Exhibit 99.1
NOTE
PURCHASE AGREEMENT
By and
Among
WORLD
HEART CORPORATION,
WORLD
HEART INC.,
and
ABIOMED, INC.
Dated: December 11,
2007
Table of
Contents
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Page
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ARTICLE I.
DEFINITIONS
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1
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1.1
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Definitions
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1
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ARTICLE II. PURCHASE AND SALE
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8
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2.1
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Initial
Closing
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8
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2.2
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Initial Closing
Deliveries
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8
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2.3
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Second
Closing
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9
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ARTICLE III. REPRESENTATIONS AND
WARRANTIES
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10
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3.1
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Representations and
Warranties of the Company
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10
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3.2
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Representations and
Warranties of the Investor
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20
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ARTICLE IV. OTHER AGREEMENTS OF THE
PARTIES
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22
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4.1
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Transfer
Restrictions
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22
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4.2
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Furnishing of
Information
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24
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4.3
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Board/Observer
Rights
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25
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4.4
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Distribution
Rights
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25
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4.5
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Special Shareholder
Meeting
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26
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4.6
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Acknowledgment of
Dilution
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27
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4.7
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Integration
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27
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4.8
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Reservation of
Shares
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28
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4.9
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Conversion and Exercise
Procedures
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28
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4.10
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Securities Laws
Disclosure; Publicity
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28
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4.11
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Indemnification of
Investor
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28
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4.12
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Listing of
Securities
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28
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4.13
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Issuances of New
Securities
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29
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4.14
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Use of
Proceeds
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29
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4.15
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Payment of Cash
Dividend
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29
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4.16
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Existence; Conduct of
Business
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29
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4.17
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Price
Modification
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29
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4.18
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Pledge of
Securities
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30
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4.19
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Compliance with
Laws
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30
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4.20
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Payment of
Taxes
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30
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4.21
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Monetization
Plan
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30
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ARTICLE V. CONDITIONS PRECEDENT TO INITIAL
CLOSING AND SECOND CLOSING
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30
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5.1
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Conditions Precedent to
the Obligations of the Investor to Purchase the Note
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30
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5.2
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Conditions Precedent to
the Obligations of the Company to sell the Note
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31
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5.3
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Conditions Precedent to
the Obligation of the Investor to Conduct the Second
Closing
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32
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ii
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5.4
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Conditions Precedent to
the Obligation of the Company and WHI to Conduct the Second
Closing
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32
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ARTICLE VI. NEGATIVE COVENANTS OF THE
COMPANY
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32
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6.1
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Subsequent Equity
Issuances
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32
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6.2
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Mergers with Affiliated
Parties
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33
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6.3
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Shareholder
Meeting
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33
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6.4
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Debt
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33
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6.5
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Liens
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33
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6.6
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Amendment of
Organizational Documents
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33
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6.7
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Transactions with
Affiliates
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33
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6.8
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Limitation on
Restrictions
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34
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6.9
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Investments
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34
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6.10
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Asset Sales
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34
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6.11
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Restricted
Payments
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34
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ARTICLE VII. MISCELLANEOUS
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34
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7.1
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Fees and
Expenses
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34
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7.2
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Entire
Agreement
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35
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7.3
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Notices
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35
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7.4
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Amendments; Waivers; No
Additional Consideration
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36
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7.5
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Termination
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36
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7.6
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Construction
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37
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7.7
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Successors and
Assigns
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37
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7.8
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No Third-Party
Beneficiaries
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37
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7.9
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Governing
Law
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37
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7.10
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Survival
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37
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7.11
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Execution
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37
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7.12
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Severability
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37
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7.13
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Replacement of
Securities
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38
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7.14
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Remedies
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38
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7.15
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Payment Set
Aside
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38
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7.16
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Limitation of
Liability
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38
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7.17
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Reincorporation
Plan
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38
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iii
NOTE PURCHASE
AGREEMENT
This Note Purchase Agreement (this “
Agreement ”) is dated as of December 11, 2007, by
and among World Heart Corporation , a Canadian corporation
(the “ Company ”), World Heart Inc., a Delaware
corporation and a wholly owned subsidiary of the Company (“
WHI ”), and ABIOMED, Inc. , a Delaware
corporation (the “ Investor ”).
WHEREAS, subject to the terms and conditions
set forth in this Agreement and pursuant to
Section 4(2) of the Securities Act of 1933, as amended
(the “ Securities Act ”) and Rule 506
promulgated thereunder and Canadian Securities Laws (as defined
below), the Company desires to issue and sell to the Investor and
the Investor desires to purchase from the Company securities of the
Company, as more fully described in this Agreement.
WHEREAS, the Company anticipates that most of
the net proceeds from the sale of the Note hereunder will be used
by WHI for working capital purposes, the Investor has required, as
an inducement and a condition to the Investor entering into this
Agreement, that WHI become a party to this Agreement and
co-borrower under the Note.
WHEREAS, as an inducement and a condition to
the Investor entering into this Agreement, certain shareholders of
the Company representing at least a majority of the Common Stock
issued and outstanding have executed voting agreements, dated as of
the date hereof, pursuant to which each such shareholder has agreed
to vote or consent in writing with respect to shares of Common
Stock owned by such shareholder in favor of the transactions
contemplated by the Transaction Documents (the “ Voting
Agreements ”).
NOW, THEREFORE, IN CONSIDERATION of the mutual
covenants contained in this Agreement, and for other good and
valuable consideration the receipt and adequacy of which are hereby
acknowledged, the Company, WHI and the Investor hereby agree as
follows:
ARTICLE I.
