As filed with the Securities and Exchange Commission on July 29, 1999
Registration No. ___________
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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MIRAVANT MEDICAL TECHNOLOGIES
(Exact name of registrant as specified in its charter)
Delaware 77-0222872
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
336 Bollay Drive
Santa Barbara, California 93117
(805) 685-9880
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)
GARY S. KLEDZIK, Ph.D.
Chairman and Chief Executive Officer
Miravant Medical Technologies
336 Bollay Drive
Santa Barbara, California 93117
(805) 685-9880
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
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Copies to:
JOSEPH E. NIDA, Esq. JAMES L. NOUSS, JR., Esq.
THEODORE R. MALONEY, Esq. ELIZABETH A. KING, Esq.
Nida & Maloney LLP Bryan Cave LLP
800 Anacapa Street 120 Broadway, Suite 500
Santa Barbara, California 93101 Santa Monica, California 90401
(805) 568-1151 (310) 576-2100
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Approximate date of commencement of proposed sale to the public:
From time to time after this registration statement becomes effective.
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If the only securities being registered on the form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. |_|
If any of the securities registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. |X|
If this Form is 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. |_|
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CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
<S> <C> <C> <C>
Proposed Maximum Proposed Maximum
Amount of Shares Offering Price Aggregate Offering Amount of
Title of Securities to be Registered to be Registered Per Share Price Registration Fee
Common Stock, par value $.01 per share................ 3,856,710(1) $9.00 (2) $34,710,390(2) $9,649.07
</TABLE>
(1) Includes 360,000 shares of Common Stock of Miravant Medical Technologies
(the "Company" or the "Registrant") issuable upon exercise of Common Stock
Purchase Warrants (the "Warrants") and pursuant to the provisions of the
Warrants, as such number may be adjusted in accordance with Rule 416.
(2) Estimated pursuant to Rule 457(h) solely for the purpose of calculating the
amount of the registration fee on the basis of the average of the high and
low reported sale prices of a share of Common Stock of the Company of $9.00
for 3,856,710 shares on July 26, 1999, as reported by the NASDAQ National
Market.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8 (a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8 (a),
MAY DETERMINE.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED _____________
PROSPECTUS
3,856,710 Shares
MIRAVANT
MEDICAL TECHNOLOGIES
Common Stock
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Shares of common stock of Miravant Medical Technologies registered pursuant
to the registration statement of which this prospectus is a part (the "Shares")
may be sold from time to time for the accounts of and by the persons named under
the caption "Selling Shareholders." The Shares include 360,000 Shares of common
stock issuable upon the exercise of Common Stock Purchase Warrants (the
"Warrants"), as such number may be adjusted in accordance with Rule 416 of the
Securities Act of 1933. See "Selling Shareholders." The Selling Shareholders
have advised Miravant that the Shares may be sold from time to time on the
Nasdaq National Market or in negotiated transactions, in each case at prices
satisfactory to the seller. The Selling Shareholders and the brokers and dealers
through which the sales of the Shares may be made may be deemed to be
"underwriters" within the meaning set forth in the Securities Act, and their
commissions and discounts and other compensation may be regarded as
underwriters' compensation. See "Plan of Distribution." Miravant has issued, or
will issue upon the exercise of the Warrants, the Shares in accordance with
certain private placement transactions.
Miravant will not receive any proceeds from the sale of Shares by the
Selling Shareholders, but will receive the exercise prices payable upon the
exercise of the Warrants, if exercised for cash. There can be no assurance that
all or any of the Warrants will be exercised or that they will be exercised for
cash. All expenses incurred in connection with this offering are being borne by
Miravant, other than any commissions or discounts paid or allowed by the Selling
Shareholders to underwriters, dealers, brokers or agents.
Miravant's common stock is traded on the Nasdaq under the symbol "MRVT." On
July 28, 1999, the last sale price of the common stock as reported by the Nasdaq
was $9.44.
The common stock offered by this prospectus involves a high degree of risk.
See "Risk Factors" beginning on page 4.
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THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE 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.
July ____, 1999
AVAILABLE INFORMATION
Miravant is subject to the informational requirements of the Securities
Exchange Act of 1934 and files reports, proxy statements and other information
with the Securities and Exchange Commission. Reports, proxy statements and other
information filed by Miravant can be inspected and copied at the public
reference facilities maintained by the Commission at Room 1024, 450 Fifth
Street, N.W., Washington, D.C. 20549 and at the Commission's Regional Offices at
Citicorp Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661
and Seven World Trade Center, Suite 1300, New York, New York 10048. Copies can
be obtained at prescribed rates from the Public Reference Branch of the
Commission at 450 Fifth Street, N.W., Washington, D.C. 20549. The Commission
maintains a Web site that contains reports, proxy and information statements and
other materials that are filed through the Commission's Electronic Data
Gathering, Analysis and Retrieval (EDGAR) system. This Web site can be accessed
at http://www.sec.gov. Miravant's common stock is listed on the Nasdaq and the
reports, proxy statements and other information filed by Miravant also can be
inspected at the offices of the National Association of Securities Dealers, Inc.
at 1735 K Street, N.W., Washington, D.C. 20006.
Miravant has filed with the Commission a registration statement on Form S-3
under the Securities Act with respect to the common stock offered by this
prospectus. This prospectus does not contain all the information set forth in
the registration statement, portions of which have been omitted as permitted by
the rules and regulations of the Commission. Statements contained in this
prospectus as to the contents of any contract or other document are not
necessarily complete, and in each instance readers should refer to the copy of
that contract or other document filed or incorporated by reference as an exhibit
to the registration statement. Each of those statements is qualified in all
respects by this reference to the registration statement and the exhibits and
schedules to the registration statement. For further information pertaining to
Miravant or the common stock offered by this prospectus, we refer you to the
registration statement and the exhibits and schedules to the registration
statement, which may be inspected without charge at, and copies thereof may be
obtained at prescribed rates from, the Public Reference Branch of the Commission
at 450 Fifth Street, N.W., Washington, D.C. 20549.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
This prospectus incorporates documents by reference that are not presented
in or delivered with this prospectus, as indicated below. Miravant will provide
without charge to each person to whom a copy of this prospectus has been
delivered, upon written or oral request, a copy of any or all of the documents
referred to below which are incorporated in this prospectus by reference (other
than exhibits to those documents, unless they are specifically incorporated by
reference into the documents). Requests for copies should be directed to Shadean
Runyen, Miravant Medical Technologies, 336 Bollay Drive, Santa Barbara,
California 93117; telephone number (805) 685-9880.
The following documents filed with the Commission by Miravant under File
No. 0-25544 pursuant to the Exchange Act are incorporated in this prospectus by
reference:
* Annual report on Form 10-K for the fiscal year ended December 31,
1998;
* Quarterly report on Form 10-Q for the fiscal quarter ended March 31,
1999;
* Definitive proxy statement dated May 10, 1999;
* Current report on Form 8-K dated January 15, 1999; and
* Description of Miravant's common stock as contained in Item 1 of
Miravant's registration statement on Form 8-A filed February 9, 1995.
