Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))
o
Definitive Proxy Statement
o
Definitive Additional Materials
o
Soliciting Material Under Rule 14a-12
ISOTIS, INC.
(Name of Registrant as Specified in its Charter)
Payment of Filing Fee (Check the appropriate box):
o
No fee required.
þ
Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11
(1)
Title of each class of securities to which transaction applies:
Common Stock, par value $0.0001 per share, of IsoTis, Inc. (the “Common Stock”)
(2)
Aggregate number of securities to which transaction applies:
7,099,343
Shares of Common Stock
797,810
Shares of Common Stock issuable upon exercise of outstanding stock options
7,897,153
Total Shares of Common Stock
(3)
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):
The proposed maximum aggregate value of the transaction for purposes of calculating the filing fee is $51,489,672.
The total consideration for the filing fee was determined by multiplying 0.0000307 by the sum of:
(i)
the product of 7,099,343 shares of IsoTis, Inc. Common Stock outstanding as of August 6, 2007, and the merger consideration of $7.25 per share in cash, which is $51,470,237; and
(ii)
the product of 23,000 shares of IsoTis, Inc. Common Stock issuable upon the exercise of in-the-money outstanding options to purchase IsoTis Common Stock as of August 6, 2007, and $7.25 per share in cash in consideration for the cancellation of such options (which is the excess of the merger consideration of $7.25 over the weighted average exercise price of such options), which is $19,435.
(4)
Proposed maximum aggregate value of transaction: $51,489,672
(5)
Total fee paid: $1,580.73
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.
On behalf of the board of directors of IsoTis, Inc., I cordially
invite you to attend a special meeting of stockholders to be
held
at
on ,
2007
at
local time.
At the special meeting, you will be asked to consider and vote
upon (i) a proposal to adopt the Agreement and Plan of
Merger, dated as of August 6, 2007, among IsoTis, Integra
LifeSciences Holdings Corporation, referred to as Integra, and
Ice MergerCorp, Inc., a wholly-owned subsidiary of Integra, and
approve the merger contemplated by the merger agreement, and
(ii) a proposal to approve the adjournment of the special
meeting, if necessary, to solicit additional proxies if there
are insufficient votes at the time of the special meeting to
adopt the merger agreement and approve the merger. If the merger
is consummated, we will become a subsidiary of Integra and you
will be entitled to receive $7.25 in cash, without interest, for
each share of our common stock that you own.
After careful consideration of the terms of the merger agreement
and the transactions contemplated by the merger agreement, as
well as the items set forth on pages 18 through 23 under
“The Merger — Background of the Merger” and
on pages 24 through 26 under “The Merger — Our
Reasons for the Merger,” our board of directors unanimously
approved the merger agreement and determined that the merger and
the other transactions contemplated by the merger agreement are
advisable and in the best interests of IsoTis and its
stockholders. As discussed under “The Merger —
Background of the Merger” and “The Merger —
Our Reasons for the Merger,” based on its deliberations and
consultations with its advisors, our board of directors
concluded that the only reasonably likely alternative to
entering into the merger agreement with Integra (which our board
of directors concluded offered our stockholders fair value for
their shares) would be to seek bankruptcy protection. Our
board of directors unanimously recommends that you vote
“FOR” the adoption of the merger agreement and
approval of the merger and “FOR” the adjournment of
the special meeting, if necessary, to solicit additional
proxies.
Your vote is very important. We cannot
consummate the merger unless the holders of a simple majority
(i.e., more than 50%) of the outstanding shares of our common
stock vote to adopt the merger agreement and approve the merger.
The obligations of each of Integra and IsoTis to complete the
merger are also subject to the satisfaction or waiver of several
other conditions to the merger. We encourage you to read the
accompanying proxy statement, including the annexes, in its
entirety because it explains the proposed merger, the documents
related to the merger and other related matters.
Whether or not you plan to attend the special meeting, please
take the time to vote by completing and mailing to us the
enclosed proxy card or by granting your proxy electronically
over the Internet or by telephone, as soon as possible. If your
shares are held in an account at a brokerage firm, bank or other
nominee, you should instruct your broker, bank or nominee how to
vote in accordance with the voting instruction form furnished by
your broker, bank or nominee. If you do not vote or do not
instruct your broker, bank or nominee how to vote, it will have
the same effect as voting against the adoption of the merger
agreement.
If you sign, date and send your proxy and do not indicate how
you want to vote, your proxy will be voted “FOR” the
adoption of the merger agreement and “FOR” the
proposal to adjourn the special meeting to solicit additional
proxies, provided that no proxy that is specifically marked
“AGAINST” the proposal to adopt the merger agreement
and approve the merger will be voted in favor of the adjournment
proposal, unless it is specifically marked “FOR” the
adjournment proposal.
I enthusiastically support this transaction and join the other
members of our board of directors in recommending that you vote
“FOR” the adoption of the merger agreement and
approval of the merger.
Neither the Securities and Exchange Commission nor any state
securities regulatory agency has approved or disapproved the
merger, passed upon the merits or fairness of the merger or
passed upon the adequacy or accuracy of the disclosure in the
proxy statement. Any representation to the contrary is a
criminal offense.
This proxy statement is
dated ,
2007, and is first being mailed to stockholders on or
about ,
2007.
NOTICE OF
SPECIAL MEETING OF STOCKHOLDERS
To Be Held
on ,
2007
To the Stockholders of IsoTis, Inc.:
We will hold a special meeting of the stockholders of IsoTis at
on ,
2007 at local time. The purpose of
the special meeting will be:
1. To consider and vote upon a proposal to adopt the
Agreement and Plan of Merger, dated as of August 6, 2007,
among IsoTis, Integra LifeSciences Holdings Corporation,
referred to as Integra, and Ice MergerCorp, Inc., a wholly-owned
subsidiary of Integra, and approve the merger contemplated by
the merger agreement;
2. To approve the adjournment of the special meeting, if
necessary, to solicit additional proxies if there are
insufficient votes at the time of the special meeting to adopt
the merger agreement and approve the merger; and
3. To transact any other business as may properly come
before the special meeting or any adjournment or postponement of
the special meeting.
Only holders of record of our common stock at the close of
business on August 24, 2007, the record date for the
special meeting, may vote at the special meeting. Each share of
our common stock is entitled to one vote on each matter to be
voted upon at the special meeting.
Our board of directors unanimously recommends that you vote
“FOR” the adoption of the merger agreement and
approval of the merger and “FOR” the adjournment of
the special meeting, if necessary, to solicit additional
proxies.
A complete list of our stockholders of record entitled to vote
at the special meeting will be available for ten days prior to
the special meeting at our executive offices and principal place
of business for inspection by stockholders during ordinary
business hours for any purpose germane to the special meeting
and will also be available at the special meeting.
Stockholders of IsoTis who do not vote in favor of the adoption
of the merger agreement are entitled to appraisal rights under
the Delaware General Corporation Law in connection with the
merger if they meet certain conditions. See “TheMerger — Appraisal Rights” in this proxy
statement.
Your vote is very important. Even if you do
not expect to attend the meeting in person, it is important that
your shares be represented.
You may vote by completing and mailing the enclosed proxy card
or by granting your proxy electronically via the Internet or
telephone. If your shares are held in “street name,”
which means shares held of record by a broker, bank or other
nominee, you should check the voting form used by that firm to
determine whether you will be able to submit your proxy by
telephone or over the Internet. Submitting a proxy by mailing
the enclosed proxy card will ensure that your shares are
represented at the special meeting. Please review the
instructions in this proxy statement and the enclosed proxy card
or the information forwarded by your bank, broker or other
holder of record regarding each of these options. If you do
not vote in person, submit the proxy, vote your shares
electronically via the Internet or by telephone, or instruct
your broker on how to vote at the special meeting, the effect
will be the same as a vote against the proposal to adopt the
merger agreement and to approve the transactions contemplated by
the merger agreement, including the merger.
For more information about the merger described above and the
other transactions contemplated by the merger agreement, please
review the accompanying proxy statement and the merger agreement
attached to it as Annex A.
The following questions and answers address briefly some
questions you may have regarding the special meeting and the
proposed merger. These questions and answers may not address all
questions that may be important to you as a stockholder of
IsoTis. Please refer to the more detailed information contained
elsewhere in this proxy statement, the annexes to this proxy
statement and the documents referred to in this proxy statement.
We encourage you to read this proxy statement, including the
annexes, in its entirety because it explains the proposed
merger, the documents related to the merger and other related
matters. In this proxy statement, the terms “the
Company,”“we,”“our,”“ours,” and “us” refer to IsoTis. We refer
to Integra LifeSciences Holdings Corporation as Integra, and Ice
MergerCorp, Inc. as Merger Sub.
Q:
Why am I receiving this proxy statement?
A:
We have entered into a merger agreement with Integra and Merger
Sub. Upon completion of the merger contemplated by the merger
agreement, we will become a wholly-owned subsidiary of Integra
and our common stock will no longer be listed on the NASDAQ
Global Market. A copy of the merger agreement is attached to
this proxy statement as Annex A.
In order to consummate the merger, our stockholders must vote to
adopt the merger agreement and approve the merger. Our board of
directors is providing this proxy statement to give you
information for use in determining how to vote on the proposals
submitted to the stockholders at the special meeting of
stockholders. You should read this proxy statement and the
annexes carefully. The enclosed proxy card and voting
instructions allow you, as our stockholder, to vote your shares
without attending the special meeting.
Your vote is very important. We encourage you to vote as soon as
possible.
Q:
As a stockholder, what will I be entitled to receive in the
merger?
A:
At the effective time of the merger, each share of our common
stock outstanding immediately prior to the effective time of the
merger (including any shares of common stock issued prior to the
effective time upon exercise of stock options), other than
shares held by us, our wholly-owned subsidiaries, Integra or
Merger Sub or by holders who properly exercise appraisal rights
under Delaware law, will be automatically converted into the
right to receive $7.25 in cash, without interest and less any
applicable withholding taxes. Any withheld amounts will be
treated for all purposes as having been paid to the holder of
our common stock in respect of whose shares the withholding was
made.
Q:
When and where is the special meeting?
A:
The special meeting of stockholders will take place
at
on ,
2007, at local time.
Q:
What matters will be voted on at the special meeting?
A:
You will vote on a proposal to adopt the merger agreement and
approve the merger and a proposal to adjourn the special meeting
for the purpose of soliciting additional proxies, if necessary.
Q:
How does our board of directors recommend that I vote?
A:
Our board of directors recommends that you vote “FOR”
the proposal to adopt the merger agreement and approve the
merger and “FOR” the proposal to adjourn the special
meeting for the purpose of soliciting additional proxies, if
necessary.
Q:
Why is our board of directors recommending that I vote
“FOR” the proposal to adopt the merger agreement and
approve the merger?
A:
Our board of directors carefully reviewed and considered the
terms and conditions of the merger agreement and proposed
merger. Based on this review, our board of directors determined
that the merger is our only advisable course of action and in
the best interests of us and our stockholders. In reaching its
decision to adopt the merger agreement and to recommend the
adoption of the merger agreement by our stockholders, our board
of directors consulted with our management, as well as our legal
and financial advisors, and considered the terms of the merger
agreement and the transactions contemplated by the merger
agreement. Our board of directors also considered each of the
items set forth on pages 24 through 26 under “TheMerger — Our Reasons for the Merger.”
What vote of our stockholders is required to adopt the merger
agreement and approve the merger?
A:
Approval of the proposal to adopt the merger agreement and
approve the merger requires the affirmative vote of the holders
of a simple majority (i.e., more than 50%) of the outstanding
shares of our common stock entitled to vote at the special
meeting. Therefore, if you abstain or fail to vote, it will be
the same as voting against the merger agreement and the merger.
Approval of the proposal to adjourn the special meeting for the
purpose of soliciting additional proxies, if necessary, requires
the affirmative vote of the holders of a simple majority (i.e.,
more than 50%) of the shares represented at the meeting.
Q:
How many votes am I entitled to cast for each share of common
stock I own?
A:
For each share of our common stock that you owned on
August 24, 2007, the record date for the special meeting,
you are entitled to cast one vote on each matter voted upon at
the special meeting.
Q:
Is the approval of the stockholders of Integra or its
subsidiaries required to effectuate the merger?
A:
No. Only the approval of Integra as the sole stockholder of
Merger Sub is required to effectuate the merger, which approval
has already been obtained.
Q:
Who can vote or submit a proxy to vote and attend the special
meeting?
A:
All stockholders as of the close of business on August 24,2007, the record date for the special meeting, are entitled to
receive notice of and to attend and vote or submit a proxy to
vote at the special meeting. If you want to attend the special
meeting and your shares are held in an account at a brokerage
firm, bank or other nominee, you will need to bring a copy of
your voting instruction card or brokerage statement reflecting
your stock ownership as of the record date.
Q:
How do I cast my vote?
A:
Before you vote, you should read this proxy statement in its
entirety, including its annexes, and carefully consider how the
merger affects you. If you were a holder of record on
August 24, 2007, you may vote in person at the special
meeting by submitting a proxy for the special meeting or by
voting electronically via the Internet or by telephone by
following the instructions on the enclosed proxy card. You can
submit your proxy by completing, signing, dating and returning
the enclosed proxy card in the accompanying pre-addressed,
postage paid envelope.
If you hold your shares in “street name,” which means
your shares are held of record by a broker, bank or nominee, you
must provide the record holder of your shares with instructions
on how to vote your shares in accordance with the voting
directions provided by your broker, bank or nominee. If you do
not provide your broker, bank or nominee with instructions on
how to vote your shares, it will not be permitted to vote your
shares.
If you sign, date and send your proxy card and do not indicate
how you want to vote, your proxy will be voted “FOR”
the adoption of the merger agreement and approval of the merger
and “FOR” the proposal to adjourn the special meeting
for the purpose of soliciting additional proxies, if necessary,
provided that no proxy that is specifically marked
“AGAINST” the proposal to adopt the merger agreement
and approve the merger will be voted in favor of the adjournment
proposal, unless it is specifically marked “FOR” the
adjournment proposal.
Q:
What will happen if I abstain from voting or fail to vote on
the proposals or fail to instruct my broker to vote on the
proposals?
A:
Abstentions, failure to cast your vote in person, by proxy, or
electronically via the Internet or by telephone, or failure to
give voting instructions to your broker, bank or nominee, have
the same effect as a vote against the proposal to adopt the
merger agreement and approve the merger. Abstentions and failure
to give voting instructions to your broker, bank or nominee will
have the same effect as a vote against the proposal to adjourn
the special meeting for the purpose of soliciting additional
proxies.
What will happen to IsoTis if a simple majority (i.e., more
than 50%) of the stockholders fail to vote in favor of the
merger at the special meeting?
A:
If the merger agreement is not adopted and the merger is not
approved by a simple majority (i.e., more than 50%) of our
stockholders at the special meeting, we will likely be forced to
seek bankruptcy protection. As explained under “TheMerger — Background of the Merger”
(page 18) and “The Merger — Our Reasons
for the Merger” (page 24), we have been unable to
obtain viable financing alternatives. Consequently, as discussed
in our press release on August 7, 2007, we believe that we
will run out of cash to operate our business in October 2007.
Our board of directors believes that declaring bankruptcy would
immediately and significantly reduce the value of our common
stock to a fraction of the $7.25 per share consideration offered
under the merger agreement.
Q:
Can I change my vote after I have delivered my proxy?
A:
Yes, you may revoke and change your vote at any time before your
proxy card is voted at the special meeting. You can do this in
one of four ways:
• you can provide a written instrument or transmission
to our corporate secretary prior to the special meeting stating
that you revoke your proxy;
• you can complete and submit a later dated proxy in
writing;
• you can vote at a later date via the Internet or by
telephone; or
• if you are a holder of record, you can attend the
special meeting and vote in person, which will automatically
cancel any proxy previously given; your attendance alone,
however, will not revoke any proxy that you have previously
given.
If you have instructed a broker, bank or other nominee to vote
your shares, you must follow the directions received from your
broker, bank or other nominee to change those instructions.
Q:
What should I do if I receive more than one set of voting
materials?
A.
You may receive more than one set of voting materials, including
multiple copies of this proxy statement and multiple proxy cards
or voting instruction cards. For example, if you hold your
shares in more than one brokerage account, you will receive a
separate voting instruction card for each brokerage account in
which you hold shares. If you are a holder of record and your
shares are registered in more than one name, you will receive
more than one proxy card. Please complete, sign, date and return
each proxy card and voting instruction card that you receive.
Q:
Am I entitled to appraisal rights?
A:
Yes. As a holder of our common stock, you are entitled to
appraisal rights under the Delaware General Corporation Law in
connection with the merger if you meet certain conditions, which
conditions are described in this proxy statement under the
caption “The Merger — Appraisal Rights”
(page 43).
Q:
Is the merger expected to be taxable to me?
A:
Generally, yes. The receipt of cash in exchange for shares of
our common stock pursuant to the merger will be a taxable
transaction for United States federal income tax purposes. In
general, a United States Holder (as defined in “TheMerger — Material United States Federal Income Tax
Consequences” on page 40) who receives cash in
exchange for shares of our common stock pursuant to the merger
will recognize capital gain or loss for United States federal
income tax purposes equal to the difference, if any, between the
amount of cash per share received and the holder’s adjusted
tax basis in the share of our common stock exchanged therefor.
Any such gain or loss would be long-term capital gain or loss if
the holding period for the shares of our common stock exceeded
one year. In addition, payments made to United States Holders in
the merger will be subject to information reporting and may be
subject to withholding under applicable tax laws. Any withheld
amounts will be treated for all purposes as having been paid to
the holder in respect of whose shares the withholding was made.
United States Holders may use amounts withheld as a credit
against their United States federal income tax liability or may
claim a refund of any excess amounts withheld by timely filing a
claim for refund with the IRS.
A Non-United
States Holder (as defined in “The Merger —
Material United States Federal Income Tax Consequences” on
page 40) generally will not be subject to United
States federal income tax on any gain realized on the receipt of
cash for shares of our common stock in the merger unless:
(i) the holder is an individual who was present in the
United States for 183 days or more during the taxable year
of the disposition and certain other conditions are met or
(ii) the gain is effectively connected with the
holder’s conduct of a trade or business in the United
States, or, if required by an applicable tax treaty,
attributable to a permanent establishment maintained by the
holder in the United States. In addition, payments made to
Non-United
States Holders in the merger may be subject to information
reporting and backup withholding for United States federal
income tax purposes.
Non-United
States Holders may use amounts withheld as a credit against
their United States federal income tax liability or may claim a
refund of any excess amounts withheld by timely filing a claim
for refund with the IRS.
You should read “The Merger — Material United
States Federal Income Tax Consequences” on page 40 for
a more complete discussion of the United States federal income
tax consequences of the merger to holders of our common stock.
Tax matters can be complicated, and the tax consequences of the
merger to you will depend on your particular tax situation.
We urge you to consult your tax advisor on the tax
consequences of the merger to you.
THIS PROXY STATEMENT DOES NOT ADDRESS
NON-UNITED
STATES TAX LAW CONSIDERATIONS RELATING TO THE MERGER. YOU ARE
URGED TO CONSULT YOUR TAX ADVISOR WITH RESPECT TO ANY POTENTIAL
TAX CONSEQUENCES OF THE MERGER ARISING UNDER ANY APPLICABLE
NON-UNITED
STATES TAX LAWS.
Q:
Should I send in my share certificates now?
A:
No. Promptly after the merger is consummated, you will be
sent a letter of transmittal with written instructions for
exchanging your share certificates for the cash consideration.
These instructions will tell you how and where to send in your
certificates for your cash consideration. You will receive your
cash payment after the exchange agent receives your stock
certificates and any other documents requested in the
instructions. Alternatively, if you exercise appraisal rights,
you will receive an appraisal notice from us instructing you
where and when your certificates must be deposited if the
deposit of your certificates is required in connection with the
exercise of your appraisal rights.
Q:
When do you expect the merger to be consummated?
A:
We are working toward consummating the merger as quickly as
possible and expect to consummate the merger in the fourth
quarter of 2007. In addition to obtaining stockholder approval,
we must satisfy all other closing conditions. See “The
Merger Agreement — Conditions to the Merger”
(page 54).
Q:
Who can help answer my questions?
A:
If you have any questions about the merger or how to submit your
proxy, please call our proxy solicitor, Georgeson Inc. at
(212) 440-9800
(banks and brokers),
(888) 605-8339
(U.S. stockholders),
+800 6590-6590
(toll free outside the U.S.) or
+44 (0)117 378 5985 (collect outside the U.S.).
If you would like additional copies, without charge, of this
proxy statement or the enclosed proxy card you should contact:
This summary term sheet, together with the section of this
proxy statement entitled “Questions and Answers About the
Merger and the Special Meeting,” highlights selected
information from this proxy statement and may not contain all of
the information that is important to you as a stockholder of
IsoTis or that you should consider before voting on the proposal
to adopt the merger agreement and approve the merger. To better
understand the merger, you should read carefully this entire
proxy statement and all of its annexes, including the merger
agreement, which is attached as Annex A, before voting on
the proposal to adopt the merger agreement and approve the
merger. Each item in this summary includes a page reference
directing you to a more complete description of that item.
IsoTis is a leading orthobiologics company that develops,
manufactures and markets proprietary products for the treatment
of musculoskeletal diseases and disorders. IsoTis’ current
orthobiologics products are bone graft substitutes that promote
the regeneration of bone and are used to repair natural,
trauma-related and surgically-created defects common in
orthopedic procedures, including spinal fusions. IsoTis’
current commercial business is highlighted by its Accell line of
products, which we believe represents the next generation in
bone graft substitution.
For additional information about IsoTis and its business, see
page 17 and “Where You Can Find More Information”
on page 61.
Integra LifeSciences Holdings Corporation, a world leader in
regenerative medicine, is dedicated to improving the quality of
life for patients through the development, manufacturing and
marketing of cost-effective surgical implants and medical
instruments. Integra’s products, used primarily in
neurosurgery, extremity reconstruction, orthopedics and general
surgery, are used to treat millions of patients every year.
Integra’s principal executive offices are located in
Plainsboro, New Jersey.
For additional information about Integra and its business, see
page 18 and “Where You Can Find More Information”
on page 61.
Ice MergerCorp, Inc., a Delaware corporation and a wholly-owned
subsidiary of Integra, was organized solely for the purpose of
entering into the merger agreement and consummating the merger
and has not conducted any business operations.
The
Merger (page 17)
We have agreed to be acquired by Integra pursuant to the terms
of the merger agreement that is described in this proxy
statement and attached as Annex A. We encourage you
to read the merger agreement carefully and in its entirety. It
is the principal document governing the merger.
The merger agreement provides that Merger Sub will merge with
and into IsoTis, with IsoTis continuing as the surviving
corporation and a wholly-owned subsidiary of Integra. At the
effective time of the merger, each share of our common stock
outstanding immediately prior to the effective time of the
merger, other than shares held by us, our wholly-owned
subsidiaries, Integra or Merger Sub or by holders properly
exercising appraisal rights under Delaware law, will be
automatically converted into the right to receive $7.25 in cash,
without interest and less any applicable withholding taxes. Any
withheld amounts will be treated for all purposes as having been
paid to the holder of our common stock in respect of whose
shares the withholding was made.
All stock options not exercised prior to the effective time of
the merger will be cancelled in the merger, with the holder of
each stock option becoming entitled to receive, in full
satisfaction of the rights of such holder with respect thereto,
an amount in cash equal to the product of (i) the excess,
if any, of $7.25 over the applicable per share exercise price of
our common stock subject to such stock option, multiplied by
(ii) the number of shares of our common stock subject to
such stock option. All amounts payable will be paid at or as
soon as practicable following the effective time of the merger,
but in any event no later than ten business days following the
effective time, without interest.
The special meeting of our stockholders will be held
at
on ,
2007 at local time. At the special
meeting, you will be asked to vote on the proposal to adopt the
merger agreement and approve the merger, and, if necessary, the
proposal to adjourn the special meeting to solicit additional
proxies.
Only holders of record of our common stock at the close of
business on August 24, 2007, the record date for the
special meeting, may vote at the special meeting. For each share
of our common stock that you owned on the record date, you are
entitled to cast one vote on each matter voted upon at the
special meeting.
Adoption of the merger agreement and approval of the merger
requires the affirmative vote of the holders of a simple
majority (i.e., more than 50%) of the outstanding shares of our
common stock entitled to vote at the special meeting. Approval
of the proposal to adjourn the special meeting for the purpose
of soliciting additional proxies, if necessary, requires the
affirmative vote of the holders of a simple majority (i.e., more
than 50%) of the voting stock represented in person or by proxy.
On the record date, there
were shares
of our common stock entitled to vote at the special meeting.
As of August 24, 2007, the record date for the special
meeting, our directors and executive officers were record owners
of and were entitled to vote
approximately shares
of common stock, or approximately %
of our total common stock outstanding on that date excluding
those shares held by Integra and its subsidiaries. These numbers
do not give effect to outstanding but unexercised stock options,
which are not entitled to vote at the special meeting.
Our common stock is listed on the NASDAQ Global Market under the
symbol “ISOT”. On August 6, 2006, the last full
trading day prior to the public announcement of the proposed
merger, our common stock closed at $6.88.
On ,
2007, the last full trading day prior to the date of this proxy
statement, our common stock closed at
$ .
We have never declared or paid cash dividends on our common
stock. Our current policy is to retain earnings for use in our
business. Following the merger there will be no further market
for our common stock.
Our board of directors, by the unanimous vote of all directors:
•
approved and adopted the merger agreement and other transactions
contemplated by the merger agreement, and declared the merger to
be advisable to our stockholders; and
•
determined that it was in the best interests of us and our
stockholders to enter into the merger agreement and consummate
the merger on the terms and conditions set forth in the merger
agreement.
Our board of directors unanimously recommends that our
stockholders vote “FOR” the proposal to adopt the
merger agreement and approve the merger, and “FOR” the
proposal to adjourn the special meeting to solicit additional
proxies, if necessary. To review the factors that our board
of directors considered when deciding whether to approve the
merger agreement and the transactions contemplated by the merger
agreement, see “The Merger — Our Reasons for the
Merger” beginning on page 24.
When considering our board of directors’ recommendation
that you vote in favor of the proposal to adopt the merger
agreement and approve the merger, you should be aware that
members of our board of directors and our executive officers may
have interests in the merger that differ from, or are in
addition to, those of our other stockholders generally. For
example:
•
our executive officers may be entitled to certain cash severance
payments, including payments in lieu of certain health care
benefits and tax
gross-up
payments, and accelerated vesting of stock options and
restricted stock awards, if they are terminated under certain
circumstances following stockholder approval of the merger;
•
certain of our executive officers may be offered opportunities
to become employees or service providers of Integra and its
affiliates following the effective time of the merger;
•
options (including unvested options) to purchase shares of our
common stock held by our executive officers will be cancelled
and the holder will be entitled to receive a cash payment,
without interest, equal to the product of (i) the excess,
if any, of $7.25 over the applicable per share exercise price
and (ii) the number of shares subject to the
option; and
•
our directors and executive officers will continue to be
indemnified for acts and omissions occurring at or prior to the
effective time of the merger and will have the benefit of
director and officer liability insurance for six years following
completion of the merger.
Our board of directors was aware of these interests and
considered them, among other matters, in reaching its decision
to approve the merger agreement and to recommend that our
stockholders vote in favor of the adoption of the merger
agreement.
In connection with the merger, our board of directors received a
written opinion from Thomas Weisel Partners LLC (“Thomas
Weisel Partners”), as to the fairness, from a financial
point of view, of the consideration to be received by holders of
our common stock. The full text of Thomas Weisel Partners’
written opinion, dated August 6, 2007, is attached to this
proxy statement as Annex B. Holders of our common
stock are encouraged to read this opinion carefully and in its
entirety for a description of the assumptions made, matters
considered and qualifications and limitations on the scope of
review undertaken by Thomas Weisel Partners. Thomas Weisel
Partners’ opinion was directed to our board of directors in
connection with its evaluation of the consideration, does not
address any other aspect of the merger and does not constitute a
recommendation to any stockholder as to how to vote or act with
respect to the merger agreement.
If the merger is consummated, our common stock will no longer be
listed on the NASDAQ Global Market and will be deregistered
under the Securities Exchange Act of 1934 (or Exchange Act), and
we will no longer file periodic reports with the United States
Securities and Exchange Commission.
Our, Integra’s and Merger Sub’s obligations to effect
the merger are subject to the satisfaction of the following
conditions:
•
the adoption of the merger agreement and approval of the merger
by our stockholders;
•
no statute, rule, regulation, executive order, decree or ruling
is promulgated, and no temporary restraining order, preliminary
or permanent injunction or other order issued by a court or
other U.S. governmental authority of competent jurisdiction
is in effect that has the effect of making the merger illegal or
otherwise prohibiting consummation of the merger; provided
however, the right to rely on this condition is not available to
any party whose failure to fulfill its obligations related to
obtaining such consents is the cause of such order or
injunction; and
•
all material consents, orders or approvals of, declarations or
filings with and expirations of waiting periods imposed by any
governmental entity required for consummation of the merger
having been obtained and in effect except for those that would
not, individually or in the aggregate, reasonably be expected to
have a material adverse effect on the business, assets,
condition (financial or otherwise) or results of operations of
Integra and its subsidiaries, taken as a whole.
Integra’s and Merger Sub’s obligations to consummate
the merger are also subject to the satisfaction by us or waiver
by them of the following conditions:
•
our representations and warranties concerning capitalization and
the stockholder vote required being true and correct in all
respects (except, in the case of our capitalization for such
inaccuracies as are de minimis in the aggregate), in each case
both when made and at and as of the closing date, as if made at
and as of such time (except to the extent expressly made as of
an earlier date, in which case as of such date) and each of our
other representations and warranties set forth in the merger
agreement being true and correct in all material respects both
when made and at and as of the closing date, as if made at and
as of such time (except to the extent expressly made as of an
earlier date, in which case as of such date), and Integra having
received a certificate of our chief executive officer and the
chief financial officer to such effect;
•
the performance and compliance by us in all material respects of
our obligations under the merger agreement and Integra having
received a certificate of our chief executive officer and the
chief financial officer to such effect;
•
a material adverse effect has not occurred with respect to us
between signing and closing;
•
our obtaining clearance for the 510(k), K061880, which was
subsequently obtained on August 15, 2007;
•
completion of certain actions relating to the restructuring of
our European operations;
•
Integra’s credit agreement having been amended, or the
lenders party thereto having granted Integra a waiver, in either
case, to permit the consummation of the merger, and to provide
for such other revisions as Integra deems necessary or advisable
in its sole and absolute discretion; and
•
holders of no more than 10% of the number of shares of our stock
outstanding immediately prior to the effective time having
exercised their appraisal rights in the merger.
Our obligation to consummate the merger is also subject to the
satisfaction by Integra and Merger Sub or waiver by us of the
following conditions:
•
Integra’s and Merger Sub’s representations and
warranties made pursuant to the merger agreement that are
qualified as to materiality or material adverse effect being
true and correct and the representations and warranties that are
not so qualified being true and correct in all material
respects, in each case both when made and at and as of the
closing date (except to the extent expressly made as of an
earlier date, in which case as of such date) and our having
received a certificate of an executive officer of Integra to
such effect; and
•
the performance and compliance by Integra in all material
respects of its obligations under the merger agreement and our
having received a certificate of an executive officer of Integra
to such effect.
No
Solicitation and Change of Recommendation Covenant
(page 52)
We have agreed that we will not, and will not permit any of our
subsidiaries to, nor will we authorize or permit any of our or
our subsidiaries’ directors, officers, employees,
investment bankers, attorneys, accountants or other advisors or
representatives to, directly or indirectly:
•
solicit, initiate or take any action to knowingly facilitate or
encourage the submission of inquiries, proposals or offers from
any person (other than Integra and Merger Sub) relating to any
acquisition proposal, or agree to or endorse any acquisition
proposal;
•
enter into any agreement to knowingly facilitate or consummate
any acquisition proposal or approve or endorse any acquisition
proposal;
•
enter into or participate in any discussions or negotiations in
connection with any acquisition proposal or inquiry with respect
to any acquisition proposal, or furnish to any person any
information with respect to our business, properties or assets
in connection with any acquisition proposal or inquiry with
respect to any acquisition proposal; or
•
agree to resolve or take any of the actions prohibited by the
above.
If our board of directors receives a bona fide unsolicited
written acquisition proposal by a third party prior to our
obtaining stockholder approval, it may participate in
discussions or negotiations with such third party directly or
through its representatives if, among other things, it
determines in good faith by a majority vote that such
acquisition proposal would result in, or would reasonably be
expected to result in, a superior proposal, it furnishes to the
third party making the acquisition proposal information with
respect to us and our subsidiaries pursuant to a confidentiality
and standstill agreement which contains terms that are no less
restrictive than those contained in the confidentiality
agreement between us and Integra and such information has been
or is provided to Integra on a prior or concurrent basis and,
after considering the advice of outside legal counsel, the board
determines that failing to take such action would reasonably be
expected to result in a breach of its fiduciary duties under
Delaware law.
Our board of directors may withdraw or modify or change in a
manner adverse to Integra its approval or recommendation of the
merger agreement, if and only if, our board of directors, after
considering the advice of outside legal counsel, has determined
that (i) the acquisition proposal constitutes a superior
proposal and that failing to take such action would result in a
breach of its fiduciary duties under Delaware law or
(ii) in response to an intervening event that failing to
take such action would result in a breach of its fiduciary
duties under Delaware law.
Termination
of the Merger Agreement (page 55)
The merger agreement may be terminated under the following
circumstances:
the effective time has not occurred by February 6, 2008;
provided that the right to terminate pursuant to this provision
is not available to any party whose failure to fulfill any
obligation under the merger agreement is the primary cause of
the failure of the effective time to occur by February 6,2008 and such action or failure to perform constitutes a breach
of the merger agreement;
•
any governmental entity issues an order, decree or ruling or
takes any other action permanently restraining, enjoining or
otherwise prohibiting or making illegal the transactions
contemplated by the merger agreement, and such order, decree,
ruling or other action is final and nonappealable; or
•
our stockholders do not adopt the merger agreement and approve
the merger at the stockholders meeting;
•
by us if:
•
prior to our stockholders meeting, we accept a superior proposal
in accordance with the terms of the merger agreement; provided
that we pay the termination fee, as discussed below,
concurrently with terminating;
•
Integra breaches a representation, warranty, covenant or
agreement so that the related closing conditions will not be
satisfied and such breach is not reasonably capable of being
cured, or, in the case of a breach of a covenant or agreement,
if such breach is reasonably capable of being cured, Integra
does not cure it prior to the earlier of 20 days after we
provide notice of such breach or February 6, 2008; provided
that we will not be able to terminate pursuant to this provision
if we are then in material breach of any of our representations,
warranties, covenants or agreements contained in the merger
agreement; or
•
Integra’s credit agreement is not amended prior to
September 7, 2007 or such later date as is mutually agreed
to by Integra and us to permit the consummation of the merger
and such other revisions as Integra deems necessary or advisable
in its sole and absolute discretion; provided that we may not
terminate pursuant to this provision if Integra agrees to waive
satisfaction of the closing condition that its credit agreement
be amended;
•
by Integra if:
•
prior to our stockholder meeting, our board of directors
fails to recommend or withdraws or modifies or changes in a
manner adverse to Integra its approval or recommendation of the
merger agreement, or approves or recommends a superior proposal;
provided that the disclosure of any acquisition proposal that is
not recommended by our board of directors or the disclosure of
any facts or circumstances, together with a statement by our
board of directors that they continue to recommend the merger
agreement and the merger, is not considered to be a withdrawal,
modification or change to our board of directors’ approval
or recommendation of the merger agreement or the merger;
•
we fail to call or hold the stockholder meeting in accordance
with the terms of the merger agreement and such breach is not
cured within 15 days after we receive notice thereof from
Integra;
•
we materially and knowingly breach any of our material
obligations regarding acquisition proposals; or
•
we breach a representation, warranty, covenant or agreement so
that the related closing conditions will not be satisfied and
such breach is not reasonably capable of being cured, or, in the
case of a breach of a covenant or agreement, such breach is
reasonably capable of being cured but is not cured prior to the
earlier of 20 days following notice of such breach or
February 6, 2008; provided that, Integra will not be able
to terminate pursuant to this provision if it or Merger Sub is
then in material breach of any of its representations,
warranties, covenants or agreements contained in the merger
agreement.
Each party will generally pay its own fees and expenses in
connection with the merger, whether or not the merger is
consummated.
We will be required to pay a termination fee of
$2.25 million to Integra if:
•
Integra terminates the merger agreement because:
•
prior to our stockholder meeting, our board of directors fails
to recommend or withdraws or modifies or changes in a manner
adverse to Integra its approval or recommendation of the merger
agreement, or approves or recommends a superior proposal;
provided that the disclosure of any acquisition proposal that is
not recommended by our board of directors or the disclosure of
any facts or circumstances, together with a statement by our
board of directors that they continue to recommend the merger
agreement and the merger, is not considered to be a withdrawal,
modification or change to our board of directors’ approval
or recommendation of the merger agreement or the merger;
•
we fail to call or hold the stockholder meeting in accordance
with the terms of the merger agreement and such breach is not
cured within 15 days after we receive notice of such breach
from Integra; or
•
we materially and knowingly breach any of our material
obligations regarding the no solicitation provisions of the
merger agreement;
•
we terminate to accept a superior proposal in accordance with
the terms of the merger agreement; or
•
we or Integra terminate the merger agreement because:
•
the effective time does not occur on or before February 6,2008, or our stockholders do not adopt the merger agreement and
(i) at or prior to the time of the event giving rise to
such termination, an acquisition proposal is made known to us or
otherwise publicly disclosed or announced and (ii) within
12 months of termination of the merger agreement, we enter
into a definitive agreement with respect to, or consummate, an
acquisition proposal; provided that any expenses previously
reimbursed to Integra will be deducted from the termination fee.
We will also be required to reimburse Integra and its affiliates
for actual and reasonably documented out-of-pocket fees and
expenses incurred in connection with the merger agreement of up
to a maximum of $1.5 million if (i) we do not obtain
the requisite stockholder vote to adopt the merger agreement, or
(ii) we or Integra terminate because the effective time
does not occur by February 6, 2008 and at the time of
termination, an acquisition proposal is made known or proposed
to us or otherwise publicly disclosed and announced.
The receipt of cash in exchange for shares of our common stock
pursuant to the merger will be a taxable transaction for United
States federal income tax purposes. In general, a United States
Holder (as defined in “The Merger — Material
United States Federal Income Tax Consequences” on
page 40) who receives cash in exchange for shares of
our common stock pursuant to the merger will recognize capital
gain or loss for United States federal income tax purposes equal
to the difference, if any, between the amount of cash per share
received and the holder’s adjusted tax basis in the share
of our common stock exchanged therefor. Any such gain or loss
would be long-term capital gain or loss if the holding period
for the shares of our common stock exceeded one year. In
addition, payments made to United States Holders in the merger
will be subject to information reporting and may be subject to
withholding under applicable tax laws. Any withheld amounts will
be treated for all purposes as having been paid to the holder of
our common stock in respect of whose shares the withholding was
made. United States Holders may use amounts withheld as a credit
against their United States federal income tax liability or may
claim a refund of any excess amounts withheld by timely filing a
claim for refund with the IRS.
