As filed with the Securities and Exchange Commission on June 27, 2003
Registration No. 333-
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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NORTHFIELD LABORATORIES INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 36-3378733
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization Identification Number)
1560 SHERMAN AVENUE
SUITE 1000
EVANSTON, ILLINOIS 60201-4800
(847) 864-3500
(Address, Including Zip Code, and Telephone Number, Including Area Code,
of Registrant's Principal Executive Offices)
Jack J. Kogut
Chief Financial Officer
Northfield Laboratories Inc.
1560 Sherman Avenue
Suite 1000
Evanston, Illinois 60201-4800
(847) 864-3500
(Name, Address, Including Zip Code, and Telephone Number,
Including Area Code, of Agent For Service)
Copies to:
Craig A. Roeder, Esq.
Baker & McKenzie
One Prudential Plaza
130 East Randolph Drive
Chicago, Illinois 60601
(312) 861-8000
Approximate date of commencement of proposed sale to the public: From
time to time after the effective date of this Registration Statement as
determined by market conditions and other factors.
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. [X]
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 delivery of the prospectus is expected to be made pursuant to Rule
434, please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
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Proposed Maximum Proposed Maximum
Title Of Shares To Be Registered Aggregate Offering Price Offering Price Per Unit Registration Fee
(1)(2)
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Common Stock, par value $.01 per share(3) -- -- --
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Preferred Stock, par value $.01 per share (3) -- -- --
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Depositary Shares(3) -- -- --
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Stock Purchase Contracts -- -- --
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Warrants(4) -- -- --
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Debt Securities -- -- --
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Total(5) $50,000,000 (6) 100%(3) $4,045
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(1) Or (i) if any debt securities are issued at an original issue discount,
such greater principal amount as will result in an aggregate initial
offering price equal to the amount to be registered or (ii) if any debt
securities are issued with a principal amount denominated in a foreign
currency or composite currency, such principal amount as will result in
an aggregate initial offering price equivalent thereto in United States
dollars at the time of initial offering.
(2) These figures are estimates made solely for the purpose of calculating
the registration fee pursuant to Rule 457(o) under the Securities Act
of 1933, exclusive of accrued interest, if any, on the debt securities.
(3) In addition to any securities that may be registered hereunder, we are
also registering an indeterminate number of shares of common stock,
preferred stock, depositary shares and debt securities as may be
issued upon conversion, exercise or exchange of the securities issued
directly hereunder. No separate consideration will be received for any
shares of common stock, preferred stock, depositary shares or debt
securities so issued upon conversion, exercise or exchange.
(4) Includes warrants to purchase common stock, preferred stock, depositary
shares and debt securities.
(5) We will determine the proposed maximum offering price per unit in
connection with the issuance of the securities.
(6) The securities registered hereunder may be sold separately or as units
with other securities registered hereby. The aggregate amount of common
stock registered hereunder is limited to that which is permissible
under Rule 415(a)(4) under the Securities Act, to the extent
applicable.
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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 this 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 until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and is not soliciting an offer to buy these securities
in any state where the offer or sale is not permitted.]
Subject to Completion. Dated June 27, 2003.
Prospectus
$50,000,000
NORTHFIELD LABORATORIES INC.
Common Stock
Preferred Stock
Depositary Shares
Stock Purchase Contracts
Warrants
Debt Securities
THE SECURITIES OFFERED BY THE PROSPECTUS INVOLVE A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" BEGINNING ON PAGE 5.
We will provide you with the specific terms of the particular
securities being offered in supplements to this prospectus. You should read this
prospectus and each related supplement carefully before you invest. This
prospectus may not be used to sell securities unless accompanied by a prospectus
supplement.
Our common stock is quoted on the Nasdaq Stock Market's National Market
System under the symbol "NFLD." The last reported sale price of our common stock
on June 24, 2003 was $8.39 per share.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus is June 27, 2003.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS......................................................................................... 2
WHERE YOU CAN FIND MORE INFORMATION........................................................................... 2
FORWARD-LOOKING INFORMATION................................................................................... 3
OUR BUSINESS.................................................................................................. 4
RISK FACTORS.................................................................................................. 5
USE OF PROCEEDS............................................................................................... 10
RATIO OF EARNINGS TO FIXED CHARGES AND PREFERENCE DIVIDENDS................................................... 10
DILUTION...................................................................................................... 10
DESCRIPTION OF THE SECURITIES WE MAY OFFER.................................................................... 11
PLAN OF DISTRIBUTION.......................................................................................... 13
LEGAL MATTERS................................................................................................. 14
EXPERTS....................................................................................................... 15
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS............................................................... 15
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with
the Securities and Exchange Commission, or SEC, using a "shelf" registration
process. Using this process, we may offer the securities described in this
prospectus in one or more offerings with a total initial offering price of up to
$50,000,000 or an equivalent amount in one or more foreign currencies. We may
sell these securities separately or in units. This prospectus provides you with
a general description of the securities we may offer. Each time we offer
securities, we will provide you a prospectus supplement that will contain
information about the specific terms of that particular offering. The prospectus
supplement may also add, update or change information contained in this
prospectus. To obtain additional information that may be important to you, you
should read the exhibits filed by us with the registration statement of which
this prospectus is a part or our other filings with the SEC. You also should
read this prospectus and any prospectus supplement together with the additional
information described below under "Where You Can Find More Information."
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You can read and copy any materials we file with
the SEC at its Public Reference Room at 450 Fifth Street, N.W., Washington, D.C.
20549. You can obtain information about the operations of the SEC Public
Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains a
web site that contains information we file electronically with the SEC, which
you can access over the Internet at www.sec.gov. You may also access the
information we file electronically with the SEC through our website at
www.northfieldlabs.com.
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The SEC allows us to "incorporate by reference" the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. The information we incorporate by reference is
an important part of this prospectus, and later information that we file with
the SEC will automatically update and supersede some of this information. We
incorporate by reference the documents listed below and any future filings we
make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 until we sell all of the securities covered by this
prospectus. The documents we incorporate by reference are:
- our Annual Report on Form 10-K for the year ended May 31,
2002;
- our Quarterly Reports on Form 10-Q for the quarters ended
August 31, 2002, November 30, 2002 and February 28, 2003; and
- the description of our common stock contained in our
Registration Statement on Form 8-A, Registration No. 33-76856,
filed with the SEC on March 24, 1994, including any amendments
or reports filed for the purpose of updating this description.
You may request a copy of these filings (other than an exhibit to the
filings unless we have specifically incorporated that exhibit by reference into
the filing), at no cost, by writing or telephoning us at the following address:
Northfield Laboratories Inc.
1560 Sherman Avenue
Suite 1000
Evanston, Illinois 60201-4800
(847) 864-3500
You should rely only on the information incorporated by reference or
provided in this prospectus or any prospectus supplement. We have not authorized
anyone else to provide you with different information. We may only use this
prospectus to sell securities if it is accompanied by a prospectus supplement.
We are only offering the securities in states where the offer is permitted. You
should not assume that the information in this prospectus or any prospectus
supplement is accurate as of any date other than the date on the front of those
documents.
FORWARD-LOOKING INFORMATION
This prospectus and the documents we incorporate by reference contain
forward-looking statements concerning, among other things, our prospects,
clinical and regulatory developments affecting our potential product and our
business strategies. These forward-looking statements are identified by the use
of such terms as "intends," "expects," "plans," "estimates," "anticipates,"
"should" and "believes" and are in certain cases followed by a cross reference
to "Risk Factors."
These forward-looking statements involve risks and uncertainties.