All documents filed by Miravant with the Commission under Section 13(a),
13(c), 14 or 15(d) of the Exchange Act on or after the date of this prospectus
and prior to the termination of the offering of the common stock offered by this
prospectus, shall be deemed to be incorporated by reference in this prospectus
and to be a part of this prospectus from the date of filing of these documents.
See "Available Information." Any statement contained in a document incorporated
or deemed to be incorporated by reference in this prospectus shall be deemed to
be modified or superseded for purposes of this prospectus to the extent that a
statement contained in this prospectus or in any subsequently filed document
incorporated or deemed to be incorporated in this prospectus by reference, which
statement is also incorporated in this prospectus by reference, modifies or
supersedes the statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of this
prospectus.
No person is authorized in connection with any offering made by this
prospectus to give any information or to make any representation not contained
in this prospectus, and, if given or made, that information or representation
must not be relied upon as having been authorized by Miravant or any Selling
Shareholder. This prospectus is not an offer to sell these securities and it is
not soliciting an offer to buy these securities in any state where the offer or
sale is not permitted. Neither the delivery of this prospectus nor any sale made
under this prospectus shall under any circumstances create any implication that
the information contained in this prospectus is correct as of any date
subsequent to the date of this prospectus.
MIRAVANT MEDICAL TECHNOLOGIES
Miravant Medical Technologies is engaged in the integrated development of
drugs and medical device products for use in PhotoPoint(TM), our proprietary
technologies for photodynamic therapy. PhotoPoint is a medical procedure which
integrates the use of proprietary light-activated drugs, proprietary light
producing devices and light delivery devices to achieve selective photochemical
destruction of diseased cells. We believe that PhotoPoint has the potential to
be a safe, cost-effective, minimally invasive primary or adjunctive treatment
for indications in a broad number of disease areas, including oncology,
ophthalmology, urology, dermatology and cardiovascular disease. We are currently
conducting clinical trials in ophthalmology and oncology. Our current clinical
trials are testing our leading drug candidate, SnET2 or tin ethyl etiopurpurin.
We are developing products in collaboration with our various corporate partners.
Photodynamic therapy is a minimally invasive medical procedure that uses
photoselective, or light-activated, drugs to treat or diagnose disease. The
technology involves three components: photoselective drugs, light producing
devices and light delivery devices.
Photoselective drugs transform light energy into chemical energy in a
manner similar to the action of chlorophyll in green plants. Certain
photoselective drugs accumulate and are retained in fast-growing or
hyperproliferating, cells. Hyperproliferation is a characteristic of cells
associated with a variety of diseases such as cancer, certain vascular disorders
and skin diseases such as psoriasis.
A photoselective drug is typically administered by intravenous injection
and over time the drug associates with hyperproliferating tissues. The drug is
inactive until exposed to light of a specific wavelength, which can vary
depending on the drug's molecular structure. Exposing the target cells to the
appropriate light wavelength permits activation of the retained drug and
initiates a chemical reaction that generates a highly reactive form of oxygen.
High concentrations of this form of oxygen lead to destruction of the cellular
membrane and, ultimately, cell death. The response of the target cells depends
on, among other factors, the drug dose, the amount of light energy delivered,
the physiology of the cell and the vasculature in the diseased areas. Neither
the drug nor the light on its own can cause the desired effect. The drug is a
catalyst which transfers energy. The chemical reaction stops when the light is
turned off. The potential result of this process is that diseased cells are
destroyed with minimal damage to surrounding normal tissues.
Our objective is to apply PhotoPoint -- our photodynamic therapy systems,
which integrate photoselective drugs, light producing devices and light delivery
devices -- as a primary therapy in targeted disease areas and as an adjunct to
surgery or other therapies in these same or other disease areas. Although the
potential applications for our PhotoPoint systems are numerous, in 1998 we
announced our intention to refine our focus to target large potential market
opportunities or diseases with significant unmet medical needs. By doing so, we
believe we may be able to accelerate regulatory processes where appropriate and
facilitate commercial success. In addition, to facilitate development,
regulatory approval, manufacturing, marketing and distribution of our products,
we have or seek to form strategic collaborations with partners who are leaders
in our targeted disease areas.
We were incorporated in Delaware in 1989 and, effective September 15, 1997,
changed our name from PDT, Inc. to Miravant Medical Technologies. Our executive
offices and the offices of our three subsidiaries, Miravant Pharmaceuticals,
Inc., Miravant Systems, Inc. and Miravant Cardiovascular, Inc., are located at
336 Bollay Drive, Santa Barbara, California 93117. Our telephone number is (805)
685-9880. Unless otherwise indicated, all references to us include us and our
subsidiaries.
RISK FACTORS
We do not provide forecasts of potential future operational or financial
performance. While management is optimistic about our long-term prospects, the
following issues and uncertainties, among others, should be considered in
evaluating our outlook. This prospectus, as well as the information incorporated
by reference, contains forward-looking statements which involve known and
unknown risks and uncertainties. These statements relate to our future plans,
objectives, expectations and intentions. These statements may be identified by
the use of words such as "expects," "anticipates," "intends," "plans" and
similar expressions. Our actual results could differ materially from those
discussed in these statements. The factors listed below are not intended to
represent a complete list of the general or specific risks that may affect us.
It should be recognized that other risks may be significant, presently or in the
future, and the risks set forth below may affect us to a greater extent than
indicated.
HISTORY OF OPERATING LOSSES AND UNCERTAINTY OF FUTURE PROFITABILITY
We have not had revenues generated from sales of our drugs and only limited
revenues have been generated from sales of our devices. We have experienced
operating losses since our inception in 1989 and have not yet achieved
profitability. We have an accumulated deficit of $108.9 million (audited) and
$115.0 million (unaudited) as of December 31, 1998 and March 31, 1999,
respectively. We do not expect to achieve significant levels of revenues for at
least several years. Our revenues to date have consisted, and for the
foreseeable future are expected to consist, principally of grants awarded,
payments for our devices, license fees, royalties, clinical reimbursements,
milestone payments and interest income. Our ability to generate significant
revenues in the future is dependent upon:
* Successfully completing our research or product development efforts or
those of our collaborative partners;
* Successfully transforming our drugs or devices currently under
development into marketable products;
* Obtaining the required regulatory approvals;
* Manufacturing our products at an acceptable cost and with appropriate
quality;
* Favorable acceptance of any products marketed; and
* Successful marketing and sales efforts of our corporate partner(s).
We may not be successful in achieving any of these, and if we are not
successful, our business, financial condition and operating results could be
adversely affected. The time frame necessary to achieve these goals for any
individual product is long and uncertain. Most of our products currently under
development will require significant additional research and development and
preclinical studies and clinical trials, and all will require regulatory
approval prior to commercialization. The likelihood of our success must be
considered in light of these and other problems, expenses, difficulties,
complications and delays.