A Non-United
States Holder (as defined in “The Merger —
Material United States Federal Income Tax Consequences” on
page 40) generally will not be subject to United
States federal income tax on any gain realized on the receipt of
cash for shares of our common stock in the merger unless:
(i) the holder is an
individual who was present in the United States for
183 days or more during the taxable year of the disposition
and certain other conditions are met or (ii) the gain is
effectively connected with the holder’s conduct of a trade
or business in the United States, or, if required by an
applicable tax treaty, attributable to a permanent establishment
maintained by the holder in the United States. In addition,
payments made to
Non-United
States Holders in the merger may be subject to information
reporting and backup withholding for United States federal
income tax purposes.
Non-United
States Holders may use amounts withheld as a credit against
their United States federal income tax liability or may claim a
refund of any excess amounts withheld by timely filing a claim
for refund with the IRS.
You should read “The Merger — Material United
States Federal Income Tax Consequences” beginning on
page 40 for a more complete discussion of the federal
income tax consequences of the merger to holders of our common
stock. Tax matters can be complicated, and the tax consequences
of the merger to you will depend on your particular tax
situation. We urge you to consult your tax advisor on the tax
consequences of the merger to you.
THIS PROXY STATEMENT DOES NOT ADDRESS
NON-UNITED
STATES TAX LAW CONSIDERATIONS RELATING TO THE MERGER. YOU ARE
URGED TO CONSULT YOUR TAX ADVISOR WITH RESPECT TO ANY POTENTIAL
TAX CONSEQUENCES OF THE MERGER ARISING UNDER ANY APPLICABLE
NON-UNITED
STATES TAX LAWS.
Under Delaware law, stockholders who do not wish to accept the
consideration payable for their shares of common stock pursuant
to the merger may seek, under Section 262 of the General
Corporation Law of the State of Delaware, judicial appraisal of
the fair value of their shares by the Delaware Court of
Chancery. This value could be more than, less than or equal to
the applicable merger consideration for such shares. This right
to appraisal is subject to a number of restrictions and
technical requirements. Generally, in order to properly demand
appraisal, among other things:
•
you must not vote in favor of the proposal to adopt the merger
agreement;
•
you must deliver a written demand to us for appraisal in
compliance with the General Corporation Law of the State of
Delaware before the vote on the proposal to adopt the merger
agreement occurs at the special meeting; and
•
you must hold your shares of record continuously from the time
of making a written demand for appraisal through the effective
time of the merger; a stockholder who is the record holder of
shares of our common stock on the date the written demand for
appraisal is made, but who thereafter transfers those shares
prior to the effective time of the merger, will lose any right
to appraisal in respect of those shares.
Merely voting against, or failing to vote in favor of, the
merger agreement will not preserve your right to appraisal under
Delaware law. Also, because a submitted proxy not marked
“AGAINST” or “ABSTAIN” will be voted
“FOR” the proposal to adopt the merger agreement, the
submission of a proxy not marked “AGAINST” or
“ABSTAIN” will result in the waiver of appraisal
rights. If you hold shares in the name of a broker, bank or
other nominee, you must instruct your nominee to take the steps
necessary to enable you to demand appraisal for your shares. If
you or your nominee fails to follow all of the steps required by
Section 262 of the General Corporation Law of the State of
Delaware, you will lose your right of appraisal. See “TheMerger — Appraisal Rights” on page 43 for a
description of the procedures that you must follow in order to
exercise your appraisal rights.
Stockholders who properly perfect their appraisal rights will
receive only the judicially-determined fair value of their
shares if one or more stockholders files suit in the Delaware
Court of Chancery and litigates the resulting appraisal case to
a decision.
Annex C to this proxy statement contains the full
text of Section 262 of the General Corporation Law of the
State of Delaware, which relates to your right of appraisal. We
encourage you to read these provisions carefully and in their
entirety.
This proxy statement contains “forward-looking
statements” within the meaning of the safe harbor
provisions of Section 21E of the Securities Exchange Act of
1934, as amended. Statements other than statements of historical
fact are forward-looking statements for purposes of federal and
state securities laws, including projections of earnings,
revenue or other financial items; statements regarding future
economic conditions or performance; statements of belief; and
statements of assumptions. Forward-looking statements may
include the words “may,”“could,”“will,”“should,”“would,”“estimate,”“intend,”“continue,”“believe,”“expect,”“anticipate,”“strategy,”“plan,”“pursue,”“project,”“goal,” or “targets” or
the negative or other variations thereof and other words of
similar meaning are intended to identify such forward-looking
statements. One can also identify them by the fact that they do
not relate strictly to historical or current facts. Such
statements are based on the current expectations and projections
of the management of IsoTis only. Undue reliance should not be
placed on these statements because, by their nature, they are
subject to known and unknown risks and can be affected by
factors that are beyond the control of IsoTis. These
forward-looking statements, including, without limitation, those
projections regarding the consummation of the merger, government
consents and approvals and the outcome of the contingencies such
as legal proceedings, are necessarily estimates reflecting the
best judgment of our management and involve a number of risks
and uncertainties that could cause actual results to differ
materially from those suggested by the forward looking
statements. Our future financial condition and results of
operations, as well as any forward-looking statements, are
subject to change and to inherent risks and uncertainties. Risks
and uncertainties pertaining to the following factors, among
others, could cause actual results to differ materially from
those described in the forward-looking statements:
•
our ability to obtain the stockholder approvals required for the
merger;
•
the occurrence or non-occurrence of the other conditions to the
closing of the merger;
•
the timing of the consummation of the merger and receipt by
stockholders of the merger consideration;
•
uncertainty concerning the effects of our pending transaction
with Integra;
•
delays in receiving U.S. Food and Drug Administration or
other regulatory approvals;
•
the effects of economic, credit and capital market conditions on
the economy in general and on medical device and health care
companies in particular; and
•
additional risks and uncertainties not presently known to us or
that we currently deem immaterial.
You should consider the cautionary statements contained or
referred to in this section in connection with any subsequent
written or oral forward-looking statements that may be issued by
us or persons acting on our behalf. We do not undertake any
obligation to release publicly any revisions to any
forward-looking statements contained herein to reflect events or
circumstances that occur after the date of this proxy statement
or to reflect the occurrence of unanticipated events, except as
we are required to do by law.
We are furnishing this proxy statement to our stockholders as
part of the solicitation of proxies by our board of directors
for use at the special meeting.
At the special meeting, we are asking holders of record of our
common stock on August 24, 2007, to consider and vote on
the following proposals:
1. The adoption of the Agreement and Plan of Merger, dated
as of August 6, 2007, among IsoTis, Inc., Integra
LifeSciences Holdings Corporation and Ice MergerCorp, Inc., a
wholly-owned subsidiary of Integra, and approval of the merger
contemplated by the merger agreement;
2. The approval of the adjournment of the special meeting,
if necessary, to solicit additional proxies if there are
insufficient votes at the time of the special meeting to adopt
the merger agreement and approve the merger; and
3. The transaction of any other business as may properly
come before the special meeting or any adjournment or
postponement of the special meeting.
Our board of directors has determined that the terms of the
merger agreement are advisable and in the best interests of our
stockholders and has unanimously approved the merger agreement.
Our board of directors unanimously recommends that our
stockholders vote “FOR” the adoption of the merger
agreement and approval of the merger and “FOR” any
proposal to adjourn the special meeting to solicit additional
proxies, if necessary. See “The Merger — Our
Reasons for the Merger.”
A quorum of stockholders is necessary to hold the special
meeting. The required quorum for the transaction of business at
the special meeting is the presence, either in person or
represented by proxy, of the holders of a simple majority (i.e.,
more than 50%) of the outstanding shares of common stock
entitled to vote at the special meeting. Abstentions and
“broker non-votes,” discussed below, count as present
for establishing a quorum.
You may vote at the special meeting if you owned shares of our
common stock at the close of business on August 24, 2007,
the record date for the special meeting. For each share of our
common stock that you owned on the record date, you are entitled
to cast one vote on each matter voted upon at the special
meeting.
Adoption of the merger agreement requires the affirmative vote
of the holders of a simple majority (i.e., more than 50%) of the
outstanding shares of our common stock entitled to vote at the
special meeting. Because the vote on the proposal to adopt the
merger agreement and approve the merger is based on the total
number of shares outstanding, rather than the number of actual
votes cast or represented at the special meeting, failure to
vote your shares, abstentions and broker non-votes will have the
same effect as voting against the adoption of the merger
agreement and approval of the merger. A “broker
non-vote” occurs when a broker or other nominee holding
shares for a beneficial owner does not vote on a particular
proposal because the broker does not have discretionary voting
authority or has not received instructions from the beneficial
owner of the shares. Brokers and other nominees will not have
discretionary authority on the proposal to adopt the merger
agreement and approve the merger.
Approval of the proposal to adjourn the special meeting for the
purpose of soliciting additional proxies, if necessary, requires
the affirmative vote of the holders of a simple majority (i.e.,
more than 50%) of the shares
represented at the meeting. Because the vote on the proposal to
adjourn the special meeting requires the affirmative vote of the
holders of a simple majority (i.e., more than 50%) of the shares
represented at the meeting, abstentions and failure to give
voting instructions to your broker, bank or nominee will have
the same effect as voting against the proposal to adjourn the
special meeting.
A list of our stockholders will be available for review for any
purpose germane to the special meeting at our executive offices
and principal place of business during regular business hours
for a period of ten days before the special meeting and will
also be available at the special meeting.
As of August 24, 2007, the record date for the special
meeting, our directors and executive officers were record owners
of and were entitled to vote
approximately shares
of common stock, or approximately %
of our total common stock outstanding on that date excluding
those shares held by Integra and its subsidiaries. These numbers
do not give effect to outstanding stock options, which are not
entitled to vote at the special meeting.
You may vote by proxy or in person at the special meeting.
Voting
in Person
If you plan to attend the special meeting and wish to vote in
person, you will be given a ballot at the special meeting.
Please note, however, that if your shares are held in
“street name,” which means your shares are held of
record by a broker, bank or other nominee, and you wish to vote
at the special meeting, you must bring to the special meeting a
proxy from the record holder of the shares (your broker, bank or
nominee) authorizing you to vote at the special meeting.
Voting
by Proxy
All shares represented by properly executed proxies received in
time for the special meeting will be voted at the special
meeting in the manner specified by the stockholders giving those
proxies. Properly executed proxies that do not contain voting
instructions will be voted “FOR” the proposal to adopt
the merger agreement and approve the merger and the proposal to
adjourn the special meeting to solicit additional proxies, if
necessary, provided that no proxy that is specifically marked
“AGAINST” the proposal to adopt the merger agreement
and approve the merger will be voted in favor of the adjournment
proposal, unless it is specifically marked “FOR” the
adjournment proposal.
Only shares affirmatively voted for the proposal to adopt the
merger agreement and approve the merger and the proposal to
adjourn the special meeting to solicit additional proxies, if
necessary, and properly executed proxies that do not contain
voting instructions, will be counted as votes “FOR”
the proposals. Shares of our common stock held by persons
attending the special meeting but abstaining from voting, and
shares of our common stock for which we received proxies
directing an abstention, will have the same effect as votes
“AGAINST” the adoption of the merger agreement and
approval of the merger and the proposal to adjourn the special
meeting to solicit additional proxies, if necessary. Shares
represented by proxies that reflect a “broker
non-vote” will be counted for purposes of determining
whether a quorum exists, but those proxies will have the same
effect as votes “AGAINST” the proposal to adopt the
merger agreement and approve the merger and no effect on the
adjournment proposal. A “broker non-vote” occurs when
a nominee holding shares for a beneficial owner has not received
instructions from the beneficial owner and does not have
discretionary authority to vote the shares.
Although it is not currently expected, if the proposal to
adjourn the special meeting to solicit additional proxies is
approved, the special meeting may be adjourned for the purpose
of soliciting additional proxies to approve the proposal to
adopt the merger agreement and approve the merger. Other than
for the purposes of adjournment to solicit additional proxies,
whether or not a quorum exists, holders of a simple majority
(i.e.,
more than 50%) of the outstanding common stock present in person
or represented by proxy at the special meeting and entitled to
vote thereat may adjourn the special meeting. Any signed proxies
received by us in which no voting instructions are provided on
such matter will be voted in favor of an adjournment in these
circumstances.
Any adjournment may be made without notice (if the adjournment
is not for more than sixty days from the record date), other
than by an announcement made at the special meeting of the time,
date and place of the adjourned meeting. Any adjournment of the
special meeting for the purpose of soliciting additional proxies
will allow our stockholders who have already sent in their
proxies to revoke them at any time prior to their use at the
special meeting as adjourned or postponed.
A stockholder of record may revoke a proxy at any time before it
is voted by filing with our corporate secretary a duly executed
revocation of proxy, by submitting a duly executed proxy to our
corporate secretary with a later date, by voting at a later date
via Internet or by telephone or by appearing at the special
meeting and voting in person. A stockholder of record may revoke
a proxy by any of these methods, regardless of the method used
to deliver the stockholder’s previous proxy. Attendance at
the special meeting without voting will not itself revoke a
proxy. If your shares are held in street name, you must contact
your broker, bank or nominee to revoke your proxy.
We and our proxy solicitation firm, Georgeson Inc., are
soliciting proxies for the special meeting from our
stockholders. We will bear the entire cost of soliciting proxies
from our stockholders, including the payment of an aggregate fee
of $50,000, plus certain other fees and reasonable expenses, to
Georgeson Inc. for its services. In addition to the solicitation
of proxies by mail, we will request that banks, brokers and
other record holders send proxies and proxy materials to the
beneficial owners of our common stock held by them and secure
their voting instructions, if necessary. We will reimburse those
record holders for their reasonable expenses in so doing. We may
use several of our executive officers and regular employees, who
will not be specially compensated, to solicit proxies from our
stockholders, either personally or by telephone, telegram,
facsimile, special delivery letter or other electronic means.
Under the General Corporation Law of the State of Delaware,
holders of our common stock who do not vote in favor of the
proposal to adopt the merger agreement will have the right to
seek appraisal of the fair value of their shares as determined
by the Delaware Court of Chancery if the merger is consummated,
but only if they submit a written demand for an appraisal prior
to the vote on the adoption of the merger agreement and they
comply with the provisions of Section 262 of the General
Corporation Law of the State of Delaware set forth in full at
Annex C to this proxy statement, including by not
voting in favor of the adoption of the merger agreement.
Dissenting stockholders who properly perfect their appraisal
rights will receive only the judicially-determined fair value of
their shares if one or more dissenting stockholders files suit
in the Delaware Court of Chancery and litigates the resulting
appraisal case to a decision. For more information on appraisal
rights, see below under “The Merger — Appraisal
Rights.”
We do not expect that any matter other than the proposal to
adopt the merger agreement and approve the merger, and, if
necessary, the proposal to adjourn the special meeting to
solicit additional proxies, will be brought before the special
meeting. If, however, other matters are properly presented at
the special meeting, the persons named as proxies will vote in
accordance with their best judgment with respect to those
matters.
We are asking our stockholders to adopt the merger agreement and
approve the merger contemplated therein. If we consummate the
merger, we will become a wholly-owned subsidiary of Integra and
our stockholders will have the right to receive $7.25 in cash,
without interest and less any applicable withholding taxes, for
each share of common stock that is outstanding immediately prior
to the effective time of the merger. Any withheld amounts will
be treated for all purposes as having been paid to the holder of
our common stock in respect of whose shares the withholding was
made.
We are an orthobiologics company that develops, manufactures and
markets proprietary products for the treatment of
musculoskeletal diseases and disorders. Our current
orthobiologics products are bone graft substitutes that promote
the regeneration of bone and are used to repair natural,
trauma-related and surgically-created defects common in
orthopedic procedures, including spinal fusions. Our current
commercial business is highlighted by our Accell line of
products, which we believe represents the next generation in
bone graft substitution. We also sell our traditional bone graft
substitute products in the United States and internationally.
Our principal offices and manufacturing facilities are located
at 2 Goodyear, Irvine, California92618, and our telephone
number is
(949) 595-8710.
We were originally formed in 1996 as IsoTis S.A., a Swiss
entity. In 2003, IsoTis S.A. acquired GenSci OrthoBiologics,
Inc., or GenSci, and shifted its focus to orthobiologics. GenSci
was subsequently renamed IsoTis OrthoBiologics, Inc., or IsoTis
OrthoBiologics. The results of operations of IsoTis
OrthoBiologics have been included in IsoTis S.A.’s
financial statements from November 1, 2003. In connection
with that transaction, IsoTis S.A.’s executive management
team and its offices moved from Switzerland to the facility in
Irvine, California. IsoTis S.A. continued to maintain
international sales and marketing headquarters in Lausanne,
Switzerland. Most recently, IsoTis S.A. formed IsoTis, Inc. for
the purpose of reorganizing IsoTis S.A. as a
U.S. company. The reorganization was effected by means of
an exchange offer commenced in December 2006. Following the
closing of the transactions contemplated by the exchange offer
on August 3, 2007, IsoTis, Inc.’s business and
operations consist solely of the business and operations of
IsoTis S.A.
Integra LifeSciences Holdings Corporation, a world leader in
regenerative medicine, is dedicated to improving the quality of
life for patients through the development, manufacturing and
marketing of cost-effective surgical implants and medical
instruments. Integra’s products, used primarily in
neurosurgery, extremity reconstruction, orthopedics and general
surgery, are used to treat millions of patients every year.
Integra’s principal executive offices are located at 311
Enterprise Drive, Plainsboro, New Jersey08536 and its telephone
number is
(609) 275-0500.
Founded in 1989, Integra has grown to be a leader in applying
the principles of biotechnology to medical devices, particularly
for neurosurgery and extremity reconstruction, and is one of the
largest surgical instrument companies in the United States. In
the United States, Integra sells its products for neurosurgery
and extremity reconstruction directly to customers and its
surgical instruments through manufacturers’ representatives
and stocking distributors. Outside the United States, Integra
sells its products directly in major European markets and
through stocking distributors elsewhere.
Integra has approximately 400 sales and marketing employees, who
sell its products in 120 countries.
Ice
MergerCorp, Inc.
Ice MergerCorp, Inc., a Delaware corporation and a wholly owned
subsidiary of Integra, was organized solely for the purpose of
entering into the merger agreement and consummating the merger
and has not conducted any business operations.
Merger Sub’s mailing address is
c/o Integra
LifeSciences Holdings Corporation, 311 Enterprise Drive,
Plainsboro, New Jersey08536 and its telephone number is
(609) 275-0500.
Our board of directors and management, in their ongoing effort
to maximize stockholder value, have periodically reviewed and
assessed our business strategy, a variety of strategic
alternatives and the various trends and conditions impacting our
business in general. These industry trends include consolidation
in the U.S. medical device industry, major competitors
increasingly being able to use their size and portfolio breadth
as leverage for a competitive advantage in our market and other
competitive pressures such as increased pricing pressures as a
result of more competitors and rapid technological change. More
recently, the board had become concerned about our ability to
execute our strategic plan in light of our limited financial
resources, an increasingly competitive environment, our history
of operating losses and disappointing developments in obtaining
regulatory approval of our Accell products.
On September 12 and 13, 2006, our board of directors
together with our management conducted an in-depth strategic
planning review to assess our future prospects. We decided on a
two-fold strategy of becoming listed on a U.S. stock
exchange and conducting an initial public offering in the United
States.
Until recently, shares of our predecessor company, IsoTis S.A.,
a Swiss corporation, were listed on SWX Swiss Exchange (ISON),
Euronext Amsterdam N.V. (ISON) and the Toronto Stock Exchange
(ISO). On November 6, 2006, IsoTis S.A. announced its plans
to become a U.S. listed company with a single listing on
the NASDAQ Global Market, for the purposes of increasing
visibility to institutional investors, improving stockholder
liquidity, reducing the complexity and cost of securities
compliance requirements, facilitating access to capital markets
and aligning the company’s listing with the location of its
primary market and operations. To that end, we were formed as a
wholly-owned subsidiary of IsoTis S.A. on November 3, 2006,
for the purpose of reorganizing IsoTis S.A. as a
U.S. company. On November 3, 2006, we applied to list
our shares on the NASDAQ Global Market. On December 15,2006, we commenced an exchange offer for all of the issued and
outstanding common shares of IsoTis S.A., pursuant to which we
offered to exchange one of our shares of common stock for each
ten common shares of IsoTis S.A. and planned to conduct a
second-step merger to acquire any shares that remained
outstanding after the consummation of the exchange offer.
On December 20, 2006, Pieter Wolters, our president and chief
executive officer, and Stuart Essig, the president and chief
executive officer of Integra, met and discussed the possibility
of a private label or distribution agreement for certain of our
products.
On January 8, 2007, we announced plans to raise between
$30 million and $40 million by offering newly issued
NASDAQ-listed shares of our common stock to the public in an
underwritten public offering. We intended to use the net
proceeds from the offering to support sales, marketing and
general administrative activities, clinical research and product
development, and to fund working capital and other general
corporate purposes.
On January 24, 2007, we initiated discussions with Merrill
Lynch Capital for a term loan to provide a cash buffer for our
operational needs in the event that we experienced a delay in
our public offering.
On January 26, 2007, our shares were listed and began
trading on the NASDAQ Global Market (ticker: ISOT).
On January 29, 2007, we filed a registration statement on
Form S-1
for our initial public offering in the United States.
On February 7, 2007, we received a letter from the FDA with
comments and questions regarding our 510(k) application for our
Accell products. The letter raised a question as to whether the
Accell products should be regulated as biologics, as tissue or
as a medical device. Moreover, if regulated as a medical device,
the letter questioned whether the Accell products are
Class II or Class III devices. We concluded based on
the FDA letter that FDA approval of our Accell products would
not occur during the first quarter of 2007, as we previously
anticipated, and possibly could occur significantly later.
In light of the FDA letter, we determined that our proposed
public offering of common stock would be very difficult to
complete because the public would likely be unable to properly
assess the risk of a lengthy FDA approval process. On
February 12, 2007, our board of directors authorized the
withdrawal of our registration statement. On February 13,2007, we filed a request to withdraw our
Form S-1
registration statement that had been filed with the SEC on
January 29, 2007.
Following these events, our board of directors and management
conducted an in-depth strategic planning review to explore
options for raising the capital necessary for us to continue
operating our business in the short and long-term. On
February 12, 2007, our board of directors approved the
engagement of Thomas Weisel Partners to assist us with
identifying options for an offering by private placement of our
equity, equity-linked or debt securities in hopes of raising up
to $20 million to $25 million to be used for working
capital and other general corporate purposes, sales, marketing
and general administrative activities, and research and
development activities.
From February 2007 through April 2007, we had a number of
discussions with Integra regarding a possible private label or
distribution agreement for certain of our products.
On March 16, 2007, Thomas Weisel Partners commenced
discussions with potential private placement investors. Between
March 16, 2007 and May 21, 2007, we approached
approximately 60 investors, 40 on a named basis. Twenty-two of
these investors began performing due diligence on us.
On March 28, 2007, our management met with the FDA to
discuss the FDA’s letter concerning our 510(k) application
for our Accell products.
On April 19, 2007, Merrill Lynch Capital informed us that
it would not provide us a term loan because of the risk of a
lengthy FDA approval process for our Accell products.
On April 27, 2007, the FDA sent us a letter indicating that
it deemed the Accell products to be medical devices. The FDA
verbally informed us that it would continue to review our
pending 510(k) application and would not require a premarket
approval application.
On May 1, 2007, we re-initiated discussions with Merrill
Lynch Capital for a term loan.
On May 7, 2007, as a result of unsuccessful efforts to
obtain financing and our continued capital constraints, our
board of directors authorized management to approach potential
acquirors in order to explore the potential for a strategic
transaction with these parties. On May 8, 2007, our
management and Thomas Weisel Partners began contacting potential
acquirors. On May 10, 2007, we entered into a
confidentiality agreement and began sharing information with a
potential strategic acquiror in hopes of pursuing a potential
transaction, but we did not receive an indication of interest
from this party.
On May 18, 2007, our board of directors held a telephonic
meeting to discuss developments regarding potential private
financing and strategic transactions. The board authorized our
management to approach a broader group of potential buyers. In
addition, we entered into a confidentiality agreement with
Integra on May 18, 2007. Pursuant to this confidentiality
agreement, we began providing Integra and its advisors with
confidential information about our business for the purpose of
Integra’s evaluation of a potential transaction.
Throughout May 2007, we approached a total of 15 potential
strategic acquirors, two of whom requested management
presentations from us.
On May 21, 2007, Integra made a non-binding verbal offer to
acquire IsoTis in an at-market transaction. The closing price of
our common stock on this date was $6.42.
On May 21, 2007, our board of directors held a telephone
meeting to discuss the verbal indication of interest submitted
by Integra. Following a discussion, our board of directors
concluded that Integra’s proposal was insufficient and
authorized management and Thomas Weisel Partners to reject the
proposal. Thomas Weisel Partners advised Integra of the
board’s conclusion and invited Integra to submit a revised
bid, along with other potential bidders, by May 30, 2007.
On May 29, 2007, Merrill Lynch Capital and Silicon Valley
Bank agreed to provide us a $20 million credit facility.
The credit facility requires us to raise an additional
$20 million in funding by August 31, 2007. If we fail
to raise this additional financing, we will be required to pay
back Merrill Lynch $7.5 million by September 1, 2007.
On May 30, 2007, Integra submitted a revised indication of
interest to us. In the revised offer, Integra proposed a
stock-for-stock transaction and indicated its willingness to
entertain an at-market deal. However, Integra’s proposal
also provided that the price of our common stock had risen to
levels that made an at-market transaction less attractive to
Integra, and that Integra was concerned that our current share
price overestimated the underlying value of our business.
Integra’s proposal also stated that it would require that
we agree to pay Integra a
“break-up
fee” of 5% of the equity value of the transaction and also
reimburse it for the expenses it incurred in connection with the
transaction.
We also received a letter from a third-party potential strategic
acquiror on May 30, 2007 proposing three options for a
transaction with us. The first option involved our issuance of
$10 million of senior secured convertible debt but the
third party noted in the letter that this option would be
difficult for the party to consummate. The second option
involved the creation of a new
50-50 joint
venture between us and the third party. The third option
involved a potential partnering transaction where the third
party would find another party to jointly acquire us.
On June 1, 2007, our board of directors held a telephonic
meeting during which management made a presentation on the
status of the financing search, as well as the proposals
submitted by Integra and the third party on May 30, 2007.
Representatives of Latham & Watkins LLP, our outside
counsel, provided an overview of the board of directors’
fiduciary duties in the potential transactions. Following a
discussion, the board determined that it was not in the best
interests of us or our stockholders to rely on a private
financing as a primary strategic option because it was unlikely
that the company would obtain private financing on acceptable
terms. Management then discussed the status of discussions with
potential strategic acquirors, including the proposals submitted
by Integra and the third party. The board discussed, among other
things, the nature of the potential strategic acquirors, the
likelihood of closing a potential transaction, the timing
involved in negotiating and completing a potential transaction
and a comparison of these transactions to other alternatives
available to us. Based on the discussion, the board authorized
management to continue its discussions with Integra and obtain
additional clarity regarding the terms of a potential
transaction, including price. The board concluded
that the proposal submitted by the third party was unlikely to
lead an acceptable transaction and instructed Thomas Weisel
Partners to seek a more attractive proposal from the party.
Following a discussion with Thomas Weisel Partners, this third
party indicated that it was not able to modify its proposal.
On June 5, 2007, our board of directors held a special
telephonic meeting to receive an update on Integra’s
proposal to acquire us. Management and representatives from
Thomas Weisel Partners summarized the discussions to date with
Integra, including Integra’s verbal offer to increase the
offer price to $7.00 per share of our common stock. As a
condition to moving forward with a transaction, Integra
indicated that it would require us to negotiate exclusively with
Integra regarding a sale of the company. Management also advised
the board that no other potential strategic acquirors who had
been previously contacted were currently interested in acquiring
us, other than the party that submitted a bid on May 30,2007 which had not since submitted a revised proposal. The board
then authorized management to continue negotiations with
Integra, including seeking an increase in the offer price and a
reduction in the duration of the exclusivity period. Management
also informed the board that management continued to be
unsuccessful in its efforts to obtain acceptable terms on a
private financing.
On June 8, 2007, Integra submitted a revised proposal for a
stock-for-stock transaction. Pursuant to the revised proposal,
Integra (1) increased its offer to $7.25 per share of our
common stock, subject to a collar, (2) shortened the
duration of the exclusivity period from July 31, 2007 to
July 15, 2007, and (3) agreed to permit us to continue
our discussions with potential financing sources during the
exclusivity period. Integra’s proposal also stated that it
would require that we agree to pay Integra a
“break-up
fee” of $2.25 million and also reimburse it for the
expenses it incurred in connection with the transaction.
Later that day, our board of directors held a special telephonic
meeting where our management and financial advisors discussed
the terms of Integra’s offer, including the proposed price,
length and scope of the exclusivity period and size of the
breakup fee. The board also discussed the lack of interest by
other potential strategic parties in pursuing a transaction with
us. The board then authorized management to enter into an
exclusivity agreement with Integra on the terms presented to the
board.
On June 15, 2007, we received a due diligence request
letter from Integra. From June 15, 2007 through
August 6, 2007, Integra conducted an extensive due
diligence review of IsoTis.
On June 18 and 19, 2007, members of our and Integra’s
management met with each other and gave management presentations
regarding their respective companies to each other.
On June 22, 2007, our board of directors held a special
telephonic meeting to review with members of our senior
management the status of the discussions with Integra and
Integra’s due diligence review. Representatives of
Latham & Watkins LLP provided an overview of the board
of directors’ fiduciary duties in the potential
transaction. At this meeting, the board and management also
discussed the financing alternatives under consideration. Thomas
Weisel Partners informed the board of directors of the
continuing lack of interest among potential financing sources in
pursuing a transaction with us. In addition, our board of
directors approved the agreement and other matters required for
the merger of IsoTis S.A. into IsoTis International SA, that
would complete the transactions contemplated by the exchange
offer and result in IsoTis S.A. becoming our wholly-owned
subsidiary.
On June 26, 2007, Integra’s counsel, Willkie
Farr & Gallagher LLP, distributed an initial draft of
a merger agreement to us and our counsel.
On June 29, 2007, we entered into a confidentiality
agreement with Integra whereby we agreed to maintain the
confidentiality of information Integra would provide to us for
purposes of our evaluation of a potential transaction.
On July 2, 2007, Latham & Watkins LLP, delivered
a revised merger agreement to Integra and its counsel. Between
July 2, 2007 and August 6, 2007, we, Integra and our
respective advisors discussed the terms of the proposed merger
agreement on numerous occasions. Among other terms, we discussed
the
proposed representations and warranties, covenants, conditions
to closing the merger, deal protection and termination
provisions and termination fees.
On July 2 and 3, 2007, Integra’s management made a
presentation to our management, which was also attended by
representatives from Thomas Weisel Partners, regarding its
operations, and members of our management and Integra’s
management had meetings to discuss the potential transaction and
our operations.
From July 2, 2007 through August 6, 2007, members of
our and Integra’s management teams held numerous
discussions regarding due diligence matters communications plans
and various other matters related to the potential transaction.
During certain of these discussions, Integra’s management
reiterated to our management that Integra was not willing to
increase the offer price in excess of $7.25 per share.
On July 13, 2007, our board of directors met in person in
Costa Mesa, California to review the progress of discussions
with Integra, our financing alternatives, our operational plan
going forward and the strategic alternatives to pursuing the
potential transaction with Integra. Representatives of
Latham & Watkins LLP provided an overview of the board
of directors’ fiduciary duties in the potential transaction
and a summary of the terms and condition of the draft merger
agreement, including the various issues that remained subject to
negotiation, including the deal protection, termination and
termination fee provisions. Management and representatives of
Thomas Weisel Partners made a presentation on the risks
associated with Integra’s business and issues regarding the
potential transaction with Integra. Management informed the
board that it had received a draft term sheet from a potential
financial investor. After a review of the proposed terms of the
financing, the board concluded that the proposed financing was
subject to various conditions that were not able to be satisfied
by us and would not likely provide sufficient funds to maintain
our operations for an extended period of time. Despite having
contacted approximately 60 potential investors, we had received
financing proposals from only this potential investor and the
party who submitted a proposal on May 30, 2007. The board
also approved, and later that day we entered into, an extension
of our exclusivity agreement with Integra through July 29,2007.
On July 23, 2007, we accomplished the final step of the
transactions contemplated by the exchange offer by consummating
a second-step merger, pursuant to which the remaining 9.5% of
the issued and outstanding shares of IsoTis S.A. common stock
were exchanged for shares of our common stock at the same
exchange ratio as used in the exchange offer.
On July 24, 2007, we received a draft distribution
agreement from Integra, pursuant which we would agree to
manufacture certain of our products (other than our Accell
products) under Integra’s label. We also received a draft
option agreement from Integra pursuant to which Integra would
have the option to include our Accell products in the
distribution agreement. Between July 24, 2007 and
August 6, 2007, we and our advisors had numerous
discussions with Integra and its advisors regarding the terms
and conditions of the distribution agreement and the option
agreement, including our willingness to pursue such arrangements
only if they contained market terms and were otherwise in the
best interests of IsoTis.
On July 26, 2007, Integra proposed pursuing an all cash
transaction rather than a stock transaction and indicated that
it was no longer willing to pursue a stock transaction.
On July 27, 2007, our board of directors held a special
telephonic meeting to receive an update on the potential
transaction with Integra, at which time our management informed
the board that Integra had now proposed an all cash transaction.
Representatives of Latham & Watkins LLP also informed
our board of its fiduciary obligations when considering the
potential transaction with Integra. After a lengthy discussion,
the board concluded to proceed with discussions with Integra
regarding an all cash transaction. The board also authorized the
extension of the exclusivity period to August 6, 2007.
Later on July 27, 2007, we entered into an extension of our
exclusivity agreement with Integra through August 6, 2007.
On August 4, 2007, our board of directors held a special
telephonic meeting to discuss the progress of negotiations with
Integra. Prior to the meeting, our board of directors was
provided with drafts of the merger agreement, the distribution
agreement and the option agreement. At the meeting:
•
Mr. Wolters reviewed the history of the discussions between
us and Integra;
representatives of Latham & Watkins LLP reviewed with
our board of directors their fiduciary duties when considering
the proposed transaction;
•
members of our management discussed the strategic alternatives
available to us and our prospects on a stand-alone basis,
including the likelihood that we will run out of cash to
continue our operations after October 2007;
•
representatives of Latham & Watkins LLP also reviewed
with our board of directors the terms and conditions of the
proposed merger agreement, distribution agreement and option
agreement; and
•
representatives of Thomas Weisel Partners discussed certain
financial analyses related to the proposed transaction.
The board authorized management to finalize negotiations with
Integra.
On August 6, 2007, our board of directors held a special
telephonic meeting in the afternoon to consider the proposed
transaction with Integra. Prior to the meeting, our board of
directors was provided with substantially final drafts of the
merger agreement, the distribution agreement and the option
agreement. At the meeting:
•
Mr. Wolters provided the board with an update as to the
discussions with Integra and reviewed the final terms of the
proposed transaction;
•
representatives of Latham & Watkins LLP reviewed with
our board of directors their fiduciary duties when considering
the proposed transaction;
•
members of our management discussed the strategic alternatives
available to us and our prospects on a stand-alone basis,
including our inability to raise additional financing and the
likelihood that we would run out of cash to continue our
operations after October 2007;
•
representatives of Latham & Watkins LLP again reviewed
with our board of directors the terms and conditions of the
proposed merger agreement, the distribution agreement and the
option agreement; and
•
representatives of Thomas Weisel Partners discussed certain
financial analyses related to the proposed transaction and
delivered its opinion described herein that the consideration to
be received by holders of our common stock pursuant to the
proposed transaction was fair from a financial point of view to
such holders, which was subsequently confirmed in a written
opinion dated August 6, 2007. See “— Opinion of
Thomas Weisel Partners LLC.”
After discussions with management and our financial and legal
advisors, our board of directors unanimously determined it to be
in our best interest and the best interests of our stockholders
to enter into the merger agreement and consummate the merger on
the terms set forth in the merger agreement. Our board of
directors resolved unanimously to adopt the merger agreement and
to approve the other transactions contemplated by the merger
agreement, and resolved unanimously to recommend that our
stockholders vote to adopt the merger agreement and to approve
the transactions contemplated by the merger agreement. The board
also unanimously approved the distribution agreement and the
option agreement.
The merger agreement, the distribution agreement and the option
agreement were executed by the parties on the evening of
August 6, 2007.
On August 7, 2007, before the opening of the
U.S. markets, we and Integra issued a joint press release
announcing the execution of the merger agreement.
Our board of directors, by the unanimous vote of all directors:
•
approved and adopted the merger agreement and other transactions
contemplated by the merger agreement, and declared the merger to
be advisable to our stockholders; and
determined that it was in the best interests of us and our
stockholders to enter into the merger agreement and consummate
the merger on the terms and conditions set forth in the merger
agreement.
Accordingly, our board of directors recommends that you vote
“FOR” the adoption of the merger agreement and
approval of the merger.
In reaching its determination to approve and adopt the merger
agreement and the transactions contemplated thereby and to
recommend that you vote in favor of the proposal to adopt the
merger agreement and approve the merger, our board of directors
consulted with our management, as well as our legal and
financial advisors. These consultations included discussions
regarding our strategic business plans, the historical prices
for our common stock, our past and current business operations
and financial condition, our shortage of cash needed to continue
operations, our future prospects, our unsuccessful attempts to
find financial and strategic partners and the potential merger
with Integra. Our board of directors consulted with Thomas
Weisel Partners as to the fairness, from a financial point of
view, to our stockholders of the merger consideration. Based on
its discussions and consultations, our board of directors also
concluded that the only reasonably likely alternative to
entering into the merger agreement with Integra would be
bankruptcy.
