AMENDMENT
NO. 1 TO
SCHEDULE
14A
Proxy
Statement Pursuant to Section 14(a) of the Securities
Exchange
Act of 1934
Filed
by
the Registrant [X]
Filed
by
a Party other than the Registrant [ ]
Check
the
appropriate box:
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Preliminary
Proxy Statement
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Confidential,
for Use of the Commission Only (as permitted by Rule
14a-6(e)(2))
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Definitive
Proxy Statement
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Definitive
Additional Materials
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Soliciting
Material Pursuant to Rule 14a-11(c) or Rule
14a-12
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VIOQUEST
PHARMACEUTICALS, INC.
Payment
of Filing Fee (Check the appropriate box):
x
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No
fee required.
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o
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Fee
computed on table below per Exchange Act Rules 14a-6(i)(1) and
0-11.
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1)
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Title
of each class of securities to which transaction applies:
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2)
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Aggregate
number of securities to which transaction applies:
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3)
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Per
unit price or other underlying value of transaction computed pursuant
to
Exchange Act Rule 0-11 (Set forth the amount on which the
filing fee
is calculated and state how it was determined):
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4)
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Proposed
maximum aggregate value of transaction:
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5)
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Total
fee paid:
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o Fee
paid
previously with preliminary materials.
o Check
box
if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2)
and
identify the filing for which the offsetting fee was paid previously. Identify
the previous filing by registration statement number, or the form or schedule
and the date of its filing.
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1)
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Amount
previously paid:
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2)
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Form,
schedule or registration statement no.:
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3)
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Filing
party:
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4)
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Date
filed:
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VIOQUEST
PHARMACEUTICALS, INC.
7
Deer Park Drive, Suite E
Monmouth
Junction, New Jersey 08852
_______________
NOTICE
OF SPECIAL MEETING OF SHAREHOLDERS
To
Be Held On
_______,
2005
_______________
Notice
is
hereby furnished to the shareholders of VioQuest Pharmaceuticals, Inc., a
Minnesota corporation (the “Company”), of a special meeting of shareholders (the
“Meeting”), to be held at __:00 _.m. on __________, 2005, at
__________________________________, to consider and act upon a proposal to
merge
the Company with and into VioQuest Delaware, Inc., a Delaware corporation and
wholly-owned subsidiary of the Company, with VioQuest Delaware, Inc. remaining
as the surviving corporation.
The
Company recently announced that it has entered into an Agreement and Plan of
Merger with Greenwich Therapeutics, Inc., pursuant to which a wholly-owned
subsidiary of the Company would merge into Greenwich and Greenwich would remain
as the surviving corporation and a wholly-owned subsidiary of the Company.
Greenwich is a privately-held, New York-based biotechnology company that holds
exclusive license rights to develop and commercialize two pharmaceutical drug
candidates for use in the treatment of cancer. Dr. Lindsay A. Rosenwald and
certain trusts established for the benefit of Dr. Rosenwald and his family
collectively hold approximately 48 percent
of Greenwich’s capital stock. Together, Dr. Rosenwald and such trusts also
beneficially own approximately 16 percent of the Company’s common stock. Because
of such cross-ownership, the proposed acquisition of Greenwich is prohibited
under the Minnesota Business Corporation Act, to which we are subject as a
Minnesota corporation. However, the same transaction would be permissible if
the
Company were incorporated under the laws of the State of Delaware. The primary
purpose of the proposal to reincorporate the Company under the Delaware law
is
to allow the Company to complete the Company’s proposed acquisition of
Greenwich. Accordingly, the shareholders will be asked to consider and act
upon
the following proposals: (i) to reincorporate the Company under the laws of
the
State of Delaware by merging the Company with and into VioQuest Delaware, Inc.,
a Delaware corporation and the Company’s wholly-owned subsidiary, with VioQuest
Delaware, Inc. remaining as the surviving corporation (the “Reincorporation”);
(ii) to amend the Company’s articles of incorporation to increase the number of
shares of authorized common stock to 100 million and to fix a number of
authorized shares of preferred stock at 10 million (the “Charter Amendment”);
and (iii) if necessary, to adjourn the Meeting to permit further solicitation
of
proxies if there are not sufficient votes to approve the Reincorporation and/or
the Charter Amendment.
The
Board
of Directors of the Company has approved the foregoing proposals and recommends
that the shareholders of the Company vote in their favor.
Only
shareholders of record as of the close of business on August 19, 2005, or their
legal representatives, are entitled to notice and to vote at the Meeting or
any
adjournment thereof. Each shareholder is entitled to one vote per share on
all
matters to be voted on at the Meeting.
A
Proxy
and Proxy Statement are enclosed herewith. You are requested to complete and
sign the Proxy, which is being solicited by the Board of Directors and
management of the Company, and to return it in the envelope
provided.
By
Order
of the Board of Directors,
President
and Chief Executive Officer
August___,
2005
PROXY
STATEMENT
OF
VIOQUEST
PHARMACEUTICALS, INC.
7
Deer Park Drive, Suite E
Monmouth
Junction, New Jersey 08852
For
a Special Meeting of Shareholders
To
Be Held __________, 2005
This
Proxy Statement is furnished to the shareholders of VioQuest Pharmaceuticals,
Inc. (referred to as “we,”“us,”“our” or the “Company”), in connection with the
solicitation by the Board of Directors of the Company of proxies to be voted
at
the special meeting of the Company’s shareholders or any adjournment thereof
(the “Meeting”), to be held at __:00 _.m. on _________, 2005, at
______________________________________. This Proxy Statement and the
accompanying proxy were first mailed on approximately _________, 2005, to the
Company’s shareholders of record as of the close of business on August 19, 2005.
The Company intends to mail this Proxy Statement and the accompanying Notice
of
Special Meeting on or about September ___, 2005 to all shareholders entitled
to
vote at the Meeting.
As
indicated in the accompanying Notice of Special Meeting, the matters to be
considered at the Meeting are proposals: (i) to reincorporate the Company under
the laws of the State of Delaware by merging the Company with and into VioQuest
Delaware, Inc., a Delaware corporation and the Company’s wholly-owned
subsidiary, with VioQuest Delaware, Inc. remaining as the surviving corporation
(the “Reincorporation”); (ii) to amend the Company’s articles of incorporation
to increase the number of shares of authorized common stock and to establish
a
number of authorized shares of preferred stock (the “Charter Amendment”); and
(iii) if necessary, to adjourn the Meeting to permit further solicitation of
proxies if there are not sufficient votes to approve the Reincorporation and/or
the Charter Amendment (the “Adjournment”). The accompanying Proxy authorizes the
appointees named in the Proxy, acting at the request of the management of the
Company, to vote the shares indicated in the Proxy for or against each
of
the proposals and, in their discretion, to vote on other matters incidental
to the Meeting.
A
form of proxy is enclosed for your use. Please date, sign and return the proxy
at your earliest convenience. Prompt return of your proxy will be appreciated.
The solicitation of proxies from the shareholders is being made by the Board
of
Directors and management of the Company who will not be specially compensated
for such solicitation.
TABLE
OF CONTENTS
QUESTIONS
AND ANSWERS ABOUT THE REINCORPORATION, THE CHARTER AMENDMENT,
THE
MERGER AND THE
SPECIAL MEETING
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4
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SUMMARY
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8
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The
Reincorporation Proposal
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8
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The
Charter Amendment Proposal
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9
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Description
of the Merger with Greenwich Therapeutics
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9
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The
Special Meeting
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11
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RISK
FACTORS
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12
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Risks
Relating to the Merger
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12
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Risks
Relating to Greenwich’s Operations
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13
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SHAREHOLDER
PROPOSAL No. 1: REINCORPORATION UNDER DELAWARE LAW
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21
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General
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21
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Reasons
for the Reincorporation - Condition to Completing Merger with
Greenwich
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21
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Other
Reasons for the Reincorporation
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22
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Effect
on VioQuest Stock
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22
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Comparative
Rights of VioQuest Stockholders and VioQuest Delaware
Stockholders
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23
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Abandonment
of Reincorporation Merger
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33
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Required
Vote for the Reincorporation
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33
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Board
Recommendation and Voting Requirements
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33
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Dissenters’
Rights
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33
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Federal
Income Tax Consequences of Reincorporation
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33
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SHAREHOLDER
PROPOSAL No. 2: AMENDMENT TO THE ARTICLES OF INCORPORATION
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35
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Effect
on VioQuest Stock
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35
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Required
Vote for the Charter Amendment
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35
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Board
Recommendation and Voting Requirements
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36
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THE
MERGER
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37
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Background
of Merger
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37
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VioQuest’s
Reasons for the Merger
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38
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The
Merger Agreement
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39
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Interest
of Certain VioQuest Directors in Greenwich
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44
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Management
of Company after the Merger
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44
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Regulatory
Approval
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44
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Material
Federal Income Tax Consequences
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44
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CERTAIN
INFORMATION REGARDING VIOQUEST
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44
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General
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44
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Chiral
Business
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45
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Our
Technology
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46
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Proposed
Drug Development Business
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49
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Market
for Company Common Stock
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49
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INFORMATION
REGARDING GREENWICH THERAPEUTICS
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50
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Overview
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50
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Oncology
Overview
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50
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Greenwich
Therapeutics’ Product Candidates - Sodium Stibogluconate
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54
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Greenwich
Therapeutics’ Product Candidates - Triciribine
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56
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License
Agreements & Intellectual Property
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58
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Legal
Proceedings
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59
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Plan
of Operation
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59
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Information
Concerning Greenwich Stock
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60
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Selected
Historical Financial Data
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60
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Officers
and Directors of Greenwich
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61
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Principal
Stockholders
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62
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CERTAIN
TRANSACTIONS AND RELATIONSHIPS
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64
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SUMMARY
OF DISSENTERS’ RIGHTS
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64
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PRINCIPAL
SHAREHOLDERS
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67
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PRO
FORMA FINANCIAL INFORMATION
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69
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Where
You Can Find More Information; Incorporation by Reference
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76
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INDEX
TO APPENDICES TO PROXY STATEMENT
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78
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Appendix
A: Agreement and Plan of Merger dated July 1, 2005 by and among
VioQuest
Pharmaceuticals, Inc., Greenwich Therapeutics, Inc. and VQ Acquisition
Corp.
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A-1
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Appendix
B: Sections 302A.471 and 302A.473 of the Minnesota Business Corporation
Act.
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B-1
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Appendix
C: Financial Statements of Greenwich Therapeutics, Inc.
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C-1
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Appendix
D: License Agreement dated February 8, 2005 by and between Greenwich
Therapeutics, Inc. and The Cleveland Clinic Foundation.
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D-1
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Appendix
E: License Agreement dated April 19, 2005 by and between Greenwich
Therapeutics,
Inc. and the University of South Florida Research Foundation,
Inc.
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E-1
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Appendix
F: Certificate of Incorporation of VioQuest Delaware, Inc.
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F-1
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QUESTIONS
AND ANSWERS ABOUT THE REINCORPORATION, THE CHARTER
AMENDMENT, THE
ADJOURNMENT, THE MERGER AND
THE
SPECIAL MEETING
Who
is entitled to vote?
The
holders of record of the Company’s common stock as of the close of business on
August 19, 2005 may vote at the Meeting. As of August 19, 2005, there were
17,827,924 shares of our common stock outstanding.
What
are you voting on?
The
matters to be voted upon at the Meeting are: (i) the Reincorporation; (ii)
the
Charter Amendment; and (iii) the Adjournment. The shareholders will not be
directly voting on the proposed Merger with Greenwich Therapeutics, Inc.,
although completion of the Reincorporation is necessary to complete the Merger.
Shareholders will also be voting on such other matters incidental to conducting
the Meeting.
What
is the purpose of the Reincorporation?
The
Reincorporation is being proposed to facilitate the acquisition of Greenwich
Therapeutics pursuant to the Merger Agreement. A copy of the Merger Agreement
without schedules is included in this Proxy Statement as Appendix A. In the
Merger, the stockholders of Greenwich Therapeutics are to receive a number
of
our common shares and warrants to purchase common shares, such that, following
completion of the Merger, they will collectively own approximately 47 percent
of
our outstanding common stock on a fully-diluted basis (i.e., assuming the
issuance of all shares issuable under outstanding options and warrants).
What
is the purpose of the Charter Amendment?
The
Charter Amendment is being proposed to provide the Company with a larger pool
of
authorized capital and, subsequently, greater flexibility to raise additional
capital in the future by selling shares of its stock. Currently, the Company’s
articles of incorporation authorize the issuance of 50,000,000 shares of
undesignated capital stock. The Company currently has outstanding approximately
17,800,000 shares of common stock and options and warrants to acquire an
additional approximately 6,200,000 shares of common stock. In connection with
the Merger, we will be required to issue approximately 17,200,000 shares of
common stock to Greenwich’s stockholders, plus warrants to purchase an
additional 4,000,000 shares. Accordingly, following the Merger we expect to
have
outstanding approximately 35,000,000 shares of common stock and options and
warrants to purchase an additional 10,200,000 common shares. Without the
increased number of authorized shares resulting from the Charter Amendment,
the
Company will have very few additional authorized shares remaining for issuance
and would likely need to seek shareholder approval in the near future.
Will
the Merger proceed if the Reincorporation proposal is
defeated?
Very
unlikely. A vote against the proposed Reincorporation is essentially a vote
against the Merger. Currently, as a Minnesota corporation, we are subject to
the
Minnesota Business Corporation Act, which prohibits us from completing a
“business combination” (as that term is defined under the act) transaction with
Greenwich. If we were a Delaware corporation, however, the proposed transaction
with Greenwich would be permissible. Unless the ownership structure of either
or
both of our company and/or Greenwich changes, the Merger with Greenwich cannot
be completed without the proposed Reincorporation.
Will
the Merger with Greenwich proceed if the Reincorporation is
approved?
Very
likely. The proposed Reincorporation is a condition to completing the Merger.
The Merger Agreement, however, has conditions other than the Reincorporation
of
the Company, which, if not satisfied, may allow either us or Greenwich to
terminate the Merger Agreement. These include conditions requiring
that:
· |
the
warranties and representations of the parties made in the Merger
Agreement
are true as of the time of the
Merger;
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the
Merger be accomplished by October 31,
2005;
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the
Merger qualify as a tax free reorganization; and
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the
Merger is approved by the stockholders of
Greenwich.
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What
will happen if the proposed Reincorporation is approved, but either the Merger
is not completed or the Charter Amendment is not
approved?
If
either
of those were to occur, we would likely still effect the Reincorporation. We
believe reincorporating under Delaware law is advisable even if the Merger
is
not completed or the Charter Amendment is not approved because Delaware is
a
nationally recognized leader in adopting and implementing comprehensive and
flexible corporate laws with a specialized, responsive and efficient judiciary.
Further, reincorporation from Minnesota to Delaware may make it easier to
attract future candidates for our board of directors because many candidates
are
familiar with Delaware corporate law, specifically, provisions relating to
director indemnification.
What
will happen if the Charter Amendment is approved, but the Reincorporation is
not
approved?
If
that
were to occur, we would likely still proceed with the Charter Amendment. The
Company currently has outstanding approximately 17,800,000 shares of common
stock and options and warrants to acquire an additional approximately 6,200,000
shares of common stock. Increasing the authorized number of shares of the
Company from 50,000,000 shares of undesignated capital stock to 100,000,000
shares of common stock and 10,000,000 shares of preferred stock will provide
us
with greater flexibility for additional fundraising activities in the future.
Do
you have statutory rights of appraisal if you oppose the
Reincorporation?
Yes.
Under Minnesota law, a shareholder asked to approve a merger of that
shareholder’s corporation has the right to dissent from the transaction and
receive the fair value of his or her shares in cash. Since the proposed
Reincorporation involves merging the Company into a Delaware corporation, you
are entitled to receive the fair value of shares under Minnesota
law.
How
does the Board recommend you vote on the proposals?
The
Board
recommends you vote your shares FOR
the
proposed Reincorporation, Charter Amendment and Adjournment.
Who
will be soliciting your vote?
The
Board
of Directors is soliciting your vote by mail through this Proxy Statement.
Your
vote may also be solicited in person or by telephone by officers of the Company.
Brokers, nominees, fiduciaries and other custodians will be requested to forward
soliciting materials to beneficial owners of our common stock, and will be
reimbursed for their expenses in connection with that activity. The cost of
all
of this solicitation is being paid for by the Company.
How
can I vote?
If
you
hold your shares as a shareholder of record, you can vote in person at the
Meeting or you can vote by completing and mailing the form of proxy provided
to
you. You are a “shareholder of record” if you hold your shares directly in your
own name. If you hold your shares indirectly in the name of a bank, broker
or
other nominee, you are a “street name shareholder.” If you are a street name
shareholder, you will receive instructions from your bank, broker or other
nominee describing how to vote your shares.
How
do I vote by mail?
You
can
vote by mail by following the instructions on the accompanying form of proxy,
signing the proxy and mailing it to the address noted on the form of proxy
or by
using the accompanying envelope provided for that purpose. The individuals
named
as proxies on the form of proxy will vote your shares in accordance with your
instructions. If you sign and submit your proxy without giving instructions,
the
proxies named on the form of proxy will vote your shares as recommended by
the
Board of Directors.
How
can you revoke your proxy after mailing it?
If
you
are a shareholder of record, you can revoke your proxy by:
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Submitting
a new form of proxy with a later date on it;
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· |
Giving
written notice before the Meeting to the Company’s Secretary, at 7 Deer
Park Drive, Suite E, Monmouth Junction, New Jersey 08852, stating
that you
are revoking your proxy; or
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· |
Attending
the Meeting and voting your shares in person.
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Merely
attending the Meeting without voting will not revoke your proxy. If you are
a
street name shareholder, you may revoke your proxy only as instructed by the
bank, broker or other nominee holding your shares.
How
do I sign the proxy?
Sign
your
name exactly as it appears on the form of proxy. If you are signing in a
representative capacity (for example, as a guardian, trustee, executor,
administrator, attorney-in-fact or the officer or agent of a company), include
your name and title or capacity. If the shares are held in custody (for example,
under the Uniform Transfer to Minors Act), the custodian should sign, not the
minor or other beneficiary. If the shares are held in joint ownership, both
owners must sign.
What
does it mean if you receive more than one proxy or voting instruction
form?
It
means
your shares are registered differently or are in more than one account. Please
complete, sign and return all proxy forms you receive to ensure all your shares
are voted.
What
constitutes a quorum?
A
quorum
of shareholders is necessary to hold a valid meeting of our shareholders. A
majority of the outstanding shares, present in person or represented by proxy,
constitutes a quorum for the Meeting. Shareholders who send in their proxy
but
abstain from voting and broker non-votes are counted as present for establishing
a quorum.
How
many votes are needed for approval of the Reincorporation, the Charter Amendment
and the Adjournment?
The
Reincorporation requires the affirmative vote of at least a majority of the
issued and outstanding shares of the Company. Each of the Charter Amendment
and
the Adjournment requires the affirmative vote of a majority of the shares
represented at the Meeting. Abstentions and broker non-votes are counted as
shares present at the Meeting. Accordingly, an abstention from voting on any
proposal or a broker non-vote is the same as a vote against that
proposal.
What
is a broker non-vote?
A
broker
non-vote occurs when a broker submits a proxy form that does not indicate a
vote
for some of the proposals because the broker did not receive instructions from
the beneficial owner on how to vote on those proposals and does not have
discretionary authority to vote in the absence of instructions.
How
can I attend the Meeting?
If
you
are a shareholder of record on August 19, 2005, you can attend the Meeting
by
presenting acceptable identification at the Meeting. If you are a street name
shareholder you may attend the Meeting by presenting acceptable identification
along with evidence of your beneficial ownership of the Company’s common stock.
As a street name shareholder, however, you will not be able to vote your shares
unless the organizations through which you hold your shares provide proxies
giving you authority to vote the shares held for you. This may require more
than
one proxy, as the record owner of your shares is usually not the organization
providing you the account in which your shares are held.
SUMMARY
This
summary highlights selected information from this proxy statement. It does
not
contain all of the information that is important to you. We urge you to read
carefully the entire proxy statement, including the appendices to this proxy
statement, to understand fully the proposed Reincorporation and Charter
Amendment and proposed acquisition of Greenwich. A copy of the
Agreement and Plan of Merger dated July 1, 2005 by and among VioQuest, Greenwich
and VQ Acquisition Corp. is attached as Appendix A to this proxy statement.
The
Reincorporation Proposal
Our
management has called the Meeting, and is asking our shareholders to approve
a
proposal to reincorporate VioQuest under the laws of the State of Delaware
(the
“Reincorporation”). The Reincorporation is being proposed to facilitate our
proposed acquisition of Greenwich Therapeutics, Inc. (“Greenwich”). On July 1,
2005, we entered into an Agreement and Plan of Merger with Greenwich (the
“Merger Agreement”) pursuant to which Greenwich will merge with and into our
wholly-owned subsidiary, VQ Acquisition Corp., a Delaware corporation, with
Greenwich remaining as the surviving corporation and a wholly-owned subsidiary
of the Company (the “Merger”). The business of Greenwich and the terms of the
Merger are discussed elsewhere in this proxy statement. Dr. Lindsay A. Rosenwald
and certain trusts established for the benefit of Dr. Rosenwald (collectively,
the “Rosenwald Trusts”) collectively own approximately 48 percent of the
outstanding stock of Greenwich and approximately 16 percent of our outstanding
common stock. The Minnesota Business Corporation Act (the “MBCA”), to which the
Company is currently subject as a Minnesota corporation, prohibits a business
combination transaction between the Company and Dr. Rosenwald, including an
entity of which Dr. Rosenwald owns at least 10 percent of its outstanding stock.
The General Corporation Law of Delaware (the “DGCL”), which governs Delaware
corporations, would not prohibit the proposed Merger with Greenwich.
Accordingly, the Company can complete the proposed Merger by reincorporating
under Delaware law prior to completion of the transaction.
The
Reincorporation would be effected by merging VioQuest with and into VioQuest
Delaware, Inc.,
a
wholly-owned subsidiary of VioQuest formed for the specific purpose of the
Reincorporation. The outstanding shares of VioQuest’s common stock and each
outstanding option and warrant to purchase VioQuest common stock would convert
into the same number of shares of VioQuest Delaware’s common stock and the right
to purchase the same number of shares of VioQuest Delaware common stock,
respectively. VioQuest Delaware would remain as the surviving corporation in
this merger and the separate existence of VioQuest would cease. The name of
VioQuest Delaware will be changed to “VioQuest Pharmaceuticals,
Inc.”
If
a
sufficient number of our shareholders do not approve the Reincorporation, the
Merger cannot occur as currently structured. Accordingly, voting on the
Reincorporation has the practical effect of voting on the Merger
itself.
Right
to Dissent.
Under
Minnesota law, VioQuest shareholders have the right to dissent from the proposed
Reincorporation and obtain payment for the fair value of their shares of
VioQuest common stock. A full disclosure of these dissenters’ rights is included
on pages 63 to 65 and the provisions of the MBCA relating to dissenters’
rights is attached as Appendix
B
to this
proxy statement.
The
Charter Amendment Proposal
We
are
also asking our shareholders to approve a proposal to amend the articles of
incorporation to increase the authorized number of shares from 50,000,000
undesignated shares of capital stock to 100,000,000 shares of common stock
and
10,000,000 shares of undesignated preferred stock.
Description
of the Merger with Greenwich Therapeutics
Terms
of the Merger
General.
On July
1, 2005, we entered into the Merger Agreement pursuant to which Greenwich will
merge with and into our wholly-owned subsidiary, VQ Acquisition Corp., a
Delaware corporation, with Greenwich remaining as the surviving corporation
and
a wholly-owned subsidiary of the Company. The Merger will become effective
upon
the filing of a certificate of merger with the Secretary of State of Delaware.
Assuming all conditions to the Merger are met or waived by the appropriate
party
or parties, it is anticipated that the Merger will be completed within one
week
after the date of the Special Meeting.
Information
Regarding Greenwich.
Greenwich is a Delaware corporation formed on October 28, 2004 which has focused
primarily on acquiring the rights to develop and commercialize pharmaceutical
drug candidates, particularly candidates for usse in oncology. Greenwich
currently has the exclusive rights to develop and commercialize two oncology
drug candidates - Sodium Stibogluconate, or “SSG,” and Triciribine, or “TCN.”
Greenwich borrowed from Paramount BioCapital, Inc., a New York-based merchant
and investment bank and venture capital firm that focuses on biotechnology
companies, and which is owned and controlled by Lindsay A. Rosenwald, M.D.,
substantially all of the funds necessary to conduct operations and to acquire
the licenses for SSG and TCN. Most of this indebtedness will be repaid to
Paramount BioCapital from the proceeds of proposed or future VioQuest financing
transactions. As a result, Greenwich stockholders will acquire their controlling
interest in VioQuest for nominal consideration.
Conversion
of Greenwich Shares.
As
consideration for their shares of Greenwich common stock, the stockholders
of
Greenwich are entitled to receive a number of shares of VioQuest common stock
(the “Merger Shares”) such that immediately following the Merger they will own
approximately 49 percent of VioQuest’s issued and outstanding common stock.
Accordingly, assuming VioQuest will have 17,827,924 shares of its common stock
issued and outstanding immediately prior to the Merger, the Greenwich
stockholders will be entitled to receive an aggregate of approximately
17,128,790 shares of VioQuest common stock. The last closing sale price of
VioQuest’s common stock prior to the execution of the Merger Agreement, as
quoted on the OTC Bulletin Board, was $0.70 per share. Based on such price,
the
aggregate value of the Merger Shares issuable to the Greenwich stockholders
would be approximately $12 million. In addition to the Merger Shares, the
Greenwich stockholders are also entitled to receive 5-year warrants to purchase
an aggregate of 4,000,000 shares of VioQuest common stock at a price of $1.41
per share (the “Merger Warrants”). One-half of the total number of Merger Shares
and Merger Warrants will be deposited into an escrow account and released upon
the achievement of milestones relating to the development of Greenwich’s product
candidates, as discussed below. See “—Escrow of Merger Shares and
Warrants.”
Escrow
of Merger Shares and Warrants.
One-half
of the Merger Shares and the Merger Warrants will be deposited with an escrow
agent pursuant to an escrow agreement to be entered into among VioQuest,
Greenwich and a representative appointed by the stockholders of Greenwich.
The
Merger Shares and the Merger Warrants subject to the escrow agreement will
be
outstanding at the closing of the Merger. As such, the Greenwich stockholders
will hold approximately 49 percent of the issued and outstanding shares of
VioQuest common stock upon the closing of the Merger and will be entitled to
vote the Merger Shares and otherwise have all rights of a stockholder with
respect to such shares, subject to restrictions on transfer. The escrowed
securities will be released, if ever, upon the completion of the following
milestones relating to the clinical development of Greenwich’s two product
candidates:
· |
35
percent upon the conclusion of a Phase I clinical trial for Sodium
Stibogluconate;
|
· |
15
percent upon
conclusion of a Phase II clinical trial for Sodium
Stibogluconate;
|
· |
35
percent upon the conclusion of a Phase I clinical trial for Triciribine
under a corporate-sponsored investigational new drug application
accepted
by the FDA; and
|
· |
15
percent upon
conclusion of a Phase II clinical trial for Triciribine.
|
See
“The
Merger - The Merger Agreement - Escrow of Merger Consideration.”
If
the
milestones are not achieved on or before June 30, 2008, then the escrow shall
terminate and all of the Merger Shares and Merger Warrants remaining in the
escrow will be returned to VioQuest for cancellation.
Registration
Rights; Lock-Up Agreement.
The
Merger Shares and Merger Warrants are being issued to Greenwich’s stockholders
in reliance upon certain exemptions from the registration requirements of the
Securities Act of 1933, as amended. VioQuest will grant to the Greenwich
stockholders “piggy-back” registration rights. This means that VioQuest will
register the resale of the Merger Shares and the shares issuable upon exercise
of the Merger Warrants in the next registration statement filed by VioQuest
under the Securities Act. Under the terms of the Merger Agreement, however,
the
Greenwich stockholders will be required to enter into a lockup agreement
providing that they will not sell or transfer (subject to certain exceptions)
the Merger Shares or shares issuable upon exercise of the Merger Warrants for
a
period of one year following the effective date of the Merger.
Voting
Agreements.
Approval
of the Merger Agreement requires the affirmative vote of the holders of a
majority of Greenwich’s outstanding common stock. Pursuant to the terms of the
Merger Agreement, however, Lester E. Lipschutz, as the trustee of the Rosenwald
Trusts, J. Jay Lobell, the President of Greenwich, and Dr. Rosenwald have
entered into a voting agreement with VioQuest. The voting agreements impose
on
the Greenwich stockholders an obligation to vote in favor of the Merger in
connection with any stockholder action taken by Greenwich in connection with
the
Merger and grant an irrevocable proxy to vote the stockholders’ shares in such a
manner.
Conditions
to the Merger.
The
obligations of the parties to complete the Merger are subject to the
satisfaction of certain conditions, including without limitation:
· |
the
accuracy of each party’s representations and warranties contained in the
Merger Agreement;
|
· |
the
absence of any material adverse change in the financial condition
of the
parties;
|
· |
the
receipt by VioQuest of a fairness opinion from its financial advisor
to
the effect that the transaction is fair to VioQuest from a financial
point
of view;
|
· |
approval
of the Merger by the holders of a majority of Greenwich’s outstanding
common stock and approval of the proposed Reincorporation by VioQuest’s
shareholders;
|
· |
VioQuest’s
completion of a financing transaction which generates $5,000,000
in
proceeds (see “The Merger - The Merger Agreement - Closing Conditions”);
and
|
· |
the
receipt by Greenwich of an opinion of its counsel that the Merger
will
qualify as a tax-free reorganization under Section 368(a) of the
Internal
Revenue Code.
|
Market
Price Data
No
established trading market exists for Greenwich common stock. VioQuest’s common
stock trades on the OTC Bulletin Board® under the symbol “VQPH.” The closing
price per share of VioQuest common stock, as reported on the OTC Bulletin Board®
on July 1, 2005, the last full trading day prior to the execution of the Merger
Agreement was $0.70.
The
Special Meeting
Record
Date; Voting Power
You
are
entitled to vote at the Special Meeting if you owned shares of VioQuest common
stock as of the close of business on August 19, 2005, the record date for the
Special Meeting. On that date, there were 17,827,924 shares of VioQuest common
stock issued and outstanding. VioQuest has no other shares of voting stock
outstanding. Each VioQuest shareholder will have one vote for each share of
VioQuest common stock owned at the record date.
Meeting
Quorum; Votes Required
Under
the
Minnesota Business Corporation Act and VioQuest’s bylaws, a majority of the
shares of common stock outstanding on the record date must be present in person
or represented by proxy to establish a quorum for transaction of business at
the
Special Meeting. The affirmative vote of a majority of the outstanding shares
of
VioQuest common stock is required to approve the Reincorporation. The
affirmative vote of a majority of the shares represented at the Meeting is
required to approve the Charter Amendment. Accordingly, based on the number
of
shares outstanding as of the record date, in order for the Reincorporation
to be
approved, the Reincorporation must receive the affirmative vote of at least
8,913,963 shares. In order for each of the Charter Amendment to be approved,
each must receive the affirmative vote of at least 4,456,982
shares.
Risk
Factors
In
considering whether to approve and adopt the the Reincorporation and the Charter
Amendment, you should carefully review and consider the information contained
below under the caption “Risk Factors.”
RISK
FACTORS
Information
or statements provided by VioQuest from time to time, including statements
contained in this proxy statement, may contain certain "forward-looking
statements," including comments regarding anticipated future operations, market
opportunities, operating results and financial performance of VioQuest.
VioQuest’s future operating performance and share price are influenced by many
factors, including factors which may be treated in forward-looking statements.
You are cautioned that any forward-looking statements made in this proxy
statement or in any other reports, filings, press releases, speeches or other
comments, are not a guarantee of future performance. Any such forward-looking
statements are subject to risks and uncertainties that may cause actual results
to differ materially from those which may be projected on the basis of such
forward-looking statements. Furthermore, VioQuest assumes no obligation to
update such forward-looking statements, except as otherwise required by law.
Among the risks and uncertainties which may affect future performance are those
described below. In deciding to approve the proposed Reincorporation, you are
urged to consider the following risk factors:
Risks
Relating to the Merger
We
may not realize the anticipated benefits of the
Merger.
Although
our Board of Directors believes that the Merger is in the best interests of
our
company and our shareholders, Greenwich is a very early-stage company with
no
operating history on which to evaluate its business and prospects. Greenwich
was
formed in October, 2004 and only acquired the licenses to its two product
candidates in February 2005 and April 2005, respectively. We are proposing
to
acquire Greenwich because it has rights to develop and commercialize two
oncology drug candidates, both of which are in the early stages of development.
The Cleveland Clinic Foundation, from which Greenwich licenses its rights,
has
commenced a Phase I clinical trial for sodium stibogluconate, or SSG, pursuant
to its own Investigational New Drug Application, or “IND.” Greenwich is in the
process of finalizing the protocol for an initial Phase I clinical trial for
triciribine, or TCN, which
Greenwich licenses from the University of South Florida Research Foundation,
Inc. The drug development business is very risky and there is no assurance
either of these drug candidates will ever be successfully developed.
Accordingly, there can be no assurance that, following the Merger, we will
be
successful in developing Greenwich’s product candidates or that the Merger will
enhance the Company’s profitability or otherwise benefit its stockholders,
including the former stockholders of Greenwich who receive shares of the
Company’s common stock in the Merger. In the event that the benefits of the
Merger fail to materialize, the market price of the Company’s common stock may
be materially adversely affected.
The
Merger will significantly dilute your percentage ownership in the
Company.
If
the
Merger is completed, we will issue to the stockholders of Greenwich a number
of
shares of our common stock, including warrants to purchase additional shares
of
our common stock, that will represent up to approximately 47 percent of our
outstanding common shares on a fully-diluted basis, including the Merger Shares
and Warrants to be deposited into escrow at the closing of the Merger.
Accordingly, the Merger will result in substantial dilution to your current
ownership and voting interests in our company.
The
Merger will result in a significant dilution in the book value of your
shares.
As
of
June 30, 2005, we had a net tangible book value of $919,000 or approximately
$0.05 per share. As of that date, Greenwich’s liabilities exceeded its tangible
assets by $795,000. If the Merger were to have occurred on June 30, 2005 and
all
shares and warrants subject to escrow were issued to the Greenwich stockholders,
it would have resulted in a dilution, on a per share net tangible book value
basis, to our current shareholders of approximately $0.05 per
share.
Following
the Merger, a small group of persons will be able to exert significant control
over our company, including with respect to the election of
directors.
Following
the Merger, our current officers and directors will beneficially own or control
approximately 17.7% of our issued and outstanding common stock. Individually
and
in the aggregate, these persons will have significant influence over the
management of our business, the election of directors and all matters requiring
shareholder approval. In particular, this concentration of ownership may have
the effect of facilitating, delaying, deferring or preventing a potential
acquisition of the Company and may adversely affect the market price of our
common stock. Following the Merger, Dr. Lindsay A. Rosenwald will beneficially
own 8.1% of our outstanding common stock, and several trusts for the benefit
of
Dr. Rosenwald and his family will beneficially own 28.9% of our outstanding
common stock. Dr. Rosenwald does not have the legal authority to exercise voting
power or investment discretion over the shares held by those trusts; however,
as
a result of the foregoing, Dr. Rosenwald may have the ability to exert
significant influence over our Company.
In
connection with the Merger, Greenwich stockholders will be acquire a significant
interest in our company for nominal consideration and license agreements for
unproven and undeveloped drug candidates.
Greenwich
stockholders borrowed from Paramount BioCapital, Inc., a New York-based merchant
and investment bank and venture capital firm that focuses on biotechnology
companies, Lindsay A. Rosenwald, M.D., and their affiliates substantially all
of
the funds necessary to conduct operations and to acquire the licenses held
by
Greenwich to the two drug candidates from The Cleveland Clinic Foundation and
the University of South Florida Research Foundation, Inc. Most of this
indebtedness will be repaid to Paramount BioCapital, Dr. Rosenwald and their
affiliates from the proceeds of VioQuest private placements. Greenwich
stockholders will therefore acquire their controlling interest in VioQuest
for
nominal consideration, including license agreements for uproven and undeveloped
drug candidates.
A
fairness opinion will not be delivered until the close of the
Merger.
A
fairness opinion will not be delivered until closing pursuant to the terms
of
the Merger Agreement. As such, you will not have the benefit of reviewing the
fairness opinion in determining your vote with respect to the Reincorporation.
The board of directors, however, will have received the fairness opinion prior
to the close of the Merger and will have the benefit of its contents to assess
the fairness of the Merger and to determine whether to proceed with closing
the
Merger.
Risks
Relating to Greenwich’s Operations
Greenwich
has no meaningful operating history on which to evaluate its business or
prospects.
Greenwich
was formed on October 28, 2004 and only acquired the licenses to its two product
candidates in February 2005 and April 2005, respectively. Greenwich has only
a
limited operating history on which you can base an evaluation of its business
and prospects. Accordingly, its business prospects must be considered in the
light of the risks, uncertainties, expenses and difficulties frequently
encountered by companies in their early stages of development, particularly
companies in new and rapidly evolving markets, such as the fine chemical,
pharmaceutical and biotechnology markets.
Greenwich’s
management anticipates experiencing a significant negative cash flow for the
foreseeable future and may never become profitable.
Because
drug development takes several years and is extremely expensive, Greenwich
expects that it will incur substantial losses and negative operating cash flow
for the foreseeable future, and may never achieve or maintain profitability,
even if it succeeds in acquiring, developing and commercializing one or more
drug candidates. Greenwich expects to incur significant operating and capital
expenditures and anticipates that its expenses will increase substantially
in
the foreseeable future as it:
· |
undertakes
pre-clinical development and clinical trials for its drug
candidates;
|
· |
seeks
regulatory approvals for its drug
candidates;
|
· |
implements
additional internal systems and
infrastructure;
|
· |
leases
additional or alternative office facilities;
and
|
· |
hires
additional personnel.
|
Greenwich’s
drug development business may not be able to generate revenue or achieve
profitability. Greenwich’s failure to achieve or maintain profitability could
negatively impact the value of our Common Stock.
Following
the Merger, we will require substantial additional financing in order to fund
the development of Greenwich’s products. Such financing may not be available on
acceptable terms, or even at all.
We
will
require substantial additional capital, both in the near future and long term,
in order to fund the development of Greenwich’s product candidates. Greenwich’s
combined capital requirements will depend on numerous factors, including costs
for clinical trials; the extent of regulatory approval processes; the purchase
of capital equipment to build its infrastructure; fluctuating real estate
markets; the costs associated with hiring necessary personnel; and the cost
of
defending and enforcing patent claims and other intellectual property rights
and
the outcome of any potentially related litigation or other dispute. We cannot
be
sure that we will be able to obtain the necessary financing at the times when
we
need it and on acceptable terms. If we do not have sufficient capital available
to us to fund development of these product candidates, we may be forced to
slow
down or cease all together our development efforts, which will significantly
reduce the value of Greenwich’s product candidates to our company.
Greenwich’s
success depends upon license agreements.
Greenwich
does not directly own the rights to its product candidates, but rather has
exclusive world-wide rights to develop, manufacture, use, commercialize, lease,
sell and/or sublicense the product candidates pursuant to license agreements
with The Cleveland Clinic Foundation (“CCF”) and the University of South Florida
Research Foundation, Inc. (“USF”). Pursuant to the license agreement by and
between Greenwich and CCF, Greenwich
paid CCF an initial license fee of $500,000, reimbursed CCF for certain costs
and expenses incurred by it, agreed to pay CCF an annual license maintenance
fee
of $35,000 until the first commercial sale of the licensed product, at which
time Greenwich will be obligated to pay to CCF an annual royalty based on net
sales of the product, and is obligated to pay CCF up to an aggregate of $4.5
million upon the achievement of milestones. In the event that Greenwich
sublicenses SSG to a third party, Greenwich will be obligated to pay CCF a
portion of fees and royalties received from the sublicense. Pursuant
to the license agreement by and between Greenwich and USF, Greenwich
paid USF an initial license fee of $40,000, reimbursed the University of South
Florida Research Foundation for certain costs and expenses incurred, agreed
to
sponsor a Research Project involving the licensed technology in the amount
of
$25,000 annually for the term of the agreement and is obligated to pay USF
up to
an aggregate of $5.8 million upon the achievement of milestones. Should a
product incorporating the licensed technology be commercialized, Greenwich
is
obligated to pay to USF an annual royalty based on net sales of the product.
In
the event that the Company sublicenses TCN to a third party, Greenwich is
obligated to pay USF a portion of fees and royalties received from the
sublicense. Currently, Greenwich
has indebtedness in an aggregate amount of approximately $795,000 and
anticipates needing approximately $5 million for the next twelve months to
continue its proposed development of the technology licensed from CCF and USF.
Currently, Greenwich’s commercial success depends entirely on this licensed
technology. In the event Greenwich materially breaches the license agreements,
CCF or USF may have the right to terminate the licenses. Since, following the
Merger, our drug development business will depend entirely on the availability
of Greenwich’s license rights, the termination of the licenses would
significantly reduce the value of our company. See “Information Concerning
Greenwich Therapeutics - License Agreements & Intellectual
Property.”
Following
the Merger, if we are unable to hire additional qualified personnel, our
ability
to successfully develop Greenwich’s and any other product candidates that we may
acquire in the future, will be harmed.
Greenwich
does not currently have any employees and even its officers and directors,
none
of whom will continue with VioQuest following the Merger, only devote a small
portion of their time to Greenwich’s business. Accordingly, following completion
of the Merger, we will need to hire additional qualified personnel with
expertise in pre-clinical testing, clinical research, government regulation,
formulation and manufacturing and, eventually, sales and marketing. In
particular, as soon as practicable following the Merger, we anticipate hiring
a
chief medical officer and other employees with experience in drug
development.
Our
future success is dependent on the management of our potential
growth.
Following
the Merger, the future success of our company depends upon our ability to grow
our business over a period of three to five years. Such growth, if it occurs,
will require us to establish management and operating systems, hire additional
support technical and sales personnel, and establish and maintain an independent
office, research and production facilities for the Greenwich business.
Currently, we have thirty employees: twenty-four individuals are located in
our
New Jersey facility while six are in our China facility. Of these employees,
three are individuals in senior management serving our VioQuest drug development
business and twenty-seven are technical, operations and administrative employees
serving our subsidiary, Chiral Quest. Failure to manage that growth efficiently
could have a material adverse affect on our business.
Competition
in this market sector is intense.
The
market for Greenwich’s product candidates is characterized by intense
competition and rapid technological advances. If our product candidates receive
FDA approval, they will compete with a number of existing and future drugs
and
therapies developed, manufactured and marketed by others. In particular,
assuming we obtain approval for SSG, we will compete with other developers
of
protein
tyrosine phosphatases, or “PTPs,” inhibitors for oncology
treatment.
Although there are no approved PTPs currently on the market, there are several
product candidates in development that will compete with SSG and which are
significantly further in development. Companies that have PTP inhibitor drugs
in
development include CEPTYR,
Inc., Combinatorx, Kinetek Pharmaceuticals, Ontogen Corporation, and Sugen
(Pfizer).
