fv10
As
filed with the Securities and Exchange Commission on September 19, 2007
Registration No. 333-
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM F-10
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Æterna Zentaris Inc.
(Exact name of registrant as specified in its charter)
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Canada
(Province or other jurisdiction
of incorporation or organization)
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2834
(Primary Standard Industrial Classification
Code Number, if applicable)
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Not Applicable
(I.R.S. Employer Identification Number
if applicable) |
1405, boul. du Parc-Technologique
Quebec City, Quebec
Canada, G1P 4P5
(418) 652-8525
(Address and telephone number of Registrants principal executive offices)
Æterna
Zentaris, Inc.,
20 Independence Boulevard,
Warren, New Jersey 07059-2731
(908) 626-5428
(Name, address (including zip code) and telephone number
(including area code) of agent for service in the United States)
Copies to:
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Mario Paradis
Æterna Zentaris Inc.
1405, boul. du Parc-Technologique
Quebec City, Quebec
Canada, G1P 4P5
418-652-8525
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Andrew G. Bleau, Esq.
Ogilvy Renault LLP
1981 McGill College Avenue
Montreal, Quebec
Canada, H3A 3C1
514-847-4747 |
Approximate date of commencement of proposed sale of the securities to the public:
From time to time after the effective date of this Registration Statement.
Province of Quebec, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check appropriate box):
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A.
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o
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upon filing with the Commission, pursuant to Rule 467(a) (if in connection with an offering being made
contemporaneously in the United States and Canada). |
B.
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x
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at some future date (check the appropriate box below). |
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1. |
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o pursuant to Rule 467(b) on (date) at (time) (designate a time not sooner than 7 calendar days after filing). |
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o pursuant to Rule 467(b) on (date) at (time) (designate a time 7 calendar days or sooner after filing)
because the securities regulatory authority in the review jurisdiction has issued a receipt or notification of
clearance on (date). |
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3. |
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o pursuant to Rule 467(b) as soon as practicable after notification of the Commission by the Registrant or
the Canadian securities regulatory authority of the review jurisdiction that a receipt or notification of clearance
has been issued with respect hereto. |
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4. |
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x after the filing of the next amendment to this Form (if preliminary material is being filed). |
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to the home jurisdictions shelf prospectus offering procedures, check
the following box. x
CALCULATION OF REGISTRATION FEE
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Title of each class of |
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Proposed maximum |
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Amount of |
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securities to be registered |
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aggregate offering price(1)(2) |
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registration fee |
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Common Shares(3) |
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Warrants to Purchase Common Shares(4) |
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Total |
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US$90,000,000 |
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US$2,763 |
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(1)
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There is being registered under this Registration Statement such indeterminate
number of common shares (no par value) and warrants to purchase common shares of the
Registrant as shall have an aggregate initial offering price not to exceed US$90,000,000
(or its equivalent in any other currency). The proposed maximum initial offering price per
security will be determined, from time to time, by the Registrant in connection with the
sale of the securities registered under this Registration Statement. |
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(2)
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Estimated solely for purposes of calculating the registration fee pursuant to
Rule 457(o) under the Securities Act of 1933, as amended. |
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(3)
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There is being registered an indeterminate number of common shares (no par value)
as from time to time may be issued at indeterminate prices. An
indeterminate number of common shares may also be issued upon
exercise of warrants to purchase common shares. |
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(4)
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There is being registered an indeterminate number of warrants to purchase common
shares as from time to time may be issued at indeterminate prices. |
The Registrant hereby amends this Registration Statement on such date or dates as may be
necessary to delay its effective date until the Registration Statement shall become effective as
provided in Rule 467 under the Securities Act of 1933 or on such date as the Commission, acting
pursuant to Section 8(a) of the Act, may determine.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
I-1
The information
in this preliminary prospectus is not complete and may be
changed. These securities may be sold until the registration
statement filed with the Securities and Exchange Commission is
effective. This document is not an offer to sell and is not
soliciting an offer to buy these securities in any jurisdiction
where the offer or sale is not permitted.
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No securities regulatory
authority has expressed an opinion about these securities and it
is an offence to claim otherwise.
A copy of this
preliminary short form base shelf prospectus has been filed with
the securities regulatory authorities in each of the provinces
of Canada, but has not yet become final for the purpose of the
sale of securities. Information contained in this preliminary
short form base shelf prospectus may not be complete and may
have to be amended. These securities may not be sold until a
receipt for the short form base shelf prospectus is obtained
from the securities regulatory
authorities. This short form
base shelf prospectus constitutes a public offering of
securities only in those jurisdictions where such securities may
be lawfully offered for sale and therein only by persons
permitted to sell such securities and it is an offence to claim
otherwise.
This short form
base shelf prospectus has been filed under legislation in all
provinces of Canada that permits certain information about these
securities to be determined after this short form base shelf
prospectus has become final and that permits the omission from
this short form base shelf prospectus of that information. The
legislation requires the delivery to purchasers of a prospectus
supplement containing the omitted information within a specified
period of time after agreeing to purchase any of these
securities. Information
has been incorporated by reference in this short form base shelf
prospectus from documents filed with securities commissions or
similar securities regulatory authorities in Canada. Copies
of the documents incorporated herein by reference may be
obtained on request without charge from the Corporate Secretary
of Æterna Zentaris Inc. either at 20 Independence
Boulevard, Warren, New Jersey 07059-2731 or at 1405
du Parc-Technologique
Blvd., Quebec City, Quebec, Canada G1P 4P5,
Tel. (418) 652-8525,
and are also available electronically at www.sedar.com. For the
purpose of the Province of Québec, this simplified
prospectus contains information to be completed by consulting
the permanent information record. A copy of the permanent
information record may be obtained without charge from the
Corporate Secretary of Æterna Zentaris at either of the
above-mentioned addresses and telephone number and is also
available electronically at www.sedar.com.
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New
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PRELIMINARY
SHORT FORM BASE SHELF PROSPECTUS |
Dated September 19, 2007
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U.S.$90,000,000
Common Shares
Warrants to Purchase Common Shares
We may from time to time during the
25-month
period that this short form base shelf prospectus (the
Prospectus), including any amendments, remains
valid, offer, sell, and issue under this Prospectus up to
U.S.$90,000,000 aggregate initial offering price of our common
shares (the Common Shares) and/or warrants to
purchase Common Shares (the Warrants, and,
together with the Common Shares, the Securities). We
may offer Securities from time to time in one or more
transactions in such amounts and, in the case of the Warrants,
with such terms, as we may determine in light of prevailing
market conditions at the time of sale. We may sell and issue the
Warrants under this Prospectus in one or more series.
The specific variable terms of any offering of Securities will
be set out in the applicable supplement to this Prospectus
(each, a Prospectus Supplement), including, where
applicable: (i) in the case of the Common Shares, the
number of Common Shares offered, the currency in which the
Common Shares will be issued and any other specific terms; and
(ii) in the case of the Warrants, the designation, the
number of Warrants offered, the currency in which the Warrants
will be issued, the number of Common Shares that may be acquired
upon exercise of the Warrants, the exercise price, dates and
periods of exercise, adjustment procedures and any other
specific terms applicable thereto.
A Prospectus Supplement may include specific terms pertaining to
the Securities that are not within the alternatives and
parameters described in this Prospectus. All shelf information
permitted under applicable laws to be omitted from this
Prospectus will be contained in one or more Prospectus
Supplements that will be delivered to purchasers together with
this Prospectus. Each Prospectus Supplement will be incorporated
by reference into this Prospectus for the purposes of securities
legislation as of the date of the Prospectus Supplement and only
for the purposes of the distribution of the Securities to which
the Prospectus Supplement pertains.
We are a foreign private issuer under United States
(U.S.) securities laws and are permitted, under a
multi-jurisdictional disclosure system (MJDS)
adopted by the U.S., to prepare this Prospectus in accordance
with Canadian disclosure requirements. You should be aware that
such requirements are different from those of the U.S. We have
prepared our financial statements in accordance with Canadian
generally accepted accounting
principles (GAAP), and they are subject to
Canadian auditing and auditor independence standards. Thus, they
may not be comparable to the financial statements of U.S.
companies. Information regarding the impact upon our financial
statements of significant differences between Canadian and U.S.
GAAP is contained in the supplemental notes entitled
Summary of differences between generally accepted
accounting principles in Canada and in the United States
included in our Annual Report on
Form 40-F
filed with the United States Securities and Exchange
Commission (SEC) on March 23, 2007 and
subsequently amended on September 19, 2007 (available
electronically at www.sec.gov) and incorporated by reference
into this Prospectus. See Reconciliation to
U.S. GAAP.
Owning the Securities may subject you to tax consequences
both in the U.S. and Canada. This Prospectus and any applicable
Prospectus Supplement may not describe these tax consequences
fully. You should read the tax discussion in this Prospectus and
any applicable Prospectus Supplement.
Your ability to enforce civil liabilities under U.S. federal
securities laws may be affected adversely by the fact that we
are incorporated under the laws of Canada, many of our officers
and directors and all of the experts named in this Prospectus
are residents of Canada or elsewhere outside of the U.S., and a
substantial portion of our assets and the assets of such persons
are located outside the U.S. See Enforceability of Civil
Liabilities.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ACCURACY OF THIS PROSPECTUS. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE.
Investing in the Securities involves risk. See Risk
Factors.
Our outstanding Common Shares are listed for trading on the
Toronto Stock Exchange (TSX) under the trading
symbol AEZ and on the NASDAQ Stock Market
(NASDAQ) under the trading symbol AEZS.
There is currently no market through which the Warrants may
be sold and purchasers may not be able to resell Warrants
purchased under this Prospectus. This may affect the pricing of
the Warrants in the secondary market, the transparency and
availability of trading prices, the liquidity of the Warrants,
and the extent of issuer regulation.
See the Risk Factors section of
the applicable Prospectus Supplement.
We may sell Securities to or through underwriters or dealers or
directly to investors or through agents. The Prospectus
Supplement relating to a particular offering of Securities will
identify each person who may be deemed to be an underwriter with
respect to such offering and will set forth the terms of the
offering of such Securities, including, to the extent
applicable, the offering price, the proceeds that we will
receive, the underwriting discounts or commissions and any other
discounts or concessions to be allowed or reallowed to dealers.
The managing underwriter or underwriters with respect to
Securities sold to or through underwriters will be named in the
related Prospectus Supplement. See Plan of
Distribution.
You should rely only on the information contained in this
Prospectus. We have not authorized anyone to provide you with
information different from that contained in this Prospectus.
The information contained in this Prospectus is accurate only as
of the date of this Prospectus, regardless of the time of
delivery of this Prospectus or of any sale of our Securities.
Our registered office is located at 1405 du Parc-Technologique
Blvd., Quebec City, Quebec, Canada G1P 4P5.
TABLE OF
CONTENTS
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1
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3
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3
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4
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5
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9
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21
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21
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21
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22
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22
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23
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23
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23
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24
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24
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DOCUMENTS
INCORPORATED BY REFERENCE
The following documents have been filed with the various
securities commissions or similar securities regulatory
authorities in Canada and are specifically incorporated by
reference into, and form an integral part of, this Prospectus:
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(a)
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our Annual Information Form dated March 23, 2007 for the
financial year ended December 31, 2006 (which was
included as Exhibit 99.1 to our Annual Report on
Form 40-F
filed with the SEC on March 23, 2007 and subsequently
amended on September 19, 2007);
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(b)
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our audited consolidated balance sheets as at
December 31, 2006 and 2005 and our audited
consolidated statements of operations, deficit, other capital
and cash flows for each of the years in the
three-year
period ended December 31, 2006, together with the
report thereon dated March 2, 2007, except as to
Note 24(g) and (h), which is as of September 17, 2007
of our independent auditors PricewaterhouseCoopers LLP as filed
with the Canadian securities regulatory authorities on
September 19, 2007 (which was included as Exhibit 99.2
to our Annual Report on
Form 40-F
filed with the SEC on March 23, 2007 and subsequently
amended on September 19, 2007);
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(c)
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our Managements Discussion and Analysis for the year ended
December 31, 2006, dated March 2, 2007 as filed
with the Canadian securities regulatory authorities on
September 19, 2007 (which was included as Exhibit 99.4
to our Annual Report on
Form 40-F
filed with the SEC on March 23, 2007 and subsequently
amended on September 19, 2007);
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(d)
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the Management Information Circular dated March 9, 2007 in
connection with our annual meeting of shareholders held on
May 2, 2007 (which was included as Exhibit 99.5
to our Annual Report on
Form 40-F
filed with the SEC on March 23, 2007 and subsequently
amended on September 19, 2007);
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(e)
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our unaudited interim consolidated financial statements for the
six-month period ended June 30, 2007 (which was
furnished to the SEC on
Form 6-K
on August 16, 2007);
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(f)
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our Managements Discussion and Analysis of Financial
Conditions and Results of Operations for the
six-month
period ended June 30, 2007 (which was furnished to the
SEC on
Form 6-K
on August 16, 2007);
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(g)
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the Material Change Report dated January 8, 2007
announcing that we had effected the distribution in kind to our
shareholders of 11,052,996 Subordinate Voting Shares in the
capital of Atrium Biotechnologies Inc.
