AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 11, 2000
REGISTRATION NO. 333-45180
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
AMENDMENT NO. 1 TO
FORM S-3
______________
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF 1933
_______________________
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. [_]
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 OCTOBER 11, 2000
PROSPECTUS
LIFECELL CORPORATION
2,810,771 SHARES
COMMON STOCK
The selling stockholders listed on page 21 are offering for resale
2,810,771 shares of our common stock under this prospectus.
Our common stock is listed on the Nasdaq National Market under the symbol
"LIFC". On October 10, 2000, the closing price of the common stock on the
Nasdaq National Market was $4.43 per share.
_____________________
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.
_____________________
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. . . . . . . . . . . . . 17
Where You Can Find More Information. . . . . . . . . . . . . . . . . . . . 17
Use of Proceeds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Selling Stockholders. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Plan of Distribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Legal Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Experts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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THE COMPANY
LifeCell Corporation develops and markets biologic solutions for the
repair, replacement and preservation of human tissue. Our core technology
removes all cells from the tissue and preserves the tissue without damaging the
essential biochemical and structural components necessary for normal tissue
regeneration. We currently market three products based on this technology:
AlloDerm(R) for the plastic reconstructive, burn and dental markets; Cymetra a
version of AlloDerm(R) for the plastic reconstructive and dermatology markets;
and Repliform for the urology and gynecology markets. Our product development
programs include the use of small diameter blood vessel grafts produced by us as
an alternative to blood vessel grafts taken from the patient, orthopedic
applications of our technology, 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. In addition to the following risks, there may also be
risks that we do not yet know of or that we currently think are immaterial that
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 for the year ended December 31, 1997;
- $7.3 million for the year ended December 31, 1998;
- $9.2 million for the year ended December 31, 1999;
- $4.2 million for the six months ended June 30, 1999; and
- $3.3 million for the six months ended June 30, 2000.
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 in the short term as we continue 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 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 funds for:
- product research and development;
- expansion of sales and marketing activities;
- product education efforts; and
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- 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;
- the cost of maintaining, enforcing and defending patents and other
intellectual property rights;
- competing technological and market developments; and
- developments related to regulatory and third-party reimbursement
matters.
We expect that our current resources, including the funds received in our
private placement in October 2000, will satisfy our cash needs for at least the
next 12 months. However, operating and other expenses incurred by us could
increase because of the factors set forth above. As a result, we may need
additional capital to operate our business sooner than expected. 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. 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. 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.
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THE UNITED STATES FOOD AND DRUG ADMINISTRATION MAY IMPOSE ENFORCEMENT SANCTIONS
IF WE FAIL TO COMPLY WITH APPLICABLE FDA REGULATIONS.
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.
IF THE FDA IMPOSES MEDICAL DEVICE OR OTHER REGULATIONS THAT AFFECT OUR PRODUCTS,
THE COSTS OF DEVELOPING, MANUFACTURING AND MARKETING OUR PRODUCTS WILL BE
INCREASED.
The FDA generally permits transplanted human tissue to be commercially
distributed without obtaining prior FDA approval of the product. 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, tissue that lines or covers the body and its
compartments or cavities, would be regulated as transplanted human tissue. On
that basis, we began commercial distribution of this product for the treatment
of burns, periodontal surgery and plastic reconstructive surgery procedures,
without prior FDA approval. In its decision with respect to the regulation of
AlloDerm, the FDA stated that the regulatory status of any different uses, such
as a void filler for soft tissue, for cosmetic augmentation procedures or as a
wound healing agent, would need to be determined on a case-by-case basis.
In recent months, we began marketing:
- Cymetra, a version of AlloDerm in a particulate form, for non-surgical
plastic reconstructive procedures; and
- Repliform, a version of AlloDerm, for urological and gynecological
surgical procedures.
