AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON SEPTEMBER 5, 2000
REGISTRATION NO. 333-
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
FORM S-3
______________
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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LIFECELL CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 76-0172936
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(State or other jurisdiction of incorporation (I.R.S. Employer ID No.)
or organization)
1 Millennium Way
Branchburg, NJ 08876
(908) 947-1100
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(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
Steven T. Sobieski
LifeCell Corporation
1 Millennium Way
Branchburg, NJ 08876
(908) 947-1100
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(Name, address and telephone number of agent for service)
Copy to:
Alan Wovsaniker, Esq.
Lowenstein Sandler PC
65 Livingston Avenue
Roseland, New Jersey 07068
(973) 597-2500
Approximate date of proposed commencement of sale to 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 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 in connection with dividend or interest
reinvestment plans, please 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, check the following box and list the
Securities Act registration statement number of the earlier 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 for the same
offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434, check
the following box. [_]
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CALCULATION OF REGISTRATION FEE UNDER THE SECURITIES ACT OF 1933
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Proposed
Proposed Maximum
Title of Each Class of Amount to Maximum Aggregate Aggregate Amount of
Securities to be Registered be Registered(1) Price per Share(2) Offering Price(2) Registration Fee
----------------------------- ---------------- ------------------- ------------------ -----------------
<S> <C> <C> <C> <C>
Common Stock, $.001 par value 2,810,771 $ 4.906 $ 13,789,643 $ 3,641
<FN>
(1) Registered for resale by selling stockholders of the Company.
(2) Estimated solely for purposes of calculating the registration fee pursuant to Rule 457(c) under the
Securities Act of 1933, as amended, based on the average of the high and low price of the common
stock on the Nasdaq National Market on August 31, 2000.
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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 THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
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SUBJECT TO COMPLETION DATED SEPTEMBER 5, 2000
PROSPECTUS
LIFECELL CORPORATION
2,810,771 SHARES
COMMON STOCK
The selling stockholders listed on page 20 are offering for resale
2,810,771 shares of our common stock under this prospectus.
The selling stockholders may offer their common stock through public or
Private transactions, on or off the Nasdaq National Market, at prevailing market
prices, or at privately negotiated prices. We will not receive any of the
proceeds from the sale of the common stock by the selling stockholders, but
will pay all registration expenses.
Our common stock is listed on the Nasdaq National Market under the symbol
"LIFC". On September 1, 2000, the closing price of the common stock on the
Nasdaq National Market was $4.875 per share.
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THE SHARES OF COMMON STOCK OFFERED OR SOLD UNDER THIS PROSPECTUS INVOLVE A
HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 5.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus. Any representation to the contrary is
a criminal offense.
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The date of this prospectus is _______________, 2000.
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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 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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TABLE OF CONTENTS
PAGE
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The Company. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Risk Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Special Note Regarding Forward-Looking Statements. . . . . . . . . . . 15
Where You Can Find More Information . . . . . . .. . . . . . . . . . . 16
Use of Proceeds . . . . . . . . . . . . . . . . .. . . . . . . . . . . 18
Selling Stockholders. . . . . . . . . . . . . . .. . . . . . . . . . . 18
Plan of Distribution. . . . . . . . . . . . . . .. . . . . . . . . . . 21
Legal Matters . . . . . . . . . . . . . . . . . .. . . . . . . . . . . 23
Experts . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . 23
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THE COMPANY
LifeCell Corporation is engaged in developing and marketing biologic
solutions for the repair, replacement and preservation of human tissue. Our
core preservation technology produces an acellular tissue matrix, which retains
the essential biochemical and structural components necessary for normal tissue
regeneration. We currently market three products based on this technology:
AlloDerm for the plastic reconstructive, burn and dental markets; Cymetra a
micronized version of AlloDerm for the plastic reconstructive and dermatology
markets; and Repliform for the urogynecology market. Our product development
programs include small diameter vascular grafts as an alternative to autografted
blood vessels, orthopedic applications of our acellular tissue matrix, and
ThromboSol, a formulation for extended storage of platelets.
We were incorporated in the State of Delaware in 1992 as the successor to a
Delaware corporation that was incorporated in 1986. Our address is 1 Millennium
Way, Branchburg, New Jersey 08876 and our phone number is (908) 947-1100.
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RISK FACTORS
You should carefully consider these risk factors in addition to our
financial statements. The risks described below are not the only risks we face.
Additional risks that we do not yet know of or that we currently think are
immaterial may also impair our business operations. If any of the following
risks occur, our business, financial condition or operating results could be
adversely affected. In that case, the trading price of our common stock could
decline, and you may lose all or part of your investment.
WE HAVE A HISTORY OF OPERATING LOSSES AND A SUBSTANTIAL ACCUMULATED EARNINGS
DEFICIT AND WE MAY CONTINUE TO INCUR LOSSES.
Since our inception in 1986, we have generated only limited revenues from
product sales and have incurred substantial net losses of approximately $6.1
million, $7.3 million, $9.2 million, and $4.2 million and $3.3 million for the
years ended December 31, 1997, 1998, 1999, and the six months ended June 30,
1999 and 2000, respectively. At June 30, 2000, we had an accumulated deficit of
approximately $58.0 million. We expect to incur additional operating losses as
well as negative cash flow from operations as we continue to use substantial
resources to expand our marketing efforts with respect to our current products
and to continue our product development programs. Our ability to increase
revenues and achieve profitability and positive cash flows from operations will
depend on increased market acceptance and sales of AlloDerm, Repliform and
Cymetra and commercialization of products under development. We may not achieve
profitability and positive cash flows from operations.
WE ARE A PARTY TO PENDING LITIGATION AND ADVERSE RESULTS OF SUCH LITIGATION
MATTERS COULD NEGATIVELY IMPACT OUR FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
We are a party to pending litigation in the Superior Court of California,
San Bernadino County, Central District, captioned Ann Regner, et al., on behalf
of themselves and others similarly situated, v. Inland Eye & Tissue Bank of
Redlands, et al. The complaint was brought as a class action on behalf of all
close family members of deceased person whose tissues were collected, processed,
stored or distributed in California. The defendants, 19 of whom are named, are
the class of all licensed tissue banks in California as well as other companies,
including us, which store, process, or distribute human tissue as part of their
business. The complaint alleges that tissue banks routinely fail to obtain
proper informed consent from family members when soliciting the donation of
human tissue for transplant. The complaint also alleges that the defendants,
including us, make profits from the storing, processing, and distribution of
human tissue in contravention of California law. Plaintiffs' application for a
preliminary injunction seeking to enjoin the defendants, including us, from
doing business in California was denied in June 2000.