DEFINITIONS
1.1
Definitions
. In
addition to the terms defined elsewhere in this Agreement:
(a) capitalized terms that are not otherwise defined herein
have the meanings given to such terms in the Note (as defined
herein), and (b) the following terms shall have the meanings
indicated in this Section 1.1:
“ Action ” means any action,
suit, inquiry, notice of violation, proceeding (including any
partial proceeding such as a deposition) or investigation pending
or threatened in writing against or affecting the Company, any
Subsidiary or any of their respective properties before or by any
court, arbitrator, governmental or administrative agency,
regulatory authority (federal, state, county, local or foreign),
stock market, stock exchange or trading facility.
“ Affiliate ” means any
Person that, directly or indirectly through one or more
intermediaries, controls or is controlled by or is under common
control with a Person, as such terms are used in and construed
under Rule 144.
“ Benefit Arrangement ”
means at any time an employee benefit plan within the meaning of
Section 3(3) of ERISA which is not a Plan or
“multiemployer plan” (as such term is defined in
Section 3(37) of ERISA) and which is maintained or otherwise
contributed by the Company.
“ Benefit Plan ” has the
meaning set forth in Section 3.1(cc)(ii).
“ Business Day ” means any
day except Saturday, Sunday and any day that is a federal legal
holiday in the United States, Canada or a day on which banking
institutions in the State of New York or the Province of Ontario
are authorized or required by law or other governmental action to
close.
“ Canadian Securities Laws ”
means the Securities Act (Ontario) and all other applicable
Canadian provincial securities laws and the rules, regulations and
published policies made thereunder.
“ Code ” means the Internal
Revenue Code of 1986, as amended.
“ Commission ” means the
Securities and Exchange Commission.
“ Common Stock ” means the
common shares of the Company and any securities into which such
common shares may hereafter be reclassified.
“ Common Stock Equivalents ”
means any securities of the Company or any Subsidiary which entitle
the holder thereof to acquire Common Stock at any time, including
without limitation, any debt, preferred shares, rights, options,
warrants or other instrument that is at any time convertible into
or exchangeable for, or otherwise entitles the holder thereof to
receive, Common Stock or other securities that entitle the holder
to receive, directly or indirectly, Common Stock.
“ Company Deliverables ” has
the meaning set forth in Section 2.2(a)(i).
“ Company Reports ” has the
meaning set forth in Section 3.1(h).
“ Consents from Ethics Committees
” shall mean approvals or opinions from any Ethics Committee
relating to the conduct of any Product clinical trial sponsored by
the Company within the European Union.
“ Debt ” of any Person means
at any date, without duplication, (i) all obligations of such
Person for borrowed money, (ii) all obligations of such Person
evidenced by bonds, debentures, notes, or other similar instruments
issued by such Person, (iii) all obligations of such Person as
lessee which (y) are capitalized in accordance with GAAP or
(z) arise pursuant to sale-leaseback transactions,
(iv) all reimbursement obligations of such Person in respect
of letters of credit or other similar instruments, (v) all
Debt of others secured by a Lien on any asset of such
2
Person, whether or not such Debt is otherwise
an obligation of such Person and (vi) all Debt of others
guaranteed by such Person.
“ Disclosure Materials ” has
the meaning set forth in Section 3.1(h).
“ dollars ” or “
$ ” shall mean lawful money of the United
States.
“ ERISA ” means the Employee
Retirement Income Security Act of 1974, as amended, or any
successor statute.
“ ERISA Group ” means the
Company and each Subsidiary and all members of a controlled group
of corporations and all trades or businesses (whether or not
incorporated) under common control which, together with the Company
or any Subsidiary, are treated as a single employer under the
Code.
“ EU ” means the European
Union.
“ Event of Default ” has the
meaning set forth in the Note.
“ Exchange Act ” means the
Securities Exchange Act of 1934, as amended.
“ FDA ” shall mean the
United States Food and Drug Administration.
“ GAAP ” means U.S.
generally accepted accounting principles, as in effect from time to
time.
“ Governmental Authority ”
shall mean any nation, territory or government, foreign or
domestic, any state, province, local or other political subdivision
thereof, and any bureau, tribunal, board, commission, department,
agency or other entity exercising executive, legislative, judicial,
regulatory or administrative functions of government, including all
taxing authorities and all European notification bodies and all
other entities exercising regulatory authority over medical
products or devices including any Notified Body and Ethics
Committee as defined in any EU medical device
legislation.
“ Initial Closing ” means
the initial closing of the purchase and sale of the Note pursuant
to Article II, and the advancement of $1,000,000 of the
principal amount thereunder.
“ Initial Closing Date ”
means the Business Day immediately following the date on which all
of the conditions set forth in Sections 5.1 and 5.2 hereof are
satisfied, or such other date as the parties may agree.
“ Intellectual Property Rights
” has the meaning set forth in
Section 3.1(p).
“ Investment ” means, with
respect to any Person, directly or indirectly, (a) to own,
purchase or otherwise acquire, in each case whether beneficially or
otherwise, any interest in any security of any other Person (other
than any evidence of any obligation under the Transaction
Documents), (b) to incur, or to remain liable under, any
guaranty obligation for Debt of any other Person, to assume the
Debt of any other Person or to make, hold, purchase or
3
otherwise acquire, in each case directly or
indirectly, any deposit, loan, advance, commitment to lend or
advance or other extension of credit (including by deferring or
extending the date of, in each case outside the ordinary course of
business, the payment of the purchase price for Sales of property
or services to any other Person, to the extent such payment
obligation constitutes Indebtedness of such other Person),
excluding deposits with financial institutions available for
withdrawal on demand, prepaid expenses, accounts receivable and
similar items created in the ordinary course of business and other
than the assumption of any Debt resulting from an acquisition of
intellectual property or other strategic assets, or (c) to
make, directly or indirectly, any contribution to the capital of
any other Person.
