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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON SEPTEMBER 21, 2000
REGISTRATION NO.
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U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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REGISTRATION STATEMENT
FILED ON FORM S-3
UNDER THE SECURITIES ACT OF 1933
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ORTEC INTERNATIONAL, INC.
(NAME OF ISSUER IN ITS CHARTER)
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DELAWARE 11-3068704
(STATE OR OTHER (I.R.S. EMPLOYER
JURISDICTION OF IDENTIFICATION NUMBER)
INCORPORATION)
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3960 BROADWAY, NEW YORK, NEW YORK 10032 (212) 740-6999
(ADDRESS AND TELEPHONE NUMBER OF PRINCIPAL EXECUTIVE OFFICES)
DR. STEVEN KATZ
PRESIDENT AND CHIEF EXECUTIVE OFFICER
ORTEC INTERNATIONAL, INC.
3960 BROADWAY, NEW YORK, NEW YORK 10032 (212) 740-6999
(NAME, ADDRESS AND TELEPHONE NUMBER OF AGENT FOR SERVICE)
-----------------
COPIES TO:
GABRIEL KASZOVITZ, ESQ.
GEOFFREY A. BASS, ESQ.
FEDER, KASZOVITZ, ISAACSON, WEBER, SKALA & BASS LLP
750 LEXINGTON AVENUE, NEW YORK, NEW YORK 10022-1200
(212) 888-8200
FAX: (212) 888-7776
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Approximate date of proposed sale to the public: Not applicable.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
<PAGE>
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, other than securities offered only in connection with dividend
or interest reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to
Rule 434, please check the following box. [ ]
ii
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CALCULATION OF REGISTRATION FEE
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========================================================================================================
PROPOSED
TITLE OF EACH CLASS OF PROPOSED AGGREGATE AMOUNT OF
SECURITIES BEING AMOUNT TO BE OFFERING PRICE OFFERING REGISTRATION
REGISTERED REGISTERED PER SECURITY (1) PRICE(1) FEE (1)
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Common Stock, par value 1,247,566 $8.15625(2) $10,175,460 $2,687
$.001 per share Shares
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(1) Estimated solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457.
(2) Represents the average of the high and low sales prices of the Common Stock
for September 19, 2000 as reported by the Nasdaq Stock Market.
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 AN AMENDMENT THAT 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 SECURITIES AND EXCHANGE COMMISSION
(THE "COMMISSION"), ACTING PURSUANT TO SECTION 8(a),
MAY DETERMINE.
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ORTEC INTERNATIONAL, INC.
1,247,566 SHARES OF COMMON STOCK
This prospectus covers 1,100,000 shares of common stock, par value
$.001 per share, for sale by our shareholders. Our common stock is traded on the
NASDAQ Stock Market under the symbol "ORTC." On , 2000, the last
reported sale price of the common stock was $ .
----------------
SEE "RISK FACTORS" BEGINNING ON PAGE 7 FOR
INFORMATION THAT SHOULD BE CONSIDERED BY PROSPECTIVE INVESTORS.
----------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION, NOR HAS THE SECURITIES AND EXCHANGE COMMISSION
OR ANY STATE SECURITIES COMMISSION 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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In this prospectus references to the "Company," "Ortec,", "we,""us" and "our"
refer to Ortec International, Inc.
TABLE OF CONTENTS
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Prospectus Summary.............................................................. 3
Risk Factors.................................................................... 7
Disclosure Regarding Forward Looking Statements................................. 11
Use of Proceeds................................................................. 12
Selling Shareholders............................................................ 13
Description of Securities....................................................... 14
Plan of Distribution............................................................ 15
Incorporation of Certain Information by Reference............................... 16
Legal Matters................................................................... 16
Experts......................................................................... 16
Disclosure of Commission Position on Indemnification
for Securities Act Liabilities............................................... 17
Where You Can Find More Information............................................. 18
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PROSPECTUS SUMMARY
All of the information in this summary is qualified in its entirety by
the more detailed information appearing elsewhere in this prospectus, including
information under "Risk Factors."
ORTEC INTERNATIONAL, INC.
We are a development stage tissue engineering and cell culture
biotechnology company that has developed a patented technology which we call
Composite Cultured Skin. Our Composite Cultured Skin is a two layered dressing
that consists of human derived dermal and epidermal cells supported within a
porous collagen matrix. The matrix is seeded with keratinocytes for epidermal
growth and fibroblasts for dermal growth. This biologically active dressing
stimulates the repair, replacement and regeneration of human skin. When our
Composite Cultured Skin is applied to the wound site, it produces a mix of
growth factors that stimulate wound closure.
Our product is intended to be utilized for the treatment of numerous
skin wounds, such as venous stasis ulcers, autograft donor sites, diabetic
ulcers, indeterminate depth burns and damage from epidermolysis bullosa. With
the approval of the United States Food and Drug Administration we are currently
conducting clinical trials of the use of our Composite Cultured Skin in the
treatment of venous stasis ulcers and diabetic ulcers and have completed
clinical trials for the treatment of autograft donor sites and epidermolysis
bullosa. We are still conducting follow up studies of the patients in the
autograft donor site trials to determine the effectiveness of our Composite
Cultured Skin in that clinical trial.
We believe that after we have received FDA approval for the commercial
sale of our Composite Cultured Skin for treatment of all the medical indications
described below, that our Composite Cultured Skin could be used to treat
approximately 1,100,000 patients constituting a potential of almost a $3.5
billion market. Each potential market is explained below.