We are also a party to pending litigation which was filed in the United
States District Court, District of New Jersey entitled Inamed Corporation,
McGhan Medical Corporation and Collagen Aesthetics, Inc. vs. LifeCell
Corporation and Obagi Medical Products Inc. The complaint alleges that we and
Obagi, our marketing agent, have disseminated false advertisements with respect
to the marketing of our Cymetra product that misleadingly compares it to and
unlawfully disparages the bovine collagen products of Inamed and its
subsidiaries. The plaintiffs are seeking injunctive relief to prohibit what
they allege to be such unlawful advertising, as well as unspecified damages.
Plaintiffs' motion for a preliminary injunction prohibiting use of the current
advertisements was recently granted by the court and we have changed our
advertising accordingly.
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We are vigorously defending such actions. However, we cannot guarantee the
successful resolution of these actions and an adverse result in either of these
litigation matters could negatively impact our financial condition and results
of operations. In addition, defending such actions could result in substantial
costs and diversion of resources which could adversely affect our financial
condition and results of operations.
WE MAY NEED ADDITIONAL CAPITAL TO MARKET OUR CURRENT PRODUCTS AND TO DEVELOP AND
COMMERCIALIZE NEW PRODUCTS AND IT IS UNCERTAIN WHETHER SUCH CAPITAL WILL BE
AVAILABLE.
We intend to expend substantial funds for:
- product research and development;
- expansion of sales and marketing activities;
- expansion of manufacturing capacity;
- product education efforts; and
- other working capital and general corporate purposes, including
potential acquisitions of complementary technologies or products.
We may need additional capital, depending on:
- the costs and progress of our research and development efforts;
- the number and types of product development programs undertaken;
- the costs and timing of expansion of sales and marketing activities;
- the costs and timing of expansion of manufacturing capacity;
- the amount of revenues from sales of our existing and new products;
- changes in, termination of, and the success of existing and new
distribution arrangements;
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- the cost of maintaining, enforcing and defending patents and other
intellectual property rights;
- competing technological and market developments;
- developments related to regulatory and third-party reimbursement
matters; and
- other factors.
We have no commitments for any future funding and there can be no assurance
that we will be able to obtain additional financing in the future from either
debt or equity financings, bank loans, collaborative arrangements or other
sources on terms acceptable to us, or at all. Any additional equity financing
may be dilutive to stockholders, and debt financing, if available, may involve
significant restrictive covenants. Collaborative arrangements, if necessary to
raise additional funds, may require us to relinquish our rights to certain of
our technologies, products or marketing territories. If adequate funds are not
available, we expect that we will be required to delay, scale back or eliminate
one or more of our product development programs.
OUR FAILURE TO COMPLY WITH APPLICABLE REGULATION COULD LEAD THE UNITED STATES
FOOD AND DRUG ADMINISTRATION TO IMPOSE ENFORCEMENT SANCTIONS.
Significant government regulation, both domestic and foreign, applies to
the manufacturing and marketing of our current and developing products. In the
United States, our products are subject to regulation by the FDA. Noncompliance
with the FDA's requirements can result in:
- fines;
- injunctions;
- civil penalties;
- recall or seizure of products;
- total or partial suspension of production;
- refusal of the government to authorize the marketing of new
products or allow us to enter into supply contracts; and
- criminal prosecution.
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THE COSTS OF DEVELOPING, MANUFACTURING AND MARKETING OUR PRODUCTS WOULD BE
INCREASED IF THE FDA IMPOSES MEDICAL DEVICE OR OTHER REGULATIONS UPON SUCH
PRODUCTS.
The FDA generally permits transplanted human tissue to be commercially
distributed without obtaining 510(k) clearance or pre-market, or PMA, approval.
In contrast, products regulated as medical devices usually require such
approval. In 1996, the FDA determined that AlloDerm used for the repair or
replacement of damaged or inadequate integumental tissue, including gingiva,
would be regulated as transplanted human tissue. On that basis, we began
commercial distribution of this product for plastic reconstructive surgery,
periodontal surgery and burn grafts without 510(k) clearance or PMA approval
from the FDA.
In its decision with respect to the regulation of AlloDerm, the FDA stated
that the regulatory status of any different uses would need to be determined on
a case-by-case basis. In recent months, we began marketing:
- Cymetra, a micronized version of AlloDerm, for plastic and
reconstructive procedures; and
- Repliform, an acellular tissue matrix, for urogynecological surgical
procedures.
Because we believe that these products meet the regulatory definition of human
tissue, we have not sought a determination of this question from the FDA.
However, the FDA's regulatory approach to tissue products continues to evolve.
There is a risk that the FDA could alter its regulatory approach and determine
that AlloDerm, Repliform or Cymetra is more appropriately regulated as a medical
device. If so, the FDA could require us to cease marketing and/or recall
product already sold and require us to seek 510(k) clearance or PMA approval for
these products. The process of obtaining 510(k) clearance or PMA approval may
be expensive, lengthy and unpredictable. We do not know if such clearance or
approval could be obtained in a timely fashion, or at all, or if the FDA would
require extensive clinical data to support clearance or approval. In addition,
the FDA also could seek to impose enforcement sanctions for marketing these
products without 510(k) clearance or PMA approval.
In the United States, devices and biologics, such as ThromboSol, our
proposed blood cell preservation product, must be manufactured in registered
establishments and must be produced in accordance with the Quality System
Regulation for medical devices or Good Manufacturing Practices regulations for
biologics. If any of our products are regulated as devices or biologics, we
will be required to comply with Quality System Regulation or Good Manufacturing
Practices regulation. Compliance with these regulations could significantly
increase the costs and difficulties of manufacturing our products.
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Biologic products require FDA licensing prior to commercialization in the
United States. To obtain licensing approval for these products, we must submit
proof of their safety, purity and potency. Testing, preparation of necessary
applications and the processing of those applications by the FDA is expensive
and time consuming. We do not know if the FDA will act favorably or quickly in
making such reviews, and significant difficulties or costs may be encountered by
us in our efforts to obtain FDA licenses. The FDA may also place conditions on
clearances that could restrict commercial applications of such products.
