<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JUNE 27, 1997
REGISTRATION NO. 333-__________
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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CONCEPTUS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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DELAWARE 94-3170244
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
1021 HOWARD AVENUE
SAN CARLOS, CALIFORNIA 94070
(415) 802-7240
(Address, Including Zip Code, and Telephone Number, Including Area
Code, of Registrant's Principal Executive Offices)
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KATHRYN A. TUNSTALL
PRESIDENT AND CHIEF EXECUTIVE OFFICER
CONCEPTUS, INC.
1021 HOWARD AVENUE
SAN CARLOS, CALIFORNIA 94070
(415) 802-7240
(Name, Address, Including Zip Code, and Telephone Number,
Including Area Code, of Agent for Service)
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COPIES TO:
Cathryn S. Chinn
Amy Elizabeth Paye
Venture Law Group
A Professional Corporation
2800 Sand Hill Road
Menlo Park, CA 94025
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
AS SOON AS PRACTICABLE AFTER THE EFFECTIVE DATE OF THIS REGISTRATION STATEMENT.
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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, check the following box. /X/
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. / / _______________
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / / _______________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
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PROPOSED PROPOSED
MAXIMUM MAXIMUM
AGGREGATE AGGREGATE AMOUNT OF
TITLE OF EACH CLASS OF AMOUNT TO BE PRICE PER UNIT OFFERING PRICE REGISTRATION
SECURITIES TO BE REGISTERED REGISTERED (1) (1) FEE
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<S> <C> <C> <C> <C>
Common Stock, par value $0.003 52,352 $10.44 $546,554.88 $ 165.62
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</TABLE>
(1) Estimated solely for the purpose of computing the amount of the
registration fee based on the average of the high and low closing price of the
Common Stock as reported on the Nasdaq National Market on June 24, 1997 pursuant
to Rule 457(c).
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 THIS REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
<PAGE>
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 or qualification under the securities laws of
any such State.
<PAGE>
SUBJECT TO COMPLETION, DATED JUNE 27, 1997
CONCEPTUS, INC.
52,352 SHARES
COMMON STOCK
------------
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" ON PAGE 5 OF THIS PROSPECTUS FOR INFORMATION THAT SHOULD BE CONSIDERED
BY PROSPECTIVE INVESTORS.
------------
All references herein to "Conceptus" or the "Company" mean Conceptus, Inc.
unless otherwise indicated by the context.
The 52,352 shares of Conceptus Common Stock, $0.003 par value, covered by
this Prospectus (the "Shares") are offered for the account of certain
stockholders of the Company (the "Selling Stockholders"). The Shares were
issued to the Selling Stockholders in connection with the acquisition of
Microgyn, Inc., a Massachusetts corporation, by the Company on November 26, 1996
(the "Acquisition"). For additional information concerning the Acquisition, see
"Issuance of Common Stock to Selling Stockholders." The Selling Stockholders
may sell the Shares from time to time on the over-the-counter market in regular
brokerage transactions, in transactions directly with market makers or in
certain privately negotiated transactions. See "Plan of Distribution." Each
Selling Stockholder has advised the Company that no sale or distribution other
than as disclosed herein will be effected until after this Prospectus shall have
been appropriately amended or supplemented, if required, to set forth the terms
thereof. The Company will not receive any proceeds from the sale of the Shares
by the Selling Stockholders.
All expenses of registration of the Shares, estimated to be
approximately $15,000.00, shall be borne by the Company. Selling
commissions, brokerage fees, any applicable stock transfer taxes and any fees
and disbursements of counsel to the Selling Stockholders are payable
individually by the Selling Stockholders.
Each of the Selling Stockholders may be deemed to be an "Underwriter,"
as such term is defined in the Securities Act of 1933, as amended (the
"Securities Act").
On June 24, 1997, the last sale price of the Company's Common Stock on the
Nasdaq National Market was $10 3/8 per share.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF
THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
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PROCEEDS TO
UNDERWRITING SELLING
PRICE TO DISCOUNTS AND STOCKHOLDERS
PUBLIC COMMISSIONS(1) SHAREHOLDERS
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Per Share . . . . . . See Text Above See Text Above See Text Above
Total . . . . . .
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The date of this Prospectus is _____________, 1997
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files proxy statements, reports and other information with the
Securities and Exchange Commission (the "Commission"). Reports, proxy and
information statements and other information filed by the Company with the
Commission can be inspected and copied at the public reference facilities
maintained by the Commission in Washington, D.C., and at its Regional Offices
located at Citicorp Center, 500 West Madison Street, Suite 1400, Chicago,
Illinois 60661-2511 and 7 World Trade Center, Suite 1300, New York, New York
10048; and at the Public Reference Office of the Commission at 450 Fifth Street,
N.W., Washington, D.C. 20549. Copies of such material can be obtained from the
Public Reference Section of the Commission, 450 Fifth Street, N.W., Washington,
D.C. 20549 at prescribed rates. In addition, the Company is an electronic filer
and copies of such material may be retrieved from the Web site
(http://www.sec/gov) maintained by the Commission.
The Company's Common Stock is quoted on The Nasdaq National Market under
the symbol "CPTS." Reports, proxy and information statements and other
information about the Company may be inspected at The Nasdaq National Market,
1735 K Street, N.W., Washington, DC 20006-1506.
INFORMATION INCORPORATED BY REFERENCE
The following documents filed by the Company with the Commission are
incorporated by reference in this Prospectus:
1. The Company's Annual Report on Form 10-K for the year ended
December 31, 1996, as amended by the filing of Form 10-K/A on April 3, 1997.
2. The Company's definitive Proxy Statement dated April 4, 1997, filed in
connection with the Company's May 13, 1997 Annual Meeting of Stockholders.
3. The Company's Quarterly Report on Form 10-Q for the quarter ended
March 31, 1997.
4. The Company's Current Report on Form 8-K filed with the Commission on
December 10, 1996, as amended by the filing of Form 8-K/A by the Company on
February 7, 1997.
5. The description of the Company's Common Stock set forth in the
Company's Registration Statement on Form 8-A filed with the Commission on
December 26, 1995 and the Company's Registration Statement on Form 8-A filed
with the Commission on February 28, 1997.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act after the date of this Prospectus and prior to the
termination of the offering of the Common Stock offered hereby shall be deemed
to be incorporated by reference in this Prospectus. Any statement contained in
a document incorporated by reference herein shall be deemed to be modified or
superseded for purposes hereof to the extent that a statement contained herein
(or in any other subsequently filed document which also is incorporated by
reference herein) modifies or supersedes such statement. Any such statement so
modified or superseded shall not be deemed to constitute a part hereof, except
as so modified or superseded.
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<PAGE>
The Company will furnish without charge to each person, including any
beneficial owner, to whom this Prospectus is delivered, on the written or oral
request of such person, a copy of any or all of the documents incorporated by
reference, other than exhibits to such documents. Requests should be directed
to Sanford Fitch, Senior Vice President and Chief Financial Officer, Conceptus,
Inc., 1021 Howard Avenue, San Carlos, California 94070, telephone:
(415) 802-7240.
-3-
<PAGE>
THE COMPANY
Conceptus, Inc. ("Conceptus" or the "Company") designs, develops and
markets minimally invasive devices for reproductive medical applications. The
Company's initial focus is on improving the diagnosis and treatment of fallopian
tube diseases and disorders, primary causes of infertility, and on providing a
non-surgical approach to fallopian tube sterilization, the most commonly
performed contraceptive procedure worldwide. Conceptus has developed
proprietary micro-catheter and guidewire systems that allow physicians to
transcervically (through the cervix) access and navigate the full length of the
fallopian tubes in a nonsurgical approach. The Company believes that its
fallopian tube access systems will facilitate more rapid and accurate diagnosis
of fallopian tube diseases and disorders than conventional diagnostic methods,
which are known to be inaccurate, leading to more appropriate selection of
therapies, and ultimately, improved reproductive outcomes. The Company also
believes that its systems will allow many tubal therapies for both infertility
and permanent contraception that are currently performed surgically to be
performed transcervically, thereby reducing the cost, trauma and recovery time
associated with those therapies. The Company's systems are based on technology
initially developed by Target Therapeutics, Inc. ("Target") and licensed
exclusively to Conceptus in the field of reproductive physiology. Conceptus
commenced marketing of its catheter systems internationally for a number of
applications in September 1995 and, to date, has received six 510(k) clearances
to market applications of its T-TAC-TM (Transcervical Tubal Access Catheter)
systems, one 510(k) clearance for falloposcopy for proximal tubal occlusion and
one 510(k) clearance for resectoscopy in the United States.
On November 26, 1996, Conceptus acquired Microgyn, Inc. ("Microgyn"), a
private medical device company, for $3 million paid upon the date of acquisition
and $1 million payable six months after the date of acquisition. The $1 million
is payable, at the option of the Company, in either cash or stock and was paid
in stock on May 23, 1997. Additional contingent consideration (cash or stock)
is payable to the shareholders of Microgyn based upon the meeting of certain
future milestones.
The Company's goal is to become a global leader in reproductive healthcare
with an initial focus on women's reproductive health. The Company is directing
its marketing efforts, both domestically and internationally, toward those
interventional gynecologists who maintain high volume practices in infertility,
pre- and peri-menopausal conditions and gynecological endoscopy. Conceptus
intends to expand its product development and marketing efforts to address new
clinical applications in reproductive physiology, such as assisted reproductive
techniques and male reproductive disorders, in which the Company's technologies
may satisfy clinical needs or achieve cost reductions. In addition, the
Microgyn products have urologic applications and the Company intends to address
this market through appropriate partnership or distribution arrangements.
The Common Stock is currently traded on The Nasdaq Stock Market under the
symbol "CPTS." The Company's principal executive offices are located at 1021
Howard Avenue, San Carlos, California 94070, and its telephone number at that
location is (415) 802-7240.
