As filed with the Securities and Exchange Commission on December 7, 1999
Registration No. 333-[ ]
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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BIOVAIL CORPORATION INTERNATIONAL.
(Exact name of registrant as specified in its charter)
Ontario Not Applicable
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
2488 Dunwin Drive
Mississauga, Ontario
Canada, L5L 1J9
(Address of Principal Executive Offices)
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Biovail corporation international 1993 STOCK OPTION PLAN
Biovail corporation international 1996 EMPLOYEE STOCK PURCHASE PLAN
(Full title of the plans)
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CT Corporation
1633 Broadway
New York, New York 10019
(212) 664-1666
(Name, address (including zip code) and telephone number (including area
code) of agent for service in the United States)
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Copy to:
Roger Andrus, Esq.
Cahill Gordon & Reindel
80 Pine Street
New York, NY 10005-1702
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<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
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Title of Securities to Amount to be Proposed Maximum Proposed Maximum Amount of
be Registered Registered(1)(2) Offering Price Per Aggregate Offering Price Registration Fee
Share (3) (3) (3)
- ------------------------ --------------- ------------------------- --------------------------- ------------------
<S> <C> <C> <C> <C>
Common Shares,
No Par Value 4,700,000 $69.06 $324,582,000 $85,689.65
shares
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</TABLE>
(1) Subject to adjustment to prevent dilution resulting from stock splits,
stock dividends or similar transactions. Pursuant to Rule 416 under the
Securities Act of 1933, as amended (the "Act"), there is also being
registered an indeterminate number of Common Shares which may become
issuable as a result of the anti-dilution provisions of the 1993 Stock
Option Plan and the 1996 Employee Stock Purchase Plan.
(2) Includes 4,400,000 Common Shares issuable upon exercise of options granted
under the 1993 Stock Option Plan, and 300,000 Common Shares issuable under
the 1996 Employee Stock Purchase Plan.
(3) Estimated solely for purposes of calculating the registration fee. Pursuant
to Rules 457(c) and 457(h) under the Act, the registration fee has been
calculated based on the average of the high and low sale prices reported
for the Common Shares of Biovail Corporation International on December 2,
1999, which was $69.06 per share, as reported on the New York Stock
Exchange.
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<PAGE>
EXPLANATORY NOTE
This Registration Statement is intended to register 4,400,000 Common
Shares, no par value (the "Common Shares"), of Biovail Corporation International
(the "Company") that have been or may be issued under the Company's 1993 Stock
Option Plan (the "Stock Option Plan") and 300,000 Common Shares that have been
or may be issued under the Company's 1996 Employee Stock Purchase Plan (the
"Employee Stock Purchase Plan).
This Registration Statement contains two parts. The first part contains a
reoffer Prospectus prepared in accordance with the requirements of Part I of
Form F-3 (pursuant to Section C of the General Instructions to Form S-8) which
covers reoffers and resales by certain shareholders of Common Shares issued
under the Stock Option Plan to employees of the Company who may be considered
affiliates as defined by Rule 405 under the Securities Act. Such Common Shares
constitute "control securities."
The second part contains "Information Required in the Registration
Statement" pursuant to Part II of Form S-8. Pursuant to the Note to Part I of
Form S-8, the information relating to the Stock Option Plan and the Employee
Stock Purchase Plan specified by Part I is not filed with the Securities and
Exchange Commission (the "Commission"), but documents containing such
information have been or will be sent or given to employees and directors as
specified by Rule 428(b)(1). Such document(s) are not being filed with the
Commission but constitute (along with the documents incorporated by reference
into the Registration Statement pursuant to Item 3 of Part II hereof) a
prospectus that meets the requirements of Section 10(a) of the Securities Act of
1933, as amended (the "Securities Act").
<PAGE>
PROSPECTUS
Biovail Corporation International
4,400,000 Shares
Common Shares
(no par value)
----------------------
Certain of our stockholders are using this Prospectus to offer Common
Shares they received from us upon the exercise of options we granted to them.
Some of these stockholders may be considered our "affiliates," as defined in
Rule 405 under the Securities Act of 1933.
We expect that sales made pursuant to this Prospectus will be made:
-- in broker's transactions;
-- in transactions directly with market makers; or
-- in negotiated sales or otherwise.
The selling stockholders will determine when they will sell their shares,
and in all cases they will sell their shares at the current market price or at
prices negotiated at the time of the sale. We will not receive any proceeds from
these sales.