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Cymetra is used for the correction of soft tissue deficits, such as acne or
other depressed scars, and to restore tissue loss from disease. Repliform is
used as a bladder sling for the treatment of urinary incontinence and for the
repair of pelvic floor defects. We believe that both Cymetra and Repliform are
forms of AlloDerm that are used for the repair or replacement of damaged or
inadequate integumental tissue and that these products meet the regulatory
definition of human tissue. We also believe that Cymetra and Repliform have not
been manipulated in such a way that would require regulation as a medical
device. As a result, we have not sought a determination from the FDA as to
whether these products are medical devices. There is a risk that the FDA could
determine that AlloDerm, Repliform or Cymetra should be regulated as a medical
device. If so, the FDA could require us to:
- cease marketing and/or recall product already sold; and/or
- seek FDA approval for these products.
The process of obtaining FDA approval may be expensive, lengthy and
unpredictable. We anticipate that it could take from one to three years to
obtain such approval. We do not know if such approval could be obtained in a
timely fashion, or at all, or if the FDA would require extensive supporting
clinical data. In addition, the FDA also could seek to impose enforcement
sanctions for marketing these products without FDA approval and could require us
to cease marketing and/or recall products already sold.
In the United States, devices and biologics, such as ThromboSol, our
proposed blood cell preservation product, must be:
- manufactured in registered establishments; and
- produced in accordance with the Quality System Regulation for medical
devices or Good Manufacturing Practice regulation 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 Practice
regulation. We anticipate that it could take us up to one year, or longer, to
achieve compliance with these regulations during which time the FDA could
require us to cease marketing and/or recall product already sold. In addition,
our manufacturing facility:
- would need to be registered as a medical device manufacturing site
with the FDA; and
- would be subject to inspection by the FDA.
As a result, our manufacturing and compliance costs would increase and our
products would be subject to more comprehensive development, testing, monitoring
and validation standards.
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The FDA requires producers of biologic products to obtain 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 licenses that could restrict
commercial applications of such products. Product approvals may be withdrawn if
compliance with regulatory standards is 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.
THE FDA CAN IMPOSE CIVIL AND CRIMINAL ENFORCEMENT ACTIONS AND OTHER PENALTIES ON
US IF WE FAIL TO COMPLY WITH STRINGENT FDA REGULATIONS AT OUR TISSUE FACILITIES.
Failure to comply with any applicable FDA requirements could result in
civil and criminal enforcement actions and other penalties that would increase
our expenses and adversely affect our cash flows. 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
are 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 which
may require us to alter our business methods.
THE NATIONAL ORGAN TRANSPLANT ACT COULD BE INTERPRETED IN A WAY THAT COULD
REDUCE OUR REVENUES AND PROFITABILITY.
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The National Organ Transplant Act prohibits the acquisition, receipt or
transfer of certain human organs, including skin and heart valves and blood
vessel 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. The National Organ Transplant Act
payment allowances may be interpreted to exclude 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.
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 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 distributed in Brazil, Italy, Korea, Mexico,
Taiwan, the Netherlands and the United Kingdom and we are pursuing clearance to
distribute Cymetra in Brazil and Korea. The uncertainty of the regulations in
each country may delay or impede the marketing of AlloDerm or Cymetra and other
products in the future 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 our ability to export or distribute
our products to licensed not-for-profit organizations in those countries.
Noncompliance with foreign country requirements may include some or all of the
risks associated with noncompliance with FDA regulation as well as other risks.
INCREASING OUR REVENUES AND ACHIEVING PROFITABILITY WILL DEPEND ON OUR ABILITY
TO INCREASE MARKET PENETRATION OF OUR CURRENT PRODUCTS AND TO DEVELOP AND
COMMERCIALIZE NEW PRODUCTS.
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, physicians, health care payers and patients
may not accept our current products or products under development. 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
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acceptance. Moreover, health care payers' approval of reimbursement for our
products in development may be an important factor in establishing market
acceptance.
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. 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:
- 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 HIGHLY DEPENDENT UPON SALES OF OUR PRODUCTS THROUGH BOSTON SCIENTIFIC,
OBAGI MEDICAL PRODUCTS AND OUR OTHER INDEPENDENT AGENTS TO GENERATE OUR
REVENUES.