Actual results may differ materially from those predicted by the forward-looking
statements because of various factors and possible events, including those
discussed under "Risk Factors." Because these forward-looking statements involve
risks and uncertainties, actual results may differ significantly from those
predicted in these forward-looking statements. You should not place undue weight
on these statements. These statements speak only as of the date of this
prospectus or, in the case of any document incorporated by reference, the date
of that document.
All subsequent written and oral forward-looking statements attributable
to Northfield or any person acting on our behalf are qualified by the cautionary
statements in this section. We will have no obligation to revise these
forward-looking statements.
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OUR BUSINESS
Northfield Laboratories Inc. is a leader in the development of a safe
and effective alternative to transfused blood for use in the treatment of acute
blood loss. Our PolyHeme(R) blood substitute product is a solution of chemically
modified hemoglobin derived from human blood. PolyHeme simultaneously restores
lost blood volume and hemoglobin levels and is designed for rapid, massive
infusion. PolyHeme requires no cross- matching, and is therefore immediately
available and compatible with all blood types. PolyHeme has an extended shelf
life compared to blood. We believe PolyHeme is the only blood substitute in
development that has been safely infused in clinical trials in sufficient
quantities to be useful in the treatment of urgent, large volume blood loss in
trauma and surgical settings, with a particular focus on situations where
donated blood is not immediately available.
We have conducted Phase II and Phase III clinical trials of PolyHeme at
multiple locations in the United States in trauma and emergency surgical
applications, in elective surgical procedures, and as life-saving therapy in
situations of compassionate use. The observations in these trials have
demonstrated the potential clinical utility of PolyHeme in the treatment of
urgent blood loss and life-threatening hemoglobin levels. In these trials in
hospitalized trauma patients, PolyHeme significantly improved survival compared
to historical control patients who did not receive blood. Our trials have
involved high dosage and rapid infusion of PolyHeme in situations that are
life-threatening and where massive blood loss routinely occurs. We believe that
this application addresses the largest world-wide clinical need and has the
greatest market opportunity. We believe we are the only company in our field
with an oxygen-carrying blood substitute that has been rapidly infused at such
high doses -- as much as 20 units (1,000 grams) or twice the blood volume of the
average adult.
On March 5, 2003, we received clearance from the U.S. Food and Drug
Administration, or FDA, to proceed with a pivotal Phase III trial in which
PolyHeme will be used for the first time in civilian, urban trauma settings to
treat severely injured patients in hemorrhagic shock before they reach the
hospital. Under this protocol, treatment with PolyHeme will begin at the scene
of the injury or in the ambulance and continue during transport and the initial
12 hour post-injury period in the hospital. Since blood is not presently carried
in ambulances, the use of PolyHeme in this setting has the potential to improve
survival and thereby address a critical, unmet medical need.
On June 11, 2003, we received a response from FDA on our request for
Special Protocol Assessment, or SPA, for our urban ambulance trial, confirming
that agreement had been reached on the primary endpoints for the protocol and
the concepts for clinical indications those endpoints would support. An SPA
represents acknowledgement and confirmation of a mutual agreement between a
clinical trial sponsor and FDA that successful completion of the proposed trial
will form the primary basis for an efficacy claim in a marketing application for
product approval. Such agreements become part of the administrative record and
may only be changed by mutual agreement of the parties, or if FDA identifies a
substantial scientific issue relevant to safety or efficacy after the trial has
begun.
We are currently in contact with over 30 potential clinical sites in an
effort to complete the trial at the earliest possible date. We anticipate that
approximately 20 Level I trauma centers throughout the United States will
eventually participate in the PolyHeme trial, which has an expected enrollment
of 720 patients. The process of public disclosure and community consultation
required under the regulations is underway at a number of potential trial sites
across the country.
Our principal executive offices are located at 1560 Sherman Avenue,
Suite 1000, Evanston, Illinois 60201-4800, and our telephone number is (847)
864-3500. We maintain an Internet web site at www.northfieldlabs.com. The
information contained on our web site, or on other web sites linked to our web
site, is not a part of this prospectus.
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RISK FACTORS
The securities offered by this prospectus involve a high degree of
risk. You should consider the following risk factors when reviewing the
information contained in this prospectus. You also should consider the other
information incorporated by reference in this prospectus. These risk factors may
be supplemented and amended by any risk factors set forth in a prospectus
supplement.
RISKS RELATED TO OUR BUSINESS
WE ARE REQUIRED TO CONDUCT ADDITIONAL CLINICAL TRIALS IN THE FUTURE.
The results of our clinical trials conducted to date are not sufficient
to demonstrate adequately the safety and effectiveness of PolyHeme in order to
obtain approval from FDA for the commercial sale of PolyHeme. We are preparing
to commence enrollment a pivotal Phase III trial in which PolyHeme will be used
for the first time in civilian trauma applications to treat severely injured
patients before they reach the hospital. Under this protocol, treatment with
PolyHeme will begin at the scene of the injury and continue during transport to
the hospital by ambulance. This trial is likely to be expensive and
time-consuming and the timing of FDA review process is uncertain. We cannot
ensure that we will be able to complete our clinical trials successfully or
obtain FDA approval of PolyHeme, or that FDA approval, if obtained, will not
include limitations on the indicated uses for which PolyHeme may be marketed.
Our business, financial condition and results of operations are critically
dependent on receiving FDA approval of PolyHeme. A significant delay in our
planned clinical trials or a failure to achieve FDA approval of commercial sales
of PolyHeme would have a material adverse effect on us and could result in the
cessation of our business. We or FDA may in the future suspend clinical trials
at any time if it is believed that the subjects participating in such trials are
being exposed to unacceptable health risks.
OUR ACTIVITIES ARE AND WILL CONTINUE TO BE SUBJECT TO EXTENSIVE
GOVERNMENT REGULATION.
Our research, development, testing, manufacturing, marketing and
distribution of PolyHeme are, and will continue to be, subject to extensive
regulation, monitoring and approval by FDA. The regulatory approval process to
establish the safety and effectiveness of PolyHeme and the safety and
reliability of our manufacturing process has already consumed several years and
considerable expenditures. The data obtained from clinical trials are
susceptible to varying interpretations, which could delay, limit or prevent FDA
regulatory approval. The lack of established criteria for evaluating the
effectiveness of blood substitute products could also delay or prevent FDA
regulatory approval. In addition, delay or rejection could be caused by changes
in FDA policies and regulations. We cannot ensure that, even after extensive
clinical trials, regulatory approval will ever be obtained for PolyHeme. We will
be required to file a Biologics License Application, or BLA, with FDA in order
to obtain regulatory approval for the commercial sale of PolyHeme in the United
States. Under FDA guidelines, FDA may comment upon the acceptability of a BLA
following its submission. After a BLA is submitted there is an initial review by
FDA to be sure that all of the required elements are included in the submission.
There can be no assurance that the submission will be accepted for filing or
that FDA may not issue a refusal to file, or RTF. If an RTF is issued, there is
opportunity for dialogue between the sponsor and FDA in an effort to resolve all
concerns. There can be no assurance that such a dialogue will be successful in
leading to the filing of the BLA. If the submission is filed, there can be no
assurance that the full review will result in product approval. Moreover, if
regulatory approval of PolyHeme is granted, the approval may include limitations
on the indicated uses for which PolyHeme may be marketed. Further, even if such
regulatory approval is obtained, we do not presently have manufacturing
facilities sufficient to produce commercial quantities of PolyHeme. In order to
seek FDA approval of the sale of PolyHeme produced at its first commercial
manufacturing facility, we may be required to conduct a portion of our clinical
trials with product manufactured at that facility. Discovery of previously
unknown problems with PolyHeme or unanticipated problems with our manufacturing
facilities, even after FDA approval of PolyHeme for commercial sale, may result
in the imposition of significant restrictions, including withdrawal of PolyHeme
from the market. Additional laws and
5
regulations may also be enacted which could prevent or delay regulatory approval
of PolyHeme, including laws or regulations relating to the price or
cost-effectiveness of medical products. Any delay or failure to achieve
regulatory approval of commercial sales of PolyHeme is likely to have a material
adverse effect on our financial condition. FDA continues to review products even
after they receive agency approval. If and when FDA approves PolyHeme, its
manufacture and marketing will be subject to ongoing regulation, including
compliance with current good manufacturing practices, adverse event reporting
requirements and FDA's general prohibitions against promoting products for
unapproved or "off-label" uses. We are also subject to inspection and market
surveillance by FDA for compliance with these and other requirements. Any
enforcement action resulting from failure, even by inadvertence, to comply with
these requirements could affect the manufacture and marketing of PolyHeme. In
addition, FDA could withdraw a previously approved product from the market upon
receipt of newly discovered information. FDA could also require us to conduct
additional, and potentially expensive, studies in areas outside our approved
indicated uses.