Our board of directors considered a number of positive factors
in its deliberations:
•
the merger consideration of $7.25 per share of our common stock
represents an approximately 5.4% premium over the closing
price of our common stock on August 6, 2007, the last
trading day prior to the announcement of the transaction;
•
the view of management that the trading value for shares of our
common stock was not likely to exceed the $7.25 per share merger
consideration in the foreseeable future if we remained
independent;
•
our board considered the presentation by Thomas Weisel Partners
on August 6, 2007, and its opinion that, as of
August 6, 2007, and based on and subject to the assumptions
made, matters considered and qualifications and limitations on
the scope of review undertaken by Thomas Weisel Partners, as set
forth in its opinion, the consideration to be received by
holders of our common stock in the merger was fair, from a
financial point of view, to such holders;
•
the lack of any other viable financing or strategic alternatives
available to us that would be expected to enhance stockholder
value, despite our extensive efforts to pursue such alternatives
since the withdrawal of our initial public offering;
•
the risks of remaining independent, including our
management’s assessment that if we remain independent, we
likely will not be able to obtain financing and will run out of
cash to continue our operations after October 2007, requiring us
to consider seeking bankruptcy protection;
•
the fact that we are currently operating at net income and cash
flow deficits, both of which are expected to continue for the
foreseeable future;
•
the fact that raising funds through private financing, even if
successful, would necessarily result in substantial dilution to
our existing stockholders and a decrease in the value of our
common stock;
•
the fact that the merger consideration consists solely of cash,
which provides immediate liquidity and certainty of value to our
stockholders compared to a transaction in which stockholders
would receive stock;
•
management’s assessment, after consultation with its
financial advisors, that Integra will have adequate capital
resources to pay the merger consideration;
•
the view of our board of directors, after receiving the advice
of management and after consultation with our legal counsel,
that regulatory approvals necessary to consummate the merger, if
any, are likely to be obtained;
our ability under the merger agreement to furnish information to
and conduct negotiations with a third party in certain
circumstances, as more fully described under “The Merger
Agreement — Covenants — No Solicitation of
Acquisition Proposals”;
•
the board of directors’ ability to modify and change its
recommendation of the transaction in certain circumstances if
required by its fiduciary obligations to the stockholders;
•
the fact that the merger would be subject to the approval of our
stockholders and that our stockholders would be free to reject
the merger, provided that we comply with certain requirements
including reimbursement of up to $1.5 million of
Integra’s expenses incurred in connection with the proposed
merger and, in certain circumstances, the payment of the
termination fee of $2.25 million (less any expenses
previously reimbursed);
•
our board of directors can terminate the merger agreement if a
superior proposal for an alternative transaction were to be made
by a third party;
•
the fact that the merger agreement provides sufficient operating
flexibility for us to conduct our business in the ordinary
course between the signing of the merger agreement and the
consummation of the merger;
•
the availability of appraisal rights for our stockholders who
properly exercise these statutory rights;
•
the consolidation occurring in the medical device
industry; and
•
the risks associated with operating a medical device company,
including competition and the potential for our products to
become obsolete.
Our board of directors also considered potential drawbacks or
risks relating to the merger, including the following:
•
we will no longer exist as an independent company and our
stockholders will no longer participate in our future prospects;
•
the merger agreement precludes us from actively soliciting
alternative proposals;
•
we are obligated to pay Integra a termination fee of
$2.25 million if we or Integra terminate the merger
agreement under certain circumstances, which may deter others
from proposing alternative transactions that might be more
advantageous to our stockholders;
•
while the merger is expected to be consummated, there can be no
assurance that all conditions to the parties’ obligations
to consummate the merger will be satisfied, and as a result, it
is possible that the merger may not be consummated even if the
merger agreement is adopted by our stockholders. See “The
Merger Agreement — Conditions to the Merger.” If
the merger does not close, we may incur significant risks and
costs, including the possibility of disruption to our
operations, diversion of management and employee attention,
employee attrition and a potentially negative effect on business
and customer relationships;
•
our management projects that if the merger does not close and we
fail to obtain alternative financing, we will not be able to
fund our operations past October 2007 and we likely will need to
seek bankruptcy protection;
•
the potential impact of the transaction on our employees,
including the probability that jobs will be eliminated;
•
the risk that the merger will not be approved by the appropriate
governmental authorities; and
•
the merger will be a taxable transaction and, therefore, our
common stockholders generally will be required to pay tax on any
gains they recognize as a result of the receipt of cash in the
merger.
Our board of directors also considered that certain of our
directors and officers may have conflicts of interest in
connection with the merger, as they may receive certain benefits
that are different from, and in
addition to, those of our other stockholders. See “—
Interests of our Directors and Executive Officers in the
Merger.”
After taking into account all of the factors set forth above, as
well as others, our board of directors unanimously agreed that
the benefits of the merger outweigh the risks and that the
transactions contemplated by the merger agreement, including the
merger, are advisable and in the best interests of our
stockholders. Our board of directors has unanimously approved
the merger agreement and the merger and recommends that our
stockholders vote to adopt the merger agreement and the merger
at the special meeting. Based on its discussions and
consultations with its advisors, our board of directors has
concluded that the only reasonably likely alternative to
entering into the merger agreement with Integra (which our board
of directors concluded offered our stockholders fair value for
their shares) would be to seek bankruptcy protection.
The foregoing discussion is not intended to be exhaustive, but
we believe it addresses the material information and principle
factors considered by our board of directors in its
consideration of the merger. In view of the number and variety
of factors and the amount of information considered, our board
of directors did not find it practicable to, and did not make
specific assessments of, quantify or otherwise assign relative
weights to, the specific factors considered in reaching its
determination. In addition, our board of directors did not
undertake to make any specific determination as to whether any
particular factor, or any aspect of any particular factor, was
favorable or unfavorable to its ultimate determination, and
individual members of our board of directors may have given
different weights to different factors. Our board of directors
made its recommendation based on the totality of information
presented to, and the investigation conducted by, the board of
directors.
On July 18, 2007, we engaged Thomas Weisel Partners LLC to
act as our financial advisor in connection with the merger and
to render to our board of directors an opinion as to the
fairness, from a financial point of view, to the holders of our
common stock, of the merger consideration payable pursuant to
the merger agreement. We selected Thomas Weisel Partners to act
as our financial advisor in connection with the merger based on
Thomas Weisel Partners’ experience, expertise and
reputation, and its familiarity with our business.
On August 6, 2007, Thomas Weisel Partners delivered to our
board of directors its written opinion that, as of that date,
and based upon and subject to the assumptions made, matters
considered and limits of review set forth in Thomas Weisel
Partners’ written opinion, the merger consideration to be
received by holders of our common stock pursuant to the merger
agreement was fair, from a financial point of view, to such
holders.
The full text of Thomas Weisel Partners’ written opinion,
which sets forth, among other things, the assumptions made,
procedures followed, matters considered and limitations on the
scope of the review undertaken by Thomas Weisel Partners in
delivering its opinion, is attached as Annex B to
this proxy statement and is incorporated herein by reference.
Stockholders should read the opinion carefully and in its
entirety. The following description of Thomas Weisel
Partners’ opinion is only a summary of the written opinion,
is qualified in its entirety by the written opinion and is not a
substitute for the written opinion.
Thomas Weisel Partners directed its opinion to our board of
directors in its consideration of the merger. The opinion was
one of a number of factors considered by our board of directors
in deciding to approve the merger. The opinion does not
constitute a recommendation to our stockholders as to how they
should vote with respect to the merger. The opinion addresses
only the fairness, from a financial point of view, of the
consideration to be received by the holders of our common stock
in the merger, as of the date of the opinion. It does not
address the underlying or relative merits of the merger or any
related transaction and any other transactions or business
strategies discussed by our board of directors or that might be
available as alternatives to the merger. Further, it does not
address our underlying decision to proceed with or effect the
merger, or any other aspect of the merger.
In connection with rendering its opinion, Thomas Weisel
Partners, among other things:
•
reviewed a copy of the merger agreement, and the financial terms
and conditions set forth therein, as well as the schedules
thereto;
reviewed certain publicly available information concerning us,
including our Quarterly Report on
Form 10-Q
for the period ended March 31, 2007;
•
reviewed certain unaudited internal information, primarily
financial in nature and including financial forecasts for the
fiscal years ending December 31, 2007 through
December 31, 2012, as well as unaudited financial
information for the period ending June 30, 2007, prepared
and furnished to Thomas Weisel Partners by our management for
purposes of Thomas Weisel Partners’ analysis;
•
reviewed certain publicly available information concerning the
trading of, and the trading market for, our common stock;
•
reviewed certain publicly available information with respect to
certain other companies that it believed to be comparable to us
and the trading markets for certain of such other
companies’ securities;
•
compared the proposed financial terms of the merger with certain
publicly available information concerning the nature and terms
of certain other transactions that it considered to be relevant;
•
discussed our past and current operations and financial
condition and our prospects, as well as other matters Thomas
Weisel Partners believed relevant to its inquiry, with certain
of our officers and employees; and
•
conducted such other financial studies, analyses and
investigations, and considered such other information, as Thomas
Weisel Partners deemed necessary or appropriate, including its
assessment of general financial, economic, market and other
conditions.
In its review and analysis and in arriving at its opinion,
Thomas Weisel Partners relied upon, without any responsibility
for independent verification or liability therefor, the accuracy
and completeness of all of the financial and other information
that was publicly available or supplied or otherwise made
available to it by us, and upon assurances of our management
that no relevant information was omitted or remained undisclosed
to it. Thomas Weisel Partners was not engaged to, and did not
independently attempt to, verify any of such information. Thomas
Weisel Partners has also made the following assumptions:
•
with respect to our financial and operating forecasts provided
to Thomas Weisel Partners by our management, Thomas Weisel
Partners relied upon our management as to the reasonableness and
achievability of such forecasts (and the assumptions and bases
therefor) provided to it and, with the consent of our board of
directors, assumed that such forecasts reflected the best
currently available estimates and judgments of our management,
and Thomas Weisel Partners expressed no opinion with respect to
such forecasts or any of the analyses or the assumptions upon
which they were based. Thomas Weisel Partners was not engaged to
assess the reasonableness or achievability of such forecasts or
the assumptions on which they were based. Thomas Weisel Partners
further understood from us that our ability to continue as a
going concern and achieve the results reflected in its financial
and operating forecasts was dependent on us raising a
significant amount of new capital in the near future, and that
our ability to raise such capital within the necessary time
frame was unlikely. In addition, Thomas Weisel Partners has not
evaluated or appraised any of our assets, properties or
facilities nor has it been furnished with any such evaluation or
appraisal;
•
that there had been no material changes in our assets, financial
condition, results of operations, business or prospects since
the respective dates of its last financial statements made
available to Thomas Weisel Partners;
•
that all the representations and warranties of each party
contained in the merger agreement were true and correct, that
each party to the merger agreement will perform all of the
covenants and agreements required to be performed by it
thereunder without any consents or waivers of the other parties
thereto, and that all conditions to the consummation of the
proposed merger will be satisfied without waiver thereof;
that the proposed merger will be consummated in a manner that
complies in all respects with the applicable provisions of the
Securities Exchange Act of 1934, as amended, and all other
applicable federal and state statutes, rules and
regulations; and
•
that the merger will be consummated in accordance with the terms
described in the merger agreement and in compliance with all
applicable law.
In addition:
•
Thomas Weisel Partners noted that it was not a legal, tax or
regulatory expert, and that it had made no independent
investigation of any legal matters involving us or the merger,
and that it assumed the correctness of all statements with
respect to legal matters made or otherwise provided to us and
Thomas Weisel Partners by counsel;
•
Thomas Weisel Partners’ opinion was not, and should not be
construed as, a valuation of us or our respective assets or any
of our common stock, and Thomas Weisel Partners expressed no
opinion as to the price at which our common stock will trade at
any future time; and
•
Thomas Weisel Partners’ opinion was necessarily based on
economic, monetary, market and other conditions as in effect on,
and the information made available to Thomas Weisel Partners as
of, the date of its opinion, and thus the opinion did not
address any matters subsequent to such date. Accordingly,
although subsequent developments may affect its opinion, Thomas
Weisel Partners does not have any obligation to update, revise
or reaffirm its opinion after the date thereof, and it
disclaimed any undertaking or obligation to advise any person of
any change in any fact or matter affecting its opinion which may
come or be brought to its attention after the date of its
opinion.
The following represents a brief summary of the material
financial analyses performed by Thomas Weisel Partners in
connection with providing its opinion to our board of directors.
Some of the summaries of financial analyses performed by Thomas
Weisel Partners include information presented in tabular format.
In order to fully understand the financial analyses performed by
Thomas Weisel Partners, you should read the tables together with
the text of each summary. The tables alone do not constitute a
complete description of the underlying financial analyses
performed by Thomas Weisel Partners. Considering the data set
forth in the tables without considering the full narrative
description of the financial analyses, including the
methodologies and assumptions underlying the analyses, could
create a misleading or incomplete view of the financial analyses
performed by Thomas Weisel Partners. Except as indicated, the
quantitative information below (to the extent based on market
data) is based on market data as it existed on or before
August 3, 2007 and is not necessarily indicative of current
market conditions.
Financial
Forecast Assumptions
Certain of Thomas Weisel Partners’ analyses were based on
our estimates as of August 3, 2007 for two cases: one which
assumed that we would raise $5 million in capital to fund
our ongoing operations (the “Minimally Financed
Case”), and one which assumed that we would raise
$20 million in capital to fund our ongoing operations (the
“Fully Financed Case”). Both cases assumed positive
outcomes for planned clinical studies. Thomas Weisel Partners
based such analyses on the assumption that additional capital
funding (and related dilution to our existing stockholders) was
necessary to support both a Minimally Financed Case and a Fully
Financed Case. Based on the views of our management, Thomas
Weisel Partners assumed that our current stockholders would be
diluted by 10%-30% in order to raise the $5 million
necessary to support the Minimally Financed Case, and by 35%-65%
in order to raise the $20 million necessary to support the
Fully Financed Case. Thomas Weisel Partners accounted for such
dilution when calculating the implied value of the merger to our
current stockholders. In addition, such analyses assumed an
adding back of proceeds, net of fees, of $4.5 million from
the capital raised in the Minimally Financed Case and of
$18.5 million from the capital raised in the Fully Financed
Case. Relevant multiples and values are highlighted for each
such analysis.
Based on public and other available information, Thomas Weisel
Partners calculated the implied enterprise value (which Thomas
Weisel Partners defined as implied equity value plus total debt
less cash and cash equivalents), implied equity value to our
current stockholders and implied per share equity value to our
current stockholders using multiples for selected medical
technology companies of enterprise value (based on closing stock
prices on August 3, 2007) to estimated revenue for
2007 and 2008 and enterprise value to estimated earnings before
interest, taxes, depreciation and amortization, or EBITDA, for
2008. Estimates for the selected companies were based on
publicly available investment banking research. Projected 2007
and 2008 information for us used in the analysis was based on
our management estimates for both the Minimally Financed Case
and the Fully Financed Case. The selected public companies
analysis compared us to five companies contained in the relevant
peer group. Thomas Weisel Partners did not include every company
that could be deemed to be a participant in the same industry as
us, or in any specific sectors of this industry. Thomas Weisel
Partners believed that the five companies listed below had
operations similar to some of our operations, but noted that
none of these companies had the same management, composition,
size or combination of businesses as us:
•
Exactech
•
Orthovita
•
Osteotech
•
Regeneration
•
Wright Medical
In addition, a subset of three of the preceding companies was
selected based on the determination by Thomas Weisel Partners
that such companies shared more similar growth characteristics
with us than the other two companies. Accordingly, the
applicable multiples of the following companies were used to
calculate the implied enterprise value, the implied equity value
to our current stockholders, and the implied per share equity
value to our current stockholders:
•
Exactech
•
Osteotech
•
Wright Medical
The multiples derived from enterprise values and estimated
EBITDA of the three selected companies listed above were
calculated using data that excluded all extraordinary items and
non-recurring charges, and were pro forma for material changes
(e.g., capital raises, debt issuances, etc.). In each case,
Thomas Weisel Partners
utilized the multiples derived from its analysis to calculate
the resulting valuation ranges based upon our applicable
estimated revenue and EBITDA. All figures are in millions except
multiples and per share data.
Enterprise Value/
Revenue
2007E
Osteotech
1.1x
Exactech
1.8x
Wright Medical
2.2x
Implied IsoTis Enterprise Value
(Minimally Financed Case)
$43-$86 MM
Implied IsoTis Equity Value to
Current Stockholders (Minimally Financed Case)
$33-$81 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Minimally Financed Case)
$4.66-$11.42
Implied IsoTis Enterprise Value
(Fully Financed Case)
$51-$101 MM
Implied IsoTis Equity Value to
Current Stockholders (Fully Financed Case)
$24-$78 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Fully Financed Case)
$3.41-$10.99
Enterprise Value/
Revenue
2008E
Osteotech
1.0x
Exactech
1.6x
Wright Medical
1.9x
Implied IsoTis Enterprise Value
(Minimally Financed Case)
$35-$66 MM
Implied IsoTis Equity Value to
Current Stockholders (Minimally Financed Case)
$28-$64 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Minimally Financed Case)
$3.88-$8.97
Implied IsoTis Enterprise Value
(Fully Financed Case)
$57-$107 MM
Implied IsoTis Equity Value to
Current Stockholders (Fully Financed Case)
$26-$82 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Fully Financed Case)
$3.70-$11.53
Enterprise Value/
EBITDA
2008E
Osteotech
7.7x
Exactech
8.3x
Wright Medical
10.1x
Implied IsoTis Enterprise Value
(Minimally Financed Case)
$45-$59 MM
Implied IsoTis Equity Value to
Current Stockholders (Minimally Financed Case)
$34-$57 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Minimally Financed Case)
$4.85-$7.99
Implied IsoTis Enterprise Value
(Fully Financed Case)
$21-$27 MM
Implied IsoTis Equity Value to
Current Stockholders (Fully Financed Case)
$14-$30 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Fully Financed Case)
$1.93-$4.17
Thomas Weisel Partners noted that the merger consideration to be
received by the holders of our common stock in the merger was
$7.25 per share, which was in the range of values implied by
this analysis.
Based on public and other available information, Thomas Weisel
Partners calculated the implied enterprise value, implied equity
value to our current stockholders, and implied per share equity
value to our current stockholders based on multiples of
enterprise value to latest reported twelve months (or LTM)
revenue and next twelve months (or NTM) revenue with respect to
14 selected acquisitions for the time period from 2001 to
present, with transaction values from $25 million to
$150 million and target revenues in excess of
$15 million per annum. In each case, Thomas Weisel Partners
used estimates based on public filings, news articles, press
releases, public Wall Street research analysts’ reports and
forecasts and other publicly available third party sources. The
acquisitions reviewed in this analysis were the following:
The following table sets forth the implied enterprise value,
implied equity value to our current stockholders and implied per
share equity value to our current stockholders based on the
multiples, as highlighted below, indicated by this analysis. Our
implied per share equity values listed below were based on a
range of multiples of first quartile to third quartile. In each
case, Thomas Weisel Partners utilized the multiples derived from
its
analysis to calculate the resulting valuation ranges based upon
our estimated LTM and NTM revenue. All figures are in millions
except multiples and per share data.
Enterprise Value/Revenue
LTM
NTM
Third Quartile
2.7x
1.7x
Mean
2.4x
1.4x
Median
2.2x
1.2x
First Quartile
1.2x
0.9x
Implied IsoTis Enterprise Value
$49-$109 MM
Implied IsoTis Equity Value Per
Share to Current Stockholders
$3.31-$11.70
Implied IsoTis Enterprise Value
(Minimally Financed Case)
$33-$63
Implied IsoTis Equity Value to
Current Stockholders (Minimally Financed Case)
$27-$61 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Minimally Financed Case)
$3.73-$8.56
Implied IsoTis Enterprise Value
(Fully Financed Case)
$49-$92 MM
Implied IsoTis Equity Value to
Current Stockholders (Fully Financed Case)
$23-$72 MM
Implied IsoTis Per Share Equity
Value to Current Stockholders (Fully Financed Case)
$3.31-$10.11
Thomas Weisel Partners again noted that the merger consideration
to be received by the holders of our common stock in the merger
was $7.25 per share, which was within the range of values
implied by this analysis.
No company or transaction used in the comparable company
analysis or the comparable transactions analysis is identical to
us or the merger. Accordingly, an analysis of the results of the
foregoing is not mathematical; rather, it involves complex
considerations and judgments concerning differences in financial
and operating characteristics of the companies and other factors
that could affect the public trading value of the companies to
which we and the merger are being compared.
Discounted
Cash Flow Analysis
Thomas Weisel Partners used free cash flow forecasts based on
estimates provided by our management for the full calendar years
2007 through 2012, both for the Minimally Financed Case and the
Fully Financed Case, to perform a discounted cash flow analysis.
In conducting this analysis, Thomas Weisel Partners assumed that
we would perform in accordance with these forecasts. Thomas
Weisel Partners also assumed, based on the guidance of our
management, that our ability to continue as a going concern and
achieve the results reflected in the financial and operating
forecasts was dependent on us raising a significant amount of
new capital in the near future and that our ability to raise
such capital within the necessary time frame is unlikely. Thomas
Weisel Partners first estimated the discounted value of the
projected cash flows using discount rates ranging from 20% to
25%, which range of discount rates was selected based upon a
weighted average cost of capital analysis for us and other
medical devices companies with similar operating profiles plus a
small cap premium. Thomas Weisel Partners then calculated a
terminal value based on EBITDA exit multiples of 8.0x-12.0x
(based on the trading multiples of selected public companies).
These terminal values were discounted to present value using
discount rates ranging from 20% to 25%. This analysis indicated
a range of implied enterprise value, to which cash and cash
equivalents were added and from which debt was subtracted, to
calculate a range of implied equity value. This analysis
indicated a range of implied per share equity value to our
current stockholders ranging from $5.11 to $8.81 for the
Minimally Financed Case, and $7.05 to $18.09 for the Fully
Financed Case. Thomas Weisel Partners noted that the merger
consideration to be received by the holders of our common stock
in the merger was $7.25 per share, which was within the range of
values implied by this analysis.
Based on public information, Thomas Weisel Partners reviewed the
consideration paid in 39 healthcare company acquisitions
announced since January 1, 2000 with transaction values
from $25 million to $150 million. Thomas Weisel
Partners calculated our implied price per share based on the
implied premiums paid in these transactions over:
•
the stock price of the target company one day prior to the
announcement of the acquisition;
•
the stock price of the target company one week prior to the
announcement of the acquisition; and
•
the stock price of the target company one month prior to the
announcement of the acquisition.
The implied per share equity values for us below were based on a
range of premiums of first quartile to third quartile. The
results of this analysis are summarized in the following table:
Average Stock Premium
1 Day
1 Week
1 Month
3rd Quartile
51.4%
62.9%
75.5%
Mean
41.2%
45.5%
59.2%
Median
39.9%
39.7%
46.7%
1st Quartile
23.9%
26.1%
29.6%
Implied IsoTis Per Share Equity
Value to Current Stockholders
$8.51-$10.40
$8.88-$11.47
$9.25-$12.52
Thomas Weisel Partners noted that the merger consideration to be
received by the holders of our common stock in the merger was
$7.25 per share, which was below the range of values implied by
this analysis.
Bankruptcy
Impact Analysis
Thomas Weisel Partners performed an analysis of the impact to
share price of the following selected healthcare companies
entering bankruptcy proceedings:
Using public and other available information with respect to the
foregoing selected companies, Thomas Weisel Partners calculated
a range of implied per share equity values to our existing
stockholders based on a comparison of:
•
the stock price of each selected company one month prior to the
announcement of bankruptcy; to
•
the stock price of each selected company one month after the
announcement of bankruptcy.
The per share equity values for us below were based on a range
of percentage impacts of first quartile to third quartile. The
results of the analysis are summarized in the following table:
Average Change in Stock Price
1 Month Pre/1 Month Post
Bankruptcy Announcement
3rd Quartile
(62.2
)%
Mean
(61.0
)%
Median
(66.4
)%
1st Quartile
(68.8
)%
Implied IsoTis Per Share Equity
Value to Current Stockholders
$
2.15-$2.60
Thomas Weisel Partners noted that the merger consideration to be
received by the holders of our common stock in the merger was
$7.25 per share, which was above the ranges of prices implied by
this analysis.
The foregoing description is only a summary of the analyses and
examinations that Thomas Weisel Partners deemed material to its
opinion. It is not a comprehensive description of all analyses
and examinations actually conducted by Thomas Weisel Partners.
The preparation of a fairness opinion necessarily is not
susceptible to partial analysis or summary description. Thomas
Weisel Partners believes that its analyses and the summary set
forth above must be considered as a whole and that selecting
portions of its analyses and of the factors considered, without
considering all analyses and factors, would create an incomplete
view of the process underlying the analyses set forth in its
presentation to our board of directors. In addition, Thomas
Weisel Partners may have given some analyses more or less weight
than other analyses, and may have deemed various assumptions
more or less probable than other assumptions. The fact that any
specific analysis has been referred to in the summary above is
not meant to indicate that this analysis was given greater
weight than any other analysis. Similarly, the order of analyses
described does not represent relative importance or weight given
to those analyses performed by Thomas Weisel Partners.
Accordingly, the ranges of valuations resulting from any
particular analysis described above should not be taken to be
the view of Thomas Weisel Partners with respect to the actual
value of our common stock.
In performing its analyses, Thomas Weisel Partners made numerous
assumptions with respect to industry performance, general
business and economic conditions and other matters, many of
which are beyond our control. The analyses performed by Thomas
Weisel Partners are not necessarily indicative of actual values
or actual future results, which may be significantly more or
less favorable than those suggested by these analyses. These
analyses were prepared solely as part of the analysis performed
by Thomas Weisel Partners with respect to the financial fairness
of the consideration to be received by holders of our common
stock pursuant to the merger as of the date of the opinion, and
were provided to our board of directors in connection with the
delivery of Thomas Weisel Partners’ opinion. The analyses
do not purport to be appraisals or to reflect the price for
which we might actually be sold or the prices at which any of
our securities may trade at any time in the future.
As described above, Thomas Weisel Partners’ opinion and
presentation were among the many factors that our board of
directors took into consideration in making its determination to
approve the merger agreement and the merger, and to recommend
that the our stockholders approve the the merger agreement and
the merger. We determined the consideration to be paid to the
holders of our common stock through arms’-length
negotiations with Integra. Although Thomas Weisel Partners
provided advice to us during the course of these negotiations,
the decision to enter into the merger agreement was solely that
of our board of directors. Thomas Weisel Partners did not
recommend any specific amount of consideration to us or our
board of directors, or that any specific amount of consideration
constituted the only appropriate consideration for the merger.
We did not impose any limitations on Thomas Weisel Partners with
respect to the investigation made or procedures followed in
rendering its opinion.
Pursuant to a letter agreement dated July 18, 2007, we
confirmed the engagement of Thomas Weisel Partners to render a
fairness opinion in connection with the proposed merger. We have
agreed to pay Thomas Weisel Partners for its financial advisory
services a cash success fee of $1.5 million, provided that
the success fee is to be reduced by $250,000 which became
payable to Thomas Weisel Partners by us upon delivery of the
fairness opinion. Our board of directors was aware of this fee
structure and took it into account in considering Thomas Weisel
Partners’ opinion and in approving the merger. Further, we
have agreed to reimburse Thomas Weisel Partners for its
reasonable out-of-pocket costs and expenses and to indemnify
Thomas Weisel Partners, its affiliates, and its respective
partners, directors, officers, agents, employees and controlling
persons against specific liabilities, including liabilities
under the federal securities laws.
In the ordinary course of its business, Thomas Weisel Partners
may actively trade the equity securities of us and Integra for
its own account and for the accounts of its customers and,
accordingly, may at any time hold a long or short position in
such securities.
In connection with Integra’s due diligence review of us, we
provided Integra with certain non-public business and financial
information about us. We also provided our financial advisor,
Thomas Weisel Partners, with these and other forecasts in
connection with its financial analysis of the merger
consideration and Thomas Weisel Partners considered these
forecasts in preparing the financial analysis it presented to
our board of directors (see “— Opinion of Thomas
Weisel Partners LLC”).
We have included below the material financial projections to
provide our stockholders access to certain nonpublic information
that was provided to these parties in connection with the
merger. The inclusion of this information should not be regarded
as an indication that any recipient of this information
considered, or now considers, these projections to be a reliable
prediction of our future results. We did not prepare the
projections with a view toward public disclosure or compliance
with published guidelines of the Securities and Exchange
Commission, the guidelines established by the American Institute
of Certified Public Accountants for preparation and presentation
of prospective financial information or generally accepted
accounting principles. Our independent registered public
accounting firm has neither examined nor compiled the
projections and, accordingly, does not express an opinion or any
other form of assurance with respect thereto.
The projections included below are forward-looking statements
that are subject to risks and uncertainties that could cause
actual results to differ materially from those shown below and
should be read with caution. See “Cautionary Statement
Concerning Forward-Looking Information” beginning on
page 13 of this proxy statement. The projections are
subjective in many respects and thus susceptible to
interpretations and periodic revisions based on actual
experience and developments occurring since the date the
projections was prepared. Although presented with numerical
specificity, the projections are based upon a variety of
estimates and hypothetical assumptions made by our management.
Some or all of the assumptions may not be realized, and they are
inherently subject to significant business, economic and
competitive uncertainties and contingencies, all of which are
difficult to predict and many of which are beyond our control,
and such uncertainties and contingencies can generally be
expected to increase with the passage of time from the dates of
the projections. Accordingly, the assumptions made in preparing
the projections might not prove accurate, and actual results
might differ materially. In addition, the projections do not
take into account any of the transactions contemplated by the
merger agreement, including the merger, which might also cause
actual results to differ materially.
For these reasons, as well as the bases and assumptions on which
the projections were compiled, the inclusion of the projections
in this proxy statement should not be regarded as an indication
that the projections will be an accurate prediction of future
events, and they should not be relied on as such.. No one has
made, or makes, any representation regarding the information
contained in the projections and we do not intend to update or
otherwise revise the projections to reflect circumstances
existing after the date when made or to reflect the occurrences
of future events even if any or all of the assumptions are shown
to be in error. You are cautioned not to rely on this
information in making a decision whether to vote in favor of
adoption of the merger agreement, thereby approving the merger.
The annual long-term forecasts are summarized below (dollars in
millions):
2007E
2008E
2009E
2010E
2011E
2012E
Total Revenue
$
46.1
$
56.5
$
69.7
$
101.5
$
148.9
$
179.0
Gross Profit
28.9
36.8
45.8
70.4
109.0
128.9
Operating Profit
(9.9
)
(1.7
)
(1.9
)
12.6
27.1
35.8
Net Income
(10.1
)
(2.6
)
(2.5
)
12.3
27.2
36.1
The annual long-term business plan was based on the following
material assumptions:
•
we prepared the forecast in June 2007 based upon information
available to us at that time;
•
we assumed that we could successfully raise $20 million to
support the projections and our operations;
•
we assumed we would receive 510(k) approval from the FDA for our
Accell products;
•
we assumed that planned clinical trials would have successful
outcomes which would impact results beginning in 2010; and
•
we assumed that we would grow our sales force to 25 people
to support revenue growth.
Additionally, we developed alternative annual long-term
forecasts that required less capital financing. This alternative
forecast is summarized below (dollars in millions):
2007E
2008E
2009E
2010E
2011E
2012E
Total Revenue
$
38.9
$
34.9
$
32.8
$
38.5
$
52.9
$
67.1
Gross Profit
23.6
22.0
21.0
25.7
34.4
44.4
Operating Profit
(5.6
)
1.4
(0.7
)
2.3
4.8
9.1
Net Income
(5.7
)
1.6
(0.5
)
2.5
5.0
9.3
The alternative annual long-term forecasts were based on the
following material assumptions:
•
we prepared the forecast in June 2007 based upon information
available to us at that time;
•
we assumed that we could successfully raise $5 million
necessary to support the projections and our operations;
•
we assumed we would receive 510(k) approval from the FDA for our
Accell products;
•
we assumed that planned clinical trials would have successful
outcomes which would impact results beginning in 2011; and
•
we assumed that we would grow our sales force to 10 people
to support lower revenue growth.
In considering the recommendation of our board of directors with
respect to the merger agreement, you should be aware that our
directors and executive officers may have interests in the
merger and have arrangements that are different from, or in
addition to, those of our stockholders generally. These
interests are described below, and except as described below,
our directors and executive officers have, to our knowledge, no
material interest in the merger apart from those of our
stockholders generally. Our board of directors was aware of
these interests and considered them, among other matters, in
reaching its decisions to approve the merger agreement and to
recommend that our stockholders vote in favor of the adoption of
the merger agreement.
Beneficial
Ownership of Directors and Executive Officers
As of August 24, 2007, the record date for the special
meeting, our directors and executive officers were record owners
of and were entitled to vote
approximately shares
of common stock, or approximately %
of our total common stock outstanding on that date excluding
those shares held by Integra and its
subsidiaries. These numbers do not give effect to outstanding
but unexercised stock options, which are not entitled to vote at
the special meeting.
Severance
Benefits of Executive Officers
Pursuant to our historical practices, we have entered into
employment agreements with each of our executive officers that
provide for certain severance payments in the event that the
executive officer’s employment is terminated by us without
“Cause” or as a result of the executive officer’s
disability or by the executive officer for “Good
Reason” (each, a “qualifying termination”).
Generally, the severance benefits that an executive officer
would be entitled to receive upon a qualifying termination
consist of a cash severance payment, accelerated vesting of all
outstanding stock options and restricted stock, if any, held by
the executive officer and a cash payment in lieu of health care
benefits.
The amount of the cash severance payment that an executive
officer would be entitled to receive upon a qualifying
termination is based on (i) the executive officer’s
highest monthly base salary amount multiplied by a prescribed
number of months plus (ii) a portion of the executive
officer’s “average annual bonus” as specified in
his or her respective employment agreement. Pursuant to their
employment agreements, our executive officers may become
entitled to cash severance payments as follows:
•
Pieter Wolters, our president and chief executive officer, may
become entitled to 24 months of his highest monthly base
salary plus 100% of his average annual bonus;
•
Robert Morocco, our chief financial officer, treasurer and
secretary, James Poser our senior vice president, research and
development and chief technology officer, James Abraham, our
senior vice president, sales, and Gene Reu, our senior vice
president, operations, may become entitled to 18 months of
their highest monthly base salary plus 75% of their average
annual bonus; and
•
John Kay, our chief scientific officer, and Karon Morell, our
vice president regulation and quality, may become entitled to
12 months of their highest monthly base salary plus 50% of
their average annual bonus.
Generally, without a “change in control,” if the
executive officer has less than five years of service at the
time of the qualifying termination, the actual amount of the
cash severance payment and accelerated vesting of stock options
and restricted stock may be limited based on the executive
officer’s actual length of service, determined as follows:
Percentage of Severance
Length of Service at Termination
Benefits Provided
Less than 90 days
0
%
At least 90 days, but less
than 1 year
20
%
At least 1 year, but less
than 2 years
30
%
At least 2 years, but less
than 3 years
50
%
At least 3 years, but less
than 4 years
70
%
At least 4 years, but less
than 5 years
90
%
At least 5 years
100
%
Stockholder approval of the merger will be considered a
“change in control” for purposes of the employment
agreements. In the event of a qualifying termination (other than
as a result of the executive officer’s disability)
following a change in control, the executive officers will
receive 100% of the cash severance payments described above. In
addition, the amount of the cash payment in lieu of health care
benefits that an executive officer would be entitled to receive
upon a qualifying termination, whether or not occurring in
connection with a change in control, is equal to 18 times the
difference between the monthly COBRA premium for the executive
officer and the executive officer’s monthly contribution
towards health care benefits immediately prior to the qualifying
termination.
Additionally, if any payments or benefits to which any of
Messers. Wolters, Morocco, Poser, Abraham or Reu become entitled
would be subject to an excise tax on “excess parachute
payments” under Internal
Revenue Code Section 4999, the employment agreements
provide that such executive also will be entitled to receive an
additional payment equal to the amount of such excise taxes. Any
such additional payment will be made within 30 days of the
payment giving rise to the excise tax.
For purposes of illustration, if each executive officer
experienced a qualifying termination on August 20, 2007,
each executive officer would have been entitled to receive the
following severance payments (exclusive of the value of the
accelerated vesting of any stock options awards and any payments
to indemnify the executives for excise taxes that may be due by
reason of section 4999 of the Internal Revenue Code):
The severance payments described above generally are payable in
a single lump sum 30 days following the executive
officer’s separation from service, but may be delayed for a
period of six months if necessary to comply with certain
requirements of the Internal Revenue Code.
For purposes of the employment agreements, “Cause”
means the executive officer’s (a) conviction of or
plea of nolo contender to a felony or any crime involving moral
turpitude; (b) commission of any act of theft, embezzlement
or misappropriation against us; (c) failure to
substantially perform his or her duties under the employment
agreement (other than such failure resulting from incapacity due
to physical or mental illness) and such failure is not remedied
within 30 days after written demand is made by us; or
(d) material breach of his or her obligations under the
employment agreement and the breach is not remedied within
30 days after written notice is delivered by us.
For purposes of the employment agreements, “Good
Reason” means (a) our material breach of the salary
and benefit obligations under the employment agreements, and
either such breach or action is incurable or irreversible, or,
if curable or reversible, has not been cured or reversed within
15 days following receipt of written notice by the
executive officer; or (b) we take any of the following
actions without the executive officer’s prior written
consent:
•
A material reduction in the authority of the executive officer;
•
An adverse change in the executive officer’s title;
•
The executive officer’s primary reporting relationship is
changed such that the executive officer no longer reports to our
president and chief executive officer (or in the case of
Mr. Wolters, such that Mr. Wolters no longer reports
to our board of directors); or
•
A relocation of the executive officer’s primary office to a
location more than 80 miles from Irvine, California.
Notwithstanding the foregoing, the executive officer is deemed
to have waived his or her right to terminate for “good
reason” with respect to a breach or action described above
if the executive officer does not notify us in writing of such
breach or action within 15 days of his or her actual
knowledge of such breach or action.
For purposes of the employment agreements, “Average annual
bonus” means the average of the annual merit bonuses paid
to the executive officer during the
24-month
period immediately preceding the executive officer’s
termination of employment. However, if the executive officer has
not been employed through the date
of an award of any annual merit bonus, the average annual bonus
is the target bonus for the bonus year in which the termination
occurs, or, if the executive officer has been eligible to
participate in only one bonus period during the
24-month
period immediately preceding the executive officer’s date
of termination, the bonus awarded for that bonus period is used
as the average annual bonus.
Treatment
of Equity Compensation Arrangements
The merger agreement provides that each stock option to purchase
shares of our common stock that remains outstanding at the
effective time of the merger will be cashed out in the merger.
For the purposes of the treatment of options to purchase our
common stock, “cashed out in the merger” means that
the option will be cancelled in exchange for a cash payment
equal to the product of (i) the excess, if any, of $7.25
over the applicable per share option exercise price and
(ii) the number of shares of our common stock subject to
the option at such time, whether or not then the option is then
vested and exercisable with respect to such shares. Integra will
pay the amount of cash payable in respect of each stock option
as soon as practicable following the effective time, but in any
event no later than 10 business days following the effective
time.
None of our executive officers currently hold any shares of
restricted stock.
The following table shows the total number of shares of our
common stock subject to outstanding options held by each of our
directors and executive officers as of August 20, 2007 that
are expected to be cashed out in the merger. The options have
exercise prices ranging between $6.00 per share and $24.02 per
share.