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(which has been since renamed Atrium Innovations Inc.
(Atrium)) (which was furnished to the SEC on
Form 6-K
on January 24, 2007);
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(h)
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the Material Change Report dated February 13, 2007
announcing the restatement of our unaudited interim consolidated
financial statements for the third quarter and nine-month period
ended September 30, 2006 (which was included as
Exhibit 1 to a
Form 6-K
furnished to the SEC on February 14, 2007);
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(i)
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the Material Change Report dated March 27, 2007
announcing the appointment of David J. Mazzo, Ph.D. as
our President and Chief Executive Officer (CEO)
(which was furnished to the SEC on
Form 6-K
on March 28, 2007); and
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(j)
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to the extent permitted by applicable securities law, any other
documents which we elect to incorporate by reference into this
Prospectus.
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Any documents of the type referred to in the preceding
paragraph, or similar material, including any annual information
form, annual and interim financial statements and related
managements discussion and analysis, material change
report (excluding any confidential material change report, if
any), business acquisition report and information circular of
Æterna Zentaris filed with the various securities
commissions or similar securities regulatory authorities in
Canada after the date of this Prospectus and prior to the
completion or withdrawal of any offering hereunder shall be
deemed to be incorporated by reference into this Prospectus.
Information has been incorporated by reference into this
Prospectus from documents filed with securities commissions or
similar securities regulatory authorities in Canada. Copies of
the documents incorporated herein by reference may be obtained
on request without charge from the Corporate Secretary of
Æterna Zentaris either at 20 Independence
Boulevard, Warren, New Jersey 07059-2731 or at 1405 du
Parc-Technologique Blvd., Quebec City, Quebec, Canada
G1P 4P5, Tel.
(418) 652-8525,
or through the Internet on the Canadian System for Electronic
Document Analysis and Retrieval (SEDAR) which can be
accessed at www.sedar.com. For the purpose of the
Province of Québec, this Prospectus contains information to
be completed by consulting the permanent information record. A
copy of the permanent information record may be obtained without
charge from our Corporate Secretary at either of the
above-mentioned addresses and telephone number.
In addition to our continuous disclosure obligations under the
securities laws of the provinces of Canada, we are subject to
the information requirements of the U.S. Securities Exchange
Act of 1934, as amended (the Exchange Act), and
in accordance therewith we file with or furnish to the SEC
reports and other information. Under the MJDS adopted by the
U.S., documents and other information that we file with or
furnish to the SEC may be prepared in accordance with the
disclosure requirements of Canada, which are different from
those of the U.S. You may read and copy any document that we
have filed with the SEC at the SECs public reference room
at Room 1580, 100 F Street N.E., Washington,
D.C., 20549. You may also obtain copies of the same documents
from the public reference room of the SEC by paying a fee.
You should call the SEC at
1-800-SEC-0330
or access its website at www.sec.gov for further
information about the public reference rooms. The SECs
EDGAR Internet site also contains reports and other information
about us and any public documents that we file electronically
with the SEC. The EDGAR site can be accessed at
www.sec.gov.
Any statement contained in this Prospectus or in a document
incorporated or deemed to be incorporated by reference herein
shall be deemed to be modified or superseded, for the purposes
of this Prospectus, to the extent that a statement contained
herein or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein
modifies or supersedes such statement. The modifying or
superseding statement need not state that it has modified or
superseded a prior statement or include any other
information set forth in the document that it modifies or
supersedes. The making of a modifying or superseding
statement shall not be deemed an admission for any purposes that
the modified or superseded statement, when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be
stated or that is necessary to make a statement not misleading
in light of the circumstances in which it was made. Any
statement so modified or superseded shall not constitute a part
of this Prospectus, except as so modified or superseded.
Upon a new annual information form and the related annual
audited consolidated financial statements together with the
auditors report thereon and managements discussion
and analysis related thereto being filed by us with the
applicable securities regulatory authorities during the currency
of this Prospectus, the previous annual information form, the
previous annual audited consolidated financial statements and
all interim financial statements, annual and quarterly
managements discussion and analyses, material change
reports and business acquisition reports filed by us prior to
the commencement
2
of our financial year in which the new annual information form
was filed, no longer shall be deemed to be incorporated by
reference into this Prospectus for the purpose of future offers
and sales of Securities hereunder.
We have filed with the SEC a registration statement on
Form F-10
relating to the Securities. This Prospectus, which constitutes a
part of the registration statement, does not contain all of the
information contained in the registration statement, certain
items of which are contained in the exhibits to the registration
statement as permitted by the rules and regulations of the SEC.
Statements included or incorporated by reference in this
Prospectus about the contents of any contract, agreement or
other documents referred to are not necessarily complete, and in
each instance, you should refer to the exhibits for a more
complete description of the matter involved. Each such statement
is qualified in its entirety by such reference.
One or more Prospectus Supplements containing the specific
variable terms of an offering of Securities and other
information in relation to such Securities will be delivered to
purchasers of such Securities together with this Prospectus and
shall be deemed to be incorporated by reference into this
Prospectus as of the date of such Prospectus Supplement solely
for the purposes of the offering of the Securities covered by
any such Prospectus Supplement.
A Prospectus Supplement containing any additional or updated
information that we elect to include therein will be delivered
with this Prospectus to purchasers of Securities who purchase
such Securities after the filing of this Prospectus and shall be
deemed to be incorporated into this Prospectus as of the date of
such Prospectus Supplement.
In this Prospectus and in any Prospectus Supplement, unless
otherwise indicated, references to we,
us, our, Æterna
Zentaris or the Company are to Æterna
Zentaris Inc., a Canadian corporation, and its wholly-owned
subsidiaries, including Æterna Zentaris GmbH, Æterna
Zentaris, Inc. and Echelon Biosciences, Inc. Unless otherwise
indicated, all financial information included in and
incorporated by reference into this Prospectus and any
Prospectus Supplement is determined using Canadian GAAP.
CURRENCY
AND EXCHANGE RATES
All references to dollars, U.S.$ or
$ are to U.S. dollars and all references to
Cdn$ are to Canadian dollars. The following table
sets out the high and low exchange rates for one U.S. dollar
expressed in Canadian dollars, for the period indicated and, the
average of such exchange rates, and the exchange rate at the end
of such period, in each case, based upon the noon rates as
quoted by the Bank of Canada:
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Six Months Ended
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Year ended December 31,
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June 30, 2007
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2006
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2005
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2004
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High
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1.1853
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1.1726
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1.2704
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1.3968
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Low
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1.0580
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1.0990
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1.1507
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1.1774
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Rate at end of period
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1.0634
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1.1653
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1.1659
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1.2036
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Average rate per period
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1.1348
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1.1340
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1.2116
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1.3015
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On September 18, 2007, the exchange rate for one U.S.
dollar expressed in Canadian dollars based upon the noon rate of
the Bank of Canada was Cdn$1.0236.
FORWARD-LOOKING
STATEMENTS
This Prospectus and the documents incorporated herein by
reference contain forward-looking statements concerning the
business, operations, financial performance and condition of
Æterna Zentaris. When used in this Prospectus, words such
as may, will, should, could, expects, plans, seeks,
anticipates, intends, believes, estimates, predicts,
potential or continue or the negative of these terms
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
such words. These forward-looking statements are based on
current expectations and are naturally subject to uncertainty
and changes in circumstances that may cause actual results to
differ materially from those expressed or implied by such
forward-looking statements. Such statements, based as they are
on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of
which are beyond our control. Such risks include but are not
limited to:
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the fact that investments in biopharmaceutical companies are
generally considered to be speculative;
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we may never achieve or maintain operating profitability;
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we may never receive the required regulatory approvals to market
certain of our product candidates;
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our clinical trials may not yield results which will enable us
to obtain regulatory approval for our products;
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our trials could be delayed or otherwise adversely affected by
difficulties enrolling patients in our clinical trials;
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possible setbacks in any phase of the clinical development of
our product candidates;
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the impact of the strict and ongoing government regulation to
which our product candidates are subject and future changes in
such regulatory environment;
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we may not be able to generate significant revenues if our
products do not gain market acceptance;
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failure to achieve our projected development goals in the
time-frames we announce and expect;
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the impact of any failure on our part to obtain acceptable
prices or adequate reimbursement for our products on our ability
to generate revenues;
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competition in our targeted markets;
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we may not obtain adequate protection for our products through
our intellectual property;
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we may infringe the intellectual property rights of others;
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we may incur liabilities from our involvement in any patent
litigation;
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we may not obtain trademark registrations in connection with our
product candidates;
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we may require significant additional financing, and we may not
have access to sufficient capital;
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we may not be able to make adequate arrangements with third
parties for the purpose of commercializing our product
candidates;
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the fact that our arrangements with strategic partners may not
provide us with the benefits we expect and may expose us to a
number of risks;
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the failure to perform satisfactorily by third parties on which
we rely to conduct, supervise and monitor our clinical trials;
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our ability to retain or attract key personnel;
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risks related to product liability claims;
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the impact of legislative actions, new accounting pronouncements
and higher insurance costs on our future financial position or
results of operations;
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fluctuations in currency exchange rates;
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the impact of general economic conditions;
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stock market volatility; and
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fluctuations in costs and changes to the competitive environment
due to consolidation.
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More detailed information about these and other factors is
included in this Prospectus under the section entitled
Risk Factors as well as in other documents
incorporated by reference into this Prospectus. Many of these
factors are beyond our control. Future events may vary
substantially from what we currently foresee. You should not
place undue reliance, if any, on such forward-looking
statements. Æterna Zentaris disavows and is under no
obligation to update or alter such forward-looking statements
whether as a result of new information, future events or
otherwise.
ENFORCEABILITY
OF CIVIL LIABILITIES
We are a corporation incorporated under and governed by the
Canada Business Corporations Act. Many of our officers
and directors, and all of the experts named in this Prospectus,
are Canadian residents, and a substantial portion of our assets
and the assets of such persons are located outside the U.S. As a
result, it may be difficult for investors in the U.S. to effect
service of process within the U.S. upon such directors, officers
and representatives of experts who are not residents of the U.S.
or to enforce against them judgments of a U.S. court predicated
solely upon civil liability under U.S. federal securities laws
or the securities laws of any state within the U.S. We have been
advised by our legal counsel, Ogilvy Renault LLP, that a
judgment of a U.S. court predicated solely upon civil liability
under U.S. federal securities laws would probably be enforceable
in Canada if the U.S. court in which the judgment was obtained
has a basis for jurisdiction in the matter that would be
recognized by a Canadian court for the same purposes. We have
also been advised
4
by Ogilvy Renault LLP, however, that there is substantial
doubt as to whether an action could be brought in Canada in the
first instance on the basis of liability predicated solely upon
U.S. federal securities laws.
We filed with the SEC, concurrently with our registration
statement on
Form F-10,
an appointment of agent for service of process on
Form F-X.
Under the
Form F-X,
we appointed Æterna Zentaris, Inc., our wholly-owned
subsidiary and a Delaware corporation, as our agent for service
of process in the U.S. in connection with any investigation or
administrative proceeding conducted by the SEC, and any civil
suit or action brought against or involving us in a U.S. court
arising out of or related to or concerning the offering of
Securities under this Prospectus.
