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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JULY 20, 1999
REGISTRATION NUMBER 333-
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
________________________
NORTHFIELD LABORATORIES INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 2036 36-3378733
(STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (IRS EMPLOYER IDENTIFICATION
INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) NUMBER)
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1560 SHERMAN AVENUE
SUITE 1000
EVANSTON, ILLINOIS 60201-4800
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
____________________
JACK J. KOGUT
VICE PRESIDENT - FINANCE
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.
JENNER & BLOCK
601 THIRTEENTH STREET, N.W.
WASHINGTON, D.C. 20005
(202) 639-6000
________________________
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APPROXIMATE DATE OF COMMENCEMENT OF THE PROPOSED SALE TO THE PUBLIC: As
soon as practicable after this Registration Statement becomes effective.
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 the form are to 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 addition securities for an offering
pursuant to Rule 462(b) 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 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 Proposed Maximum Amount of
Title of each Class of Amount to be Maximum Offering Aggregate Registration
Securities to be Registered Registered Price Per Share(1) Offering Price Fee
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Common Stock, par value 125,000 $13.13 1,641,250 456.27
$.01 per share
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(1) Estimated solely for purpose of calculating the registration fee in
accordance with Rule 457 under the Securities Act of 1933, as amended, based on
an average of the high and low sales prices on The Nasdaq Stock Market's
National Market Systems of the common stock, par value $.01 per share, of the
Registrant on July 19, 1999, which was $13.13 per share.
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 SECTION 8(a), MAY
DETERMINE.
The information in this prospectus will be amended or completed.
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The information in this prospectus is not complete and may be changed. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. The Selling Stockholder 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 it is not soliciting an offer to buy these securities in any
state where the offer or sale is not permitted.
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SUBJECT TO COMPLETION, DATED JULY 20, 1999
125,000 SHARES
NORTHFIELD LABORATORIES INC.
COMMON STOCK
__________________
THE SELLING STOCKHOLDER IS OFFERING 125,000 SHARES COMMON STOCK OF NORTHFIELD
LABORATORIES INC.
__________________
NORTHFIELD LABORATORIES COMMON STOCK IS LISTED ON THE NASDAQ
STOCK MARKET'S NATIONAL MARKET SYSTEM UNDER THE SYMBOL
"NFLD." ON JULY 19, 1999, THE REPORTED LAST SALE PRICE
OF THE COMMON STOCK ON THE NASDAQ STOCK
MARKET WAS $12.88 PER SHARE.
__________________
INVESTING IN THE COMMON STOCK INVOLVES RISKS.
SEE "RISK FACTORS" BEGINNING ON PAGE 7.
__________________
The Selling Stockholder may sell the shares in transactions on The
Nasdaq Stock Market, Inc., in negotiated transactions or otherwise, at market
prices prevailing at the time of the sale or at negotiated or fixed prices. The
Selling Stockholder may sell some or all of its shares in transactions involving
broker-dealers, who may act either as agent or principal. To the extent
required, the aggregate amount of common stock being offered and the terms of
the offering, the names of any agents, dealers or underwriters and any
applicable commission or discount with respect to a particular offer will be set
forth in an accompanying prospectus supplement. The aggregate proceeds to the
Selling Stockholder from the sale of the common stock will be the selling price
of the common stock sold less the aggregate agents' commissions and
underwriters' discounts, if any, and other expenses of issuance and
distribution. See "Selling Stockholder" and "Plan of Distribution."
The Securities and Exchange Commission and state securities regulators have not
approved or disapproved these securities or determined if this prospectus
is truthful or complete. Any representation to the contrary is a
criminal offense.
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Table of Contents
PAGE
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Cautionary Statement Regarding Forward-Looking Information 6
Prospectus Summary 7
Risk Factors 8
Use of Proceeds 11
Selling Stockholder 11
Plan of Distribution 12
Legal Matters 12
Experts 12
Where You Can Find More Information 12
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This prospectus contains 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 a lot of
weight on these statements. These statements speak only as of the date of this
document 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.
<PAGE> 7
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PROSPECTUS SUMMARY
You should read the following summary together with the more detailed
information incorporated into this prospectus regarding Northfield, the common
stock being sold and our financial statements and notes thereto.