Product approvals may be withdrawn if compliance with regulatory standards are
not maintained or if problems occur following initial marketing. Delays imposed
by the FDA licensing process may materially reduce the period during which we
have the exclusive right to commercialize patented products.
In addition, there can be no assurance that the various states in which our
products are sold will not impose additional regulatory requirements or
marketing impediments which could adversely affect our business.
WE ARE REQUIRED TO COMPLY WITH STRINGENT REGULATIONS AT OUR TISSUE FACILITIES.
Tissue establishments must engage in donor screening, infectious disease
testing and stringent record keeping. As a result, our involvement in the
processing and distribution of human tissue requires us to ensure that proper
donor screening and infectious disease testing is done appropriately and
conducted under strict procedures. In addition, we must maintain records, which
are available for FDA inspectors documenting that the procedures were followed.
The FDA has authority to conduct inspections of tissue establishments and to
detain, recall, or destroy tissue if the procedures were not followed or
appropriate documentation is not available. Labeling and promotional activities
are also subject to scrutiny by the FDA and, in certain instances, by the
Federal Trade Commission. From time to time, the FDA may modify such
requirements, imposing additional or different requirements. Failure to comply
with any applicable FDA requirements could result in civil and criminal
enforcement actions and other penalties that would have a material adverse
effect on us.
THERE IS A RISK THAT CHANGES TO EXISTING LAWS OR NEW INTERPRETATIONS OF SUCH
LAWS WILL LIMIT OUR ABILITY TO SELL OUR PRODUCTS AT A PROFIT.
The National Organ Transplant Act prohibits the acquisition, receipt or
transfer of certain human organs, including skin and heart valves and vascular
grafts, for valuable consideration, but permits the payment of reasonable
expenses associated with the removal, transportation, processing, preservation,
quality control and storage of human tissue and skin. We include in our
AlloDerm, Repliform and Cymetra pricing structure certain of the educational
costs and reasonable processing expenses. There is a risk that existing laws
may change or NOTA payment allowances may be interpreted differently in the
future for our products, and if they are, it would adversely affect our profits,
by limiting recovery of educational costs and processing expenses.
WE ARE SUBJECT TO VARYING AND EXTENSIVE REGULATION BY FOREIGN GOVERNMENTS WHICH
CAN BE COSTLY, TIME CONSUMING AND SUBJECT US TO UNANTICIPATED DELAYS.
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The regulation of our products outside the United States varies by country.
Certain countries regulate our products as a pharmaceutical product, requiring
us to make extensive filings and obtain regulatory approvals before selling our
product. Certain countries classify our products as a transplant tissue but may
restrict its import or sale. Other countries have no applicable regulations
regarding the import or sale of products similar to our products, creating
uncertainty as to what standards we may be required to meet.
AlloDerm currently is being marketed in certain foreign countries, and we
are pursuing clearance to market AlloDerm and our other products in additional
countries. The uncertainty of the regulations in each country may delay or
impede the marketing of AlloDerm or our other products or impede our ability to
negotiate distribution arrangements on favorable terms. Certain foreign
countries have laws similar to the National Organ Transplant Act. These laws may
restrict the amount that we can charge for our products and may restrict the
importation or distribution of our products to licensed not-for-profit
organizations. Noncompliance with foreign country requirements may include some
or all of the risks associated with noncompliance with FDA regulation as well as
other risks.
OUR PRODUCTS REPRESENT NEW METHODS OF TREATMENT WHICH MAY NOT BE ACCEPTED BY
DOCTORS.
Much of our ability to increase revenues and to achieve profitability and
positive cash flows from operations will depend on expanding the use and market
penetration of our current products and the successful introduction of our
products in development. Products based on our technologies represent new
methods of treatment. Physicians will not use our products unless they
determine that the clinical benefits to the patient are greater than those
available from competing products or therapies. Even if the advantage of our
products is established as clinically significant, physicians may not elect to
use such products for any number of reasons. Consequently, our current products
or products under development may not attain market acceptance among physicians,
health care payers and patients. Broad market acceptance of our products may
require the training of numerous physicians and clinicians, as well as
conducting or sponsoring clinical studies to demonstrate the benefits of such
products. The amount of time required to complete such training and studies
could result in a delay or dampening of such market acceptance. Moreover,
health care payers' approval of reimbursement for our products in development
may be an important factor in establishing market acceptance.
WE MAY NOT BE SUCCESSFUL IN DEVELOPING AND COMMERCIALIZING NEW PRODUCTS.
Our growth and profitability will depend, in part, upon our ability to
complete development of and successfully introduce new products. We may be
required to undertake time-consuming and costly development activities and seek
regulatory clearance or approval for new products. Although we have conducted
animal studies on many of our products under development which indicate that the
product may be feasible for a particular application, results obtained from
expanded studies may not be consistent with earlier trial results or be
sufficient for us to obtain any required regulatory approvals or clearances. We
may experience difficulties that could delay or prevent the successful
development, introduction and marketing of new products. Regulatory clearance
or approval of these or any new products may not be granted on a timely basis,
if ever, and the new products may not adequately meet the requirements of the
applicable market or achieve market acceptance. The completion of the
development of any of our products under development remains subject to all the
risks associated with the commercialization of new products based on innovative
technologies, including:
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- unanticipated technical or other problems;
- manufacturing difficulties; and
- the possible insufficiency of the funds allocated for the completion
of such development.
The inability to complete successfully the development of a product or
application, or a determination by us, for financial, technical or other
reasons, not to complete development of any product or application, particularly
in instances in which we have made significant capital expenditures, could have
a material adverse effect on our business.
WE ARE DEPENDENT UPON INDEPENDENT AGENTS AND DISTRIBUTORS TO MARKET OUR
PRODUCTS.
We have engaged:
- Boston Scientific Corporation as our exclusive worldwide sales and
marketing representative for Repliform for use in urogynecology; and
- Obagi Medical Products as the exclusive sales and marketing
representative of Cymetra for office-based dermatologists and plastic
surgeons.
Other distributors have been and in the future may be granted exclusive
distribution rights. If an exclusive distributor fails adequately to promote,
market and sell our products, our financial condition and results of operations
could be adversely affected. In addition, our results of operations could be
adversely affected if we are not able to secure a replacement distributor until
after the term of the distribution contract is complete or until such contract
is otherwise be terminated. Our financial condition and results of operations
could be materially adversely affected by any adverse change in our
relationships with our agents and distributors.
OUR BUSINESS MAY BE ADVERSELY AFFECTED BY THE LIMITED AVAILABILITY OF MATERIALS.