Venous Stasis Ulcers. Roughly 700,000 Americans are plagued with venous
stasis ulcers. This type of ulcer is generally found in the lower leg proximate
to the ankle and can result from trauma, but is typically associated with
chronic venous insufficiency. Chronic venous insufficiency occurs when the
venous valves do not close completely and blood is allowed to flow back from the
deep venous system through the perforator veins into the superficial venous
system. The weight of the backlogged blood pushes on the surrounding tissues of
the lower leg and produces swollen, hyperpigmented ankles. Over time the
pressure will cause tissue breakdown and an ulcer will form. Roughly 50% of
venous leg ulcers are successfully treated with traditional methods, which
include compression therapy followed by suggested regular walking and resting
with legs elevated for two hours a day. The remaining 50% of ulcer patients,
totaling about 350,000, are candidates for our Composite Cultured Skin. We
assume that we will be able to sell our Composite Cultured Skin for $975 per
unit because that is the per unit selling price at which our primary competitor
sells its product. In the pilot clinical trial for the use of our product for
the treatment of venous stasis ulcers, four units of our product were used for
the treatment of one ulcer. Assuming that each patient has one ulcer to be
treated with our Composite Cultured Skin, the potential annual market revenue
for use of our Composite Cultured Skin for the treatment of venous stasis ulcers
is approximately $1.365 billion.
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Donor Site Wounds. A donor site wound results from the removal of
healthy skin from an uninjured part of the body to cover an open wound at
another part of that patient's body. There are about 1,200,000 people treated
annually for burns at medical facilities across the United States. Approximately
96% of the burns cover a relatively small portion of the total body surface area
and are treated on an outpatient basis in doctors' offices, hospitals and burn
units. Roughly 4%, or 50,000, of the burn cases are severe and we believe could
require donor site harvesting. We estimate that in the typical severe burn case
in which autograft skin transplants are performed, four donor site wounds per
patient are created, or a total of 200,000 donor site wounds. Due to differing
severity of burns, we estimate that our Composite Cultured Skin would be used to
treat the donor site wounds of 43% of the 50,000 (or 21,500) severely burned
patients. Further assuming that eight units of our Composite Cultured Skin would
be needed to treat each of those 21,500 patients with donor site wounds, the
potential annual market revenue for use of our Composite Cultured Skin to treat
donor site wounds is approximately $170 million.
Indeterminate Depth Burns. Indeterminate depth burns are treated on
both an inpatient and outpatient basis. The estimated 50,000 patients with
severe burns are treated on an inpatient basis. Of such 50,000 estimated
patients, the burns of the estimated 57% (28,500 patients) which would not be
treated with autograft skin transplants, could be treated with our Composite
Cultured Skin. Assuming that six units of our Composite Cultured Skin would be
needed for the treatment of each of those 28,500 patients with indeterminate
depth burns, the potential annual market revenue for the use of our Composite
Cultured Skin to treat indeterminate depth burns is also approximately $170
million.
Of the other approximately 1,150,000 people treated annually for lesser
burns on an outpatient basis, we believe that approximately 180,000 have severe
enough burns that they are candidates for treatment with our Composite Cultured
Skin. Assuming that one unit of our Composite Cultured Skin would be necessary
to treat each of those 180,000 patients, the potential annual market revenue for
the use of our Composite Cultured Skin to treat those outpatient burn patients
would be another approximately $176 million.
Diabetic Foot Ulcers. Diabetic foot ulcers will affect about 2 million
of the 14 million diabetics in the United States during their lifetime. We
estimate that annually there are between 800,000 and 1,200,000 Americans
infected with a diabetic foot ulcer. The ulcers are open sores that remain after
the destruction of surface tissue. Approximately 67,000 amputations each year
are due to complications with these ulcers. Current treatments, which include
off-loading of pressure, debridement, maintenance of a moist wound environment,
wound cleansing, and nutritional support will cure between 50% and 60% of
diabetic ulcers. Assuming that there are 800,000 cases annually and 50% are
cured with traditional treatments, nearly 400,000 people suffering from diabetic
foot ulcers are candidates each year for treatment of those ulcers with our
Composite Cultured Skin. In the FDA approved pilot clinical trial currently
being conducted using our Composite Cultured Skin for the treatment of diabetic
foot ulcers, approximately four units of our Composite Cultured Skin were used
for the treatment of one ulcer. Assuming that each patient has one ulcer to be
treated with our Composite Cultured Skin, the potential annual market revenue
for use of our Composite Cultured Skin for the treatment of diabetic foot ulcers
is approximately $1.56 billion.
Chronic Wounds. We have completed the FDA approved clinical trials for
the use of our Composite Cultured Skin for the treatment of chronic wounds
caused by epidermolysis bullosa. Epidermolysis bullosa is a condition in which a
newborn's skin constantly blisters and can peel off at the slightest touch and
leave raw wounds. Few babies born with severe epidermolysis bullosa survive the
first
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year. Those that do survive are bombarded with constant blistering, which causes
scarring that constricts the skin so much that the hands can become disfigured
and fingers and toes can fuse together. In 1986 a national registry was
established to track the number of people with epidermolysis bullosa. Our
Composite Cultured Skin would be used to treat patients who have the dystrophic
and junctional form of the disease, a population of about 900 according to the
national registry's database. Advocacy groups for epidermolysis bullosa patients
argue that the registry's estimate is significantly under-reported. We believe
it is possible that the registry only accounts for about one-third of the total
population of people with severe forms of epidermolysis bullosa. We believe that
patients with dystrophic and junctional epidermolysis bullosa will have, on
average, two distinct non healing skin ulcers treated each year. In our
concluded clinical trials, approximately four units of our Composite Cultured
Skin were used to treat each ulcer. Based on these figures and assumptions, the
potential annual market revenue for use of our Composite Cultured Skin for the
treatment of epidermolysis bullosa patients is approximately $22 million.
We have developed the technology for the cryopreservation of our
product without diminishing its effectiveness. Cryopreservation means the
freezing of our product to give it a shelf life of a minimum of six months, as
opposed to a few days when our product is not cryopreserved. We plan to use our
product in its cryopreserved form in our pivotal clinical trials for the
treatment of venous stasis ulcers and diabetic foot ulcers.
Our immediate focus is to use our Composite Cultured Skin to treat
acute and chronic skin wounds and associated diseases. However, we believe that
there is an opportunity to apply our core technologies to repair selected
structural tissues such as tendon, ligament, cartilage, bone and blood vessels.
