<PAGE>
EXHIBIT 1.1
2,500,000 Shares of Common Stock
IVIVI TECHNOLOGIES, INC.
UNDERWRITING AGREEMENT
October 18, 2006
MAXIM GROUP LLC
405 Lexington Avenue
New York, NY 10174
As Representative of the Underwriters
named on Schedule A hereto
Ladies and Gentlemen:
Ivivi Technologies, Inc., a corporation organized and existing
under
the laws of New Jersey (the "COMPANY"), confirms its agreement,
subject to the
terms and conditions set forth herein, with each of the
underwriters listed on
Exhibit A hereto (collectively, the "UNDERWRITERS"), for whom Maxim
Group LLC is
acting as representative (in such capacity, the "REPRESENTATIVE"),
to sell and
issue to the Underwriters an aggregate of 2,500,000 shares (the
"FIRM SHARES")
of its common stock, no par value per share (the "COMMON STOCK").
In addition,
the Company proposes to sell to the Underwriters, upon the terms
and conditions
set forth in Section 2 hereof, an aggregate additional amount of
375,000 shares
of Common Stock, representing up to 15% of the Firm Shares (the
"ADDITIONAL
SHARES"). The Firm Shares and any Additional Shares purchased by
the
Underwriters are referred to herein as the "SHARES." The Shares are
more fully
described in the Registration Statement and Prospectus referred to
below. The
offering and sale of the Shares contemplated by this underwriting
agreement
(this "AGREEMENT") is referred to herein as the "OFFERING."
1. Representations and Warranties of the Company. The Company
represents, warrants and covenants to, and agrees with, each of the
Underwriters
that, as of the date hereof and as of the Closing Date and each
Additional
Closing Date:
(a) The Company has filed with the Securities and Exchange
Commission
(the "COMMISSION") a registration statement on Form SB-2
(Registration No.
333-122768), and amendments thereto, and related preliminary
prospectuses for
the registration under the Securities Act of 1933, as amended (the
"SECURITIES
ACT"), of the Shares, which registration statement, as so amended
(including
post-effective amendments, if any), has been declared effective by
the
Commission and copies of which have heretofore been delivered to
the
Underwriters. Promptly after execution and delivery of this
Agreement, the
Company will prepare and file a prospectus in accordance with the
provisions of
Rule 430A ("RULE 430A") of the rules and regulations of the
Commission (the
"RULES AND REGULATIONS") and paragraph (b) of Rule 424 ("RULE
424(b)") of the
Regulations. The information included in such prospectus that was
omitted from
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Maxim Group LLC
October 18, 2006
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such registration statement at the time it became effective but
that is deemed
to be part of such registration statement at the time it became
effective
pursuant to paragraph (b) of Rule 430A is referred to as "RULE
430A
INFORMATION." Each prospectus used before such registration
statement became
effective, and any prospectus that omitted the Rule 430A
Information that was
used after such effectiveness and prior to the execution and
delivery of this
Agreement, is referred to herein as a "PRELIMINARY PROSPECTUS."
Such
registration statement, including the amendments thereto, the
exhibits and any
schedules thereto, at the time it became effective, and including
the Rule 430A
Information, is herein called the "REGISTRATION STATEMENT." The
Preliminary
Prospectus dated October 13, 2006, that was included in the
Registration
Statement at the Time of Sale is referred to herein as the "SALE
PRELIMINARY
PROSPECTUS", except that if any revised prospectus or prospectus
supplement
shall be provided to the Underwriters by the Company for use in
connection with
the Offering which differs from the Sale Preliminary Prospectus
(whether or not
such revised prospectus or prospectus supplement is required to be
filed by the
Company pursuant to Rule 424(b)), the term "Prospectus" shall also
refer to such
revised prospectus or prospectus supplement, as the case may be,
from and after
the time it is first provided to the Underwriters for such use. For
purposes of
this Agreement and the Securities Act, "TIME OF SALE", means 4:30
p.m., New York
City time, on the date of this Agreement. The final prospectus in
the form first
furnished to the Underwriters for use in connection with the
offering of the
Securities is referred to herein as the "PROSPECTUS." If the
Company has filed
or is required pursuant to the terms hereof to file a registration
statement
pursuant to Rule 462(b) under the Securities Act registering
additional shares
of Common Stock (a "RULE 462(B) REGISTRATION STATEMENT"), then,
unless otherwise
specified, any reference herein to the term "Registration
Statement" shall be
deemed to include such Rule 462(b) Registration Statement. Other
than a Rule
462(b) Registration Statement, which, if filed, becomes effective
upon filing,
no other document with respect to the Registration Statement has
heretofore been
filed with the Commission. All of the Shares have been registered
under the
Securities Act pursuant to the Registration Statement or, if any
Rule 462(b)
Registration Statement is filed, will be duly registered under the
Securities
Act with the filing of such Rule 462(b) Registration Statement.