As of August 20, 2007, the total number of stock options
held by our directors and executive officers that are
in-the-money (i.e. whose exercise price is less than the merger
consideration of $7.25) is 16,500 options, consisting of 5,000
options held by Mr. Gill and 11,500 options held by
Mr. Abraham. As of August 20, 2007, the total number
of stock options held by our directors and executive officers
that are underwater (i.e. whose exercise price is more than the
merger consideration of $7.25) is 337,087 options, consisting of
90,600 options held by Mr. Wolters, 50,000 options held by
each of Messers. Morocco and Poser, 7,500 options held by
Ms. Morell, 40,000 options held by Mr. Reu, 37,847
options held by Mr. Trotman, 14,200 options held by
Mr. Brouwer, 24,496 options held by Dr. Kay, 5,000
options held by each of Ms. Boyan and Messers. Elliott and
Hart, and 7,444 options held by Mr. Kollin.
Prior to the consummation of the merger, Integra may offer
certain of our executive officers the opportunity to continue in
employment or service with Integra and its affiliates.
Indemnification
and Insurance
The merger agreement provides for director and officer
indemnification and insurance. We describe these provisions in
“The Merger Agreement — Indemnification and
Insurance.”
If the merger is consummated, our common stock will be delisted
from the NASDAQ Global Market and deregistered under the
Exchange Act, and IsoTis will no longer file periodic reports
with the United States Securities and Exchange Commission.
The following is a summary of certain material United States
federal income tax consequences of the merger to holders of our
common stock whose shares are converted into the right to
receive cash under the merger. This summary is based on the
Internal Revenue Code of 1986, as amended, or the Code,
applicable Treasury Regulations, and administrative and judicial
interpretations thereof, each as in effect as of the date
hereof, all of which may change, possibly with retroactive
effect.
This summary is limited to holders who hold shares of our common
stock as capital assets. This summary also does not address tax
considerations applicable to a holder’s particular
circumstances or to holders that may be subject to special tax
rules, including, without limitation, United States Holders (as
defined below) that are:
•
banks, insurance companies or other financial institutions;
•
broker-dealers;
•
traders;
•
expatriates;
•
tax-exempt organizations;
•
persons who are subject to alternative minimum tax;
•
persons that are partnerships, S-corporations or other
pass-through entities;
•
persons who hold their shares of common stock as a position in a
hedging transaction, “straddle,”“conversion
transaction” or other risk reduction transaction;
•
persons deemed to sell their shares of common stock under the
constructive sale provisions of the Code;
•
persons that have a functional currency other than the United
States dollar; or
•
persons who acquired their shares of our common stock upon the
exercise of stock options or otherwise as compensation.
In addition, this summary does not address tax considerations
applicable to any
Non-United
States Holder (as defined below) that owns more than 5% of our
common stock and any United States federal estate or gift tax
consequences, nor any state, local or foreign tax consequences,
of the merger, and this summary does not address the tax
consequences to holders of our common stock who exercise
appraisal rights under Delaware law. Also, if a portion of the
merger consideration is withheld pursuant to any law in respect
of withholding taxes, such withheld amounts will be treated for
purposes of this summary as having been received by the holder
in respect of whose shares the withholding was made.
THIS SUMMARY DOES NOT PURPORT TO BE A COMPLETE ANALYSIS OF THE
POTENTIAL TAX CONSIDERATIONS RELATING TO THE MERGER, AND IS NOT
TAX ADVICE. THEREFORE, YOU ARE URGED TO CONSULT YOUR TAX ADVISOR
WITH RESPECT TO THE APPLICATION OF THE UNITED STATES FEDERAL
INCOME TAX LAWS TO YOUR PARTICULAR SITUATION, AS WELL AS ANY TAX
CONSEQUENCES OF THE MERGER ARISING UNDER THE FEDERAL ESTATE OR
GIFT TAX RULES OR UNDER THE LAWS OF ANY STATE, LOCAL,
FOREIGN OR OTHER TAXING JURISDICTION OR UNDER ANY APPLICABLE TAX
TREATY.
For purposes of this discussion, a “United States
Holder” means a holder of our common stock that is:
•
an individual citizen or resident of the United States;
•
a corporation or an entity treated as a corporation for United
States federal income tax purposes created or organized in or
under the laws of the United States, any state thereof or the
District of Columbia;
•
an estate the income of which is subject to United States
federal income taxation regardless of its source; or
•
a trust (a) the administration over which a United States
court can exercise primary supervision and all of the
substantial decisions of which one or more United States persons
have the authority to control, and (b) that has made a
valid election to be a United States person for federal income
tax purposes.
A
“Non-United
States Holder” is any beneficial owner of shares of our
common stock who is not a United States Holder for United
States federal income tax purposes.
United
States Federal Income Tax Consequences for United States
Holders
Consequences
of the Merger
The receipt of cash in exchange for shares of our common stock
pursuant to the merger will be a taxable transaction for United
States federal income tax purposes. In general, a United States
Holder who receives cash in exchange for shares of our common
stock pursuant to the merger will recognize capital gain or loss
for United States federal income tax purposes equal to the
difference, if any, between the amount of cash received and the
holder’s adjusted tax basis in the shares of our common
stock exchanged therefor. Any such gain or loss would be
long-term capital gain or loss if the United States
Holder’s holding period for the shares of our common stock
exceeded one year. Long-term capital gains of noncorporate
taxpayers generally are taxable at a maximum federal income tax
rate of 15%. Capital gains of corporate taxpayers generally are
taxable at the regular income tax rates applicable to
corporations. The deductibility of capital losses is subject to
limitations. Gain or loss must be calculated separately for each
block of common stock (i.e., shares acquired at the same cost in
a single transaction) exchanged for cash in the merger.
Information
Reporting and Backup Withholding
Payments made to United States Shareholders in the merger
generally will be subject to information reporting. Backup
withholding (currently at a rate of 28%) may apply to payments
made in connection with the merger. Backup withholding will not
apply, however, to a United States Holder who (a) furnishes
a correct taxpayer identification number and certifies that it
is not subject to backup withholding on the substitute Internal
Revenue Service
Form W-9
or successor form included in the letter of transmittal to be
delivered to holders of our common stock prior to consummation
of the merger, or (b) is otherwise exempt from backup
withholding. Any amounts withheld under the backup withholding
rules may be allowed as a refund or a credit against such
holder’s United States federal income tax liability
provided the required information is furnished to the Internal
Revenue Service.
United
States Federal Income Tax Consequences for
Non-United
States Holders
Consequences
of the Merger
A Non-United
States Holder generally will not be subject to United States
federal income tax on any gain realized on the receipt of cash
for shares of our common stock in the merger unless:
•
the holder is an individual who was present in the United States
for 183 days or more during the taxable year of the
disposition and certain other conditions are met; or
•
the gain is effectively connected with the holder’s conduct
of a trade or business in the United States, or, if required by
an applicable tax treaty, attributable to a permanent
establishment maintained by the holder in the United States.
Gains described in the first bullet point above generally will
be subject to United States federal income tax at a flat 30%
rate (or applicable lower treaty rate), but may be offset by
United States source capital losses. Unless a tax treaty
provides otherwise, gain described in the second bullet point
above will be subject to United States federal income tax on a
net income basis in the same manner as if the
Non-United
States Holder were a resident of the United States.
Non-United
States Holders that are foreign corporations also may be subject
to a 30% branch profits tax (or applicable lower treaty rate).
Non-United
States Holders are urged to consult any applicable tax treaties
that may provide for different rules.
Information
Reporting and Backup Withholding
Payments made to
Non-United
States Holders in the merger may be subject to information
reporting and backup withholding (currently at a rate of 28%).
Non-United
States Holders can avoid backup withholding by providing the
Depositary with a properly executed IRS
Form W-8BEN
(or other applicable IRS
Form W-8)
certifying the holder’s
non-United
States status or by otherwise establishing an exemption,
provided that the Depositary does not have actual knowledge or
reason to know that the holder is a United States holder. Backup
withholding is not an additional tax.
Non-United
States Holders may use amounts withheld as a credit against
their United States federal income tax liability or may claim a
refund of any excess amounts withheld by timely and duly filing
a claim for refund with the IRS.
Foreign
Tax Consequences
THIS PROXY STATEMENT DOES NOT ADDRESS
NON-UNITED
STATES TAX LAW CONSIDERATIONS RELATING TO THE MERGER. YOU ARE
URGED TO CONSULT YOUR TAX ADVISOR WITH RESPECT TO ANY POTENTIAL
TAX CONSEQUENCES OF THE MERGER ARISING UNDER ANY APPLICABLE
NON-UNITED
STATES TAX LAWS.
We and Integra have agreed to use commercially reasonable
efforts to obtain all necessary consents and approvals of
governmental entities and all necessary consents, approvals and
waivers from any other person to consummate the merger. We have
also agreed with Integra to use our respective commercially
reasonable best efforts to cooperate in all respects with each
other in connection with any filing or submission and in
connection with any investigation or other inquiry, including
any proceeding initiated by a private party.
Despite our and Integra’s general obligation to use
commercially reasonable efforts in connection with any filing or
submission required or action to be taken to consummate the
merger, Integra is not obligated to propose or agree to accept
any undertaking or condition, to enter into any consent decree,
to make any divestiture, or accept any operational restriction,
or take or commit to take any action that could reasonably be
expected to limit (i) the freedom of action of Integra, its
subsidiaries or its affiliates with respect to the operation of,
or the ability to retain, us or any of our businesses, product
lines or assets, or (ii) the ability to retain, own or
operate any portion of Integra’s, or any of its
subsidiaries’ or affiliates’, businesses, product
lines or assets, or alter or restrict in any way our,
Integra’s or its Subsidiaries’ or affiliates’,
business or commercial practices. We have also agreed to not
enter into any such agreement with respect to our or our
subsidiaries’ assets or businesses without the prior
written consent of Integra. We have further agreed to keep
Integra informed of, and cooperate with Integra in connection
with, any stockholder litigation or claim against us or our
directors or executive officers relating to the merger
agreement. We may not settle any such stockholder litigation
without Integra’s prior written consent.
Holders of record of our shares of common stock who do not vote
in favor of the adoption of the merger agreement or consent
thereto in writing and who properly demand appraisal of their
shares will be entitled to appraisal rights in connection with
the merger under Section 262 of the General Corporation Law
of the State of Delaware, or Section 262.
The following discussion is not a complete statement of the
law pertaining to appraisal rights under Section 262 and is
qualified in its entirety by the full text of Section 262
which is attached to this proxy statement as
Annex C. The following summary does not constitute
any legal or other advice nor does it constitute a
recommendation that stockholders exercise their appraisal rights
under Section 262. All references in Section 262 and
in this summary to a “stockholder” or “holders of
shares of our common stock” are to the record holder or
holders of the shares of our common stock entitled to vote as to
which appraisal rights are asserted. A person having a
beneficial interest in shares of our common stock held of record
in the name of another person, such as a broker, fiduciary,
depositary or other nominee, must act promptly to cause the
record holder to follow the steps summarized below properly and
in a timely manner to perfect appraisal rights.
Under Section 262, a record holder of shares of our common
stock who makes the demand described below with respect to such
shares, who continuously is the record holder of such shares
through the effective time of the merger, who does not vote in
favor of the adoption of the merger agreement and who otherwise
follows the procedures set forth in Section 262, will be
entitled to have his or her shares appraised by the Delaware
Court of Chancery and to receive payment in cash of the
“fair value” of the shares, exclusive of any element
of value arising from the accomplishment or expectation of the
merger, as determined by the court.
Under Section 262, where a merger is to be submitted for
approval at a meeting of stockholders, as in the case of the
adoption of the merger agreement by our stockholders, the
corporation, not less than 20 days prior to the meeting,
must notify each of its stockholders entitled to appraisal
rights that appraisal rights are available and include in the
notice a copy of Section 262. This proxy statement shall
constitute the notice, and the full text of Section 262 is
attached to this proxy statement as Annex C. Any
holder of our common stock who wishes to exercise appraisal
rights, or who wishes to preserve such holder’s right to do
so, should review the following discussion and
Annex C carefully because failure to timely and
properly comply with the procedures specified will result in the
loss of appraisal rights. Moreover, because of the complexity of
the procedures for exercising the right to seek appraisal of
shares of our common stock, we believe that if you consider
exercising such rights, you should seek the advice of legal
counsel.
Any stockholder wishing to exercise appraisal rights must
deliver to us, before the vote on the adoption of the merger
agreement at the special meeting
on ,
2007, a written demand for the appraisal of the
stockholder’s shares, and a holder of shares of our common
stock must not vote in favor of the adoption of the merger
agreement. A holder of shares of our common stock wishing to
exercise appraisal rights must hold of record the shares on the
date the written demand for appraisal is made and must continue
to hold the shares of record through the effective time of the
merger, since appraisal rights will be lost if the shares are
transferred prior to the effective time of the merger. A proxy
which is signed and does not contain voting instructions will,
unless revoked, be voted in favor of the adoption of the merger
agreement. Therefore, a stockholder who votes by proxy and who
wishes to exercise appraisal rights must vote against the
adoption of the merger agreement or abstain from voting on the
merger agreement. Neither voting against the adoption of the
merger agreement (in person or by proxy), nor abstaining from
voting or failing to vote on the proposal to adopt the merger
agreement will in and of itself constitute a written demand for
appraisal satisfying the requirements of Section 262. The
written demand for appraisal must be in addition to and separate
from any proxy or vote on the proposal to adopt the merger
agreement. The demand must reasonably inform us of the identity
of the
record holder as well as the intention of the holder to demand
an appraisal of the “fair value” of the shares held by
the holder. A stockholder’s failure to make the written
demand prior to the taking of the vote on the adoption of the
merger agreement at the special meeting of stockholders will
constitute a waiver of appraisal rights.
At the effective time, the stock of any stockholder that
exercises such appraisal rights shall no longer be outstanding
and will automatically be cancelled and will cease to exist, and
each such holder of a certificate immediately prior to the
effective time will cease to have any rights with respect
thereto, except the right to receive the fair value of such
shares in accordance with the provisions of Section 262. We
will serve prompt notice to Integra of any demands for appraisal
of any shares of common stock, withdrawals of any such demands
and any other related instruments served on us pursuant to
Delaware law, and Integra will have the right to participate in
and direct all negotiations and proceedings with respect to such
demands. We will not, without the prior written consent of
Integra, make any payment with respect to, or settle or offer to
settle, any such demands, or agree to do or commit to do any of
the foregoing.
Only a holder of record of shares of our common stock is
entitled to assert appraisal rights for the shares registered in
that holder’s name. A demand for appraisal in respect of
shares of our common stock should be executed by or on behalf of
the holder of record, and must state that the person intends
thereby to demand appraisal of the holder’s shares in
connection with the merger. If the shares are owned of record by
a person other than the beneficial owner, including a broker,
fiduciary (such as a trustee, guardian or custodian), depositary
or other nominee, execution of the demand should be by or for
the record owner, and if the shares are owned of record by more
than one person, as in a joint tenancy and tenancy in common,
the demand should be executed by or on behalf of all joint
owners. An authorized agent, including an agent for two or more
joint owners, may execute a demand for appraisal on behalf of a
holder or record; however, the agent must identify the record
owner or owners and expressly disclose that, in executing the
demand, the agent is acting as agent for the record owner or
owners. A record holder such as a broker who holds shares as
nominee for several beneficial owners may exercise appraisal
rights with respect to the shares held for one or more
beneficial owners while not exercising the rights with respect
to the shares held for other beneficial owners; in such case,
however, the written demand should set forth the number of
shares as to which appraisal is sought and where no number of
shares is expressly mentioned the demand will be presumed to
cover all shares of our common stock entitled to vote held in
the name of the record owner. Stockholders who hold their shares
in brokerage accounts or other nominee forms and who wish to
exercise appraisal rights are urged to consult with their
brokers to determine the appropriate procedures for the making
of a demand for appraisal by such a nominee.
All written demands for appraisal pursuant to Section 262
should be sent or delivered to IsoTis, Inc., 2 Goodyear,
Irvine, California92618, Attention: Corporate Secretary.
Within ten days after the effective time of the merger, the
surviving corporation must notify each holder of our common
stock who has complied with Section 262, and who has not
voted in favor of the adoption of the merger agreement that the
merger has become effective. Within 120 days after the
effective time of the merger, but not thereafter, the surviving
corporation or any holder of our common stock who has so
complied with Section 262 and is entitled to appraisal
rights under Section 262 may file a petition in the
Delaware Court of Chancery with a copy served on the surviving
corporation demanding a determination of the fair value of the
shares held by all dissenting holders. If a petition for
appraisal is not timely filed, then the right to an appraisal
for all dissenting stockholders will cease. The surviving
corporation is under no obligation to and has no present
intention to file a petition and holders should not assume that
the surviving corporation will file a petition or that the
surviving corporation will initiate any negotiations with
respect to the fair value of such shares. Accordingly, the
holders of our common stock who desire to have their shares
appraised should initiate all necessary action to perfect their
appraisal rights in respect of shares of our common stock within
the time and in the manner prescribed in Section 262.
Within 120 days after the effective time of the merger, any
holder of our common stock who has complied with the
requirements for exercise of appraisal rights will be entitled,
upon written request, to receive from the surviving corporation
a statement setting forth the aggregate number of shares not
voted in
favor of the adoption of the merger agreement and with respect
to which demands for appraisal have been received and the
aggregate number of holders of such shares. The statement must
be mailed within ten days after a written request therefor has
been received by the surviving corporation or within ten days
after the expiration of the period for delivery of demands for
appraisal, whichever is later.
Under the merger agreement, we have agreed to provide Integra
prompt notice of any demands for appraisal, withdrawals of such
demands and any other related instruments served pursuant to the
General Corporation Law of the State of Delaware received by us
pursuant to Section 262. Integra will have the right to
participate in, and direct negotiations and proceedings with
respect to, demands for appraisal under Section 262. We
will not make any payments with respect to, or settle or offer
to settle, any demands for appraisal without the written consent
of Integra.
If a petition for an appraisal is timely filed by a holder of
shares of our common stock and a copy thereof is served upon the
surviving corporation, the surviving corporation will then be
obligated within 20 days to file with the Delaware Register
in Chancery a duly verified list containing the names and
addresses of all stockholders who have demanded an appraisal of
their shares and with whom agreements as to the value of their
shares have not been reached. After notice to the stockholders
as required by the Court, the Delaware Court of Chancery is
empowered to conduct a hearing on the petition to determine
those stockholders who have complied with Section 262 and
who have become entitled to appraisal rights thereunder. The
Delaware Court of Chancery may require the stockholders who
demanded payment for their shares to submit their stock
certificates to the Register in Chancery for notation thereon of
the pendency of the appraisal proceedings, and if any
stockholder fails to comply with the direction, the Court of
Chancery may dismiss the proceedings as to the stockholder.
After determining the holders of our common stock entitled to
appraisal, the Delaware Court of Chancery will determine the
“fair value” of their shares, exclusive of any element
of value arising from the accomplishment or expectation of the
merger. In determining fair value, the Delaware Court of
Chancery will take into account all relevant factors. In
Weinberger v. UOP, Inc., the Delaware Supreme Court
discussed the factors that could be considered in determining
fair value in an appraisal proceeding, stating that “proof
of value by any techniques or methods which are generally
considered acceptable in the financial community and otherwise
admissible in court” should be considered, and that
“[f]air price obviously requires consideration of all
relevant factors involving the value of a company.” The
Delaware Supreme Court stated that, in making this determination
of fair value, the court must consider market value, asset
value, dividends, earnings prospects, the nature of the
enterprise and any other facts that could be ascertained as of
the date of the merger that throw any light on future prospects
of the merged corporation. Section 262 provides that fair
value is to be “exclusive of any element of value arising
from the accomplishment or expectation of the merger.” In
Cede & Co. v. Technicolor, Inc., the
Delaware Supreme Court stated that such exclusion is a
“narrow exclusion [that] does not encompass known elements
of value,” but which rather applies only to the speculative
elements of value arising from such accomplishment or
expectation. In Weinberger, the Delaware Supreme Court
also stated that “elements of future value, including the
nature of the enterprise, which are known or susceptible of
proof as of the date of the merger and not the product of
speculation, may be considered.”
Stockholders considering seeking appraisal should be aware that
the fair value of their shares as so determined could be more
than, the same as or less than the merger consideration that
they would receive pursuant to the merger if they did not seek
appraisal of their shares and that an investment banking opinion
as to the fairness from a financial point of view of the
consideration to be received in a merger is not necessarily an
opinion as to fair value under Section 262. Although we
believe that the merger consideration is fair, no representation
is made as to the outcome of the appraisal of fair value as
determined by the Delaware Court of Chancery and stockholders
should recognize that such an appraisal could result in a
determination of a value higher or lower than, or the same as,
the merger consideration. The Delaware Court of Chancery will
also determine the amount of interest, if any, to be paid upon
the amounts to be received by persons whose shares of our common
stock have been appraised. Unless the Court of Chancery in its
discretion determines otherwise for good cause shown, interest
on the amount determined by the Court to be the “fair
value” of the shares as of the effective date of the merger
will be compounded quarterly and will accrue from the effective
date of the merger through the date of payment of the judgment
at the rate which is 5% over the Federal Reserve discount
rate as in effect from time to time during the period between
the effective date of the merger and the date of payment of the
judgment. The costs of the action may be determined by the Court
and taxed upon the parties as the Court deems equitable under
the circumstances. However, costs do not include attorneys’
and expert witness fees. Each dissenting stockholder is
responsible for his or her attorneys’ and expert witness
expenses, although upon application of a dissenting stockholder
or the surviving corporation, the Court may also order that all
or a portion of the expenses incurred by a stockholder in
connection with an appraisal, including, without limitation,
reasonable attorneys’ fees and the fees and expenses of
experts utilized in the appraisal proceeding, be charged pro
rata against the value of all the shares entitled to be
appraised.
Any holder of shares of our common stock who has duly demanded
an appraisal in compliance with Section 262 will not, after
the effective time of the merger, be entitled to vote the shares
subject to the demand for any purpose or be entitled to the
payment of dividends or other distributions on those shares
(except dividends or other distributions payable to holders of
record of our common stock as of a record date prior to the
effective time of the merger).
If any stockholder who demands appraisal of shares of our common
stock under Section 262 fails to perfect, or successfully
withdraws or loses, such holder’s right to appraisal, the
stockholder’s shares of our common stock will be deemed to
have been converted at the effective time of the merger into the
right to receive $7.25 in cash per share, without interest and
less any applicable withholding taxes. A stockholder will fail
to perfect, or effectively lose or withdraw, the holder’s
right to appraisal if no petition for appraisal is filed within
120 days after the effective time of the merger, or if the
stockholder delivers to the surviving corporation a written
withdrawal of the holder’s demand for appraisal and an
acceptance of the merger consideration, except that any attempt
to withdraw made more than 60 days after the effective time
of the merger will require the written approval of the surviving
corporation and, once a petition for appraisal is filed, the
appraisal proceeding may not be dismissed as to any holder
absent approval by the Delaware Court of Chancery, which
approval may be conditioned upon the terms the Court deems just.
Failure to comply with all of the procedures set forth in
Section 262 may result in the loss of a stockholder’s
statutory appraisal rights. Consequently, any stockholder
wishing to exercise appraisal rights is urged to consult legal
counsel before attempting to exercise those rights.
The following description summarizes the material provisions
of the merger agreement. Stockholders should read carefully the
merger agreement, which is attached as Annex A to this
proxy statement.
The merger agreement has been included to provide you with
information regarding its terms. It is not intended to provide
any other factual information about us. Such information can be
found elsewhere in this proxy statement and in the other public
filings we make with the Securities and Exchange Commission,
which are available without charge at www.sec.gov.
The merger agreement contains representations and warranties
of IsoTis, Integra and Merger Sub made to each other as of
specific dates. The assertions embodied in those representations
and warranties were made solely for purposes of the contract
among IsoTis, Integra and Merger Sub and may be subject to
important qualifications and limitations agreed by IsoTis,
Integra and Merger Sub in connection with negotiating its terms.
Moreover, certain representations and warranties may not be
accurate or complete as of any specified date because they are
subject to a contractual standard of materiality different from
those generally applicable to stockholders or were used for the
purpose of allocating risk among IsoTis, Integra and Merger Sub
rather than establishing matters as facts. For the foregoing
reasons, no person should rely on the representations and
warranties as statements of factual information.
The merger agreement provides that, if our stockholders adopt
the merger agreement and approve the merger and all other
conditions to the merger are satisfied or waived, Merger Sub, a
Delaware corporation and wholly-owned subsidiary of Integra,
will merge with and into us. We will survive the merger and
continue to exist after the merger as a wholly-owned subsidiary
of Integra.
Unless the parties agree otherwise, the closing date for the
merger will be the third business day after the satisfaction or
waiver of all conditions to closing in the merger agreement. We
anticipate that the merger will be consummated in the fourth
quarter of calendar year 2007. However, we cannot assure you
when, or if, all of the conditions to the closing of the merger
will be satisfied. See “— Conditions to the
Merger.”
The merger will be effective when a certificate of merger is
duly filed with and accepted by with the Secretary of State of
the State of Delaware, or at such later time as we and Integra
specify in the certificate of merger. We expect to make this
filing at the time of the closing under the merger agreement.
Merger
Consideration
The merger agreement provides that each share of our common
stock outstanding immediately prior to the effective time of the
merger (other than shares held by us, our wholly-owned
subsidiaries, Integra or Merger Sub or by holders properly
exercising appraisal rights under Delaware law) will be
converted at the effective time of the merger into the right to
receive $7.25 in cash, without interest and less any applicable
withholding taxes.
If any of our stockholders perfect appraisal rights with respect
to any of our shares, then we will treat those shares as
described under “— Appraisal Rights.”
If the merger occurs, stock options will be treated as described
below. All stock options not exercised prior to the effective
time of the merger will be cancelled in the merger, with the
holder of each stock option becoming entitled to receive, in
full satisfaction of the rights of such holder with respect
thereto, an amount in cash equal to the product of (i) the
excess, if any, of $7.25 over the applicable per share exercise
price of our common stock subject to such stock option,
multiplied by (ii) the number of shares of our common stock
subject to such stock option. All amounts payable will be paid
at or as soon as practicable following the effective time of the
merger, but in any event no later than ten business days
following the effective time, without interest.
After the effective time of the merger, Integra will deposit
funds with American Stock Transfer and Trust Company, the
exchange agent, in amounts necessary for the payment of the
merger consideration.
As promptly as practicable after the effective time of the
merger, the exchange agent will mail to each person who was a
holder of record of our common stock immediately prior to the
effective time of the merger a letter of transmittal containing
instructions for exchanging certificates representing shares of
our common stock. As soon as reasonably practicable after the
effective time of the merger, each holder of a certificate
previously representing shares of our issued and outstanding
common stock will, upon surrender to the exchange agent of a
certificate, together with such letter of transmittal, be
entitled to receive a check for the merger consideration of
$7.25 in cash, less any withholding taxes, for each share of our
common stock represented by such certificate.
No interest will be paid or will accrue on the cash payable upon
surrender of any certificate. The cash paid upon conversion of
our common stock will be deemed to have been paid in full
satisfaction of all rights pertaining to the shares of our
common stock.
If any certificate representing our common stock has been lost,
stolen or destroyed, the exchange agent will pay the merger
consideration with respect to each share of our common stock
formerly represented by such certificate upon the making of an
affidavit of that fact by the person claiming such certificate
to be lost, stolen or destroyed and, if required by the
surviving corporation, the posting by such person of a bond in
such reasonable amount as the surviving corporation may direct
as indemnity against any claim that may be made against the
surviving corporation with respect to such certificate.
The merger agreement provides that the directors of Merger Sub
immediately before the effective time of the merger will be the
directors of the surviving corporation, and our officers
immediately prior to the effective time will be the officers of
the surviving corporation, until their death, resignation or
removal or until their respective successors are duly elected
and qualified, as the case may be.
We have made a number of representations and warranties to
Integra and Merger Sub in the merger agreement regarding aspects
of our business and other matters pertinent to the merger. The
topics covered by these representations and warranties include
the following:
•
our and our subsidiaries’ organization, good standing and
qualification and similar corporate matters;
•
the lack of conflict with or violation of our charter documents
and the charter documents of our subsidiaries, any laws or
certain contracts as a result of entering into the merger
agreement and consummation of the merger;
•
consents, approvals, orders and authorizations of, and
registrations, declarations and filings with, and notices to,
governmental authorities required as a result of our entering
into and performing under the merger agreement;
•
our corporate power and authority to enter into the merger
agreement and consummate the merger, the enforceability of the
merger agreement against us and the approval of our board of
directors of the merger agreement;
the filing of required company reports and other documents with
the Securities and Exchange Commission, compliance of such
reports and documents with applicable requirements of federal
securities laws, rules and regulations, and the accuracy and
completeness of such reports and documents, including the
content of our financial statements included in such reports and
documents;
•
the preparation of our financial reports in compliance with GAAP;
•
the absence of any material adverse effect, material write-downs
of material assets, material change in any method of accounting,
and any loss of employment of our chief executive officer and
senior management, in each case since December 31, 2006;
•
we and our subsidiaries not having incurred any liability
outside the ordinary course of business, failed to satisfy any
lien or liability, subjected to a lien any of our material
assets, mortgaged or sold any material assets, cancelled any
material debts or claims, disposed of any intellectual property,
defaulted on any material obligation, increased the compensation
of any of our key employees outside the ordinary course of
business, entered into any employment, change of control,
retention or severance agreement, committed to capital
expenditures in excess of $100,000, laid off a significant
number of employees, received notice from any distributor of its
intent to terminate its relationship with us, discontinued
offering any material service or product, incurred any severance
obligations, declared or paid any dividends or other
distributions on our capital stock, or entered into any
agreement or committed to do any of the foregoing, in each case
since December 31, 2006;
•
tax matters;
•
the absence of undisclosed liabilities;
•
title to our material properties and tangible assets and our
rights to use our leased properties;
the lack of any petition, action, investigation, notice of
violation or apparent liability, notice of forfeiture, order to
show cause, complaint, or proceeding seeking to revoke,
reconsider, cancel, suspend, or modify any of our licenses and
permits;
•
regulatory matters;
•
our compliance with all required quality certifications
including FDA Quality System Regulations;
•
the lack of any product liability claims;
•
our compliance with all applicable laws, regulations, orders,
permits and judgments;
•
the maintenance of disclosure controls and procedures to ensure
timely and adequate reporting and compliance with the
Sarbanes-Oxley Act of 2002;
•
certain outstanding, pending and threatened litigation;
our engagement of, and payment of fees to, brokers, investment
bankers and financial advisors, and fees payable by us to other
advisors in connection with the merger agreement and the merger;
•
applicability of any state takeover statutes’ requirements
and the satisfaction of those statutes;
•
our receipt of a fairness opinion from Thomas Weisel Partners;
•
the accuracy of the information supplied in connection with this
proxy statement;
•
the required approval by our board;
•
the required vote of our stockholders;
•
the absence of unlawful payments;
•
the Swiss exchange offer’s compliance with all applicable
laws, regulations and contracts;
•
actions necessary to effectuate the merger of IsoTis S.A.;
•
absence of any product warranties beyond our applicable standard
warranties;
•
compliance with all applicable law related to our product
sales; and
Some of our representations and warranties are qualified by
materiality or a material adverse effect standard. Subject to
certain exclusions, a material adverse effect means any event,
change, circumstance, effect, development or state of facts
that, individually or in the aggregate:
•
is, or is reasonably likely to become, materially adverse to our
and our subsidiaries’ business, assets, condition
(financial or otherwise) or results of operations, taken as a
whole; provided that a material adverse effect does not include
the effect of any event, change, circumstance, development or
state of facts arising out of or attributable to
(i) general economic conditions, provided that the adverse
effects are not disproportionate to us as compared to other
companies in the same industry; (ii) general conditions
that affect our industry and the industry of our subsidiaries,
provided that the adverse effects are not disproportionate to us
as compared to other companies in the same industry; and
(iii) the execution and public announcement of the merger
agreement and the pendency of the transactions contemplated
thereby; or
•
would prevent or materially delay our ability to perform our
obligations under the merger agreement or to consummate the
transactions contemplated thereby.
Integra and Merger Sub have made a number of representations to
us regarding various matters pertinent to the merger. The topics
covered by these representations and warranties include the
following:
•
their organization and good standing;
•
the lack of violation of their charter documents, any laws or
certain contracts as a result of entering into the merger
agreement and consummation of the merger;
•
consents, approvals, orders and authorizations of, and
registrations, declarations and filings with, and notices to,
governmental authorities required as a result of our entering
into and performing the merger agreement;
•
their corporate power and authority to enter into the merger
agreement and consummate the merger and the enforceability of
the merger agreement against them;
•
the lack of brokers;
•
the accuracy of information supplied by Integra or Merger Sub in
connection with this proxy statement;
•
Merger Sub’s lack of prior operating activity; and
•
Integra’s sufficiency of funds to consummate the merger or
access to such funds.
The representations and warranties set forth in the merger
agreement as described above should not be relied upon by any
person as statements of factual information.
The representations and warranties of each of the parties to the
merger agreement will expire upon consummation of the merger.
In the merger agreement, we have agreed that before the
effective time of the merger, subject to certain exceptions, we
will (i) conduct our, and we will cause each of our
subsidiaries to conduct their, business, in all material
respects, in the ordinary course of business consistent with
past practice and, in all material respects, in compliance with
applicable laws, (ii) maintain and cause our subsidiaries
to maintain, in all material respects, our assets, properties,
rights and operations in accordance with our present practice
and in a condition suitable for their current use and
(iii) use commercially reasonable efforts consistent with
the foregoing to preserve substantially intact our business
organization, keep available our officers’ and key
employees’ services and to preserve, in all material
respects, our significant business relationships.
issue additional, or make any changes to, shares of capital
stock (other than upon the exercise of outstanding options),
membership interests or partnership interests or other equity
securities or grant any option, warrant or right to acquire any
of the foregoing;
•
sell, assign, transfer, abandon, sublease, assign or otherwise
convey any of our material assets, subject to certain exceptions
for actions in the ordinary course of business consistent with
past practice;
•
encumber any of our assets, properties or rights or any part
thereof;
•
redeem, retire purchase or otherwise acquire any shares of our
or our subsidiaries’ capital stock, membership interests or
partnership interests or other equity securities or declare or
pay any dividends in respect of such shares or interests;
•
acquire, lease or sublease any assets, raw materials or
properties, other than in the ordinary course of business and
consistent with past practice;
•
subject to certain exceptions and except as required by law, to
the extent necessary to avoid imposition of any taxes under
Section 409A of the Code, enter into any new (or amend any
existing to increase benefits) employee benefit plan, program or
arrangement, employment, severance, change of control or
consulting agreement, grant any general increase in the
compensation of executive officers or employees or grant any
increase in the compensation payable or to become payable to any
employee;
•
pay, lend or advance any amount to, or sell, transfer or lease
any properties or assets to, or enter into any agreement or
arrangement with, any of our affiliates;
•
cancel any insurance maintained by us;
•
change our method of accounting except for any such change
required by reason of a concurrent change in GAAP;
•
make or change any material tax election, change our annual
accounting period, adopt or change any accounting method, file
any amended tax return, enter into any closing agreement, settle
any material tax claim or assessment, surrender any right to
claim a refund of a material amount of taxes or consent to any
extension or waiver of the limitation period applicable thereto;
•
settle, release or forgive any material claim or litigation or
waive any right thereto;
•
make, enter into, modify, amend in any manner that would be
reasonably expected to have an adverse effect on us and our
subsidiaries certain contracts bids or expenditures;
•
waive any right or remedy under certain contracts, bids or
expenditures, other than in the ordinary course of business and
consistent with past practice;
•
lend money or incur or guarantee any indebtedness in excess of
$100,000;
We have agreed that we will not, and will not permit any of our
subsidiaries to, nor will we authorize or permit any of our or
our subsidiaries’ directors, executive officers, employees,
investment bankers, attorneys, accountants or other advisors or
representatives to, directly or indirectly:
•
solicit, initiate or take any action to knowingly facilitate or
encourage the submission of inquiries, proposals or offers from
any person (other than Integra and Merger Sub) relating to any
acquisition proposal, or agree to or endorse any acquisition
proposal;
•
enter into any agreement to knowingly facilitate or consummate,
any acquisition proposal or approve or endorse any acquisition
proposal;
•
enter into or participate in any discussions or negotiations in
connection with any acquisition proposal or inquiry with respect
to any acquisition proposal, or furnish to any person any
information with respect to its business, properties or assets
in connection with any acquisition proposal or inquiry with
respect to any acquisition proposal; or
•
agree to resolve or take any of the actions prohibited by the
above.
If our board of directors receives a bona fide unsolicited
written acquisition proposal by a third party prior to our
obtaining stockholder approval, it may participate in
discussions or negotiations with such third party directly or
through representatives if, among other things, it determines in
good faith by a majority vote that such acquisition proposal
constitutes, or could reasonably be expected to result in, a
superior proposal, it furnishes to the third party making the
acquisition proposal information with respect to us and our
subsidiaries pursuant to a confidentiality and standstill
agreement which contains terms that are no less restrictive than
those contained in the confidentiality agreement between us and
Integra and such information has been or is provided to Integra
on a prior or concurrent basis and, after considering the advice
of outside legal counsel, the board determines that failing to
take such action would reasonably be expected to result in a
breach of its fiduciary duties under Delaware law.
Board
Recommendation
Our board of directors may withdraw or modify or change in a
manner adverse to Integra its approval or recommendation of the
merger agreement, if and only if, our board of directors, after
considering the advice of outside legal counsel, has determined
that (i) the acquisition proposal constitutes a superior
proposal and that failing to take such action would result in a
breach of its fiduciary duties under Delaware law or
(ii) in response to an intervening event and failing to
take such action would result in a breach of its fiduciary
duties under the General Corporation Law of the State of
Delaware.
The covenant in the merger agreement generally prohibiting us
from soliciting acquisition proposals does not prevent us from
complying with
Rule 14d-9
and 14e-2(a)
promulgated under the Exchange Act with regard to an acquisition
proposal or from making any disclosure to our stockholders if
our board of directors determines in good faith that failure to
take such action would be inconsistent with applicable law.
In addition, if, at any time prior to our stockholders meeting,
our board of directors determines in good faith, after
consultation with its financial advisors and outside legal
counsel, in response to an acquisition proposal that was
unsolicited and that did not otherwise result from a breach of
the merger agreement, that such proposal is a superior proposal,
we or our board of directors may, pursuant to and subject to the
satisfaction of certain conditions in the merger agreement,
accept such superior proposal; provided however, we must provide
Integra with 5 business days’ written notice advising
Integra of our intent to accept such superior proposal. During
such 5 business day period, we must negotiate in good faith with
Integra to adjust the terms and conditions of the merger
agreement such that such acquisition proposal would no longer
constitute a superior proposal.