-4-
<PAGE>
RISK FACTORS
PROSPECTIVE PURCHASERS OF THE COMMON STOCK OFFERED HEREBY SHOULD CAREFULLY
CONSIDER THE FOLLOWING RISK FACTORS IN ADDITION TO THE OTHER INFORMATION
APPEARING IN OR INCORPORATED BY REFERENCE INTO THIS PROSPECTUS. CERTAIN
STATEMENTS CONTAINED IN THIS PROSPECTUS, AS WELL AS DOCUMENTS INCORPORATED
HEREIN BY REFERENCE, INCLUDING, WITHOUT LIMITATION, STATEMENTS CONTAINING THE
WORDS "BELIEVES," "ANTICIPATES," "INTENDS," "EXPECTS" AND WORDS OF SIMILAR
IMPORT, CONSTITUTE "FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH FORWARD-LOOKING
STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT
MAY CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF CONCEPTUS OR
INDUSTRY RESULTS TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE
OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD-LOOKING ACHIEVEMENTS. SUCH
FACTORS INCLUDE, AMONG OTHERS, THE FOLLOWING: THE UNCERTAINTY OF MARKET
ACCEPTANCE OF THE COMPANY'S PRODUCTS; THE LIMITED OPERATING HISTORY OF THE
COMPANY; THE ABILITY OF THE COMPANY TO DEVELOP AND MAINTAIN PROPRIETARY ASPECTS
OF ITS TECHNOLOGY; THE ABILITY OF THE COMPANY TO OBTAIN THE NECESSARY
GOVERNMENTAL CLEARANCE OR APPROVAL TO MARKET ITS PRODUCTS; INTENSE COMPETITION
IN THE MEDICAL DEVICE INDUSTRY; THE INHERENT RISK OF EXPOSURE TO PRODUCT
LIABILITY CLAIMS AND PRODUCT RECALLS; AND OTHER FACTORS REFERENCED IN THIS
PROSPECTUS. CERTAIN OF THESE FACTORS ARE DISCUSSED IN MORE DETAIL BELOW. GIVEN
THESE UNCERTAINTIES, PROSPECTIVE PURCHASERS OF THE COMMON STOCK OFFERED HEREBY
ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON SUCH FORWARD-LOOKING STATEMENTS.
UNCERTAINTY OF MARKET ACCEPTANCE. The Company's products have generated
limited revenue to date. There can be no assurance that any of the Company's
existing or future products will gain any significant degree of market
acceptance among physicians, patients and healthcare payors, even if
reimbursement and necessary international and United States regulatory approvals
are obtained. The Company believes that recommendations and endorsements by
physicians will be essential for market acceptance of the Company's products,
and there can be no assurance that any such recommendations or endorsements will
be obtained. The Company believes that physicians will not use the Company's
products unless they determine, based on clinical data and other factors, that
these systems are an attractive alternative to other means of diagnosing and
treating diseases and disorders of the female reproductive system and that the
products offer clinical utility in a cost-effective manner. Acceptance among
physicians will also depend upon the Company's ability to train interventional
gynecologists and other potential users of the Company's products in new
interventional techniques and upon the willingness of such users to learn these
new techniques. Failure of the Company's products to achieve significant market
acceptance would have a material adverse effect on the Company's business,
financial condition and results of operations.
DEPENDENCE UPON TRANSCERVICAL TUBAL ACCESS AND CATHETERIZATION PRODUCTS.
The Company's primary near-term commercial products, the Transcervical Tubal
Access Catheter ("T-TAC") and Selective Tubal Assessment to Refine Reproductive
Therapy ("STARRT") Falloposcopy systems, have been developed for limited
indications to date. Current applications for these systems include accessing,
diagnosing and treating diseases and disorders of the fallopian tubes.
Expanding the number of applications for these products will require additional
development and, in certain cases, clinical trials and regulatory approvals.
The Company would experience a material adverse effect on its business,
financial condition and results of operations if these products are not
successfully commercialized for existing or future applications.
LIMITED OPERATING HISTORY; ANTICIPATED FUTURE LOSSES. The Company has a
limited history of operations. Since its inception in September 1992, the
Company has been engaged primarily in research
-5-
<PAGE>
and development of its T-TAC and STARRT Falloposcopy systems. The Company has
generated only limited revenues, primarily from sales in international markets
for clinical trials, and does not have experience in manufacturing, marketing or
selling its products in commercial quantities. The Company has experienced
significant operating losses since inception and, as of March 31, 1997, had an
accumulated deficit of $26.5 million. The Company expects its operating losses
to continue for at least the next several years as it continues to expend
substantial resources in funding clinical trials in support of regulatory and
reimbursement approvals, expansion of manufacturing, marketing and sales
activities and research and product development or acquisition. Due to the
expense and unpredictable nature of these activities, there can be no assurance
that the Company will achieve or sustain profitability in the future.
RELIANCE ON PATENTS AND PROTECTION OF PROPRIETARY TECHNOLOGY. The
Company's ability to compete effectively will depend substantially on its
ability to develop and maintain proprietary aspects of its technology. There can
be no assurance that the Company's three issued patents, any future patents that
may be issued as a result of the Company's United States or foreign patent
applications, or the patents under which the Company has license rights, will
offer any degree of protection to the Company's products against competitive
products. There can be no assurance that any patents that may be issued or
licensed to the Company or any of the Company's patent applications will not be
challenged, invalidated or circumvented in the future. In addition, there can
be no assurance that competitors, many of whom have substantial resources and
have made substantial investments in competing technologies, will not seek to
apply for and obtain patents that will prevent, limit or interfere with the
Company's ability to make, use or sell its products either in the United States
or in international markets.
The medical device industry has been characterized by extensive litigation
regarding patents and other intellectual property rights, and companies in the
industry have employed intellectual property litigation to gain a competitive
advantage. There can be no assurance that the Company will not in the future
become subject to patent infringement claims and litigation or interference
proceedings declared by the United States Patent and Trademark Office ("USPTO")
to determine the priority of inventions. The defense and prosecution of
intellectual property suits, USPTO interference proceedings and related legal
and administrative proceedings are both costly and time consuming. Litigation
may be necessary to enforce patents issued to the Company, to protect the
Company's trade secrets or know-how or to determine the enforceability, scope
and validity of the proprietary rights of others.
Any litigation or interference proceedings involving the Company will
result in substantial expense to the Company and significant diversion of effort
by the Company's technical and management personnel. An adverse determination
in litigation or interference proceedings to which the Company may become a
party could subject the Company to significant liabilities to third parties or
require the Company to seek licenses from third parties. Although patent and
intellectual property disputes in the medical device area have often been
settled through licensing or similar arrangements, costs associated with such
arrangements may be substantial and could include ongoing royalties.
Furthermore, there can be no assurance that necessary licenses would be
available to the Company on satisfactory terms, if at all. Adverse
determinations in a judicial or administrative proceeding or failure to obtain
necessary licenses could prevent the Company from manufacturing and selling its
products, which would have a material adverse effect on the Company's business,
financial condition and results of operations.
A patent issued to Target and subject to Target's license to the Company,
which contains claims relating to the design of the Company's Variable Softness
micro-catheters (the "Target patent"), has been the subject of four
reexamination proceedings in the USPTO. Following the completion of the first
of
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<PAGE>
such proceedings, the USPTO issued a reexamination certificate and confirmed the
patentability of the claims set forth in the certificate. Requests for second,
third and fourth reexaminations were initiated by one of Target's competitors,
SciMed Life Systems, Inc. ("SciMed"), a subsidiary of Boston Scientific
Corporation ("BSC"), and after the USPTO's review of such petitions, Target
received notice from the USPTO that it had reaffirmed the patentability of the
claims of the Target patent. Notwithstanding this result, no assurance can be
given that SciMed will not mount a legal challenge to the validity of the Target
patent or that Target would prevail in any such action. In addition, in November
1994, Target filed a lawsuit in United States District Court against SciMed and
Cordis Endovascular Systems, Inc. ("Cordis"), a subsidiary of Johnson & Johnson,
Inc., alleging infringement of a Target patent relating to variable stiffness in
microcatheters, and seeking damages and preliminary and permanent injunctive
relief against sales of such companies' products believed to be infringing the
Target patent. The defendants responded by challenging the validity of the
Target patent, denying infringement and raising other defenses. In May 1996,
the District Court granted Target's motion for an injunction prohibiting the
defendants from continuing to sell the products alleged to infringe the patent.
In July 1996, the United States Court of Appeals for the Federal Circuit stayed
the injunction pending an appeal by the defendants, and the Court of Appeals
heard oral argument on the appeal in January 1997. Any invalidation of the
Target patent could have a material adverse effect on the Company's business,
financial condition and results of operations.
On January 20, 1997, Target and BSC announced the signing of a definitive
agreement to merge in a tax-free stock-for-stock transaction. As a result of
the merger, which closed during the second calendar quarter of 1997, Target
became a separate business unit of BSC. Following the consummation of the
merger, it is anticipated that Target will continue the litigation of Cordis.
Legislation is pending in Congress that, if enacted in its present form,
would limit the ability of medical device manufacturers in the future to obtain
patents on surgical and medical procedures that are not performed by, or as a
part of, devices or compositions which are themselves patentable. While the
Company cannot predict whether the legislation will be enacted, or precisely
what limitations will result from the law if enacted, any limitation or
reduction in the patentability of medical and surgical methods and procedures
could have a material adverse effect on the Company's ability to protect its
proprietary methods and procedures.