Assuming
we obtain approval for TCN, we will compete with existing oncology therapies
currently being sold by Keryx
Biopharmaceuticals, Inc., Astex Therapeutics (and AstraZeneca under their
collaboration), Bristol-Myers Squib, Abbott Laboratories, Kinetek
Pharmaceuticals, Inc., ProIX Pharmaceuticals, Inc. and Kinetix Pharmaceuticals.
In addition, Keryx Biopharmaceuticals, Inc. has a drug in development that
will
compete directly with TCN. These
or
other future competing products and product candidates may provide greater
therapeutic convenience or clinical or other benefits for a specific indication
than our products, or may offer comparable performance at a lower cost. If
our
products fail to capture and maintain market share, we may not achieve
sufficient product revenues and our business will suffer.
Developments
by competitors may render our products or technologies obsolete or
non-competitive.
Alternative
technologies are being developed to treat cancer, several of which are in
advanced clinical trials. In addition, companies pursuing different but related
fields represent substantial competition. Many of these organizations have
substantially greater capital resources, larger research and development staffs
and facilities, longer drug development history in obtaining regulatory
approvals and greater manufacturing and marketing capabilities than we do.
These
organizations also compete with us to attract qualified personnel, parties
for
acquisitions, joint ventures or other collaborations.
If
we are not able to obtain the necessary U.S. or worldwide regulatory approvals
to commercialize any product candidates, we will not be able to sell those
products.
We
will
need FDA approval to commercialize any drug candidates in the U.S. and approvals
from the FDA equivalent regulatory authorities in foreign jurisdictions to
commercialize any product candidates in those jurisdictions. In order to obtain
FDA approval of a drug candidate, we will be required to first submit to the
FDA
for approval an Investigational New Drug Application, or an IND, which will
set
forth plans for clinical testing of a particular drug candidate. Currently,
we
have no regulatory applications before the FDA or any other governmental agency
for TCN. However, CCF has filed, and the FDA has accepted, an IND for SSG.
When
the
clinical testing for the product candidates is complete, we will then be
required to submit to the FDA a New Drug Application, or NDA, demonstrating
that
the product candidate is safe for humans and effective for its intended use.
This demonstration will require significant research and animal tests, which
are
referred to as pre-clinical studies, as well as human tests, which are referred
to as clinical trials. Satisfaction of the FDA’s regulatory requirements
typically takes many years, depends upon the type, complexity and novelty of
the
product candidate and requires substantial resources for research, development
and testing. The FDA has substantial discretion in the drug approval process
and
may require us to conduct additional pre-clinical and clinical testing or to
perform post-marketing studies. The approval process may also be delayed by
changes in government regulation, future legislation or administrative action
or
changes in FDA policy that occur prior to or during the regulatory review.
Delays in obtaining regulatory approvals may:
· |
delay
commercialization of, and our ability to derive product revenues
from, a
drug candidate;
|
· |
impose
costly procedures on us; and
|
· |
diminish
any competitive advantages that we may otherwise
enjoy.
|
Even
if
we comply with all FDA requests, the FDA may still ultimately reject an NDA.
Failure to obtain FDA approval of a drug candidate will severely undermine
our
business development by reducing our ability to recover the development costs
expended in connection with a drug candidate and realize any profit from
commercializing a drug candidate.
In
foreign jurisdictions, we will be required to obtain approval from the
appropriate regulatory authorities before we can commercialize our drugs.
Foreign regulatory approval processes generally include all of the risks
associated with the FDA approval procedures described above.
Clinical
trials are very expensive, time-consuming and difficult to design and
implement.
Following
completion of the Merger, we will be required to expend significant time, effort
and money to conduct human clinical trials necessary to obtain regulatory
approval of the product candidates we will acquire from Greenwich. Human
clinical trials are very expensive and difficult to design and implement, in
part because they are subject to rigorous regulatory requirements. The clinical
trial process is also time consuming. Clinical trials of any product candidate
are estimated to take at least several years to complete. Furthermore, failure
can occur at any stage of the trials, and we could encounter problems that
cause
us to abandon or repeat clinical trials. The commencement and completion of
clinical trials may be delayed by several factors, including:
· |
unforeseen
safety issues;
|
· |
determination
of dosing issues;
|
· |
lack
of effectiveness during clinical
trials;
|
· |
slower
than expected rates of patient
recruitment;
|
· |
inability
to monitor patients adequately during or after treatment;
and
|
· |
inability
or unwillingness of medical investigators to follow Greenwich’s clinical
protocols.
|
In
addition, we or the FDA may suspend clinical trials at any time if it appears
that we are exposing participants to unacceptable health risks or if the FDA
finds deficiencies in the IND submissions or the conduct of these
trials.
The
results of any clinical trial may not support the results of pre-clinical
studies relating to Greenwich’s product candidates, which may delay development
of any product candidate or cause us to abandon development
altogether.
Even
if
any clinical trials we undertake with respect to Greenwich’s product candidates,
we cannot be certain that the results will support the findings of pre-clinical
studies upon which a development plan would be based. Success in pre-clinical
testing and early clinical trials does not ensure that later clinical trials
will be successful, and we cannot be sure that the results of later clinical
trials will replicate the results of prior clinical trials and pre-clinical
testing. The clinical trial process may fail to demonstrate that the product
candidates are safe and effective for indicated uses. This failure may cause
us
to delay the development of a product candidate or even to abandon clinical
development of a product candidate altogether. Such failure may also cause
delay
in other product candidates. Any delay in, or termination of, the clinical
trials will delay the filing of our NDAs with the FDA and, ultimately, our
ability to commercialize Greenwich’s product candidates and generate product
revenues.
If
physicians and patients do not accept and use Greenwich’s drugs after regulatory
approvals are obtained, we will not realize sufficient revenue from such product
to cover our development costs.
Even
if
the FDA approved any of Greenwich’s product candidates, physicians and patients
may not accept and use them. Acceptance and use of the product candidates will
depend upon a number of factors including:
· |
perceptions
by members of the healthcare community, including physicians, about
the
safety and effectiveness of Greenwich’s
drugs;
|
· |
cost-effectiveness
of the product relative to competing
products;
|
· |
availability
of reimbursement for the products from government or other healthcare
payers; and
|
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
Our
drug development business plan contemplates that substantially all of any future
revenues realized will result from sales of product candidates developed. The
failure of any of the drugs to find market acceptance would significantly and
adversely affect our ability to generate cash flow and become profitable.
We
will rely exclusively on third parties to formulate and manufacture its product
candidates.
We
do not
currently have, and have no current plans to develop, the capability
to
formulate or manufacture drugs. Rather, we intend to contract with one or more
manufacturers to manufacture, supply, store and distribute drug supplies that
will be needed for any clinical trials undertaken. If
we
received FDA approval for any product candidate, we would rely on one or more
third-party contractors to manufacture the drugs. Our anticipated future
reliance on a limited number of third-party manufacturers will expose us to
the
following risks:
· |
We
may be unable to identify manufacturers on commercially reasonable
terms
or at all because the number of potential manufacturers is limited
and the
FDA must approve any replacement contractor. This approval would
require
new testing and compliance inspections. In addition, a new manufacturer
would have to be educated in, or develop substantially equivalent
processes for, production of the products after receipt of FDA approval,
if any.
|
· |
Our
third-party manufacturers might be unable to formulate and manufacture
the
drugs in the volume and of the quality required to meet clinical
and
commercial needs, if any.
|
· |
Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
the
clinical trials or to successfully produce, store and distribute
the
products.
|
· |
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Administration, and corresponding state
agencies to ensure strict compliance with good manufacturing practice
and
other government regulations and corresponding foreign standards.
We do
not have control over third-party manufacturers’ compliance with these
regulations and standards.
|
· |
If
any third-party manufacturer makes improvements in the manufacturing
process for the products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
|
If,
following the Merger, we are not able to successfully compete against other
drug
companies, our drug development business will fail.
The
market for new drugs is characterized by intense competition and rapid
technological advances. If any drug candidate that we develop, including the
drug candidates acquired from Greenwich, receives FDA approval, we will likely
compete with a number of existing and future drugs and therapies developed,
manufactured and marketed by others. Existing or future competing products
may
provide greater therapeutic convenience or clinical or other benefits for a
specific indication than our products, or may offer comparable performance
at a
lower cost or with fewer side-effects. If our products fail to capture and
maintain market share, we may not achieve sufficient product revenues and our
business will suffer.
We
will
be competing against fully integrated pharmaceutical companies and smaller
companies that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have drug candidates already approved
or in development. In addition, many of these competitors, either alone or
together with their collaborative partners, operate larger research and
development programs and have substantially greater financial resources than
we
do, as well as significantly greater experience in:
· |
undertaking
pre-clinical testing and human clinical
trials;
|
· |
obtaining
FDA and other regulatory approvals of
drugs;
|
· |
formulating
and manufacturing drugs; and
|
· |
launching,
marketing and selling drugs.
|
If
we fail to adequately protect or enforce Greenwich’s intellectual property
rights or secure rights to patents of others, the value of those intellectual
property rights would diminish.
Our
success, competitive position and future revenues in connection with our drug
development business will depend in part on our ability and the abilities of
our
licensors to obtain and maintain patent protection for our products, methods,
processes and other technologies, to preserve our trade secrets, to prevent
third parties from infringing on our proprietary rights and to operate without
infringing the proprietary rights of third parties. Neither
Greenwich nor either of its licensors has any obligations to defend or instigate
any suits against any patent or licensed-related suits of third parties. Neither
we nor Greenwich
is aware of any third party infringing on any of Greenwich’s intellectual
property rights.
To
date,
through Greenwich’s license agreements for SSG and TCN, it holds certain
exclusive patent rights, including rights under U.S. patents and U.S. patent
applications. Greenwich also has patent applications pending in several foreign
jurisdictions. Greenwich anticipates filing additional patent applications
both
in the U.S. and in other countries, as appropriate. However, we cannot
predict:
· |
the
degree and range of protection any patents will afford Greenwich
against
competitors, including whether third parties will find ways to invalidate
or otherwise circumvent its licensed
patents;
|
· |
if
and when patents will issue;
|
· |
whether
or not others will obtain patents claiming aspects similar to those
covered by Greenwich’s licensed patents and patent applications;
or
|
· |
whether
Greenwich will need to initiate litigation or administrative proceedings
which may be costly whether Greenwich wins or
loses.
|
Following
the Merger, our success will also depend upon the skills, knowledge and
experience of scientific and technical personnel, consultants and advisors
as
well as licensors and contractors. To help protect proprietary know-how and
our
inventions for which patents may be unobtainable or difficult to obtain, we
intend to rely on trade secret protection and confidentiality agreements. To
this end, we currently require, and will continue to require in the future,
all
of our employees to enter into agreements which prohibit the disclosure of
confidential information and, where applicable, require disclosure and
assignment to us of the ideas, developments, discoveries and inventions
important to our business. We intend to require new employees hired in
connection with our drug development business to also enter into such
agreements. These agreements may not provide adequate protection for our trade
secrets, know-how or other proprietary information in the event of any
unauthorized use or disclosure or the lawful development by others of such
information. If any of our trade secrets, know-how or other proprietary
information is disclosed, the value of our trade secrets, know-how and other
proprietary rights would be significantly impaired and our business and
competitive position would suffer.
If
we infringe the rights of third parties we could be prevented from selling
products, forced to pay damages, and defend against litigation.
To
date,
to the best of its knowledge, Greenwich has not received any threats, claims
or
other notices from third parties alleging that Greenwich’s product candidates or
methods infringe their rights. If, following the Merger, it is determined that
Greenwich’s products, methods, processes and other technologies infringe on the
proprietary rights of other parties, however, we could incur substantial costs
and we may have to:
· |
obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
|
· |
redesign
our products or processes to avoid
infringement;
|
· |
stop
using the subject matter claimed in the patents held by others, which
could cause us to lose the use of one or more of the product candidates
acquired from Greenwich;
|
· |
defend
litigation or administrative proceedings which may be costly whether
we
win or lose.
|
SHAREHOLDER
PROPOSAL NO. 1:
REINCORPORATION
UNDER DELAWARE LAW
General
As
a
condition to completing the Merger, the Company proposes to reincorporate under
the laws of Delaware. Accordingly, the Board of Directors has unanimously
approved and recommended for shareholder approval a proposal to reincorporate
the Company under the laws of the State of Delaware (the “Reincorporation”). The
Reincorporation would be effected by merging the Company into VioQuest Delaware,
Inc., a Delaware corporation and wholly owned subsidiary of the Company. The
Reincorporation will be effected pursuant to the terms of an agreement and
plan
of merger between the Company and VioQuest Delaware. The Company anticipates
that the Reincorporation will become effective as soon as practicable following
shareholder approval. However, the Reincorporation may be abandoned by the
Board
of Directors before the effective date of the Reincorporation, either before
or
after shareholder approval. Further, for the reasons identified below under
“Shareholder Proposal No. 1: Reincorporation Under Delaware Law - Other Reasons
for Reincorporation,” the Company intends to complete the Reincorporation even
if the proposed Merger with Greenwich is abandoned.
Reasons
for the Reincorporation - Condition to Completing Merger with
Greenwich
The
primary purpose of the proposed Reincorporation is to allow VioQuest to complete
the Merger with Greenwich. As a Minnesota corporation, VioQuest is subject
to
the Minnesota Business Corporation Act (“MBCA”), which prohibits “business
combinations” with “interested shareholders.” Under the MBCA, an “interested
shareholder” includes any person that beneficially owns, directly or indirectly,
10 percent or more of an issuing public corporation’s outstanding voting stock.
For purposes of this definition, a person is deemed the “beneficial owner” of
shares held by a relative or spouse residing in such person’s home, and any
estate or trust in which the person owns 10 percent or more of the total
beneficial interest. A “business combination” includes the merger of an issuing
public corporation or any subsidiary of such corporation with an interested
shareholder or another corporation that is an affiliate (a person or entity
that
controls, is controlled by or is under common control with a specified person)
or associate (including a corporation of which the interested shareholders
beneficially owns more than 10 percent of the voting stock) of the interested
shareholder. Such business combinations are prohibited under the MBCA for a
period of four years after the interested shareholder first became an interested
shareholder unless the shareholders of the issuing public corporation approved
the business combination transaction prior to the date the interested
shareholder first became an interested shareholder.
Lindsay
A. Rosenwald, M.D. is an “interested shareholder” of VioQuest because, since
February 2003, he and various trusts established for his benefit have
collectively owned approximately 16 percent of VioQuest’s outstanding common
stock. Dr. Rosenwald is deemed to beneficially own (as defined under the MBCA)
the shares held by the trusts because he is generally the sole beneficiary
of
the trust assets, although the power to dispose of those assets rests with
a
third party trustee. Dr. Rosenwald and such trusts also own approximately 48
percent of Greenwich’s outstanding voting stock, which makes Greenwich an
associate (and perhaps an affiliate) of Dr. Rosenwald. As a result, the proposed
Merger is a “business combination” under the MBCA because Dr. Rosenwald is an
“interested shareholder” of VioQuest and because Greenwich is an associate
and/or an affiliate of Dr. Rosenwald. Since it has not yet been four years
since
Dr. Rosenwald became an interested shareholder, the proposed Merger with
Greenwich is not permitted under the MBCA.
Although
the General Corporation Law of Delaware (“DGCL”), which sets forth corporate
laws applicable to companies incorporated under Delaware law, contains a
provision similar to the MBCA concerning business combinations with interested
stockholders, the DGCL provision contains certain exceptions that would exempt
the Merger from the restrictions of the business combination provision if
VioQuest were a Delaware corporation. For example, the DGCL’s business
combination provision does not apply to corporations that do not have a class
of
voting stock (i) listed on a national securities exchange, (ii) quoted on the
NASDAQ Stock Market, or (iii) held of record by more than 2,000 stockholders.
VioQuest is neither listed on a national securities exchange (e.g., the New
York
Stock Exchange or the American Stock Exchange) or on the NASDAQ Stock Market,
and the number of holders of record of VioQuest common stock was only
approximately 1,500 as of the record date for the Special Meeting. Accordingly,
if VioQuest were a Delaware corporation, the proposed Merger with Greenwich
would not be a prohibited “business combination.”
Other
Reasons for the Reincorporation
VioQuest
also believes reincorporating under Delaware law is advisable because Delaware
is a nationally recognized leader in adopting and implementing comprehensive
and
flexible corporate laws. The DGCL is frequently revised and updated to
accommodate changing legal and business needs. Delaware has also established
a
specialized court, the Court of Chancery, having exclusive jurisdiction over
matters relating to the DGCL. The Chancery Court has no jurisdiction over
criminal and tort cases, and corporate cases are heard by judges, without
juries, who have many years of experience with corporate law issues.
Traditionally, this has meant that the Delaware courts are able in most cases
to
process corporate litigation relatively quickly and effectively. As a result,
Delaware courts have developed considerable expertise in dealing with corporate
illegal issues and produced a substantial body of case law construing Delaware
corporate laws. Because our legal system is based largely on legal precedents,
the abundance of Delaware case law should serve to enhance the relative clarity
and predictability of many areas of corporate law, which should offer added
advantages to VioQuest by allowing our board of directors and management to
make
corporate decisions and take corporate actions with greater assurance as to
the
validity and consequences of those decisions and actions. For these reasons,
most public corporations have chosen to incorporate under the laws of Delaware
or have, like VioQuest’s proposes, reincorporated under Delaware
law.
Reincorporation
from Minnesota to Delaware may also make it easier to attract future candidates
willing to serve on VioQuest’s board of directors since many of such candidates
are already familiar with Delaware corporate law, including provisions relating
to director indemnification, from their past business experience.
Effect
on VioQuest Stock
The
proposed Reincorporation will be effected by completing a merger transaction
in
which VioQuest would merge with and into VioQuest Delaware. Prior to the
proposed Reincorporation, VioQuest and VioQuest Delaware will enter into an
agreement and plan of merger, which will provide, as follows:
· |
VioQuest
will be merged with and into VioQuest Delaware, with VioQuest Delaware
remaining as the surviving corporation and VioQuest’s separate existence
as a Minnesota corporation will
cease;
|
· |
each
holder of VioQuest common stock, par value $.01 per share, will receive
one share of VioQuest Delaware common stock, par value $.001 per
share,
for each share of VioQuest common stock owned by such
holder;
|
· |
certificates
formerly representing shares of VioQuest common stock will thereafter
represent shares of VioQuest Delaware common
stock;
|
· |
all
outstanding options, warrants and other rights to purchase shares
of
VioQuest common stock will automatically convert into an option,
warrant
or other right to purchase the same number of shares of VioQuest
Delaware
common stock;
|
· |
the
certificate of incorporation of VioQuest Delaware, substantially
in the
form attached to this proxy statement as Appendix
F, will
replace VioQuest’s existing articles of incorporation;
and
|
· |
the
name of VioQuest Delaware, as the surviving corporation, will be
changed
to “VioQuest Pharmaceuticals, Inc.”
|
It
will
not be necessary for shareholders of VioQuest to exchange their existing stock
certificates for stock certificates of VioQuest Delaware;
outstanding certificates of VioQuest common stock should not be destroyed or
sent to VioQuest.
Following the Reincorporation, delivery of previously outstanding stock
certificates of VioQuest will constitute “good delivery” in connection with
sales through a broker, or otherwise, of shares of VioQuest
Delaware.
Comparative
Rights of VioQuest Stockholders and VioQuest Delaware
Stockholders
If
the
Reincorporation is approved by the requisite vote of the shareholders at the
Special Meeting, the holders of VioQuest common stock, whose rights are
currently governed by the MBCA and VioQuest’s Articles of Incorporation and
Bylaws, will become stockholders of VioQuest Delaware, which is a Delaware
corporation. Accordingly, following Reincorporation, their rights will be
governed in accordance with the DGCL and VioQuest Delaware’s Certificate of
Incorporation, in substantially the form attached hereto as Appendix
F,
and
Bylaws, which will be substantially identical to VioQuest’s existing bylaws.
Certain differences in the rights of shareholders arise from distinctions
between the MBCA and the DGCL, as well as from VioQuest’s charter instruments as
compared to VioQuest Delaware’s charter instruments. The following is a brief
description of those differences. This discussion is not intended to be a
complete statement of the differences, but rather a summary of the more
significant differences affecting the rights of such shareholders and certain
important similarities. The identification of certain provisions or differences
is not meant to indicate that other equally or more significant differences
do
not exist. The following summary discussion is qualified in its entirety by
reference to the MBCA, DGCL, VioQuest’s Articles of Incorporation and Bylaws and
VioQuest Delaware’s Certificate of Incorporation and Bylaws, to which you are
referred.
Shareholders’
Action Without a Meeting
Under
Minnesota law, any action required or permitted to be taken at a shareholders’
meeting may be taken without a meeting by written consent signed by all of
the
shareholders entitled to vote on such action, and a publicly-held company cannot
provide for a lower threshold in its articles of incorporation. This power
cannot be restricted by a corporation’s articles of incorporation. In contrast,
Delaware law permits such an action to be taken if the written consent is signed
by the holders of shares that would have been required to effect the action
at a
meeting of the stockholders. Stockholders who do not sign the written consent
must be notified promptly following the effectiveness of a written consent.
Generally, holders of a majority of the Company’s outstanding shares may take
action by written consent in lieu of a shareholder meeting. However, Delaware
law also provides that a corporation’s certificate of incorporation may restrict
or prohibit stockholders’ action without a meeting. VioQuest Delaware’s
Certificate does not contain any such restriction, so actions may be adopted
by
a written consent signed by the holders of shares that would have been required
to vote in favor of the proposed action at a meeting of stockholders.
Anti-Takeover
Legislation
Both
the
MBCA and the DGCL contain provisions intended to protect shareholders from
individuals or companies attempting a takeover of a corporation in certain
circumstances. The anti-takeover provisions of the MBCA and the DGCL differ
in a
number of respects, and it is not practical to summarize all of the differences.
However, the following is a summary of certain significant differences.
The
Minnesota control share acquisition statute establishes various disclosure
and
shareholder approval requirements that must be satisfied by individuals or
companies attempting a takeover. Delaware has no comparable provision. The
Minnesota statute applies to an “issuing public corporation.” An “issuing public
corporation” is a publicly-held corporation which is incorporated under or
governed by the MBCA and has at least fifty shareholders. The Company is subject
to the statute; VioQuest Delaware, because it is a Delaware corporation, will
not be subject to the statute. The Minnesota statute requires disinterested
shareholder approval for acquisitions of shares of an “issuing public
corporation” which result in the “acquiring person” owning more than a
designated percentage of the outstanding shares of such corporation.
Accordingly, shareholders who acquire shares without shareholder approval and
in
excess of a designated percentage of outstanding shares lose their voting rights
and are subject to certain redemption privileges of the corporation. Such shares
regain their voting rights only if the acquiring person discloses certain
information to the corporation and such voting rights are granted by the
shareholders at an annual or special meeting of the shareholders. The Minnesota
control share acquisition statute applies unless the “issuing public
corporation” opts out of the statute in its articles of incorporation or bylaws.
The Company has not opted out of such provisions.
While
there is no Delaware statute comparable to the Minnesota control share
acquisition statute, both Minnesota and Delaware have business combination
statutes that are intended primarily to deter takeover bids which propose to
use
the target’s assets as collateral for the offeror’s debt financing and to
liquidate the target, in whole or in part, to satisfy financing obligations.
Proponents of the business combination statute argue that such takeovers have
a
number of abusive effects when the target is broken up, such as adverse effects
on the community and employees. Further, proponents argue that if the offeror
can wholly finance its bid with the target’s assets, that fact suggests that the
price offered was not fair in relation to the value of the company, regardless
of the current market price.
The
Minnesota business combination statute provides that an issuing public
corporation (as described above with respect to the Minnesota control share
acquisition statute) may not engage in certain business combinations with any
person that acquires beneficial ownership of 10% or more of the voting stock
of
that corporation (i.e., an interested shareholder) for a period of four years
following the date on which the person became a 10% shareholder (the share
acquisition date) unless, before that share acquisition date, a committee of
the
corporation’s disinterested directors approve either the business combination or
the acquisition of shares. Only specifically defined types of “business
combinations” are prohibited by the Minnesota statute. In general, the
definition includes:
· |
any
merger or exchange of securities of the corporation with the interested
shareholder;
|
· |
certain
sales, transfers, or other disposition of assets of the corporation
to an
interested shareholder;
|
· |
transfers
by the corporation to interested shareholders of shares that have
a market
value of 5% or more of the value of all outstanding shares, except
for a
pro rata transfer made to all shareholders;
|
· |
any
liquidation or dissolution of, or reincorporation in another jurisdiction
of, the corporation which is proposed by the interested shareholder;
|
· |
certain
transactions proposed by the interested shareholder or any affiliate
or
associate of the interested shareholder that would result in an increase
in the proportion of shares entitled to vote owned by the interested
shareholder; and
|
· |
transactions
whereby the interested shareholder receives the benefit of loans,
advantages, guarantees, pledges, or other financial assistance or
tax
advances or credits from the corporation.
|
For
purposes of selecting a disinterested committee, a director or person is
“disinterested” if the director or person is neither an officer nor an employee
of the issuing public corporation or a related corporation, nor has been an
officer or employee within five years preceding the formation of the committee
of the issuing public corporation or a related corporation. The disinterested
committee must consider and act on any written, good faith proposal to acquire
shares or engage in a business combination. The disinterested committee must
consider and take action on the proposal and within 30 days render a decision
in
writing regarding the proposal.
In
contrast to the Minnesota statute, the Delaware statute provides that if a
person acquires 15% or more of the voting stock of a Delaware corporation,
the
person is designated an interested stockholder and the corporation may not
engage in certain business combinations with such person for a period of three
years. However, an otherwise prohibited business combination may be permitted
if
one of three conditions is satisfied:
· |
if
before the date the person became an interested stockholder, the
board of
directors approved either the business combination or the transaction
which resulted in the stockholder becoming an interested stockholder;
|
· |
if
the tender offer or other transaction pursuant to which the person
acquires 15% stock ownership is attractive enough such that the interested
stockholder is able to acquire ownership in the same transaction
of at
least 85% of the outstanding voting stock (excluding for purposes
of
determining the number of shares outstanding those shares owned by
directors who are also officers and those shares owned by certain
employee
stock ownership plans); or
|
· |
if
the combination receives approval from the board of directors and
is
authorized at an annual or special meeting of stockholders (action
by
written consent is not permitted) by the affirmative vote of at least
two-thirds of the outstanding voting shares held by disinterested
stockholders.
|
As
in
Minnesota, only certain Delaware corporations are subject to the business
combination provisions of Delaware corporation law. A corporation is subject
to
the statute if it is incorporated under the laws of Delaware and has a class
of
voting stock that is listed on a national securities exchange, quoted on the
NASDAQ Stock Market, or held of record by more than 2,000 shareholders. Because
VioQuest Delaware will not meet any of these conditions, it will not be subject
to the Delaware business combination statute for purposes of the Merger.
However, VioQuest Delaware may be subject to the Delaware business combination
statute in the future.
The
“business combinations” prohibited under Delaware law include any of the
following:
· |
any
merger or consolidation with the interested stockholder;
|
· |
any
sale, transfer or other disposition of assets to the interested
stockholder if the assets have a market value equal to or greater
than 10%
of the aggregate market value of all of the corporation’s assets;
|
· |
any
transfer of stock of the corporation to the interested stockholder,
except
for transfers in a conversion or exchange or a pro rata distribution;
and
any receipt by the interested stockholder of any loans, advances,
guarantees, pledges, and
|
· |
other
financial benefits, except in connection with a pro rata transfer.
|
The
Delaware statute does not apply to any business combination in which the
corporation, with the support of a majority of those directors who were serving
as directors before any person became an interested stockholder, proposes a
merger, sale, lease, exchange or other disposition of at least 50% of its
assets, or supports (or does not oppose) a tender offer for at least 50% of
its
voting stock. In such a case, all interested stockholders are not required
to
comply with the three year prohibition and may compete with the
corporation-sponsored transaction.
Minnesota
law is somewhat more restrictive than Delaware law with respect to a prospective
takeover attempt. In Minnesota, an interested shareholder is one who owns 10%
of
the outstanding shares while in Delaware 15% is the share ownership threshold.
An interested shareholder must wait four years in Minnesota to engage in
prohibited business combinations, compared to a three-year waiting period in
Delaware. Minnesota also has a potentially broader definition of a business
combination which arguably encompasses a larger variety of transactions. Another
difference between the two business combination statutes is the method by which
prohibited transactions become permissible. In Delaware, an otherwise prohibited
business combination may be permitted by board approval, by stockholder
approval, or by an acquisition of 85% of the outstanding shares of voting stock.
In Minnesota, a prohibited transaction is permitted only by advance board
committee approval. In addition, the Delaware statute provides that if the
corporation proposes a merger or sale of assets, or does not oppose a tender
offer, all interested stockholders are not required to comply with the three
year prohibition and in certain circumstances may compete with such proposed
transaction. The Minnesota statute does not have a comparable provision. Both
the Minnesota and Delaware provisions permit a corporation to “opt out” of the
business combination statute by electing to do so in its articles or certificate
of incorporation within a specified time period. Neither the Bylaws nor the
Articles of Incorporation of the Company contain such an “opt out” provision.
Similarly, neither the Certificate of Incorporation nor the Bylaws of VioQuest
Delaware contain such an “opt out” provision.
The
MBCA
includes other provisions relating to takeovers that are not included in the
DGCL. Some of these provisions address a corporation’s use of golden parachutes,
greenmail and the standard of conduct of the Board of Directors in connection
with the consideration of takeover proposals. The MBCA contains a provision
which prohibits a publicly-held corporation from entering into or amending
agreements (commonly referred to as golden parachutes) that increase current
or
future compensation of any officer or director during any tender offer or
request or invitation for tenders. The MBCA provides that a publicly-held
corporation is prohibited from purchasing or agreeing to purchase any shares
from a person who beneficially owns more than 5% of the voting power of the
corporation if the shares had been beneficially owned by that person for less
than two years, and if the purchase price would exceed the market value of
those
shares. However, such a purchase will not violate the statute if the purchase
is
approved at a meeting of the shareholders by a majority of the voting power
of
all shares entitled to vote or if the corporation’s offer is of at least equal
value per share and made to all holders of shares of the class or series and
to
all holders of any class or series into which the securities may be converted.
In considering the best interests of the corporation with respect to a proposed
acquisition of an interest in the corporation, the MBCA authorizes the board
of
directors to consider the interest of the corporation’s employees, customers,
suppliers and creditors, the economy of the state and nation, community and
social considerations and the long-term as well as short-term interests of
the
corporation and its shareholders, including the possibility that these interests
may be best served by the continued independence of the corporation.
Directors’
Standard of Care and Personal Liability
Minnesota
law provides that a director must discharge the director’s duties in good faith,
in a manner the director reasonably believes to be in the best interests of
the
corporation, and with the care an ordinarily prudent person in a like position
would exercise under similar circumstances. A director who complies with such
standards may not be held liable by reason of being a director or having been
a
director of the corporation. Delaware law provides that the business and affairs
of a Delaware corporation are to be managed by or under the direction of its
board of directors. The directors of a company owe fiduciary duties to the
company and its stockholders. These fiduciary duties require directors in making
a business decision to act on an informed basis, in good faith, and in the
honest belief that the action to be taken is in the best interests of the
company and its stockholders. In general, directors owe two distinct fiduciary
duties: the duty of care and the duty of loyalty.
Limitation
or Elimination of Director’s Personal Liability
Minnesota
law provides that the personal liability of a director for breach of fiduciary
duty may be eliminated or limited if the articles of incorporation so provide,
but the articles may not limit or eliminate such liability for (a) any breach
of
the directors’ duty of loyalty to the corporation or its shareholders, (b) acts
or omissions not in good faith or that involve intentional misconduct or a
knowing violation of law, (c) the payment of unlawful dividends, stock
repurchases or redemptions, (d) any transaction in which the director received
an improper personal benefit, (e) certain violations of the Minnesota securities
laws, and (f) any act or omission that occurs before the effective date of
the
provision in the articles eliminating or limiting liability. The Company’s
Articles of Incorporation provide that, to the fullest extent permitted by
the
MBCA, a director shall not be personally liable to the Company or its
shareholders for monetary damages for breach of a directors’ fiduciary duty.
Delaware law provides that if the certificate of incorporation so provides,
the
personal liability of a director for breach of fiduciary duty as a director
may
be eliminated or limited, but that the liability of a directors is not limited
or eliminated for (a) any breach of the directors’ duty of loyalty to the
corporation or its shareholders, (b) acts or omissions not in good faith or
involving intentional misconduct or a knowing violation of law, (c) the payment
of unlawful dividends, stock repurchases or redemptions, or (d) any transaction
in which the director received an improper personal benefit. VioQuest Delaware’s
Certificate of Incorporation contains a provision eliminating the personal
liability of its directors for breach of fiduciary duty, subject to the
foregoing limitations. The Company is not aware of any pending or threatened
litigation to which the limitation of directors’ liability would apply.
Indemnification
Minnesota
law generally provides for mandatory indemnification of persons acting in an
official capacity on behalf of the corporation if such a person acted in good
faith, did not receive any improper personal benefit, acted in a manner the
person reasonably believed to be in, or not opposed to, the best interests
of
the corporation and, in the case of a criminal proceeding, had no reasonable
cause to believe that the conduct was unlawful. Delaware law permits a
corporation to indemnify its officers, directors, employees and agents and
expressly provides that such indemnification shall not be deemed exclusive
of
any indemnification right provided under any bylaw, vote of shareholders or
disinterested directors or otherwise. Delaware law permits indemnification
against expenses and certain other liabilities arising out of legal actions
brought or threatened against parties entitled to indemnity for their conduct
on
behalf of the corporation, provided that each such person acted in good faith
and in a manner such person reasonably believed was in or not opposed to the
best interests of the corporation. In Delaware indemnification is available
in a
criminal action only if the person seeking indemnity had no reasonable cause
to
believe that the person’s conduct was unlawful. Delaware law does not allow
indemnification for directors in the case of an action by or in the right of
the
corporation (including stockholder derivative suits) as to which such director
shall have been adjudged to be liable to the corporation unless indemnification
(limited to expenses) is ordered by a court. The Certificate of VioQuest
Delaware provides for indemnification to the fullest extent permitted by
Delaware law.
Stockholder
Voting
Under
both Minnesota law and Delaware law, action on certain matters, including the
sale, lease or exchange of all or substantially all of the corporation’s
property or assets, mergers, and consolidations and voluntary dissolution,
must
be approved by the holders of a majority of the outstanding shares. In addition,
both states’ laws provide that the articles or certificate of incorporation may
provide for a supermajority of the voting power of the outstanding shares to
approve such extraordinary corporate transactions. Neither the Company’s
Articles nor VioQuest Delaware’s Certificate contain such a provision.
Action
by Directors Without a Meeting
Minnesota
and Delaware law permit directors to take written action without a meeting
for
an action otherwise required or permitted to be taken at a board meeting.
Minnesota law provides that a corporation’s articles of incorporation may
provide for such written action, other than an action requiring shareholder
approval, by the number of directors that would be required to take the same
action at a meeting of the board at which all directors were present. The
Company’s Articles of Incorporation contain such a provision allowing an action
to be taken by written consent of less than all of the directors. Delaware
law
contains no such provision and, thus, written actions by the directors of
VioQuest Delaware must be unanimous. Minnesota law also states that if the
articles of incorporation or bylaws so provide, a director may give advance
written consent or opposition to a proposal to be acted on at a board meeting;
however, such consent or opposition of a director not present at a meeting
does
not constitute presence for determining the existence of a quorum. The Company’s
Bylaws contain such a provision. Delaware law does not contain any advance
written consent or opposition provision.
Conflicts
of Interest
Under
both Minnesota law and Delaware law, a contract or transaction between a
corporation and one or more of its directors, or an entity in or of which one
or
more of the corporation’s directors are directors, officers, or legal
representatives or have a material financial interest, is not void or voidable
solely because of such reason, provided that the contract or transaction is
fair
and reasonable at the time it is authorized, such contract or transaction is
ratified by the corporation’s disinterested stockholders after disclosure of the
relationship or interest, or such contract or transaction is authorized in
good
faith by a majority of the disinterested members of the board of directors
after
disclosure of the relationship or interest. However, if such contract or
transaction is authorized by the board, under Minnesota law the interested
director may not be counted in determining the presence of a quorum and may
not
vote on such contract or transaction. Delaware law permits the interested
director to be counted in determining whether a quorum of the directors is
present at the meeting approving the contract or transaction, and further
provides that the contract or transaction shall not be void or voidable solely
because the interested director’s vote is counted at the meeting which
authorizes the contract or transaction.
Number
of Directors
Minnesota
law provides that the number of directors shall be fixed by or in the manner
provided in the articles of incorporation or bylaws, and that the number of
directors may be changed at any time by amendment to or in the manner provided
in the articles of incorporation or bylaws. The Company’s Bylaws provide that
the Board of Directors shall consist of a seven directors. Delaware law provides
that the number of directors shall be fixed by, or in the manner provided in,
the bylaws, unless the certificate of incorporation fixes the number of
directors, in which case a change in the number of directors shall be made
only
by amendment of the certificate. Under the Bylaws and the Certificate of
Incorporation of VioQuest Delaware, the number of directors may be fixed by
resolution of the Board of Directors.
Classified
Board of Directors
Both
Minnesota and Delaware permit a corporation’s bylaws to provide for a classified
board of directors. Delaware permits a maximum of three classes; Minnesota
law
does not limit the number of classes. The Company currently has a classified
board of directors and the Certificate of Incorporation and the Bylaws of
VioQuest Delaware provide for a classified board of directors.
Removal
of Director
Under
Minnesota law, unless a corporation’s articles of incorporation provide
otherwise, a director may be removed with or without cause by the affirmative
vote of a majority of the shareholders or, if the director was named by the
board to fill a vacancy, by the affirmative vote of a majority of the other
directors. Under Delaware law a director of a corporation may be removed with
or
without cause by the affirmative vote of a majority of shares entitled to vote
for the election of directors. However, a director of a Delaware corporation
that has a classified board may be removed but only for cause, unless the
certificate of incorporation provides otherwise. The Bylaws of VioQuest Delaware
provide that a director may be removed at any time but only for cause by the
stockholders.
Vacancies
on Board of Directors
Under
Minnesota law, unless the articles of incorporation or bylaws provide otherwise,
(a) a vacancy on a corporation’s board of directors may be filled by the vote of
a majority of directors then in office, although less than a quorum, (b) a
newly
created directorship resulting from an increase in the number of directors
may
be filled by the board, and (c) any director so elected shall hold office only
until a qualified successor is elected at the next regular or special meeting
of
shareholders. The Company’s Bylaws follow these provisions. Under Delaware law,
a vacancy on a corporation’s board of directors may be filled by a majority of
the remaining directors, even if less than a quorum, or by the affirmative
vote
of a majority of the outstanding voting shares, unless otherwise provided in
the
certificate of incorporation or bylaws. The Certificate of Incorporation of
VioQuest Delaware provides that a vacancy on a board of directors shall be
filled by the affirmative vote of a majority of the remaining directors, and
not
by the stockholders.
Annual
Meetings of Stockholders
Minnesota
law provides that if a regular meeting of shareholders has not been held during
the immediately preceding 15 months, a shareholder or shareholders holding
3% or
more of the voting power of all shares entitled to vote may demand a regular
meeting of shareholders. Delaware law provides that if no date has been set
for
an Annual Meeting of stockholders for a period of 13 months after the last
Annual Meeting, any stockholder or director may request the Delaware court
to
order a meeting to be held.
Special
Meetings of Stockholders
Minnesota
law provides that the chief executive officer, the chief financial officer,
two
or more directors, a person authorized in the articles or bylaws to call a
special meeting, or a shareholder holding 10% or more of the voting power of
all
shares entitled to vote, may call a special meeting of the shareholders, except
that a special meeting concerning a business combination must be called by
25%
of the voting power. Under Delaware law, only the board of directors or those
persons authorized by the corporation’s certificate of incorporation or bylaws
may call a special meeting of the corporation’s stockholders. The Bylaws of
VioQuest Delaware provide that special meetings of shareholders may be called
by
the corporation’s President, Board of Directors, Chairman of the Board, Chief
Executive Officer or at the request of stockholders owning a majority of the
voting power of the outstanding shares entitled to vote.
Voluntary
Dissolution
Minnesota
law provides that a corporation may be dissolved by the voluntary action of
holders of a majority of a corporation’s shares entitled to vote at a meeting
called for the purpose of considering such dissolution. Delaware law provides
that voluntary dissolution of a corporation first must be deemed advisable
by a
majority of the board of directors and then approved by a majority of the
outstanding stock entitled to vote. Delaware law further provides for voluntary
dissolution of a corporation without action of the directors if all of the
stockholders entitled to vote on such dissolution consent in writing to such
dissolution.
Minnesota
law provides that a court may dissolve a corporation in an action by a
shareholder where: (a) the situation involves a deadlock in the management
of
corporate affairs and the shareholders cannot break the deadlock; (b) the
directors have acted fraudulently, illegally, or in a manner unfairly
prejudicial to the corporation; (c) the shareholders are divided in voting
power
for two consecutive regular meetings to the point where successor directors
are
not elected; (d) there is a case of misapplication or waste of corporate assets;
or (e) the duration of the corporation has expired. Delaware law provides that
courts may revoke or forfeit the charter of any corporation for abuse, misuse
or
nonuse of its corporate powers, privileges or franchises.
Inspection
of Shareholder Lists
Under
Minnesota law, any shareholder has an absolute right, upon written demand,
to
examine and copy, in person or by a legal representative, at any reasonable
time, the corporation’s share register. Under Delaware law, any stockholder,
upon written demand under oath stating the purpose thereof, has the right during
the usual hours for business to inspect for any proper purpose a list of the
corporation’s stockholders and to make copies or extracts therefrom.
Amendment
of the Charter
Under
Minnesota law, before shareholders may vote on an amendment to the articles
of
incorporation, either a resolution to amend the articles must have been approved
by the affirmative vote of the majority of the directors present at the meeting
where such resolution was considered, or the amendment must have been proposed
by shareholders holding 3% or more of the voting power of the shares entitled
to
vote. Amending the articles of incorporation requires the affirmative vote
of
the holders of the majority of the voting power present and entitled to vote
at
the meeting (and of each class, if entitled to vote as a class), unless the
articles of incorporation require a larger proportion. Minnesota law provides
that a proposed amendment may be voted upon by the holders of a class or series
even if the articles of incorporation would deny that right, if among other
things, the proposed amendment would change the rights or preferences of the
class or series, create a new class or series of shares having rights and
preferences prior and superior to the shares of that class or series or limit
or
deny any existing preemptive right of the shares of the class or series. Under
Delaware law, the board of directors must adopt a resolution setting forth
an
amendment to the certificate of incorporation before the stockholders may vote
on such amendment. Unless the certificate of incorporation provides otherwise,
amendments to the certificate of incorporation generally require the approval
of
the holders of a majority of the outstanding stock entitled to vote thereon,
and
if the amendment would increase or decrease the number of authorized shares
of
any class or series or the par value of such shares, or would adversely affect
the rights, powers or preferences of such class or series, a majority of the
outstanding stock of such class or series also must approve the amendment.
