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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JULY 16, 1996
REGISTRATION NO. 333-3995
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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AMENDMENT NO. 1 TO
FORM S-3/A
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
----------------
ORGANOGENESIS INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 04-2871690
(STATE OR OTHER JURISDICTION (I.R.S. EMPLOYER
OF 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)
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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:
JEFFREY M. WIESEN, ESQ.
MINTZ, LEVIN, COHN, FERRIS,
GLOVSKY AND POPEO, P.C.
ONE FINANCIAL CENTER
BOSTON, MASSACHUSETTS 02111
(617) 542-6000
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: At the
discretion of the Selling Stockholders.
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. 333- [_]
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. 333- [_]
If delivery of the prospectus is expected to be made pursuant Rule 434,
please check the following box. [_]
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS
REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT
SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID
SECTION 8(A), SHALL DETERMINE.
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++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+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. +
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
SUBJECT TO COMPLETION
PRELIMINARY PROSPECTUS DATED MAY 17, 1996
P R O S P E C T U S
[LOGO] 234,375 SHARES
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 Fondation Danonia and Gerard Klauer
Mattison & Co. (the "Selling Stockholders"). See "The Selling Stockholders."
All of the shares offered hereunder are to be sold by the Selling Stockholders.
The Company will not receive any of the proceeds from the sale of the shares by
the Selling Stockholders.
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THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 4 OF THIS PROSPECTUS.
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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 , 1996.
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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, 1995; and
(3) the Company's Quarterly Report on Form 10-Q for the quarter ended March
31, 1996.
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., Donna L. Abelli, Chief
Financial 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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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 medical 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 utilize working capital in 1996 related to ongoing product
research and development activities, conducting preclinical and clinical
trials, enhancement of proprietary manufacturing technologies, manufacturing
scale-up, filing and maintaining patents, expansion of business development,
public and investor relations programs and general and administrative
resources. These activities will require substantial additional financial
resources before the Company can expect to realize a net profit from product
sales. The Company has not had, and does not anticipate having, significant
revenue from the sale of its lead product, Graftskin(TM), before 1997, at the
earliest. No assurance can be given that additional financing composed of
equity investments and funding provided under collaborative agreements will be
available to fund future operations or that additional funds will be available
when required on terms acceptable to the Company. If funds are raised by
issuing equity securities, further dilution to existing stockholders will
result. 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. Depending
on future equity and research contributions from Sandoz Ltd., the Company may
need additional capital as soon as the end of the second quarter of 1997. The
Company's capital requirements may vary depending on numerous factors,
including: progress of the Company's research and development programs; time
required to obtain regulatory approvals; resources the Company devotes to
self-funded projects, proprietary manufacturing methods and advanced
technologies; and the demand for the Company's products, if and, when
approved.
HISTORY OF LOSSES AND ACCUMULATED DEFICIT
The Company experienced net losses of $9.9 million, $10.4 million and $12.7
million for the years ended December 31, 1993, 1994 and 1995, respectively.
The Company's accumulated deficit at March 31, 1995 was $61.4 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. Failure of the Company to attract and retain a
sufficient number of qualified scientific and business personnel could
adversely affect the Company's business and future prospects.
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. The
Company has a proprietary portfolio of patent rights and applications, and
exclusive licenses to patents and patent applications relating to tissue
equivalents, cell therapies and other aspects of tissue engineering. These
patent applications include patents relating to tissue sourcing, methods of
preparation, cell structure technologies, sterilization technologies,
manufacturing methods and cryopreservation of living tissue. There can be no
assurance that any patents will be issued as a result of the Company's
applications, or that issued patents will provide the Company with significant
protection against competitors. Moreover, there can be no assurance that any
patents issued to or licensed by the Company will not be infringed, or that
third parties will not independently develop either the same or similar
technology. 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. 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. Additional
information on Organogenesis' patent position is contained under the caption
"Patents and Proprietary Technology" in the Company's Annual Report on Form
l0-K for its fiscal year ended December 31, 1995, and is incorporated herein
by reference. The Company intends to continue to pursue aggressively patenting
its 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. 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
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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 competitors in the wound care products market include Johnson &
Johnson, Kendall, Smith & Nephew, Advanced Tissue Sciences, Bristol-Myers
Squibb 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, attract and retain
qualified scientific personnel, obtain patent or other protection for its
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 LIMITATIONS
The Company has only limited experience in the commercial manufacturing of
medical device products. The process of manufacturing the Company's products
is complex, requiring strict adherence to manufacturing protocols. The Company
is producing its lead product, Graftskin(TM), on a pilot-scale in adherence to
these manufacturing protocols in quantities sufficient to meet its clinical
testing needs. However, the transition from 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 products on a commercial basis,
the Company will be required to maintain a manufacturing facility in
compliance with Good Manufacturing Practices requirements. Manufacturing
facilities and processes must pass a pre-approval inspection before the FDA
will issue any product licenses necessary to market medical therapeutics, and
are subject to continual review and periodic inspection. There can be no
assurance that the Company will be able to manufacture any products
successfully and in a cost effective manner. If the Company is unable to
manufacture its potential products independently or obtain or retain third-
party manufacturing on commercially acceptable terms, the submission of
products for final regulatory approval and initiation of marketing would be
delayed. This, in turn, may cause the Company to be unable to commercialize
its product candidates as planned, which may have a material adverse effect on
the Company.
