<PAGE> 1
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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
-------------------------
ORGANOGENESIS INC.
(Exact name of registrant as specified in its charter)
<TABLE>
<CAPTION>
Delaware 04-2871690
<S> <C>
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification number)
-------------------------
</TABLE>
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.
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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.
/ /
CALCULATION OF REGISTRATION FEE
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<TABLE>
<CAPTION>
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>
- --------------------------------------------------------------------------------------------------------------------
Common Stock, $.01 par
value.... 312,500 shares $17.75 $5,546,875.00 $1,912.72
</TABLE>
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(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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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.
312,500 Shares
LOGO
ORGANOGENESIS INC.
COMMON STOCK
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The shares of Common Stock, $0.01 par value per share (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, for the
account of Dominion Capital, Inc. (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.
-12-
<PAGE> 14
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. It is anticipated
that the outstanding shares of Series A Stock will be converted into
Common Stock on or before the effective date of this Prospectus. 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
-13-
<PAGE> 15
future. Issuance of Preferred Stock, while providing desirable
flexibility in connection with possible acquisitions, and other
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 the Selling Stockholder. 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.
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
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.
-14-
<PAGE> 16
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
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
-15-
<PAGE> 17
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. Mr. William J. Hopke, a
member of the Company's Board of Directors since 1990, was an
officer (most recently as Senior Vice President and Treasurer) of
the Selling Stockholder from 1985 to August 1, 1995 and has been
Executive Vice President and Chief Operating Officer of Trilon
Dominion Partners, L.L.C., an investment management company which
manages portfolio investments for the Selling Stockholder since
August 1, 1995.
<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>
Dominion Capital, 443,125 3.3% 312,500 (2) (2)
Inc.
</TABLE>
-------------------
* Less than 1%.
(1) Includes securities exercisable or convertible into Common Stock
within 60 days after September 30, 1995.
(2) The Company cannot determine the number of shares of Common Stock
which will be held by the Selling Stockholder upon the completion
of the offering, as the length of time of the offering period and
the determination of whether to buy or sell additional securities
of the Company during the offering period are at the discretion
of the Selling Stockholder.
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 it 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. Pursuant to the Stock Registration Rights Agreement,
dated as of May 13, 1991, between the Company and the Selling
Stockholder, the Company has agreed to indemnify the Selling
Stockholder against certain liabilities under the Securities Act.
In offering the shares of Common Stock covered hereby, the
Selling Stockholder and any broker-dealers and any other
-17-
<PAGE> 19
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
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 it may be engaged in a distribution of Common Stock
included herein it 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 it may not engage
in any stabilization activity in connection with the Company's
securities, it is required to furnish to each broker-dealer,
through which Common Stock included herein may be offered, copies
of this Prospectus and that it 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)
April 30, 1997 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.................................. $ 1,913
AMEX Listing Fee...................................... 6,250
Accounting Fees and Expenses*......................... 5,000
Legal Fees and Expenses*.............................. 5,000
Printing and Engraving*............................... 5,000
Miscellaneous*........................................ 6,837
-------
Total............................................ $30,000
=======
</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
<TABLE>
<CAPTION>
Signature Title Date
<S> <C> <C>
/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
</TABLE>
II-4
<PAGE> 25
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit Description of Exhibit
<S> <C>
*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.
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)
</TABLE>
____________________
* 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 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 312,500 shares of Common Stock, $.01 par value
per share (the "Shares"), of Organogenesis Inc., a Delaware
corporation (the "Company"), issuable upon the conversion of
shares of Series A Convertible Preferred Stock (the "Series A
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 when issued to the Selling
Stockholder upon conversion of the Series A Shares, 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
<PAGE> 1
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 30, 1995