Northfield believes it 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(TM) blood substitute product is a solution of
chemically modified hemoglobin derived from human blood. Clinical studies to
date indicate that PolyHeme carries as much oxygen, and loads and unloads oxygen
in the same manner, as transfused blood. Infusion of PolyHeme also restores
blood volume. Therefore, PolyHeme should be effective as an oxygen-carrying
resuscitative fluid in the treatment of hemorrhagic shock resulting from
extensive blood loss. Our method of manufacturing PolyHeme is designed to
eliminate the risk of transmission of diseases such as AIDS or hepatitis.
Clinical studies to date indicate that PolyHeme is universally compatible and
accordingly should not require blood typing prior to infusion. Therefore,
PolyHeme should be available for immediate use in emergency situations. In
addition, PolyHeme has an extended shelf life compared to blood.
We are presently conducting Phase III clinical trials of PolyHeme in
elective surgical applications at multiple locations in the United States. We
are also continuing to conduct Phase II clinical trials of PolyHeme in trauma
and emergency surgical applications.
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THE OFFERING
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Common Stock offered by
the Selling Stockholder Up to 125,000 shares.
Use of Proceeds......................................... Northfield will not receive any of the proceeds of the
offering.
Risk Factors............................................ See "Risk Factors" for a discussion of factors you
should carefully consider before deciding to invest in
shares of the common stock.
Dividend Policy......................................... We do not currently pay dividends and do not
anticipate paying dividends in the foreseeable future.
Nasdaq Symbol........................................... "NFLD"
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<PAGE> 8
RISK FACTORS
You should consider the following matters in deciding whether to
purchase shares of common stock pursuant to this offering. You also should
consider the other information included or incorporated by reference in this
document.
EXTENSIVE CLINICAL TRIALS MAY BE REQUIRED BEFORE WE CAN SELL POLYHEME
COMMERCIALLY
The results of our clinical trials may not be sufficient at present to
demonstrate adequately the safety and effectiveness of PolyHeme in order to file
a Biologic License Application ("BLA") with the Food & Drug Administration. If
additional trials are necessary, they may be expensive and time-consuming. The
timing of the FDA review process is uncertain. We cannot ensure that we will be
able to complete our clinical trials successfully or even 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 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
the 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.
NORTHFIELD IS 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 the FDA and its foreign counterparts. 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. Similar delays or rejections may
also be encountered in foreign countries. We cannot ensure that, even after
extensive clinical trials, regulatory approval will ever be obtained for
PolyHeme. Under new FDA guidelines, the FDA may comment upon the acceptability
of a BLA following its submission. We cannot ensure that the FDA will accept our
BLA or, if our BLA is deemed acceptable, that PolyHeme will ultimately be
approved for manufacture and sale based on our BLA. 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 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.
<PAGE> 9
NORTHFIELD IS AT AN EARLY STAGE OF DEVELOPMENT
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
and interest income. 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.
NORTHFIELD RELIES ON A SINGLE PRODUCT
Northfield's 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.
OUR ABILITY TO MANUFACTURE POLYHEME IS NOT CERTAIN
We intend to build a commercial-scale manufacturing facility
significantly larger than that currently being used to produce PolyHeme for our
clinical testing. We have no experience in commercial-scale manufacturing, and
we cannot ensure 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 manufacturing
capabilities will have a material adverse effects on the completion of our
clinical trials and therefore on the commercial manufacture and sale 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 the 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.
THE SUPPLY OF STARTING MATERIAL TO MANUFACTURE POLYHEME MAY BE LIMITED
We currently purchase donated blood from the American Red Cross and
Blood Centers of America for use as the starting material for PolyHeme. In 1996,
we entered into an agreement with hemerica, Inc., a subsidiary of Blood Centers
of America, under which hemerica would supply us with 82,500 units per year of
packed red cells, the source material for PolyHeme, over a three year period. 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
<PAGE> 10
blood substitute products, some of which are derived from human blood, thereby
limiting our available supply of starting material.
COMPETITION
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 to 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. Many 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.
NORTHFIELD LACKS SALES AND MARKETING EXPERIENCE
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.
NORTHFIELD HAS A HISTORY OF LOSSES; FUTURE PROFITABILITY AND FUNDING ARE NOT
CERTAIN
From its inception to February 28, 1999, Northfield has incurred net
losses totaling $65,877,000. We will require substantial additional expenditures
to complete clinical trials, 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. We may require substantial additional funds to
achieve commercial production of PolyHeme. Our future capital requirements will
depend on many factors, including the scope and results of 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. Any additional funding
may result in significant dilution to then existing stockholders.
