<PAGE> 1
As filed with the Securities and Exchange Commission on October 13, 1995
Registration No. 33-
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-------------------------
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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ORGANOGENESIS INC.
(Exact name of registrant as specified in its charter)
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DELAWARE 04-2871690
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification number)
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150 DAN ROAD, CANTON, MASSACHUSETTS 02021
(617) 575-0775
(Address, including zip code, and telephone number, including area
code, of registrant's principal executive offices)
-------------------------
HERBERT M. STEIN, CHIEF EXECUTIVE OFFICER
ORGANOGENESIS INC.
150 DAN ROAD, CANTON, MASSACHUSETTS 02021
(617) 575-0775
(Name, address, including zip code, and telephone number, including area
code, of agent for service)
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COPY TO:
HALE AND DORR
60 STATE STREET
BOSTON, MASSACHUSETTS 02109
(617) 526-6000
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: At the
discretion of the Selling Stockholder.
-------------------------
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box.
/ /
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box.
/X/
If this form is registering additional securities 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. 33-
/ /
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. 33-
/ /
If delivery of the prospectus is expected to be made pursuant Rule 434,
please check the following box.
/ /
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
======================================================================================================
PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF EACH CLASS OF AMOUNT TO BE OFFERING PRICE(1) AGGREGATE AMOUNT OF
SECURITIES TO BE REGISTERED REGISTERED(1) PER SHARE OFFERING PRICE(1) REGISTRATION FEE
- ------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Common Stock, $.01 par
value.... 28,125 shares $17.75 $499,218.75 $172.15
======================================================================================================
</TABLE>
(1) Estimated for purposes of calculating registration fee pursuant to Rule
457(c) of the Securities Act of 1933, as amended, on the basis of the
average of the high and low sales prices of the Registrant's Common Stock on
the American Stock Exchange on October 10, 1995.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
SHALL DETERMINE.
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<PAGE> 2
PROSPECTUS (SUBJECT TO COMPLETION)
INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT.
A REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
28,125 SHARES
LOGO
ORGANOGENESIS INC.
COMMON STOCK
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The shares of Common Stock, $0.01 par value per shares (the "Common
Stock"), of Organogenesis Inc. ("Organogenesis" or the "Company") covered by
this Prospectus are issued and outstanding shares which may be offered and sold,
from time to time prior to 60 days after the effective date of this Prospectus,
for the account of Mr. Thomas M. Tully (the "Selling Stockholder"). See "The
Selling Stockholder." All of the shares offered hereunder are to be sold by the
Selling Stockholder. The Company will not receive any of the proceeds from the
sale of the shares by the Selling Stockholder.
THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 4 OF THIS PROSPECTUS.
-------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE 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 _________ __, 1995.
<PAGE> 3
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by the Company with the Securities and
Exchange Commission (the "Commission") are incorporated herein by reference: (1)
the description of the Company's capital stock contained in Organogenesis'
Registration Statement on Form 8-A filed on April 7, 1988; (2) the Company's
Annual Report on Form 10-K for the fiscal year ended December 31, 1994; (3) the
Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 1995;
(4) the Company's Current Report on Form 8-K filed with the Commission on August
2, 1995; (5) the Company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 1995; and (6) the Company's Current Report on Form 8-K filed with the
Commission on August 31, 1995.
All documents filed by the Company with the Commission pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended
(the "Exchange Act") subsequent to the date hereof and prior to the termination
of the offering of the Common Stock offered hereby shall be deemed to be
incorporated by reference into this Prospectus and to be a part hereof from the
date of filing such documents. Any statement contained 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 or is 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.
The Company will provide without charge to each person to whom this
Prospectus is delivered, upon written or oral request of such person, a copy of
any or all of the foregoing documents incorporated by reference into this
Prospectus (without exhibits to such documents other than exhibits specifically
incorporated by reference into such documents). Requests for such copies should
be directed to Organogenesis Inc., Herbert M. Stein, Chief Executive Officer,
150 Dan Road, Canton, Massachusetts 02021; telephone (617) 575-0775.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Exchange
Act and in accordance therewith files reports and other information with the
Commission. Reports, proxy statements and other information filed by the
Company with the Commission pursuant to the informational requirements of the
Exchange Act may be inspected and copied at the public reference facilities
maintained by the Commission at the Public Reference Section of the Commission
at 450 Fifth Street, N.W., Washington, D.C. 20549 and at the Commission's
regional offices located at 7 World Trade Center, Suite 1300, New York, New
York 10048, and at Citicorp Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661-2511. Copies of such materials also may be obtained
from the Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549 at prescribed rates. The Common Stock of the Company is
traded on the American Stock Exchange. Reports and other information concerning
the Company may be inspected at the offices of the American Stock Exchange, 86
Trinity Place, New York, NY 10006-1181.
The Company has filed with the Commission a Registration Statement on
Form S-3 under the Securities Act of 1933, as amended (the "Securities Act"),
with respect to the shares of Common Stock offered hereby. This Prospectus does
not contain all the information set forth in the Registration Statement and the
exhibits and schedules thereto, as certain items are omitted in accordance with
the rules and regulations of the Commission. For further information pertaining
to the Company and the shares of Common Stock offered hereby, reference is made
to such Registration Statement and the exhibits and schedules thereto, which may
be inspected without charge at the office of the Commission at 450 Fifth Street,
N.W., Washington, D.C. 20549, and copies of which may be obtained from the
Commission at prescribed rates.
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THE COMPANY
Organogenesis designs, develops and manufactures innovative medical
therapeutics using living human cells and natural connective tissue components.
Organogenesis was the first company founded to develop and commercialize
therapies based on innovations in tissue engineering, a relatively new
discipline focused on developing specialized biomaterials and cellular
constructs to assist, repair, regenerate, or replace diseased or damaged tissue.
An understanding of the biology of cells, the structure and function of the
extracellular matrix, and the critical interactions between the two is needed to
fully exploit the potential of tissue engineering. The Company's leadership in
combining theses technologies has resulted in a wide variety of product
opportunities, including GRAFTSKIN(TM), the Company's full-thickness skin
replacement product, which has completed enrollment of over 500 patients in
pivotal clinical trials.
The Company is developing its technology in the following areas: wound
care, cardiovascular, general surgery, urology and orthopedics. GRAFTSKIN is
intended to provide immediate wound closure while effectively promoting the
establishment of new skin tissue. GRAFTSKIN is currently in clinical trials for
chronic venous ulcers, wounds resulting from dermatological surgery, and burns.
Interim results appear to demonstrate GRAFTSKIN's safety, effectiveness over
standard care, improvement in patient quality of life, and excellent cosmetic
results. On June 5, 1995, the Company announced that it had received notice from
the U.S. Food and Drug Administration (the "FDA") that its GRAFTSKIN Premarket
Approval ("PMA") application to be submitted will receive expedited review. The
Company submitted a PMA application for GRAFTSKIN to the FDA on October 2,
1995.
