to said Rule 430A and to notify B. Riley FBR
promptly of all such filings. If during the Prospectus Delivery
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 Prospectus Delivery
Period it is necessary to amend or supplement the Registration
Statement or Prospectus to comply with the Securities Act, the
Company will promptly notify B. Riley FBR 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;
provided, however
, that the Company may
delay the filing of any amendment or supplement, if in the judgment
of the Company, it is in the best interest of the
Company.
d.
Listing
of Placement Shares.
During the Prospectus Delivery Period,
the Company will use its commercially reasonable efforts to cause
the Placement Shares to be listed on the Exchange and to qualify
the Placement Shares for sale under the securities laws of such
jurisdictions in the United States as B. Riley FBR reasonably
designates and to continue such qualifications in effect so long as
required for the distribution of the Placement Shares;
provided, however
, that the Company
shall not be required in connection therewith to qualify as a
foreign corporation or dealer in securities or file a general
consent to service of process in any jurisdiction.
e.
Delivery
of Registration Statement and Prospectus.
The Company will
furnish to B. Riley FBR and its counsel (at the reasonable expense
of the Company) copies of the Registration Statement, the
Prospectus (including all documents incorporated by reference
therein) and all amendments and supplements to the Registration
Statement or Prospectus that are filed with the Commission during
the Prospectus Delivery Period (including all documents filed with
the Commission during such period that are deemed to be
incorporated by reference therein), in each case as soon as
reasonably practicable and in such quantities as B. Riley FBR may
from time to time reasonably request and, at B. Riley FBR’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 B. Riley FBR to the extent such
document is available on EDGAR.
f.
Earnings
Statement.
The Company will make generally available to its
security holders 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) and Rule 158 of the
Securities Act.
g.
Use
of Proceeds.
The Company will use the Net Proceeds as
described in the Prospectus in the section entitled “Use of
Proceeds.”
h.
Notice of Other
Sales.
Without the prior written consent of B. Riley FBR,
the Company will not, directly or indirectly, offer to sell, sell,
contract to sell, grant any option to sell or otherwise dispose of
any Common Stock (other than the Placement Shares offered pursuant
to this Agreement) or securities convertible into or exchangeable
for Common Stock, warrants or any rights to purchase or acquire,
Common Stock during the period beginning on the date on which any
Placement Notice is delivered to B. Riley FBR hereunder and ending
on the third (3rd) 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” or continuous equity transaction offer
to sell, sell, contract to sell, grant any option to sell or
otherwise dispose of any Common Stock (other than the Placement
Shares offered pursuant to this Agreement) or securities
convertible into or exchangeable for Common Stock, warrants or any
rights to purchase or acquire, Common Stock prior to the
termination of this Agreement;
provided, however
, that such
restrictions will not be required in connection with the
Company’s issuance or sale of (i) Common Stock, options to
purchase Common Stock or Common Stock issuable upon the exercise of
options, pursuant to any employee or director stock option or
benefits plan, stock ownership plan or dividend reinvestment plan
(but not 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) 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 B. Riley
FBR, and (iii) Common Stock, or securities convertible into or
exercisable for Common Stock, offered and sold in a privately
negotiated transaction to vendors, customers, strategic partners or
potential strategic partners or other investors conducted in a
manner so as not to be integrated with the offering of Common Stock
hereby.
i.
Change
of Circumstances.
The Company will, at any time during the
pendency of a Placement Notice advise B. Riley FBR promptly after
it shall have received notice or obtained knowledge thereof, of any
information or fact that would alter or affect in any material
respect any opinion, certificate, letter or other document required
to be provided to B. Riley FBR pursuant to this
Agreement.
j.
Due
Diligence Cooperation.
During the term of this Agreement,
the Company will cooperate with any reasonable due diligence review
conducted by B. Riley FBR or its representatives in connection with
the transactions contemplated hereby, including, without
limitation, providing information and making available documents
and senior corporate officers, during regular business hours and at
the Company’s principal offices, as B. Riley FBR may
reasonably request.
k.
Required
Filings Relating to Placement of Placement Shares.
The
Company agrees that on 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 (each and every filing under Rule 424(b), a
“
Filing
Date
”), which prospectus supplement will set forth,
within the relevant period, the amount of Placement Shares sold
through B. Riley FBR, the Net Proceeds to the Company and the
compensation payable by the Company to B. Riley FBR 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.
l.
Representation
Dates; Certificate.
Each time during the term of this
Agreement that the Company:
(i)
amends or supplements (other than a prospectus supplement relating
solely to an offering of securities other than the Placement
Shares) the Registration Statement or the Prospectus relating to
the Placement Shares by means of a post-effective amendment,
sticker, or supplement but not by means of incorporation of
documents 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 its quarterly reports on Form 10-Q under the Exchange Act;
or
(iv)
files a current report on Form 8-K containing amended
financial information (other than information
“furnished” pursuant to Items 2.02 or 7.01 of Form 8-K
or to provide disclosure pursuant to Item 8.01 of Form 8-K relating
to the reclassification of certain properties as discontinued
operations in accordance with Statement of Financial Accounting
Standards No. 144) 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.
”)
the
Company shall furnish B. Riley FBR (but in the case of clause (iv)
above only if B. Riley FBR determines that the information
contained in such Form 8-K is material) with a certificate, in the
form attached hereto as
Exhibit 7(1)
. The requirement
to provide a certificate under this
Section 7(1)
shall be waived
for any Representation Date occurring at a time at which no
Placement Notice is pending, which waiver shall continue until the
earlier to occur of the date the Company delivers a Placement
Notice hereunder (which for such calendar quarter shall be
considered a Representation Date) and the next occurring
Representation Date on which the Company files its annual report on
Form 10-K. Notwithstanding the foregoing, (i) upon the delivery of
the first Placement Notice hereunder and (ii) if the Company
subsequently decides to sell Placement Shares following a
Representation Date when the Company relied on such waiver and did
not provide B. Riley FBR with a certificate under this
Section 7(1)
, then before B.
Riley FBR sells any Placement Shares, the Company shall provide B.
Riley FBR with a certificate, in the form attached hereto as
Exhibit 7(1)
, dated
the date of the Placement Notice.
m.
Legal
Opinion.
On or prior to the date of the first Placement
Notice given hereunder the Company shall cause to be furnished to
B. Riley FBR written opinions and a negative assurance letter of
Wyrick Robbins Yates & Ponton LLP (“
Company Counsel
”), or
other counsel reasonably satisfactory to B. Riley FBR, in the form
attached hereto as Exhibit 7(m)(1) and 7(m)(2), respectively.
Thereafter, within five (5) Trading Days of each Representation
Date with respect to which the Company is obligated to deliver a
certificate in the form attached hereto as Exhibit 7(l) for which
no waiver is applicable, the Company shall
cause to be furnished to B. Riley FBR a written letter of Company
Counsel in the form attached hereto as Exhibit 7(m)(2), modified,
as necessary, to relate to the Registration Statement and the
Prospectus as then amended or supplemented;
provided that
, in lieu of such negative
assurance for subsequent periodic filings under the Exchange Act,
counsel may furnish B. Riley FBR with a letter (a
“
Reliance
Letter
”) to the effect that B. Riley FBR may rely on
the negative assurance letter previously delivered under this
Section 7(m) to the same extent as if it were dated the date of
such letter (except that statements in such prior letter shall be
deemed to relate to the Registration Statement and the Prospectus
as amended or supplemented as of the date of the Reliance
Letter).
n.
Comfort
Letter.
On or prior to the date of the first Placement
Notice given hereunder and within five (5) Trading Days after each
subsequent Representation Date, other than pursuant to
Section 7(l)(iii)
, the Company
shall cause its independent accountants to furnish B. Riley FBR
letters (the “
Comfort Letters
”), dated
the date the Comfort Letter is delivered, which shall meet the
requirements set forth in this
Section 7(n)
; provided, that if
requested by B. Riley FBR, the Company shall cause a Comfort Letter
to be furnished to B. Riley FBR within ten (10) Trading Days of
such request following the date of occurrence of any restatement of
the Company’s financial statements. The Comfort Letter from
the Company’s independent accountants shall be in a form and
substance reasonably satisfactory to B. Riley FBR, (i) confirming
that they are an independent public accounting firm within the
meaning of the Securities Act and the PCAOB, (ii) stating, 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) updating 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.
o.
Market
Activities.
The Company will not, directly or indirectly,
(i) take any action designed to cause or result in, or that
constitutes or would 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 Common Stock or (ii)
sell, bid for, or purchase Common Stock in violation of Regulation
M, or pay anyone any compensation for soliciting purchases of the
Placement Shares other than B. Riley FBR.
p.
Investment
Company Act.
The Company will conduct its affairs in such a
manner so as to reasonably ensure that neither it nor the
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.
q.
No
Offer to Sell.
Other than an Issuer Free Writing Prospectus
approved in advance by the Company and B. Riley FBR in its capacity
as agent hereunder pursuant to
Section 23
, neither B. Riley
FBR nor the Company (including its agents and representatives,
other than B. Riley FBR in their capacity as such) will make, use,
prepare, authorize, approve or refer to any written communication
(as defined in Rule 405), required to be filed with the Commission,
that constitutes an offer to sell or solicitation of an offer to
buy Placement Shares hereunder.
r.
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 consolidated 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, without
limitation, 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 or
the Subsidiaries is made known to them by others within those
entities, particularly during the period in which such periodic
reports are being prepared.
8.
Representations
and Covenants of B. Riley FBR.
B. Riley FBR represents and
warrants that it is duly registered as a broker-dealer under FINRA,
the Exchange Act and the applicable statutes and regulations of
each state in which the Placement Shares will be offered and sold,
except such states in which B. Riley FBR is exempt from
registration or such registration is not otherwise required. B.
Riley FBR shall continue, for the term of this Agreement, to be
duly registered as a broker-dealer under FINRA, the Exchange Act
and the applicable statutes and regulations of each state in which
the Placement Shares will be offered and sold, except such states
in which B. Riley FBR is exempt from registration or such
registration is not otherwise required, during the term of this
Agreement. B. Riley FBR shall comply with all applicable law and
regulations, including but not limited to Regulation M, in
connection with the transactions contemplated by this Agreement,
including the issuance and sale through B. Riley FBR of the
Placement Shares.
9.
Payment
of Expenses.
The Company will pay all expenses incident to
the performance of its obligations under this Agreement, including
(i) the preparation, filing, including any fees required by the
Commission, and printing of the Registration Statement (including
financial statements and exhibits) as originally filed and of each
amendment and supplement thereto and each Free Writing Prospectus,
in such number as B. Riley FBR shall deem reasonably necessary,
(ii) the printing and delivery to B. Riley FBR 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, (iii) the preparation, issuance and delivery of the
certificates, if any, for the Placement Shares to B. Riley FBR,
including any stock or other transfer taxes and any capital duties,
stamp duties or other duties or taxes payable upon the sale,
issuance or delivery of the Placement Shares to B. Riley FBR, (iv)
the fees and disbursements of the counsel, accountants and other
advisors to the Company, (v) the fees and disbursements of counsel
to B. Riley FBR up to $25,000, (vi) the fees and expenses of the
transfer agent and registrar for the Common Stock, (vii) the filing
fees incident to any review by FINRA of the terms of the sale of
the Placement Shares, and (viii) the fees and expenses incurred in
connection with the listing of the Placement Shares on the
Exchange.
10.
Conditions
to B. Riley FBR’s Obligations.
The obligations of B.
Riley FBR 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 by
the Company of its obligations hereunder, to the completion by B.
Riley FBR of a due diligence review satisfactory to it in its
reasonable judgment, and to the continuing satisfaction (or waiver
by B. Riley FBR in its sole discretion) of the following additional
conditions:
a.
Registration
Statement Effective.
The Registration Statement shall have
become effective and shall be available for the sale of all
Placement Shares contemplated to be issued by any Placement
Notice.
b.
No
Material Notices.
None of the following events shall have
occurred and be continuing: (i) receipt by the Company 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 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 document incorporated or deemed to be incorporated therein
by reference untrue in any material respect or that requires the
making of any changes in the Registration Statement, the Prospectus
or documents so that, in the case of the Registration Statement, it
will not contain any materially 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, that
in the case of the Prospectus, it will not contain any materially
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.
c.
No
Misstatement or Material Omission.
B. Riley FBR 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 B. Riley FBR’s reasonable
opinion is material, or omits to state a fact that in B. Riley
FBR’s reasonable opinion is material and is required to be
stated therein or is necessary to make the statements therein not
misleading.
d.
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 Effect, or any
development that could reasonably be expected to cause a Material
Adverse Effect, or a downgrading in or withdrawal of the rating
assigned to any of the Company’s securities (other than asset
backed securities) 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), the effect of
which, in the case of any such action by a rating organization
described above, in the reasonable judgment of B. Riley FBR
(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.
e.
Legal
Opinion.
B. Riley FBR shall have received the opinions and
negative assurances of Company Counsel required to be delivered
pursuant
Section
7(m)
on or before the date on which such delivery of such
opinions are required pursuant to
Section 7(m)
.
f.
Comfort
Letter.
B. Riley FBR shall have received the Comfort Letter
required to be delivered pursuant
Section 7(n)
on or before the
date on which such delivery of such letter is required pursuant to
Section
7(n)
.
g.
Representation
Certificate.
B. Riley FBR shall have received the
certificate required to be delivered pursuant to
Section 7(1)
on or before the
date on which delivery of such certificate is required pursuant to
Section
7(1)
.
h.
Secretary’s
Certificate
. On the date of this Agreement, B. Riley FBR
shall have received a certificate, signed on behalf of the Company
by its corporate Secretary, in form and substance reasonably
satisfactory to B. Riley FBR and its counsel.
i.
No
Suspension.
Trading in the Common Stock shall not have been
suspended on the Exchange and the Common Stock shall not have been
delisted from the Exchange.
j.
Other
Materials.
On each date on which the Company is required to
deliver a certificate pursuant to
Section 7(1)
, the Company shall
have furnished to B. Riley FBR such appropriate further
information, certificates and documents as B. Riley FBR may
reasonably request. All such opinions, certificates, letters and
other documents will be in compliance with the provisions hereof.
The Company will furnish B. Riley FBR with such conformed copies of
such opinions, certificates, letters and other documents as B.
Riley FBR shall reasonably request.
k.
Securities Act Filings
Made.
All filings with the Commission required by Rule 424
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.
l.
Approval for
Listing.
The Placement Shares shall either have been
approved for listing on the Exchange, subject only to notice of
issuance, or the Company shall have filed an application for
listing of the Placement Shares on the Exchange at, or prior to,
the issuance of any Placement Notice.
m.
No
Termination Event.
There shall not have occurred any event
that would permit B. Riley FBR to terminate this Agreement pursuant
to
Section
13(a)
.
11.
Indemnification and
Contribution.
(a)
Company
Indemnification.
The Company agrees to indemnify and
hold
harmless B. Riley
FBR, its partners, members, directors, officers, employees and
agents and each person, if any, who controls B. Riley FBR within
the meaning of Section 15 of the Securities Act or Section 20 of
the Exchange Act as follows:
(i)
against
any and all loss, liability, claim, damage and expense whatsoever,
as incurred, joint or several, arising out of or based upon any
untrue statement or alleged untrue statement of a material fact
contained in the Registration Statement (or any amendment thereto),
or the omission or alleged omission therefrom of a material fact
required to be stated therein or necessary to make the statements
therein not misleading, or arising out of any untrue statement or
alleged untrue statement of a material fact included in any related
Issuer Free Writing Prospectus or the Prospectus (or any amendment
or supplement thereto), or the omission or alleged omission
therefrom of a material fact necessary in order to make the
statements therein, in the light of the circumstances under which
they were made, not misleading;
(ii)
against
any and all loss, liability, claim, damage and expense whatsoever,
as incurred, joint or several, to the extent of the aggregate
amount paid in settlement of any litigation, or any investigation
or proceeding by any governmental agency or body, commenced or
threatened, or of any claim whatsoever based upon any such untrue
statement or omission, or any such alleged untrue statement or
omission; provided that (subject to
Section 11(d)
below) any such
settlement is effected with the written consent of the Company,
which consent shall not unreasonably be delayed or withheld;
and
(iii)
against
any and all expense whatsoever, as incurred (including the fees and
disbursements of counsel), reasonably incurred in investigating,
preparing or defending against any litigation, or any investigation
or proceeding by any governmental agency or body, commenced or
threatened, or any claim whatsoever based upon any such untrue
statement or omission, or any such alleged untrue statement or
omission, to the extent that any such expense is not paid under (i)
or (ii) above.
Provided, however
, that this indemnity
agreement shall not apply to any loss, liability, claim, damage or
expense to the extent arising out of any untrue statement or
omission or alleged untrue statement or omission made solely in
reliance upon and in conformity with written information furnished
to the Company by B. Riley FBR expressly for use in the
Registration Statement (or any amendment thereto), or in any
related Issuer Free Writing Prospectus or the Prospectus (or any
amendment or supplement thereto).
(b)
B. Riley FBR
Indemnification.
B. Riley FBR agrees to indemnify and hold
harmless the Company and its directors and each officer of the
Company who 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 11(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 in any related Issuer Free Writing
Prospectus or the Prospectus (or any amendment or supplement
thereto) in reliance upon and in conformity with information
relating to B. Riley FBR and furnished to the Company in writing by
B. Riley FBR expressly for use therein.
(c)
Procedure.
Any
party that proposes to assert the right to be indemnified under
this
Section 11
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 11
, 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
11
and (ii) any liability that it may have to any
indemnified party under the foregoing provision of this
Section 11
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 legal or other 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 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 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 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 11
(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 from all liability arising out of
such litigation, investigation, proceeding or claim 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.
(d)
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 11
is applicable in
accordance with its terms but for any reason is held to be
unavailable from the Company or B. Riley FBR, the Company and B.
Riley FBR 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 or proceeding or any claim
asserted, but after deducting any contribution received by the
Company from persons other than B. Riley FBR, such as persons who
control the Company within the meaning of the Securities Act or the
Exchange 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 B. Riley FBR may be subject
in such proportion as shall be appropriate to reflect the relative
benefits received by the Company on the one hand and B. Riley FBR
on the other hand. The relative benefits received by the Company on
the one hand and B. Riley FBR 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 B. Riley FBR
(before deducting expenses) 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 B. Riley FBR, on the other hand, with
respect to the statements or omission that resulted in such loss,
claim, liability, expense or damage, or action 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 B. Riley FBR, 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 B.
Riley FBR agree that it would not be just and equitable if
contributions pursuant to this
Section 11(d)
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 in respect thereof, referred to above
in this
Section
11(d)
shall be deemed to include, for the purpose of this
Section 11(d)
, any
legal or other expenses reasonably incurred by such indemnified
party in connection with investigating or defending any such action
or claim to the extent consistent with
Section 11(c)
hereof.
Notwithstanding the foregoing provisions of this
Section 11(d)
, B. Riley FBR
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 11(d)
, any person who
controls a party to this Agreement within the meaning of the
Securities Act or the Exchange Act, and any officers, directors,
partners, employees or agents of B. Riley FBR, will have the same
rights to contribution as that party, and each officer and director
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
11(d)
, 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 11(d)
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 11(c)
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
11(c)
hereof.
12.
Representations and
Agreements to Survive Delivery.
The indemnity and
contribution agreements contained in Section 11 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 B. Riley FBR, any controlling persons, or the Company (or
any of their respective officers, directors or controlling
persons), (ii) delivery and acceptance of the Placement Shares and
payment therefor or (iii) any termination of this
Agreement.
13.
Termination.
a. B.
