<PAGE> 1
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST ___, 1999
REGISTRATION NO. 333-80979
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------
AMENDMENT NO. 1 TO
REGISTRATION STATEMENT
FILED ON FORM S-3
UNDER THE SECURITIES ACT OF 1933
----------------
ORTEC INTERNATIONAL, INC.
(NAME OF ISSUER IN ITS CHARTER)
DELAWARE 8099 11-3068704
(STATE OR OTHER (PRIMARY STANDARD (I.R.S. EMPLOYER
JURISDICTION OF INDUSTRIAL CODE IDENTIFICATION NUMBER)
INCORPORATION) NUMBER)
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.
SAUL M. KASZOVITZ, ESQ.
FEDER, KASZOVITZ, ISAACSON, WEBER, SKALA & BASS LLP
750 LEXINGTON AVENUE, NEW YORK, NEW YORK 10022-1200
(212) 888-8200
FAX: (212) 888-7776
----------------
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. / /
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/
<PAGE> 2
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
<PAGE> 3
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
=========================================================================================================================
Proposed
Title of Each Offering Proposed Amount of
Class of Amount to be Price Per Aggregate Registration
Securities Being Registered Security Offering Fee
Registered (2) (1) Price(1) (1)
- -------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, par
value $.001 per 1,031,246 Shares $ 7.41875(3) $ 7,650,564 $ 2,127
share (2)
=========================================================================================================================
</TABLE>
(1) Estimated solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457.
(2) Pursuant to Rule 416, this Registration Statement also covers any
additional shares of Common Stock which may become issuable by virtue
of the anti-dilution provisions of any warrants or options to which the
shares of Common Stock being registered hereby are included.
(3) Represents the average of the high and low sales prices of the Common
Stock for June 14, 1999, as reported by the Nasdaq SmallCap 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.
iii
<PAGE> 4
ORTEC INTERNATIONAL, INC.
1,031,246 SHARES OF COMMON STOCK
This prospectus covers 1,031,246 shares of common stock, par value
$.001 per share, of ORTEC INTERNATIONAL, INC., a Delaware corporation, held by
our shareholders, including 348,557 shares issuable by us upon the exercise of
certain options and warrants granted by us in the past. The holders of those
shares intend to sell them from time to time for their own respective accounts
in the open market at the prices then available or in individually negotiated
transactions at such prices as may be agreed upon. Our common stock is traded on
the NASDAQ SmallCap Market System under the symbol "ORTC." On August ____, 1999,
the last reported sale price of the common stock was $_________.
SEE "RISK FACTORS" BEGINNING ON PAGE 6 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 ___________, 1999
<PAGE> 5
In this prospectus, references to the "Company", "Ortec" , "we", "us" and "our"
refer to Ortec International, Inc.
TABLE OF CONTENTS
Page
Disclosure Regarding Forward-Looking Statements............................. 2
Prospectus Summary.......................................................... 3
Risk Factors................................................................ 6
Use of Proceeds............................................................. 9
Selling Shareholders........................................................ 10
Description of Securities................................................... 12
Plan of Distribution........................................................ 14
Incorporation of Certain Information by Reference........................... 14
Legal Matters............................................................... 15
Experts..................................................................... 15
Disclosure of Commission Position on Indemnification
for Securities Act Liabilities........................................... 15
Where You Can Find More Information......................................... 16
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 future clinical trials for our one product, approvals
by the United States Food and Drug Administration and other plans and objectives
for the future and assumptions and predictions about future supply,
manufacturing, costs and marketing are all forward-looking statements. When we
use words like "intend, "anticipate", "believe", "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 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.
2
<PAGE> 6
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."
The Company
We are a development stage biomaterial and cell culture biotechnology
company that has developed a patented technology which we call Composite
Cultured Skin. Our Composite Cultured Skin acts as a biologically active
dressing that stimulates the repair, replacement and regeneration of human skin.
Our product is intended to be utilized for the treatment of numerous skin
wounds, including partial thickness burns, venous stasis ulcers, diabetic
ulcers, damage from Epidermolysis Bullosa disease, as well as the treatment of
autograft donor sites. An autograft donor site is an area of a patient's body
from which the patient's skin was taken to cover a wound at another part of such
patient's body.
Our Composite Cultured Skin's permeable, bi-layer structure utilizing a
collagen-based scaffolding (framework) containing immature dermal and epidermal
cells stimulates rapid regeneration and remodeling of human skin. The dermal and
epidermal cells are the two major layers that form the human skin. When our
Composite Cultured Skin is applied to the wound site, it produces a mix of
growth factors that stimulate wound closure.