Our business is dependent on the availability of donated human skin and
other tissues. A finite supply of donated tissue is available. Although we
have established what we believe to be adequate sources of donated human skin to
satisfy the expected demand for our products in the foreseeable future,
including from various non-profit organizations which procure skin and other
donated human tissue, there can be no assurance that the availability of donated
human skin will be sufficient to meet our demand for such materials. Any
significant interruption in the availability of such tissue would likely have a
material adverse effect on our financial condition and results of operations.
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We have performed limited activities to develop products using porcine
dermis and other animal tissues as a substitute for donated human skin. If
successfully developed, animal tissue could replace the need for human tissue as
a raw material. There can be no assurance that such animal tissue products can
be successfully developed, that such development and required regulatory
approvals could result in timely replacement of human tissue used by us in the
event of a reduced supply of human tissue or that the cost of such animal tissue
would not materially adversely affect our business, financial condition and
results of operations.
Donors of organs and tissues, including donated human skin, have various
motivations. Although we do not promote the use of AlloDerm for cosmetic
applications, AlloDerm has been used by surgeons in a variety of applications
that may be considered "cosmetic." Knowledge of such use by potential donors
could impact their willingness to donate skin for such uses.
WE NEED TO ATTRACT AND RETAIN KEY EMPLOYEES AND PERSONNEL. IF WE LOSE KEY
MANAGEMENT AND SCIENTIFIC PERSONNEL ON WHOM WE DEPEND, OUR BUSINESS MAY BE
ADVERSELY AFFECTED.
We are dependent in large part on the efforts of our executive officers,
including Paul G. Thomas, President and Chief Executive Officer of LifeCell, and
Stephen A. Livesey, M.D., Ph.D., Executive Vice President and Chief Science
Officer of LifeCell. Further, our success is also dependent upon our ability to
hire and retain qualified operating, marketing and technical personnel. The
competition for qualified personnel in the biochemical industry is intense, and
accordingly, there can be no assurance that we will be able to hire or retain
such personnel.
THE BIOMEDICAL FIELD WHICH WE ARE IN IS HIGHLY COMPETITIVE AND SUSCEPTIBLE TO
RAPID CHANGE AND SUCH CHANGES COULD RENDER OUR PRODUCTS OBSOLETE.
The biomedical field is undergoing rapid and significant technological
change. Our success depends upon our ability to develop and commercialize
efficient and effective products based on our technology. There are many
companies and academic institutions that are capable of developing products
based on similar technology, and that have developed and are capable of
developing products based on other technologies, which are or may be competitive
with our products. Many of these companies and academic institutions are
well-established, have substantially greater financial and other resources,
research and development capabilities and more experience in conducting clinical
trials, obtaining regulatory approvals, manufacturing and marketing than us.
These companies and academic institutions may succeed in developing competing
products that are more effective than our products, or that receive government
approvals more quickly than our products, which may render our products or
technology uncompetitive, uneconomical or obsolete.
THE ABILITY TO OBTAIN THIRD-PARTY REIMBURSEMENT FOR THE COSTS OF NEW MEDICAL
TECHNOLOGIES IS LIMITED.
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Generally, hospitals, physicians and other health care providers purchase
products, such as the products being sold or developed by us, for use in
providing care to their patients. These parties typically rely on third-party
payers, including Medicare, Medicaid, private health insurance and managed care
plans, to reimburse all or part of the costs of acquiring those products and
costs associated with the medical procedures performed with those products.
Cost control measures adopted by third-party payers in recent years have had and
may continue to have a significant effect on the purchasing practices of many
health care providers, generally causing them to be more selective in the
purchase of medical products. Significant uncertainty exists as to the
reimbursement status of newly approved health care products. We believe that
certain third-party payers provide reimbursement for medical procedures at a
specified rate without additional reimbursement for products, such as those
being sold or developed by us, used in such procedures. Adequate third-party
payer reimbursement may not be available for us to maintain price levels
sufficient for realization of an appropriate return on our investment in
developing new products. In addition, government and other third-party payers
continue to refuse, in some cases, to provide any coverage for uses of approved
products for indications for which the FDA has not granted marketing approval.
Many uses of AlloDerm have not been granted such marketing approval and there
can be no assurance that any such uses will be approved. Further, certain of
our products are used in medical procedures that typically are not covered by
third-party payers, such as cosmetic procedures, or for which patients sometimes
do not obtain coverage, such as dental procedures. These and future changes in
third-party payer reimbursement practices regarding the procedures performed
with our products could adversely affect the market acceptance of our products.
OUR SUCCESS DEPENDS ON THE SCOPE OF OUR INTELLECTUAL PROPERTY RIGHTS AND NOT
INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. THE VALIDITY,
ENFORCEABILITY AND COMMERCIAL VALUE OF THESE RIGHTS ARE HIGHLY UNCERTAIN.
Our ability to compete effectively with other companies is materially
dependent upon the proprietary nature of our technologies. We rely primarily on
patents and trade secrets to protect our technologies. We currently license the
exclusive right to nine United States patents and related foreign patents and
non-exclusive rights to 14 patents. In addition, we have been issued five
United States utility patents, one United States design patent and have seven
pending United States patent applications. Any patents or proprietary rights
owned by or licensed to us may be challenged, invalidated, circumvented, or
rendered unenforceable based on, among other things:
- subsequently discovered prior art;
- lack of entitlement to the priority of an earlier, related
application; or
- failure to comply with the written description, best mode, enablement
or other applicable requirements.
The invalidation, circumvention or unenforceability of key patents or
proprietary rights owned by or licensed to us could have a material adverse
effect on us.
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In general, the patent position of biotechnology and medical product firms
is highly uncertain, still evolving and involves complex legal, scientific and
factual questions. We are at risk that:
- other patents may be granted with respect to the patent applications
filed by us; and
- any patents issued or licensed to us may not provide commercial
benefit to us or will be infringed, invalidated or circumvented
by others.
The United States Patent and Trademark Office currently has a significant
backlog of patent applications, and the approval or rejection of patents may
take several years. Prior to actual issuance, the contents of United States
patent applications are generally not made public. Once issued, such a patent
would constitute prior art from its filing date, which might predate the date of
a patent application on which we rely. Conceivably, the issuance of such a
prior art patent, or the discovery of "prior art" of which we are currently
unaware, could invalidate a patent of ours or our licensor or prevent
commercialization of a product claimed thereby.