UNPROVEN SAFETY AND EFFICACY; CLINICAL TRIALS
All of our drug and device products currently under development will
require extensive preclinical studies and clinical trials prior to regulatory
approval for commercial use. None of our products have completed testing for
efficacy or safety in humans. Some of the risks and uncertainties related to
safety and efficacy testing and the completion of preclinical studies and
clinical trials include:
* Our ability to demonstrate to the Food and Drug Administration or FDA
that SnET2 or any other of our products is safe and efficacious;
* Our ability to successfully commence and complete the testing for any
of our compounds within any specified time period, if at all;
* Clinical data reported may change as a result of the continuing
evaluation of patients;
* Data obtained from preclinical studies and clinical trials are subject
to varying interpretations which can delay, limit or prevent approval
by the FDA or other regulatory authorities;
* Problems in research and development, preclinical studies or clinical
trials that will cause us to delay, suspend or cancel clinical trials;
and
* As a result of changing economic considerations, competitive or new
technological developments, market approvals or changes, clinical or
regulatory conditions, or clinical trial results, our focus may shift
to other indications, or we may determine not to further pursue one or
more of the indications currently being pursued.
To date, we have limited experience in conducting clinical trials. We will
either need to rely on third parties, including our collaborative partners, to
design and conduct any required clinical trials or expend resources to hire
additional personnel or engage outside consultants or contract research
organizations to administer the clinical trials. We may not be able to find
appropriate third parties to design and conduct clinical trials or we may not
have the resources to administer clinical trials in-house.
RELIANCE ON COLLABORATIVE PARTNERS
We have entered into collaborative relationships with certain corporations
and academic institutions for the research and development, preclinical studies
and clinical trials, licensing, manufacturing, sales and distribution of our
products. These collaborative relationships include:
* In 1995, we entered into a collaborative agreement with Pharmacia &
Upjohn, Inc. or Pharmacia & Upjohn, which was subsequently amended in
1996, 1998 and 1999, pursuant to which we granted to Pharmacia &
Upjohn an exclusive worldwide license to use, distribute and sell
SnET2 for therapeutic or diagnostic applications in photodynamic
therapy for ophthalmology, oncology and urology;
* Collaborations with Fresenius Kabi or Fresenius, for final drug
formulation and drug product supply, Fresenius manufacturing
facilities were previously owned by Pharmacia & Upjohn and sold to
Fresenius in June 1998;
* Collaborations with Medicis Pharmaceutical Corporation or Medicis, for
the clinical development of PhotoPoint in dermatology;
* Collaborations with Chiron Diagnostics or Chiron, for the early
detection and treatment of lung cancer;
* Collaborations with Iridex Corporation or Iridex, Ramus Medical
Technologies or Ramus and Xillix Technologies Corp. or Xillix, for the
development of devices for use in photodynamic therapy in the fields
of ophthalmology, cardiovascular disease and oncology, respectively;
and
* Collaborations with Boston Scientific Corporation or Boston Scientific
and Cordis Corporation for the co-development of catheters for use in
photodynamic therapy.
The amount of royalty revenues and other payments, if any, ultimately paid
by Pharmacia & Upjohn globally to Miravant for sales of SnET2 is dependent, in
part, on the amount and timing of resources Pharmacia & Upjohn commits to
research and development, preclinical studies and clinical testing and
regulatory and marketing and sales activities, which are entirely within the
control of Pharmacia & Upjohn. Pharmacia & Upjohn may not pursue the development
and commercialization of SnET2 and/or may not perform its obligations as
expected. Also, we have not yet entered into any definitive collaborative
agreements with Boston Scientific, Cordis, Medicis or Chiron. These
collaborations may not culminate in definitive collaborative agreements or
marketable products. Additionally, Iridex, Ramus and Xillix may not continue the
development of devices for use in photodynamic therapy, or such development may
not result in marketable products.
We are currently at various stages of discussions with other companies
regarding the establishment of collaborations. Our current and future
collaborations are important to us because they allow us greater access to
funds, to research, development or testing resources and to manufacturing, sales
or distribution resources that we would otherwise not have. We intend to
continue to rely on such collaborative arrangements. Some of the risks and
uncertainties related to the reliance on collaborations include:
* Our ability to negotiate acceptable collaborative arrangements;
* Future or existing collaborative arrangements may not be successful or
may not result in products that are marketed or sold;
* Such collaborative relationships may limit or restrict us;
* Collaborative partners are free to pursue alternative technologies or
products either on their own or with others, including our
competitors, for the diseases targeted by our programs and products;
* Our partners may terminate the relationships described above, and we
may be required to seek other partners, or expend substantial
additional resources to pursue these activities independently. These
efforts may not be successful; and
* Our ability to manage, interact and coordinate our timelines and
objectives with our strategic partners.
ADDITIONAL FINANCING REQUIREMENTS AND UNCERTAINTY OF CAPITAL FUNDING
We have incurred negative cash flows from operations since our inception
and have expended substantial funds on our research and development programs and
preclinical studies and clinical testing. We may require substantial funding to
continue or undertake our research and development activities, preclinical
studies and clinical testing and manufacturing, marketing, sales, distribution
and administrative activities. Our existing capital resources, together with the
proceeds from future offerings and future cash flows, may not be sufficient to
fund our future operations.
COMPETITION AND TECHNOLOGICAL UNCERTAINTY
Many of our competitors have substantially greater financial, technical and
human resources than we do, and may also have substantially greater experience
in developing products, conducting preclinical studies or clinical trials,
obtaining regulatory approvals and manufacturing and marketing. Further, our
competitive position could be materially adversely affected by the establishment
of patent protection by our competitors. The existing competitors or other
companies may succeed in developing technologies and products that are more
safe, effective or affordable than those being developed by us or that would
render our technology and products less competitive or obsolete.
LIABILITY OR RECALL
The use of our products in clinical trials and the sale of our products may
expose us to liability claims. These claims could be made directly by patients
or consumers, or by companies, institutions or others using or selling our
products. The following are some of the risks related to liability and recall:
* We are subject to the inherent risk that a governmental authority or
third party may require the recall of one or more of our products;
* We have not obtained liability insurance that would cover a claim
relating to the use or recall of our products;
* In the absence of liability insurance, claims made against us or a
product recall could have a material adverse effect on us;
* If we obtain insurance coverage in the future, this coverage may not
be available at a reasonable cost and in amounts sufficient to protect
us against claims that could have a material adverse effect on our
financial condition and prospects; and
* Liability claims relating to our products or a product recall could
negatively effect our ability to obtain or maintain regulatory
approval for our products.
We have agreed to indemnify certain of our collaborative partners against
certain potential liabilities relating to the manufacture and sale of SnET2 and
PhotoPoint light devices.