Based on
communications from the Commission, no stop order suspending the
effectiveness
of either the Registration Statement or the Rule 462(b)
Registration Statement,
if any, has been issued and, to the Company's knowledge, no
proceeding for that
purpose has been initiated or threatened by the Commission. Any
reference herein
to the Registration Statement, any Preliminary Prospectus, the Sale
Preliminary
Prospectus or the Prospectus shall be deemed to refer to and
include the
exhibits incorporated by reference therein pursuant to the Rules
and Regulations
on or before the effective date of the Registration Statement, the
date of such
Preliminary Prospectus, the Sale Preliminary Prospectus or the date
of the
Prospectus, as the case may be. Any reference herein to the terms
"amend",
"amendment" or "supplement" with respect to the Registration
Statement, any
Preliminary Prospectus or the Prospectus shall be deemed to refer
to and
include: (i) the filing of any document under the Securities
Exchange Act of
1934, as amended, and together with the Rules and Regulations
promulgated
thereunder (the "EXCHANGE ACT") after the effective date of the
Registration
Statement, the date of such Preliminary Prospectus, the Sale
Preliminary
Prospectus or the date of the Prospectus, as the case may be, which
is
incorporated therein by reference, and (ii) any such document so
filed. All
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Maxim Group LLC
October 18, 2006
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references in this Agreement to the Registration Statement, the
Rule 462(b)
Registration Statement, a Preliminary Prospectus, the Sale
Preliminary
Prospectus and the Prospectus, or any amendments or supplements to
any of the
foregoing shall be deemed to include any copy thereof filed with
the Commission
pursuant to its Electronic Data Gathering, Analysis and Retrieval
System
("EDGAR"). The Sale Preliminary Prospectus and the Prospectus
delivered to the
Underwriters for use in connection with the Offering were or will
be identical
to the electronically transmitted copies thereof filed with the
Commission
pursuant to EDGAR, except to the extent permitted by Regulation
S-T. If,
subsequent to the date of this Agreement, the Company or the
Representative
determine that, at the Time of Sale, the Sale Preliminary
Prospectus included an
untrue statement of a material fact or omitted a statement of
material fact
necessary to make the statements therein, in the light of the
circumstances
under which they were made, not misleading and have agreed to
provide an
opportunity to purchasers of the Firm Units to terminate their old
purchase
contracts and enter into new purchase contracts, then the Sale
Preliminary
Prospectus will be deemed to include any additional information
available to
purchasers at the time of entry into the first such new purchase
contract.
(b) At the time of the effectiveness of the Registration Statement
or
any Rule 462(b) Registration Statement or the effectiveness of
any
post-effective amendment to the Registration Statement, when the
Prospectus is
first filed with the Commission pursuant to Rule 424(b), when any
supplement to
or amendment of the Prospectus is filed with the Commission, when
any document
filed under the Exchange Act was or is filed and at the Closing
Date and the
Additional Closing Date (as hereinafter respectively defined), if
any, the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus and
any amendments thereof and supplements or exhibits thereto complied
or will
comply in all material respects with the applicable provisions of
the Securities
Act, the Exchange Act and the Rules and Regulations, and did not
and will not
contain an untrue statement of a material fact and did not and will
not omit to
state any material fact required to be stated therein or necessary
in order to
make the statements therein: (i) in the case of the Registration
Statement, not
misleading, and (ii) in the case of the Sale Preliminary Prospectus
or the
Prospectus in light of the circumstances under which they were
made, not
misleading. When any Preliminary Prospectus (including the Sale
Preliminary
Prospectus) was first filed with the Commission (whether filed as
part of the
registration statement for the registration of the Shares or any
amendment
thereto or pursuant to Rule 424(a) under the Securities Act), and
when any
amendment thereof or supplement thereto was first filed with the
Commission,
such Preliminary Prospectus and any amendments thereof and
supplements thereto
complied in all material respects with the applicable provisions of
the
Securities Act, the Exchange Act and the Rules and Regulations and
did not
contain an untrue statement of a material fact and did not omit to
state any
material fact required to be stated therein or necessary in order
to make the
statements therein, in light of the circumstances under which they
were made,
not misleading. No representation and warranty is made in this
subsection (b),
however, with respect to any information contained in or omitted
from the
Registration Statement or the Prospectus or any related Preliminary
Prospectus
or any amendment thereof or supplement thereto in reliance upon and
in
conformity with information furnished in writing to the Company by
or on behalf
of any Underwriter through the Representative specifically for use
therein. The
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Maxim Group LLC
October 18, 2006
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parties acknowledge and agree that such information provided by or
on behalf of
any Underwriter consists solely of the names of the Underwriters
appearing in
the "Underwriting" section of the Prospectus and the contents of
paragraphs 7,
14, 17, 20, 21 and 24 through 34 of the "Underwriting" section of
the Prospectus
(the "UNDERWRITERS' INFORMATION").
(c) The Company has filed with the Commission a Form 8-A (File
Number
001-33088) providing for the registration under the Exchange Act of
the Common
Stock. The registration of the Common Stock under the Exchange Act
has been
declared effective by the Commission on the date hereof.
(d) The documents, exhibits or other materials incorporated or
deemed
to be incorporated by reference in the Sale Preliminary Prospectus
or the
Prospectus, at the time they were or hereafter are filed with the
Commission,
complied and will comply in all material respects with the
requirements of the
Securities Act, the Exchange Act and the Rules and Regulations,
and, when read
together with the other information in the Sale Preliminary
Prospectus or the
Prospectus, do not contain an untrue statement of a material fact
or omit to
state a material fact required to be stated therein or necessary to
make the
statements therein, in the light of the circumstances under which
they were
made, not misleading. There are no contracts or other documents
(including,
without limitation, any voting agreement), which are required to be
described in
the Registration Statement, the Sale Preliminary Prospectus and the
Prospectus
or filed as exhibits to the Registration Statement by the
Securities Act, the
Exchange Act or the Rules and Regulations and which have not been
so described,
filed or incorporated by reference.