Amendment
of the Bylaws
Minnesota
law provides that unless the articles of incorporation reserve the power to
the
shareholders, the power to adopt, amend, or repeal a corporation’s bylaws is
vested in the board of directors, subject to the power of the shareholders
to
adopt, repeal, or amend the bylaws. After adoption of initial bylaws, the board
of directors of a Minnesota corporation cannot adopt, amend, or repeal a bylaw
fixing a quorum for meetings of shareholders, prescribing procedures for
removing directors or filling vacancies on the board, or fixing the number
of
directors or their classifications, qualifications, or terms of office, but
may
adopt or amend a bylaw to increase the number of directors. Delaware law
provides that the power to adopt, amend, or repeal bylaws remains with the
corporation’s stockholders, but permits the corporation, in its certificate of
incorporation, to place such power in the board of directors. Under Delaware
law, the fact that such power has been placed in the board of directors neither
divests nor limits the stockholders’ power to adopt, amend, or repeal bylaws.
Proxies
Both
Minnesota and Delaware law permit proxies of definite duration. If the proxy
is
indefinite as to its duration, under Minnesota law it is valid for 11 months,
under Delaware law, the proxy is valid for three years.
Preemptive
Rights
Under
Minnesota law, shareholders have preemptive rights to acquire a certain fraction
of the unissued securities or rights to purchase securities of a corporation
before the corporation offers them to other persons, unless the corporation’s
articles of incorporation otherwise provide. The Company’s Articles provide that
the Company’s shareholders do not have preemptive rights. Under Delaware law,
preemptive rights do not exist unless the corporation’s certificate of
incorporation specifies otherwise. VioQuest Delaware’s Certificate does not
provide for any such preemptive rights.
Dividends
Generally,
a Minnesota corporation may pay a dividend if its board of directors determines
that the corporation will be able to pay its debts in the ordinary course of
business after paying the dividend and if, among other things, the dividend
payment does not reduce the remaining net assets of the corporation below the
aggregate preferential amount payable in the event of liquidation to the holders
of the shares having preferential rights, unless the payment is made to those
shareholders in the order and to the extent of their respective priorities.
A
Delaware corporation may pay dividends out of surplus or, if there is no
surplus, out of net profits for the fiscal year in which the dividend is
declared and/or for the preceding fiscal year, except that dividends may not
be
paid out of net profits if, after the payment of the dividend, capital is less
than the capital represented by the outstanding stock of all classes having
a
preference upon the distribution of assets.
Stock
Repurchases
A
Minnesota corporation may acquire its own shares if, after the acquisition,
it
is able to pay its debts as they become due in the ordinary course of business
and if enough value remains in the corporation to satisfy all preferences of
senior securities. Under Delaware law, a corporation may purchase or redeem
shares of any class except when its capital is impaired or such purchase would
cause impairment of capital, except that a corporation may purchase or redeem
any of its preferred shares if such shares will be retired upon the acquisition
and the capital of the corporation will be reduced by such retirement of shares.
Treasury
Shares
The
MBCA
does not allow treasury shares. Under the DGCL, the Company may hold treasury
shares and such shares may be held, sold, loaned, pledged or exchanged by the
Company. Such treasury shares, however, are not outstanding shares and therefore
do not receive any dividends and do not have voting rights.
Dissenting
Shareholder Rights
In
some
circumstances under Minnesota law and Delaware law, shareholders have the right
to dissent from certain corporate transactions by demanding payment in cash
for
their shares equal to the fair value of the shares as determined by agreement
with the corporation or by a court in an action timely brought by the dissenting
shareholders. Minnesota law, in general, affords dissenters’ rights upon certain
amendments to the articles of incorporation that materially and adversely affect
the rights or preferences of the shares of the dissenting shareholder, upon
the
sale of substantially all corporate assets and upon merger or exchange by a
corporation. However, no such appraisal rights exist for the holders of any
shares listed on the New York Stock Exchange, the American Stock Exchange or
designated as a national market system security on an interdealer quotation
system. Delaware law allows for dissenters’ rights only in connection with
certain mergers or consolidations. No such appraisal rights exist, however,
for
corporations whose shares are listed on a national securities exchange or held
of record by more than 2,000 stockholders unless the certificate of
incorporation provides otherwise (the VioQuest Delaware Certificate does not
provide otherwise) or the shareholders are to receive in the merger or
consolidation anything other than (a) shares of stock of the corporation
surviving or resulting from such merger or consolidation, (b) shares of stock
of
any other corporation which at the effective date of the merger or consolidation
will be either listed on a national securities exchange or held of record by
more than 2,000 shareholders, (c) cash in lieu of fractional shares of the
corporation described in the foregoing clauses (a) and (b), or (d) any
combination of clauses (a), (b), or (c). The procedures for asserting
dissenters’ rights in Delaware impose most of the initial costs of such
assertion on the dissenting shareholder, whereas the Minnesota procedures pose
little financial risk to the dissenting shareholder in demanding payment in
excess of the amount the corporation determined to be the fair value of its
shares.
Abandonment
of Reincorporation Merger
Notwithstanding
shareholder approval, the Board of Directors may abandon the proposed
Reincorporation at any time before the effective time of the Reincorporation
if
the Board of Directors of the Company determines that in its judgment the
Reincorporation does not appear to be in the best interests of the Company
or
its shareholders. In the event the Board of Directors abandons the
Reincorporation, or the Company’s shareholders fail to approve the
Reincorporation, the Company would remain a Minnesota corporation.
Required
Vote for the Reincorporation
The
affirmative vote of a majority of all shares of VioQuest common stock entitled
to vote at the Meeting is required to authorize the Reincorporation. The
enclosed form of Proxy provides a means for shareholders (i) to vote for the
Reincorporation and its resulting effects, (ii) to vote against the
Reincorporation and its resulting effects, or (iii) to abstain from voting
with
respect to the Reincorporation and its resulting effects. Each properly executed
proxy received in time for the Meeting will be voted at such meeting as
specified therein. If
a shareholder executes and returns a proxy but does not specify otherwise,
the
shares represented by such shareholder’s proxy will be voted for the
Reincorporation and all its resulting effects.
A vote
for the proposal will constitute specific approval of the Reincorporation and
its resulting effects, VioQuest Delaware’s Bylaws, and all transactions and
proceedings related to the Reincorporation described in this proxy statement.
Board
Recommendation and Voting Requirements
The
Board of Directors recommends a vote FOR
approval of the proposal to change the state of incorporation from Minnesota
to
Delaware. Provided
a quorum is present, the
affirmative vote of holders of a majority of the voting power of the outstanding
shares of common stock entitled to vote on this item and present, in person
or
by proxy, at the Special Meeting is required for approval of the proposal to
change the state of incorporation from Minnesota to Delaware. Proxies solicited
by our Board of Directors will be voted for approval of the Reincorporation,
unless shareholders specify otherwise in their proxies.
Dissenters’
Rights
Under
Minnesota law, you have the right to dissent from the proposed Reincorporation
and receive the fair value of your shares in cash. See “Summary of Dissenters’
Rights.”
Federal
Income Tax Consequences of Reincorporation
The
Reincorporation is intended to be tax free under the Internal Revenue Code.
We
have been advised by counsel that no gain or loss will be recognized by
shareholders for federal income tax purposes as a result of the consummation
of
the Reincorporation. We have further been advised that each shareholder will
have a tax basis in the shares of capital stock of VioQuest Delaware deemed
received upon the effective time of the Reincorporation equal to the tax basis
of the shareholder in the shares of capital stock deemed exchanged therefore,
and, provided that the shareholder held the shares of capital stock as a capital
asset, such shareholder’s holding period for the shares of capital stock of
VioQuest Delaware deemed to have been received will include the holding period
of the shares of capital stock deemed exchanged therefore. No gain or loss
will
be recognized for federal income tax purposes by the Company or VioQuest
Delaware and VioQuest Delaware will succeed, without adjustment, to the tax
attributes of the Company.
NOTWITHSTANDING
THE FOREGOING, SHAREHOLDERS SHOULD CONSULT THEIR OWN TAX ADVISERS REGARDING
THE
PARTICULAR TAX CONSEQUENCES OF THE REINCORPORATION UNDER APPLICABLE STATE,
LOCAL
OR FOREIGN TAX LAWS.
SHAREHOLDER
PROPOSAL NO. 2:
AMENDMENT
TO THE ARTICLES OF INCORPORATION
General
The
Board
of Directors is proposing that the Articles of Incorporation of the Company
be
amended to increase the authorized capital stock of the Company from 50,000,000
shares of undesignated capital stock, $.01 per share par value, to 100,000,000
shares of common stock and 10,000,000 shares of preferred stock, $.001 per
share
par value.
Purpose
of the Charter Amendment
The
Charter Amendment will have the effect of increasing the number of shares of
the
Company’s authorized capital stock. Currently, the Company’s articles of
incorporation authorize the issuance of 50,000,000 shares of undesignated
capital stock. VioQuest Delaware’s certificate of incorporation, however,
authorizes the issuance of 100,000,000 shares of common stock and 10,000,000
shares of preferred stock. The Company currently has outstanding approximately
17,800,000 shares of common stock and options and warrants to acquire an
additional approximately 6,200,000 shares of common stock. In connection with
the Merger, we will be required to issue approximately 17,200,000 shares of
common stock to Greenwich’s stockholders, plus warrants to purchase an
additional 4,000,000 shares. Accordingly, following the Merger we expect to
have
outstanding approximately 35,000,000 shares of common stock and options and
warrants to purchase an additional 10,200,000 common shares. Without the
increased number of authorized shares resulting from the Charter Amendment,
the
Company will have very few additional authorized shares remaining for issuance
and would likely need to seek shareholder approval in the near future. The
increased number of authorized shares resulting from the Charter Amendment
will
provide the Company with flexibility to raise additional capital in the future
by selling shares of its stock. Apart from the Merger and the proposed financing
transaction to generate proceeds in the amount of $5 million, the Company has
no
current intentions or understandings to issue the additional authorized shares
of common stock.
Effect
on VioQuest Stock
Because
the proposed Charter Amendment will increase the number of shares of the
Company’s authorized capital stock, there is a potential for further dilution of
shares of capital stock currently held by the Company’s shareholders if the
Company issues additional authorized shares of common stock. Further, if the
Company issues additional shares in financings or otherwise, the issued shares
may have rights, preferences or privileges senior to those of our common stock.
Other
than as contemplated by the Merger, we currently have no specific plans to
issue
additional stock. However, because the drug development business is very
expensive and we expect to incur losses for the foreseeable future, we will
need
to raise significant amounts of additional capital in the future, likely by
selling shares of our stock.
Additionally,
the proposed increase in the number of authorized shares of capital sotck,
and
the flexibility in structuring the terms and conditions of those shares may
be
viewed as giving the Board of Directors the ability to make a takeover attempt
more difficult. Management may use the shares to counter an offer by a bidder
wanting to obtain control of the Company. For example, management could issue
preferred shares with rights and preferences superior to common stock, such
as
superior voting rights, to persons friendly to management. Management has no
current intention to issue preferred shares for that purpose.
Required
Vote for the Charter Amendment
The
affirmative vote of a majority of the shares represented at the special meeting
is required to authorize the Charter Amendment. The enclosed form of Proxy
provides a means for shareholders (i) to vote for the Charter Amendment and
its
resulting effects, (ii) to vote against the Charter Amendment and its resulting
effects, or (iii) to abstain from voting with respect to the Charter Amendment
and its resulting effects. Each properly executed proxy received in time for
the
Meeting will be voted at such meeting as specified therein. If
a shareholder executes and returns a proxy but does not specify otherwise,
the
shares represented by such shareholder’s proxy will be voted for the Charter
Amendment and all its resulting effects.
A vote
for the proposal will constitute specific approval of the Charter Amendment
and
its resulting effects.
Board
Recommendation and Voting Requirements
The
Board of Directors recommends a vote FOR
approval of the proposal to amend the articles of incorporation of the Company.
Provided
a quorum is present, the
affirmative vote of holders of a majority of the shares represented at the
Meeting is required for approval of the proposal to amend the articles of
incorporation of the Company. Proxies solicited by our Board of Directors will
be voted for approval of the Charter Amendment, unless shareholders specify
otherwise in their proxies.
THE
MERGER
Background
of Merger
Greenwich
is a company founded by Lindsay A. Rosenwald, M.D. and his associates. Dr.
Rosenwald is the chairman and chief executive officer of Paramount BioCapital,
Inc., a New York-based merchant and investment bank and venture capital firm
that focuses on biotechnology companies. Among other business activities, with
its affiliates, Paramount BioCapital creates new companies to then in-license
novel drug and therapeutic technologies to develop and commercialize.
Under
this model, Paramount founded Greenwich in October 2004 and shortly thereafter
began negotiating with academic and research institutions to in-license the
rights to develop and commercialize novel drug and therapeutic technologies.
Aside from Dr. Rosenwald and various trusts established for his benefit, who
collectively own approximately 48 percent of Greenwich’s outstanding common
stock, the rest of Greenwich’s common stock is owned substantially by employees
and other associates of Paramount BioCapital, including Stephen C. Rocamboli
and
Michael Weiser, M.D., Ph.D., both of whom are directors of
VioQuest.
In
February 2005, Daniel Greenleaf, the President and Chief Executive Officer
of
VioQuest, became aware that Greenwich was in negotiations with both the
Cleveland Clinic to in-license the rights to develop and commercialize sodium
stibogluconate, or SSG, and with the Moffitt Cancer Center at the University
of
South Florida to in-license the rights to develop and commercialize triciribine,
or TCN. Mr. Greenleaf initiated preliminary discussions with Dr. Jeffrey Serbin,
an analyst employed by Paramount BioCapital who was involved in conducting
due
diligence research relating to SSG and TCN on behalf of Paramount and Greenwich
to determine if the technologies were available for sale to VioQuest. On several
occasions from February into March 2005, Mr. Greenleaf also had similar
discussions with Dr. Jason Stein, a senior analyst at Paramount, who is also
vice president of Greenwich and a member of its board of directors.
On
March
22, 2005, Mr. Greenleaf informed the VioQuest board of directors of his
discussions with Greenwich concerning acquiring the rights to its two drug
candidates and made a summary presentation of SSG and TCN. No action by the
VioQuest board was taken at this time.
Following
the March 22, 2005 VioQuest board meeting, Mr. Greenleaf continued in
discussions with Drs. Stein and Serbin and J. Jay Lobell, Paramount BioCapital’s
chief operating officer and the president of Greenwich, concerning the terms
and
form of a proposed transaction whereby VioQuest would acquire the rights to
SSG
and TCN.
On
April
4, 2005, at a meeting of the VioQuest board of directors, Dr. Serbin and Dr.
Matthew Wykoff made a presentation to the VioQuest board concerning SSG and
TCN,
which included a lengthy question and answer session with VioQuest’s board. The
VioQuest board took no action at the meeting.
On
April
14, 2005, Greenwich sent a preliminary term sheet to VioQuest’s management,
which outlined the terms of a proposed merger transaction between the two
companies. On April 19, 2005, the VioQuest board of directors met telephonically
to consider the term sheet. Mr. Rocamboli and Dr. Weiser did not participate
in
this meeting as a result of their interest in Greenwich. The board did not
take
any action at the meeting, but agreed to appoint a committee of disinterested
directors to consider and, if warranted, approve the term sheet. Following
this
board meeting, a written consent of the VioQuest board approving resolutions
that appointed a special committee consisting of Kenneth W. Brimmer, David
M.
Tanen and Mr. Greenleaf.
On
April
26, 2005, VioQuest engaged CRA International, a business valuation consultant
to
undertake to render a fairness opinion to VioQuest.
Through
the remainder of April, Mr. Greenleaf, Mr. Lenz and VioQuest’s legal counsel
held numerous discussions with representatives of Greenwich, including Mr.
Lobell, Dr. Stein and its counsel. VioQuest’s special committee of the board
also met several times to discuss and consider various proposed terms of the
transaction. On May 2, 2005, the VioQuest special committee authorized
VioQuest’s management to enter into a non-binding term sheet that outlined the
terms and conditions of a proposed merger transaction whereby a wholly-owned
subsidiary of VioQuest would merge with and into Greenwich, with Greenwich
becoming a wholly-owned subsidiary of VioQuest following the transaction. The
term sheet was executed on the evening of May 3, 2005, which VioQuest publicly
announced on May 4, 2005.
Following
the execution of the term sheet, the parties proceeded to negotiate a definitive
merger agreement and commenced due diligence. From early May through the end
of
June 2005, the parties conducted negotiations of the terms of a definitive
merger agreement, with both sides being assisted by its respective legal
counsel.
On
April
28, 2005, Mr. Greenleaf met with representatives of the Cleveland Clinic in
Cleveland, Ohio to discuss the development plans for SSG, and on May 17, 2005,
Mr. Greenleaf met with representatives of the Moffitt Cancer Center in Tampa,
Florida to discuss the development plans relating to TCN.
On
June
17, 2005, CRA International delivered an oral report to the VioQuest board
of
directors concerning its analysis of the financial terms of the Merger. The
VioQuest board of directors approved the terms of the merger at that date.
However,
following that date, additional negotiations were required with respect to
certain terms. On June 28, 2005, VioQuest’s management informed its board of
directors of the additional items that remained open. The next day, Mr.
Greenleaf met with Mr. Lobell in New York to finalize the agreement on these
open terms. The definitive merger agreement was signed July 1,
2005.
As
a
result of their past business relationships, the officers and
directors of VioQuest have known the founders and principals of Greenwich
for, in some cases, several years. Specifically, because VioQuest itself was
founded, in part, by Dr. Rosenwald and others at Paramount, many of VioQuest’s
officers and directors have developed business relationships with various
Paramount employees who have co-founded Greenwich.
VioQuest’s
Reasons for the Merger
In
August
2004, VioQuest determined to expand its business into biotechnology and drug
development, in addition to its chiral products and services business. VioQuest
then began searching for a chief executive officer candidate with experience
in
biotechnology and drug development, particularly with the development of
therapeutics for use in oncology, viral and autoimmune diseases. In February
2005, the Company hired Mr. Greenleaf as its President and CEO, who was then
charged with finding and acquiring the rights to one or more promising drug
candidates for the Company to develop and commercialize. As indicated above,
shortly after his hiring, Mr. Greenleaf became aware that Greenwich had just
acquired the rights to SSG and was about to acquire the rights to TCN. Following
research and due diligence of these two drug candidates, as well as
approximately two dozen other drug candidates held by various unaffiliated
third
parties, VioQuest’s management believed the Greenwich drugs offered exciting
potential as oncology therapeutics. The Company continued its scientific due
diligence, which concluded that SSG and TCN are promising drug candidates.
VioQuest’s management believes that the Merger and resulting acquisition of SSG
and TCN will help fulfill VioQuest’s objective of developing a therapeutics
business, which it believes will enhance shareholder value.
In
addition to its consideration of the potential of Greenwich’s two product
candidates, in determining to approve the Merger and the transactions
contemplated by the Merger Agreement, the VioQuest board also considered
potential negative factors relating to the transaction. For example, the Board
considered the substantial dilution that will result to VioQuest’s shareholders
as a result of the issuance of the Merger Shares and Merger Warrants to the
stockholders of Greenwich. The board concluded that this factor was mitigated,
to some extent, by the requirement that one-half of the Merger Shares and Merger
Warrants will be placed in escrow and released only upon the achievement of
milestones relating to the clinical development of Greenwich’s product
candidates, as discussed in more detail below. See “ - The Merger Agreement -
Escrow of Merger Consideration.” The VioQuest board also considered the need and
expense involved in reincorporating the Company under Delaware law as a result
of the fact that the Merger is a transaction with a related party.
The
Merger Agreement
General
Terms of the Merger
Pursuant
to an Agreement and Plan of Merger dated July 1, 2005 (the “Merger Agreement”),
between the Company, VQ Acquisition Corp., a Delaware corporation and our
wholly-owned subsidiary (“VQ Merger Sub”), and Greenwich, we have agreed to
effect a merger transaction in which SubCo will merge with and into Greenwich,
with Greenwich remaining as the surviving corporation and our wholly-owned
subsidiary (the “Merger”). In exchange for their shares of common stock, the
stockholders of Greenwich will be entitled to receive such number of shares
of
VioQuest common stock representing approximately 47 percent of the outstanding
fully-diluted common shares of VioQuest after giving effect to the Merger.
Upon
completion of the Merger, Greenwich will continue its current operations as
a
wholly owned operating subsidiary of VioQuest.
Manner
and Basis of Converting Greenwich Shares
At
the
effective time of the Merger, each of the issued and outstanding shares of
Greenwich common stock, other than shares held by persons who exercise
dissenters’ rights, will be converted into a number of shares of VioQuest common
stock (the “Merger Shares”) determined by applying an exchange ratio calculated
by dividing:
|
(a)
|
the
fraction 49/51, multiplied
by
|
|
(b)
|
the
number of shares of VioQuest common stock issued and outstanding
immediately prior to the effective time of the Merger; by
|
|
(2)
|
the
number of shares of Greenwich Common Stock issued and outstanding
immediately prior to the Effective Time on a fully diluted basis.
|
In
addition to the Merger Shares, the Greenwich stockholders will collectively
receive five-year warrants to purchase an aggregate of 4,000,000 shares of
VioQuest common stock at an exercise price of $1.41 per share (the “Merger
Warrants”), which approximates the blended terms of the currently outstanding
options and warrants to purchase VioQuest common stock. As of the date of this
proxy statement, there were 17,827,924 shares of VioQuest common stock issued
and outstanding and 4,000,000 shares of Greenwich common stock issued and
outstanding. Assuming no additional shares of either company are issued prior
to
the closing of the Merger, each share of Greenwich common stock will
automatically convert into and be exchangeable for 4.2822 shares of VioQuest
common stock (or approximately 17,128,800 shares of VioQuest common stock in
the
aggregate) and one Merger Warrant. Based on the foregoing, the Greenwich
stockholders will hold 49 percent of the issued and outstanding shares of
VioQuest common stock, or approximately 47 percent of VioQuest’s common stock on
a fully-diluted basis (i.e., assuming the issuance of all shares subject to
outstanding options, warrants and other rights to acquire VioQuest common stock,
including the issuance of all shares and warrants subject to escrow pursuant
to
the Merger Agreement).
Escrow
of Merger Consideration
Pursuant
to the Merger Agreement, one-half of both the Merger Shares and Merger Warrants
issuable to the stockholders of Greenwich will be placed in escrow (the
“Escrowed Securities”) with an unaffiliated escrow agent pursuant to an escrow
agreement to be entered into among VioQuest, Greenwich, a third party escrow
agent, and a representative appointed by the stockholders of Greenwich.
The
Escrowed Securities shall be released from escrow after closing and delivered
to
the Greenwich stockholders as follows:
|
(i)
|
thirty-five
percent (35%) of the Escrowed Securities shall be released immediately
upon the conclusion of a Phase I clinical trial pursuant to an
investigational new drug, or IND, application accepted by the U.S.
Food
and Drug Administration, or FDA, for Sodium Stibogluconate, or SSG;
|
|
(ii)
|
fifteen
percent (15%) of the Escrowed Securities shall
be released immediately upon conclusion of a Phase II clinical trial
for
SSG under a VioQuest-sponsored IND; provided that a majority of the
members of VioQuest’s then existing medical advisory board conclude that
such trial yielded results which, in the opinion of such advisory
board,
warrant initiation of Phase III trial(s) (provided that this milestone
shall be deemed to have been satisfied in the event a new drug
application, or NDA, relating to SSG has been accepted for review
by the
FDA prior to any determination by the medical advisory board to initiate
a
Phase III trial);
|
|
(iii)
|
thirty-five
percent (35%) of such Escrowed Securities shall be released immediately
upon the conclusion of a Phase I clinical trial pursuant to a
VioQuest-sponsored IND application accepted by the FDA for Triciribine,
or
TCN; and
|
|
(iv)
|
fifteen
percent (15%) of such Escrowed Securities shall
be released immediately upon conclusion of a Phase II clinical
trial for
TCN under a VioQuest-sponsored IND; provided that a majority of
the
members of VioQuest’s then existing medical advisory board conclude that
such trial yielded results which, in the opinion of such advisory
board,
warrant initiation of Phase III trial(s) (provided that this milestone
shall be deemed to have been satisfied in the event an NDA relating
to TCN
has been accepted for review by the FDA prior to any determination
by the
medical advisory board to initiate a Phase III
trial.
|
Notwithstanding
the foregoing, all Escrowed Securities
will
be
released to the Greenwich stockholders upon a “change of control” of VioQuest or
Greenwich occurring after the Merger but prior to June 30, 2008. For purposes
of
the Merger Agreement, a “Change of Control” means (a)
the
merger or consolidation of VioQuest
or Greenwich with
or
into another entity in which the stockholders of VioQuest or Greenwich, as
applicable, immediately prior to such merger or consolidation own less than
60
percent of the voting securities of the surviving entity, (b) any other
transaction or series of transactions as a result of which the shareholders
of
VioQuest or Greenwich, as applicable, immediately
prior to such transaction or series of transactions own less than 60 percent
of
the voting securities of VioQuest or Greenwich, as applicable, or other
surviving entity following such transaction (other than the sale of equity
securities by Parent in a capital raising transaction) or (c) the sale or
license of all or substantially all of the assets of Parent or Greenwich, as
applicable, provided that in the case of Greenwich such sale is not to a wholly
owned subsidiary of VioQuest.
In
the
event that the Escrowed Securities relating to the milestones described above
have not been released to Greenwich stockholders by June 30, 2008, any Escrowed
Shares still remaining in the escrow shall be released and delivered to VioQuest
for cancellation, and the Greenwich shareholders will have no further right,
title or interest to such Escrowed Shares. Notwithstanding the foregoing, the
Escrowed Securities shall be deemed to be issued and outstanding for economic
purposes while such Escrowed Securities are in escrow, and all cash dividends
or
other consideration or distributions (including without limitation additional
securities) declared by VioQuest on any Escrowed Securities and or otherwise
received by VioQuest for payment or distribution to shareholders of record
of
VioQuest at any point that any Escrowed Securities are in escrow, will be
credited to such Escrowed Shares on a pro rata basis and immediately deposited
by VioQuest with the escrow agent as additional Escrowed Securities or as
additional consideration or distributions to be held and distributed by the
escrow agent in accordance with the terms hereof.
Nominal
Consideration
Greenwich
stockholders borrowed from Paramount BioCapital, Inc., a New York-based merchant
and investment bank and venture capital firm that focuses on biotechnology
companies, Lindsay A. Rosenwald, M.D., and their affiliates substantially all
of
the funds necessary to conduct operations and to acquire the licenses held
by
Greenwich to the two drug candidates from The Cleveland Clinic Foundation and
the University of South Florida Research Foundation, Inc. Most of this
indebtedness will be repaid to Paramount BioCapital, Dr. Rosenwald and their
affiliates from the proceeds of VioQuest private placements. Greenwich
stockholders will therefore acquire their controlling interest in VioQuest
for
nominal consideration, including license agreements for uproven and undeveloped
drug candidates.
Registration
Rights; Lockup Agreement
VioQuest
has agreed to grant “piggy-back” registration rights with respect to the Merger
Shares issuable to Greenwich’s stockholders. This means that, in connection with
the next registration statement to be filed by VioQuest under the Securities
Act
(other than registrations on Forms S-4 or S-8), VioQuest will include the Merger
Shares in such registration. Notwithstanding this obligation, however, the
Greenwich stockholders will not be permitted to sell or otherwise transfer
their
Merger Shares (subject to limited exceptions for transfers made by
operation of law and pursuant to a bona fide gift or private sale to any person
or other entity that agrees in writing to be bound by the provisions of the
Registration Rights Agreement)
for a
period of one year from the closing of the Merger.
Representations
and Warranties
The
Merger Agreement contains various mutual customary representations and
warranties relating to, among other things:
· |
the
due organization, power and standing of the Company and
Greenwich;
|
· |
the
capital structure and the authorization and validity of the outstanding
shares of capital stock of the Company, VQ Merger Sub and
Greenwich;
|
· |
the
authorization, execution, delivery and performance by and enforceability
of the Merger Agreement against, the Company and
Greenwich;
|
· |
the
absence of any provision of each party’s articles or bylaws or any
agreements, governmental authorizations, laws, regulations or orders
in
conflict with such party’s authorization, execution, delivery or
performance of the Merger
Agreement;
|
· |
the
absence of any public body, court or authority’s authorization, consent or
approval required for the consummation of the Merger by the Company,
VQ
Merger Sub and Greenwich;
|
· |
conformity
with generally accepted accounting principles of the respective financial
statements;
|
· |
the
absence of certain changes or events with respect to the Company
and
Greenwich;
|
· |
the
filing of tax returns, the absence of tax audits, the payment of
taxes and
related tax matters by the Company and Greenwich;
|
· |
the
rights in certain intellectual property of the Company and
Greenwich;
|
· |
compliance
with applicable laws and possession of necessary permits by the Company
and Greenwich, including compliance with the
FDA;
|
· |
the
absence of pending or threatened actions against such party with
respect
to the Merger;
|
· |
the
absence of claims for brokerage commissions, finders’ fees, investment
advisory fees or similar compensation based upon arrangements made
by or
on behalf of the Company or Greenwich with respect to the
Merger;
|
· |
employee
relations and certain other matters related to employees of the Company
and Greenwich;
|
· |
certain
employee benefit plans and matters arising under the Employee Retirement
Income Security Act of 1974, as
amended;
|
· |
title
(including leashold title) of the Company and Greenwich to, and the
absence of liens against certain properties and
assets;
|
· |
the
absence of environmental liabilities and compliance with environmental
laws;
|
· |
certain
material contracts to which the Company or Greenwich is a party and
the
absence of defaults and breaches with respect
thereto;
|
· |
insurance
policies of the Company and Greenwich and certain matters related
thereto;
and
|
· |
material
disclosure by the Company and
Greenwich.
|
In
addition to the mutual representations and warranties listed above, VioQuest
and
VQ Merger Sub have given representations and warranties relating to the
following:
· |
the
filing of reports and other documents with the SEC, the material
compliance of such documents with SEC fules and regulations and the
accuracy of the information contained therein;
|
· |
the
absence of interim operations of VQ Merger Sub;
and
|
· |
the
authorization and validity of the shares of common stock to be
issued
pursuant to the Merger Agreement
|
Closing
Conditions
The
closing of the Merger is subject to the following conditions: (i) the Company’s
shareholders will have approved the Reincorporation; (ii) the Company will
have
succeeded in raising $5,000,000 in proceeds in a financining transaction; (iii)
holders of 98 percent of Greenwich’s common stock having completed a stockholder
questionnaire; (iv) the parties to the Merger Agreement will have executed
a
registration rights agreement and an escrow agreement; (v) no more than 2
percent of Greenwich stockholders will have exercised their statutory appraisal
rights under Delaware law; (vi) receipt by VioQuest of a fairness opinion from
its financial advisor; and (vii) customary officer certificates and tax and
legal opinions will have been delivered.
Termination
The
Merger Agreement may be terminated at any time prior to the effective time
of
the Merger:
(1) by
either
VioQuest or Greenwich if:
· |
the
Merger shall not have been completed by October 31, 2005;
or
|
· |
a
governmental authority or court shall have issued an order or taken
other
action prohibiting the Merger;
|
(2) by
VioQuest if:
· |
the
Reincorporation proposal is not approved by VioQuest’s
shareholders;
|
· |
any
of the conditions precedent to VioQuest’s obligation to complete the
Merger become incapable of satisfaction prior to October 31, 2005,
provided that the failure of such condition is not the fault of
VioQuest;
|
· |
Greenwich
materially breaches or fails to perform any representation, warranty
or
covenant made by Greenwich in the Merger Agreement;
or
|
· |
the
board of directors of Greenwich withdraws its approval of the Merger
or
takes any other adverse action relating to the Merger or the Greenwich
board of directors fails to reaffirm in writing its recommendation
to the
Greenwich stockholders that they approve the Merger within five days
of
VioQuest’s request to do so;
|
(3) by
Greenwich if:
· |
any
of the conditions precedent to Greenwich’s obligation to complete the
Merger become incapable of satisfaction prior to October 31, 2005,
provided that the failure of such condition is not the fault of
Greenwich;
|
· |
VioQuest
materially breaches or fails to perform any representation, warranty
or
covenant made by VioQuest in the Merger Agreement;
or
|
· |
the
board of directors of VioQuest withdraws its approval of the Merger
or
takes any other adverse action relating to the
Merger.
|
If
prior
to receiving the approval of Greenwich’s stockholders, Greenwich terminates the
Merger Agreement as a result of having received a superior unsolicited offer
or
if VioQuest terminates the Merger Agreement as a result of having received
a
superior unsolicited offer, then the terminating party must reimburse the
non-terminating party for all reasonable out-of-pocket expenses actually
incurred by the non-terminating party in connection with the Merger Agreement
up
to a limit of $25,000. Such expenses may include fees paid to counsel,
accountants, experts and other consultants.
Interest
of Certain VioQuest Directors in Greenwich
Stephen
C. Rocamboli and Michael Weiser, M.D., Ph.D., both of whom are directors of
VioQuest, are stockholders of Greenwich. Mr. Rocamboli owns 144,000 shares
of
Greenwich common stock and Dr. Weiser owns 280,000 shares of Greenwich common
stock. Accordingly, upon completion of the Merger, Mr. Rocamboli will receive
approximately 616,320 Merger Shares (assuming a merger conversion ratio of
approximately 4.28 shares of VioQuest common stock for each share of Greenwich
common stock owned) and 144,000 Merger Warrants, and will beneficially own
approximately 2.5 percent of the VioQuest’s outstanding common stock upon the
Merger. Dr. Weiser will receive approximately 1,198,400 Merger Shares and
280,000 Merger Warrants, and will beneficially own approximately 5.4 percent
of
the VioQuest’s outstanding common stock upon the Merger. Mr. Rocamboli’s and Dr.
Weiser’s interests in Greenwich were made known to VioQuest’s board of directors
at the outset of the negotiating process between the companies and neither
attended or otherwise participated in any meeting and other discussion of the
VioQuest board in all matters relating to the Merger.
Each
of
Mr. Rocamboli and Dr. Weiser are also employed by Paramount BioCapital, Inc.,
of
which Dr. Lindsay Rosenwald is the chairman and sole stockholder. Together
with
various trusts established for his and his family’s benefit, Dr. Rosenwald owns
approximately 48 percent of Greenwich’s outstanding common stock and
approximately 16 percent of VioQuest’s common stock. Upon completion of the
Merger, Dr. Rosenwald and the Rosenwald Trusts will beneficially own
approximately 37 percent of VioQuest’s outstanding common stock. See
“Shareholder Proposal No. 1: Reincorporation Under Delaware Law - Reasons for
the Reincorporation - Condition to Completing the Merger with
Greenwich.”
Management
of Company after the Merger
Those
individuals serving as directors and officers of the Company prior to the Merger
will continue to serve as directors and officers of the Company following the
Merger.
Regulatory
Approval
No
federal or state regulatory approvals are required in connection with the
Merger.
Material
Federal Income Tax Consequences
Pursuant
to the merger agreement, a wholly-owned subsidiary of VioQuest will be merged
with and into Greenwich, with Greenwich as the surviving corporation, in
exchange for approximately 49 percent of the issued and outstanding common
stock
of VioQuest on a post-transaction basis, plus warrants to purchase an additional
4,000,000 shares of VioQuest common stock. For federal income tax purposes,
it
is expected that no gain or loss will be recognized by VioQuest or VioQuest
shareholders as a result of the Merger.
CERTAIN
INFORMATION REGARDING VIOQUEST
General
VioQuest
Pharmaceuticals, Inc. has two subsidiaries - VioQuest Drug Development, Inc.,
which was created for the purpose of acquiring, developing and eventually
commercializing human therapeutics in the areas of oncology, viral and
autoimmune diseases and disorders that are current unmet medical needs,
and
Chiral Quest, Inc., which continues our historical business of providing chiral
products, technology and services to pharmaceutical and fine chemical companies
in all stages of the product lifecycles with innovative chiral products and
services. Chiral Quest has three main lines of products and services -
proprietary chiral catalysts and chiral building blocks or client-defined
molecules and process synthesis contract research services. We have the rights
to certain chemical compounds known as chiral ligands which, with the
introduction of a metal, serve as catalysts in facilitating the production
of
chiral molecules in such a manner that there is a preferential manufacture
of
the desired molecule versus the unwanted mirror-image molecule. We provide
pharmaceutical and fine chemical manufacturers and other prospective clients
with broad access to our technologies for testing purposes at a low upfront
cost, coupled with the opportunity to gain access to such technologies for
specific applications for fees, royalties and certain manufacturing and
development rights. Our ligands may also find use in producing fine chemicals
other than pharmaceuticals - chiral molecules are used in flavors, fragrances,
agrochemicals, animal health, food and feed additives (including vitamins)
and
nutraceuticals. In connection with our chiral technology, we provide specialized
services to pharmaceutical, biotechnology and fine chemical companies relating
to the development of chiral manufacturing processes for their
products.
Our
proprietary chiral technology was developed by Dr. Xumu Zhang, a professor
at
Pennsylvania State University (“Penn State”) and is owned by the Penn State
Research Foundation (“PSRF”), the technology development arm of Penn State. In
November 2000, we obtained from the PSRF an exclusive, worldwide license to
certain patents based on Dr. Zhang’s research relating to asymmetrical catalysis
technologies. This license gives us the right to, among other things,
sub-license technology rights on a non-exclusive basis to clients, or sell
molecule groups, known as ligands, to pharmaceutical and fine chemical company
clients for both research and commercial applications.
Through
Chiral Quest, we are also engaged in developing and making client-defined
building blocks and drug candidate fragments, mainly in the chiral area. With
this process chemistry offering to life sciences companies, we develop new
synthetic routes or optimize existing ones and produce certain quantities of
material for further processing at the clients’ needs either for further
elaboration, clinical trials or beyond.
We
are a
Minnesota corporation that resulted from the reverse merger of Chiral Quest,
LLC, a Pennsylvania limited liability company that commenced operations in
October 2000, and Surg II, Inc., a Minnesota corporation, on February 18,
2003.
Chiral
Business
Chiral
Quest has the rights to certain chemical compounds known as chiral ligands
which, with the introduction of a metal, serve as catalysts in facilitating
the
production of chiral molecules in such a manner that there is a preferential
manufacture of the desired molecule. Our products include bulk chiral catalysts,
proprietary building blocks / client-defined targets and a proprietary “Chiral
ToolKit”, comprised of a diverse set of chiral ligands that when combined with
transition metals to catalyze reactions leading to chiral molecules.
A
molecule is considered “chiral” because it exists in two “enantiomers,” or
non-superimposable mirror images of each other analogous to one’s left and right
hands. Most drugs interact with biological targets in a specific manner,
requiring the drug to be of a specific shape and orientation. Contaminating
“wrong-handed” enantiomers of the active drug molecule will probably not
interact with the biological drug target, or worse, interact with a different
biological molecule in an unintended and often toxic manner. Thalidomide, the
morning sickness drug used by pregnant women in the 1960’s, is a notorious
example of an impure chiral drug. One enantiomer of the drug’s chiral molecules
treated morning sickness, while its undesired enantiomer impurity caused birth
defects. Pharmaceutical companies are typically required, at great expense,
to
purify the active mirror-image form of the drug molecule away from its
contaminating or inactive counterpart, to maximize both safety and efficacy.
We
also
use our technology to provide specialized services to pharmaceutical,
biotechnology and fine chemical companies relating to the development of chiral
manufacturing processes for their products. Furthermore, Chiral Quest offers
a
variety of services covering specialized chiral transformation screening, chiral
synthetic or process support and chiral manufacturing solutions to be delivered
on a partnership/contract basis with client firms.
It
is
estimated that more than one-half of new drugs in Phases II and III development
are chiral and approximately 90 percent of the new chiral substances are
developed anantiomerically pure. In 2003, chiral drug sales exceeded $160
billion, which represents more than one-third of total pharmaceutical sales
for
that year. It is estimated that the market for chiral drugs is increasing at
an
annual rate of 8-10 percent and worldwide revenues are expected to reach $15
billion by 2008.
After
the
Merger, our working capital requirements will also be substantially impacted
by
the costs associated with the development of Greenwich’s product candidates.
These development costs will significantly impact our working capital based
upon
milestone payments, license fees, and regulatory approval and manufacturing
costs. As a result, the Company will experience a significant increase in losses
on a consolidated basis for the foreseeable future.
Given
that Greenwich’s officers and directors will not continue in their roles, the
Company intends to build upon its experience base to continue the development
of
Greenwich’s product candidates. Further, the Company intends to hire appropriate
personnel to bolster the development and commercialization of the product
candidates.
Our
Technology
The
Chiral Quest “Chiral Library” depicted below identifies the current commercial
portfolio of proprietary ligands from which clients order both the Chiral
ToolKit selection sets for Research and Development testing as
well as
bulk quantities for larger scale uses and commercialization.
Our
Products and Services
Chiral
ToolKit.
We
currently sell products that represent several of the proprietary families
of
our chiral ligands to which the Company has exclusive rights. These ligands
are
sold in research quantities that are packaged in convenient Chiral ToolKit
sets
for exclusive use in research applications by client companies. These
innovative, patent protected ligands are screened by clients for applications
in
the manufacturing of their chiral molecules. Clients use this screening process
to determine which ligands may prove optimal for their chiral manufacturing
needs. The sale of research quantities of ligands allows clients to gain initial
access to our technology and to independently validate the advantages provided
by that technology.
Screening
Services.
We also
provide focused screening of client supplied target compounds using our
proprietary ligands. In addition to the select ligands included in the Chiral
ToolKit, we have several families of chiral ligands that are used to “screen”
target compounds. In other words, we “test” our ligands with target compounds to
determine whether our ligands can be used efficiently to manufacture a desired
building block or compound for a client. Accordingly, we will identify and
prepare individual ligands optimized for particular client needs. Sometimes,
because of their expertise and know-how, our chemists can develop a “higher
yield” manufacturing process using our ligands with a client target than outside
chemists using our Chiral Toolkit independently on the same chiral targets.
We
work with our clients to help optimize the conditions under which our ligands
are used and also produce certain molecules of customer interest. This may
involve the development of novel manufacturing processes.
Bulk
Ligands.
We also
sell larger quantities of proprietary chiral ligands to which we have exclusive
rights, including some that are not included in our Chiral ToolKit. These
ligands are sold individually to clients in amounts specified by the client
according to their research, development or semi-commercial needs. One of our
objectives is to provide clients with their required ligands and catalysts,
either from our own laboratories or through third party manufacturers, for
research, clinical and commercial purposes.
Proprietary
Building Blocks / Client-Defined Targets.
We may
also produce and sell certain selected chiral products defined by our clients
such as chiral building blocks or intermediates. “Building Blocks” or
“intermediates” are completed parts or refined raw material used to ultimately
manufacture a finished product.
Sales
and Marketing
We
sell
our products and services directly to clients both in the pharmaceutical and
fine chemical areas. In September 2004 and January 2005, we hired
a Director of Global Operations and Vice President of Business Development,
who are focused on sales and marketing activities. We intend to hire
additional marketing personnel in the near future.