The brokers and dealers the selling stockholders utilize in selling these
shares may receive compensation in the form of underwriting discounts,
concessions, or commissions from the sellers or purchasers of the shares. Any
compensation may exceed customary commissions. The selling stockholders and the
brokers and dealers they utilize may be deemed to be "underwriters" within the
meaning of the securities laws, and any commissions received and any profits
realized by them on the sale of shares may be considered to be underwriting
compensation.
The Common Shares are listed on the New York Stock Exchange under the
symbol "BVF." On December 6, 1999, the last reported sale price of the Common
Shares as reported on the New York Stock Exchange was $74.75 per share.
Our principal executive offices are located at 2488 Dunwin Drive,
Mississauga, Ontario, L5L 1J9, and our telephone number is (416) 285-6000.
----------------------
This investment involves risks. See the Risk Factors section beginning on page
3.
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Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of the securities or passed upon the
adequacy or accuracy of this prospectus. Any representation to the contrary is a
criminal offense.
----------------------
This prospectus is dated December 7, 1999.
<PAGE>
Available Information
We are subject to the informational requirements of the 1934 Act, and in
accordance therewith we file reports and other information with the Commission.
Reports, proxy and information statements, and other information filed by us,
can be inspected and copied at the public reference facilities maintained by the
Commission at 450 Fifth Street, N.W., Washington, D.C. 20549 and at certain of
its Regional Offices at Seven World Trade Center, 13th Floor, New York, N.Y.
10048 and Citicorp Center, 500 West Madison Street, Suite 1400, Chicago, IL
60661. Copies of such material can be obtained at prescribed rates from the
Public Reference Section of the Commission, 450 Fifth Street, N.W., Washington,
D.C. 20549 and by accessing the Commission's Web site, http://www.sec.gov. The
public may obtain information on the operation of the Public Reference Room by
calling the Commission at (800) SEC-0330. Certain of our securities are listed
on the New York Stock Exchange (the "NYSE"), and reports, proxy statements and
other information concerning us can be inspected at the offices of such
Exchange, 20 Broad Street, New York, N.Y. 10005.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by us with the Securities and Exchange
Commission (the "Commission") are incorporated herein by reference as of their
respective dates of filing and shall be deemed to be a part hereof:
1. Our annual report on Form 20-F for the year ended December 31, 1998;
2. Our reports on Form 6-K, filed with the Commission on June 23, 1999,
August 30, 1999, and November 30, 1999;
3. The description of our Common Shares contained in our Form 8-A filed
with the Commission on October 8, 1997.
All documents filed by us pursuant to Sections 13(a), 13(c), 14, or 15(d)
of the Securities Exchange Act of 1934, as amended (the "1934 Act") subsequent
to the date of this prospectus and before the termination of the offering shall
be deemed to be incorporated by reference and a part of this prospectus from the
date such documents are filed.
For purposes of this prospectus, any statement in a document incorporated
or deemed incorporated by reference is modified or superseded to the extent that
a statement in this prospectus, or in any subsequently filed document which is
or is deemed to be incorporated by reference, modifies or supersedes it. Any
statement so modified or superseded is not, except as so modified or superseded,
to constitute a part of this prospectus.
We will provide without charge to each person, including any beneficial
owner, to whom a copy of this prospectus has been delivered, on the written or
oral request of any such person, a copy of any or all documents referred to
above which have been or may be incorporated by reference in this prospectus
(not including exhibits to such incorporated information that are not
specifically incorporated by reference into such information). Requests for such
copies should be directed to us at the following address: Biovail Corporation
International, 2488 Dunwin Drive, Mississauga, Ontario, L5L 1J9, Attention:
Kenneth Howling, Vice President and Chief Financial Officer, telephone number:
(416) 285-6000.
2
<PAGE>
RISK FACTORS
Before you invest in the Common Shares, you should consider carefully the
following factors, in addition to the other information contained in this
prospectus.
The pharmaceutical industry is highly competitive and is subject to rapid
and significant technological change which could render our technologies and
products obsolete and uncompetitive.
Our products face intense competition from conventional forms of drug
delivery and from controlled-release drug delivery systems developed, or under
development, by other pharmaceutical companies. We compete with companies in the
United States and abroad, including major pharmaceutical and chemical companies,
specialised contract research organisations, research and development firms,
universities and other research institutions. Some of our competitors are also
licensees (or potential licensees) of our products. Many of our competitors have
greater financial resources and marketing capabilities than we do, and they may
be less leveraged. Some of our competitors have greater experience than we do in
clinical testing and human clinical trials of pharmaceutical products and in
obtaining FDA and other regulatory approvals. Our competitors may succeed in
developing technologies and products that are more effective or cheaper to use
than any which we may develop or license. These developments could render our
technologies and products obsolete or uncompetitive, which would have a material
adverse effect on our business and financial results.