An “acquisition proposal” means any offer or proposal
for a merger, reorganization, recapitalization, consolidation,
share exchange, business combination or other similar
transaction (excluding the transactions contemplated by the
exchange offer) or any proposal or offer to acquire, directly or
indirectly,
securities representing more than 20% of our voting
power; or
•
more than 20% of our, and our subsidiaries’ assets taken as
a whole.
The term “acquisition proposal” does not include the
merger contemplated by the merger agreement.
A “superior proposal” means a proposal (on its most
recently amended or modified terms, if amended or modified) made
by a third party to enter into any transaction involving an
acquisition proposal that our board of directors determines in
its good faith judgment (following consultation with an
independent financial advisor) to be more favorable to our
stockholders than the merger agreement, taking into account all
terms and conditions of such transaction (including any
break-up
fees, expense reimbursement provision and financial terms, the
anticipated timing, conditions and prospects for completion of
such transaction, including the prospects for obtaining
regulatory approvals and financing, and any third party
approvals) and that is reasonably likely to be consummated,
except that the reference to “more than 20%” in the
definition of “acquisition proposal” shall be deemed
to be a reference to “more than 50%”.
The merger agreement provides that an “intervening
event” means a material event with respect to our business,
neither known by our board of directors nor reasonably
foreseeable as of the date hereof, which event (or any material
consequence of which) becomes known to or by (or understood by)
our board of directors prior to our stockholders meeting. The
term “intervening event” does not include
•
any event resulting from our, or our subsidiaries’ breach
of the merger agreement; or
•
the receipt, existence or terms of an acquisition proposal or
any matter relating thereto or consequence thereof.
Under the merger agreement, we have agreed to convene and hold a
stockholders’ meeting as soon as reasonably practicable
following the mailing of the definitive proxy statement to our
stockholders.
We, Integra and Merger Sub have each agreed to use our
commercially reasonable efforts to take, or cause to be taken,
all actions and to do, or cause to be done, all things
necessary, proper or advisable under applicable laws and
regulations to consummate the merger and the other transactions
contemplated by the merger agreement as soon as practicable,
including:
•
making any filing required by any applicable regulatory law;
•
cooperating with each other in connection with any filing or
submission and in connection with any investigation or other
inquiry, including any proceeding initiated by a private party;
•
promptly informing each other of any communication with any
governmental authority and of any material communication
received or given in connection with any proceeding by a private
party, in each case regarding any of the transactions
contemplated hereby;
•
permitting each other to review any communication given by it
to, and consult with each other in advance of any meeting or
conference with any governmental authority or, in connection
with any proceeding by a private party, with any other person,
and to the extent permitted by the applicable governmental
authority or other person, give the other party the opportunity
to attend and participate in such meetings and
conferences; and
•
obtaining all necessary consents, waivers, authorizations and
approvals of all third parties, including governmental entities.
Under the terms of the merger agreement, Integra is not required
to propose or agree to accept any undertaking or condition, to
enter into any consent decree, to make any divestiture, or
accept any operational restriction, or take or commit to take
any action that could reasonably be expected to limit
Integra’s, or its subsidiaries’ or affiliates’,
freedom of action with respect to their operation of, or their
ability to retain, us or any of our businesses, product lines or
assets; or
•
ability to retain, own or operate any portion of their
businesses, product lines, or assets, or alter or restrict in
any way their or our business or commercial practices.
No filing under the
Hart-Scott-Rodino
Antitrust Improvement Act of 1976, as amended, or any foreign
competition act is required for the consummation of the merger.
We have agreed to keep Integra informed of, and cooperate with
Integra in connection with, any stockholder litigation or claim
against us or our directors or officers relating to the merger
or other transactions contemplated by the merger agreement. We
have further agreed that we will not settle any such stockholder
litigation without Integra’s prior written consent, which
shall not be unreasonably withheld.
Our, Integra’s and Merger Sub’s obligations to effect
the merger are subject to the satisfaction of the following
conditions:
•
the adoption of the merger agreement and approval of the merger
by our stockholders;
•
no statute, rule, regulation, executive order, decree or ruling,
is promulgated, and no temporary restraining order, preliminary
or permanent injunction or other order issued by a court or
other U.S. governmental authority of competent jurisdiction
is in effect that has the effect of making the merger illegal or
otherwise prohibiting consummation of the merger; provided
however, the right to rely on this condition is not available to
any party whose failure to fulfill its obligations related to
obtaining such consents is the cause of such order or
injunction; and
•
all material consents, orders or approvals of, declarations or
filings with and expirations of waiting periods imposed by any
governmental entity required for consummation of the merger
having been obtained and in effect except for those that would
not, individually or in the aggregate, reasonably be expected to
have a material adverse effect on the business, assets,
condition (financial or otherwise) or results of operations of
Integra and its subsidiaries, taken as a whole.
Integra’s and Merger Sub’s obligations to consummate
the merger are also subject to the satisfaction by us or waiver
by them of the following conditions:
•
our representations and warranties concerning capitalization and
the stockholder vote required being true and correct in all
respects (except, in the case of our capitalization for such
inaccuracies as are de minimis in the aggregate), in each case
both when made and at and as of the closing date, as if made at
and as of such time (except to the extent expressly made as of
an earlier date, in which case as of such date) and each of our
other representations and warranties set forth in the merger
agreement being true and correct in all material respects both
when made and at and as of the closing date, as if made at and
as of such time (except to the extent expressly made as of an
earlier date, in which case as of such date), and Integra having
received a certificate of our chief executive officer and the
chief financial officer to such effect;
•
the performance and compliance by us in all material respects of
our obligations under the merger agreement and Integra having
received a certificate of our chief executive officer and the
chief financial officer to such effect;
•
a material adverse effect has not occurred with respect to us
between signing and closing;
•
our obtaining clearance for the 510(k), K061880, submitted by us
to the FDA on June 28, 2006 for our Accell products for
certain indications; we subsequently received notice of this
clearance from the FDA on August 15, 2007;
completion of certain actions relating to the restructuring of
our European operations;
•
Integra’s credit agreement having been amended, or the
lenders party thereto having granted Integra a waiver, in either
case, to permit the consummation of the merger, and to provide
for such other revisions as Integra deems necessary or advisable
in its sole and absolute discretion; and
•
holders of no more than 10% of the number of shares of our stock
outstanding immediately prior to the effective time having
exercised their appraisal rights in the merger.
Our obligation to consummate the merger is also subject to the
satisfaction by Integra and Merger Sub or waiver by us of the
following conditions:
•
Integra’s and Merger Sub’s representations and
warranties made pursuant to the merger agreement that are
qualified as to materiality or material adverse effect being
true and correct and the representations and warranties that are
not so qualified being true and correct in all material
respects, in each case both when made and at and as of the
closing date (except to the extent expressly made as of an
earlier date, in which case as of such date) and our having
received a certificate of an executive officer of Integra to
such effect; and
•
the performance and compliance by Integra in all material
respects of its obligations under the merger agreement and our
having received a certificate of an executive officer of Integra
to such effect.
The merger agreement may be terminated under the following
circumstances:
•
by our and Integra’s mutual written consent;
•
by either Integra or us if:
•
the effective time has not occurred by February 6, 2008;
provided that the right to terminate pursuant to this provision
is not available to any party whose failure to fulfill any
obligation under the merger agreement is the primary cause of
the failure of the effective time to occur by February 6,2008 and such action or failure to perform constitutes a breach
of the merger agreement;
•
any governmental entity issues an order, decree or ruling or
takes any other action permanently restraining, enjoining or
otherwise prohibiting or making illegal the transactions
contemplated by the merger agreement, and such order, decree,
ruling or other action is final and nonappealable; or
•
our stockholders do not adopt the merger agreement and approve
the merger at the stockholders meeting;
•
by us if:
•
prior to our stockholders meeting, we accept a superior proposal
in accordance with the terms of the merger agreement; provided
that we pay the termination fee, as discussed below,
concurrently with terminating;
•
Integra breaches a representation, warranty, covenant or
agreement so that the related closing conditions will not be
satisfied and such breach is not reasonably capable of being
cured, or, in the case of a breach of a covenant or agreement,
if such breach is reasonably capable of being cured, Integra
does not cure it prior to the earlier of 20 days after we
provide notice of such breach or February 6, 2008; provided
that we will not be able to terminate pursuant to this provision
if we are then in material breach of any of our representations,
warranties, covenants or agreements contained in the merger
agreement; or
•
Integra’s credit agreement is not amended prior to
September 7, 2007 or such later date as is mutually agreed
to by Integra and us to permit the consummation of the merger
and such other revisions as Integra deems necessary or advisable
in its sole and absolute discretion; provided that
we may not terminate pursuant to this provision if Integra
agrees to waive satisfaction of the closing condition that its
credit agreement be amended;
•
by Integra if:
•
prior to our stockholder meeting, our board of directors fails
to recommend or withdraws or modifies or changes in a manner
adverse to Integra its approval or recommendation of the merger
agreement, or approves or recommends a superior proposal;
provided that the disclosure of any acquisition proposal that is
not recommended by our board of directors or the disclosure of
any facts or circumstances, together with a statement by our
board of directors that they continue to recommend the merger
agreement and the merger, is not considered to be a withdrawal,
modification or change to our board of directors’ approval
or recommendation of the merger agreement or the merger;
•
we fail to call or hold the stockholder meeting in accordance
with the terms of the merger agreement and such breach is not
cured within 15 days after we receive notice of such breach
from Integra;
•
we materially and knowingly breach any of our material
obligations regarding the no solicitation provisions of the
merger agreement; or
•
we breach a representation, warranty, covenant or agreement so
that the related closing conditions will not be satisfied and
such breach is not reasonably capable of being cured, or, in the
case of a breach of a covenant or agreement, such breach is
reasonably capable of being cured but is not cured prior to the
earlier of 20 days following notice of such breach or
February 6, 2008; provided that, Integra will not be able
to terminate pursuant to this provision if it or Merger Sub is
then in material breach of any of its representations,
warranties, covenants or agreements contained in the merger
agreement.
Each party will generally pay its own fees and expenses in
connection with the merger, whether or not the merger is
consummated.
We will be required to pay a termination fee of
$2.25 million to Integra if:
•
Integra terminates the merger agreement because:
•
prior to our stockholder meeting, our board of directors fails
to recommend or withdraws or modifies or changes in a manner
adverse to Integra its approval or recommendation of the merger
agreement, or approves or recommends a superior proposal;
provided that the disclosure of any acquisition proposal that is
not recommended by our board of directors or the disclosure of
any facts or circumstances, together with a statement by our
board of directors that they continue to recommend the merger
agreement and the merger, is not considered to be a withdrawal,
modification or change to our board of directors’ approval
or recommendation of the merger agreement or the merger;
•
we fail to call or hold the stockholder meeting in accordance
with the terms of the merger agreement and such breach is not
cured within 15 days after we receive notice of such breach
from Integra; or
•
we materially and knowingly breach any of our material
obligations regarding the no solicitation provisions of the
merger agreement;
•
we terminate to accept a superior proposal in accordance with
the terms of the merger agreement; or
•
we or Integra terminate the merger agreement because:
•
the effective time does not occur on or before February 6,2008, or our stockholders do not adopt the merger agreement and
(i) at or prior to the time of the event giving rise to
such termination, an acquisition proposal is made known to us or
otherwise publicly disclosed or announced and (ii) within
12 months of termination of the merger agreement, we enter
into a definitive agreement with respect to, or consummate, an
acquisition proposal; provided that any expenses previously
reimbursed to Integra will be deducted from the termination fee.
We will also be required to reimburse Integra and its affiliates
for actual and reasonably documented
out-of-pocket
fees and expenses incurred in connection with the merger
agreement of up to a maximum of $1.5 million if (i) we
do not obtain the requisite stockholder vote to adopt the merger
agreement, or (ii) we or Integra terminate because the
effective time does not occur by February 6, 2008 and at
the time of termination, an acquisition proposal is made known
or proposed to us or otherwise publicly disclosed and announced.
For purposes of its application to termination fees and
expenses, acquisition proposal means the same except that
reference to “more than 20%” in the definition is
changed to a reference to “more than 50%.”
Integra will cause the surviving corporation to provide
indemnification to each of our directors and officers to the
same extent and under similar conditions as such indemnified
person is entitled as of the date of the merger agreement in
connection with any proceeding based directly or indirectly on
the fact that such indemnified person is or was an officer or
director of us, or is or was serving at our request as an
officer or director of another company, joint venture or other
enterprise or general partner of any partnership or a trustee of
any trust, whether pertaining to any matter arising before or
after the effective time. An indemnified person will repay the
surviving corporation for any expenses advanced in connection
with the indemnification of such person if it is ultimately
determined that such indemnified person did not meet the
standard of conduct necessary for indemnification.
For six years following the effective time of the merger through
the purchase of run-off coverage, Integra will maintain
directors’ and officers’ liability insurance covering
those persons who were, as of the date of the merger agreement,
covered by our directors’ and officers’ liability
insurance policies, on terms substantially comparable in the
aggregate to our existing policy. Notwithstanding the foregoing,
Integra is not required to expend in the aggregate more than
200% of the current annual premium paid by us for such insurance
with respect to the tail period, and if the premiums of such
insurance coverage exceed such amount, Integra will be obligated
to maintain a policy with the greatest coverage available for a
cost not exceeding such amount. In lieu of the foregoing, either
we or the surviving corporation may purchase a six-year
“tail” prepaid officers’ and directors’
liability insurance policy in respect of acts or omissions
occurring at or prior to the effective time covering such
indemnified person.
Except as would violate applicable law, we and Integra have
agreed that no public release or announcement concerning the
merger will be released without our and Integra’s prior
written consent, except as such release or announcement may be
required by law or the rules or regulations of any applicable
United States securities exchange, in which case the party
required to make the release or announcement shall use its
reasonable best efforts to allow each other party reasonable
time to comment on such release or announcement in advance of
such issuance. The final form and content of any such release or
announcement, to the extent so required, shall be at the final
discretion of the disclosing party. Notwithstanding the above,
upon prior consultation with the other party, each of the
parties may make statements that are not inconsistent with
previous press releases, public disclosures or public statements
made by any of the parties in compliance with the merger
agreement.
We have agreed to give prompt notice to Integra of any matter
that constitutes a breach of any representation, warranty,
agreement or covenant contained in the merger agreement.
We have agreed to consult with Integra prior to communicating or
corresponding with the FDA, whether in the form of a notice,
supplemental report or any other material, in connection with
our efforts to obtain 510(k) clearance for our Accell products.
We have further agreed to promptly provide Integra with copies
of any correspondence with the FDA and any written comments,
notices, supplemental reports or materials received from or
provided to the FDA and promptly advise Integra of any oral
communications with the FDA. As it is used in the merger
agreement, “Accell products” includes our line of
demineralized bone matrix products included in our 510(k),
K061880, submitted to the FDA on June 28, 2006, including,
Accell Putty
(A2i), Accell DBM 100, Accell TBM and Accell Connexus. We
received notice from the FDA of its clearance of our 510(k) for
the Accell products on August 15, 2007, and we promptly
informed Integra.
We have agreed to use our commercially reasonable efforts to
complete the restructuring of our European operations, including
accomplishing certain specified actions.
We have agreed not to adopt, approve or agree to adopt a
shareholder rights plan.
We have agreed that any of our employees who continue their
employment with Merger Sub or who become employees of Integra
will be given credit for all service with us, our subsidiaries
and predecessors under all employee benefit and fringe benefit
plans, programs and policies of Integra in which they become
participants for purposes of determining eligibility, vesting
and level of benefits, except under any defined benefit pension
plans or except as would otherwise result in a duplication of
benefits. If our employees who continue their employment become
eligible to participate in any medical, dental or health plan of
Integra or any of its affiliates, Integra will cause such plan
to waive any preexisting condition limitations for conditions
covered under similar plans maintained by us and honor any
deductible and out-of-pocket expenses incurred by such employee
and his or her beneficiaries under our plans during the portion
of the applicable plan year preceding the effective time.
Integra has the right to modify, amend, terminate or establish
employee benefit plans or arrangements at any time after the
effective time.
Upon reasonable notice, we have agreed to afford Integra and its
representatives reasonable access during normal business hours,
prior to the effective time, to all our books and records and to
furnish promptly to Integra all other information Integra may
reasonably request. Our responsibilities in such capacity are
limited to the extent such access would violate any law, treaty,
rule or regulation or result in the disclosure of any trade
secrets of third parties or violate any of our obligations with
respect to confidentiality, so long as we have used all
reasonable efforts to obtain the consent of such third party to
such access.
We have agreed to advise Integra of any notice we receive or any
request for additional information from the Securities and
Exchange Commission with respect to this proxy statement. We
have agreed to obtain Integra’s prior approval before
supplementing or amending this proxy statement. We have also
agreed to convene and hold a stockholders’ meeting for the
purpose of voting on the merger and the merger agreement as soon
as reasonably practicable.
The merger agreement is governed by the laws of the state of
Delaware and any dispute arising in connection with the merger
agreement will be adjudicated in the courts of the state of
Delaware.
On August 6, 2007, our wholly-owned subsidiary, IsoTis
OrthoBiologics, Inc. (“IsoTis OrthoBiologics”) entered
into a private label distribution agreement with Integra.
Pursuant to this agreement, concurrently with executing the
merger agreement, IsoTis OrthoBiologics will produce and sell to
Integra at specified prices, and Integra will have nonexclusive
worldwide rights to distribute, under its own brand names, other
than for dental applications, the following products:
DynaGraft®
II Demineralized Bone Matrix Putty,
DynaGraft®
II Demineralized Bone Matrix Gel,
OrthoBlast®
II DBM and Cancellous Bone in Reverse Phase Medium Putty and
OrthoBlast®
II DBM and Cancellous Bone in Reverse Phase Medium Paste. The
private label distribution agreement became effective upon
execution and terminates on December 31, 2012, and may be
renewed for two additional successive three-year periods. The
private label distribution agreement is attached as
Annex D to this proxy statement.
Letter
Agreement Regarding Option to Extend Scope of Distribution
Agreement
On August 6, 2007, IsoTis OrthoBiologics and Integra
entered into a letter agreement regarding an option to extend
the scope of the private label distribution agreement. Pursuant
to the option agreement, IsoTis OrthoBiologics granted Integra
an option to expand the scope of the private label distribution
agreement to include the exclusive right to distribute our
Accell line of proprietary natural and synthetic bone graft
substitutes, including, without limitation, Accell 100, Accell
Connexus, Accell TBM and A2i, solely for use in surgical
applications for the foot and ankle. The option becomes
exercisable on January 1, 2008 and terminates on
December 31, 2008, and, if exercised, Integra shall pay
IsoTis OrthoBiologics $1 million in cash. Under certain
circumstances, the option agreement will immediately terminate
upon the termination of the merger agreement. The option
agreement is attached as Annex E to this proxy
statement.
If at the special meeting of stockholders, the number of shares
of our common stock represented and voting in favor of adoption
of the merger agreement is insufficient to adopt that proposal
under the Delaware General Corporation Law, we intend to move to
adjourn the special meeting in order to enable our board of
directors to solicit additional proxies in respect of such
proposal. In that event, we will ask our stockholders to vote
only upon the adjournment proposal, and not the proposal
regarding the adoption of the merger agreement.
In this proposal, we are asking you to authorize the holder of
any proxy solicited by our board of directors to vote in favor
of granting discretionary authority to the proxy or
attorney-in-fact to adjourn the special meeting to another time
and place for the purpose of soliciting additional proxies. If
the stockholders approve the adjournment proposal, we could
adjourn the special meeting and any adjourned session of the
special meeting and use the additional time to solicit
additional proxies, including the solicitation of proxies from
stockholders that have previously voted. Among other things,
approval of the adjournment proposal could mean that, even if we
had received proxies representing a sufficient number of votes
against the adoption of the merger agreement to defeat that
proposal, we could adjourn the special meeting without a vote on
the merger agreement and seek to convince the holders of those
shares to change their votes to votes in favor of adoption of
the merger agreement.
Approval of the proposal to adjourn the special meeting for the
purpose of soliciting additional proxies, if necessary, requires
the affirmative vote of the holders of a simple majority (i.e.,
more than 50%) of the votes cast on the proposal. No proxy that
is specifically marked “AGAINST” adoption of the
merger agreement will be voted in favor of the adjournment
proposal, unless it is specifically marked “FOR” the
adjournment proposal.
Our board of directors recommends that you vote
“FOR” the adjournment proposal.
Our common stock started trading on the NASDAQ Global Market
under the symbol “ISOT” on January 26, 2007. The
table below shows, for the periods indicated, the range of high
and low closing prices for our common stock as quoted on the
NASDAQ Global Market.
The following table sets forth the closing per share sales price
of our common stock, as reported on the NASDAQ Global Market on
August 6, 2007, the last full trading day before the public
announcement of the
We have never declared or paid cash dividends on our common
stock. Our current policy is to retain earnings for use in our
business. Following the merger there will be no further market
for our common stock.
The following table sets forth as of August 20, 2007 the
number and percentage of the outstanding shares of our common
stock which, according to the information supplied to us, are
beneficially owned by (i) each person who, to our
knowledge, is the beneficial owner of more than 5% of our
outstanding common stock, (ii) each person who is currently
one of our directors, (iii) each of our executive officers,
including our chief executive officer, chief financial officer
and our other three most highly compensated executive officers,
and (iv) all of our current directors and executive
officers as a group. Except to the extent indicated in the
footnotes to the following table, the person or entity listed
has sole voting and dispositive power with respect to the shares
that are deemed beneficially owned by such person or entity,
subject to community property laws, where applicable.
All executive officers and
directors as a group (14 persons)
20,749
185,464
208,713
2.94
%
*
Represents less than 1%.
(1)
Represents shares of our common stock that the holder may
acquire upon exercise of currently vested options or options
that will become vested within 60 days after
August 20, 2007.
As of August 20, 2007, the total number of stock options
held by our directors and executive officers that are
in-the-money (i.e. whose exercise price is less than the merger
consideration of $7.25) is 16,500 options, consisting of 5,000
options held by Mr. Gill and 11,500 options held by
Mr. Abraham. As of August 20, 2007, the total number
of stock options held by our directors and executive officers
that are underwater (i.e. whose exercise price is more than the
merger consideration of $7.25) is 337,087 options, consisting of
90,600 options held by Mr. Wolters, 50,000 options held by
each of Messers. Morocco and Poser, 7,500 options held by
Ms. Morell, 40,000 options held by Mr. Reu, 37,847
options held by Mr. Trotman, 14,200 options held by
Mr. Brouwer, 24,496 options held by Dr. Kay, 5,000
options held by each of Ms. Boyan and Messers. Elliott and
Hart, and 7,444 options held by Mr. Kollin.
(3)
The percentage of shares beneficially owned is based on
7,099,343 shares of our common stock outstanding as of
August 20, 2007.
We will hold our 2007 annual meeting of stockholders only if the
merger is not consummated because following the merger our
common stock will be delisted from the NASDAQ Global Market, our
common stock will be deregistered under the Exchange Act and we
will no longer be a publicly-held company. Any stockholder
wishing to have a proposal considered for inclusion in our 2007
annual meeting proxy solicitation materials must set forth such
proposal in writing and file it with our secretary a reasonable
period of time before we print and send our 2007 annual meeting
proxy materials. We will publicly notify you of the expected
date that we plan to print and send our 2007 annual meeting
proxy materials at the time we establish a date for such meeting
if the merger is not consummated. Proposals must be received a
reasonable period of time before such date to be considered
timely. Our board of directors will review any timely submitted
stockholder proposals which are filed as required and will
determine whether such proposals meet applicable criteria for
inclusion in our 2007 annual meeting proxy solicitation
materials.
If you wish to submit a proposal for consideration at our next
annual general meeting of stockholders but that is not to be
included in our proxy statement, you must delivery the proposal
in writing (and otherwise comply with the requirements in our
bylaws relating to the submission of proposals) to: IsoTis,
Inc., 2 Goodyear, Irvine, California92618 Attention:
Secretary.
As of the date of this proxy statement, our board of directors
knows of no other matters which may be presented for
consideration at the special meeting. However, if any other
matter is presented properly for consideration and action at the
meeting, it is intended that the proxies will be voted with
respect thereto in accordance with the best judgment and in the
discretion of the proxy holders.
We and Integra are each subject to the informational
requirements of the Exchange Act. Each company files annual,
quarterly and current reports, proxy statements and other
information with the Securities and Exchange Commission.
You may read and copy these reports, proxy statements and other
information at the Securities and Exchange Commission’s
Public Reference Room at 100 F Street, N.E.,
Washington, DC 20549. You may obtain information on the
operation of the Public Reference Room by calling the Securities
and Exchange Commission at
1-800-SEC-0330.
The Securities and Exchange Commission also maintains an
Internet website, located at
http://www.sec.gov,
that contains reports, proxy statements and other information
regarding us, Integra and other registrants that file
electronically with the Securities and Exchange Commission.
You may also read reports, proxy statements and other
information relating to IsoTis at the offices of the National
Association of Securities Dealers, Inc., Listing Section,
1735 K Street, Washington, D.C.20006.
If you have questions about the special meeting or the merger
with Integra after reading this proxy, or if you would like
additional copies of this proxy statement or the proxy card,
please contact:
Georgeson
Inc. 17
State Street, 10th Floor New York, New York10004
Banks and Brokers Call:
(212) 440-9800
U.S. Stockholders Call Toll Free:
(888) 605-8339
Outside the U.S. Call Toll Free +800 6590 6590 or
Collect +44 (0)117 378 5985
AGREEMENT AND PLAN OF MERGER, dated as of August 6, 2007
(this “Agreement”), among INTEGRA LIFESCIENCES
HOLDINGS CORPORATION, a Delaware corporation
(“Parent”), ICE MERGERCORP, INC., a Delaware
corporation and a direct wholly owned Subsidiary of Parent
(“Merger Sub”), and ISOTIS, INC., a Delaware
corporation (the “Company”).
WITNESSETH:
WHEREAS, the respective Boards of Directors of Parent, Merger
Sub and the Company have each approved and declared advisable
the merger of Merger Sub with and into the Company (the
“Merger”), upon the terms and subject to the
conditions set forth in this Agreement, pursuant to which each
outstanding share of common stock, par value $0.0001 per share,
of the Company (“Company Common Stock”) issued
and outstanding immediately prior to the Effective Time, other
than shares owned or held directly or indirectly by Parent or
the Company and Appraisal Shares, will be converted into the
right to receive $7.25 per share in cash;
WHEREAS, Parent, Merger Sub and the Company desire to make
certain representations, warranties, covenants and agreements in
connection with the transactions contemplated hereby and also to
prescribe various conditions to the transactions contemplated
hereby; and
NOW, THEREFORE, in consideration of the foregoing and the
respective representations, warranties, covenants and agreements
set forth herein, and intending to be legally bound hereby, the
parties hereto agree as follows:
ARTICLE I.
THE MERGER
Section 1.1. The
Merger. Upon the terms and subject to the
conditions hereof, at the Effective Time, Merger Sub shall be
merged with and into the Company and the separate existence of
Merger Sub shall thereupon cease, and the Company, as the
surviving corporation in the Merger (the “Surviving
Corporation”), shall by virtue of the Merger continue
its existence under the laws of the State of Delaware.
Section 1.2. Closing. Unless
this Agreement shall have been terminated pursuant to the
provisions of Section 9.1, the closing of the Merger (the
“Closing”) will take place on the third
Business Day after the satisfaction or waiver (subject to
applicable law) of the conditions (excluding conditions that, by
their terms, cannot be satisfied until the Closing Date, but
subject to the satisfaction or, where permitted, waiver of those
conditions as of the Closing) set forth in Article VIII,
unless another time or date is agreed to in writing by the
parties hereto (the date of the Closing, the “Closing
Date”). The Closing shall be held at the offices of
Willkie Farr & Gallagher LLP, 787 Seventh Avenue, NewYork, New York10019, unless another place is agreed to in
writing by the parties hereto.
Section 1.3. Effective
Time. Upon the Closing, the parties shall
file with the Secretary of State of the State of Delaware a
certificate of merger (the “Certificate of
Merger”). The Merger shall become effective at such
time as the Certificate of Merger is duly filed with and
accepted by the Secretary of State of the State of Delaware or
at such subsequent time as Parent and the Company shall agree
and as shall be specified in the Certificate of Merger (the date
and time the Merger becomes effective being the
“Effective Time”).
Section 1.4. Effects
of the Merger. The Merger shall have the
effects set forth in the DGCL. Without limiting the generality
of the foregoing, and subject thereto, at the Effective Time,
all the property, rights, privileges, powers, and franchises of
the Company and Merger Sub shall vest in the Surviving
Corporation, and all debts, liabilities and duties of the
Company and Merger Sub shall become the debts, liabilities and
duties of the Surviving Corporation.
immediately prior to the Effective Time, except that the name of
the Company shall continue to be “IsoTis, Inc.” and
the provisions of the certificate of incorporation of the
Company related to the incorporator of the Company shall not be
amended, and as so amended shall be the certificate of
incorporation of the Surviving Corporation after the Effective
Time, and thereafter may be amended as provided therein or by
law.
Section 1.6. Bylaws. The
bylaws of Merger Sub as in effect at the Effective Time shall be
the bylaws of the Surviving Corporation, and thereafter may be
amended as provided therein or by law.
Section 1.7. Directors;
Officers. The directors of Merger Sub
immediately prior to the Effective Time shall be the directors
of the Surviving Corporation and the officers of the Company
immediately prior to the Effective Time shall be the officers of
the Surviving Corporation, in each case until their respective
successors are duly elected and qualified or until their death,
resignation or removal in accordance with the DGCL and the
certificate of incorporation and bylaws of the Surviving
Corporation.
Section 1.8. Effect
on Capital Stock. At the Effective Time by
virtue of the Merger and without any action on the part of the
holder thereof:
(a) Each share of Company Common Stock issued and
outstanding immediately prior to the Effective Time (other than
treasury shares and any shares held directly or indirectly by
Parent and, except as provided in Section 1.8(e), Appraisal
Shares) shall be converted into the right to receive $7.25 in
cash, without interest (the “Merger
Consideration”).
(b) All shares of Company Common Stock shall cease to be
outstanding and shall be canceled and retired and shall cease to
exist, and each holder of a certificate which immediately prior
to the Effective Time represented any such shares of Company
Common Stock (a “Certificate”) shall thereafter
cease to have any rights with respect to such shares of Company
Common Stock, except the right to receive the Merger
Consideration. Each Treasury Share at the Effective Time shall,
by virtue of the Merger, cease to be outstanding and shall be
canceled and no Merger Consideration or other consideration
shall be delivered in exchange therefor.
(c) Each share of common stock, par value $0.01 per share,
of Merger Sub issued and outstanding immediately prior to the
Effective Time shall be converted into one share of common
stock, par value $0.01 per share, of the Surviving Corporation.
(d) If prior to the Effective Time, the Company should
split, combine or otherwise reclassify the Company Common Stock,
or pay a stock dividend or other stock distribution in Company
Common Stock, or otherwise change the Company Common Stock into
any other securities, or make any other such stock dividend or
distribution in capital stock of the Company in respect of the
Company Common Stock, then the Merger Consideration will be
appropriately adjusted to reflect such split, combination,
dividend or other distribution or change. For avoidance of
doubt, the issuance of shares of Company Common Stock pursuant
to the Exchange Offer shall not give rise to any adjustment
contemplated by this Section 1.8(d).
(e) Notwithstanding anything in this Agreement to the
contrary, shares (the “Appraisal Shares”) of
Company Common Stock issued and outstanding immediately prior to
the Effective Time that are held by any holder who is entitled
to demand and properly demands appraisal of such shares pursuant
to, and who complies in all respects with, the provisions of
Section 262 of the DGCL
(“Section 262”), shall not be converted
into the right to receive the Merger Consideration as provided
in Section 1.8(a), but instead such holder shall be
entitled to payment of the fair value of such Appraisal Shares
in accordance with the provisions of Section 262. At the
Effective Time, the Appraisal Shares shall no longer be
outstanding and shall automatically be canceled and shall cease
to exist, and each holder of a certificate that immediately
prior to the Effective Time represented Appraisal Shares shall
cease to have any rights with respect thereto, except the right
to receive the fair value of such shares in accordance with the
provisions of Section 262. Notwithstanding the foregoing,
if any such holder shall fail to perfect or otherwise shall
waive, withdraw or lose the right to appraisal under
Section 262 or a court of competent jurisdiction shall
determine that such holder is not entitled to the relief
provided by Section 262, then the right of such holder to
be paid the fair value of such holder’s Appraisal Shares
under Section 262 shall cease and such
Appraisal Shares shall be deemed to have been converted at the
Effective Time into, and shall have become, the right to receive
the Merger Consideration as provided in Section 1.8(a). The
Company shall serve prompt notice to Parent of any demands for
appraisal of any shares of Company Common Stock, withdrawals of
any such demands and any other related instruments served
pursuant to the DGCL received by the Company, and Parent shall
have the right to participate in and direct all negotiations and
proceedings with respect to such demands. The Company shall not,
without the prior written consent of Parent, make any payment
with respect to, or settle or offer to settle, any such demands,
or agree to do or commit to do any of the foregoing.
Section 1.9. Treatment
of Options.
(a) Each option to purchase shares of Company Common Stock
(individually a “Company Option” and
collectively, the “Company Options”)
outstanding immediately prior to the Effective Time pursuant to
any Company Stock Plan or otherwise will at the Effective Time
be cancelled and the holder of such Company Option will, in full
settlement of such Company Option, receive from the Company an
amount (subject to any applicable withholding), if any, in cash
equal to the product of (x) the excess, if any, of the
Merger Consideration over the exercise price per share of
Company Common Stock underlying such Company Option multiplied
by (y) the number of shares of Company Common Stock subject
to such Company Option, whether or not vested or exercisable;
provided that the aggregate amount of such payment shall be
rounded down to the nearest whole cent. If the applicable
exercise price of any Company Option equals or exceeds the
Merger Consideration, such Company Option shall be cancelled
without payment of additional consideration, and all rights with
respect to such Company Option shall terminate as of the
Effective Time. Parent shall pay, or shall cause the Surviving
Corporation to pay, the amount of cash payable in respect of
each Company Option as soon as practicable following the
Effective Time, but in any event no later than ten
(10) Business Days following the Effective Time. The
holders of Stock Options will have no further rights in respect
of any Company Options from and after the Effective Time.
(b) Prior to the Effective Time, the Company will adopt
such resolutions and take such other actions as are necessary in
order to (i) effectuate the actions contemplated by this
Section 1.9 or to otherwise cancel the Company Options
prior to the Effective Time, and (ii) terminate each
Company Stock Plan, in each case without paying any
consideration or incurring any debts or obligations on behalf of
the Company or the Surviving Corporation, provided that such
resolutions and actions shall expressly be conditioned upon the
consummation of the Merger and the other transactions
contemplated hereby and shall be of no effect if this Agreement
is terminated.
ARTICLE II.
EXCHANGE OF
CERTIFICATES
Section 2.1. Exchange
Fund. At or prior to the Effective Time,
Parent shall deposit with American Stock Transfer and
Trust Company or such other bank or trust company as Parent
shall determine and who shall be reasonably satisfactory to the
Company (the “Exchange Agent”), in trust for
the benefit of holders of shares of Company Common Stock, for
exchange in accordance with Section 1.8, the cash to be
paid pursuant to this Agreement in exchange for outstanding
Company Common Stock. Any cash deposited with the Exchange Agent
shall hereinafter be referred to as the “Exchange
Fund.”
Section 2.2. Exchange
Procedures. As promptly as practicable after
the Effective Time, the Exchange Agent will send to each record
holder of a Certificate, (i) a letter of transmittal (which
shall specify that delivery shall be effected, and risk of loss
and title to the Certificates shall pass, only upon delivery of
the Certificates to the Exchange Agent and shall be in a form
and have such other provisions as Parent may reasonably specify)
and (ii) instructions for use in effecting the surrender of the
Certificates in exchange for the Merger Consideration. As soon
as reasonably practicable after the Effective Time, each holder
of a Certificate, upon surrender of a Certificate to the
Exchange Agent together with such letter of transmittal, duly
executed, and such other documents as may reasonably be required
by the Exchange Agent, shall be entitled to receive in exchange
therefor a check in the amount equal to the per share cash
amount of the Merger
Consideration (after giving effect to any required tax
withholdings), which such holder has the right to receive
pursuant to Section 1.8. The Exchange Agent shall accept
such Certificates upon compliance with such reasonable terms and
conditions as the Exchange Agent may impose to effect an orderly
exchange thereof in accordance with normal exchange practices.
No interest will be paid or will accrue on any cash payable upon
due surrender of the Certificates. In the event of a transfer of
ownership of Company Common Stock which is not registered in the
transfer records of the Company, the Merger Consideration with
respect to such Company Common Stock shall be paid to such a
transferee only if the Certificate representing such shares of
Company Common Stock is presented to the Exchange Agent,
accompanied by all documents required to evidence and effect
such transfer and to evidence that any applicable stock transfer
taxes have been paid.
Section 2.3. No
Further Ownership Rights in Company Common
Stock. The Merger Consideration paid upon
conversion of shares of Company Common Stock in accordance with
the terms of Article I and this Article II shall be
deemed to have been paid in full satisfaction of all rights
pertaining to the shares of Company Common Stock.
Section 2.4. Termination
of Exchange Fund. Any portion of the Exchange
Fund which remains undistributed to the holders of Certificates
for twelve months after the Effective Time shall be delivered to
the Surviving Corporation or otherwise on the instruction of the
Surviving Corporation, and any holders of Certificates who have
not theretofore complied with this Article II shall
thereafter look only to the Surviving Corporation and Parent
(subject to abandoned property, escheat or other similar laws)
for the Merger Consideration with respect to the shares of
Company Common Stock formerly represented thereby to which such
holders are entitled pursuant to Section 1.8.
Section 2.5. No
Liability. None of Parent, Merger Sub, the
Company, the Surviving Corporation or the Exchange Agent shall
be liable to any Person in respect of any Merger Consideration
from the Exchange Fund delivered to a public official pursuant
to any applicable abandoned property, escheat or similar law.
Section 2.6. Lost
Certificates. If any Certificate shall have
been lost, stolen or destroyed, upon the making of an affidavit
of that fact by the Person claiming such Certificate to be lost,
stolen or destroyed and, if required by the Surviving
Corporation, the posting by such Person of a bond in such
reasonable amount as the Surviving Corporation may direct as
indemnity against any claim that may be made against it with
respect to such Certificate or other documentation (including an
indemnity in customary form) reasonably requested by Parent, the
Exchange Agent will deliver in exchange for such lost, stolen or
destroyed Certificate the applicable Merger Consideration with
respect to the shares of Company Common Stock formerly
represented thereby.