“ Investment Amount ” has
the meaning set forth in Section 2.1.
“ Investor Deliverables ”
has the meaning set forth in Section 2.2(b).
“ Investor Party ” has the
meaning set forth in Section 4.11.
“ Lien ” means any lien,
charge, encumbrance, security interest, right of first refusal or
other restrictions of any kind.
“ Losses ” has the meaning
set forth in Section 4.11.
“ Machinery and Equipment ”
means all machinery, equipment, furniture and fixtures (including,
by way of example, all dies, jigs, and tooling), owned, used or
held for use or planned to be used or held for use in connection
with the design, development, manufacture, operation, sale or use
of any Product.
“ Material Adverse Effect ”
means any of (i) a material and adverse effect on the
legality, validity or enforceability of any Transaction Document,
(ii) a material and adverse effect on the results of
operations, assets, business or condition (financial or otherwise)
of the Company and the Subsidiaries, taken as a whole, or
(iii) an adverse impairment to the Company’s ability to
perform on a timely basis its obligations under any Transaction
Document.
“ MDRs ” shall mean medical
device reports of adverse events required to be filed by medical
device manufacturers and user facilities pursuant to Regulatory
Laws of jurisdictions in which human clinical studies have been
conducted (including observational studies) or other clinical use
has occurred.
“ Note ” means the 8%
secured convertible promissory note, in the Form of
Exhibit A , due, subject to the terms therein, on the
two year anniversary of the Initial Closing Date, issued by the
Company and WHI to the Investor hereunder.
“ Outside Date ” means
December 20, 2007.
“ PBGC ” means the Pension
Benefit Guarantee Corporation or any entity succeeding to any or
all of its functions under ERISA.
“ Permitted Indebtedness ”
has the meaning set forth in Section 6.4.
4
“ Permitted Liens ”
means: (a) liens for taxes, assessments or governmental
charges not delinquent or being contested in good faith and by
appropriate proceedings and for which adequate reserves in
accordance with GAAP are maintained on the books of the Company or
the applicable Subsidiary; (b) liens arising out of deposits
in connection with workers’ compensation, unemployment
insurance, old age pensions or other social security or retirement
benefits legislation; (c) deposits or pledges to secure bids,
tenders, contracts (other than contracts for the payment of money),
leases, statutory obligations, surety and appeal bonds, and other
obligations of like nature arising in the ordinary course of
business of the Company or a Subsidiary; (d) liens imposed by
law, such as mechanics’, workers’, materialmens’,
carriers’ or other like liens arising in the ordinary course
of business of the Company or a Subsidiary which secure the payment
of obligations which are not past due or which are being diligently
contested in good faith by appropriate proceedings and for which
adequate reserves in accordance with GAAP are maintained on the
books of the Company or the applicable Subsidiary;
(e) purchase money security interests or liens for the
purchase of fixed assets to be used in the business of the Company
or a Subsidiary, securing solely the fixed assets so purchased and
the proceeds thereof; (f) capitalized leases which do not
violate any provision of this Agreement; (g) liens of
commercial depository institutions, arising in the ordinary course
of business, constituting a statutory or common law right of setoff
against amounts on deposit with such institution; (h) rights
of way, zoning restrictions, easements and similar encumbrances
affecting the Company’s real property which do not materially
interfere with the use of such property; and (i) liens on any
asset existing at the time of acquisition of such asset by the
Company or WHI.
“ Person ” means an
individual or corporation, partnership, trust, incorporated or
unincorporated association, joint venture, limited liability
company, joint stock company, government (or an agency or
subdivision thereof) or other entity of any kind.
“ PIPE ” means a private
placement transaction in which the Company sells up to 12 million
shares of Common Stock (subject to appropriate adjustment in the
event of any stock dividend, stock split, combination or other
similar event with respect to the Common Stock) and may also
include warrants to purchase additional shares of Common Stock
subject to Section 6.1.
“ Plan ” means at any time
an employee pension plan benefit plan which is covered by Title IV
of ERISA or subject to the minimum funding standards under the Code
and either (i) is maintained, or contributed to, by any member
of the ERISA group for employees of any member of the ERISA group
or (ii) has at any time within the preceding five years been
maintained, or contributed to, by any Person which was at such time
a member of the ERISA Group for employees of any Person which was
at such time a member of the ERISA group.
“ Proceeding ” means an
action, claim, suit, investigation or proceeding (including,
without limitation, an investigation or partial proceeding, such as
a deposition), whether commenced or threatened.
“ Products ” shall mean all
items manufactured by or for, sold or distributed by, or under
development by, the Company or any Subsidiary on or before the date
of this Agreement.
“ Purchase Money Financing ”
has the meaning set forth in Section 6.4.
5
“ Registration Rights Agreement
” means the Registration Rights Agreement, dated as of the
Initial Closing Date, by and between the Company and the Investor,
in the form of Exhibit B hereto.
“ Registration Statement ”
means a registration statement meeting the requirements set forth
in the Registration Rights Agreement and covering the resale by the
Investor of the Underlying Shares and Warrant Shares.