Competition
Competition
in the traditional area of separation manufacture of chiral molecules comes
from
a few distinct sources, including Chiral Technologies Inc., ChromTech Ltd.,
NovaSep, Inc. and Advance Separation Technologies Inc. Traditional methods
of
manufacturing chiral molecules involve the production of a mixture of both
chiral forms of molecules of interest, followed by a process which separates
the
desired enantiomer from the undesired enantiomer. This methodology, though
still
commonly used, is extremely cost-ineffective, as it results in the loss of
greater than 50 percent of the intermediate product at each chiral purification
step. We believe we have a competitive advantage over companies using
traditional methods of separation because our technology drives the preferential
manufacture of chiral enantiomers of interest, which can result in 95 to 99
percent yields. This can result in significant cost savings in the manufacturing
process, particularly for chiral molecules that may require several chiral
separation steps by traditional methods.
In
the
area of chemical catalysts for chiral drug manufacturing, we compete with
pharmaceutical and fine chemical companies, including our current and potential
clients and collaborators, as well as academic and research institutions. Some
of these companies include the Dow Chemical Company, Degussa AG, Rhodia ChiRex
Inc. and Solvias AG. Many of these companies are developing or marketing
technologies and services similar to the ones developed or offered by us. We
anticipate continued competition from other manufacturers of chiral catalysts
in
the future.
Some
of
our competitors, such as Codexis, a wholly owned subsidiary of Maxygen, or
Diversa Corporation, attempt to genetically modify biological enzymes for the
purpose of serving as biological catalysts for asymmetric chiral manufacturing.
While this approach works in certain circumstances, it is extremely
time-consuming to develop for each individual manufacturing process. We believe
our technology has the competitive advantage of being more broadly applicable
to
a number of common asymmetric transformations.
Proposed
Drug Development Business
In
2004,
we determined to also pursue a drug development business. Accordingly, we are
seeking to acquire, develop and bring to market therapies for
oncological, viral and autoimmune diseases. Pursuant to these
ends, on
July 1, 2005, we entered into a definitive agreement to acquire Greenwich
Therapeutics, which holds exclusive rights to develop and commercialize two
oncology drug candidates as discussed in “INFORMATION REGARDING GREENWICH
THERAPEUTICS.”
Market
for Company Common Stock
Since
August 27, 2004, VioQuest’s common stock has traded on the OTC Bulletin Board
under the symbol “VQPH.OB”. From February 18, 2003, VioQuest’s common stock
traded on the OTC Bulletin Board under the symbol “CQST.OB.” From October 4,
2002 to February 18, 2003, it traded under the symbol “SURG.OB.” The following
table lists the high and low bid price for VioQuest’s common stock as quoted, in
U.S. dollars, by the OTC Bulletin Board, as applicable, during each quarter
within the last two completed fiscal years and the first two completed quarters
of fiscal 2005. These quotations reflect inter-dealer prices, without retail
mark-up, markdown, or commission and may not represent actual transactions.
Trading on our common stock has been sporadic, exemplified by the low trading
volume and many days upon which no trades occurred.
|
|
Price
Range
|
Quarter
Ended
|
|
High
|
|
Low
|
March
31, 2003
|
|
1.65
|
|
1.62
|
June
30, 2003
|
|
2.50
|
|
1.55
|
September
30, 2003
|
|
2.23
|
|
2.00
|
December
31, 2003
|
|
1.83
|
|
1.50
|
March
31, 2004
|
|
1.76
|
|
1.76
|
June
30, 2004
|
|
1.05
|
|
1.05
|
September
30, 2004
|
|
1.25
|
|
1.25
|
December
31, 2004
|
|
0.95
|
|
0.80
|
March
31, 2005
|
|
0.95
|
|
0.60
|
June
30, 2005
|
|
1.01
|
|
0.59
|
As
of
July 11, 2005, VioQuest had approximately 1,500 shareholders of record. It
is
believed that approximately 2,500 additional shareholders own shares of VioQuest
common stock in street name.
INFORMATION
REGARDING GREENWICH THERAPEUTICS
Overview
Greenwich
is a corporation formed on October 28, 2004 under the laws of the State of
Delaware. Since inception, it has been focused on acquiring the rights to
develop and commercialize pharmaceutical drug candidates, particularly
candidates for use in oncology. Greenwich currently has the exclusive rights
to
develop and commercialize two oncology drug candidates - Sodium Stibogluconate,
also called “SSG,” and Triciribine, or “TCN.”
To
date,
Greenwich is only in the early stages of development of its product candidates,
which is a very lengthy and expensive process. None of its product candidates
have been approved for sale by the U.S. Food and Drug Administration or any
other regulatory body, and neither Greenwich nor us, assuming completion of
the
Merger, expects to have obtained such approvals for several years, if ever.
Accordingly, Greenwich has not received any commercial revenues to date and,
until the necessary regulatory approvals for Greenwich’s drug candidates are
obtained, Greenwich’s business will not generate any commercial revenues.
Further, Greenwich (or our company, assuming completion of the Merger) will
need
substantial additional capital in the future in order to fund the development
of
Greenwich’s product candidates to completion. Greenwich has a history of losses
since its inception and expects to continue incurring substantial losses and
negative operating cash flow for the foreseeable future.
Greenwich’s
principal executive office is located at 787 Seventh Avenue, 48th
Floor,
New York, New York 10019 and its telephone number is (212)
554-4300.
Oncology
Overview
Cancer
is
the second leading cause of death in America. In the U.S., half of all men
and
one third of all women will develop cancer at some point in their lives. Since
1990, over 17 million new cancer cases have been diagnosed. A number of drugs
are used in the treatment of cancer. These drugs are used to reduce pain,
prolong the life of the patient, send the cancer into remission or eliminate
the
cancer completely. There is great opportunity for improvement in all types
of
cancer treatment. Recognizing this vast health and commercial opportunity,
Greenwich was established as a biopharmaceutical company that acquires,
develops, and commercializes innovative products for the treatment of important
unmet medical needs in cancer and immunological diseases.
Definition
of Cancer
Cancer
develops when abnormal cells in the body begin to grow out of control. These
cancer cells will out live normal cells and go on to form additional cancerous
cells. The danger is that these cells will often travel to other parts of the
body and replace normal tissue, a process called metastasis. Frequently, these
metastases ultimately lead to a patient’s death. Although the exact cause of
cancer is still uncertain, it is believed that genetics and environmental toxins
play a role.
Cancer
Statistics and Market Overview
The
American Cancer Society estimates that 1,372,910 new cases of cancer will be
diagnosed in 2005 alone. The National Institute of Health estimated an overall
cost of cancer to be $189.8 billion in 2004. This cost includes $69.4 billion
in
direct medical expenses, $16.9 billion in indirect morbidity costs, and $103.5
billion in indirect mortality costs. This year, 570,280 deaths are expected
to
be due to cancer or one in four deaths in the US. For all types of cancer
diagnosed between 1995 and 2000 combined, the 5-year relative survival rate
is
64%. A list of incidence rates of leading cancers in the US can be found on
the
following page.
|
|
Estimated
|
|
Actual
|
|
5-Year
Relative
|
|
|
Cancer
|
|
Cancer
|
|
Survival
Rates
|
|
|
Cases
|
|
Deaths
|
|
(Percent)
|
Primary
Site
|
|
in
2000
|
|
in
2000
|
|
1950-54
|
|
1992-99
|
Oral
cavity and Pharynx
|
|
30,200
|
|
7,492
|
|
46
|
|
59.7
|
Esophagus
|
|
12,300
|
|
12,232
|
|
4
|
|
15.4
|
Stomach
|
|
21,500
|
|
12,645
|
|
12
|
|
21.4
|
Colon
and Rectum
|
|
130,200
|
|
57,477
|
|
37
|
|
63.0
|
Colon
|
|
93,800
|
|
48,570
|
|
41
|
|
63.0
|
Rectum
|
|
36,400
|
|
8,907
|
|
40
|
|
63.0
|
Liver
and Intrahep
|
|
15,300
|
|
16,582
|
|
1
|
|
6.8
|
Pancreas
|
|
28,300
|
|
29,331
|
|
1
|
|
4.4
|
Larynx
|
|
10,100
|
|
3,861
|
|
52
|
|
66.6
|
Lung
and Bronchus
|
|
164,100
|
|
155,788
|
|
6
|
|
15.1
|
Males
|
|
89,500
|
|
90,676
|
|
5
|
|
13.4
|
Females
|
|
74,600
|
|
65,112
|
|
9
|
|
17.2
|
Melanoma
of the skin
|
|
47,700
|
|
7,420
|
|
49
|
|
89.8
|
Breast(females)
|
|
182,800
|
|
41,872
|
|
60
|
|
87.9
|
Cervix
uteri
|
|
12,800
|
|
4,200
|
|
59
|
|
72.9
|
Corpus
and Uterus, NOS
|
|
36,100
|
|
6,585
|
|
72
|
|
86.3
|
Ovary
|
|
23,100
|
|
14,453
|
|
30
|
|
52.4
|
Prostate
|
|
180,400
|
|
31,078
|
|
43
|
|
98.4
|
Testis
|
|
6,900
|
|
338
|
|
57
|
|
95.8
|
Urinary
bladder
|
|
53,200
|
|
12,306
|
|
53
|
|
82.6
|
Kidney
and Renal pelvis
|
|
31,200
|
|
12,038
|
|
34
|
|
62.9
|
Brain
and Other nervous
|
|
16,500
|
|
12,655
|
|
21
|
|
32.1
|
Thyroid
|
|
18,400
|
|
1,328
|
|
80
|
|
96.1
|
Hodgkin
lymphoma
|
|
7,400
|
|
1,287
|
|
30
|
|
85.0
|
Non-Hodgkin
lymphoma
|
|
54,900
|
|
22,553
|
|
33
|
|
57.2
|
Myeloma
|
|
13,600
|
|
10,697
|
|
6
|
|
30.9
|
Leukemia
|
|
30,800
|
|
21,339
|
|
10
|
|
47.6
|
Childhood(0-14
yrs)
|
|
8,600
|
|
1,526
|
|
20
|
|
78.7
|
All
Sites
|
|
1,220,100
|
|
553,080
|
|
35
|
|
64.4
|
Source:
SEER Cancer Statistics Review
1975-2000.
|
Government
Regulation
The
research, development, testing, manufacture, labeling, promotion, advertising,
distribution, and marketing, among other things, of our products are extensively
regulated by governmental authorities in the United States and other countries.
In the United States, the FDA regulates drugs under the Federal Food, Drug,
and
Cosmetic Act, or the “FDCA,” and its implementing regulations. Failure to comply
with the applicable U.S. requirements may subject us to administrative or
judicial sanctions, such as FDA refusal to approve pending NDAs, warning
letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, and/or criminal
prosecution.
Drug
Approval Process
None
of
Greenwich’s drugs may be marketed in the U.S. until the drug has received FDA
approval. The steps required before a drug may be marketed in the U.S.
include:
· |
preclinical
laboratory tests, animal studies, and formulation
studies;
|
· |
submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin;
|
· |
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication;
|
· |
submission
to the FDA of an NDA;
|
· |
satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or “cGMPs”;
and
|
· |
FDA
review and approval of the NDA.
|
Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and
formulation, as well as animal studies. The conduct of the preclinical tests
and
formulation of the compounds for testing must comply with federal regulations
and requirements. The results of the preclinical tests, together with
manufacturing information and analytical data, are submitted to the FDA as
part
of an IND, which must become effective before human clinical trials may begin.
An IND will automatically become effective 30 days after receipt by the FDA,
unless before that time the FDA raises concerns or questions about issues such
as the conduct of the trials as outlined in the IND. In such a case, the IND
sponsor and the FDA must resolve any outstanding FDA concerns or questions
before clinical trials can proceed. We cannot be sure that submission of an
IND
will result in the FDA allowing clinical trials to begin.
Clinical
trials involve the administration of the investigational drug to human subjects
under the supervision of qualified investigators. Clinical trials are conducted
under protocols detailing the objectives of the study, the parameters to be
used
in monitoring safety, and the effectiveness criteria to be evaluated. Each
protocol must be submitted to the FDA as part of the IND.
Clinical
trials typically are conducted in three sequential phases, but the phases may
overlap. The study protocol and informed consent information for study subjects
in clinical trials must also be approved by an Institutional Review Board for
each institution where the trials will be conducted. Study subjects must sign
an
informed consent form before participating in a clinical trial. Phase I usually
involves the initial introduction of the investigational drug into people to
evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics
and pharmacologic actions, and, if possible, to gain an early indication of
its
effectiveness. Phase II usually involves trials in a limited patient population
to: (i) evaluate dosage tolerance and appropriate dosage; (ii) identify possible
adverse effects and safety risks; and (iii) evaluate preliminarily the efficacy
of the drug for specific indications. Phase III trials usually further evaluate
clinical efficacy and test further for safety by using the drug in its final
form in an expanded patient population. There can be no assurance that Phase
I,
Phase II, or Phase III testing will be completed successfully within any
specified period of time, if at all. Furthermore, the Company or the FDA may
suspend clinical trials at any time on various grounds, including a finding
that
the subjects or patients are being exposed to an unacceptable health
risk.
The
FDCA
permits the FDA and the IND sponsor to agree in writing on the design and size
of clinical studies intended to form the primary basis of an effectiveness
claim
in an NDA application. This process is known as Special Protocol Assessment,
or
SPA. These agreements may not be changed after the clinical studies begin,
except in limited circumstances.
Assuming
successful completion of the required clinical testing, the results of the
preclinical studies and of the clinical studies, together with other detailed
information, including information on the manufacture and composition of the
drug, are submitted to the FDA in the form of an NDA requesting approval to
market the product for one or more indications. The testing and approval process
requires substantial time, effort, and financial resources. The agencies review
the application and may deem it to be inadequate to support the registration
and
we cannot be sure that any approval will be granted on a timely basis, if at
all. The FDA may also refer the application to the appropriate advisory
committee, typically a panel of clinicians, for review, evaluation and a
recommendation as to whether the application should be approved. The FDA is
not
bound by the recommendations of the advisory committee.
The
FDA
has various programs, including fast track, priority review, and accelerated
approval, that are intended to expedite or simplify the process for reviewing
drugs, and/or provide for approval on the basis surrogate endpoints. Generally,
drugs that may be eligible for one or more of these programs are those for
serious or life-threatening conditions, those with the potential to address
unmet medical needs, and those that provide meaningful benefit over existing
treatments. We cannot be sure that any of our drugs will qualify for any of
these programs, or that, if a drug does qualify, that the review time will
be
reduced.
Section
505(b)(2) of the FDCA allows the FDA to approve a follow-on drug on the basis
of
data in the scientific literature or a prior FDA approval of an NDA for a
related drug. This procedure potentially makes it easier for generic drug
manufacturers to obtain rapid approval of new forms of drugs based on
proprietary data of the original drug manufacturer.
Before
approving an NDA, the FDA usually will inspect the facility or the facilities
at
which the drug is manufactured, and will not approve the product unless cGMP
compliance is satisfactory. If the FDA evaluates the NDA and the manufacturing
facilities as acceptable, the FDA may issue an approval letter, or in some
cases, an approvable letter followed by an approval letter. Both letters usually
contain a number of conditions that must be met in order to secure final
approval of the NDA. When and if those conditions have been met to the FDA’s
satisfaction, the FDA will issue an approval letter. The approval letter
authorizes commercial marketing of the drug for specific indications. As a
condition of NDA approval, the FDA may require postmarketing testing and
surveillance to monitor the drug’s safety or efficacy, or impose other
conditions.
After
approval, certain changes to the approved product, such as adding new
indications, making certain manufacturing changes, or making certain additional
labeling claims, are subject to further FDA review and approval. Before we
can
market our product candidates for additional indications, we must obtain
additional approvals from FDA. Obtaining approval for a new indication generally
requires that additional clinical studies be conducted. We cannot be sure that
any additional approval for new indications for any product candidate will
be
approved on a timely basis, or at all.
Post-Approval
Requirements
Often
times, even after a drug has been approved by the FDA for sale, the FDA may
require that certain post-approval requirements be satisfied, including the
conduct of additional clinical studies. If such post-approval conditions are
not
satisfied, the FDA may withdraw its approval of the drug. In addition, holders
of an approved NDA are required to: (i) report certain adverse reactions to
the
FDA; (ii) comply with certain requirements concerning advertising and
promotional labeling for their products; and (iii) continue to have quality
control and manufacturing procedures conform to cGMP after approval. The FDA
periodically inspects the sponsor’s records related to safety reporting and/or
manufacturing facilities; this latter effort includes assessment of compliance
with cGMP. Accordingly, manufacturers must continue to expend time, money,
and
effort in the area of production and quality control to maintain cGMP
compliance. We intend to use third party manufacturers to produce our products
in clinical and commercial quantities, and future FDA inspections may identify
compliance issues at the facilities of our contract manufacturers that may
disrupt production or distribution, or require substantial resources to correct.
In addition, discovery of problems with a product after approval may result
in
restrictions on a product, manufacturer, or holder of an approved NDA, including
withdrawal of the product from the market.
Orphan
Drug
The
FDA
may grant orphan drug designation to drugs intended to treat a “rare disease or
condition,” which generally is a disease or condition that affects fewer than
200,000 individuals in the United States. Orphan drug designation must be
requested before submitting an NDA. If the FDA grants orphan drug designation,
which it may not, the identity of the therapeutic agent and its potential orphan
use are publicly disclosed by the FDA. Orphan drug designation does not convey
an advantage in, or shorten the duration of, the review and approval process.
If
a product which has an orphan drug designation subsequently receives the first
FDA approval for the indication for which it has such designation, the product
is entitled to orphan exclusivity, meaning that the FDA may not approve any
other applications to market the same drug for the same indication, except
in
certain very limited circumstances, for a period of seven years. Orphan drug
designation does not prevent competitors from developing or marketing different
drugs for that indication.
Non-United
States Regulation
Before
our products can be marketed outside of the United States, they are subject
to
regulatory approval similar to that required in the United States, although
the
requirements governing the conduct of clinical trials, including additional
clinical trials that may be required, product licensing, pricing and
reimbursement vary widely from country to country. No action can be taken to
market any product in a country until an appropriate application has been
approved by the regulatory authorities in that country. The current approval
process varies from country to country, and the time spent in gaining approval
varies from that required for FDA approval. In certain countries, the sales
price of a product must also be approved. The pricing review period often begins
after market approval is granted. Even if a product is approved by a regulatory
authority, satisfactory prices may not be approved for such
product.
In
Europe, marketing authorizations may be submitted at a centralized, a
decentralized or national level. The centralized procedure is mandatory for
the
approval of biotechnology products and provides for the grant of a single
marketing authorization that is valid in all EU members states. As of January
1995, a mutual recognition procedure is available at the request of the
applicant for all medicinal products that are not subject to the centralized
procedure. There can be no assurance that the chosen regulatory strategy will
secure regulatory approvals on a timely basis or at all.
Greenwich
Therapeutics’ Product Candidates - Sodium Stibogluconate
Sodium
Stibogluconate, or SSG, is a pentavalent antimonial drug that has been used
for
over 50 years in parts of Africa and Asia for the treatment of leishmaniasis,
a
protozoan disease. Recent research at the Cleveland Clinic has revealed the
mechanism of action of SSG. Based on such research, we believe that SSG acts
by
inhibiting the enzymatic action of multiple protein tyrosine phosphatases,
or
PTPases, specifically, the SRC homology PTPase (SHP-1). PTPases are enzymes
involved in the intracellular signaling pathways of a number of receptor
tyrosine kinases involved in controlling cell growth, proliferation and
differentiation. SHP-1 is a PTPase involved in the regulation of intracellular
signaling in hematopoietic cells, and mutations in this enzyme in cancerous
cells leads to hyper-responsiveness to normal stimuli, and thus cancerous
transformation. By inhibiting the enzymatic action of the SHP-1 protein tyrosine
phosphatase, it is believed that SSG may be effective in triggering apoptosis,
or cell death, in malignant cancer cells. However, future tests might not
corroborate the results of these tests. To date, Greenwich has not submitted
any
application to the FDA, although CCF has filed an investigator IND which has
been accepted by the FDA, and pursuant to which it is conducting a clinical
trial in SSG.
Preclinical
Data
We
believe, based on the results of in vivo testing of SSG in mice to date, that
SSG has anti-proliferative effects against a broad number of tumor cell lines,
including melanoma and renal cell carcinoma. These effects were seen whether
used as part of a combination therapy with existing treatments, including
interferon and interleukin-2. In addition, based on preclinical data, we believe
that SSG has promise as a monotherapy to treat certain other tumor types,
including prostate cancer. The preclinical data suggests that SSG utilizes
multiple modes of action, including having a direct effect on cancer cells,
as
well as generally empowering the immune system. These multiple modes of action,
along with SSG’s historical modest toxicity profile, indicate to us that SSG is
an ideal drug to evaluate as an anti-cancer agent.
Potential
Lead Indication of SSG
The
standard of care for solid tumors, lymphoma, myeloma and certain other
hematological malignancies, such as low-grade lymphoma and chronic myelogenous
leukemia, includes Interferon alpha-2b, or IFN a-2b.
However, many patients treated with IFN a-2b
become refractory, or non-responsive to continued treatment. In addition, the
toxicity profile of IFN a-2b
often
limits its clinical efficacy. We believe that the effectiveness of this existing
treatment may be improved by utilizing SSG as a combination therapy with IFN
a-2b.
Specifically, we believe that SSG, due to its demonstrated ability to inhibit
PTPases, will augment the anti-proliferative activity and improve the efficacy
of IFN a-2b
therapy. Therefore, we believe that the efficacy shown in preclinical studies
by
SSG in combination therapy with IFN a-2b,
when
considered with its acceptable historical safety profile, may position it well
as a combination therapy effective in treating solid tumors and certain other
hematological malignancies.
Clinical
Development
SSG
is
currently being studied in a twenty-four patient Phase I clinical trial at
the
Cleveland Clinic Taussig Cancer Center for combination therapy using IFN
a-2b
paired with SSG in the treatment of refractory solid tumors, lymphoma and
melanoma. The primary objective of this clinical trial is to confirm the
tolerance, safety and maximum tolerated dose, or MTD, of SSG in combination
with
IFN a-2b.
In
addition, the trial will also provide pharmacokinetic data and may provide
anecdotal indicators of efficacy, although the trials will not be designed
to
measure or demonstrate efficacy. This clinical trial is expected to be completed
by the second quarter of 2006. The Cleveland Clinic intends to fund all costs
associated with this clinical trial although we may incur costs relating to
the
completion of this trial as the Cleveland Clinic has no specific obligation
to
us to fund this trial. If the Cleveland Clinic determines to discontinue the
trials, we intend to continue product testing at an alternative facility such
as
a medical center or university to run our clinical trials. In order for us
to
sponser clinical trials, however, it will be necessary for us to submit our
own
IND to the FDA. Pending a successful completion of this Phase I clinical trial,
we anticipate initiating a Phase II trial in the second half of 2006. The Phase
II trial will be designed to provide information concerning efficacy among
other
information. Prior
to
a initiating the Phase II trial, we will need to apply for approval with the
IRB
“Institutional Review Board” and the Principal Investigator to run the study.
There may potentially be delays in receiving this approval such as unforeseen
safety issues and dosing issues. See “Risk Factors - Risks Relating to
Greenwich’s Operations.”
Advantages
Over Existing Developmental Therapeutics
Potential
advantages of SSG over existing therapies include SSG’s long history of use,
favorable toxicity and side effect profiles, and efficacy in refractory
preclinical cancer models. As previously discussed, SSG has been utilized in
the
treatment of leishmaniasis for over fifty years in parts of Africa and Asia.
In
connection with such use, SSG has demonstrated favorable toxicity and side
effect profiles, at dosages well in excess of the dosages we intend to utilize
in our clinical trials using SSG in the treatment of cancer. Also, based on
preclinical in vivo cancer models, we believe that SSG may have better efficacy
in treating refractory cancer than existing standards of care.
Competition
To
the
knowledge of VioQuest or Greenwich, no clinically feasible inhibitors of such
PTPases have previously been demonstrated to be effective to treat cancer.
CombinatoRx, Incorporated, a privately held biotechnology company, is developing
a clinical drug candidate containing Pentamidine + Thorazine. Pentamidine may
also be a PTPase inhibitor and has also previously been used for the treatment
of leishmaniasis. Hoffman-La Roche Inc. and Wyeth are investigating PTPase
inhibitors for the potential treatment of non-insulin dependent diabetes. See
"Risk Factors- Risks Relating to Greenwich's Operations- Competition in this
market sector is intense."
Greenwich
Therapeutics’ Product Candidates - Triciribine
Triciribine,
or TCN, is a nucleoside analog that had been under development for many years
as
an anti-cancer therapy and as an anti-viral therapy. The National Cancer
Institute, or NCI, previously advanced TCN into clinical trials in oncology
in
the 1980s and 1990s. While an anti-cancer signal was seen in these clinical
trials in various tumor types, including sarcoma, colorectal, hepatic and breast
cancers, the drug was limited by its side effect profile (specifically,
hyperglycemia and hepatotoxicity). Recently, investigators at the Moffitt Cancer
Center at the University of South Florida screened a library of over 2,000
compounds for Akt (Protein Kinase B) inhibition, and TCN had the strongest
signal at low dose concentrations. We believe that this discovery shows that
the
anti-cancer mechanism of action of TCN involves the inhibition of Akt.
Though
not normally active in human cells, Akt, a serine/threonine protein kinase,
is
typically hyperactivated, or hyperphosphorylated,
in many
tumor types. Since
Akt
has
been shown to play a critical role in malignant transformation by inducing
cell
survival, growth, migration, and angiogenesis, and since research demonstrates
disruption of the Akt pathway leads to apoptosis and inhibition of tumor growth,
we believe that Akt is an attractive therapeutic target. Therefore, if TCN
inhibits Akt, as available research indicates, we believe that TCN may be
effective in the treatment of certain malignancies. Future
tests might not corroborate the results of these tests. To date, no application
has been submitted or is expected to be submitted to the FDA in the near
future.
Preclinical
Data
We
believe that the in vitro preclinical experiments performed to date on human
tumor cell lines and in vivo experiments in nude mice xenograft experiments
demonstrate that TCN inhibits cancer cell growth and induces apoptosis, or
cell
death, in cancer cells that express elevated Akt. Moreover, since TCN had little
effect in these preclinical models on cancer cell lines in which Akt was not
overexpressed, or elevated, we believe that TCN’s anticancer mechanism is
through the inhibition of Akt in tumors that express elevated Akt levels, by
directly and irreversibly binding the Akt receptor. Furthermore,
the effectiveness of the low doses used in these preclinical experiments
suggests that the side effects prevalent in previous clinical trials conducted
by the NCI may be minimized.
Potential
Lead Indication of Triciribine
The
efficacy of TCN as an anti-cancer drug in previous clinical trials was limited
by the side effects associated with its usage. We believe, however, that these
side effects were closely related to the high dosage levels used in these
trials. In addition, we believe that the hyperglycemia seen as a side effect
may
have resulted from TCN’s mechanism of action on Akt, as recent preclinical
studies have shown that a deficiency of Akt impairs the ability of insulin
to
lower blood glucose, which could lead to a hyperglycemic condition. The previous
NCI-sponsored clinical trials used dosages that ranged up to 256mg/m2, and
these
trials targeted tumors without regard to whether such tumors overexpressed
Akt,
since, at the time of such trials, the mechanism of action for TCN was not
fully
understood. We believe that, based on the preclinical studies conducted to
date,
TCN effectively and selectively induces apoptosis and inhibits growth in tumor
cells with elevated levels of Akt at doses lower than those used in the previous
clinical trials. Therefore, we believe that by selectively screening and
treating only those patients with tumors that overexpress Akt, TCN in low doses
could achieve tumor inhibition and regression without the significant side
effects previously associated with its usage at higher dose levels. As a result,
our initial potential lead indication for TCN will be for the treatment of
solid
tumors known to overexpress Akt, which constitute a significant percentage
of
all colorectal, ovarian, pancreatic and breast tumors.
Additional
Potential Indications for TCN
While
TCN
continues in clinical development for solid tumors that overexpress Akt, we
intend to continue evaluating, in consultation with our Scientific Advisory
Board, management team and other consultants, TCN’s potential in treatment for
hematological and other malignancies. We intend to continue the preclinical
and
clinical development of TCN in those indications in which we believe it shows
potential.
Clinical
Development
Greenwich
is currently finalizing a protocol for a Phase I clinical trial to be conducted
at the Moffitt Cancer Center at the University of South Florida for TCN in
the
treatment of metastatic colorectal, pancreatic, breast and ovarian tumors.
Each
patient enrolled in the clinical trial will have refractory solid tumors that
have demonstrated hyperphosphorylated, or overexpressed, Akt on archived
pathology samples. The primary objective of this clinical trial will be to
confirm the tolerance, safety and maximum tolerated dose, or MTD, of TCN. In
addition, the trial will also provide pharmacokinetic data and may provide
us
with anecdotal indicators of efficacy, although the trials will not be designed
to measure or demonstrate efficacy. The trial is designated to provide
information related to the efficacy, not the effectiveness, of TCN. It is
expected that this clinical trial will begin in late 2005 and will take
approximate 6 to 9 months to complete. Pending a successful completion of this
Phase I clinical trial, we anticipate initiating a Phase II trial in the second
half of 2006. Prior to a initiating the Phase II trial, we will need to apply
for approval with the IRB “Institutional Review Board” and the Principal
Investigator to run the study. There may potentially be delays in receiving
this
approval such as unforeseen circumstances in Phase I, unforeseen toxicities,
etc. There may potentially be delays in receiving this approval such as
unforeseen safety issues and dosing issues. See “Risk Factors - Risks Relating
to Greenwich’s Operations.”
Advantages
over Existing Developmental Therapeutics
The
planned clinical trials utilizing TCN in patients that have demonstrated tumors
that express elevated Akt is a strategy that we believe offers significant
advantages over classic anticancer therapies. Our research indicates to us
that
low dose treatment with TCN directly binds the Akt molecule. This will target
cancer cells specifically, while sparing healthy cells, resulting in fewer
side
effects. This “targeted therapy” takes advantage of the biologic differences
between cancer cells and healthy cells. We expect this approach to result in
a
decreased number of patients required to see a clinical effect, as we predict
that a larger percentage of the patients treated will benefit from treatment
with TCN. We expect that this will decrease both the clinical trial regulatory
time period, and also the costs associated with such clinical trials, as
compared to other anticancer products currently in clinical
development.
Competition
There
is
currently no approved Akt inhibitor on the market. Keryx Biopharmaceuticals,
Inc., a public company, is developing Perifosine. Perifosine is an
alkylphospholipid that has been shown to inhibit the PI3K/Akt pathway, but
research to date has not demonstrated that it directly binds the Akt molecule.
Multiple pharmaceutical companies have Akt inhibitors in the early discovery
stage of development, including Abbott Laboratories, Merck & Co., Inc. and
Eli Lilly. See "Risk Factors- Risks Relating to Greenwich's Operations-
Competition in this market sector is intense."
License
Agreements & Intellectual Property
General
Greenwich’s
goal is to obtain, maintain and enforce patent protection for its products,
formulations, processes, methods and other proprietary technologies, preserve
its trade secrets, and operate without infringing on the proprietary rights
of
other parties, both in the United States and in other countries. Greenwich’s
policy is to actively seek to obtain, where appropriate, the broadest
intellectual property protection possible for its current product candidates
and
any future product candidates, proprietary information and proprietary
technology through a combination of contractual arrangements and patents, both
in the U.S. and abroad. However, even patent protection may not always afford
complete protection against competitors who seek to circumvent its patents.
See
“Risk Factors - If
we
fail to adequately protect or enforce Greenwich’s intellectual property rights
or secure rights to patents of others, the value of those intellectual property
rights would diminish”
above.
SSG
In
February 2005, Greenwich entered into an exclusive, worldwide license agreement
attached to this proxy statement as Appendix
D with
The
Cleveland Clinic Foundation (“CCF”) for the
rights to develop, manufacture, use, commercialize, lease, sell and/or
sublicense Sodium
Stibogluconate, or SSG. As consideration for the license of these rights to
SSG,
Greenwich has paid CCF to date an aggregate of approximately $595,000 as
consideration for the license, consisting of the initial license fees,
reimbursement for certain costs and expenses incurred by it and an annual
license maintenance fee. Greenwich is also obligated to make an annual license
maintenance payment of $35,000 until the first commercial sale of the licensed
product, at which time Greenwich is no longer obligated to pay this maintenance
fee. In addition, the license agreement requires Greenwich to make payments
in
an aggregate amount of up to $4.5 million to CCF upon the achievement of certain
clinical and regulatory milestones. Should
SSG become commercialized, Greenwich will be obligated to pay CCF an annual
royalty based on net sales of the product. In the event that Greenwich
sublicenses SSG to a third party, Greenwich will be obligated to pay CCF a
portion of fees and royalties received from the sublicense. Greenwich holds
the
exclusive right to negotiate for a license on any improvements to SSG and has
the obligation to use all commercially reasonable efforts to bring SSG to
market. Greenwich has agreed to procecute and maintain the patents associated
with SSG or provide notice to CCF so that it may so elect. Each of CCF and
Greenwich has the right, but not the obligation, to prosecute or defend any
infringement actions. The license agreement shall automatically terminate upon
Greenwhich’s bankruptcy and upon the date of the last to expire claim contained
in the patents subject to the license agreement. The license agreement may
be
terminated by CCF, upon notice with an opportunity for cure, for Greenwich’s
failure to make required payments or its material breach, or by Greenwich,
upon
thirty day’s written notice. The license agreement contains other customary
clauses and terms relating to, among others, reports and records, dispute
resolution, indemnity, assignment, confidentiality and insurance, as are common
in similar agreements in the industry.
TCN
In
April
2005, Greenwich entered into an exclusive, worldwide license agreement attached
to this proxy statement as Appendix
E with
the
University of South Florida Research Foundation, Inc. (“USF”), for the
rights to develop, manufacture, use, commercialize, lease, sell and/or
sublicense Triciribine,
or TCN. As consideration for the license of these rights to Triciribine,
Greenwich paid USF an initial license fee of $40,000, reimbursed USF for certain
costs and expenses incurred and agreed to sponsor a Research Project involving
the licensed technology in the amount of $25,000 annually for the term of the
license agreement, one of which has been made. In addition, the license
agreement requires Greenwich to make payments in an aggregate amount of up
to
$5.8 million to USF upon the achievement of certain clinical and regulatory
milestones. Should a product incorporating the licensed technology be
commercialized, Greenwich is obligated to pay to USF an annual royalty based
on
net sales of the product. In the event that the Company sublicenses TCN to
a
third party, Greenwich is obligated to pay USF a portion of fees and royalties
received from the sublicense. Greenwich holds a right of first refusal to obtain
an exclusive license on any improvements to TCN and has the obligation to use
all commercially reasonable efforts to bring TCN to market. Greenwich has agreed
to procecute and maintain the patents associated with TCN or provide notice
to
USF so that it may so elect. Each of USF and Greenwich has the right, but not
the obligation, to prosecute or defend any infringement actions. The license
agreement shall automatically terminate upon Greenwhich’s bankruptcy or upon the
date of the last to expire claim contained in the patents subject to the license
agreement. The license agreement may be terminated by USF, upon notice with
an
opportunity for cure, for Greenwich’s failure to make required payments or its
material breach, or by Greenwich, upon six month’s written notice. The license
agreement contains other customary clauses and terms relating to, among others,
reports and records, dispute resolution, indemnity, assignment, confidentiality
and insurance, as are common in similar agreements in the industry.
Legal
Proceedings
Greenwich
is not a party to any material legal proceedings.
Plan
of Operation
Research
and Development. Over
the
next 12 months, Greenwich expects to develop and initiate clinical Phase
I/II trials for both the licensed anti-cancer treatment compounds. Greenwich
believes its planned development activities for the next 12 months will require
additional financing of approximately $5,000,000.
As
a
result of the Merger, the Company will be obligated to pay CCF and USF
substantial payments upon the achievement of certain milestones as outlined
in
the license agreements. Pursuant to Greenwich’s license agreements with CCF and
USF, Greenwich has agreed to make payments to CCF and USF in an aggregate amount
of up to $4.5 million and $5.8 million, respectively, upon the achievement
of
certain clinical and regulatory milestones. These milestone payments may have
a
significant impact upon the Company’s liquidity. The Company anticipates that in
the next twelve months it will be obligated to pay CCF and USF an aggregate
amount equal to $600,000 for milestones achieved.
Purchases
of Facilities and Significant Equipment.
Greenwich has no operating facilities or equipment. Assuming completion of
the
Merger, VioQuest’s management intends to move Greenwich’s offices for
administration and corporate development to new offices in Basking Ridge, New
Jersey at a rental cost of approximately $4,000 per month.
Employees. As
of
June 30, 2005, Greenwich had no employees. VioQuest’s management anticipates
hiring a Chief Medical Officer and in July 2005 hired a Vice President of
Corporate Business Development.
Information
Concerning Greenwich Stock
Shares
of
Greenwich’s common stock are not publicly traded. Greenwich’s certificate of
incorporation authorize it to issue 25,000,000 shares of capital stock, of
which
20,000,000 shares are authorized as common stock and 5,000,000 shares are
authorized as preferred stock. As of the date of this proxy statement, 4,000,000
shares of Greenwich’s common stock were outstanding and no shares of preferred
stock were outstanding. Greenwich does not have outstanding any options,
warrants or other rights to purchase shares of its common stock.
As
of the
date of this proxy statement, there were 50 holders of Greenwich common stock.
Greenwich has not paid or declared any dividends on its common stock and does
not anticipate doing so in the near future.
Selected
Historical Financial Data
The
following table summarizes certain selected historical financial data of
Greenwich, which are derived from and should be read in conjunction with the
audited financial statements of Greenwich attached to this proxy statement
as
Appendix
C.
Historical
results are not necessarily indicative of the results to be expected in the
future.
|
|
Six
Months Ended Ended
June
30, 2005
(Unaudited)
|
|
Three
Months Ended
March
31, 2005
|
|
Period
from October 28, 2004 (Inception) to December 31,
2004
|
|
Period
from
October
28 2004
(Inception)
to
June
30, 2005
(Unaudited)
|
|
Statement
of Operations Data:
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
--
|
|
$
|
--
|
|
$
|
--
|
|
$
|
--
|
|
Operating
expenses
|
|
|
714,348
|
|
|
596,459
|
|
|
68,552
|
|
|
782,900
|
|
Loss
from operations
|
|
|
(714,348
|
)
|
|
(596,459
|
)
|
|
(68,552
|
)
|
|
(782,900
|
)
|
Interest
expense
|
|
|
(11,449
|
)
|
|
(3,072
|
)
|
|
(415
|
)
|
|
(11,864
|
)
|
Net
loss
|
|
|
(725,797
|
)
|
|
(599,531
|
)
|
|
(68,967
|
)
|
|
(794,764
|
)
|
Basic
and diluted net loss per share
|
|
$
|
(0.18
|
)
|
$
|
(0.15
|
)
|
$
|
(0.02
|
)
|
$
|
(0.20
|
)
|
|
|
June
30, 2005
(Unaudited)
|
|
March
31, 2005
|
|
December
31, 2004
|
|
Balance
Sheet Data:
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
--
|
|
$
|
--
|
|
$
|
--
|
|
Current
liabilities
|
|
|
67,425
|
|
|
30,228
|
|
|
415
|
|
Total
liabilities
|
|
|
794,764
|
|
|
668,498
|
|
|
68,967
|
|
Stockholders’
deficiency
|
|
|
(794,764
|
)
|
|
(668,498
|
)
|
|
(68,967
|
)
|
Shares
outstanding
|
|
|
4,000,000
|
|
|
4,000,000
|
|
|
4,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
book
value per share: |
|
$ |
.08
|
|
|
|
|
|
|
|
Pro forma
information: |
|
$ |
.04 |
|
|
|
|
|
|
|
Officers
and Directors of Greenwich
Biographical
information concerning each of Greenwich’s current officers and directors is set
forth below. None of Greenwich’s officers and directors, all of whom are also
employed by Paramount BioCapital or an affiliate of Paramount BioCapital, will
continue as an officer, director or other employee of either VioQuest or
Greenwich following the completion of the Merger.
Name
|
Age
|
Positions
|
J.
Jay Lobell
|
42
|
President
and Director
|
Jason
Stein, M.D.
|
32
|
Vice
President and Director
|
John
Liatos
|
36
|
Treasurer
|
Louis
Smookler
|
27
|
Secretary
|
J.
Jay Lobell has
been
President and a member of Greenwich’s Board of Directors since February 16,
2005. Mr. Lobell has served as President and Chief Operating Officer of
Paramount Biosciences, LLC, an affiliate of Paramount BioCapital, since January
2005. From January 1995 to December 2004, Mr. Lobell was a partner at Covington
& Burling, a law firm where he provided business, litigation and regulatory
advice. Mr. Lobell received a B.A. from Queens College and a J.D. from Yale
Law
School.
Jason
Stein, M.D.
has been
Vice President and a director of Greenwich since February 16, 2005. Dr. Stein
has served as the Senior Analyst at Paramount BioCapital Asset Management,
Inc.,
an affiliate of Paramount BioCapital, where he is responsible for medical,
scientific, and financial research of pharmaceutical products and technologies,
since January 2000. Dr. Stein also serves as an officer and/or director of
several other privately held development-stage biotechnology companies. Dr.
Stein received his undergraduate degree from the University of Michigan and
his
medical degree from Saba University.
John
Liatos has
served as Greenwich’s Treasurer since February 16, 2005. Mr. Liatos
is the Vice President of Finance of
Paramount BioCapital, where he has worked since 2005. Previously, he
served as Vice President at Gefinor USA, Inc. since October 1997. Prior to
joining Gefinor he served as Senior Associate at RJR Nabisco in Financial
Reporting and Consolidations from May 1995 through October 1997. From October
1991 through May 1995 he served as an auditor at Eisner LLP (f/k/a Richard
A.
Eisner & Company, LLP). Mr. Liatos received his Bachelors degree in Business
from The Citadel in May 1991.
Louis
Smookler has
served as Greenwich’s Secretary since February 16, 2005. Mr. Smookler is
Associate
General Counsel at
Paramount
BioCapital. Prior to joining Paramount
BioCapital,
from
February 2003 until March 2004,
Mr.
Smookler served as an in-house attorney in the Private Client Litigation
Department of Merrill Lynch & Co. Inc.’s Office of General Counsel. Mr.
Smookler received his B.S.B.A. degree summa
cum laude in
Corporate Finance from West Virginia University and his J.D. from Brooklyn
Law
School. Mr. Smookler is
admitted
to the bars of both New York and New Jersey.
Each
of
these individuals will resign from their directorships and offices,
respectively, upon completion of the Merger.
Principal
Stockholders
The
following table sets forth certain information regarding beneficial ownership
of
Greenwich common stock by (i) each person beneficial owning more than 5 percent
of outstanding Greenwich common stock, (ii) each director of Greenwich; (iii)
each executive officer of Greenwich and (iv) each director or executive of
VioQuest.
Beneficial
Owner
|
Number
of Shares
Beneficially
Owned
|
|
Percentage
Ownership
|
Lester
Lipschutz
|
1,633,000
|
(1) |
|
40.8
|
Jeffrey
Serbin
|
300,000
|
|
|
7.5
|
Jason
Stein, M.D.
|
280,000
|
|
|
7.0
|
Michael
Weiser, M.D.
|
280,000
|
|
|
7.0
|
Lindsay
Rosenwald, M.D.
|
270,000
|
|
|
6.8
|
J.