In addition to patents, the Company relies on trade secrets and technical
know-how and continuing technological innovation to develop and maintain its
competitive position. The Company typically requires its employees, consultants
and advisors to execute appropriate confidentiality and assignment of inventions
agreements in connection with their employment, consulting or advisory
relationship with the Company. These agreements generally provide that all
confidential information developed or made known to the individual by the
Company during the course of the individual's relationship with the Company is
to be kept confidential and not disclosed to third parties, except in specific
circumstances. The agreements also generally provide that all inventions
conceived by the individual in the course of rendering services to the Company
shall be the exclusive property of the Company. There can be no assurance,
however, that these agreements will not be breached or that the Company will
have adequate remedies for any breach. Furthermore, no assurance can be given
that competitors will not independently develop substantially equivalent
proprietary information and techniques or otherwise gain access to the Company's
proprietary technology, or that Conceptus can meaningfully protect its rights in
unpatented proprietary technology.
GOVERNMENT REGULATION. The manufacture and sale of medical devices,
including the medical devices used in the Company's T-TAC and STARRT
Falloposcopy systems, are subject to extensive
-7-
<PAGE>
regulation by numerous government authorities, both in the United States and
internationally. In the United States, the principal regulatory authorities are
the Food and Drug Administration ("FDA") and corresponding state agencies, such
as the California Department of Health Services ("CDHS"). The process of
obtaining and maintaining required regulatory clearances is lengthy, expensive
and uncertain. The FDA requires companies that wish to market a new medical
device or an existing medical device for use for a new indication to obtain
either a premarket notification clearance under Section 510(k) of the Federal
Food, Drug, and Cosmetic Act ("510(k)") or a premarket approval ("PMA") prior to
the introduction of such product into the market. In addition, material changes
to medical devices are also subject to FDA review and clearance or approval. If
a medical device manufacturer or distributor can establish, among other things,
that a device is "substantially equivalent" in intended use and technological
characteristics to certain legally marketed devices, for which the FDA has not
required a PMA, the manufacturer or distributor may seek clearance from the FDA
to market the device by filing a 510(k). Though generally believed to be a
shorter, less costly regulatory path than a PMA, the 510(k) may need to be
supported by appropriate data establishing to the satisfaction of the FDA the
claim of substantial equivalence to the predicate device. In addition, the FDA
may require review by an advisory panel as a condition for 510(k) clearances,
which can further lengthen the regulatory process. The PMA approval process can
take several years from initial filing and requires the submission of extensive
supporting data and clinical information. No assurance can be given that any
future products or applications developed by the Company will not require
approval under the more lengthy and expensive PMA process. If the Company is
required to obtain approval for any products pursuant to the PMA procedure or,
if the 510(k) process with respect to any products is extended for a
considerable length of time, the commencement of commercial sales of the
Company's products will be delayed substantially.
There can be no assurance that the Company will be able to obtain necessary
510(k) clearances or PMA or other approvals to market its products for the
intended uses on a timely basis, if at all, and delays in receipt of or failure
to receive such clearances or approvals, the loss of previously received
clearances or approvals, or failure to comply with existing or future regulatory
requirements could have a material adverse affect on the Company's business,
financial condition and results of operations. Moreover, regulatory clearances,
if granted, may include significant limitations on the indicated uses for which
a product may be marketed.
Sales of medical devices outside of the United States are subject to
international regulatory requirements that vary widely from country to country.
The time required to obtain clearance required by foreign countries may be
longer or shorter than that required for FDA clearance, and requirements for
licensing may differ significantly from FDA requirements.
The European Union has promulgated rules which require that medical
products receive by mid-1998 the right to affix the CE mark, an international
symbol of adherence to quality assurance standards and compliance with
applicable European Union Medical Device Directives. The ISO 9000 series of
standards for quality operations have been developed to ensure that companies
know the standards of quality to which they must adhere to receive European
Union certification. ISO 9000 certification is one of the CE mark certification
requirements. Failure to receive the right to affix the CE mark will prohibit
the Company from selling its products in member countries of the European Union
after mid-1998. The Company is in the process of developing and implementing
policies and procedures that are intended to allow the Company to receive ISO
9000 qualification of its processes in 1997. There can be no assurance that the
Company will be successful in meeting certification requirements. Many
countries in which the Company currently operates or intends to operate either
do not currently regulate medical devices or have minimal registration
requirements; however, these countries may develop more extensive regulations in
the future that could adversely affect the Company's ability to market its
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<PAGE>
products. In addition, significant costs and requests by regulators for
additional information may be encountered by the Company in its efforts to
obtain regulatory approvals. Any such events could substantially delay or
preclude the Company from marketing its products in the United States or
internationally.
Regulatory approvals, if granted, may include significant limitations on
the indicated uses for which the Company's products may be marketed. In
addition, in order for companies to obtain such approvals, the FDA and certain
foreign regulatory authorities impose numerous additional requirements with
which medical device manufacturers must comply. FDA enforcement policy strictly
prohibits the promotion of approved medical devices for uses other than those
specifically cleared for marketing by the FDA. The Company will be required to
adhere to applicable FDA regulations regarding Good Manufacturing Practices
("GMP") and similar regulations in other countries, which include testing,
control, and documentation requirements. Ongoing compliance with GMP and other
applicable regulatory requirements will be monitored through periodic
inspections by federal and state agencies, including the FDA and the CDHS, and
by comparable agencies in other countries. Failure to comply with applicable
regulatory requirements, could result in, among other things, warning letters,
fines, injunctions, civil penalties, recall or seizure of products, total or
partial suspension of production, refusal of the government to grant premarket
clearance or premarket approval for devices, withdrawal of approvals and
criminal prosecution. Changes in existing regulations or adoption of new
government regulations or policies could prevent or delay regulatory approval of
the Company's products. The Company cannot predict the impact, if any, such
changes might have on its business, financial condition or results of
operations.
LIMITED DOMESTIC MARKETING AND SALES EXPERIENCE; EMERGING MARKET. The
Company has only limited experience marketing and selling its products and does
not have experience marketing and selling its products in commercial quantities.
The Company intends to substantially increase its United States marketing
efforts by increasing the sales coverage throughout the United States during
1997. Establishing marketing and sales capability sufficient to support sales
in commercial quantities will require significant resources, and there can be no
assurance that the Company will be able to recruit and retain qualified
marketing personnel, direct sales personnel or contract sales representatives or
that future sales efforts of the Company will be successful. Furthermore,
interventional gynecology is an emerging medical market with widely varying
practice patterns. Therefore, there is no proven distribution channel for
marketing the Company's products in the United States. While the Company is
committed to establishing an effective distribution channel for its products,
there can be no assurance that the Company will be successful in doing so. The
failure to establish and maintain an effective distribution channel for the
Company's products, or to retain qualified sales personnel to support commercial
sales of the Company's products, would have a material adverse effect on the
Company's business, financial condition and results of operations.
DEPENDENCE UPON INTERNATIONAL DISTRIBUTORS AND SALES. To date, the
majority of the Company's sales have been outside the United States. The
Company anticipates that a large percentage of its revenues for the next several
years will continue to be derived from international sales. The Company
currently has a limited network of distributors, some of which were recently
engaged by the Company, which market the Company's products to certain European,
African and Middle Eastern countries and Australia. The Company's international
sales are dependent upon the marketing efforts of, and sales by, these
distributors. The Company relies on these distributors to assist it in
obtaining product registration and reimbursement approvals in certain
international markets. The Company's strategy is to operate internationally
through distributors with an established franchise in the field of gynecology.
If a distributor were to fail to invest adequate capital promoting the Company's
products and training
-9-
<PAGE>
physicians in the proper techniques for utilizing the Company's products, or
were to cease operations, the Company would likely be unable to achieve
significant sales in the subject territory. In addition, because the Company
has recently strategically replaced several of its international distributors,
it has only limited sell-through experience with its current distributors.
Furthermore, Conceptus does not currently have distributors in a number of
international markets that it has targeted and will need to establish additional
international distribution relationships. There can be no assurance that the
Company will engage qualified distributors in these markets in a timely manner,
if at all. The failure to engage such distributors would have a material
adverse effect on the Company's business, financial condition and results of
operations.
A number of risks are inherent in international operations and
transactions. International sales and operations may be limited or disrupted by
the imposition of government controls, changes in regulatory requirements or
interpretations thereof, export license requirements, political instability,
trade restrictions, changes in tariffs, and difficulties in staffing,
coordinating and managing international operations. Additionally, the Company's
business, financial condition and results of operations may be adversely
affected by fluctuations in international currency exchange rates as well as
constraints on the Company's ability to maintain or increase prices. There can
be no assurance that the Company will be able to commercialize successfully its
current or future products in any international market.
UNCERTAINTY RELATING TO THIRD-PARTY REIMBURSEMENT. In the United States,
hospitals, physicians and other healthcare providers that purchase medical
devices generally rely on third-party payors, such as private health insurance
plans, to reimburse all or part of the cost associated with the treatment of
patients. Although reimbursement for catheterization procedures has generally
been available in the United States, there can be no assurance that this will
continue to be the case. The Company does not expect that third-party
reimbursement will be available for its products unless and until FDA clearance
or approval is received. There can be no assurance, even if the Company's
products are cleared by the FDA for new clinical applications, that full
reimbursement will be available for such procedures. If FDA clearance or
approval is received, third-party reimbursement for these products will be
dependent upon decisions by individual health maintenance organizations, private
insurers and other payors. However, the Company believes that procedures using
its STARRT system may be reimbursed in the United States under existing
procedure codes for diagnosis and re-establishment of patency of the fallopian
tubes and, if applicable, for related interpretation of such procedures.
However, there can be no assurance that such procedure codes will remain
available or that the reimbursement under these codes will be adequate. Given
the efforts to control and decrease health care costs in recent years, there can
be no assurance that any reimbursement will be sufficient to permit the Company
to achieve or maintain profitability. The Company could also be adversely
affected by changes in reimbursement policies of government or private
healthcare payors, particularly to the extent that any such changes affect
reimbursement for therapeutic or diagnostic catheterization procedures in which
the Company's products are used. Failure by physicians, hospitals and other
users of the Company's products to obtain sufficient reimbursement from
healthcare payors for procedures in which the Company's products are used, or
adverse changes in government and private third party payors' policies toward
reimbursement for such procedures, could have a material adverse effect on the
Company's business, financial condition and results of operations.