“ Regulated Product ” shall
mean any Product or component, including any medical device, that
is required to bear a CE Mark under applicable EU law and related
national legislation respectively or that is required to be cleared
or approved by the FDA, and that is studied, used, held or offered
for sale for human use, including for human research or
investigation or clinical use.
“ Regulatory Law ” shall
mean any statute, regulation or judicial interpretation applicable
to any Regulated Product, including, without limitation:
(i) the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
301 et seq., the Food and Drug Administration Modernization Act of
1997, Stand Alone Provisions, Pub. L. No. 105-115, 111 Stat.
2295 (1997), the Public Health Service Act, 42 U.S.C. § 201 et
seq., all regulations promulgated under such statutes, including 21
C.F.R. § 820; (ii) EU Directives 90/385/EEC of
June 20, 1990 on the Approximation of the Laws of the Member
States Relating to Active Implantable Medical Devices, and
93/42/EEC of June 14, 1993 concerning medical devices, and any
laws, rules or regulations promulgated by any Governmental
Authority of any EU member state in furtherance of these
Directives; and (iii) equivalent statutes and regulations
adopted by other countries, international bodies and jurisdictions
outside the United States and EU, in which the Company has
facilities, does business, or directly or through others, sells or
offers for sale any Regulated Product.
“ Reincorporation Plan ”
means any recapitalization, restructuring, subsidiary spin-off or
other reorganization transaction solely for the purposes of the
Company’s reincorporation in the United States, provided,
that, as a result of such transaction: (a) the shareholders of
and lenders to the Company, including the Investor, and their
respective shareholdings, rights, economic interests and voting
interests in the Company immediately prior to such transaction
shall be substantially equivalent as their respective
shareholdings, rights, economic interests and voting interests in
the corporation surviving such transaction immediately following
such transaction, and (b) the Company shall have taken all
necessary steps to ensure that the Investor’s security
interest and economic and other rights provided for in the
Transaction Documents shall be properly assigned to and enforceable
against the surviving corporation.
“ Required Minimum ” means,
as of any date, the maximum aggregate number of shares of Common
Stock potentially issuable in the future pursuant to the
Transaction Documents, including any Underlying Shares or Warrant
Shares issuable upon conversion or exercise in full of the Note and
the Warrant, ignoring any conversion or exercise limits set forth
therein.
“ Restricted Payment ” means
(a) any dividend, return of capital, distribution or any other
payment or Sale of property for less than fair market value,
whether direct or indirect
6
and
whether in cash, securities or other property, in each case on
account of any stock or stock equivalent of any Borrower, in each
case now or hereafter outstanding, including with respect to a
claim for rescission of a Sale of such stock or stock equivalent,
and (b) any redemption, retirement, termination, defeasance,
cancellation, purchase or other acquisition for value, whether
direct or indirect, of any stock or stock equivalent of either
Borrower, now or hereafter outstanding, and any payment or other
transfer setting aside funds for any such redemption, retirement,
termination, cancellation, purchase or other acquisition, whether
directly or indirectly and whether to a sinking fund, a similar
fund or otherwise.
“ Rule 144 ” means
Rule 144 promulgated by the Commission pursuant to the
Securities Act, as such Rule may be amended from time to time,
or any similar rule or regulation hereafter adopted by the
Commission having substantially the same effect as such
Rule.
“ Sale and Leaseback Transaction
” means, with respect to any Person (the
“obligor”), any contractual obligation or other
arrangement with any other Person (the “counterparty”)
consisting of a lease by such obligor of any property that,
directly or indirectly, has been or is to be Sold by the obligor to
such counterparty or to any other Person to whom funds have been
advanced by such counterparty based on a Lien on, or an assignment
of, such property or any obligations of such obligor under such
lease.
“ Second Closing ” means the
additional closing pursuant to Article II, pursuant to which
the Investor is to advance the remaining $4,000,000 of the
principal amount of the Note.
“ Second Closing Date ”
means January 3, 2008 or such later date as of which all of
the conditions set forth in Sections 5.3 and 5.4 hereof are first
satisfied, or such other date as the parties may agree.
“ Securities ” means the
Note, the Underlying Shares, the Warrant and the Warrant
Shares.
“ Security Agreements ” has
the meaning set forth in Section 2.2(a).
“ Sell ” means, with respect
to any property, to sell, convey, transfer, assign, license, lease
or otherwise dispose of, any interest therein or to permit any
Person to acquire any such interest, including, in each case,
through a Sale and Leaseback Transaction or through a sale,
factoring at maturity, collection of or other disposal, with or
without recourse, of any notes or accounts receivable.
Conjugated forms thereof and the noun “Sale” have
correlative meanings.
“ Subsidiary ” means any
subsidiary of the Company included in the Company
Reports.
“ Support Services Agreement
” has the meaning set forth in
Section 2.2(a).
“ Trading Day ” means
(i) a day on which the Common Stock is traded on a Trading
Market (other than the OTC Bulletin Board), or (ii) if the
Common Stock is not listed on a Trading Market (other than the OTC
Bulletin Board), a day on which the Common Stock is traded in the
over-the-counter market, as reported by the OTC Bulletin Board,
(iii) if the
7
Common Stock is not quoted on any Trading
Market, a day on which the Common Stock is quoted in the
over-the-counter market as reported by the National Quotation
Bureau Incorporated (or any similar organization or agency
succeeding to its functions of reporting prices), or (iv) in
the event that the Common Stock is not listed or quoted as set
forth in (i), (ii) and (iii) hereof, then Trading Day
shall mean a Business Day.