Jay Lobell
|
220,000
|
|
|
5.5
|
Matthew
Wyckoff
|
200,000
|
|
|
5.0
|
Stephen
Rocamboli
|
144,000
|
|
|
3.6
|
Louis
Smookler
|
31,500
|
|
|
*
|
John
Liatos
|
19,000
|
|
|
*
|
|
|
|
|
|
*
Represents
less than 1%. |
|
|
|
|
______________________
(1)
|
Mr.
Lipschutz is the trustee or investment advisor of four trusts established
for the benefit of Lindsay Rosenwald, M.D. which collectively own
701,000
shares of Greenwich common stock. Mr. Lipschutz also serves as the
trustee
for the Rosenwald 2000 Family Trust, a trust established for the
benefit
of Dr. Rosenwald’s minor children, which owns 932,000 shares of Greenwich
common stock. Mr. Lipschutz may be deemed to beneficially own the
shares
held by the aforementioned trusts as he has sole control over the
voting
and disposition of any shares held by such
trusts.
|
CERTAIN
TRANSACTIONS AND RELATIONSHIPS
Dr.
Weiser and Mr. Rocamboli both of whom are directors of our company, are
employees of Paramount BioCapital, Inc. or its affiliates, a corporation of
which Dr. Lindsay A. Rosenwald is the chairman and sole shareholder. Dr.
Rosenwald beneficially owns approximately 5.5 percent of our outstanding common
stock and various trusts for the benefit of Dr. Rosenwald or members of his
immediate family (the “Rosenwald Trusts”) beneficially own approximately 14
percent of our outstanding common stock. Dr. Weiser and Mr. Rocamboli
collectively own approximately 3 percent of our outstanding common stock.
Paramount BioCapital participated as a placement agent in connection with our
February 2004 private placement, for which it received aggregate commissions
of
approximately $300,000.
In
addition, Dr. Rosenwald, the Rosenwald Trusts, Dr. Weiser and Mr. Rocamboli
hold
6.8 percent, 40.8 percent, 7.0 percent and 3.6 percent of the outstanding shares
of Greenwich, respectively. As a result of their ownership interests in
Greenwich and their relationship with Paramount, both Dr. Weiser and Mr.
Rocamboli have recused themselves from our board of directors’ consideration of
the Merger with Greenwich.
SUMMARY
OF DISSENTERS’ RIGHTS
Pursuant
to the relevant sections of the Minnesota Business Corporation Act (the
“MBCA”),
you
have the right to an appraisal of the value of your shares of VioQuest common
stock in connection with the Reincorporation proposal.
Sections
302A.471 and 302A.473 of the MBCA entitle any shareholder of the Company who
objects to the Reincorporation proposal and who follows the procedures
prescribed by Section 302A.473 to receive cash equal to the “fair value” of such
shareholder’s shares of the Company. Set forth below is a summary of the
procedures relating to the exercise of such dissenters’ rights. This summary
does not purport to be a complete statement of dissenters’ rights and is
qualified in its entirety by reference to Sections 302A.471 and 302A.473 of
the
MBCA, which are reproduced in full as Appendix
B attached
to this proxy statement and to any amendments to such provisions as may be
adopted after the date of this proxy statement.
Any
shareholder contemplating the possibility of dissenting from the Reincorporation
proposal should carefully review the text of Appendix B (particularly the
specified procedural steps required to perfect the dissenters’ rights, which are
complex) and should also consult such shareholder’s legal counsel. Such rights
will be lost if the procedural requirements of Section 302A.473 of the MBCA
are
not fully and precisely satisfied.
The
MBCA
provides dissenters’ rights for any shareholder of the Company who objects to
the Reincorporation proposal and who meets the requisite statutory requirements
contained in the MBCA. Under the MBCA, any shareholder of the Company who (i)
files with the Company a written notice of his, her or its intent to demand
the
fair value of such shareholder’s shares of stock if the Reincorporation proposal
is approved and the actions contemplated by the Reincorporation proposal is
consummated, which notice is filed with the Company on or before the vote is
taken at the Special Meeting, and (ii) does not vote such shares of stock at
the
Special Meeting in favor of the Reincorporation proposal, shall be entitled,
if
the Reincorporation proposal is approved and the actions contemplated by the
Reincorporation proposal is consummated, to receive a cash payment of the fair
value of such shareholder’s shares of Company stock upon compliance with the
applicable statutory procedural requirements. A failure by any shareholder
of
the Company to vote against the Reincorporation proposal will not in and of
itself constitute a waiver of the dissenters’ rights of such shareholder under
the MBCA. In addition, a shareholder’s vote against the Reincorporation proposal
will not satisfy the notice requirement referred to in clause (i) above.
Any
written notice of a shareholder’s intent to demand payment for such
shareholder’s shares if the Reincorporation proposal is approved and the actions
contemplated by the Reincorporation proposal are consummated must be filed
with
the Company at 7 Deer Park Drive, Suite E, Monmouth Junctions, New Jersey 08852,
Attention: Brian Lenz, prior to the vote on the Proposal at the Special Meeting.
A shareholder who votes for the Proposal will have no dissenters’ rights with
respect thereto. A shareholder who does not satisfy each of the requirements
of
Sections 302A.471 and 302A.473 of the MBCA is not entitled to payment for such
shareholder’s shares of Company stock under the dissenters’ rights provisions of
the MBCA and will be bound by the terms governing the subject
transaction.
If
the
Reincorporation proposal is approved, the Company must send written notice
to
all shareholders who have given written notice of their intent to demand the
fair value of their shares and who have not voted in favor of the
Reincorporation proposal as described above. The notice will contain: (i) the
address where the demand for payment and certificates representing shares of
the
Company’s stock (each a “Certificate”) must be sent and the date by which they
must be received, (ii) any restrictions on transfer of uncertificated shares
that will apply after the demand for payment is received, (iii) a form to be
used to certify the date on which the shareholder, or the beneficial owner
on
whose behalf the shareholder dissents, acquired the shares (or an interest
in
them) and to demand payment, and (iv) a copy of the provisions of the MBCA
set
forth in Appendix
B
with a
brief description of the procedures to be followed under those provisions.
A
shareholder of the Company who is sent a notice and who wishes to assert
dissenters’ rights must demand payment and deposit his or her Certificate or
Certificates within 30 days after such notice is given by the Company. Prior
to
the effective time of the consummation of the actions contemplated by the
Reincorporation proposal, a shareholder exercising dissenters’ rights retains
all other rights of a shareholder of the Company. From and after such effective
time, dissenting shareholders will no longer be entitled to any rights of a
shareholder of the Company, including, but not limited to, the right to receive
notice of meetings, to vote at any meetings or to receive dividends, and will
only be entitled to any rights to appraisal as provided by the
MBCA.
After
the
effective time of the consummation of the actions contemplated by the
Reincorporation proposal, or upon receipt of a valid demand for payment,
whichever is later, the Company must remit to each dissenting shareholder who
complied with the requirements of the MBCA the amount the Company estimates
to
be the fair value of such shareholder’s shares of stock, plus interest accrued
from the effective time of the sale to the date of payment. The payment also
must be accompanied by certain financial data relating to the Company, the
Company’s estimate of the fair value of the shares and a description of the
method used to reach such estimate, and a copy of the applicable provisions
of
the MBCA with a brief description of the procedures to be followed in demanding
supplemental payment. The dissenting shareholder may decline the offer and
demand payment for the fair value of the Company’s stock. Failure to make such
demand on a timely basis entitles the dissenting shareholder only to the amount
offered. If the Company fails to remit payment within 60 days of the deposit
of
the Certificates or the imposition of transfer restrictions on uncertificated
shares, it shall return all deposited Certificates and cancel all transfer
restrictions; provided, however, that the Company may again give notice
regarding the procedure to exercise dissenters’ rights and require deposit or
restrict transfer at a later time. If a dissenting shareholder believes that
the
amount remitted is less than the fair value of the Company’s stock plus
interest, such dissenting shareholder may give written notice to the Company
of
his or her own estimate of the fair value of the shares, plus interest, within
30 days after the Company mails its remittance, and demand payment of the
difference.
If
the
Company receives a demand from a dissenting shareholder to pay such difference,
it shall, within 60 days after receiving the demand, either pay to the
dissenting shareholder the amount demanded or agreed to by the dissenting
shareholder after discussion with the Company or file in court a petition
requesting that the court determine the fair value of the Company’s
stock.
The
court
may appoint one or more appraisers to receive evidence and make recommendations
to the court on the amount of the fair value of the shares. The court shall
determine whether the dissenting shareholder has complied with the requirements
of Section 302A.473 of the MBCA and shall determine the fair value of the
shares, taking into account any and all factors the court finds relevant,
computed by any method or combination of methods that the court, in its
discretion, sees fit to use. The fair value of the shares as determined by
the
court is binding on all dissenting shareholders. If the court determines that
the fair value of the shares is in excess of the amount, if any, remitted by
the
Company, then the court will enter a judgment for cash in favor of the
dissenting shareholders in an amount by which the value determined by the court,
plus interest, exceeds such amount previously remitted. A dissenting shareholder
will not be liable to the Company if the amount, if any, remitted to such
shareholder exceeds the fair value of the shares, as determined by the court,
plus interest.
Costs
of
the court proceeding shall be determined by the court and assessed against
the
Company, except that part or all of the costs may be assessed against any
dissenting shareholders whose actions in demanding supplemental payments are
found by the court to be arbitrary, vexatious or not in good faith.
If
the
court finds that the Company did not substantially comply with the relevant
provisions of the MBCA, the court may assess the fees and expenses, if any,
of
attorneys or experts as the court deems equitable against the Company. Such
fees
and expenses may also be assessed against any party in bringing the proceedings
if the court finds that such party has acted arbitrarily, vexatiously or not
in
good faith, and may be awarded to a party injured by those actions. The court
may award, in its discretion, fees and expenses of an attorney for the
dissenting shareholders out of the amount awarded to such shareholders, if
any.
A
shareholder of record may assert dissenters’ rights as to fewer than all of the
shares registered in such shareholder’s name only if he or she dissents with
respect to all shares beneficially owned by any one beneficial shareholder
and
notifies the Company in writing of the name and address of each person on whose
behalf he or she asserts dissenters’ rights. The rights of such a partial
dissenting shareholder are determined as if the shares as to which he or she
dissents and his or her other shares were registered in the names of different
shareholders.
Under
Subdivision 4 of Section 302A.471 of the MBCA, a shareholder of the Company
has
no right, at law or in equity, to set aside the approval of the Proposal or
the
consummation of the actions contemplated thereby except if such adoption or
consummation was fraudulent with respect to such shareholder or the
Company.
PRINCIPAL
SHAREHOLDERS
The
following table sets forth certain information regarding beneficial ownership
of
VioQuest common stock as of the record date for the Special Meeting by (i)
each
person known by us to be the beneficial owner of more than 5 percent of
VioQuest’s outstanding common stock, (ii) each director, (iii) each executive
officer, and (iv) all executive officers and directors as a group. Unless
otherwise indicated, the address of each of the following persons is
7
Deer
Park Drive, Suite E, Monmouth Junction, New Jersey 08852.
|
|
Before
Merger
|
|
Assuming
Completion of the Merger(11)
|
|
Name
and Address
|
|
Number
of Shares Beneficially Owned(1)
|
|
Percentage
of
Class
|
|
Number
of Shares Beneficially Owned
|
|
Percentage of
Class
|
|
Vincent
M. Aita, Ph.D.
|
|
|
233,774
|
(2)
|
|
1.3
|
|
|
233,774
|
|
|
*
|
|
Kenneth
W. Brimmer
|
|
|
154,300
|
(2)
(3)
|
|
*
|
|
|
154,300
|
|
|
*
|
|
Stephen
C. Rocamboli
|
|
|
111,999
|
(2)
(4)
|
|
*
|
|
|
868,335
|
(12)
|
|
2.5
|
|
Stephen
A. Roth, Ph.D.
|
|
|
37,633
|
(2)
(5)
|
|
*
|
|
|
37,633
|
|
|
*
|
|
David
M. Tanen
|
|
|
111,999
|
(2)
(4)
|
|
*
|
|
|
111,999
|
|
|
*
|
|
Michael
Weiser, M.D., Ph.D.
|
|
|
417,353
|
(2)
|
|
2.3
|
|
|
1,892,068
|
(13)
|
|
5.4
|
|
Daniel
Greenleaf
|
|
|
20,000
|
(6)
|
|
*
|
|
|
20,000
|
|
|
*
|
|
Brian
Lenz
|
|
|
13,333
|
(7)
|
|
*
|
|
|
13,333
|
|
|
*
|
|
Michael
Cannarsa
|
|
|
0
|
|
|
--
|
|
|
0
|
|
|
--
|
|
Xumu
Zhang, Ph.D.
|
|
|
2,943,268
|
(8)
|
|
16.2
|
|
|
2,943,268
|
|
|
8.3
|
|
All
Executive Officers and Directors as a group (10
persons)
|
|
|
4,038,659
|
|
|
22.0
|
|
|
6,274,710
|
|
|
17.7
|
|
Lester
Lipschutz
1650
Arch Street - 22nd
Floor
Philadelphia,
PA 19103
|
|
|
1,915,534
|
(9)
|
|
10.7
|
|
|
10,641,364
|
(14)
|
|
28.9
|
|
Lindsay
A. Rosenwald, M.D. 787
Seventh Avenue, 48th
Floor
New
York, NY 10019
|
|
|
990,678
|
(10)
|
|
5.5
|
|
|
2,863,300
|
(15)
|
|
8.1
|
|
_____________
*
Less
than 1%.
(1)
|
Assumes
in each case that the shareholder exercised all options or warrants
available to the person that have vested or will vest within
60 days of
July 1, 2005.
|
|
|
(2)
|
Includes
4,300 shares issuable upon the exercise of a vested portion of
an option
and does not include the remaining 8,600 unvested shares subject
thereto,
which vest in equal installments in October 2005 and October
2006.
|
|
|
(3)
|
Includes
7,500 shares which are owned by Mr. Brimmer’s Individual Retirement
Account, 2,500 shares which are owned by the Individual Retirement
Account
of Mr. Brimmer’s spouse (to which he disclaims any beneficial interest),
and 100,000 shares issuable upon the exercise of a vested
option.
|
|
|
(4)
|
Represents
5,000 shares issuable upon the exercise of a warrant.
|
|
|
(5)
|
Represents
33,334 shares issuable upon exercise (at a price of $1.70 per
share) of
the vested portion of an option; the remaining 16,666 shares
subject to
such option vest in July 2006.
|
|
|
(6)
|
Does
not include 891,396 shares issuable (at a price of $0.88 per
share) upon
the exercise of an option vesting in three equal annual installments
commencing February 2006. Does not include any options which
may be
subsequently issued to Mr. Greenleaf pursuant to the terms of
his
employment agreement in order to maintain his beneficial ownership
(assuming the exercise of all stock options issued to him) at
five percent
(5%) percent of the Company’s outstanding Common
Stock
|
(7)
|
Represents
shares issuable upon the exercise of vested options. Pursuant
to such
options, an additional 10,000 shares will vested in two installments
on
each of October 2005 and October 2006, and an additional 16,667
will vest
in two equal installments on each of April 2006 and April 2007.
Does not
include any shares issuable pursuant to an option to purchase
60,000
shares, none of which has vested to date, but vests in three
equal annual
installments commencing January 2006.
|
|
|
(8)
|
Includes
325,026 shares issuable upon the exercise of the vested portion
of an
option. The remaining 325,026 shares subject to such option vest
in two
equal installments on June 2006 and June 2007.
|
|
|
(9)
|
Based
on Schedule 13G filed with the SEC on December 17, 2004. Represents
shares
owned equally by several trusts established for the benefit of
Dr. Lindsay
A. Rosenwald or members of his immediate family, for which Mr.
Lipschutz
is the trustee/investment manager, and over which he has voting
control
and investment power. Dr. Rosenwald disclaims beneficial ownership
of
these shares.
|
|
|
(10)
|
Based
on a Schedule 13G filed February 11, 2005. Includes 102,871 shares
issuable upon the exercise of a warrant for purposes of determining
beneficial ownership prior to giving effect to the
Merger.
|
|
|
(11)
|
Assumes
the issuance of an aggregate of approximately 17,128,800 Merger
Shares and
the Merger Warrants to purchase an additional 4,000,000 shares
of common
stock in connection with the Merger.
|
|
|
(12)
|
Includes
an additional 144,000 shares issuable upon the exercise of Merger
Warrants
issued in connection with the Merger.
|
|
|
(13)
|
Includes
an additional 280,000 shares issuable upon the exercise of Merger
Warrants
issued in connection with the Merger.
|
|
|
(14)
|
Includes
an additional 1,633,000 shares issuable upon the exercise of
Merger
Warrants issued in connection with the Merger.
|
|
|
(15)
|
Includes
an additional 372,871 shares issuable upon the exercise of Merger
Warrants
issued in connection with the Merger and approximately 446,429
shares
issuable upon the conversion, in accordance with the terms of
the Merger,
of a portion of the outstanding indebtedness under promissory
note issued
to Paramount BioCapital Investments LLC by
Greenwich.
|
PRO
FORMA FINANCIAL INFORMATION
Introduction
to Unaudited Pro Forma Condensed Combined Financial
Statements
In
consideration for their shares of Greenwich common stock and in accordance
with
the Merger Agreement, the stockholders of Greenwich will receive a number of
shares of VioQuest common stock such that, upon the effective time of the
Merger, the Greenwich stockholders collectively will receive (or be entitled
to
receive) up to approximately 49% of VioQuest’s outstanding shares (the
“Merger Shares”) of common stock and warrants to purchase an aggregate of
4,000,000 shares of VioQuest common stock. Based on the number of outstanding
shares of VioQuest common stock on the date of the Merger Agreement, the former
stockholders of Greenwich are to receive up to an aggregate of 17,128,790 shares
of VioQuest common stock and 4,000,000 warrants (the “Merger Warrants”). At June
30, 2005, Greenwich had outstanding indebtedness of approximately $795,000
resulting principally from a series of promissory notes issued to Paramount
BioCapital Investments, LLC, an entity owned and controlled by Dr. Lindsay
Rosenwald. The notes having a maturing date of October 28, 2006, will be payable
in three equal installments, as follows: (1) one-third will be payable at such
time as VioQuest completes a financing(s) resulting in aggregate gross proceeds
of at least $5 million; (2) one-third will be converted into securities of
VioQuest upon the terms and at the completion of the financing referred to
in
clause (1); and (3) one-third will be payable at such time as VioQuest completes
a financing(s) resulting in aggregate gross proceeds of at least $10 million,
or
prior to the notes' maturity date whichever occurs first including the proceeds
from the financing described in clause (1). In the event that VioQuest does
not
complete the financing(s) resulting in aggregate gross proceeds of at least
$10
million, or prior to the notes' maturity date, whichever occurs first,
then
VioQuest will be required to satisfy the final one-third in October 2006. The
completion of the Merger is conditioned upon obtaining at least $5 million
in a
financing transaction.
One-half
of the Merger Shares and Merger Warrants will be placed in escrow and released
upon the achievement of certain milestones relating the the clinical development
of Greenwich’s product candidates. Using the share price around the date of the
execution of the Merger Agreement, which was $0.70 per share, the release of
the
escrowed securities would result in an additional purchase price of $5,995,000
and a corresponding increase to in-process research and development
("IPRD").
The
Unaudited Pro Forma Condensed Combined Statements of Operations combine the
historical consolidated statements of operations of the Company and Greenwich
giving effect to the merger as if it had been consummated on January 1, 2004.
The Unaudited Pro Forma Condensed Combined Balance Sheet combines the historical
consolidated balance sheet of the Company and the historical balance sheet
of
Greenwich, giving effect to the merger as if it had been consummated on June
30,
2005.
You
should read this information in conjunction with the:
· |
Accompanying
notes to the Unaudited Pro Forma Condensed Combined Financial Statements;
|
· |
Separate
historical financial statements of the Company as of and for the
year
ended December 31, 2004 and as of and for the six months ended
June 30,
2005 (Unaudited) included in the Company’s Annual Report on Form 10-KSB
for the year ended December 31, 2004 and the Quarterly Report on
Form
10-QSB for the six months ended June 30, 2005,
respectively;
|
· |
Separate
historical financial statements of Greenwich as of June 30, 2005
(Unaudited) and March 31, 2005 and December 31, 2004 and for the
six
months ended June 30, 2005 and for the period from October 28,
2004
(inception) to June 30, 2005 (Unaudited) and for the three months
ended
March 31, 2005 and for the period from October 28, 2004 (inception)
to
December 31, 2004 which are attached as Appendix
C to
this proxy statement.
|
We
present the unaudited pro forma condensed combined financial information for
informational purposes only. The pro forma information is not necessarily
indicative of what our financial position or results of operations actually
would have been had we completed the merger on June 30, 2005 or on January
1,
2004. In addition, the unaudited pro forma condensed combined financial
information does not purport to project the future financial position or
operating results of the combined company.
We
prepared the unaudited pro forma condensed combined financial information using
the purchase method of accounting with the Company treated as the acquirer.
Accordingly, the Company’s cost to acquire Greenwich will be allocated to the
assets acquired and liabilities assumed (substantially IPRD) based upon their
estimated fair values as of the date of acquisition. The allocation is dependent
upon certain valuations and other studies that have not progressed to a stage
where there is sufficient information to make a definitive
allocation.
UNAUDITED
PRO FORMA CONDENSED COMBINED BALANCE SHEET
|
|
|
|
|
VioQuest
|
|
Greenwich
|
|
Pro
Forma
|
|
Pro
Forma
|
|
|
|
Pharmaceuticals,
Inc.
|
|
Therapeutics,
Inc.
|
|
Adjustments
|
|
Combined
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
1,155
|
|
$ |
|
|
$
|
(246
|
)
|
|
(3)
|
|
$
|
909
|
|
|
|
|
|
|
|
|
|
|
4,600
|
|
|
(5)
|
|
|
4,600
|
|
Accounts
receivable
|
|
|
229
|
|
|
|
|
|
|
|
|
|
|
|
229
|
|
Inventories
|
|
|
380
|
|
|
|
|
|
|
|
|
|
|
|
380
|
|
Prepaid
expenses
|
|
|
59
|
|
|
|
|
|
|
|
|
|
|
|
59
|
|
Total
current assets
|
|
|
1,823
|
|
|
—
|
|
|
4,354
|
|
|
|
|
|
6,177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
776
|
|
|
|
|
|
|
|
|
|
|
|
776
|
|
Security
deposits
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
61
|
|
Intellectual
property rights, net
|
|
|
571
|
|
|
|
|
|
|
|
|
|
|
|
571
|
|
Other
|
|
|
55
|
|
|
|
|
|
|
|
|
|
|
|
55
|
|
Total
assets
|
|
$
|
3,286
|
|
$
|
—
|
|
$
|
4,354
|
|
|
|
|
$
|
7,640
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity (Deficiency)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,369
|
|
$ |
|
|
$
|
150
|
|
|
(4)
|
|
$
|
1,519
|
|
Accrued
expenses
|
|
|
302
|
|
|
56
|
|
|
|
|
|
|
|
|
358
|
|
Accrued
interest - related party
|
|
|
|
|
|
12 |
|
|
(12
|
)
|
|
(3)
|
|
|
|
|
Deferred
revenue
|
|
|
125 |
|
|
|
|
|
|
|
|
|
|
|
125
|
|
Total
current liabilities
|
|
|
1,796
|
|
|
68
|
|
|
138
|
|
|
|
|
|
2,002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
payable - related party
|
|
|
|
|
|
727
|
|
|
(481
|
)
|
|
(3)
|
|
|
246
|
|
Total
liabilities
|
|
|
1,796
|
|
|
795
|
|
|
(343
|
)
|
|
|
|
|
2248
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity (deficiency):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
178
|
|
|
4
|
|
|
89
|
|
|
(3)
|
|
|
356
|
|
|
|
|
|
|
|
|
|
|
(4
|
)
|
|
(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89
|
|
|
(5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
subscriptions receivable
|
|
|
|
|
|
(4
|
)
|
|
4
|
|
|
(2)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
paid-in capital
|
|
|
11,509
|
|
|
|
|
|
6,153
|
|
|
(3)
|
|
|
22,173
|
|
|
|
|
|
|
|
|
|
|
4,511
|
|
|
(5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
consulting expenses
|
|
|
(317
|
)
|
|
|
|
|
|
|
|
|
|
|
(317
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
deficit
|
|
|
(9,880
|
)
|
|
(795
|
)
|
|
(6,940
|
)
|
|
(3)
|
|
|
(16,820
|
)
|
|
|
|
|
|
|
|
|
|
795 |
|
|
(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders’ equity (deficiency)
|
|
|
1,490
|
|
|
(795
|
)
|
|
4,697
|
|
|
|
|
|
5,392
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity (deficiency)
|
|
$
|
3,286
|
|
$
|
—
|
|
$
|
4,354
|
|
|
|
|
$
|
7,640
|
|
See
accompanying notes to unaudited condensed combined financial
statements.
|
|
|
For
the six months ended June 30, 2005
|
(Unaudited)
|
($000's,
except share and per share
information)
|
|
|
VioQuest
|
|
Greenwich
|
|
Pro
Forma
|
|
Pro
Forma
|
|
|
|
Pharmaceuticals,
Inc.
|
|
Therapeutics,
Inc.
|
|
Adjustments
|
|
Combined
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
1,502
|
|
$
|
—
|
|
|
|
|
$
|
$1,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold (excluding depreciation)
|
|
|
1,059
|
|
|
|
|
|
|
|
|
1,059
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
443
|
|
|
|
|
|
|
|
|
443
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Management
and consulting fees
|
|
|
139
|
|
|
|
|
|
|
|
|
139
|
|
Research
and development
|
|
|
138
|
|
|
714
|
|
|
|
|
|
852
|
|
Selling,
general and administrative
|
|
|
1,250
|
|
|
|
|
|
|
|
|
1,250
|
|
Depreciation
and amortization
|
|
|
68
|
|
|
|
|
|
|
|
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
1,595
|
|
|
714
|
|
|
—
|
|
|
2,309
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,152
|
)
|
|
(714
|
)
|
|
—
|
|
|
(1,866
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income, (expense), Net
|
|
|
5
|
|
|
(11
|
)
|
|
|
|
|
(6
|
)
|
Net
loss
|
|
$
|
(1,147
|
)
|
$
|
(725
|
)
|
$
|
—
|
|
$
|
(1,872
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
$
|
(0.05
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
17,827,924
|
|
|
|
|
|
|
|
|
35,636,702
|
|
See
accompanying notes to unaudited condensed combined financial
statements.
|
UNAUDITED
PRO FORMA CONDENSED COMBINED STATEMENT OF
OPERATIONS
|
|
For
the year ended December 31, 2004
|
(Unaudited)
|
($000's,
except share and per share
information)
|
|
|
VioQuest
|
|
Greenwich
|
|
Pro
Forma
|
|
Pro
Forma
|
|
|
|
Pharmaceuticals,
Inc.
|
|
Therapeutics,
Inc.
|
|
Adjustments
|
|
Combined
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
1,485
|
|
$
|
—
|
|
|
|
|
$
|
$1,485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold (excluding depreciation)
|
|
|
838
|
|
|
|
|
|
|
|
|
838
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
647
|
|
|
|
|
|
|
|
|
647
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Management
and consulting fees
|
|
|
627
|
|
|
|
|
|
|
|
|
627
|
|
Research
and development
|
|
|
902
|
|
|
69
|
|
|
|
|
|
971
|
|
Selling,
general and administrative
|
|
|
1,612
|
|
|
|
|
|
|
|
|
1,612
|
|
Compensation
|
|
|
1,389
|
|
|
|
|
|
|
|
|
1,389
|
|
Depreciation
and amortization
|
|
|
179
|
|
|
|
|
|
|
|
|
179
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
4,709
|
|
|
69
|
|
|
—
|
|
|
4,778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(4,062
|
)
|
|
(69
|
)
|
|
—
|
|
|
(4,131
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income, Net
|
|
|
38
|
|
|
|
|
|
|
|
|
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(4,024
|
)
|
$
|
(69
|
)
|
$
|
—
|
|
$
|
(4,093
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
$
|
(0.12
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
|
17,100,582
|
|
|
|
|
|
|
|
|
34,909,360
|
|
See
accompanying notes to unaudited condensed combined financial
statements.
Notes
To Unaudited Pro Forma Condensed Combined Financial
Statements
(1)
Description of Transaction and Basis of Presentation
On
July
1, 2005, VioQuest entered into the Merger Agreement with Greenwich Therapeutics,
Inc., a Delaware corporation. In consideration for their shares of Greenwich
common stock and in accordance with the Merger Agreement, the stockholders
of
Greenwich will receive a number of shares of the Company’s common stock such
that, upon the effective time of the Merger, the Greenwich stockholders
collectively will receive (or be entitled to receive) up to approximately
49% of the Company’s outstanding common stock. Based on the number of
outstanding shares of the Company’s common stock on the date of the Merger, the
former stockholders of Greenwich are to receive up to an aggregate of 17,128,790
shares of the Company’s common stock and warrants to purchase 4,000,000 shares
of the Company’s common stock. At June 30, 2005, Greenwich had outstanding
indebtedness of approximately $795,000 resulting principally from a series
of
promissory notes issued to Paramount BioCapital Investments, LLC owned and
controlled by Dr. Lindsay Rosenwald. The notes having a maturity date of October
28, 2006, will be payable in three equal installments, as follows: (1) one-third
will be payable at such time as VioQuest completes a financing(s) resulting
in
aggregate gross proceeds of at least $5 million; (2) one-third will be converted
into securities of VioQuest upon the terms and at the completion of the
financing referred to in clause (1); and (3) one-third will be payable at such
time as VioQuest completes a financing(s) resulting in aggregate gross proceeds
of at least $10 million or prior to the notes’ maturity date whichever occurs
first, including the proceeds from the financing described in clause (1). In
the
event that VioQuest does not complete the financing(s) resulting in aggregate
gross proceeds of at least $10 million, or prior to the notes' maturity
date, whichever occurs first, then VioQuest will be required to satisfy the
final one-third in October 2006. The completion of the Merger is conditioned
upon obtaining at least $5 million in a financing transaction.
The
Merger will be accounted for as a purchase by the Company under accounting
principles generally accepted in the United States of America. Under the
purchase method of accounting, the liabilities of Greenwich will be recorded
as
of the acquisition date, at their respective fair values, and combined with
those of the Company. The reported financial condition and results of operations
of the Company after completion of the Merger will reflect these values, but
will not be restated retroactively to reflect the historical financial position
or results of operations of Greenwich. The estimated purchase price has been
preliminarily allocated to acquired IPRD.
As
required by FASB Interpretation No. 4, “Applicability of FASB Statement No. 2 to
Business Combinations Accounted for by the Purchase Method”, the Company will
record a charge upon the closing of the transaction of $6,940,000 for the
preliminary estimate of the portion of the purchase price allocated to acquired
IPRD.
One-half
of the Merger Shares and Merger Warrants will be placed in escrow and released
upon the achievement of certain milestones relating to the clinical development
of Greenwich’s product candidates. Using the share price around the date of the
execution of the Merger Agreement, which was $0.70 per share, the release of
the
escrowed securities would result in an additional purchase price of $5,995,000
and a corresponding increase to IPRD.
A
valuation using the guidance in SFAS No. 141, “Business Combinations” and the
AICPA Practice Aid “Assets Acquired in a Business Combination to Be Used in
Research and Development Activities: A Focus on Software, Electronic Devices
and
Pharmaceutical Industries” is being performed to determine the fair value of
research and development projects of Greenwich which were in-process but not
yet
completed. The valuation is a preliminary allocation of IPRD. If the actual
fair
value is materially different we will adjust the preliminary estimate
accordingly.
Notes
To Unaudited Pro Forma Condensed Combined Financial
Statements
(2) |
To
eliminate the stockholders’ deficiency accounts of Greenwich. The
Greenwich stock subscription receivable has been collected in full
as of
August 19, 2005.
|
(3) |
To
reflect the issuance of 8,880,207 shares, including 315,812 shares
for the
repayment of $246,000 of the indebtedness, of the Company’s $.01 par value
common stock to the stockholders of Greenwich and repayment of certain
indebtedness of the Company to Greenwich. The Company is obligated
to
repay the note in its entirety prior to its maturity date of October
28,
2006
|
The
components of the preliminary purchase price, which we anticipate will
be
charged to IPRD, are summarized as follows ($000’s):
Common
stock issued
|
|
$
|
5,995
|
|
Liabilities
assumed
|
|
|
795
|
|
Estimated
transaction costs
|
|
|
150
|
|
Total
purchase price
|
|
$
|
6,940
|
|
The
preliminary purchase price does not include any of the achievement based
milestone payments described above.
(4) |
To
reflect estimated transaction
costs.
|
(5) |
To
reflect the proposed minimum sale of shares of the Company’s capital stock
for gross proceeds of $5,000,000 and net proceeds to the Company
of
$4,600,000. If the maximum number of shares of capital stock is
sold the
gross proceeds received would be $11,000,000 and net proceeds to
the
Company of $10,180,000. The estimated completion of the offering
upon the
reincorporation and closing of the merger agreement. If the maximum
number
of shares is sold the pro forma net loss per share would be $.04
for the
six months ended June 30, 2005, and $.09 for the year ended
December
31, 2004.
|
Such
shares of common stock will not be registered under the Securities Act of 1933
and may not be offered or sold in the United States absent registration or
an
applicable exemption from the registration requirements of the Securities
Act.
Where
You Can Find More Information; Incorporation by Reference
We
are
allowed to “incorporate by reference” certain information which we file with the
Securities and Exchange Commission (the “SEC”). This means that we can provide
important information regarding the Company to you by referring to documents
previously filed with the SEC. Any new information that we may provide in any
filing with the SEC will automatically update and supersede the information
contained in this Proxy Statement. All information filed or to be filed with
the
SEC is considered a part of this Proxy Statement.
We
incorporate by reference the documents listed below, and any additional filing
we may make with the SEC, under Sections 13 and 14 of the Securities Exchange
Act of 1934:
• Form
10-KSB annual report for the period ended December 31, 2004, as amended by
Form
10-KSB/A filed on July 28, 2005;
• Quarterly
Report on Form 10-QSB for the quarter ended June 30, 2005; and
• Current
Reports on Form 8-K filed on January 12, 2005, February 7, 2005, July 8, 2005
and July 13, 2005, respectively.
We
will
provide you with a copy of any document incorporated by reference in this Proxy
Statement free of charge if you request it by writing us at VioQuest
Pharmaceuticals, Inc., 7 Deer Park Drive, Suite E, Monmouth Junction, New Jersey
08852, Attention: Secretary, or by calling us at (732) 274-0399, ext. 17. Upon
such request, the document will be sent to you by first class mail within one
business day of our receipt of the request.
You
may
also read and copy any materials we file with SEC at the Public Reference
Facility maintained by the SEC at Judiciary Plaza, 450 5th Street, N.W., Room
1024, Washington, D.C. 20549. You can receive additional information about
the
operation of the SEC’s Public Reference Facilities by calling the SEC at
1-800-SEC-0330. The SEC also maintains a web site at http://www.sec.gov
that
contains reports, proxy and information statements and other information
regarding companies that, like us, file information electronically with the
SEC.
INDEX
TO
APPENDICES
TO PROXY STATEMENT
Appendix
|
|
Description
|
|
|
|
A
|
|
Agreement
and Plan of Merger dated July 1, 2005 by and among VioQuest
Pharmaceuticals, Inc., Greenwich Therapeutics, Inc. and VQ Acquisition
Corp.
|
|
|
|
B
|
|
Sections
302A.471 and 302A.473 of the Minnesota Business Corporation
Act.
|
|
|
|
C
|
|
Financial
Statements of Greenwich Therapeutics, Inc.
|
|
|
|
D
|
|
License
Agreement dated February 8, 2005 by and between Greenwich Therapeutics,
Inc. and The Cleveland Clinic Foundation. (portions of this appendix
have
been omitted pursuant to a request for confidential treatment and
have
been filed separately with the Commission pursuant to Rule 24b-2
of the
Securities Exchange Act of 1934, as amended).
|
|
|
|
E
|
|
License
Agreement dated April 19, 2005 by and between Greenwich Therapeutics,
Inc.
and the University of South Florida Research Foundation, Inc. (portions
of
this appendix have been omitted pursuant to a request for confidential
treatment and have been filed separately with the Commission pursuant
to
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended).
|
|
|
|
F
|
|
Certificate
of Incorporation of VioQuest Delaware,
Inc.
|
Appendix
B
SECTIONS
302A.471 AND 302A.473 OF THE MINNESOTA BUSINESS
CORPORATION
ACT
Set
forth
below are Sections 302A.471 and 302A.473 of the Minnesota Business Corporation
Act, which provide that shareholders may dissent from and, and obtain the fair
value of their shares in the event of certain corporate actions, and establish
procedures for the exercise of such dissenters’ rights.
302A.471
Rights
of dissenting shareholders.
Subdivision
1. Actions creating rights.
A
shareholder of a corporation may dissent from, and obtain payment for the fair
value of the shareholder's shares in the event of, any of the following
corporate actions:
(a)
unless otherwise provided in the articles, an amendment of the articles that
materially and adversely affects the rights or preferences of the shares of
the
dissenting shareholder in that it:
(1)
alters or abolishes a preferential right of the shares;
(2)
creates, alters, or abolishes a right in respect of the redemption of the
shares, including a provision respecting a sinking fund for the redemption
or
repurchase of the shares;
(3)
alters or abolishes a preemptive right of the holder of the shares to acquire
shares, securities other than shares, or rights to purchase shares or securities
other than shares;
(4)
excludes or limits the right of a shareholder to vote on a matter, or to
cumulate votes, except as the right may be excluded or limited through the
authorization or issuance of securities of an existing or new class or series
with similar or different voting rights; except that an amendment to the
articles of an issuing public corporation that provides that section
302A.671
does not
apply to a control share acquisition does not give rise to the right to obtain
payment under this section; or
(5)
eliminates the right to obtain payment under this subdivision;
(b)
a
sale, lease, transfer, or other disposition of property and assets of the
corporation that requires shareholder approval under section 302A.661,
subdivision 2, but not including a disposition in dissolution described in
section 302A.725,
subdivision 2, or a disposition pursuant to an order of a court, or a
disposition for cash on terms requiring that all or substantially all of the
net
proceeds of disposition be distributed to the shareholders in accordance with
their respective interests within one year after the date of disposition;
(c)
a
plan of merger, whether under this chapter or under chapter 322B, to which
the
corporation is a constituent organization, except as provided in subdivision
3,
and except for a plan of merger adopted under section 302A.626;
(d)
a
plan of exchange, whether under this chapter or under chapter 322B, to which
the
corporation is a party as the corporation whose shares will be acquired by
the
acquiring corporation, except as provided in subdivision 3;
(e)
a
plan of conversion adopted by the corporation; or
(f)
any
other corporate action taken pursuant to a shareholder vote with respect to
which the articles, the bylaws, or a resolution approved by the board directs
that dissenting shareholders may obtain payment for their shares.
Subd.
2. Beneficial owners.
(a) A
shareholder shall not assert dissenters' rights as to less than all of the
shares registered in the name of the shareholder, unless the shareholder
dissents with respect to all the shares that are beneficially owned by another
person but registered in the name of the shareholder and discloses the name
and
address of each beneficial owner on whose behalf the shareholder dissents.
In
that
event, the rights of the dissenter shall be determined as if the shares as
to
which the shareholder has dissented and the other shares were registered in
the
names of different shareholders.
(b)
A
beneficial owner of shares who is not the shareholder may assert dissenters'
rights with respect to shares held on behalf of the beneficial owner, and shall
be treated as a dissenting shareholder under the terms of this section and
section 302A.473,
if the
beneficial owner submits to the corporation at the time of or before the
assertion of the rights a written consent of the shareholder.
Subd.
3. Rights not to apply.
(a)
Unless the articles, the bylaws, or a resolution approved by the board otherwise
provide, the right to obtain payment under this section does not apply to a
shareholder of (1) the surviving corporation in a merger with respect to shares
of the shareholder that are not entitled to be voted on the merger and are
not
canceled or exchanged in the merger or (2) the corporation whose shares will
be
acquired by the acquiring corporation in a plan of exchange with respect to
shares of the shareholder that are not entitled to be voted on the plan of
exchange and are not exchanged in the plan of exchange.
(b)
If a
date is fixed according to section 302A.445,
subdivision 1, for the determination of shareholders entitled to receive notice
of and to vote on an action described in subdivision 1, only shareholders as
of
the date fixed, and beneficial owners as of the date fixed who hold through
shareholders, as provided in subdivision 2, may exercise dissenters' rights.
(c)
Notwithstanding subdivision 1, the right to obtain payment under this section,
other than in connection with a plan of merger adopted under section
302A.621,
is
limited in accordance with the following provisions:
(1)
The
right to obtain payment under this section is not available for the holders
of
shares of any class or series of shares that is listed on the New York Stock
Exchange or the American Stock Exchange or designated as a national market
system security on an interdealer quotation system by the National Association
of Securities Dealers, Inc.
(2)
The
applicability of clause (1) is determined as of: (i) the record date fixed
to
determine the shareholders entitled to receive notice of, and to vote at, the
meeting of shareholders to act upon the corporate action described in
subdivision 1; or (ii) the day before the effective date of corporate action
described in subdivision 1 if there is no meeting of shareholders.
(3)
Clause (1) is not applicable, and the right to obtain payment under this section
is available pursuant to subdivision 1, for the holders of any class or series
of shares who are required by the terms of the corporate action described in
subdivision 1 to accept for such shares anything other than shares, or cash
in
lieu of fractional shares, of any class or any series of shares of the
corporation, or any other proprietary interest of any other entity, that
satisfies the standards set forth in clause (1) at the time the corporate action
becomes effective.
Subd.
4. Other rights.
The
shareholders of a corporation who have a right under this section to obtain
payment for their shares do not have a right at law or in equity to have a
corporate action described in subdivision 1 set aside or rescinded, except
when
the corporate action is fraudulent with regard to the complaining shareholder
or
the corporation.
302A.473 Procedures
for asserting dissenters' rights.
Subdivision
1. Definitions.
(a) For
purposes of this section, the terms defined in this subdivision have the
meanings given them.
(b)
"Corporation" means the issuer of the shares held by a dissenter before the
corporate action referred to in section 302A.471,
subdivision 1 or the successor by merger of that issuer.
(c)
"Fair
value of the shares" means the value of the shares of a corporation immediately
before the effective date of the corporate action referred to in section
302A.471,
subdivision 1.
(d)
"Interest" means interest commencing five days after the effective date of
the
corporate action referred to in section 302A.471,
subdivision 1, up to and including the date of payment, calculated at the rate
provided in section 549.09
for
interest on verdicts and judgments.
Subd.
2. Notice of action.
If a
corporation calls a shareholder meeting at which any action described in section
302A.471,
subdivision 1 is to be voted upon, the notice of the meeting shall inform each
shareholder of the right to dissent and shall include a copy of section
302A.471
and this
section and a brief description of the procedure to be followed under these
sections.