Market acceptance of the Company's products in international markets may be
dependent in part upon the availability of reimbursement within prevailing
healthcare payment systems. Reimbursement systems in international markets vary
significantly by country, and include both government-sponsored and private
healthcare insurance. Obtaining reimbursement approvals can require 12 to 18
months or longer. There can be no assurance that the Company will obtain
reimbursement in any country within a particular time, for a particular amount,
or at all. Failure to obtain such approvals could have a material
-10-
<PAGE>
adverse effect on market acceptance of the Company's products in the
international markets in which the Company is seeking approvals and could have a
material adverse effect on the Company's sales, business, financial condition
and results of operations.
COMPETITION; UNCERTAINTY OF TECHNOLOGICAL CHANGE. The medical device
industry is highly competitive. The Company expects competition for devices to
diagnose and treat female reproductive disorders to increase. Many of the
Company's competitors have substantially greater name recognition and financial
resources than the Company and have greater resources and expertise in research
and development, obtaining regulatory approvals, manufacturing and marketing.
Certain of these companies are developing and marketing devices for the
diagnosis and treatment of disorders of the female reproductive system and
others may choose to enter this market at a later date. Additionally, certain
smaller companies are developing alternative catheter-based systems for the
diagnosis and treatment of female reproductive disorders that may compete
directly with the Company's systems. There can be no assurance that the
Company's competitors will not succeed in developing technologies and products
that are more effective or less costly than those developed by the Company or
that would render the Company's products obsolete or noncompetitive.
Additionally, there can be no assurance that the Company will be able to compete
effectively against such competitors based on its abilities to manufacture,
market and sell its products.
As the Company commercializes its S/TOP system, it expects to compete
against other surgical procedures for permanent contraception, mechanical
devices and other contraceptive methods. The Company also competes with other
companies for clinical sites to conduct trials. The medical device industry is
characterized by rapid and significant technological change. The length of time
required for product development and regulatory approval plays an important role
in a company's competitive position. Consequently, the Company's success will
depend in part on its ability to respond quickly to medical and technological
changes through the development and commercialization of new products. Product
development involves a high degree of risk and there can be no assurance that
the Company's research and development efforts will result in commercially
successfully products. The Company believes that it competes favorably with
respect to these factors, although there can be no assurance that it will
continue to do so and that competition will not have a material adverse effect
on the Company's business, financial condition and results of operations.
LIMITED MANUFACTURING EXPERIENCE. The Company has limited experience in
manufacturing its products in commercial quantities. The Company currently
manufactures products in small quantities for United States clinical trials,
international clinical trials and limited commercial sales. Manufacturers often
encounter difficulties in scaling up production of new products, including
problems involving production yields, quality control and assurance, component
supply and shortages of qualified personnel. There can be no assurance that the
Company will not encounter manufacturing difficulties, which could have a
material adverse effect on the Company's business, financial condition and
results of operations.
DEPENDENCE UPON SOLE SOURCE SUPPLIERS; LACK OF CONTRACTUAL ARRANGEMENTS.
Conceptus purchases both raw materials used in its products and finished goods
from various suppliers and relies on single sources for most of these items.
The Company does not have formal supply contracts with several key vendors and,
accordingly, no assurance can be made that such firms will continue to supply
the Company with such raw materials or finished goods in sufficient quantities,
or at all. Delays associated with any future raw materials or finished goods
shortages could have a material adverse effect on the Company's business,
financial condition and results of operations, particularly as the Company
scales up its manufacturing activities in support of international commercial
sales and, to the extent that FDA approvals are received, United States
commercial sales.
-11-
<PAGE>
POSSIBLE FUTURE CAPITAL REQUIREMENTS. Conceptus believes that its existing
capital resources will be sufficient to fund its operations through 1998.
However, the Company's future liquidity and capital requirements will depend
upon numerous factors, including the progress of the Company's clinical research
and product development programs, the receipt of and the time required to obtain
regulatory clearances and approvals, and the resources the Company devotes to
developing, manufacturing and marketing its products. The Company's capital
requirements will also depend on, among other things, the resources required to
hire and develop a direct sales force in the United States and internationally,
the resources required to expand manufacturing capacity and facilities
requirements and the extent to which the Company's products generate market
acceptance and demand. Accordingly, there can be no assurance that the Company
will not require additional financing within this time frame and, therefore, may
in the future seek to raise additional funds through bank facilities, debt or
equity offerings or other sources of capital. Additional funding may not be
available when needed or on terms acceptable to the Company, which would have a
material adverse effect on the Company's business, financial condition and
results of operations.
PRODUCT LIABILITY RISK AND RECALLS; LIMITED INSURANCE COVERAGE. The
manufacture and sale of medical products involve an inherent risk of exposure to
product liability claims and product recalls. Although the Company has not
experienced any product liability claims to date, there can be no assurance that
the Company will be able to avoid significant product liability claims and
potential related adverse publicity. The Company currently maintains product
liability insurance with coverage limits of $5,000,000 per occurrence and an
annual aggregate maximum of $5,000,000, which the Company believes is comparable
to that maintained by other companies of similar size serving similar markets.
However, there can be no assurance that product liability claims in connection
with clinical trials or sale of the Company's products will not exceed such
insurance coverage limits, which could have a material adverse effect on the
Company, or that such insurance will continue to be available on commercially
reasonable terms, or at all. In addition, the Company may require increased
product liability coverage as its products are commercialized. Such insurance
is expensive and in the future may not be available on acceptable terms, if at
all. A successful product liability claim or series of claims brought against
the Company in excess of its insurance coverage, or a recall of the Company's
products, could have a material adverse effect on the Company's business,
financial condition and results of operations.
DEPENDENCE UPON KEY PERSONNEL. The Company is dependent upon a number of
key management and technical personnel. The loss of the services of one or more
key employees could have a material adverse effect on the Company's business,
financial condition and results of operations. The Company's success will also
depend on its ability to attract and retain additional highly qualified
management and technical personnel. The Company faces intense competition for
qualified personnel, many of whom are often subject to competing employment
offers, and there can be no assurance that the Company will be able to attract
and retain such personnel. Furthermore, the Company relies on the services of
several medical and scientific consultants, all of whom are employed on a full-
time basis by hospitals or academic or research institutions. Such consultants
are therefore not available to devote their full time or attention to the
Company's affairs.
INFLUENCE OF BOSTON SCIENTIFIC CORPORATION. As of June 1, 1997, BSC
beneficially owned approximately 15.24% of the Company's outstanding Common
Stock. Accordingly, BSC may be able to exercise influence over the business and
financial affairs of the Company. Furthermore, certain of the Company's
products are based upon patents and other intellectual property licensed from
Target, a subsidiary of BSC, on an exclusive basis within the field of
reproductive physiology. In the event that such Target patents are at any time
invalidated, the Company's proprietary position in the marketplace would be
severely compromised. In addition, should the Target technology licensed to the
Company be
-12-
<PAGE>
found to infringe upon a third party's technology, the Company's sale of
products based on such infringing Target technology could be limited. Finally,
in the event that the Company materially breaches the terms of its license from
Target, Target will have the right to terminate the license. Any such
termination of this license would deprive the Company of the right to develop or
sell products based on the licensed technology, which would have a material
adverse effect on the Company's business, financial condition and results of
operations.
CONTROL BY DIRECTORS, EXECUTIVE OFFICERS AND PRINCIPAL STOCKHOLDERS. As of
June 1, 1997, the Company's directors, executive officers and principal
stockholders, including BSC, beneficially own, in the aggregate, approximately
35.47% of the Company's outstanding Common Stock. These stockholders, if acting
together, would be able to control substantially all matters requiring approval
by the stockholders of the Company, including any determination with respect to
the acquisition or disposition of assets by the Company, future issuances of
Common Stock or other securities by the Company, declaration of dividends on the
Common Stock and the election of directors. Such concentration of ownership may
also have the effect of delaying, deferring or preventing a change in control of
the Company.
POTENTIAL FLUCTUATIONS IN FUTURE QUARTERLY RESULTS. Future revenues and
results of operations may fluctuate significantly from quarter to quarter and
will depend upon, among other factors, actions relating to regulatory and
reimbursement matters, the extent to which the Company's products gain market
acceptance, progress of clinical trials and introduction of competitive
products.
POSSIBLE VOLATILITY OF STOCK PRICE. The stock market has from time to time
experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. The Company's stock price may be
subject to significant volatility, particularly on a quarterly basis. Any
shortfall in revenue or earnings from levels expected by securities analysts
could have an immediate and significant adverse effect on the trading price of
the Company's Common Stock in any given period. Additionally, the Company may
not learn of, or be able to confirm, revenue or earnings variations from
estimates until late in the fiscal quarter, which could result in an even more
immediate and adverse effect on the trading price of the Company's Common Stock.
Finally, the Company participates in a highly dynamic industry, which often
results in significant stock price volatility.
In addition, the market prices of the common stock of many publicly held
medical device companies have in the past been, and can in the future be
expected to be, especially volatile. Factors such as fluctuations in the
Company's operating results, announcements of technological innovations or new
products by the Company or its competitors, FDA and international regulatory
actions, changes in reimbursement levels, developments with respect to patents
or proprietary rights, public concern as to the safety of products developed by
the Company or others, changes in healthcare policy in the United States and
internationally, changes in stock market analyst recommendations regarding the
Company, its competitors or the medical device industry generally, and changes
in general market conditions may have a significant impact on the market price
of the Company's Common Stock.