“ Trading Market ” means
whichever one or more of the Toronto Stock Exchange, the New York
Stock Exchange, the American Stock Exchange, the Nasdaq Capital
Market, the Nasdaq Global Market, the Nasdaq Global Select Market
or OTC Bulletin Board on which the Common Stock is listed or quoted
for trading on the date in question.
“ Transaction Documents ”
means this Agreement, the Note, the Registration Rights Agreement,
the Warrant, the Security Agreements, the Support Services
Agreement and any other documents or agreements executed in
connection with the transactions contemplated hereunder.
“ TSX ” means the Toronto
Stock Exchange.
“ Underlying Shares ” means
the shares of Common Stock issuable upon conversion of the Note,
including the conversion of any interest under the Note.
“ Warrant ” means the Common
Stock purchase warrant issued to the Investor pursuant to the
Support Services Agreement.
“ Warrant Shares ” means the
shares of Common Stock issuable upon exercise of the
Warrant.
ARTICLE II.
PURCHASE AND SALE
2.1
Initial Closing . Subject to the terms and conditions set
forth in this Agreement, at the Initial Closing the Company and WHI
shall issue and sell to the Investor, and the Investor shall
purchase from the Company and WHI, the Note having a stated maximum
amount of $5,000,000 (the “ Investment Amount
”). The Initial Closing shall take place at the offices
of Foley Hoag LLP, counsel for the Investor, 155 Seaport Boulevard,
Boston, Massachusetts on the Initial Closing Date or at such other
location or date as the parties may agree.
2.2
Initial Closing Deliveries .
(a)
At or prior to the Initial Closing, the Company shall deliver or
cause to be delivered to the Investor the following (the “
Company Deliverables ”):
(i)
the Note in the aggregate principal amount of the Investment
Amount, registered in the name of the Investor;
(ii)
the legal opinion of McCarthy Tétrault LLP, in the form of
Exhibit C , addressed to the Investor;
8
(iii)
the legal opinion of Howard Rice Nemerovski Canady Falk &
Rabkin, A Professional Corporation, in the form of
Exhibit D , addressed to the Investor;
(iv)
the Registration Rights Agreement, duly executed by the
Company;
(v)
security agreements, duly executed by each of the Company and WHI,
in the forms attached hereto as Exhibit E and
Exhibit F , respectively (as amended, supplemented or
otherwise modified from time to time, the “ Security
Agreements ”);
(vi)
a clinical and marketing support services agreement, duly executed
by the Company, in the form attached hereto as
Exhibit G (as amended, supplemented or otherwise
modified from time to time, the “ Support Services
Agreement ”);
(vii)
appropriate Lien and record search reports as of the most recent
practicable date, showing that there are no liens on the collateral
security granted under the Security Agreements, other than
Permitted Liens;
(viii)
the Voting Agreements, duly executed by each of the Company’s
shareholders listed on Exhibit 2.2(a)(viii) , in the
form attached hereto as Exhibit H ;
(ix)
this Agreement duly executed by the Company and WHI;
and
(x)
any other documents reasonably requested by the
Investor.
(b)
At the Initial Closing, the Investor shall deliver or cause to be
delivered to the Company the following (the “ Investor
Deliverables ”):
(i)
$1,000,000 of its Investment Amount in immediately available funds,
by wire transfer to an account designated in writing by the Company
for such purpose;
(ii)
the Registration Rights Agreement, duly executed by the
Investor;
(iii)
the Security Agreements, duly executed by the Investor;
(iv)
the Support Services Agreement, duly executed by the Investor;
and
(v)
this Agreement, duly executed by the Investor.
2.3
Second Closing . Subject to the terms and conditions set
forth in this Agreement, including the conditions to the Second
Closing set forth in Sections 5.3 and 5.4, at the Second Closing,
the Investor shall deliver or cause to be delivered to the Company
the remaining $4,000,000 of the Investment Amount. The Second
Closing shall take place at the offices of Foley Hoag LLP, counsel
for the Investor, 155 Seaport Boulevard, Boston, Massachusetts on
the Second Closing Date or at such other location or date as the
parties may agree.
9
ARTICLE III.
REPRESENTATIONS AND WARRANTIES
3.1
Representations and Warranties of the Company . The
Company hereby makes the following representations and warranties
to the Investor:
(a)
Subsidiaries . The Company has no direct or indirect
Subsidiaries other than as specified on Schedule 3.1(a)
. Except as disclosed in Schedule 3.1(a) , the Company
owns, directly or indirectly, all of the capital stock of each
Subsidiary free and clear of any and all Liens, and all the issued
and outstanding shares of capital stock of each Subsidiary are
validly issued and are fully paid, non-assessable and free of
preemptive and similar rights.
(b)
Organization and Qualification . The Company and each
Subsidiary are duly incorporated or otherwise organized, validly
existing and in good standing under the laws of the jurisdiction of
its incorporation or organization (as applicable), with the
requisite power and authority to own and use its properties and
assets and to carry on its business as currently conducted.
Neither the Company nor any Subsidiary is in violation of any of
the provisions of its respective certificate or articles of
incorporation, bylaws or other organizational or charter
documents. The Company and each Subsidiary are duly qualified
to conduct its respective businesses and are in good standing as a
foreign corporation or other entity in each jurisdiction in which
the nature of the business conducted or property owned by it makes
such qualification necessary, except where the failure to be so
qualified or in good standing, as the case may be, could not,
individually or in the aggregate, have or reasonably be expected to
result in a Material Adverse Effect.