<PAGE> 11
MARKET ACCEPTANCE OF POLYHEME IS NOT CERTAIN
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 by health care providers or third party payors of
if PolyHeme does not otherwise receive market acceptance.
PROTECTION OF OUR PROPRIETARY TECHNOLOGY IS NOT CERTAIN
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 such 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.
USE OF PROCEEDS
We will not receive any proceeds from the offering. The Selling
Stockholder will receive the proceeds from the offering.
SELLING STOCKHOLDER
The Selling Stockholder is VSII Stockholders Trust I. VSII currently
owns 125,000 shares of our common stock. We cannot provide an estimate of the
exact number of shares that VSII will hold after completion of this offering
because it may sell some or all of its shares.
<PAGE> 12
The address of the Selling Stockholder is 1751 Lake Cook Road, Suite
350, Deerfield, Illinois 60015. The Selling Stockholder's phone number is (847)
940-1970.
PLAN OF DISTRIBUTION
The Selling Stockholder may sell the shares being offered hereby in
transactions on The Nasdaq Stock Market, Inc., in negotiated transactions or
otherwise, at market prices prevailing at the time of the sale or at negotiated
or fixed prices. The Selling Stockholder may sell some or all of its shares in
transactions involving broker-dealers, who may act either as agent or principal,
and who may receive compensation in the form of discounts, commissions or
concessions from Selling Stockholder or the purchaser of shares for whom such
broker-dealers act as agent or to whom they sell as principal, or both.
At the time a particular offer of shares of common stock is made, a
prospectus supplement will be distributed, to the extent required, which will
set forth the aggregate number of shares of common stock being offered and the
material terms of the offering, including the name or names of any underwriters,
dealers or agents, the purchase price to be paid by any underwriter or dealer
for the common stock being purchased, any discounts, commissions and other items
constituting compensation from the Selling Stockholder and any discounts,
commissions or concessions allowed or reallowed or paid to dealers, and the
proposed selling price to the public.
The Selling Stockholder will pay substantially all of the expenses to
be incurred in connection with the registration statement of which this
prospectus is a part, estimated to be $7,936. Northfield will not receive any
proceeds from this offering.
The Selling Stockholder and any underwriters, dealers or agents that
participate in the distribution of the common stock may be deemed to be
"underwriters" under the Securities Act, and any profit on the sale of the
common stock by them and any discounts, commissions or concessions received by
any such underwriters, dealers or agents might be deemed to be underwriting
discounts and commissions under the Securities Act.
LEGAL MATTERS
The validity of the issuance of the common stock being offered by this
document is being passed upon by Jenner & Block, counsel for Northfield.
EXPERTS
The financial statements of Northfield Laboratories Inc. as of May 31,
1998, and for each of the years in the three-year period ended May 31, 1998 have
been incorporated by reference herein and in the registration statement in
reliance upon the report of KPMG LLP, independent certified public accountants,
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, 1998, November 30, 1998 and February 28, 1999,
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, 1998, November 30, 1998 and February 28,
1999, 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 accounts within the meaning of sections 7 and 11 of the Act.
WHERE YOU CAN FIND MORE INFORMATION
Northfield files reports, proxy statements and other information with the
SEC under the Securities Exchange Act. Please call the SEC at 1-800-SEC-0330 for
further information on the public reference rooms. You may read and copy this
information at the following locations of the SEC:
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Public Reference Room New York Regional Office Chicago Regional Office
450 Fifth Street, N.W. 7 World Trade Center Citicorp Center
Room 1024 Suite 1300 500 West Madison Street
Washington, D.C. 20549 New York, New York 10048 Suite 1400
Chicago, Illinois 60661-2511
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You may also obtain copies of this information by mail from the Public
Reference Section of the SEC, 450 Fifth Street, N.W., Room 1024, Washington,
D.C. 20549, at prescribed rates. The SEC also maintains an Internet world wide
web site that contains reports, proxy statements and other information about
issuers, including Northfield, who file electronically with the SEC. The address
of that site is www.sec.gov. You can also inspect reports, proxy statements and
other information about Northfield at the offices of The Nasdaq Stock Market,
Inc., 1735 K Street, N.W., Washington, D.C. 20006-1500.