Our business is subject to limitations imposed by government regulations.
The cost of complying with governmental regulation can be substantial.
Governmental authorities in the United States and Canada and comparable
authorities in foreign countries also regulate the research and development,
manufacture, testing and safety of controlled-release products. The regulations
applicable to our existing and future products may change. There can be long
delays in obtaining required clearances from regulatory authorities in any
country after applications are filed. Government agencies in the United States,
Canada and other countries in which we carry on our business regulate
pharmaceutical products intended for human use. Regulations require extensive
clinical trials and other testing and government review and final approval
before we can market these products.
Requirements for approval vary widely from country to country outside of
the United States and Canada. Whether or not approved in the United States or
Canada, regulatory authorities in other countries must approve a product prior
to the commencement of marketing the product in those countries. The time
required to obtain any such approval may be longer or shorter than in the United
States or Canada.
Any failure or delay in obtaining regulatory approvals could adversely
affect the marketing of any products which we develop and our financial results.
We are currently dependent on a particular product and several customers.
If a new drug were developed that was significantly more effective in the
treatment of hypertension or angina than Tiazac(R), our most significant
product, or if the medical industry determined that another pre-existing product
was significantly more effective in the treatment of hypertension or angina, the
result could be a significant reduction in Tiazac(R) sales. This could have a
material adverse effect on our business, results of operations, financial
condition and cash flows. Furthermore, the three-year marketing exclusivity
period for Tiazac(R) has expired and one generic drug manufacturer has submitted
an ANDA for a generic version of Tiazac(R). Under current law, if the ANDA is
approved, they may be able to begin marketing as early as mid-2001. This may
affect Tiazac(R)'s market share and may reduce the price at which Tiazac(R)
could be sold and could therefore have a material adverse effect on our
business, results of operations, financial condition and cash flows. Sales of
Tiazac(R) pursuant to agreements with Forest Laboratories, Inc. accounted for
approximately 48% and 51% of total revenues for the six-month period ended June
30, 1999 and for the year ended December 31, 1998, respectively. Our total sales
of Tiazac(R), including sales by Crystaal (our marketing division) in Canada,
accounted for approximately 50% and 62% of total revenue in the six-month period
ended June 30, 1999 and in the year ended December 31, 1998, respectively.
3
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Research and development services rendered to Intelligent Polymers and Teva
accounted for approximately 18% and 0% of total revenues, respectively, for the
six months ended June 30, 1999 and 9% and 12%, respectively, for the year ended
December 31, 1998.
There is uncertainty regarding our patents and proprietary technology and patent
protection is unpredictable.
Competitors may have filed patent applications, or hold issued patents,
relating to products or processes competitive with those we are developing. Our
patent applications for a product may not be approved. The patents of our
competitors may impair our ability to do business in a particular area. Others
may independently develop similar products or duplicate any of our unpatented
products. While we have not routinely sought patents on our controlled-release
technology, we do have the exclusive right to the patented technology for
Tiazac(R). Our success will depend, in part, on our ability in the future to
obtain patents, protect trade secrets and other proprietary information and
operate without infringing on the proprietary rights of others.
Historically, we have relied on trade secrets, know-how and other
proprietary information as well as requiring our employees and other vendors and
suppliers to sign confidentiality agreements. However, these confidentiality
agreements may be breached, and we may not have adequate remedies for any
breach. Others may independently develop substantially equivalent proprietary
information. Third parties may otherwise gain access to our proprietary
information.
There has been substantial litigation in the pharmaceutical industry
concerning the manufacture, use and sale of new products that are the subject of
conflicting patent rights. When we file an ANDA for a generic drug, we are
required to certify to the FDA that any patent which has been listed with the
FDA as covering the branded product has expired, the date any such patent will
expire, or that any such patent is invalid or will not be infringed by the
manufacture, sale or use of the new drug for which the application is submitted.