Subd.
3. Notice of dissent.
If the
proposed action must be approved by the shareholders and the corporation holds
a
shareholder meeting, a shareholder who is entitled to dissent under section
302A.471
and who
wishes to exercise dissenters' rights must file with the corporation before
the
vote on the
proposed
action a written notice of intent to demand the fair value of the shares owned
by the shareholder and must not vote the shares in favor of the proposed action.
Subd.
4. Notice of procedure; deposit of shares.
(a)
After the proposed action has been approved by the board and, if necessary,
the
shareholders, the corporation shall send to (i) all shareholders who have
complied with subdivision 3, (ii) all shareholders who did not sign or consent
to a written action that gave effect to the action creating the right to obtain
payment under section 302A.471,
and
(iii) all shareholders entitled to dissent if no shareholder vote was required,
a notice that contains:
(1)
the
address to which a demand for payment and certificates of certificated shares
must be sent in order to obtain payment and the date by which they must be
received;
(2)
any
restrictions on transfer of uncertificated shares that will apply after the
demand for payment is received;
(3)
a
form to be used to certify the date on which the shareholder, or the beneficial
owner on whose behalf the shareholder dissents, acquired the shares or an
interest in them and to demand payment; and
(4)
a
copy of section 302A.471
and this
section and a brief description of the procedures to be followed under these
sections.
(b)
In
order to receive the fair value of the shares, a dissenting shareholder must
demand payment and deposit certificated shares or comply with any restrictions
on transfer of uncertificated shares within 30 days after the notice required
by
paragraph (a) was given, but the dissenter retains all other rights of a
shareholder until the proposed action takes effect.
Subd.
5. Payment; return of shares.
(a)
After the corporate action takes effect, or after the corporation receives
a
valid demand for payment, whichever is later, the corporation shall remit to
each dissenting shareholder who has complied with subdivisions 3 and 4 the
amount the corporation estimates to be the fair value of the shares, plus
interest, accompanied by:
(1)
the
corporation's closing balance sheet and statement of income for a fiscal year
ending not more than 16 months before the effective date of the corporate
action, together with the latest available interim financial statements;
(2)
an
estimate by the corporation of the fair value of the shares and a brief
description of the method used to reach the estimate; and
(3)
a
copy of section 302A.471
and this
section, and a brief description of the procedure to be followed in demanding
supplemental payment.
(b)
The
corporation may withhold the remittance described in paragraph (a) from a person
who was not a shareholder on the date the action dissented from was first
announced to the public or who is dissenting on behalf of a person who was
not a
beneficial owner on that date. If the dissenter has complied with subdivisions
3
and 4, the corporation shall forward to the dissenter the materials described
in
paragraph (a), a statement of the reason for withholding the remittance, and
an
offer to pay to the dissenter the amount listed in the materials if the
dissenter agrees to accept that amount in full satisfaction. The dissenter
may
decline the offer and demand payment under subdivision 6. Failure to do so
entitles the dissenter only to the amount offered. If the dissenter makes
demand, subdivisions 7 and 8 apply.
(c)
If
the corporation fails to remit payment within 60 days of the deposit of
certificates or the imposition of transfer restrictions on uncertificated
shares, it shall return all deposited certificates and cancel all transfer
restrictions. However, the corporation may again give notice under subdivision
4
and require deposit or restrict transfer at a later time.
Subd.
6. Supplemental payment; demand.
If a
dissenter believes that the amount remitted under subdivision 5 is less than
the
fair value of the shares plus interest, the dissenter may give written notice
to
the corporation of the dissenter's own estimate of the fair value of the shares,
plus interest, within 30 days after the corporation mails the remittance under
subdivision 5, and demand payment of the difference. Otherwise, a dissenter
is
entitled only to the amount remitted by the corporation.
Subd.
7. Petition; determination.
If the
corporation receives a demand under subdivision 6, it shall, within 60 days
after receiving the demand, either pay to the dissenter the amount demanded
or
agreed to by the dissenter after discussion with the corporation or file in
court a petition requesting that the court determine the fair value of the
shares, plus interest. The petition shall be filed in the county in which the
registered office of the corporation is located, except that a surviving foreign
corporation that receives a demand relating to the shares of a constituent
domestic corporation shall file the petition in the county in this state in
which the last registered office of the constituent corporation was located.
The
petition shall name as parties all dissenters who have demanded payment under
subdivision 6 and who have not reached agreement with the corporation. The
corporation shall, after filing the petition, serve all parties with a summons
and copy of the petition under the Rules of Civil Procedure. Nonresidents of
this state may be served by registered or certified mail or by publication
as
provided by law. Except as
otherwise
provided, the Rules of Civil Procedure apply to this proceeding. The
jurisdiction of the court is plenary and exclusive. The court may appoint
appraisers, with powers and authorities the court deems proper, to receive
evidence on and recommend the amount of the fair value of the shares. The court
shall
determine whether the shareholder or shareholders in question have fully
complied with the requirements of this section, and shall determine the fair
value of the shares, taking into account any and all factors the court finds
relevant, computed by any method or combination of methods that
the
court, in its discretion, sees fit to use, whether or not used by the
corporation or by a dissenter. The fair value of the shares as determined by
the
court is binding on all shareholders, wherever located. A dissenter is entitled
to judgment in cash for the amount by which the fair value of the shares as
determined by the court, plus interest, exceeds the amount, if any, remitted
under subdivision 5, but shall not be liable to the corporation for the amount,
if any, by which the amount, if any, remitted to the dissenter under subdivision
5 exceeds the fair value of the shares as determined by the court, plus
interest.
Subd.
8. Costs; fees; expenses.
(a) The
court shall determine the costs and expenses of a proceeding under subdivision
7, including the reasonable expenses and compensation of any appraisers
appointed by the court, and shall assess those costs and expenses against the
corporation, except that the court may assess part or all of those costs and
expenses against a dissenter whose action in demanding payment
under
subdivision 6 is found to be arbitrary, vexatious, or not in good faith.
(b)
If
the court finds that the corporation has failed to comply substantially with
this section, the court may assess all fees and expenses of any experts or
attorneys as the court deems equitable. These fees and expenses may also be
assessed against a person who has acted arbitrarily, vexatiously, or not in
good
faith in bringing the proceeding, and may be awarded to a party injured by
those
actions.
(c)
The
court may award, in its discretion, fees and expenses to an attorney for the
dissenters out of the amount awarded to the dissenters, if any.
Appendix
C
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
Index
|
Page
|
|
|
Report
of Independent Registered Public Accounting Firm
|
C-2
|
|
|
Balance
Sheets
|
|
June
30, 2005 (Unaudited), March 31, 2005 and December 31, 2004
|
C-3
|
|
|
Statements
of Operations
|
|
Six
Months Ended June 30, 2005 (Unaudited) and Three Months Ended March
31,
2005,
|
|
Period
from October 28, 2004 (Inception)
|
|
to
December 31, 2004 and Period from October 28, 2004
(Inception)
|
|
to
June 30, 2005
|
C-4
|
|
|
Statements
of Changes in Stockholders' Deficiency
|
|
Six
Months Ended June 30, 2005 (Unaudited), Period from October 28, 2004
(Inception)
|
|
to
December 31, 2004 and Period from October 28, 2004
(Inception)
|
|
to
June 30, 2005
|
C-5
|
|
|
Statements
of Cash Flows
|
|
Six
Months Ended June 30, 2005 (Unaudited) and Three Months Ended March
31,
2005,
|
|
Period
from October 28, 2004 (Inception)
|
|
to
December 31, 2004 and Period from October 28, 2004
(Inception)
|
|
to
June 30, 2005
|
C-6
|
|
|
Notes
to Financial Statements
|
C-7-9
|
Report
of Independent Registered Public Accounting Firm
The
Board
of Directors and Stockholders
Greenwich
Therapeutics, Inc.
We
have
audited the accompanying balance sheets of Greenwich Therapeutics, Inc. (A
Development Stage Company) as of March 31, 2005 and December 31, 2004, and
the
related statements of operations, changes in stockholders' deficiency and cash
flows for the three months ended March 31, 2005, the period from October 28,
2004 (Inception) to December 31, 2004 and the cumulative amounts for the period
from October 28, 2004 (Inception) to March 31, 2005. These financial statements
are the responsibility of the Company's management. Our responsibility is to
express an opinion on these financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Greenwich Therapeutics, Inc. as
of
March 31, 2005 and December 31, 2004, and its results of operations and cash
flows for the three months ended March 31, 2005, the period from October 28,
2004 (Inception) to December 31, 2004 and the cumulative amounts for the period
from October 28, 2004 (Inception) to March 31, 2005, in conformity with
accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has incurred net losses from its inception through
March
31, 2005 and it had a stockholders' deficiency as of March 31, 2005 of $668,498.
These matters raise substantial doubt about the Company's ability to continue
as
a going concern. Management's plans concerning these matters are also described
in Note 1. The accompanying financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
/s/J.H.
Cohn LLP
Roseland,
New Jersey
June
4,
2005
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
BALANCE
SHEETS
JUNE
30, 2005 (Unaudited), MARCH 31, 2005 AND DECEMBER 31, 2004
|
|
June
|
|
|
|
|
|
|
|
30,
2005
|
|
March
|
|
December
|
|
ASSETS
|
|
(Unaudited)
|
|
31,
2005
|
|
31,2004
|
|
|
|
|
|
|
|
|
|
Totals
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$
|
55,561
|
|
$
|
26,741
|
|
$
|
-
|
|
Accrued
interest - related party
|
|
|
11,864
|
|
|
3,487
|
|
|
415
|
|
Total
current liabilities
|
|
|
67,425
|
|
|
30,228
|
|
|
415
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
payable - related party
|
|
|
727,339
|
|
|
638,270
|
|
|
68,552
|
|
Total
liabilities
|
|
|
794,764
|
|
|
668,498
|
|
|
68,967
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
deficiency:
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock, $.001 par value; 5,000,000 shares
|
|
|
|
|
|
|
|
|
|
|
authorized;
none issued
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Common
stock, $.001 par value; 20,000,000 shares
|
|
|
|
|
|
|
|
|
|
|
authorized;
4,000,000 shares issued and outstanding
|
|
|
4,000
|
|
|
4,000
|
|
|
4,000
|
|
Less
stock subscriptions receivable
|
|
|
(4,000
|
)
|
|
(4,000
|
)
|
|
(4,000
|
)
|
Deficit
accumulated during the development stage
|
|
|
(794,764
|
)
|
|
(668,498
|
)
|
|
(68,967
|
)
|
Total
stockholders' deficiency
|
|
|
(794,764
|
)
|
|
(668,498
|
)
|
|
(68,967
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
See
Notes
to Financial Statements.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
STATEMENTS
OF OPERATIONS
SIX
MONTHS ENDED JUNE 30, 2005 (Unaudited), THREE MONTHS ENDED MARCH 31, 2005,
PERIOD FROM OCTOBER 28, 2004 (Inception) TO DECEMBER 31, 2004 AND
PERIOD
FROM OCTOBER 28, 2004 (Inception) TO JUNE 30, 2005
(Unaudited)
|
|
Six
|
|
|
|
|
|
Period
from
|
|
|
|
Months
|
|
|
|
|
|
October
28, 2004
|
|
|
|
Ended
|
|
|
|
|
|
(Inception)
to
|
|
|
|
June
|
|
|
|
|
|
June
|
|
|
|
30,
2005
|
|
|
|
|
|
30,
2005
|
|
|
|
(Unaudited)
|
|
|
|
31,
2004
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses - research
|
|
|
|
|
|
|
|
|
|
and
development,
principally
|
|
|
|
|
|
|
|
|
|
license
fee
|
|
$
|
714,348
|
|
$
|
596,459
|
|
$
|
68,552
|
|
$
|
782,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(714,348
|
)
|
|
(596,459
|
)
|
|
(68,552
|
)
|
|
(782,900
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(11,449
|
)
|
|
(3,072
|
)
|
|
(415
|
)
|
|
(11,864
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(725,797
|
)
|
$
|
(599,531
|
)
|
$
|
(68,967
|
)
|
$
|
(794,764
|
)
|
See
Notes
to Financial Statements.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' DEFICIENCY
SIX
MONTHS ENDED JUNE 30, 2005 (Unaudited), PERIOD FROM
OCTOBER
28,
2004 (Inception) TO DECEMBER 31, 2004 AND PERIOD FROM
OCTOBER
28, 2004 (Inception) TO JUNE 30, 2005 (Unaudited)
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
Stock
|
|
During
the
|
|
|
|
|
|
Common
Stock
|
|
Subscriptions
|
|
Development
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Receivable
|
|
Stage
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock to
|
|
|
|
|
|
|
|
|
|
|
|
founders
in October 2004
|
|
|
|
|
|
|
|
|
|
|
|
at
$.001 per share
|
|
|
4,000,000
|
|
$
|
4,000
|
|
$
|
(4,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
$
|
(68,967
|
)
|
$
|
(68,967
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2004
|
|
|
4,000,000
|
|
|
4,000
|
|
|
(4,000
|
)
|
|
(68,967
|
)
|
|
(68,967
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
(725,797
|
)
|
|
(725,797
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2005 (Unaudited)
|
|
|
4,000,000
|
|
$
|
4,000
|
|
$
|
(4,000
|
)
|
$
|
(794,764
|
)
|
$
|
(794,764
|
)
|
See
Notes
to Financial Statements.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
SIX
MONTHS ENDED JUNE 30, 2005 (Unaudited), THREE MONTHS ENDED MARCH 31, 2005,
PERIOD
FROM OCTOBER 28, 2004 (Inception) TO DECEMBER 31, 2004 AND
PERIOD
FROM OCTOBER 28, 2004 (Inception) TO JUNE 30, 2005
(Unaudited)
|
|
Six
|
|
|
|
|
|
Period
from
|
|
|
|
Months
|
|
|
|
|
|
October
28, 2004
|
|
|
|
Ended
|
|
|
|
|
|
(Inception)
to
|
|
|
|
June
|
|
|
|
|
|
June
|
|
|
|
30,
2005
|
|
|
|
|
|
30,
2005
|
|
|
|
(Unaudited)
|
|
|
|
31,
2004
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(725,797
|
)
|
$
|
(599,531
|
)
|
$
|
(68,967
|
)
|
$
|
(794,764
|
)
|
Adjustments
to reconcile net loss to net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
cash
provided by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses
paid by related party on
|
|
|
|
|
|
|
|
|
|
|
|
|
|
behalf
of the Company
|
|
|
658,787
|
|
|
569,718
|
|
|
68,552
|
|
|
727,339
|
|
Changes
in operating assets and
|
|
|
|
|
|
|
|
|
|
|
|
|
|
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expenses
|
|
|
55,561
|
|
|
26,741
|
|
|
|
|
|
55,561
|
|
Accrued
interest - related party
|
|
|
11,449
|
|
|
3,072
|
|
|
415
|
|
|
11,864
|
|
Net
cash provided by
|
|
|
|
|
|
|
|
|
|
|
|
|
|
operating
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and
cash, beginning
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and
end of period
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
See
Notes
to Financial Statements.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to June 30, 2005 and the six months then
ended)
Note
1 - Business,
basis of presentation and summary of significant accounting
policies:
Business:
Greenwich
Therapeutics, Inc. ("Greenwich" or the "Company") was incorporated in the State
of Delaware on October 28, 2004. Greenwich is a specialty pharmaceutical company
focused on the acquisition, development and commercialization of innovative
pharmaceutical products. The Company's current licensed compound targets the
treatment of cancer, conditions stemming from the abnormal regulation of cell
growth and other immunological diseases.
Basis
of presentation:
The
Company's primary activities since incorporation have been organizational
activities, payment of a license fee and performing business and financial
planning. Accordingly, the Company is considered to be in the development stage.
On
May 3,
2005, VioQuest Pharmaceuticals, Inc. ("VIO") entered into a letter of intent
("LOI") with Greenwich. Pursuant to the LOI, VIO will issue up to 49% of its
common stock to Greenwich's stockholders in exchange for 100% of the outstanding
common stock of Greenwich. VIO is a pharmaceutical company that acquires and
develops proprietary prescription drugs.
The
Company's financial statements have been prepared on a going concern basis
which
contemplates the realization of assets and the settlement of liabilities and
commitments in the normal course of business. For the six months ended June
30,
2005, the Company reported a net loss of $725,797 and it had a loss from
inception through June 30, 2005 and a stockholders' deficiency as of June 30,
2005 of $794,764. Management believes that the Company will continue to incur
losses for the foreseeable future and will need additional equity or debt
financing or will need to generate revenue from the licensing of its products
or
by entering into strategic alliances to be able to sustain its operations until
it can achieve profitability, if ever. These matters raise substantial doubt
about the Company's ability to continue as a going concern. The accompanying
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty.
The
accompanying unaudited financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America
for interim financial information. Accordingly, the financial statements
do
not include all information and footnotes required by accounting principles
generally accepted in the United States of America for complete annual financial
statements. In the opinion of management, the accompanying unaudited financial
statements reflect all adjustments, consisting of only normal recurring
adjustments, considered necessary for a fair presentation. Interim operating
results are not necessarily indicative of results that may be expected for
the
year ending December 31, 2005 or for any subsequent period.
Use
of estimates:
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts and disclosures.
Accordingly, actual results could differ from those estimates.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to June 30, 2005 and the six months then
ended)
Note
1 - Business,
basis of presentation and summary of significant accounting policies
(concluded):
Research
and development:
Research
and development costs are expensed as incurred.
Research
and development costs for the six months ended June 30, 2005, for the three
months ended March 31, 2005 and the period from October 28, 2004 through
the year ended December 31, 2004 were $714,348, $596,459 and
$68,522,
respectively, primarily for license fees (see Note 3).
Income
taxes:
Under
Statement of Financial Accounting Standards No. 109, "Accounting for Income
Taxes," ("SFAS 109") deferred tax assets and liabilities are recognized for
the
future tax consequences attributable to temporary differences between the
financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled.
Under
SFAS 109, the effect on deferred tax assets and liabilities of a change in
tax
rates is recognized in income in the period that includes the enactment date.
Valuation allowances are established when it is more likely than not that
deferred tax assets will not be realized.
Note
2 - Notes payable - related party:
In
October 2004, the Company entered into an open-ended future advance promissory
note whereby Paramount BioCapital Investments, LLC ("PBCI"), an affiliate of
a
significant stockholder of Greenwich, agreed to advance funds for obligations
arising out of the operations of Greenwich's business. The note accrues interest
at a fixed rate equal to 5% per annum and becomes payable upon the earlier
of
two years from the date of issuance of the note or the date on which Greenwich
enters into certain specified financing transactions. The amount due PBCI,
including accrued interest, was $739,203, $641,757 and $68,967 as of
June
30, 2005, March 31, 2005 and December 31, 2004, respectively.
Note
3 - License agreements:
In
February 2005, the Company entered into an agreement to acquire the rights
to an
exclusive, world-wide, royalty-bearing sublicense to develop and commercialize
technology for treatment of cancer, conditions stemming from the abnormal
regulation of cell growth and other immunological diseases (the "Sodium
Stibogluconate Technology").
The
amount expended under this agreement and charged to research and development
expense for the three months ended March 31, 2005 and for the six months ended
June 30, 2005 was $549,718 and for the period from October 28, 2004 (inception)
to December 31, 2004 was $35,000. Future potential milestone payments under
this
agreement total approximately $4,550,000. The Company may also owe the licensor
royalty payments based on future net sales, as defined, from Sodium
Stibogluconate Technology. There are no minimum royalties required under the
agreement.
GREENWICH
THERAPEUTICS, INC.
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS
(Unaudited
with respect to June 30, 2005 and the six months then
ended)
Note
3 - License agreements (concluded):
On
April
19, 2005, Greenwich entered into a license agreement with the University of
South Florida as the exclusive licensee under certain patent rights relating
to
technology for anticancer and antiviral therapy (the "Triciribine Technology").
The Company intends to develop, produce, manufacture, market and/or sell
products related to the licensed technology. In May 2005, the Company made
an
initial payment of $41,000 under this agreement. Future potential milestone
payments under this agreement total approximately $5,800,000. The Company may
also owe the licensor royalty payments based on future net sales, as defined,
from the Triciribine Technology. There are no minimum royalties required under
the agreement.
Note
4 - Stockholders' deficiency:
In
2004,
the Company issued 4,000,000 shares of common stock to its founders for
subscriptions receivable of $4,000 or $.001 per share.
Note
5 - Income taxes:
There
was
no current or deferred income tax expense or credit for the six months ended
June 30, 2005 and for the period from October 28, 2004 (inception) to December
31, 2004.
The
Company's deferred tax assets as of June 30, 2005, March 31, 2005 and
December 31, 2004 are as follows:
|
|
June
30,
2005
|
|
March
31,
2005
|
|
December
31,
2004
|
|
|
|
|
|
|
|
|
|
Net
operating loss carryforwards - Federal
|
|
$
|
247,000
|
|
$
|
204,000
|
|
$
|
23,000
|
|
Net
operating loss carryforwards - state
|
|
|
44,000
|
|
|
36,000
|
|
|
4,000
|
|
Totals
|
|
|
291,000
|
|
|
240,000
|
|
|
27,000
|
|
Less
valuation allowance
|
|
|
291,000
|
|
|
(240,000
|
)
|
|
27,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax assets
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
At
June
30, 2005, the Company had potentially utilizable Federal and state net operating
loss tax carryforwards of approximately $795,000.
The
utilization of the Company's net operating losses may be subject to a
substantial limitation due to the "change of ownership provisions" under Section
382 of the Internal Revenue Code and similar state provisions. Such limitation
may result in the expiration of the net operating loss carryforwards before
their utilization.
Note
7 - Subsequent events:
During
the period from July 1, 2005 through August 12, 2005, the Company received
additional advances of $3,948 under the promissory note issued to PBCI (see
Note
2).
Appendix
D
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act
of 1934.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
LICENSE
AGREEMENT
(as
amended)
THIS
LICENSE AGREEMENT
(hereinafter referred to as this “Agreement”),
effective as of this February 8, 2005 is entered into by and between The
Cleveland Clinic Foundation, an Ohio non-profit corporation located at
9500
Euclid Avenue, Cleveland, Ohio 44195 (the “Licensor”),
and
Greenwich Pharmaceuticals, Inc., a Delaware for-profit corporation located
at
787 Seventh Avenue, New York, New York 10019 (the “Company”).
Licensor and Company shall individually be referred to as “Party”
and
collectively referred to as the “Parties.”
WHEREAS,
the
Licensor owns rights to the research, development and commercialization
of
intellectual property relating to Sodium Stibogluconate, Pentamidine, analogues
of Sodium Stibogluconate and Pentamidine, pentavalent antimony-based compounds
and other compounds (collectively, the “Technology”)
as
claimed in Patent Rights or covered by Know-How (as defined below);
and
WHEREAS,
the
Company is interested in obtaining rights for the use, production, distribution,
and marketing of products derived from the Technology, and Licensor is
willing
to grant such rights so that the Technology may be developed and the benefits
enjoyed by the public.
NOW,
THEREFORE,
it is
agreed as follows:
ARTICLE
1 - DEFINITIONS
For
the
purposes of this Agreement, the following words and phrases shall have
the
following meanings:
1.1 “Affiliate”
shall
mean, with respect to any Entity (as hereinafter defined), any Entity that
directly or indirectly controls, is controlled by, or is under common control
with such Entity.
1.2 “Control”
shall
mean, for this purpose, direct or indirect control of more than fifty percent
(50%)
of the
voting securities of an Entity or, if such Entity does not have outstanding
voting securities, more than fifty percent (50%)
of the
directorships or similar positions with respect to such Entity.
1.3 “Entity”
shall
mean any corporation, association, joint venture, partnership, trust,
university, business, individual, government or political subdivision thereof,
including an agency, or any other organization that can exercise independent
legal standing.
1.4 “Company”
shall
mean Greenwich Pharmaceuticals, Inc., a Delaware corporation.
1.5 “Fair
Market Value”
shall
mean a commercially reasonable price agreed to between a willing buyer
and a
willing seller in an arm’s length transaction.
1.6 “Field
of Use”
shall
mean all uses.
1.7 “Improvements”
shall
mean (i) any modifications of a Licensed Process or Licensed Product developed
by the Licensor after the date of this Agreement; (ii) any invention (whether
patentable or not), information and data developed or discovered after
the date
of this Agreement that the manufacture, use or sale of which would be reasonably
necessary in the manufacturing, use or sale of Licensed Products or Processes
or
would infringe an issued or pending claim within the Patent Rights.
1.8 “Investigator(s)”
shall
mean Taolin Yi, Ph.D., members of his laboratory during their respective
employment by Licensor, and any Licensor employee acting under Dr. Yi’s
direction or control.
1.9 “Know-how”
shall
mean all tangible information (other than those contained in the Patent
Rights)
whether patentable or not (but which have not been patented), which are
reasonably necessary to practice the Patent Rights or to sell Licensed
Compound,
Licensed Products or practice Licensed Processes, including formulations,
processes and procedures, data, drawings and sketches, in vitro and in
vivo
data, animal data, laboratory data, observations, designs, testing and
test
results, regulatory information of a like nature, manufacturing processes
developed by Investigators and owned by the Licensor, which Licensor have
the
right to disclose and license to the Company.
1.10 “Licensed
Compound”
shall
mean, separately, (i) Sodium Stibogluconate; (ii) Pentamidine; (iii) each
analogue of Sodium Stibogluconate; (iv) each analogue of Pentamidine, and
(v)
pentavalent antimony-based compounds; provided,
however,
such
compounds in (i)-(v) are covered under the Patent Rights; and (v) any other
compound described in the patent or patent application listed on Exhibit
A.
1.11 “Licensed
Product(s)”
shall
mean:
1.11.1 Any
product that is covered in whole or in part by Patent Rights in the country
in
which the product is made, used, leased or sold;
1.11.2 Any
product which is manufactured using a process which is covered in whole
or in
part by Patent Rights in the country in which the process is used;
1.11.3 Any
product which is used according to a method or use which is covered in
whole or
in part by Patent Rights in the country in which the method is
used.
1.12 “Licensed
Process(es)”
shall
mean any process, use or method, which is covered, in whole, or in part,
by
Patent Rights in the country in which the process or method is
used.
1.13 “Net
Sales”
shall
mean the total gross receipts for sales of Licensed Products or practice
of
Licensed Processes by or on behalf of the Company or any of its Affiliates
or
sublicensees, whether invoiced or not, less only the sum of the
following:
1.13.1 Usual
trade discounts to customers;
1.13.2 Sales,
tariff duties and/or taxes directly imposed and with reference to particular
sales;
1.13.3 Amounts
allowed or credited on returns or rejections;
1.13.4 Licensed
Product or Licensed Process revenues deemed uncollectible and actually
written
off during the accounting period; and
1.13.5 Outbound
transportation prepaid or allowed and transportation insurance.
1.14 “Patent
Rights”
shall
mean all U.S. and foreign patents and patent applications set forth in
Exhibit
A
and:
1.14.1 Any
other
United States and/or foreign patent applications and/or patents filed on
behalf
of the Investigators by CCF and owned by CCF that claim priority to any
of the
patents or applications listed in Exhibit
A,
together with any and all patents issuing thereon, including continuations,
continuations in part, divisionals, reexaminations, extensions, and reissue
applications and continuation-in-part applications and any United States
or
foreign patents granted upon such applications;
1.14.2 U.S.
and
foreign patents and patent applications claiming Improvements developed
in the
first year immediately following the Effective Date of this Agreement including
any continuations, continuations-in-part, divisionals, reissues, reexaminations
or extensions thereof;
1.14.3 Any
United States and/or foreign patents issuing from any application or other
right
listed in this Article 1.14.
1.14.4 Any
patent or patent application owned as of the Effective Date by Licensor
claiming
Licensed Compounds or their use or manufacture that that would be reasonably
necessary for the Company to manufacture, use, or sell Licensed Products
or
Licensed Processes.
1.15 “Territory”
shall
mean the world.
ARTICLE
2 - GRANT
2.1 Licensor
hereby grants to the Company and the Company accepts, subject to the terms
and
conditions of this Agreement, an exclusive license in the Field of Use
to
practice under the Patent Rights and to utilize the Know-how in the Territory,
and (a) to make, have made, use, lease and/or sell the Licensed Products
and to
practice and have practiced the Licensed Processes, to the full end of
the term
for which the Patent Rights are granted, unless sooner terminated as hereinafter
provided and (b) sublicense to third parties, in accordance with Section
2.2
below, the rights granted under subsection (a) of this Section 2.1.
Notwithstanding the foregoing, Licensor reserves the right to practice
under the
Patent Rights and utilize the Know-How for its own non-commercial research
and
educational purposes; provided,
however,
the
Licensor shall not conduct any human clinical trials with a Licensed Product
without first receiving written permission from Company.
2.2 In
accordance with Section 2.1 above, Licensor hereby grants to the Company
the
right to grant sublicenses to third parties under the license granted hereunder
in its sole discretion provided that such sublicenses shall be in writing.
Within thirty- (30) days after execution or receipt thereof, as applicable,
the
Company shall provide Licensor with a copy of each sublicense issued hereunder.
Upon termination of this Agreement, any sublicensee shall survive such
termination provided that sublicensees agree in writing to fully comply
with the
terms and conditions this Agreement, provided, further, however, that such
sublicensee is in good standing at the time of such termination and that
if such
sublicensee is not in good standing at the time of termination of this
Agreement, the Company shall notify sublicensee of its default and such
sublicensee shall have sixty- (60) days to cure any breach of its sublicense
agreement. Notwithstanding the foregoing, if Company believes that Licensor
has
terminated this Agreement for the primary purpose of doing business directly
with the sublicensee, the termination may be disputed under the provisions
of
Article 8.
2.3 The
licenses granted in Sections 2.1 may be subject to the rights of the United
States Government as set forth in 35 U.S.C. § 200 et seq. If there is any
conflict between any Government rights and the rights granted herein, such
Government rights shall prevail.
2.4 The
Licensor hereby grants to the Company, and the Company hereby accepts,
the
exclusive right to negotiate for a license, on a worldwide basis in all
fields
of use, and on commercially reasonable terms, any Improvements developed
on or
after the first anniversary of the Effective Date of this Agreement through
the
end of the Term (hereinafter “Follow-on
Improvements”).
In
the event that Licensor files a U.S. patent application on any Follow-on
Improvements, Licensor shall under confidentiality notify Company of such
Follow-on Improvements prior to discussing a license with any third party.
Company shall have no longer than thirty- (30) days immediately following
the
disclosure of such Follow-on Improvements to notify Licensor in writing
of its
desire to obtain a license to the Follow-on Improvements. Parties shall
enter
into good-faith negotiations for a license to the Follow-on Improvements
for a
period of ninety- (90) days. If within such time period, the Parties are
not
able to agree upon a license, Licensor shall have no further obligation
to
Company relating to such Follow-on Improvement.
2.5 The
Licensor covenants that it will not, during the term of this Agreement,
(a)
cause or assist in the assertion, instigation, maintenance or pursuit of
any
claim or litigation against the Company based on or alleging that the Company’s
manufacture, use, or sale of Licensed Processes or License Products infringe
on
any rights under any patents or patent applications having the Investigator
as
an inventor and owned by the Licensor as of the Effective Date or (b) enter
into
a license with respect to or otherwise convey rights under, any of the
patents
and patent applications listed in Exhibit
A
to any
third party.
2.6 Licensor
shall, to the extent permitted by applicable law and regulations, provide
the
Company with, and/or give the Company access to the following information
specifically pertaining to the research and development of the Technology
to the
extent that such information is reasonably available and accessible to
Licensor:
(i) copies of all regulatory submissions by the Licensor, its Affiliates,
contractors or agents, (ii) copies of or access to all patient records
and data
(including those held by physicians, care facilities, or clinical trial
organizations) to the extent the Licensor has copies thereof or can provide
access thereto, (iii) copies of all computer data and reports pertaining
to
clinical trials, (iv) copies of all adverse event reports, (v) copies of
all
pre-clinical evaluations, (vi) any clinical trial material in the Licensor’s
possession that has not expired, (vii) reasonable storage of and access
to
biological samples, (viii) physicians, CROs and health care administrators
involved in trials, to the extent such persons are available, (ix) all
drug
manufacture files, if any, along with the right to use manufacturing processes,
(x) remaining quantities of any active pharmaceutical ingredient intermediates
pursuant to the terms of a supply agreement to be negotiated between the
parties
and (xi) all other information that the Company may reasonably request
from the
Licensor. All costs related to the duplication and transfer of such materials
shall be borne by the Company. In addition, the Licensor shall assign or,
if the
Licensor is legally prohibited from assigning or the parties agree to
cross-reference, cross-reference to the Company all regulatory filings
relating
to Licensed Products. To the extent that the Licensor has access to patient
records, data, computer files, patient samples or other patient clinical
trial
information, the Licensor, to the extent permitted by law, on written request
by
the Company, shall arrange for the Company access to such documents,
information, and materials. From time to time during the term of this Agreement,
at the request and expense of the Company, the Licensor agrees to execute
and
deliver to the Company such documents and take such other actions as the
Company
may reasonably request in order to consummate more effectively the transactions
contemplated hereby. The Licensor shall reasonably cooperate with the Company
and provide the Company with such assistance as reasonably may be requested
by
the Company, including with respect to the transfer of clinical data and
filings
with the FDA.
ARTICLE
3 - COMMERCIALIZATION
The
Company shall use all commercially reasonable efforts to bring a Licensed
Product to market through a thorough, vigorous and diligent program for
exploitation of the Technology as timely and efficiently as possible. Such
program shall include the preclinical and clinical development of Licensed
Products, including research and development, manufacturing, laboratory
and
clinical testing and marketing. The Company shall continue active, diligent
marketing efforts for a Licensed Product throughout the term of this Agreement.
Company intends to fund and support ongoing research and clinical development
at
CCF, provided however, the Company funded research or clinical trials are
conducted under the direction and control of the Company and such research
and
clinical development is in the best interest of commercially developing
the
compounds as determined by the Company in its sole discretion. Should the
Company discontinue such research and clinical development with the Technology
at the Cleveland Clinic, such action shall not be deemed a breach of this
Agreement
ARTICLE
4 - ROYALTIES AND OTHER CONSIDERATION
4.1 In
partial consideration for the License Grant herein, Company will remit
to the
Licensor a non-creditable, non-refundable fee of Five Hundred Thousand
Dollars
($500,000)
within
fifteen- (15) days of the Effective Date of this Agreement. Additionally,
the
Company will remit to Licensor [***] Dollars ($[***]) promptly upon execution
of
this Agreement to reimburse Licensor for accountable out of pocket expenses
incurred directly from the filing, prosecuting, and maintaining of the
Licensed
Patents accrued prior to the execution of the License Agreement.
4.2 Within
thirty- (30) days immediately following the first anniversary of the License
Agreement and every anniversary thereafter for the duration of the Term,
Company
would pay Licensor Thirty Five Thousand Dollars ($35,000)
(the
“Maintenance
Fee”).
Maintenance Fees will be fully creditable against Earned Royalties payable
pursuant to Section 4.1 and Milestone Payments due Licensor within the
twelve-
(12) months immediately following each payment.
4.3 As
further consideration for the license granted hereunder, the Company will
make
the following one-time milestone payments (each a “Milestone
Payment”)
to
Licensor. The Company will not pay the same milestone twice on any Licensed
Product containing a Licensed Compound already developed by the Company.
For
clarity, should the Company develop a Licensed Product containing Pentamidine,
it would not have to pay the Milestone Payment listed below for the development
of a subsequent Licensed Product containing Pentamidine, but would only
be
obligated to pay the Milestone Payment below if such subsequent Licensed
Product
contains an active ingredient other than Pentamidine and that is not present
in
a prior Licensed Product. Payments made pursuant to this Section 4.5 shall
be
credited against Earned Royalties payable pursuant to Section 4.1 and accrued
for the same Licensed Product within the twelve (12) months immediately
following the payment of such Milestone Payment. Accordingly, the Company
shall
remit to the Licensor:
4.3.1 [***]
Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
in
the first Phase II clinical trial (or if in a country other than the United
States, a regulatory equivalent of a Phase II Clinical Trial) under a
Company-sponsored (or sublicensee-sponsored) Investigational New Drug
Application (an “IND”)
for
such Licensed Product;
4.3.2 [***]
Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
in
the first Phase III clinical trial (or if in a country other than the United
States, a regulatory equivalent of a Phase III Clinical Trial) under a
Company
sponsored (or sublicensee sponsored) IND for such Licensed Product;
4.3.3 [***]
Dollars ($[***]) upon the acceptance for review a Company sponsored (or
sublicensee sponsored) New Drug Application (an “NDA”)
by the
United States Food and Drug Administration (the “FDA”)
for
such Licensed Product (or if in a country other than the United States,
that
countries regulatory equivalent on an NDA); and
4.3.4 [***]
Dollars ($[***]) upon the final approval by the FDA of a Company-sponsored
(or
sublicensee-sponsored) NDA for such Licensed Product filed by the Company
or its
sublicensee (or if in a country other than the United States, that countries
regulatory equivalent of an NDA).
For
clarity, one time payments due to the Licensor in Sections 4.3.1-4.3.4
above
shall be due on the first to occur of a United States and foreign clinical
event
(as applicable), but in no case both. The Company shall be responsible
for
notifying Licensor in writing of achievement of the milestones listed above
within ten- (10) business days of their occurrence and Milestone Payments
shall
be due within thirty- (30) days following such written
notification.
4.4 During
the Term, the Company shall pay to the Licensor royalties equal to [***]
percent
([***]%) of annual Net Sales by the Company or its sublicensees resulting
from
the sale of any Licensed Product by the Company or its sublicensees to
an end
user (hereinafter “Earned
Royalty”).
4.5 No
multiple Earned Royalties shall be payable because the use, lease or sale
of any
Licensed Product or Licensed Process is, or shall be, covered by more than
one
valid and unexpired claim contained in the Patent Rights.
4.6 In
the
event that a Licensed Product is sold in the form of a combination product
containing one or more products or technologies which are themselves not
a
Licensed Product, the Net Sales for such combination product shall be calculated
by multiplying the sales price of such combination product by the fraction
A/(A+B) where A is the invoice price of the Licensed Product or the Fair
Market
Value of the Licensed Product if sold to an Affiliate and B is the total
invoice
price of the other products or technologies or the Fair Market Value of
the
other products or technologies if purchased from an Affiliate. In the case
of a
combination product that includes one or more Licensed Products, the Net
Sales
for such combination product upon which the royalty due to Licensor is
based
shall not be less than the normal aggregate Net Sales for such Licensed
Product.
In no event shall Licensor’s Earned Royalty be calculated on a pro rata
contribution to a combination product of less than [***] percent ([***]%)
of the
Net Sales.
4.7
Royalty
payments shall be paid in United States dollars at such place as Licensor
may
reasonably designate consistent with the laws and regulations controlling
in the
United States and if applicable in any foreign country. If Company is required
by law, rule or regulation to withhold taxes from the types of payment
due
Licensor hereunder, the parties shall (a) deduct those taxes from the amount
otherwise remittable to Licensor hereunder, (b) pay such taxes to the proper
taxing authority, and (c) send evidence of the obligation together with
proof of
payment to Licensor within fifteen- (15) business days following that payment.
If any currency conversion shall be required in connection with the payment
of
royalties hereunder, such conversion shall be made by using the exchange
rate
prevailing at Citibank, N.A. in New York, New York on the last business
day of
the calendar quarterly reporting period to which such royalty payments
relate.
4.8 Royalties
payable to Licensor shall be paid quarterly on or before March 30, June
30,
September 30, and December 31 of each calendar year. Each such payment
shall be
for unpaid royalties that accrued within or prior to the Company’s most recently
completed fiscal quarters.
4.9 No
Earned
Royalty obligations shall be due with respect to any sale or sublicense
covering
any Licensed Product in a country if there are no Patent Rights underlying
such
Licensed Product in such country.
4.10 To
the
extent that the Company or any Affiliate of the Company is required (i)
in its
sole discretion after appropriate legal analysis, or (ii) by order or judgment
of any court in any jurisdiction, to obtain a license from a third party
in
order to use or sell Licensed Products or Licensed Processes under the
Patent
Rights, the Earned Royalty payable under Section 4.1 shall be reduced by
[***]
the royalty payable to such third party; provided,
however,
in no
event shall the Earned Royalty be reduced to less than [***] percent ([***]%)
of
Net Sales.
4.11 Company
will pay Licensor a fee of [***] percent ([***]%) of all revenue received
from
granting of sublicenses to sublicensees, excluding amounts paid by sublicensee
to Company directly relating to (a) any issuance of debt or equity securities
of
the Company; (b) the research and development of the Technology or dedicated
to
establish a marketing and sales force for sales of the Technology; (c)
Net Sales
of Licensed Products; and/or (iv) in exchange for goods and/or services
relating
to a Licensed Product having a Fair Market Value equivalent to the amount
received by the Company (the “Sublicense
Fee”).
For
instance, the Company would not owe the Licensor a Sublicense Fee based
on
royalties it receives from a sublicensee for Net Sales of Licensed Products,
other than those described in Section 4.4.
ARTICLE
5 - REPORTS AND RECORDS
5.1 The
Company shall keep full, true and accurate books of account containing
all
particulars that may be necessary for the purpose of showing the amounts
payable
to Licensor by way of royalty as aforesaid. Said books of account shall
be kept
at the Company’s principal place of business and the supporting data shall be
open up to once per year upon reasonable notice to the Company, for three-
(3)
years following the end of the calendar year to which they pertain, for
inspection by Licensor’s internal audit division and/or by another designated
auditor selected by Licensor, except one to whom the Company has reasonable
objection, for the purpose of verifying the Company’s royalty statement or
compliance in other respects with this Agreement. If an inspection shows
an
under reporting or underpayment in excess of the greater of [***] percent
([***]%) and [***] Dollars ($[***]) for any twelve- (12) month period the
Company shall reimburse Licensor for the cost of the inspection at the
time the
Company pays the unreported royalties, including any late charges as required
by
Section 5.4 of this Agreement. Notwithstanding the foregoing, all payments
required under this Article 5 shall be due within thirty- (30) days of
the date
Licensor provides the Company notice of the payment due.
5.2 Within
sixty- (60) days from the end of each quarter of each calendar year, the
Company
shall deliver to Licensor complete and accurate reports, giving such particulars
of the business conducted by the Company during the preceding quarter under
this
Agreement as shall be pertinent to a royalty accounting hereunder. These
shall
include at least the following:
5.2.1 All
Licensed Products and Licensed Processes used, leased or sold, by or for
the
Company or its Affiliates;
5.2.2 Total
amounts invoiced for Licensed Products and Licensed Processes used, leased
or
sold, by or for the Company or its Affiliates;
5.2.3 Deductions
applicable in computed Net Sales, if any;
5.2.4 Total
Earned Royalties due based on Net Sales by or for the Company or its Affiliates
or any sublicensee;
5.2.5 Names
and
addresses of all sublicensees and Affiliates of the Company;
5.2.6 On
an
annual basis, the Company’s year-end financial statements.
5.3 With
each
such quarterly report submitted, the Company shall pay to Licensor the
royalties
due and payable under this Agreement. If no royalties shall be due, the
Company
shall indicate so in writing.