(c)
Authorization; Enforcement . The Company and WHI have
the requisite corporate power and authority to enter into and to
consummate the transactions contemplated by each of the Transaction
Documents and otherwise to carry out their obligations
thereunder. The execution and delivery of each of the
Transaction Documents by the Company and WHI and the consummation
by them of the transactions contemplated thereby have been duly
authorized by all necessary action on the part of the Company and
WHI and, subject to shareholder approval as required for compliance
with Nasdaq Marketplace Rule 4350(i) and any applicable
rule of the TSX solely for the purpose of removing the
limitations set forth in the Note and Warrant with respect to the
issuance of more than 19.9% of the outstanding shares of the
Company’s Common Stock, no further action is required by the
Company or WHI in connection therewith. Each Transaction
Document has been (or upon delivery will have been) duly executed
by the Company or WHI, as applicable, and, when delivered in
accordance with the terms hereof, will constitute the valid and
binding obligation of the Company and WHI enforceable against the
Company and WHI in accordance with its terms, except as such
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium, liquidation or similar laws relating
to, or affecting generally the enforcement of, creditors’
rights and remedies or by other equitable principles of general
application.
(d)
No Conflicts . Except as disclosed in Schedule
3.1(d) , the execution, delivery and performance of the
Transaction Documents by the Company and WHI and the consummation
by the Company and WHI of the transactions contemplated thereby do
not and will not (i) conflict with or violate any provision of
the Company’s or any Subsidiary’s
certificate
10
or articles of
incorporation, bylaws or other organizational or charter documents,
or (ii) conflict with, or constitute a default (or an event
that with notice or lapse of time or both would become a default)
under, or give to others any rights of termination, amendment,
acceleration or cancellation (with or without notice, lapse of time
or both) of, any agreement, credit facility, debt or other
instrument (evidencing a Company or Subsidiary debt or otherwise)
or other understanding to which the Company or any Subsidiary is a
party or by which any property or asset of the Company or any
Subsidiary is bound or affected, or (iii) result in a
violation of any law, rule, regulation, order, judgment,
injunction, decree or other restriction of any court or
Governmental Authority to which the Company or a Subsidiary is
subject (including federal and state securities laws and
regulations), or by which any property or asset of the Company or a
Subsidiary is bound or affected; except in the case of each of
clauses (ii) and (iii), such as could not, individually or in
the aggregate, have or reasonably be expected to result in a
Material Adverse Effect. Payments of cash on account of
principal of or interest under the Note, upon any Event of Default
under the Note, or as a result of liquidated damages under any
Transaction Document will not require the consent of, any payment
to, or the springing of any Lien in favor of any lender to or
creditor of the Company or any Subsidiary (under a credit facility,
loan agreement or otherwise) and will not result in a default under
any such credit facilities, loans or other agreements.
(e)
Filings, Consents and Approvals . Except as disclosed
in Schedule 3.1(e) , the Company and WHI are not required to
obtain any consent, waiver, authorization or order of, give any
notice to, or make any filing or registration with, any court or
other federal, state, local or other governmental authority or
other Person in connection with the execution, delivery and
performance by the Company and WHI of the Transaction Documents,
other than (i) the filing with the Commission of one or more
Registration Statements in accordance with the requirements of the
Registration Rights Agreement, (ii) filings required by state
securities laws, (iii) the filing of a Notice of Sale of
Securities on Form D with the Commission under Regulation D of
the Securities Act (iv) the filings required in accordance
with Section 4.10, (v) those that have been made or
obtained prior to the date of this Agreement, and (vi) any
filings required in connection with the security interests granted
pursuant to the Security Agreements.
(f)
Issuance of the Securities . The Securities have been
duly authorized and, when issued and paid for in accordance with
the Transaction Documents, will be duly and validly issued, fully
paid and nonassessable, free and clear of all Liens. The
Company has reserved from its duly authorized capital stock a
number of shares of Common Stock issuable upon conversion of the
Note and upon exercise of the Warrant which number of reserved
shares is not less than the Required Minimum calculated as of the
date hereof.
(g)
Capitalization . The number of shares and type of all
authorized, issued and outstanding capital stock of the Company,
and all shares of Common Stock reserved for issuance under the
Company’s various option and incentive plans, is specified in
Schedule 3.1(g) . Except as specified in Schedule
3.1(g) , no securities of the Company are entitled to
preemptive or similar rights, and no Person has any right of first
refusal, preemptive right, right of participation, or any similar
right to participate in the transactions contemplated by the
Transaction Documents. Except as specified in Schedule
3.1(g) , there are no outstanding options, warrants, scrip
rights to subscribe to, calls or commitments of any character
whatsoever relating to, or securities, rights or obligations
convertible into or exchangeable for, or giving any
11
Person any
right to subscribe for or acquire, any shares of Common Stock, or
contracts, commitments, understandings or arrangements by which the
Company or any Subsidiary is or may become bound to issue
additional shares of Common Stock, or securities or rights
convertible or exchangeable into shares of Common Stock. The
issue and sale of the Securities will not, immediately or with the
passage of time, obligate the Company to issue shares of Common
Stock or other securities to any Person (other than the Investor)
and will not result in a right of any holder of Company securities
to adjust the exercise, conversion, exchange or reset price under
such securities. Schedule 3.1(g) sets forth the
name, address, and number of shares of Common Stock held by each
shareholder of the Company holding ten percent or more of the
outstanding shares of Common Stock.