WE ARE A DEVELOPMENT STAGE COMPANY WITHOUT REVENUES OR PROFITS.
Northfield was founded in 1985 and is a development stage company.
Since 1985, we have been engaged primarily in the development and clinical
testing of PolyHeme. No revenues have been generated to date from commercial
sales of PolyHeme. Our revenues to date have consisted solely of license fees.
We cannot ensure that our clinical testing will be successful, that regulatory
approval of PolyHeme will be obtained, that we will be able to manufacture
PolyHeme at an acceptable cost and in appropriate quantities or that we will be
able to successfully market and sell PolyHeme. We also cannot ensure that we
will not encounter unexpected difficulties which will have a material adverse
effect on us, our operations or our properties.
WE WILL NEED TO RAISE ADDITIONAL CAPITAL TO CONTINUE OUR BUSINESS.
We intend to use the proceeds of this offering to fund our planned
clinical trials and ongoing business operations and for other general corporate
purposes. We will be required to raise capital, in addition to the proceeds of
this offering, to achieve commercial production of PolyHeme. Our future capital
requirements will depend on many factors, including the scope and results of our
clinical trials, the timing and outcome of regulatory reviews, administrative
and legal expenses, the status of competitive products, the establishment of
manufacturing capacity and the establishment of collaborative relationships. We
cannot ensure that this additional funding will be available or, if it is
available, that it can be obtained on terms and conditions we will deem
acceptable. If we are unable to raise additional capital, our independent
accountants may qualify their audit opinions based on uncertainty regarding our
ability to continue as a going concern. A qualification of this type may
interfere with our ability to issue our securities to the public or in private
transactions. Any additional funding derived from the sale of equity securities
may result in significant dilution to our existing stockholders.
WE ARE DEVELOPING A SINGLE PRODUCT THAT IS SUBJECT TO A HIGH LEVEL OF
TECHNOLOGICAL RISK.
Our operations have to date consisted primarily of the development and
clinical testing of PolyHeme. We do not expect to realize product revenues
unless we successfully develop and achieve commercial introduction of PolyHeme.
We expect that such revenues, if any, will be derived solely from sales of
PolyHeme. We also expect the use of PolyHeme to be limited primarily to the
acute blood loss segment of the transfusion market. The biomedical field has
undergone rapid and significant technological changes. Technological
developments may result in PolyHeme becoming obsolete or non-competitive before
we are able to recover any portion of the research and development and other
expenses we have incurred to develop and clinically test PolyHeme. Any such
occurrence would have a material adverse effect on us and our operations.
WE ARE NOT CERTAIN THAT WE WILL BE ABLE TO MANUFACTURE POLYHEME
COMMERCIALLY.
Commercial-scale manufacturing of PolyHeme will require the
construction of a manufacturing facility significantly larger than that
currently being used to produce PolyHeme for our clinical trials. We have no
experience in commercial-
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scale manufacturing, and there can be no assurance that we can achieve
commercial-scale manufacturing capacity. It is also possible that we may incur
substantial cost overruns and delays compared to existing estimates in building
and equipping a commercial-scale manufacturing facility. Moreover, in order to
seek FDA approval of the sale of PolyHeme produced at our first commercial
manufacturing facility, we may be required to conduct a portion of our clinical
trials with product manufactured at that facility. Accordingly, a delay in
achieving scale-up of commercial manufacturing capabilities will have a material
adverse effect on sales of PolyHeme. Additionally, the manufacture of PolyHeme
will be subject to extensive government regulation. Among the conditions for
marketing approval is that our quality control and manufacturing procedures
conform to FDA's good manufacturing practice regulations. We cannot ensure that
we will be able to obtain the necessary regulatory clearances or approvals to
manufacture PolyHeme on a timely basis or at all.
THERE MAY BE LIMITATIONS IN THE SUPPLY OF THE STARTING MATERIAL FOR
POLYHEME.
We currently purchase donated blood from The American Red Cross and
Blood Centers of America for use as the starting material for PolyHeme. We have
also entered into an agreement with hemerica, Inc., a subsidiary of Blood
Centers of America, under which hemerica would supply us with up to 160,000
units per year of packed red cells, the source material for PolyHeme. We have
not purchased any blood supplies under this agreement to date. We have plans to
enter long-term supply arrangements with other blood collectors. We cannot
ensure that we will be able to enter into satisfactory long-term arrangements
with blood bank operators, that the price we may be required to pay for starting
material will permit us to price PolyHeme competitively or that we will be able
to obtain an adequate supply of starting material. Additional demand for blood
may arise from competing blood substitute products, some of which are derived
from human blood, thereby limiting our available supply of starting material.
THERE ARE SIGNIFICANT COMPETITORS DEVELOPING SIMILAR PRODUCTS.
If approved for commercial sale, PolyHeme will compete directly with
established therapies for acute blood loss and may compete with other
technologies currently under development. We cannot ensure that PolyHeme will
have advantages which will be significant enough to cause medical professionals
to adopt it rather than continue to use established therapies or to adopt other
new technologies or products. We also cannot ensure that the cost of PolyHeme
will be competitive with the cost of established therapies or other new
technologies or products. The development of blood substitute products is a
rapidly evolving field. Competition is intense and expected to increase. Several
companies have developed or are in the process of developing technologies which
are, or in the future may be, the basis for products which will compete with
PolyHeme. Certain of these companies are pursuing different approaches or means
of accomplishing the therapeutic effects sought to be achieved through the use
of PolyHeme. Some of these companies have substantially greater financial
resources, larger research and development staffs, more extensive facilities and
more experience than Northfield in testing, manufacturing, marketing and
distributing medical products. We cannot ensure that one or more other companies
will not succeed in developing technologies or products which will become
available for commercial use prior to PolyHeme, which will be more effective or
less costly than PolyHeme or which would otherwise render PolyHeme obsolete or
non-competitive. A bovine-source hemoglobin-based oxygen-carrier has been
approved for human use in South Africa and a BLA is under review by FDA for its
use in the United States.
WE DO NOT HAVE EXPERIENCE IN THE SALE AND MARKETING OF MEDICAL
PRODUCTS.
If approved for commercial sale, we intend to market PolyHeme in the
United States using our own sales force. We have no experience in the sale or
marketing of medical products. Our ability to implement our sales and marketing
strategy for the United States will depend on our ability to recruit, train and
retain a marketing staff and sales force with sufficient technical expertise. We
cannot ensure that we will be able to establish an effective marketing staff and
sales force, that the cost of establishing such a marketing staff and sales
force will not exceed revenues from the sale of PolyHeme or that our marketing
and sales efforts will be successful.
7
WE HAVE A HISTORY OF LOSSES AND OUR FUTURE PROFITABILITY IS UNCERTAIN.