While we believe that our bi-layered product will be effective in
treating the medical indications in our target markets, many companies and
academic institutions have developed, or are capable of developing, products
based on other technologies that are or may be competitive with our Composite
Cultured Skin. We know of only one other company, Organogenesis, Inc., that has
developed a bilayered product to treat the same wounds which are targeted for
treatment by our Composite Cultured Skin. Organogenesis has licensed Novartis,
Inc. to market its skin replacement product and that product, having received
FDA approval, is currently being sold for the treatment of venous stasis and
diabetic foot ulcers. We believe that our Composite Cultured Skin will have
certain competitive advantages over other comparable bio-engineered products in
that our Composite Cultured Skin: (i) has demonstrated superior clinical results
in recently released clinical data, accelerating healing in comparison to
standard of care and other competitive products; (ii) may be less expensive to
produce; (iii) is easier for the physician to handle and use, and (iv) can be
stored and delivered in a cryopreserved form, providing production and
distribution efficiencies.
As a development stage company we have not yet sold any products. Our
activities have been limited to human clinical tests of our Composite Cultured
Skin and research and development. From the creation of Ortec in March 1991
through June 30, 2000, we have spent an aggregate of $11,368,034 for human
clinical trials and research and development, which figure does not include
employee salaries. From inception in March 1991 through June 30, 2000 we have
sustained a net loss of $36,602,094 and used cash in operations of $30,811,640.
We expect to continue to incur substantial operating losses and use cash in
operations until at least 2003. We believe that we may reach cash flow break
even in 2004. Revenues from sale of our Composite Cultured Skin for treatment of
chronic wounds of epidermolysis bullosa patients could begin as early as the
second half of 2001.
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Ortec was organized in 1991 under the laws of the State of Delaware for
the purpose of acquiring our skin replacement product and to develop, test and
market it. Our executive offices are located at 3960 Broadway, New York, New
York, and our telephone number is (212) 740-6999.
THE OFFERING
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Securities offered 1,247,566 shares of common stock.
Sellers The shares are being offered by our shareholders
and not by us.
Offering prices Prices then available on the Nasdaq Stock Market
or in individually negotiated transactions.
Common stock to be
outstanding after the
offering(1) 9,677,783 shares
Use of proceeds We will not receive any proceeds from the
sale of the shares.
Risk factors An investment in the shares involves a high degree
of risk. See "Risk Factors."
Nasdaq Stock Market
trading symbol "ORTC"
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(1) Does not include (i) 14,325 shares reserved by us for issuance for
three warrants already exercised; (ii) 1,188,600 shares reserved by us
for issuance upon the exercise of our publicly traded Class B Warrants
at $15 per share and expiring December 31, 2000; (iii) 2,989,750
shares reserved by us for issuance upon the exercise of stock options
included in our 1996 Stock Option Plan, of which options to purchase
1,229,400 shares at prices ranging from $6.00 to $21.38 have already
been granted by us ; and (iv) 714,773 shares reserved by us for
issuance upon the exercise of other outstanding warrants granted by us,
at prices ranging from $7.70 to $15.00 and expiring at various times
from March 10, 2001 to March 10, 2005.
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RISK FACTORS
The purchase of the shares involves a high degree of risk, including,
but not necessarily limited to, the risks described below. Before purchasing the
shares, you should consider carefully the general investment risks enumerated
elsewhere in this prospectus and the following risk factors, as well as the
other information contained in this prospectus. This prospectus contains forward
looking statements that involve risks and uncertainties.
1. WE DO NOT HAVE SUFFICIENT FUNDS TO BRING OUR PRODUCT TO MARKET, WHICH MAY
IMPACT OUR CONTINUED VIABILITY.
We anticipate that with the proceeds we receive from a private
placement sale of the 1,247,566 shares offered by this prospectus, our cash on
hand is sufficient to meet our cash requirements through approximately December
2001, assuming that we will not incur unexpected costs. Before the end of that
period we will be required to raise additional funds to complete our human
clinical trials and produce and market our Composite Cultured Skin. We may seek
additional funds through sale of our securities to the public and through
private placements, debt financing or short term loans. Our failure to obtain
additional financing will have a material adverse effect on us and on our
operations. We have no current commitments from any persons that they will
provide any additional financing. Additional financing may result in dilution
for then current shareholders.
2. WE ARE A DEVELOPMENT STAGE COMPANY AND BECAUSE WE HAVE NEVER REALIZED
OPERATING REVENUES OR EXPECT TO REALIZE SUFFICIENT OPERATING REVENUES FOR A
WHILE, UNLESS WE SECURE ADDITIONAL FINANCING WE WILL NOT BE ABLE TO CONTINUE TO
OPERATE OUR BUSINESS.
Ortec was organized in March 1991. We have no products approved for
commercial sale and we have not realized any operating revenues. We do not
expect our Composite Cultured Skin to be available for commercial sale until the
second half of 2001 at the earliest and then only for a disease with a very
small patient population. We will need to secure additional financing to
complete our other human clinical trials and to produce and market our Composite
Cultured Skin for use by larger patient populations for other wounds. We may not
be able to secure such financing nor may we be able to reach that larger
marketing stage with funds that we may be able to raise. We are also likely to
continue to encounter difficulties which are common to development stage
companies, including unanticipated costs relating to development, delays in the
testing of products, regulatory approval and compliance and competition.
3. WE MAY NOT BE ABLE TO OBTAIN FDA APPROVAL FOR COMMERCIAL SALE OF OUR PRODUCT
SO THAT WE MAY NEVER RECEIVE ANY REVENUES.
Pursuant to the Federal Food Drug and Cosmetic Act and regulations
promulgated thereunder, the FDA regulates the manufacture, distribution and
promotion of medical devices in the United States. Our Composite Cultured Skin
is regulated as a medical device. We must receive premarket approval by the FDA
for any commercial sale of our product. Before receiving such approval we must
provide proof in human clinical trials of the nontoxicity, safety and efficacy
of our Composite Cultured Skin. Premarket approval is a lengthy and expensive
process. We may not be able to obtain FDA approval for any commercial sale of
our product. We will not generate any revenues until we obtain FDA approval to
sell
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our product in commercial quantities for human application. Even if such FDA
approval is obtained, we may not be able to make sales of our product on a
profitable basis.