Riley FBR may terminate this Agreement, by notice to the Company,
as hereinafter specified at any time (1) if there has been, since
the time of execution of this Agreement or since the date as of
which information is given in the Prospectus, any Material Adverse
Effect, or any development that is reasonably likely to have a
Material Adverse Effect or, in the sole judgment of B. Riley FBR,
is material and adverse and makes it impractical or inadvisable to
market the Placement Shares or to enforce contracts for the sale of
the Placement Shares, (2) if there has occurred any material
adverse change in the financial markets in the United States or the
international financial markets, any outbreak of hostilities or
escalation thereof or other calamity or crisis or any change or
development involving a prospective change in national or
international political, financial or economic conditions, in each
case the effect of which is such as to make it, in the judgment of
B. Riley FBR, impracticable or inadvisable to market the Placement
Shares or to enforce contracts for the sale of the Placement
Shares, (3) if trading in the Common Stock has been suspended or
limited by the Commission or the Exchange, or if trading generally
on the Exchange has been suspended or limited, or minimum prices
for trading have been fixed on the Exchange, (4) if any suspension
of trading of any securities of the Company on any exchange or in
the over-the-counter market shall have occurred and be continuing,
(5) if a major disruption of securities settlements or clearance
services in the United States shall have occurred and be
continuing, or (6) if a banking moratorium has been declared by
either U.S. Federal or New York authorities. Any such termination
shall be without liability of any party to any other party except
that the provisions of
Section
9 (Payment of
Expenses),
Section
11
(Indemnification and Contribution),
Section 12
(Representations and
Agreements to Survive Delivery),
Section 18
(Governing Law and
Time; Waiver of Jury Trial) and
Section 19
(Consent to
Jurisdiction) hereof shall remain in full force and effect
notwithstanding such termination. If B. Riley FBR elects to
terminate this Agreement as provided in this Section 13(a), B.
Riley FBR shall provide the required notice as specified in
Section 14
(Notices).
b. The
Company shall have the right, by giving ten (10) days 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 9
(Payment of
Expenses),
Section
11
(Indemnification and Contribution),
Section 12
(Representations and
Agreements to Survive Delivery),
Section 18
(Governing Law and
Time; Waiver of Jury Trial) and
Section 19
(Consent to
Jurisdiction) hereof shall remain in full force and effect
notwithstanding such termination.
c. B.
Riley FBR shall have the right, by giving ten (10) days 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 9
(Payment of
Expenses),
Section
11
(Indemnification and Contribution),
Section 12
(Representations and
Agreements to Survive Delivery),
Section 18
(Governing Law and
Time; Waiver of Jury Trial) and
Section 19
(Consent to
Jurisdiction) hereof shall remain in full force and effect
notwithstanding such termination.
d. Unless
earlier terminated pursuant to this
Section 13
, this Agreement
shall automatically terminate upon the issuance and sale of all of
the Placement Shares through B. Riley FBR on the terms and subject
to the conditions set forth herein except that the provisions of
Section 9
(Payment
of Expenses),
Section
11
(Indemnification and Contribution),
Section 12
(Representations and
Agreements to Survive Delivery),
Section 18
(Governing Law and
Time; Waiver of Jury Trial) and
Section 19
(Consent to
Jurisdiction) 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
13(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
9
(Payment of Expenses),
Section 11
(Indemnification and
Contribution),
Section
12
(Representations and Agreements to Survive Delivery),
Section 18
(Governing Law and Time; Waiver of Jury Trial) and
Section 19
(Consent to
Jurisdiction) shall remain in full force and effect. Upon
termination of this Agreement, the Company shall not have any
liability to B. Riley FBR for any discount, commission or other
compensation with respect to any Placement Shares not otherwise
sold by B. Riley FBR under this Agreement.
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 B. Riley FBR 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.
14.
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, and if
sent to B. Riley FBR, shall be delivered to:
B.
Riley FBR, Inc.
299
Park Avenue
New
York, NY 10171
Attention:
General Counsel
Telephone:
(212) 457-9947
Email:
atmdesk@brileyfbr.com
with a
copy to:
Duane
Morris LLP
One
Riverfront Plaza
1037
Raymond Boulevard, Suite 1800
Newark,
NJ 07102
Attention:
James T. Seery
Telephone:
(973) 424-2088
Email:
jtseery@duanemorris.com
and if
to the Company, shall be delivered to:
CorMedix
Inc.
400
Connell Drive, Suite 5000
Berkeley Heights,
NJ 07922
Attention:
Khoso Baluch
Telephone:
(908) 517-9500
Email:
kbaluch@cormedix.com
with a
copy to:
Wyrick
Robbins Yates & Ponton LLP
4101
Lake Boone Trail, Suite 300
Raleigh, NC
27607
Attention:
Alexander M. Donaldson
Telephone:
(919) 781-4000
Email:
adonaldson@wyrick.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, by email, or
by verifiable facsimile transmission (with an original to follow)
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) on the next Business Day after timely delivery to a
nationally-recognized overnight courier and (iii) 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 Exchange 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 14
if sent to the
electronic mail address specified in Schedule 3 hereof. Electronic
Notice shall be deemed received at the time the party sending
Electronic Notice receives confirmation of receipt by the receiving
party. 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 ten (10) days of receipt of the written request for
Nonelectronic Notice.
15.
Successors
and Assigns.
This Agreement shall inure to the benefit of
and be binding upon the Company and B. Riley FBR and their
respective successors and the affiliates, controlling persons,
officers and directors referred to in
Section 11
hereof. References
to any of the parties contained in this Agreement shall be deemed
to include the successors and permitted assigns of such party.
Nothing in this Agreement, express or implied, is intended to
confer upon any party other than the parties hereto or their
respective successors and permitted 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.
16.
Adjustments for Stock
Splits.
The parties acknowledge and agree that all
share-related numbers contained in this Agreement shall be adjusted
to take into account any share consolidation, stock split, stock
dividend, corporate domestication or similar event effected with
respect to the Placement Shares.
17.
Entire Agreement;
Amendment; Severability.
This Agreement (including all
schedules 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, between 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 B. Riley FBR. 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.
18.
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. THE COMPANY 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.
19.
CONSENT
TO JURISDICTION.
EACH PARTY HEREBY IRREVOCABLY SUBMITS TO
THE NON-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
TRANSACTION 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 THEREOF
(CERTIFIED OR REGISTERED MAIL, RETURN RECEIPT REQUESTED) TO SUCH
PARTY AT THE ADDRESS IN EFFECT FOR NOTICES TO IT UNDER THIS
AGREEMENT AND AGREES THAT SUCH SERVICE SHALL CONSTITUTE GOOD AND
SUFFICIENT SERVICE 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.
20.
Use
of Information.
B. Riley FBR may not use any information
gained in connection with this Agreement and the transactions
contemplated by this Agreement, including due diligence, to advise
any party with respect to transactions not expressly approved by
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
transmission.
22.
Effect
of Headings.
The section and Exhibit headings herein are for
convenience only and shall not affect the construction
hereof.
23.
Permitted
Free Writing Prospectuses.
The
Company represents, warrants and agrees that, unless it obtains the
prior consent of B. Riley FBR, and B. Riley FBR represents,
warrants and agrees that, unless it obtains the prior consent of
the Company, 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 B. Riley FBR 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,” as defined in Rule 433, and 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. For the
purposes of clarity, the parties hereto agree that all free writing
prospectuses, if any, listed in
Exhibit 23
hereto are Permitted
Free Writing Prospectuses.
24.
Absence
of Fiduciary Relationship.
The Company acknowledges and
agrees that:
a. B.
Riley FBR is acting solely as agent in connection with the public
offering of the Placement Shares and in connection with each
transaction contemplated by this Agreement and the process leading
to such transactions, 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 B. Riley FBR, on the other
hand, has been or will be created in respect of any of the
transactions contemplated by this Agreement, irrespective of
whether or not B. Riley FBR has advised or is advising the Company
on other matters, and B. Riley FBR has no obligation to the Company
with respect to the transactions contemplated by this Agreement
except the obligations expressly set forth in this
Agreement;
b. it
is capable of evaluating and understanding, and understands and
accepts, the terms, risks and conditions of the transactions
contemplated by this Agreement;
c. B.
Riley FBR has not 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. it
is aware that B. Riley FBR and its affiliates are engaged in a
broad range of transactions which may involve interests that differ
from those of the Company and B. Riley FBR has no obligation to
disclose such interests and transactions to the Company by virtue
of any fiduciary, advisory or agency relationship or otherwise;
and
e. it
waives, to the fullest extent permitted by law, any claims it may
have against B. Riley FBR for breach of fiduciary duty or alleged
breach of fiduciary duty in connection with the sale of Placement
Shares under this Agreement and agrees that B. Riley FBR shall not
have any liability (whether direct or indirect, in contract, tort
or otherwise) to it in respect of such a fiduciary duty claim or to
any person asserting a fiduciary duty claim on its behalf or in
right of it or the Company, employees or creditors of Company,
other than in respect of B. Riley FBR’s obligations under
this Agreement and to keep information provided by the Company to
B. Riley FBR and B. Riley FBR’s counsel confidential to the
extent not otherwise publicly-available.
25.
Definitions.
As used
in this Agreement, the following terms have the respective meanings
set forth below:
“
Applicable Time
” means
(i) each Representation Date and (ii) the time of each sale of any
Placement Shares pursuant to this Agreement.
“
Issuer Free Writing
Prospectus
” means any “issuer free writing
prospectus,” as defined in Rule 433, relating to the
Placement Shares that (1) is required to be filed with the
Commission by the Company, (2) is a “road show” that is
a “written communication” within the meaning of Rule
433(d)(8)(i) whether or not required to be filed with the
Commission, or (3) is exempt from filing pursuant to Rule
433(d)(5)(i) because it contains a description of the Placement
Shares or of the offering that does not reflect the final terms, 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) under the
Securities Act.
“
Rule 172
,”
“
Rule
405
,” “
Rule 415
,”
“
Rule
424
,” “
Rule 424(b)
,”
“
Rule
430B
,” and “
Rule 433
” refer to such
rules under the Securities Act.
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 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 any Issuer
Free Writing Prospectus (other than any Issuer Free Writing
Prospectuses that, pursuant to Rule 433, are not required to be
filed with the Commission) shall be deemed to include the copy
thereof filed with the Commission pursuant to EDGAR; and all
references in this Agreement to “supplements” to the
Prospectus shall include, without limitation, any supplements,
“wrappers” or similar materials prepared in connection
with any offering, sale or private placement of any Placement
Shares by B. Riley FBR outside of the United States.
[Remainder
of the page intentionally left blank]
If the
foregoing correctly sets forth the understanding between the
Company and B. Riley FBR, please so indicate in the space provided
below for that purpose, whereupon this Agreement shall constitute a
binding agreement between the Company and B. Riley
FBR.
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Very
truly yours,
CORMEDIX
INC.
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By:
|
/s/
Khoso
Baluch
|
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Name:
Khoso Baluch
|
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Title: Chief
Executive Officer
|
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ACCEPTED
as of the date first-above written:
B.
RILEY FBR, INC.
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By:
|
/s/
Patrice
McNicoll
|
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Name: Patrice
McNicoll
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Title:
Co-Head of Investment Banking
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SCHEDULE 1
FORM OF
PLACEMENT NOTICE
From:
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CorMedix
Inc.
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To:
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B.
Riley FBR, Inc.
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Attention:
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Patrice
McNicoll
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Subject:
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At
Market Issuance--Placement Notice
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Gentlemen:
Pursuant to the
terms and subject to the conditions contained in the At Market
Issuance Sales Agreement between CorMedix Inc., a Delaware
corporation (the “
Company
”), and B. Riley
FBR, Inc. (“
B. Riley
FBR
”), dated March 9, 2018, the Company hereby
requests that B. Riley FBR sell up to [_______] shares of the
Company’s Common Stock, $0.001 par value per share, at a
minimum market price of $___ per share, during the time period
beginning [month, day, time] and ending [month, day,
time].
SCHEDULE 2
Compensation
The
Company shall pay to B. Riley FBR in cash, upon each sale of
Placement Shares pursuant to this Agreement, an amount equal to
3.0% of the gross proceeds from each sale of Placement
Shares.
SCHEDULE 3
________________________
Notice Parties
________________________
The
Company
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Khoso
Baluch
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kbaluch@cormedix.com
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Robert
Cook
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rcook@cormedix.com
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B. Riley
FBR
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Matthew
Feinberg
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mfeinberg@brileyfbr.com
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Ryan
Loforte
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rloforte@brileyfbr.com
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Patrice
McNicoll
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pmcnicoll@brileyfbr.com
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Keith
Pompliano
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kpompliano@brileyfbr.com
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with a
copy to
atmdesk@brileyfbr.com
|
SCHEDULE 6(g)
________________________
Subsidiaries
________________________
CorMedix
Europe GmbH
EXHIBIT 7(1)
Form of Representation Date Certificate
________________, 20__
This
Representation Date Certificate (this “
Certificate
”) is executed
and delivered in connection with
Section 7(1)
of the At Market
Issuance Sales Agreement (the “
Agreement
”), dated March
9, 2018, and entered into between CorMedix Inc. (the
“
Company
”) and B. Riley
FBR, Inc. All capitalized terms used but not defined herein shall
have the meanings given to such terms in the
Agreement.
The
Company hereby certifies as follows:
1.
As
of the date of this Certificate (i) the Registration Statement 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 and (ii)
neither the Registration Statement nor the Prospectus 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 (iii) no event has occurred as a
result of which it is necessary to amend or supplement the
Prospectus in order to make the statements therein not untrue or
misleading for this paragraph 1 to be true.
2.
Each
of the representations and warranties of the Company contained in
the Agreement were, when originally made, and are, as of the date
of this Certificate, true and correct in all material
respects.
3.
Except
as waived by B. Riley FBR in writing, each of the covenants
required to be performed by the Company in the Agreement on or
prior to the date of the Agreement, this Representation Date, and
each such other date prior to the date hereof as set forth in the
Agreement, has been duly, timely and fully performed in all
material respects and each condition required to be complied with
by the Company on or prior to the date of the Agreement, this
Representation Date, and each such other date prior to the date
hereof as set forth in the Agreement has been duly, timely and
fully complied with in all material respects.
4.
Subsequent
to the date of the most recent financial statements in the
Prospectus, and except as described in the Prospectus, including
Incorporated Documents, there has been no Material Adverse
Effect.
5.
No stop order suspending
the effectiveness of the Registration Statement or of any part
thereof has been issued, and no proceedings for that purpose have
been instituted or are pending or threatened by any securities or
other governmental authority (including, without limitation, the
Commission).
6.
No order suspending the
effectiveness of the Registration Statement or the qualification or
registration of the Placement Shares under the securities or Blue
Sky laws of any
jurisdiction are in
effect and no proceeding for such purpose is pending before, or
threatened, to the Company’s knowledge or in writing by, any
securities or other governmental authority (including, without
limitation, the Commission).
The
undersigned has executed this Representation Date Certificate as of
the date first written above.
|
CORMEDIX
INC.
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By:
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Name:
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Title:
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EXHIBIT 7(m)(1)
Form of Legal Opinion
1. The
Company has been duly incorporated and is validly existing as a
corporation in good standing under the laws of the State of
Delaware. The Company is qualified to do business as a foreign
corporation under the laws of the State of New Jersey. The Company
has the corporate power and authority, and, to our knowledge, all
material governmental licenses, authorizations, consents and
approvals that are required to own, lease and operate its
properties and assets and to carry on its business as now conducted
(and described in the Company’s Annual Report on Form 10-K
for its fiscal year ended December 31, 20__).
2. The
Company has the corporate power and authority to (a) execute,
deliver and perform the Agreement, (b) to issue, sell and
deliver the Placement Shares pursuant to the Agreement and
(c) to carry out and perform its obligations under, and to
consummate the transactions contemplated by, the
Agreement.
3. All
action on the part of the Company, its directors and its
stockholders necessary for the authorization, execution and
delivery by the Company of the Agreement, the authorization,
issuance, sale and delivery of the Placement Shares pursuant to the
Agreement and the consummation by the Company of the transactions
contemplated by the Agreement has been duly taken. The Agreement
has been duly and validly authorized, executed and delivered by the
Company.
4. All
presently issued and outstanding shares of Common Stock have been
duly authorized and validly issued and are fully paid and
nonassessable and free of any preemptive or similar rights arising
by operation of the Certificate of Incorporation or Bylaws or the
General Corporation Law of the State of Delaware, and, to our
knowledge, have been issued in compliance with applicable
securities laws and regulations. To our knowledge, except for
rights described or referred to in the Prospectus, there are no
other options, warrants, conversion privileges or other rights
presently outstanding to purchase or otherwise acquire from the
Company any capital stock or other securities of the Company, or
any other agreements to issue any such securities or rights. The
Placement Shares have been duly authorized and, when issued and
paid for pursuant to the terms of the Agreement, will be validly
issued, fully paid and nonassessable and free of any preemptive or
similar rights arising by operation of the Certificate of
Incorporation or Bylaws or the General Corporation Law of the State
of Delaware or, to our knowledge, rights of first refusal or other
similar rights to subscribe for the Placement Shares.
5. The
Registration Statement filed with the Commission (No. 333-_____)
which registers the sale of the Placement Shares is currently
effective and no stop order suspending the effectiveness of the
Registration Statement has been issued and no proceedings for that
purpose have been instituted or, to our knowledge, threatened. Any
required filing of the Prospectus pursuant to Rule 424(b) under the
Securities Act has been made in the manner and within the time
required by Rule 424(b).
6. The
Registration Statement and the Prospectus and the documents
incorporated therein by reference (other than the financial
statements and schedules and other financial data included or
incorporated by reference therein, as to which we express no
opinion), complied as of their respective effective or filing dates
in all material respects as to form with the requirements of the
Securities Act and the rules and regulations of the Commission
promulgated thereunder.
7. The
execution, delivery and performance by the Company of, and the
compliance by the Company with the terms of, the Agreement and the
issuance, sale and delivery of the Placement Shares pursuant to the
Agreement do not (a) conflict with or result in a violation of
any provision of law, rule or regulation or any rule or regulation
of any securities exchange applicable to the Company or of the
Certificate of Incorporation or Bylaws of the Company,
(b) conflict with, result in a breach of or constitute a
default (or an event which with notice or lapse of time or both
would become a default) under, or result in or permit the
termination or modification of, any agreement filed or incorporated
by reference as an exhibit to the Company’s Annual Report on
the Form 10-K for the year ended December 31, 20__, or any
instrument, order, writ, judgment or decree known to us to which
the Company is a party or is subject that would result in a
Material Adverse Change or (c) to our knowledge, result in the
creation or imposition of any lien, claim or encumbrance on any of
the assets or properties of the Company that would result in a
Material Adverse Change.
8. To
our knowledge, there is (i) no claim, action, suit,
proceeding, arbitration, investigation or inquiry, pending or
threatened, before any court or governmental or administrative body
or agency, or any private arbitration tribunal, against the
Company, or any of the officers, directors or employees (in
connection with the discharge of their duties as officers,
directors and employees) of the Company, or affecting any of its
properties or assets and (ii) no indenture, contract, lease,
mortgage, deed of trust, note agreement, loan or other agreement or
instrument of a character required to be filed as an exhibit to the
Registration Statement, which is not filed as required by the
Securities Act and the rules thereunder.
9. In
connection with the valid execution, delivery and performance by
the Company of the Agreement, or the offer, sale, issuance or
delivery of the Placement Shares or the consummation of the
transactions contemplated thereby, no consent, license, permit,
waiver, approval or authorization of, or designation, declaration,
registration or filing with, any governmental or regulatory
authority, self-regulatory organization, or court is
required.