From Northfield's inception through February 28, 2003, we have incurred
net operating losses totaling $107,142,000. We will require substantial
additional expenditures to complete clinical trials, to pursue regulatory
approval for PolyHeme, to establish commercial scale manufacturing processes and
facilities, and to establish marketing, sales and administrative capabilities.
These expenditures are expected to result in substantial losses for at least the
next several years. The expense and the time required to realize any product
revenues or profitability are highly uncertain. We cannot ensure that we will be
able to achieve product revenues or profitability on a sustained basis or at
all.
THE MARKET MAY NOT ACCEPT OUR PRODUCT.
We anticipate that the market price for PolyHeme, if FDA approval is
received, will exceed the cost of transfused blood. Competitors may also develop
new technologies or products which are more effective or less costly than
PolyHeme. We cannot ensure that the price of PolyHeme, considered in relation to
PolyHeme's expected benefits, will be perceived by health care providers and
third party payors as cost-effective, or that the price of PolyHeme will be
competitive with transfused blood or with other new technologies or products.
Our results of operations may be adversely affected if the price of PolyHeme is
not considered cost-effective or if PolyHeme does not otherwise receive market
acceptance.
OUR PATENTS AND OTHER PROPRIETARY RIGHTS MAY NOT PROTECT OUR
TECHNOLOGY.
Our ability to compete effectively with other companies will depend, in
part, on our ability to protect and maintain the proprietary nature of our
technology. We cannot be certain as to the degree of protection offered by our
patents or as to the likelihood that additional patents in the United States and
certain other countries will be issued based upon pending patent applications.
Patent applications in the United States are maintained in secrecy until patents
are issued. We cannot be certain that we were the first creator of the
inventions covered by our patents or pending patent applications or that we were
the first to file patent applications for our inventions. The high costs of
enforcing patent and other proprietary rights may also limit the degree of
protection afforded to us. We also rely on unpatented proprietary technology,
and we cannot ensure that others may not independently develop the same or
similar technology or otherwise obtain access to our proprietary technology. We
cannot ensure that our patents or other proprietary rights will be determined to
be valid or enforceable if challenged in court or administrative proceedings or
that we will not become involved in disputes with respect to the patents or
proprietary rights of third parties. An adverse outcome from these proceedings
could subject us to significant liabilities to third parties, require disputed
rights to be licensed from third parties or require us to stop using this
technology, any of which would result in a material adverse effect on our
results of operations.
OUR PROFITABILITY WILL BE AFFECTED IF WE INCUR PRODUCT LIABILITY CLAIMS
IN EXCESS OF OUR INSURANCE COVERAGE.
The testing and marketing of medical products, even after FDA approval,
have an inherent risk of product liability. We maintain limited product
liability insurance coverage for our clinical trials in the total amount of $10
million. However, our profitability will be adversely affected by a successful
product liability claim in excess of our insurance coverage. We cannot guarantee
that product liability insurance will be available in the future or be available
on reasonable terms.
WE DEPEND ON THE SERVICES OF A LIMITED NUMBER OF KEY PERSONNEL.
Our success is highly dependent on the continued services of a limited
number of skilled managers and scientists. The loss of any of these individuals
could have a material adverse effect on us. In addition, our success will
depend, among other factors, on the recruitment and retention of additional
highly skilled and
8
experienced management and technical personnel. We cannot ensure that we will be
able to retain existing employees or to attract and retain additional skilled
personnel on acceptable terms given the competition for such personnel among
numerous large and well-funded pharmaceutical and health care companies,
universities and non-profit research institutions.
HEALTH CARE REFORM AND CONTROLS ON HEALTH CARE SPENDING MAY LIMIT THE
PRICE WE CAN CHARGE FOR POLYHEME AND THE AMOUNT WE CAN SELL.
The federal government and private insurers have considered ways to
change, and have changed, the manner in which health care services are provided
in the United States. Potential approaches and changes in recent years include
controls on health care spending and the creation of large purchasing groups. In
the future, it is possible that the government may institute price controls and
limits on Medicare and Medicaid spending. These controls and limits might affect
the payments we collect from sales of our product. Assuming we succeed in
bringing PolyHeme to market, uncertainties regarding future health care reform
and private market practices could affect our ability to sell PolyHeme in large
quantities at profitable pricing.
UNCERTAINTY OF THIRD-PARTY REIMBURSEMENT COULD AFFECT OUR
PROFITABILITY.
Sales of medical products largely depend on the reimbursement of
patients' medical expenses by governmental health care programs and private
health insurers. There is no guarantee that governmental health care programs or
private health insurers will reimburse our sales of PolyHeme, or permit us to
sell our product at high enough prices to generate a profit.
RISKS RELATED TO THE OFFERING
OUR STOCK PRICE COULD BE VOLATILE AND YOUR INVESTMENT COULD SUFFER A
DECLINE IN VALUE.
The market price of our common stock has fluctuated significantly in
response to a number of factors, many are which are beyond our control,
including:
- regulatory developments relating to our PolyHeme blood
substitute product;
- announcements by us relating to the results of our clinical
trials of PolyHeme;
- developments relating to our efforts to obtain additional
financing to fund our operations;
- announcements by us regarding transactions with potential
strategic partners;
- announcements relating to blood substitute products being
developed by our competitors;
- changes in industry trends or conditions;
- our issuance of additional debt or equity securities; and
- sales of significant amounts of our common stock or other
securities in the market.
In addition, the stock market in general, and the Nasdaq National
Market and the biotechnology industry market in particular, have experienced
significant price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of listed companies. These broad
market and industry factors may seriously harm the market price of our common
stock, regardless of our operating performance. In the past, securities class
action litigation has often been instituted following periods of volatility in
the market price of a
9
company's securities. A securities class action suit against us could result in
substantial costs, potential liabilities and the diversion of our management's
attention and resources.
ANTI-TAKEOVER PROVISIONS CONTAINED IN OUR CHARTER AND BYLAWS COULD
DISCOURAGE POTENTIAL TAKEOVER ATTEMPTS.
Our certificate of incorporation contains a "fair price" provision
which requires approval of the holders of at least 80% of our voting stock,
excluding shares held by certain interested stockholders and their affiliates,
as a condition to mergers or certain other business combinations with, or
proposed by, any holder of 15% or more of our voting stock, except in cases
where approval of our disinterested directors is obtained or certain minimum
price criteria and other procedural requirements are satisfied. In addition, our
board of directors has the authority, without further action by our
stockholders, to fix the rights and preferences and issue shares of preferred
stock. These provisions, and other provisions of the our certificate of
incorporation and bylaws and Delaware law, may have the effect of deterring
hostile takeovers or delaying or preventing changes in our control or
management, including transactions in which stockholders might otherwise receive
a premium for their shares over the then prevailing market prices.
THERE IS A LARGE NUMBER OF SHARES THAT MAY BE SOLD IN THE MARKET
FOLLOWING THIS OFFERING, WHICH MAY DEPRESS THE MARKET PRICE OF OUR COMMON STOCK.
Sales of a substantial number of shares of our common stock or
securities convertible into or exercisable for our common stock in the public
market following this offering could cause the market price of our common stock
to decline. If there are more shares of common stock offered for sale than
buyers are willing to purchase, then the market price of our common stock may
decline to a market price at which buyers are willing to purchase the offered
shares of common stock and sellers remain willing to sell the shares. All of the
shares sold in the offering will be freely tradeable without restriction or
further registration under the Securities Act, except for any shares purchased
by our "affiliates" as defined in Rule 144 of the Securities Act.
YOU WILL EXPERIENCE IMMEDIATE AND SUBSTANTIAL DILUTION.
The public offering price of the securities offered hereby is likely to
be substantially higher than the book value per share of our common stock.