(e) Raich Ende Malter & Co. LLP ("REM"), whose reports relating
to the
Company are included in the Registration Statement, are independent
public
accountants as required by the Securities Act, the Exchange Act,
the Rules and
Regulations and the rules and regulations promulgated by the Public
Company
Accounting Oversight Board (the "PCAOB"). REM is duly registered
and in good
standing with the PCAOB. REM has not, during the periods covered by
the
financial statements included in the Registration Statement, the
Preliminary
Prospectus and the Prospectus, provided to the Company any
non-audit services,
as such term is used in Section 10A(g) of the Exchange Act.
(f) The Shares have been authorized for listing on the American
Stock
Exchange ("AMEX") and, to the Company's knowledge, no proceedings
have been
instituted or threatened which would effect, and no event or
circumstance has
occurred which is reasonably likely to effect, the listing of the
Shares on the
AMEX.
(g) The Company has no direct or indirect subsidiaries and owns
no
equity interest in any other foreign or domestic individual,
corporation, trust,
general or limited partnership, joint venture, limited liability
company or
other entity (each, a "PERSON").
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Maxim Group LLC
October 18, 2006
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(h) Subsequent to the respective dates as of which information
is
presented in the Registration Statement, the Sale Preliminary
Prospectus and the
Prospectus, and except as disclosed in the Registration Statement,
the Sale
Preliminary Prospectus and the Prospectus: (i) the Company has not
declared,
paid or made any dividends or other distributions of any kind on or
in respect
of its capital stock, and (ii) there has been no material adverse
change (or any
development which has a high probability of involving a material
adverse change
in the future), whether or not arising from transactions in the
ordinary course
of business, in or affecting: (A) the business, condition
(financial or
otherwise), results of operations, shareholders' equity, properties
or prospects
(as such prospects are disclosed or described in the Sale
Preliminary Prospectus
and the Prospectus) of the Company; (B) the long-term debt or
capital stock of
the Company; or (C) the Offering or consummation of any of the
other
transactions contemplated by this Agreement, the Registration
Statement or the
Prospectus (a "MATERIAL ADVERSE CHANGE"). Since the date of the
latest balance
sheet presented in the Registration Statement, the Sale Preliminary
Prospectus
and the Prospectus, the Company has not incurred or undertaken any
liabilities
or obligations, whether direct or indirect, liquidated or
contingent, matured or
unmatured, or entered into any transactions, including any
acquisition or
disposition of any business or asset, which are material to the
Company, except
for liabilities, obligations and transactions which are disclosed
in the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus.
(i) As of the dates indicated in the Sale Preliminary Prospectus
and
the Prospectus, the authorized, issued and outstanding shares of
capital stock
of the Company were as set forth therein in the column headed
"Actual" under the
section thereof captioned "Capitalization" and, after giving effect
to the
Offering and the other transactions contemplated by this Agreement
and the
Registration Statement, will be as set forth in the column headed
"As Adjusted"
in such section. All of the issued and outstanding shares of
capital stock of
the Company are fully paid and non-assessable (and those shares of
Common Stock
issuable upon conversion of the Company's notes as described in the
Registration
Statement and the Prospectus, upon conversion thereof as described
in the
Registration Statement, will be fully paid and non-assessable) and
have been
duly and validly authorized and issued, in compliance with all
applicable state
and federal securities laws, rules and regulations and not in
violation of or
subject to any preemptive or similar right that does or will
entitle any Person
(as defined below), upon the issuance or sale of any security, to
acquire any
Relevant Security from the Company. As used herein, the term
"RELEVANT SECURITY"
means any Common Stock or other security of the Company that is
convertible
into, or exercisable or exchangeable for Common Stock or equity
securities, or
that holds the right to acquire any Common Stock or equity
securities of the
Company or any other such Relevant Security, except for such rights
as may have
been fully satisfied or waived prior to the effectiveness of the
Registration
Statement.
(j) The Shares have been duly and validly authorized and, when
issued,
delivered and paid for in accordance with this Agreement and as
described in the
Sale Preliminary Prospectus and the Prospectus on each of the
Closing Date and
the Additional Closing Date, as applicable, will be duly and
validly issued,
fully paid and non-assessable, will have been issued in compliance
with all
applicable state and federal laws, rules and regulations and will
not have been
issued in violation of or subject to any preemptive or similar
right that does
or will entitle any Person to acquire any Relevant Security from
the Company
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Maxim Group LLC
October 18, 2006
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upon issuance or sale of Shares in the Offering. The shares of
Common Stock
representing the Shares conform to the descriptions thereof
contained in the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus.
Except as disclosed in the Registration Statement, the Sale
Preliminary
Prospectus and the Prospectus, the Company has no outstanding
warrants, options
to purchase, or any preemptive rights or other rights to subscribe
for or to
purchase, or any contracts or commitments to issue or sell, any
Relevant
Security.
(k) Except as disclosed in the Registration Statement, the Sale
Preliminary Prospectus and the Prospectus, no director or officer
of the Company
who will be acting as such following the Closing as described in
the Sale
Preliminary Prospectus or the Prospectus holds any direct equity,
debt or other
pecuniary interest in any Person with whom the Company does
business or is in
privity of contract with, other than, in each case, indirectly
through the
ownership by such individuals of shares of Common Stock.
(l) The Company has been duly incorporated, and validly exists as
a
corporation in good standing under the laws of the State of New
Jersey. The
Company has all requisite power and authority to carry on its
business as it is
currently being conducted and as described in the Sale Preliminary
Prospectus
and the Prospectus, and to own, lease and operate its properties.
