Edgar Filing: NORTHFIELD LABORATORIES INC /DE/

As filed with the Securities and Exchange Commission on December 23, 2004
Registration No. 333-
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UNITED STATES
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 LLP
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

PROPOSED MAXIMUM PROPOSED MAXIMUM
Title Of Shares To Be Registered AGGREGATE OFFERING PRICE(1)(2) OFFERING PRICE PER UNIT REGISTRATION FEE
--------------------------------------------- ------------------------------ ----------------------- ----------------

Common Stock, par value $.01 per share(3) -- -- --
Preferred Stock, par value $.01 per share (3) -- -- --
Depositary Shares(3) -- -- --
Stock Purchase Contracts -- -- --
Warrants(4) -- -- --
Debt Securities -- -- --
Total(5) $100,000,000 (6) 100%(3) $11,770

(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.

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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 December 23, 2004.

Prospectus

$100,000,000

NORTHFIELD LABORATORIES INC.

Common Stock

Preferred Stock

Depositary Shares

Stock Purchase Contracts

Warrants

Debt Securities

THE SECURITIES OFFERED BY THE PROSPECTUS INVOLVED A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" BEGINNING ON PAGE 4.

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 December 17, 2004 was $20.18 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 December __, 2004.

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS........................................................... 1
WHERE YOU CAN FIND MORE INFORMATION............................................. 1
FORWARD-LOOKING INFORMATION..................................................... 2
OUR BUSINESS.................................................................... 3
RISK FACTORS.................................................................... 4
USE OF PROCEEDS................................................................. 9
RATIO OF EARNINGS TO FIXED CHARGES AND PREFERENCE DIVIDENDS..................... 9
DILUTION........................................................................ 9
DESCRIPTION OF THE SECURITIES WE MAY OFFER...................................... 9
PLAN OF DISTRIBUTION............................................................ 12
LEGAL MATTERS................................................................... 13
EXPERTS......................................................................... 13
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS................................. II-1

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
$100,000,000 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.

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, 2004;

- our Quarterly Report on Form 10-Q for the quarter ended August 31,
2004; 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 25, 1994, including any amendments or reports filed for the
purpose of updating this description.

Information in Current Reports on Form 8-K furnished to the SEC, including
under Item 2.02 or 7.01 of Form 8-K prior, on or subsequent to the date hereof
is not being and will not be incorporated herein by reference.

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,"
"forecasts," "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.

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 well tolerated when infused in patients in clinical
trials in sufficient quantities for 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 are currently enrolling patients in a pivotal Phase III trial in which
PolyHeme is being 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 begins at the scene of
the injury or in the ambulance and continues during transport and the initial 12
hour post-injury period in the hospital. Since blood is not routinely carried in
ambulances, the use of PolyHeme in this setting has the potential to improve
survival and address a critical, unmet medical need.

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. We make available
free of charge on our Web site our Form 10-Ks, Form 10-Qs, Form 8-Ks and other
documents that we file with or furnish to the Securities and Exchange
Commission, or "SEC," as soon as reasonably practicable after filing with the
SEC. The information contained on our Web site, or on other Web sites linked to
our Web site, is not a part of this document.

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.

RISK RELATED TO OUR BUSINESS

WE ARE REQUIRED TO COMPLETE OUR CURRENT CLINICAL TRIAL BEFORE WE MAY SELL
POLYHEME COMMERCIALLY AND WE MAY BE 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 currently
conducting a pivotal Phase III trial in which PolyHeme is being 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
begins at the scene of the injury,continues during transport to the hospital by
ambulance and further in the hospital. This trial will be expensive and
time-consuming and the timing of the FDA review process is uncertain. We cannot
ensure that we will be able to complete our current clinical trial successfully
or that FDA will not require us to conduct additional clinical trials of
PolyHeme in the future. If FDA approval for the commercial sale of PolyHeme is
obtained, it may include significant 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 trial or a failure to achieve FDA approval for
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 our clinical trial at any time if it is believed that the subjects
participating in the trial 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 considerable time
and 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 submit 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. We received an
RTF from FDA in November 2001 in connection with our submission of a BLA seeking
approval to market PolyHeme for use in the treatment of urgent, life-threatening
blood loss based on data from patients in the hospital setting only. The
subsequent dialogue with FDA resulted in the mutual decision to proceed with the
current pivotal Phase III trial that starts in the prehospital setting. If a new
BLA 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 to produce sufficient quantities of PolyHeme to
achieve profitability. In order to seek FDA approval of the sale of PolyHeme
produced at a larger-scale 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.