We are a global biopharmaceutical company focused on endocrine
therapy and oncology with expertise in drug discovery,
development and commercialization, primarily targeting the North
American and European markets.
Our Company was incorporated on September 12, 1990 under
the laws of Canada. Our registered office is located at 1405 du
Parc-Technologique
Blvd., Quebec City, Quebec, Canada G1P 4P5, our telephone
number is
(418) 652-8525
and our website is www.aeternazentaris.com. None of the
documents or information found on our website shall be deemed to
be included in or incorporated into this Prospectus, unless such
document is specifically incorporated herein by reference and
enumerated as such under Documents Incorporated by
Reference.
We recently opened an office in the U.S., located at
20 Independence Boulevard, Warren, New Jersey
07059-2731.
We have three wholly-owned subsidiaries,
Æterna Zentaris GmbH (AEZS Germany), based
in Frankfurt, Germany, Æterna Zentaris, Inc., based in
Warren, New Jersey in the U.S., and Echelon Biosciences,
Inc. (Echelon) based in Salt Lake City, Utah in
the U.S.
During the last three years, we have advanced our product
development pipeline with a focus on our lead product
candidates, cetrorelix, ozarelix and perifosine, as well as our
targeted earlier-stage programs, as depicted in the
chart below:
Our Common Shares are listed for trading on the TSX under the
trading symbol AEZ and on the NASDAQ under the
trading symbol AEZS.
5
Recent
Developments
Spin-off
of Atrium
During 2006, we made the decision to spin off our subsidiary,
Atrium, which specializes in Active Ingredients &
Specialty Chemicals, and Health & Nutrition. This
spin-off was completed in two steps. First, in October 2006, we
sold a partial interest in Atrium (approximately
3.5 million shares) by way of a secondary offering. We
subsequently distributed our remaining interest in Atrium
(approximately 11 million shares) to our shareholders by
way of return of capital on January 2, 2007. Therefore, in
the first quarter of 2007, our long-term investment in Atrium
was removed from our consolidated balance sheet.
Appointment
of Key Executives and Changes to our Board of
Directors
On March 27, 2007, we announced the appointment of David J.
Mazzo, Ph.D. as our new President and CEO. Prior to joining
Æterna Zentaris, Dr. Mazzo spent more than
20 years in the pharmaceutical industry, and he previously
served as President and CEO of Chugai Pharma USA from April 2003
until March 2007. He also held positions of increasing
responsibility with Merck, Baxter, Rhône-Poulenc Rorer,
Hoechst Marion Roussel and Schering-Plough. Dr. Mazzo holds
a B.A. in Honors (Interdisciplinary Humanities) and a B.S. in
Chemistry from Villanova University, as well as an M.S. in
Chemistry and a Ph.D. in Analytical Chemistry from the
University of Massachusetts (Amherst). He further complemented
his American education as a Research Fellow at the Ecole
Polytechnique Fédérale de Lausanne, Switzerland.
Shortly after the appointment of Dr. Mazzo, we established
an office in Warren, New Jersey in the U.S.
On May 7, 2007, we announced the filling of two key
management positions with the appointment of Ellen McDonald,
M.B.A., as Senior Vice President, Business Operations and Chief
Business Officer, and Nicholas J. Pelliccione, Ph.D., as
Senior Vice President, Regulatory Affairs and Quality Assurance.
On August 14, 2007, we announced the appointments of
Jürgen Ernst as Chairman of our Board of Directors and
David J. Mazzo, Ph.D., our President and CEO, to our Board of
Directors. Mr. Ernst had served as our Vice Chairman since
November 2005 and has 35 years of pharmaceutical industry
experience, specifically corporate development and
pharmaceutical product marketing expertise. He succeeds our
founder, Eric Dupont, Ph.D., who served as our Executive
Chairman since January 2003 and who stepped down from the Board
of Directors on the same day.
On August 16, 2007, we completed the formation of our new
management team with the announcement of Paul Blake, M.D.
as Senior Vice President and Chief Medical Officer.
Our executive management team is now comprised of the following
members:
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David J. Mazzo, Ph.D., President and CEO;
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Paul Blake, M.D., Senior Vice President and Chief Medical
Officer;
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Jürgen Engel, Ph.D., Executive Vice President and Chief
Scientific Officer;
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Ellen McDonald, M.B.A., Senior Vice President, Business
Operations and Chief Business Officer;
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Mario Paradis, C.A., Senior Vice President, Administrative and
Legal Affairs, and Corporate Secretary;
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Nicholas J. Pelliccione, Ph.D., Senior Vice President,
Regulatory Affairs and Quality Assurance; and
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Dennis Turpin, C.A., Senior Vice President and Chief Financial
Officer.
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Pipeline
Developments
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Cetrorelix: Patient dosing commenced with our
flagship product candidate, cetrorelix, our lead luteinizing
hormone-releasing hormone (LHRH) antagonist
compound, in the first of three expected clinical trials of an
extensive Phase 3 program in benign prostatic hyperplasia
(BPH) that will enroll a total of approximately
1,500 patients. This first trial is expected to enroll
approximately 600 patients and will primarily be conducted in
the U.S. and Canada. Our partner Shionogi & Co
(Shionogi) is currently conducting a 300-patient
Phase 2b trial with cetrorelix for the treatment of BPH in Japan.
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6
Additionally, we announced the termination of the License and
Cooperation Agreement for cetrorelix for all remaining
indications, including endometriosis, with Solvay
Pharmaceuticals (Solvay). We regained exclusive
worldwide ex-Japan rights for cetrorelix in all indications,
without any financial compensation payable to Solvay. Cetrorelix
was not a priority for Solvay as it shifted its focus to newly
defined therapeutic areas as a result of the acquisition of
Fournier Pharma, which was announced in March 2005. We now have
full rights ex-Japan to cetrorelix and are in the process of
conducting an updated, comprehensive strategic analysis to
determine how best to proceed with the development for the
endometriosis indication. We anticipate announcing the outcome
of this strategic analysis in the fall of 2007.
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Ozarelix: Our partner, Spectrum
Pharmaceuticals (Spectrum), presented an abstract
outlining detailed Phase 2 BPH results for ozarelix, our
fourth-generation LHRH/GnRH antagonist. Results indicated that
ozarelix was well tolerated and demonstrated statistically
significant as well as clinically meaningful efficacy in the
treatment of lower urinary tract symptoms (LUTS)
secondary to BPH. Results also showed no statistically
significant impact on quality of life or erectile function. The
abstract was presented at the American Urological Association
(AUA) Annual Meeting in May 2007. In January 2007, a Phase 2b
study in the BPH indication was initiated in the U.S. and Canada
by our partner, Spectrum. Furthermore, Spectrum completed
enrollment for this Phase 2b trial in BPH in June 2007.
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Perifosine: At the American Society of
Clinical Oncologys (ASCO) Annual Meeting, our partner,
Keryx Biopharmaceuticals (Keryx) presented a poster
outlining Phase 1 and Phase 2 results for perifosine, our oral
anti-cancer signal transduction inhibitor compound, for the
treatment of patients with advanced sarcoma. Results of the
Phase 1 and Phase 2 studies of perifosine showed an overall
clinical benefit rate (CBR) of 52%, which compares favorably
with the activity of mTOR inhibitors. Our partner Keryx is
conducting multiple Phase 1 and 2 clinical trials in monotherapy
as well as in combination with chemotherapy and biologics for
multiple cancers.
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AEZS-108: Detailed, Phase 1 results for our
targeted cytotoxic LHRH analog, AEZS-108, were reported in
female patients with cancers expressing LHRH at the ASCO Annual
Meeting. Evidence of anti-tumor activity was found at 160 mg/m2
or 267 mg/m2 doses of AEZS-108, where 7 of 13 patients showed
signs of tumor response, including 3 patients with complete or
partial responses.
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AEZS-112: This is a novel small molecule,
anti-cancer drug in development involving two mechanisms of
action: tubulin and topoisomerase II inhibition. On
January 8, 2007, we announced the initiation of a Phase 1
trial for AEZS-112 in patients with solid tumors and lymphoma.
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Our
Business Strategy
Our strategy is to aggressively advance our product development
pipeline with a focus on our lead product candidates and value
drivers: cetrorelix, ozarelix and perifosine, as well as our
targeted earlier-stage programs that we believe to have high
potential. With the collective experience of our new management
team in place and our expertise in drug discovery,
pharmaceutical development and commercialization, we believe we
are well positioned to execute our strategy. Furthermore, as a
priority, we believe in the potential of our LHRH antagonist
platform and our signal transduction inhibitor therapeutic
approach.
Our foremost priority and lead product candidate is cetrorelix
in the BPH indication. Based on various
third-party
sources, the prevalence of BPH in 2007 in the U.S. is estimated
to be 21.5 million individuals as defined by International
Prostate Symptom Score (IPSS) >7. Additionally, it is
estimated that approximately 6 million men will be treated
in the U.S. for LUTS associated with BPH. The prevalence of BPH
in the U.S. is expected to increase to 26.8 million in
2020, and the LUTS treated population to approximately
7.5 million men. We intend to continue to aggressively
advance cetrorelix Phase 3 program with the objective of filing
a New Drug Application (NDA). We also have the intent to file in
Europe a Marketing Authorization Application (MAA).
In addition, we intend to further advance ozarelix in the BPH
indication with the collaboration of our partner Spectrum.
Spectrum announced earlier this year that it is their intention,
dependent upon successful discussions with the United States
Food and Drug Administration (FDA), to initiate a
Phase 3 development program in BPH by the end of 2007 or in
early 2008.
7
With respect to perifosine, we, along with our partner, Keryx,
intend to continue development in multiple Phase 1 and 2 trials
in oncology. Our goal is to initiate one Phase 3 trial by the
end of 2007 or early 2008 in collaboration with Keryx, depending
on the positive outcome of selected Phase 2 trials ongoing and
successful discussions with the FDA.
We intend to further advance our earlier-stage product
candidates with what we believe to be high potential during the
year, including AEZS-108 and AEZS-112. With respect to AEZS-108,
we intend to initiate a Phase 2 trial in endometrial and ovarian
cancers before the end of 2007. Regarding AEZS-112, we plan to
announce interim Phase 1 data before the end of the year as well.
Additionally, we have a drug discovery unit which includes high
throughput screening systems and a library of nearly 120,000
compounds. We also have several
pre-clinical
programs underway with targeted potential development
candidates. Among the targets that we expect to propose for
clinical development in the coming years are: Ghrelin receptor
ligands, PI3K/Erk inhibitors, AEZS-115 LHRH Peptidomimetics and
AEZS-127 (erucylphosphocholine).
Furthermore, we intend to continue marketing
Cetrotide®
(cetrorelix) in more than 80 countries, in collaboration with
our partner, Merck Serono, on a world-wide ex-Japan basis, and
with Shionogi in Japan.
We are currently in a phase in which our products and product
candidates are being further developed or marketed jointly with
strategic partners. We expect we will continue to develop
strategic partnerships in the future as we move to realize our
vision of becoming a fully integrated specialty
biopharmaceutical company.
8
The purchase of Securities offered under this Prospectus
involves risks which prospective purchasers should take into
consideration when making a decision to purchase such
Securities. Investors should carefully consider the risks
described below, together with all of the other information
included in this Prospectus and the documents incorporated by
reference into this Prospectus, before making an investment
decision. Certain of these risk factors have been disclosed in
our Managements Discussion and Analysis of Financial
Condition and Results of Operations for the financial year ended
December 31, 2006 under the heading Risks Factors and
Uncertainties, which document is incorporated by reference
into this Prospectus. This discussion of risk factors will be
updated from time to time in our subsequent filings with the
Canadian securities regulatory authorities, including in
subsequent annual and quarterly managements discussion and
analysis and annual information forms. If any of the following
risks actually occurs or materializes, our business, financial
condition or results of operations could be adversely affected,
even materially adversely affected. In such an event, the
trading price of our Securities could decline and you may lose
part or all of your investment. Any reference in this section to
our products includes a reference to our product
candidates and future products we may develop.
Risks
Related to Us and Our Business
Investments
in biopharmaceutical companies are generally considered to be
speculative.