SOURCES OF SUPPLY
The Company manufactures Graftskin(TM) for use in its clinical trials at its
Canton, Massachusetts facility and intends to manufacture Graftskin(TM) for
its commercial sale at the facility. Among the fundamental raw materials
needed to manufacture Graftskin(TM), are small numbers of keratinocytes and
fibroblast cells. These cells are
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derived from donated infant foreskin. In order for the Company's products made
with these initial cells to be used as a replacement for human skin, it is
critical that the cells be pathogen free. Extensive testing is performed on
the blood from the donor's mother to assure a pathogen free condition. In
addition, frozen storage banks of cells derived from the foreskin tissue
undergo further in vitro testing to assure a pathogen free condition. There
can be no assurance that additional cells of adequate purity can be created,
or once created, that the cells derived from it will in fact be pathogen free.
Another major additional material required to produce the Company's products
is collagen, a protein ordinarily obtained from animal source tissue by
commercial suppliers. 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 Company currently obtains its animal source
tissue from U.S. suppliers only, as required by the U.S. Department of
Agriculture ("USDA"); there is currently only one other USDA approved country
from which these materials may be purchased. There can be no assurance that
the Company will be able to obtain adequate supplies of animal source tissue
to meet its future needs or that the Company will be able to obtain such
supplies on a cost effective basis.
The thermo formed tray assembly that is used in the manufacturing process of
Graftskin(TM), is available under a supply arrangement with only one FDA-
approved manufacturing source. Because the FDA approval process requires
manufacturers to specify their proposed materials of certain component parts
in their applications, FDA approval of a new material would be required if a
currently approved material became unavailable from a supplier. There can be
no assurance that the Company will be able to obtain adequate supplies of
thermo formed tray assemblies to meet its future Graftskin(TM) manufacturing
needs or that the Company will be able to obtain such assemblies on a cost
effective basis.
There can be no assurance that interruptions in supplies will not occur in
the future or that the Company would not have to obtain substitute vendors for
these materials. Any significant supply interruption would adversely affect
the Company's clinical trials, non commercial samples or future large scale
commercial manufacturing of Graftskin(TM). In addition, an uncorrected
impurity or suppliers variation in a raw material, either unknown to the
Company or incompatible with the Company's manufacturing process, could have a
material adverse effect on the Company's ability to manufacture its products.
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.
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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
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. 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. 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
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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.
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
such as Sandoz 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.
ABSENCE OF DIVIDENDS
The Company has never declared or paid any cash dividends on its capital
stock. The Company currently intends to retain earnings, if any, to support
the development of its business and does not anticipate paying cash dividends
in the foreseeable future.
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 March 31, 1996, 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 $21.625. From December 31,
1992 until March 31, 1996, the per share price range has been between $4.40
and $21.625. 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.
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. Tissue
engineering is a relatively new discipline focused on developing specialized
biomaterials and cellular constructs to assist, repair, regenerate, or replace
diseased or damaged organs. An understanding of the biology of cells and 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 these technologies
has resulted in a wide variety of product opportunities, including
Graftskin(TM), the Company's full-thickness skin replacement product.
Graftskin(TM), is currently under review by the FDA for marketing approval and
is not commercially available at this time. See "Risks Factors-Uncertainty of
Successful Commercialization."