GOVERNMENT REGULATION
The production and marketing of our products and our ongoing research and
development, preclinical studies and clinical trial activities are subject to
extensive regulation and review by numerous governmental authorities in the
United States, including the FDA, and in other countries. All drugs and most
medical devices we develop must undergo rigorous preclinical studies and
clinical trials and an extensive regulatory approval process administered by the
FDA under the Food, Drug and Cosmetic Act or FDC Act, and comparable foreign
authorities, before they can be marketed. These processes involve substantial
cost and can often take many years. We have limited experience in, and limited
resources available for regulatory activities. Failure to comply with the
applicable regulatory requirements can, among other things, result in
non-approval, suspensions of regulatory approvals, fines, product seizures and
recalls, operating restrictions, injunctions and criminal prosecution. To date,
none of our product candidates being developed have been submitted for approval
or have been approved by the FDA or any other regulatory authority for
marketing. Some of the risks and uncertainties include:
* Delays in obtaining approval or rejections due to regulatory review of
each submitted new drug, device or combination drug/device application
or product license application, as well as changes in regulatory
policy during the period of product development;
* If regulatory approval of a product is granted, such approval may
entail limitations on the uses for which the product may be marketed;
* If regulatory approval is obtained, the product, our manufacturer and
the manufacturing facilities are subject to continual review and
periodic inspections;
* If regulatory approval is obtained, such approval may be conditional
on the satisfaction of the completion of clinical trials or require
additional clinical trials;
* Later discovery of previously unknown problems with a product,
manufacturer or facility may result in restrictions on such product or
manufacturer, including withdrawal of the product from the market and
litigation; and
* Photodynamic therapy products have been categorized by the FDA as
combination drug-device products. If current or future drug/device
products do not continue to be categorized for regulatory purposes as
combination products, then:
* The FDA may require separate drug and device submissions; and
* The FDA may require separate approval by regulatory authorities.
Internationally, beginning in 1995, a new regulatory system to approve drug
market registration applications was implemented in the European Union or EU.
The system provides for new centralized, decentralized and national registration
procedures through which a company may obtain drug marketing registrations. The
centralized procedure allows for expedited review and approval of biotechnology
and high technology/innovative product marketing applications by a central
Committee for Proprietary Medicinal Products. The decentralized procedure allows
a company to petition individual EU member states to review and recognize a
market application previously approved in one member state by the national
route. Some of the international risks and uncertainties include:
* Foreign regulatory requirements governing testing, development,
marketing, licensing, pricing and/or distribution of drugs and devices
in other countries;
* Our drug products may not qualify for the centralized review procedure
or we may not be able to obtain a national market application that
will be accepted by other EU member states;
* Our devices must also meet the new Medical Device Directive effective
in Europe in 1998. The Directive requires that our manufacturing
quality assurance systems and compliance with technical essential
requirements be certified with a CE Mark authorized by a registered
notified body of an EU member state prior to free sale in the EU; and
* Registration and approval of a photodynamic therapy product in other
countries, such as Japan, may include additional procedures and
requirements, nonclinical and clinical studies, and may require the
assistance of native corporate partners.
OTHER LAWS; FUTURE LEGISLATION OR REGULATIONS
In addition to the regulations for drug or device approvals, we are subject
to regulation under state, federal or other law, including regulations for
worker occupational safety, laboratory practices, environmental protection and
hazardous substance control. We continue to make capital and operational
expenditures for protection of the environment in amounts which are not
material. Some of the risks and uncertainties related to laws and future
legislation or regulations include:
* Our future capital and operational expenditures may increase and
become material;
* We may also be subject to other present and possible future local,
state, federal and foreign regulation;
* Heightened public awareness and concerns regarding the growth in
overall health care expenditures in the United States, combined with
the continuing efforts of governmental authorities to contain or
reduce costs of health care, may result in the enactment of national
health care reform or other legislation or regulations that impose
limits on the number and type of medical procedures which may be
performed or which have the effect of restricting a physician's
ability to select specific products for use in certain procedures;
* Such new legislation or regulations may materially adversely affect
the demand for our products. In the United States, there have been,
and we expect that there will continue to be, a number of federal and
state legislative proposals and regulations to implement greater
governmental control in the health care industry;
* The announcement of such proposals may materially adversely affect our
ability to raise capital or to form collaborations; and
* Legislation or regulations that impose restrictions on the price that
may be charged for health care products or medical devices may
adversely affect our results of operations.
We are unable to predict the likelihood of adverse effects which might
arise from future legislative or administrative action, either in the United
States or abroad.
HEALTH CARE REIMBURSEMENT
Our products may not be covered by the various health care providers. If
they are not covered, our products may or may not be purchased or sold as
expected. Our ability to commercialize our products successfully may depend, in
part, on the extent to which reimbursement for these products and related
treatment will be available from collaborative partners, government health
administration authorities, private health insurers, managed care entities and
other organizations. These payers are increasingly challenging the price of
medical products and services and establishing protocols and formularies, which
effectively limit physicians' ability to select products and procedures.
Uncertainty exists as to the reimbursement status of health care products
(especially innovative technologies). Additionally, reimbursement coverage, if
available, may not be adequate to enable us to achieve market acceptance of our
products or to maintain price levels sufficient for realization of an
appropriate return on our products.
LIMITED MANUFACTURING AND MARKETING CAPABILITY AND EXPERIENCE
To be successful, our products must be manufactured in commercial
quantities under current Good Manufacturing Practices or GMP, prescribed by the
FDA and at acceptable costs. Although we intend to manufacture drugs and
devices, we have not yet manufactured any products in commercial quantities
under GMP and have no experience in such commercial manufacturing. We currently
have the capacity, in conjunction with our manufacturing partners Fresenius Kabi
and Iridex, to manufacture products at certain commercial levels and will be
able to do so upon FDA approval. If we receive an FDA or other regulatory
approval we may need to expand our manufacturing capabilities and/or depend on
our collaborators, licensees or contract manufacturers for the expanded
commercial manufacture of our products. If we expand our manufacturing
capabilities, we will need to expend substantial funds, hire and retain
significant additional personnel and comply with extensive regulations. We may
not be able to expand successfully or we may be unable to manufacture products
in increased commercial quantities for sale at competitive prices. Further, we
may not be able to enter into future manufacturing arrangements with
collaborators, licensees, or contract manufacturers on acceptable terms or at
all. If we are not able to expand our manufacturing capabilities or enter into
additional commercial manufacturing agreements, our business growth could be
limited and could be materially and adversely affected.
We have limited experience in marketing, distributing and selling
pharmaceutical or medical device products. We will need to develop a sales force
or rely on our collaborators or licensees or make arrangements with others to
provide for the marketing, distribution and sale of our products. We are
currently relying on Pharmacia & Upjohn and Iridex for these needs. Our
marketing, distribution and sales capabilities or current or future arrangements
with third parties for such activities may not be adequate for the successful
commercialization of our products.
UNCERTAINTY REGARDING PATENTS AND PROPRIETARY TECHNOLOGY
Our success will depend, in part, on our and our licensors' ability to
obtain, assert and defend our patents, protect trade secrets and operate without
infringing the proprietary rights of others. The exclusive license relating to
various drug compounds, including our leading drug candidate SnET2, may become
non-exclusive if we fail to satisfy certain development and commercialization
objectives. The termination or restriction of our rights under this or other
licenses for any reason would likely have a material adverse impact on our
business and financial condition. Although we believe we should be able to
achieve such objectives, we may not be successful.
The patent position of pharmaceutical and medical device firms generally is
highly uncertain. Some of the risks and uncertainties include:
* The patent applications owned by or licensed to us may not result in
issued patents;
* Our issued patents may not provide us with proprietary protection or
competitive advantages;
* Our issued patents may be infringed upon or designed around by others;
* Our issued patents may be challenged by others and held to be invalid
or unenforceable; and
* The patents of others may have a material adverse effect on us.