The Company is
duly qualified to do business and is in good standing as a foreign
corporation
in each jurisdiction in which the character or location of its
properties
(owned, leased or licensed) or the nature or conduct of its
business makes such
qualification necessary, except, in each case, for those failures
to be so
qualified or in good standing which (individually and in the
aggregate) could
not reasonably be expected to have a material adverse effect on:
(i) the
business, condition (financial or otherwise), results of
operations,
shareholders' equity, properties or prospects (as such prospects
are disclosed
or described in the Sale Preliminary Prospectus and the Prospectus)
of the
Company; (ii) the long-term debt or capital stock of the Company;
or (iii) the
Offering or consummation of any of the other transactions
contemplated by this
Agreement, the Registration Statement or the Prospectus (any such
effect being a
"MATERIAL ADVERSE EFFECT").
(m) The Company is not: (i) in violation of its certificate of
incorporation, by-laws or other organizational documents
(including
shareholders', voting or similar agreements), (ii) in default
under, and no
event has occurred which, with notice or lapse of time or both,
would constitute
a default under or result in the creation or imposition of any
lien, charge,
mortgage, pledge, security interest, claim, equity, trust or other
encumbrance,
preferential arrangement, defect or restriction of any kind
whatsoever ("LIEN")
upon any of its property or assets pursuant to, any indenture,
mortgage, deed of
trust, loan agreement or other agreement or instrument to which it
is a party or
by which it is bound or to which any of its property or assets is
subject or
(iii) is in violation in any respect of any law, rule, regulation,
ordinance,
directive, judgment, decree or order of any judicial, regulatory or
other legal
or governmental agency or body, foreign or domestic, except (in the
case of
clause (ii) above) for any Lien disclosed in the Registration
Statement, the
Sale Preliminary Prospectus and the Prospectus and except, in the
case of each
of clauses (ii) and (iii), for any default, violation or event that
would not,
individually or in the aggregate, have or reasonably be expected to
have a
Material Adverse Effect.
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Maxim Group LLC
October 18, 2006
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(n) The Company has full right, power and authority to execute
and
deliver this Agreement and all other agreements, documents,
certificates and
instruments required to be delivered pursuant to this Agreement
(collectively,
the "TRANSACTION DOCUMENTS") and to perform its obligations
hereunder and
thereunder and to consummate each of the transactions contemplated
by each of
the Transaction Documents. The Company has duly and validly
authorized each of
the Transaction Documents and each of the transactions contemplated
by the
Transaction Documents. Each of the Transaction Documents have been
or will be
duly and validly executed and delivered by the Company and
constitutes the
legal, valid and binding obligation of the Company and is
enforceable against
the Company in accordance with its terms, except as enforceability
may be
limited by applicable bankruptcy, insolvency, reorganization,
moratorium or
similar laws affecting creditors' rights generally and except as
enforceability
may be subject to general principles of equity (regardless of
whether such
enforceability is considered in a proceeding in equity or at
law).
(o) The execution, delivery, and performance of the Transaction
Documents and the consummation of the transactions contemplated
thereby do not
and will not: (i) conflict with, require consent under or result in
a breach of
any of the terms and provisions of, or constitute a default (or an
event which
with notice or lapse of time, or both, would constitute a default)
under, or
result in the creation or imposition of any Lien upon any property
or assets of
the Company pursuant to any indenture, mortgage, deed of trust,
loan agreement
or other agreement, instrument, franchise, license or permit to
which the
Company or its "affiliates" (as such term is defined in Rule 144
under the
Securities Act, "AFFILIATES") is a party or by which the Company or
its
properties, operations or assets may be bound or (ii) violate or
conflict with
any provision of the certificate of incorporation, by-laws or
other
organizational documents of the Company, or (iii) violate or
conflict with any
law, rule, regulation, ordinance, directive, judgment, decree or
order of any
judicial, regulatory or other legal or governmental agency or body,
domestic or
foreign, except, in the case of each of clauses (i) and (iii), for
any default,
violation or event that would not, individually or in the
aggregate, have or
reasonably be expected to have a Material Adverse Effect.
(p) The Company has all material consents, approvals,
authorizations,
orders, registrations, qualifications, licenses, filings and
permits of, with
and from all judicial, regulatory and other legal or governmental
agencies and
bodies and all third parties, foreign and domestic (collectively,
the
"CONSENTS"), to own, lease and operate its properties and conduct
its business
as it is now being conducted and as disclosed in the Registration
Statement, the
Sale Preliminary Prospectus and the Prospectus, and each such
Consent is valid
and in full force and effect. The Company has not received notice
of any
investigation or proceedings which results in or, if decided
adversely to the
Company, could reasonably be expected to result in, the revocation
of any
Consent or reasonably be expected to have a Material Adverse
Effect. No Consent
contains a materially burdensome restriction not adequately
disclosed in the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus.
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Maxim Group LLC
October 18, 2006
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(q) The Company is in compliance with all applicable laws,
rules,
regulations, ordinances, directives, judgments, decrees and orders,
foreign and
domestic, including those relating to transactions with Affiliates,
the
non-compliance with which would not have a Material Adverse
Effect.