10.
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 within the meaning of the Investment Company Act of 1940,
as amended.
11.
The information included in the Registration Statement and the
Prospectus under the caption “Description of Common
Stock,” to the extent that it constitutes matters of law,
summaries of legal matters, documents referred to therein or legal
conclusions, has been reviewed by us and fairly summarizes the
matters set forth therein in all material respects.
EXHIBIT
7(m)(2)
Form of Negative Assurance Letter
We
advise you that no facts have come to our attention that lead us to
believe that (
in each case, except for
financial statements and schedules and other financial data and
management’s report on the effectiveness of internal control
over financial reporting
included or incorporated by reference therein or
omitted therefrom
as to which
we
make no statement): (i) the
Registration Statement, as of the time it became effective
or is deemed to have become effective under Section 11(d) of the
Securities Act and Rule 430B thereunder
, contained any untrue statement of a material
fact or omitted to state a material fact
required to be
stated therein or
necessary to make
the statements therein not misleading; and (ii)
the
Prospectus, as of its date and the date hereof, contained or
contains any untrue statement of a material fact or omitted or
omits to state a material fact necessary to make the statements
therein, in the light of the circumstances under which they were
made, not misleading.
EXHIBIT 23
Permitted Issuer Free Writing Prospectuses
None.
Exhibit 4.16
CORMEDIX INC.
and
,
as Trustee
INDENTURE
Dated as of
,
20__
TABLE OF CONTENTS
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PAGE
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ARTICLE 1 DEFINITIONS
AND INCORPORATION BY REFERENCE
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1
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1.1.
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DEFINITIONS
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1
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1.2.
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OTHER
DEFINITIONS
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4
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1.3.
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INCORPORATION BY
REFERENCE OF TRUST INDENTURE ACT
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5
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1.4.
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RULES
OF CONSTRUCTION
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5
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ARTICLE
2 THE
SECURITIES
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5
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2.1.
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ISSUABLE IN
SERIES
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5
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2.2.
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ESTABLISHMENT OF
TERMS OF SERIES OF SECURITIES
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6
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2.3.
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EXECUTION AND
AUTHENTICATION
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7
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2.4.
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REGISTRAR AND
PAYING AGENT
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8
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2.5.
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PAYING
AGENT TO HOLD ASSETS IN TRUST
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9
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2.6.
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SECURITYHOLDER
LISTS
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9
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2.7.
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TRANSFER AND
EXCHANGE
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9
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2.8.
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REPLACEMENT
SECURITIES
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10
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2.9.
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OUTSTANDING
SECURITIES
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10
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2.10.
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WHEN
TREASURY SECURITIES DISREGARDED; DETERMINATION OF HOLDERS’
ACTION
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11
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2.11.
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TEMPORARY
SECURITIES
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11
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2.12.
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CANCELLATION
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11
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2.13.
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PAYMENT
OF INTEREST; DEFAULTED INTEREST; COMPUTATION OF
INTEREST
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11
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2.14.
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CUSIP
NUMBER
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11
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2.15.
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PROVISIONS FOR
GLOBAL SECURITIES
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12
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2.16.
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PERSONS
DEEMED OWNERS
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13
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ARTICLE 3 REDEMPTION
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13
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3.1
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NOTICES
TO TRUSTEE
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13
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3.2.
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SELECTION BY
TRUSTEE OF SECURITIES TO BE REDEEMED
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13
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3.3.
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NOTICE
OF REDEMPTION
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13
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3.4.
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EFFECT
OF NOTICE OF REDEMPTION
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14
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3.5
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DEPOSIT
OF REDEMPTION PRICE
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14
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3.6
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SECURITIES REDEEMED
IN PART
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15
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ARTICLE 4 COVENANTS
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15
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4.1.
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PAYMENT
OF SECURITIES
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15
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4.2.
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SEC
REPORTS
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15
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4.3.
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WAIVER
OF STAY, EXTENSION OR USURY LAWS
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15
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4.4.
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COMPLIANCE
CERTIFICATE
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15
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4.5.
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CORPORATE
EXISTENCE
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16
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ARTICLE 5 SUCCESSOR
CORPORATION
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16
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5.1.
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LIMITATION ON
CONSOLIDATION, MERGER AND SALE OF ASSETS
|
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16
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5.2.
|
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SUCCESSOR PERSON
SUBSTITUTED
|
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17
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ARTICLE 6 DEFAULTS
AND REMEDIES
|
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17
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6.1.
|
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EVENTS
OF DEFAULT
|
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17
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6.2.
|
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ACCELERATION
|
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18
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6.3.
|
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REMEDIES
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18
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6.4.
|
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WAIVER
OF PAST DEFAULTS AND EVENTS OF DEFAULT
|
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18
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6.5
|
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CONTROL
BY MAJORITY
|
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19
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6.6.
|
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LIMITATION ON
SUITS
|
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19
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6.7.
|
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RIGHTS
OF HOLDERS TO RECEIVE PAYMENT
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19
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6.8.
|
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COLLECTION SUIT BY
TRUSTEE
|
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19
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6.9.
|
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TRUSTEE
MAY FILE PROOFS OF CLAIM
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20
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6.10.
|
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PRIORITIES
|
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20
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6.11.
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UNDERTAKING FOR
COSTS
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20
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ARTICLE 7 TRUSTEE
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20
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7.1.
|
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DUTIES
OF TRUSTEE
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20
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7.2.
|
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RIGHTS
OF TRUSTEE
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21
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7.3.
|
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INDIVIDUAL RIGHTS
OF TRUSTEE
|
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22
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7.4.
|
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TRUSTEE’S
DISCLAIMER
|
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22
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7.5.
|
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NOTICE
OF DEFAULT
|
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22
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7.6.
|
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REPORTS
BY TRUSTEE TO HOLDERS
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22
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7.7.
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COMPENSATION AND
INDEMNITY
|
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23
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7.8.
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REPLACEMENT OF
TRUSTEE
|
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23
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7.9.
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SUCCESSOR TRUSTEE
BY CONSOLIDATION, MERGER OR CONVERSION
|
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24
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7.10.
|
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ELIGIBILITY;
DISQUALIFICATION
|
|
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24
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7.11.
|
|
PREFERENTIAL
COLLECTION OF CLAIMS AGAINST COMPANY
|
|
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24
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7.12.
|
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PAYING
AGENTS
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24
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ARTICLE 8 AMENDMENTS,
SUPPLEMENTS AND WAIVERS
|
|
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25
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8.1.
|
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WITHOUT
CONSENT OF HOLDERS
|
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25
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8.2.
|
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WITH
CONSENT OF HOLDERS
|
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25
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8.3.
|
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COMPLIANCE WITH
TRUST INDENTURE ACT
|
|
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26
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8.4.
|
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REVOCATION AND
EFFECT OF CONSENTS
|
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26
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8.5.
|
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NOTATION ON OR
EXCHANGE OF SECURITIES
|
|
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27
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8.6.
|
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TRUSTEE
TO SIGN AMENDMENTS, ETC.
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27
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ARTICLE 9 DISCHARGE
OF INDENTURE; DEFEASANCE
|
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27
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9.1.
|
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DISCHARGE OF
INDENTURE
|
|
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27
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9.2.
|
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LEGAL
DEFEASANCE
|
|
|
27
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9.3.
|
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COVENANT
DEFEASANCE
|
|
|
28
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9.4.
|
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CONDITIONS TO LEGAL
DEFEASANCE OR COVENANT DEFEASANCE
|
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28
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9.5.
|
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DEPOSITED MONEY AND
U.S. AND FOREIGN GOVERNMENT OBLIGATIONS TO BE HELD IN TRUST; OTHER
MISCELLANEOUS PROVISIONS
|
|
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29
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9.6.
|
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REINSTATEMENT
|
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30
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9.7.
|
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MONEYS
HELD BY PAYING AGENT
|
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30
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9.8.
|
|
MONEYS
HELD BY TRUSTEE
|
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30
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ARTICLE 10 MISCELLANEOUS
|
|
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30
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10.1.
|
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TRUST
INDENTURE ACT CONTROLS
|
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30
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10.2.
|
|
NOTICES
|
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30
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10.3.
|
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COMMUNICATIONS BY
HOLDERS WITH OTHER HOLDERS
|
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31
|
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10.4.
|
|
CERTIFICATE AND
OPINION AS TO CONDITIONS PRECEDENT
|
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32
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10.5.
|
|
STATEMENT REQUIRED
IN CERTIFICATE AND OPINION
|
|
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32
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10.6.
|
|
RULES
BY TRUSTEE AND AGENTS
|
|
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32
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10.7.
|
|
BUSINESS DAYS;
LEGAL HOLIDAYS; PLACE OF PAYMENT
|
|
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32
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10.8.
|
|
GOVERNING
LAW
|
|
|
32
|
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10.9.
|
|
NO
ADVERSE INTERPRETATION OF OTHER AGREEMENTS
|
|
|
32
|
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10.10.
|
|
NO
RECOURSE AGAINST OTHERS
|
|
|
33
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10.11.
|
|
SUCCESSORS
|
|
|
33
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10.12.
|
|
MULTIPLE
COUNTERPARTS
|
|
|
33
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|
|
|
|
10.13.
|
|
TABLE
OF CONTENTS, HEADINGS, ETC.
|
|
|
33
|
|
|
|
|
10.14.
|
|
SEVERABILITY
|
|
|
33
|
|
|
|
|
10.15.
|
|
SECURITIES IN A
FOREIGN CURRENCY OR IN EUROS
|
|
|
33
|
|
|
|
|
10.16.
|
|
JUDGMENT
CURRENCY
|
|
|
34
|
|
CROSS-REFERENCE TABLE
|
|
|
TIA
SECTION
|
|
INDENTURE
SECTION
|
310(a)(1)(2)(5)
|
|
7.10
|
310(a)(3)(4)
|
|
Inapplicable
|
310(b)
|
|
7.8;
7.10
|
310(c)
|
|
Inapplicable
|
|
|
311(a)(b)
|
|
7.11
|
311(c)
|
|
Inapplicable
|
|
|
312(a)
|
|
2.6
|
312(b)(c)
|
|
10.3
|
|
|
313(a)(b)
|
|
7.6
|
313(c)
|
|
7.6;
10.2
|
313(d)
|
|
7.6
|
|
|
314(a)
|
|
4.2;
4.4; 10.2
|
314(b)
|
|
N/A
|
314(c)(1)(2)
|
|
10.4;
10.5
|
314(c)(3)
|
|
Inapplicable
|
314(d)
|
|
Inapplicable
|
314(e)
|
|
10.5
|
314(f)
|
|
Inapplicable
|
|
|
315(a)
|
|
7.1,
7.2
|
315(b)
|
|
7.5;
10.2
|
315(c)
|
|
7.1
|
315(d)
|
|
7.1;
7.2
|
315(e)
|
|
6.11
|
|
|
316(a)(last
sentence)
|
|
2.10
|
316(a)(1)(A)
|
|
6.5
|
316(a)(1)(B)
|
|
6.4
|
316(a)(2)
|
|
8.2
|
316(b)
|
|
6.7
|
316(c)
|
|
8.4
|
|
|
317(a)(1)
|
|
6.8
|
317(a)(2)
|
|
6.9
|
317(b)
|
|
2.5;
7.12
|
|
|
318(a)
|
|
10.1
|
Note: This Cross-Reference Table shall not, for any purpose, be
deemed to be a part of the Indenture.
INDENTURE,
dated as of
,
20__, by and between CorMedix Inc., a Delaware corporation, as
Issuer (the “Company”) and
,
a
organized
under the laws of
,
as Trustee (the “Trustee”).
RECITALS OF THE COMPANY
The
Company has duly authorized the execution and delivery of this
Indenture to provide for the issuance from time to time of its
debentures, notes or other evidences of indebtedness to be issued
in one or more series (the “Securities”), as herein
provided, up to such principal amount as may from time to time be
authorized in or pursuant to one or more resolutions of the Board
of Directors or by supplemental indenture.
All
things necessary to make this Indenture a valid agreement of the
Company in accordance with its terms have been done, and the
execution and delivery thereof have been in all respects duly
authorized by the parties hereto.
NOW, THEREFORE, THIS INDENTURE WITNESSETH:
For
and in consideration of the premises and the purchase of the
Securities by the Holders thereof, it is mutually agreed, for the
equal and proportionate benefit of all Holders of the Securities of
a Series thereof, as follows:
ARTICLE 1
DEFINITIONS AND INCORPORATION BY REFERENCE
“Affiliate”
of any specified Person means any other Person which, directly or
indirectly through one or more intermediaries, controls, or is
controlled by or is under common control with, such specified
Person. For the purposes of this definition, “control”
(including, with correlative meanings, the terms
“controlling,” “controlled by” and
“under common control with”), as used with respect to
any Person, means the possession, directly or indirectly, of the
power to direct or cause the direction of the management or
policies of such Person, whether through the ownership of voting
securities, by agreement or otherwise.
“Agent”
means any Registrar, Paying Agent, co-registrar or agent for
service of notices and demands.
“Board
of Directors” means the Board of Directors of the Company or
any committee duly authorized to act therefor.
“Board
Resolution” means a copy of a resolution certified pursuant
to an Officers’ Certificate to have been duly adopted by the
Board of Directors of the Company and to be in full force and
effect on the date of such certification which has been delivered
to the Trustee.
“Capital
Stock” means, with respect to any Person, any and all shares
or other equivalents (however designated) of capital stock,
partnership interests or any other participation, right or other
interest in the nature of an equity interest in such Person or any
option, warrant or other security convertible into any of the
foregoing.
“Company”
means the party named as such in the first paragraph of this
Indenture until a successor replaces such party pursuant to Article
5 of this Indenture, and thereafter means the successor and any
other primary obligor on the Securities.
“Company
Order” means a written order signed in the name of the
Company by two Officers, one of whom must be its Chief Executive
Officer or its Chief Financial Officer.
“Company
Request” means any written request signed in the name of the
Company by its Chief Executive Officer, its President, any Vice
President, its Chief Financial Officer or its Treasurer and
attested to by its Secretary or any Assistant
Secretary.
“Corporate
Trust Office” means the office of the Trustee at which at any
particular time its corporate trust business shall be principally
administered.
“Default”
means any event that is, or that with the passing of time or giving
of notice or both would be, an Event of Default.
“Depository”
means, with respect to the Securities of any Series issuable or
issued in whole or in part in the form of one or more Global
Securities, the Person designated as Depository for such Series by
the Company, which Depository shall be a clearing agency registered
under the Exchange Act, until a successor Depository shall have
become such pursuant to the applicable provisions of this
Indenture, and thereafter “Depository” shall mean each
Person who is then a Depository hereunder, and if at any time there
is more than one such Person, such Persons.
“Dollars”
means the currency of the United States of America.
“Euro”
means the single currency of participating member states of the
economic and monetary union as contemplated in the Treaty on
European Union.
“Exchange
Act” means the Securities Exchange Act of 1934, as
amended.
“Foreign
Currency” means any currency or currency unit issued by a
government other than the government of the United States of
America.
“Foreign
Government Obligations” means, with respect to Securities
that are denominated in a Foreign Currency, (i) direct
obligations of the government that issued or caused to be issued
such currency for the payment of which obligations its full faith
and credit is pledged or (ii) obligations of a Person
controlled or supervised by, or acting as an agency or
instrumentality of, such government, the timely payment of which is
unconditionally guaranteed as a full faith and credit obligation by
such government, which, in either case under clauses (i) and
(ii), are not callable or redeemable at the option of the issuer
thereof.
“GAAP”
means generally accepted accounting principles consistently applied
as in effect in the United States of America from time to
time.
“Global
Security” or “Global Securities” means a Security
or Securities, as the case may be, in the form established pursuant
to Section 2.2, evidencing all or part of a Series of
Securities issued to the Depository for such Series or its nominee,
and registered in the name of such Depository or nominee, and
bearing the legend set forth in Section 2.15(c) (or such other
legend(s) as may be applied to such Securities in accordance with
Section 2.2(24)).
“Holder”
or “Securityholder” means the Person in whose name a
Security is registered on the Registrar’s books.
“Indebtedness”
means (without duplication), with respect to any Person, any
indebtedness at any time outstanding, secured or unsecured,
contingent or otherwise, which is for borrowed money (whether or
not the recourse of the lender is to the whole of the assets of
such Person or only to a portion thereof), or evidenced by bonds,
notes, debentures or similar instruments, or representing the
balance deferred and unpaid of the purchase price of any property
(excluding any balances that constitute accounts payable or trade
payables, and other accrued liabilities arising in the ordinary
course of business), if and to the extent any of the foregoing
indebtedness would appear as a liability upon a balance sheet of
such Person prepared in accordance with GAAP.
“Indenture”
means this Indenture as amended, restated or supplemented from time
to time.
“Interest
Payment Date,” when used with respect to any Security, means
the Stated Maturity of an installment of interest on such
Security.
“Lien”
means, with respect to any property or assets of any Person, any
mortgage or deed of trust, pledge, hypothecation, assignment,
deposit arrangement, security interest, lien, charge, easement,
encumbrance, preference, priority or other security agreement or
preferential arrangement of any kind or nature whatsoever on or
with respect to such property or assets (including, without
limitation, any capitalized lease obligation, conditional sales or
other title retention agreement having substantially the same
economic effect as any of the foregoing).
“Maturity,”
when used with respect to any Security, means the date on which the
principal of such Security, or an installment of principal, becomes
due and payable as therein or herein provided, whether at the
Stated Maturity or by declaration of acceleration, call for
redemption, notice of option to elect payment or
otherwise.
“Officer”
means the Chief Executive Officer, the President, any Vice
President, the Chief Financial Officer, the Treasurer or the
Secretary of the Company, or any other officer designated by the
Board of Directors, as the case may be.
“Officers’
Certificate” means, with respect to any Person, a certificate
signed by the Chairman, Chief Executive Officer, President or any
Senior or Executive Vice President and the Chief Financial Officer
or any Treasurer of such Person, that shall comply with applicable
provisions of this Indenture.
“Opinion
of Counsel” means a written opinion from legal counsel, which
counsel is reasonably acceptable to the Trustee. The counsel may be
an employee of or counsel to the Company.
“Person”
means any individual, corporation, limited liability company,
partnership, joint venture, association, joint-stock company,
trust, unincorporated organization or government (including any
agency or political subdivision thereof).
“Redemption
Date,” when used with respect to any Security to be redeemed,
means the date fixed for such redemption pursuant to this
Indenture.
“Responsible
Officer,” when used with respect to the Trustee, means any
officer within the corporate trust department or division of the
Trustee (or any successor group of the Trustee) or any other
officer of the Trustee customarily performing functions similar to
those performed by any of the above designated officers, and also
means, with respect to a particular corporate trust matter, any
other officer to whom such matter is referred because of his
knowledge of and familiarity with the particular
subject.
“SEC”
means the United States Securities and Exchange Commission as
constituted from time to time, or any successor performing
substantially the same functions.
“Securities”
means the securities that are issued under this Indenture, as
amended or supplemented from time to time pursuant to this
Indenture.
“Securities
Act” means the Securities Act of 1933, as
amended.
“Series”
or “Series of Securities” means each series of
debentures, notes or other debt instruments of the Company created
pursuant to Sections 2.1 and 2.2.
“Significant
Subsidiary” means (i) any direct or indirect Subsidiary
of the Company that would be a “significant subsidiary”
as defined in Article 1, Rule 1-02 of Regulation S-X, promulgated
pursuant to the Securities Act, as such regulation is in effect on
the date hereof, or (ii) any group of direct or indirect
Subsidiaries of the Company that, taken together as a group, would
be a “significant subsidiary” as defined in Article 1,
Rule 1-02 of Regulation S-X, promulgated pursuant to the Securities
Act, as such regulation is in effect on the date
hereof.