Other product candidates which are intended to enable the recipient's (or
host's) body to form a fully functional replacement for diseased or damaged
tissue are in various stages of preclinical development. These products, such as
the GRAFTARTERY(TM) small diameter vascular graft, are being developed as
"off-the-shelf" repair or replacement material for applications where no graft
material is currently available, or where an "off-the-shelf" implant would
obviate the need to obtain autologous repair material (material from another
part of the host's body). The Company's product candidates are intended to
provide highly efficacious, cost-effective treatment for poorly managed diseases
and disorders.
Scientists at Organogenesis have expertise in a broad range of
disciplines, including cell biology, immunology, tissue cryopreservation,
matrix biochemistry, and vascular biology. In addition to the Company's core
scientific expertise, the Company has established capabilities in process
development and manufacturing, preclinical testing, clinical development and
regulatory affairs.
The Company was organized as a Delaware corporation in 1985. The Company's
executive offices are located at 150 Dan Road, Canton, Massachusetts 02021 and
its telephone number is (617) 575-0775.
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RISK FACTORS
In evaluating the Company's business, prospective investors should
carefully consider the following factors, in addition to the other information
contained in this Prospectus.
UNCERTAINTY OF SUCCESSFUL COMMERCIALIZATION
The Company has not begun to market or generate revenues from the
commercialization of products. The products under development by the Company
will require significant additional research and development efforts, including
extensive clinical testing and regulatory approval, prior to commercial use. The
Company's potential products are subject to the risks of failure inherent in the
development of pharmaceutical products based on new technologies. These risks
include the possibilities that the Company's therapeutic approach will not be
successful; that any or all of the Company's potential products will be found to
be unsafe, ineffective, toxic or otherwise fail to meet applicable regulatory
standards or receive necessary regulatory clearances; that the potential
products, if safe and effective, will be difficult to develop into commercially
viable products, to manufacture on a large scale, be uneconomical to market, or
fail to obtain acceptance by the medical community; that proprietary rights of
third parties will preclude the Company from marketing such products; or that
third parties will market superior or equivalent products.
FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FUNDING
The Company will require substantial additional funds in order to continue
its research and development programs, preclinical and clinical testing of its
product candidates and to conduct full scale manufacturing and marketing of any
pharmaceutical products that may be developed. The Company's capital
requirements depend on numerous factors, including but not limited to the
progress of its research and development programs, the progress of preclinical
and clinical testing, the time and costs involved in obtaining regulatory
approvals, the cost of filing, prosecuting, defending and enforcing any patent
claims and
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other intellectual property rights, competing technological and market
developments, changes in the Company's existing research relationships, the
ability of the Company to establish collaborative arrangements, the development
of commercialization activities and arrangements, and the purchase of additional
facilities and capital equipment. Based upon its current plans, the Company
believes that its existing capital resources and income earned on investment
capital will be sufficient to fund its operations at least through the third
quarter of 1996. There can be no assurance, however, that changes in the
Company's research and development plans or other events affecting the Company's
operations will not result in accelerated or unexpected expenditures.
Thereafter, the Company will need to raise substantial additional capital
to fund its operations. The Company intends to seek such additional funding
through public or private financings or collaborative or other arrangements with
corporate partners. If funds are raised by issuing equity securities, further
dilution to existing stockholders will result and future investors may be
granted rights superior to those of existing stockholders. There can be no
assurance, however, that additional financing will be available from any of
these sources, or if available, will be available on acceptable or affordable
terms. If adequate funds are not available, the Company may be required to
delay, reduce the scope of or eliminate one or more of its research and
development programs or to obtain funds through entering into arrangements with
collaborative partners or others that may require the Company to issue
additional equity or to relinquish rights to certain technologies or product
candidates that the Company would not otherwise issue or relinquish.
HISTORY OF LOSSES AND ACCUMULATED DEFICIT
The Company experienced net losses of $6.2 million, $9.9 million and $10.4
million for the years ended December 31, 1992, 1993 and 1994, respectively. The
Company's accumulated deficit at June 30, 1995 was $53.1 million. The Company
expects to incur additional losses as its research, development and clinical
trial programs continue to expand. The Company's ability to achieve a profitable
level of operations is dependent on successfully completing the development of
its products, obtaining required regulatory approvals, and manufacturing of its
products. Accordingly, the extent of future losses and the time required to
achieve profitability is highly uncertain. There can be no assurance that the
Company will achieve a profitable level of operations.
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RETENTION OF KEY PERSONNEL
Because of the specialized nature of the Company's business, the Company's
success will depend, in large part, on its continued ability to attract and
retain highly qualified scientific and business personnel and on its ability to
develop and maintain relationships with leading research institutions. The
competition for those relationships and for experienced scientists and
management personnel that exists among the numerous biotechnology,
pharmaceutical and healthcare companies, universities and nonprofit research
institutions is intense.
PATENTS AND PROPRIETARY TECHNOLOGY
The Company's success will depend, in part, upon its ability to develop
patentable products and technologies and obtain patent protection for its
products and technologies both in the United States and other countries. There
can be no assurance that patent applications owned or licensed by the Company
will issue as patents, that patent protection will be secured for any particular
technology, or that, if issued, such patents will be valid or that they will
provide the Company with meaningful protection against competitors or with a
competitive advantage. There can be no assurance that patents will not be
challenged or designed around by others. The Company could incur substantial
costs in proceedings before the United States Patent Office, including
interference proceedings. These proceedings could also result in adverse
decisions as to the patentability of the Company's licensed or assigned
inventions. Further, there can be no assurance that the Company will not
infringe upon prior or future patents owned by others, that the Company will not
need to acquire licenses under patents belonging to others for technology
potentially useful or necessary to the Company, or that such licenses will be
available to the Company, if at all, on terms acceptable to the Company.
Moreover, there can be no assurance that any patent issued to or licensed by the
Company will not be infringed by others. Lastly, there can be no assurance that
third parties will not bring suit against the Company for patent infringement or
for declaratory judgment to have the patents owned or licensed by the Company
declared invalid. The Company also relies on trade secrets and other unpatented
proprietary technology. No assurance can be given that the Company can
meaningfully protect its rights in such unpatented technology or that others
will not independently develop substantially equivalent products and processes
or otherwise gain access to the Company's technology.
The Company seeks to protect its trade secrets and proprietary know-how, in
part, through confidentiality agreements with its employees, consultants,
advisors and collaborators.