We are aware that our competitors and others have been issued patents
relating to photodynamic therapy. In addition, our competitors and others may
have been issued patents or filed patent applications relating to other
potentially competitive products of which we are not aware. Further, our
competitors and others may in the future file applications for, or otherwise
obtain proprietary rights to, such products. These existing or future patents,
applications or rights may conflict with our or our licensors' patents or
applications. Such conflicts could result in a rejection of our or our
licensors' applications or the invalidation of the patents. This could have a
material adverse effect on our competitive position. If such conflicts occur, or
if we believe that such products may infringe on our proprietary rights, we may
pursue litigation or other proceedings, or may be required to defend against
such litigation. Such proceedings may materially adversely affect our
competitive position, and we may not be successful in any such proceeding.
Litigation and other proceedings can be expensive and time consuming, regardless
of whether we prevail. This can result in the diversion of substantial
financial, managerial and other resources from other activities. An adverse
outcome could subject us to significant liabilities to third parties or require
us to cease any related research and development activities or product sales.
Some of the risks and uncertainties include:
* We do not have contractual indemnification rights against the
licensors of the various drug patents;
* We may be required to obtain licenses under dominating or conflicting
patents or other proprietary rights of others;
* Such licenses may not be made available on terms acceptable to us, if
at all; and
* If we do not obtain such licenses, we could encounter delays or could
find that the development, manufacture or sale of products requiring
such licenses is foreclosed.
We also seek to protect our proprietary technology and processes in part by
confidentiality agreements with our collaborative partners, employees and
consultants. These agreements could be breached and we may not have adequate
remedies for any breach. Also, our trade secrets may become known or be
independently discovered by competitors. Certain research activities relating to
the development of certain patents owned by or licensed to us were funded, in
part, by agencies of the United States Government. When the United States
Government participates in research activities, it retains certain rights that
include the right to use the resulting patents for government purposes under a
royalty-free license.
We also rely upon unpatented trade secrets, and no assurance can be given
that others will not independently develop substantially equivalent proprietary
information and techniques, or otherwise gain access to our trade secrets or
disclose such technology, or that we can meaningfully protect its rights to its
unpatented trade secrets and know-how.
DEPENDENCE UPON KEY PERSONNEL AND CONSULTANTS
Our success will depend in large part on our ability to attract and retain
highly qualified scientific, management and other personnel and to develop and
maintain relationships with leading research institutions and consultants. We
are highly dependent upon principal members of our management, key employees,
scientific staff and consultants which we may retain from time to time.
Competition for such personnel and relationships is intense, and we may not be
able to continue to attract and retain such personnel. Our consultants may be
affiliated with or employed by others, and some have consulting or other
advisory arrangements with other entities that may conflict or compete with
their obligations to us. Inventions or processes discovered by such persons will
not necessarily become our property and may remain the property of such persons
or others.
DEPENDENCE UPON SUPPLIERS
We depend on outside suppliers for certain raw materials and components for
our products. Such raw materials or components may not continue to be available
to our standards or on acceptable terms, if at all, and alternative suppliers
may not be available to us on acceptable terms, if at all. Further, we may not
be able to adequately produce needed materials or components in-house. We are
currently dependent on single, contracted sources for a couple of key materials
or services used by us in our drug development, light producing and light
delivery device development and production operations. Although most of our raw
materials and components are available from various sources, we are currently
developing qualified backup suppliers for each of these resources. We have or
will enter into agreements with these suppliers, which may or may not be
successful or which may encounter delays or other problems, which may materially
adversely affect our business.
ENVIRONMENTAL MATTERS
We are subject to federal, state, county and local laws and regulations
relating to the protection of the environment. In the course of our business, we
are involved in the handling, storage and disposal of materials that are
classified as hazardous. Our safety procedures for handling, storage and
disposal of such materials are designed to comply with applicable laws and
regulations. However, we may be involved in contamination or injury from these
materials. If this occurs, we could be held liable for any damages that result,
and any such liability could materially and adversely affect us. Further, the
cost of complying with these laws and regulations may increase materially in the
future.
YEAR 2000
The Year 2000 issue is the result of computer programs being written using
two digits rather than four to define the applicable year. Our computer
equipment and software and devices with embedded technology that are
time-sensitive may recognize a date using "00" as the year 1900 rather than the
year 2000. This could result in a system failure or miscalculations causing
disruptions of operations, such as:
* A temporary inability to process accounting, payroll, database,
network and software transactions;
* Possible disruption of environmental, lighting, security controls and
other corporate equipment;
* A temporary inability to process clinical and preclinical testing and
data; and
* Loss of telephone and related voicemail and internet messages, in
addition to other similar normal business activities.
We have undertaken various initiatives intended to ensure that our computer
equipment and software will function properly with respect to dates in the Year
2000 and thereafter. The term "computer equipment and software" includes systems
that are commonly thought of as information technology or IT systems, including
accounting, data processing and telephone/PBX systems and other miscellaneous
systems. It also includes systems that are not commonly thought of as IT
systems, such as alarm systems, fax machines, air conditioning units, internally
developed software and other miscellaneous systems. Based upon our efforts to
date, we believe that certain of the computer equipment and software we use may
require replacement or modification. Utilizing both internal and external
resources to identify and assess needed Year 2000 remediation, we currently
anticipate that our Year 2000 identification, assessment, remediation and
testing efforts, which began in February 1998, will be completed by August 31,
1999. We estimate that as of June 30, 1999, we had completed approximately 90%
of the initiatives that we believe will be necessary to fully address potential
Year 2000 issues relating to our computer equipment software and non-IT systems.
The projects comprising the remaining 10% of the initiatives are in process and
are expected to be completed on or about August 31, 1999. The following table
describes the Year 2000 initiatives as well as our progress and the anticipated
completion dates as of June 30, 1999:
Year 2000 Initiatives
<TABLE>
<CAPTION>
<S> <C> <C>
Expected Percent
Completion Date Complete
----------------- ---------------
Initial IT system identification..................................... 10/98 100%
Initial IT system assessment......................................... 11/98 100%
Remediation regarding central system issues.......................... 6/99 100%
Testing regarding central system issues............................. 8/99 50%
Identification, assessment, remediation and testing regarding
desktop and individual system issues........................... 6/99 100%
Identification regarding non-IT system issues........................ 10/98 100%
Assessment regarding non-IT system issues............................ 11/98 100%
Remediation regarding non-IT system issues........................... 6/99 100%
Testing regarding non-IT system issues............................... 8/99 50%
</TABLE>
We are in the process of communicating with our significant vendors and
service providers and strategic partners to determine the extent to which
interfaces with such entities are vulnerable to Year 2000 issues and whether the
products and services utilized by such entities are Year 2000 compliant. This
process is expected to be completed in August 1999.
We believe that the cost of our Year 2000 efforts, as well as those costs
related to Year 2000 issues of third parties, will approximate $250,000. As of
June 30, 1999, we had not incurred any external costs related to our Year 2000
efforts. Other non-Year 2000 IT efforts have not been materially delayed or
impacted by Year 2000 initiatives. We presently believe that the Year 2000 issue
will not pose significant operational problems for us. However, if all Year 2000
issues are not properly identified, the Year 2000 issue may materially adversely
impact our results of operations or adversely affect our relationships with
vendors, or others. Additionally, the Year 2000 issues of other entities may
have a material adverse impact on our systems or results of operations.