5.4 Amounts
which are not paid when due and which are not the subject of a bona fide
dispute
shall accrue interest from the due date until paid, at a rate equal to
the then
prevailing prime rate of Citibank, N.A., plus [***] percent
([***]%).
5.5 The
Company agrees to forward to Licensor annually a copy of any report, which
is in
substance similar to the report required by this Article 5, received from
any
sublicensee and other documents received from any sublicensee as Licensor
may
reasonably request, as may be pertinent to an accounting of
royalties.
5.6 On
a
semi-annual basis, the Company shall provide Licensor with a report detailing
the clinical progress of Licensed Products that have been made since the
previous such report and steps that are being taken to further develop
and
commercialize Licensed Products.
5.7 Licensor
agrees to hold in confidence each report delivered by the Company pursuant
to
this Article 5 until the termination of this Agreement. Notwithstanding
the
foregoing, Licensor may disclose any such information required to be disclosed
pursuant to any judicial, administrative or governmental request, subpoena,
requirement or order, provided that Licensor take reasonable steps to provide
the Company with the opportunity to contest such request, subpoena, requirement
or order.
ARTICLE
6 - PATENT PROSECUTION AND MAINTENANCE
6.1 Following
the Effective Date, at the Company’s expense and providing Licensor has received
the Patent Fee, the Company shall diligently prosecute and maintain the
Patent
Rights set forth in Exhibit
A
hereto
(as the same may be amended or supplemented from time to time after the
date
hereof), including, but not limited to, the filing of patent applications
which
may be required. The Company agrees to keep Licensor reasonably well informed
with respect to the status and progress of any such applications, prosecutions
and maintenance activities and to consult in good faith with Licensor and
take
into account Licensor’s comments and requests with respect thereto. Both parties
agree to provide reasonable cooperation to each other to facilitate the
application and prosecution of patents pursuant to this Agreement.
6.2 The
Company may, in its discretion, elect to abandon any patent applications
or
issued patent in the Patent Rights. Prior to any such abandonment, the
Company
shall give Licensor at least sixty- (60) days notice and a reasonable
opportunity to take over prosecution of such patent or patent application.
In
such event, Licensor shall have the right, but not the obligation, to commence
or continue such prosecution and to maintain any such patent or patent
obligation under its own control and at its expense in which case the license
to
Company to such patent or patent application in such jurisdiction will
terminate. The Company agrees to cooperate in such activities including
execution of any assignments or other documents necessary to enable Licensor
to
obtain and retain sole ownership and control of such patents or patent
applications.
6.3 Licensor
hereby authorizes the Company (a) to include in any NDA for a Licensed
Product,
as the Company may deem appropriate under the Federal Food, Drug and Cosmetic
Act (the “Act”),
a
list of patents included among the Licensed Patents that relate to such
Licensed
Product and such other information as the Company in its reasonable discretion
believes is appropriate to be filed pursuant to the Act; (b) to commence
suit
for any infringement of the Licensed Patents under §271(e) of Title 35 of the
United States Code occasioned by the submission by a third party of an
IND, an
Abbreviated New Drug Application (as that term is defined in the Act )
for a
Licensed Product pursuant to §505(j) of the Act or an NDA for a Licensed Product
pursuant to §505(b)(2) of the Act; and (c) to exercise any rights that may be
exercisable by Licensor as patent owner under the Act to apply for an extension
of the term of any patent included among the Licensed Patents. In the event
that
applicable law in any other country of the Territory hereafter provides
for the
extension of the term of any patent included among the Licensed Patents
in such
country, upon request by and at the expense of the Licensee, the Licensor
shall
use commercially reasonable efforts to obtain such extension or, in lieu
thereof, shall authorize the Company or, if requested by the Company or
its
sublicensees to apply for such extension, in consultation with
Licensor.
6.4 Licensor,
at the Company’s expense, agrees to reasonably cooperate with the Company or its
sublicensees, as applicable, in the exercise of the authorization granted
herein
or which may be granted pursuant to this Article 6 and will execute such
documents and take such additional actions as the Company may reasonably
request
in connection therewith, including, if necessary, permitting itself to
be joined
as a proper party in any suit for infringement brought by the Company under
Section 6.2 and/or Section 6.3 above.
ARTICLE
7 - TERMINATION
7.1 If
the
Company shall become bankrupt, or shall file a petition in bankruptcy,
or if the
business of the Company shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of the
Company or otherwise, this Agreement shall automatically terminate.
7.2 Upon
any
material breach or default of this Agreement by the Company, other than
as set
forth in Section 7.1 above, Licensor shall have the right to terminate
this
Agreement and the rights, privileges and license granted hereunder by giving
ninety- (90) days prior written notice to the Company. Subject to Article
8,
such termination shall become effective immediately upon notice from the
Company
following such ninety- (90) day period unless the Company shall have cured
any
such breach or default prior to the expiration of the ninety- (90) day
period
referred to above. If a dispute regarding termination is addressed according
to
Article 8, this Agreement shall remain in full force and effect until such
dispute is settled in a manner that is not further appealable or not appealed
provided however, that Company fulfills all rights and obligations to Licensor
under this Agreement that are not in dispute.
7.3 The
Company shall have the right at any time to terminate this Agreement in
whole or
as to any portion of the Patent Rights, for any reason or no reason, by
giving
thirty- (30) days notice thereof in writing to Licensor.
7.4 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination or obligations under Articles 4, 5, 8, 10, 13,
and 15.
The Company and/or any sublicensee thereof may, however, after the effective
date of such termination and continuing for a period not to exceed twelve-
(12)
months thereafter, sell all completed Licensed Products, and any Licensed
Products in the process of manufacture at the time of such termination,
and sell
the same, provided that the Company shall pay or cause to be paid to Licensor
the royalties thereon as required by Article 4 of this Agreement and shall
submit the reports required by Article 5 hereof on the sales of Licensed
Products.
7.5 If
not
terminated sooner, this Agreement shall terminate, on a country by country
basis, on the date of the last to expire claim contained in the Patent
Rights
(the “Term”),
at
which time the Company will have an irrevocable, paid up, royalty-free
license
under the Patent Rights to make, have made, use, have used, sell and have
sold
Licensed Products.
ARTICLE
8 - DISPUTE RESOLUTION
8.1 The
Parties shall attempt in good faith to promptly resolve any dispute arising
out
of or relating to payments required under this Agreement between representatives
who have authority to settle the controversy within thirty- (30) days of
one
party notifying the second party of such dispute in writing.
8.2 If
the
matter pertaining to payments has not been resolved by negotiation within
thirty- (30) days, the parties shall attempt in good faith to settle the
dispute
by mediation under the then-current rules of the American Arbitration
Association (“AAA”).
The
neutral third party will be selected from the panel of neutrals of the
AAA in
accordance with the selection process of the AAA.
8.3 If
the
matter has not been resolved by mediation within ninety- (90) days of the
initiation of such procedure, or if either party does not participate in
mediation in good faith, the dispute shall be settled by arbitration before
a
tribunal of three arbitrators in a location mutually agreeable to both
parties
in accordance with the rules of the AAA. Licensor shall select one- (1)
arbitrator, the Company shall select one- (1) arbitrator, and the third
arbitrator shall be selected by mutual agreement of the first two- (2)
arbitrators.
8.4 Any
claim, dispute, or controversy that does not concern payments, including
concerning the validity, enforceability, or infringement of any patent
contained
in the Patent Rights licensed hereunder shall be resolved in any court
having
jurisdiction thereof.
8.5 In
the
event that, in any arbitration proceeding, any issue shall arise concerning
the
validity, enforceability, or infringement of any patent contained in the
Patent
Rights licensed hereunder or any other issue not subject to arbitration,
the
arbitrators shall, to the extent possible, resolve all issues other than
such
issues including validity, enforceability, and infringement; in any event,
the
arbitrators shall not delay the arbitration proceeding for the purpose
of
obtaining or permitting either party to obtain judicial resolution of such
issues, unless an order staying the arbitration proceeding shall be entered
by a
court of competent jurisdiction. Neither Party shall raise any issue concerning
the validity, enforceability, and/or infringement of any patent contained
in the
Patent Rights licensed hereunder, in any proceeding to enforce any arbitration
award hereunder, or in any proceeding otherwise arising out of any such
arbitration award.
8.6 The
costs
of such arbitration shall be borne proportionate to the finding of fault
as
determined by the Arbitrator. Any court of competent jurisdiction may enter
judgment on the arbitration award.
ARTICLE
9 - INFRINGEMENT AND OTHER ACTIONS
9.1 The
Company and Licensor shall promptly provide written notice, to the other
party,
of any alleged infringement by a third party of the Patent Rights and provide
such other party with any available evidence of such infringement.
9.2 During
the term of this Agreement, the Company shall have the right, but not the
obligation, to prosecute and/or defend, at its own expense and utilizing
counsel
of its choice, any infringement of, and/or challenge to, the Patent Rights.
In
furtherance of such right, Licensor hereby agrees that the Company may
join
Licensor as a party in any such suit (and will join at the Company’s request),
provided that the Company pays all of Licensor’s reasonable out-of-pocket
expenses. The Company shall indemnify and hold Licensor harmless against
any
costs, expenses or liability that may be found or assessed against Licensor
in
any such suit other than resulting from Licensor’s negligence or willful
misconduct. Any recovery of damages pursuant to this Section 9.2 shall
be
retained entirely by the Company and allocated pursuant to Section 9.4
below.
9.3 In
the
event that a claim or suit is asserted or brought against the Company alleging
that the manufacture or sale of any Licensed Product by the Company, an
Affiliate of the Company, or any sublicensee, or the use of such Licensed
Product by any customer of any of the foregoing, infringes proprietary
rights of
a third party, the Company shall give written notice thereof to Licensor.
The
Company may, in its sole discretion, modify such Licensed Product to avoid
such
infringement and/or may settle on terms that it deems advisable in its
sole
discretion, subject to Section 9.2 above. Otherwise, the Company shall
have the
right, but not the obligation, to defend any such claim or suit. In the
event
the Company elects not to defend such suit, Licensor shall have the right,
but
not the obligation to do so at its sole expense.
9.4 Any
recovery of damages by the Company, in any such suit, shall be applied
first in
satisfaction of any unreimbursed expenses and legal fees of the Company
relating
to the suit. The balance remaining from any such recovery shall be treated
as
royalties received by the Company from sublicensees and shared by Licensor
and
the Company in accordance with Section 4.1.1.
9.5 If
within
six- (6) months after receiving notice of any alleged infringement, the
Company
shall have been unsuccessful in persuading the alleged infringer to desist,
or
shall not have brought and shall not be diligently prosecuting an infringement
action, or if the Company shall notify Licensor, at any time prior thereto,
of
its intention not to bring suit against the alleged infringer, then, and
in
those events only, Licensor shall have the right, but not the eobligation,
to
prosecute, at its own expense and utilizing counsel of its choice, any
infringement of the Patent Rights, and the Company may, for such purposes,
join
the Licensor as a party plaintiff. The total cost of any such infringement
action commenced solely by Licensor shall be borne by Licensor and Licensor
shall keep any recovery or damages for infringement or otherwise derived
therefrom and such shall not be applicable to any royalty obligation of
the
Company.
9.6 In
any
suit to enforce and/or defend the Patent Rights pursuant to this Agreement,
the
party not in control of such suit shall, at the request and expense of
the
controlling party, cooperate in all respects and, to the extent possible,
have
its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.
ARTICLE
10 - LIMITATION OF LIABILITY, INDEMNITY
10.1 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR
PENDING.
10.2 Nothing
in this Agreement should be construed as:
10.2.1 A
warranty or representation by Licensor as to the validity or scope of any
Patent
Rights;
10.2.2 A
warranty or representation that anything made, used, sold or otherwise
disposed
of under any license granted in this Agreement is or will be free from
infringement of patents of third parties; or
10.2.3 A
requirement that Licensor shall file any patent application, secure any
patent,
or maintain any patent, including without limitation any Licensed Patents,
in
force.
10.3 The
Company agrees to defend, indemnify and hold Licensor harmless from and
against
all liability, demands, damages, including without limitation, expenses
or
losses including death, personal injury, illness or property damage arising
directly or indirectly: (a) out of use by the Company or its transferees
of
inventions licensed or information furnished under this Agreement or (b)
out of
any use, sale or other disposition by the Company or its transferees of
Patent
Rights, Licensed Products or Licensed Processes, in each case which are
not the
result of Licensor’s negligence or willful misconduct. The Company agrees that
any sublicense agreement it enters relative to the Licensed Products and/or
Licensed Processes shall contain a covenant by such sub-licensee providing
for
the indemnification of Licensor as provided in this Article. The Licensor
agrees
to defend, indemnify and hold Company harmless from and against all liability,
demands, damages, including without limitation, expenses or losses including
death, personal injury, illness or property damage arising directly or
indirectly out of a negligent or willful act of Licensor including pertaining
to
clinical evaluations of Licensed Compounds, Processes and Products.
ARTICLE
11 - ASSIGNMENT
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other party, shall be null and of no
effect.
Notwithstanding the foregoing, the Company may assign this Agreement without
the
consent of Licensor (i) to a purchaser, merging or consolidating corporation,
or
acquiror of substantially all of the Company’s assets or business and/or
pursuant to any reorganization qualifying under Section 368 of the Internal
Revenue Code of 1986 as amended, as may be in effect at such time, or (ii)
to an
Affiliate of the Company.
ARTICLE
12 - PAYMENT OF FEES AND EXPENSES
Each
of
the Company and Licensor shall be responsible for their own expenses relating
to
the preparation and consummation of this Agreement and the agreements and
transactions contemplated hereby.
ARTICLE
13 - USE OF NAMES AND PUBLICATION
13.1 Nothing
contained in this Agreement shall be construed as granting any right to
the
Company or its Affiliates to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of Licensor
or
any of its units (including contraction, abbreviation or simulation of
any of
the foregoing) without the prior, written consent of Licensor; provided,
however, that Licensor acknowledges and agrees that the Company may use
the
names of Licensor in various documents used by the Company for capital
raising
and financing without such prior written consent where the use of such
names may
be required by law.
13.2 Nothing
herein shall be deemed to establish a relationship of principal and agent
between Licensor and the Company, nor any of their agents or employees
for any
purpose whatsoever.
13.3 In
the
event that Licensor desires to publish or disclose, by written, oral or
other
presentation, Patent Rights, Know-how, or any material information related
thereto then Licensor shall notify the Company in writing by facsimile
where
confirmed by the receiving party, and/or by certified or registered mail
(return
receipt requested) of their intention at least sixty- (60) days prior to
any
speech, lecture or other oral presentation and at least ninety- (90) days
before
any written or other publication or disclosure. The Licensor shall include
with
such notice a description of any proposed oral presentation or, in any
proposed
written or other disclosure, a current draft of such proposed disclosure
or
abstract. The Company may request that the Licensor, no later than thirty-
(30)
days following the receipt of such notice, delay such presentation, publication
or disclosure for up to an additional sixty- (60) days in order to enable
the
Company to file, or have filed on their behalf, a patent application, copyright
or other appropriate form of intellectual property protection related to
the
information to be disclosed or request that Licensor do so. Upon receipt
of such
request to delay such presentation, publication or disclosure, Licensor
shall
arrange for a delay of such presentation, publication or disclosure until
such
time as the Company or Licensor have filed, or had filed on its behalf,
such
patent application, copyright or other appropriate form of intellectual
property
protection in form and in substance reasonably satisfactory to the Company
and
Licensor. If the Licensor does not receive any request from the Company
to delay
such presentation, publication or disclosure, Licensor may submit such
material
for presentation, publication or other form of disclosure.
ARTICLE
14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any
payment, notice or other communication required or permitted to be given
pursuant to this Agreement shall be in writing and sent by certified first
class
mail, postage prepaid, by hand delivery or by facsimile if confirmed in
writing,
in each case effective upon receipt, at the addresses below or as otherwise
designated by written notice given to the other party:
In
the
case of Licensor:
Notices
or other Communications:
CCF
Innovations
9500
Euclid Avenue / Mailcode D20
Cleveland,
Ohio 44195
Attn:
Licensing Coordinator
Tel:
216-444-5757
Fax:
216-445-6515
E-mail:
arasr@ccf.org (Dr. Rahul Aras)
For
technical/scientific issues, with a copy to:
Taolin
Yi, Ph.D. / Mailcode NB40
For
legal
issues, with a copy to:
Office
of
General Counsel / Mailcode H18
For
use
of name and/or publicity issues, with a copy to:
Chief
Communications Officer / Mailcode H18
Payments:
The
Cleveland Clinic Foundation
Attention:
CCF Innovations (Agreement No. 02190-001)
P.O.
Lockbox 931532
Cleveland,
OH 44193
Licensor’s
Federal Tax Identification Number: 34-0714585.
In
the
case of the Company:
Greenwich
Therapeutics, Inc.
787
Seventh Avenue
48th
Floor
New
York,
NY 10019
Attn:
President and CEO
Tel:
(212) 554 4381
Fax:
(212) 554 4490
ARTICLE
15 - CONFIDENTIALITY
Any
proprietary or confidential information relating to the Patent Rights (including
but not limited to Know-how and patent prosecution documents relating to
Patent
Rights) collectively constitute the “Confidential
Information.”
The
Company and Licensor agree that they will not use the Confidential Information
for any purpose unrelated to this Agreement, and will hold it in confidence
during the term of this Agreement and for a period of five- (5) years after
the
termination or expiration date of this Agreement. The Company shall exercise
with respect to such the Confidential Information the same degree of care
as the
Company exercises with respect to its own confidential or proprietary
information of a similar nature, and shall not disclose it or permit its
disclosure to any third party (except to those of its employees, consultants,
or
agents who are bound by the same obligation of confidentiality as the Company
is
bound by pursuant to this Agreement). However, such undertaking of
confidentiality by the Company shall not apply to any information or data
which:
(i) The
Company receives at any time from a third-party lawfully in possession
of same
and having the right to disclose same;
(ii) Is,
as of
the date of this Agreement, in the public domain, or subsequently enters
the
public domain through no fault of the Company;
(iii) Is
independently developed by the Company as demonstrated by written evidence
without reference to information disclosed to the Company by
Licensor;
(iv) Is
disclosed pursuant to the prior written approval of Licensor; or
(v) Is
required to be disclosed pursuant to law or legal process (including, without
limitation, to a governmental authority) provided, in the case of disclosure
pursuant to legal process, reasonable notice of the impending disclosure
is
provided to Licensor and Licensor has agreed to such disclosure in writing
or
has exhausted its right to contest such disclosure.
ARTICLE
16 - INSURANCE
16.1 At
such
time as any product, process, service relating to, or developed pursuant
to,
this Agreement is being commercially distributed or sold (other than for
the
purpose of obtaining regulatory approvals) by Company or sublicensee, Company
shall at its sole cost and expense, procure and maintain comprehensive
general
liability insurance in amounts not less than [***] Dollars ($[***]) per
incident
and naming the Licensor as additional insureds. Such comprehensive general
liability insurance shall provide product liability coverage for Company’s
indemnification under this Agreement. If Company elects to self-insure
all or
part of the limits described above (including deductibles or retentions
which
are in excess of [***] Dollars ($[***]) annual aggregate) such self-insurance
program must be acceptable to Licensor. Such insurance will be considered
primary as to any other valid and collectible insurance, but only as to
acts of
the named insured. The minimum amounts of insurance coverage required shall
not
be construed to create a limit of Company’s liability with respect to its
indemnification under this Agreement.
16.2 Company
shall provide Licensor with written evidence of such insurance upon request
of
the Licensor. Company shall provide the Licensor with written notice at
least
sixty- (60) days prior to the cancellation or non-renewal of such insurance;
if
Company does not obtain replacement insurance providing commercially reasonable
coverage within such sixty- (60) day period, the Licensor shall have the
right
to terminate this Agreement effective at the end of such sixty- (60) day
period
without notice or any additional waiting periods.
16.3 Company
shall maintain such comprehensive general liability insurance beyond the
expiration or termination of this Agreement during (i) the period that
any
product, process, or service, relating to, or developed pursuant to, this
Agreement is being commercially distributed or sold by Company or by a
sublicensee, and (ii) a commercially reasonable period thereafter.
ARTICLE
17 - MISCELLANEOUS PROVISIONS
17.1 This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of Ohio, without regard to its principles of
conflicts of laws.
17.2 If
this
Agreement or any associated transaction is required by the law of any nation
to
be either approved or registered with any governmental agency, the Company
shall
assume all legal obligations to do so and the costs in connection
therewith.
17.3 The
parties hereto acknowledge that this Agreement, including the Appendices
and
documents incorporated by reference, sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and
shall
not be subject to any change of modification except by the execution of
a
written instrument subscribed to by the parties hereto.
17.4 The
provisions of this Agreement are severable, and in the event that any provision
of this Agreement shall be determined to be invalid or unenforceable under
any
controlling body of law, such invalidity or unenforceability shall not
in any
way affect the validity or enforceability of the remaining provisions
hereof.
17.5 The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver
of
that right or excuse a similar subsequent failure to perform any such term
or
condition by the other party.
17.6 The
headings of the several articles are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
17.7 This
Agreement will not be binding upon the parties until it has been signed
below on
behalf of each party, in which event, it shall be effective as of the date
recited on page one.
17.8 This
Agreement embodies the entire understanding of the parties and shall supersede
all previous communications, representations or understandings, either
oral or
written, between the parties relating to the subject matter hereof.
17.9 Each
party hereto shall be excused from any breach of this Agreement that is
proximately caused by governmental regulation, act of war, strike, act
of God or
other similar circumstance normally deemed outside the control of the
parties.
ARTICLE
18 - REPRESENTATIONS AND WARRANTIES OF LICENSOR
As
of the
Effective Date of this Agreement, Licensor represents and warrants that
to its
knowledge and belief:
(i) Licensor
has all right, title, and interest in and to the Patent Rights and Know-how,
including the exclusive, absolute, and irrevocable right, title and interest
thereto, free and clear of all liens, charges, encumbrances or other
restrictions or limitations of any kind whatsoever;
(ii) Licensor
has not issued any licenses, options, restrictions, liens, rights of third
parties, disputes, royalty obligations, proceedings or claims limiting
Licensor’s rights or the rights of the Company under this Agreement or which may
reasonably lead to a claim of infringement or invalidity regarding, any
part or
all of the Patent Rights or Know How or their use;
(iii) None
of
the Patent Rights, Licensed Products or Licensed Processes infringes or
conflicts in any material respect with, and the Licensor has not received
any
notice of infringement of, or conflict with, any license, patent, or other
intellectual property right of any third party and, to the knowledge of
the
Licensor. There is no claim pending, filed or threatened against Licensor,
of
infringement, interference or invalidity regarding any part or all of the
Patent
Rights or Know-how or their use;
(iv) The
US
and foreign patent applications and patents itemized on Exhibit A set forth
all
of the patents and patent applications owned by or licensed by Licensor
as of
the Effective Date claiming the Technology in the Field of Use; and
(v) Licensor
has provided Company with copies of all documents reflecting support or
funding
for all or part of the research leading to Patent Rights and Know How,
and has
listed all funding agencies on Exhibit
B.
IN
WITNESS WHEREOF,
the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.
THE
CLEVELAND CLINIC FOUNDATION (LICENSOR):
By: ______________________________ Date: __________,
2005
Name: Michael
P. O’Boyle
Title: Chief
Financial Officer
GREENWICH
PHARMACEUITICALS, INC.
By: ______________________________ Date: __________,
2005
Name: ______________________________
Title: ______________________________
Acknowledged
(not signatories):
By: ______________________________ Date: __________,
2005
Name: Derek
Raghavan, M.D., Ph.D.
Title: Chairman
and Director, Cleveland Clinic Taussig Cancer Center
By: ______________________________ Date: __________,
2005
Name: Paul
DiCorleto, Ph.D.
Title: Chairman,
Lerner Research Institute
By: ______________________________ Date: __________,
2005
Name: Taolin
Yi, Ph.D.
Title: Staff
Scientist
EXHIBIT
A
Serial
Number
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EXHIBIT
B
Funding
Sources:
The
following National Institute of Health grants to Taolin Yi, Ph.D. have
funded
the development of the Technology:
1. R01
CA79891 (Principal Investigator: Taolin Yi, Ph.D.);
2. R01
GM58893 (Principal Investigator: Taolin Yi, Ph.D.);
3. R01
CA096636 (Principal Investigator: Taolin Yi, Ph.D.); and
4. R01
CA102481 (Principal Investigator: Taolin Yi, Ph.D.)
Appendix
E
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act
of 1934.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
LICENSE
AGREEMENT
(as
amended)
This
Agreement (hereinafter referred to as this "Agreement"), effective as of
this
April 19, 2005, is entered into by and between the UNIVERSITY OF SOUTH
FLORIDA
RESEARCH FOUNDATION, INC., a corporation not for profit under Chapter 617
Florida Statutes, and a direct support organization of the University of
South
Florida (“University”) pursuant to section 1004.28 Florida Statutes, having its
principal office at 4202 East Fowler Avenue, Tampa, Florida 33620, U.S.A.
(hereinafter referred to as “Licensor”), and GREENWICH THERAPEUTICS, INC. a
corporation duly organized and existing under the laws of the State of
Delaware
with head quarters at 787 Seventh Avenue, 48th
Floor,
New York, NY 10019 (the "Company").
WHEREAS,
Licensor is the exclusive licensee under certain “Patent Rights” (as later
defined herein) relating to Triciribine
a/k/a Triciribine Monphosphate a/k/a Tricyclic Nucleoside a/k/a API-2 for
inhibition of AKT
with
antitumor activity in cancer cells overexpressing AKT
(the
“Technology”)
and has
the right to grant sublicenses under said Patent Rights;
WHEREAS,
Licensor desires to have the Patent Rights utilized in the public interest
and
is willing to grant a license thereunder; and
WHEREAS,
Company intends to develop, produce, manufacture, market and/or sell products
similar to the “Licensed Product(s)” (as later defined herein) and is willing to
commit itself to a diligent program of exploiting the Patent Rights so
that
public utilization shall result therefrom; and
WHEREAS,
Company desires to obtain a license under the Patent Rights upon the terms
and
conditions hereinafter set forth.
NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein, the parties hereto agree as follows:
ARTICLE
1 - DEFINITIONS
For
the
purposes of this Agreement, the following words and phrases shall have
the
following meanings:
1.1 "Affiliate"
shall mean, with respect to any Entity (as hereinafter defined), any Entity
that
directly or indirectly controls, is controlled by, or is under common control
with such Entity.
1.1.1 “Control”
shall mean, for this purpose, direct or indirect control of more than fifty
percent (50%) of the voting securities of an Entity or, if such Entity
does not
have outstanding voting securities, more than 50% of the directorships
or
similar positions with respect to such Entity.
1.1.2 “Entity”
shall mean any corporation, association, joint venture, partnership, trust,
business, individual, or any other organization that can exercise independent
legal standing.
1.2
"Company"
shall mean Greenwich Therapeutics, Inc.,
a
Delaware corporation.
1.3 “Field
of
Use” shall mean all uses.
1.4 "Improvements"
shall mean any modification of a Licensed Process or Licensed
Product or any inventions (whether patentable or not), information and
data, in
the Field of Use that, created or derived during the term of this Agreement,
the
manufacture use or sale of which would be commercially important or necessary
in
the practice of, or would infringe an issued or pending claim within the
Patent
Rights.
1.5 "Know-how"
shall mean all tangible information
(other than those contained in the Patent Rights), existing prior to the
Effective Date of this Agreement, whether patentable or not (but which
have not
been patented) and physical objects related to the Licensed Product, including
but not limited to formulations, biological samples, tissues, animals,
organisms, compounds, intermediates, laboratory notebooks, in vitro, preclinical
or clinical design, information or results, other proprietary materials,
processes, including but not limited to manufacturing processes, data,
drawings
and sketches, designs, testing and test results, regulatory information
of a
like nature, owned by any of Licensor, which Licensor has the right to
disclose
and license to the Company.
1.6 “Licensed
Product(s)" shall mean:
1.6.1 Any
product which is covered in whole or in part by Patent Rights in the country
in
which the product is made, used, leased or sold;
1.6.2 Any
product which is manufactured using a process which is covered in whole
or in
part by Patent Rights in the country in which the process is used;
1.6.3 Any
product which is used according to a method or use which is covered in
whole or
in part by Patent Rights in the country in which the method is
used.
1.7 "Licensed
Process(es)" shall mean any process, use or method, which is covered, in
whole,
or in part, by Patent Rights in the country in which the process or method
is
used.
1.8 "Net
Sales" shall mean the total gross receipts for sales of Licensed Products
or
practice of Licensed Processes by or on behalf of the Company, any of its
Affiliates or sublicensees whether invoiced or not, less only the sum of
the
following:
1.8.1
Usual
trade discounts allowed and provided to customers;
1.8.2
Sales,
tariff duties and/or taxes directly imposed and with reference to particular
sales;
1.8.3
Amounts
allowed or credited on returns or rejections;
1.8.4
Bad debt
deductions actually written off during the accounting period; and
1.8.5
Outbound
transportation prepaid or allowed and transportation insurance;
1.8.6
No
deductions shall be made for commissions paid to individuals whether they
be
with independent sales agencies or regularly employed by Licensee and on
its
payroll, or for cost of collections. Notwithstanding anything to the contrary
in
this Article 1.8, Net Sales does not include sales of Licensed Products
at or
below the fully burdened cost of manufacturing solely for non-profit research
or
clinical testing or for indigent or similar public support or compassionate
use
programs. Net sales are calculated based on the final sale of the Licensed
Product to an independent third party end user. If (i) the end user is
a
Sublicensee or Affiliate or (ii) if Licensed Product or Licensed Process
is sold
for consideration other than money, then Net Sales shall be calculated
based on
the final gross selling price of comparable Licensed Products sold in arm’s
length transactions by Licensee to an end user.
1.9 "Patent
Rights" shall mean all U.S. and foreign patents and patent applications
set
forth in Exhibit A and:
1.9.1 Any
other
United States or foreign patent applications or patents that claim priority
to
any of the patents or applications listed in Exhibit A, together with any
and
all patents issuing thereon, including continuations, divisionals,
reexaminations, extensions, and reissue applications and any United States
or
foreign patents granted upon such applications, all of which shall be deemed
added to Exhibit A;
1.9.2 Any
other
intellectual property rights owned or controlled by the Licensor relating
to the
Technology that the Licensor has the right to license to the Company existing
prior to the Effective Date of this Agreement.
1.10 “Territory”
shall mean the world.
ARTICLE
2 - GRANT
2.1 Licensor
hereby grants to the Company and the Company accepts, subject to the terms
and
conditions of this Agreement, an exclusive license in the Field of Use
to
practice under the Patent Rights and to utilize the Know-how in the Territory,
and (a) to make, have made, use, lease and/or sell the Licensed Products
and to
practice and have practiced the Licensed Processes, to the full end of
the term
for which the Patent Rights are granted, unless sooner terminated as hereinafter
provided and (b) to sublicense to third parties, in accordance with Section
2.2
below, the rights granted under subsection (a) of this Paragraph
2.1.
2.2 In
accordance with 2.1 above, Licensor hereby grants to the Company the right
to
grant sublicenses to third parties under the license granted hereunder
in its
sole discretion, provided, however, that the Company provides Licensor
with
notice of its intent to enter into each such sublicense and the Company
reasonably considers Licensor’s objections to such sublicense, if any, before
the Company grants any such sublicense. Company agrees that any sublicenses
granted by it shall contain such provisions as are necessary for the Company
to
meet its obligations under this Agreement. The Company will remain obligated
to
Licensor under the terms of this Agreement, unless this Agreement terminates
in
accordance with its terms, without regard to whether the Company has entered
into a sublicense with a third party.
2.2.1 Within
thirty (30) days after execution or receipt thereof, as applicable, the
Company
shall provide Licensor with a copy of each sublicense issued
hereunder.
2.2.2 Upon
termination of this Agreement other than by expiration in accordance with
paragraph 7.6, any and all sublicenses shall survive such termination,
provided,
however, such sublicensee is not in default of such sublicense 90 days
after
receiving notification from Licensor that (i) Licensor has terminated this
Agreement and (ii) Licensor believes that such sublicensee is in default
of the
sublicense agreement. Moreover, Licensor shall not be required to take
on any
additional obligations or restrictions in its agreement with sublicensee
not
already imposed on Licensor by this Agreement. Notwithstanding the foregoing,
if
Company believes that Licensor has terminated this Agreement for the primary
purpose of doing business directly with the sublicensee, the termination
may be
disputed under the provisions of Article 8.
2.3 Licensor
reserves to the University, Moffitt Research & Cancer Center, and the
inventors the right to practice under the Patent Rights for noncommercial
research and education purposes, including research for any sponsors (provided
such research is for noncommercial purposes and funded by a not-for-profit
sponsor). Licensor, the University, Moffitt Research & Cancer Center, and
the inventors shall not have the right to conduct human clinical trials
with any
Licensed Product or Licensed Process except if (i) other non-licensees
would
have the right to conduct such clinical trials without the consent of the
Company or (ii) Licensor is granted the right to conduct human clinical
trials
with a Licensed Product or Licensed Process by written agreement with the
Company.
2.4 Company
shall initially have a right of first refusal to obtain the exclusive rights
to
Licensor (a) continuations in part relating to the patents or patent
applications included in the Patent Rights and (b) United States and foreign
patent applications based on research funded by Company that would be
commercially important or necessary to practice the Patent Rights, including
any
continuations, continuations-in-part, divisionals, reissues, reexaminations,
or
extensions thereof (collectively (a) and (b) shall be the “Future Rights”).
Accordingly, promptly after such filing, invention or creation and prior
to
disclosing to any third party the existence of any Future Rights, the Licensor
shall disclose the applicable Future Rights to the Company. If the Company
so
determines, the Company and the Licensor shall negotiate, in good faith,
a
commercially reasonable exclusive license of the Future Rights to the Company.
If the Company and Licensor do not enter into a definitive exclusive license
with ninety (90) days from the date the Company received notice of such
Future
Right from the Licensor, then the Licensor shall have the right to solicit
offers from third parties. If an offer relating
to a Future Right(s) is
extended to a third party under more
favorable
terms
than those offered to the Company
for such
Future Right(s),
such
terms presented to the third party shall be presented to Company and Company
shall have fifteen (15) days to accept such license on such offered terms
(the
Company’s “Right of First Refusal”). Both the Licensor and the Company shall be
obligated to negotiate such terms in good faith. If
an
offer is extended to a third party for less favorable terms then the last
offer
to the Company than Licensor has no obligation to present such offer to
the
Company. The Right of First Refusal under this paragraph 2.4 shall extend
for
one year after the ninety (90) day negotiation period between the Company
and
the Licensor has expired under this paragraph 2.4 for the Future Rights
being
negotiated after which Licensor shall have the right to solicit offers
from
third parties relating to such Future Rights with no further obligation
to
Company.
2.5 The
Company shall have the exclusive first option to negotiate in good faith
for a
license agreement to obtain the exclusive rights to any Improvement relating
to
the Technology created by or under the direction or control of the Inventor(s),
filed,
created or invented after the date of this Agreement (“Option Rights”).
Accordingly, promptly after such filing, invention or creation and prior
to
disclosing to any third party the existence of any Improvement, the Licensor
shall disclose the applicable Option Rights to the Company. If the Company
so
determines, the Company and the Licensor shall negotiate, in good faith,
a
commercially reasonable exclusive license of the Option Rights to the Company.
If the Company and Licensor do not enter into a definitive exclusive license
with ninety (90) days from the date the Company received notice of such
Option
Rights from the Licensor, then the Licensor shall have the right to solicit
offers from third parties relating to such Option Rights with no further
obligation to Company.
2.6 The
license granted hereunder shall not be construed to confer any rights upon
Company by implication, estoppel or otherwise as to any technology except
as
specifically set forth herein.
ARTICLE
3 - COMMERCIALIZATION
3.1 The
Company shall use its commercially reasonable efforts to meet the Milestones
under Article 4.5 and to bring a Licensed Product to market through a thorough,
vigorous and diligent program for exploitation of the Licensed Products
and
Licensed Processes as timely and efficiently as possible. Such program
shall
include the preclinical and clinical development of Licensed Products and
Licensed Processes, including research and development, manufacturing,
laboratory and clinical testing and marketing. The Company shall continue
active, diligent marketing efforts for Licensed Product(s) throughout the
term
of this Agreement.
3.2 A
Development Committee (the “Committee”) shall be organized to monitor the
clinical progress of the Licensed Products at the Company’s expense. The
Committee will consist of independent scientific and technical thought
leaders
that are highly regarded by the scientific community in the field of each
Licensed Product and at least one representative from each of Licensor
and the
Company. The Committee will be responsible for (i) making recommendations
to the
Company’s management relating to the pre-clinical and clinical development
strategy; (ii) analysis and assessment of ongoing pre-clinical and clinical
development of each Licensed Product; and (iii) assisting the Company to
prepare
pre-clinical and clinical development budgets. The actions and opinions
of the
Committee will be confidential, however, the Licensor representative may
report
clinical updates to a designated senior official at the Licensor who will
agree
to keep such information confidential. The Committee will meet at least
two (2)
times per year.
3.3 The
Company will conduct its first clinical study entitled "Targeted Inhibition
of
Akt Activation in patients with metastatic colorectal, pancreatic, breast
and
ovarian cancer: A phase I/II study and pharmacodynamic/pharmacokinetic
evaluation of the Akt activation inhibitor, Triciribine (TCN-P)." at the
facilities of the Licensor. The Company will reasonably consider using
the
facilities of the Licensor to conduct future clinical studies.
ARTICLE
4 - ROYALTIES AND OTHER CONSIDERATION
4.1 The
Company agrees to pay to Licensor the royalties set forth below, and in
accordance with the provisions of Articles 4.5 and 4.6, to the end of the
term
of the Patent Rights or until this Agreement shall be terminated as hereinafter
provided:
4.1.1 During
the term of the License Agreement, the Company shall pay to the Licensor
“Running Royalties” equal to [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees, of up to
[***]
Dollars ($[***]) in
any
calendar year; [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees in excess
of
[***]
Dollars ($[***]) but
less
than [***]
Dollars ($[***]) in
any
calendar year; and [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees equal to
or in
excess of [***]
Dollars ($[***]) in
any
calendar year.
4.2 In
the
event that a Licensed Product is sold in the form of a combination product
containing one or more products or technologies which are themselves not
a
Licensed Product, the Net Sales for such combination product shall be calculated
by multiplying the sales price of such combination product by the fraction
A/(A+B) where A is the invoice price of the Licensed Product or the Fair
Market
Value of the Licensed Product if sold to an Affiliate and B is the total
invoice
price of the other products or technologies or the Fair Market Value of
the
other products or technologies if purchased from an Affiliate. In the case
of a
combination product which includes one or more Licensed Products, the Net
Sales
for such combination product upon which the royalty due to Licensor is
based
shall not be less than the normal aggregate Net Sales for such Licensed
Product.
4.3
Royalty
payments shall be paid in United States dollars in Tampa, Florida or at
such
place as Licensor may reasonably designate consistent with the laws and
regulations controlling in the United States and if applicable in any foreign
country. Any taxes which the Company, its Affiliate or any sublicensee
shall be
required by law to withhold on remittance of the royalty payments shall
be
deducted from such royalty payment to Licensor. The Company shall furnish
Licensor with the original copies of all official receipts for such taxes.
If
any currency conversion shall be required in connection with the payment
of
royalties hereunder, such conversion shall be made by using the exchange
rate
prevailing at Chase Manhattan Bank (N.A.) on the last business day of the
calendar quarterly reporting period to which such royalty payments
relate.
4.4 Royalties
payable to Licensor shall be paid semi-annually on or before June 30 and
December 31 of each calendar year. Each such payment shall be for unpaid
royalties which accrued within or prior to the Company's two most recently
completed fiscal quarters.
4.5 As
further consideration for the license granted hereunder, the Company shall
pay
to Licensor the following one time “Milestone Payments” which shall not be
deducted from royalties otherwise owed or which may in the future be owing
payable to Licensor on account of sublicensing royalties and/or lump sum
payments received by the Company or its Affiliate from sublicensees pursuant
to
paragraph 4.1.2:
4.5.1 $40,000
upon execution of this Agreement.
4.5.2 Reimbursement
for costs incurred by Licensor with respect to Patent Rights upon execution
of
this Agreement, which in no case shall exceed $[***].
4.5.3 [***]
Dollars ($[***]) upon
the
acceptance by the Food and Drug Administration (the “FDA”) of a Company
sponsored Investigative New Drug Application (“an IND”) for a Licensed Product.
For the purposes of this section 4.5.3, the IND shall be deemed “accepted” by
the FDA sixty (60) days after submission of the IND to the FDA by the Company,
provided, however, that the FDA has not notified the Company that it will
not
allow human clinical trials to commence under such IND;
4.5.4 [***]
Dollars ($[***]) upon
the
first dosing of a patient, with a Licensed Product, in the first Phase
II
clinical trial sponsored by the Company or its sublicensee in any country
under
a Company sponsored IND or equivalent;
4.5.5 [***]
Dollars ($[***]) upon
the
first dosing of a patient, with a Licensed Product, in the first Phase
III
clinical trial sponsored by the Company or its sublicense in any country
under a
Company sponsored IND or equivalent;
4.5.6 [***]
Dollars ($[***]) upon
the
acceptance for review of the first Company sponsored (or sublicensee sponsored)
New Drug Application (and “NDA”) by the FDA;
4.5.7 [***]
Dollars ($[***]) upon
the
final approval by the FDA of the first Company sponsored (or sublicensee
sponsored) NDA for a Licensed Product filed by the Company or its
sublicensee;
4.6 No
payment obligations shall be due with respect to any sale or sublicense
covering
any Licensed Product in a country if there are no issued Patent Rights
underlying such Licensed Product in such country.
4.7 Should
the Company or their sublicensees fail to file an IND for a Licensed Product
with the FDA by the first anniversary of this Agreement (the “Penalty Date”),
the Company shall remit a payment to the Licensor equal to [***]
Dollars ($[***]) The
Company shall remit an additional [***]
Dollars ($[***]) (each
a
“Penalty Payment”) for each thirty (30) day period following the Penalty Date
that it does not file an IND for a Licensed Product with the FDA. Upon
submission of an IND for a Licensed Product with the FDA, the Company shall
no
longer be required to make Penalty Payments.
4.8 To
the
extent that the Company or any Affiliate of the Company is required (i)
after
appropriate legal analysis, or (ii) by order or judgment of any court in
any
jurisdiction, to obtain a license from a third party in order to practice
the
rights purported to be granted to the Company by Licensor hereunder under
Patent
Rights in such jurisdiction, then up to [***]
percent ([***]%) of
the
royalties payable under such license in such jurisdiction may be deducted
from
royalties otherwise payable to Licensor hereunder, provided that in no
event
shall the aggregate royalties payable to Licensor in any semi-annual period
in
such jurisdiction be reduced by more than [***]
percent ([***]%) as
a
result of any such deduction.
4.9 Upon
each
anniversary of this Agreement, the Company shall commit at least twenty-five
thousand dollars ($25,000) specifically to be used in research and development
related to potential products, research or development of Licensed Process
or
Licensed Product (the “Sponsored Research Funds”).