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There can be no assurance that these agreements will not be violated by the
other parties, that the Company will have adequate remedies for any breach, or
that the Company's trade secrets will not otherwise become known or be
independently developed by competitors. The Company has relationships with a
number of academic consultants who are employed by organizations other than the
Company. Accordingly, the Company has limited control over their activities and
can expect only limited amounts of their time to be dedicated to the Company's
activities. These persons may have consulting, employment or advisory
arrangements with other entities that may conflict with or compete with their
obligations to the Company. Consultants generally sign agreements which provide
for confidentiality of the Company's proprietary information and results of
studies. However, there can be no assurance that the Company will, in connection
with every relationship, be able to maintain the confidentiality of the
Company's technology, dissemination of which could have a materially adverse
effect on the Company's business. To the extent that the Company's scientific
consultants develop inventions or processes independently that may be applicable
to the Company's proposed products, disputes may arise as to the ownership of
the proprietary rights to such information. Such inventions or processes will
not necessarily become the property of the Company, but may remain the property
of such persons or their full-time employers. The Company could be required to
make payments to the owners of such inventions or processes, either in the form
of cash, equity or a combination thereof. In addition, protracted and costly
litigation may be necessary to enforce and determine the scope and validity of
the Company's proprietary rights.
COMPETITION
The Company is engaged in the rapidly evolving and competitive field of
tissue engineering. Many major pharmaceutical, biotechnology and medical product
companies in the United States and abroad are seeking to develop competitive
products for the treatment of skin wounds and organ equivalent products.
Competition from these companies and others is intense and is expected to
increase. Many of these companies have substantially greater capital resources,
research and development staffs, facilities and experience in the marketing and
distribution of products than the Company. In addition, competitive companies
are working on alternate approaches to many of the diseases targeted by the
Company.
The Company is currently aware of other companies which have or are
planning to commercialize products intended to serve as skin replacements, in
addition to several companies that concentrate on skin repair devices. The
Company's principal
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competitors in the wound care products market include Johnson & Johnson,
Kendall, Smith & Nephew, Advanced Tissue Sciences and Genzyme Tissue Repair. The
Company believes that its competitive position will be based on its ability to
create and maintain scientifically advanced technology and proprietary products
and processes, obtain required government approvals on a timely basis,
manufacture its products on a cost-effective basis and successfully market its
products. There can be no assurance that the Company's products under
development will be able to compete successfully with existing products or
products under development by other companies, universities and other
institutions or that they will attain regulatory approval in the United States
or elsewhere.
MANUFACTURING AND SOURCES OF SUPPLY
The Company manufactures GRAFTSKIN for use in its clinical trials at its
Canton, Massachusetts facility and intends to manufacture GRAFTSKIN for its
commercial sale at the facility. Among the fundamental raw materials needed to
fabricate GRAFTSKIN is a small number of keratinocytes and fibroblasts. In order
for products of the Company made with these initial cells to be used as a
replacement for human skin, it is critical that the cells be disease-free. The
Company has experienced no difficulty obtaining cells, and has established a
mechanism for obtaining screened cells from donors certified by blood testing to
be free of the "HIV" or "AIDS" virus and other pathogens.
The major additional material required to produce the Company's products is
collagen, a protein ordinarily obtained from cows or pigs by commercial
suppliers. The Company determined that collagen provided by the usual commercial
sources is not suitable for the Company's purposes. Accordingly, the Company has
developed a proprietary method of producing its own collagen. This process
yields collagen which the Company believes is superior in quality and strength
to collagen available from commercial sources and which provides the Company
with a continuous, high-quality source of supply.
The other raw materials required in the production of the Company's
products are primarily chemical nutrients, which are readily available from a
number of commercial sources.
The process of manufacturing the Company's products is complex, requiring
strict adherence to manufacturing protocols. Organogenesis is producing
GRAFTSKIN on a pilot-scale adherence to manufacturing protocols. Organogenesis
is producing GRAFTSKIN on a pilot-scale basis in quantities sufficient to meet
its clinical testing needs, and the Company believes that it can produce
increased quantities as needed. However, the transition from
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pilot-scale manufacturing to large-scale production of the Company's products is
difficult, and there can be no assurance that the Company will be able to make
this transition successfully. As the Company undertakes the manufacture of
additional products on a commercial basis, the Company will be required to
construct a manufacturing facility in compliance with Good Manufacturing
Practices requirements.
GOVERNMENT REGULATION
The Company's present and proposed activities are subject to government
regulation in the United States and other countries. In order to clinically
test, produce and market medical devices for human use, the Company must satisfy
mandatory procedures and safety and efficacy requirements established by the FDA
and comparable state and foreign regulatory agencies. Typically, such rules
require that products be approved by the government agency as safe and effective
for their intended use prior to being marketed. The approval process is
expensive, time-consuming and subject to unanticipated delays, and no assurance
can be given that any agency will grant its approval.
Testing is necessary to determine safety and efficacy before a submission
may be filed with the FDA to obtain authorization to market regulated products.
In addition, the FDA imposes various requirements on manufacturers and sellers
of products under its jurisdiction, such as labeling, good manufacturing
practices, record keeping and reporting requirements. The FDA also may require
post-marketing testing and surveillance programs to monitor a product's effects.
If the Company develops any product to a point where FDA authorization
becomes required, there can be no assurance that the appropriate authorization
will be granted, that the process to obtain such authorization will not be
excessively expensive or lengthy, or that the Company will have sufficient funds
to pursue such approvals. Moreover, the failure to receive requisite
authorization for the Company's products or processes when and if developed or
significant delays in obtaining such authorization would prevent the Company
from commercializing its products as anticipated and may have a materially
adverse effect on the business of the Company.
Additional government regulation may be established that could prevent or
delay regulatory approval of the Company's product candidates. Delays in
obtaining regulatory approvals would adversely affect the marketing of any
products developed by the Company and the Company's ability to receive product
revenues or royalties. If regulatory approval of a potential product is
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granted, such approval may include significant limitations on the indicated uses
for which such product may be marketed.
Even if initial regulatory approvals for the Company's product candidates
are obtained, the Company, its products and its manufacturing facilities are
subject to continual review and periodic inspection. The regulatory standards
for manufacturing are applied stringently by the FDA. Discovery of previously
unknown problems with a product, manufacturer or facility may result in
restrictions on such product or manufacturer or facility, including warning
letters, fines, suspensions of regulatory approvals, product recalls, operating
restrictions, delays in obtaining new product approvals, withdrawal of the
product from the market, and criminal prosecution. Other violations of FDA
requirements can result in similar penalties.
PRODUCT LIABILITY AND AVAILABILITY OF INSURANCE
The Company's business exposes it to potential liability risks that are
inherent in the testing, manufacturing and marketing of medical products. The
use of the Company's product candidates in clinical trials may expose the
Company to product liability claims and possible adverse publicity. These risks
also exist with respect to the Company's product candidates, if any, that
receive regulatory approval for commercial sale. The Company currently has
limited product liability coverage for the clinical research use of its product
candidates. The Company does not have product liability insurance for the
commercial sale of its product candidates but intends to obtain such coverage if
and when its products are commercialized. However, there can be no assurance
that the Company will be able to obtain additional insurance coverage at
acceptable costs, if at all, or that a product liability claim would not
materially adversely affect the business or financial condition of the Company.