Although we generally conduct a cursory review of issued patents prior to
engaging in research or development activities, we may be required to obtain a
license from others to commercialize any of our new products under development.
If patents that cover our existing or new products are issued to other
companies, there can be no assurance that any necessary license could be
obtained on favorable terms or at all. Any of the foregoing matters could have
a material adverse effect on our financial condition and results of operations.
There can be no assurance that we will not be required to resort to
litigation to protect our patented technologies or other proprietary rights or
that we will not be the subject of additional patent litigation to defend our
existing or proposed products or processes against claims of patent infringement
or other intellectual property claims. Any of such litigation could result in
substantial costs and diversion of resources.
We also have applied for patent protection in several foreign countries.
Because of the differences in patent laws and laws concerning proprietary
rights, the extent of protection provided by United States patents or
proprietary rights owned by or licensed to us may differ from that of their
foreign counterparts.
We may decide for business reasons to retain certain knowledge that we
consider proprietary as confidential and elect to protect such information as a
trade secret, as business confidential information or as know-how. In that
event, we must rely upon trade secrets, know-how and continuing technological
innovation to maintain our competitive position. There can be no assurance that
others will not independently develop substantially equivalent proprietary
information or otherwise gain access to or disclose such information. The
independent development or disclosure of our trade secrets could have a material
adverse effect on our financial condition and results of operations.
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<PAGE>
WE ARE EXPOSED TO PRODUCT LIABILITY CLAIMS FOR WHICH OUR PRODUCT LIABILITY
INSURANCE MAY BE INADEQUATE.
Our business exposes us to potential product liability risks which are
inherent in the testing, manufacturing and marketing of medical products. We
cannot assure that our insurance will provide adequate coverage against
potential liabilities, that adequate product liability insurance will continue
to be available in the future or that it can be maintained on acceptable terms.
The obligation to pay any product liability claim in excess of whatever
insurance we are able to acquire could have a material adverse effect on our
business, financial condition and results of operations.
We use donated human skin as the raw material for our acellular tissue
products. The non-profit organizations that supply such skin are required to
follow FDA regulations and guidelines published by the American Association of
Tissue Banks to screen donors for potential disease transmission. Such
procedures include donor testing for certain viruses, including HIV. Our
manufacturing process also has been demonstrated to inactivate concentrated
suspensions of HIV in tissue. While we believe such procedures are adequate to
reduce the threat of disease transmission, there can be no assurance that our
products will not be associated with transmission of disease or that a patient
otherwise infected with disease would not erroneously assert a claim that the
use of our acellular tissue products resulted in the disease transmission. Any
such transmission or alleged transmission could have a material adverse effect
on our ability to manufacture or market our products or could otherwise have a
material adverse effect on our financial condition and results of operations.
WE ARE SUBJECT TO EXTENSIVE REGULATION REGARDING DISPOSAL OF HAZARDOUS
MATERIALS.
Our research and development and processing techniques generate waste that
is classified as hazardous by the United States Environmental Protection Agency,
the Texas Natural Resources Commission and the New Jersey Natural Resources
Commission. We segregate such waste and dispose of it through licensed
hazardous waste transporters. Although we believe we are currently in
compliance in all material respects with applicable environmental regulations,
our failure to comply fully with any such regulations could result in the
imposition of penalties, fines or sanctions that could have a material adverse
effect on our financial condition and results of operations.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements typically are identified by use of terms such as
"may," "will," "should," "plan," "expect," "anticipate," "estimate" and similar
words, although some forward-looking statements are expressed differently.
Forward-looking statements represent our management's judgment regarding future
events. Although we believe that the expectations reflected in such
forward-looking statements are reasonable, we can give no assurance that such
expectations will prove to be correct. All statements other than statements of
historical fact included in this prospectus regarding our financial position,
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business strategy, products, products under development and clinical trials,
markets, budgets, plans, or objectives for future operations are forward-looking
statements. We cannot guarantee the accuracy of the forward-looking statements,
and you should be aware that our actual results could differ materially from
those contained in the forward-looking statements due to a number of factors,
including:
- competitive factors;
- general economic conditions;
- our ability to develop safe and efficacious products;
- demand for our products and services;
- our ability to enter into future collaborative agreements;
- uncertainty of product development;
- our failure to achieve positive results in clinical trials;
- uncertainty regarding our patents and patent rights (including the
risk that we may be forced to engage in costly litigation to
protect such patent rights and the material harm to us if there were
an unfavorable outcome of any such litigation);
- governmental regulation, approval and suspension;
- technological change;
- pending litigation; and
- changes in industry practices.
You should also consider carefully the statements under "Risk Factors" and
other sections of this prospectus, which address additional factors that could
cause our results to differ from those set forth in the forward -looking
statements. All subsequent written and oral forward-looking statements
attributable to us or persons acting on our behalf are expressly qualified in
their entirety by the applicable cautionary statements. We have no plans to
update these forward-looking statements.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the information requirements of the Exchange Act. We
file annual, quarterly, and current reports, proxy statements, and other
documents with the SEC. You may read and copy any document we file at the SEC's
public reference rooms at the following locations:
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- Main Public Reference Room
Judiciary Plaza Building
450 Fifth Street, N.W.
Washington, D.C. 20549
- Regional Public Reference Room
75 Park Place, 14th Floor
New York, New York 10007
You may obtain information on the operation of the SEC's public reference
rooms by calling 1-800-SEC-0330. We are required to file these documents with
the SEC electronically. You can access the electronic versions of these filings
at the SEC's website, located at www.sec.gov.
-----------
This prospectus is part of a registration statement that we filed with the
SEC. The registration statement contains more information than this prospectus
regarding LifeCell and its common stock, including certain exhibits. You can
get a copy of the registration statement from the SEC at the address listed
above or from its web site.
The SEC allows us to "incorporate" into this prospectus information we file with
it in other documents. This means that we can disclose important information to
you by referring to other documents that contain that information. The
information incorporated by reference is considered to be part of this
prospectus, and information we file later with the SEC will automatically update
and supersede this information. For further information about the Company and
our common stock, you should refer to the registration statement and the
following documents which we are incorporating by reference except to the extent
information in those documents is different from the information contained in
this prospectus:
- Our Annual Report on Form 10-K for the year ended December 31, 1999;
- Our Quarterly Reports on Form 10-Q for the quarters ended March 31
and June 30, 2000;
- Our Current Reports on Form 8-K filed with the SEC on July 7, 2000
and September 5, 2000;
- Our definitive Proxy Statement for our 2000 Annual Meeting of
Stockholders;
- The description of our common stock set forth in our registration
statement filed pursuant to Section 12 of the Exchange Act and any
amendment or report filed for the purpose of updating such
description; and
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- All documents we file pursuant to Sections 13(a), 13(c), 14 and
15(d) of the Securities Exchange Act after the date of this
prospectus until we terminate the offering of these shares.