“Stated
Maturity,” when used with respect to any Security or any
installment of principal thereof or interest thereon, means the
date specified in such Security as the fixed date on which the
principal of such Security, or such installment of principal or
interest, is due and payable, and when used with respect to any
other Indebtedness, means the date specified in the instrument
governing such Indebtedness as the fixed date on which the
principal of such Indebtedness, or any installment of interest
thereon, is due and payable.
“Subsidiary” of any
specified Person means any corporation, limited liability company,
partnership, joint venture, association or other business entity,
whether now existing or hereafter organized or acquired,
(i) in the case of a corporation, of which more than 50% of
the total voting power of the Capital Stock entitled (without
regard to the occurrence of any contingency) to vote in the
election of directors thereof is held, directly or indirectly, by
such Person or any of
its
Subsidiaries; or (ii) in the case of a partnership, joint
venture, association or other business entity, with respect to
which such Person or any of its Subsidiaries has the power to
direct or cause the direction of the management and policies of
such entity by contract or otherwise, or if in accordance with GAAP
such entity is consolidated with such Person for financial
statement purposes.
“TIA”
means the Trust Indenture Act of 1939 (15 U.S. Code
Section 77aaa-77bbbb) as in effect on the date of this
Indenture (except as provided in Section 8.3).
“Trustee”
means the party named as such in this Indenture until a successor
replaces it pursuant to this Indenture, and thereafter means the
successor, and if at any time there is more than one such Person,
“Trustee” as used with respect to the Securities of any
Series shall mean the Trustee with respect to Securities of that
Series.
“U.S.
Government Obligations” means direct non-callable obligations
of, or non-callable obligations guaranteed by, the United States of
America for the payment of which obligation or guarantee the full
faith and credit of the United States of America is
pledged.
The
definitions of the following terms may be found in the sections
indicated as follows:
|
|
|
TERM
|
|
DEFINED
IN SECTION
|
|
|
“Bankruptcy
Law”
|
|
6.1
|
|
|
“Business
Day”
|
|
10.7
|
|
|
“Covenant
Defeasance”
|
|
9.3
|
|
|
“Custodian”
|
|
6.1
|
|
|
“Event of
Default”
|
|
6.1
|
|
|
“Journal”
|
|
10.15
|
|
|
“Judgment
Currency”
|
|
10.16
|
|
|
“Legal
Defeasance”
|
|
9.2
|
|
|
“Legal
Holiday”
|
|
10.7
|
|
|
“Market
Exchange Rate”
|
|
10.15
|
|
|
“New York
Paying Agent”
|
|
2.4
|
|
|
“Paying
Agent”
|
|
2.4
|
|
|
“Place of
Payment”
|
|
10.7
|
|
|
“Registrar”
|
|
2.4
|
|
|
“Required
Currency”
|
|
10.16
|
|
|
“Service
Agent”
|
|
2.4
|
1.3.
|
INCORPORATION
BY REFERENCE OF TRUST INDENTURE ACT.
|
Whenever
this Indenture refers to a provision of the TIA, the portion of
such provision required to be incorporated herein in order for this
Indenture to be qualified under the TIA is incorporated by
reference in and made a part of this Indenture. The following TIA
terms used in this Indenture have the following
meanings:
“Commission”
means the SEC.
“indenture
securities” means the Securities.
“indenture
securityholder” means a Holder or
Securityholder.
“indenture
to be qualified” means this Indenture.
“indenture
trustee” or “institutional trustee” means the
Trustee.
“obligor
on the indenture securities” means the Company.
All
other terms used in this Indenture that are defined by the TIA,
defined in the TIA by reference to another statute or defined by
SEC rule have the meanings therein assigned to them.
1.4.
|
RULES
OF CONSTRUCTION.
|
Unless
the context otherwise requires:
(1)
a term has the meaning assigned to it herein, whether defined
expressly or by reference;
(2)
an accounting term not otherwise defined has the meaning assigned
to it in accordance with GAAP;
(3)
“or” is not exclusive;
(4)
words in the singular include the plural, and in the plural include
the singular;
(5)
words used herein implying any gender shall apply to each gender;
and
(6)
the words “herein”, “hereof” and
“hereunder” and other words of similar import refer to
this Indenture as a whole and not to any particular Article,
Section or other subdivision.
ARTICLE 2
THE SECURITIES
The
aggregate principal amount of Securities that may be authenticated
and delivered under this Indenture is
$[ ].
The Securities may be issued in one or more Series. All Securities
of a Series shall be identical except as may be set forth in a
Board Resolution, a supplemental indenture or an Officers’
Certificate detailing the adoption of the terms thereof pursuant to
the authority granted under a Board Resolution. In the case of
Securities of a Series to be issued from time to time, the Board
Resolution, Officers’ Certificate or supplemental indenture
may provide for the method by which specified terms (such as
interest rate, Stated Maturity, record date or date from which
interest shall accrue) are to be determined. Securities may differ
between Series in respect of any matters, PROVIDED, that all Series
of Securities shall be equally and ratably entitled to the benefits
of the Indenture.
2.2.
|
ESTABLISHMENT
OF TERMS OF SERIES OF SECURITIES.
|
At
or prior to the issuance of any Securities within a Series, the
following shall be established (as to the Series generally, in the
case of Subsection 2.2(1) and either as to such Securities within
the Series or as to the Series generally in the case of Subsections
2.2(2) through 2.2(24)) by a Board Resolution, a supplemental
indenture or an Officers’ Certificate, in each case, pursuant
to authority granted under a Board Resolution:
(1)
the title of the Series (which shall distinguish the Securities of
that particular Series from the Securities of any other
Series);
(2)
any limit upon the aggregate principal amount of the Securities of
the Series which may be authenticated and delivered under this
Indenture (except for Securities authenticated and delivered upon
registration of transfer of, or in exchange for, or in lieu of,
other Securities of the Series pursuant to Section 2.7, 2.8,
2.11, 3.6 or 8.5);
(3)
the price or prices (expressed as a percentage of the principal
amount thereof) at which the Securities of the Series will be
issued;
(4)
the date or dates on which the principal of the Securities of the
Series is payable;
(5)
the rate or rates (which may be fixed or variable) per annum or, if
applicable, the method used to determine such rate or rates
(including, but not limited to, any commodity, commodity index,
stock exchange index or financial index) at which the Securities of
the Series shall bear interest, if any, the date or dates from
which such interest, if any, shall accrue, the date or dates on
which such interest, if any, shall commence and be payable and any
regular record date for the interest payable on any Interest
Payment Date;
(6)
the place or places where the principal of, and interest and
premium, if any, on, the Securities of the Series shall be payable,
or the method of such payment, if by wire transfer, mail or other
means;
(7)
if applicable, the period or periods within which, the price or
prices at which and the terms and conditions upon which the
Securities of the Series may be redeemed, in whole or in part, at
the option of the Company;
(8)
the obligation, if any, of the Company to redeem or purchase the
Securities of the Series pursuant to any sinking fund or analogous
provisions or at the option of a Holder thereof, and the period or
periods within which, the price or prices at which and the terms
and conditions upon which Securities of the Series shall be
redeemed or purchased, in whole or in part, pursuant to such
obligation;
(9)
the dates, if any, on which and the price or prices at which the
Securities of the Series will be repurchased by the Company at the
option of the Holders thereof, and other detailed terms and
provisions of such repurchase obligations;
(10)
if other than denominations of $1,000 and any integral multiple
thereof, the denominations in which the Securities of the Series
shall be issuable;
(11)
the forms of the Securities of the Series in bearer (if to be
issued outside of the United States of America) or fully registered
form (and, if in fully registered form, whether the Securities will
be issuable as Global Securities);
(12)
if other than the principal amount thereof, the portion of the
principal amount of the Securities of the Series that shall be
payable upon declaration of acceleration of the Maturity thereof
pursuant to Section 6.2;
(13)
the currency of denomination of the Securities of the Series, which
may be Dollars or any Foreign Currency, including, but not limited
to, the Euro, and, if such currency of denomination is a composite
currency other than the Euro, the agency or organization, if any,
responsible for overseeing such composite currency;
(14)
the designation of the currency, currencies or currency units in
which payment of the principal of, and interest and premium, if
any, on, the Securities of the Series will be made;
(15)
if payments of principal of, or interest or premium, if any, on,
the Securities of the Series are to be made in one or more
currencies or currency units other than that or those in which such
Securities are denominated, the manner in which the exchange rate
with respect to such payments will be determined;
(16)
the manner in which the amounts of payment of principal of, or
interest and premium, if any, on, the Securities of the Series will
be determined, if such amounts may be determined by reference to an
index based on a currency or currencies or by reference to a
commodity, commodity index, stock exchange index or financial
index;
(17)
the provisions, if any, relating to any collateral provided for the
Securities of the Series;
(18)
any addition to or change in the covenants set forth in Articles 4
or 5 that applies to Securities of the Series;
(19)
any addition to or change in the Events of Default which applies to
any Securities of the Series, and any change in the right of the
Trustee or the requisite Holders of such Securities to declare the
principal amount thereof due and payable pursuant to
Section 6.2;
(20)
the terms and conditions, if any, for conversion of the Securities
into or exchange of the Securities for shares of common stock or
preferred stock of the Company that apply to Securities of the
Series;
(21)
any depositories, interest rate calculation agents, exchange rate
calculation agents or other agents with respect to Securities of
such Series if other than those appointed herein;
(22)
the terms and conditions, if any, upon which the Securities shall
be subordinated in right of payment to other Indebtedness of the
Company;
(23)
if applicable, that the Securities of the Series, in whole or any
specified part, shall be defeasible pursuant to Article 9;
and
(24)
any other terms of the Securities of the Series (which terms shall
not be inconsistent with the provisions of this Indenture, except
as permitted by Section 8.1, but which may modify or delete
any provision of this Indenture insofar as it applies to such
Series).
All
Securities of any one Series need not be issued at the same time,
and may be issued from time to time, consistent with the terms of
this Indenture, if so provided by or pursuant to the Board
Resolution, supplemental indenture or Officers’ Certificate
referred to above, however, the authorized principal amount of any
Series may not be increased to provide for issuances of additional
Securities of such Series, unless otherwise provided in such Board
Resolution, supplemental indenture or Officers’
Certificate.
2.3.
|
EXECUTION
AND AUTHENTICATION.
|
The
Securities shall be executed on behalf of the Company by two
Officers of the Company or an Officer and an Assistant Secretary of
the Company. Each such signature may be either manual or facsimile.
The Company’s seal may be impressed, affixed, imprinted or
reproduced on the Securities and may be in facsimile
form.
If
an Officer whose signature is on a Security no longer holds that
office at the time the Security is authenticated, the Security
shall nevertheless be valid.
A Security shall not be valid
until authenticated by the manual signature of the Trustee or an
authenticating agent. The signature shall be conclusive evidence
that the Security has been authenticated under this Indenture. The
Trustee shall at any time, and from time to
time,
authenticate
Securities for original issue in the principal amount provided in
the Board Resolution, supplemental indenture hereto or
Officers’ Certificate, upon receipt by the Trustee of a
Company Order. Such Company Order may authorize authentication and
delivery pursuant to oral or electronic instructions from the
Company or its duly authorized agent or agents, which oral
instructions shall be promptly confirmed in writing. Each Security
shall be dated the date of its authentication.
The
aggregate principal amount of Securities of any Series outstanding
at any time may not exceed any limit upon the maximum principal
amount for such Series set forth in the Board Resolution,
supplemental indenture hereto or Officers’ Certificate
delivered pursuant to Section 2.2, except as provided in
Section 2.8.
Prior
to the issuance of Securities of any Series, the Trustee shall have
received and (subject to Section 7.1) shall be fully protected
in relying on: (a) the Board Resolution, supplemental
indenture hereto or Officers’ Certificate establishing the
form of the Securities of that Series or of Securities within that
Series and the terms of the Securities of that Series or of
Securities within that Series, (b) an Officers’
Certificate complying with Section 10.4, and (c) an
Opinion of Counsel complying with Section 10.4.
The
Trustee shall have the right to decline to authenticate and deliver
any Securities of any Series: (a) if the Trustee, being
advised in writing by outside counsel, determines that such action
may not lawfully be taken; or (b) if the Trustee in good faith
by its board of directors or trustees, executive committee or a
trust committee of directors and/or vice-presidents shall
reasonably determine that such action would expose the Trustee to
personal liability, or cause it to have a conflict of interest with
respect to Holders of any then outstanding Series of
Securities.
The
Trustee may appoint an authenticating agent acceptable to the
Company to authenticate Securities. An authenticating agent may
authenticate Securities whenever the Trustee may do so. Any
appointment shall be evidenced by an instrument signed by an
authorized officer of the Trustee, a copy of which shall be
furnished to the Company. Each reference in this Indenture to
authentication by the Trustee includes authentication by such
agent. An authenticating agent has the same rights as an Agent to
deal with the Company or an Affiliate of the Company.
2.4.
|
REGISTRAR
AND PAYING AGENT.
|
The Company shall maintain in
each Place of Payment for any Series of Securities (i) an
office or agency where such Securities may be presented for
registration of transfer or for exchange (“Registrar”),
(ii) an office or agency where such Securities may be
presented for payment (“Paying Agent”) (PROVIDED that
the Company shall at all times maintain a Paying Agent in the
Borough of Manhattan, City of New York, State of New York (the
“New York Paying Agent”), and PROVIDED, FURTHER, that
at the option of the Company payment of interest may be made by
check mailed to the address of the Person entitled thereto as such
address shall appear in the register for the Securities maintained
by the Registrar), and (iii) an office or agency where notices
and demands to or upon the Company in respect of the Securities and
this Indenture may be served (“Service Agent”). The
Registrar shall keep a register of the Securities and of their
transfer and exchange. The Company may have one or more
co-registrars
and
one or more additional paying agents. The Company shall give prompt
written notice to the Trustee of the location, and any change in
the location, of such office or agency. If at any time the Company
shall fail to maintain any such required office, or to furnish the
Trustee with the address thereof, such presentations, surrenders,
notices and demands may be made or served at the address of the
Trustee as set forth in Section 10.2. If the Company acts as
Paying Agent, it shall segregate the money held by it for the
payment of principal of, and interest and premium, if any, on, the
Securities and hold it as a separate trust fund. The Company may
change any Paying Agent, Registrar, co-registrar or any other Agent
without notice to any Securityholder.
The
Company may also from time to time designate one or more other
offices or agencies where the Securities may be presented or
surrendered for any or all such purposes, and may from time to time
rescind such designations; PROVIDED, HOWEVER, that no such
designation or rescission shall in any manner relieve the Company
of its obligation to maintain an office or agency in each Place of
Payment for Securities of any Series for such purposes. The Company
hereby initially designates the Corporate Trust Office of the
Trustee as such office of the Company. The Company shall give
prompt written notice to the Trustee of such designation or
rescission, and of any change in the location of any such other
office or agency.
The
Company shall enter into an appropriate agency agreement with any
Registrar or Paying Agent not a party to this Indenture. The
agreement shall implement the provisions of this Indenture that
relate to such Agent. The Company shall notify the Trustee of the
name and address of any such Agent. If the Company fails to
maintain a Registrar or Paying Agent, or agent for service of
notices and demands, or fails to give the foregoing notice, the
Trustee shall act as such. The Company hereby appoints the Trustee
as the initial Registrar, Paying Agent and Service Agent for each
Series unless another Registrar, Paying Agent or Service Agent, as
the case may be, is appointed prior to the time Securities of that
Series are first issued. The Company designates
,
as the New York Paying Agent, with offices
at .
2.5.
|
PAYING
AGENT TO HOLD ASSETS IN TRUST.
|
The
Trustee as Paying Agent shall, and the Company shall require each
Paying Agent other than the Trustee to agree in writing that each
Paying Agent shall, hold in trust for the benefit of the Holders of
any Series of Securities or the Trustee all assets held by the
Paying Agent for the payment of principal of, or interest or
premium, if any, on, such Series of Securities (whether such assets
have been distributed to it by the Company or any other obligor on
such Series of Securities), and the Company and the Paying Agent
shall notify the Trustee in writing of any Default by the Company
(or any other obligor on such Series of Securities) in making any
such payment. The Company at any time may require a Paying Agent to
distribute all assets held by it to the Trustee and account for any
assets disbursed, and the Trustee may, at any time during the
continuance of any payment default with respect to any Series of
Securities, upon written request to a Paying Agent, require such
Paying Agent to distribute all assets held by it to the Trustee and
to account for any assets distributed. Upon distribution to the
Trustee of all assets that shall have been delivered by the Company
to the Paying Agent, the Paying Agent shall have no further
liability for such assets.
2.6.
|
SECURITYHOLDER
LISTS.
|
The
Trustee shall preserve in as current a form as is reasonably
practicable the most recent list available to it of the names and
addresses of Securityholders of each Series of Securities. If the
Trustee is not the Registrar, the Company shall furnish to the
Trustee as of each regular record date for the payment of interest
on the Securities of a Series and before each related Interest
Payment Date, and at such other times as the Trustee may request in
writing, a list in such form and as of such date as the Trustee may
reasonably require of the names and addresses of Securityholders of
each Series of Securities.
2.7.
|
TRANSFER
AND EXCHANGE.
|
When
Securities of a Series are presented to the Registrar with a
request to register the transfer thereof, the Registrar shall
register the transfer as requested if the requirements of
applicable law are met, and when such Securities of a Series are
presented to the Registrar with a request to exchange them for an
equal principal amount of other authorized denominations of
Securities of the same Series, the Registrar shall make the
exchange as requested. To permit transfers and exchanges, upon
surrender of any Security for registration of transfer at the
office or agency maintained pursuant to Section 2.4, the
Company shall execute and the Trustee shall authenticate Securities
at the Registrar’s request.
If
Securities are issued as Global Securities, the provisions of
Section 2.15 shall apply.
All
Securities issued upon any registration of transfer or exchange of
Securities shall be the valid obligations of the Company,
evidencing the same debt, and entitled to the same benefits under
this Indenture, as the Securities surrendered upon such
registration of transfer or exchange.
Every
Security presented or surrendered for registration of transfer or
for exchange shall (if so required by the Company or the Registrar
or a co-registrar) be duly endorsed, or be accompanied by a written
instrument of transfer in form satisfactory to the Company and the
Registrar or a co-registrar, duly executed by the Holder thereof or
his attorney duly authorized in writing.
Any
exchange or transfer shall be without charge, except that the
Company may require payment by the Holder of a sum sufficient to
cover any tax or other governmental charge that may be imposed in
relation to a transfer or exchange, but this provision shall not
apply to any exchange pursuant to Section 2.11, 3.6 or 8.5.
The Trustee shall not be required to register transfers of
Securities of any Series, or to exchange Securities of any Series,
for a period of 15 days before the record date for selection for
redemption of such Securities. The Trustee shall not be required to
exchange or register transfers of Securities of any Series called
or being called for redemption in whole or in part, except the
unredeemed portion of such Security being redeemed in
part.