HAZARDOUS MATERIALS
Medical and biopharmaceutical research and development involves the
controlled use of hazardous materials, such as various radioactive compounds.
The Company is subject to federal, state and local laws and regulations
governing the use, manufacture, storage, handling and disposal of such materials
and certain waste products. Although the Company believes that its safety
procedures for handling and disposing of such materials comply with the
standards prescribed by state and federal regulations, the risk of accidental
contamination or injury from those materials cannot be completely eliminated. In
the event of such an accident, the Company could be held liable for any damages
that result and any such liability could exceed the resources of the Company.
Although the Company believes that it is in
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compliance in all material respects with applicable environmental laws and
regulations and currently does not expect to make material capital expenditures
for environment control facilities in the near-term, there can be no assurance
that the Company will not be required to incur significant costs to comply with
environmental laws and regulations, or any assurance that the operations,
business or assets of the Company will not be materially adversely affected by
current or future environmental laws or regulations.
UNCERTAINTY OF THIRD-PARTY REIMBURSEMENT
In both domestic and foreign markets, the ability of the Company to
commercialize its product candidates will depend, in part, on the availability
of reimbursement from third-party payors, such as government health
administration authorities, private health insurers and other organizations.
Third-party payors are increasingly challenging the price and cost-
effectiveness of medical products. There can be no assurance that
Company-developed products will be considered cost effective. Significant
uncertainty exists as to the reimbursement status of newly-approved healthcare
products. There can be no assurance that adequate third-party insurance coverage
will be available for the Company to establish and maintain price levels
sufficient for realization of an appropriate return on its investment in
developing new therapies. Government and other third-party payors are
increasingly attempting to contain healthcare costs by limiting both coverage
and the level of reimbursement for new therapeutic products approved for
marketing by the FDA and by refusing, in some cases, to provide any coverage for
uses of approved products for disease indications for which the FDA has not
granted marketing approval. If adequate coverage and reimbursement levels are
not provided by government and third-party payors for uses of the Company's
therapeutic products, the market acceptance of these products would be adversely
affected.
UNCERTAINTY RELATED TO HEALTH CARE REFORM MEASURES
There have been a number of federal and state proposals during the last few
years to subject the pricing of pharmaceuticals to government control and to
make other changes to the health care system of the United States. It is
uncertain what legislative proposals will be adopted or what actions federal,
state or private payors for health care goods and services may take in response
to any health care reform proposals or legislation. The Company cannot predict
the effect health care reforms may have on its business, and no assurance can be
given that any such reforms will not have a material adverse effect on the
Company.
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DEPENDENCE ON STRATEGIC RELATIONSHIPS
The Company has limited experience in sales, marketing and distribution.
The Company will need to develop long-term strategic relationships with
companies that have marketing and sales forces with technical expertise and
distribution capability. To the extent that the Company enters into such
relationships, any revenues received by the Company will depend upon the efforts
of third parties and there can be no assurance that such efforts will be
successful. There can be no assurance that the Company will be able to establish
such long-term relationships or that it or its collaborators will be successful
in gaining market acceptance for any products that may be developed by the
Company.
STOCK PRICE VOLATILITY
The market prices of securities of biotechnology companies have been
volatile. Factors such as announcements of technological innovations, new
commercial products by the Company or its competitors, governmental regulations,
patent or proprietary rights developments, public concern as to safety or other
implications of biotechnology products and market conditions in general may have
a significant impact on the market price of the Common Stock. Between the date
of the Company's initial public offering in December 1986 and September 15,
1995, the Company's stock has traded at per share prices (after adjustment to
account for the 25% Common Stock dividend distributed by the Company on
September 8, 1995) between $3.80 and $20.10. From December 31, 1992 until
September 15, 1995, the per share price range has been between $4.40 and $20.10.
There can be no assurance that this high level of volatility will not persist in
the future, and that investors in this offering will not be adversely affected.
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USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common Stock by
the Selling Stockholder.
DESCRIPTION OF CAPITAL STOCK
AUTHORIZED AND OUTSTANDING CAPITAL STOCK. The Company is authorized to
issue 20,000,000 shares of Common stock, $.01 par value per share ("Common
Stock"), and 1,000,000 shares of Preferred Stock, $1.00 par value per share
("Preferred Stock"). Unless otherwise specified, all share prices and numbers
have been adjusted to account for a 25% Common Stock dividend distributed by the
Company on September 8, 1995.
As of September 15, 1995, there were issued and outstanding 13,270,051
shares of Common Stock and 250,000 shares of Series A Convertible Preferred
Stock (the "Series A Stock"). The Series A Stock is convertible into 312,500
shares of Common Stock. In addition, as of September 15, 1995, the Company had
reserved an aggregate of 2,500,000 (1,768,463 of which are available for future
issuances) shares of Common Stock for issuance under its 1986 Stock Option
Plan, 187,500 (179,476 of which are available for future issuances) shares of
Common Stock for issuance under its 1991 Employee Stock Purchase Plan, 125,000
(56,250 of which are available for future issuances) shares of Common Stock
for issuance under the 1991 Directors' Stock Option Plan, 250,000 shares of
Common Stock for issuance under its 1994 Directors' Stock Option Plan,
1,500,000 shares of Common Stock for issuance under its 1995 Stock Option Plan,
375,000 shares of Common Stock for issuance pursuant to a stock option
agreement with the Chairman of the Company, and 521,875 shares of Common Stock
for issuance upon the exercise of certain warrants described below. Except as
described above with respect to the 1986 Stock Option Plan, the 1991 Employee
Stock Purchase Plan and the 1991 Directors' Stock Option Plan, all shares
reserved for issuance under the Company's stock plans are available for future
issuances.
COMMON STOCK. The holders of Common Stock are entitled to one vote per
share for each share held of record on all matters submitted to a vote of
stockholders and are entitled to receive ratably such dividends as may be
declared by the Board of Directors out of funds legally available therefor. In
the event of a liquidation, dissolution or winding up of the Company, holders of
Common Stock have the right to a ratable portion of assets remaining after
payment of liabilities and the liquidation preferences of any outstanding
Preferred Stock. The holders of Common Stock have no preemptive rights or rights
to convert their Common Stock into any other securities and are not subject to
future calls or assessments by the Company. All outstanding shares of Common
Stock are fully paid and non-assessable.
PREFERRED STOCK. The Board of Directors may, without further action of the
stockholders of the Company, issue Preferred Stock in one or more series and fix
the rights and preferences thereof, including dividend rights, dividend rates,
conversion rights, voting rights, terms of redemption (including sinking fund
provisions), redemption price or prices, liquidation preferences and the number
of shares constituting any series or the designation of such series.
The rights of the holders of Common Stock as described above will be
subject to, and may be adversely affected by, the rights of holders of any
Preferred Stock that may be issued in the future. Issuance of Preferred Stock,
while providing desirable flexibility in connection with possible acquisitions,
and other
-13-
<PAGE> 15
corporate purposes, could have the effect of making it more difficult for a
third party to acquire, or of discouraging a third party from acquiring, a
majority of the outstanding voting stock of the Company. The Company has no
present plans to issue any additional shares of Preferred Stock.