The prospects for companies operating in the biopharmaceutical
industry may generally be considered to be uncertain, given the
very nature of the industry and, accordingly, investments in
biopharmaceutical companies should be considered to be
speculative.
We
have a history of operating losses and we may never achieve or
maintain operating profitability.
Our product candidates remain at the development stage and we
have incurred substantial expenses in our efforts to develop
products. Consequently, we have incurred recurrent operating
losses and, as of June 30, 2007, we had an accumulated
deficit of approximately $20.7 million. Our operating
losses have adversely impacted, and will continue to adversely
impact, our working capital, total assets and shareholders
equity. We do not expect to reach operating profitability in the
immediate future, and our expenses are likely to increase as we
continue to expand our research and development
(R&D) and clinical study programs and our sales
and marketing activities and seek regulatory approval for our
product candidates. Even if we succeed in developing new
commercial products, we expect to incur additional operating
losses for at least the next several years. If we do not
ultimately generate sufficient revenue from commercialized
products and achieve or maintain operating profitability, an
investment in our Securities could result in a significant or
total loss.
We do not have the required regulatory approvals to market
certain of our product candidates, and we do not know if we will
ever receive such approvals.
With the exception of
Cetrotide®
(cetrorelix) for the treatment of infertility and
Impavido®
(miltefosine for the treatment of leishmaniasis), none of our
product candidates has to date received regulatory approval for
its intended commercial sale. We cannot market a pharmaceutical
product in any jurisdiction until it has completed rigorous
pre-clinical testing and clinical trials and passed such
jurisdictions extensive regulatory approval process. In
general, significant research and development and clinical
studies are required to demonstrate the safety and efficacy of
our product candidates before we can submit regulatory
applications. Preparing, submitting and advancing applications
for regulatory approval is complex, expensive and
time-consuming
and entails significant uncertainty. Even if a product candidate
is approved by the FDA, the Canadian Therapeutic Products
Directorate or any other regulatory authority, we may not obtain
approval for an indication whose market is large enough to
recuperate our investment in that product candidate. In
addition, there can be no assurance that we will ever obtain all
or any required regulatory approvals for any of our product
candidates.
We are currently developing our product candidates based on
R&D activities,
pre-clinical
testing and clinical trials conducted to date, and we may not be
successful in developing or introducing to the market these or
any other new products or technology. If we fail to develop and
deploy new products successfully and on a timely basis, we may
become non-competitive and unable to recoup the R&D and
other expenses we incur to develop and test new products.
9
Our clinical trials may not yield results which will
enable us to obtain regulatory approval for our products, and a
setback in any of our clinical trials would likely cause a drop
in the price of our Securities.
We will only receive regulatory approval for a product candidate
if we can demonstrate in carefully designed and conducted
clinical trials that the product candidate is both safe and
effective. We do not know whether our pending or any future
clinical trials will demonstrate sufficient safety and efficacy
to obtain the requisite regulatory approvals or will result in
marketable products. Unfavorable data from those studies could
result in the withdrawal of marketing approval or an extension
of the review period. Clinical trials are inherently lengthy,
complex, expensive and uncertain processes. It typically takes
many years to complete testing, and failure can occur at any
stage of testing. Results attained in pre-clinical testing and
early clinical studies, or trials, may not be indicative of
results that are obtained in later studies.
We may suffer significant setbacks in advanced clinical trials,
even after promising results in earlier studies. Based on
results at any stage of clinical trials, we may decide to repeat
or redesign a trial or discontinue development of one or more of
our product candidates. Further, actual results may vary once
the final and quality-controlled verification of data and
analyses has been completed. If we fail to adequately
demonstrate the safety and efficacy of our products under
development, we will not be able to obtain the required
regulatory approvals to commercialize our product candidates.
Clinical trials are subject to continuing oversight by
governmental regulatory authorities and institutional review
boards and:
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must meet the requirements of these authorities;
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must meet requirements for informed consent; and
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must meet requirements for good clinical practices.
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We may not be able to comply with these requirements in respect
of one or more of our product candidates.
In addition, we rely on third parties, including contract
research organizations (CROs) and outside
consultants, to assist us in managing and monitoring clinical
trials. Our reliance on these third parties may result in delays
in completing, or in failing to complete, these trials if one or
more third parties fails to perform with the speed and level of
competence we expect.
A failure in the development of any one of our programs or
product candidates could have a negative impact on the
development of the others. Setbacks in any phase of the clinical
development of our product candidates would have an adverse
financial impact (including with respect to any agreements and
partnerships that may exist between us and other entities),
could jeopardize regulatory approval and would likely cause a
drop in the price of our Securities.
If we encounter difficulties enrolling patients in our
clinical trials, our trials could be delayed or otherwise
adversely affected.
Clinical trials for our product candidates require that we or
third parties identify and enroll a specific number of patients.
We or such third parties may not be able to enroll a sufficient
number of patients to complete our clinical trials in a timely
manner. Patient enrollment is a function of many factors
including:
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design of the protocol;
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the size of the patient population;
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eligibility criteria for the study in question;
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perceived risks and benefits of the drug under study;
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availability of competing therapies already approved;
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number of competing clinical trials ongoing in the same
indication;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians; and
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availability of clinical trial sites.
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If we or any third party have difficulty enrolling a sufficient
number of patients to conduct our clinical trials as planned, we
may need to delay or terminate ongoing clinical trials.
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Even if we obtain regulatory approvals for our product
candidates, we will be subject to stringent ongoing government
regulation.
Even if regulatory authorities approve any of our product
candidates, the manufacture, marketing and sale of such products
will be subject to strict and ongoing regulation. Compliance
with such regulation will be expensive and consume substantial
financial and management resources. For example, an approval for
a product may be conditioned on our conducting costly
post-marketing follow-up studies. In addition, if based on these
studies, a regulatory authority does not believe that the
product demonstrates a benefit to patients, such authority could
limit the indications for which the product may be sold or
revoke the products regulatory approval.
We, and our contract manufacturers, will be required to comply
with applicable current Good Manufacturing Practice (cGMP)
regulations for the manufacture of our products. These
regulations include requirements relating to quality assurance,
as well as the corresponding maintenance of rigorous records and
documentation. Manufacturing facilities must be approved before
we can use them in the commercial manufacturing of our products
and are subject to subsequent periodic inspection by regulatory
authorities. In addition, material changes in the methods of
manufacturing or changes in the suppliers of raw materials are
subject to further regulatory review and approval.
If we, or any future marketing collaborators or contract
manufacturers, fail to comply with applicable regulatory
requirements, we may be subject to sanctions including fines,
product recalls or seizures, injunctions, total or partial
suspension of production, civil penalties, withdrawals of
previously granted regulatory approvals, import or export bans
or restrictions, and criminal prosecution. Any of these
penalties could delay or prevent the promotion, marketing or
sale of our products.
If our
products do not gain market acceptance, we may be unable to
generate significant revenues.
Even if our products are approved for commercialization, they
may not be successful in the marketplace. Market acceptance of
any of our products will depend on a number of factors
including, but not limited to:
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demonstration of clinical efficacy and safety;
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the advantages and disadvantages of our products relative to
current or alternative treatments;
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the availability of acceptable pricing and adequate third-party
reimbursement; and
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the effectiveness of marketing and distribution methods for the
products.
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If our products do not gain market acceptance among physicians,
patients, healthcare payers and others in the medical community
which may not accept or utilize our products, our ability to
generate significant revenues from our products would be limited
and our financial conditions will be materially adversely
affected. In addition, if we fail to further penetrate our core
markets and existing geographic markets or successfully expand
our business into new markets, the growth in sales of our
products, along with our operating results, could be negatively
impacted. Our ability to further penetrate our core markets and
existing geographic markets in which we compete or to
successfully expand our business into additional countries in
Europe, Asia or elsewhere is subject to numerous factors, many
of which are beyond our control. Our products, if successfully
developed, may compete with a number of drugs and therapies
currently manufactured and marketed by major pharmaceutical and
other biotechnology companies. Our products may also compete
with new products currently under development by others or with
products which may be less expensive than our products. We
cannot assure that our efforts to increase market penetration in
our core markets and existing geographic markets will be
successful. Our failure to do so could have an adverse effect on
our operating results and would likely cause a drop in the price
of our Securities.
We may not achieve our projected development goals in the
time-frames we announce and expect.
We set goals and make public statements regarding timing of the
accomplishment of objectives material to our success, such as
the commencement, enrollment and completion of clinical trials,
anticipated regulatory submission and approval dates and time of
product launch. The actual timing of these events can vary
dramatically due to factors such as delays or failures in our
clinical trials, the uncertainties inherent in the regulatory
approval process and delays in achieving manufacturing or
marketing arrangements sufficient to commercialize our products.
There can be no assurance that our clinical trials will be
completed, that we will make regulatory submissions or receive
regulatory approvals as planned or
11
that we will be able to adhere to our current schedule for the
launch of any of our products. If we fail to achieve one or more
of these milestones as planned, the price of the Securities
would likely decline.
If we fail to obtain acceptable prices or adequate
reimbursement for our products, our ability to generate revenues
will be diminished.
The ability for us and/or our partners to successfully
commercialize our products will depend significantly on our
ability to obtain acceptable prices and the availability of
reimbursement to the patient from third-party payers, such as
government and private insurance plans. These third-party payers
frequently require companies to provide predetermined discounts
from list prices, and they are increasingly challenging the
prices charged for pharmaceuticals and other medical products.
Our products may not be considered cost-effective, and
reimbursement to the patient may not be available or sufficient
to allow us or our partners to sell our products on a
competitive basis. It may not be possible to negotiate favorable
reimbursement rates for our products.
In addition, the continuing efforts of third-party payers to
contain or reduce the costs of healthcare through various means
may limit our commercial opportunity and reduce any associated
revenue and profits. We expect proposals to implement similar
government control to continue. In addition, increasing emphasis
on managed care will continue to put pressure on the pricing of
pharmaceutical and biopharmaceutical products. Cost control
initiatives could decrease the price that we or any current or
potential collaborators could receive for any of our products
and could adversely affect our profitability. In addition, in
the U.S., in Canada and in many other countries, pricing and/or
profitability of some or all prescription pharmaceuticals and
biopharmaceuticals are subject to government control.
If we fail to obtain acceptable prices or an adequate level of
reimbursement for our products, the sales of our products would
be adversely affected or there may be no commercially viable
market for our products.
Competition in our targeted markets is intense, and
development by other companies could render our products or
technologies non-competitive.
The biomedical field is highly competitive. New products
developed by other companies in the industry could render our
products or technologies non-competitive. Competitors are
developing and testing products and technologies that would
compete with the products that we are developing. Some of these
products may be more effective or have an entirely different
approach or means of accomplishing the desired effect than our
products. We expect competition from biopharmaceutical and
pharmaceutical companies and academic research institutions to
increase over time. Many of our competitors and potential
competitors have substantially greater product development
capabilities and financial, scientific, marketing and human
resources than we do. Our competitors may succeed in developing
products earlier and in obtaining regulatory approvals and
patent protection for such products more rapidly than we can or
at a lower price.
We may not obtain adequate protection for our products
through our intellectual property.
We rely heavily on our proprietary information in developing and
manufacturing our product candidates. Our success depends, in
large part, on our ability to protect our competitive position
through patents, trade secrets, trademarks and other
intellectual property rights. The patent positions of
pharmaceutical and biopharmaceutical firms, including
Æterna Zentaris, are uncertain and involve complex
questions of law and fact for which important legal issues
remain unresolved. The patents issued or to be issued to us may
not provide us with any competitive advantage. Our patents may
be challenged by third parties in patent litigation, which is
becoming widespread in the biopharmaceutical industry. In
addition, it is possible that third parties with products that
are very similar to ours will circumvent our patents by means of
alternate designs or processes. We may have to rely on method of
use protection for our compounds in development and any
resulting products, which may not confer the same protection as
compounds per se. We may be required to disclaim part of
the term of certain patents. There may be prior art of which we
are not aware that may affect the validity or enforceability of
a patent claim. There also may be prior art of which we are
aware, but which we do not believe affects the validity or
enforceability of a claim, which may, nonetheless ultimately be
found to affect the validity or enforceability of a claim. No
assurance can be given that our patents would, if challenged, be
held by a court to be valid or enforceable or that a
competitors technology or product would be found by a
court to infringe our patents. Applications for patents and
trademarks in Canada, the U.S. and in foreign markets have been
filed and are being actively pursued by us. Pending patent
applications may not result in the issuance of patents, and we
may not develop additional proprietary products which are
patentable.