Investors purchasing common stock in this offering may, therefore, incur
immediate dilution in net tangible book value per share of common stock.
Investors will also incur additional dilution upon the exercise of outstanding
stock options and warrants. See "Dilution" for a more detailed discussion of the
dilution you will incur in this offering.
USE OF PROCEEDS
Unless we inform you otherwise in the prospectus supplement, we intend
to use the proceeds of this offering to fund our planned clinical trials and
ongoing business operations and for other general corporate purposes. Pending
any specific application, we may initially invest funds in short-term marketable
securities.
RATIO OF EARNINGS TO FIXED CHARGES AND PREFERENCE DIVIDENDS
We reported no revenues or earnings during our last five fiscal years.
During this period, we did not have any debt or related interest expense and
were not a party to any capital lease arrangements. No preference securities
were outstanding during this period.
DILUTION
Our net tangible book value at February 28, 2003 was $10,504,000, or
$.74 per share of common stock. Net tangible book value per share represents
total tangible assets less total liabilities divided by
10
the number of outstanding shares of our common stock on February 28, 2003.
Assuming that we issue an aggregate of $50 million of common stock at an assumed
public offering price of $8.39 per share (the last reported sale price of our
common stock on the Nasdaq National Market on June 24, 2003), with estimated net
proceeds to us (after assumed commissions and expenses) of $46,375,000, our pro
forma net tangible book value at February 28, 2003 would have been $56,879,000
or $2.81 per share. This represents an immediate increase in the tangible book
value of $2.07 per share to our existing stockholders and an immediate dilution
of $5.58 per share to new investors purchasing common stock in this offering, as
illustrated in the following table:
Assumed public offering price per share(1) $8.39
Net tangible book value per share as of February 28, 2003 $0.74
Increase per share attributable to new investors $2.07
Pro forma net tangible book value per share after offering $2.81
-----
Dilution per share to new investors $5.58
=====
(1) We assumed an offering price of $8.39 per share based on the last
reported sale price of the common stock on the Nasdaq National Market on June
24, 2003. The assumed offering price of the common stock at the time any common
stock is offered hereby may differ significantly from the offering price assumed
for purposes of this prospectus.
The computations in the table above assume no exercise of any
outstanding stock options after February 28, 2003. At February 28, 2003, there
were options outstanding to purchase a total of 958,000 shares of our common
stock at a weighted average exercise price of $9.62 per share. If any of these
options are exercised, there will be further dilution to new investors.
If the securities offered hereby are common stock, the prospectus
supplement will include a revised dilution table setting forth any increase in
net tangible book value to existing stockholders and any dilution to new
investors based on the proposed number of shares of common stock to be offered
and the public offering price at the time of such offering.
DESCRIPTION OF THE SECURITIES WE MAY OFFER
We may offer up to $50,000,000 of common stock, preferred stock,
depositary shares, stock purchase contracts, warrants and debt securities, in
one or more offerings and in any combination. A prospectus supplement, which we
will provide each time we offer securities, will describe the specific amounts,
prices and terms of these securities.
We may sell the securities to or through underwriters, dealers or
agents or directly to purchasers. We, as well as any persons acting on our
behalf, reserve the sole right to accept and to reject in whole or in part any
proposed purchase of securities. Each prospectus supplement will set forth the
names of any underwriters, dealers or agents involved in the sale of securities
described in that prospectus supplement and any applicable fee, commission or
discount arrangements with them.
COMMON STOCK
We may issue shares of our common stock either alone or underlying
other registered securities convertible into or exercisable or exchangeable for
shares of our common stock. Holders of our common stock are entitled to receive
dividends declared by our board of directors out of funds legally available for
the payment of dividends, subject to rights, if any, of preferred stock holders.
Currently, we do not pay a dividend. The holders of our common stock are
entitled to one vote per share and are not entitled to cumulative voting rights
for the election of our directors. The holders of our common stock have no
preemptive rights.
11
PREFERRED STOCK AND DEPOSITARY SHARES
We may issue preferred stock, in one or more series, alone or
underlying other registered securities convertible into or exercisable or
exchangeable for shares of our preferred stock. Our board of directors or a
committee designated by the board will determine the dividend, voting and
conversion rights and other provisions of the preferred stock at the time of
sale. Each series of preferred stock will be more fully described in the
particular prospectus supplement that will accompany this prospectus, including
redemption provisions, rights in the event of liquidation, dissolution or the
winding up of Northfield, voting rights and conversion rights. We may also issue
fractional shares of preferred stock that will be represented by depositary
shares and depositary receipts. Each particular series of depositary shares will
be more fully described in the prospectus supplement that will accompany this
prospectus.
WARRANTS
We may issue warrants for the purchase of common stock, preferred
stock, depositary shares or debt securities. We may issue warrants independently
or together with other securities. The specific terms of any warrants will be
described in the prospectus supplement that will accompany this prospectus.
STOCK PURCHASE CONTRACTS
We may issue stock purchase contracts, including contracts obligating
holders to purchase from us, and us to sell to the holders, a specified number
of securities, at a future date or dates, or similar contracts issued on a
"prepaid" basis, which in each case are referred to herein as "stock purchase
contracts." The price per share of securities and the number of shares of
securities may be fixed at the time the stock purchase contracts are issued or
may be determined by reference to a specific formula set forth in the stock
purchase contracts. The stock purchase contracts will require either the stock
purchase price be paid at the time the stock purchase contracts are issued or
that payment be made at a specified future date. The stock purchase contracts
also may require us to make periodic payments to the holders of the stock
purchase contracts or vice versa, and such payments may be unsecured or refunded
on some basis. The specific terms of any stock purchase contracts will be
described in the prospectus supplement that will accompany this prospectus.
DEBT SECURITIES
General
We may issue secured or unsecured obligations in the form of either
senior or subordinated debt. The senior debt securities and the subordinated
debt securities are together referred to in this prospectus as "debt
securities." The senior unsecured debt securities will have the same rank as all
of our other unsecured unsubordinated debt. The subordinated debt securities
generally will be entitled to payment only after payment of our senior debt.
Senior debt generally includes all debt for money borrowed by us, except debt
that is stated in the instrument governing the terms of that debt to be not
senior to, or to have the same rank in right of payment as, or to be expressly
junior to, the senior debt securities. We may issue debt securities that are
convertible into or exchangeable for shares of common stock or other securities
or property.
The senior and subordinated debt securities will be issued under
separate indentures between a trustee and us. We have summarized the general
features of the debt securities to be governed by the indentures. These
indentures have been filed as exhibits or will be incorporated by reference into
the registration statement that we have filed with the SEC of which this
prospectus is a part. We encourage you to read these indentures. Instructions on
how you can get copies of these documents are provided above in "Where You Can
Find More Information."
12
General Indenture Provisions that Apply to Senior and Subordinated Debt
The following general indenture provisions will apply to any senior and
subordinated debt securities:
- each indenture allows debt to be issued in series with terms
particular to each series;
- neither indenture limits the amount of debt that we may issue
or generally provides holders any protection should we engage
in a highly leveraged transaction;
- the indentures allow us to merge or to consolidate with
another U.S. entity or convey, transfer or lease our
properties and assets substantially as an entirety to another
U.S. entity, as long as certain conditions are met. If these
events occur, the other company will be required to assume our
responsibilities on the debt securities, and we will be
released from all liabilities and obligations, except in the
case of a lease;
- the indentures provide that the trustee and we may generally
amend the indenture with the consent of holders of a majority
of the total principal amount of the debt outstanding in any
series to change certain of our obligations or your rights
concerning the debt. However, to change the payment of
principal, interest or adversely affect the right to convert
or certain matters, every holder in that series must consent;
and
- we may discharge the indentures and defease restrictive
covenants by depositing sufficient funds with the trustee to
pay the obligations when due, as long as certain conditions
are met. The trustee would pay all amounts due to you on the
debt from the deposited funds.