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The Company has cell science and connective tissue science technologies and
expertise which it is using in a number of areas including wound care,
urology, cardiovascular surgery and general surgery. It is also exploring
additional opportunities in the areas of plastic surgery, orthopedics,
ophthalmalogy and oral cavity medicine. The Company's most advanced product,
Graftskin(TM), is a Living Skin Equivalent (LSE(TM)) for the treatment of skin
wounds, including wounds traditionally treated with skin, such as burn wounds
and wounds due to dermatological surgery, as well as the broader market of
wounds which would benefit from a biologically active cell therapy, such as
chronic wounds (e.g. venous stasis ulcers, diabetic ulcers and decubitus
ulcers). Graftskin(TM) was found to provide biological wound closure and was
thus able to contribute directly to the wound healing process.
In the Graftskin(TM) pivotal clinical trial for chronic venous ulcers, the
results showed that Graftskin(TM) achieved 100% wound closure in more
patients, and achieved it faster, than standard compression therapy, the
current standard of care. Graftskin(TM) was found to be highly effective even
in difficult-to-heal ulcers, and was found to have an excellent safety
profile, with no sign of tissue rejection. The Company is currently initiating
a pivotal clinical trial to study Graftskin(TM) in the treatment of diabetic
ulcers, and expects to initiate a pivotal clinical trial to study
Graftskin(TM) in the treatment of decubitus ulcers within the next twelve
months. The Company has completed the patient enrollment and efficacy
evaluation phase of a pivotal clinical trial to study Graftskin(TM) in the
treatment of burn wounds and is currently doing safety follow-up and data
analysis. Available data for this study suggests that meshed Graftskin(TM)
placed over meshed autograft may function as a skin replacement. Additionally,
the Company has completed patient enrollment and the efficacy and safety
evaluation phase for a pivotal clinical trial to study Graftskin(TM) in the
treatment of wounds created by dermatological surgery and the data are being
analyzed. Interim results suggest that Graftskin(TM)'s treatment provides
immediate closure, resurfacing of the wound with epithelium, rapid healing and
good cosmetic results.
In 1995, the Company submitted to the United States Food and Drug
Administration ("FDA"), and the FDA accepted for filing, the Graftskin(TM)
Premarket Approval Application ("PMA") for use in the treatment of venous
ulcers. The official filing date for this PMA was October 4, 1995. The FDA has
granted expedited review status to this PMA, which means it receives priority
in review over pending device regulatory applications. PMA applications under
expedited review status are still subject to all other controls and
requirements applicable to PMAs in the standard review process.
On January 17, 1996, Organogenesis and Sandoz Ltd. ("Sandoz") jointly
announced that Sandoz has been granted exclusive worldwide marketing rights
for Graftskin(TM), while Organogenesis has exclusive global manufacturing
rights. Organogenesis will receive royalties on all Graftskin(TM) sales,
payment for each unit supplied to Sandoz and equity payments, research support
payments and milestone payments potentially totaling $37.5 million.
In addition to Graftskin(TM), the Company has a number of other products in
development which capitalize on its experience in cell biology and connective
tissue sciences. Products in the preclinical stage include an injectable
product for the treatment of female urinary incontinence, a small diameter
graft for use in coronary artery by-pass procedures, a coating for
endovascular stents, a surgical repair patch for use in procedures such as
hernia repair, and a soft tissue augmentation product for use in plastic
surgery procedures. These products are being designed to allow the patient's
system to gradually replace the Organogenesis material with his or her own
tissue and thus provide permanence of benefit without permanence of product.
The Company's research programs also include such fields as cell
transplantation, organ assist devices and oral medicine.
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.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common Stock by
the Selling Stockholders.
DESCRIPTION OF CAPITAL STOCK
AUTHORIZED AND OUTSTANDING CAPITAL STOCK. The Company's Stockholders at the
Company's Annual Meeting of Stockholders held on May 15, 1996, authorized the
Company to issue up to 40,000,000 shares of Common Stock, $.01 par value per
share ("Common Stock"). The Company intends to file an amendment to its
9
<PAGE>
Restated Certificate of Incorporation as soon as practicable, whereupon the
Company will be authorized to issue up to 40,000,000 shares. The Company is
authorized to issue up to 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 March 31, 1996, there were issued and outstanding 13,970,663 shares of
Common Stock. 250,000 shares of Series A Stock have been issued; all such
shares have been converted to Common Stock and no shares of Series A
Convertible Preferred Stock (the "Series A Stock") are currently outstanding.