12
Patent applications relating to or affecting our business have
been filed by a number of pharmaceutical and biopharmaceutical
companies and academic institutions. A number of the
technologies in these applications or patents may conflict with
our technologies, patents or patent applications, and such
conflict could reduce the scope of patent protection which we
could otherwise obtain. We could become involved in interference
proceedings in the U.S. in connection with one or more of our
patents or patent applications to determine priority of
invention. Our granted patents could also be challenged and
revoked in opposition proceedings in certain countries outside
the U.S.
In addition to patents, we rely on trade secrets and proprietary
know-how to protect our intellectual property. We generally
require our employees, consultants, outside scientific
collaborators and sponsored researchers and other advisors to
enter into confidentiality agreements. These agreements provide
that all confidential information developed or made known to the
individual during the course of the individuals
relationship with us is to be kept confidential and not
disclosed to third parties except in specific circumstances. In
the case of our employees, the agreements provide that all of
the technology which is conceived by the individual during the
course of employment is our exclusive property. These agreements
may not provide meaningful protection or adequate remedies in
the event of unauthorized use or disclosure of our proprietary
information. In addition, it is possible that third parties
could independently develop proprietary information and
techniques substantially similar to ours or otherwise gain
access to our trade secrets.
We currently have the right to use certain technology under
license agreements with third parties. Our failure to comply
with the requirements of material license agreements could
result in the termination of such agreements, which could cause
us to terminate the related development program and cause a
complete loss of our investment in that program.
As a result of the foregoing factors, we may not be able to rely
on our intellectual property to protect our products in the
marketplace.
We may
infringe the intellectual property rights of
others.
Our commercial success depends significantly on our ability to
operate without infringing the patents and other intellectual
property rights of third parties. There could be issued patents
of which we are not aware that our products infringe or patents,
that we believe we do not infringe, but that we may ultimately
be found to infringe. Moreover, patent applications are in some
cases maintained in secrecy until patents are issued. The
publication of discoveries in the scientific or patent
literature frequently occurs substantially later than the date
on which the underlying discoveries were made and patent
applications were filed. Because patents can take many years to
issue, there may be currently pending applications of which we
are unaware that may later result in issued patents that our
products infringe. For example, pending applications may exist
that provide support or can be amended to provide support for a
claim that results in an issued patent that our product
infringes.
The biopharmaceutical industry has produced a proliferation of
patents, and it is not always clear to industry participants,
including us, which patents cover various types of products. The
coverage of patents is subject to interpretation by the courts,
and the interpretation is not always uniform. In the event of
infringement or violation of another partys patent, we may
not be able to enter into licensing arrangements or make other
arrangements at a reasonable cost. Any inability to secure
licenses or alternative technology could result in delays in the
introduction of our products or lead to prohibition of the
manufacture or sale of products by us or our partners and
collaborators.
Patent
litigation is costly and time consuming and may subject us to
liabilities.
Our involvement in any patent litigation, interference,
opposition or other administrative proceedings will likely cause
us to incur substantial expenses, and the efforts of our
technical and management personnel will be significantly
diverted. In addition, an adverse determination in litigation
could subject us to significant liabilities.
We may not obtain trademark registrations.
The Company has filed applications for trademark registrations
in connection with our product candidates in various
jurisdictions, including the U.S. We intend to file further
applications for other possible trademarks for our product
candidates. No assurance can be given that any of our trademarks
will be registered in the U.S. or elsewhere or that the use of
any trademark will confer a competitive advantage in the
marketplace. Furthermore, even if we are successful in our
trademark registrations, the FDA and regulatory authorities in
other countries have their own process for drug nomenclature and
their own views concerning appropriate proprietary names. The
FDA and other regulatory authorities also have the power, even
after granting market approval, to request a company to
reconsider the name for a product
13
because of evidence of confusion in the marketplace. No
assurance can be given that the FDA or any other regulatory
authority will approve of any of our trademarks or will not
request reconsideration of one of our trademarks at some time in
the future. The loss of any of our current trademarks could
negatively affect the success of the product candidate to which
it relates.
We may require significant additional financing, and we
may not have access to sufficient capital.
We may require additional capital to pursue planned clinical
trials, regulatory approvals, as well as further R&D and
marketing efforts for our product candidates and potential
products. Except as expressly described in this Prospectus and
the documents incorporated by reference herein, we do not
anticipate generating significant revenues from operations in
the near future, and we have no other committed sources of
capital.
We may attempt to raise additional funds through public or
private financings, collaborations with other pharmaceutical
companies or financing from other sources. Additional funding
may not be available on terms which are acceptable to us. If
adequate funding is not available on reasonable terms, we may
need to delay, reduce or eliminate one or more of our product
development programs or obtain funds on terms less favorable
than we would otherwise accept. To the extent that additional
capital is raised through the sale of equity securities or
securities convertible into or exchangeable for equity
securities, the issuance of those securities could result in
dilution to our shareholders. Moreover, the incurrence of debt
financing could result in a substantial portion of our future
operating cash flow, if any, being dedicated to the payment of
principal and interest on such indebtedness and could impose
restrictions on our operations. This could render us more
vulnerable to competitive pressures and economic downturns.
We anticipate that our existing working capital, including the
proceeds from the sale of Securities and anticipated revenues,
will be sufficient to fund our development programs, clinical
trials and other operating expenses for the foreseeable future.
However, our future capital requirements are substantial and may
increase beyond our current expectations depending on many
factors including:
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the duration and results of our clinical trials for cetrorelix,
ozarelix and perifosine, as well as other product candidates
going forward;
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unexpected delays or developments in seeking regulatory
approvals;
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the time and cost in preparing, filing, prosecuting, maintaining
and enforcing patent claims;
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other unexpected developments encountered in implementing our
business development and commercialization strategies;
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the outcome of litigation, if any; and
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further arrangements, if any, with collaborators.
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Our revenues and expenses may fluctuate significantly, and
any failure to meet financial expectations may disappoint
securities analysts or investors and result in a decline in the
price of the Securities.
We have a history of operating losses. Our revenues and expenses
have fluctuated in the past and are likely to do so in the
future. These fluctuations could cause our share price to
decline. Some of the factors that could cause our revenues and
expenses to fluctuate include but are not limited to:
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the inability to complete product development in a timely manner
that results in a failure or delay in receiving the required
regulatory approvals to commercialize our product candidates;
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the timing of regulatory submissions and approvals;
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the timing and willingness of any current or future
collaborators to invest the resources necessary to commercialize
our product candidates;
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the revenue available from royalties derived from our strategic
partners;
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licensing fees revenues;
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tax credits and grants (R&D);
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the outcome of litigation, if any;
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changes in foreign currency fluctuations;
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the timing of achievement and the receipt of milestone payments
from current or future collaborators; and
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failure to enter into new or the expiration or termination of
current agreements with collaborators.
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Due to fluctuations in our revenues and expenses, we believe
that
period-to-period
comparisons of our results of operations are not indicative of
our future performance. It is possible that in some future
quarter or quarters, our revenues and expenses will be above or
below the expectations of securities analysts or investors. In
this case, the price of the Securities could fluctuate
significantly or decline.
We may invest or spend the proceeds of an offering in ways
with which investors may not agree and in ways that may not earn
a profit.
Our management team will have broad discretion concerning the
use of the proceeds of this offering as well as the timing of
their expenditure. As a result, investors will be relying on the
judgement of management for the application of the proceeds of
any offering of Securities under this Prospectus. We intend to
use the proceeds from any offering primarily for general
corporate purposes, which may include, but are not limited to,
our current clinical development programs. Investors may not
agree with the ways we decide to use these proceeds, and our use
of the proceeds may not yield any results or profits.
We will not be able to successfully commercialize our
product candidates if we are unable to make adequate
arrangements with third parties for such purposes.
We currently have a lean sales and marketing staff. In order to
commercialize our product candidates successfully, we need to
make arrangements with third parties to perform some or all of
these services in certain territories.
We contract with third parties for the sales and marketing of
our products. Our revenues will depend upon the efforts of these
third parties, whose efforts may not be successful. If we fail
to establish successful marketing and sales capabilities or to
make arrangements with third parties for such purposes, our
business, financial condition and results of operations will be
materially adversely affected.
If we had to resort to developing a sales force internally, the
cost of establishing and maintaining a sales force would be
substantial and may exceed its cost effectiveness. In addition,
in marketing our products, we would likely compete with many
companies that currently have extensive and well-funded
marketing and sales operations. Despite our marketing and sales
efforts, we may be unable to compete successfully against these
companies.
We are currently dependent on strategic partners and may
enter into future collaborations for the research, development
and commercialization of our product candidates. Our
arrangements with these strategic partners may not provide us
with the benefits we expect and may expose us to a number of
risks.
We are dependent on, and rely upon, strategic partners to
perform various functions related to our business, including,
but not limited to, the research, development and
commercialization of some of our product candidates. Our
reliance on these relationships poses a number of risks.
We may not realize the contemplated benefits of such agreements
nor can we be certain that any of these parties will fulfill
their obligations in a manner which maximizes our revenue. These
arrangements may also require us to transfer certain material
rights or issue our equity securities to corporate partners,
licensees and others. Any license or sublicense of our
commercial rights may reduce our product revenue.
These agreements also create certain risks. The occurrence of
any of the following or other events may delay product
development or impair commercialization of our products:
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not all of our strategic partners are contractually prohibited
from developing or commercializing, either alone or with others,
products and services that are similar to or competitive with
our product candidates, and, with respect to our strategic
partnership agreements that do contain such contractual
prohibitions or restrictions, prohibitions or restrictions do
not always apply to our partners affiliates and they may
elect to pursue the development of any additional product
candidates and pursue technologies or products either on their
own or in collaboration with other parties, including our
competitors, whose technologies or products may be competitive
with ours;
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our strategic partners may under-fund or fail to commit
sufficient resources to marketing, distribution or other
development of our products;
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we may not be able to renew such agreements;
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our strategic partners may not properly maintain or defend
certain intellectual property rights that may be important to
the commercialization of our products;
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our strategic partners may encounter conflicts of interest,
changes in business strategy or other issues which could
adversely affect their willingness or ability to fulfill their
obligations to us (for example, pharmaceutical companies
historically have re-evaluated their priorities following
mergers and consolidations, which have been common in recent
years in this industry);
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delays in, or failures to achieve, scale-up to commercial
quantities, or changes to current raw material suppliers or
product manufacturers (whether the change is attributable to us
or the supplier or manufacturer) could delay clinical studies,
regulatory submissions and commercialization of our product
candidates; and
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disputes may arise between us and our strategic partners that
could result in the delay or termination of the development or
commercialization of our product candidates, resulting in
litigation or arbitration that could be time-consuming and
expensive, or causing our strategic partners to act in their own
self-interest and not in our interest or those of our
shareholders or other stakeholders.
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In addition, our strategic partners can terminate our agreements
with them for a number of reasons based on the terms of the
individual agreements that we have entered into with them. If
one or more of these agreements were to be terminated, we would
be required to devote additional resources to developing and
commercializing our product candidates, seek a new partner or
abandon this product candidate which would likely cause a drop
in the price of our Securities.
Some of our more important strategic partnership agreements
include:
In relation to cetrorelix, we have entered into agreements with:
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Merck Serono (formerly Serono), which holds an exclusive
worldwide license (ex-Japan) to commercialize
Cetrotide®
(cetrorelix in the indication of in vitro fertilization). This
agreement provides the Company, among other things, with
manufacturing income, royalties on worldwide (ex-Japan) net
sales as well as fixed annual lump-sum payments until 2010.
After 2010, these fixed annual lump-sum payments will become
high double-digit royalties on the net worldwide (ex-Japan)
sales of
Cetrotide®
(cetrorelix);
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Nippon Kayaku Co. Ltd. of Japan, (Nippon Kayaku)
which has the right to manufacture, and Shionogi of Japan has
the right to commercialize,
Cetrotide®
(cetrorelix) in Japan. We also granted Shionogi the exclusive
rights to develop and commercialize
Cetrotide®
(cetrorelix) for human use in Japan, including the BPH
indication.