(r) [Intentionally Omitted]
(s) No Consent of, with or from any judicial, regulatory or other
legal
or governmental agency or body or any third party, foreign or
domestic, is
required for the execution, delivery and performance of this
Agreement or
consummation of each of the transactions contemplated by this
Agreement,
including the issuance, sale and delivery of the Shares to be
issued, sold and
delivered hereunder and thereunder, except: (i) the registration
under the
Securities Act of the Shares and the approval for listing of the
Shares on AMEX,
each of which has become effective and (ii) such Consents as may be
required
under state securities or blue sky laws, the National Association
of Securities
Dealers, Inc. (the "NASD") or NASD Regulation, Inc. in connection
with the
purchase and distribution of the Shares by the Underwriters.
(t)
Except as disclosed in the Registration Statement, the Sale
Preliminary Prospectus and the Prospectus, there is no judicial,
regulatory,
arbitral or other legal or governmental proceeding or other
litigation or
arbitration, domestic or foreign, pending to which the Company is a
party or of
which any property, operations or assets of the Company is the
subject which,
either individually or in the aggregate, if determined adversely to
the Company,
could reasonably be expected to have a Material Adverse Effect. To
the Company's
knowledge, no such proceeding, litigation or arbitration is
threatened or
contemplated. The defense of all pending proceedings, litigation
and arbitration
against or involving the Company is not reasonably expected by the
Company to
have a Material Adverse Effect.
(u) The financial statements, including the notes thereto, and
the
supporting schedules included in the Registration Statement, the
Sale
Preliminary Prospectus and the Prospectus present fairly the
financial position
as of the dates indicated and the cash flows and results of
operations for the
periods specified of the Company. Except as otherwise stated in the
Registration
Statement, the Sale Preliminary Prospectus and the Prospectus, said
financial
statements have been prepared in conformity with United States
generally
accepted accounting principles applied on a consistent basis
throughout the
periods involved, subject, in the case of unaudited financial
statements, to the
absence of footnotes and year end adjustments required by
accounting principles
generally accepted in the United States of America for complete
financial
statements. The supporting schedules included in the Registration
Statement and
the Prospectus present fairly the information required to be stated
therein. No
other financial statements or supporting schedules are required to
be included
or incorporated by reference in the Registration Statement. The
other financial
and statistical information included in the Registration Statement,
the Sale
Preliminary Prospectus and the Prospectus present fairly the
information
included therein and have been prepared on a basis consistent with
that of the
financial statements that are included in the Registration
Statement, the Sale
Preliminary Prospectus and the Prospectus and the books and records
of the
respective entities presented therein.
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Maxim Group LLC
October 18, 2006
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(v) There are no pro forma or as adjusted financial statements
which
are required to be included in the Registration Statement, the Sale
Preliminary
Prospectus and the Prospectus in accordance with Regulation S-X
under the
Securities Act which have not been included as so required. The pro
forma and/or
as adjusted financial information included in the Registration
Statement, the
Sale Preliminary Prospectus and the Prospectus has been properly
compiled and
prepared in accordance with the applicable requirements of the
Securities Act
and the Rules and Regulations and include all adjustments necessary
to present
fairly in accordance with generally accepted accounting principles
the pro forma
and as adjusted financial position of the respective entity or
entities
presented therein at the respective dates indicated and their cash
flows and the
results of operations for the respective periods specified. The
assumptions used
in preparing the pro forma and as adjusted financial information
included in the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus
provide a reasonable basis for presenting the significant effects
directly
attributable to the transactions or events described therein. The
related pro
forma and pro forma as adjusted adjustments give appropriate effect
to those
assumptions; and the pro forma and pro forma as adjusted financial
information
reflect the proper application of those adjustments to the
corresponding
historical financial statement amounts.
(w) The statistical, industry-related and market-related data
included
in the Registration Statement, the Sale Preliminary Prospectus and
the
Prospectus are based on or derived from sources which the Company
reasonably and
in good faith believes are reliable and accurate, and such data
agree with the
sources from which they are derived.
(x) Except as disclosed in the Registration Statement, the Sale
Preliminary Prospectus and the Prospectus, the Company maintains a
system of
internal accounting and other controls sufficient to provide
reasonable
assurances that: (i) transactions are executed in accordance with
management's
general or specific authorizations, (ii) transactions are recorded
as necessary
to permit preparation of financial statements in conformity with
United States
generally accepted accounting principles and to maintain
accountability for
assets, (iii) access to assets is permitted only in accordance with
management's
general or specific authorization, and (iv) the recorded accounting
for assets
is compared with existing assets at reasonable intervals and
appropriate action
is taken with respect to any differences.
(y) The Company's Board of Directors has validly appointed an
audit
committee and nominating committee whose composition satisfies the
requirements
of the rules and regulations of the AMEX and the Company's Board of
Directors
and/or audit committee and the nominating committee has each
adopted a charter
that satisfies the requirements of AMEX. Neither the Company's
Board of
Directors nor the audit committee thereof has been informed, nor is
any director
of the Company aware, of: (i) except as disclosed in the
Registration Statement,
the Sale Preliminary Prospectus and the Prospectus, any significant
deficiencies
and material weaknesses in the design or operation of internal
control over
financial reporting which are reasonably likely to adversely affect
the
Company's ability to record, process, summarize and report
financial
information; or (ii) any fraud, whether or not material, that
involves
management or other employees who have a significant role in the
Company's
internal control over financial reporting.