FDA continues to monitor 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 HAVE A HISTORY OF LOSSES AND OUR FUTURE PROFITABILITY IS UNCERTAIN.

From Northfield's inception through August 31, 2004, we have incurred net
operating losses totaling $129,906,524. 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
few years and are expected to substantially exceed our currently available
capital resources. 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 NEED TO RAISE ADDITIONAL CAPITAL TO CONTINUE OUR BUSINESS.

We currently believe we have sufficient capital resources to complete the
enrollment phase of our clinical trials. We intend to use the proceeds of this
offering to fund our post-enrollment activities in our clinical trial and to
prepare and submit a BLA application to FDA, to prepare for the commercial
launch of PolyHeme, to fund ongoing business operations and for other general
corporate purposes. Our specific use of the proceeds of this offering will be
described in the prospectus supplement that will accompany this prospectus. We
may be required to raise capital, in addition to the proceeds of this offering,
to continue our business. 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 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 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 initially to be limited 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
large-scale manufacturing, and there

can be no assurance that we can achieve large-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 large-scale manufacturing
facility. Moreover, in order to seek FDA approval of the sale of PolyHeme
produced at a larger-scale manufacturing facility, we may be required to conduct
a portion of our clinical trials with product manufactured at that facility. A
significant delay in achieving scale-up of commercial manufacturing capabilities
would 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 into
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
continuously evolving field. Competition is intense and may 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 may 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.

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.

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.
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 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 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 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 post-enrollment activities in our
clinical trial and to prepare and submit a BLA application to FDA, to prepare
for the commercial launch of PolyHeme, to fund ongoing business operations and
for other general corporate purposes. Our specific use of the proceeds of this
offering will be described in the prospectus supplement that will accompany this
prospectus. 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 August 31, 2004 was $36,748,000, or $1.72
per share of common stock. Net tangible book value per share represents total
tangible assets less total liabilities divided by the number of outstanding
shares of our common stock on August 31, 2004. Assuming that we issue an
aggregate of $100 million of common stock at an assumed public offering price of
$20.18 per share (the last reported sale price of our common stock on the Nasdaq
National Market on December 17, 2004), with estimated net proceeds to us (after
assumed commissions and expenses) of $93,850,000, our pro forma net tangible
book value at August 31, 2004 would have been $130,598,000 or $4.96 per share.
This represents an immediate increase in the tangible book value of $3.24 per
share to our existing stockholders and an immediate dilution of $15.22 per share
to new investors purchasing common stock in this offering, as illustrated in the
following table:

Assumed public offering price per share(1) $20.18
Net tangible book value per share as of August 31, 2004 $ 1.72
Increase per share attributable to new investors $ 3.24
Pro forma net tangible book value per share after offering $ 4.96
------
Dilution per share to new investors $15.22
======

(1) We assumed an offering price of $20.18 per share based on the last
reported sale price of the common stock on the Nasdaq National Market on
December 17, 2004. 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 or warrants after August 31, 2004. At August 31, 2004, there were
options outstanding to purchase a total of 1,238,000 shares of our common stock
at a weighted average exercise price of $8.81 per share and warrants outstanding
to purchase a total of 212,392 shares of our common stock at a weighted average
exercise price of $9.00 per share. If any of these options or warrants 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 $100,000,000 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.

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."

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.

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 over allotment 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 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 LLP, 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,
2004, and for each of the years in the three-year period ended May 31, 2004 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 registered public accounting firm, incorporated
by reference herein, and upon the authority of such firm as experts in
accounting and auditing.