Series A Stock. On May 12, 1991, the Board of Directors authorized the
designation of 250,000 shares of Series A Stock. All of the authorized and
issued shares of Series A Stock were purchased by Dominion Capital, Inc.
("Dominion"). The Company may redeem the Series A Stock at any time, in whole or
in part, by paying a redemption price of $8.00 per share. The Series A Stock has
a liquidation preference over Common Stock equal to $10.00 per share.
Each holder of shares of Series A Stock is entitled to the number of votes
equal to the number of whole shares of Common Stock into which the shares of
Series A Stock are convertible (currently, 1.25 votes per share). The Company
may not (a) amend, alter or repeal the preferences, special rights or other
powers of the Series A Stock so as to adversely affect the Series A Stock, or
(b) amend, alter or modify its Restated Certificate of Incorporation to increase
the number of authorized shares of Series A Stock, without the written consent
of the holders of a majority of the then outstanding shares of Series A Stock.
Dominion has notified the Company that it intends to convert the 250,000
shares of Series A Stock held by it (the "Dominion Shares") into Common Stock.
The Dominion Shares are convertible into 312,500 shares of Common Stock (the
"Conversion Shares"). Dominion has requested that the Company file a
registration statement with the Commission to register the Conversion Shares
under the Securities Act (the "Conversion Shares Registration Statement"). The
Company expects to file the Conversion Shares Registration Statement
concurrently with the filing of the Registration Statement of which this
Prospectus is a part. If, and when, the Conversion Shares Registration Statement
is declared effective by the Commission, the Conversion Shares will become
freely tradeable in the public market.
Series B Stock. On August 24, 1995 the Board authorized the designation of
50,000 shares of Series B Junior Participating Preferred Stock (the "Series B
Stock"). No shares of Series B Stock have been issued by the Company and the
Company has no present intent to issue any such shares. Shares of Series B Stock
rank, with respect to the payment of dividends and the distribution of assets,
junior to all series of any other class of Preferred Stock, including, but not
limited to, the Series A Stock, unless the terms of any such series shall
provide otherwise. Subject to the foregoing, each share of Series B
-14-
<PAGE> 16
Stock, when and if issued, would be entitled to a minimum quarterly dividend
payment of $10.00 per share and would be entitled to an aggregate dividend of
1,000 times any dividend declared per share of Common Stock. In the event of a
liquidation, the holders of the Series B Stock would be entitled to, subject to
the rights of the holders of Series A Stock and holders of any other Preferred
Stock which is senior to the Series B Stock, a minimum preferential liquidating
payment of $10.00 per share and would be entitled to an aggregate payment of
1,000 times the payment made per share on Common Stock. If and when issued, each
share of Series B Stock would be entitled to 1,000 votes, when voting together
with the Common Stock.
COMMON STOCK PURCHASE WARRANTS. There are currently outstanding Common
Stock Purchase Warrants (the "Warrants") issued by the Company to certain
investors to purchase an aggregate of 521,875 shares of its Common Stock, for
exercise prices ranging from $9.60 per share to $12.00 per share. Warrants to
purchase 287,500 shares of Common Stock were issued by the Company in July 1995
(the "1995 Warrants"). Each of the 1995 Warrants entitles the holders thereof to
purchase shares of Common Stock at an exercise price of $15.90 per share during
the period from October 14, 1995 through October 14, 2001. The remainder of the
Warrants (the "Pre-1995 Warrants") are exercisable at any time by the holders
thereof. Pre-1995 Warrants to purchase an aggregate of 187,500 shares of Common
Stock expire in November 1996 and Pre-1995 Warrants to purchase an aggregate of
46,875 shares of Common Stock expire on April 3, 1996.
The shares of Common Stock issuable upon exercise of the 1995 Warrants have
been registered under the Securities Act of 1933, as amended, (the "Securities
Act"). The shares of Common Stock issuable upon exercise of the Pre-1995
Warrants (the "Registrable Shares") have not been registered under the
Securities Act. However, the Company has granted the holders of the Pre-1995
Warrants demand registration rights to require the Company to register the
Registrable Shares under the Securities Act at the Company's expense. The
Company has also granted incidental registration rights to each holder of
Pre-1995 Warrants.
SHAREHOLDER RIGHTS. On August 24, 1995 the Board declared a dividend
distribution of one right (the "Rights") for each outstanding share of Common
Stock. Each Right entitles the registered holder to purchase from the Company
one-one thousandth of a share of Series B Stock at a purchase price of $85.00 in
cash, subject to adjustment. Initially, the Rights will be attached to all
Common Stock certificates representing shares then outstanding and no separate
Rights Certificates will be distributed. The Rights will separate from the
Common Stock and a "Distribution Date" will occur upon the earlier of (i) ten
days
-15-
<PAGE> 17
following a public announcement that a person or group of affiliated or
associated persons (an "Acquiring Person") has acquired or obtained the right to
obtain beneficial ownership of 15% or more of the outstanding shares of Common
Stock (the "Stock Acquisition Date"), or (ii) ten business days following the
commencement of a tender offer or exchange offer that would result in a person
or group beneficially owning 30% or more of the Company's outstanding shares of
Common Stock. The rights are not exercisable until the Distribution Date and
will expire at the close of business on September 1, 2005, unless earlier
redeemed or exchanged by the Company. At any time until ten days following the
Stock Acquisition Date, the Company may redeem the Rights, in whole but not in
part, at a price of $.01 per Right (payable in cash or stock).
If any person becomes the beneficial owner of 15% or more of the shares of
Common Stock of the Company, except pursuant to a tender or exchange offer for
all shares at a fair price as determined by the non-employee members of the
Board of Directors, each Right not owned by the 15% or more shareholder will
enable its holder to purchase that number of shares of the Company's Common
Stock which equals the exercise price of the Right divided by one-half of the
current market price of such Common Stock at the date of the occurrence of the
event. In addition, if the Company is involved in a merger or other business
combination transaction with another person or group in which it is not the
surviving corporation or in connection with which its Common Stock is changed or
converted, or it sells or transfers 50% or more of its assets or earning power
to another person, each Right that has not previously been exercised would
entitle its holder to purchase that number of shares of Common Stock of such
other person which equals the exercise price of the Right divided by one-half of
the current market price of such Common Stock at the date of the occurrence of
the event.
TRANSFER AGENT AND REGISTRAR
The transfer agent and registrar for the Company's Common Stock is American
Stock Transfer & Trust Company.
-16-
<PAGE> 18
THE SELLING STOCKHOLDER
The following table sets forth the name and the number of shares of
Common Stock beneficially owned by the Selling Stockholder as of September 15,
1995, the number of the shares to be offered by the Selling Stockholder
pursuant to this Prospectus and the number of shares to be beneficially owned
by the Selling Stockholder if all of the shares offered hereby by the Selling
Stockholder are sold as described herein. The Selling Stockholder was
President and Chief Operating Officer of the Company from August 1991 until
February 1994.