We will provide without charge to each person, including any beneficial
owner of common stock to whom this prospectus is delivered, upon written or oral
request of such person, a copy of any and all of the documents that have been
incorporated by reference in this prospectus (not including exhibits to such
documents unless such exhibits are specifically incorporated by reference
therein). Requests for such copies should be directed to: LifeCell Corporation,
1 Millennium Way, Branchburg, NJ 08876, Attention: Secretary (telephone (908)
947-1106).
You should rely only on the information contained or incorporated by
reference in this document. We have not authorized anyone to provide you with
information that is different. The common stock is not being offered in any
state where the offer is not permitted. You should not assume that the
information in this prospectus is accurate as of any date other than the date on
the front of this prospectus.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the common stock
by the selling stockholders named in this prospectus. All proceeds from the
sale of the common stock will be paid directly to the selling stockholders.
SELLING STOCKHOLDERS
The shares are being registered to permit public secondary trading of the
shares, and the selling stockholders, or their pledgees, donees, transferees or
other successors-in interest, may offer all or any portion of the shares for
resale from time to time. See "Plan of Distribution."
We have filed with the Commission under the Securities Act a registration
statement on Form S-3, of which this prospectus forms a part, relating to the
resale of the shares. We have agreed to pay expenses in connection with the
registration and sale of the shares being offered by the selling stockholders.
See "Plan of Distribution."
Agreements with the Selling Stockholders
--------------------------------------------
On September 1, 2000, we and the selling stockholders, other than
Medtronic, Inc., entered into a series of purchase agreements under which we
sold 2,500,000 shares of our common stock to such selling stockholders in a
private placement. In consideration for the issuance of the common stock, such
selling stockholders paid us an aggregate of $10,000,000 in cash. We are
registering the shares of common stock purchased by such selling stockholders as
a condition to the purchase of such shares of common stock.
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<PAGE>
In March 1994, we entered into a License and Development Agreement with
Medtronic, Inc. to jointly develop our heart valve products. Under the
agreement, Medtronic paid us an initial $1.5 million license fee. Under the
agreement, Medtronic funded a part of our cost of research and development, had
the exclusive right to market any resulting commercial products and agreed to
pay us royalties on sales of products covered by the agreement. During 1996,
1997 and 1998, Medtronic funded $546,460, $217,854 and $59,519 of our research
and development costs. In December 1998, we and Medtronic mutually agreed to
terminate the agreement and we regained all rights to our cardiovascular
technology. As a result of the termination, we issued 310,771 shares of our
common stock to Medtronic and granted Medtronic registration rights with respect
to such shares of our common stock. James G. Foster, one of our directors,
serves as a Vice President of Medtronic. Medtronic has exercised its right to
require us to include these shares of common stock owned by Medtronic for resale
in this offering.
Based on information provided by the selling stockholders, the following
table lists:
- the name of the selling stockholders;
- the number of shares of common stock beneficially owned before the
commencement of the offering;
- the number of shares of common stock offered for resale in this offering;
and
- the number of shares and percentage of common stock owned after this
offering, assuming the sale of all shares offered in this offering by each
selling stockholder.
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<PAGE>
<TABLE>
<CAPTION>
Number of
Shares of Common stock beneficially
Common owned after the offering
Stock ------------------------
Selling Beneficially Shares Being Number Percent of
Stockholders Owned Offered of Shares Outstanding
-------------------------- ------------- ------------ --------- ------------
<S> <C> <C> <C> <C>
Special Situations Fund
III, L.P. 625,000 625,000 0 0
Special Situations Private
Equity Fund, L.P. 412,500 412,500 0 0
Special Situations
Cayman Fund, L.P. 212,500 212,500 0 0
HSBC Global Investor
Services, as Trustee for
Framlington Health Fund 512,500 512,500 0 0
Bay Star Capital, LP 300,000 300,000 0 0
Bay Star International,
Ltd. 75,000 75,000 0 0
Foundation Partners, L.P. 137,500 137,500 0 0
Active Site Partners, L.P. 67,500 50,000 17,500 *
Meriken Nominees Ltd. 40,000 40,000 0 0
Ashton Partners 35,000 35,000 0 0
Narragansett Offshore,
Ltd. 28,500 28,500 0 0
Narragansett I, LP 21,500 21,500 0 0
Lawrence S. Doyle 25,000 25,000 0 0
Carl Goldfischer 25,000 25,000 0 0
Medtronic, Inc. 655,962(1) 310,771 345,191 2.1%
<FN>
_____________________
* Less than 1%
(1) Includes 345,191 shares of common stock registered in the name of Bank
of America. Medtronic has sole voting power with respect to these
shares of common stock.
</TABLE>
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<PAGE>
PLAN OF DISTRIBUTION
The selling stockholders, their pledgees, donees, transferees or other
successors-in-interest, may from time to time, sell all or a portion of the
shares in privately negotiated transactions or otherwise, at fixed prices that
may be changed, at market prices prevailing at the time of sale, at prices
related to these market prices or at negotiated prices.
The shares may be sold by the selling stockholders by one or more of the
following methods:
- a block trade in which the broker or dealer so engaged will attempt
to sell the shares as agent but may position and resell a portion of
the block as principal to facilitate the transaction;
- purchases by a broker or dealer as principal and resale by such
broker or dealer for its account pursuant to this prospectus;
- an exchange distribution in accordance with the rules of the
applicable exchange;
- ordinary brokerage transactions and transactions in which the broker
solicits purchasers;
- privately negotiated transactions;
- short sales;
- a combination of any such methods of sale; and
- any other method permitted pursuant to applicable law.
The selling stockholders are not restricted as to the price or prices at
which they may sell their shares. Sales of shares by the selling stockholders
may depress the market price of our common stock since the number of shares
which may be sold by the selling stockholders are relatively large compared to
the historical average weekly trading of our common stock. Accordingly, if the
selling stockholders were to sell, or attempt to sell, all of such shares at
once or during a short time period, we believe such transactions could adversely
affect the market price of our common stock.