<PAGE>
Maxim Group LLC
October 18, 2006
Page 10 of 39
(z) The Company is in material compliance with the provisions of
the
Sarbanes-Oxley Act of 2002, as amended ("SARB-OX"), applicable to
the Company,
and the rules and regulations promulgated thereunder and related or
similar
rules and regulations promulgated by AMEX or any other governmental
or self
regulatory entity or agency, except for violations which, singly or
in the
aggregate, would not have a Material Adverse Effect. Without
limiting the
generality of the foregoing, as of the effective date of the
Registration
Statement: (i) all members of the Company's Board of Directors who
are required
to be "independent" (as that term is defined under applicable laws,
rules and
regulations), including, without limitation, all members of the
audit committee
of the Company's Board of Directors, meet the qualifications of
independence as
set forth under applicable laws, rules and regulations and (ii) the
audit
committee of the Company's Board of Directors has at least one
member who is an
"audit committee financial expert" (as that term is defined under
applicable
laws, rules and regulations).
(aa) No relationship, direct or indirect, exists between or among
any
of the Company or any Affiliate of the Company, on the one hand,
and any
director, officer, shareholder, customer or supplier of the Company
or any
Affiliate of the Company, on the other hand, which is required by
the Securities
Act, the Exchange Act or the Rules and Regulations to be described
in the
Registration Statement, the Sale Preliminary Prospectus or the
Prospectus which
is not so described as required. Except as disclosed in the
Registration
Statement, the Sale Preliminary Prospectus and the Prospectus,
there are no
outstanding loans, advances (except normal advances for business
expenses in the
ordinary course of business) or guarantees of indebtedness by the
Company to or
for the benefit of any of the officers or directors of the Company
or any of
their respective family members, except as disclosed in the
Registration
Statement, the Sale Preliminary Prospectus and the Prospectus. The
Company has
not, in violation of Sarb-Ox, directly or indirectly, including
through any
Affiliate of the Company (other than as permitted under the Sarb-Ox
for
depositary institutions), extended or maintained credit, arranged
for the
extension of credit, or renewed an extension of credit, in the form
of a
personal loan to or for any director or executive officer of the
Company.
(bb) (i) Except as described in the Registration Statement, the
Sale
Preliminary Prospectus and the Prospectus, there are no claims,
payments,
arrangements, agreements or understandings relating to the payment
of a
finder's, consulting or origination fee by the Company with respect
to the sale
of the Shares hereunder or any other arrangements, agreements or
understandings
of the Company or, to the Company's knowledge, the Company's
officers, directors
and employees that may affect the Underwriters' compensation, as
determined by
the NASD.
(ii) Except as previously disclosed to the
Representative in writing, no officer, director, or beneficial
owner of any
class of the Company's securities (whether debt or equity,
registered or
unregistered, regardless of the time acquired or the source from
which derived)
or any other Affiliate is a member or a person associated, or
affiliated with a
member of the NASD.
<PAGE>
Maxim Group LLC
October 18, 2006
Page 11 of 39
(iii) No proceeds from the sale of the Shares
(excluding underwriting compensation) will be paid to any NASD
member, or any
persons associated or affiliated with a member of the NASD, except
as
specifically contemplated herein.
(iv) Except as previously disclosed to the
Representative in writing, no person to whom securities of the
Company have been
privately issued within the 180-day period prior to the initial
filing date of
the Registration Statement has any relationship or affiliation or
association
with any member of the NASD.
(cc) (i) The Company owns or possess the right to use
sufficient
trademarks, trade names, patent rights, copyrights, domain names,
licenses,
approvals, trade secrets, inventions, technology, know-how and
other similar
rights (collectively, "INTELLECTUAL PROPERTY RIGHTS") as are
necessary or
material: (A) to conduct its business as now conducted and (B) in
connection
with the commercialization of the medical technologies described in
the
Registration Statement, the Sale Preliminary Prospectus and
Prospectus as being
under development by the Company.
(ii) Except as set forth in the Registration
Statement, the Sale Preliminary Prospectus and Prospectus: (A)
there is no
pending or, to the Company's knowledge, threatened action, suit,
proceeding, or
claim by others challenging the Company's rights in or to any
Intellectual
Property Rights, and the Company is unaware of any facts which
would form a
reasonable basis for any such claim; (B) there is no pending or, to
the
Company's knowledge, threatened action, suit, proceeding, or claim
by others
that the Company infringes, misappropriates, or otherwise violates
any
Intellectual Property Rights of others, and the Company is unaware
of any facts
which would form a reasonable basis for any such claim; (C) there
is no pending
or, to the Company's knowledge, threatened action, suit,
proceeding, or claim by
others challenging the validity or scope of any such Intellectual
Property
Rights owned by the Company and the Company is unaware of any facts
which would
form a reasonable basis for any such claim; (D) the operation of
Company's
business as now conducted and in connection with the development
and
commercialization of the medical technology described in the
Registration
Statement, the Sale Preliminary Prospectus and Prospectus, as being
under
development by the Company (either independently or in
collaboration with third
parties), does not infringe any claim of any patent or published
patent
application; (E) there is no prior art of which the Company is
aware that may
render any patent owned or licensed by the Company invalid or any
patent
application owned or licensed by the Company unpatentable which has
not been
disclosed to the applicable government patent office; and (F) the
patents,
trademarks, and copyrights granted or issued to the Company have
been duly
maintained and are in full force and in effect, and none of such
patents,
trademarks and copyrights have been adjudged invalid or
unenforceable in whole
or in part. The Company is not a party to or bound by any options,
licenses or
agreements with respect to the Intellectual Property Rights of any
other person
or entity that are required to be set forth in the Registration
Statement, the
Sale Preliminary Prospectus and Prospectus and are not described
therein in all
material respects.