In addition, as of March 31, 1996, the Company had reserved an aggregate of
2,500,000 (1,630,128 of which are available for future issuances) shares of
Common Stock for issuance under its 1986 Stock Option Plan, 187,500 (177,551
of which are available for future issuances) shares of Common Stock for
issuance under its 1991 Employee Stock Purchase Plan, 125,000 shares of Common
Stock for issuance under the 1991 Directors' Stock Option Plan, 250,000
(246,250 of which are available for future issuances) 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 an officer
of the Company, and 521,875 shares of Common Stock for issuance upon the
exercise of certain warrants described below.
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 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. See "Description of
Capital Stock--Shareholder Rights." 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 such shares have been
converted to Common Stock and no shares of the Series A Stock are currently
outstanding.
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
10
<PAGE>
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 $15.90 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, 1996 through October 14, 2001. The
remainder of the Warrants to purchase an aggregate of 234,375 shares of Common
Stock were exercised by the Selling Stockholders on February 14, 1996 in the
amount of 187,500 shares at an exercise price of $9.75 per share, and on
January 15, 1996 in the amounts of 15,625 shares at an exercise price of
$12.00 per share and of 31,250 shares at an exercise price of $9.60 per share
(the "Exercised Warrants").
The shares of Common Stock issuable upon exercise of the 1995 Warrants have
been registered under the Securities Act. The shares of Common Stock issuable
upon exercise of the Exercised Warrants (the "Registrable Shares") are being
registered herein under the Securities Act.
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 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.
11
<PAGE>
THE SELLING STOCKHOLDERS
The following table sets forth the name and the number of shares of Common
Stock beneficially owned by the Selling Stockholders as of March 31, 1996, the
number of the shares to be offered by the Selling Stockholders pursuant to
this Prospectus and the number of shares to be beneficially owned by the
Selling Stockholders if all of the shares offered hereby by the Selling
Stockholders are sold as described herein.
<TABLE>
<CAPTION>
SHARES OF
SHARES OF COMMON STOCK
COMMON STOCK BENEFICIALLY OWNED
BENEFICIALLY OWNED AFTER OFFERING
----------------------- SHARES OF --------------------
NAME OF SELLING PERCENTAGE OF COMMON STOCK PERCENTAGE OF
STOCKHOLDER NUMBER(1) COMMON STOCK OFFERED HEREBY NUMBER COMMON STOCK
- --------------- --------- ------------- -------------- ------ -------------
<S> <C> <C> <C> <C> <C>
Fondation Danonia....... 46,875 *% 46,875 (2) (2)
Gerard Klauer Mattison &
Co..................... 187,500 *% 187,500 (2) (2)
</TABLE>
- --------
* less than 1%
(1) Represents shares of Common Stock which may be acquired within 60 days
after May 1, 1996.
(2) The Company cannot determine the number of shares of Common Stock which
will be held by the Selling Stockholders 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
Stockholders.
PLAN OF DISTRIBUTION
Shares of Common Stock covered hereby may be offered and sold from time to
time by the Selling Stockholders. The Selling Stockholders 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 Stockholders that they have not made any
arrangements relating to the distribution of the shares covered by this
Prospectus. In effecting sales, broker-dealers engaged by the Selling
Stockholders may arrange for other broker-dealers to participate. Broker-
dealers will receive commissions or discounts from the Selling Stockholders in
amounts to be negotiated immediately prior to the sale. Pursuant to each of
the Common Stock Purchase Warrants and the Warrant for the Purchase of Shares
of Common Stock, dated as of April 3, 1991 and November 21, 1991,
respectively, between the Company and the respective Selling Stockholders, the
Company has agreed to indemnify the respective Selling Stockholders against
certain liabilities under the Securities Act.
In offering the shares of Common Stock covered hereby, the Selling
Stockholders and any broker-dealers and any other participating broker-dealers
who execute sales for the Selling Stockholders 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 Stockholders 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 Stockholders that during such times as
they may be engaged in a distribution of Common Stock included herein they are
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
they
12
<PAGE>
may not engage in any stabilization activity in connection with the Company's
securities, they are required to furnish to each broker-dealer, through which
Common Stock included herein may be offered, copies of this Prospectus and
that they 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 Stockholders have 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) six months from the
effective date hereof or (b) the date upon which all shares offered hereby
have been sold by the Selling Stockholders.
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, 1995 and
1994 and the related consolidated statements of operations, stockholders'
deficit and cash flows for each of the three years in the period ended
December 31, 1995 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.
13
<PAGE>
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
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.