2.8.
|
REPLACEMENT
SECURITIES.
|
If a mutilated Security is
surrendered to the Trustee, or if the Holder of a Security presents
evidence to the satisfaction of the Company and the Trustee that
the Security has been lost, destroyed or wrongfully taken, the
Company shall issue and the Trustee shall authenticate
a
replacement
Security of the same Series and of like tenor and principal amount
and bearing a number not contemporaneously outstanding. An
indemnity bond may be required by the Company or the Trustee that
is sufficient in the reasonable judgment of the Company or the
Trustee, as the case may be, to protect the Company, the Trustee or
any Agent from any loss which any of them may suffer if a Security
is replaced. The Company may charge such Holder for the
Company’s out-of-pocket expenses in replacing a Security,
including the fees and expenses of the Trustee. Every replacement
Security shall constitute an original additional obligation of the
Company, whether or not the destroyed, lost or stolen Security
shall be at any time enforceable by anyone, and shall be entitled
to all the benefits of this Indenture equally and proportionately
with any and all other Securities of that Series duly issued
hereunder.
2.9.
|
OUTSTANDING
SECURITIES.
|
Securities
outstanding at any time are all Securities authenticated by the
Trustee, except for those canceled by it, those delivered to it for
cancellation and those described in this Section 2.9 as not
outstanding.
If
a Security is replaced pursuant to Section 2.8 (other than a
mutilated Security surrendered for replacement), it ceases to be
outstanding until the Company and the Trustee receive proof
satisfactory to each of them that the replaced Security is held by
a bona fide purchaser. A mutilated Security ceases to be
outstanding upon surrender of such Security and replacement thereof
pursuant to Section 2.8.
If
a Paying Agent holds on a Redemption Date or the Stated Maturity
money sufficient to pay the principal of, premium, if any, and
accrued interest on, Securities payable on that date, and is not
prohibited from paying such money to the Holders thereof pursuant
to the terms of this Indenture (PROVIDED, that if such Securities
are to be redeemed, notice of such redemption has been duly given
pursuant to this Indenture or provision therefor satisfactory to
the Trustee has been made), then on and after that date such
Securities cease to be outstanding and interest on them ceases to
accrue.
A
Security does not cease to be outstanding solely because the
Company or an Affiliate holds the Security.
2.10.
|
WHEN
TREASURY SECURITIES DISREGARDED; DETERMINATION OF HOLDERS’
ACTION.
|
In
determining whether the Holders of the required aggregate principal
amount of the Securities of any Series have concurred in any
direction, waiver or consent, the Securities of any Series owned by
the Company or any other obligor on such Securities, or by any
Affiliate of any of them, shall be disregarded, except that for the
purposes of determining whether the Trustee shall be protected in
relying on any such direction, waiver or consent, only Securities
of such Series which the Trustee actually knows are so owned shall
be so disregarded. Securities of such Series so owned which have
been pledged in good faith shall not be disregarded if the pledgee
establishes to the satisfaction of the Trustee the pledgee’s
right so to act with respect to the Securities of such Series and
that the pledgee is not the Company or any other obligor on the
Securities of such Series, or an Affiliate of any of
them.
2.11.
|
TEMPORARY
SECURITIES.
|
Until
definitive Securities are ready for delivery, the Company may
prepare and execute, and the Trustee shall authenticate, temporary
Securities. Temporary Securities shall be substantially in the
form, and shall carry all rights, of definitive Securities, but may
have variations that the Company considers appropriate for
temporary Securities. Without unreasonable delay, the Company shall
prepare and execute, and the Trustee shall authenticate, definitive
Securities in exchange for temporary Securities without charge to
the Holder.
All
Securities surrendered for payment, redemption or registration of
transfer or exchange, or for credit against any sinking fund
payment, shall, if surrendered to any Person other than the
Trustee, be delivered to the Trustee for cancellation. The Company
may at any time deliver to the Trustee for cancellation any
Securities previously authenticated and delivered hereunder which
the Company may have acquired in any manner whatsoever, and may
deliver to the Trustee (or to any other Person for delivery to the
Trustee) for cancellation any Securities previously authenticated
hereunder which the Company has not issued and sold. The Registrar
and the Paying Agent shall forward to the Trustee any Securities
surrendered to them for transfer, exchange or payment. The Trustee
or, at the direction of the Trustee, the Registrar or the Paying
Agent, and no one else, shall cancel, and at the written request of
the Company shall dispose of, all Securities surrendered for
transfer, exchange, payment or cancellation. If the Company shall
acquire any of the Securities, such acquisition shall not operate
as a redemption or satisfaction of the Indebtedness represented by
such Securities unless and until the same are surrendered to the
Trustee for cancellation pursuant to this Section 2.12. No
Securities shall be authenticated in lieu of or in exchange for any
Securities cancelled as provided in this Section 2.12, except
as expressly permitted by this Indenture.
2.13.
|
PAYMENT
OF INTEREST; DEFAULTED INTEREST; COMPUTATION OF
INTEREST.
|
Except
as otherwise provided as contemplated by Section 2.2 with
respect to any Series of Securities, interest on any Security which
is payable, and is punctually paid or duly provided for, on any
Interest Payment Date shall be paid to the Person in whose name
that Security is registered at the close of business on the regular
record date for such interest, as provided in the Board Resolution,
supplemental indenture hereto or Officers’ Certificate
establishing the terms of such Series.
If
the Company defaults in a payment of interest on the Securities, it
shall pay the defaulted amounts, plus any interest payable on
defaulted amounts pursuant to Section 4.1, to the Persons who
are Securityholders on a subsequent special record date, which date
shall be the 15th day next preceding the date fixed by the Company
for the payment of defaulted interest, or the next succeeding
Business Day if such date is not a Business Day. At least 15 days
before the special record date, the Company shall mail or cause to
be mailed to each Securityholder, with a copy to the Trustee, a
notice that states the special record date, the payment date and
the amount of defaulted interest, and interest payable on such
defaulted interest, if any, to be paid.
Except
as otherwise specified as contemplated by Section 2.2 for
Securities of any Series, interest on the Securities of each Series
shall be computed on the basis of a 360-day year of twelve 30-day
months.
The
Company in issuing the Securities may use one or more
“CUSIP” numbers, and, if the Company does so, the
Trustee shall use the CUSIP number(s) in notices of redemption or
exchange as a convenience to Holders, PROVIDED, that any such
notice may state that no representation is made as to the
correctness or accuracy of the CUSIP number(s) printed in the
notice or on the Securities, and that reliance may be placed only
on the other identification numbers printed on the Securities, and
that any such redemption or exchange shall not be affected by any
defect in or omission of any such numbers.
2.15.
|
PROVISIONS
FOR GLOBAL SECURITIES.
|
(a)
A Board Resolution, a supplemental indenture hereto or an
Officers’ Certificate shall establish whether the Securities
of a Series shall be issued in whole or in part in the form of one
or more Global Securities, and the Depository for such Global
Securities or Securities.
(b)
Notwithstanding any provisions to the contrary contained in
Section 2.7 and in addition thereto, if, and only if the
Depository (i) at any time is unwilling or unable to continue
as Depository for such Global Security or ceases to be a clearing
agency registered under the Exchange Act and (ii) a successor
Depository is not appointed by the Company within 90 days after the
date the Company is so informed in writing or becomes aware of the
same, the Company promptly will execute and deliver to the Trustee
definitive Securities, and the Trustee, upon receipt of a Company
Request for the authentication and delivery of such definitive
Securities (which the Company will promptly execute and deliver to
the Trustee) and an Officers’ Certificate to the effect that
such Global Security shall be so exchangeable, will authenticate
and deliver definitive Securities, without charge, registered in
such names and in such authorized denominations as the Depository
shall direct in writing (pursuant to instructions from its direct
and indirect participants or otherwise) in an aggregate principal
amount equal to the principal amount of the Global Security with
like tenor and terms. Upon the exchange of a Global Security for
definitive Securities, such Global Security shall be canceled by
the Trustee. Unless and until it is exchanged in whole or in part
for definitive Securities, as provided in this
Section 2.15(b), a Global Security may not be transferred
except as a whole by the Depository with respect to such Global
Security to a nominee of such Depository, by a nominee of such
Depository to such Depository or another nominee of such Depository
or by the Depository or any such nominee to a successor Depository
or a nominee of such a successor Depository.
(c)
Any Global Security issued hereunder shall bear a legend in
substantially the following form:
“This Security is a Global
Security within the meaning of the Indenture hereinafter referred
to, and is registered in the name of the Depository or a nominee of
the Depository. This Security is exchangeable for Securities
registered in the name of a Person
other
than the Depository or its nominee only in the limited
circumstances described in the Indenture, and may not be
transferred except as a whole by the Depository to a nominee of the
Depository, by a nominee of the Depository to the Depository or
another nominee of the Depository or by the Depository or any such
nominee to a successor Depository or a nominee of such a successor
Depository.”
(d)
The Depository, as a Holder, may appoint agents and otherwise
authorize participants to give or take any request, demand,
authorization, direction, notice, consent, waiver or other action
which a Holder is entitled to give or take under the
Indenture.
(e)
Notwithstanding the other provisions of this Indenture, unless
otherwise specified as contemplated by Section 2.2, payment of
the principal of, and interest and premium, if any, on, any Global
Security shall be made to the Depository or its nominee in its
capacity as the Holder thereof.
(f)
Except as provided in Section 2.15(e) above, the Company, the
Trustee and any Agent shall treat a Person as the Holder of such
principal amount of outstanding Securities of any Series
represented by a Global Security as shall be specified in a written
statement of the Depository (which may be in the form of a
participants’ list for such Series) with respect to such
Global Security, for purposes of obtaining any consents,
declarations, waivers or directions required to be given by the
Holders pursuant to this Indenture, PROVIDED, that until the
Trustee is so provided with a written statement, it may treat the
Depository or any other Person in whose name a Global Security is
registered as the owner of such Global Security for the purpose of
receiving payment of the principal of, and any premium and (subject
to Section 2.13) any interest on, such Global Security and for
all other purposes whatsoever, and none of the Company, the Trustee
or any agent of the Company or the Trustee shall be affected by
notice to the contrary.
2.16.
|
PERSONS
DEEMED OWNERS.
|
Prior
to due presentment of a Security for registration of transfer, the
Company, the Trustee, the Registrar and any agent of the Company,
the Registrar or the Trustee may treat the Person in whose name
such Security is registered as the owner of such Security for the
purpose of receiving payment of the principal of, and any premium
and (subject to Section 2.13) any interest on, such Security
and for all other purposes whatsoever, and none of the Company, the
Trustee, the Registrar or any agent of the Company, the Trustee or
the Registrar shall be affected by notice to the
contrary.
ARTICLE 3
REDEMPTION
The Company may, with respect to
any Series of Securities, reserve the right to redeem and pay the
Series of Securities, or may covenant to redeem and pay the Series
of Securities or
any
part thereof, prior to the Stated Maturity thereof at such time and
on such terms as provided for in such Securities or the related
Board Resolution, supplemental indenture or Officers’
Certificate. If a Series of Securities is redeemable and the
Company elects to redeem all or part of such Series of Securities,
it shall notify the Trustee of the Redemption Date and the
principal amount of Securities to be redeemed at least 45 days
(unless a shorter notice shall be satisfactory to the Trustee)
before the Redemption Date. Any such notice may be canceled at any
time prior to notice of such redemption being mailed to any Holder,
and shall thereby be void and of no effect.
3.2.
|
SELECTION
BY TRUSTEE OF SECURITIES TO BE REDEEMED.
|
Unless
otherwise indicated for a particular Series of Securities by a
Board Resolution, a supplemental indenture or an Officers’
Certificate, if fewer than all of the Securities of a Series are to
be redeemed, the Trustee shall select the Securities of a Series to
be redeemed pro rata, by lot or by any other method that the
Trustee considers fair and appropriate (unless the Company
specifically directs the Trustee otherwise) and, if such Securities
are listed on any securities exchange, by a method that complies
with the requirements of such exchange.
The
Trustee shall make the selection from Securities of a Series
outstanding and not previously called for redemption, and shall
promptly notify the Company in writing of the Securities selected
for redemption and, in the case of any Security selected for
partial redemption, the principal amount thereof to be redeemed at
least 35 but not more than 60 days before the Redemption Date.
Securities of a Series in denominations of $1,000 may be redeemed
only in whole. The Trustee may select for redemption portions of
the principal of Securities of a Series that have denominations
larger than $1,000. Securities of a Series and portions of them it
selects shall be in amounts of $1,000 or, with respect to
Securities of any Series issuable in other denominations pursuant
to Section 2.2(10), the minimum principal denomination for
each Series and integral multiples thereof. Provisions of this
Indenture that apply to Securities called for redemption also apply
to portions of Securities called for redemption.
3.3.
|
NOTICE
OF REDEMPTION.
|
Unless
otherwise indicated for a particular Series by Board Resolution, a
supplemental indenture hereto or an Officers’ Certificate, at
least 30 days, and no more than 60 days, before a Redemption Date,
the Company shall mail, or cause to be mailed, a notice of
redemption by first-class mail to each Holder of Securities to be
redeemed at his or her last address as the same appears on the
registry books maintained by the Registrar. The notice shall
identify the Securities to be redeemed and shall
state:
(1)
the Redemption Date;
(2)
the redemption price, and that such redemption price shall become
due and payable on the Redemption Date;
(3)
if any Security of a Series is being redeemed in part, the portion
of the principal amount of such Security of a Series to be redeemed
and that, after the Redemption Date and upon surrender of such
Security of a Series, a new Security or Securities in principal
amount equal to the unredeemed portion will be issued;
(4)
the name and address of the Paying Agent;
(5)
that Securities of a Series called for redemption must be
surrendered to the Paying Agent to collect the redemption price,
and the place or places where each such Security is to be
surrendered for such payment;
(6)
that, unless the Company defaults in making the redemption payment,
interest on the Securities of a Series called for redemption ceases
to accrue on the Redemption Date, and the only remaining right of
the Holders of such Securities is to receive payment of the
redemption price upon surrender to the Paying Agent of the
Securities redeemed;
(7)
if fewer than all of the Securities of a Series are to be redeemed,
the identification of the particular Securities of a Series (or
portion thereof) to be redeemed, as well as the aggregate principal
amount of Securities of a Series to be redeemed and the aggregate
principal amount of Securities of a Series to be outstanding after
such partial redemption.
(8)
the CUSIP number, if any, printed on the Securities being redeemed;
and
(9)
that no representation is made as to the correctness or accuracy of
the CUSIP number, if any, listed in such notice or printed on the
Securities.
At
the Company’s request, the Trustee shall give the notice of
redemption in the Company’s name and at the Company’s
sole expense.
3.4.
|
EFFECT
OF NOTICE OF REDEMPTION.
|
Once
the notice of redemption described in Section 3.3 is mailed,
Securities of a Series called for redemption become due and payable
on the Redemption Date and at the redemption price, plus interest,
if any, accrued to the Redemption Date. Upon surrender to the
Trustee or Paying Agent, such Securities of a Series shall be paid
at the redemption price, plus accrued interest, if any, to the
Redemption Date; PROVIDED, that if the Redemption Date is after a
regular interest payment record date and on or prior to the next
Interest Payment Date, the accrued interest shall be payable to the
Holder of the redeemed Securities registered on the relevant record
date, as specified by the Company in the notice to the Trustee
pursuant to Section 3.1.
3.5.
|
DEPOSIT
OF REDEMPTION PRICE.
|
On
or prior to the Redemption Date (but no later than 11:00 A.M.
Eastern Time on such date), the Company shall deposit with the
Paying Agent money sufficient to pay the redemption price of and
accrued interest, if any, on all Securities to be redeemed on that
date other than Securities or portions thereof called for
redemption on that date which have been delivered by the Company to
the Trustee for cancellation.
On
and after any Redemption Date, if money sufficient to pay the
redemption price of, and accrued interest on, Securities called for
redemption shall have been made available in accordance with the
preceding paragraph and the Company and the Paying Agent are not
prohibited from paying such moneys to Holders, the Securities
called for redemption will cease to accrue interest and the only
right of the Holders of such Securities will be to receive payment
of the redemption price of and, subject to the proviso in
Section 3.4, accrued and unpaid interest on such Securities to
the Redemption Date. If any Security called for redemption shall
not be so paid, interest will be paid, from the Redemption Date
until such redemption payment is made, on the unpaid principal of
the Security and any interest or premium, if any, not paid on such
unpaid principal, in each case, at the rate and in the manner
provided in the Securities.
3.6.
|
SECURITIES
REDEEMED IN PART.
|
Upon
surrender of a Security of a Series that is redeemed in part, the
Company shall execute, and the Trustee shall authenticate, for a
Holder a new Security of the same Series equal in principal amount
to the unredeemed portion of the Security surrendered.
ARTICLE 4
COVENANTS
4.1.
|
PAYMENT
OF SECURITIES.
|
The
Company shall pay the principal of, and interest and premium, if
any, on, each Series of Securities on the dates and in the manner
provided in such Securities and this Indenture.
An
installment of principal or interest shall be considered paid on
the date it is due if the Trustee or Paying Agent holds on that
date money designated for and sufficient to pay such installment
and is not prohibited from paying such money to the Holders
pursuant to the terms of this Indenture or otherwise.
The
Company shall pay interest on overdue principal, and overdue
interest, to the extent lawful, at the rate specified in the Series
of Securities.
The
Company will deliver to the Trustee within 15 days after the filing
of the same with the SEC, copies of the quarterly and annual
reports and of the information, documents and other reports, if
any, which the Company is required to file with the SEC pursuant to
Section 13 or 15(d) of the Exchange Act; PROVIDED, HOWEVER,
that each such report or document will be deemed to be so delivered
to the Trustee if the Company files such report or document with
the SEC through the SEC’s EDGAR database no later than the
time such report or document is required to be filed with the SEC
pursuant to the Exchange Act. Notwithstanding that the Company may
not be subject to the reporting requirements of Section 13 or
15(d) of the Exchange Act, the Company will file with the SEC, to
the extent permitted, and provide the Trustee with, such quarterly
and annual reports and such information, documents and other
reports specified in Sections 13 and 15(d) of the Exchange Act. The
Company will also comply with the other provisions of TIA
Section 314(a).
4.3.
|
WAIVER
OF STAY, EXTENSION OR USURY LAWS.
|
The
Company covenants (to the extent that it may lawfully do so) that
it will not at any time insist upon, or plead (as a defense or
otherwise) or in any manner whatsoever claim or take the benefit or
advantage of, any stay, extension, usury or other law which would
prohibit or forgive the Company from paying all or any portion of
the principal of, and/or interest and premium, if any, on, the
Securities as contemplated herein, wherever enacted, now or at any
time hereafter in force, or which may affect the covenants or the
performance of this Indenture; and the Company hereby expressly
waives (to the extent that they may lawfully do so) all benefit or
advantage of any such law, and covenants that it will not hinder,
delay or impede the execution of any power herein granted to the
Trustee, but will suffer and permit the execution of every such
power as though no such law had been enacted.
4.4.
|
COMPLIANCE
CERTIFICATE.
|
(a)
The Company shall deliver to the Trustee, within 120 days after the
end of each fiscal year of the Company, an Officers’
Certificate which complies with TIA Section 314(a)(4) stating
that a review of the activities of the Company and its Subsidiaries
during such fiscal year has been made under the supervision of the
signing Officers with a view to determining whether the Company has
kept, observed, performed and fulfilled its obligations under this
Indenture, and further stating, as to each such Officer signing
such certificate, that to the best of his or her knowledge the
Company has kept, observed, performed and fulfilled each and every
covenant contained in this Indenture and that there is no default
in the performance or observance of any of the terms, provisions
and conditions hereof (or, if a Default or Event of Default shall
have occurred, describing all such Defaults or Events of Default of
which he or she may have knowledge and what action the Company is
taking or proposes to take with respect thereto) and that to the
best of his or her knowledge no event has occurred and remains in
existence by reason of which payments on account of the principal
of, or interest or premium, if any, on, the Securities is
prohibited, or if such event has occurred, a description of the
event and what action the Company is taking or proposes to take
with respect thereto.