<PAGE>
Maxim Group LLC
October 18, 2006
Page 12 of 39
(ii) The Company has duly and properly filed or
caused to be filed with the U. S. Patent and Trademark Office (the
"PTO") and
applicable foreign and international patent authorities all patent
applications
owned by the Company (the "COMPANY PATENT APPLICATIONS"). The
Company has
complied in all material repsects with the PTO's duty of candor and
disclosure
for the Company Patent Applications and has made no material
misrepresentation
in the Company Patent Applications. The Company Patent Applications
disclose
patentable subject matters, and the Company has not been notified
of any
inventorship challenges nor has any interference been declared or
provoked nor
is any material fact known by the Company that would preclude the
issuance of
patents with respect to the Company Patent Applications or would
render such
patents invalid or unenforceable. No third party possesses rights
to the
Company's Intellectual Property Rights that, if exercised, could
enable such
party to develop products competitive to those the Company intends
to develop as
described in the Sale Preliminary Prospectus and the
Prospectus.
(iii) Other than as disclosed in the Registration
Statement, the Sale Preliminary Prospectus and Prospectus, there
are no
rulemaking or similar proceedings before the U.S. Food and Drug
Administration
("FDA") or PTO which affect or involve the Company or any of the
processes or
medical technologies that the Company has developed, is developing
or proposes
to develop or uses or proposes to use which, if the subject of an
action
unfavorable to the Company, would result in a Material Adverse
Change.
(iv) The Company has obtained legally binding written
agreements from all employees and third parties with whom the
Company has shared
confidential proprietary information: (A) of the Company, or (B)
received from
others which the Company is obligated to treat as confidential,
which agreements
require such employees and third parties to keep such information
confidential.
(dd) Neither the Company nor, to the Company's knowledge, any of
the
Company's directors, officers or employees has violated: (i) the
Bank Secrecy
Act, as amended, (ii) the Money Laundering Control Act of 1986, as
amended,
(iii) the Foreign Corrupt Practices Act, or (iv) the Uniting and
Strengthening
of America by Providing Appropriate Tools Required to Intercept and
Obstruct
Terrorism (USA PATRIOT ACT) Act of 2001, and/or the rules and
regulations
promulgated under any such law, or any successor law, except for
such violations
which, singly or in the aggregate, would not have a Material
Adverse Effect.
(ee) Neither the Company nor any of its Affiliates has, prior to
the
date hereof, made any offer or sale of any securities which are
required to be
"integrated" pursuant to the Securities Act or the Rules and
Regulations with
the offer and sale of the Shares pursuant to the Registration
Statement.
<PAGE>
Maxim Group LLC
October 18, 2006
Page 13 of 39
(ff) Except as disclosed in the Registration Statement, the
Sale
Preliminary Prospectus and the Prospectus, no holder of any
Relevant Security
has any rights to require registration of any Relevant Security as
part or on
account of, or otherwise in connection with, the offer and sale of
the Shares
contemplated hereby, and any such rights so disclosed have either
been fully
complied with by the Company or effectively waived by the holders
thereof, and
any such waivers remain in full force and effect.
(gg) The Company is not and, at all times up to and including
consummation of the transactions contemplated by this Agreement,
and after
giving effect to application of the net proceeds of the Offering,
will not be,
subject to registration as an "investment company" under the
Investment Company
Act of 1940, as amended, and is not and will not be an entity
"controlled" by an
"investment company" within the meaning of such act.
(hh) Except as disclosed in the Registration Statement, the
Sale
Preliminary Prospectus and the Prospectus, there are no contracts,
agreements or
understandings between the Company and any Person that would give
rise to a
valid claim against the Company or any Underwriter for a brokerage
commission,
finder's fee or other like payment in connection with the
transactions
contemplated by this Agreement or any arrangements, agreements,
understandings,
payments or issuance with respect to the Company or any of its
officers,
directors, shareholders, partners, employees or Affiliates that may
affect the
Underwriters' compensation as determined by the NASD.
(ii) The Company owns or leases all such properties as are
necessary to
the conduct of its business as presently operated and as proposed
to be operated
as described in the Registration, the Sale Preliminary Prospectus
and the
Prospectus. The Company has good and marketable title in fee simple
to all real
property and good and marketable title to all personal property
owned by it, in
each case free and clear of all Liens except such as are described
in the
Registration Statement, the Sale Preliminary Prospectus and the
Prospectus or
such as do not (individually or in the aggregate) materially affect
the business
or prospects of the Company. Any real property and buildings held
under lease or
sublease by the Company is held by under valid, subsisting and
enforceable
leases with such exceptions as are not material to, and do not
interfere with,
the use made and proposed to be made of such property and buildings
by the
Company. The Company has not received any notice of any claim
adverse to its
ownership of any real or personal property or of any claim against
the continued
possession of any real property, whether owned or held under lease
or sublease
by the Company.
(jj) The Company maintains insurance of the types and in the
amounts
which are customary for companies engaged in similar businesses,
including, but
not limited to: (i) directors' and officers' insurance (including
insurance
covering the Company, its directors and officers for liabilities or
losses
arising in connection with this Offering, including, without
limitation,
liabilities or losses arising under the Securities Act, the
Exchange Act, the
Rules and Regulations and applicable foreign securities laws), (ii)
insurance
covering real and personal property owned or leased by the Company
against
theft, damage, destruction, acts of vandalism and all other risks
customarily
insured against, (iii) business interruption insurance and (iv)
product
<PAGE>
Maxim Group LLC
October 18, 2006
Page 14 of 39
liability insurance. The Company maintains and will continue to
maintain
insurance (of which the Company is the beneficiary) with at least
$1,500,000 of
coverage of the life of Andre' DiMino for a period of three (3)
years from the
Closing Date with an insurer rated at least AA or better in the
most recent
addition of "Best's Life Reports". There are no claims by the
Company under any
policy or instrument described in this paragraph as to which any
insurance
company is denying liability or defending under a reservation of
rights clause.