From time to time the selling stockholders may engage in short sales, short
sales against the box, puts and calls and other transactions in our securities
or derivatives of our securities, and can sell and deliver the shares in
connection with any of these transactions or in settlement of securities loans.
From time to time the selling stockholders may pledge their shares under margin
provisions of their customer agreements with their brokers. Upon a default by
the selling stockholders, the broker may offer and sell the pledged shares from
time to time.
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In effecting sales, brokers and dealers engaged by the selling stockholders
may arrange for other brokers or dealers to participate in the sale. Brokers or
dealers may receive commissions or discounts from the selling stockholders or,
if the broker-dealer acts as agent for the purchaser of such shares, from the
purchaser in amounts to be negotiated. Broker-dealers may agree with the selling
stockholders to sell a specified number of such shares at a stipulated price per
share, and to the extent the broker-dealer is unable to do so acting as agent
for the selling stockholders, to purchase as principal any unsold shares at the
price required to fulfill the broker-dealer commitment to the selling
stockholders. Broker-dealers who acquire shares as principal may then resell
those shares from time to time in transactions:
- in the over-the counter market or otherwise;
- at prices and on terms then prevailing at the time of sale;
- at prices then related to the then-current market price; or
- in negotiated transactions.
These resales may involve block transactions or sales to and through other
broker-dealers, including any of the transactions described above. In connection
with these sales, these broker-dealers may pay to or receive from the purchasers
of those shares commissions as described above. The selling stockholders may
also sell the shares under Rule 144 under the Securities Act, rather than under
this prospectus.
The selling stockholders and any broker-dealers or agents that participate
with the selling stockholders in sales of the shares may be deemed to be
"underwriters" within the meaning of the Securities Act in connection with these
sales. In this event, any commissions received by these broker-dealers or agents
and any profit on the resale of the shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act. Because selling
stockholders may be deemed to be "underwriters" within the meaning of the
Securities Act, the selling stockholders will be subject to the prospectus
delivery requirements of the Securities Act.
We are required to pay all fees and expenses incident to the registration
of the shares. We have agreed to indemnify the selling stockholders against
certain losses, claims, damages and liabilities, including liabilities under the
Securities Act. The selling stockholders may agree to indemnify any agent,
dealer or broker-dealer that participates in transactions involving sales of the
shares against certain liabilities, including liabilities arising under the
Securities Act. The selling stockholders will be required to pay commissions
and brokerage expenses on their sales, if any.
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<PAGE>
At the time a particular offer of shares is made, to the extent required, a
supplement to this prospectus will be distributed which will identify and set
forth the following:
- the names of the selling stockholders;
- the number of shares being sold;
- the price;
- commissions being paid;
- that there has been no investigation by broker-dealer; and
- any other facts material to the transaction.
The selling stockholders are subject to applicable provisions of the
Exchange Act and the Commission's rules and regulations, including Regulation M,
which provisions may limit the timing of purchases and sales of the shares by
the selling stockholders. We will make copies of this prospectus available to
the selling stockholders and have informed them of the need to deliver copies of
this prospectus to purchasers at or prior to the time of any sale of the shares.
In order to comply with certain states' securities laws, if applicable, the
shares may be sold in those jurisdictions only through registered or licensed
brokers or dealers. In certain states the shares may not be sold unless the
shares have been registered or qualified for sale in such state, or unless an
exemption from registration or qualification is available and is obtained.
LEGAL MATTERS
The validity of the securities offered hereby have been passed upon for us
by Lowenstein Sandler PC, Roseland, New Jersey.
EXPERTS
The audited financial statements incorporated by reference in this
prospectus and elsewhere in the registration statement, to the extent and for
the periods indicated in their report, have been audited by Arthur Andersen LLP,
independent certified public accountants, and are incorporated herein in
reliance upon the authority of said firm as experts in accounting and auditing
in giving said report.
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<PAGE>
Prospective investors may rely only on the information contained in this
prospectus. LifeCell Corporation has not authorized anyone to provide
prospective investors with information different from that contained in this
prospectus. This prospectus is not an offer to sell nor is it seeking an offer
to buy these securities in any jurisdiction where the offer or sale is not
permitted. The information contained in this prospectus is correct only as of
the date of this prospectus, regardless of the time of the delivery of this
prospectus or any sale of these securities.
LIFECELL CORPORATION
2,810,771 SHARES OF COMMON STOCK
PROSPECTUS
________, 2000
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table lists the expenses which will be incurred by the
issuance and distribution of the common stock being registered.
Expense
---------
Securities and Exchange Commission
Registration Fee $ 3,641
Accounting Fees and Expenses 5,000
Legal Fees and Expenses 10,000
Miscellaneous 1,359
---------
Total $ 20,000
=========
All of the above amounts, other than the SEC filing fee, are estimates
only. All of the above expenses will be paid by the Company.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law ("GCL") provides
generally that a person sued as a director, officer, employee or agent of a
corporation may be indemnified by the corporation in nonderivative suits for
expenses (including attorneys' fees), judgments, fines and amounts paid in
settlement if such person acted in good faith and in a manner he or she
reasonably believed to be in or not opposed to the best interests of the
corporation. In the case of criminal actions and proceedings, such person must
have had no reasonable cause to believe his or her conduct was unlawful.
Indemnification of expenses is authorized in stockholder derivative suits where
such person acted in good faith and in a manner reasonably believed to be in or
not opposed to the best interests of the corporation and so long as he or she
had not been found liable for negligence or misconduct in the performance of his
or her duty to the corporation. Even in this latter instance, the court may
determine that in view of all the circumstances such person is entitled to
indemnification for such expenses as the court deems proper. A person sued as a
director, officer, employee or agent of a corporation who has been successful in
defense of the action must be indemnified by the corporation against expenses.
Article Seventh (B) of the Company's Restated Certificate of Incorporation,
as amended provides that:
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<PAGE>
The Corporation shall indemnify any director or officer to the full
extent permitted by Delaware law.