4.9.1 To
the
extent consistent with University’s rules and policy, and Florida Law, the
“Sponsored Research Funds” will be placed in a designated University of South
Florida Research Foundation Research Fund(s) and disbursed to researchers
by
mutual agreement of Company and University’s Director of Sponsored Research, as
further described in a Sponsored Research Agreement.
4.10 Company
agrees to provide Licensor [***]
percent ([***]%) of
any
Fees received by Company prior to meeting the milestone contained hereunder
Article 4.5.3 and [***]
percent ([***]%) of
any
Fees received by the Company thereafter. As used herein, the term “Fees” means
any fees, payments, or monies received by Company directly related to the
sublicensing by the Company of rights to commercialize Licensed Products
or
Licensed Processes, excluding (a) payments received from the sale or issuance
of
debt or equity securities of the Company; (b) payments received by the
Company
that are specifically designated in any agreement with a third party to
be
dedicated to the research and development of the Technology or dedicated
to
establish a marketing and sales force for sales of the Technology; and
(c)
payments resulting from the sale of one or more Licensed Products, including
royalties which shall be subject to Article 4.1.1.
ARTICLE
5 - REPORTS AND RECORDS
5.1 The
Company shall keep full, true and accurate books of account containing
all
particulars that may be necessary for the purpose of showing the amounts
payable
to Licensor by way of royalty as aforesaid. Said books of account shall
be kept
at the Company's principal place of business and the supporting data shall
be
open upon reasonable notice to the Company, for three (3) years following
the
end of the calendar year to which they pertain, for inspection by Licensor’s
internal audit division and/or by another designated auditor selected by
Licensor, except one to whom the Company has reasonable objection, for
the
purpose of verifying the Company's royalty statement or compliance in other
respects with this Agreement. Such obligation to maintain accurate books
of
account and the right to inspect them shall survive termination of this
Agreement. If an inspection shows an under reporting or underpayment in
excess
of the greater of [***] Dollars ($[***]) or [***] percent ([***]%) of royalties
payable for any quarter then the Company shall reimburse Licensor for the
cost
of the inspection at the time the Company pays the unreported royalties,
including any late charges as required by paragraph 5.4 of this Agreement.
All
payments required under this Article 5 shall be due within thirty (30)
days of
the date Licensor provides the Company notice of the payment due.
5.2 Within
sixty (60) days from the end of each quarter of each calendar year, specifically
sixty days from March 31, June 30, September 30, and December 31, the Company
shall deliver to Licensor complete and accurate reports, giving such particulars
of the business conducted by the Company during the preceding quarter under
this
Agreement as shall be pertinent to a royalty accounting hereunder, in a
format
similar to Exhibit D and shall include at least the following along with
the
information requested in Exhibit D:
5.2.1 All
Licensed Products and Licensed Processes used, leased or sold, by or for
the
Company or its Affiliates;
5.2.2 Total
amounts invoiced for Licensed Products and Licensed Processes used, leased
or
sold, by or for the Company or its Affiliates;
5.2.3 Deductions
applicable in computed Net Sales, if any;
5.2.4 Total
royalties due based on Net Sales by or for the Company or its Affiliates
or any
sublicensee;
5.2.5 Names
and
addresses of all sublicensees and Affiliates of the Company;
5.2.6 On
an
annual basis, the Company's year-end financial statements.
5.3 With
each
such quarterly report submitted, the Company shall pay to Licensor the
royalties
due and payable under this Agreement. If no royalties shall be due, the
Company
shall indicate such in the report.
5.4 Amounts
which are not paid when due and which are not the subject of a bona fide
dispute
shall accrue interest from the due date until paid, at a rate equal to
the then
prevailing prime rate of Citibank, N.A., plus [***] percent ([***]%), compounded
annually.
5.5 The
Company agrees to forward to Licensor annually a copy of any report, which
is in
substance similar to the report required by this Article 5, received from
any
sublicensee and other documents received from any sublicensee as may be
pertinent to an accounting of royalties.
5.6 Licensor
agrees to hold in confidence each report delivered by the Company pursuant
to
this Article 5 until the termination of this Agreement. Notwithstanding
the
foregoing, Licensor may disclose any such information required to be disclosed
pursuant to any judicial, administrative or governmental request, subpoena,
requirement or order, provided that Licensor take reasonable steps to provide
the Company with the opportunity to contest such request, subpoena, requirement
or order. However, it is understood and agreed that according to Florida
Statute
1004.22, Licensor shall make available upon request the title and description
of
a research project, the name of the researcher, and the amount and source
of
funding provided for such project.
5.7 Company
may submit a new statement correcting for an unintentional and newly discovered
overpayment for a period of one (1) year after the receipt of any such
report
and payment. Company’s sole remedy for such overpayment shall be credit against
the following years payments due Licensor.
5.8 Company
shall provide Development Reports, of which a sample is attached hereto
as
Exhibit C, semiannually, the first report being due six (6) months after
the
Effective Date of this Agreement.
ARTICLE
6 - PATENT PROSECUTION AND MAINTENANCE
6.1 The
Company shall diligently prosecute and maintain the Patent Rights as set
forth
in Exhibit A hereto (as the same may be amended or supplemented from time
to
time after the date hereof), including, but not limited to, the filing
of patent
applications which may be required. The Company agrees to keep Licensor
reasonably well informed with respect to the status and progress of any
such
applications, prosecutions and maintenance activities and to consult in
good
faith with Licensor and take into account Licensor’s comments and requests with
respect thereto. The Company will provide Licensor, under confidentiality,
with
copies of all filings covering products
incorporating the Technology.
Company
shall ensure that Licensor is simultaneously copied with Company on all
communication from patent counsel, including attachments related to Patent
Rights between Company and patent counsel. The Licensor shall be given
the
opportunity to review and comment upon the breadth and coverage of said
patent
applications, and patent counsel chosen by the Company and approved by
Licensor,
such approval not to be unreasonably withheld, shall use all due care to
address
and incorporate any comments offered by the Licensor. In addition, Licensor
shall have the right to designate its own separate counsel, at Licensor’s
expense, to review and comment upon the prosecution and drafting of any
applications, prosecution or maintenance documents and said comments shall
also
be given due consideration. Both parties agree to provide reasonable cooperation
to each other to facilitate the application and prosecution of patents
pursuant
to this Agreement.
6.2 The
Company may, in its discretion, elect to abandon any patent applications
or
issued patent in the Patent Rights, in which case the Company shall have
no
further royalty obligation to Licensor in respect of any Licensed Products
and
Licensed Processes, the manufacture, use or sale of which is covered by
an
issued claim of such abandoned Patent Rights. Prior to any such abandonment,
the
Company shall give Licensor at least sixty (60) days notice and a reasonable
opportunity to take over prosecution of such Patent Rights. In such event,
Licensor shall have the right, but not the obligation, to commence or continue
such prosecution and to maintain any such Patent Rights under its own control
and at its expense and the Company shall then have no royalty or other
obligation to Licensor in respect of any Licensed Products and Licensed
Processes, the manufacture, use or sale of which is covered by an issued
claim
of such Patent Rights. The Company agrees to cooperate in such activities
including execution of any assignments or other documents necessary to
enable
Licensor to obtain and retain sole ownership and control of such Patent
Rights.
ARTICLE
7 - TERMINATION
7.1 If
the
Company shall become bankrupt, or shall file a petition in bankruptcy,
or if the
business of the Company shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of the
Company or otherwise, this Agreement shall automatically terminate.
7.2 Should
the Company fail to make payment to Licensor of royalties due in accordance
with
the terms of this Agreement which are not the subject of a bona fide dispute
between Licensor and the Company, Licensor shall have the right to terminate
this License Agreement within seventy five (75) days after giving written
notice
of termination unless the Company shall pay to Licensor, within the seventy
five
(75) day period, all such royalties due and payable. In the event of a
bona fide
dispute over royalties, the parties shall resolve such dispute in accordance
with Article 8. Subject to Article 8 and the immediately preceding sentence,
upon the expiration of the seventy five (75) day period, if the Company
shall
not have paid all such royalties due and payable, the rights, privileges
and
license granted hereunder shall, at the option of Licensor,
terminate.
7.3 Upon
any
material breach or default of this Agreement by the Company, other than
as set
forth in Paragraph 7.1 and 7.2 above, which shall always take precedence
in that
order over any material breach or default referred to in this Section 7.3,
Licensor shall have the right to terminate this Agreement and the rights,
privileges and license granted hereunder by giving seventy five (75) days
prior
written notice to the Company. Such termination shall become effective
immediately unless the Company shall have cured any such breach or default
prior
to the expiration of the seventy five (75) day period referred to above.
If a
dispute regarding termination is addressed according to Article 7, this
license
shall remain in full force and effect until such dispute is settled in
a manner
that is not further appealable or not appealed.
7.4 The
Company shall have the right at any time to terminate this Agreement in
whole or
as to any portion of the Patent Rights, for any reason or no reason, by
giving
six (6) months notice thereof in writing to Licensor, and upon payment
of all
amounts due Licensor through the effective date of the termination.
7.5 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination or obligations under Articles 4, 5, 8, 10, 13,
and 15,
or as specifically specified in such Article. The Company and/or any sublicensee
thereof may, however, after the effective date of such termination and
continuing for a period not to exceed twelve (12) months thereafter, sell
all
completed Licensed Products, and any Licensed Products in the process of
manufacture at the time of such termination, and sell the same, provided
that
the Company shall pay or cause to be paid to Licensor the royalties thereon
as
required by Article 4 of this Agreement and shall submit the reports required
by
Article 5 hereof on the sales of Licensed Products.
7.6 In
the
event of termination under this Article 7, Licensor shall have the right
to
cross-reference and rely upon any such approvals and use all data submitted
by
Company to
any
regulatory agency in
connection with Licensed Products, Licensed Processes or any products covered
under the Patent Rights that Licensor or its other Licensee’s may seek approval
on
and,
following termination of this Agreement, Licensor shall have the unrestricted
right to provide such data to third parties.
7.7 If
not
terminated sooner, this Agreement shall terminate, on a country by country
basis, on the date of the last to expire claim contained in the Patent
Rights,
at which time the Company will have an irrevocable, paid up, royalty-free
license under the Patent Rights to make, have made, use, have used, sell
and
have sold Licensed Products and Licensed Processes.
ARTICLE
8 - DISPUTE RESOLUTION
8.1 Any
dispute arising from or relating to this Agreement, excluding any dispute
relating to patent validity or infringement, which have not been resolved
by
good faith negotiations between the parties, shall be resolved by final
and
binding arbitration in Tampa, Florida, in accordance with the rules of
the
American Arbitration Association. One arbitrator shall be selected by Licensor,
one arbitrator shall be selected by the Company and the third arbitrator
shall
be selected by mutual agreement of the first two arbitrators. The arbitrators
shall have no power to add to, subtract from or modify any of the terms
or
conditions of this Agreement. Any award rendered in such arbitration may
be
enforced by either party in either the courts of the State of Florida or
in the
United States District Court for the Middle District of Florida, to whose
jurisdiction for such purposes Licensor and Company each hereby irrevocably
consents and submits.
8.2 Any
claim, dispute, or controversy concerning the validity, enforceability,
or
infringement of any patent contained in the Patent Rights licensed hereunder
shall be resolved in any court having jurisdiction thereof.
8.3 In
the
event that, in any arbitration proceeding, any issue shall arise concerning
the
validity, enforceability, or infringement of any patent contained in the
Patent
Rights licensed hereunder, the arbitrators shall, to the extent possible,
resolve all issues other than validity, enforceability, and infringement;
in any
event, the arbitrators shall not delay the arbitration proceeding for the
purpose of obtaining or permitting either party to obtain judicial resolution
of
such issues, unless an order staying the arbitration proceeding shall be
entered
by a court of competent jurisdiction. Neither party shall raise any issue
concerning the validity, enforceability, or infringement of any patent
contained
in the Patent Rights licensed hereunder, in any proceeding to enforce any
arbitration award hereunder, or in any proceeding otherwise arising out
of any
such arbitration award.
8.4
The
costs of such arbitration shall be borne proportionate to the finding of
fault
as determined by the Arbitrator. Judgment on the arbitration award may
be
entered by any court of competent jurisdiction.
8.5 Notwithstanding
the foregoing, nothing in this Article shall be construed to waive any
rights or
timely performance of any obligations existing under this
Agreement.
ARTICLE
9 - INFRINGEMENT AND OTHER ACTIONS
9.1 The
Company and Licensor shall promptly provide written notice, to the other
party,
of any alleged infringement by a third party of the Patent Rights and provide
such other party with any available evidence of such infringement. Licensor
and
Company shall consult one another in a timely manner concerning any appropriate
response to the infringement.
9.2 During
the term of this Agreement, the Company shall have the right, but not the
obligation, to prosecute and/or defend, at its own expense and utilizing
counsel
of its choice, any infringement of, and/or challenge to, the Patent Rights.
In
furtherance of such right, Licensor hereby agrees that the Company may
join
Licensor as a party in any such suit (and will join at the Company’s request),
provided that the Company pay all of Licensor’s reasonable out-of-pocket
expenses. The Company shall indemnify and hold Licensor harmless against
any
costs, expenses, liability, claims or damages made against or sustained
by
Licensor in connection with such involvement, other than resulting from
Licensor's negligence or willful misconduct. Company may not settle or
compromise any such suit in a manner that imposes additional obligations
or
restrictions on Licensor not already imposed by this Agreement without
Licensor’s written permission. Any recovery of damages pursuant to this
Paragraph 9.2 shall be retained entirely by the Company and allocated pursuant
to 9.4 below.
9.3 In
the
event that a claim or suit is asserted or brought against the Company alleging
that the manufacture or sale of any Licensed Product by the Company, an
Affiliate of the Company, or any sublicensee, or the use of such Licensed
Product by any customer of any of the foregoing, infringes proprietary
rights of
a third party, the Company shall give written notice thereof to Licensor.
The
Company may, in its sole discretion, modify such Licensed Product to avoid
such
infringement and/or may settle on terms that it deems advisable in its
sole
discretion, subject to paragraph 9.2. Otherwise,
the Company shall have the right, but not the obligation, to defend any
such
claim or suit. In the event the Company elects not to defend such suit,
Licensor
shall have the right, but not the obligation to do so at its sole
expense.
9.4 Any
recovery of damages by the Company, in any such suit, shall be applied
first in
satisfaction of any unreimbursed expenses and legal fees of the Company
relating
to the suit. The balance remaining from any such recovery shall be treated
as
royalties received by the Company from sublicensees and shared by Licensor
and
the Company in accordance with Paragraphs 4.1 and 4.2 hereof as applicable.
9.5 The
Company may credit the cost of any litigation costs incurred by the Company
in
any country pursuant to this Article 9 including all amounts paid in judgment
or
settlement of litigation within the scope of this Article 9 against royalties
or
other fees thereafter payable to the Licensors hereunder for such country.
If
the costs of such litigation in such country exceeds the royalties payable
to
the Licensors in any year in which such costs are incurred then the amount
of
such costs, expenses and amounts paid in judgment or settlement, in excess
of
the royalties payable shall be carried over and credited against royalty
payments in future years for such country.
9.6 If
within
six (6) months after receiving notice of any alleged infringement, the
Company
shall have been unsuccessful in persuading the alleged infringer to desist,
or
shall not have brought and shall not be diligently prosecuting an infringement
action, or if the Company shall notify Licensor, at any time prior thereto,
of
its intention not to bring suit against the alleged infringer, then, and
in
those events only, Licensor shall have the right, but not the obligation,
to
prosecute, at its own expense and utilizing counsel of its choice, any
infringement of the Patent Rights, and the Company may, for such purposes,
join
the Licensor as a party plaintiff. The total cost of any such infringement
action commenced solely by Licensor shall be borne by Licensor and Licensor
shall keep any recovery or damages for infringement or otherwise derived
therefrom and such shall not be applicable to any royalty obligation of
the
Company.
9.7 In
any
suit to enforce and/or defend the Patent Rights pursuant to this Agreement,
the
party not in control of such suit shall, at the request and expense of
the
controlling party, cooperate in all respects and, to the extent possible,
have
its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.
ARTICLE
10 - LIMITATION OF LIABILITY, INDEMNITY
10.1 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR
PENDING.
10.2 The
Company agrees to defend, indemnify and hold Licensor, the University and
their
trustees, inventors, officers, employees and affiliates, harmless from
and
against all liability, demands, damages, including without limitation,
expenses
or losses including death, personal injury, illness or property damage
arising
directly or indirectly: (a) out of use by the Company, Company’s Affiliates,
sublicensees, or its transferees of inventions licensed or information
furnished
under this Agreement or (b) out of any use, sale or other disposition by
the
Company, Company’s Affiliates, sublicensees, or its transferees of Patent
Rights, Licensed Products or Licensed Processes, in each case which are
not the
result of Licensor's negligence or willful misconduct. The Company agrees
that
any sublicense agreement it enters relative to the Licensed Products and/or
Licensed Processes shall contain a covenant by such sub-licensee providing
for
the indemnification of Licensor as provided in this Article.
10.3 Licensor
shall not be liable to Company or Company’s customers or sublicensees for any
damages, including but not limited to, direct, special, incidental, indirect,
economic, or consequential damages resulting from design defects, testing,
labeling, manufacture, or other application of Licensed Products manufactured,
tested, designed, sublicensed or sold pursuant to this Agreement.
10.4 Company
shall procure and maintain commercial general liability insurance, including
without limitation, product liability insurance, in amounts customary in
the
relevant industry in which Company commercially exploits Licensed Products
or
Licensed Process. Such insurance coverage shall extend to indemnities of
Company
and Licensor shall be named as an insured. Insurance coverage shall be
obtained
through insurance carriers reasonably acceptable to Licensor. Product liability
insurance shall be maintained prior to the first commercial sale of a Licensed
Product and shall be continued for a commercially reasonable amount of
time
after the expiration of this Agreement.
10.5 LICENSEE
shall promptly notify RESEARCH FOUNDATION of all claims involving the
Indemnities.
10.6 Nothing
in this Agreement shall be construed as a warranty or representation by
RESEARCH
FOUNDATION or University that it will not grant licenses to others to make,
use
or sell products or processes not covered by the claims of the Patent Rights
which may be similar to or compete with products made or sold by LICENSEE
or its
sublicensee.
ARTICLE
11 - ASSIGNMENT
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other party, shall be null and of no
effect.
Notwithstanding the foregoing, the Company may assign this Agreement without
the
consent of Licensor (i) to a purchaser, merging or consolidating corporation,
or
acquiror of substantially all of the Company's assets or business and/or
pursuant to any reorganization qualifying under section 368 of the Internal
Revenue Code of 1986 as amended, as may be in effect at such time, or (ii)
to an
Affiliate of the Company. In either such case, Company shall notify Licensor
in
writing within thirty (30) days of such assignment. Notwithstanding the
foregoing, Licensor may assign this Agreement or any individual sections
or
paragraphs under this Agreement, without the consent of Company, to Moffitt
Research & Cancer Center.
ARTICLE
12 - PAYMENT OF FEES AND EXPENSES
Each
of
the Company and Licensor shall be responsible for their own expenses relating
to
the preparation and consummation of this Agreement and the agreements and
transactions contemplated hereby.
ARTICLE
13 - USE OF NAMES AND PUBLICATION
13.1 Nothing
contained in this Agreement shall be construed as granting any right to
the
Company or its Affiliates to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of Licensor,
the inventors, the University nor any of its employees, any of its units
(including contraction, abbreviation or simulation of any of the foregoing),
nor
any adaptation thereof, without the prior, written consent of Licensor;
provided, however,
Company
may state that such has been licensed by Licensor under one or more of
the
patents and/or applications comprising the Patent Rights.
13.2 Nothing
herein shall be deemed to establish a relationship of principal and agent
between Licensor and the Company, nor any of their agents or employees
for any
purpose whatsoever.
13.3 In
the
event that Licensor desires to publish or disclose, by written, oral or
other
presentation, Patent Rights, Know-how, or any material information related
thereto then Licensor shall notify the Company and in writing by facsimile
where
confirmed by the receiving party, and/or by certified or registered mail
(return
receipt requested) of their intention at least sixty (60) days prior to
any
speech, lecture or other oral presentation and at least ninety (90) days
before
any written or other publication or disclosure. The Licensor shall include
with
such notice a description of any proposed oral presentation or, in any
proposed
written or other disclosure, a current draft of such proposed disclosure
or
abstract. The Company may request that the Licensor, no later than thirty
(30)
days following the receipt of such notice, delay such presentation, publication
or disclosure for up to an additional sixty (60) days in order to enable
the
Company to file, or have filed on their behalf, a patent application, copyright
or other appropriate form of intellectual property protection related to
the
information to be disclosed or request that Licensor do so. Upon receipt
of such
request to delay such presentation, publication or disclosure, Licensor
shall
arrange for a delay of such presentation, publication or disclosure until
such
time as the Company or Licensor have filed, or had filed on its behalf,
such
patent application, copyright or other appropriate form of intellectual
property
protection in form and in substance reasonably satisfactory to the Company
and
Licensor. If the Licensor does not receive any request from the Company
to delay
such presentation, publication or disclosure, Licensor may submit such
material
for presentation, publication or other form of disclosure.
ARTICLE
14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any
payment, notice or other communication required or permitted to be given
pursuant to this Agreement shall be in writing and sent by certified first
class
mail, postage prepaid, by hand delivery or by facsimile if confirmed in
writing,
in each case effective upon receipt, at the addresses below or as otherwise
designated by written notice given to the other party:
In
the
case of Licensor:
USF
Research Foundation, Inc.
USF
Box
30445
Tampa,
Florida 33620-3044
Attention:
Assistant Director
Tel:
813-974-4903
Fax:
813-974-3348
In
the
case of the Company:
Greenwich
Therapeutics, Inc.
787
Seventh Avenue, 48th Floor
New
York,
NY 10019
Attn:
President
Tel:
212-554-4300
Fax:
212-554-4355
15.
CONFIDENTIALITY
15.1 Any
proprietary or confidential information relating to the Patent Rights (including
but not limited to Know-how and patent prosecution documents relating to
Patent
Rights) collectively constitute the “Confidential Information." The Company and
Licensor agree that they will not use the Confidential Information for
any
purpose unrelated to this Agreement, and will hold it in confidence during
the
term of this Agreement and for a period of five (5) years after the termination
or expiration date of this Agreement. The Company shall exercise with respect
to
such the Confidential Information the same degree of care as the Company
exercises with respect to its own confidential or proprietary information
of a
similar nature, and shall not disclose it or permit its disclosure to any
third
party (except to those of its employees, consultants, or agents who are
bound by
the same obligation of confidentiality as the Company is bound by pursuant
to
this Agreement). However, such undertaking of confidentiality by the Company
shall not apply to any information or data which:
15.1.1 The
Company receives at any time from a third-party lawfully in possession
of same
and having the right to disclose same.
15.1.2 Is,
as of
the date of this Agreement, in the public domain, or subsequently enters
the
public domain through no fault of the Company.
15.1.3 Is
independently developed by the Company as demonstrated by written evidence
without reference to information disclosed to the Company by
Licensor.
15.1.4 Is
disclosed pursuant to the prior written approval of Licensor.
15.1.5 Is
required to be disclosed pursuant to law or legal process (including, without
limitation, to a governmental authority) provided, in the case of disclosure
pursuant to legal process, reasonable notice of the impending disclosure
is
provided to Licensor and Licensor has agreed to such disclosure in writing
or
has exhausted its right to contest such disclosure.
ARTICLE
16 - MISCELLANEOUS PROVISIONS
16.1 This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of Florida, without regard to principles of
conflicts
of laws.
16.2 If
this
Agreement or any associated transaction is required by the law of any nation
to
be either approved or registered with any governmental agency, the Company
shall
assume all legal obligations to do so and the costs in connection therewith.
16.3 The
parties hereto acknowledge that this Agreement, including the Appendices
and
documents incorporated by reference, sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and
shall
not be subject to any change of modification except by the execution of
a
written instrument subscribed to by the parties hereto.
16.4 The
provisions of this Agreement are severable, and in the event that any provision
of this Agreement shall be determined to be invalid or unenforceable under
any
controlling body of law, such invalidity or unenforceability shall not
in any
way affect the validity or enforceability of the remaining provisions
hereof.
16.5 The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver
of
that right or excuse a similar subsequent failure to perform any such term
or
condition by the other party.
16.6 The
headings of the several articles are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
16.7 This
Agreement will not be binding upon the parties until it has been signed
below on
behalf of each party, in which event, it shall be effective as of the date
recited on page one. The provision of this Agreement shall be binding upon
and
shall inure to the benefit of the parties hereto, their heirs, administrators,
successors and assigns.
16.8 This
Agreement embodies the entire understanding of the parties and shall supersede
all previous communications, representations or understandings, either
oral or
written, between the parties relating to the subject matter hereof.
16.9 Each
party hereto shall be excused from any breach of this Agreement which is
proximately caused by governmental regulation, act of war, strike, act
of God or
other similar circumstance normally deemed outside the control of the
parties.
16.10 Company
agrees to mark the Licensed Products sold in the United States with all
applicable United States patent numbers. All Licensed Products shipped
to or
sold in other countries shall be marked in such a manner as to conform
with the
patent laws and practice of the country of manufacture or sale.
16.11 It
is
understood that Licensor is subject to United States laws and regulations
controlling the export or transfer of defense articles, technical data,
computer
software, laboratory prototypes, and other commodities (collectively “technical
information”). Said laws include but are not limited to: the Export Control Act,
International Traffic in Arms Regulations and the Export Administration
Act of
1979. Licensor’s obligations hereunder are contingent on compliance with said
laws and regulations. It is understood that compliance with said laws and
regulations may require of both Licensor and Company: (1) export license(s);
(2)
written compliance plan(s) with said laws and regulations; or (3)
modification(s) to existing facilities. Licensor does not represent that
a
license(s), compliance plan(s) or modification(s) will or will not be required.
In the event that an export license(s) is required, Licensor does not represent
that it shall be issued by the cognizant governmental agencies. In the
event
that a compliance plan(s) or modification(s) is required, Licensor does
not
represent that said plan(s) or modification(s) will be approved by the
cognizant
governmental agencies. In all cases the cost of any (1) export licenses
for
Company or Company’s employees; (2) compliance plans required of Company; and
(3) modifications to Company’s facilities shall be the sole responsibility of
Company. Company hereby agrees to comply with any export controls or federal
regulations which may apply to the Licensed Products or Licensed
Processes.
ARTICLE
17-REPRESENTATIONS AND WARRANTIES
17.1 Licensor,
to the best of its knowledge, represents and warrants that:
17.1.1 Licensor
has all right, title, and interest in and to the Patent Rights and Know-how,
including the exclusive, absolute, irrevocable right, title and interest
thereto, free and clear of all liens, charges, encumbrances or other
restrictions or limitations of any kind whatsoever.
17.1.2 There
are
no licenses, options, restrictions, liens, rights of third parties, disputes,
royalty obligations, proceedings or claims relating to, affecting, or limiting
Licensor’s rights or the rights of the Company under this Agreement, or which
may lead to a claim of infringement or invalidity regarding, any part or
all of
the Patent Rights or Know How or their use.
17.1.3 There
is
no claim, pending or threatened, of infringement, interference or invalidity
regarding any part or all of the Patent Rights or Know-how or their use.
17.1.4 The
US
and foreign patent applications and patents itemized on Exhibit A set forth
all
of the patents and patent applications for the Technology in the Field
of Use
owned by or licensed by Licensor on the Effective Date.
17.1.5 There
are
no inventors of Patent Rights other than those listed as inventors on the
patent
filings.
17.1.6 Licensor
has provided Company with copies of all documents reflecting support or
funding
for all or part of the research leading to Patent Rights and Know How,
and has
listed all funding agencies on Exhibit B.
17.2 It
is
understood that the United States Government (through its agencies or otherwise)
or the Government of the State of Florida may have funded research during
the
course of or under which some of the inventions of the Patent Rights may
have
been conceived or made. The United States Government and the Government
of the
State of Florida are entitled, as a right, under the provisions of 35 U.S.C.
§202-212 and applicable regulations of Title 37 of the Code of Federal
Regulations and other federal and state regulations, to a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have practiced
the
inventions of such Patent Rights for governmental purposes. Any license
granted
to LICENSEE in this Agreement shall be subject to such right, if
any.
17.3 Each
of
Company and Licensor warrants and represents that the persons signing this
Agreement on its behalf have authority to execute this Agreement and that
execution of this Agreement does not violate any law, rule, or regulation
applicable to it or any contract or other agreement by which it is
bound.
(signatures
on next page)
IN
WITNESS WHEREOF,
the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.
GREENWICH
THERAPEUTICS, INC. |
|
|
UNIVERSITY
OF SOUTH FLORIDA RESEARCH FOUNDATION, Inc. |
/s/ |
|
|
/s/ |
|
|
|
|
Name: Title:
Date:
|
|
|
Name:
Rod Casto, Ph.D. Title:
Executive Director & Secretary
Date:
|
UNIVERSITY
OF SOUTH FLORIDA BOARD
OF TRUSTEES,
a
public body corporate
|
|
|
|
/s/ |
|
|
|
|
|
|
|
Name Title More
Title |
|
|
|
(signature
page to the License Agreement by and among
the
parties above date April 19, 2005)
EXHIBIT
A
[***]
EXHIBIT
B
Support
& funding leading to Patent Rights and Know How:
National
Cancer Institute
CA89242
& CA77935
EXHIBIT
C
Form
of
Development Report
THIS
REPORT IS CONFIDENTIAL AND MAY CONTAIN MATERIAL NON PUBLIC
INFORMATION
When
appropriate, indicate estimated start date and finish date for
activities.
A. Date
Development Plan Initiated and Time Period Covered by this Report.
B. Development
Report
1. Activities
completed since last report including the object and parameters of the
development, when initiated, when
completed and the results.
2. Activities
currently under investigation, i.e., ongoing activities including object
and
parameters of such
activities,
when initiated, and projected date of completion.
C. Future
Development Activities
1. Activities
to be undertaken before next report including, but not limited to, the
type and
object of any studies conducted
and their projected starting and completion dates.
2. Estimated
total development time remaining before a product will be
commercialized.
D. Changes
to Initial Development Plan
1. Reasons
for change.
2. Variables
that may cause additional changes.
E.
Items
to be Provided if Applicable:
1. Information
relating to Licensed Products that has become publicly available, e.g.,
published articles, competing products,
patents, etc.
2. Development
work being performed by third parties, other than Licensee, to include
name of
third party,
reasons
for use of third party, planned future uses of third parties including
reasons
why and type of work.
3. Update
of
competitive information trends in industry, government compliance (if
applicable) and market plan.
|
4.
|
Information
and copies of relevant materials evidencing the status of any
patent
applications or other protection relating to Licensed Products
or the
Licensed Patents.
|
PLEASE
SEND DEVELOPMENT REPORTS TO:
University
of South Florida Research Foundation, Inc.
|
University
of South Florida
|
4202
E. Fowler Avenue, FAO126
|
Division
of Patents & Licensing
|
Tampa,
FL 33620
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4202
E. Fowler Avenue, FAO126
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ATTN:
Assistant Director
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Tampa,
FL 33620
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Phone
No.: 813-974-4903
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ATTN:
Director
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Fax
No.: 813-974-3348
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Phone
No.: 813-974-0994
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Fax
No.: 813-974-8490
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Exhibit
D
USF
Royalty Report
Licensee:__________________________ Agreement
No:_______________________
Inventor(s):_______________________
USF Ref: No:_______________________
Period
Covered: From:____/_____/_____ Through:_______/_______/_____________
Prepared
By:_______________________ Approved
by:________________________
If
License covers several major product lines, please prepare a separate report
for
each line. Then combine all product lines into a summary report.
Report
Type: ___Single Product Line Report
________________________________
___Multiproduct
Summary Report Page __ of ___ Pages
Report
Currency: ___US Dollars ___Other_________________________
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Royalty
Due
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Country
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Gross
Sales
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*Less
Allowances
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Net
Sales
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Royalty
Rate
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This
Year
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Last
Year
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U.S.A.
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Canada
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Europe
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Japan
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Others:
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TOTAL:
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Total
Royalty:________Conversion Rate(s):___________Royalty in U.S.
Dollars:________________
Milestone
Payment 1:_________;Milestone Payment 2:_________Milestone Payment
3:__________
The
following Royalty forecast is non-binding and for USF’s internal planning
purposes only:
Royalty
Forecast Under this Agreement: Next
Quarter:________Q2:______Q3:______Q4:______
On
a
separate page, please indicate the reason for returns or other adjustments
if
significant. Also, note any unusual occurrences that affect royalty amounts
during this period. To assist USF’s forecasting, please comment on any
significant expected trends in sales volume.
Appendix
F
CERTIFICATE
OF INCORPORATION
of
VIOQUEST
DELAWARE, INC.
The
undersigned incorporator, in order to form a corporation under the General
Corporation Law of the State of Delaware (the “General Corporation Law”),
certifies as follows:
1. Name.
The
name of the corporation is “VioQuest Delaware, Inc.” (the
“Corporation”).
2. Address; Registered Office
and Agent.
The
address of the Corporation’s registered office in the State of Delaware is 1209
Orange Street, Wilmington, Delaware 19801, in New Castle County; and the name
of
its registered agent at such address is The Corporation Trust Company. The
Corporation may from time to time, in the manner provided by law, change the
registered agent and the registered office within the State of Delaware. The
Corporation may also maintain an office or offices for the conduct of its
business, either within or without the State of Delaware.
3. Purposes.
The
purpose of the Corporation is to engage in any lawful act or activity for which
corporations may be organized under the General Corporation Law.
4. Number of Shares.
The
total number of shares of all classes of stock that the Corporation shall have
authority to issue is One Hundred Ten Million (110,000,000) shares consisting
of: One Hundred Million (100,000,000) shares of common stock, $.001 par value
per share (“Common Stock”); and Ten Million (10,000,000) shares of preferred
stock, $.001 par value per share (“Preferred Stock”).
The
Preferred Stock may be divided into, and may be issued from time to time in
one
or more series. The Board of Directors of the Corporation (“Board”) is
authorized from time to time to establish and designate any such series of
Preferred Stock, to fix and determine the variations in the relative rights,
preferences, privileges and restrictions as between and among such series and
any other class of capital stock of the Corporation and any series thereof,
and
to fix or alter the number of shares comprising any such series and the
designation thereof. The authority of the Board from time to time with respect
to each such series shall include, but not be limited to, determination of
the
following:
(a) The
designation of the series;
(b) The
number of shares of the series and (except where otherwise provided in the
creation of the series) any subsequent increase or decrease therein;
(c) The
dividends, if any, for shares of the series and the rates, conditions, times
and
relative preferences thereof;
(d) The
redemption rights, if any, and price or prices for shares of the series;
(e) The
terms
and amounts of any sinking fund provided for the purchase or redemption of
the
series;
(f) The
relative rights of shares of the series in the event of any voluntary or
involuntary liquidation, dissolution or winding up of the affairs of the
Corporation;
(g) Whether
the shares of the series shall be convertible into shares of any other class
or
series of shares of the Corporation, and, if so, the specification of such
other
class or series, the conversion prices or rate or rates, any adjustments
thereof, the date or dates as of which such shares shall be convertible and
all
other terms and conditions upon which such conversion may be made;
(h) The
voting rights, if any, of the holders of such series; and
(i) Such
other designations, powers, preference and relative, participating, optional
or
other special rights and qualifications, limitations or restrictions
thereof.
5. Name and Mailing
Address of Incorporator.
The
name and mailing address of the incorporator are: Christopher J. Melsha, Esq.,
90 South Seventh Street, Suite 3300, Minneapolis, Minnesota 55402.
6. Election of Directors.
Unless
and except to the extent that the By-laws of the Corporation (the “By-laws”)
shall so require, the election of directors of the Corporation need not be
by
written ballot.
7. Limitation
of Liability.
To the
fullest extent permitted under the General Corporation Law, as amended from
time
to time, no director of the Corporation shall be personally liable to the
Corporation or its stockholders for monetary damages for breach of fiduciary
duty as a director. Any amendment, repeal or modification of the foregoing
provision shall not adversely affect any right or protection of a director
of
the Corporation hereunder in respect of any act or omission occurring prior
to
the time of such amendment, repeal or modification.
8. Indemnification.
8.1 Right
to Indemnification.
The
Corporation shall indemnify and hold harmless, to the fullest extent permitted
by applicable law as it presently exists or may hereafter be amended, any person
(a “Covered Person”) who was or is made or is threatened to be made a party or
is otherwise involved in any action, suit or proceeding, whether civil,
criminal, administrative or investigative (a “Proceeding”), by reason of the
fact that he or she, or a person for whom he or she is the legal representative,
is or was a director or officer of the Corporation or, while a director or
officer of the Corporation, is or was serving at the request of the Corporation
as a director, officer, employee or agent of another corporation or of a
partnership, joint venture, trust, enterprise or nonprofit entity (an “Other
Entity”), including service with respect to employee benefit plans, against all
liability and loss suffered and expenses (including attorneys’ fees) reasonably
incurred by such Covered Person. Notwithstanding the preceding sentence, except
as otherwise provided in Section 8.3, the Corporation shall be required to
indemnify a Covered Person in connection with a Proceeding (or part thereof)
commenced by such Covered Person only if the commencement of such Proceeding
(or
part thereof) by the Covered Person was authorized by the Board of Directors
of
the Corporation (the “Board”).
8.2 Prepayment
of Expenses.
The
Corporation shall pay the expenses (including attorneys’ fees) incurred by a
Covered Person in defending any Proceeding in advance of its final disposition,
provided,
however,
that,
to the extent required by applicable law, such payment of expenses in advance
of
the final disposition of the Proceeding shall be made only upon receipt of
an
undertaking by the Covered Person to repay all amounts advanced if it should
be
ultimately determined that the Covered Person is not entitled to be indemnified
under this Article 8 or otherwise.
8.3 Claims.
If a
claim for indemnification or advancement of expenses under this Article 8 is
not
paid in full within 30 days after a written claim therefor by the Covered Person
has been received by the Corporation, the Covered Person may file suit to
recover the unpaid amount of such claim and, if successful in whole or in part,
shall be entitled to be paid the expense of prosecuting such claim. In any
such
action the Corporation shall have the burden of proving that the Covered Person
is not entitled to the requested indemnification or advancement of expenses
under applicable law.
8.4 Nonexclusivity
of Rights.
The
rights conferred on any Covered Person by this Article 8 shall not be exclusive
of any other rights that such Covered Person may have or hereafter acquire
under
any statute, provision of this Certificate of Incorporation, the By-laws,
agreement, vote of stockholders or disinterested directors or
otherwise.
8.5 Other
Sources.
The
Corporation’s obligation, if any, to indemnify or to advance expenses to any
Covered Person who was or is serving at its request as a director, officer,
employee or agent of an Other Entity shall be reduced by any amount such Covered
Person may collect as indemnification or advancement of expenses from such
Other
Entity.
8.6 Amendment
or Repeal.
Any
repeal or modification of the foregoing provisions of this Article 8 shall
not
adversely affect any right or protection hereunder of any Covered Person in
respect of any act or omission occurring prior to the time of such repeal or
modification.
8.7 Other
Indemnification and Prepayment of Expenses.
This
Article 8 shall not limit the right of the Corporation, to the extent and in
the
manner permitted by applicable law, to indemnify and to advance expenses to
persons other than Covered Persons when and as authorized by appropriate
corporate action.
9. Adoption, Amendment and/or Repeal of By-Laws.
In
furtherance and not in limitation of the powers conferred by the laws of the
State of Delaware, the Board is expressly authorized to make, alter and repeal
the By-laws.
10. Powers
of Incorporators.
The
powers of the incorporator are to terminate upon the filing of this Certificate
of Incorporation with the Secretary of State of the State of Delaware. The
name
and mailing address of the person who is to serve as the initial director of
the
Corporation, or until his successor is duly elected and qualified,
are:
Daniel
Greenleaf
7
Deer
Park Drive, Suite E
Monmouth
Junction, NJ 08852
11. Certificate
Amendments.
The
Corporation reserves the right at any time, and from time to time, to amend,
alter, change or repeal any provision contained in this Certificate of
Incorporation, and other provisions authorized by the laws of the State of
Delaware at the time in force may be added or inserted, in the manner now or
hereafter prescribed by applicable law; and all rights, preferences and
privileges of whatsoever nature conferred upon stockholders, directors or any
other persons whomsoever by and pursuant to this Certificate of Incorporation
in
its present form or as hereafter amended are granted subject to the rights
reserved in this Section.
WITNESS
the signature of this Certificate of Incorporation this [ ] day of [ ],
2005.
__________________________________
Christopher
J. Melsha, Incorporator
VioQuest
Pharmaceuticals, Inc.
PROXY
FOR SPECIAL MEETING OF SHAREHOLDERS - [ ],
2005
The
undersigned, a shareholder of VioQuest Pharmaceuticals, Inc., hereby appoints
Daniel Greenleaf and Brian Lenz, and each of them, as proxies, with full power
of substitution, to vote on behalf of the undersigned the number of shares
which
the undersigned is then entitled to vote, at the Special Meeting of Shareholders
of VioQuest Pharmaceuticals, Inc. to be held on [ ], 2005 at
[ ] (Eastern time)
at
[ ],
and at any and all
adjournments thereof, with all the powers which the undersigned would possess
if
personally present, upon:
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To
approve and adopt a proposal to reincorporate the Company under
the laws
of the State of Delaware by merging the Company with and into VioQuest
Delaware, Inc., a Delaware corporation and wholly owned subsidiary
of the
Company (the "Reincorporation"), as more fully described in the
Company’s
Proxy Statement relating to the Special
Meeting.
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FOR
❑ AGAINST
❑ ABSTAIN
❑
The
Board of Directors Recommends a Vote FOR this Proposal.
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To
approve and adopt a proposal to amend the Company’s articles of
incorporation to authorize an increased number of shares of common
stock
and the issuance of shares of preferred stock (the "Charter Amendment"),
as more fully described in the Company’s Proxy Statement relating to the
Special Meeting.
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FOR
❑ AGAINST
❑ ABSTAIN
❑
The
Board of Directors Recommends a Vote FOR this Proposal.
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If
necessary, to approve and adopt a proposal to to adjourne the Special
Meeting to permit further solicitation of proxies if there are
not
sufficient votes to approve the Reincorporation and/or the Charter
Amendment.
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FOR
❑ AGAINST
❑ ABSTAIN
❑
The
Board of Directors Recommends a Vote FOR this Proposal.
The
undersigned hereby revokes all previous proxies relating to the shares covered
hereby and acknowledges receipt of the Notice and Proxy Statement relating
to
the Special Meeting of Shareholders.
THIS
PROXY IS SOLICITED ON BEHALF OF THE BOARD OF DIRECTORS.
When
properly executed, this proxy will be voted on the proposals set forth herein
as
directed by the shareholder, but if no direction is made in the space provided,
this proxy will be voted FOR the Reincorporation, Charter Amendment and, if
necessary, Adjournment.
Dated
___________, 2005
×_____________________________
×_____________________________
(When
signed as a corporate officer, executor, administrator, trustee, guardian,
etc.,
please give full title as such. If shares are held in joint tenancy, both joint
tenants must sign.)