With respect to the unaudited interim financial information of the period
ended August 31, 2004, incorporated by reference herein, the independent
registered public accounting firm has reported that they applied limited
procedures in accordance with professional standards for a review of such
information. However, their separate report included in Northfield Laboratories
Inc.'s quarterly report on Form 10-Q for the quarter ended August 31, 2004,
incorporated by reference herein, states that they did not audit and they do not
express an opinion on that interim financial information. Accordingly, the
degree of reliance on their report on such information should be restricted in
light of the limited nature of the review procedures applied. The independent
registered public accounting firm is 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 independent
registered public accounting firm within the meaning of Sections 7 and 11 of the
Act.

The audit report covering the May 31, 2004 financial statements refers to
a change in accounting due to the adoption of the provisions of Statement of
Financial Accounting Standards No. 143, "Accounting for Asset Retirement
Obligations."

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 $ 11,770
Legal fees and expenses 65,000
Printing and engraving 7,500
Fees of accountants 5,000
Miscellaneous 60,730
--------
$150,000
--------

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 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.

II-1

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 $15,000,000 for annual
aggregate claims.

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 LLP.

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).

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 by 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 Fourth Amendment to Lease dated as of September 22, 2003, between
the Registrant and OTR (incorporated by reference to Exhibit 10.18
to the Registrant's Quarterly Report on Form 10-Q for the
Registrant's quarter ended August 31, 2003).

10.7 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).

10.8 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).

10.9 Northfield Laboratories Inc. 401(K) Plan (incorporated herein by
reference to Exhibit 10.14 to the Registration

II-2

Statement).

10.10 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).

10.11 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).

10.12 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).

10.13 Northfield Laboratories Inc. Stock Option Plan for New Employees
(incorporated herein by reference to Exhibit 10.12 to the
Registrant's Registration Statement on Form S-3 filed with the
Securities and Exchange Commission on June 27, 2003, File No.
333-106615 (the "S-3 Registration Statement")).

10.14 Northfield Laboratories Inc. 2003 Equity Compensation Plan
(incorporated herein by reference to Exhibit 10.1 to the
Registrant's Registration Statement on Form S-8 filed with the
Securities and Exchange Commission on October 30, 2003, File No.
333-110110).

10.15 Employment Agreement dated as of January 1, 2003 between the
Registrant and Steven A. Gould, M.D. (incorporated herein by
reference to Exhibit 10.13 to the S-3 Registration Statement).

10.16 Employment Agreement dated as of January 1, 2003 between the
Registrant and Jack Kogut (incorporated herein by reference to
Exhibit 10.14 to the S-3 Registration Statement).

10.17 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).

10.18 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).

10.19 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 LLP (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.

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;

II-3

(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.

II-4

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 23rd day of
December, 2004.

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
Steven A. Gould, M.D. (Principal Executive Officer) December 23, 2004

/s/ Jack J. Kogut Senior Vice President, Chief Financial
----------------- Officer, Secretary and Treasurer
Jack J. Kogut (Principal Financial and Accounting Officer) December 23, 2004

/s/ John F. Bierbaum Director December 23, 2004
---------------------
John F. Bierbaum

/s/ Bruce S. Chelberg Director December 23, 2004
-----------------------
Bruce S. Chelberg

/s/ Paul M. Ness, M.D. Director December 23, 2004
-----------------------
Paul M. Ness, M.D.

/s/ Jack Olshansky Director December 23, 2004
-------------------
Jack Olshansky

/s/ David A. Savner Director December 23, 2004
-----------------------
David A. Savner

II-5

EXHIBIT INDEX

NUMBER DESCRIPTION
------- --------------------------------------------------------------------

1.1* Form of Underwriting Agreement.

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 LLP.

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).

10.8 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).

10.9 Northfield Laboratories Inc. 401(K) Plan (incorporated herein by
reference to Exhibit 10.14 to the Registration Statement).

10.15 Employment Agreement dated as of January 1, 2003 between the
Registrant and Steven A. Gould, M.D. (incorporated herein by
reference to Exhibit 10.13 to the S-3 Registration Statement).

10.16 Employment Agreement dated as of January 1, 2003 between the
Registrant and Jack Kogut (incorporated herein by reference to
Exhibit 10.14 to the S-3 Registration Statement).

15.1** Letter re unaudited interim financial information.

23.1** Consent of Baker & McKenzie LLP (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.