Section 2.7. Withholding
Rights. Each of the Surviving Corporation and
Parent shall be entitled to deduct and withhold from the
consideration otherwise payable pursuant to this Agreement to
any holder of shares of Company Common Stock and any holder of
Company Options such amounts as it is required to deduct and
withhold with respect to the making of such payment under the
Internal Revenue Code of 1986, as amended (the
“Code”), and the rules and regulations
promulgated thereunder (“Treasury
Regulations”), or any provision of state, local or
foreign tax law. To the extent that amounts are so withheld by
the Surviving Corporation or Parent, as the case may be, such
withheld amounts shall be treated for all purposes of this
Agreement as having been paid to the holder of the shares of
Company Common Stock in respect of which such deduction and
withholding was made by the Surviving Corporation or Parent, as
the case may be.
Section 2.8. Further
Assurances. At and after the Effective Time,
the officers and directors of the Surviving Corporation will be
authorized to execute and deliver, in the name and on behalf of
the Company or Merger Sub, any deeds, bills of sale, assignments
or assurances and to take and do, in the name and on behalf of
the Company or Merger Sub, any other actions and things to vest,
perfect or confirm of record or otherwise in the Surviving
Corporation any and all right, title and interest in, to and
under any of the rights, properties or assets acquired or to be
acquired by the Surviving Corporation as a result of, or in
connection with, the Merger.
Section 2.9. Stock
Transfer Books. At the close of business, New
York time, on the day the Effective Time occurs, the stock
transfer books of the Company shall be closed and there shall be
no further registration
of transfers of shares of Company Common Stock thereafter on the
records of the Company. From and after the Effective Time, the
holders of Certificates shall cease to have any rights with
respect to such shares of Company Common Stock formerly
represented thereby, except as otherwise provided herein or by
law. On or after the Effective Time, any Certificates presented
to the Exchange Agent or Parent for any reason shall be
converted into the Merger Consideration with respect to the
shares of Company Common Stock formerly represented thereby.
Except as set forth in the Company Disclosure Letter delivered
by the Company to Parent prior to the execution of this
Agreement (the “Company Disclosure Letter”)
(provided that the disclosures in any section or subsection of
the Company Disclosure Letter shall qualify other sections and
subsections of this Agreement as to which such information may
be applicable only if (a) it is readily apparent on the
face of any such section of the Company Disclosure Letter that
the matters, facts or circumstances disclosed therein are
applicable to another section of the Company Disclosure Letter
or (b) such disclosure is cross-referenced to in such other
section of the Company Disclosure Letter) and subject to
Section 10.2 hereof, the Company hereby represents and
warrants to Parent and Merger Sub as follows:
Section 3.1. Corporate
Organization. Each of the Company and its
Subsidiaries is duly organized, validly existing and in good
standing under the laws of the jurisdiction of its organization
and has all requisite corporate, limited liability company or
limited partnership power (as the case may be) to own its
properties and assets and to conduct its business as now
conducted. Copies of the Company Organizational Documents and
the organizational documents of each Subsidiary of the Company,
with all amendments thereto to the date hereof, have been made
available to Parent or its representatives, and such copies are
accurate and complete as of the date hereof. A complete and
correct chart showing the Company and all of its direct and
indirect Subsidiaries is set forth on Section 3.1 of the
Company Disclosure Letter.
Section 3.2. Qualification
to Do Business. Each of the Company and its
Subsidiaries is duly qualified to do business as a foreign
corporation, limited liability company or partnership (as the
case may be) and is in good standing in every jurisdiction in
which the character of the properties owned or leased by it or
the nature of the business conducted by it makes such
qualification necessary, except where the failure to be so
qualified or in good standing would not, individually or in the
aggregate, have a Company Material Adverse Effect.
Section 3.2 of the Company Disclosure Letter sets forth for
each of the Company and its Subsidiaries all jurisdictions in
which each of the Company and its Subsidiaries are qualified to
do business.
Section 3.3. No
Conflict or Violation. The execution,
delivery and performance by the Company of this Agreement does
not and will not (i) violate or conflict with any provision
of any Company Organizational Document or any of the
organizational documents of the Subsidiaries of the Company,
(ii) violate any provision of law, or any order, judgment
or decree of any Governmental Entity, (iii) except as set
forth on Section 3.3 of the Company Disclosure Letter,
violate or result in a breach of or constitute (with due notice
or lapse of time or both) a default under any Contract or result
in the creation or imposition of any Lien (other than any
Permitted Lien) upon any of the assets, properties or rights of
either of the Company or any of its Subsidiaries or result in or
give to others any rights of cancellation, modification,
amendment, acceleration, revocation or suspension of any of the
Contracts or obligations thereunder, or Licenses and Permits or
(iv) violate or result in a breach of or constitute (with
due notice or lapse of time or both) a default under any
contract, agreement or instrument to which the Company or any of
its Subsidiaries is a party or by which it is bound or to which
any of its properties or assets is subject, except with respect
to clauses (iii) and (iv), for any violations, breaches,
conflicts or other occurrences which would not, individually or
in the aggregate, have a Company Material Adverse Effect.
Section 3.4. Consents
and Approvals. No consent, waiver,
authorization or approval of any Governmental Entity, and no
declaration or notice to or filing or registration with any
Governmental Entity, is required in connection with the
execution and delivery of this Agreement by the Company or the
performance
by the Company or its Subsidiaries of their obligations
hereunder or thereunder, except for: (i) any required
competition or other regulatory approvals required of foreign or
domestic authorities; (ii) applicable requirements of the
Securities Act of 1933, as amended, and the rules and
regulations promulgated thereunder (the “Securities
Act”) and of the Securities Exchange Act of 1934, as
amended, and the rules and regulations promulgated thereunder
(the “Exchange Act”) and the rules and
regulations of Nasdaq; (iii) the consents, waivers,
authorizations or approvals of any Governmental Entity set forth
on Section 3.4 of the Company Disclosure Letter;
(iv) the amendment of Establishment Registrations and
Device Listings under the United States Food and Drug
Administration’s (“FDA”) Establishment
Registration and Device Listing regulations, as set forth in
21 C.F.R. Part 807; and (v) such other consents,
waivers, authorizations, approvals, declarations, notices,
filings or registrations, which if not obtained or made would
not, individually or in the aggregate, have a Company Material
Adverse Effect.
Section 3.5. Authorization
and Validity of Agreement.The Company has
the requisite corporate power and authority to execute, deliver
and perform its obligations under this Agreement and to
consummate the transactions contemplated hereby. The execution
and delivery of this Agreement by the Company and the
performance by the Company of its obligations hereunder and the
consummation of the transactions contemplated hereby have been
duly authorized by the Board of Directors of the Company and all
other necessary corporate action on the part of the Company,
other than the adoption of this Agreement by the stockholders of
the Company, and no other corporate proceedings on the part of
the Company are necessary to authorize this Agreement and the
transactions contemplated hereby. This Agreement has been duly
and validly executed and delivered by the Company and, assuming
due execution and delivery by Parent and Merger Sub, shall
constitute a legal, valid and binding obligation of the Company,
enforceable against it in accordance with its terms, subject to
(i) the effect of bankruptcy, fraudulent conveyance,
reorganization, moratorium and other similar laws relating to or
affecting the enforcement of creditors’ rights generally,
(ii) general equitable principles (whether considered in a
proceeding in equity or at law) and (iii) an implied
covenant of good faith and fair dealing.
Section 3.6. Capitalization
and Related Matters.
(a) As of the date hereof, the authorized capital stock of
the Company consists of 100,000,000 shares of Company
Common Stock and 10,000,000 shares of Company Preferred
Stock. As of the close of business on August 3, 2007:
(i) 7,099,229 shares of Company Common Stock are
issued and outstanding, and there are no shares of Company
Preferred Stock issued or outstanding;
(ii) 1,300,000 shares of Company Common Stock are
reserved for issuance and issuable upon or otherwise deliverable
under the Company’s 2006 Incentive Award Plan, the IsoTis,
S.A. Stock Option Plan 2003/0, the IsoTis, S.A. Stock Option
Plan 2003/1, the IsoTis, S.A. Stock Option Plan 2003/2
(collectively, the “Company Stock Plans”) in
connection with the exercise of outstanding Company Options.
Section 3.6(a)(ii) of the Company Disclosure Letter sets
forth, for each outstanding Company Option, whether or not
vested, the (x) name of the holder of such Company Option,
(y) the exercise price per share for such Company Option
and (z) the expiration date of such Company Option; and
(iii) 681,297 shares of Company Common Stock were
reserved for issuance, and were issued, pursuant to the
consummation of the Swiss Merger.
The outstanding shares of Company Common Stock (i) have
been duly authorized and validly issued and are fully paid and
nonassessable and (ii) were issued in compliance with all
applicable federal, state and foreign securities laws. All
grants of Company Options were validly issued and properly
approved by the Company’s Board of Directors or a duly
authorized committee thereof (and all required approvals by the
stockholders of the Company have been obtained) no later than
the date on which the grant of such Company Stock Option was by
its terms to be effective in accordance with all applicable law
and all grants of options to purchase equity interests of
IsoTis, S.A. which were subsequently converted into Company
Options were validly issued and properly approved by IsoTis,
S.A.’s Board of Directors or a duly authorized committee
thereof (and all required approvals by the stockholders of
IsoTis, S.A. have been obtained) no later than the
date on which the grant of such option was by its terms to be
effective in accordance with all applicable law and, neither the
Company nor IsoTis, S.A. has knowingly granted, and there is no
and has been no policy or intentional practice by the Company or
IsoTis, S.A. to grant, Company Stock Options or options to
purchase equity interests of IsoTis, S.A., as applicable, prior
to, or otherwise intentionally coordinate the grant of such
options with, the release of material information regarding the
Company or its Subsidiaries. Each Company Option was properly
accounted for in all material respects in accordance with GAAP
in the financial statements (including the related notes) of the
Company and its Subsidiaries and disclosed in the filings of the
Company and its Subsidiaries with the SEC in accordance with the
Exchange Act and other applicable securities laws. Except as set
forth above in Section 3.6(a), no shares of capital stock
of the Company are outstanding and the Company does not have
outstanding any securities convertible into or exchangeable for
any shares of capital stock, including Company Options, any
rights to subscribe for or to purchase or any options for the
purchase of, or any agreements providing for the issuance
(contingent or otherwise) of, or any calls, commitments or known
claims of any other character relating to the issuance of, any
capital stock, or any stock or securities convertible into or
exchangeable for any capital stock; and the Company is not
subject to any obligation (contingent or otherwise) to
repurchase or otherwise acquire or retire, or to register under
the Securities Act, any shares of capital stock. Except as set
forth above in Section 3.6(a), the Company does not have
outstanding any bonds, debentures, notes or other obligations
the holders of which have the right to vote (or convertible into
or exercisable for securities having the right to vote) with the
stockholders of the Company on any matter.
(b) All of the outstanding shares of capital stock, or
membership interests or other ownership interests of, each
Subsidiary of the Company, as applicable, is validly issued,
fully paid and nonassessable and is owned of record and
beneficially by the Company, directly or indirectly. The Company
has, as of the date hereof and shall have on the Closing Date,
valid and marketable title to all of the shares of capital stock
of, or membership interests or other ownership interests in,
each Subsidiary of the Company, free and clear of any Liens
other than Permitted Liens. Such outstanding shares of capital
stock of, or membership interests or other ownership interests
in, the Subsidiaries of the Company, as applicable, are the sole
outstanding securities of such Subsidiaries; the Subsidiaries of
the Company do not have outstanding any securities convertible
into or exchangeable for any capital stock of, or membership
interests or other ownership interests in, such Subsidiaries,
any rights to subscribe for or to purchase or any options for
the purchase of, or any agreements providing for the issuance
(contingent or otherwise) of, or any calls, commitments or
claims of any other character relating to the issuance of, any
capital stock of, or membership interests or other ownership
interests in, such Subsidiaries, or any stock or securities
convertible into or exchangeable for any capital stock of, or
membership interests or other ownership interests in, such
Subsidiaries; and neither the Company or any of its Subsidiaries
is subject to any obligation (contingent or otherwise) to
repurchase or otherwise acquire or retire, or to register under
the Securities Act, any capital stock of, or membership
interests or other ownership interests in, any Subsidiary of the
Company.
Section 3.7. Subsidiaries
and Equity Investments.The Company and its
Subsidiaries do not directly or indirectly own, or hold any
rights to acquire, any capital stock or any other securities,
interests or investments in any other Person other than
investments that constitute cash or cash equivalents.
Section 3.8. Company
SEC Reports. (a) The Company and its
Subsidiaries, including, without limitation, IsoTis, S.A., have
filed each registration statement, prospectus, definitive proxy
statement or information statement, form, report, schedule and
other document (together with all amendments thereof and
supplements thereto) required to be filed by the Company or any
of its Subsidiaries pursuant to the Exchange Act or the
Securities Act or comparable foreign law or regulation with the
SEC or any comparable foreign regulatory authority or exchange
since January 1, 2004 (as such documents have since the
time of their filing been amended or supplemented, the
“Company SEC Reports”). As of their respective
dates, after giving effect to any amendments or supplements
thereto filed prior to the date hereof, the Company SEC Reports
(i) complied as to form in all material respects with the
requirements of the Exchange Act or the Securities Act, as
applicable, and (ii) did not contain any untrue statement
of a material fact or omit to state a material fact required to
be stated therein or necessary in order to make the statements
therein, in light of the circumstances under which they were
made, not misleading.
(b) The audited consolidated financial statements and
unaudited interim consolidated financial statements (including,
in each case, the notes, if any, thereto) included in the
Company SEC Reports complied as to form in all material respects
with the published rules and regulations of the SEC with respect
thereto, were prepared in accordance with GAAP applied on a
consistent basis during the periods involved (except as may be
indicated therein or in the notes thereto and except with
respect to unaudited statements as permitted by
Form 10-Q
of the SEC) and fairly present (subject, in the case of the
unaudited interim financial statements included therein, to
normal year-end adjustments and the absence of complete
footnotes) in all material respects the consolidated financial
position of the Company or its predecessor and its consolidated
Subsidiaries as of the respective dates thereof and the
consolidated results of their operations and cash flows for the
respective periods then ended.
Section 3.9. Absence
of Certain Changes or Events.
(a) Except as set forth in Section 3.9(a) of the
Company Disclosure Letter, since December 31, 2006, there
has not been:
(i) any Company Material Adverse Effect;
(ii) any loss, damage, destruction or other casualty to the
material assets or properties of either of the Company or any of
its Subsidiaries (other than any for which insurance awards have
been received or guaranteed);
(iii) any material change in any method of accounting or
accounting practice of either of the Company or any of its
Subsidiaries except for any such change required by reason of a
concurrent change in GAAP; or
(iv) any loss of the employment, services or benefits of
the chief executive officer of the Company and members of the
Company’s senior management who report directly to such
chief executive officer.
(b) Since December 31, 2006, each of the Company and
each of its Subsidiaries has operated in the ordinary course of
its business and consistent with past practice and, except as
set forth on Section 3.9(b) of the Company Disclosure
Letter, has not:
(i) incurred any material obligation or liability (whether
absolute, accrued, contingent or otherwise) except in the
ordinary course of business and consistent with past practice;
(ii) failed to discharge or satisfy any Lien or pay or
satisfy any material obligation or liability (whether absolute,
accrued, contingent or otherwise), other than Permitted Liens
and liabilities being contested in good faith and for which
adequate reserves have been provided;
(iii) mortgaged, pledged or subjected to any Lien (other
than Permitted Liens) any of its material assets, properties or
rights;
(iv) sold or transferred any of its material assets, or
cancelled any material debts or claims or waived any material
rights;
(v) disposed of any patents, trademarks or copyrights or
any patent, trademark or copyright applications;
(vi) defaulted on any material obligation;
(vii) granted any increase in the compensation or benefits
of its key employees other than increases in the ordinary course
of business not exceeding 20% of the key employee’s annual
compensation then in effect or entered into any employment,
change of control, retention or severance agreement or
arrangement with any of them;
(viii) contractually committed to make any capital
expenditure for any periods after the date hereof or additions
to property, plant and equipment used in its operations other
than ordinary repairs and maintenance in excess of $100,000 in
the aggregate;
(ix) laid off any significant number of its employees;
(x) received notice from any domestic distributor of its
intention to terminate its relationship or contract with the
Company or any of its Subsidiaries or had any such relationship
or contract terminated by any distributor;
(xi) received notice from any international distributor of
its intention to terminate its material relationship or material
contract with the Company or any of its Subsidiaries or had any
such relationship or contract terminated by any distributor;
(xii) discontinued the offering of any material services or
product;
(xiii) incurred any obligation or liability for the payment
of severance benefits;
(xiv) declared, paid, or set aside for payment any dividend
or other distribution in respect of shares of its capital stock,
membership interests or other securities, or redeemed, purchased
or otherwise acquired, directly or indirectly, any shares of its
capital stock, membership interests or other securities, or
agreed to do so; or
(xv) entered into any agreement or made any commitment to
do any of the foregoing.
Section 3.10. Tax
Matters. Except as set forth on
Section 3.10 of the Company Disclosure Letter:
(a) The Company and each of its Subsidiaries have filed
when due all material Tax Returns required by applicable law to
be filed with respect to the Company and each of its
Subsidiaries; (ii) all such Tax Returns were true, correct
and complete in all material respects as of the time of such
filing; (iii) all material Taxes owed by the Company and
each of its Subsidiaries, if required to have been paid, have
been paid (except for Taxes which are being contested in good
faith); and (iv) any material liability of the Company or
any of its Subsidiaries for Taxes not yet due and payable, or
which are being contested in good faith, has been provided for
on the financial statements of the Company in accordance with
GAAP.
(b) There is no material action, suit, proceeding,
investigation, audit or claim now pending with respect to the
Company or any of its Subsidiaries in respect of any Tax, nor
has any material claim for additional Tax been asserted in
writing by any taxing authority.
(c) Since January 1, 2002, no claim has been made in
writing by any taxing authority in a jurisdiction where the
Company or any of its Subsidiaries has not filed a Tax Return
that it is or may be subject to Tax by such jurisdiction.
(d) (i) There is no outstanding request for any
extension of time for the Company or any of its Subsidiaries to
pay any Taxes or file any Tax Returns; (ii) there has been
no waiver or extension of any applicable statute of limitations
for the assessment or collection of any Taxes of the Company or
any of its Subsidiaries that is currently in force; and
(iii) neither the Company nor any of its Subsidiaries is a
party to or bound by any agreement, whether written or
unwritten, providing for the payment of Taxes, payment for Tax
losses, entitlements to refunds or similar Tax matters, other
than agreements among the Company and its Subsidiaries and other
than customary Tax indemnifications or allocations in commercial
lending or lease agreements.
(e) The Company and each of its Subsidiaries have withheld
and paid all material Taxes required to be withheld in
connection with any amounts paid or owing to any employee,
creditor, independent contractor or other third party.
(f) The Company has not been a United States real property
holding corporation within the meaning of Section 897(c)(2)
of the Code during the applicable period specified in
Section 897(c)(1)(A)(ii) of the Code.
(g) Neither the Company nor any of its Subsidiaries has
distributed stock of another Person, or has had its stock
distributed by another Person, in a transaction that was
purported or intended to be governed in whole or in part by
Section 355 or Section 361 of the Code.
(h) There is no material Lien, other than a Permitted Lien,
affecting any of the assets, properties or rights of the Company
and its Subsidiaries that arose in connection with any failure
or alleged failure to pay any Tax.
(i) Neither the Company nor any of its Subsidiaries
(i) has been a member of an affiliated group (within the
meaning of Code § 1504(a)) filing a consolidated
federal income Tax Return (other than a group the common parent
of which is the Company) or (ii) has any liability for the
Taxes of any Person (other than any of the Company and its
Subsidiaries) under Treasury Regulations § 1.1502-6
(or any similar provision of state, local, or foreign law), as a
transferee or successor, by contract, or otherwise.
Section 3.11. Absence
of Undisclosed Liabilities. Except as set
forth on Section 3.11 of the Company Disclosure Letter,
there are no material liabilities or obligations of the Company
or any Subsidiary thereof of any kind whatsoever, whether
accrued, contingent, absolute, determined, determinable or
otherwise, and there is no existing condition, situation or set
of circumstances that could be reasonably expected to result in
such a liability or obligation, other than (A) liabilities
or obligations disclosed and provided for in the consolidated
balance sheet of the Company as of March 31, 2007 included
in the Company SEC Reports filed prior to the date hereof or
referred to in the notes thereto, (B) liabilities or
obligations incurred in the ordinary course of business
consistent with past practice since March 31, 2007 or
(C) liabilities or obligations which would not,
individually or in the aggregate, have a Company Material
Adverse Effect. Neither of the Company or any of its
Subsidiaries is directly or indirectly liable upon or with
respect to (by discount, repurchase agreements or otherwise), or
obliged in any other way to provide funds in respect of, or to
guarantee or assume, any material debt, obligation or dividend
of any Person, except endorsements in the ordinary course of
business in connection with the deposit, in banks or other
financial institutions, of items for collection.
Section 3.12. Company
Property.
(a) Section 3.12(a) of the Company Disclosure Letter
contains a true and complete description of all real property
owned by the Company and its Subsidiaries (the “Owned
Real Property”) as of the date hereof. The Company has
made available to Parent copies of any title insurance policies
(together with copies of any documents of record listed as
exceptions to title on such policies) currently insuring each
Owned Real Property and copies of the most recent surveys of the
same. The Company and its Subsidiaries have good, marketable and
valid fee title to all of the Owned Real Property free and clear
of Liens other than Permitted Liens.
(b) Section 3.12(b) of the Company Disclosure Letter
sets forth a list of all leases, licenses (for real property),
subleases and occupancy agreements, together with all amendments
thereto, in which either of the Company or its Subsidiaries has
a leasehold interest or similar occupancy rights, whether as
lessor or lessee, and (i) are material to the operation of
the Company and its Subsidiaries, taken as a whole, or
(ii) involve payments by the Company or its Subsidiaries in
excess of $150,000 per year (each, a “Lease”
and collectively, the “Leases”; the property
covered by Leases under which either of the Company or its
Subsidiaries is a lessee is referred to herein as the
“Leased Real Property”; the Leased Real
Property, together with the Owned Real Property, collectively
being the “Company Property”). Neither the
Company nor any of its Subsidiaries is a party to any Contract
(other than a Lease) with the lessor of any of the Leased Real
Properties, which gives such lessor any right to terminate or
adversely alter the terms of the Lease to which such lessor is a
party. The Company or its Subsidiaries enjoys peaceful and
undisturbed possession of, the Leased Real Property pursuant to
the Leases. No option has been exercised under any of such
Leases, except options whose exercise has been evidenced by a
written document, a true, complete and accurate copy of which
has made available to Parent with the corresponding Lease. The
transactions contemplated by this Agreement do not require the
consent or approval of the other party or parties to the Leases.
(c) With respect to each Lease, (i) such Lease is in
full force and effect, (ii) all rents, required deposits
and additional rents due to date pursuant to each Lease have
been paid in full, (iii) the Company has not prepaid rent
or any other amounts due under a Lease more than thirty
(30) days in advance, and (iv) no party has any rights
of offset against any rents, required security deposits or
additional rents payable under such Lease, including, but not
limited to the security deposits paid by the Company pursuant to
the Leases for the Unit B Premises (as hereinafter defined) and
the Leased Real Property. As of the date hereof, no Lease has
been materially modified or amended. That certain Industrial
Real Estate Lease between New Goodyear, LTD. (“Goodyear
Landlord”) and GenSci Regeneration Laboratories, Inc.
dated as of December 28, 1998, as amended by that certain
(i) Rider No. 1 between Goodyear Landlord and GenSci
Regeneration Laboratories, Inc. dated as of December 28,1998, (ii) Option to Extend Lease Term Rider between
Goodyear Landlord and GenSci Regeneration Laboratories, Inc.
dated as of December 28, 1998, and (iii) Rider
No. 2 between Goodyear Landlord, and the Company, as
successor-in-interest
to GenSci Regeneration Laboratories, Inc. dated as of
December 9, 2003, with respect to the premises commonly
known as Unit B in the building located at 2 Goodyear, Irvine,
CA (the “Unit B Premises”), has expired and the
Company has no further obligations to Goodyear Landlord
thereunder.
(d) Except as set forth in Section 3.12(d) of the
Company Disclosure Letter, none of the Company Property is
subject to any option, lease, sublease, license or other
agreement granting to any Person or entity any right to the use,
occupancy or enjoyment of such property or any portion thereof
or to obtain title to all or any portion of such property.
(e) Except as set forth in Section 3.12(e) of the
Company Disclosure Letter, all material improvements, systems,
equipment, machinery and fixtures on the Company Property are in
good operating condition and repair and generally are adequate
and suitable in all material respects for the present and
continued use, operation and maintenance thereof as now used,
operated or maintained. All improvements on the Company Property
constructed by or on behalf of the Company or any Subsidiary
were constructed, to the Knowledge of the Company, in compliance
in all material respects with applicable laws, ordinances and
regulations affecting such Company Property, including but not
limited to the American with Disabilities Act.
(a) The assets, properties and rights of each of the
Company and its Subsidiaries constitute all of the assets,
properties and rights which are used in the operation of their
business as currently conducted. There are no assets,
properties, rights or interests of any kind or nature that
either of the Company or any of its Subsidiaries has been using,
holding or operating in their business prior to the Closing that
will not be used, held or owned by each of the Company or its
Subsidiaries immediately following the Closing.
(b) Each of the Company and its Subsidiaries has good and
marketable fee simple title, free and clear of any Liens other
than Permitted Liens, to, or a valid leasehold interest under
enforceable leases in, all of its material assets, properties
and rights.
Section 3.14. Intellectual
Property.
(a) The Company and its Subsidiaries own all right, title
and interest in and to, or have valid and enforceable licenses
to use, all the Intellectual Property, and such Intellectual
Property represents all intellectual property rights necessary
for the conduct of their business as and where conducted on the
date hereof and on the Closing. The Company and its Subsidiaries
are in compliance in all material respects with all licenses
relating to the protection of such of the Intellectual Property
as it uses pursuant to license or other agreement. To the
Knowledge of the Company, there are no conflicts with or
infringements of any Intellectual Property by any third party.
To the Knowledge of the Company, the conduct of the business of
the Company and its Subsidiaries does not conflict with,
violate, misappropriate, misuse or infringe any proprietary or
intellectual property right of any third party. Except as set
forth on Section 3.14(a) of the Company Disclosure Letter,
there is no claim, suit, action or proceeding pending or, to the
Knowledge of the Company, threatened against the Company or its
Subsidiaries: (i) alleging any such conflict, violation,
misappropriation, misuse or infringement with any third
party’s proprietary or intellectual property rights; or
(ii) challenging the Company’s or its
Subsidiaries’ ownership or use of, or the validity or
enforceability of any Intellectual Property.
(b) Section 3.14(b) of the Company Disclosure Letter
sets forth a complete and current list of all registrations,
certificates, applications, filings or other material documents
issued by, filed with, or recorded by, any Governmental Entity
pertaining to the Intellectual Property (“Registered
Intellectual Property”) as of the date hereof and the
owner of record, date of application or issuance, and relevant
jurisdiction as to each. All Registered Intellectual Property is
owned by the Company
and/or its
Subsidiaries, free and clear of all
Liens other than Permitted Liens. All Registered Intellectual
Property is valid, subsisting, unexpired, and all renewal fees
and other maintenance fees that have fallen due on or prior to
the Closing have been paid. Except as listed on
Section 3.14(b)(iv) of the Company Disclosure Letter, no
Registered Intellectual Property is the subject of any
proceeding before any governmental, registration or other
authority in any jurisdiction. The consummation of the
transactions contemplated by this Agreement will not alter or
impair any Intellectual Property.
(c) Section 3.14(c) of the Company Disclosure Letter
sets forth a complete list of all license agreements pertaining
to Intellectual Property as of the date hereof, except for
agreements pertaining to commercially available, off-the-shelf
software. The Company and its Subsidiaries are in compliance in
all material respects with all agreements pertaining to the
Intellectual Property, and, except as set forth in
Section 3.14(c) of the Company Disclosure Letter are not
under any obligation to pay royalties or other payments in
connection with any agreement, nor restricted from assigning its
rights respecting Intellectual Property, such rights including
the right to sue and obtain damages for past and future
infringements thereof, nor will the Company or its Subsidiaries
otherwise be, as a result of the execution and delivery of this
Agreement or the performance of its obligations under this
Agreement, in breach of any agreement relating to the
Intellectual Property. Neither the Company nor its Subsidiaries
is in material default of any such agreement.
(d) Except as set forth in Section 3.14(d) of the
Company Disclosure Letter, neither the Company nor any of its
Subsidiaries has made any claim of a violation, infringement,
misuse or misappropriation by any third party (including any
employee or former employee of the Company or its Subsidiaries)
of its rights to, or in connection with, any Intellectual
Property, which claim is pending. Neither the Company nor any of
its Subsidiaries has entered into any agreement to indemnify any
other Person against any charge of infringement of any
Intellectual Property.
Section 3.15. Software.
(a) To the Knowledge of the Company, none of the operating
and applications computer software programs and databases used
by the Company and its Subsidiaries that are material to the
conduct of their business (collectively, the
“Software”), nor any use thereof, conflicts
with, infringes upon or violates any intellectual property or
other proprietary right of any other Person and, no claim, suit,
action or other proceeding with respect to any such infringement
or violation is pending, or to the Knowledge of the Company,
threatened.
(b) The Company and its Subsidiaries have not purchased any
material amount of telecommunications equipment without
procuring a software license for the imbedded software in such
equipment nor is the Company or its Subsidiaries subject to any
claim for failing to procure such a license.
Section 3.16. Licenses
and Permits.
(a) The Company and its Subsidiaries own or possess all
right, title and interest in and to each of their respective
material licenses, permits, franchises, registrations,
authorizations and approvals issued or granted to any of the
Company or its Subsidiaries by any Governmental Entity (the
“Licenses and Permits”) and has taken all
necessary action to maintain such Licenses and Permits. Each
License and Permit has been duly obtained, is valid and in full
force and effect, and is not subject to any pending or, to the
Knowledge of the Company, threatened administrative or judicial
proceeding to revoke, cancel, suspend or declare such License
and Permit invalid in any respect. The Licenses and Permits are
sufficient and adequate in all material respects to permit the
continued lawful conduct of the business of the Company and its
Subsidiaries, and none of the operations of the Company or its
Subsidiaries are being conducted in a manner that violates in
any material respects any of the terms or conditions under which
any License and Permit was granted.
(b) No petition, action, investigation, notice of violation
or apparent liability, notice of forfeiture, order to show
cause, complaint, or proceeding seeking to revoke, reconsider
the grant of, cancel, suspend, or modify any of the Licenses and
Permits is pending or, to the Knowledge of the Company,
threatened before any Governmental Entity. No notices have been
received by and, to the Knowledge of the Company, no claims have
been filed against the Company or its Subsidiaries alleging a
failure to hold any requisite permits, regulatory approvals,
licenses or other authorization.
(a) The Company and its Subsidiaries manufacture, market,
test and distribute and for the past three years have
manufactured, marketed, tested and distributed their products in
material compliance with the Federal Food, Drug, and Cosmetic
Act (the “FDCA”) and all applicable rules and
regulations of the FDA or similar laws in any state or foreign
jurisdiction (including, but not limited to, the “Good
Manufacturing Practices” otherwise known as the
“Quality System Regulation,” the “Medical Device
Reporting” regulations and those related to investigational
use or pre-market notification for medical devices and approval
of abbreviated applications to market new drugs, regulations
regarding labeling, advertising and record-keeping, and
regulations addressing human cells, tissues, and cellular and
tissue-based products) and in material compliance with the
Company’s and its Subsidiaries’ quality control
procedures in effect at the time of manufacture. Except as set
forth on Section 3.17(a) of the Company Disclosure Letter,
all of the products currently sold by the Company and its
Subsidiaries have been approved or cleared for marketing by the
FDA and all other applicable federal, state and foreign
regulatory agencies and the Company and its Subsidiaries have
obtained all necessary authorizations, consents and approvals
from any applicable Governmental Entity and neither the Company
nor any of its Subsidiaries promotes or, to the Knowledge of the
Company, has promoted any “off-label” use for such
products or received any notice from any other Person alleging
such promotion. Neither the Company nor any Subsidiary has
received any notice or other communication from the FDA, Person
or any other federal, state or foreign regulatory agency
questioning its manufacturing practices or threatening to revoke
or curtail any product clearance or approval or otherwise
alleging any violation applicable to any products of the Company
or its Subsidiaries, and the Company is not aware of any intent
to deliver any such notice to it or the Company’s
Subsidiaries. Section 3.17(a) of the Company Disclosure
Letter contains a complete list of all products manufactured or
marketed by the Company and its Subsidiaries, including those
which require the approval of, or premarket notification to, or
listing with the FDA or any other United States federal or state
or foreign governmental agency or bureau under any existing law,
regulation or policy, specifying (i) with respect to each
domestic product, the type of approval, premarket notification
or listing required and the reference number or identification
of each currently effective approval, notice and registration
and (ii) with respect to each foreign product, the
regulatory status of such product. None of the products of the
Company or its Subsidiaries have been recalled, withdrawn,
suspended or discontinued by the Company or its Subsidiaries in
the United States or outside the United States whether voluntary
or involuntary and to the Company’s Knowledge, there exists
no basis for any action by the FDA or any other Governmental
Entity to revoke, suspend, cancel or withdraw any product
approval, clearance, registration, license or other
authorization or permit with respect to any product of the
Company or its Subsidiaries. All United States and international
regulatory approvals or premarket notifications therefor are
owned by and registered in the name of the Company or one of its
Subsidiaries and are in full force and effect.
(b) Neither the Company nor any of its Subsidiaries has
failed to file with the applicable regulatory authorities
(including, without limitation, the FDA or any foreign, federal,
state or local governmental or regulatory authority performing
functions similar to those performed by the FDA) any material
required filing, declaration, listing, registration, report or
submission; all such filings, declarations, listings,
registrations, reports or submissions were in compliance with
applicable laws when filed and no deficiencies have been
asserted by any applicable regulatory authority with respect to
any such filings, declarations, listing, registrations, reports
or submissions.
(c) Any clinical, pre-clinical and other studies and tests
conducted by or on behalf of or sponsored by the Company or its
Subsidiaries were and, if still pending, are being conducted in
accordance with all United States and foreign statutes, laws,
rules, directives and regulations, as applicable. The Company
has no knowledge of other studies or tests the results of which
are inconsistent with the Company’s or its
Subsidiaries’ studies or tests or otherwise call into
question the safety or efficacy of the Company’s or its
Subsidiaries’ current or previous products. Neither the
Company nor any of its Subsidiaries has received any notices or
other correspondence from the FDA or any other foreign, federal,
state or local governmental or regulatory authority performing
functions similar to those performed by the FDA with respect to
any ongoing clinical or pre-clinical studies or tests requiring
the termination, suspension or material modification of such
studies or tests.
(d) To the Knowledge of the Company, there are no facts,
circumstances or conditions that would reasonably be expected to
form the basis for any investigation, suit, claim or action or
proceeding against or affecting the Company or its Subsidiaries
relating to or arising under the FDCA or the regulations of the
FDA promulgated thereunder or similar foreign regulations,
except for any such investigation, suit, claim, action or
proceeding that is not material.
(e) Neither the Company nor any of its Subsidiaries, nor,
to the Knowledge of the Company, any employee of the Company or
any of its Subsidiaries or any Person retained by the Company or
any of its Subsidiaries, has made on behalf of the Company or
any of its Subsidiaries any false statement or material
omissions in any application or other Submission relating to
products governed by the FDA or other Governmental Entity.
(f) Except as set forth in Section 3.17(f) of the
Company Disclosure Letter, to the Knowledge of the Company, all
of the manufacturing facilities and operations of the suppliers
of the Company and its Subsidiaries of products sold in the
United States are in material compliance with applicable FDA
regulations, including current Good Manufacturing Practices, and
meet sanitation standards set by the FDCA.
(g) Except as set forth in Section 3.17(g) of the
Company Disclosure Letter, to the Knowledge of the Company, no
legislative or regulatory proposal or other proposal for a
change in any applicable law or the interpretations thereof has
been adopted or is pending which could materially adversely
affect the Company or its Subsidiaries or the business of the
Company or its Subsidiaries.
(h) All of the products sold by the Company and its
Subsidiaries are classified as Class I and Class II
Medical Devices (as defined in 21 U.S.C.
§ 360c(a)(1)(A) and (B) and applicable rules
thereunder. Except as set forth on Section 3.17(h) of the
Company Disclosure Letter, the Company and its Subsidiaries, and
the products sold by the Company and its Subsidiaries, are in
compliance in all material respects with all current and
otherwise applicable statutes, rules, regulations or orders
administered or issued by the FDA and all other Governmental
Entities (except for environmental agencies or bodies) having
regulatory authority over the products of the Company and its
Subsidiaries (except with respect to environmental matters) and
the Company and its Subsidiaries.
(i) Except as set forth on Section 3.17(i) of the
Company Disclosure Letter, since their founding neither the
Company nor any of its Subsidiaries has received any of the
following communications and, to the Knowledge of the Company,
no facts exist which furnish any reasonable basis for, any
Notice of Inspectional Observation (Form FDA 483), Notice
of Adverse Findings, FDA Warning Letter, Section 305
notice, subpoena, an Unacceptable Determination under the
Government-Wide Quality Assurance Program (GWQAP) or other
similar communication by any Governmental Entity.
(j) Except as set forth on Section 3.17(j) of the
Company Disclosure Letter, since their founding, neither the
Company nor any of its Subsidiaries has either filed any
premarket approval applications (“PMA”) or
received any premarket notification (“510(k)”)
clearance or concurrence letters from the FDA.
Section 3.17(j) of the Company Disclosure Letter contains a
complete list of all of the products of the Company and its
Subsidiaries not marketed under an approved PMA or 510(k).
(k) Since their founding, neither the Company nor any of
its Subsidiaries has filed any investigational device exemptions
(“IDE”) or conducted any clinical
investigations under an IDE.
(l) Except as set forth on Section 3.17(l) of the
Company Disclosure Letter, since January 1, 2002, neither
the Company nor any of its Subsidiaries has received any FDA
inspection reports and the FDA has not inspected the
Company’s or any of its Subsidiaries’ facilities. The
Company has furnished Parent with access to material internal
audit reports (as required by 21 C.F.R. Part 820,
Section 820.22) conducted by the Company and its
Subsidiaries since January 1, 2002. Section 3.17(l) of
the Company Disclosure Letter contains an accurate and complete
list of all such internal audit reports.
contains a complete list of all such complaints and Product
Experience Reports received or compiled by the Company and its
Subsidiaries since January 1, 2003. Except as set forth on
Section 3.17(m) of the Company Disclosure Letter, since
January 1, 2003, the Company has not filed any Medical
Device Reports (pursuant to 21 C.F.R. Part 803).
Section 3.18. Certifications;
Product Safety.