Approval of an ANDA is not effective until each listed patent expires, unless
the applicant certifies that the patents at issue are not infringed or are
invalid and so notifies the patent holder and the holder of the branded product
New Drug Application ("NDA"). A patent holder may challenge a notice of
non-infringement or invalidity by suing for patent infringement within 45 day of
receiving notice. Such a challenge would prevent FDA approval for a period which
ends 30 months after the receipt of notice, or sooner if an appropriate court
rules that the patent is invalid or not infringed. From time to time, in the
ordinary course of business, we face such challenges.
The expense of litigation, whether or not we are successful, could have a
material adverse effect on our business, results of operations, financial
condition and cash flows. Such lawsuits may be brought and the ultimate outcome
of such litigation, if commenced, could have a material adverse effect on our
business, results of operations, financial condition and cash flows. Regardless
of FDA approval, should anyone commence a lawsuit with respect to any alleged
patent infringement by us, whether because of the filing of an ANDA or
otherwise, the uncertainties inherent in patent litigation make the outcome of
such litigation difficult to predict.
There is no assurance that we will continue to be successful in our licensing
and marketing operations.
Except in Canada, our products are marketed by third parties by way of
license agreements or otherwise. Such third-party arrangements may not be
successfully negotiated in the future. Any such arrangements may not be
available on commercially reasonable terms. Even if acceptable and timely
marketing arrangements are available, the products we develop may not be
accepted in the marketplace. Even if such products are initially accepted, sales
may thereafter decline. Additionally, our clients or marketing partners may make
important marketing and other commercialisation decisions with respect to
products which we develop, without our input. As a result, many of the variables
that may affect revenues and net income are not exclusively within our control.
We are not assured of successful development of our product pipeline.
We have sixteen products at various stages of development or which are not
yet marketed and have filed ANDA's relating to seven of these products with the
FDA, one of which (Cardizem SR) has been approved and one of which (Adalat CC)
has been tentatively approved. FDA approval may not be granted for all or any of
these products and we may not be successful in filing NDA's or ANDA's for the
remaining nine products with the FDA.
4
<PAGE>
We depend on key scientific and managerial personnel for our continued success.
Much of our success to date has resulted from the particular scientific and
management skills of our available personnel. If these individuals were not
available, we might not be able to attract or retain employees with similar
skills. In particular, our success to date in developing new products has
resulted from the activities of a core group of research scientists. The
continued availability of this group is important to our ongoing success.
We must continue to address remaining year 2000 issues.
The Year 2000 issue involves the potential exposures related to the
erroneous generation of business and financial information resulting from the
fact that certain computer systems and programs use two digits, rather than
four, to define the applicable year of business transactions. These programs do
not properly recognise a year that begins with "20" instead of the familiar
"19." These programs may process data incorrectly or stop processing data
altogether. We rely upon our own and vendor-supplied technology and recognise
the potential business risk to our assets and systems associated with the
arrival of the Year 2000. We are currently nearing completion in addressing
potential Year 2000 readiness issues associated with our systems and our
suppliers' products, services, systems and operations, and expects to complete
this process by September 30, 1999. Our cash cost of achieving Year 2000
compliance is estimated to be approximately $500,000. To date, we have incurred
approximately $450,000 related to the assessment of, and efforts on, our Year
2000 project and the development of a contingency plan.
We utilise enterprise resource planning systems in the operation of our
core business functions. In conjunction with third party consultants,
substantial efforts have been made to test all components of the enterprise
resource planning system for Year 2000 compliance. The evaluation of test
results and any required remediation is expected to be completed by September
30, 1999. Our customers and suppliers may not have management information
systems that are Year 2000 compliant and required systems modifications may not
be completed by the Year 2000. Our failure to be Year 2000 compliant, or the
failure of our customers or suppliers, could have a material adverse effect on
our results of operations, business, prospects and financial condition. We have
identified and contacted key suppliers, partners and collaborators to determine
their stage of readiness for the Year 2000. Despite our best efforts, risks of
third party compliance are not directly within our control and are difficult to
assess.
Our business may be adversely affected by environmental laws and regulations.
We may incur substantial costs to comply with such requirements. In
addition, we may discover currently unknown environmental problems or
conditions. We are subject to extensive federal, state, provincial and local
environmental laws and regulations which govern the discharge, emission,
storage, handling and disposal of a variety of substances that may be used in or
result from our operations. Environmental laws or regulations (or their
interpretation) may become more stringent in the future. Any such event could
have a material adverse effect on our business. We do not currently use any
hazardous materials in the manufacture of our products.
The Common Shares are subject to market price volatility.