<TABLE>
<CAPTION>
SHARES OF
SHARES OF COMMON STOCK
COMMON STOCK BENEFICIALLY OWNED
BENEFICIALLY OWNED(1) AFTER OFFERING(1)
--------------------- SHARES OF --------------------
PERCENTAGE OF COMMON STOCK PERCENTAGE OF
NAME OF SELLING STOCKHOLDER NUMBER COMMON STOCK OFFERED HEREBY NUMBER COMMON STOCK
- --------------------------- ------ ------------ -------------- ------ ------------
<S> <C> <C> <C> <C> <C>
Thomas M. Tully 28,125 * 28,125 0 *
</TABLE>
- -------------------
* Less than 1%.
(1) Includes securities exercisable or convertible into Common Stock within 60
days after September 30, 1995.
PLAN OF DISTRIBUTION
Shares of Common Stock covered hereby may be offered and sold from time to
time by the Selling Stockholder. The Selling Stockholder will act independently
of the Company in making decisions with respect to the timing, manner and size
of each sale. Such sales may be made on the American Stock Exchange or
otherwise, at prices related to the then current market price or in negotiated
transactions, including pursuant to an underwritten offering or one or more of
the following methods: (a) purchases by a broker-dealer as principal and resale
by such broker or dealer for its account pursuant to this Prospectus; (b)
ordinary brokerage transactions and transactions in which a broker solicits
purchasers; and (c) block trades in which a broker-dealer so engaged will
attempt to sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction. The Company has been advised
by the Selling Stockholder that he has not made any arrangements relating to the
distribution of the shares covered by this Prospectus. In effecting sales,
broker-dealers engaged by the Selling Stockholder may arrange for other
broker-dealers to participate. Broker-dealers will receive commissions or
discounts from the Selling Stockholder in amounts to be negotiated immediately
prior to the sale.
In offering the shares of Common Stock covered hereby, the Selling
Stockholder and any broker-dealers and any other participating broker-dealers
who execute sales for the Selling Stockholder may be deemed to be "underwriters"
within the meaning of the Securities Act in connection with such sales, and any
profits realized by the Selling Stockholder and the compensation of such
broker-dealer may be deemed to be underwriting discounts
-17-
<PAGE> 19
and commissions. In addition, any shares covered by this Prospectus which
qualify for sale pursuant to Rule 144 may be sold under Rule 144 rather than
pursuant to this Prospectus. None of the shares covered by this Prospectus
presently qualify for sale pursuant to Rule 144.
The Company has advised the Selling Stockholder that during such times as
he may be engaged in a distribution of Common Stock included herein he is
required to comply with Rules 10b-6 and 10b-7 under the Exchange Act (as those
Rules are described in more detail below) and, in connection therewith, that he
may not engage in any stabilization activity in connection with the Company's
securities, is required to furnish to each broker-dealer, through which Common
Stock included herein may be offered, copies of this Prospectus and that he may
not bid for or purchase any securities of the Company or attempt to induce any
person to purchase any of the Company's securities except as permitted under the
Exchange Act. The Selling Stockholder has agreed to inform the Company when the
distribution of the shares is completed.
Rule 10b-6 under the Exchange Act prohibits, with certain exceptions,
participants in a distribution from bidding for or purchasing, for an account in
which the participant has a beneficial interest, any of the securities that are
the subject of the distribution. Rule 10b-7 governs bids and purchases made in
order to stabilize the price of a security in connection with a distribution of
the security.
This offering will terminate on the earlier of (a) 60 days after the date
upon which the Registration Statement, of which this Prospectus is a part, is
declared effective by the Commission or (b) the date upon which all shares
offered hereby have been sold by the Selling Stockholder.
LEGAL MATTERS
The validity of the shares offered hereby will be passed upon for the
Company by Hale and Dorr, Boston, Massachusetts.
EXPERTS
The consolidated balance sheets of the Company as of December 31, 1994 and
1993 and the related consolidated statements of operations, stockholders'
deficit and cash flows for each of the three years in the period ended December
31, 1994 are incorporated by reference in this Prospectus and elsewhere in the
registration statement and have been incorporated herein in reliance upon the
reports of Coopers & Lybrand L.L.P., independent accountants, given on the
authority of such firm as experts in accounting and auditing.
-18-
<PAGE> 20
================================================================================
No dealer, sales representative or any other person has been authorized to give
any information or to make any representation in connection with this offering
other than those contained in this Prospectus, and if given or made, such
information or representation must not be relied upon as having been authorized
by the Company. This Prospectus does not constitute an offer to sell, or a
solicitation of an offer to buy, any securities other than the registered
securities to which it relates or an offer to, or solicitation of, any person in
any jurisdiction where such an offer or solicitation would be unlawful. Neither
the delivery of this Prospectus nor any sale made hereunder shall, under any
circumstance, create any implication that there has been no change in the
affairs of the Company since the date hereof or that the information contained
herein is correct as of any date subsequent to the date hereof.
================================================================================
ORGANOGENESIS INC.
LOGO
____________________
PROSPECTUS
____________________
______ __ , 1995
================================================================================
-19-
<PAGE> 21
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The costs of issuance and distribution will be borne by the Registrant as
follows:
<TABLE>
<S> <C>
SEC Registration Fee.................................. $ 172
AMEX Listing Fee...................................... 563
Accounting Fees and Expenses*......................... 5,000
Legal Fees and Expenses*.............................. 5,000
Printing and Engraving*............................... 5,000
Miscellaneous*........................................ 4,265
-------
Total............................................ $20,000
=======
</TABLE>
- ---------------
* Estimated
Item 15. Indemnification of Directors and Officers.
Section 145 of the General Corporation Law of the State of Delaware
provides that a corporation has the power to indemnify a director, officer,
employee or agent of the corporation and certain other persons serving at the
request of the corporation in related capacities against amounts paid and
expenses incurred in connection with an action or proceeding to which he is or
is threatened to be made a party by reason of such position, if such person
shall have acted in good faith and in a manner he reasonably believed to be in
or not opposed to the best interests of the corporation, and, in any criminal
proceeding, if such person had no reasonable cause to believe his conduct was
unlawful, provided that, in the case of actions brought by or in the right of
the corporation, no indemnification shall be made with respect to any matter as
to which such person shall have been adjudged to be liable to the corporation
unless and only to the extent that the adjudicating court determines that such
indemnification is proper under the circumstances.