VOLATILITY OF STOCK PRICE
The market prices for our common stock, and the securities of emerging
pharmaceutical and medical device companies, have historically been highly
volatile and subject to extreme price fluctuations, which may have a material
adverse effect on the market price of the common stock. Extreme price
fluctuations could be the result of the following:
* Future announcements concerning Miravant or our collaborators,
competitors or industry;
* The results of our testing, technological innovations or new
commercial products;
* The achievement of or failure to achieve certain milestones; and
* Governmental regulations, rules and orders, or developments concerning
safety of our products.
In addition, the stock market has experienced extreme price and volume
fluctuations. This volatility has significantly affected the market prices of
securities of many emerging pharmaceutical and medical device companies for
reasons frequently unrelated or disproportionate to the performance of the
specific companies. These broad market fluctuations may materially adversely
affect the market price of our common stock.
CONTROL BY OFFICERS AND DIRECTORS
As of July 15, 1999, our officers and directors beneficially own
approximately 5.51% of our outstanding common stock (approximately 16.83% is
beneficially owned if all options granted to such officers and directors become
vested and are exercised). These shareholders will have the ability to
significantly influence us and the direction of our business and affairs. Such
concentration of ownership may have the effect of delaying or preventing a
change in control of Miravant, which could adversely affect the market price for
the common stock.
OUTSTANDING OPTIONS AND WARRANTS
As of July 15, 1999, there were outstanding options to purchase 2,802,691
shares of our common stock at a weighted average exercise price of $18.05 per
share, and warrants to purchase 4,031,928 shares of common stock at a weighted
average exercise price of $25.49 per share. The exercise of these options and
warrants would result in significant book value and earnings dilution to
existing shareholders.
SHARES ELIGIBLE FOR FUTURE SALE
Sales of common stock in the public market following this offering,
pursuant to Rule 144 under the Securities Act, or upon the exercise of
outstanding options or warrants under Rule 701 or pursuant to our registration
statements on Form S-8, could materially adversely affect prevailing market
prices and may have a material and adverse effect on our ability to raise the
capital necessary to fund our future operations. Additionally, certain holders
of shares of common stock are entitled to have their shares registered for sale
under the Securities Act by us under certain circumstances. The exercise of
these rights and the sale of such shares could have a material adverse effect on
the market price for the common stock.
USE OF PROCEEDS
Miravant will not receive any of the proceeds from the sale of the Shares
by the Selling Shareholders, but will receive the exercise prices payable upon
the exercise of the Warrants, if exercised for cash. Any proceeds received form
the exercise of the Warrants will be used for working capital and general
corporate purposes.
SELLING SHAREHOLDERS
The following table sets forth information with respect to the number of
Shares beneficially owned by each of the Selling Shareholders, the number of
Shares that may be offered hereby by each Selling Shareholder and the number of
shares of common stock to be owned after the offering, assuming all the Shares
offered hereby are sold to persons not affiliated with the Selling Shareholders.
Pharmacia & Upjohn, Inc., including its wholly owned subsidiaries, is a
collaborative partner of Miravant and beneficially owns 11.00% of our common
stock. None of the other Selling Shareholders, has, or in the past has had, any
other position, office or relationship with Miravant (other than as a security
holder) or any of its affiliates. As of July 15, 1999 there were 18,006,300
shares of our common stock issued and outstanding.
Of the Shares set forth below as beneficially owned and offered by
Pharmacia & Upjohn Treasury Services AB, 360,000 represent Shares issuable upon
the exercise of Warrants issued or to be issued to Pharmacia & Upjohn Treasury
Services AB in connection with our Credit Agreement entered into with Pharmacia
& Upjohn Treasury Services AB in January 1999. Of those Warrants, 120,000
Warrants have been issued, are vested and have been priced at an exercise price
of $11.87 per share. The remaining 240,000 Warrants, when issued to Pharmacia &
Upjohn Treasury Services AB under the terms of the Credit Agreement, will be
exercisable at price equal to 140% of the average closing bid prices of the
common stock for the ten (10) trading days immediately preceding the borrowing
request of the related loan and expire five years from the date of issuance. The
Shares issuable upon the exercise of the 240,000 Warrants are not deemed to be
beneficially owned by Pharmacia & Upjohn or its subsidiaries under Rule 13d-3 of
the Exchange Act. The Registration Rights Agreement requires us to register all
the shares underlying the Warrants. The Shares being offered by Pharmacia &
Upjohn Treasury Services AB include additional Shares that may become issuable
pursuant to the terms of the Warrants, as such number may be adjusted in
accordance with Rule 416.
With respect to the other three Selling Shareholders, 499,000 of the shares
of common stock set forth below represent shares issuable upon the exercise of
warrants issued to those Selling Shareholders in October 1997 in connection with
our October 1997 private placement offerings. Of those warrants, 50% are
exercisable at $55.00 per share and 50% are exercisable at $60.00 per share, and
all expire on December 25, 2001. The 499,000 shares issuable upon the exercise
of those warrants and the 499,000 other shares of common stock set forth in the
table below with respect to those Selling Shareholders are the subject of an
earlier registration statement we filed on Form S-3 and are not offered by this
prospectus.
<TABLE>
<CAPTION>
<S> <C> <C> <C> <C> <C>
Number of Shares Owned After
Owned Prior To Offering Offering
Shares
Name Number Percent Being Offered Number Percent
- ------------------------------------------------- ------------ ---------- ----------------- ------------ ----------
Pharmacia & Upjohn, Inc........................ 125,001 0.69% --- 125,001 0.69%
Pharmacia & upjohn, S.p.A...................... 1,736,533 9.64% 1,136,533 600,000 3.33%
Pharmacia & Upjohn Treasury Services AB........ 360,000 2.00% 360,000 --- ---
St. Cloud Investments, Ltd..................... 1,746,252 9.70% 1,320,105 426,147 2.37%
Dandelion Investments, Ltd..................... 809,324 4.49% 522,398 286,926 1.59%
Bomoseen Investments, Ltd...................... 802,601 4.46% 517,674 284,927 1.58%
------------ ---------- ----------------- ------------ ----------
5,579,711 30.99% 3,856,710 1,723,001 9.57%
</TABLE>
PLAN OF DISTRIBUTION
The Shares may be sold from time to time by the Selling Shareholders or
their pledgees or donees. See "Selling Shareholders." Those sales may be made on
the Nasdaq or in negotiated transactions, at prices and on terms then prevailing
or at prices related to the then current market price or at negotiated prices.
The methods by which the Shares may be sold may include, but are not limited to,
the following:
* Blocktrades in which the broker or dealer will attempt to sell the
Shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction;
* Purchases by a broker or dealer as principal and resale by the broker
or dealer for its account;
* Ordinary brokerage transactions and transactions in which the broker
solicits purchasers;
* Privately negotiated transactions;
* Short sales; and
* A combination of any these methods of sale.
In effecting sales, brokers or dealers engaged by the Selling Shareholders may
receive commissions or discounts from the Selling Shareholders or from the
purchasers in amounts to be negotiated immediately prior to the sale.