EFFECT OF CERTAIN CHARTER AND BYLAW PROVISIONS. Certain provisions of the
Company's Certificate of Incorporation and Bylaws may have the effect of making
it more difficult for a third party to acquire, or of discouraging a third party
from attempting to acquire, control of the Company. Such provisions could limit
the price that certain investors might be willing to pay in the future for
shares of the Company's Common Stock. Certain of these provisions allow the
Company to issue Preferred Stock without any vote or further action by the
stockholders, provide for a classified board of directors,
-13-
<PAGE>
eliminate the right of stockholders to act by written consent without a meeting
and eliminate cumulative voting in the election of directors. In addition, the
Company has adopted a stockholder rights plan. The stockholder rights plan, and
the charter and Bylaw provisions described above, may make it more difficult for
stockholders to take certain corporate actions and could have the effect of
delaying or preventing a change in control of the Company.
ABSENCE OF DIVIDENDS. The Company has never paid cash dividends on its
Common Stock and does not anticipate paying cash dividends in the foreseeable
future. The Company intends to retain future savings for reinvestment in its
business. Any future determination to pay cash dividends will be at the
discretion of the Board of Directors and will be dependent upon the Company's
financial condition, results of operations, capital requirements and such other
factors as the Board of Directors deems relevant.
-14-
<PAGE>
ISSUANCE OF COMMON STOCK TO SELLING STOCKHOLDERS
On November 26, 1996, Conceptus acquired Microgyn pursuant to an Agreement
and Plan of Reorganization, dated as of October 29, 1996 (the "Reorganization
Agreement"), among Conceptus, Microgyn and a wholly owned subsidiary of
Conceptus ("Sub"). Pursuant to the Reorganization Agreement, Sub merged with
and into Microgyn and the Company acquired all of the outstanding shares of
Microgyn capital stock. In exchange for all of the outstanding shares of
Microgyn capital stock, the former shareholders of Microgyn received rights to
receive cash and shares of Conceptus Common Stock. On May 23, 1997, the Company
issued to the former shareholders $1,000,000 in Conceptus Common Stock (the
"Merger Shares") as the second payment required pursuant to the Reorganization
Agreement. This Prospectus covers approximately fifty percent (50%) of the
Merger Shares held by the Selling Stockholders (excluding those Merger Shares
held in escrow to satisfy certain indemnification obligations of the Selling
Stockholders pursuant to the Reorganization Agreement).
PLAN OF DISTRIBUTION
The Selling Stockholders may sell the Shares in whole, or in part, from
time to time on the over-the-counter market at prices and on terms prevailing at
the time of any such sale. Any such sale may be made in broker's transactions
through broker-dealers acting as agents, in transactions directly with market
makers or in privately negotiated transactions where no broker or other third
party (other than the purchaser) is involved. The Selling Stockholders will pay
selling commissions or brokerage fees, if any, with respect to the sale of the
Shares in amounts customary for the type of transaction effected. Each Selling
Stockholder will also pay all applicable transfer taxes and all fees and
disbursements of counsel for such Selling Stockholder incurred in connection
with the sale of Shares.
Each Selling Stockholder has advised the Company that during such time as
such Selling Stockholder may be engaged in the attempt to sell Shares registered
hereunder, such person will:
(i) not engage in any stabilization activity in connection with any of the
Company's securities;
(ii) cause to be furnished to each person to whom Shares included herein
may be offered, and to each broker-dealer, if any, through whom Shares are
offered, such copies of this Prospectus, as supplemented or amended, as may be
required by such person;
(iii) not bid for or purchase any of the Company's securities or any rights
to acquire the Company's securities, or attempt to induce any person to purchase
any of the Company's securities or rights to acquire the Company's securities
other than as permitted under the Exchange Act;
(iv) not effect any sale of distribution of the Shares until after the
Prospectus shall have been appropriately amended or supplemented, if required,
to set forth the terms thereof; and
(v) effect all sales of Shares in broker's transactions through broker-
dealers acting as agents, in transactions directly with market makers or in
privately negotiated transaction where no broker or other third party (other
than the purchaser) is involved.
The Selling Stockholders, and any other persons who participate in the sale
of the Shares, may be deemed to be "Underwriters" as defined in the Securities
Act. Any commissions paid or any discounts or concessions allowed to any such
persons, and any profits received on resale of the Shares, may be deemed to be
underwriting discounts and commissions under the Securities Act.
-15-
<PAGE>
The Company has agreed to maintain the effectiveness of this Registration
Statement until the earlier of the sale of all the Shares registered pursuant to
this Prospectus or ___________, 1997 (75 days after the date of this
Prospectus). No sales may be made pursuant to this Prospectus after such date
unless the Company amends or supplements this Prospectus to indicate that it has
agreed to extend such period of effectiveness.
The Company has agreed to indemnify the Selling Stockholders against
certain liabilities, including liabilities under the Securities Act.
SELLING STOCKHOLDERS
The following table sets forth certain information as of June 1, 1997
with respect to the Selling Stockholders:
<TABLE>
<CAPTION>
Shares Beneficially Owned Shares of Common Stock Shares Beneficially Owned
Name Of Selling Stockholder Prior to the Offering(1) Registered Hereby(1) After the Offering(1)(2)
--------------------------- ------------------------- -------------------- -------------------------
Number Percent Number Percent
------ ------- ------ -------
<S> <C> <C> <C> <C> <C>
Craig D. Traub . . . . . . . . . . . . . . . . 32,928 * 15,214 17,714 *
Keith Isaacson . . . . . . . . . . . . . . . . 30,428 * 15,214 15,214 *
John F. Cvinar, Inc. . . . . . . . . . . . . . 7,544 * 3,272 4,272 *
Paul C. Nardella . . . . . . . . . . . . . . . 6,544 * 3,272 3,272 *
Medical Scientific, Inc. . . . . . . . . . . . 5,890 * 2,945 2,945 *
William R. Cowen . . . . . . . . . . . . . . . 4,014 * 2,007 2,007 *
Jonathan D. Donaldson. . . . . . . . . . . . . 3,490 * 1,745 1,745 *
Jeremy J. Nobel. . . . . . . . . . . . . . . . 3,098 * 1,549 1,549 *
Robert Cowen . . . . . . . . . . . . . . . . . 2,182 * 11,091 1,091 *
Paul Grunder and Lois Grunder, JTWROS. . . . . 2,182 * 1,091 1,091 *
Frederick Lane . . . . . . . . . . . . . . . . 2,182 * 1,091 1,091 *
Paul Cowen, William R. Cowen and
George Rooks, Trustees of The Lishon Trust . . 2,182 * 1,091 1,091 *
Thomas G. Stemberg . . . . . . . . . . . . . . 2,182 * 1,091 1,091 *
Thomas G. Morrison . . . . . . . . . . . . . . 1,832 * 916 916 *
Katherine Hunt . . . . . . . . . . . . . . . . 872 * 436 436 *
Thomas Wrublewski. . . . . . . . . . . . . . . 654 * 327 327 *
</TABLE>
- ---------------
-16-
<PAGE>
* Less than 1%
(1) Information with respect to beneficial ownership is based upon information
obtained from the Company's transfer agent and the Selling Stockholders.
(2) Assumes sale of all Shares offered hereby and no other purchases or sales
of the Company's Common Stock. See "Plan of Distribution."
No Selling Stockholder has had any material relationship with the Company
or any of its predecessors or affiliates within the last three years, although
Mr. Isaacson is a consultant to the Company and Mr. Traub is an employee of the
Company.
LEGAL MATTERS
Certain legal matters with respect to the legality of the issuance of the
Common Stock offered hereby will be passed upon for the Company by Venture Law
Group, A Professional Corporation, 2800 Sand Hill Road, Menlo Park, California
94025.
EXPERTS
The consolidated financial statements of Conceptus, Inc. as of December
31, 1996 and 1995, and for the years ended December 31, 1996, 1995 and 1994,
incorporated by reference herein and in the registration statement have been
audited by Ernst & Young LLP, independent auditors as set forth in their
report thereon incorporated by reference herein and in the Registration
Statement, and are included in reliance upon such report given upon the
authority of such firm as experts in accounting and auditing.
-17-
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses payable by the
Registrant in connection with the sale and distribution of the Common Stock
being registered. Selling commissions and brokerage fees and any applicable
transfer taxes and fees and disbursements of counsel for the Selling
Stockholders are payable individually by the Selling Stockholders. All amounts
are estimates except the registration fee.
Amount
To be Paid
----------
Registration Fee . . . . . . . . . . . . . . . . . . . $ 165.62
Legal Fees and Expenses. . . . . . . . . . . . . . . . 10,000.00
Accounting Fees and Expenses . . . . . . . . . . . . . 3,000.00
Miscellaneous. . . . . . . . . . . . . . . . . . . . . 1,834.38
----------
Total . . . . . . . . . . . . . . . . . . . . . . $15,000.00
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law authorizes a court to
award, or a corporation's Board of Directors to grant, indemnity to directors
and officers in terms sufficiently broad to permit such indemnification under
certain circumstances for liabilities (including reimbursement for expenses
incurred) arising under the Securities Act of 1933. Article XI of the
Registrant's Amended and Restated Certificate of Incorporation and Article VII,
Section 6.1 of the Registrant's Bylaws provide for indemnification of its
directors, officers, employees and other agents to the maximum extent permitted
by law. In addition, the Registrant has entered into Indemnification Agreements
with its officers and directors and maintains director and officer liability
insurance.
ITEM 16. EXHIBITS
Exhibit
Number Description of Exhibit
------- ----------------------
2.1(1) Agreement and Plan of Reorganization dated October 29, 1996
between the Registrant, Microgyn, Inc. and CPTS Acquisition
Corporation (a wholly owned subsidiary of the Registrant), as
amended November 7, 1996
4.1 Registration Rights Agreement, dated as of November 26, 1996,
between the Registrant and Microgyn, Inc.
5.1 Opinion of Venture Law Group, A Professional Corporation
23.1 Consent of Ernst & Young LLP, Independent Auditors
23.2 Consent of Counsel (included in Exhibit 5.1)
24.1 Power of Attorney (see page II-4)
II-1
<PAGE>
- ---------------
(1) Incorporated by reference to Exhibit 2.1 filed in response to Item 7
"Financial Statements, Pro Forma Financial Information and Exhibits" of the
Registrant's Current Report on Form 8-K as filed on December 10, 1996.