4. EVEN IF WE OBTAIN FDA APPROVAL FOR COMMERCIAL SALE OF OUR PRODUCT, THE
MANUFACTURE AND SALE OF OUR PRODUCT WILL CONTINUE TO BE REGULATED BY THE FDA. IF
WE DO NOT COMPLY WITH THE FDA'S MANUFACTURING AND RECORD KEEPING REGULATIONS, WE
MAY NOT BE ABLE TO START OR CONTINUE SELLING OUR PRODUCT.
There will be periodic FDA inspections of the facilities used to
manufacture our Composite Cultured Skin and of our records. Such manufacturing
facilities must meet the FDA's good manufacturing processes standards. We will
also always have to comply with the FDA's recordkeeping, reporting, product
testing, design, safety and labeling requirements. Such regulatory compliance
will increase our operating costs. More important, non-compliance will prevent
us from making commercial sales of our product.
5. THE SUCCESSFUL MARKETING OF OUR PRODUCT WILL DEPEND ON ITS ACCEPTANCE BY THE
MEDICAL COMMUNITY. SECURING SUCH ACCEPTANCE WILL REQUIRE SUBSTANTIAL EFFORT AND
EXPENSE AND IF SUCH ACCEPTANCE BY THE MEDICAL COMMUNITY IS NOT SECURED WE WILL
NOT BE ABLE TO SUCCESSFULLY MARKET OUR PRODUCT.
Our Composite Cultured Skin must be accepted by the medical community
as an effective skin regeneration product in order for us to make any
significant commercial sales. Securing such acceptance will require substantial
effort. We do not have any experience marketing to the medical community and
will either have to employ persons experienced in securing such acceptance or
rely on other companies which have such marketing expertise. We may not be able
to secure the services of such experienced persons or any company having such
expertise.
6. SINCE WE HAVE DEVELOPED ONLY ONE PRODUCT, OUR FAILURE TO SELL THAT PRODUCT ON
A PROFITABLE BASIS MIGHT LIMIT OUR ABILITY TO CONTINUE OUR OPERATIONS.
To date, we have developed only one product, our Composite Cultured
Skin. In the event we fail to develop additional products and our product does
not obtain FDA approval for commercial distribution, or even if FDA approval is
obtained, our product is not viewed favorably by the medical community or it
becomes obsolete, we will be unable to become profitable and we may be required
to discontinue our operations.
7. MANY OF OUR COMPETITORS ARE LARGER AND HAVE GREATER FINANCIAL AND OTHER
RESOURCES THAN WE DO. SOME ARE ALREADY MAKING COMMERCIAL SALES OF THEIR SKIN
REPLACEMENT PRODUCTS.
Many companies and academic institutions have developed, or are capable
of developing products based on other technologies that are or may be
competitive with our Composite Cultured Skin. Our competitors include
Organogenesis, Inc., Genzyme Tissue Repair, Inc., Advanced Tissue Sciences,
Inc., Life Cell Corporation and Integra Life Sciences. Many of those competitors
have skin replacement products that are being commercially sold or are available
for commercial sale. Organogenesis has licensed Novartis, Inc. to distribute its
skin replacement product and Advanced Tissue Sciences has licensed Smith &
Nephew, Plc to distribute its skin replacement product. Many of those and other
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potential competitors, and particularly Novartis and Smith & Nephew, are well
established, are much larger than we are and have substantially greater
financial and other resources than we have. In addition, the biomedical field is
undergoing rapid and significant technological change. Such companies and
academic institutions may succeed in developing other products that are more
effective than our Composite Cultured Skin. Our success will depend on our
ability to establish and maintain a competitive position in this marketplace,
which we may not be able to do.
8. WE MAY NOT BE ABLE TO DEVELOP AND SELL OUR PRODUCT IF SOME OF OUR SUPPLIERS
DISCONTINUE OR ARE DELAYED IN SUPPLYING US WITH THE MATERIALS NECESSARY TO
MANUFACTURE OUR PRODUCT.
We currently purchase bovine collagen sponges, a key component of our
Composite Cultured Skin, from one supplier who produces the sponges to our
specifications. We have no written agreement with that supplier obligating the
supplier to supply sponges to us. If we are required to secure another source
for bovine collagen sponges, we would encounter additional delay and expense in
continuing our human clinical trials and, consequently, in marketing our
Composite Cultured Skin.
We will continue to rely on a limited number of outside suppliers to
supply other materials that we use in producing and testing our Composite
Cultured Skin. Replacing all or some of our suppliers could delay our clinical
trials and create additional expense for us.
9. WHILE WE RELY ON OUR PATENTS TO PROTECT OUR PROPRIETARY INTEREST IN OUR
TECHNOLOGY, WE COULD LOSE THAT PROTECTION IF OUR PATENTS ARE SUCCESSFULLY
CHALLENGED IN FUTURE COURT PROCEEDINGS OR IF OUR TECHNOLOGY IS RENDERED OBSOLETE
BY NEW TECHNOLOGIES DEVELOPED BY OTHERS.
Our U.S. patent expires in 2011. We have also been granted a European
patent for most of Europe, as well as patents in Australia, New Zealand,
Ireland, Israel, Japan, Thailand and South Africa. We are prosecuting patent
claims in Canada, the Russian Federation, Brazil and China. One of our
competitors filed an opposition with the European Patent Office challenging the
validity of our patent in Europe. The opposition in Europe is now being
considered and may not be resolved for at least another year. While the result
in Europe will not affect the validity of our patent in the United States, our
patents might be successfully challenged in court proceedings. In addition, our
United States and foreign patents may not provide us with any commercial
benefits if our product is not effective or if new technologies makes our
product obsolete.
Several of our competitors, including Organogenesis, Inc., Advanced
Tissue Sciences, Inc., Genzyme Tissue Repair Inc., Integra Life Sciences and
LifeCell Corporation, have been granted patents relating to their particular
skin technologies.
10. WE ARE EXPOSED TO THE RISK OF PRODUCT LIABILITY CLAIMS IN THE EVENT THAT OUR
COMPOSITE CULTURED SKIN CAUSES INJURY OR OTHERWISE RESULTS IN ADVERSE EFFECTS.