(b)
(i) If any Default or Event of Default has occurred and is
continuing or (ii) if any Holder seeks to exercise any remedy
hereunder with respect to a claimed Default under this Indenture or
the Securities, within five Business Days after the Company
becoming aware of such occurrence the Company shall deliver to the
Trustee an Officers’ Certificate specifying such event,
notice or other action and what action the Company is taking or
proposes to take with respect thereto.
4.5.
|
CORPORATE
EXISTENCE.
|
Subject
to Article 5, the Company shall do or cause to be done all things
necessary to preserve and keep in full force and effect its
corporate existence, in accordance with the organizational
documents (as the same may be amended from time to time) of the
Company and the rights (charter and statutory), licenses and
franchises of the Company; PROVIDED, HOWEVER, that the Company
shall not be required to preserve any such right, license or
franchise, or its corporate existence, if the Board of Directors
shall determine that the preservation thereof is no longer
desirable in the conduct of the business of the Company and that
the loss thereof is not adverse in any material respect to the
Holders.
ARTICLE 5
SUCCESSOR CORPORATION
5.1.
|
LIMITATION
ON CONSOLIDATION, MERGER AND SALE OF ASSETS.
|
(a)
The Company will not, in any transaction or series of transactions,
merge or consolidate with or into, or sell, assign, convey,
transfer, lease or otherwise dispose of all or substantially all of
its properties and assets (as an entirety or substantially as an
entirety in one transaction or a series of related transactions),
to any Person or Persons, unless at the time of and after giving
effect thereto (i) either (A) if the transaction or
series of transactions is a merger or consolidation, the Company
shall be the surviving Person of such merger or consolidation, or
(B) the Person formed by such consolidation or into which the
Company is merged or to which the properties and assets of the
Company are transferred (any such surviving Person or transferee
Person being the “Surviving Entity”) shall be a
corporation organized and existing under the laws of the United
States of America, any state thereof or the District of Columbia,
or a corporation or comparable legal entity organized under the
laws of a foreign jurisdiction and shall expressly assume by a
supplemental indenture executed and delivered to the Trustee, in
form reasonably satisfactory to the Trustee, all of the obligations
of the Company (including, without limitation, the obligation to
pay the principal of, and premium and interest, if any, on, the
Securities and the performance of the other covenants) under the
Securities of each Series and this Indenture, and in each case,
this Indenture shall remain in full force and effect; and
(ii) immediately before and immediately after giving effect to
such transaction or series of transactions on a pro forma basis
(including, without limitation, any Indebtedness incurred or
anticipated to be incurred in connection with or in respect of such
transaction or series of transactions), no Default or Event of
Default shall have occurred and be continuing.
(b)
In connection with any consolidation, merger or transfer of assets
contemplated by this Section 5.1, the Company shall deliver,
or cause to be delivered, to the Trustee, in form and substance
reasonably satisfactory to the Trustee, an Officers’
Certificate and an Opinion of Counsel, each stating that such
consolidation, merger or transfer, and the supplemental indenture
in respect thereto, comply with this Section 5.1, and that all
conditions precedent herein provided for relating to such
transaction or transactions have been complied with.
5.2.
|
SUCCESSOR
PERSON SUBSTITUTED.
|
Upon
any consolidation, merger or transfer of all or substantially all
of the assets of the Company in accordance with Section 5.1
above, the successor corporation formed by such consolidation, or
into which the Company is merged or to which such transfer is made,
shall succeed to, and be substituted for, and may exercise every
right and power of, the Company under this Indenture with the same
effect as if such successor corporation had been named as the
Company herein, and thereafter (except with respect to any such
transfer which is a lease) the predecessor corporation shall be
relieved of all obligations and covenants under this Indenture and
the Securities.
ARTICLE 6
DEFAULTS AND REMEDIES
“Events
of Default,” wherever used herein with respect to Securities
of any Series, means any one of the following events, unless in the
establishing Board Resolution, supplemental indenture or
Officers’ Certificate, it is provided that such Series shall
not have the benefit of said Event of Default:
(1)
there is a default in the payment of any principal of, or premium,
if any, on, the Securities when the same becomes due and payable at
Maturity, upon acceleration, redemption or otherwise;
(2)
there is a default in the payment of any interest on any Security
of a Series when the same becomes due and payable, and the Default
continues for a period of 30 days;
(3)
the Company defaults in the observance or performance of any other
covenant in the Securities of a Series or in this Indenture for 60
days after written notice from the Trustee or the Holders of not
less than 25% in the aggregate principal amount of the Securities
of such Series then outstanding, which notice must specify the
Default, demand that it be remedied and state that the notice is a
“Notice of Default”;
(4)
the Company or any Significant Subsidiary pursuant to or within the
meaning of any Bankruptcy Law:
(A)
commences a voluntary case,
(B)
consents to the entry of an order for relief against it in an
involuntary case,
(C)
consents to the appointment of a Custodian of it or for all or
substantially all of its property,
(D)
makes a general assignment for the benefit of its creditors,
or
(E)
generally is not paying its debts as they become due;
(5)
a court of competent jurisdiction enters an order or decree under
any Bankruptcy Law that:
(A)
is for relief against the Company or any Significant Subsidiary in
an involuntary case;
(B)
appoints a Custodian of the Company or any Significant Subsidiary,
or for all or substantially all of the property of the Company or
any Significant Subsidiary; or
(C)
orders the liquidation of the Company or any Significant
Subsidiary, and the order or decree remains unstayed and in effect
for 90 consecutive days; or
(6)
any other Event of Default provided with respect to Securities of
that Series, which is specified in a Board Resolution, a
supplemental indenture hereto or an Officers’ Certificate, in
accordance with Section 2.2(19).
The
term “Bankruptcy Law” means Title 11, U.S. Code, or any
similar federal or state law for the relief of debtors. The term
“Custodian” means any receiver, trustee, assignee,
liquidator or similar official under any Bankruptcy
Law.
The
Trustee may withhold notice of any Default (except in the payment
of the principal of, or interest or premium, if any, on, the
Securities) to the Holders of the Securities of any Series in
accordance with Section 7.5. When a Default is cured, it
ceases to exist.
If
an Event of Default with respect to Securities of any Series at the
time outstanding (other than an Event of Default arising under
Section 6.1(4) or (5)) occurs and is continuing, the
Trustee by written notice to the Company, or the Holders of not
less than 25% in aggregate principal amount of the Securities of
that Series then outstanding by written notice to the Company and
the Trustee, may declare that the entire principal amount of all
the Securities of that Series then outstanding plus accrued and
unpaid interest to the date of acceleration are immediately due and
payable, in which case such amounts shall become immediately due
and payable; PROVIDED, HOWEVER, that after such acceleration but
before a judgment or decree based on such acceleration is obtained
by the Trustee, the Holders of a majority in aggregate principal
amount of the outstanding Securities of that Series may rescind and
annul such acceleration and its consequences if (i) all
existing Events of Default, other than the nonpayment of
accelerated principal, interest or premium, if any, that has become
due solely because of the acceleration, have been cured or waived,
(ii) to the extent the payment of such interest is lawful,
interest on overdue installments of interest and overdue principal,
which has become due otherwise than by such declaration of
acceleration, has been paid and (iii) the rescission would not
conflict with any judgment or decree. No such rescission shall
affect any subsequent Default or impair any right consequent
thereto. In case an Event of Default specified in
Section 6.1(4) or (5) with respect to the Company occurs,
such principal, premium, if any, and interest amount with respect
to all of the Securities of that Series shall be due and payable
immediately without any declaration or other act on the part of the
Trustee or the Holders of the Securities of that
Series.
If
an Event of Default with respect to Securities of any Series at the
time outstanding occurs and is continuing, the Trustee may pursue
any available remedy by proceeding at law or in equity to collect
the payment of the principal of, or interest and premium, if any,
on, the Securities of that Series, or to enforce the performance of
any provision of the Securities of that Series or this
Indenture.
The
Trustee may maintain a proceeding even if it does not possess any
of the Securities of that Series or does not produce any of them in
the proceeding. A delay or omission by the Trustee or any
Securityholder in exercising any right or remedy accruing upon an
Event of Default shall not impair the right or remedy or constitute
a waiver of or acquiescence in the Event of Default. No remedy is
exclusive of any other remedy. All available remedies are
cumulative to the extent permitted by law.
6.4.
|
WAIVER
OF PAST DEFAULTS AND EVENTS OF DEFAULT.
|
Subject
to Sections 6.2, 6.7 and 8.2, the Holders of a majority in
principal amount of the Securities of any Series then outstanding
have the right to waive any existing Default or Event of Default
with respect to such Series or compliance with any provision of
this Indenture (with respect to such Series) or the Securities of
such Series. Upon any such waiver, such Default with respect to
such Series shall cease to exist, and any Event of Default with
respect to such Series arising therefrom shall be deemed to have
been cured for every purpose of this Indenture; but no such waiver
shall extend to any subsequent or other Default or Event of Default
or impair any right consequent thereto. This Section 6.4 shall
be in lieu of TIA Section 316(a)(1)(B), and TIA
Section 316(a)(1)(B) is hereby expressly excluded from this
Indenture and Section as permitted by the TIA.
6.5.
|
CONTROL
BY MAJORITY.
|
Subject
to Sections 6.2, 6.7 and 8.2, the Holders of a majority in
principal amount of the Securities of any Series then outstanding
may direct the time, method and place of conducting any proceeding
for any remedy available to the Trustee or exercising any trust or
power conferred on the Trustee by this Indenture with respect to
such Series. The Trustee, however, may refuse to follow any
direction that conflicts with law or this Indenture, or that the
Trustee determines may be unduly prejudicial to the rights of
another Securityholder, or that may involve the Trustee in personal
liability; PROVIDED, that the Trustee may take any other action
deemed proper by the Trustee which is not inconsistent with such
direction. This Section 6.5 shall be in lieu of TIA
Section 316(a)(1)(A), and TIA Section 316(a)(1)(A) is
hereby expressly excluded from this Indenture and Section as
permitted by the TIA.
6.6.
|
LIMITATION
ON SUITS.
|
Subject
to Section 6.7, a Securityholder may not institute any
proceeding or pursue any remedy with respect to this Indenture or
the Securities of a Series unless:
(1)
the Holder gives to the Trustee written notice of a continuing
Event of Default with respect to the Securities of that
Series;
(2)
the Holders of at least 25% in aggregate principal amount of the
Securities of such Series then outstanding make a written request
to the Trustee to pursue the remedy;
(3)
such Holder or Holders offer to the Trustee indemnity reasonably
satisfactory to the Trustee against any loss, liability or expense
to be incurred in compliance with such request;
(4)
the Trustee does not comply with the request within 60 days after
receipt of the request and the offer of indemnity; and
(5)
no direction inconsistent with such written request has been given
to the Trustee during such 60-day period by the Holders of a
majority in aggregate principal amount of the Securities of such
Series then outstanding.
A
Securityholder may not use this Indenture to prejudice the rights
of another Securityholder, or to obtain a preference or priority
over another Securityholder.
6.7.
|
RIGHTS
OF HOLDERS TO RECEIVE PAYMENT.
|
Notwithstanding
any other provision of this Indenture, the right of any Holder of a
Security of a Series to receive payment of the principal of, and
interest and premium, if any, on, the Security of such Series on or
after the respective due dates expressed in the Security of such
Series, or to bring suit for the enforcement of any such payment on
or after such respective dates, is absolute and unconditional, and
shall not be impaired or affected without the consent of the
Holder.
6.8.
|
COLLECTION
SUIT BY TRUSTEE.
|
If
an Event of Default in payment of principal, interest or premium,
if any, specified in Section 6.1(1) or (2) with respect
to Securities of any Series at the time outstanding occurs and is
continuing, the Trustee may recover judgment in its own name and as
trustee of an express trust against the Company (or any other
obligor on the Securities of that Series) for the whole amount of
unpaid principal and premium, if any, and accrued interest
remaining unpaid, together with interest on overdue principal and
premium, if any, and, to the extent that payment of such interest
is lawful, interest on overdue installments of interest, in each
case at the rate then borne by the Securities of that Series, and
such further amounts as shall be sufficient to cover the costs and
expenses of collection, including the reasonable compensation,
expenses, disbursements and advances of the Trustee, its agents and
counsel, as set forth in Section 7.7.
6.9.
|
TRUSTEE
MAY FILE PROOFS OF CLAIM.
|
The
Trustee may file such proofs of claim and other papers or
documents, and take other actions (including sitting on a committee
of creditors), as may be necessary or advisable in order to have
the claims of the Trustee (including any claim for the reasonable
compensation, expenses, disbursements and advances of the Trustee,
its agents and counsel) and the Securityholders allowed in any
judicial proceedings relative to the Company (or any other obligor
on the Securities), any of their respective creditors or any of
their respective property, and the Trustee shall be entitled and
empowered to collect and receive any monies or other property
payable or deliverable on any such claims, and to distribute the
same after deduction of its charges and expenses to the extent that
any such charges and expenses are not paid out of the estate in any
such proceedings, and any custodian in any such judicial proceeding
is hereby authorized by each Securityholder to make such payments
to the Trustee, and in the event that the Trustee shall consent to
the making of such payments directly to the Securityholders, to pay
to the Trustee any amount due to it for the reasonable
compensation, expenses, disbursements and advances of the Trustee,
its agents and counsel, and any other amounts due the Trustee under
Section 7.7.
Nothing
herein contained shall be deemed to authorize the Trustee to
authorize or consent to, or accept or adopt on behalf of any
Securityholder, any plan of reorganization, arrangement, adjustment
or composition affecting the Securities of a Series or the rights
of any Holder thereof, or to authorize the Trustee to vote in
respect of the claim of any Securityholder in any such
proceedings.
If
the Trustee collects any money pursuant to this Article 6, it shall
pay out the money in the following order:
FIRST:
to the Trustee for amounts due under Section 7.7;
SECOND:
to Securityholders for amounts then due and unpaid for the
principal of, and interest and premium, if any, on, the Securities
in respect of which, or for the benefit of which, such money has
been collected, ratably, without preference or priority of any
kind, according to the amounts due and payable on such Securities;
for principal and any premium and interest, respectively;
and
THIRD:
to the Company.
The
Trustee may fix a record date and payment date for any payment to
Securityholders pursuant to this Section 6.10. At least 15
days before such record date, the Trustee shall mail to each
Securityholder a notice that states the record date, the payment
date and amount to be paid.
6.11.
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UNDERTAKING
FOR COSTS.
|
In
any suit for the enforcement of any right or remedy under this
Indenture, or in any suit against the Trustee for any action taken
or omitted by it as Trustee, a court in its discretion may require
the filing by any party litigant in the suit of an undertaking to
pay the costs of the suit, and the court in its discretion may
assess reasonable costs, including reasonable attorneys’
fees, against any party litigant in the suit, having due regard to
the merits and good faith of the claims or defenses made by the
party litigant. This Section 6.11 does not apply to a suit by
the Trustee, a suit by a Holder pursuant to Section 6.7 or a
suit by Holders of more than 10% in principal amount of the
Securities of a Series then outstanding.
ARTICLE 7
TRUSTEE
(a)
If an Event of Default has occurred and is continuing, the Trustee
shall exercise such of the rights and powers vested in it by this
Indenture and use the same degree of care and skill in their
exercise as a prudent Person would exercise or use under the same
circumstances in the conduct of his own affairs.
(b)
Except during the continuance of an Event of Default:
(1)
The Trustee need perform only those duties that are specifically
set forth in this Indenture, and no covenants or obligations shall
be implied in this Indenture against the Trustee.
(2)
In the absence of bad faith on its part, the Trustee may
conclusively rely, as to the truth of the statements and the
correctness of the opinions expressed therein, upon certificates or
opinions furnished to the Trustee and conforming to the
requirements of this Indenture, but, in the case of any such
certificates or opinions which by any provision hereof are
specifically required to be furnished to the Trustee, the Trustee
shall be under a duty to examine the same to determine whether or
not they conform to the requirements of this
Indenture.
(c)
The Trustee may not be relieved from liability for its own
negligent action, its own negligent failure to act or its own
willful misconduct, except that:
(1)
This paragraph does not limit the effect of paragraph (b) of
this Section 7.1.
(2)
The Trustee shall not be liable for any error of judgment made in
good faith by a Responsible Officer, unless it is proved that the
Trustee was negligent in ascertaining the pertinent
facts.
(3)
The Trustee shall not be liable with respect to any action it takes
or omits to take in good faith in accordance with a direction
received by it pursuant to Sections 6.2 and 6.5.
(d)
No provision of this Indenture shall require the Trustee to expend
or risk its own funds, or otherwise incur any financial liability,
in the performance of any of its rights or powers if it shall have
reasonable grounds for believing that repayment of such funds or
adequate indemnity satisfactory to it against such risk or
liability is not reasonably assured to it.
(e)
Whether or not therein expressly so provided, paragraphs (a), (b),
(c) and (d) of this Section 7.1 shall govern every
provision of this Indenture that in any way relates to the
Trustee.
(f)
The Trustee and Paying Agent shall not be liable for interest on
any money received by either of them, except as the Trustee and
Paying Agent may agree in writing with the Company. Money held in
trust by the Trustee need not be segregated from other funds except
to the extent required by the law.
(g)
The Paying Agent, the Registrar and any authenticating agent shall
be entitled to the protections, immunities and standard of care set
forth in paragraphs (a), (b), (c), (d) and (f) of this
Section 7.1 and in Section 7.2 with respect to the
Trustee.
(a)
Subject to Section 7.1:
(1)
The Trustee may rely on, and shall be protected in acting or
refraining from acting upon, any document reasonably believed by it
to be genuine and to have been signed or presented by the proper
Person. The Trustee need not investigate any fact or matter stated
in the document.
(2)
Before the Trustee acts or refrains from acting, it may require an
Officers’ Certificate or an Opinion of Counsel, or both,
which shall conform to the provisions of Section 10.5. The
Trustee shall be protected and shall not be liable for any action
it takes or omits to take in good faith in reliance on such
certificate or opinion.
(3)
The Trustee may act through agents and attorneys, and shall not be
responsible for the misconduct or negligence of any agent appointed
by it with due care.
(4)
The Trustee shall not be liable for any action it takes or omits to
take in good faith which it reasonably believes to be authorized or
within its rights or powers.
(5)
The Trustee may consult with counsel reasonably acceptable to the
Trustee, which may be counsel to the Company, and the advice or
opinion of such counsel as to matters of law shall be full and
complete authorization and protection from liability in respect of
any action taken, omitted or suffered by it hereunder in good faith
and in accordance with the advice or opinion of such
counsel.
(6)
The Trustee shall be under no obligation to exercise any of the
rights or powers vested in it by this Indenture at the request,
order or direction of any of the Holders pursuant to the provisions
of this Indenture, unless such Holders shall have offered to the
Trustee reasonable security or indemnity against the costs,
expenses and liabilities which may be incurred therein or
thereby.
(7)
The Trustee shall not be deemed to have knowledge of any fact or
matter (including, without limitation, a Default or Event of
Default) unless such fact or matter is known to a Responsible
Officer of the Trustee.
(8) Unless otherwise expressly
provided herein or in the Securities of a Series or the related
Board Resolution, supplemental indenture or Officers’
Certificate, the Trustee shall not have any responsibility with
respect to reports, notices, certificates or other
documents
filed
with it hereunder, except to make them available for inspection, at
reasonable times, by Securityholders, it being understood that
delivery of such reports, information and documents to the Trustee
is for informational purposes only and the Trustee’s receipt
of such shall not constitute constructive notice of any information
contained therein or determinable from information contained
therein, including the Company’s compliance with any of its
covenants hereunder (except as set forth in
Section 4.4).