We have engaged:
- Boston Scientific Corporation as our exclusive worldwide sales and
marketing representative for Repliform for use in the urology and
gynecology markets; and
- Obagi Medical Products, Inc. as the exclusive sales and marketing
representative of Cymetra for office-based dermatologists and plastic
surgeons.
We have granted other distributors exclusive distribution rights and may grant
additional exclusive distribution rights in the future. During the year ended
December 31, 1999 and six months ended June 30, 2000, sales of our products
through independent agents and distributors represented approximately 18% and
46%, respectively, of our total product revenues. During such periods, sales of
our products through Boston Scientific and Obagi represented approximately 4%
and 33%, respectively, of our total product revenues. We expect sales of our
products through such independent agents to continue to increase as a percentage
of total revenues. If an exclusive agent, especially Boston Scientific or
Obagi, fails adequately to promote, market and sell our products, our revenues
could be adversely affected until a replacement agent or distributor could be
retained by us. Finding replacement agents and distributors could be a time
consuming process during which our revenues could be negatively impacted.
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WE DEPEND HEAVILY UPON A LIMITED NUMBER OF SOURCES OF HUMAN TISSUE AND ANY
INTERRUPTION IN THE AVAILABILITY OF HUMAN TISSUE WOULD INTERFERE WITH OUR
ABILITY TO PROCESS AND DISTRIBUTE OUR PRODUCTS.
Our business is dependent on the availability of donated human tissue. In
1999, we received all of our human tissue from 19 United States tissue banks.
Although we have established what we believe to be adequate sources of donated
human tissue to satisfy the expected demand for our products in the foreseeable
future, we cannot be sure that donated human tissue will continue to be
available at current levels or will be sufficient to meet our needs. If our
current sources can no longer supply human tissue or our requirements for human
tissue exceed their current capacity, we may not be able to locate other
sources. Any significant interruption in the availability of human tissue would
likely cause us to slow down the processing and distribution of our products.
We have performed limited activities to develop products using animal
tissue as a substitute for donated human tissue. If successfully developed,
animal tissue could replace the need for human tissue as a raw material. There
can be no assurance that:
- animal tissue products can be successfully developed;
- 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
- the cost of such animal tissue would not increase our expenses.
NEGATIVE PUBLICITY CONCERNING THE USE OF DONATED HUMAN TISSUE IN COSMETIC
PROCEDURES COULD REDUCE THE DEMAND FOR OUR PRODUCTS AND MAY NEGATIVELY IMPACT
THE SUPPLY OF AVAILABLE DONOR TISSUE.
Although we do not promote the use of Cymetra or AlloDerm for cosmetic
applications, clinicians may use our products in applications or procedures that
may be considered "cosmetic." Negative publicity concerning the use of donated
human tissue in cosmetic procedures could reduce the demand for our products or
negatively impact the willingness of families of potential donors to agree to
donate tissue.
THE BIOMEDICAL FIELD WHICH WE ARE IN IS HIGHLY COMPETITIVE AND SUSCEPTIBLE TO
RAPID CHANGE AND SUCH CHANGES COULD RENDER OUR PRODUCTS OBSOLETE.
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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 technologies. 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, and 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 we do.
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.
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.
Third-party payers have adopted cost control measures in recent years that 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.
The FDA has not granted marketing approval for many uses of AlloDerm and there
can be no assurance that the FDA will approve such uses. Further, certain of
our products are used in medical procedures that typically are not covered by
third-party payers or for which patients sometimes do not obtain coverage.
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.
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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 one United States design patent and five United
States utility patents, and
- have seven United States patent applications pending.
Third parties may seek to challenge, invalidate, circumvent or render
unenforceable any patents or proprietary rights owned by or licensed to us 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.
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.
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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.
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 our 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.
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;
- adequate product liability insurance will continue to be available in
the future; or
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- our insurance 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
financial condition and results of operations.
We use donated human tissue as the raw material for some of our products.