Although we have obtained product liability insurance coverage in the
amount of $2,000,000, such insurance coverage may not be adequate to protect us
against future product liability claims. Product liability insurance may not be
available to us in the future on terms acceptable to us, if at all.
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11. WE ARE DEPENDENT ON OUR EXECUTIVE OFFICERS AND CERTAIN OTHER KEY PERSONNEL
FOR MANAGING OUR AFFAIRS AND CONTINUING OUR CLINICAL TRIALS AND RESEARCH AND
DEVELOPMENT ACTIVITIES. THE LOSS OF THEIR SERVICES COULD DELAY OUR CLINICAL
TRIALS AND THE TIME WHEN WE CAN SELL OUR PRODUCT.
The management of our day-to-day operations is handled by our executive
officers. The development of our product is managed by a wide array of
scientific personnel. The loss of the services of some of these individuals
could cause delays in our ongoing operations, including delays in the conduct of
our clinical trials and the times when we can start sales of our product for
treating different medical conditions.
12. OUR OUTSTANDING OPTIONS AND WARRANTS MAY ADVERSELY AFFECT THE MARKET PRICE
OF OUR COMMON STOCK.
2,680,611 shares that are issuable upon exercise of outstanding
warrants and options that can be exercised now at prices ranging from $6.00 to
$21.38 per share, will be eligible for immediate sale into the public securities
markets after such warrants and options are exercised. Options that can be
exercised from November 15, 2000 through December 31, 2001 to purchase an
additional 89,213 shares, and from January 1, 2002 through August 18, 2004, to
purchase an additional 122,399 shares, all at prices ranging between $6.625 and
$12.75 per share, will also be eligible for immediate sale into the public
securities markets after such options are exercised. 240,550 shares that are
issuable upon exercise of other outstanding warrants exercisable at prices
ranging from $8.00 to $14.25 are eligible for sale in the public securities
markets one or two years after such warrants are exercised. We cannot make any
prediction as to the effect, if any, that sales of those shares, or the
availability of those shares for sale, will have on the market prices of our
common stock prevailing from time to time.
13. THE MARKET PRICE OF OUR COMMON STOCK MAY BE HIGHLY VOLATILE, AS HAS BEEN THE
CASE WITH THE SECURITIES OF OTHER DEVELOPMENT STAGE BIOTECHNOLOGY COMPANIES.
The market price of our common stock has ranged from $5.13 to $23
during the past three years. We believe that in the future factors such as our
or our competitors' announcements concerning technological innovations, new
commercial products or procedures, proposed government regulations and
developments or disputes relating to patents or proprietary rights may have a
significant impact on the market price of our common stock.
14. SINCE WE HAVE NOT PAID ANY DIVIDENDS ON OUR COMMON STOCK AND DO NOT INTEND
TO DO SO IN THE FORESEEABLE FUTURE, A PURCHASER IN THIS OFFERING WILL ONLY
REALIZE AN ECONOMIC GAIN ON HIS INVESTMENT FROM AN APPRECIATION, IF ANY, IN THE
MARKET PRICE OF OUR COMMON STOCK.
We have never paid, and have no intentions in the foreseeable future to
pay, any dividends on our common stock. Therefore, an investor in this offering,
in all likelihood, will only realize a profit on his investment if the market
price of our common stock increases in value.
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15. THE CONCENTRATION OF OWNERSHIP OF OUR COMMON STOCK AND CERTAIN CHANGE OF
CONTROL AGREEMENTS WILL DISCOURAGE PURCHASES OF OUR COMMON STOCK BY PERSONS WHO
MIGHT OTHERWISE SEEK TO GAIN CONTROL OF ORTEC.
Our executive officers, directors, founders and affiliated persons
beneficially own 2,054,005 shares of our outstanding common stock representing
approximately [21.6] of the total of our outstanding shares before the exercise
of any outstanding warrants and options. Accordingly, such persons will be able
to exercise substantial control in the election of Ortec's directors, increases
in our authorized capital or the dissolution or merger of Ortec, or sale of our
assets, and otherwise influence the control of our affairs. Such substantial
control by these persons could serve to impede or prevent a change of control of
our Company.
In addition, we will enter into certain agreements with Dr. Steven Katz
and Messrs. Ron Lipstein and Alain Klapholz which provide that, in the event of
a change of control of Ortec, we will be required to (1) pay to such three
persons between 2 and 2.99 times the compensation paid to such three persons in
the twelve months prior to the date of change of control; (2) extend the
expiration dates of options and warrants held by them so that they expire not
less than three years after such change in control occurs; (3) at their option
lend them, interest free and for a period of three years, the funds needed by
them to pay the exercise prices of warrants and options they exercise; and (4)
pay any special federal excise taxes payable by such three persons on the
amounts we have agreed to pay them and the value of such benefits we have agreed
to give them. Messrs. Katz, Lipstein and Klapholz are all executive officers,
directors and founders of Ortec.
As a result, potential purchasers may not seek to acquire control of
our company through the purchase of common stock which may tend to reduce the
market price of our common stock. In addition, we are subject to provisions of
the General Corporation Law of the State of Delaware respecting business
combinations which could, under certain circumstances, also hinder or delay a
change in control.
DISCLOSURE REGARDING FORWARD LOOKING STATEMENTS
This prospectus includes "forward looking statements" within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. For example, statements included in this
prospectus regarding the potential market revenues from the sale of our
Composite Cultured Skin, the number of patients with medical conditions who can
be treated with our Composite Cultured Skin, the future clinical trials for our
one product, approvals by the FDA and other plans and objectives for the future
and assumptions and predictions about future supply, manufacturing, costs and
sales are all forward looking statements. When we use words like "intend,"
"anticipate," "believe," "assume," "estimate," "plan" or "expect," we are making
forward looking statements. We believe that the assumptions and expectations
reflected in such forward looking statements are reasonable, based on
information available to us on the date of this prospectus, but we cannot assure
you that these assumptions and expectations will prove to have been correct or
that we will take any action that we may presently be planning. We have
disclosed certain important factors that could cause our actual results to
differ materially from our current expectations under "Risk Factors" elsewhere
in this prospectus. You should understand that forward looking statements made
in connection with this offering are necessarily qualified
11
<PAGE>
by these factors. We are not undertaking to publicly update or revise any
forward looking statement if we obtain new information or upon the occurrence of
future events or otherwise.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares covered by
this prospectus.