ITEM 17. UNDERTAKINGS
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 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.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, 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.
(4) That, for purposes of determining any liability under the Securities
Act of 1933, each filing of the Registrant's annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan's annual report pursuant to
Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by
reference in the Registration Statement 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.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the provisions referred to in Item 15 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 of 1933 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 against the Registrant by such director, officer
or controlling person in connection with the securities being registered
hereunder, 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 of 1933 and will be governed by the
final adjudication of such issue.
II-2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of San Carlos, State of California, on the 26 day of
June 1997.
CONCEPTUS, INC.
By: /s/ Sanford Fitch
-------------------------------------------------
Sanford Fitch
Senior Vice President and Chief Financial Officer
II-3
<PAGE>
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints, Kathryn A. Tunstall and Sanford
Fitch, and each of them acting individually, as his attorney-in-fact, each with
full power of substitution, for him in any and all capacities, to sign any and
all amendments to this Registration Statement (including post-effective
amendments), and to file the same, with exhibits thereto and other documents in
connection therewith, with the Securities and Exchange Commission, hereby
ratifying and confirming our signatures as they may be signed by our said
attorney to any and all amendments to said Registration Statement. Pursuant to
the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates
indicated:
SIGNATURE TITLE DATE
- ------------------------------- ----------------------------- -------------
/s/ Kathryn A. Tunstall
----------------------------- President, Chief Executive June 26, 1997
(Kathryn A. Tunstall) Officer and Director
(Principal Executive Officer)
/s/ Sanford Fitch
----------------------------- Senior Vice President, Chief June 26, 1997
(Sanford Fitch) Financial Officer and
Director (Principal Financial
and Accounting Officer)
/s/ Robert F. Kuhling
----------------------------- Director June 26, 1997
(Robert F. Kuhling)
/s/ Thomas C. McConnell
----------------------------- Director June 26, 1997
(Thomas C. McConnell)
/s/ Nancy S. Olson
----------------------------- Director June 26, 1997
(Nancy S. Olson)
/s/ Richard D. Randall
----------------------------- Director June 26, 1997
(Richard D. Randall)
II-4
<PAGE>
CONCEPTUS, INC.
INDEX TO EXHIBITS
Exhibit
Number
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4.1 Registration Rights Agreement, dated as of November 26,
1996, between the Registrant and Microgyn, Inc.
5.1 Opinion of Venture Law Group, A Professional Corporation
23.1 Consent of Ernst & Young LLP, Independent Auditors
23.2 Consent of Counsel (included in Exhibit 5.1)
24.1 Power of Attorney (see page II-4)
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CONCEPTUS, INC.
REGISTRATION RIGHTS AGREEMENT
This Registration Rights Agreement (the "AGREEMENT") is made as of November
26, 1996 by and among Conceptus, Inc., a Delaware corporation (the "COMPANY"),
and Microgyn, Inc., a Massachusetts corporation ("MICROGYN").
RECITALS
A. Conceptus, Microgyn and CPTS Acquisition Corporation, a
Massachusetts corporation and wholly-owned subsidiary of Conceptus ("MERGER
SUB"), have entered into an Agreement and Plan of Reorganization (the
"REORGANIZATION AGREEMENT"), dated as of October 29, 1996, providing for the
merger of Merger Sub with and into Microgyn (the "MERGER").
B. At the Effective Time (as defined in the Reorganization Agreement),
each issued and outstanding share of Microgyn capital stock will be converted
into the right to receive cash and shares of the Company's Common Stock (such
shares being referred to as the "MERGER SHARES").
C. While the Company intends that the issuance of the Merger Shares will
qualify for an exemption under Section 3(a)(10) of the Securities Act of 1933,
as amended (the "ACT"), in the event that the issuance of the Merger Shares
would not so qualify, the Company will have the option of paying the former
shareholders of Microgyn (the "MICROGYN SHAREHOLDERS") an equal amount of cash
or proceeding with the issuance of the Merger Shares under another exemption.
D. In the event that the Section 3(a)(10) exemption is not available and
the Company proceeds with the issuance of Merger Shares to the Microgyn
Shareholders, the Company and Microgyn have agreed that the following provisions
shall apply with respect to the resale of such issued Merger Shares.
AGREEMENT
The parties hereby agree as follows:
1. REGISTRATION RIGHTS. The Company and Microgyn covenant and agree
as follows:
1.1 DEFINITIONS. For purposes of this Section 1:
(a) The terms "REGISTER," "REGISTERED," and
"REGISTRATION" refer to a registration effected by preparing and filing a
registration statement on Form S-1, S-3, SB-1 or SB-2 or their successor
forms (or other functionally equivalent form under the Act) in compliance
with the Act, and the declaration or ordering of effectiveness of such
registration statement or document;
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(b) The term "REGISTRABLE SECURITIES" means the Merger
Shares of any Tranche for which Rule 144 or another similar exemption under
the Act is not available for the sale of all of such shares by the Holder
thereof during a three-month period without registration; PROVIDED, HOWEVER,
that the foregoing definition shall exclude in all cases any Registrable
Securities sold by a person in a transaction in which his or her rights under
this Agreement are not assigned. Notwithstanding the foregoing, Merger
Shares or other securities shall only be treated as Registrable Securities if
and so long as they have not been (A) sold to or through a broker or dealer
or underwriter in a public distribution or a public securities transaction,
or (B) sold in a transaction exempt from the registration and prospectus
delivery requirements of the Act under Section 4(1) thereof so that all
transfer restrictions, and restrictive legends with respect thereto, if any,
are removed upon the consummation of such sale;
(c) The number of shares of "REGISTRABLE SECURITIES THEN
OUTSTANDING" shall be the number of Merger Shares outstanding which are then
Registrable Securities;
(d) The term "HOLDER" means any person owning or having
the right to acquire Registrable Securities or any assignee thereof in
accordance with Section 1.13 hereof;
(e) The term "TRANCHE" means an installment of Merger
Shares issued by the Company to the Microgyn Shareholders pursuant to Section
1.3(b), 1.3(c) or 1.3(d) of the Reorganization Agreement;
(f) The term "FORM S-3" means such form under the Act as
in effect on the date hereof or any successor form under the Act; and
(g) The term "SEC" means the Securities and Exchange
Commission.
1.2 REQUEST FOR REGISTRATION.
(a) If the Company shall receive at any time after the
issuance of Merger Shares a written request from the Holders of not less than
twenty-five percent (25%) of the Registrable Securities then outstanding that
the Company file a registration statement under the Act covering the the
Registrable Securities then outstanding held by the Holders initiating such
request (the "INITIATING HOLDERS"), the Company shall, within seven (7)
business days of the receipt thereof, give written notice of such request to
all Holders and shall, subject to the limitations set forth in this Section
1.2, use its best efforts to effect as soon as practicable, and in any event
within 30 days of the receipt of such request (or such longer period as may
be necessary to satisfy any SEC review period, if applicable), the
registration under the Act of all Registrable Securities which the Holders
request to be registered pursuant to written notice delivered to the Company
within fifteen (15) days of the mailing of the Company's notice.
(b) If the Initiating Holders intend to distribute the
Registrable Securities covered by their request by means of an underwriting,
they shall so advise the Company as a part of their request made pursuant to
this Section 1.2 and the Company shall
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include such information in the written notice referred to in subsection
1.2(a). The underwriter will be selected by a majority in interest of the
Initiating Holders and shall be reasonably acceptable to the Company. In
such event, the right of any Holder to include his Registrable Securities in
such registration shall be conditioned upon such Holder's participation in
such underwriting and the inclusion of such Holder's Registrable Securities
in the underwriting (unless otherwise mutually agreed by a majority in
interest of the Initiating Holders and such Holder) to the extent provided
herein. All Holders proposing to distribute their securities through such
underwriting shall (together with the Company as provided in subsection
1.3(e)) enter into an underwriting agreement in customary form with the
underwriter or underwriters selected for such underwriting by a majority in
interest of the Initiating Holders. Notwithstanding any other provision of
this Section 1.2, if the underwriter advises the Initiating Holders in
writing that marketing factors require a limitation of the number of shares
to be underwritten, then the Initiating Holders shall so advise all Holders
of Registrable Securities which would otherwise be underwritten pursuant
hereto, and the number of shares of Registrable Securities that may be
included in the underwriting shall be allocated among all Holders thereof,
including the Initiating Holders, in proportion (as nearly as practicable) to
the amount of Registrable Securities of the Company owned by each Holder;
PROVIDED, HOWEVER, that the number of shares of Registrable Securities to be
included in such underwriting shall not be reduced unless all other
securities are first entirely excluded from the underwriting.
(c) Notwithstanding the foregoing, if the Company shall
furnish to Holders requesting a registration statement pursuant to this
Section 1.2, a certificate signed by the President of the Company stating
that in the good faith judgment of the Board of Directors of the Company, it
would be seriously detrimental to the Company and its stockholders for such
registration statement to be filed and it is therefore essential to defer the
filing of such registration statement, the Company shall have the right to
defer such filing for a period of not more than thirty (30) days after
receipt of the request of the Initiating Holders.
(d) In addition, the Company shall not be obligated to
effect, or to take any action to effect, any registration pursuant to this
Section 1.2:
(i) If the Company has already effected a number of
registrations pursuant to this Section 1.2 equal to the product of (A) two,
multiplied by (B) the number of Tranches of Merger Shares issued as of such
date; or
(ii) During the six-month period following the
termination date of a registration effected pursuant to Section 1.2 hereof.