Market prices for the securities of pharmaceutical and biotechnology
companies, including ours, have historically been highly volatile, and the
market has from time to time experienced significant price and volume
fluctuations that are unrelated to the operating performance of particular
companies. Factors such as fluctuations in operating results, the aftermath of
public announcements, concern as to safety of drugs, and general market
conditions, can have an adverse effect on the market price of the Common Shares.
Our ability to obtain third-party reimbursement for the cost of products and
related treatment may not be adequate.
Our ability to successfully commercialise our products and product
candidates, if FDA approval is obtained, depends in part on whether appropriate
reimbursement levels for the cost of the products and related treatments are
obtained from government authorities and private health insurers and other
organisations, such as health maintenance organisations ("HMO's") and managed
care organisations ("MCO's").
Third-party payors increasingly challenge pricing of pharmaceutical
products. In addition, the trend
5
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toward managed health care in the United States, the growth of organisations
such as HMO's and MCO's and legislative proposals to reform health care and
government insurance programs could significantly influence the purchase of
pharmaceutical products, resulting in lower prices and a reduction in product
demand. Such cost containment measures and health care reform could affect our
ability to sell our products and may have a material adverse effect on our
business, results of operations and financial condition.
Uncertainty exists about the reimbursement status of newly approved
pharmaceutical products. Reimbursement in the United States or foreign countries
may not be available for some of our products. Any reimbursement granted may not
be maintained or limits on reimbursement available from third-party payors may
reduce the demand for, or negatively affect the price of, those products. These
issues could have a material adverse effect on our business, results of
operations and financial condition. We are unable to predict if additional
legislation or regulation impacting the health care industry or third-party
coverage and reimbursement may be enacted in the future, or what effect such
legislation or regulation would have on our business.
OUR COMPANY
We are an integrated international pharmaceutical company specialising in
the development of advanced oral controlled-release drugs. We have proprietary
technologies which are used to develop products which are either (1) generically
equivalent to existing once-daily branded products or (2) branded products that
improve upon conventional multiple daily dose immediate-release forms of
existing products by providing the therapeutic benefits of controlled-release
drug delivery. As a fully-integrated company, we control all facets of the drug
development process from formulation development to clinical testing,
manufacturing and obtaining regulatory approval. This integrated approach
results in operational synergies, flexibility and cost efficiencies. In Canada,
we market our products directly, while in the rest of the world we market our
products through strategic licensing partners. We do not engage in basic
research to discover new chemical entities.
Biovail was established under the Business Corporations Act (Ontario) on
March 29, 1994 as a result of the amalgamation of Trimel Corporation and our
then subsidiary, Biovail Corporation International. Our head and principal
office is located at 2488 Dunwin Drive, Mississauga, Ontario, L5L 1J9, and our
telephone number is (416) 285-6000.
6
<PAGE>
SELLING STOCKHOLDERS
Set forth below for each of the selling stockholders is the number of
Common Shares that may be sold by such selling stockholders hereunder. All
selling stockholders are current employees, officers or directors of the Company
and all such shares were acquired pursuant to the Stock Option Plan. Selling
stockholders may in the future receive additional Common Shares under our stock
option plans and may sell such shares.
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<CAPTION>
Name of Owner Position with the Number of Number of Common Number of
Company Common Shares Shares to be Common Shares
Owned Offered by Selling owned after the
Stockholders(1) Offering(2)
- ------------------------- ---------------------- ---------------- ------------------ ------------------
<S> <C> <C> <C> <C>
Eugene N. Melnyk Chairman of the 7,081,127 n/a 7,081,127
Board and Director
Bruce D. Brydon Chief Executive 112,000 n/a 112,000
Officer and Director
Robert A. Podruzny President, Chief 51,600 n/a 51,600
Operating Officer
and Director
Kenneth C. Cancellara Senior Vice 36,650 n/a 36,650
President, General
Counsel, Secretary
and Director
Rolf. K. Reininghaus Senior Vice 117,066 n/a 117,066
President and
Director
</TABLE>
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1 The Company does not know whether any of the Selling Shareholders will use
this Prospectus in connection with the offer or sale of any Common Shares,
or, if this Prospectus is so used, how many Common Shares will be offered
or sold. Pursuant to Rule 424(b) under the Securities Act, the Company will
supplement this Prospectus with the number of Common Shares, if any, to be
offered or sold by the Selling Shareholders as that information becomes
known.
2 Assumes the sale of all Common Shares eligible to be sold.
7
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PLAN OF DISTRIBUTION
The selling stockholders may sell registered Common Shares in any of the
following ways:
-- through dealers;
-- through agents; or
-- directly to one or more purchasers.