The non-profit organizations that supply such tissue 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
- a patient otherwise infected with disease would not erroneously assert
a claim that the use of our 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.
OUR FAILURE TO COMPLY WITH REGULATIONS REGARDING DISPOSAL OF HAZARDOUS MATERIALS
COULD RESULT IN THE IMPOSITION OF PENALTIES, FINES OR SANCTIONS.
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.
WE ARE A PARTY TO PENDING LITIGATION AND ADVERSE RESULTS OF SUCH LITIGATION
MATTER COULD NEGATIVELY IMPACT OUR FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
We were a party to litigation in the Superior Court of California, San
Bernardino 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 persons whose tissues were collected,
processed, stored or distributed in California. The complaint alleged 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 alleged 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
~16~
<PAGE>
enjoin the defendants, including us, from doing business in California was
denied in June 2000 and the complaint was voluntarily dismissed in September
2000. Later that month, a new complaint, with substantially similar allegations
about profiting from the storing, processing and distribution of human tissue,
but without the class action allegations was filed in Los Angeles County. The
plaintiff seeks injunctive relief, disgorgement of illegal profits, restitution,
statutory penalties, fines and attorney's fees. We have not yet been served
with that complaint.
If served, we intend to vigorously defend such action, which we believe is
without merit. Our defense of such action could result in substantial costs and
diversion of our resources.
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,
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 the statements under "Risk Factors" set forth above. 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.
WHERE YOU CAN FIND MORE INFORMATION
~17~
<PAGE>
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:
- 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,
September 6, 2000 and September 26, 2000;
- Our definitive Proxy Statement for our 2000 Annual Meeting of
Stockholders filed on Schedule 14A filed with the SEC on April 28,
2000;
- The description of our common stock set forth in our registration
statement on Form 8-A filed pursuant to Section 12 of the Exchange Act
and declared effective by the SEC on February 27, 1992 and any
amendment or report filed for the purpose of updating such
description; and
- 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).
~18~
<PAGE>
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.
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.
~19~
<PAGE>
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.
~20~
<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>
~21~
<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 selling stockholders may sell the shares 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 is 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.
~22~
<PAGE>
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.
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:
~23~
<PAGE>
- 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
selling stockholders may sell the shares in those jurisdictions only through
registered or licensed brokers or dealers. In certain states the selling
stockholders may not sell the shares 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.
~24~
<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
~25~
<PAGE>
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 25,000
Legal Fees and Expenses 25,000
Miscellaneous 1,359
---------
Total $ 55,000
=========
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:
<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.
II~2
<PAGE>
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,
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.
II~3
<PAGE>
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.
10.1 Form of Purchase Agreement between the Company and the selling
stockholders
23.1 Consent of Independent Public Accountants.
23.2+ Consent of Lowenstein SandlerPC is included in Exhibit 5.1.
_________________________
+ Previously filed
* 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.
II~4
<PAGE>
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.
(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.
II~5
<PAGE>
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 11th day of
October, 2000.
LIFECELL CORPORATION
/s/ Steven T. Sobieski
------------------------------
By: Steven T. Sobieski
Vice President and Chief
Financial Officer
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.
<TABLE>
<CAPTION>
Name Title Date
---- ----- ----
<S> <C> <C>
* President and Chief Executive October 11, 2000
----------------------------------
Paul G. Thomas Officer and Director
/s/ Steven T. Sobieski Vice President and October 11, 2000
----------------------------------
Steven T. Sobieski Chief Financial Officer
* Executive Vice President October 11, 2000
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Stephen A. Livesey and Director
* Director October 11, 2000
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Michael E. Cahr
* Director October 11, 2000
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James G. Foster
* Director October 11, 2000
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David A. Thompson
II~6
<PAGE>
* Director October 11, 2000
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Peter D. Costantino
* Director October 11, 2000
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K. Flynn McDonald
/s/ Steven T. Sobieski October 11, 2000
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By: Steven T. Sobieski
Attorney-In-Fact
</TABLE>
II~7
<PAGE>