Article Seventh (A) of the Company's Restated Certificate of
Incorporation, as amended provides that:
A director of the Corporation shall not be personally liable to the
Corporation or its stockholders for monetary damages for breach of
fiduciary duty as a director, except for liability (i) for any breach of
the director's duty of loyalty to the Corporation or its stockholders, (ii)
for acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under Section 174 of the
Delaware General Corporation Law, or (iv) for any transaction from which
the director derived an improper personal benefit. If the Delaware General
Corporation Law hereafter is amended to authorize the further elimination
or limitation of the liability of directors, then the liability of a
director of the Corporation, in addition to the limitation on personal
liability provided herein, shall be limited to the fullest extent permitted
by the amended Delaware General Corporation Law. Any repeal or modification
of this paragraph by the stockholders of the Corporation shall be
prospective only, and shall not adversely affect any limitation on the
personal liability of a director of the Corporation existing at the time of
such repeal or modification.
Article X of the Company's Amended and Restated By-Laws provides that:
Third Party Actions. The corporation shall indemnify any person who
was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of
the corporation) 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 or agent 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 proceeding,
had no reasonable cause to believe his conduct was unlawful. The
termination of any action, suit or proceeding by judgment, order,
settlement or conviction, or upon a plea of NOLO CONTENDERE or its
equivalent, shall not, of itself, create a presumption that the person did
not act in good faith and in a manner which he reasonably believed to be in
or not opposed to the best interests of the corporation, and, with respect
to any criminal action or proceeding, had reasonable cause to believe that
his conduct was unlawful.
Actions by or in the Right of the Corporation. The corporation shall
indemnify any person who was or is a party or is threatened to be made a
party to any threatened, pending or completed action or suit by or in the
right of the corporation to procure a judgment in its favor 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 or agent of another corporation, partnership,
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<PAGE>
joint venture, trust or other enterprise against expenses (including
attorneys' fees) actually and reasonably incurred by him in connection with
the defense or settlement of such action or suit 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 except that 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 or the court in which such action or suit
was brought shall determine upon application that, despite the adjudication
of liability but in view of all the circumstances of the case, such person
is fairly and reasonably entitled to indemnity for such expenses which the
Court of Chancery or such other court shall deem proper.
Mandatory Indemnification. To the extent that a director, officer,
employee or agent of the corporation has been successful on the merits or
otherwise in defense of any action, suit or proceeding referred to in
Sections 10.01 and 10.02, or in defense of any claim, issue or matter
therein, he shall be indemnified against expenses (including attorneys'
fees) actually and reasonably incurred by him in connection therewith.
Determination of Conduct. The determination that a director,
officer, employee or agent has met the applicable standard of conduct set
forth in Sections 10.01 and 10.02 (unless indemnification is ordered by a
court) shall be made (a) by the Board of Directors by a majority vote of a
quorum consisting of directors who were not parties to such action, suit or
proceeding, or (b) if such quorum is not obtainable, or, even if obtainable
a quorum of disinterested directors so directs, by independent legal
counsel in a written opinion, or (c) by the stockholders.
Payment of Expenses in Advance. Expenses incurred in defending
a civil or criminal action, suit or proceeding shall be paid by the
corporation in advance of the final disposition of such action, suit or
proceeding upon receipt of an undertaking by or on behalf of the director,
officer, employee or agent to repay such amount if it shall ultimately be
determined that he is not entitled to be indemnified by the corporation as
authorized in this Article X.
Indemnity Not Exclusive. The indemnification and advancement of
expenses provided by or granted pursuant to, the other sections of this
Article X shall not be deemed exclusive of any other rights to which those
seeking indemnification or advancement of expenses may be entitled under
the Restated Certificate of Incorporation, any other by-law, agreement,
vote of stockholders or disinterested directors or otherwise, both as to
action in his official capacity and as to action in another capacity while
holding such office.
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ITEM 16. EXHIBITS
The following exhibits are filed as part of this Registration Statement:
4.1* Restated Certificate of Incorporation of the Company, as amended.
4.2** By-laws of the Company, as amended and restated.
4.3*** Form of Certificate evidencing ownership of the Company's Common
Stock.
5.1 Opinion of Lowenstein Sandler PC.
23.1 Consent of Independent Public Accountants.
23.2 Consent of Lowenstein Sandler PC is included in Exhibit 5.1.
* Incorporated by reference to Exhibit 3.1 to the Company's Quarterly
Report on Form 10-Q for the period ended June 30, 1998.
** Incorporated by reference to Exhibit 3.2 to the Company's Quarterly
Report on Form 10-Q for the period ended June 30, 1996.
*** Incorporated by reference to Exhibit 4.1 to the Company's Registration
Statement on Form S-1 (File No. 33-44969).
ITEM 17. UNDERTAKINGS
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the
information set forth in the registration statement.
Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed
with the 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.
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<PAGE>
(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.
(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.
The undersigned Company hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the Company's
annual report pursuant to Section 13(a) or Section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the Registration Statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
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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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 or amendment thereto to be signed on its behalf by the undersigned,
thereunto duly authorized, in the Township of Branchburg on the 5th day of
September, 2000.
LIFECELL CORPORATION
/s/ Steven T. Sobieski
----------------------------
By: Steven T. Sobieski
Vice President and Chief
Financial Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears
below under the heading "Signature" constitutes and appoints Paul G. Thomas and
Steven T. Sobieski or either of them, his true and lawful attorney-in-fact and
agent with full power of substitution and resubstitution, for him and in his
name, place and stead, in any and all capacities to sign any or all amendments
(including post-effective amendments) to this Registration Statement and any
related Registration Statement filed under Rule 462(b), and to file the same,
with all exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents, each acting alone, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the
premises, as fully for all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said attorneys-in-fact and
agents, each acting alone, or his substitute or substitutes, may lawfully do or
cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this Registration
Statement or amendment thereto has been signed by the following persons in the
capacities and on the dates indicated.
Name Title Date
---- ----- ----
/s/ Paul G. Thomas President and Chief Executive September 5, 2000
-----------------------
Paul G. Thomas Officer and Director
/s/ Steven T. Sobieski Vice President and September 5, 2000
-----------------------
Steven T. Sobieski Chief Financial Officer
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/s/ Stephen A. Livesey Executive Vice President September 5, 2000
-----------------------
Stephen A. Livesey and Director
/s/ Michael E. Cahr Director September 5, 2000
-----------------------
Michael E. Cahr
/s/ James G. Foster Director September 5, 2000
-----------------------
James G. Foster
/s/ David A. Thompson Director September 5, 2000
-----------------------
David A. Thompson
/s/ Peter D. Costantino Director September 5, 2000
-----------------------
Peter D. Costantino
/s/ K. Flynn McDonald Director September 5, 2000
-----------------------
K. Flynn McDonald
II-7
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