The distribution of the Common Shares may be effected from time to time in
one or more transactions (which may involve crosses or block transactions)
-- on the New York Stock Exchange in transactions pursuant to and in
accordance with the rules of such exchanges,
-- on the Toronto Stock Exchange in transactions pursuant to and in
accordance with the rules of such exchanges,
-- in the over-the-counter market, or
-- in transactions other than on such exchanges or in the over-the-counter
market, or a combination of such transactions.
Any such transaction may be effected at market prices prevailing at the
time of sale, at prices related to such prevailing market prices, at negotiated
prices or at fixed prices. The selling stockholders may effect such transactions
by selling shares to or through broker-dealers, and such broker-dealers may
receive compensation in the form of discounts, concessions or commissions from
the selling stockholders and/or commissions from purchasers of Common Shares for
whom they may act as agent. The selling stockholders and any broker-dealers or
agents that participate in the distribution of Common Shares by them might be
deemed to be underwriters, and any discounts, commissions or concessions
received by any such broker-dealers or agents might be deemed to be underwriting
discounts and commissions, under the Securities Act. Affiliates of one or more
selling stockholders may act as principal or agent in connection with the offer
or sale of Common Shares by the selling stockholders.
USE OF PROCEEDS
The Company will not receive any of the proceeds from the reoffer and
resale of the Common Shares by the Selling Shareholders.
8
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LEGAL MATTERS
Certain U.S. legal matters relating to the Common Shares will be passed
upon on behalf of the Company by Cahill Gordon & Reindel, a partnership
including a professional corporation, New York, New York. Certain Canadian legal
matters relating to the Common Shares will be passed upon on behalf of the
Company by Goodman and Carr, Toronto, Ontario, Canada.
EXPERTS
Our financial statements incorporated by reference in this prospectus and
elsewhere in the Registration Statement have been audited by Deloitte & Touche
LLP, independent public accountants, as indicated in their reports with respect
thereto, and are included herein in reliance upon the authority of said firm as
experts in giving said reports.
9
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No person is authorized to give any information or to
make any representations other than those contained in
this prospectus, and, if given or made, such information
or representations must not be relied upon as having been Biovail Corporation
authorized. This prospectus does not constitute an offer International
to sell or a solicitation of an offer to buy such securities
in any circumstance in which such offer or solicitation is
unlawful. Neither the delivery of this prospectus nor any sale
made hereunder shall, under any circumstances, create any
implication that there has been no change in our affairs
since the date hereof or that the information contained or
incorporated by reference herein is correct as of any time
subsequent to the date of this prospectus .
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____________________ PROSPECTUS
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TABLE OF CONTENTS
Page
Incorporation of Certain Documents
by Reference.............................. 2
Risk Factors................................ 3
Our Company................................. 6 4,400,000 Shares
Selling Stockholders........................ 7 Common Shares
Plan of Distribution........................ 8 (no par value)
Use of Proceeds............................. 8
Legal Matters............................... 9
Experts..................................... 9
December 7, 1999
======================================================= ================================================
</TABLE>
<PAGE>
PART II
INFORMATION REQUIRED
IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF DOCUMENTS BY REFERENCE.
The following documents, which are on file with the Commission, are
incorporated in this Registration Statement by reference and made a part hereof:
1. Our annual report on Form 20-F for the year ended December 31, 1998,
filed with the Commission on June 2, 1999;
2. Our reports on Form 6-K, filed with the Commission on June 23, 1999,
August 30, 1999, and November 30, 1999;
3. The description of our Common Shares contained in our Form 8-A filed
with the Commission on October 8, 1997.
All documents subsequently filed by the Registrant with the Commission
pursuant to Sections 13(a), 13(c), 14 or 15(d) of the 1934 Act prior to the
filing of a post-effective amendment which indicates that all securities offered
have been sold or which deregisters all securities then remaining unsold, shall
be deemed to be incorporated by reference in this Registration Statement and to
be part thereof from the date of filing of such documents.
ITEM 4. DESCRIPTION OF SECURITIES.
Not applicable.
ITEM 5. INTERESTS OF NAMED EXPERTS AND COUNSEL.
Not applicable.