Events of Default
Each of the following is an event of default under the indentures:
- principal not paid when due;
- any sinking fund payment not made when due;
- failure to pay interest for 30 days;
- covenants not performed for 90 days after notice; and
- certain events of bankruptcy, insolvency or reorganization of
Northfield.
A prospectus supplement may describe deletions of, or changes or
additions to, the events of default.
Remedies
Upon an event of default, other than a bankruptcy, insolvency or
reorganization, the trustee or holders of 25 percent of the principal amount
outstanding in a series may declare the outstanding principal, plus accrued
interest, if any, immediately payable. However, the holders of a majority in
principal amount may, under certain circumstances, rescind this action.
13
Indenture Provisions that Apply Only to the Subordinated Debt
Securities
The subordinated indenture provides that the subordinated debt
securities will be subordinated to all senior debt as defined in the
subordinated indenture.
PLAN OF DISTRIBUTION
We may sell the offered securities in and outside the United States
through underwriters, dealers or agents or directly to purchasers. The
prospectus supplement will set forth the following information:
- the terms of the offering;
- the names of any underwriters, dealers or agents;
- the purchase price;
- the net proceeds to us;
- any delayed delivery arrangements;
- any underwriting discounts and other items constituting
underwriters' compensation;
- the initial public offering price;
- any discounts or concessions allowed, reallowed or paid to
dealers; and
- any commissions paid to agents.
If we use underwriters in the sale of the offered securities, the
underwriters will acquire the securities for their own account. The underwriters
may resell the securities from time to time in one or more transactions,
including negotiated transactions, at a fixed public offering price or at
varying prices determined at the time of sale. Underwriters may offer the
securities to the public either through underwriting syndicates represented by
one or more managing underwriters or directly by one or more firms acting as
underwriters. Unless we inform you otherwise in the prospectus supplement, the
obligations of the underwriters to purchase the securities will be subject to
conditions, and the underwriters will be obligated to purchase all the
securities if they purchase any of them. The underwriters may change from time
to time any initial public offering price and any discounts or concessions
allowed or reallowed or paid to dealers.
During and after an offering through underwriters, the underwriters may
purchase and sell the securities in the open market. These transactions may
include overallotment and stabilizing transactions and purchases to cover
syndicate short positions created in connection with the offering. The
underwriters may also impose a penalty bid, in which selling concessions allowed
to syndicate members or other broker-dealers for the offered securities sold for
their account may be reclaimed by the syndicate if the offered securities are
repurchased by the syndicate in stabilizing or covering transactions. These
activities may stabilize, maintain or otherwise affect the market price of the
offered securities, which may be higher than the price that might otherwise
prevail in the open market. If commenced, these activities may be discontinued
at any time. If we use dealers in the sale of securities, we will sell the
securities to them as principals. They may then resell those securities to the
public at varying prices determined by the dealers at the time of resale. The
dealers participating in any sale of our securities may be deemed to be
underwriters within the meaning of the Securities Act with respect to any sale
of those securities. We will include in the prospectus supplement the names of
the dealers and the terms of the transaction.
We may sell the securities directly. In that event, no underwriters,
dealers or agents would be involved. We may also sell the securities through
agents we designate from time to time. In the prospectus supplement, we will
name any agent involved in the offer or sale of the offered securities, and we
will describe any
14
commissions payable by us to the agent. Unless we inform you otherwise in the
prospectus supplement, any agent will agree to use its reasonable best efforts
to solicit purchases for the period of its appointment. We may sell the
securities directly to institutional investors or others who may be deemed to be
underwriters within the meaning of the Securities Act with respect to any sale
of those securities. We will describe the terms of any of these sales in the
prospectus supplement.
We may have agreements with the underwriter, dealers and agents to
indemnify them against civil liabilities, including liabilities under the
Securities Act, or to contribute with respect to payments that the underwriter,
dealers or agents may be required to make. Underwriters, dealers and agents may
engage in transactions with us or may perform services for us in the ordinary
course of their businesses.
Underwriters, dealers and agents participating in a sale of securities
may be deemed to be underwriters as defined in the Securities Act, and any
discounts and commissions received by them and any profit realized by them on
resale of the securities may be deemed to be underwriting discounts and
commissions under the Securities Act.
LEGAL MATTERS
The validity of the securities offered herein will be passed upon for
us by Baker & McKenzie, Chicago, Illinois. If the securities are distributed in
an underwritten offering, the underwriters will be advised by their own legal
counsel with respect to any offering.
EXPERTS
The financial statements of Northfield Laboratories Inc. as of May 31,
2002, and for each of the years in the three-year period ended May 31, 2002 and
for the cumulative period from June 19, 1985 (inception) have been incorporated
by reference herein and in the registration statement in reliance upon the
report of KPMG LLP, independent certified public, incorporated by reference
herein, and upon the authority of said firm as experts in accounting and
auditing.
With respect to the unaudited interim financial information of the
periods ended August 31, 2002, November 30, 2002 and February 28, 2003,
incorporated by reference herein, the independent certified public accountants
have reported that they applied limited procedures in accordance with
professional standards for a review of such information. However, their separate
reports included in Northfield Laboratories Inc.'s quarterly reports on Form
10-Q for the quarters ended August 31, 2002, November 30, 2002 and February 28,
2003, incorporated by reference herein, state that they did not audit and they
do not express an opinion on that interim financial information. Accordingly,
the degree of reliance on their reports on such information should be restricted
in light of the limited nature of the review procedures applied. The accountants
are not subject to the liability provisions of Section 11 of the Securities Act
of 1933 for their report on the unaudited interim financial information because
that report is not a "report" or a "part" of the registration statement prepared
or certified by the accountants within the meaning of Sections 7 and 11 of the
Act.
PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the expenses in connection with the
issuance and distribution of the securities being registered, other than
underwriting discounts and commissions. All of the amounts shown are estimated,
except the SEC registration fee.
SEC registration fee $4,045
Legal fees and expenses 75,000
Printing and engraving 7,500
Fees of accountants 10,000
Miscellaneous 28,445
-------
125,000
=======
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section 145 of the General Corporation Law of the State of Delaware
provides that a corporation may indemnify any person who was or is a party to or
is threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative, by
reason of the fact that he is or was a director, officer, employee or agent of
the corporation, or is or was serving at the request
15
of the corporation as a director, officer, employee of another corporation,
partnership, joint venture, trust or other enterprise, against expenses
(including attorneys' fees), judgments, fines and amounts paid in settlement
actually and reasonably incurred by him in connection with such action, suit or
proceeding if he acted in good faith and in a manner he reasonably believed to
be in or not opposed to the best interests of the corporation, and, with respect
to any criminal action or proceedings, had no reasonable cause to believe his
conduct was unlawful, except that in a suit by or in the right of the
corporation no indemnification may be made in respect of any claim, issue or
matter as to which such person has been adjudged to be liable to the corporation
unless and only to the extent that the Court of Chancery of the State of
Delaware or the court in which such action or suit was brought has determined
upon application that, despite the adjudication of liability but in view of all
of the circumstances of the case, such person is fairly and reasonably entitled
to indemnity or such expenses deemed proper by the court.
Our certificate of incorporation provides that we must indemnify our
directors, officers, employees and agents to the fullest extent permitted by
Delaware law. Our certificate of incorporation additionally requires us to
advance expenses incurred by our directors, officers, employees and agents to
the fullest extent permitted by Delaware law in connection with any matter with
respect to which such persons may be entitled to seek indemnification.