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 autograft donor site wounds, venous stasis ulcers and
partial thickness burns. We are proceeding to secure FDA approval to conduct a
clinical trial of the use of our Composite Cultured Skin in the treatment of
diabetic foot ulcers. We have already completed an FDA approved clinical trial
of the use of our Composite Cultured Skin in the treatment of chronic ulcers in
patients with Epidermolysis Bullosa. In August 1999, the FDA notified us that we
could also use our Composite Cultured Skin as a humanitarian use device for the
treatment of skin lesions in patients suffering from Erythema Multiforme,
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. We expect to file an
application with the FDA for a humanitarian device exemption which, if approved,
will allow us to make commercial sales of our Composite Cultured Skin for the
treatment of Epidermolysis Bullosa, Erythema Multiforme, Stevens-Johnson
Syndrome and Toxic Epidermal Necrolysis patients. We hope to begin making
commercial sales of our Composite Cultured Skin for the treatment of such
patients by the end of 1999. See "Disclosure Regarding Forward Looking
Information".
We are also currently focusing on the treatment of donor site wounds.
We conducted a donor site pilot study which was completed in the fourth quarter
of 1998. During the second quarter of 1999, we initiated patient enrollment for
a pivotal donor site trial which, if successful, will enable us to secure FDA
approval for commercial sale of our Composite Cultured Skin for the treatment of
donor
3
<PAGE> 7
site wounds. A pivotal trial requires a significantly larger patient population
than a pilot study. See "Disclosure Regarding Forward Looking Information."
We have recently 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 approximately six months, as
opposed to a few days when our product is not cryopreserved. We have recently
requested FDA approval to conduct a pilot clinical trial for the use of our
product in its cryopreserved form in the treatment of donor site wounds.
Dr. Mark Eisenberg, a physician in Sydney, Australia, developed the
technology for our Composite Cultured Skin. Dr. Eisenberg is an officer and
director of Ortec and one of its largest shareholders.
Dr. Eisenberg received a U.S. patent for our Composite Cultured Skin in
February 1994, which was reissued in December 1996, claiming a composite living
skin having an epidermal layer of non-porous collagen and a dermal layer of
porous cross-linked collagen sponge matrix, each layer containing appropriate
cells. Dr. Eisenberg assigned his patent to us in April 1998. We also have a
European patent for most of Europe, as well as patents in Australia and New
Zealand, Israel, Japan, Thailand and South Africa. We are prosecuting patent
claims in Russia, China and Canada. One of our competitors recently filed an
opposition with the European Patent Office challenging the validity of our
patent in Europe.
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.
In order to achieve our objectives, we have identified five strategic
initiatives:
4
<PAGE> 8
- developing a commercial manufacturing operation;
- seeking a corporate sales and distribution partner;
- implementing a plan to operate in a managed care/reimbursement
environment;
- continuing our human clinical trials; and
- continuing our research and development.
See "Disclosure Regarding Forward Looking Information."
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, 1999, we have spent an aggregate of $7,985,726 for human
clinical trials and research and development, which figure does not include
employee salaries. From inception in March 1991 through June 30, 1999 we have
sustained a net loss of $25,801,325.
Ortec was organized in 1991 under the laws of the State of Delaware for
the purpose of acquiring our skin replacement product from Dr. Eisenberg 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.
5
<PAGE> 9
THE OFFERING
<TABLE>
<S> <C>
Securities offered 1,031,246 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 SmallCap Market or in
individually negotiated
transactions.
Common stock to be outstanding
after the offering(1) 6,911,310 shares
Use of proceeds Other than the proceeds from
the exercise of the
348,557 options and
warrants, 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 SmallCap System
trading symbol "ORTC"
</TABLE>
- -----------
(1) Includes 348,557 shares offered by this prospectus issuable by us upon
exercise of outstanding options and warrants. Does not include (i)
161,011 shares reserved by us for issuance upon exercise of warrants
granted by us expiring January 19, 2000 exercisable at $1.00 per share;
(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
November 30, 1999; (iii) 1,543,250 shares reserved by us for issuance
upon the exercise of stock options included in our 1996 Stock Option
Plan, of which options to purchase 940,500 shares at prices ranging
from $6.00 to $21 3/8 have already been granted by us; and (iv) 386,549
shares reserved by us for issuance upon the exercise of other
outstanding warrants granted by us, at prices ranging from $8.00 to
$14.25 and expiring at various times from September 8, 1999 to December
1, 2002.