(h)
Company Reports; Financial Statements . The Company
has filed all documents, reports and information required to be
filed by it under the Securities Act, the Exchange Act, including
pursuant to Section 13(a) or 15(d) thereof, Canadian
Securities Laws and with the TSX for the twelve (12) months
preceding the date hereof (or such shorter period as the Company
was required by law to file such reports) (the foregoing materials
being collectively referred to herein as the “ Company
Reports ” and, together with the Schedules to this
Agreement (if any), the “ Disclosure Materials
”) on a timely basis. As of their respective dates, the
Company Reports complied in all material respects with the
requirements of the Securities Act, the Exchange Act and the
rules and regulations of the Commission promulgated
thereunder, and Canadian Securities Laws and none of the Company
Reports, when filed, contained any untrue statement of a material
fact or omitted to state a material fact required to be stated
therein or necessary in order to make the statements therein, in
light of the circumstances under which they were made, not
misleading. The financial statements of the Company included
in the Company Reports comply in all material respects with
applicable accounting requirements, the rules and regulations
of the Commission and Canadian Securities Laws with respect thereto
as in effect at the time of filing. Such financial statements
have been prepared in accordance with GAAP applied on a consistent
basis during the periods involved, except as may be otherwise
specified in such financial statements or the notes thereto, and
fairly present in all material respects the financial position of
the Company and its consolidated Subsidiaries as of and for the
dates thereof and the results of operations and cash flows for the
periods then ended, subject, in the case of unaudited statements,
to normal, immaterial, year-end audit adjustments.
(i)
Material Changes . Except as set forth in Schedule
3.1(i) , since the date of the latest audited financial
statements included within the Company Reports, except as
specifically disclosed in the Company Reports, (i) there has
been no event, occurrence or development that has had or that could
reasonably be expected to result in a Material Adverse Effect,
(ii) the Company has not incurred any liabilities (contingent
or otherwise) other than (A) trade payables, accrued expenses
and other liabilities incurred in the ordinary course of business
consistent with past practice and (B) liabilities not required
to be reflected in the Company’s financial statements
pursuant to GAAP or required to be disclosed in filings made with
the Commission, (iii) the Company has not altered its method
of accounting or the identity of its auditors, (iv) the
Company has not declared or made any dividend or distribution of
cash or other property to its shareholders or purchased, redeemed
or made any agreements to purchase or redeem any shares of its
capital stock, and (v) the Company has not issued any equity
securities to any officer, director or Affiliate, except pursuant
to existing Company stock option plans and
12
other equity
compensation arrangements. The Company does not have pending
before the Commission any request for confidential treatment of
information.
(j)
Litigation . Except as disclosed in Schedule
3.1(j) , to the knowledge of the Company, there is no Action
which (i) adversely affects or challenges the legality,
validity or enforceability of any of the Transaction Documents or
the Securities or (ii) except as specifically disclosed in the
Company Reports, would, if there were an unfavorable decision,
individually or in the aggregate, have or reasonably be expected to
result in a Material Adverse Effect. To the knowledge of the
Company, neither the Company nor any Subsidiary, nor any director
or officer thereof (in his or her capacity as such), is or has been
the subject of any Action involving a claim of violation of or
liability under federal or state securities laws, Canadian
Securities Laws, or a claim of breach of fiduciary duty, except as
specifically disclosed in the Company Reports. There has not
been, and to the knowledge of the Company, there is not pending any
investigation by the Commission involving the Company or any
current or former director or officer of the Company (in his or her
capacity as such). The Commission has not issued any stop
order or other order suspending the effectiveness of any
registration statement filed by the Company or any Subsidiary under
the Exchange Act or the Securities Act.
(k)
Labor Relations . No material labor dispute exists or,
to the knowledge of the Company, is imminent with respect to any of
the employees of the Company or any Subsidiary.
(l)
Compliance . Neither the Company nor any Subsidiary
(i) is in default under or in violation of (and no event has
occurred that has not been waived that, with notice or lapse of
time or both, would result in a default by the Company or any
Subsidiary under), nor has the Company or any Subsidiary received
notice of a claim that it is in default under or that it is in
violation of, any indenture, loan or credit agreement or any other
agreement or instrument to which it is a party or by which it or
any of its properties is bound (whether or not such default or
violation has been waived), (ii) is in violation of any order
of any court, arbitrator or governmental body, or (iii) is or
has been in violation of any statute, rule or regulation of
any governmental authority, including without limitation all
foreign, federal, state and local laws relating to taxes,
environmental protection, occupational health and safety, product
quality and safety and employment and labor matters, except in each
case as could not, individually or in the aggregate, have or
reasonably be expected to result in a Material Adverse
Effect. The Company is in compliance with all effective
requirements of the Sarbanes-Oxley Act of 2002, as amended, and the
rules and regulations thereunder, that are applicable to it,
except where such noncompliance could not have or reasonably be
expected to result in a Material Adverse Effect.
(m)
Regulatory Permits . The Company and the Subsidiaries
possess all certificates, authorizations and permits issued by the
appropriate federal, state, provincial, local or foreign regulatory
authorities necessary to conduct their respective businesses as
described in the Company Reports, except where the failure to
possess such permits could not, individually or in the aggregate,
have or reasonably be expected to result in a Material Adverse
Effect, and neither the Company nor any Subsidiary has received any
notice of proceedings relating to the revocation or modification of
any such permits.
13
(n)
Title to Assets . The Company and the Subsidiaries
have good and marketable title in fee simple to all real property
owned by them that is material to their respective businesses and
good and valid title in all personal property owned by them that is
material to their respective businesses, in each case free and
clear of all Liens, except for Permitted Liens. Any real property
and facilities held under lease by the Company and the Subsidiaries
are held by them under valid, subsisting and enforceable leases of
which the Company and the Subsidiaries are in compliance, except as
could not, individually or in the aggregate, have or reasonably be
expected to result in a Material Adverse Effect.