1.3 OBLIGATIONS OF THE COMPANY. Whenever required under this
Section 1 to effect the registration of any Registrable Securities, the
Company shall, as expeditiously as reasonably possible:
(a) Prepare and file with the SEC a registration
statement with respect to such Registrable Securities and use its best
efforts to cause such registration statement to become effective, and keep
such registration statement effective until the earlier of (a) the close of
business on the date seventy-five (75) days following the effective date of
the
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registration, (b) the completion of the distribution of securities registered
thereunder, (c) the date agreed to by the consent of the Holders of at least
sixty-six percent (66%) of the Registrable Securities subject to such
registration, or (d) such other date on which registration rights would
terminate as may be set forth in Section 1.10 below.
(b) Prepare and file with the SEC such amendments and
supplements to such registration statement and the prospectus used in
connection with such registration statement as may be necessary to comply
with the provisions of the Act with respect to the disposition of all
securities covered by such registration statement for up to seventy-five (75)
days.
(c) Furnish to the Holders such numbers of copies of a
prospectus, including a preliminary prospectus, in conformity with the
requirements of the Act, and such other documents as they may reasonably
request in order to facilitate the disposition of Registrable Securities
owned by them.
(d) Use its best efforts to register and qualify the
securities covered by such registration statement under such other securities
or Blue Sky laws of such jurisdictions as shall be reasonably requested by
the Holders, provided that the Company shall not be required in connection
therewith or as a condition thereto to qualify to do business or to file a
general consent to service of process in any such states or jurisdictions.
(e) In the event of any underwritten public offering,
enter into and perform its obligations under an underwriting agreement, in
usual and customary form, with the managing underwriter of such offering.
Each Holder participating in such underwriting shall also enter into and
perform its obligations under such an agreement.
(f) Notify each Holder of Registrable Securities covered
by such registration statement at any time when a prospectus relating thereto
is required to be delivered under the Act of the happening of any event as a
result of which the prospectus included in such registration statement, as
then in effect, includes an untrue statement of a material fact or omits to
state a material fact required to be stated therein or necessary to make the
statements therein not misleading in the light of the circumstances then
existing, such obligation to continue for seventy-five (75) days.
(g) Cause all such Registrable Securities registered
pursuant hereunder to be listed on each securities exchange on which similar
securities issued by the Company are then listed.
(h) Provide a transfer agent and registrar for all
Registrable Securities registered pursuant hereunder and a CUSIP number for
all such Registrable Securities, in each case not later than the effective
date of such registration.
1.4 FURNISH INFORMATION. It shall be a condition precedent to
the obligations of the Company to take any action pursuant to this Section 1
with respect to the Registrable Securities of any selling Holder that such
Holder shall furnish to the Company such information regarding itself, the
Registrable Securities held by it, and the intended method of
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disposition of such securities as shall be required to effect the
registration of such Holder's Registrable Securities. The Company shall have
no obligation with respect to any registration requested pursuant to Section
1.2 of this Agreement if, as a result of the application of the preceding
sentence, the number of shares of Registrable Securities to be included in
the registration does not equal or exceed the number of shares required to
originally trigger the Company's obligation to initiate such registration as
specified in subsection 1.2(a).
1.5 EXPENSES OF REGISTRATION. The Company shall pay all
expenses (other than underwriting discounts and commissions) incurred in
connection with underwritings, registrations, filings or qualifications
pursuant to Section 1.2, including (without limitation) all registration,
filing and qualification fees, printers' and accounting fees, fees and
disbursements of counsel for the Company; provided, however, that the Company
shall not be required to pay for any expenses of any registration proceeding
begun pursuant to Section 1.2 if the registration request is subsequently
withdrawn at the request of the Holders of a majority of the Registrable
Securities to be registered (in which case all participating Holders shall
bear such expenses), unless the Holders of a majority of the Registrable
Securities agree to forfeit their right to one demand registration pursuant
to Section 1.2; provided further, however, that if at the time of such
withdrawal, the Holders have learned of a material adverse change in the
condition, business, or prospects of the Company from that known to the
Holders at the time of their request and have withdrawn the request with
reasonable promptness following disclosure by the Company of such material
adverse change, then the Holders shall not be required to pay any of such
expenses and shall retain their rights pursuant to Section 1.2. Expenses of
special counsel, if any, for the selling Holders shall be borne entirely by
such Holders.
1.6 DELAY OF REGISTRATION. No Holder shall have any right to
obtain or seek an injunction restraining or otherwise delaying any such
registration as the result of any controversy that might arise with respect
to the interpretation or implementation of this Section 1.
1.7 INDEMNIFICATION. In the event any Registrable Securities
are included in a registration statement under this Section 1:
(a) To the extent permitted by law, the Company will
indemnify and hold harmless each Holder, any underwriter (as defined in the
Act) for such Holder and each person, if any, who controls such Holder or
underwriter within the meaning of the Act or the Exchange Act, against any
losses, claims, damages, or liabilities (joint or several) to which they may
become subject under the Act, the Exchange Act or other federal or state law,
insofar as such losses, claims, damages, or liabilities (or actions in
respect thereof) arise out of or are based upon any of the following
statements, omissions or violations (collectively a "VIOLATION"): (i) any
untrue statement or alleged untrue statement of a material fact contained in
such registration statement, including any preliminary prospectus or final
prospectus contained therein or any amendments or supplements thereto, (ii)
the omission or alleged omission to state therein a material fact required to
be stated therein, or necessary to make the statements therein not
misleading, or (iii) any violation or alleged violation by the Company of the
Act, the Exchange Act, any state securities law or any rule or regulation
promulgated under the Act, the Exchange Act or any state securities law; and
the Company will pay to each such Holder,
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underwriter or controlling person, as incurred, any legal or other expenses
reasonably incurred by them in connection with investigating or defending any
such loss, claim, damage, liability, or action; provided, however, that the
indemnity agreement contained in this subsection 1.7(a) shall not apply to
amounts paid in settlement of any such loss, claim, damage, liability, or
action if such settlement is effected without the consent of the Company
(which consent shall not be unreasonably withheld), nor shall the Company be
liable in any such case for any such loss, claim, damage, liability, or
action to the extent that it arises out of or is based upon a Violation which
occurs in reliance upon and in conformity with written information furnished
expressly for use in connection with such registration by any such Holder,
underwriter or controlling person.
(b) To the extent permitted by law, each selling Holder
will indemnify and hold harmless the Company, each of its directors, each of
its officers who has signed the registration statement, each person, if any,
who controls the Company within the meaning of the Act, any underwriter, any
other Holder selling securities in such registration statement and any
controlling person of any such underwriter or other Holder, against any
losses, claims, damages, or liabilities (joint or several) to which any of
the foregoing persons may become subject, under the Act, the Exchange Act or
other federal or state law, insofar as such losses, claims, damages, or
liabilities (or actions in respect thereto) arise out of or are based upon
any Violation, in each case to the extent (and only to the extent) that such
Violation occurs in reliance upon and in conformity with written information
furnished by such Holder expressly for use in connection with such
registration; and each such Holder will pay, as incurred, any legal or other
expenses reasonably incurred by any person intended to be indemnified
pursuant to this subsection 1.7(b), in connection with investigating or
defending any such loss, claim, damage, liability, or action; provided,
however, that the indemnity agreement contained in this subsection 1.7(b)
shall not apply to amounts paid in settlement of any such loss, claim,
damage, liability or action if such settlement is effected without the
consent of the Holder, which consent shall not be unreasonably withheld;
provided, that, in no event shall any indemnity under this subsection 1.7(b)
exceed the net proceeds from the offering received by such Holder, except in
the case of willful fraud by such Holder.
(c) Promptly after receipt by an indemnified party under
this Section 1.7 of notice of the commencement of any action (including any
governmental action), such indemnified party will, if a claim in respect
thereof is to be made against any indemnifying party under this Section 1.7,
deliver to the indemnifying party a written notice of the commencement
thereof and the indemnifying party shall have the right to participate in,
and, to the extent the indemnifying party so desires, jointly with any other
indemnifying party similarly noticed, to assume the defense thereof with
counsel mutually satisfactory to the parties; provided, however, that an
indemnified party (together with all other indemnified parties which may be
represented without conflict by one counsel) shall have the right to retain
one separate counsel, with the reasonable fees and expenses to be paid by the
indemnifying party, if representation of such indemnified party by the
counsel retained by the indemnifying party would be inappropriate due to
actual or potential differing interests between such indemnified party and
any other party represented by such counsel in such proceeding. The failure
to deliver written notice to the indemnifying party within a reasonable time
of the commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve such indemnifying party of any liability to
the indemnified party under this Section 1.7, but the omission so to deliver
written
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notice to the indemnifying party will not relieve it of any liability that it
may have to any indemnified party otherwise than under this Section 1.7.
(d) If the indemnification provided for in this Section
1.7 is held by a court of competent jurisdiction to be unavailable to an
indemnified party with respect to any loss, liability, claim, damage, or
expense referred to therein, then the indemnifying party, in lieu of
indemnifying such indemnified party hereunder, shall contribute to the amount
paid or payable by such indemnified party as a result of such loss,
liability, claim, damage, or expense in such proportion as is appropriate to
reflect the relative fault of the indemnifying party on the one hand and of
the indemnified party on the other in connection with the statements or
omissions that resulted in such loss, liability, claim, damage, or expense as
well as any other relevant equitable considerations; provided, that, in no
event shall any contribution by a Holder under this Subsection 1.7(d) exceed
the net proceeds from the offering received by such Holder, except in the
case of willful fraud by such Holder. The relative fault of the indemnifying
party and of the indemnified party shall be determined by reference to, among
other things, whether the untrue or alleged untrue statement of a material
fact or the omission to state a material fact relates to information supplied
by the indemnifying party or by the indemnified party and the parties'
relative intent, knowledge, access to information, and opportunity to correct
or prevent such statement or omission.
(e) Notwithstanding the foregoing, to the extent that the
provisions on indemnification and contribution contained in the underwriting
agreement entered into in connection with the underwritten public offering
are in conflict with the foregoing provisions, the provisions in the
underwriting agreement shall control.