The SEC allows us to "incorporate by reference" information into this
document. This means that can disclose important information to you by referring
you to another document filed separately with the SEC. The information
incorporated by reference is considered to be a part of this document, except
for any information that is superseded by information that is included directly
in this document.
This document incorporates by reference the documents listed below that we
have previously filed with the SEC. They contain important information about us
and our financial condition.
- Annual Report on Form 10-K for the fiscal year ended May 31,
1998.
- Quarterly Report on Form 10-Q for the fiscal quarter ended
August 31, 1998.
- Quarterly Report on Form 10-Q for the fiscal quarter ended
November 30, 1998.
- Quarterly Report on Form 10-Q for the fiscal quarter ended
February 28, 1999.
- Description of the common stock of the Company included in the
Company's Registration Statement on Form S-1, Registration No.
33-76856, as filed with the SEC on March 25, 1994, including any
amendments or reports filed for the purpose of updating such
description.
We also incorporate by reference additional documents that we may file with
the SEC after the date of this document. These documents include periodic
reports, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K.
You can obtain any of the documents incorporated by reference in this
document through us or from the SEC through the SEC's web site at the address
provided above. Documents incorporated by reference are available from us
without charge, excluding any exhibits to those documents unless the exhibit is
specifically incorporated by reference as an exhibit in this document. You can
obtain documents incorporated by reference in this document by requesting them
in writing or by telephone from us at the following address:
Northfield Laboratories Inc.
1560 Sherman Avenue
Suite 1000
Evanston, Illinois 60201-4800
(847) 864-3500
If you request any incorporated documents from us, we will mail them to you
by first class mail, or another equally prompt means, within one business day
after we receive your request.
<PAGE> 14
We have not authorized anyone to give any information or make any
representation about Northfield that differs from, or adds to, the information
in this document or in our documents that are publicly filed with the SEC.
Therefore, if anyone does give you different or additional information, you
should not rely on it.
If you are in a jurisdiction where it is unlawful to offer to exchange or
sell, or to ask for offers to exchange or buy, the securities offered by this
document or to ask for proxies, or if you are a person to whom it is unlawful to
direct these activities, then the offer presented by this document does not
extend to you.
The information contained in this document speaks only as of its date
unless the information specifically indicates that another date applies.
<PAGE> 15
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the estimated expenses in connection with
the issuance and distribution of the securities being registered hereby, other
than underwriting and commissions, if any.
SEC registration fee..................$ 436
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Legal fees and expenses...............$ 7,500
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Total.................................$ 7,936
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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 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;
provided, however, in a suit by or in the right of the corporation no
indemnification shall be made in respect of any claim, issue or matter as to
which such person shall have 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.
Northfield's Restated Certificate of Incorporation provides that Northfield
will indemnify its directors, officers, employees and agents to the fullest
extent permitted by Delaware law. Northfield's Restated Certificate of
Incorporation additionally requires Northfield to advance expenses incurred by
its 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.
Northfield's Restated Certificate of Incorporation also provides that, to
the fullest extent permitted by Delaware law, Northfield's directors will not be
liable for monetary damages for breach of the directors' fiduciary duty of care
to Northfield and its 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 Northfield or its 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.
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<PAGE> 16
Northfield has purchased an insurance policy which purports to insure the
officers and directors of Northfield against certain liabilities incurred by
them in the discharge of their functions as officers and directors, except for
liabilities resulting from their own malfeasance. The insurance policy provides
coverage in the amount of $10,000,000 for annual aggregate claims.
ITEM 16. EXHIBITS.
(a) Exhibits. The following is a list of exhibits filed as part of the
Registration Statement.
EXHIBIT
NUMBER DESCRIPTION
------ -----------
5.1 Opinion of Jenner & Block, counsel to Northfield,
regarding the legality of the shares being offered
23.1 Consent of Jenner & Block (included in Exhibit 5.1)
23.2 Consent of KPMG LLP
23.3 Acknowledgment of Independent Certified Public
Accountants Regarding Independent Auditor's Review
Report
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 and 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 20 percent 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;
unless, in the case of clauses (i) and (ii) above, 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
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<PAGE> 17
Commission by the registrant pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in 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.
(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 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) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of
1933, the information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act
of 1933, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(d) 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
Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer, or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer, or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
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<PAGE> 18
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, 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 June 25, 1999.
NORTHFIELD LABORATORIES INC.