Our certificate of incorporation also provides that, to the fullest
extent permitted by Delaware law, our directors will not be liable for monetary
damages for breach of the directors' fiduciary duty of care to us or our
stockholders. This provision does not eliminate the duty of care and, in
appropriate circumstances, equitable remedies such as an injunction or other
forms of non-monetary relief will remain available under Delaware law. Each
director will also continue to be subject to liability for breach of the
director's duty of loyalty to us or our stockholders, for acts or omissions not
in good faith or involving intentional misconduct or a knowing violation of law,
for unlawful distributions to stockholders and for any transaction from which
the director derives an improper personal benefit. In addition, this provision
does not affect a director's responsibilities under any other laws, such as the
federal securities laws or state or federal environmental laws.
We are a party to separate indemnification agreements with each of our
directors and senior executive officers. These agreements require us to
indemnify our directors and executive officers to the maximum extent permitted
by law and to advance all expenses they may reasonably incurred in connection
with the defense of any claim or proceeding in which they may be involved as a
party or witness. The agreements specify certain procedures and assumptions
applicable in connection with requests for indemnification and advancement of
expenses and also require us to continue to maintain directors and officers and
fiduciary liability insurance for a six-year period following any change in
control transaction. The rights provided to our directors and executive officers
under their indemnification agreements are in addition to any other rights such
individuals may have under our certificate of incorporation or bylaws,
applicable law or otherwise.
We have purchased an insurance policy which insures our directors and
officers against certain liabilities incurred by them in the discharge of their
official functions, except for liabilities resulting from their own malfeasance.
The insurance policy provides coverage in the amount of $10,000,000 for annual
aggregate claims.
17
ITEM 16. EXHIBITS.
The exhibits listed below are filed or incorporated by reference as
part of this registration statement.
NUMBER DESCRIPTION
1.1* Form of Underwriting Agreement.
3.1 Restated Certificate of Incorporation of the
Registrant (incorporated herein by reference
to Exhibit 3.2 to the Registrant's
Registration Statement on Form S-1, filed
with the Securities and Exchange Commission
on March 25, 1994, File No. 33-76856 (the
"Registration Statement")).
3.2 Certificate of Amendment to Certificate of
Incorporation of the Registrant (incorporated
herein by reference to Exhibit 3.1.1 to the
Registrant's Quarterly Report on Form 10-Q
for the Registrant's quarter ended November
30, 1999).
3.3 Restated Bylaws of the Registrant
(incorporated herein by reference to Exhibit
3.4 to the Registration Statement).
4.1** Form of Senior Indenture.
4.2** Form of Subordinated Indenture.
4.3** Form of Senior Debt Security (included as
Exhibit 4.1).
4.4** Form of Subordinated Debt Security (included
as Exhibit 4.2).
4.5* Form of Certificate of Amendment.
4.6* Form of Preferred Stock Certificate.
4.7* Form of Deposit Agreement.
4.8* Form of Depositary Receipt (included in
Exhibit 4.7).
4.9* Form of Warrant Agreement.
4.10* Form of Warrant Certificate.
5.1** Opinion of Baker & McKenzie.
10.1 Office Sublease dated as of April 20, 1993
between the Registrant and First Illinois
Bank of Evanston, N.A., as Trustee
(incorporated herein by reference to Exhibit
10.1 to the Registration Statement).
17
NUMBER DESCRIPTION
10.2 Amendment to Lease dated as of January 7,
1998 between the Registrant and First
Illinois Bank of Evanston, N.A. (incorporated
herein by reference to Exhibit 10.1.1 to the
Registrant's Quarterly Report on Form 10-Q
for the Registrant's quarter ended February
28, 1998).
10.3 Lease dated as of June 8, 1989 between the
Registrant and OTR (incorporated by reference
to Exhibit 10.2 to the Registration
Statement).
10.4 Amendment to Lease dated as of May 6, 1998
between the Registrant and OTR (incorporated
herein by reference to Exhibit 10.11 to the
Registrant's Annual Report on Form 10-K for
the Registrant's fiscal year ended May 31,
1998).
10.5 Third Amendment to Lease dated as of
September 16, 1999 between the Registrant and
OTR (incorporated be reference to Exhibit
10.4.1 to the Registrant's Quarterly Report
on Form 10-Q for the Registrant's quarter
ended November 30, 1999).
10.6 License Agreement dated as of March 6, 1989
between the Registrant and KabiVitrum AB
(predecessor of Pharmacia Corporation)
(incorporated herein by reference to Exhibit
10.6 to the Registration Statement)
10.7 License Agreement dated as of July 20, 1990
between the Registrant and Eriphyle BV
(incorporated herein by reference to Exhibit
10.7 to the Registration Statement).
10.8 Northfield Laboratories Inc. 401(K) Plan
(incorporated herein by reference to Exhibit
10.14 to the Registration Statement).
10.9 Northfield Laboratories Inc. Nonqualified
Stock Option Plan for Outside Directors
(incorporated herein by reference to Exhibit
10.15 to the Registrant's Annual Report on
Form 10-K for the Registrant's fiscal year
ended May 31, 1994).
10.10 Northfield Laboratories Inc. 1996 Stock
Option Plan (incorporated herein by reference
to Exhibit 10.5.1 to the Registrant's
Quarterly Report on Form 10-Q for the
Registrant's quarter ended November 30,
1997).
10.11 Northfield Laboratories Inc. 1999 Stock
Option Plan (incorporated herein by reference
to Exhibit 10.10 to the Registrant's Annual
Report on Form 10-K for the
18
NUMBER DESCRIPTION
Registrant's fiscal year ended May 31, 1999).
10.12** Northfield Laboratories Stock Option Plan for
New Employees.
10.13** Employment Agreement dated as of January 1,
2003 between the Registrant and Steven A.
Gould, M.D.
10.14** Employment Agreement dated as of January 1,
2003 between the Registrant and Jack Kogut.
10.15 Form of Indemnification Agreement -- Director
and Executive Officer (incorporated herein by
reference to Exhibit 10.18 to the
Registrant's Quarterly Report on Form 10-Q
for the Registrant's quarter ended February
28, 2001).
10.16 Form of Indemnification Agreement -- Director
(incorporated herein by reference to Exhibit
10.19 to the Registrant's Quarterly Report on
Form 10-Q for the Registrant's quarter ended
February 28, 2001).
10.17 Form of Indemnification Agreement --
Executive Officer (incorporated herein by
reference to Exhibit 10.20 to the
Registrant's Quarterly Report on Form 10-Q
for the Registrant's quarter ended February
28, 2001).
15.1** Letter re unaudited interim financial
information.
23.1** Consent of Baker & McKenzie (contained in
their opinion filed as Exhibit 5.1 to this
Registration Statement).
23.2** Consent of KPMG LLP.
25.1* Form T-1 Statement of Eligibility of Trustee
from Senior Indenture under the Trust
Indenture Act of 1939.
25.2* Form T-1 Statement of Eligibility of Trustee
from Subordinated Indenture under the Trust
Indenture Act of 1939.
* To be filed by amendment or as an exhibit to a report pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of 1934.
** Filed herewith.
19
ITEM 17. UNDERTAKINGS.
The 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:
(a) to include any prospectus required by Section 10(a)(3) of the
Securities Act;
(b) to reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most
recent post-effective amendment thereof\ which, individually
or in the aggregate, represent a fundamental change in the
information set forth in the registration statement.
Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered)
and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate
offering price set forth in the "Calculation of Registration
Fee" table in the effective registration statement;
(c) 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)(a) and (1)(b) do not apply if
the registration statement is on Form S-3, Form S-8 or Form F-3, and
the information required to be included in a post-effective amendment
by those paragraphs is contained in periodic reports filed with or
furnished to the Commission by the Registrant pursuant to Section 13 or
15(d) of the Exchange Act that are incorporated by reference in the
registration statement.