(f) The obligations of the Company and Holders under this
Section 1.7 shall survive the completion of any offering of Registrable
Securities in a registration statement under this Section 1, and otherwise.
1.8 REPORTS UNDER SECURITIES EXCHANGE ACT OF 1934. With a
view to making available to the Holders the benefits of Rule 144 promulgated
under the Act and any other rule or regulation of the SEC that may at any
time permit a Holder to sell securities of the Company to the public without
registration or pursuant to a registration on Form S-3 or other applicable
form incorporating by reference the Company's public information, the Company
agrees to:
(a) make and keep public information available, as those
terms are understood and defined in SEC Rule 144 so long as the Company
remains subject to the periodic reporting requirements under Sections 13 or
15(d) of the Exchange Act;
(b) take such action, including the voluntary
registration of its Common Stock under Section 12 of the Exchange Act, as is
necessary to enable the Holders to utilize Form S-3 for the sale of their
Registrable Securities, such action to be taken as soon as practicable after
the end of the fiscal year in which the first registration statement filed by
the Company for the offering of its securities to the general public is
declared effective;
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(c) file with the SEC in a timely manner all reports and
other documents required of the Company under the Act and the Exchange Act;
and
(d) furnish to any Holder, so long as the Holder owns any
Registrable Securities, forthwith upon request (i) a written statement by the
Company that it has complied with the reporting requirements of SEC Rule 144
(at any time after ninety (90) days after the effective date of the first
registration statement filed by the Company), the Act and the Exchange Act
(at any time after it has become subject to such reporting requirements), or
that it qualifies as a registrant whose securities may be resold pursuant to
Form S-3 (at any time after it so qualifies), (ii) a copy of the most recent
annual or quarterly report of the Company and such other reports and
documents so filed by the Company, and (iii) such other information as may be
reasonably requested in availing any Holder of any rule or regulation of the
SEC which permits the selling of any such securities without registration or
pursuant to such form.
1.9 ASSIGNMENT OF REGISTRATION RIGHTS. The rights to cause
the Company to register Registrable Securities pursuant to this Section 1 may
be assigned (but only with all related obligations) by a Holder to a
transferee or assignee of such securities, provided the Company is, within a
reasonable time after such transfer, furnished with written notice of the
name and address of such transferee or assignee and the securities with
respect to which such registration rights are being assigned; and provided,
further, that such assignment shall be effective only if immediately
following such transfer the further disposition of such securities by the
transferee or assignee is restricted under the Act. For assignments in
connection with the transfer of less than all of a Holder's Registrable
Securities to an assignee, the assigning Holder and all assignees of such
Holder's Registrable Securities shall appoint a single attorney-in-fact for
the purpose of exercising any rights, receiving notices or taking any action
under Section 1.
1.10 TERMINATION OF REGISTRATION RIGHTS. The registration
obligations of the Company will terminate (i) with respect to any Holder, at
such time as (a) all Merger Shares held by such Holder may be sold within a
three-month period pursuant to Rule 144 and (b) the holder owns less than one
percent (1%) of the outstanding capital stock of the Company, or (ii) upon
completion of the distribution under the registration statements of all the
Merger Shares which may hereafter be issued.
2. MISCELLANEOUS.
2.1 SUCCESSORS AND ASSIGNS. Except as otherwise provided
herein, the terms and conditions of this Agreement shall inure to the benefit
of and be binding upon the respective successors and assigns of the parties.
Except as specifically set forth in this paragraph, nothing in this
Agreement, express or implied, is intended to confer upon any party other
than the parties hereto or their respective successors and assigns any
rights, remedies, obligations, or liabilities under or by reason of this
Agreement, except as expressly provided in this Agreement. It is intended
that the Microgyn Shareholders be third party beneficiaries to this
Registration Rights Agreement and that this Registration Rights Agreement may
be enforced on their behalf by the Representatives (as defined in the
Reorganization Agreement).
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2.2 GOVERNING LAW. This Agreement and all acts and
transactions pursuant hereto shall be governed, construed and interpreted in
accordance with the laws of the State of California, without giving effect to
principles of conflicts of laws.
2.3 COUNTERPARTS. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
2.4 TITLES AND SUBTITLES. The titles and subtitles used in
this Agreement are used for convenience only and are not to be considered in
construing or interpreting this Agreement.
2.5 NOTICES. Unless otherwise provided, any notice required
or permitted by this Agreement shall be in writing and shall be deemed
sufficient upon delivery, when delivered personally or by overnight courier
or sent by telegram or fax, or seventy-two (72) hours after being deposited
in the U.S. mail, as certified or registered mail, with postage prepaid, and
addressed to the party to be notified at such party's address as set forth
below or on EXHIBIT A hereto, or as subsequently modified by written notice.
Notices under Section 1.2(a) to the Holders from Company must be delivered
personally or by overnight courier.
2.6 EXPENSES. If any action at law or in equity is necessary to
enforce or interpret the terms of this Agreement, the prevailing party shall be
entitled to reasonable attorneys' fees, costs and necessary disbursements in
addition to any other relief to which such party may be entitled.
2.7 AMENDMENTS AND WAIVERS. Any term of this Agreement may be
amended and the observance of any term of this Agreement may be waived
(either generally or in a particular instance and either retroactively or
prospectively), only with the written consent of the Company and the holders
of sixty-six percent (66%) of the Registrable Securities then outstanding.
Any amendment or waiver effected in accordance with this paragraph shall be
binding upon each holder of any Registrable Securities then outstanding, each
future holder of all such Registrable Securities, and the Company.
2.8 SEVERABILITY. If one or more provisions of this Agreement
are held to be unenforceable under applicable law, the parties agree to
renegotiate such provision in good faith. In the event that the parties
cannot reach a mutually agreeable and enforceable replacement for such
provision, then (a) such provision shall be excluded from this Agreement, (b)
the balance of the Agreement shall be interpreted as if such provision were
so excluded and (c) the balance of the Agreement shall be enforceable in
accordance with its terms.
[Signature Page Follows]
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The parties have executed this Registration Rights Agreement as of the date
first above written.
CONCEPTUS, INC. MICROGYN, INC.
By: /S/ SANFORD FITCH By: /S/ CRAIG D. TRAUB
--------------------------- ----------------------------
Title: CFO Title: PRESIDENT
------------------------ -------------------------
1021 Howard Avenue
San Carlos, CA 94070
Attn: Chief Financial Officer
Phone: (415) 802-7240
Fax: (415) 508-7600 or 610-8363
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Revised 11/22/96
EXHIBIT A
MICROGYN SHAREHOLDERS
Shareholder Addresses
NAME/ADDRESS NAME/ADDRESS
Rob Cowen Katherine Hunt
172 Mountain Shadow Drive 129 Dedham Street
Bayfield, CO 81122 Dover, MA 02030
William R. Cowen Keith B. Isaacson, M.D.
Firepond Partners, Inc. Massachusetts General Hospital
8 Faneuil Hall Marketplace Vincent Memorial Gyn. Service
Boston, MA 02109 Wang Ambulatory Care Center
Suite 231
Boston, MA 02114
John F. Cvinar Fred Lane
94 Ridge Street 17 Pheasant Lane
Winchester, MA 01890 Greenwich, CT 06830
John Donaldson Thomas G. Morrison
7 Old Lexington Road 19 Woodvine Street, 3rd Floor
Lincoln, MA 01773 Newton, MA 02166
Paul and Lois Grunder Medical Scientific, Inc.
149 E. Allendale Road 125 John Hancock Road
Saddle River, NJ 07458 Taunton, MA 02780
Heritage Capital Management, Inc. Paul Nardella
Pauline Cowen, William R. Cowen and 12 Cromesett Road
George Rooks, Wareham, MA 02571
Trustees of The Lishon Trust)
31 Milk Street
Boston, MA 02109
Jeremy Nobel
77 Stearns Road
Brookline, MA 02146
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Thomas Stemberg
5 Louisburg Square
Boston, MA 02108
Craig Traub
7 Fairfax Drive
Andover, MA 01810
Thomas Wrublewski
5 Tall Tree Road
Sharon, MA
Tax Identification Numbers provided in Letters of Transmittal.
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EXHIBIT 5.1
June 25, 1997
Conceptus, Inc.
1021 Howard Avenue
San Carlos, CA 94070
REGISTRATION STATEMENT ON FORM S-3
Ladies and Gentlemen:
We have examined the Registration Statement on Form S-3 (the "REGISTRATION
STATEMENT") filed by you with the Securities and Exchange Commission on or about
June 26, 1997 in connection with the registration under the Securities Act of
1933, as amended, of 52,352 shares of your Common Stock, par value $0.003 per
share (the "SHARES"), to be sold by certain stockholders listed in the
Registration Statement (the "SELLING STOCKHOLDERS"). As your counsel in
connection with this transaction, we have examined the proceedings taken and we
are familiar with the proceedings proposed to be taken in connection with the
sale of the Shares by the Selling Stockholders in the manner set forth in the
Registration Statement under the heading "Plan of Distribution."
It is our opinion that the Shares, when sold by the Selling Stockholders in
the manner referred to in the Registration Statement, will be legally and
validly issued, fully paid and nonassessable.
We consent to the use of this opinion as an exhibit to the Registration
Statement, and further consent to the use of our name wherever appearing in the
Registration Statement, including the Prospectus constituting a part thereof,
and any amendment thereto.
Very truly yours,
VENTURE LAW GROUP
A Professional Corporation
/s/ VENTURE LAW GROUP
[CSC]
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23.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" in the
Registration Statement (Form S-3) and related Prospectus of Conceptus, Inc.
for the registration of 52,352 shares of its common stock and to the
incorporation by reference therein of our report dated February 3, 1997, with
respect to the consolidated financial statements of Conceptus, Inc. included
in its Annual Report (Form 10-K) for the year ended December 31, 1996, filed
with the Securities and Exchange Commission.
ERNST & YOUNG, LLP
Palo Alto, California
June 23, 1997