12
<PAGE>
SELLING SHAREHOLDERS
The following table sets forth certain information regarding beneficial
ownership of our common stock as of September 20, 2000 by each selling
shareholder. Except as indicated in the footnotes to this table, we believe that
the persons named in this table have sole voting and investment power with
respect to all shares of common stock shown as beneficially owned by them.
<TABLE>
<CAPTION>
AMOUNT AND
NATURE OF SHARES BENEFICIALLY
NAME OF BENEFICIAL REGISTERED OWNED
BENEFICIAL OWNER OWNERSHIP* FOR SALE AFTER SALE*
---------------- ---------- ---------- -----------
<S> <C> <C> <C>
Franklin Small Cap
Growth Fund 444,444 444,444 0
Franklin Health Cap Fund 232,222 222,222 0
KCM Biomedical, L.P.(1) 274,000 274,000 0
KCM Biomedical Offshore
Fund, Ltd.(1) 31,200 31,200 0
The FMG Bio-Med Hedge
Fund, Ltd.(1) 6,800 6,800 0
Stephens Group, Inc. 135,000 135,000 0
Stephens Investment Partners
2000, LLC 15,000 15,000 0
Bank One Trust
Company, N.A. as
Trustee of the
Ronald L. Chez IRA 30,000 30,000 0
</TABLE>
---------------
* The number of shares of common stock beneficially owned by each person or
entity is determined under rules promulgated by the United States
Securities and Exchange Commission. Under such rules, beneficial ownership
includes any shares as to which the person or entity has sole or shared
voting power or investment power.
(1) These three entities have informed us that they are affiliated and that
each has a beneficial interest in the shares owned by the other two.
13
<PAGE>
Except for information in our records and reports filed by them with us, we
have no knowledge of whether any of the selling shareholders own any other
shares of our common stock or options or warrants to purchase shares of our
common stock. We believe that none of the selling shareholders will own 1%
or more of our outstanding shares if they sell all of their shares
registered for sale.
DESCRIPTION OF SECURITIES
COMMON STOCK
We are currently authorized to issue 25,000,000 shares of common stock, par
value $.001 per share, of which 9,677,783 shares were issued and outstanding
as of , 2000.
The holders of our common stock are entitled to one vote per share for the
election of directors and with respect to all other matters to be voted on by
shareholders. Shares of common stock do not have cumulative voting rights.
Therefore, the holders of more than 50% of the shares voting for the election of
directors can elect all of the directors if they choose to do so and, in that
event, the holders of the remaining shares will not be able to elect any
directors. The holders of common stock are entitled to receive dividends when,
as and if declared by our board of directors out of legally available funds. In
the event of liquidation, dissolution or winding up of Ortec, the holders of
common stock are entitled to share ratably in all assets remaining available for
distribution to them after payment of liabilities and after provision has been
made for each class of stock, if any, having preference over the common stock.
Holders of shares of common stock, as such, have no conversion, preemptive or
other subscription rights, and there are no redemption provisions applicable to
the common stock.
OPTIONS AND WARRANTS
The following options and warrants to purchase shares of our common stock
which we have granted are presently outstanding.
CLASS B WARRANTS. These warrants are publicly traded, are exercisable at a
price of $15.00 per share and expire on December 31, 2000. There are 1,188,600
Class B Warrants outstanding.
STOCK OPTION PLAN. We have reserved 2,989,750 shares for issuance upon the
exercise of stock options included in our 1996 Stock Option Plan. Options to
purchase 1,229,400 shares at prices ranging from $6.00 to $21.38 have been
granted by us and are currently outstanding.
OTHER WARRANTS. We have reserved 714,773 shares for issuance upon the
exercise of other warrants granted by us. Such warrants are exercisable at
prices ranging from $7.70 to $15.00 per share and expire at various times from
March 10, 2001 to March 10, 2005.
GENERAL CORPORATION LAW PROVISIONS
A Delaware statute prevents an "interested stockholder" (defined generally
as a person owning 15% or more of a corporation's voting stock) from engaging in
a "business combination" with the Delaware corporation for three years following
the date the person became an interested stockholder unless, generally speaking,
the transaction is approved by Ortec's Board of Directors and the vote of two
thirds
14
<PAGE>
of the outstanding shares not owned by such interested stockholder. This statute
could have the effect of discouraging, delaying or preventing hostile takeovers,
including those that might result in the payment for our shares of a premium
over market price or changes in control or management of Ortec.
TRANSFER AND WARRANT AGENT
The transfer agent for our common stock and the warrant agent for our
publicly traded Class B Warrants, is Jersey Transfer and Trust Co., whose
address is 201 Bloomfield Avenue, P.O. Box 36, Verona, New Jersey 07044.
PLAN OF DISTRIBUTION
We are registering 1,247,566 shares of our common stock covered by this
prospectus on behalf of the selling shareholders. We will pay the costs and fees
of registering our common stock, but the selling shareholders will pay any
brokerage commissions, discounts or other expenses relating to the sale of their
common stock.
The selling shareholders may, from time to time, sell all or a portion of
such shares of our common stock on any market upon which the common stock may be
quoted, 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 the prevailing market prices, or at negotiated prices.
In effecting sales, brokers and dealers engaged by the selling shareholders
may arrange for other brokers or dealers to participate. Brokers and dealers may
receive commissions, discounts or concessions for their services from the
selling shareholders or, if any such broker-dealer acts as agent for the
purchaser of such shares, from such purchaser, in amounts to be negotiated.
These commissions or discounts are not expected to exceed those customary in the
types of transactions involved.