6
<PAGE> 10
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.
We do not now have sufficient funds to bring our product to market. We
anticipate that our cash on hand is sufficient to meet our cash requirements
through approximately April 2000, 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 our operations. We have no current understandings or commitments from any
persons that they will provide any additional financing. Additional financing
may result in dilution for then current shareholders. See "Disclosure Regarding
Forward Looking Statements."
We are a development stage company and do not have any product
approved for commercial sale. Ortec was organized in March 1991. We have no
products approved for commercial sale and we have not realized any operating
revenues. We are 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.
We may not be able to obtain FDA approval for commercial sale of our
product. 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 our skin replacement product in commercial quantities for human
application.
7
<PAGE> 11
Even if such FDA approval is obtained, we may not be able to make sales of our
product on a profitable basis.
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.
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. 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.
The marketing of our product will require substantial effort and
expense. 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 marketing experience and will either have to employ
persons experienced in securing such acceptance by the medical community 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.
Since we rely on only one product, our failure to sell that product on
a profitable basis will have a material adverse effect on us.
We do not expect to make significant commercial sales in the near
future. We do not expect our Composite Cultured Skin to be available for
commercial sale until the end of 1999 at the earliest and then only for four
diseases with very small patient populations. 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.
Many of our competitors are larger and have greater financial and other
resources than we do. Many companies and academic institutions have developed,
or are capable of developing
7
<PAGE> 12
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 and other potential competitors are well
established, are much larger than we are and have substantially greater
financial and other resources than we have and have skin replacement products
that are being commercially sold or are available for commercial sale. 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.
We may encounter problems if some of our suppliers discontinue
supplying us. 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.
Our patents provide us only limited protection. 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 and New Zealand, Israel, Japan, Thailand and South
Africa. We are prosecuting patent claims in Canada, Russia and China. One of our
competitors recently filed an opposition with the European Patent Office
challenging the validity of our patent in Europe. Our patent counsel is now
preparing our response. The opposition in Europe may not be resolved for at
least two years. 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.
9
<PAGE> 13
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
artificial skin technologies.
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.
We are dependent on Steven Katz, the Company's President, for managing
our affairs. The loss of Dr. Katz' services could adversely affect us.
Our outstanding options and warrants may adversely affect the market
price of our common stock. 2,759,013 shares, including 348,557 shares covered by
this prospectus, that are issuable upon exercise of outstanding warrants and
options at prices ranging from $1.00 per share for 156,807 shares to $21 3/8 per
share, will be eligible for immediate sale into the public securities markets
after such warrants and options are exercised. In addition, 266,204 shares that
are issuable upon exercise of other outstanding warrants and options exercisable
at prices ranging from $1.00 (for 4,204 shares) to $14.25 are eligible for sale
in the public securities markets one or two years after such warrants and
options 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.
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 $4 3/4 to $23
during the past three and a half years. We believe that the market price of our
common stock was adversely affected by set backs encountered by other publicly
held skin technology companies in securing FDA approval for, or marketing their
products. We believe that the market price of our common stock has also been
adversely affected in the recent past because of reduced interest by investors
in small cap biotechnology companies such as ours. 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.
The shares covered by this prospectus may only be sold in certain
states. The purchaser of such shares may then resell such shares in the public
securities markets in such states only if our common stock is then qualified for
sale or exempt from qualification under applicable state securities laws of the
jurisdictions in which the purchasers of such shares reside. Although our common
stock is qualified for
10
<PAGE> 14
sale or exempt from qualification in a number of states, our shares cannot be
sold in every state. The resale or disposition of the common stock purchased in
this offering will be unlawful in a state if we fail to meet the state
securities law requirements of that state.
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.
There is a concentration of ownership of our common stock. Our
executive officers, directors, founders and affiliated persons beneficially own
2,073,476 shares of our outstanding common stock representing approximately
31.6% 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. 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.
USE OF PROCEEDS
Other than the proceeds received by us from the exercise of 348,557
options and warrants, we will not receive any proceeds from the sale of shares
covered by this prospectus.