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In relation to ozarelix, we have entered into agreements with:
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Spectrum Pharmaceuticals Inc., Irvine CA, USA, with which, on
August 12, 2004, we entered into a licensing and
collaboration agreement for our LHRH antagonist, ozarelix. Under
the terms of the agreement, we granted Spectrum an exclusive
license to develop and commercialize ozarelix for all potential
indications in North America (including Canada and Mexico) and
India. We have access to data,
free-of-charge,
and are eligible to receive payments upon achievement of
development and regulatory milestones, in addition to royalties
(scale-up royalties from high single to low double-digit) on
potential net sales. Spectrum is entitled to receive fifty
percent of the upfront, milestone payments and royalties
received from Nippon Kayaku relating to Japan territory; and
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Nippon Kayaku, with which we entered into a licensing and
collaboration agreement on July 26, 2006. Under the terms
of the agreement, we granted Nippon Kayaku an exclusive license
to develop and market ozarelix for all potential oncological
indications in Japan. In return, we received an upfront payment
upon signature and we are eligible to receive payments upon
achievement of certain development and regulatory milestones, in
addition to low double-digit royalties on potential net sales.
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In relation to perifosine, we have entered into an agreement
with:
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Keryx Biopharmaceuticals, New York, USA: Following its
acquisition of AOI Pharma, Inc., New York, USA in January 2004,
Keryx has taken over the license and co-operation agreement
signed with AOI Pharma, Inc. and will undertake, at its own
cost, all clinical activities necessary to obtain regulatory and
marketing approvals of perifosine for all uses in the U.S.,
Canada and Mexico. The agreement provides, among other things,
availability of data generated by all parties free-of-charge,
milestones and scale-up royalties (from high single to low
double-digit)
on future net sales in the U.S., Canada and Mexico.
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In relation to AEZS-130 (growth hormone secretagogue), we have
entered into an agreement with:
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Ardana Biosciences, Limited, (Ardana) Edinburgh,
United Kingdom: In 2002, Ardana was granted an exclusive
worldwide license to develop and commercialize the growth
hormone secretagogue AEZS-130. Ardana undertakes, at its own
cost, all activities necessary to obtain regulatory and
marketing approvals for the substance. Furthermore, the
agreement provides, among other things, milestone payments as
well as low double-digit royalties on future net worldwide sales
of AEZS-130.
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In relation to
Impavido®
(miltefosine), we have entered into distribution agreements with:
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German Remedies, in India and Bangladesh.
Impavido®
is also partnered with Roche for distribution in Brazil and
Nimrall in Pakistan and Afghanistan. An agreement was signed for
South America ex-Brazil with the company Tecnofarma. An
agreement was signed for Iran with the company B.A. Shiraz and
for Iraq with the company Pioneer Pharmaceuticals. In Germany,
distribution of the registered product will be effected by our
partner Paesel + Lorei. Cooperation with Action Medeor, a German
drug aid organization, ensures availability of
Impavido®
to Non-Governmental Organizations worldwide for public use. More
partnerships are currently under negotiations to ensure an
expeditious registration and marketing of this innovative
product.
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Additional detailed information on our research and
collaboration agreements is available in Note 24 of our
annual audited consolidated financial statements as of and for
the year ended December 31, 2006, as filed with the
Canadian securities regulatory authorities on September 19,
2007 (included as Exhibit 99.2 to our Annual Report on
Form 40-F filed with the SEC on March 23, 2007 and
subsequently amended on September 19, 2007).
We have also entered into a variety of collaborative licensing
agreements with various universities and institutes under which
we are obligated to support some of the research expenses
incurred by the university laboratories and pay royalties on
future sales of the products. In turn, we have retained
exclusive rights for the worldwide exploitation of results
generated during the collaborations.
In particular, we have entered into an agreement with Tulane
University (Tulane), which provides for the payment
by the Company of single-digit royalties on future worldwide net
sales for all indications, except in the BPH indication, where
it provides the payment of low single-digit royalties. Tulane is
also entitled to receive a low double-digit royalty on any lump
sum, periodic or other cash payments received by the Company
from sub-licensees.
We rely on third parties to conduct, supervise and monitor
our clinical trials, and those third parties may not perform
satisfactorily.
We rely on third parties such as CROs, medical institutions and
clinical investigators to enroll qualified patients and conduct,
supervise and monitor our clinical trials. Our reliance on these
third parties for clinical development activities reduces our
control over these activities. Our reliance on these third
parties, however, does not relieve us of our regulatory
responsibilities, including ensuring that our clinical trials
are conducted in accordance with Good Clinical Practice
guidelines and the investigational plan and protocols contained
in an Investigational New Drug application (IND), or comparable
foreign submission. Furthermore, these third parties may also
have relationships with other entities, some of which may be our
competitors. In addition, they may not complete activities on
schedule, or may not conduct our
pre-clinical
studies or clinical trials in accordance with regulatory
requirements or our trial design. If these third parties do not
successfully carry out their contractual duties or meet expected
deadlines, our efforts to obtain regulatory approvals for, and
commercialize, our product candidates may be delayed or
prevented.
In carrying out our operations, we are dependent on a
stable and consistent supply of ingredients and raw
materials.
There can be no assurance that we, our contract manufacturers,
or partners, will be able, in the future, to continue to
purchase products from our current suppliers or any other
supplier on terms similar to current terms or at all. An
17
interruption in the availability of certain raw materials or
ingredients, or significant increases in the prices paid by us
for them, could have a material adverse effect on our business,
financial condition, liquidity and operating results.
We are subject to intense competition for our skilled
personnel, and the loss of key personnel or the inability to
attract additional personnel could impair our ability to conduct
our operations.
We are highly dependent on our management and our clinical,
regulatory and scientific staff, the loss of whose services
might adversely impact our ability to achieve our objectives.
Recruiting and retaining qualified management and clinical,
scientific and regulatory personnel is critical to our success.
Competition for skilled personnel is intense, and our ability to
attract and retain qualified personnel may be affected by such
competition.
All of our senior executives have entered into employment
agreements. These agreements are generally for an indeterminate
period.
Our strategic partners manufacturing capabilities
may not be adequate to effectively commercialize our product
candidates.
Our manufacturing experience to date with respect to our product
candidates consists of producing drug substance for clinical
studies. To be successful, these product candidates have to be
manufactured in commercial quantities in compliance with
regulatory requirements and at acceptable costs. Our strategic
partners current manufacturing facilities have the
capacity to produce projected product requirements for the
foreseeable future, but we will need to increase capacity if
sales continue to grow. Our strategic partners may not be able
to expand capacity or to produce additional product requirements
on favorable terms. Moreover, delays associated with securing
additional manufacturing capacity may reduce our revenues and
adversely affect our business and financial position. There can
be no assurance that we will be able to meet increased demand
over time.
We are subject to the risk of product liability claims,
for which we may not have or be able to obtain adequate
insurance coverage.
The sale and use of our products, in particular our
biopharmaceutical products, involve the risk of product
liability claims and associated adverse publicity. Our risks
relate to human participants in our clinical trials, who may
suffer unintended consequences, as well as products on the
market whereby claims might be made directly by patients,
healthcare providers or pharmaceutical companies or others
selling our products. We manage our liability risks by means of
insurance. We maintain liability insurance covering our
liability for our pre-clinical and clinical studies and for our
pharmaceutical products already marketed. However, we may not
have or be able to obtain or maintain sufficient and affordable
insurance coverage, including coverage for potentially very
significant legal expenses, and without sufficient coverage any
claim brought against us could have a materially adverse effect
on our business, financial condition or results of operations.
Our business involves the use of hazardous materials which
requires us to comply with environmental regulation.
Our discovery and development processes involve the controlled
use of hazardous and radioactive materials. We are subject to
federal, provincial and local laws and regulations governing the
use, manufacture, storage, handling and disposal of such
materials and certain waste products. The risk of accidental
contamination or injury from these materials cannot be
completely eliminated. In the event of such an accident, we
could be held liable for any damages that result, and any such
liability could exceed our resources. We may not be adequately
insured against this type of liability. We may be required to
incur significant costs to comply with environmental laws and
regulations in the future, and our operations, business or
assets may be materially adversely affected by current or future
environmental laws or regulations.
Legislative actions, new accounting pronouncements and
higher insurance costs are likely to impact our future financial
position or results of operations.
Changes in financial accounting standards or implementation of
accounting standards may cause adverse, unexpected revenue or
expense fluctuations and affect our financial position or
results of operations. New pronouncements and varying
interpretations of pronouncements have occurred with greater
frequency and are expected to occur in the future, and we may
make or be required to make changes in our accounting policies
in the future. Compliance with changing regulations of corporate
governance and public disclosure, notably with respect to
internal controls over financial reporting, may result in
additional expenses. Changing laws, regulations and standards
relating to corporate governance
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and public disclosure are creating uncertainty for companies
such as ours, and insurance costs are increasing as a result of
this uncertainty.
We may
incur losses associated with foreign currency
fluctuations.
Our operations are in many instances conducted in currencies
other than the U.S. dollar (principally Euros) and we hold a
significant portion of our cash, cash equivalents and debt in
other currencies (principally Canadian dollars), and
fluctuations in the value of foreign currencies relative to the
Canadian dollar could cause us to incur currency
exchange losses.
We may
not be able to successfully integrate acquired
businesses.
Future acquisitions may not be successfully integrated. The
failure to successfully integrate the personnel and operations
of businesses which we may acquire in the future with ours could
have a material adverse effect on our operations and results.
Risks
Related to the Securities
Our share price may be volatile, and an investment in
Common Shares and/or Warrants could suffer a decline
in value.
Our Common Shares are listed and traded only on the TSX and
NASDAQ. Our valuation and share price since the beginning of
trading after our initial listings, first in Canada and then in
the U.S., have had no meaningful relationship to current or
historical financial results, asset values, book value or many
other criteria based on conventional measures of the value of
shares. The market price of our Securities will fluctuate due to
various factors including:
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clinical and regulatory developments regarding our product
candidates;
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delays in our anticipated development or commercialization
timelines;
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developments regarding current or future third-party
collaborators;
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other announcements by us regarding technological, product
development or other matters;
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arrivals or departures of key personnel;
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government regulatory action affecting our product candidates
and our competitors products in the U.S., Canada and other
countries;
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developments or disputes concerning patent or proprietary rights;
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actual or anticipated fluctuations in our revenues or expenses;
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general market conditions and fluctuations for the emerging
growth and biopharmaceutical market sectors; and
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economic conditions in the U.S., Canada or abroad.
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Our listing on both the TSX and NASDAQ may increase price
volatility due to various factors including: different ability
to buy or sell our Securities; different market conditions in
different capital markets; and different trading volume.
In the past, following periods of large price declines in the
public market price of a companys securities, securities
class action litigation has often been initiated against that
company. Litigation of this type could result in substantial
costs and diversion of managements attention and
resources, which would adversely affect our business. Any
adverse determination in litigation could also subject us to
significant liabilities.
Our largest shareholders have influence over our business
and corporate matters, including those requiring shareholder
approval. This could delay or prevent a change in control. Sales
of Common Shares by such shareholders could have an impact on
the market price of the Securities.
Our largest shareholders have influence over our business and
corporate matters, including those requiring shareholder
approval. This could delay or prevent a change in control. Sales
of Common Shares by such shareholders could have an impact on
the market price of the Securities.
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We do
not intend to pay dividends in the near future.
To date, we have not declared or paid any dividends on our
Common Shares. We currently intend to retain our future
earnings, if any, to finance further research and the expansion
of our business. As a result, the return on an investment in
Securities will, for the foreseeable future, depend upon any
future appreciation in value. There is no guarantee that
Securities will appreciate in value or even maintain the price
at which shareholders have purchased their Securities.
Risks
Related to the Issuance of Securities under this
Prospectus
An
active market may not develop for the Warrants, which may hinder
your ability to liquidate your investment.