Any broker, dealer, agent or other person involved in the sale or resale of
the common stock may qualify as "underwriters" within the meaning of Section
2(a)(11) of the Securities Act of 1933, as amended, and a portion of any
proceeds of sale and the broker's, dealer's or agent's commissions, discounts,
or concessions may be deemed to be underwriter's compensation under the
Securities Act.
In addition to selling their common stock under this prospectus, the
selling shareholders may transfer their common stock in other ways not involving
market makers or established trading markets, including directly by gift,
distribution, or other transfer; and the sale of such shares may be made by such
transferees in the public securities markets by delivery of this prospectus to
the buyers in such transactions.
15
<PAGE>
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents filed by us with the Securities and Exchange
Commission (the "Commission") are incorporated by reference in this prospectus.
Our Commission file number to be used to locate these documents is 0-27368.
(a) Our Annual Report on Form 10-K for the year ended December 31, 1999.
(b) Our Quarterly Reports on Form 10-Q for the quarters ended March 31,
2000 and June 30, 2000.
(c) Our Current Report on Form 8-K filed with the Commission on July 6,
2000.
(d) The description of our common stock set forth in our registration
statement on form 8-A filed December 5, 1995, including any
amendment or report filed for the purpose of updating such
description.
All documents subsequently filed by us pursuant to Section 13(a), 13(c), 14
or 15(d) of the Securities Exchange Act of 1934 (the "Exchange Act"), prior to
the termination of this offering, shall be deemed to be incorporated by
reference in this prospectus and to be a part of this prospectus from the date
of filing of such documents. Any statement contained herein or in a document
incorporated or deemed to be incorporated by reference herein shall be deemed to
be modified or superseded for purposes of this prospectus to the extent that a
statement contained herein or in any other subsequently filed document which
also is incorporated or deemed to be incorporated by reference herein modifies
or supersedes such statement. Any statement so modified or superseded shall not
be deemed, except as so modified or superseded, to constitute a part of this
prospectus.
LEGAL MATTERS
The legality of the common stock included in this prospectus has been
passed upon for the Company by Feder, Kaszovitz, Isaacson, Weber, Skala & Bass
LLP, New York, New York.
EXPERTS
The financial statements of the Company, incorporated by reference in this
prospectus, from the Company's Annual Report on Form 10-K for the fiscal year
ended December 31, 1999, have been incorporated herein in reliance on the report
of Grant Thornton LLP, Independent Certified Public Accountants, given on the
authority of that firm as experts in accounting and auditing.
16
<PAGE>
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our certificate of incorporation provides that the personal liability
of our directors shall be limited to the fullest extent permitted by the
provisions of Section 102(b)(7) of the General Corporation Law of the State of
Delaware (the "DGCL"). Section 102(b)(7) of the DGCL generally provides that no
director shall be liable personally to us or our shareholders for monetary
damages for breach of fiduciary duty as a director, provided that our
certificate of incorporation does not eliminate the liability of a director for
(i) any breach of the director's duty of loyalty to us or our shareholders; (ii)
acts or omissions not in good faith or that involve intentional misconduct or a
knowing violation of law; (iii) acts or omissions in respect of certain unlawful
dividend payments or stock redemptions or repurchases; or (iv) any transaction
from which such director derives improper personal benefit. The effect of this
provision is to eliminate our rights and the rights of our shareholders through
stockholders' derivative suits on our behalf, to recover monetary damages
against a director for breach of her or his fiduciary duty of care as a director
including breaches resulting from negligent or grossly negligent behavior except
in the situations described in clauses (i) through (iv) above. The limitations
summarized above, however, do not affect our or our shareholders ability to seek
nonmonetary remedies, such as an injunction or rescission, against a director
for breach of her or his fiduciary duty.
In addition, our certificate of incorporation provides that we shall,
to the fullest extent permitted by Section 145 of the DGCL, indemnify all
persons who we may indemnify pursuant to Section 145 of the DGCL. Section 145 of
the DGCL permits a company to indemnify an officer or director who was or is a
party or is threatened to be made a party to any proceeding because of his or
her position, if the officer or director acted in good faith and in a manner he
or she reasonably believed to be in or not opposed to the best interests of such
company and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
We maintain a directors' and officers' liability insurance policy
covering certain liabilities that may be incurred by our directors and officers
in connection with the performance of their duties. The entire premium for such
insurance is paid by us.
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to our directors and officers, and to persons controlling
Ortec pursuant to the foregoing provisions, we have been informed that in the
opinion of the Commission, such indemnification is against public policy as
expressed in the Securities Act and is therefore unenforceable.
17
<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
Since January 20, 1996, we have been subject to the reporting
requirements of the Exchange Act. In accordance with the Exchange Act, we have
and will continue to file reports, proxy statements and other information with
the Commission. Reports and other information filed by us may be inspected and
copied at the public reference facilities of the Commission in Washington, D.C.
Copies of such materials can be obtained from the Public Reference Section of
the Commission, Washington, D.C. 20549, at prescribed rates. In addition, the
Commission maintains a web site at http://www.sec.gov that contains reports,
proxy and information statements and other information regarding registrants
that file electronically with the Commission. Our common stock is listed on the
NASDAQ SmallCap Market and reports and information concerning us can also be
inspected through such exchange. We intend to furnish our shareholders with
annual reports containing audited financial statements and such other periodic
reports as we deem appropriate or as may be required by law.
We will provide without charge to each person who receives this
prospectus, upon written or oral request of such person, a copy of any of the
information that is incorporated by reference unless the exhibits are themselves
specifically incorporated by reference. Such requests should be directed by mail
to Mr. Ron Lipstein, Secretary, Ortec International, Inc., 3960 Broadway, New
York, NY 10032, or by telephone at (212) 740-6999.