(a) All operations of the Company and its Subsidiaries have
achieved and maintained all required ISO (International
Organization for Standardization) and quality certifications and
are compliant, in all material respects, with the applicable FDA
Quality System Regulations, and there is no pending or
threatened, action to audit, repeal, fail to renew or challenge
any such certification. Except as set forth in
Section 3.18(a) of the Company Disclosure Letter, since
January 1, 2003, neither the Company nor any of its
Subsidiaries has been required to file any notification or other
report with or provide information to any product safety agency,
commission, board or other governmental entity of any
jurisdiction concerning actual or potential hazards with respect
to any product purchased, distributed, sold or leased, or with
respect to services rendered, by the Company or any of its
Subsidiaries. Each product distributed, sold, or leased, or
service rendered, by the Company and its Subsidiaries complies
in all material respects with all product safety standards of
each applicable product safety agency, commission, board or
other governmental entity having jurisdiction over the Company.
The Company and its Subsidiaries, or an agent of the Company or
its Subsidiaries, manufactures each product of the Company and
its Subsidiaries in material compliance with each device master
record (as such term is defined in the FDA Quality System
Regulations) maintained by the Company and its Subsidiaries, or
an agent of the Company or its Subsidiaries, for each product of
the Company and its Subsidiaries.
(a) Except as set forth on Section 3.19(a) of the
Company Disclosure Letter, the operations of the business of the
Company and its Subsidiaries have been conducted in accordance
in all material respects with all laws, regulations, orders and
other requirements of all Governmental Entities having
jurisdiction over such entity and its assets, properties and
operations. Since January 1, 2005, none of the Company or
its Subsidiaries has received notice of any violation (or any
investigation with respect thereto) of any such law, regulation,
order or other legal requirement, and none of the Company or its
Subsidiaries is in material default with respect to any order,
writ, judgment, award, injunction or decree of any foreign,
national, state or local court or governmental or regulatory
authority or arbitrator, domestic or foreign, applicable to any
of its assets, properties or operations.
(b) The Company and each of its officers are in compliance
in all material respects with (i) the applicable provisions
of the Sarbanes-Oxley Act of 2002 and the related rules and
regulations promulgated under such act or the Exchange Act (the
“Sarbanes-Oxley Act”) and (ii) the
applicable listing and corporate governance rules and
regulations of Nasdaq. The Company has previously disclosed to
Parent the information required to be disclosed by the Company
and certain of its officers to the Company’s Board of
Directors or any committee thereof pursuant to the certification
requirements contained in
Form 10-K
and
Form 10-Q
under the Exchange Act. Except as permitted by the Exchange Act,
including, without limitation, Sections 13(k)(2) and (3),
since the enactment of the Sarbanes-Oxley Act, neither the
Company nor any of its Affiliates has made, arranged or modified
personal loans to any executive officer or director of the
Company.
(c) The management of the Company has (i) implemented
(x) disclosure controls and procedures to ensure that
material information relating to the Company, including its
consolidated Subsidiaries, is made known to the management of
the Company by others within those entities and (y) a
system of internal control over financial reporting sufficient
to provide reasonable assurances regarding the reliability of
financial reporting and the preparation of financial statements
for external purposes in accordance with GAAP, and (ii) has
disclosed, based on its most recent evaluation prior to the date
hereof, to the Company’s auditors and the audit committee
of the Company’s Board of Directors (A) any
significant deficiencies in the design or
operation of internal controls which could adversely affect the
Company’s ability to record, process, summarize and report
financial data and have identified for the Company’s
auditors any material weaknesses in internal controls and
(B) any fraud, whether or not material, that involves
management or other employees who have a significant role in the
Company’s internal controls. The Company has made available
to Parent a summary of any such disclosure made by management to
the Company’s auditors and audit committee.
Section 3.20. Litigation. Except
as set forth in Section 3.20 of the Company Disclosure
Letter, there are no claims, actions, suits, proceedings,
subpoenas or, to the Knowledge of the Company, investigations
(each, an “Action”) pending or, to the
Knowledge of the Company, threatened, before any Governmental
Entity, or before any arbitrator of any nature, brought by or
against any of the Company or its Subsidiaries or any of their
officers or directors involving or relating to the Company or
its Subsidiaries, the material assets, properties or rights of
any of the Company and its Subsidiaries or the transactions
contemplated by this Agreement. There is no judgment, decree,
injunction, rule or order of any Governmental Entity or before
any arbitrator of any nature outstanding, or to the Knowledge of
the Company, threatened, against either of the Company or its
Subsidiaries.
(a) Section 3.21 of the Company Disclosure Letter sets
forth a complete and correct list of all Contracts as of the
date hereof.
(b) Each Contract is in full force and effect, valid,
binding and enforceable against the Company or its Subsidiaries
and, to the Knowledge of the Company, against the other parties
thereto in accordance with its terms, subject to (i) the
effect of bankruptcy, fraudulent conveyance, reorganization,
moratorium and other similar laws relating to or affecting the
enforcement of creditors’ rights generally,
(ii) general equitable principles (whether considered in a
proceeding in equity or at law) and (iii) an implied
covenant of good faith and fair dealing. Each of the Company and
its Subsidiaries has performed all obligations required to be
performed by it to date under, and is not in default or
delinquent in performance, status or any other respect (claimed
or actual) in connection with, any Contract, and no event has
occurred which, with due notice or lapse of time or both, would
constitute such a default, except as would not, individually or
in the aggregate, have a Company Material Adverse Effect. The
Company has sent no notices of default under any Contract, which
default remains uncured, and to the Knowledge of the Company, no
other party to any Contract is in material default in respect
thereof, and no event has occurred which, with due notice or
lapse of time or both, would constitute such a default. The
Company has made available to Parent or its representatives true
and complete originals or copies of all the Contracts.
(c) A “Contract” means any agreement,
contract or commitment, oral or written, to which either of the
Company or any of its Subsidiaries is a party or by which it or
any of its assets are bound constituting:
(i) a contract or agreement (A) with a customer of the
Company or any of its Subsidiaries pursuant to which the Company
or any of its Subsidiaries has sold goods
and/or
services and derived revenue (when taken together with any
revenue derived from any other contracts or agreements with that
customer) of at least $150,000 for the year ended
December 31, 2006, or (B) with any customer that
contains “most-favored nation,” pursuant to which the
Company or any of its Subsidiaries has sold goods
and/or
services (the Contracts set forth in subsection (A) and
(B) collectively, the “Customer
Contracts”);
(ii) a contract or agreement with (A) a vendor of the
Company or any of its Subsidiaries pursuant to which the Company
and its Subsidiaries paid (when taken together with any amounts
paid to that vendor pursuant to any other contracts or
agreements) at least $150,000 to such vendor for the year ended
December 31, 2006 or (B) with any tissue bank (the
Contracts set forth in subsection (A) and
(B) collectively, the “Vendor Contracts”);
(iii) a mortgage, indenture, security agreement, guaranty,
pledge and other agreement or instrument relating to the
borrowing of money or extension of credit (other than accounts
receivable or accounts payable in the ordinary course of
business and consistent with past practice);
(iv) an employment, change of control, retention, severance
or material consulting agreement or a collective bargaining
agreement or other material agreement with any association
representing employees;
(v) any agreement with a hospital under which payments in
excess of $150,000 in the aggregate have been or are expected to
be made over the term of the agreement; and
(vi) any agreement with a GPO, surgeon or hospital
organization;
(vii) a joint venture, partnership or limited liability
company agreement with third parties;
(viii) a non-competition agreement or any other agreement
or obligation which purports to limit in any material respect
(i) the manner in which, or the localities in which, the
business of the Company or its Subsidiaries may be conducted or
(ii) the ability of either of the Company or its
Subsidiaries to provide any type of service presently conducted
by the Company or its Subsidiaries;
(ix) an agreement containing any exclusivity clause or
most-favored-nations clause;
(x) a Lease;
(xi) an agreement limiting or restricting the ability of
either of the Company or its Subsidiaries to make distributions
or declare or pay dividends in respect of its capital stock or
membership interests, as the case may be;
(xii) a distribution, dealership, representative, broker,
sales agency, consulting or material advertising contract;
(xiii) an agreement requiring capital expenditures in
excess of $100,000;
(xiv) an agreement or offer to acquire all or a substantial
portion of the capital stock, business, property or assets of
any other Person or sell, transfer or otherwise dispose of any
assets or capital stock of the Company or any of its
Subsidiaries;
(xv) any agreement to indemnify any other Person against
any charge of infringement of any Intellectual Property;
(xvii) any other material agreement not in the ordinary
course of the business of the Company and its Subsidiaries.
Section 3.22. Employee
Plans.
(a) Section 3.22(a) of the Company Disclosure Letter
sets forth a list: (i) all “employee benefit
plans”, as defined in Section 3(3) of ERISA, and all
other employee benefit agreements, plans, programs, policies or
arrangements, including, without limitation, any such
agreements, plans, programs, policies or arrangements providing
severance pay, sick leave, employment, severance, retention,
change in control, consulting, vacation pay, salary continuation
for disability, retirement benefits, deferred compensation,
bonus pay, incentive pay, stock options or stock awards,
hospitalization insurance, medical insurance, life insurance,
cafeteria benefits, dependent care reimbursements, prepaid legal
benefits, scholarships or tuition reimbursements, maintained or
sponsored by the Company or any of its Subsidiaries or to which
the Company or any of its Subsidiaries is obligated to
contribute thereunder for current or former employees, officers,
directors, agents, consultants and independent contractors of
the Company and its Subsidiaries (the “Employee Benefit
Plans”), and (ii) all “employee pension
plans”, as defined in Section 3(2) of ERISA,
maintained or sponsored by the Company or any trade or business
(whether or not incorporated) which is under control or treated
as a single employer with the Company under Section 414(b),
(c), (m), or (o) of the Code (a “ERISA
Affiliate”) or to which the Company or any ERISA
Affiliate has contributed or has been obligated to contribute
thereunder (the “Pension Plans”).
(b) True, correct and complete copies of the following
documents, with respect to each of the Employee Benefit Plans
and Pension Plans, have been made available to Parent, to the
extent applicable: (i) all plans and related trust
documents, and amendments thereto; (ii) Forms 5500
filed for the three most recent plan years;
(iii) the most recent IRS determination letter, if any,
regarding the tax-qualified status of such Employee Benefit Plan
or Pension Plan; (iv) the most recent summary plan
descriptions, annual reports and material modifications;
(v) the most recent actuarial report, if any;
(vi) written descriptions of the terms of all non-written
agreements relating to the Employee Benefit Plans or Pension
Plans; and (vii) the most recent written results of all
compliance testing required pursuant to Sections 125,
401(a)(4), 401(k), 401(m), 410(b), 415 and 416 of the Code.
(c) None of the Employee Benefit Plans or Pension Plans is
a multiemployer plan, as defined in Section 3(37) of ERISA
(“Multiemployer Plan”) or subject to
Title IV or Section 302 of ERISA or Sections 412
or 4971 of the Code. None of the Company or any ERISA Affiliate
has withdrawn at any time within the preceding six years from
any Multiemployer Plan or incurred any withdrawal liability
which remains unsatisfied and no circumstances have occurred or
exist which could reasonably be expected to result in any such
liability to the Company or any Subsidiary.
(d) Each Pension Plan that is intended to qualify under
Section 401(a) of the Code has received a determination
letter from the IRS or can rely on an opinion letter as to its
qualification and the trust maintained pursuant thereto is
exempt from federal income taxation under Section 501(a) of
the Code, and nothing has occurred with respect to the operation
of any such Pension Plan that would reasonably be expected to
cause the loss of such qualification or exemption or the
imposition of any material liability, penalty or tax under ERISA
or the Code.
(e) All contributions (including all employer contributions
and employee salary reduction contributions) and all premiums
required to have been paid under any of the Employee Benefit
Plans or Pension Plans or by law (without regard to any waivers
granted under Section 412 of the Code) to any funds or
trusts established thereunder or in connection therewith have
been made by the due date thereof (including any valid
extension) and all contributions for any period ending on or
before the Closing Date which are not yet due will be paid or
accrued prior to the Closing Date.
(f) To the Knowledge of the Company, there has been no
material violation of ERISA or the Code with respect to the
filing of applicable reports, documents and notices regarding
the Employee Benefit Plans with the Secretary of Labor or the
Secretary of the Treasury or the furnishing of required reports,
documents or notices to the participants or beneficiaries of the
Employee Benefit Plans.
(g) There are no pending actions, claims or lawsuits (other
than claims for benefits in the ordinary course) which have been
instituted or, to the Knowledge of the Company, asserted against
the Employee Benefit Plans or Pension Plans, the assets of any
of the trusts under such plans or the plan sponsor or the plan
administrator, or against any fiduciary of the Employee Benefit
Plans or Pension Plans with respect to the operation or
administration of such plans or the investment of the assets of
such plans (other than routine benefit claims), nor does the
Company have Knowledge of facts which could reasonably form the
basis for any such claim or lawsuit. No Employee Benefit Plan or
Pension Plan has been the subject of an audit, investigation or
examination by any Governmental Entity to the Knowledge of the
Company.
(h) The Employee Benefit Plans and Pension Plans have been
maintained, in all material respects, in accordance with their
terms and with all provisions of ERISA and the Code (including
rules and regulations thereunder) and other applicable federal
and state laws and regulations. None of the Company, its
Subsidiaries, or, to the Knowledge of the Company, any
“party in interest” or “disqualified person”
with respect to the Employee Benefit Plans or Pension Plans, as
applicable, has engaged in a non-exempt “prohibited
transaction” within the meaning of Section 406 of
ERISA or 4975 of the Code pursuant to which the tax or penalty
could be material. No stock or other security issued by the
Company or any Affiliate forms or has formed a part of the
assets of any Employee Benefit Plan or Pension Plan.
(i) Except as set forth in Section 3.22(i) of the
Company Disclosure Letter, none of the Employee Benefit Plans or
Pension Plans provide retiree life, health or death benefits
except as may be required under COBRA or any similar state or
local law at the retirees own expense.
(j) Except as set forth in Section 3.22(j) of the
Company Disclosure Letter, neither the execution and delivery of
this Agreement nor the consummation of the transactions
contemplated hereby will, either alone or
together with the occurrence of subsequent events
(i) increase any benefits otherwise payable under any
Employee Benefit Plan or Pension Plan; (ii) result in the
acceleration of the time of payment or vesting of any benefits
under any Employee Benefit Plan, Pension Plan or Contract to any
current or former employee; or (iii) result in the payment
of any amount that would, individually or in combination with
any other such payment, fail to be deductible by reason of
Section 280G of the Code.
(k) Except as set forth on Section 3.22(k) of the
Company Disclosure Letter, no Contract, Employee Benefit Plan,
warrant or other compensatory or equity-based arrangement with
any employee, officer or director of the Company contains any
provision requiring the Company to pay on behalf of, or
otherwise reimburse, any such individual for any income or
excise taxes due by such individual upon payment of any benefits
by the Company, other than any such obligations as required by
applicable laws or regulations.
(l) Each “nonqualified deferred compensation
plan” (as defined in Section 409A(d)(1) of the Code)
of the Company has been operated in good faith compliance with
Section 409A of the Code, IRS Notice
2005-1, or
the proposed regulations or final regulations promulgated under
Section 409A of the Code.
(m) All Company Employee Benefit Plans and all Company
Pension Plans subject to the laws of any jurisdiction outside of
the United States (i) have been maintained in material
compliance with all applicable requirements, (ii) if they
are intended to qualify for special tax treatment, meet all
requirements for such treatment, and (iii) if they are
intended to be funded
and/or
book-reserved, are fully funded
and/or book
reserved, as appropriate, based upon reasonable actuarial
assumptions.
Section 3.23. Insurance. The
Company has made available to Parent true, complete and accurate
copies of all material surety bonds, fidelity bonds and all
material policies of title, liability, fire, casualty, business
interruption, workers’ compensation and other forms of
insurance insuring each of the Company and its Subsidiaries and
their assets, properties and operations. All such policies and
bonds are in full force and effect. None of the Company or its
Subsidiaries is in material default under any provisions of any
such policy of insurance nor has any of the Company or its
Subsidiaries received notice of cancellation of or cancelled any
such insurance. For all material claims made under such policies
and bonds, the Company and its Subsidiaries have timely complied
with any applicable notice provisions.
Section 3.24. Affiliate
Transactions. Except as set forth in the
Company SEC Reports (including the exhibits thereto) filed prior
to the date hereof, there are no transactions, agreements,
arrangements or understandings between the Company or any of its
Subsidiaries, on the one hand, and any director or executive
officer of the Company, on the other hand, that would be
required to be disclosed under Item 404 of
Regulation S-K
under the Securities Act other than ordinary course of business
employment agreements and similar employee arrangements
otherwise set forth on Section 3.24 of the Company
Disclosure Letter to the extent required to be set forth therein
(or any such ordinary course employment agreements and similar
arrangements not required to be set forth on Section 3.24
of the Company Disclosure Letter by the limitations contained in
the representation and warranty set forth in Section 3.21
of this Agreement).
Section 3.25. Vendors
and Customers.
(a) Section 3.25(a) of the Company Disclosure Letter
sets forth a list of the vendors that are parties to the Vendor
Contracts. No such vendor has expressed in writing or, to the
Knowledge of the Company, verbally to the Company or any of its
Subsidiaries its intention to cancel or otherwise terminate or
materially reduce or modify its relationship with the Company or
any of its Subsidiaries.
(b) Section 3.25(b) of the Company Disclosure Letter
sets forth a list of the customers that are parties to the
Customer Contracts. No customer under any such Customer Contract
has expressed in writing or, to the Knowledge of the Company,
verbally to the Company or any of its Subsidiaries its intention
to cancel or otherwise terminate or materially reduce or modify
its relationship with the Company or any of its Subsidiaries.
(c) No GPO or hospital contracting with the Company or any
of its Subsidiaries nor any Person who is a licensor to the
Company, has expressed in writing or, to the Knowledge of the
Company, verbally to the
Company or any of its Subsidiaries its intention to cancel or
otherwise terminate or materially reduce or modify its
relationship with the Company or any of its Subsidiaries.
Section 3.26. Labor
Matters.
(a) Neither the Company nor any of its Subsidiaries is a
party to any collective bargaining agreement or other labor
union contract or similar scheme or arrangement applicable to
its employees nor does the Company have Knowledge of any
activities or proceedings of any labor union to organize any
such employees.
(b) Each of the Company and its Subsidiaries is in
compliance in all material respects with all applicable laws
relating to employment and employment practices, the
classification of employees, wages, hours, collective
bargaining, unlawful discrimination, civil rights, safety and
health, workers’ compensation and terms and conditions of
employment. There are no charges with respect to or relating to
either of the Company or its Subsidiaries pending or, to the
Knowledge of the Company, threatened before the Equal Employment
Opportunity Commission or any state, local or foreign agency
responsible for the prevention of unlawful employment practices.
Neither the Company nor any of its Subsidiaries has received any
notice from any national, state, local or foreign agency
responsible for the enforcement of labor or employment laws of
an intention to conduct an investigation of either of the
Company or its Subsidiaries and no such investigation is in
progress.
(c) There has been no “mass layoff” or
“plant closing” as defined by the Worker Adjustment
and Retraining Notification Act or any similar state or local
“plant closing” law (“WARN”) with
respect to the current or former employees of the Company or its
Subsidiaries.
(d) Except as set forth on Section 3.26(d) of the
Company Disclosure Letter, neither the Company nor any of its
Subsidiaries has any severance plan or severance obligation with
respect to its employees.
Section 3.27. Environmental
Matters.
(a) Each of the Company and its Subsidiaries is, and has
been, in compliance in all material respects with all
Environmental Laws. Each of the Company and its Subsidiaries has
in effect all material licenses, permits and other
authorizations required under all Environmental Laws and all
such licenses, permits and other authorizations are in full
force and effect and the Company is in compliance in all
material respects with all such licenses, permits and
authorizations and such licenses, permits and authorizations are
transferable without cost.
(b) There is no material litigation or other proceeding or
investigation pending, or to the Knowledge of the Company,
threatened against the Company, any of its Subsidiaries or any
of their respective properties under any Environmental Law, and
the Company and its Subsidiaries have not received any notice of
material violation or potential liability under any
Environmental Laws from any Person or any Governmental Entity
inquiry, request for information, or demand letter under any
Environmental Law relating to operations or properties of the
Company or its Subsidiaries. None of the Company, its
Subsidiaries or respective properties or operations is subject
to any orders arising under Environmental Laws nor are there any
administrative, civil or criminal actions, suits, proceedings or
investigations pending or, to the Knowledge of the Company,
threatened, against the Company or its Subsidiaries under any
Environmental Law. None of the Company or its Subsidiaries has
entered into any agreement pursuant to which the Company or its
Subsidiaries has assumed or will assume any material liability
under Environmental Laws, including without limitation, any
obligation for costs of remediation, of any other Person.
(c) To the Knowledge of the Company, there has been no
release or threatened release of any Hazardous Material, on, at
or beneath any of the Company Property or other properties
currently or previously owned or operated by the Company or its
Subsidiaries or any surface waters or groundwater’s thereon
or thereunder which requires any material disclosure,
investigation, cleanup, remediation, monitoring, abatement, deed
or use restriction by the Company, or which would be expected to
give rise to any actual or alleged material liability for
personal injury, property damage, natural resources damage or
other material liability or damages to the Company or its
Subsidiaries under any Environmental Laws.
(d) None of the Company or its Subsidiaries has sent or
arranged for the disposal of any Hazardous Material, or
transported any Hazardous Material, that reasonably would be
expected to give rise to any material liability for any damages
or costs of investigation, remediation or any other action to
respond to the release or threatened release of any Hazardous
Material.
(e) The Company has made available to Parent copies of all
environmental studies, investigations, reports or assessments
concerning the Company, its Subsidiaries, the Company Property
and any owned real property currently or previously owned or
operated by the Company or its Subsidiaries.
(f) None of the Company and its Subsidiaries is or will be
required to incur material cost or expense in order to cause
their operations or properties to comply with applicable
Environmental Laws.
Section 3.28. No
Brokers; Other Advisors.
(a) No broker, finder or similar intermediary has acted for
or on behalf of, or is entitled to any broker’s,
finder’s or similar fee or other commission from the
Company or its Subsidiaries in connection with this Agreement or
the transactions contemplated hereby other than Thomas Weisel
Partners LLC. The Company has heretofore furnished to Parent a
complete and correct copy of all agreements between the Company
and Thomas Weisel Partners LLC pursuant to which Thomas Weisel
Partners LLC would be entitled to any payment relating to the
transactions contemplated hereby.
(b) Other than the agreements with Thomas Weisel Partners
LLC described in Section 3.28(a), each engagement letter or
other contract between the Company or any of its Subsidiaries
and any of its legal, accounting or other advisors in connection
with the transactions contemplated by this Agreement entitles
the applicable advisor to receive compensation only at its usual
hourly rates, without any premium, bonus or similar payment in
connection with the transactions contemplated by this Agreement.
Section 3.29. State
Takeover Statutes. The Board of Directors of
the Company has taken all action necessary to ensure that any
restrictions on business combinations contained in the DGCL,
including Section 203 of the DGCL, or in the Company
Organizational Documents will not apply to the Agreement, the
Merger and the transactions contemplated by this Agreement. No
other “fair price”, “moratorium”,
“control share acquisition” or other similar
anti-takeover statute or regulation or any anti-takeover
provision in the Company’s Organizational Documents is, or
at the Effective Time will be, applicable to the Company, the
Company Common Stock, the Agreement, the Merger or the other
transactions contemplated by this Agreement.
Section 3.30. Opinion
of Financial Advisor. The Board of Directors
of the Company has received the opinion of Thomas Weisel
Partners LLC, dated as of the date hereof, to the effect that,
as of such date, the Merger Consideration to be received by the
holders of the Company Common Stock pursuant to the Merger is
fair from a financial point of view to the holders of such
Company Common Stock. A written copy of such opinion has been
delivered to Parent.
Section 3.31. Information
Supplied. The information supplied or to be
supplied by the Company specifically for inclusion in the proxy
statement or any amendment or supplement thereto (the
“Proxy Statement”) and to be sent to the
stockholders of the Company in connection with the Company
stockholders meeting to adopt this Agreement and the Merger (the
“Company Stockholders Meeting”) shall not, on
the date the Proxy Statement is first mailed to the stockholders
of the Company or at the time of the Company Stockholders
Meeting or at the Effective Time, contain any untrue statement
of a material fact or 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. The Proxy Statement will, at the
time of the Company Stockholders Meeting, comply as to form in
all material respects with the requirements of the Exchange Act.
Section 3.32. Board
Approval. The Board of Directors of the
Company, at a meeting duly called and held, by unanimous vote
(i) determined that this Agreement and the transactions
contemplated hereby, including the Merger, are advisable and
fair to, and in the best interests of, the Company and its
stockholders, (ii) approved this Agreement and the
transactions contemplated hereby, including the Merger, and
(iii) resolved,
subject to Section 7.4, to recommend that the holders of
the shares of Company Common Stock approve and adopt this
Agreement and the transactions contemplated hereby, including
the Merger. The Company hereby agrees to the inclusion in the
Proxy Statement of the recommendation of the Board of Directors
of the Company described in this Section 3.32 (subject to
the right of the Board of Directors of the Company to withdraw,
amend or modify such recommendation in accordance with
Section 7.4).
Section 3.33. Vote
Required. The affirmative vote of the holders
of a majority of the outstanding shares of Company Common Stock
entitled to vote thereon (the “Required Company
Vote”) is the only vote of the holders of any class or
series of the Company’s capital stock necessary to approve
and adopt this Agreement and the transactions contemplated
hereby, including the Merger.
Section 3.34. Illegal
or Unauthorized Payments; Political Contributions.
(a) Neither the Company or its Subsidiaries nor, to the
Knowledge of the Company (after reasonable inquiry of its
officers and directors), any of the officers, directors,
employees, agents or other representatives of the Company or its
Subsidiaries or any other business entity or enterprise with
which the Company or any of its Subsidiaries is or has been
affiliated or associated, has, directly or indirectly, made or
authorized any payment, contribution or gift of money, property,
or services, whether or not in contravention of applicable law,
(a) as a kickback or bribe to any Person or (b) to any
political organization, or the holder of or any aspirant to any
elective or appointive public office except for personal
political contributions not involving the direct or indirect use
of funds of the Company or any of its Subsidiaries.
(b) None of the Company, any Subsidiary or, to the
Knowledge of the Company, any directors or officers, agents or
employees of the Company or any Subsidiary, has
(i) provided remuneration or received any remuneration in
violation of 42 U.S.C.
1320a-7b(b),
the “Federal anti-kickback statute” or any similar
Law, or (ii) participated in providing financial or
reimbursement information to customers that was reported to
government reimbursement agencies and that was untrue or
misleading in violation of 31 U.S.C. 3729, the
“Federal False Claims Act” or any similar Law.
Section 3.35. Exchange
Offer.
(a) Through a public exchange offer (the “Exchange
Offer”), the Company acquired, through its wholly owned
Swiss subsidiary, IsoTis International S.A. (the “Swiss
SPV”), 64,180,460 of the common shares of IsoTis, S.A.,
pursuant to Offer Memoranda (the “Offer
Memoranda”) and other informational materials made
available to IsoTis, S.A. shareholders in Switzerland, the
Netherlands, Canada and the United States and such Exchange
Offer and the transactions contemplated therein complied with
the applicable securities laws and any other applicable laws of
the above referenced jurisdictions (such laws, the
“Applicable Securities Laws”) as well as the
pertinent recommendations of the Swiss Takeover Board dated
December 12, 2006.
(b) The Offer Memoranda and other informational materials
made available to IsoTis, S.A. shareholders in connection with
the Exchange Offer, conformed, in all material respects, to the
requirements of the Applicable Securities Laws, and, as of the
date thereof, did 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 light of
the circumstances under which they were made, not misleading;
(c) The Company and the Swiss SPV, as applicable, has taken
all corporate action necessary to merge IsoTis, S.A. into a
wholly owned subsidiary of the Company and to hold and acquire
all of the shares of capital stock in the merged entity and
thereby to exchange all of the remaining shares of capital stock
of IsoTis, S.A. into shares of Company Common Stock in
compliance with the Applicable Securities Laws, including
without limitation, the Swiss Federal Act on Mergers,
De-Mergers, Transformations and Transfers of Assets of
October 3, 2003, as amended from time to time, and the
Swiss Federal Act on Stock Exchanges and Securities Trading of
March 24, 1995, as amended from time to time (the
“Swiss Merger”) and has terminated as of
July 30, 2007 the listing of shares of capital stock of
IsoTis, S.A. on each of the SWX Swiss Exchange, Euronext
Amsterdam N.V. and the Toronto Stock Exchange (collectively, the
“Listing Terminations”) in compliance with the
Applicable Securities Laws;
(d) The Swiss SPV is a corporation duly organized and
validly existing under the laws of Switzerland with full
corporate power and authority to conduct the Swiss Merger. As of
the date hereof, the Company owns 100% of the issued and
outstanding capital stock of the Swiss SPV and all of the assets
and liabilities of IsoTis, S.A., and IsoTis, S.A. has been
dissolved; and
(e) The Exchange Offer, the Swiss Merger, the Listing
Terminations and the consummation of all transactions in
connection therewith did not conflict with or result in a breach
or violation of any of the terms or provisions of, or constitute
a default under, or give rise to a right of termination under
any indenture, mortgage, deed of trust, loan agreement or other
agreement or instrument to which the Company or any of its
subsidiaries is a party or by which the Company or any of its
subsidiaries is bound or to which any of the property or assets
of the Company or any of its subsidiaries is subject, except for
such breaches or violations as would not, individually or in the
aggregate, have a Company Material Adverse Effect, nor did such
action result in any violation of the provisions of the
Certificate of Incorporation or Bylaws of the Company or any
statute or any order, rule or regulation of any court or
governmental agency or body having jurisdiction over the Company
or any of its subsidiaries or any of their properties.
Section 3.36. Product
Warranty. No product of the Company or any of
its Subsidiaries manufactured, sold, leased or delivered by the
Company or any of its Subsidiaries is subject to any oral or
written guaranty, warranty or other indemnity to its customers
with respect to the quality or absence of defects of such
product beyond the Company’s and its Subsidiaries’
applicable regular or standard or usual terms and conditions of
sale or lease or as otherwise provided by applicable law. Except
as set forth in Section 3.36 of the Company Disclosure
Letter, there are no claims pending, or to the Knowledge of the
Company, anticipated or threatened against the Company or any of
its Subsidiaries with respect to the quality of, or existence of
defects in, any of their products. The Company has made
available to Parent information which is accurate and complete
in all material respects, regarding all returns of defective or
expired products given or promised to customers since
January 1, 2003, and such information in each case
accurately describes as best known to the Company the cause
which resulted in the return, allowance or credit. Neither the
Company nor any of its Subsidiaries has since January 1,2004 paid or been required to pay or received a request or
demand for payment of any damages, including any direct,
incidental or consequential damages, to any Person in connection
with any product.
Section 3.37. Export.
(a) In the three-year period prior to the date hereof, the
Company and its Subsidiaries and, to the Knowledge of the
Company, any and all distributors of the Company’s and its
Subsidiaries’ products have (i) complied with all
applicable laws or regulations related to the sale, marketing,
promotion or export of goods promulgated or enforced by the
Office of Foreign Assets Control in the United States Department
of the Treasury, the United States Department of Commerce or any
other department or agency of the United States federal
government, including, without limitation, the Arms Export
Control Act, the trading with the Enemy Act, the International
Emergency Economic Powers Act, the Export Administration Act,
the 1930 Tariff Act, the Foreign Corrupt Practices Act, the
Export Administration Regulations, the International Traffic in
Arms Regulations, the United States Customers Regulations (the
“Trade Laws”) and (ii) made reasonable
efforts to ensure that no products have been sold directly or
indirectly to any entity where such sales are, or were at any
time during the previous two years, prohibited by these Trade
Laws or other regulations, including, without limitation, in the
case of each of clause (i) and (ii) with respect to
any sales made in Iran or to any Person in Iran.
(b) Neither the Company nor any of its Subsidiaries has
received notice that it has been the subject of any
investigation, complaint or claim of any violation of any Trade
Law by any Governmental Entity.
Section 3.38. Inventory. Section 3.38
of the Company Disclosure Letter sets forth a complete and
accurate list of addresses at which amounts of the inventory of
the Company and its Subsidiaries is located and except as set
forth therein, no amounts of inventory are held by any Person
(including any Affiliate of the Company or any of its
Subsidiaries) on consignment. All inventory reflected on the
Company’s financial statements included in the Company SEC
Reports and all other inventory acquired by the Company or any
of its Subsidiaries was acquired in the ordinary course of
business and in a manner consistent with each of the
Company’s and each of its Subsidiary’s regular
inventory practices. Adequate reserves have been established on
the Company’s financial statements and on the books and
records of the Company and each of its Subsidiaries with respect
to excessive and obsolete inventory (it being agreed that, for
purposes of this Section 3.38 the term “excessive and
obsolete inventory” shall refer to any inventory which
(i) cannot be sold at current prices in the ordinary course
of business, (ii) are not usable in the production of
current products of the Company and its Subsidiaries or
(iii) consists of on-hand quantities in excess of one
year’s historical sales or usage).
Section 3.39. No
Other Representations or Warranties. Except
for the representations and warranties contained in this
Article III, neither the Company nor any other Person makes
any other express or implied representation or warranty on
behalf of the Company with respect to the Company and its
Subsidiaries.
ARTICLE IV.
REPRESENTATIONS
AND WARRANTIES OF PARENT AND MERGER SUB.
Parent and Merger Sub hereby jointly and severally represent and
warrant to the Company as follows:
Section 4.1. Organization. Each
of Parent and Merger Sub is duly incorporated, validly existing
and in good standing under the laws of the State of Delaware,
and has all requisite corporate power to own its properties and
assets and to conduct its businesses as now conducted.
Section 4.2. No
Conflict or Violation. The execution,
delivery and performance by Parent and Merger Sub of this
Agreement do not and will not (i) violate or conflict with
any provision of any Parent Organizational Document or the
organizational documents of Merger Sub, (ii) violate any
provision of law, or any order, judgment or decree of any
Governmental Entity, (iii) result in the creation or
imposition of any Lien (other than any Permitted Lien) upon any
of the assets, properties or rights of either Parent or Merger
Sub or (iv) violate or result in a breach of or constitute
(with due notice or lapse of time or both) a default under any
material contract, agreement or instrument to which Parent or
Merger Sub is a party or by which it is are bound or to which
any of its properties or assets is subject, except in each case
as would not, individually or in the aggregate, prevent or
materially delay the ability of Parent and Merger Sub to perform
their respective obligations under this Agreement or to
consummate the transactions contemplated hereby.
Section 4.3. Consents
and Approvals. No consent, waiver,
authorization or approval of any Governmental Entity, and no
declaration or notice to or filing or registration with any
Governmental Entity, is required in connection with the
execution and delivery of this Agreement by Parent or Merger Sub
or the performance by Parent or its Subsidiaries or Merger Sub
of their obligations hereunder or thereunder, except for
(i) any required competition or other regulatory approvals
required of foreign or domestic authorities,
(ii) applicable requirements of the Securities Act, the
Exchange Act and the rules and regulations of Nasdaq,
(iii) the consents, waivers, authorizations or approvals of
any Governmental Entity set forth on Section 4.3 of the
Parent Disclosure Letter; (iv) the amendment of
Establishment Registrations and Device Listings under the
FDA’s Establishment Registration and Device Listing
regulations, as set forth in 21 C.F.R. Part 807; and
(v) such other consents, waivers, authorizations,
approvals, declarations, notices, filings or registrations,
which if not obtained or made, would prevent or materially delay
the ability of Parent and Merger Sub to perform their respective
obligations under this Agreement or to consummate the
transactions contemplated hereby.
Section 4.4. Authorization
and Validity of Agreement. Parent and Merger
Sub have all requisite corporate power and authority to execute,
deliver and perform their obligations under this Agreement and
to consummate the transactions contemplated hereby. The
execution and delivery of this Agreement by Parent and Merger
Sub and the performance by Parent and Merger Sub of their
obligations hereunder and the transactions contemplated hereby
have been duly authorized by the Board of Directors of each of
Parent and Merger Sub and all other necessary corporate action
on the part of Parent and Merger Sub, and no other corporate
proceedings on the part of Parent and Merger Sub are necessary
to authorize this Agreement and the transactions contemplated
hereby. This Agreement has been duly and validly executed and
delivered by Parent and Merger Sub and, assuming due execution
and delivery by the Company, shall constitute their legal, valid
and binding obligation, enforceable against them in accordance
with its terms, subject to (i) the effect of
bankruptcy, fraudulent conveyance, reorganization, moratorium
and other similar laws relating to or affecting the enforcement
of creditors’ rights generally, (ii) general equitable
principles (whether considered in a proceeding in equity or at
law) and (iii) an implied covenant of good faith and fair
dealing.
Section 4.5. No
Brokers. No broker, finder or similar
intermediary has acted for or on behalf of, or is entitled to
any broker’s, finder’s or similar fee or other
commission from Parent in connection with this Agreement or the
transactions contemplated hereby.
Section 4.6. Information
Supplied. The information supplied or to be
supplied by Parent specifically for inclusion in the Proxy
Statement shall not, on the date the Proxy Statement is first
mailed to the stockholders of the Company or at the time of the
Company Stockholders Meeting or at the Effective Time, contain
any untrue statement of a material fact or 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.
Section 4.7. Merger
Sub. Merger Sub was formed solely for the
purpose of engaging in the transactions contemplated by this
Agreement. All of the outstanding capital stock of Merger Sub is
directly owned of record and beneficially by Parent. Except for
obligations or liabilities incurred in connection with its
incorporation or organization and the transactions contemplated
by this Agreement, Merger Sub has not and will not have
incurred, directly or indirectly, through any Subsidiary or
Affiliate, any obligations or liabilities or engaged in any
business activities of any type or kind whatsoever or entered
into any agreements or arrangement with any other Person. Merger
Sub has no Subsidiaries.
Section 4.8. Sufficiency
of Funds. Subject to the satisfaction of the
condition set forth in Section 8.2(f), Parent will have
sufficient funds at the Effective Time for the payment of the
Merger Consideration and to perform its obligations with respect
to the transactions contemplated by this Agreement.
Section 4.9. No
Other Representations or Warranties. Except
for the representations and warranties contained in this
Article IV, none of Parent, Merger Sub or any other Person
makes any other express or implied representation or warranty on
behalf of Parent or Merger Sub with respect to Parent and its
Subsidiaries.