(2) that, for the purpose of determining any liability under the Securities
Act, 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) for purposes of determining any liability under the Securities Act,
each filing of Registrant's annual report pursuant to Section 13(a) or
15(d) of the Exchange Act (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to section 15(d) of the
Exchange Act) 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 the time shall be deemed to be the initial bona fide offering
thereof.
(5) insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the 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 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.
20
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 to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Evanston, State of Illinois, on the 25th day of June,
2003.
NORTHFIELD LABORATORIES INC.
By: /s/ Steven A. Gould, M.D.
------------------------------------------------
Steven A. Gould, M.D.
Chairman of the Board and Chief Executive Officer
We, the undersigned officers and directors of Northfield Laboratories
Inc., hereby, severally constitute and appoint each of Steven A. Gould, M.D. and
Jack J. Kogut our true and lawful attorney-in-fact and agent, with full power of
substitution and resubstitution, in any and all capacities, to sign any and all
amendments (including post-effective amendments) to this Registration Statement,
and registration statements filed pursuant to Rule 462 under the Securities Act
of 1933, and to file the same with all exhibits thereto and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
such attorney-in-fact and agent, full power and authority to do and perform each
and every act and thing requisite and necessary to be done, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that such attorney-in-fact and agent, or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities indicated and on the dates indicated:
Signature Title Date
--------- ----- ----
/s/ Steven A. Gould, M.D. Chairman of the Board and
-------------------------- Chief Executive Officer June 25, 2003
Steven A. Gould, M.D. (Principal Executive Officer)
/s/ Jack J. Kogut Senior Vice President, Chief Financial
-------------------------- Officer, Secretary and Treasurer June 25, 2003
Jack J. Kogut (Principal Financial Officer)
/s/ Gerald S. Moss, M.D.
-------------------------- Director June 25, 2003
Gerald S. Moss, M.D.
-------------------------- Director June 25, 2003
Bruce S. Chelberg
/s/ Jack Olshansky
-------------------------- Director June 25, 2003
Jack Olshansky
/s/ David A. Savner
-------------------------- Director June 25, 2003
David A. Savner
-------------------------- Director June 25, 2003
John F. Bierbaum
/s/ Paul M. Ness, M.D.
-------------------------- Director June 25, 2003
Paul M. Ness, M.D.
21
EXHIBIT INDEX
NUMBER DESCRIPTION
1.1* Form of Underwriting Agreement.
3.1 Restated Certificate of Incorporation of the
Registrant (incorporated herein by reference to
Exhibit 3.2 to the Registrant's Registration
Statement on Form S-1, filed with the Securities and
Exchange Commission on March 25, 1994, File No.
33-76856 (the "Registration Statement")).
3.2 Certificate of Amendment to Certificate of
Incorporation of the Registrant (incorporated herein
by reference to Exhibit 3.1.1 to the Registrant's
Quarterly Report on Form 10-Q for the Registrant's
quarter ended November 30, 1999).
3.3 Restated Bylaws of the Registrant (incorporated
herein by reference to Exhibit 3.4 to the
Registration Statement).
4.1** Form of Senior Indenture.
4.2** Form of Subordinated Indenture.
4.3** Form of Senior Debt Security (included as Exhibit
4.1).
4.4** Form of Subordinated Debt Security (included as
Exhibit 4.2).
4.5* Form of Certificate of Amendment.
4.6* Form of Preferred Stock Certificate.
4.7* Form of Deposit Agreement.
4.8* Form of Depositary Receipt (included in Exhibit 4.7).
4.9* Form of Warrant Agreement.
4.10* Form of Warrant Certificate.
5.1** Opinion of Baker & McKenzie.
10.1 Office Sublease dated as of April 20, 1993 between
the Registrant and First Illinois Bank of Evanston,
N.A., as Trustee (incorporated herein by reference to
1
NUMBER DESCRIPTION
Exhibit 10.1 to the Registration Statement).
10.2 Amendment to Lease dated as of January 7, 1998
between the Registrant and First Illinois Bank of
Evanston, N.A. (incorporated herein by reference to
Exhibit 10.1.1 to the Registrant's Quarterly Report
on Form 10-Q for the Registrant's quarter ended
February 28, 1998).
10.3 Lease dated as of June 8, 1989 between the Registrant
and OTR (incorporated by reference to Exhibit 10.2 to
the Registration Statement).
10.4 Amendment to Lease dated as of May 6, 1998 between
the Registrant and OTR (incorporated herein by
reference to Exhibit 10.11 to the Registrant's Annual
Report on Form 10-K for the Registrant's fiscal year
ended May 31, 1998).
10.5 Third Amendment to Lease dated as of September 16,
1999 between the Registrant and OTR (incorporated be
reference to Exhibit 10.4.1 to the Registrant's
Quarterly Report on Form 10-Q for the Registrant's
quarter ended November 30, 1999).
10.6 License Agreement dated as of March 6, 1989 between
the Registrant and KabiVitrum AB (predecessor of
Pharmacia Corporation) (incorporated herein by
reference to Exhibit 10.6 to the Registration
Statement)
10.7 License Agreement dated as of July 20, 1990 between
the Registrant and Eriphyle BV (incorporated herein
by reference to Exhibit 10.7 to the Registration
Statement).
10.8 Northfield Laboratories Inc. 401(K) Plan
(incorporated herein by reference to Exhibit 10.14 to
the Registration Statement).
10.9 Northfield Laboratories Inc. Nonqualified Stock
Option Plan for Outside Directors (incorporated
herein by reference to Exhibit 10.15 to the
Registrant's Annual Report on Form 10-K for the
Registrant's fiscal year ended May 31, 1994).
10.10 Northfield Laboratories Inc. 1996 Stock Option Plan
(incorporated herein by reference to Exhibit 10.5.1
to the Registrant's Quarterly Report on Form 10-Q for
the Registrant's quarter ended November 30, 1997).
2
NUMBER DESCRIPTION
10.11 Northfield Laboratories Inc. 1999 Stock Option Plan
(incorporated herein by reference to Exhibit 10.10 to
the Registrant's Annual Report on Form 10-K for the
Registrant's fiscal year ended May 31, 1999).
10.12** Northfield Laboratories Stock Option Plan for New
Employees.
10.13** Employment Agreement dated as of January 1, 2003
between the Registrant and Steven A. Gould, M.D.
10.14** Employment Agreement dated as of January 1, 2003
between the Registrant and Jack Kogut.
10.15 Form of Indemnification Agreement -- Director and
Executive Officer (incorporated herein by reference
to Exhibit 10.18 to the Registrant's Quarterly Report
on Form 10-Q for the Registrant's quarter ended
February 28, 2001).
10.16 Form of Indemnification Agreement -- Director
(incorporated herein by reference to Exhibit 10.19 to
the Registrant's Quarterly Report on Form 10-Q for
the Registrant's quarter ended February 28, 2001).
10.17 Form of Indemnification Agreement -- Executive
Officer (incorporated herein by reference to Exhibit
10.20 to the Registrant's Quarterly Report on Form
10-Q for the Registrant's quarter ended February 28,
2001).
15.1** Letter re unaudited interim financial information.
23.1** Consent of Baker & McKenzie (contained in their
opinion filed as Exhibit 5.1 to this Registration
Statement).
23.2** Consent of KPMG LLP.
25.1* Form T-1 Statement of Eligibility of Trustee from
Senior Indenture under the Trust Indenture Act of
1939.
25.2* Form T-1 Statement of Eligibility of Trustee from
Subordinated Indenture under the Trust Indenture Act
of 1939.
* To be filed by amendment or as an exhibit to a report pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of 1934.
** Filed herewith.
3