We have filed with the Commission a registration statement on Form S-3
and all schedules and exhibits thereto under the Securities Act with respect to
the common stock offered by this prospectus. This prospectus does not contain
all of the information set forth in the registration statement, certain parts of
which are omitted in accordance with the rules and regulations of the
Commission. For further information with respect to us and this offering,
reference is made to such registration statement, including the exhibits filed
therewith, which may be inspected without charge at the Commission's principal
office at 450 Fifth Street, N.W., Washington, D.C. 20549. Copies of the
registration statement may be obtained from the Commission at its principal
office upon payment of prescribed fees. Statements contained in this prospectus
as to the contents of any contract or other document are not necessarily
complete and, where the contract or other document has been filed as an exhibit
to the registration statement, each such statement is qualified in all respects
by reference to the applicable document filed with the Commission.
18
<PAGE>
PART II - INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
It is expected that the following expenses will be incurred in
connection with the issuance and distribution of the common stock being
registered. All such expenses are being paid by the Registrant (the "Company").
<TABLE>
<S> <C>
SEC Registration fee......................................................................... $ 2,637
*Printing and Edgarization.................................................................. 2,500
*Accountants' fees and expenses.............................................................. 15,000
*Attorneys' fees and expenses................................................................ 15,000
-------
*Total....................................................................................... $35,187
=======
</TABLE>
-------
*Estimated
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Company's certificate of incorporation provides that the personal
liability of the directors of the Company shall be limited to the fullest extent
permitted by the provisions of Section 102(b)(7) of the General Corporation Law
of the State of Delaware (the "DGCL"). Section 102(b)(7) of the DGCL generally
provides that no director shall be liable personally to the Company or its
stockholders for monetary damages for breach of fiduciary duty as a director,
provided that the Certificate of Incorporation does not eliminate the liability
of a director for (i) any breach of the director's duty of loyalty to the
Company or its stockholders; (ii) acts or omissions not in good faith or that
involve intentional misconduct or a knowing violation of law; (iii) acts or
omissions in respect of certain unlawful dividend payments or stock redemptions
or repurchases; or (iv) any transaction from which such director derives
improper personal benefit. The effect of this provision is to eliminate the
rights of the Company and its stockholders (through stockholders' derivative
suits on behalf of the Company) to recover monetary damages against a director
for breach of her or his fiduciary duty of care as a director (including
breaches resulting from negligent or grossly negligent behavior) except in the
situations described in clauses (i) through (iv) above. The limitations
summarized above, however, do not affect the ability of the Company or its
stockholders to seek nonmonetary remedies, such as an injunction or rescission,
against a director for breach of her or his fiduciary duty.
In addition, the certificate of incorporation provides that the Company
shall, to the fullest extent permitted by Section 145 of the DGCL, indemnify all
persons whom it may indemnify pursuant to Section 145 of the DGCL. Section 145
of the DGCL permits a company to indemnify an officer or director who was or is
a party or is threatened to be made a party to any proceeding because of his or
her position, if the officer or director 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
Company and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his or her conduct was unlawful.
II - 1
<PAGE>
Insofar as indemnification for liabilities arising under the Securities
Act of 1933, as amended (the "Securities Act"), may be permitted to directors,
officers, or persons controlling the Company pursuant to the foregoing
provisions, the Company has been informed 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.
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
Exhibit Number Description
-------------- -----------
<S> <C>
4.1 Form of certificate evidencing shares of common stock(1)
5.1 Opinion of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP,
counsel for the Registrant*
23.1 Consent of Grant Thornton LLP*
23.2 Consent of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
(included in Exhibit 5.1)*
</TABLE>
---------
* Filed herewith.
(1) Filed as an exhibit to the Company's registration statement on
Form SB-2 (File No. 33-96090), or amendment 1 thereto, and incorporated
herein by reference.
ITEM 17. UNDERTAKINGS
The Registrant hereby undertakes:
1. To file, during any period in which offers or sales are being made,
a post effective amendment to this registration statement to include any
material information with respect to the plan of distribution not previously
disclosed in this registration statement or any material change to such
information in this registration statement.
2. That for the purpose of determining any liability under the
Securities Act, each such post- effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
3. To remove from registration by means of a post effective amendment
any of the securities being registered that remain unsold at the termination of
the offering.
4. That for purposes of determining any liability under the Securities
Act, each filing of the Registrant's annual report pursuant to section 13(a) or
section 15(d) of the Securities Exchange Act of 1934 that is incorporated by
reference in this registration statement shall be deemed to be a new
registration
II - 2
<PAGE>
statement relating to the shares of common stock offered herein, and the
offering of such shares of common stock at that time shall be deemed to be the
initial bona fide offering thereof.
5. Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and controlling persons
of the Registrant pursuant to the Registrant's certificate of incorporation,
indemnification agreement, insurance 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 - 3
<PAGE>
SIGNATURES
In accordance with 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 authorized this
Registration Statement or amendment thereto to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of New York, State of New
York, on September 20, 2000.
ORTEC INTERNATIONAL, INC.
By: s/ Steven Katz
------------------------------
Steven Katz, PhD
President
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated:
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Steven Katz President, Chief Executive Officer and September 20, 2000
------------------------- Chairman (Principal Executive
Steven Katz, PhD Officer)
Senior Vice President, Research and
------------------------- Development, and Director
Dr. Mark Eisenberg
/s/ Ron Lipstein Chief Financial Officer, Secretary, September 20, 2000
------------------------ Treasurer and Director (Principal
Ron Lipstein Financial and Accounting Officer)
/s/ Alain M. Klapholz Vice President, Operations, and September 20, 2000
--------------------- Director
Alain M. Klapholz
Director
---------------------
Joseph Stechler
/s/ Steven Lilien Director September 20, 2000
---------------------
Steven Lilien, PhD
</TABLE>
<PAGE>
Exhibit Index
<TABLE>
<CAPTION>
Exhibit Number Description
-------------- -----------
<S> <C>
4.1 Form of certificate evidencing shares of common stock(1)
5.1 Opinion of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP,
counsel for the Registrant*
23.1 Consent of Grant Thornton LLP*
23.2 Consent of Feder, Kaszovitz, Isaacson, Weber, Skala & Bass LLP
(included in Exhibit 5.1)*
</TABLE>
-------
* Filed herewith.
(1) Filed as an exhibit to the Company's registration statement on
Form SB-2 (File No. 33-96090), or amendment 1 thereto, and incorporated
herein by reference.