Each issuance of the Warrants will be a new issue of securities
with no established trading market, and we do not currently
intend to list them on any securities exchange. A dealer
may intend to make a market in the Warrants after their issuance
pursuant to this Prospectus; however, a dealer may not be
obligated to do so and may discontinue such market-making at any
time. As a result, we cannot assure you that an active trading
market will develop for any series of the Warrants. In addition,
subsequent to their initial issuance, the Warrants may trade at
a discount to their initial offering price, depending upon the
value of the underlying Common Shares, which in turn depends on
our prospects or the prospects for companies in our industry
generally and other factors, including those described herein.
A large number of Common Shares may be issued and
subsequently sold upon the exercise of the Warrants. The sale or
availability for sale of these Securities may depress the price
of our Common Shares.
The number of Common Shares that will be initially issuable upon
the exercise of Warrants will be determined by the particular
terms of each issue of Warrants and will be described in the
relevant Prospectus Supplement. To the extent that purchasers of
Warrants sell Common Shares issued upon the exercise of the
Warrants, the market price of our Common Shares may decrease due
to the additional selling pressure in the market. The risk of
dilution from issuances of Common Shares underlying the Warrants
may cause shareholders to sell their Common Shares, which could
further contribute to any decline in the Common Share price.
The sale of Common Shares issued upon exercise of the
Warrants could encourage short sales by third parties which
could further depress the price of the Common Shares.
Any downward pressure on the price of Common Shares caused by
the sale of Common Shares issued upon the exercise of the
Warrants could encourage short sales by third parties. In a
short sale, a prospective seller borrows Common Shares from a
shareholder or broker and sells the borrowed Common Shares. The
prospective seller hopes that the Common Share price will
decline, at which time the seller can purchase Common Shares at
a lower price for delivery back to the lender. The seller
profits when the Common Share price declines because it is
purchasing Common Shares at a price lower than the sale price of
the borrowed Common Shares. Such sales could place downward
pressure on the price of our Common Shares by increasing the
number of Common Shares being sold, which could further
contribute to any decline in the market price of our Common
Shares.
We cannot predict the actual number of Common Shares that
we will issue upon the exercise of the Warrants. The number
of Common Shares that we will issue under the Warrants may
depend on the market price of our Common Shares.
The actual number of Common Shares that we will issue upon the
exercise of the Warrants is uncertain and will be determined, or
made determinable, by the particular terms of each issue of
Warrants and will be described in the relevant Prospectus
Supplement. The number of Common Shares issuable upon the
exercise of the Warrants may fluctuate based on the market price
of our Common Shares. Holders of Warrants may receive more
Common Shares if our Common Share price declines.
Future
issuances of securities and hedging activities may depress the
trading price of our Common Shares.
Any issuance of equity securities or securities convertible into
or exchangeable for equity securities after the offering of
Securities under this Prospectus, including the issuance of
Common Shares upon the exercise of stock options and upon
exercise of the Warrants, could dilute the interests of our
existing shareholders, and could substantially decrease the
trading price of our Common Shares. We may issue equity
securities in the future for a number of reasons, including to
finance our operations and business strategy, to satisfy our
obligations upon the exercise of options or for other reasons.
Our stock option plan generally permits us to have outstanding,
at any given time, stock options that are exercisable for a
20
maximum number of Common Shares equal to 10% of all then issued
and outstanding Common Shares. As of August 13, 2007,
there were:
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53,179,470 Common Shares issued and outstanding; and
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4,315,092 stock options outstanding.
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In addition, the price of Securities could also be affected by
possible sales of Securities by investors who view other
investment vehicles as more attractive means of equity
participation in us and by hedging or arbitrage trading activity
that may develop involving our Securities. This hedging or
arbitrage could, in turn, affect the trading price of our
Securities.
Unless otherwise specified in a Prospectus Supplement, the net
proceeds resulting from the issue of Securities will be used for
the general corporate purposes of Æterna Zentaris, which
may include development costs of our product pipeline. All
expenses relating to an offering of Securities and any
compensation paid to underwriters, dealers or agents, as the
case may be, will be paid out of our general funds. The amount
of net proceeds to be used for any purpose will be described in
the applicable Prospectus Supplement.
CHANGES
IN LOAN AND CAPITAL STRUCTURE
Since June 30, 2007, there has been no material change in
our loan and capital structure.
DESCRIPTION
OF SHARE CAPITAL
Our authorized share capital structure consists of an unlimited
number of shares of the following classes (all classes are
without nominal or par value):
Common Shares. Each Common Share carries the
right to attend and vote at all meetings of shareholders, except
meetings at which only shareholders of a specified class of
shares are entitled to vote. Holders of Common Shares are
entitled to receive dividends if, as and when declared by the
directors, and to receive the remaining property of the Company
upon any liquidation, dissolution or winding-up of the affairs
of the Company, whether voluntary or involuntary.
Preferred Shares. The First and Second
Preferred Shares are issuable in series with rights and
privileges specific to each class. The holders of Preferred
Shares are generally not entitled to receive notice of or to
attend or vote at meetings of shareholders.
On May 2, 2007, our shareholders approved, ratified and
confirmed our Amended and Restated Shareholder Rights Plan
Agreement dated March 5, 2007. A summary of our Amended and
Restated Shareholder Rights Plan Agreement is included in our
Management Information Circular dated March 9, 2007, which
is incorporated by reference into this Prospectus, and a copy of
the agreement has been filed with the Canadian securities
regulatory authorities on SEDAR at www.sedar.com.
21
Warrants may be offered separately or together with Common
Shares. Each series of Warrants will be issued under a separate
warrant agreement to be entered into between us and one or more
banks or trust companies acting as warrant agent. The applicable
Prospectus Supplement will include details of the warrant
agreements covering the Warrants being offered. The warrant
agent will act solely as our agent and will not assume a
relationship of agency with any holders of Warrant certificates
or beneficial owners of Warrants.
The particular terms of each issue or series of Warrants will be
described in the related Prospectus Supplement. This description
will include, where applicable:
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the designation and aggregate number of Warrants offered;
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the price at which the Warrants will be offered;
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the currency or currency unit in which the Warrants are
denominated;
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the date on which the right to exercise the Warrants will
commence and the date on which the right will expire;
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the number of Common Shares that may be purchased upon exercise
of each Warrant and the price at which and currency or
currencies in which that amount of Common Shares may be
purchased upon exercise of each Warrant;
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if offered in conjunction with the Common Shares, the number of
Warrants that will be offered with each Common Share;
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the date or dates, if any, on or after which the Warrants and
the related Common Shares will be transferable separately;
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the minimum or maximum amount, if any, of Warrants that may be
exercised at any one time;
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whether the Warrants will be subject to redemption or call, and,
if so, the terms of such redemption or call provisions; and
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any other terms, conditions and rights (or limitations on such
rights) of the Warrants.
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We reserve the right to set forth in a Prospectus Supplement
specific terms of the Warrants that are not within the options
and parameters set forth in this Prospectus. In addition, to the
extent that any particular terms of the Warrants described in a
Prospectus Supplement differ from any of the terms described in
this Prospectus, the description of such terms set forth in this
Prospectus shall be deemed to have been superseded by the
description of such differing terms set forth in such Prospectus
Supplement with respect to such Warrants.
CERTAIN
INCOME TAX CONSIDERATIONS
The applicable Prospectus Supplement will describe certain
Canadian federal income tax consequences to an investor of
acquiring any Securities offered thereunder, including, for
investors who are non-residents of Canada, whether the payments
of dividends (or any other amounts) on the Securities, if any,
will be subject to Canadian non-resident withholding tax.
The applicable Prospectus Supplement may also describe certain
U.S. federal income tax consequences of the acquisition,
ownership and disposition of any Securities offered thereunder
by an initial investor who is a U.S. person (within the meaning
of the U.S. Internal Revenue Code), including, to the extent
applicable, any such consequences relating to Securities payable
in a currency other than the U.S. dollar, issued at an original
issue discount for U.S. federal income tax purposes or
containing early redemption provisions or other special items.
22
We may offer and sell the Securities to or through underwriters
or dealers purchasing as principals, and we may also sell the
Securities to one or more purchasers directly or through agents.
Securities may be sold from time to time in one or more
transactions at a fixed price or prices, or at non-fixed prices.
If offered on a non-fixed price basis, the Securities may be
offered at prevailing market prices at the time of sale or at
prices to be negotiated with purchasers. The prices at which the
Securities may be offered may vary as between purchasers and
during the period of distribution. Consequently, any
dealers overall compensation will increase or decrease by
the amount by which the aggregate price paid for the Securities
by the purchasers exceeds or is less than the gross proceeds
paid by the dealers, acting as principals, to us.
If, in connection with the offering of Securities at a fixed
price or prices, the underwriters have made a
bona fide effort to sell all of the Securities at
the initial offering price fixed in the applicable Prospectus
Supplement, the public offering price may be decreased and
thereafter further changed, from time to time, to an amount not
greater than the initial public offering price fixed in such
Prospectus Supplement, in which case the compensation realized
by the underwriters will be decreased by the amount that the
aggregate price paid by purchasers for the Securities is less
than the gross proceeds paid by the underwriters to us.
A Prospectus Supplement will identify each underwriter, dealer
or agent engaged by us, as the case may be, in connection with
the offering and sale of a particular issue of Securities, and
will also set forth the terms of the offering, including the
public offering price (or the manner of determination
thereof if offered on a non-fixed price basis), the proceeds to
us and any compensation payable to the underwriters, dealers or
agents.
Under agreements which may be entered into by
Æterna Zentaris, underwriters, dealers and agents who
participate in the distribution of the Securities may be
entitled to indemnification by us against certain liabilities,
including liabilities arising out of any misrepresentation in
this Prospectus and the documents incorporated by reference
herein, other than liabilities arising out of any
misrepresentation made by underwriters, dealers or agents who
participate in the offering of the Securities.
Each issue of Warrants will be a new issue of securities with no
established trading market. In connection with any offering of
Securities, the underwriters, dealers or agents, as the case may
be, may over-allot or effect transactions which stabilize or
maintain the market price of the Securities of such series or
issue at a level above that which might otherwise prevail in the
open market. Such transactions, if commenced, may be
discontinued at any time. Any underwriters, dealers or agents to
or through whom Securities are sold by us for public offering
and sale may make a market in the Securities, but such
underwriters, dealers or agents will not be obligated to do so
and may discontinue any market making at any time without
notice. No assurance can be given that a trading market in the
Securities of any series or issue will develop or as to the
liquidity of any such trading market for the Securities.
Unless otherwise specified in the Prospectus Supplement relating
to any offering of Securities, certain legal matters relating to
the offering of the Securities will be passed upon for us by
Ogilvy Renault LLP, Montreal, Canada. In addition, certain
legal matters in connection with any offering of Securities will
be passed upon for any underwriters, dealers or agents by
counsel to be designated at the time of the offering by such
underwriters, dealers or agents with respect to matters of
Canadian and U.S. law.
The partners and associates of Ogilvy Renault LLP as a group
beneficially own, directly or indirectly, less than 1% of our
outstanding securities.
Our auditors are PricewaterhouseCoopers LLP, Chartered
Accountants, who have prepared an independent auditors
report dated March 2, 2007, except as to Note 24(g)
and (h), which is as of September 17, 2007, in respect of
our consolidated financial statements with accompanying notes as
at December 31, 2006 and 2005 and for each of the
years in the three-year period ended December 31, 2006.
PricewaterhouseCoopers LLP has advised that they are independent
23
within the meaning of the Rules of Professional Conduct of the
Ordre des comptables agréés du Québec and
the rules and regulations of the SEC.
RECONCILIATION
TO U.S. GAAP
Our audited annual consolidated balance sheets as at
December 31, 2006 and 2005 and our audited annual
consolidated statements of operations, deficit, other capital
and cash flows for each of the years in the three-year period
ended December 31, 2006, including the notes thereto as
filed with the Canadian securities regulatory authorities on
September 19, 2007 (included as Exhibit 99.2 to
our Annual Report on
Form 40-F
filed with the SEC on March 23, 2007 and subsequently
amended on September 19, 2007), and included as
Exhibit 4.2 to the registration statement on
Form F-10
of which this Prospectus forms part, were prepared in accordance
with Canadian GAAP that differ in some respects from U.S. GAAP.