ITEM 6. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Under Section 136 of the Business Corporations Act (Ontario), a director or
officer of a corporation, a former director or officer of the corporation or a
person who acts or acted at the corporation's request as a director or officer
of a body corporate of which the corporation is or was a shareholder or
creditor, and his or her heirs and legal representatives:
1. may be indemnified by the corporation against all costs, charges and
expenses, including an amount paid to settle an action or satisfy a
judgement, reasonably incurred by him or her in respect of any civil,
criminal or administrative action or proceeding to which he or she is
made a party by reason of being or having been a director or officer
of such corporation or body corporate.
2. may be indemnified by the corporation, with the approval of a court,
against all costs, charges and expenses reasonably incurred by the
person in connection with an action by or on behalf of the corpora-
<PAGE>
tion or body corporate to procure a judgement in its favor, to which
the person is made a party by reason of being or having been a
director or officer of the corporation or body corporate; and
3. is entitled to indemnity from the corporation in respect of all costs,
charges and expenses reasonably incurred by him or her in connection
with the defence of any civil, criminal or administrative action or
proceeding to which he or she is made a party by reason of being or
having been a director or officer of the corporation or body
corporate, if the person seeking indemnity was substantially
successful on the merits of his defence of the action or proceeding;
provided, in all cases, such person fulfills the conditions that (a) he or she
acted honestly and in good faith with a view to the best interests of the
corporation, and (b) in the case of a criminal or administrative action or
proceeding that is enforced by a monetary penalty, he or she had reasonable
grounds for believing that his or her conduct was lawful.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers or persons controlling the
Registrant pursuant to the foregoing provisions, the Registrant has been
informed that in the opinion of the U.S. Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act and is
therefore unenforceable.
As contemplated by Section 136 of the Business Corporations Act(Ontario),
Biovail Corporation International has purchased insurance against potential
claims against the directors and officers of the Registrant and against loss for
which the Registrant may be required or permitted by law to indemnify such
directors and officers.
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED.
Not applicable.
ITEM 8. EXHIBITS.
The Exhibits to this Registration Statement are listed in the Exhibit Index
on page E-1 of this Registration Statement, which Index is incorporated herein
by reference.
ITEM 9. 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)(3) 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
II-2
<PAGE>
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)The undersigned Registrant hereby undertakes 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 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 Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Registrant of expenses
incurred or paid by a director, officer or controlling person of the Registrant
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the Registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
II-3
<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-8 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunder duly
authorized, in the City of Mississauga, Province of Ontario, Canada on the 7th
of December, 1999.
BIOVAIL CORPORATION INTERNATIONAL
(Registrant)
By: /s/ Kenneth C. Cancellara
---------------------------------------
Name: Kenneth C. Cancellara, Q.C.
Title: Senior Vice President
and General Counsel
II-4
<PAGE>
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons, in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
<S> <C> <C>
* Chairman of the Board and Director December 7, 1999
- -----------------------------------------
Eugene N. Melnyk
* Chief Executive Officer and Director December 7, 1999
- -----------------------------------------
Bruce D. Brydon
* President, Chief Operating Officer and December 7, 1999
- ----------------------------------------- Director
Robert A. Podruzny
/s/ Kenneth C. Cancellara Senior Vice President, General December 7, 1999
- ----------------------------------------- Counsel, Secretary and Director
Kenneth C. Cancellara
* Senior Vice President and Director December 7, 1999
- -----------------------------------------
Rolf K. Reininghaus
* Vice President, Chief Financial December 7, 1999
- ----------------------------------------- Officer
Kenneth G. Howling
* Director December 7, 1999
- -----------------------------------------
Wilfred G. Bristow
* Director December 7, 1999
- -----------------------------------------
Roger Rowan
* Director December 7, 1999
- -----------------------------------------
Robert Vujea
</TABLE>
AUTHORIZED REPRESENTATIVE
Pursuant to the requirements of Section 6(a) of the Securities Act of 1933,
the Authorized Representative has duly signed this Registration Statement below:
By: * December 7, 1999
----------------------------
Eugene N. Melnyk
Chairman of the Board
By: /s/ Kenneth C. Cancellara
-----------------------------
(name)
Attorney-in-fact
II-5
<PAGE>
EXHIBIT INDEX
EXHIBIT NO. EXHIBIT
5 Opinion of Goodman & Carr.
23.1 Consent of Deloitte & Touche LLP.
23.2 Consent of Goodman & Carr (included in Exhibit 5).
24 Powers of Attorney
E-1
EXHIBIT 5
November 19, 1999
Biovail Corporation International
2488 Dunwin Drive
Mississauga, Ontario
L5L 1J9
Dear Sirs:
We have acted as Canadian counsel for Biovail Corporation International (the
"Corporation") in connection with the proposed registration of 4,400,00 common
shares in connection with the Corporation's 1993 stock option plan, as amended
(the "Option Plan") and the proposed registration of 300,000 common shares in
connection with the Corporation's 1996 Employee Stock Purchase Plan (the
"Purchase Plan"). The 4,400,000 Common Shares issuable upon the exercise of
stock options granted pursuant to the Optional Plan and the 300,000 Common
Shares issuable upon the purchase of Common Shares pursuant to the Purchase Plan
are hereinafter to as the "Common Shares".