----------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Incorporation of Certain Documents by Reference............................ 2
Available Information...................................................... 2
The Company................................................................ 3
Risk Factors............................................................... 4
Use of Proceeds............................................................ 10
Description of Capital Stock............................................... 10
The Selling Stockholder.................................................... 12
Plan of Distribution....................................................... 13
Legal Matters.............................................................. 14
Experts.................................................................... 14
</TABLE>
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
ORGANOGENESIS INC.
[LOGO]
----------------
PROSPECTUS
----------------
, 1996
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
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............................................. $ 1,636.58
AMEX Listing Fee................................................. 4,687.50
Accounting Fees and Expenses*.................................... 5,000.00
Legal Fees and Expenses*......................................... 10,000.00
Printing and Engraving*.......................................... 3,000.00
Miscellaneous*................................................... 5,675.92
----------
Total.......................................................... $30,000.00
==========
</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 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.
II-1
<PAGE>
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) RULE 415 OFFERING
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the 1933
Act;
(ii) To reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent post-
effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the
registration statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424 (b) ((S)230.424 (b) of this chapter) if, in the
aggregate, the changes in volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in the
"Calculation of Registration Fee" table in the effective registration
statement.
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement or any
material change to such information in the registration statement;
PROVIDED, HOWEVER, that paragraphs (1) (i) and (1) (ii) do not apply if the
registration statement is on Form S-3 or Form S-8, and the information
required to be included in a post-effective amendment by those paragraphs is
contained in periodic reports filed by the registrant pursuant to Section 13
or Section 15(d) of the 1934 Act that are incorporated by reference in the
registration statement.
(2) That, for the purpose of determining any liability under the 1933 Act,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination of
the offering.
(b) Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the 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
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.
(c) The undersigned Registrant hereby undertakes:
(1) For purposes of determining any liability under the Securities Act,
the information omitted from the form of prospectus filed as part of this
Registration Statement in reliance upon Rule 430A and contained
II-2
<PAGE>
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.
(d) 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>
Pursuant to the requirements of the Securities Act, this Amendment No. 1 to
Registration Statement No. 333-3995 has been signed by the following persons in
the capacities indicated.
Organogenesis Inc.
By: /s/ Herbert M. Stein
By: _________________________________
HERBERT M. STEIN
CHIEF EXECUTIVE OFFICER
SIGNATURE TITLE DATE
/s/ Herbert M. Stein Chief Executive
- ------------------------------------- Officer, Chairman July 16, 1996
HERBERT M. STEIN and Director
(Principal
Executive Officer)
/s/ David T. Rovee President, Chief
- ------------------------------------- Operating Officer July 16, 1996
DAVID T. ROVEE and Director
/s/ Donna L. Abelli Vice President,
- ------------------------------------- Chief Financial July 16, 1996
DONNA L. ABELLI Officer, Treasurer
and Secretary
(Principal
Financial Officer
and Principal
Accounting Officer)
Director
* July 16, 1996
- -------------------------------------
RICHARD S. CRESSE
Director
* July 16, 1996
- -------------------------------------
WILLIAM J. HOPKE
Director
* July 16, 1996
- -------------------------------------
BJORN R. OLSEN
Director
* July 16, 1996
- -------------------------------------
MARGUERITE A. PERIT
Director
* July 16, 1996
- -------------------------------------
ANTON E. SCHRAFL
/s/ Donna L. Abelli
By: ____________________________
DONNA L. ABELLI,
ATTORNEY-IN-FACT
II-4
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT DESCRIPTION OF EXHIBIT
------- ----------------------
<C> <S>
*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.
4.5.1 Common Stock Purchase Warrant, dated as of December 20, 1995, between
Organogenesis Inc. and Fondation Danonia
4.5.2 Common Stock Purchase Warrant, dated as of December 20, 1995, between
Organogenesis Inc. and Fondation Danonia
4.5.3 Warrant for the Purchase of Shares of Common Stock, dated as of
November 21, 1991, between Organogenesis Inc. and Gerard Klauer
Mattison & Co., 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-3)
</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>
EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in the Registration
Statement of Organogenesis Inc. (the "Company") on this Form S-3 of our report
dated February 16, 1996, on our audits of the consolidated financial
statements of Organogenesis Inc. as of December 31, 1995 and 1994 and for each
of the three years in the period ended December 31, 1995 which report is
included in the Company's Report on Form 10-K filed with the Securities and
Exchange Commission on March 29, 1996. We also consent to the reference to our
Firm under the caption "Experts."
/s/ Coopers & Lybrand L.L.P.
Coopers & Lybrand L.L.P.
Boston, Massachusetts
July 12, 1996