/s/ RICHARD E. DEWOSKIN
By ________________________________________
Richard E. DeWoskin
Chairman of the Board and Chief Executive
Officer
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed below by the following persons on
behalf of the Registrant in the capacities indicated on June 25, 1999.
SIGNATURE TITLE
--------- -----
/s/ RICHARD E. DEWOSKIN
_________________________________ Chairman of the Board and Chief Executive
Richard E. DeWoskin Officer
(principal executive officer)
/s/ STEVEN A. GOULD, M.D.
_________________________________ President, Director
Steven A. Gould, M.D.
/s/ JACK J. KOGUT
_________________________________ Vice President - Finance, Secretary and
Jack J. Kogut Treasurer (principal financial officer and
principal accounting officer)
/s/ GERALD S. MOSS, M.D.
_________________________________ Director
Gerald S. Moss, M.D.
/s/ BRUCE S. CHELBERG
_________________________________ Director
Bruce S. Chelberg
/s/ JACK OLSHANSKY
_________________________________ Director
Jack Olshansky
/s/ DAVID A. SAVNER
_________________________________ Director
David A. Savner
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<PAGE> 19
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
- ------ -----------
5.1 Opinion of Jenner & Block, counsel to Northfield, regarding the
legality of the shares being offered
23.1 Consent of Jenner & Block (included in Exhibit 5.1)
23.2 Consent of KPMG LLP
23.3 Acknowledgement of Independent Certified Public Accountants
Regarding Independent Auditor's Review Report
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<PAGE> 1
Exhibit 5.1
[Jenner & Block Letterhead]
July 14, 1999
Northfield Laboratories Inc.
1560 Sherman Avenue
Suite 1000
Evanston, Illinois 60201-4800
Ladies and Gentlemen:
We have acted as counsel to Northfield Laboratories Inc., a Delaware
corporation ("Northfield"), in connection with the Registration Statement on
Form S-3 (the "Registration Statement") filed by Northfield under the Securities
Act of 1933, as amended, with the Securities and Exchange Commission relating to
the resale of up to 125,000 shares (the "Shares") of the Common Stock, par value
$.01 per share, of Northfield held by Vector Securities International, Inc.
In arriving at the opinions expressed below, we have examined and relied
upon the accuracy and completeness of the facts and information contained in the
Registration Statement and have also examined and relied, without independent
verification of the statements contained therein, on certificates from
Northfield regarding certain matters, and we have assumed the accuracy of the
representations and statements made in each of the foregoing.
Based on the foregoing, we hereby advise you that in our opinion the
Shares have been duly authorized by Northfield and are validly issued, fully
paid and nonassessable.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement. In giving this consent, we do not hereby admit that we
are in the category of persons whose consent is required under Section 7 of the
Securities Act of 1933, as amended, or the rules and regulations of the
Securities and Exchange Commission thereunder.
Very truly yours,
/s/ JENNER & BLOCK
JENNER & BLOCK
<PAGE> 1
Exhibit 23.2
CONSENT OF KPMG LLP
The Board of Directors
Northfield Laboratories Inc.
We consent to the incorporation by reference in the registration statement on
Form S-3 of Northfield Laboratories Inc. of our audit report dated July 6,
1998, relating to the balance sheets of Northfield Laboratories Inc. as of May
31, 1998, and the related statements of operations, stockholders' equity
(deficit) and cash flows for each of the years in a three-year period ended May
31, 1998, which report appears in the May 31, 1998 annual report on Form 10-K of
Northfield Laboratories Inc., and to the reference of our firm under the
heading "Experts" in the registration statement.
/s/ KPMG LLP
Chicago, Illinois
July 14, 1999
<PAGE> 1
Exhibit 23.3
ACKNOWLEDGMENT OF
INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
REGARDING INDEPENDENT AUDITOR'S REVIEW REPORT
The Board of Directors
Northfield Laboratories Inc.
With respect to the registration statements on Form S-3 of Northfield
Laboratories Inc., we acknowledge our awareness of the incorporation by
reference of our reports dated September 25, 1998, December 21, 1998, and March
31, 1999 related to our reviews of interim financial information.
Pursuant to Rule 436(c) under the Securities Act of 1933, such report is not
considered part of a registration statement prepared or certified by an
accountant or a report prepared or certified by an accountant within the meaning
of sections 7 and 11 of the Act.
/s/ KPMG LLP
Chicago, Illinois
July 14, 1999