7.3.
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INDIVIDUAL
RIGHTS OF TRUSTEE.
|
The
Trustee in its individual or any other capacity may become the
owner or pledgee of Securities, and may make loans to, accept
deposits from, perform services for or otherwise deal with the
Company, or any Affiliate thereof, with the same rights it would
have if it were not Trustee. Any Agent may do the same with like
rights. The Trustee, however, shall be subject to Sections 7.10 and
7.11.
7.4.
|
TRUSTEE’S
DISCLAIMER.
|
The
Trustee makes no representation as to the validity or adequacy of
this Indenture or the Securities (except that the Trustee
represents that it is duly authorized to execute and deliver this
Indenture and authenticate the Securities and perform its
obligations hereunder), and the Trustee shall not be accountable
for the Company’s use of the proceeds from the sale of
Securities or any money paid to the Company pursuant to the terms
of this Indenture, and the Trustee shall not be responsible for any
statement in the Securities other than its certificates of
authentication.
If
a Default or an Event of Default occurs and is continuing with
respect to the Securities of any Series, and if it is known to the
Trustee, the Trustee shall mail to each Securityholder of the
Securities of that Series notice of the Default or the Event of
Default, as the case may be, within 90 days after it occurs or, if
later, after a Responsible Officer of the Trustee has knowledge of
such Default or Event of Default (except if such Default or Event
of Default has been validly cured or waived before the giving of
such notice). Except in the case of a Default or an Event of
Default in payment of the principal of, or interest or premium, if
any, on, any Security of any Series, the Trustee may withhold the
notice if and so long as the Board of Directors of the Trustee, the
executive committee or any trust committee of such board and/or its
Responsible Officers in good faith determine(s) that withholding
the notice is in the interests of the Securityholders of that
Series.
7.6.
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REPORTS
BY TRUSTEE TO HOLDERS.
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If
and to the extent required by the TIA, within 60 days after
April 1 of each year, commencing the April 1 following
the date of this Indenture, the Trustee shall mail to each
Securityholder a brief report dated as of such April 1 that
complies with TIA Section 313(a). The Trustee also shall
comply with TIA Sections 313(b) and 313(c).
A
copy of each report at the time of its mailing to Securityholders
shall be filed with the SEC and any stock exchange on which the
Securities of that Series are listed. The Company shall promptly
notify the Trustee when the Securities of any Series are listed on
any stock exchange or any delisting thereof, and the Trustee shall
comply with TIA Section 313(d).
7.7.
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COMPENSATION
AND INDEMNITY.
|
The
Company shall pay to the Trustee from time to time reasonable
compensation for its services. The Trustee’s compensation
shall not be limited by any provision of law on compensation of a
trustee of an express trust. The Company shall reimburse the
Trustee within 45 days after receipt of request for all reasonable
out-of-pocket disbursements and expenses incurred or made by it in
connection with its duties under this Indenture, including the
reasonable compensation, disbursements and expenses of the
Trustee’s agents and counsel.
The
Company shall indemnify the Trustee for, and hold it harmless
against, any and all loss or liability incurred by it in connection
with the acceptance or performance of its duties under this
Indenture including the reasonable costs and expenses of defending
itself against any claim or liability in connection with the
exercise or performance of any of its powers or duties hereunder.
The Trustee shall notify the Company promptly of any claim asserted
against the Trustee for which it may seek indemnity.
The
failure by the Trustee to so notify the Company shall not however
relieve the Company of its obligations. Notwithstanding the
foregoing, the Company need not reimburse the Trustee for any
expense or indemnify it against any loss or liability incurred by
the Trustee through its negligence or bad faith. To secure the
payment obligations of the Company in this Section 7.7, the
Trustee shall have a lien prior to the Securities of any Series on
all money or property held or collected by the Trustee except such
money or property held in trust to pay the principal of, interest
and premium, if any, on particular Securities of that
Series.
When
the Trustee incurs expenses or renders services after an Event of
Default specified in Section 6.1(4) or (5) occurs, the
expenses and the compensation for the services are intended to
constitute expenses of administration under any Bankruptcy
Law.
For
purposes of this Section 7.7, the term “Trustee”
shall include any trustee appointed pursuant to this Article
7.
7.8.
|
REPLACEMENT
OF TRUSTEE.
|
The
Trustee may resign with respect to the Securities of one or more
Series by so notifying the Company in writing at least 90 days in
advance of such resignation.
The
Holders of a majority in principal amount of the outstanding
Securities of any Series may remove the Trustee with respect to
that Series by notifying the removed Trustee in writing and may
appoint a successor Trustee with respect to that Series with the
consent of the Company, which consent shall not be unreasonably
withheld. The Company may remove the Trustee with respect to that
Series at its election if:
(1)
the Trustee fails to comply with, or ceases to be eligible under,
Section 7.10;
(2)
the Trustee is adjudged a bankrupt or an insolvent, or an order for
relief is entered with respect to the Trustee, under any Bankruptcy
Law;
(3)
a Custodian or other public officer takes charge of the Trustee or
its property; or
(4)
the Trustee otherwise becomes incapable of acting.
(5)
If the Trustee resigns or is removed, or if a vacancy exists in the
office of Trustee, with respect to any Series of Securities for any
reason, the Company shall promptly appoint, by Board Resolution, a
successor Trustee.
If
a successor Trustee with respect to the Securities of one or more
Series does not take office within 60 days after the retiring
Trustee resigns or is removed, the retiring Trustee, the Company or
the Holders of at least 10% in principal amount of the outstanding
Securities of the applicable Series may petition any court of
competent jurisdiction for the appointment of a successor
Trustee.
If
the Trustee with respect to the Securities of one or more Series
fails to comply with Section 7.10, any Securityholder of the
applicable Series may petition any court of competent jurisdiction
for the removal of the Trustee and the appointment of a successor
Trustee.
A
successor Trustee shall deliver a written acceptance of its
appointment to the retiring Trustee and to the Company. Immediately
following such delivery, (i) the retiring Trustee with respect
to one or more Series shall, subject to its rights under
Section 7.7, transfer all property held by it as Trustee with
respect to such Series to the successor Trustee, (ii) the
resignation or removal of the retiring Trustee shall become
effective and (iii) the successor Trustee with respect to such
Series shall have all the rights, powers and duties of the Trustee
under this Indenture. A successor Trustee with respect to the
Securities of one or more Series shall mail notice of its
succession to each Securityholder of such Series.
7.9.
|
SUCCESSOR
TRUSTEE BY CONSOLIDATION, MERGER OR CONVERSION.
|
If
the Trustee, or any Agent, consolidates with, merges or converts
into, or transfers all or substantially all of its corporate trust
assets to, another corporation, subject to Section 7.10, the
successor corporation without any further act shall be the
successor Trustee or Agent, as the case may be.
7.10.
|
ELIGIBILITY;
DISQUALIFICATION.
|
This
Indenture shall always have a Trustee who satisfies the
requirements of TIA Sections 310(a)(1), (2) and (5) in
every respect. The Trustee (or in the case of a Trustee that is a
Person included in a bank holding company system, the related bank
holding company) shall have a combined capital and surplus of at
least $100,000,000 as set forth in its most recent published annual
report of condition. The Trustee shall comply with TIA
Section 310(b), including the provision in
Section 310(b)(1). In addition, if the Trustee is a Person
included in a bank holding company system, the Trustee,
independently of such bank holding company, shall meet the capital
requirements of TIA Section 310(a)(2). If at any time the
Trustee shall cease to be eligible in accordance with the
provisions of this Section 7.10, it shall resign immediately
in the manner and with the effect specified in this Article
7.
7.11.
|
PREFERENTIAL
COLLECTION OF CLAIMS AGAINST COMPANY.
|
The
Trustee shall comply with TIA Section 311(a), excluding any
creditor relationship listed in TIA Section 311(b). A Trustee
who has resigned or been removed shall be subject to TIA
Section 311(a) to the extent indicated therein.
The
Company shall cause each Paying Agent other than the Trustee to
execute and deliver to it and the Trustee an instrument in which
such agent shall agree with the Trustee, subject to the provisions
of this Section 7.12:
(1)
that it will hold all sums held by it as agent for the payment of
the principal of, or interest or premium, if any, on, the
Securities (whether such sums have been paid to it by the Company
or by any obligor on the Securities) in trust for the benefit of
Holders of the Securities or the Trustee;
(2)
that it will at any time during the continuance of any Event of
Default, upon written request from the Trustee, deliver to the
Trustee all sums so held in trust by it together with a full
accounting thereof; and
(3)
that it will give the Trustee written notice within three Business
Days after any failure of the Company (or by any obligor on the
Securities) in the payment of any installment of the principal of,
or interest or premium, if any, on, the Securities when the same
shall be due and payable.
ARTICLE 8
AMENDMENTS, SUPPLEMENTS AND WAIVERS
8.1.
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WITHOUT
CONSENT OF HOLDERS.
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The
Company, when authorized by a Board Resolution, and the Trustee may
amend or supplement this Indenture or the Securities of one or more
Series without notice to or consent of any
Securityholder:
(1)
to comply with Section 5.1;
(2)
to provide for certificated Securities in addition to
uncertificated Securities;
(3)
to comply with any requirements of the SEC under the
TIA;
(4)
to cure any ambiguity, defect or inconsistency, or to make any
other change herein or in the Securities that does not materially
and adversely affect the rights of any Securityholder;
(5)
to provide for the issuance of, and establish the form and terms
and conditions of, Securities of any Series as permitted by this
Indenture; or
(6)
to evidence and provide for the acceptance of appointment hereunder
by a successor Trustee with respect to the Securities of one or
more Series, and to add to or change any of the provisions of this
Indenture as shall be necessary to provide for or facilitate the
administration of the trusts hereunder by more than one
Trustee.
The
Trustee is hereby authorized to join with the Company in the
execution of any supplemental indenture authorized or permitted by
the terms of this Indenture, and to make any further appropriate
agreements and stipulations which may be therein contained, but the
Trustee shall not be obligated to enter into any such supplemental
indenture which adversely affects its own rights, duties or
immunities under this Indenture.
8.2.
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WITH
CONSENT OF HOLDERS.
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(a)
The Company, when authorized by a Board Resolution, and the Trustee
may amend or supplement this Indenture or the Securities of one or
more Series with the written consent of the Holders of not less
than a majority in aggregate principal amount of the outstanding
Securities of such Series affected by such amendment or supplement
without notice to any Securityholder. The Holders of not less than
a majority in aggregate principal amount of the outstanding
Securities of each such Series affected by such amendment or
supplement may waive compliance by the Company in a particular
instance with any provision of this Indenture or the Securities of
such Series without notice to any Securityholder. Subject to
Section 8.4, without the consent of each Securityholder
affected, however, an amendment, supplement or waiver may
not:
(1)
reduce the amount of Securities whose Holders must consent to an
amendment, supplement or waiver to this Indenture or the
Securities;
(2)
reduce the rate of, or change the time for payment of, interest on
any Security;
(3)
reduce the principal, or change the Stated Maturity, of any
Security, or reduce the amount of, or postpone the date fixed for,
the payment of any sinking fund or analogous
obligation;
(4)
make any Security payable in money other than that stated in the
Security;
(5)
change the amount or time of any payment required by the
Securities, or reduce the premium payable upon any redemption of
the Securities, or change the time before which no such redemption
may be made;
(6)
waive a Default or Event of Default in the payment of the principal
of, or interest or premium, if any, on, any Security (except a
rescission of acceleration of the Securities of any Series by the
Holders of at least a majority in principal amount of the
outstanding Securities of such Series and a waiver of the payment
default that resulted from such acceleration);
(7)
waive a redemption payment with respect to any Security, or change
any of the provisions with respect to the redemption of any
Securities;
(8)
make any changes in Section 6.6 or this Section 8.2,
except to increase any percentage of Securities the Holders of
which must consent to any matter; or
(9)
take any other action otherwise prohibited by this Indenture to be
taken without the consent of each Holder affected
thereby.
(b)
Upon the request of the Company, accompanied by a Board Resolution
authorizing the execution of any such supplemental indenture, and
upon the receipt by the Trustee of evidence reasonably satisfactory
to the Trustee of the consent of the Securityholders as aforesaid
and of the documents described in Section 8.6, the Trustee
shall join with the Company in the execution of such supplemental
indenture, unless such supplemental indenture affects the
Trustee’s own rights, duties or immunities under this
Indenture, in which case the Trustee may in its discretion, but
shall not be obligated to, enter into such supplemental
indenture.
(c)
It shall not be necessary for the consent of the Holders under this
section to approve the particular form of any proposed amendment,
supplement or waiver, but it shall be sufficient if such consent
approves the substance thereof.
After
an amendment or supplement under this Section becomes effective,
the Company shall mail to Securityholders a notice briefly
describing the amendment or supplement. Any failure of the Company
to mail any such notice, or any defect therein, shall not, however,
in any way impair or affect the validity of any supplemental
indenture.
8.3.
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COMPLIANCE
WITH TRUST INDENTURE ACT.
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Every
amendment to, or supplement of, this Indenture or the Securities
shall comply with the TIA as then in effect.
8.4.
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REVOCATION
AND EFFECT OF CONSENTS.
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Until
an amendment, supplement, waiver or other action becomes effective,
a consent to it by a Holder of a Security is a continuing consent
conclusive and binding upon such Holder and every subsequent Holder
of the same Security or portion thereof, and of any Security issued
upon the transfer thereof or in exchange therefor or in place
thereof, even if notation of the consent is not made on any such
Security. Any such Holder or subsequent Holder, however, may revoke
the consent as to his Security or portion of a Security, if the
Trustee receives the notice of revocation before the date the
amendment, supplement, waiver or other action becomes
effective.
The
Company may, but shall not be obligated to, fix a record date for
the purpose of determining the Holders entitled to consent to any
amendment, supplement or waiver, which record date shall be at
least 30 days prior to the first solicitation of such consent. If a
record date is fixed, then, notwithstanding the preceding
paragraph, those Persons who were Holders at such record date (or
their duly designated proxies), and only such Persons, shall be
entitled to consent to such amendment, supplement or waiver, or to
revoke any consent previously given, whether or not such Persons
continue to be Holders after such record date.
After
an amendment, supplement, waiver or other action becomes effective,
it shall bind every Securityholder, unless it makes a change
described in any of clauses (1) through (9) of
Section 8.2. In that case, the amendment, supplement, waiver
or other action shall bind each Holder of a Security who has
consented to it and every subsequent Holder of a Security or
portion of a Security that evidences the same debt as the
consenting Holder’s Security; PROVIDED, that any such waiver
shall not impair or affect the right of any Holder to receive
payment of the principal of, and interest and premium, if any, on,
a Security, on or after the respective due dates expressed in such
Security, or to bring suit for the enforcement of any such payment
on or after such respective dates without the consent of such
Holder.
8.5.
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NOTATION
ON OR EXCHANGE OF SECURITIES.
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If
an amendment, supplement or waiver changes the terms of a Security
of any Series, the Trustee may request the Holder of such Security
to deliver it to the Trustee. In such case, the Trustee shall place
an appropriate notation on such Security about the changed terms
and return it to the Holder. Alternatively, the Company, in
exchange for such Security, may issue, and the Trustee shall
authenticate, a new security that reflects the changed terms.
Failure to make the appropriate notation or issue a new Security
shall not affect the validity and effect of such amendment,
supplement or waiver.
8.6.
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TRUSTEE
TO SIGN AMENDMENTS, ETC.
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The
Trustee shall sign any amendment, supplement or waiver authorized
pursuant to this Article 8 if the amendment, supplement or waiver
does not adversely affect the rights, duties, liabilities or
immunities of the Trustee. If it does, the Trustee may, but need
not, sign it. In signing or refusing to sign such amendment,
supplement or waiver the Trustee shall be entitled to receive and,
subject to Section 7.1, shall be fully protected in relying
upon an Officers’ Certificate and an Opinion of Counsel
stating that such amendment, supplement or waiver is authorized or
permitted by this Indenture. The Company may not sign an amendment
or supplement until the Board of Directors of the Company approves
it.
ARTICLE 9
DISCHARGE OF INDENTURE; DEFEASANCE
9.1.
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DISCHARGE
OF INDENTURE.
|
The Company may terminate its
obligations under the Securities of any Series and this Indenture
with respect to such Series, except the obligations referred to in
the last paragraph of this Section 9.1, if there shall have
been canceled by the Trustee, or delivered to the Trustee
for
cancellation,
all Securities of such Series theretofore authenticated and
delivered (other than any Securities of such Series that are
asserted to have been destroyed, lost or stolen and that shall have
been replaced as provided in Section 2.8) and the Company has
paid all sums payable by it hereunder or deposited all required
sums with the Trustee.
After
such delivery the Trustee upon request shall acknowledge in a
writing prepared by or on behalf of the Company the discharge of
the Company’s obligations under the Securities of such Series
and this Indenture, except for those surviving obligations
specified below.
Notwithstanding
the satisfaction and discharge of this Indenture, the obligations
of the Company in Sections 7.7, 9.5 and 9.6 shall
survive.
The
Company may at its option, by Board Resolution, be discharged from
its obligations with respect to the Securities of any Series on the
date upon which the conditions set forth in Section 9.4 below
are satisfied (hereinafter, “Legal Defeasance”). For
this purpose, such Legal Defeasance means that the Company shall be
deemed to have paid and discharged the entire indebtedness
represented by the Securities of such Series and to have satisfied
all its other obligations under such Securities and this Indenture
insofar as such Securities are concerned (and the Trustee, at the
expense of the Company, shall, subject to Section 9.6, execute
proper instruments acknowledging the same, as are delivered to it
by the Company), except for the following, which shall survive
until otherwise terminated or discharged hereunder: (A) the
rights of Holders of outstanding Securities of such Series to
receive solely from the trust funds described in Section 9.4
and as more fully set forth in such section, payments in respect of
the principal of, and interest and premium, if any, on, the
Securities of such Series when such payments are due, (B) the
Company’s obligations with respect to the Securities of such
Series under Sections 2.4, 2.5, 2.6, 2.7, 2.8 and 2.9, (C) the
rights, powers, trusts, duties and immunities of the Trustee
hereunder (including claims of, or payments to, the Trustee under
or pursuant to Section 7.7) and (D) this Article 9.
Subject to compliance with this Article 9, the Company may exercise
its option under this Section 9.2 with respect to the
Securities of any Series notwithstanding the prior exercise of its
option under Section 9.3 below with respect to the Securities
of such Series.
9.3.
|
COVENANT
DEFEASANCE.
|
At
the option of the Company, pursuant to a Board Resolution, the
Company shall be released from its obligations with respect to the
outstanding Securities of any Series under Sections 4.2 through
4.5, inclusive, and Section 5.1, with respect to the
outstanding Securities of such Series, on and after the date the
conditions set forth in Section 9.4 are satisfied
(hereinafter, “Covenant Defeasance”). For this purpose,
such Covenant Defeasance means that the Company may omit to comply
with and shall have no liability in respect of any term, condition
or limitation set forth in any such specified section or portion
thereof, whether directly or indirectly by reason of any reference
elsewhere herein to any such specified Section or portion thereof
or by reason of any reference in any such specified section or
portion thereof to any other provision herein or in any other
document, but the remainder of this Indenture and the Securities of
any Series shall be unaffected thereby.