Miravant has agreed to maintain the effectiveness of the registration of
the Shares offered by this prospectus until the earlier of the date upon which
all of the Shares have been sold without restriction on resale, or the date on
which the Shares offered by this prospectus, in the opinion of counsel, may be
immediately sold by the Selling Shareholders without registration or restriction
on resale. We cannot ensure that the Selling Shareholders will sell any or all
of the Shares offered by this prospectus.
Miravant is bearing all of the costs relating to the registration of the
Shares. Any commissions, discounts or other fees payable to a broker, dealer,
underwriter, agent or market maker in connection with the sale of any of the
Shares will be borne by the Selling Shareholders. Miravant will not receive any
of the proceeds from this offering, but will receive the exercise price payable
upon the exercise of the Warrants, if the Warrants are exercised for cash.
Pursuant to the registration rights granted to some of the Selling
Shareholders, we have agreed to indemnify those Selling Shareholders, any person
who controls those Selling Shareholders, and any underwriters for those Selling
Shareholders, against specified liabilities and expenses arising out of or based
upon the information set forth or incorporated by reference in this prospectus,
and the registration statement of which this prospectus is a part, including
liabilities under the Securities Act and the Exchange Act. The Selling
Shareholders and any brokers participating in the sales of the Shares may be
deemed to be underwriters within the meaning of the Securities Act. Any
commissions paid or any discounts or concessions allowed to any broker, dealer,
underwriter, agent or market maker and, if any broker, dealer, underwriter,
agent or market maker purchases any of the Shares as principal, any profits
received on the resale of those Shares, may be deemed to be underwriting
commissions or discounts under the Securities Act.
LEGAL MATTERS
The validity of the issuance of the Shares of common stock offered by this
prospectus has been passed upon for Miravant by Nida & Maloney, LLP, Santa
Barbara, California.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our annual report on Form 10-K for the year
ended December 31, 1998, as set forth in their report, which is incorporated in
this prospectus by reference. Our consolidated financial statements are
incorporated by reference in reliance on their report, given on their authority
as experts in accounting and auditing.
PART II.
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the estimated expenses to be incurred in
connection with the issuance and distribution of the securities being registered
hereby:
SEC registration fee............................................$ 9,649.07
Nasdaq National Market listing fee.............................. 17,500.00
Accounting fees and expenses.................................... 5,000.00*
Legal fees and expenses......................................... 10,000.00*
Printing expenses............................................... 0*
Miscellaneous................................................... 5,000.00*
-------------------------
TOTAL................................................ $47,149.07*
-------------------------
*Estimated
Item 15. Indemnification of Directors and Officers.
Section 102(b)(7) of the Delaware General Corporation Law (the "Delaware
Law") permits a corporation to provide in its certificate of incorporation that
directors of the corporation shall not be personally liable to the corporation
or its shareholders for monetary damages for breach of fiduciary duty as a
director, except for liability (i) for any breach of the director's duty of
loyalty to the corporation or its shareholders, (ii) for acts or omissions not
in good faith or which involve intentional misconduct or a knowing violation of
law, (iii) for payments of unlawful dividends or unlawful stock repurchases or
redemptions, or (iv) for any transaction from which the director derived an
improper personal benefit. The Company's Certificate of Incorporation contains
such a provision.
Section 145 of the Delaware Law provides that a corporation may indemnify
directors and officers as well as other employees and individuals against
expenses (including attorneys' fees), judgments, fines and amounts paid in
settlement in connection with specified actions, suits or proceedings, whether
civil, criminal, administrative or investigative (other than an action by or in
the right of the corporation a "derivative action"), if they acted in good faith
and in a manner they reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe their conduct was unlawful. A
similar standard is applicable in the case of derivative actions, except that
indemnification only extends to expenses (including attorneys' fees) incurred in
connection with defense or settlement of such action, and the statute requires
court approval before there can be any indemnification where the person seeking
indemnification has been found liable to the corporation. Under Section 145, a
corporation shall indemnify an agent of the corporation for expenses actually
and reasonably incurred if and to the extent such person was successful on the
merits in a proceeding or in defense of any claim, issue or matter therein.
The Registrant is presently subject to Section 2115 of the California
Corporations Code (the "California Code"), according to which Section 317 of the
California Code applies to the indemnification of officers and directors of the
Registrant. Under Section 317 of the California Code, permissible
indemnification by a corporation of its officers and directors is substantially
the same as permissible indemnification under Section 145 of the Delaware Law,
except that (i) permissible indemnification does not cover actions the person
reasonably believed were not opposed to the best interests of the corporation,
as opposed to those the person believed were in fact in the best interests of
the corporation, (ii) the Delaware Law permits advancement of expenses to agents
other than officers and directors only upon approval of the board of directors,
(iii) in a case of stockholder approval of indemnification, the California Code
requires certain minimum votes in favor of such indemnification and excludes the
vote of the potentially indemnified person, and (iv) the California Code only
permits independent counsel to approve indemnification if an independent quorum
of directors is not obtainable, while the Delaware Law permits the directors in
any circumstance to appoint counsel to undertake such determination.
The Registrant in its Bylaws has provided for indemnification of its
officers, directors, employees and other agents substantially identical to that
permitted under the California Code. Section 145 of the Delaware Law and Section
317 of the California Code provide that they are not exclusive of other
indemnification that may be granted by a corporation's charter, bylaws,
disinterested director vote, shareholder vote, agreement or otherwise. The
limitation of liability contained in the Registrant's Certificate of
Incorporation and the indemnification provision included in the Registrant's
Bylaws are consistent with Delaware Law Sections 102(b)(7) and 145. The
Registrant has also entered into separate indemnification agreements with its
directors and officers that could require the Registrant, among other things, to
indemnify them against certain liabilities that may arise by reason of their
status or service as directors and officers and to advance their expenses
incurred as a result of any proceeding against them as to which they could be
indemnified, including liabilities that may arise under the Securities Act of
1933. In addition, the Company has purchased directors and officers insurance.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers or persons controlling the
Company pursuant to such provisions, the Company has been informed that in the
opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in such Act and is therefore unenforceable.
Item 16. Exhibits.
Exhibit
Number
5.1 Opinion of Nida & Maloney, LLP.
10.1 Equity Investment Agreement dated January 15, 1999 between the
Registrant and Pharmacia & Upjohn, Inc., and Pharmacia & Upjohn,
S.p.A. (2)[10.1]
10.2 Credit Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.2]
10.3 Warrant Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.3]
10.4 Security Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.4]
10.5 Registration Rights Agreement between the Registrant and Pharmacia &
Upjohn, Inc. (2) [10.5]
10.6 Amended and Restated Ophthalmology Development & License Agreement
between the Registrant and Pharmacia & Upjohn AB. (2) [10.6]
10.7 Cardiovascular Right of First Negotiation between the Registrant and
Pharmacia & Upjohn, Inc. (2) [10.7]
10.8 Form of Securities Purchase Agreement among the Company and certain of
the Selling Shareholders. (1) [10.1]
10.9 Form of Registration Rights Agreement among the Company and certain of
the Selling Shareholder. (1) [10.3]
23.1 Consent of Ernst & Young, LLP.
23.2 Consent of Nida & Maloney, LLP. (included in Exhibit 5.1)
24 Power of Attorney. (set forth on the Signatures Page)
- -----------
(1) Incorporated herein by this reference from the exhibits referred to in
brackets filed with the Company's Registration Statement on Form S-3
(Registration No. 333-39905) effective December 9, 1997.