All of the insurance policies described in this paragraph are in
full force and
effect. The Company has not been refused any insurance coverage
sought or
applied for, and the Company has no reason to believe that it will
not be able
to renew its existing insurance coverage as and when such coverage
expires or to
obtain similar coverage from similar insurers as may be necessary
to continue
its business at a cost that would not have a Material Adverse
Effect.
(kk) The Company has accurately prepared and timely filed all
federal,
state, foreign and other tax returns that are required to be filed
by it and has
paid or made provision for the payment of all taxes, assessments,
governmental
or other similar charges, including without limitation, all sales
and use taxes
and all taxes which the Company is obligated to withhold from
amounts owing to
employees, creditors and third parties, with respect to the periods
covered by
such tax returns (whether or not such amounts are shown as due on
any tax
return). No deficiency assessment with respect to a proposed
adjustment of the
Company's federal, state, local or foreign taxes is presently in
effect or is
pending or, to the Company's knowledge, threatened. The accruals
and reserves on
the books and records of the Company in respect of tax liabilities
for any
taxable period not finally determined are adequate to meet any
assessments and
related liabilities for any such period and, since the date of the
Company's
most recent audited financial statements, the Company has not
incurred any
material liability for taxes other than in the ordinary course of
its business.
There is no tax lien, whether imposed by any federal, state,
foreign or other
taxing authority, outstanding against the assets, properties or
business of the
Company.
(ll) No labor disturbance by the employees of the Company
currently
exists or is likely to occur.
(mm) The Company has at all times operated its business in
material
compliance with all Environmental Laws, and no material
expenditures are or will
be required in order to comply therewith. The Company has not
received any
notice or communication that relates to or alleges any actual or
potential
violation or failure to comply with any Environmental Laws that
will result in a
Material Adverse Effect. As used herein, the term "ENVIRONMENTAL
LAWS" means all
applicable laws and regulations, including any licensing, permits
or reporting
requirements, and any action by a Federal state or local government
entity
pertaining to the protection of the environment, protection of
public health,
protection of worker health and safety, or the handling of
hazardous materials,
including without limitation, the Clean Air Act, 42 U.S.C. ss.
7401, et seq.,
the Comprehensive Environmental Response, Compensation and
Liability Act of
1980, 42 U.S.C. ss. 9601, et seq., the Federal Water Pollution
Control Act, 33
U.S.C. ss. 1321, et seq., the Hazardous Materials Transportation
Act, 49 U.S.C.
ss. 1801, et seq., the Resource Conservation and Recovery Act, 42
U.S.C. ss.
690-1, et seq., and the Toxic Substances Control Act, 15 U.S.C. ss.
2601, et
seq.
<PAGE>
Maxim Group LLC
October 18, 2006
Page 15 of 39
(nn)
Except as set forth in the Registration Statement, the Sale
Preliminary Prospectus or the Prospectus, the Company is not a
party to an
"employee benefit plan," as defined in Section 3(3) of the Employee
Retirement
Income Security Act of 1974 ("ERISA") which: (i) is subject to any
provision of
ERISA and (ii) is or was at any time maintained, administered or
contributed to
by the Company and covers any employee or former employee of the
Company or any
ERISA Affiliate (as defined hereafter). These plans are referred to
collectively
herein as the "EMPLOYEE PLANS." For purposes of this paragraph,
"ERISA
AFFILIATE" of any person or entity means any other person or entity
which,
together with that person or entity, could be treated as a single
employer under
Section 414(m) of the Internal Revenue Code of 1986, as amended
(the "CODE"), or
is an "affiliate," whether or not incorporated, as defined in
Section 407(d)(7)
of ERISA, of the person or entity.
(oo) The Representative has been provided with written evidence of
each
employment, severance or other similar arrangement or policy and
each material
plan or arrangement providing for insurance coverage (including any
self-insured
arrangements), workers' compensation, disability benefits,
severance benefits,
supplemental unemployment benefits, vacation benefits, retirement
benefits or
for deferred compensation, profit-sharing, bonuses, stock options,
stock
appreciation or other forms of incentive compensation, or
post-retirement
insurance, compensation or benefits which: (i) is not an Employee
Plan, (ii) is
entered into, maintained or contributed to, as the case may be, by
the Company
or any of their respective ERISA Affiliates, and (iii) covers any
employee or
former employee of the Company or any of their respective ERISA
Affiliates.
These contracts, plans and arrangements are referred to
collectively in this
Agreement as the "BENEFIT ARRANGEMENTS." Each Benefit Arrangement
has been
maintained in substantial compliance with its terms and with
requirements
prescribed by any and all statutes, orders, rules and regulations
that are
applicable to that Benefit Arrangement.
(pp) Except as set forth in the Registration Statement, the
Sale
Preliminary Prospectus or the Prospectus, there is no liability in
respect of
post-retirement health and medical benefits for retired employees
of the Company
or any of their respective ERISA Affiliates other than medical
benefits required
to be continued under applicable law, determined using assumptions
that are
reasonable in the aggregate, over the fair market value of any
fund, reserve or
other assets segregated for the purpose of satisfying such
liability (including
f