Any proceeds received by us from the exercise of any or all of the
348,557 options and warrants may be used for our general working capital
purposes, including research and development and human clinical trials. We have
not specifically allocated the proceeds among these uses, and actual
expenditures will depend on a number of factors. The use of any proceeds from
the exercise of such 348,557 options and warrants, and the timing of such use,
will depend on the availability to us of cash from other sources. Proceeds not
immediately required for the purposes described above will be invested by us
principally in United States government obligations, short term certificates of
deposit, money market funds or other short term, interest bearing investments.
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<PAGE> 15
SELLING SHAREHOLDERS
The following table sets forth certain information regarding beneficial
ownership of our common stock as of August 20, 1999 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>
Pequot Capital Management, Inc. 834,179(1) 281,153(1) 553,026(1)
Joseph Stechler 955,166(2) 117,430(2) 827,736(2)
Cygni S.A. 34,285(3) 34,285(3) -
Abraham Berliner 6,857(3) 6,857(3) -
Joseph H. Berliner Defined
Benefit Pension Plan 6,857(3) 6,857(3) -
TLG Realty, LLC 20,572(3) 20,572(3) -
Veron International Limited 54,857(3) 54,857(3) -
Dennis Choy 7,200(3) 7,200(3)
Biotechnology Development Fund LP 27,428(3) 27,428(3) -
Clarion Capital Corporation 13,713(3) 13,713(3) -
Victor S. Lee 27,360(3) 27,360(3) -
Joseph Owadeyah 13,715(3) 13,715(3) -
Paradigm Group LLC 72,321(4) 72,321(4) -
PGP Investors 1, LLC 68,571(3) 68,571(3) -
Interfiducia Trust Reg TTEE
The Vas Family Trust 27,600(3) 27,600(3) -
Roisen Mark Sater & Amanda J. Sater 16,200(3) 16,200(3) -
James O. & Janice M. York 12,000(3) 12,000(3) -
</TABLE>
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<PAGE> 16
<TABLE>
<S> <C> <C> <C>
Michael Shina 27,600(3) 27,600(3) -
Charles Chambers 13,200(3) 13,200(3) -
William Lurie 6,000(3) 6,000(3) -
Robert C. Hastings, Jr. 7,200(3) 7,200(3) -
Frank R. Kuhn 7,200(3) 7,200(3) -
Teena Lerner 30,769(5) 30,769(5) -
Oscar Gruss & Son, Incorporated 31,109(5) 31,109(5) -
Michael Feintuch 3,456(5) 3,456(5) -
Reid Howard Drescher 600(5) 600(5) -
Alan Nisselson as trustee in
bankruptcy for Rodman & Renshaw 30,000(5) 30,000(5) -
Julia Heckman 2,250(5) 2,250(5) -
John J. Borer, III 4,500(5) 4,500(5) -
Karl Schmidt 5,708 5,708 -
Andrew Swartz 496 496 -
Anthony Viscogliosi 15,000(5) 15,000(5) -
Dian Griesel 25,000(5) 25,000(5) -
Henry Orlinsky 38,183(6) 10,000(6) 28,183(6)
Menachem Genack 15,022(6) 3,039(6) 11,583(6)
</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. Included among the shares
owned by such person are any shares which such person or entity has the
right to acquire within 60 days after August 20, 1999. The inclusion
herein of any shares deemed beneficially owned does not constitute an
admission of beneficial ownership of such shares.
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
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<PAGE> 17
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, except Pequot Capital Management, Inc., who will
own 8.3%, and Joseph Stechler who will own 12.2%.
(1) Shares held by three investment funds. We believe that Pequot Capital
Management, Inc. has sole or shared investment and/or voting power for
these shares. Includes 81,153 shares issuable upon exercise of
outstanding warrants.
(2) Includes the shares owned by Stechler & Company and 30,000 shares owned
by a charitable foundation of which Mr. Stechler and another member of
his family are the trustees and the following: (a) before sale of the
registered shares, 210,500 shares to be issued by us to Mr. Stechler or
Stechler & Company upon their exercise of outstanding options or
warrants; (b) among the shares registered for sale 30,500 shares to be
issued by us to Mr. Stechler upon his exercise of outstanding warrants;
(c) after sale of the registered shares, 180,000 shares to be issued by
us to Mr. Stechler or Stechler & Company upon their exercise of
outstanding options and warrants.
(3) One of every six shares included in this total is a share issuable upon
exercise of an outstanding warrant held by such person.
(4) Includes 15,178 shares issuable upon the exercise of outstanding
warrants.
(5) All of these shares are issuable upon exercise of outstanding warrants
or options.