(2) Incorporated herein by this reference from the exhibit referred to in
brackets filed with the Company's Current Report on Form 8-K dated
January 15, 1999.
Item 17. Undertakings.
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(2) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the
information set forth in the registration statement.
Notwithstanding the foregoing, any increase or decrease in volume
of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed
with the Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than a 20%
change in the maximum aggregate offering price set forth in the
"Calculation of Registration Fee" table in the effective
registration statement;
(iii)To include any material information with respect to the plan of
distribution not previously disclosed in the registration
statement or any material change to such information in the
registration statement;
Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do
not apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in
periodic reports filed by the Registrant pursuant to Section
13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference 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.
(b) 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.
(c) 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 foregoing
provisions, 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 by such director, officer or
controlling person in connection with the securities being registered,
the Registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such indemnification by
it is against public policy as expressed in the Securities Act of 1933
and will be governed by the final adjudication of such issue.
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 Santa Barbara, State of California, on July 29, 1999.
MIRAVANT MEDICAL TECHNOLOGIES
By: /s/ Gary S. Kledzik
------------------------------
Gary S. Kledzik, Ph.D.,
Chief Executive Officer
KNOW ALL MEN BY THESE PRESENTS, that the person whose signature appears
below hereby constitutes and appoints Gary S. Kledzik, Ph.D. and John M.
Philpott, or either of them, his attorneys-in-fact and agents, each with full
power of substitution for him and in his name, place and stead, in any and all
capacities, to sign any or all amendments to this Registration Statement and the
registration statements on Forms S-3 of Miravant Medical Technologies (SEC File
No. 333-39905 and 333-60251) and any registration statements for the same
offerings effective upon filing pursuant to Rule 462(b), and to file the same
with all exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto each of said attorneys-in-fact
and agents full power and authority to do so and perform each and every act and
thing requisite and necessary to be done in connection with such registration
statements, as fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that either of said
attorneys-in-fact and agents, or his substitute or substitutes, may lawfully do
or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
<S> <C> <C>
Name Title Date
/s/ Gary S. Kledzik Chairman of the Board and Chief Executive Officer July 29, 1999
- -------------------
Gary S. Kledzik (principal executive officer)
/s/ David E. Mai* Director and President July 29, 1999
- -----------------
David E. Mai
/s/ John M. Philpott* Chief Financial Officer (principal financial officer July 29, 1999
- ---------------------
John M. Philpott and principal accounting officer)
/s/ Larry S. Barels* Director July 29, 1999
- ---------------------
Larry S. Barels
/s/ William P. Foley II* Director July 29, 1999
- ------------------------
William P. Foley II
/s/ Charles T. Foscue* Director July 29, 1999
- ----------------------
Charles T. Foscue
/s/ Jonah Shacknai* Director July 29, 1999
- ----------------------
Jonah Shacknai
</TABLE>
*By: /s/ Gary S. Kledzik
- ------------------------
Gary S. Kledzik
Attorney-in-fact
INDEX TO EXHIBITS
Exhibit
Number
5.1 Opinion of Nida & Maloney, LLP.
10.1 Equity Investment Agreement dated January 15, 1999 between the
Registrant and Pharmacia & Upjohn, Inc., and Pharmacia & Upjohn,
S.p.A. (2)[10.1]
10.2 Credit Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.2]
10.3 Warrant Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.3]
10.4 Security Agreement between the Registrant and Pharmacia & Upjohn, Inc.
(2) [10.4]
10.5 Registration Rights Agreement between the Registrant and Pharmacia &
Upjohn, Inc. (2) [10.5]
10.6 Amended and Restated Ophthalmology Development & License Agreement
between the Registrant and Pharmacia & Upjohn AB. (2) [10.6]
10.7 Cardiovascular Right of First Negotiation between the Registrant and
Pharmacia & Upjohn, Inc. (2) [10.7]
10.8 Form of Securities Purchase Agreement among the Company and certain of
the Selling Shareholders. (1) [10.1]
10.9 Form of Registration Rights Agreement among the Company and certain of
the Selling Shareholder. (1) [10.3]
23.1 Consent of Ernst & Young, LLP.
23.2 Consent of Nida & Maloney, LLP. (included in Exhibit 5.1)
24 Power of Attorney. (set forth on the Signatures Page)
- -----------
(1) Incorporated herein by this reference from the exhibits referred to in
brackets filed with the Company's Registration Statement on Form S-3
(Registration No. 333-39905) effective December 9, 1997.
(2) Incorporated herein by this reference from the exhibit referred to in
brackets filed with the Company's Current Report on Form 8-K dated
January 15, 1999.
EXHIBIT 5.1
OPINION OF COUNSEL
July 29, 1999
Miravant Medical Technologies
336 Bollay Drive
Santa Barbara, CA 93117
Re: Registration Statement on Form S-3
Ladies and Gentlemen:
We have examined the Registration Statement on Form S-3 filed by you with
the Securities and Exchange Commission (the "Commission") on or about July 29,
1999 (as such may be amended or supplemented, the "Registration Statement"), in
connection with the registration under the Securities Act of 1933, as amended
(the "Act"), of up to 3,856,710 shares of your Common Stock (the "Shares"). The
Shares, which include up to 360,000 shares of Common Stock issuable pursuant to
exercise of warrants, are to be sold by the Selling Shareholders as described in
such Registration Statement. All of the Shares being sold were or will be sold
by the Company to the Selling Shareholders and will be sold by the Selling
Shareholders to the public. As counsel in connection with this transaction, we
have examined the proceedings proposed to be taken by you in connection with the
issuance and sale of the Shares.
Based on the foregoing, it is our opinion that the registration and
issuance of the Shares has been duly authorized and that the Shares that have
been issued are legally and validly issued, fully paid and non-assessable and
that, upon conclusion of the proceedings being taken or contemplated by us, as
your counsel, to be taken prior to the issuance of the Shares issuable upon
exercise of the warrants, the Shares issuable upon exercise of the warrants,
when issued and sold in the manner described in the Registration Statement,
including payment of the exercise price for the warrants, will be legally and
validly issued, fully paid and non-assessable.
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,
which has been approved by us, as such may be further amended or supplemented,
or incorporated by reference in any Registration Statement relating to the
prospectus filed pursuant to Rule 462(b) of the Act.
Very truly yours,
/s/ Nida & Maloney, LLP
-----------------------
Nida & Maloney, LLP
EXHIBIT 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 Miravant Medical
Technologies for the registration of up to 3,856,710 shares of its common stock
and to the incorporation by reference therein of our report dated March 4, 1999,
with respect to the consolidated financial statements of Miravant Medical
Technologies included in its Annual Report (Form 10-K) for the year ended
December 31, 1998, filed with the Securities and Exchange Commission.
Woodland Hills, California
July 28, 1999
/s/ ERNST & YOUNG, LLP
-----------------------
Ernst & Young, LLP