(o)
Matters Relating to the Assets .
(i)
In the Security Agreements the Company and WHI have disclosed to
the Investor all locations at which the inventory and equipment in
excess of $25,000 (other than inventory and equipment in-transit)
of the Company and Subsidiaries are located, and the
Company’s inventory and equipment that is kept at other
locations (other than inventory or equipment in transit or in the
possession of a third party for repair or service in the ordinary
course of business) does not have a value in the aggregate in
excess of $150,000; and
(ii)
Other than WHI, no other Subsidiaries of the Company own any
material assets.
(p)
Intellectual Property Rights .
(i)
The Company and the Subsidiaries own, or have rights to use, all
patents, patent applications, trademarks, trademark applications,
service marks, trade names, copyrights and other similar rights
that are necessary or material for use in connection with their
respective businesses as described in the Company Reports and which
the failure to so have could, individually or in the aggregate,
have or reasonably be expected to result in a Material Adverse
Effect (collectively, the “ Intellectual Property
Rights ”). Schedule 3.1(p) sets forth,
for the Company’s owned and licensed Intellectual Property
Rights, a complete and accurate list of all United States,
international and foreign patent, copyright, trademark, service
mark, trade dress, and domain name registrations and current
applications, indicating, where applicable, for each applicable
jurisdiction, the registration number (or application number) and
date issued or filed.
(ii)
Neither the Company or any Subsidiary, nor to the knowledge of the
Company, any employee, officer, director or consultant to the
Company or its Subsidiaries, has intentionally misappropriated any
patent, invention, process, method, compound, design, formula or
other proprietary or intellectual property rights of any third
Person. To the knowledge of the Company, the practice of the
Intellectual Property Rights, as practiced by the Company and the
Subsidiaries prior to the Initial Closing, does not infringe or
otherwise violate any proprietary rights of any third Person and
except as set forth in Schedule 3.1(p) , the Company and the
Subsidiaries have not received any written notice alleging any such
infringement prior to the Initial Closing Date. The
consummation of the transactions contemplated by this Agreement and
the Transaction Documents and, to the Company’s knowledge,
the use by the Company and the Subsidiaries immediately after the
Initial Closing of the Intellectual Property Rights will not
infringe or otherwise violate any proprietary rights of
14
any third
Person. To the knowledge of the Company, there are no rights
owned by any third party which would prevent the development,
manufacture, operation, sale or use by the Company or any Affiliate
of the Company of any Product or that would materially impede the
ongoing operation of the business. The Company and the
Subsidiaries have received no written notice from a third Person
that threatens legal proceedings against the Company or a
Subsidiary if the Company or Subsidiary does not execute a license
with such third Person, to use such third Person’s
intellectual property rights that such third Person claims apply to
any Product.
(iii)
The Company and the Subsidiaries have taken all reasonable steps to
protect the confidentiality of all Intellectual Property Rights,
including entering into appropriate forms of confidentiality and
assignment agreements with all employees and consultants having
access to confidential information requiring them not to disclose
such information or to use the same for their own benefit or for
the benefit of any other Person. To the knowledge of the
Company, no Person is in breach of any such Confidentiality and
Assignment Agreement in any respect that could adversely affect the
Intellectual Property Rights or the Company’s rights
therein.
(q)
Accounts Receivable . The Company and WHI have
provided to Investor a true, correct and complete list, including
aging information, of all of the Company’s and WHI’s
accounts receivable as of September 30, 2007.
(r)
Conduct of Business in Compliance with Regulatory
Requirements .
(i)
Compliance . The Company is in compliance with all
applicable Regulatory Laws in each jurisdiction in which the
Company has facilities or does business. Except as set forth
in Schedule 3.1(r) , since January 1, 2005, the Company
has not been required by any Governmental Authority to make, nor
has voluntarily undertaken, any Product recall, nor has the Company
been prevented from carrying out the research and development,
manufacture, clinical testing, production, marketing, advertising,
distribution, use, offer for sale or sale of any Product as a
result of any specific action of, or notification from, any
Governmental Authority, and, to the knowledge of the Company, there
is no action or proceeding threatened by any European Union, United
States (including FDA) or other Governmental Authority or
multinational organization against the Company, other than
regulatory actions and proceedings commenced prior to the date of
this Agreement generally known to the public affecting the medical
device industry generally (and not solely relating to the Company
or its business).
(ii)
No Notices . Except as set forth in Schedule
3.1(r) , since January 1, 2005, the Company has not
received written notice of and, to the knowledge of the Company, is
not subject to, any adverse inspection, finding of deficiency,
finding of non-compliance, compelled or voluntary recall,
investigation, penalty, fine, sanction, assessment, request for
corrective or remedial action, audit, or other compliance or
enforcement action, relating to any Product or to the facilities in
which any Product is manufactured or handled, by any Governmental
Authority.
(iii)
All Necessary Approvals . Except as set forth in
Schedule 3.1(r) , the Company has obtained or, prior to the
Initial Closing, will obtain (unless such condition is waived by
the Investor prior to the Initial Closing) all necessary approvals,
certifications,
15
registrations
and authorizations from, has made or will make all necessary and
appropriate applications and other submissions to, and has prepared
and maintained or will prepare and maintain all records, studies
and other documentation needed to satisfy and demonstrate
compliance with the requirements of all applicable Governmental
Authorities for its current and past business activities and for
the sale of any Product within the European Union and the United
States, including any necessary CE Marking cert
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