9.4.
|
CONDITIONS
TO LEGAL DEFEASANCE OR COVENANT DEFEASANCE.
|
The
following shall be the conditions to application of
Section 9.2 or Section 9.3 to the outstanding Securities
of a Series:
(1)
the Company shall irrevocably have deposited or caused to be
deposited with the Trustee (or another trustee satisfying the
requirements of Section 7.10 who shall agree to comply with
the provisions of this Article 9 applicable to it) as funds in
trust for the purpose of making the following payments,
specifically pledged as security for, and dedicated solely to, the
benefit of the Holders of the Securities, (A) money in an
amount, or (B) U.S. Government Obligations or Foreign
Government Obligations which through the scheduled payment of
principal and interest in respect thereof in accordance with their
terms will provide, not later than the due date of any payment,
money in an amount, or (C) a combination thereof, sufficient,
in the opinion of a nationally recognized firm of independent
public accountants expressed in a written certification thereof
delivered to the Trustee, to pay and discharge, and which shall be
applied by the Trustee (or other qualifying trustee) to pay and
discharge, the principal of, and accrued interest and premium, if
any, on, the outstanding Securities of such Series at the Stated
Maturity of such principal, interest or premium, if any, or on
dates for payment and redemption of such principal, interest and
premium, if any, selected in accordance with the terms of this
Indenture and of the Securities of such Series;
(2)
no Event of Default or Default with respect to the Securities of
such Series shall have occurred and be continuing on the date of
such deposit, or shall have occurred and be continuing at any time
during the period ending on the 91st day after the date of such
deposit or, if longer, ending on the day following the expiration
of the longest preference period under any Bankruptcy Law
applicable to the Company in respect of such deposit as specified
in the Opinion of Counsel identified in paragraph (8) below
(it being understood that this condition shall not be deemed
satisfied until the expiration of such period);
(3)
such Legal Defeasance or Covenant Defeasance shall not cause the
Trustee to have a conflicting interest for purposes of the TIA with
respect to any securities of the Company;
(4)
such Legal Defeasance or Covenant Defeasance shall not result in a
breach or violation of, or constitute default under, any other
agreement or instrument to which the Company is a party or by which
it is bound;
(5)
the Company shall have delivered to the Trustee an Opinion of
Counsel stating that, as a result of such Legal Defeasance or
Covenant Defeasance, neither the trust nor the Trustee will be
required to register as an investment company under the Investment
Company Act of 1940, as amended;
(6) in the case of an election
under Section 9.2, the Company shall have delivered to the
Trustee an Opinion of Counsel stating that (i) the Company has
received from, or there has been published by, the Internal Revenue
Service a ruling to the effect that or (ii) there has been a
change in any applicable Federal income tax law with the effect
that, and such opinion shall confirm that, the Holders of the
outstanding Securities of such Series or Persons
in
their
positions will not recognize income, gain or loss for Federal
income tax purposes solely as a result of such Legal Defeasance and
will be subject to Federal income tax on the same amounts, in the
same manner, including as a result of prepayment, and at the same
times as would have been the case if such Legal Defeasance had not
occurred;
(7)
in the case of an election under Section 9.3, the Company
shall have delivered to the Trustee an Opinion of Counsel to the
effect that the Holders of the outstanding Securities of such
Series will not recognize income, gain or loss for Federal income
tax purposes as a result of such Covenant Defeasance, and will be
subject to Federal income tax on the same amounts, in the same
manner and at the same times as would have been the case if such
Covenant Defeasance had not occurred;
(8)
the Company shall have delivered to the Trustee an Officers’
Certificate and an Opinion of Counsel, each stating that all
conditions precedent provided for in this Article 9 relating to
either the Legal Defeasance under Section 9.2 or the Covenant
Defeasance under Section 9.3 (as the case may be) have been
complied with;
(9)
the Company shall have delivered to the Trustee an Officers’
Certificate stating that the deposit under clause (1) was not
made by the Company with the intent of defeating, hindering,
delaying or defrauding any creditors of the Company or others;
and
(10)
the Company shall have paid, or duly provided for payment under
terms mutually satisfactory to the Company and the Trustee, all
amounts then due to the Trustee pursuant to
Section 7.7.
9.5.
|
DEPOSITED
MONEY AND U.S. AND FOREIGN GOVERNMENT OBLIGATIONS TO BE HELD IN
TRUST; OTHER MISCELLANEOUS PROVISIONS.
|
All
money, U.S. Government Obligations and Foreign Government
Obligations (including the proceeds thereof) deposited with the
Trustee pursuant to Section 9.4 in respect of the outstanding
Securities shall be held in trust and applied by the Trustee, in
accordance with the provisions of such Securities and this
Indenture, to the payment, either directly or through any Paying
Agent as the Trustee may determine, to the Holders of such
Securities, of all sums due and to become due thereon in respect of
principal, accrued interest and premium, if any, but such money
need not be segregated from other funds except to the extent
required by law.
The
Company shall pay and indemnify the Trustee against any tax, fee or
other charge imposed on or assessed against the U.S. Government
Obligations and Foreign Government Obligations deposited pursuant
to Section 9.4 or the principal, interest and premium, if any,
received in respect thereof other than any such tax, fee or other
charge which by law is for the account of the Holders of the
outstanding Securities.
Anything
in this Article 9 to the contrary notwithstanding, but subject to
payment of any of its outstanding fees and expenses, the Trustee
shall deliver or pay to the Company from time to time upon Company
Request any money, U.S. Government Obligations or Foreign
Government Obligations held by the Trustee as provided in
Section 9.4 which, in the opinion of a nationally-recognized
firm of independent public accountants expressed in a written
certification thereof delivered to the Trustee, are in excess of
the amount thereof which would then be required to be deposited to
effect an equivalent Legal Defeasance or Covenant
Defeasance.
If
the Trustee or Paying Agent is unable to apply any money, U.S.
Government Obligations or Foreign Government Obligations in
accordance with Section 9.1, 9.2, 9.3 or 9.4 by reason of any
legal proceeding or by reason of any order or judgment of any court
or governmental authority enjoining, restraining or otherwise
prohibiting such application, the Company’s obligations under
this Indenture and the Securities shall be revived and reinstated
as though no deposit had occurred pursuant to this Article 9 until
such time as the Trustee or Paying Agent is permitted to apply all
such money, U.S. Government Obligations or Foreign Government
Obligations, as the case may be, in accordance with
Section 9.1, 9.2, 9.3 or 9.4; PROVIDED, HOWEVER, that if the
Company has made any payment of principal of, or accrued interest
or premium, if any, on, any Securities because of the reinstatement
of its obligations, the Company shall be subrogated to the rights
of the Holders of such Securities to receive such payment from the
money, U.S. Government Obligations or Foreign Government
Obligations held by the Trustee or Paying Agent.
9.7.
|
MONEYS
HELD BY PAYING AGENT.
|
In
connection with the satisfaction and discharge of this Indenture,
all moneys then held by any Paying Agent under the provisions of
this Indenture shall, upon demand of the Company, be paid to the
Trustee, or, if sufficient moneys have been deposited pursuant to
Section 9.1, to the Company, and thereupon such Paying Agent
shall be released from all further liability with respect to such
moneys.
9.8.
|
MONEYS
HELD BY TRUSTEE.
|
Any
moneys deposited with the Trustee or any Paying Agent or then held
by the Company in trust for the payment of the principal of, or
interest or premium, if any, on, any Security that are not applied
but remain unclaimed by the Holder of such Security for two years
after the date upon which the principal of, or interest or premium,
if any, on, such Security shall have respectively become due and
payable shall be repaid to the Company upon Company Request, or if
such moneys are then held by the Company in trust, such moneys
shall be released from such trust; and the Holder of such Security
entitled to receive such payment shall thereafter, as an unsecured
general creditor, look only to the Company for the payment thereof,
and all liability of the Trustee or such Paying Agent with respect
to such trust money shall thereupon cease; PROVIDED, HOWEVER, that
the Trustee or any such Paying Agent, before being required to make
any such repayment, may, at the expense of the Company, either mail
to each Securityholder affected, at the address shown in the
register of the Securities maintained by the Registrar, or cause to
be published once a week for two successive weeks, in a newspaper
published in the English language, customarily published each
Business Day and of general circulation in the City of New York,
New York, a notice that such money remains unclaimed and that,
after a date specified therein, which shall not be less than 30
days from the date of such mailing or publication, any unclaimed
balance of such moneys then remaining will be repaid to the
Company. After payment to the Company or the release of any money
held in trust by the Company, Securityholders entitled to the money
must look only to the Company for payment as general creditors,
unless applicable abandoned property law designates another
Person.
ARTICLE 10
MISCELLANEOUS
10.1.
|
TRUST
INDENTURE ACT CONTROLS.
|
If
any provision of this Indenture limits, qualifies or conflicts with
another provision which is required to be included in this
Indenture by the TIA, the required provision shall control. If any
provision of this Indenture modifies or excludes any provision of
the TIA which may be so modified or excluded, the latter provision
shall be deemed to apply to this Indenture as so modified or to be
excluded, as the case may be.
Any
notice or communication shall be given in writing and delivered in
Person, sent by facsimile (and receipt confirmed by telephone or
electronic transmission report), delivered by commercial courier
service or mailed by first-class mail, postage prepaid, addressed
as follows:
If
to the Company:
CorMedix
Inc.
400
Connell Drive, Suite 5000
Berkley
Heights, NJ 07922
Fax:
(908) 375-8272
Attention:
Chief Executive Officer
Copy
to:
Wyrick
Robbins Yates & Ponton LLP
4101
Lake Boone Trail, Suite 300
Raleigh,
NC 27607
Fax:
(919) 781-4865
Attention:
Alexander M. Donaldson, Esq.
If
to the Trustee:
The Company or the Trustee by
written notice to the other may designate additional or different
addresses for subsequent notices or communications. Any notice or
communication to the Company or the Trustee shall be deemed to have
been given or made as of the date so
delivered
if personally delivered; when receipt is confirmed by telephone or
electronic transmission report, if sent by facsimile; and three
Business Days after mailing if sent by registered or certified
mail, postage prepaid (except that a notice of change of address
shall not be deemed to have been given until actually received by
the addressee).
Any
notice or communication mailed to a Securityholder shall be mailed
to such Securityholder by first-class mail, postage prepaid, at
such Securityholder’s address shown on the register kept by
the Registrar.
Failure
to mail, or any defect in, a notice or communication to a
Securityholder shall not affect its sufficiency with respect to
other Securityholders. If a notice or communication to a
Securityholder is mailed in the manner provided above, it shall be
deemed duly given, three Business Days after such mailing, whether
or not the addressee receives it.
In
case by reason of the suspension of regular mail service, or by
reason of any other cause, it shall be impossible to mail any
notice as required by this Indenture, then such method of
notification as shall be made with the approval of the Trustee
shall constitute a sufficient mailing of such notice.
In
the case of Global Securities, notices or communications to be
given to Securityholders shall be given to the Depository, in
accordance with its applicable policies as in effect from time to
time.
In
addition to the manner provided for in the foregoing provisions,
notices or communications to Securityholders shall be given by the
Company by release made to Reuters Economic Services and Bloomberg
Business News.
10.3.
|
COMMUNICATIONS
BY HOLDERS WITH OTHER HOLDERS.
|
Securityholders
of any Series may communicate pursuant to TIA Section 312(b)
with other Securityholders of that Series or any other Series with
respect to their rights under this Indenture or the Securities of
that Series or any other Series. The Company, the Trustee, the
Registrar and any other Person shall have the protection of TIA
Section 312(c).
10.4.
|
CERTIFICATE
AND OPINION AS TO CONDITIONS PRECEDENT.
|
Upon
any request or application by the Company to the Trustee to take
any action under this Indenture, the Company shall furnish to the
Trustee:
(1)
an Officers’ Certificate (which shall include the statements
set forth in Section 10.5 below) stating that, in the opinion
of the signers, all conditions precedent, if any, provided for in
this Indenture relating to the proposed action have been complied
with; and
(2)
an Opinion of Counsel (which shall include the statements set forth
in Section 10.5 below) stating that, in the opinion of such
counsel, all such conditions precedent have been complied
with.
10.5.
|
STATEMENT
REQUIRED IN CERTIFICATE AND OPINION.
|
Each
certificate and opinion with respect to compliance with a condition
or covenant provided for in this Indenture (other than pursuant to
Section 4.4) shall include:
(1)
a statement that the Person making such certificate or opinion has
read such covenant or condition;
(2)
a brief statement as to the nature and scope of the examination or
investigation upon which the statements or opinions contained in
such certificate or opinion are based;
(3)
a statement that, in the opinion of such Person, it or he has made
such examination or investigation as is necessary to enable it or
him to express an informed opinion as to whether or not such
covenant or condition has been complied with; and
(4)
a statement as to whether or not, in the opinion of such Person,
such covenant or condition has been complied with.
10.6.
|
RULES
BY TRUSTEE AND AGENTS.
|
The
Trustee may make reasonable rules for action by or at meetings of
Securityholders. The Registrar and Paying Agent may make reasonable
rules for their functions.
10.7.
|
BUSINESS
DAYS; LEGAL HOLIDAYS; PLACE OF PAYMENT.
|
A
“Business Day” is a day that is not a Legal Holiday. A
“Legal Holiday” is a Saturday, a Sunday, a
federally-recognized holiday or a day on which banking institutions
are not authorized or required by law, regulation or executive
order to be open in the State of New York.
If
a payment date is a Legal Holiday at a Place of Payment, payment
may be made at that place on the next succeeding day that is not a
Legal Holiday, and no interest shall accrue for the intervening
period. “Place of Payment” means the place or places
where the principal of, and interest and premium, if any, on, the
Securities of a Series are payable as specified as contemplated by
Section 2.2. If the regular record date is a Legal Holiday,
the record date shall not be affected.
THIS INDENTURE AND THE SECURITIES SHALL BE GOVERNED BY AND
CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, AS
APPLIED TO CONTRACTS MADE AND PERFORMED WITHIN THE STATE OF NEW
YORK WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW.
10.9.
|
NO
ADVERSE INTERPRETATION OF OTHER AGREEMENTS.
|
This
Indenture may not be used to interpret another indenture, loan,
security or debt agreement of the Company or any Subsidiary
thereof. No such indenture, loan, security or debt agreement may be
used to interpret this Indenture.
10.10.
|
NO
RECOURSE AGAINST OTHERS.
|
A
director, officer, employee, stockholder or incorporator, as such,
of the Company shall not have any liability for any obligations of
the Company under the Securities or the Indenture. Each
Securityholder by accepting a Security waives and releases all such
liability. Such waiver and release are part of the consideration
for the issuance of the Securities.
All
covenants and agreements of the Company in this Indenture and the
Securities shall bind the Company’s successors and assigns,
whether so expressed or not. All agreements of the Trustee, any
additional trustee and any Paying Agents in this Indenture shall
bind their respective successors and assigns.
10.12.
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MULTIPLE
COUNTERPARTS.
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The
parties may sign multiple counterparts of this Indenture. Each
signed counterpart shall be deemed an original, but all of them
together represent one and the same agreement.
10.13.
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TABLE
OF CONTENTS, HEADINGS, ETC.
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The
table of contents, cross-reference sheet and headings of the
Articles and Sections of this Indenture have been inserted for
convenience of reference only, are not to be considered a part
hereof, and shall in no way modify or restrict any of the terms or
provisions hereof.
Each
provision of this Indenture shall be considered separable, and if
for any reason any provision which is not essential to the
effectuation of the basic purpose of this Indenture or the
Securities shall be invalid, illegal or unenforceable, the
validity, legality and enforceability of the remaining provisions
shall not in any way be affected or impaired thereby, and a Holder
shall have no claim therefor against any party hereto.
10.15.
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SECURITIES
IN A FOREIGN CURRENCY OR IN EUROS.
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Unless otherwise specified in a Board Resolution,
a supplemental indenture hereto or an Officers’ Certificate
delivered pursuant to Section 2.2 with respect to a particular
Series of Securities, whenever for purposes of this Indenture any
action may be taken by the Holders of a specified percentage in
aggregate principal amount of Securities of all Series or all
Series affected by a particular action at the time outstanding and,
at such time, there are outstanding Securities of any Series which
are denominated in a coin or currency other than Dollars (including
Euros), then the principal amount of Securities of such Series
which shall be deemed
to
be outstanding for the purpose of taking such action shall be that
amount of Dollars that could be obtained for such amount at the
Market Exchange Rate at such time. For purposes of this
Section 10.15, “Market Exchange Rate” shall mean
the noon Dollar buying rate in New York City for cable transfers of
that currency as published by the Federal Reserve Bank of New York;
PROVIDED, HOWEVER, in the case of Euros, Market Exchange Rate shall
mean the rate of exchange determined by the Commission of the
European Union (or any successor thereto) as published in the
Official Journal of the European Union (such publication or any
successor publication, the “Journal”). If such Market
Exchange Rate is not available for any reason with respect to such
currency, the Trustee shall use, in its sole discretion and without
liability on its part, such quotation of the Federal Reserve Bank
of New York or, in the case of Euros, the rate of exchange as
published in the Journal, as of the most recent available date, or
quotations or, in the case of Euros, rates of exchange from one or
more major banks in New York City or in the country of issue of the
currency in question or, in the case of Euros, in Luxembourg or
such other quotations or, in the case of Euros, rates of exchange
as the Trustee, upon consultation with the Company, shall deem
appropriate. The provisions of this paragraph shall apply in
determining the equivalent principal amount in respect of
Securities of a Series denominated in currency other than Dollars
in connection with any action taken by Holders of Securities
pursuant to the terms of this Indenture.
All
decisions and determinations of the Trustee regarding the Market
Exchange Rate or any alternative determination provided for in the
preceding paragraph shall be in the Trustee’s sole
discretion, and shall, in the absence of manifest error, be
conclusive to the extent permitted by law for all purposes and
irrevocably binding upon the Company and all Holders.
10.16.
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JUDGMENT
CURRENCY.
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The
Company agrees, to the fullest extent that it may effectively do so
under applicable law, that (a) if for the purpose of obtaining
judgment in any court it is necessary to convert the sum due in
respect of the principal of, or interest or premium, if any, or
other amount on, the Securities of any Series (the “Required
Currency”) into a currency in which a judgment will be
rendered (the “Judgment Currency”), the rate of
exchange used shall be the rate at which, in accordance with normal
banking procedures, the Trustee could purchase in The City of New
York the Required Currency with the Judgment Currency on the day on
which final unappealable judgment is entered, unless such day is
not a Business Day, in which instance, the rate of exchange used
shall be the rate at which, in accordance with normal banking
procedures, the Trustee could purchase in The City of New York the
Required Currency with the Judgment Currency on the Business Day
preceding the day on which final unappealable judgment is entered
and (b) its obligations under this Indenture to make payments
in the Required Currency (i) shall not be discharged or
satisfied by any tender or any recovery pursuant to any judgment
(whether or not entered in accordance with subsection (a)) in any
currency other than the Required Currency, except to the extent
that such tender or recovery shall result in the actual receipt, by
the payee, of the full amount of the Required Currency expressed to
be payable in respect of such payments, (ii) shall be
enforceable as an alternative or additional cause of action for the
purpose of recovering in the Required Currency the amount, if any,
by which such actual receipt shall fall short of the full amount of
the Required Currency so expressed to be payable and
(iii) shall not be affected by judgment being obtained for any
other sum due under this Indenture.
IN
WITNESS WHEREOF, the parties hereto have caused this Indenture to
be duly executed, and their respective corporate seals to be
hereunto affixed and attested, all as of the day and year first
above written.
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CORMEDIX INC.
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By:
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Name:
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Title:
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[Name of Trustee]
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By:
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Name:
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Title:
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By:
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Name:
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Title:
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