We have considered such questions of law and examined such statutes,
regulations, opinions and originals or copies, certified or otherwise identified
to our satisfaction of such documents, corporate records, certificates and other
material and we have made such investigations as we have considered necessary or
appropriate or the purposes of the following opinions.
This opinion is provided solely for your use as aforesaid and may not be quoted
or otherwise referred to in any other documents or used or relied upon by you
for any other purposes or quoted to or used or relied on by any other person
either in connection with this or any other matter or transaction.
In rendering the following opinion, we are not purporting to opine as to any
laws other than the laws of Ontario and the federal laws of Canada applicable
therein in effect on the date hereof.
Based solely upon and subject to the foregoing, we are of the opinion that:
1. The Corporation has been duly amalgamated and is validly subsisting
under the laws of the Province of Ontario.
2. All necessary proceedings have been taken by the Corporation to
authorized the issuance of the Common Shares and the Common Shares, when issued
upon the due exercise of options granted under the Option Plan and the payment
of the exercise price in accordance with the terms of the Option Plan or when
issued upon the payment of the purchase price therefor in accordance with the
terms of the Purchase Plan, will be validly issued, fully paid and
non-assessable common shares of the Corporation. No personal liability for the
debts or obligations of the Corporation will attach to the holders of the Common
Shares solely by reason of the ownership thereof.
We hereby consent to the filing of this opinion with the United States
Securities and Exchange Commission as an exhibit to the Registration Statement.
Yours very truly,
/s/ Goodman and Carr
- -----------------------
Goodman and Carr
EXHIBIT 23.1
INDEPENDENT AUDITORS' CONSENT
We consent to the incorporation by reference in this Registration Statement of
Biovail Corporation International on Form S-8 of our reports dated May 14, 1999
appearing in Biovail Corporation International's Annual Report on Form 20-F for
the year ended December 31, 1998 and to the reference to us under the heading
"Experts" in the Prospectus, which is part of this Registration Statement.
/s/ DELOITTE & TOUCHE LLP
- --------------------------------
DELOITTE & TOUCHE LLP
Toronto, Ontario
December 6, 1999
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Eugene N. Melnyk
------------------------------------
Name: Eugene N. Melnyk
Title: Chairman of the Board and
Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Kenneth C. Cancellara
----------------------------------------
Name: Kenneth C. Cancellara
Title: Senior Vice President, General Counsel,
Secretary and Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Kenneth G. Howling
-------------------------------------
Name: Kenneth G. Howling
Title: Vice President, Chief Financial Officer
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Rolf K. Reininghaus
---------------------------------------
Name: Rolf K. Reininghaus
Title: Senior Vice President and
Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Roger Rowan
------------------------------------
Name: Roger Rowan
Title: Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Robert Vujea
-------------------------------------
Name: Robert Vujea
Title: Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Bruce D. Brydon
-----------------------------------
Name: Bruce D. Brydon
Title: Chief Executive Officer and Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Robert A. Podruzny
-------------------------------------------
Name: Robert A. Podruzny
Title: President, Chief Operating
Officer and Director
<PAGE>
EXHIBIT 24
BIOVAIL CORPORATION INTERNATIONAL
KNOW ALL MEN BY THESE PRESENTS, the undersigned hereby appoints Eugene N.
Melnyk, Bruce D. Brydon and Kenneth C. Cancellara, or any of them, his true and
lawful attorneys-in-fact and agents, with full power of substitution and
restitution, for him and in his name, place and stead, in any and all
capacities, to sign any Registration Statement on Form S-8 under the Securities
Act of 1933, as amended, to sign any and all pre- or post-effective amendments
to such Registration Statement, and to file the same with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, the undersigned has executed this Power of Attorney on
December 7, 1999.
/s/ Wilfred G. Bristow
-------------------------------------
Name: Wilfred G. Bristow
Title: Director