Section 102(b)(7) of the Delaware General Corporation Law, as amended,
permits a corporation to provide in its certificate of incorporation that a
director of the corporation shall not be personally liable to the corporation or
its stockholders for monetary damages for breach of fiduciary duty as a
director, except for liability (i) for any breach of the director's duty of
loyalty to the corporation or its stockholders, (ii) for acts or omissions not
in good faith or which involve intentional
II-1
<PAGE> 22
misconduct or a knowing violation of law, (iii) under Section 174 of the
Delaware General Corporation Law, or (iv) for any transaction from which the
director derived an improper personal benefit.
The Company's Restated Certificate of Incorporation provides for
indemnification to the fullest extent permitted by law and that the Company may
advance litigation expenses to an officer or director prior to the final
disposition of an action.
The Company's Restated Certificate of Incorporation also provides, as
permitted by Delaware law, that directors shall not be personally liable to the
Company or its stockholders for monetary damages for breach of fiduciary duty as
a director, except for liability (i) for any breach of a director's duty of
loyalty to the Company or its stockholders, (ii) for acts or omissions not in
good faith or which involve intentional misconduct or knowing violations of law,
(iii) under Section 174 of the Delaware General Corporation Law or (iv) for any
transaction from which the director derived an improper personal benefit.
The Company has a Directors and Officers liability insurance policy that
insures the Company's officers and directors against certain liabilities.
Item 16. Exhibits.
See Exhibit Index included immediately preceding the Exhibits to this
Registration Statement, which is incorporated herein by reference.
Item 17. Undertakings.
(a) Insofar as indemnification for liabilities arising under the Securities
Act of 1933, as amended (the "Securities Act") may be permitted to directors,
officers and controlling persons of the Registrant pursuant to the provisions
described under "Item 15 -- Indemnification of Directors and Officers" above, 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
II-2
<PAGE> 23
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.
(b) The undersigned Registrant hereby undertakes:
(1) For purposes of determining any liability under the Securities Act
of 1933, the information omitted from the form of prospectus filed as part of
this Registration Statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4), or
497(h) under the Securities Act shall be deemed to be part of this Registration
Statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities
Act, each post-effective amendment that contains a form of prospectus 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.
(c) The undersigned Registrant hereby undertakes 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
Exchange Act (and, where applicable, each filing of an employee benefit plan's
annual report pursuant to Section 15(d) of the Exchange Act) that is
incorporated by reference in this Registration Statement shall be deemed to be a
new registration statement relating to the securities offered herein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
II-3
<PAGE> 24
SIGNATURES AND POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Herbert
M. Stein and Steven D. Singer and each of them, his true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution
in each of them, for him and in his name, place and stead, and in any and all
capacities, to sign any and all amendments (including post-effective amendments
to this Registration Statement on Form S-3 of Organogenesis Inc. (or any other
Registration Statement for the same offering that is to be effective upon filing
pursuant to Rule 462(b) under the Securities Act) and to file the same, with all
exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents, and each of them, full power and authority to do and perform each and
every act and thing requisite or necessary to be done in and about the premises,
hereby ratifying and confirming all that said attorneys-in-fact and agents or
any of them or their or his substitutes or substitute, may lawfully do or cause
to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
registration Statement has been signed by the following persons in the
capacities indicated.
ORGANOGENESIS INC.
By: /S/ HERBERT M. STEIN
------------------------
Herbert M. Stein
Chief Executive Officer
Signature Title Date
- --------- ----- ----
/S/ HERBERT M. STEIN Chief Executive Officer, October 12, 1995
- ------------------------ Chairman and Director
Herbert M. Stein (Principal Executive Officer,
Principal Financial Officer
and Principal Accounting
Officer)
/S/ DAVID T. ROVEE President, Chief Operating October 12, 1995
- ------------------------ Officer, Chief Scientific
David T. Rovee Officer and Director
/S/ RICHARD S. CRESSE Director October 12, 1995
- ------------------------
Richard S. Cresse
/S/ WILLIAM J. HOPKE Director October 12, 1995
- ------------------------
William J. Hopke
/S/ MARGUERITE A. PERIT Director October 12, 1995
- ------------------------
Marguerite A. Perit
/S/ ANTON E. SCHRAFL Director October 12, 1995
- ------------------------
Anton E. Schrafl
/S/ BJORN R. OLSEN Director October 12, 1995
- ------------------------
Bjorn R. Olsen
II-4
<PAGE> 25
EXHIBIT INDEX
Exhibit Description of Exhibit
- ------- ----------------------
*4.1 Restated Certificate of Incorporation, as amended, of Organogenesis
Inc.
**4.2 Certificate of Stock Designation, Number, Voting Powers, Preferences
and Rights of the Series of the Preferred Stock of Organogenesis
Inc., Designated Series A Convertible Preferred Stock
***4.3 Certificate of Stock Designation, Number, Voting Powers, Preferences
and Rights of the Series of Preferred Stock of Organogenesis Inc.,
Designated Series B Junior Participating Preferred Stock.
****4.4 By-Laws, as amended, of Organogenesis Inc.
4.5 Stock Option Agreement between Mr. Thomas M. Tully and Organogenesis
Inc.
5 Opinion of Hale and Dorr
23.1 Consent of Coopers & Lybrand L.L.P.
23.2 Consent of Hale and Dorr (included in Exhibit 5)
24.1 Powers of Attorney (See Page II-4)
- --------------------
* Incorporated by reference to the Company's Registration Statement on Form
S-3 (File No. 33-40287), filed with the Commission on April 30, 1991.
** Incorporated by reference to the Company's Quarterly Report on Form 10-Q
for the quarter ended June 30, 1991 (File No. 0-15246), filed with the
Commission on August 13, 1991.
*** Incorporated by reference to the Company's Current Report on Form 8-K (File
No. 0-15246), filed with the Commission on August 31, 1995.
**** Incorporated by reference to the Company's Annual Report on Form 10-K (File
No. 0-15246) filed with the Commission on March 31, 1987.
<PAGE> 1
Exhibit 4.5
ORGANOGENESIS INC.
STOCK OPTION AGREEMENT
1. Grant of Option. Organogenesis Inc., a Delaware corporation
(the "Company"), hereby grants to Thomas M. Tully ("Tully"), an option to
purchase an aggregate of 22,500 shares of Common Stock, $.01 par value ("Common
Stock"), of the Company at a price of $10.63 per share, purchasable as set
forth in and subject to the terms and conditions of this option.
2. Exercise of Option.
(a) Immediate Vesting and Expiration. Except as otherwise
provided in this Agreement, this option shall be immediately exercisable, in
whole or in part, and shall remain exercisable prior to 5:01 p.m. on June 30,
1996, at which time it shall expire (hereinafter the "Expiration Date"),
(b) Exercise Procedure. Subject to the conditions set
forth in this Agreement, this option shall be exercised by Tully's delivery to
the Company of the Exercise Form attached as Appendix I specifying the number
of shares to be purchased and the purchase price to be paid therefor and
accompanied by payment in full in accordance with Section 3. Such exercise
shall be effective upon execution by Tully and the Company of the Exercise
Form. Tully may purchase less than the number of shares covered hereby,
provided that no partial exercise of this option may be for any fractional
share or for fewer than ten whole shares.