(6) The shares shown as owned by Mr. Henry Orlinsky include shares owned by
his wife. Mr. Orlinsky disclaims any beneficial interest in such
shares. Also includes the following: (a) before the sale of the
registered shares, 28,043 shares and 12,639 shares issuable upon the
exercise of outstanding warrants owned by Mr. Orlinsky and Mr. Genack,
respectively; (b) except for 400 shares owned by Mr. Genack the shares
registered for sale consists of shares to be issued by us upon the
exercise of outstanding options and warrants owned by Messrs. Orlinsky
and Genack; (c) after the sale of the registered shares, 18,043 shares
to be issued to Mr. Orlinsky (and his wife) and 10,000 shares to be
issued to Mr. Genack by us upon their exercise of outstanding
options and warrants.
14
<PAGE> 18
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 6,562,753 shares were issued and outstanding as
of August 20, 1999.
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 the Company, 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 November 30, 1999. There are 1,188,600
Class B Warrants outstanding.
Lock Up Warrants. These warrants are exercisable at a price of $1.00 per
share and expire January 19, 2000. There are 161,011 Lock Up Warrants
outstanding.
Stock Option Plan. We have reserved 1,543,250 shares for issuance upon the
exercise of stock options included in our 1996 Stock Option Plan. Options to
purchase 940,500 shares at prices ranging from $6.00 to $21 3/8 have been
granted by us and are currently outstanding.
Other Warrants. We have reserved 735,106 shares for issuance upon the
exercise of other warrants granted by us. Such warrants are exercisable at
prices ranging from $6.00 to $14.25 per share and expire at various times from
September 8, 1999 to March 26, 2004.
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
15
<PAGE> 19
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 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
All of the shares of common stock offered pursuant to this prospectus are
being offered by the holders thereof and, therefore, we will not receive any
proceeds resulting from the sale of any of such shares, except for any proceeds
from the exercise, if any, of the options and warrants for 348,557 shares.
The shares of common stock covered by this prospectus may be sold from time
to time to purchasers directly by the holders thereof. Alternatively, such
holders may from time to time offer the shares of common stock through
underwriters, dealers or agents, who may receive compensation in the form of
underwriting discounts, concessions or commissions from such holders and any
underwriters, dealers or agents who participate in the distribution of such
shares may be deemed to be "underwriters" under the Securities Act, and any
discounts, commissions or concessions received by any such persons might be
deemed to be underwriting discounts and commissions under the Securities Act.
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, 1998.
(b) Our Quarterly Reports on Forms 10-Q for the quarters ended March 31,
1999 and June 30, 1999.
16
<PAGE> 20
(c) 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. Gabriel Kaszovitz, a member of such firm, is a
shareholder of the Company and is the owner of an option expiring April 1, 2001
for the purchase of 10,000 shares of Common Stock at $6.00 per share.
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, 1998, 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.
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
17
<PAGE> 21
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 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.
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 the
Company 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.
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 the Company 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.
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<PAGE> 22
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 the Company 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.
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<PAGE> 23
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 Company.
<TABLE>
<S> <C>
SEC Registration fee........................................................................... $ 2,127
*Printing and Edgarization.................................................................... 4,500
*Accountants' fees and expenses................................................................ 3,000
*Attorneys' fees and expenses.................................................................. 15,000
*Miscellaneous................................................................................. 373
--------
*Total....................................................................................... $ 25,000
========
</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.
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
II - 1
<PAGE> 24
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 as an exhibit to this registration statement before this amendment
No. 1.
(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
II - 2
<PAGE> 25
be deemed to be a new registration 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> 26
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 August 20, 1999.
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 August 20, 1999
- ----------------------- Executive Officer and
Steven Katz, PhD Chairman (Principal
Executive Officer)
/s/ Mark Eisenberg Senior Vice President, August 20, 1999
- ----------------------- Research and
Dr. Mark Eisenberg Development, and
Director
/s/ Ron Lipstein Chief Financial Officer, August 20, 1999
- ----------------------- Secretary, Treasurer and
Ron Lipstein Director (Principal
Financial and Accounting
Officer)
/s/ Alain M. Klapholz Vice President, August 20, 1999
- ---------------------- Operations, and Director
Alain M. Klapholz
- --------------------- Director
Joseph Stechler
/s/ Steven Lilien Director August 20, 1999
- ---------------------
Steven Lilien, PhD
</TABLE>
<PAGE> 27
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 as an exhibit to this registration statement before this amendment 1.
(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.