The Company has reconciled its financial results for significant
differences between Canadian GAAP and U.S. GAAP in accordance
with the instructions of Item 18 of SEC
Form 20-F
as set out in Note 24 to the Companys audited annual
consolidated financial statements as at and for the year ended
December 31, 2006.
Our unaudited interim consolidated financial statements for the
six months ended June 30, 2007, including the notes
thereto, incorporated by reference from our
Form 6-K
furnished to the SEC on August 16, 2007, and included as
Exhibit 4.5 to the registration statement on
Form F-10
of which this Prospectus forms part, were prepared in accordance
with Canadian GAAP. Financial statement readers should
understand that there are certain significant differences
between Canadian GAAP and U.S. GAAP. In order to facilitate the
understanding of the differences that would have arisen had
these financial statements been presented in accordance with
U.S. GAAP, refer to Note 24 of our audited annual
consolidated financial statements as of and for the year ended
December 31, 2006. In addition, financial statement readers
should refer to Note 2 to our unaudited interim
consolidated financial statements for the six months ended
June 30, 2007 that describes Canadian GAAP accounting
changes that have been adopted by the Company during that
period. The adoption of these accounting policies by the Company
is not expected to result in any additional significant
differences in 2007 between Canadian GAAP and
U.S. GAAP.
STATUTORY
RIGHTS OF WITHDRAWAL AND RESCISSION
Securities legislation in certain of the provinces of Canada
provides purchasers with the right to withdraw from an agreement
to purchase securities. This right may be exercised within two
business days after receipt or deemed receipt of
a prospectus, the accompanying prospectus supplement
relating to securities purchased by a purchaser and any
amendment. In several of the provinces, securities legislation
further provides a purchaser with remedies for rescission or, in
some jurisdictions, damages if the prospectus, the accompanying
prospectus supplement relating to securities purchased by a
purchaser and any amendment contains a misrepresentation or is
not delivered to the purchaser, provided that such remedies for
rescission or damages are exercised by the purchaser within the
time limit prescribed by the securities legislation of the
purchasers province. The purchaser should refer to any
applicable provisions of the securities legislation of the
purchasers province for the particulars of these rights or
consult with a legal adviser.
24
PART II
INFORMATION NOT REQUIRED TO BE DELIVERED
TO OFFEREES OR PURCHASERS
Indemnification of Directors and Officers
Under Section 124 of the Canada Business Corporations Act, the Registrant may indemnify a
present or former director or officer of the Registrant or another individual who acts or acted at
the Registrants request as a director or officer, or an individual acting in a similar capacity,
of another entity, against all costs, charges and expenses, including an amount paid to settle an
action or satisfy a judgment, reasonably incurred by the individual in respect of any civil,
criminal, administrative, investigative or other proceeding in which the individual is involved
because of that association with the Registrant or other entity. The Registrant may not indemnify
an individual unless the individual (i) acted honestly and in good faith with a view to the best
interests of the Registrant or, as the case may be, to the best interests of the other entity for
which the individual acted as director or officer or in a similar capacity at the Registrants
request, and (ii) in the case of a criminal or administrative action or proceeding that is enforced
by a monetary penalty, had reasonable grounds for believing that his or her conduct was lawful.
Such indemnification may be made in connection with an action by or on behalf of the Registrant or
other entity to procure a judgment in its favor only with court approval. A director or officer is
entitled to indemnification from the Registrant as a matter of right if he or she was not judged by
the Court or other competent authority to have committed any fault or omitted to do anything that
he or she ought to have done and fulfilled the conditions set forth above. The Registrant may
advance moneys to a director, officer or other individual for the costs, charges and expenses of a
proceeding referred to above. The individual shall repay the moneys if he or she does not fulfill
the conditions set forth above to qualify for indemnification.
In accordance with provisions of the Canada Business Corporations Act described above, the
by-laws of the Registrant provide that the Registrant shall indemnify a director or officer of the
Registrant, a former director or officer of the Registrant or a person who acts or acted at the
Registrants request as a director or officer of a body corporate of which the Registrant is or was
a shareholder or creditor, and his heirs and legal representatives, against all costs, losses,
charges and expenses, including an amount paid to settle an action or satisfy a judgment,
reasonably incurred by such person in respect of any civil, criminal or administrative action or
proceeding to which such person is made a party by reason of being or having been a director or
officer of the Registrant or such body corporate, if: (a) the person acted honestly and in good
faith with a view to the best interests of the Registrant and (b) in the case of criminal or
administrative action or proceeding that is enforced by a monetary penalty, the person had
reasonable grounds for believing that their conduct was lawful. The Registrant may indemnify from
time to time any director or other person who has assumed or is about to assume in the normal
course of business any liability for the Registrant or for any corporation controlled by the
Registrant, and to secure such director or other person against any loss by the pledge of all or
part of the movable or immovable property of the Registrant through the creation of a hypothec or
any other real right in all or part of such property or in any other manner.
The by-laws of the Registrant provide that the Registrant may, to the extent permitted by the
Canada Business Corporations Act, purchase and maintain insurance for the benefit of any person
referred to above against any such liability as the board of directors may from time to time
determine.
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 Securities
Act and is therefore unenforceable.
Exhibits
See Exhibit Index beginning on page E-1.
II-1
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking
The Registrant undertakes to make available, in person or by telephone, representatives to
respond to inquiries made by the Commission staff, and to furnish promptly, when requested to do so
by the Commission staff, information relating to the securities registered pursuant to Form F-10 or
to transactions in said securities.
Item 2. Consent to Service of Process
Concurrently with the filing of this Registration Statement on Form F-10, the Registrant is
filing with the Commission a written irrevocable consent and power of attorney on Form F-X.
Any change to the name or address of the agent for service of the Registrant shall be
communicated promptly to the Commission by amendment to Form F-X referencing the file number of
this Registration Statement.
III-1
SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant certifies that it has
reasonable grounds to believe that it meets all of the requirements for filing on Form F-10 and has
duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Quebec, Province of Quebec, Canada,
on September 19, 2007.
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Æterna Zentaris Inc.
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By: |
/s/ David J. Mazzo |
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Name: |
David J. Mazzo |
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Title: |
President and Chief Executive Officer |
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POWER OF ATTORNEY
Each person whose signature appears below hereby constitutes and appoints David J.
Mazzo and Dennis Turpin, any of whom may act without the joinder of the other, the true
and lawful attorney-in-fact and agent of the undersigned, with full power of substitution and
resubstitution, to execute in the name, place and stead of the undersigned, in any and all such
capacities, any and all amendments to this Registration Statement, including post-effective
amendments and supplements thereto, and all instruments necessary or in connection therewith, and
to file the same, with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, and hereby grants to such attorney-in-fact and agent, full
power and authority to do and perform in the name and on behalf of the undersigned each and every
act and thing whatsoever necessary or advisable to be done, as fully and to all intents and
purposes as the undersigned might or could do in person, hereby ratifying and confirming all that
said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be
done by virtue hereof.
This Power of Attorney may be executed in multiple counterparts, each of which shall be deemed
an original, but which taken together shall constitute one instrument.
Pursuant to the requirements of the Securities Act, this Registration Statement has been
signed by the following persons in the capacities indicated below on
September 19, 2007.
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Signature |
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Title |
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/s/ David J. Mazzo
David J. Mazzo |
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Director and President and Chief Executive Officer (Principal Executive Officer) |
/s/ Dennis Turpin
Dennis Turpin |
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Senior Vice President and Chief Financial Officer
(Principal Financial Officer) |
/s/ Mario
Paradis
Mario Paradis |
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Senior Vice President, Administrative and Legal
Affairs, and Corporate Secretary
(Principal Accounting Officer) |
III-2
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Signature |
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Title |
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/s/ Jürgen Ernst
Jürgen Ernst |
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Director and Chairman of the Board |
/s/ Marcel Aubut
Marcel Aubut |
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Director |
/s/ Stormy Byorum
Stormy Byorum |
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Director |
/s/ José P. Dorais
José P. Dorais |
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Director |
/s/ Jürgen Engel
Jürgen Engel |
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Director and Executive Vice President and Chief
Scientific Officer |
/s/ Pierre Laurin
Pierre Laurin |
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Director |
/s/ Gérard Limoges
Gérard Limoges |
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Director |
/s/ Pierre MacDonald
Pierre MacDonald |
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Director |
/s/ Gerald J. Martin
Gerald J. Martin |
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Director |
AUTHORIZED REPRESENTATIVE
Pursuant to the requirements of Section 6(a) of the Securities Act of 1933, the undersigned
has signed this Registration Statement, solely in the capacity of the duly authorized
representative of Æterna Zentaris, Inc. in the United States, on
September 19, 2007.
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Æterna Zentaris, Inc.
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By: |
/s/ David J. Mazzo |
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Name: |
David J. Mazzo |
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Title: |
President and Chief Executive
Officer |
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III-3
EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
4.1
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Annual Information Form of Æterna Zentaris Inc., dated March 23,
2007, for the year ended December 31, 2006 (included as Exhibit
99.1 to Æterna Zentaris Inc.s annual report on Form 40-F filed
with the SEC on March 23, 2007 and subsequently amended on
September 19, 2007) |
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4.2
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Audited consolidated balance sheets of Æterna Zentaris Inc. as at
December 31, 2006 and 2005 and audited consolidated statements of
operations, deficit, other capital and cash flows for each of the
years in the three-year period ended December 31, 2006, together
with the report thereon dated March 2, 2007, except as to
Note 24(g) and (h), which is as of September 17, 2007 of Æterna Zentaris
Inc.s independent auditors PricewaterhouseCoopers LLP as filed
with the Canadian securities regulatory authorities on
September 19, 2007 (included
as Exhibit 99.2 to Æterna Zentaris Inc.s Annual
Report on Form 40-F filed with the SEC on March 23, 2007 and
subsequently amended
on September 19, 2007) |
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4.3
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Managements Discussion and Analysis for the year ended December
31, 2006, dated March 2, 2007 as filed with the Canadian
securities regulatory authorities on
September 19,
2007 (included as Exhibit 99.4 to Æterna
Zentaris Inc.s Annual Report on Form 40-F filed with the SEC on
March 23, 2007 and subsequently amended on September 19, 2007) |
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4.4
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Management Information Circular dated March 9, 2007 in connection
with Æterna Zentaris Inc.s annual meeting of shareholders held on
May 2, 2007 (included as Exhibit 99.5 to Æterna Zentaris Inc.s
annual report on Form 40-F filed with the SEC on March 23,
2007 and subsequently amended on September 19, 2007) |
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4.5
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Unaudited interim consolidated financial statements of Æterna
Zentaris Inc. for the six-month period ended June 30, 2007
(furnished to the SEC on Form 6-K on August 16, 2007) |
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4.6
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Managements Discussion and Analysis of Financial Conditions and
Results of Operations of Æterna Zentaris Inc. for the six-month
period ended June 30, 2007 (furnished to the SEC on Form 6-K on
August 16, 2007) |
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4.7
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Material Change Report of Æterna Zentaris Inc. dated January 8,
2007 announcing that Æterna Zentaris Inc. had effected the
distribution in kind to its shareholders of 11,052,996 subordinate
voting shares in the capital of Atrium Biotechnologies Inc. (which
has been since renamed Atrium Innovations Inc.) (furnished to the
SEC on Form 6-K on January 24, 2007) |
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4.8
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Material Change Report of Æterna Zentaris Inc. dated February 13,
2007 announcing the restatement of its unaudited interim
consolidated financial statements for the third quarter and
nine-month period ended September 30, 2006 (included as Exhibit 1
to a Form 6-K furnished to the SEC on February 14, 2007) |
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4.9
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Material Change Report of Æterna Zentaris Inc. dated March 27,
2007 announcing the appointment of David J. Mazzo Ph.D as its
President and Chief Executive Officer (furnished to the SEC on
Form 6-K on March 28, 2007) |
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5.1
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Consent of PricewaterhouseCoopers LLP, independent auditors |
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5.2
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Consent of Ogilvy Renault LLP (to be filed by subsequent amendment) |
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6.1
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Powers of Attorney (included on the signature page hereto) |
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E-1