3. Payment of Purchase Price. Payment of the purchase price for
shares purchased upon exercise of this option shall be made by delivery to the
Company of cash or a bank or certified check to the order of the company in an
amount equal to the purchase price of such shares.
4. Nontransferability of Option. This option is personal and no
rights granted hereunder may be transferred, assigned, pledged or hypothecated
in any way (whether by operation of law or otherwise) nor shall any such rights
be subject to execution, attachment or similar process; provided, however, that
in the event of Tully's death prior to the Expiration Date, this option may be
exercised by the person or persons to whom this option is transferred by will
or the laws of descent and distribution. Upon any attempt to transfer, assign,
pledge, hypothecate or otherwise dispose of this option or of such rights
contrary to the provision hereof, or upon the levy of any attachment or similar
process upon this option or such rights, this option and such rights shall, at
the election of the Company become null and void.
<PAGE> 2
5. Withholding Taxes. The Company's obligation to deliver shares
upon the exercise of this option shall be subject to Tully's satisfaction of
all applicable federal, state and local income and employment tax withholding
requirements.
6. Restricted Stock. Tully acknowledges that the common stock of
the Company to be acquired upon exercise of this option will be "restricted
stock" under the Securities Act of 1933 (the "Act") and may not be transferred,
sold or otherwise disposed of unless registered under the Act or unless any
such transfer, sale or disposition is exempt under the Act. To allow Tully to
publicly sell the shares of common stock received upon exercise of this option,
the Company agrees that it will, as soon as practicable after written request
by Tully for registration, prepare and file with the Securities and Exchange
Commission ("SEC") a registration statement under the Act covering the shares
purchased upon exercise of this option and will use its best efforts to cause
such registration statement to be declared effective by the SEC and to keep
such registration statement effective for a period of 60 days or until such
earlier time as all such shares are sold. In addition, the Company will take
such action as is required under the securities laws of the Commonwealth of
Massachusetts to qualify all such shares in Massachusetts. The Company agrees
to pay all expenses incurred by the Company in compliance with this paragraph,
including all the registration and filing fees, printing expenses, fees and
disbursements of the Company's counsel and any fees and expenses required in
connection with qualification of the sale of such shares in Massachusetts, but
not the expenses of any counsel to Tully. Any shares of common stock issued
upon exercise of this option which are not so registered under the Act shall
have affixed thereto a legend providing that the shares are restricted and may
not be sold or otherwise disposed of in the absence of an effective
registration statement under the Act or an opinion of Company's counsel to the
effect that such registration is not required. The Company agrees to remove
this legend after such shares are registered under the Act.
7. Miscellaneous
(a) Except as provided herein, this option may not be
amended or otherwise modified unless evidenced in writing and signed by the
Company and Tully.
(b) All notices under this option shall be mailed or
delivered by hand to the parties at their respective addresses set forth
beneath their names below or at such other address as may be designated in
writing by either of the parties to one another.
-2-
<PAGE> 3
(c) This option shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts.
Date of Grant: ORGANOGENESIS, INC.
June 20, 1995 BY: /s/ HERBERT M. STEIN
--------------------------
Title: Chairman
----------------------
address: 150 Dan Road
Canton, MA 02021
ACCEPTANCE
The undersigned hereby accepts the forgoing option and agrees to the
terms and conditions thereof.
/s/ THOMAS M. TULLY
-----------------------------
Thomas M. Tully
Address: 712 High St.
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Dedham, MA 02026
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-3-
<PAGE> 4
APPENDIX I
FORM FOR EXERCISE OF STOCK OPTION
Date: __________________, 19__
Organogenesis Inc.
150 Dan Road
Canton, MA 02021
Attention: Treasurer
Dear Sir or Madam:
I am the holder of a Stock option granted to me on __________________________
for the purchase of __________________________ shares of Common Stock at a
purchase price of $______ per share.
I hereby exercise my option to purchase ___________________________ shares of
Common Stock, for which I have enclosed ________________________________ in the
amount of $_____________________. Please register my stock certificate as
follows:
Name(s): _____________________________________
_____________________________________
Address: _____________________________________
_____________________________________
Tax I.D. #: ___________________________________
Very truly yours,
_____________________________________
_____________________________________
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EXHIBIT 5
HALE AND DORR
60 STATE STREET
BOSTON, MASSACHUSETTS 02109
October 13, 1995
Organogenesis Inc.
150 Dan Road
Canton, MA 02021
Ladies and Gentlemen:
This opinion is furnished to you in connection with a Registration
Statement on Form S-3 (the "Registration Statement"), filed with the Securities
and Exchange Commission (the "Commission") under the Securities Act of 1933, as
amended, for the registration of 28,125 shares of Common Stock, $.01 par value
per share (the "Shares"), of Organogenesis Inc., a Delaware corporation (the
"Company"), issuable upon the exercise of an option (the "Option") to purchase
the Shares held by the Selling Stockholder, as defined in the Registration
Statement.
We have examined the Registration Statement and all exhibits thereto, all
as filed with the Commission. We have also examined and relied upon the
originals, or copies of minutes of meetings or actions taken by unanimous
written consent of the Board of Directors of the Company, the By-laws of the
Company and the Restated Certificate of Incorporation of the Company, as
amended, and such other documents and instruments as in our judgment are
necessary or appropriate to enable us to render the opinions expressed below.
In our examination of the foregoing documents, we have assumed (i) the
genuineness of all signatures and the authenticity of any documents submitted to
us as originals, (ii) the conformity to the originals of any documents submitted
to us as conformed or photostatic copies and (iii) the authenticity of the
originals of the latter documents.
We have not made an independent review of the laws of any state or
jurisdiction other than the General Corporation Law statute of the State of
Delaware and the United States. Accordingly, we express no opinion herein with
respect to the laws of any state or jurisdiction other than the General
Corporation Law statute of the State of Delaware and the United States.
Based upon the foregoing, we are of the opinion that the Shares have been
duly authorized and that, subject to payment in full for the Shares by the
Selling Stockholder upon exercise of the Option, when issued to the Selling
Stockholder, they will be validly issued, fully paid and nonassessable.
We hereby consent to the filing of this opinion as part of the Registration
Statement and to the use of our name therein and in the related Prospectus under
the caption "Legal Matters."
Very truly yours,
HALE AND DORR
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EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in the Registration
Statement of Organogenesis Inc. on this Form S-3 of our report dated February
15, 1995, on our audits of the consolidated financial statements of
Organogenesis Inc. as of December 31, 1994 and 1993 and for each of the three
years in the period ended December 31, 1994 which report is included in the
Company's Report on Form 10-K filed with the Securities and Exchange Commission
on March 29, 1995. We also consent to the reference to our Firm under the
caption "Experts."
COOPERS & LYBRAND L.L.P.
Boston, Massachusetts
October 10, 1995