Section 5.1. Conduct
of Business Before the Closing
Date. (a) The Company covenants and
agrees that, during the period from the date hereof to the
earlier of the termination of this Agreement in accordance with
its terms and the Effective Time (except as otherwise
specifically contemplated by the terms of this Agreement),
unless Parent shall otherwise consent in writing (which consent
shall not be unreasonably withheld): (i) the businesses of
the Company and its Subsidiaries shall be conducted, in all
material respects, in the ordinary course of business and in a
manner consistent with past practice and, in all material
respects, in compliance with applicable laws; (ii) the
Company shall and shall cause its Subsidiaries to continue to
maintain, in all material respects, its assets, properties,
rights and operations in accordance with present practice in a
condition suitable for their current use; and (iii) the
Company shall use its commercially reasonable efforts consistent
with the foregoing to preserve substantially intact the business
organization of the Company and its Subsidiaries, to keep
available the services of the present officers and key employees
of the Company and its Subsidiaries and to preserve, in all
material respects, the present relationships of the Company and
its Subsidiaries with persons with which the Company or any of
its Subsidiaries has significant business relations. Without
limiting the generality of the foregoing, neither the Company
nor any of its Subsidiaries shall (except as specifically
contemplated by the terms of this Agreement), between the date
of this Agreement and the earlier of the termination of this
Agreement in accordance with its terms and the Effective Time,
directly or indirectly do, any of the following without the
prior written consent of Parent
(which consent, with respect to clauses (vi) (but only with
respect to non-officers of the Company), (viii), (xi) and
(xii), shall not be unreasonably withheld):
(i) make any change in any of its organizational documents;
issue any additional shares of capital stock (other than
(A) upon the exercise of options to purchase shares of
Company Common Stock outstanding on the date hereof and
(B) the issuance of Company Common Stock upon consummation
of the Exchange Offer), membership interests or partnership
interests or other equity securities or grant any option,
warrant or right to acquire any capital stock, membership
interests or partnership interests or other equity securities or
issue any security convertible into or exchangeable for such
securities or alter in any way any its outstanding securities or
make any change in outstanding shares of capital stock,
membership interests or partnership interests or other ownership
interests or its capitalization, whether by reason of a
reclassification, recapitalization, stock split or combination,
exchange or readjustment of shares, stock dividend or otherwise;
(ii) make any sale, assignment, transfer, abandonment,
sublease, assignment or other conveyance of its material assets,
Company Property or rights or any part thereof, other than
dispositions of worn-out or obsolete equipment for fair or
reasonable value in the ordinary course of business and
consistent with past practice;
(iii) subject any of its assets, properties or rights or
any part thereof, to any Lien or suffer such to exist other than
Permitted Liens;
(iv) redeem, retire, purchase or otherwise acquire,
directly or indirectly, any shares of the capital stock,
membership interests or partnership interests or other ownership
interests of the Company and its Subsidiaries or declare, set
aside or pay any dividends or other distribution in respect of
such shares or interests, except for the issuance of Company
Common Stock upon consummation of the Exchange Offer;
(v) acquire, lease or sublease any assets, raw materials or
properties (including any real property), or enter into any
other transaction, other than in the ordinary course of business
and consistent with past practice;
(vi) enter into any new (or amend any existing to increase
benefits) employee benefit plan, program or arrangement or any
new (or amend any existing to increase benefits) employment,
severance, change of control or consulting agreement, grant any
general increase in the compensation of officers or employees
(including any such increase pursuant to any bonus, pension,
profit-sharing or other plan or commitment) or grant any
increase in the compensation payable or to become payable to any
employee, except as otherwise provided pursuant to the terms of
any plan or agreement, as required by law, to the extent
necessary to avoid imposition of any taxes under
Section 409A (but only to the extent such amendment does
not materially increase the cost of such plan, program or
arrangement to the Company, without regard to the time value of
money) or for increases in compensation to employees in
accordance with pre-existing contractual provisions;
(vii) pay (other than with respect to compensatory payments
to current or former employees, officers, consultants or
directors, in each case (a) in the ordinary course of
business consistent with past practice, (b) pursuant to
agreements in effect as of the date hereof or (c) which
have been accrued for on the Company’s balance sheet), lend
or advance any amount to, or sell, transfer or lease any
properties or assets to, or enter into any agreement or
arrangement with, any of its Affiliates (other than wholly owned
Subsidiaries);
(viii) fail to keep in full force and effect insurance
comparable in amount and scope to coverage maintained as of the
date hereof;
(ix) make any change in any method of accounting or
accounting principle, method, estimate or practice except for
any such change required by reason of a concurrent change in
GAAP, or write off as uncollectible any accounts receivable
except in the ordinary course of business and consistent with
past practice;
(x) make or change any material Tax election, change an
annual accounting period, adopt or change any accounting method,
file any amended Tax Return, enter into any closing agreement,
settle any material Tax claim or assessment relating to the
Company or any of its Subsidiaries, surrender any right to claim
a refund of a material amount of Taxes or consent to any
extension or waiver of the limitation period applicable to any
material Tax claim or assessment relating to the Company or any
of its Subsidiaries;
(xi) settle, release or forgive any material claim or
litigation or waive any right thereto which has not been
properly reserved on the books of the Company or its
Subsidiaries;
(xii) make, enter into, modify, amend in any manner that
would be reasonably expected to have an adverse effect on the
Company and its Subsidiaries or terminate, or waive any right or
remedy under, any Contract, bid or expenditure, where such
Contract, bid or expenditure is for a Contract entailing
payments in excess of $100,000, other than in the ordinary
course of business and consistent with past practice;
(xiii) lend money to any Person, or incur or guarantee any
indebtedness for borrowed money in excess of $100,000 in the
aggregate, or enter into any capital lease obligation; or
(xiv) commit to do any of the foregoing.
(b) Nothing contained in this Agreement shall give to
Parent or Merger Sub, directly or indirectly, rights to control
or direct the operations of the Company or its Subsidiaries
prior to the Closing Date. Prior to the Closing Date, the
Company and its Subsidiaries shall exercise, consistent with the
terms and conditions of this Agreement, complete control and
supervision of its and its Subsidiaries’ operations.
Section 5.2. Notice
of Breach. From and after the date hereof and
until the earlier to occur of the Closing Date or the
termination of this Agreement pursuant to Article IX
hereof, the Company shall promptly give written notice with
particularity upon having Knowledge of any matter that
constitutes a breach of any representation, warranty, agreement
or covenant contained in this Agreement.
Section 5.3. Affiliate
Letter.The Company shall deliver no later
than ten (10) days prior to the Company Stockholders
Meeting, a letter to Parent identifying all persons who, to the
Knowledge of the Company, are “affiliates” of the
Company for purposes of Rule 145 under the Securities Act.
Section 5.4. FDA
Correspondence.The Company will
(i) consult with Parent prior to any communication or
correspondence with, or delivery of notice, supplemental reports
or materials to, the FDA in connection with the Company’s
efforts to obtain 510(k) clearance for the Accell Products and
(ii) promptly provide Parent with copies of any
correspondence with the FDA and any written comments, notices,
supplemental reports or materials received from or provided to
the FDA and promptly advise Parent of any oral communications
with the FDA.
Section 5.5. Section 409A. To
the extent requested by Parent, the Company will work with
Parent in good faith to amend each Company Employee Benefit Plan
and Company Pension Plan to comply with or be exempt from
Section 409A of the Code (if applicable).
ARTICLE VI.
COVENANTS OF PARENT AND MERGER SUB.
Section 6.1. Employee
Benefits.
(a) Employees of Company and its Subsidiaries who continue
their employment with the Surviving Corporation or who become
employees of Parent or any subsidiary of Parent
(“Continuing Employees”) shall be given credit
for all service with the Company and its Subsidiaries (and their
respective predecessors) (or service credited by the Company and
its Subsidiaries for similar plans, programs or policies) under
all employee benefit and fringe benefit plans, programs and
policies of the Parent or its affiliates in which they become
participants for purposes of eligibility, vesting and level of
benefits (except to the extent such service
credit will result in benefit accrual under any defined benefit
pension plans or otherwise result in a duplication of benefits).
(b) If a Continuing Employee becomes eligible to
participate in any medical, dental or health plan of the Parent
or any of its affiliates, Parent shall cause such plan to
(A) waive any preexisting condition limitations for
conditions covered under the applicable medical, health or
dental plans of the Company (the “Company Welfare
Plans”) and (B) honor any deductible and
out-of-pocket expenses incurred by such employee and his or her
beneficiaries under the Company Welfare Plans during the portion
of the applicable plan year preceding the Closing.
(c) Except as provided in this Section 6.1, nothing in
this Agreement shall limit or restrict the right of Parent or
any of its Subsidiaries to modify, amend, terminate or establish
employee benefit plans or arrangements, in whole or in part, at
any time after the Effective Time.
(d) No provision of this Section 6.1 shall create any
third party beneficiary rights in any Continuing Employee or any
current or former director or consultant of the Company or its
Subsidiaries located in the United States in respect of
continued employment (or resumed employment) or any other matter.
Section 6.2. Indemnification
Continuation.
(a) For purposes of this 6.2, (i) “Indemnified
Person” shall mean any person who is now, or has been
at any time prior to the Effective Time, an officer or director
of the Company or who was serving at the request of the Company
as an officer or director of another corporation, joint venture
or other enterprise, and can provide evidence thereof to Parent
acceptable to Parent in its sole discretion and
(ii) “Proceeding” shall mean any claim,
action, suit, proceeding or investigation.
(b) From and after the Effective Time, Parent shall, or
Parent shall cause the Surviving Corporation, to provide
indemnification to each Indemnified Person to the same extent
and under similar conditions and procedures as such Indemnified
Person is entitled on the date hereof in connection with any
Proceeding based directly or indirectly (in whole or in part)
on, or arising directly or indirectly (in whole or in part) out
of, the fact that such Indemnified Person is or was an officer
or director of the Company, or is or was serving at the request
of the Company as an officer or director of another corporation,
joint venture or other enterprise or general partner of any
partnership or a trustee of any trust, whether pertaining to any
matter arising before or after the Effective Time. An
Indemnified Person shall repay the Surviving Corporation for any
expenses incurred by Surviving Corporation in connection with
the indemnification of such Indemnified Person pursuant to this
Section 6.2 if it is ultimately determined that such
Indemnified Person did not meet the standard of conduct
necessary for indemnification by the Surviving Corporation.
(c) Parent shall, or shall cause the Surviving Corporation
to, provide or maintain in effect for six years from the
Effective Time (the “Tail Period”), through the
purchase of run-off coverage or otherwise, directors’ and
officers’ liability insurance covering the Indemnified
Persons who are covered by the directors’ and
officers’ liability insurance policy provided for directors
and officers of the Company and its Subsidiaries as of the date
hereof (the “Existing Policy”) on terms
substantially comparable in the aggregate to the Existing
Policy; provided, however, that in no event shall the Surviving
Corporation be required to expend in the aggregate in excess of
200% of the current annual premium paid by the Company for such
insurance with respect to the Tail Period, and if the premiums
of such insurance coverage exceed such amount, the Surviving
Corporation shall be obligated to maintain or obtain a policy
with the greatest coverage available for a cost not exceeding
such amount. In lieu of the foregoing, the Company or the
Surviving Corporation may purchase, a six-year “tail”
prepaid officers’ and directors’ liability insurance
policy in respect of acts or omissions occurring at or prior to
the Effective Time covering each such Indemnified Person.
(d) The provisions of this Section 6.2 shall survive
the consummation of the Merger for a period of six years and are
expressly intended to benefit each of the Indemnified Persons;
provided, however, that in the event that any claim or claims
for indemnification are asserted or made within such six-year
period, all rights to indemnification in respect of any such
claim or claims shall continue until disposition of any and all
such claims.
(e) In the event that Parent or the Surviving Entity or any
of their respective successors or assigns (i) consolidates
with or merges into any other Person and is not the continuing
or surviving corporation or entity of such consolidation or
merger or (ii) transfers or conveys all or substantially
all its properties and assets to any Person, then, and in each
such case, Parent shall cause proper provisions to be made so
that the successors and assigns of Parent or the Surviving
Entity, as the case may be, assume the obligations set forth in
this Section 6.2.
ARTICLE VII.
ADDITIONAL
COVENANTS OF THE PARTIES.
Section 7.1. Preparation
of Proxy Statement, Company Stockholders Meeting.
(a) As promptly as practicable, the Company shall prepare
and file the Proxy Statement with the SEC provided, that the
Company shall consult with Parent and provide Parent a
reasonable opportunity to review and comment on such preliminary
Proxy Statement prior to filing. The parties shall reasonably
cooperate with each other in the preparation of the Proxy
Statement and to have such document cleared by the SEC as
promptly as practicable after such filing. The Proxy Statement
shall include the recommendation of the Board of Directors of
the Company in favor of approval and adoption of this Agreement
and the Merger, except to the extent the Board of Directors of
the Company shall have withdrawn or modified its approval or
recommendation of this Agreement to the extent such action is
permitted by Section 7.4. The Company shall use its
reasonable best efforts to cause the Proxy Statement to be
mailed to its stockholders as promptly as practicable upon the
earlier of (x) receiving notification that the SEC is not
reviewing the Proxy Statement and (y) the conclusion of any
SEC review of the Proxy Statement. The Company shall promptly
provide copies, consult with Parent and prepare written
responses with respect to any written comments received from the
SEC with respect to the Proxy Statement and advise Parent of any
oral comments received from the SEC. The Proxy Statement shall
comply as to form in all material respects with the rules and
regulations promulgated by the SEC under the Exchange Act.
(b) The Company shall make all necessary filings with
respect to the Merger and the transactions contemplated thereby
under the Exchange Act and the rules and regulations thereunder.
The Company will advise Parent, promptly after it receives
notice thereof, of any request by the SEC for amendment of the
Proxy Statement or comments thereon and responses thereto or
requests by the SEC for additional information. No amendment or
supplement to the Proxy Statement shall be filed without the
prior approval of Parent, which approval shall not be
unreasonably withheld or delayed. If at any time prior to the
Effective Time, any information relating to Parent or the
Company, or any of their respective Affiliates, officers or
directors, should be discovered by Parent or the Company that
should be set forth in an amendment or supplement to the Proxy
Statement, so that such documents would not include any
misstatement of a material fact or omit to state any material
fact necessary to make the statements therein, in light of the
circumstances under which they were made, not misleading, the
party which discovers such information shall promptly notify the
other parties hereto and an appropriate amendment or supplement
describing such information shall be promptly filed with the SEC
and, to the extent required by law, disseminated to the
stockholders of the Company.
(c) The Company shall cause the Company Stockholders
Meeting to be duly called and held as soon as reasonably
practicable for the purpose of obtaining the Required Company
Vote. In connection with such meeting, the Company will
(i) subject to Section 7.4(b), use its reasonable best
efforts to obtain the Required Company Vote and
(ii) otherwise comply with all legal requirements
applicable to such meeting.
Section 7.2. Access
to Information. Upon reasonable notice, the
Company shall (and shall cause its Subsidiaries to) afford to
Parent and its representatives reasonable access during normal
business hours, during the period prior to the Effective Time,
to all its officers, employees, properties, offices, plants and
other facilities and to all books and records and, during such
period, the Company shall (and shall cause its Subsidiaries to)
furnish promptly to Parent and its representatives, consistent
with its legal obligations, all other information concerning its
business, properties and personnel as Parent may reasonably
request; provided, however, that the Company may restrict the
foregoing access to the extent that, in the Company’s
reasonable judgment, (i) providing such access would result
in the disclosure of any trade secrets of third parties or
violate any of its obligations with respect to confidentiality
if the Company shall have used all reasonable efforts to obtain
the consent of such third party to such access, or (ii) any
law, treaty, rule or regulation of any Governmental Entity
applicable to the Company requires the Company or its
Subsidiaries to preclude Parent and its representatives from
gaining access to any properties or information. Parent will
hold any such information that is non-public in confidence to
the extent required by, and in accordance with, the provisions
of that certain Confidentiality Agreement, dated May 14,2007 (the “Confidentiality Agreement”), between
the Company and Parent.
Section 7.3. Efforts.
(a) Subject to the terms and conditions of this Agreement,
each party will use its commercially reasonable efforts to take,
or cause to be taken, all actions and to do, or cause to be
done, all things necessary, proper or advisable under applicable
laws and regulations to consummate the Merger and the other
transactions contemplated by this Agreement as soon as
practicable after the date hereof. In furtherance and not in
limitation of the foregoing, if applicable, each party hereto
agrees to make any filing required by any applicable Regulatory
Law (as defined below) with respect to the transactions
contemplated hereby as promptly as practicable, and to supply as
promptly as practicable any additional information and
documentary material that may be requested pursuant to such
applicable Regulatory Law and to take all other actions
necessary to cause the expiration or termination of the
applicable waiting periods under such applicable Regulatory Law
as soon as practicable.
(b) Each of Parent and the Company shall, in connection
with the efforts referenced in Section 7.3 to obtain all
requisite approvals and authorizations for the transactions
contemplated by this Agreement under any Regulatory Law (as
defined below), use its commercially reasonable best efforts to
(i) cooperate in all respects with each other in connection
with any filing or submission and in connection with any
investigation or other inquiry, including any proceeding
initiated by a private party; (ii) promptly inform the
other party of any communication received by such party from, or
given by such party to any governmental authority and of any
material communication received or given in connection with any
proceeding by a private party, in each case regarding any of the
transactions contemplated hereby, and (iii) permit the
other party to review any communication given by it to, and
consult with each other in advance of any meeting or conference
with any governmental authority or, in connection with any
proceeding by a private party, with any other Person, and to the
extent permitted by the applicable governmental authority or
other Person, give the other party the opportunity to attend and
participate in such meetings and conferences. For purposes of
this Agreement, “Regulatory Law” means the
Sherman Act, as amended, the Clayton Act, as amended, the
Hart-Scott-Rodino
Antitrust Improvement Act of 1976, as amended, the Federal Trade
Commission Act, as amended, and all other federal, state and
foreign, if any, statutes, rules, regulations, orders, decrees,
administrative and judicial doctrines and other laws that are
designed or intended to prohibit, restrict or regulate actions
having the purpose or effect of monopolization or restraint of
trade or lessening of competition through merger or acquisition.
In furtherance and not in limitation of the covenants of the
parties contained in Section 7.3 and this
Section 7.4(b), each party hereto shall use its reasonable
best efforts to resolve objections, if any, as may be asserted
with respect to the transactions contemplated by this Agreement
under any Regulatory Law. Notwithstanding anything to the
contrary contained in this Agreement, in connection with any
filing or submission required or action to be taken by either
Parent or the Company to consummate the Merger, in no event
shall Parent or any of its Subsidiaries or Affiliates be
obligated to propose or agree to accept any undertaking or
condition, to enter into any consent decree, to make any
divestiture, or accept any operational restriction, or take or
commit to take any action that could reasonably be expected to
limit (A) the freedom of action of Parent or its
Subsidiaries or Affiliates with respect to the operation of, or
Parent’s or its Subsidiaries’ or Affiliates’
ability to retain, the Company or any businesses, product lines
or assets of the Company, or (B) the ability to retain, own
or operate any portion of the businesses, product lines, or
assets, of Parent or any of its Subsidiaries or Affiliates, or
alter or restrict in any way the business or commercial
practices of the Company, Parent or its Subsidiaries or
Affiliates.
(c) The parties shall use their commercially reasonable
efforts to obtain all consents, waivers, authorizations and
approvals of all third parties, including Governmental Entities,
necessary, proper or advisable for the
consummation of the transactions contemplated by this Agreement;
provided that, without the prior written consent of Parent, the
Company shall not incur any significant expense or liability or
agree to any significant modification to any contractual
arrangement to obtain such consents or certificates, and to
provide any notices to third parties required to be provided
prior to the Effective Time.
Section 7.4. Acquisition
Proposals.
(a) None of the Company or any of its Subsidiaries shall
(whether directly or indirectly through Affiliates, directors,
officers, employees, representatives or other intermediaries),
nor shall (directly or indirectly) the Company authorize or
permit any of its or their officers, directors, representatives
or other intermediaries or Subsidiaries to, (i) solicit,
initiate or take any action to knowingly facilitate or encourage
the submission of inquiries, proposals or offers from any Person
(other than Parent and Merger Sub) relating to any Acquisition
Proposal, or agree to or endorse any Acquisition Proposal;
(ii) enter into any agreement to (x) knowingly
facilitate or consummate, any Acquisition Proposal or
(y) approve or endorse any Acquisition Proposal;
(iii) enter into or participate in any discussions or
negotiations in connection with any Acquisition Proposal or
inquiry with respect to any Acquisition Proposal, or furnish to
any Person any information with respect to its business,
properties or assets in connection with any Acquisition Proposal
or inquiry with respect to any Acquisition Proposal; or
(iv) agree to resolve or take any of the actions prohibited
by clause (i), (ii) or (iii) of this sentence.
The Company shall immediately cease, and cause its
representatives and other intermediaries to immediately cease,
any and all existing activities, discussions or negotiations
with any parties conducted heretofore with respect to any of the
foregoing and shall demand the return or destruction of any
information previously provided with respect to such activities,
discussion, or negotiations. For purposes of this
Section 7.4, the term “Person” means any
person, corporation, entity or “group,” as defined in
Section 13(d) of the Exchange Act, other than Parent or any
Subsidiaries of Parent.
“Acquisition Proposal” means any offer
or proposal for a merger, reorganization, recapitalization,
consolidation, share exchange, business combination or other
similar transaction involving the Company or any of the
Subsidiaries (excluding the transactions contemplated by the
Exchange Offer) or any proposal or offer to acquire, directly or
indirectly, securities representing more than 20% of the voting
power of the Company or more than 20% of the assets of the
Company and the Subsidiaries taken as a whole, other than the
Merger contemplated by this Agreement.
(b) Notwithstanding the foregoing, the Board of Directors
of the Company, directly or indirectly through representatives
or other intermediaries, may, in the event of an Acquisition
Proposal, (i) comply with
Rule 14d-9
and
Rule 14e-2
promulgated under the Exchange Act with regard to any
Acquisition Proposal, provided that the Board of Directors of
the Company may not withdraw, modify or amend its recommendation
of the Merger except to the extent such action is permitted by
clause (iv) of this Section 7.4(b), (ii) engage
in negotiations or discussions with any Person that has made an
unsolicited bona fide written Acquisition Proposal not resulting
from or arising out of a breach of Section 7.4(a),
(iii) furnish to any Person that has made an unsolicited
bona fide written Acquisition Proposal not resulting from or
arising out of a breach of Section 7.4(a) nonpublic
information relating to the Company or any of the Subsidiaries
pursuant to a confidentiality and standstill agreement (the
“Competing Confidentiality Agreement”) with
terms that are no less favorable to the Company than those
contained in the Confidentiality Agreement (it being understood
that the standstill provision contained in such Competing
Confidentiality Agreement may permit such Person to convey
confidentially an Acquisition Proposal to the Board of Directors
of the Company under circumstances in which the Company is
permitted under this Section 7.4 to participate in
discussions regarding an Acquisition Proposal),
and/or
(iv) if prior to the Company Stockholders Meeting, withdraw
or modify or change in a manner adverse to Parent its approval
or recommendation of this Agreement or the Merger; provided
that, the Board of Directors of the Company shall be permitted
to take an action described in the foregoing clauses (i),
(ii), (iii) or (iv) if, and only if, prior to taking
such particular action, the Board of Directors of the Company
has determined in good faith by a majority vote that
(x) such Acquisition Proposal would result in, or would
reasonably be expected to result in, a Superior Proposal, in the
case of any of the foregoing clauses (i), (ii) or (iii), or
constitutes a Superior Proposal, in the case of the foregoing
clause (iv), and (y) (after considering the advice of
outside legal counsel) failing to take such action in the case
of any of the foregoing clauses (i), (ii) or
(iii) would reasonably be expected to result in a breach of
its fiduciary duties
under the DGCL or in the case of the foregoing clause (iv)
would result in a breach of its fiduciary duties under the DGCL.
Notwithstanding the foregoing, in response to an Intervening
Event, the Board of Directors of the Company may withdraw or
modify or change in a manner adverse to Parent its approval or
recommendation of this Agreement or the Merger, if and only if,
the Board of Directors of the Company, after considering the
advice of outside legal counsel, has determined that failing to
take such action would result in a breach of its fiduciary
duties under the DGCL.
i) “Superior Proposal” means any
proposal (on its most recently amended or modified terms, if
amended or modified) made by a third party to enter into any
transaction involving an Acquisition Proposal that the Board of
Directors of the Company determines in its good faith judgment
(following consultation with an independent financial advisor)
to be more favorable to the Company’s stockholders than
this Agreement and the Merger, taking into account all terms and
conditions of such transaction (including any
break-up
fees, expense reimbursement provision and financial terms, the
anticipated timing, conditions and prospects for completion of
such transaction, including the prospects for obtaining
regulatory approvals and financing, and any third party
approvals) and that is reasonably likely to be consummated,
except that the reference to “more than 20%” in the
definition of “Acquisition Proposal” shall be deemed
to be a reference to “more than 50%”. Reference to
“this Agreement” and “the Merger” in this
paragraph shall be deemed to include any proposed alteration of
the terms of this Agreement or the Merger that are agreed to by
Parent after it receives written notice from the Company
pursuant to Section 7.4(d) of the existence of, the
identity of the Person making, and the terms and conditions of,
any Acquisition Proposal.
(c) Notwithstanding anything in this Section 7.4 to
the contrary, if, at any time prior to the Company Stockholders
Meeting, the Company’s Board of Directors determines in
good faith, after consultation with its financial advisors and
outside legal counsel, in response to an Acquisition Proposal
that was unsolicited and that did not otherwise result from a
breach of Section 7.4(a), that such proposal is a Superior
Proposal, the Company or its Board of Directors may, pursuant to
and subject to complying with Section 9.1(f), accept such
Superior Proposal; provided, however, that prior to any such
acceptance of such Superior Proposal, the Company shall have
given Parent five (5) Business Days’ written notice
(it being understood and agreed that any amendment to the amount
or form of consideration of the Superior Proposal shall require
a new notice pursuant to this Section 7.4(c) except that
all references in this Section 7.4(c) to five
(5) Business Days shall be deemed to be references to three
(3) Business Days in such event) advising Parent that the
Company’s Board of Directors intends to cause the Company
to accept such Superior Proposal, specifying the material terms
and conditions of the Superior Proposal and that the Company
shall, during such five (5) Business Day period, negotiate
in good faith with Parent to make such adjustments to the terms
and conditions of this Agreement such that such Acquisition
Proposal would no longer constitute a Superior Proposal and
provided further, however, that after the expiration of such
five (5) Business Day period and prior to the termination
of this Agreement pursuant to Section 9.1(f), the
Company’s Board of Directors shall have confirmed (after
taking into account any such adjustments to the terms and
conditions of this Agreement) that the Acquisition Proposal
continues to be a Superior Proposal.
(d) The Company shall notify Parent promptly (but in any
event within one Business Day) after receipt or occurrence of
(i) any Acquisition Proposal, (ii) any request for
information with respect to any Acquisition Proposal,
(iii) any inquiry, proposal, discussions or negotiation
with respect to any Acquisition Proposal, and (iv) the
material terms and conditions of any such Acquisition Proposal,
request for information, inquiry, proposal, discussion or
negotiation and the identity of the Person making any such
Acquisition Proposal, request for information, inquiry or
proposal or with whom discussions or negotiations are taking
place. In addition, the Company shall promptly (but in any event
within one Business Day) after the receipt thereof, provide to
Parent copies of any written documentation material to
understanding such Acquisition Proposal, request for
information, inquiry, proposal, discussion or negotiation
(“Other Acquisition Documentation”) which is
received by the Company from the Person (or from any
representatives or agents of such Person) making such
Acquisition Proposal, request for information, inquiry or
proposal or with whom such discussions or negotiations are
taking place. The Company shall not, and shall cause each of its
Subsidiaries not to, terminate, waive, amend or modify any
provision of any existing standstill or confidentiality
agreement to
which it or any of its Subsidiaries is a party, and the Company
shall, and shall cause its Subsidiaries to, enforce the
provisions of any such agreement (it being understood that the
Company may waive any standstill provision to the extent
necessary to permit any Person subject to such standstill
provision to convey confidentially an Acquisition Proposal to
the Board of Directors of the Company under circumstances in
which the Company is permitted under this Section 7.4 to
participate in discussions regarding an Acquisition Proposal).
The Company shall keep Parent reasonably informed of the status
and details (including any material amendments or proposed
material amendments) of any such Acquisition Proposal or request
for information and keep Parent reasonably informed as to the
material details of any information requested of or provided by
the Company and as to the material details of all substantive
discussions or negotiations with respect to any such Acquisition
Proposal, request for information, inquiry or proposal and shall
provide to Parent within one Business Day after receipt thereof
all copies of any additional Other Acquisition Documentation
received by the Company from the Person (or from any
representatives or agents of such Person) making such
Acquisition Proposal, request for information, inquiry or
proposal or with whom such discussions or negotiations are
taking place. The Company shall promptly provide to Parent any
non-public information concerning the Company provided to any
other Person in connection with any Acquisition Proposal that
was not previously provided to Parent. The Board of Directors of
the Company shall promptly consider in good faith (in
consultation with its outside legal counsel and financial
advisors) any proposed alteration of the terms of this Agreement
or the Merger proposed by Parent in response to any Acquisition
Proposal.
Section 7.5. Stockholder
Litigation.The Company shall keep Parent
informed of, and cooperate with Parent in connection with, any
stockholder litigation or claim against the Company
and/or its
directors or officers relating to the Merger or the other
transactions contemplated by this Agreement; provided, however,
that no settlement in connection with such stockholder
litigation shall be agreed to without Parent’s prior
written consent, which consent shall not be unreasonably
withheld, conditioned or delayed.
Section 7.6. Maintenance
of Insurance.The Company will use reasonable
best efforts to maintain in full force and effect through the
Closing Date all material insurance policies applicable to the
Company and its Subsidiaries and their respective properties and
assets in effect on the date hereof. If and as requested by
Parent, the Company will use reasonable best efforts to cause
the Company’s insurers to waive any provisions in such
insurance policies that would allow the insurer to terminate or
adversely modify coverage upon consummation of the Merger.
Section 7.7. Public
Announcements. Each of the Company, Parent
and Merger Sub agrees that no public release or announcement
concerning the transactions contemplated hereby shall be issued
by any party without the prior written consent of the Company
and Parent (which consent shall not be unreasonably withheld or
delayed), except as such release or announcement may be required
by law or the rules or regulations of any applicable United
States securities exchange, in which case the party required to
make the release or announcement shall use its reasonable best
efforts to allow each other party reasonable time to comment on
such release or announcement in advance of such issuance, it
being understood that the final form and content of any such
release or announcement, to the extent so required, shall be at
the final discretion of the disclosing party; provided, however,
that upon prior consultation with the other party, each of the
parties may make statements that are not inconsistent with
previous press releases, public disclosures or public statements
made by any of the parties in compliance with this
Section 7.7.
Section 7.8. No
Shareholder Rights Plan. From the date hereof
through the earlier of termination of this Agreement and the
Effective Time, the Company will not adopt, approve, or agree to
adopt, a shareholder rights plan.
Section 7.9. European
Restructuring.The Company shall use
commercially reasonable efforts to complete the restructuring of
its European operations, including using commercially reasonable
efforts to accomplish the each of the actions set forth on
Section 7.9 of the Company Disclosure Letter.
Section 8.1. Conditions
to Each Party’s Obligation to Effect the
Merger. The obligations of the Company,
Parent and Merger Sub to effect the Merger are subject to the
satisfaction or waiver on or prior to the Closing Date of the
following conditions:
(a) Stockholder Approval. The
Company shall have obtained the Required Company Vote in
connection with the approval and adoption of this Agreement by
the stockholders of the Company.
(b) No Injunctions or Restraints,
Illegality. No statute, rule, regulation,
executive order, decree, ruling, shall have been adopted or
promulgated, and no temporary restraining order, preliminary or
permanent injunction or other order issued by a court or other
U.S. governmental authority of competent jurisdiction shall
be in effect, having the effect of making the Merger illegal or
otherwise prohibiting consummation of the Merger; provided,
however, that the provisions of this Section 8.1(b) shall
not be available to any party whose failure to fulfill its
obligations pursuant to Section 7.3 shall have been the
cause of, or shall have resulted in, such order or injunction.
(c) Governmental Entity
Approvals. All material consents, orders or
approvals of, declarations or filings with, and expirations of
waiting periods imposed by, any Governmental Entity that are
required for the consummation of the transactions contemplated
hereby, if any, shall have been obtained and in effect, except
for such consents, orders, approvals, declarations and filings
the failure of which to be obtained or made would not,
individually or in the aggregate, reasonably be expected to have
a material adverse effect business, assets, condition (financial
or otherwise) or results of operations of Parent and its
Subsidiaries, taken as a whole.
Section 8.2. Additional
Conditions to Obligations of Parent and Merger
Sub. The obligations of Parent and Merger Sub
to effect the Merger are subject to the satisfaction of, or
waiver by Parent, on or prior to the Closing Date of the
following additional conditions:
(a) Representations and
Warranties. (i) The representations and
warranties of the Company contained in Section 3.6
(Capitalization and Related Matters) and Section 3.33 (Vote
Required) shall be true and correct in all respects (except, in
the case of Section 3.6 for such inaccuracies as are de
minimis in the aggregate), in each case both when made and at
and as of the Closing Date, as if made at and as of such time
(except to the extent expressly made as of an earlier date, in
which case as of such date) and (ii) each of the other
representations and warranties of the Company set forth in this
Agreement shall be true and correct in all material respects
both when made and at and as of the Closing Date, as if made at
and as of such time (except to the extent expressly made as of
an earlier date, in which case as of such date). Parent shall
have received a certificate of the chief executive officer and
the chief financial officer of the Company to such effect.
(b) Performance of Obligations of the
Company.The Company shall have performed in
all material respects and complied in all material respects with
all agreements and covenants required to be performed or
complied with by it under this Agreement at or prior to the
Closing Date. Parent shall have received a certificate of the
chief executive officer and the chief financial officer of the
Company to such effect.
(c) Company Material Adverse
Effect. During the period from the date
hereof to the Closing Date, there shall not have been a Company
Material Adverse Effect.
(d) Accell Products.The Company
shall have obtained clearance for the 510(k), K061880, submitted
to the FDA on June 28, 2006 and currently under review by
the FDA for the Accell Products for the indication set forth on
Section 8.2(d) of the Company Disclosure Letter.
(e) European Structuring. The
Company shall have completed the each of the actions relating to
the restructuring of its European operations set forth on
Section 8.2(e) of the Company Disclosure Letter, in a
manner satisfactory to Parent.
(f) Credit Agreement. The Credit
Agreement, dated as of December 22, 2005, as amended, among
Parent and the lenders party thereto, shall have been amended,
or the lenders party thereto shall have granted Parent a waiver,
in either case, to permit the consummation of the transactions
contemplated by this Agreement, including the Merger, and to
provide for such other revisions as Parent shall deem necessary
or advisable in its sole and absolute discretion (the
“Credit Agreement Amendment”).
(g) Appraisal Rights. Holders of
no more than 10% of the number of shares of Company Common Stock
outstanding immediately prior to the Effective Time shall have
exercised their appraisal rights in the Merger in accordance
with Section 262.
Section 8.3. Additional
Conditions to Obligations of the Company. The
obligations of the Company to effect the Merger are subject to
the satisfaction of, or waiver by the Company, on or prior to
the Closing Date of the following additional conditions:
(a) Representations and
Warranties. (i) Each of the
representations and warranties of Parent and Merger Sub set
forth in this Agreement that is qualified as to materiality or
Material Adverse Effect shall be true and correct both when made
and at and as of the Closing Date, as if made at and as of such
time (except to the extent expressly made as of an earlier date,
in which case as of such date) and (ii) each of the other
representations and warranties of Parent and Merger Sub set
forth in this Agreement shall be true and correct in all
material respects both when made and at and as of the Closing
Date, as if made at and as of such time (except to the extent
expressly made as of an earlier date, in which case as of such
date). The Company shall have received a certificate of an
executive officer of Parent to such effect.
(b) Performance of Obligations of
Parent. Parent shall have performed in all
material respects and complied in all material respects with all
agreements and covenants required to be performed or complied
with by it under this Agreement at or prior to the Closing Date.
The Company shall have received a certificate of an executive
officer of Parent to such effect.
ARTICLE IX.
TERMINATION.
Section 9.1. Termination. This
Agreement may be terminated at any time prior to the Effective
Time, by action taken or authorized by the Board of Directors of
the terminating party or parties, and except as provided below,
whether before or after approval of the matters presented in
connection with the Merger by the stockholders of the Company:
(a) By mutual written consent of Parent and the Company, by
action of their respective Boards of Directors;
(b) By either the Company or Parent if the Effective Time
shall not have occurred on or before February 6, 2008 (the
“Termination Date”); provided, however, that
the right to terminate this Agreement under this
Section 9.1(b) shall not be available to any party whose
failure to fulfill any obligation under this Agreement has been
the primary cause of the failure of the Effective Time to occur
on or before the Termination Date and such action or failure to
perform constitutes a breach of this Agreement;
(c) By either the Company or Parent if any Governmental
Entity shall have issued an order, decree or ruling or taken any
other action permanently restraining, enjoining or otherwise
prohibiting or making illegal the transactions contemplated by
this Agreement, and such order, decree, ruling or other action
shall have become final and nonappealable;
(d) By either the Company or Parent if the approval by the
stockholders of the Company required for the consummation of the
Merger shall not have been obtained by reason of the failure to
obtain the Required Company Vote at the Company Stockholders
Meeting (or any adjournment or postponement thereof) at which
the vote to adopt this Agreement and the Merger is taken;
(e) By Parent if (i) prior to the Company Stockholders
Meeting, the Board of Directors of the Company shall have failed
to recommend or shall have withdrawn or modified or changed in a
manner
adverse to Parent its approval or recommendation of this
Agreement or the Merger or shall have approved or recommended a
Superior Proposal (or the Board of Directors of the Company
resolves to do any of the foregoing), whether or not permitted
by Section 7.4, (ii) the Company shall fail to call or
hold the Company Stockholders Meeting in accordance with
Section 7.1(c) and such breach shall not have been cured
prior to fifteen (15) days following receipt of notice of
such breach from Parent or (iii) the Company shall have
materially and knowingly breached any of its material
obligations under Section 7.4; provided that with respect
to clause (i), it being understood that neither the disclosure
of any Acquisition Proposal that is not being recommended by the
Company’s Board of Directors nor disclosure of any facts or
circumstances, together with a statement that the Company’s
Board of Directors continues to recommend this Agreement and the
Merger, shall be considered to be a withdrawal, modification or
change to the Company’s Board of Directors’ approval
or recommendation of this Agreement or the Merger or approval or
recommendation of a Superior Proposal;
(f) By the Company, prior to the Company Stockholders
Meeting, to accept a Superior Proposal in accordance with, and
subject to the terms and conditions of, Section 7.4(c);
provided, however, that any such purported termination pursuant
to this Section 9.1(f) shall be void and of no force or
effect unless the Company has concurrently complied with
Section 9.2(e);
(g) By the Company if there shall have been a breach of any
representation, warranty, covenant or agreement on the part of
Parent or Merger Sub contained in this Agreement such that the
conditions set forth in Sections 8.3(a) or 8.3(b) would not
be satisfied and (A) such breach is not reasonably capable
of being cured or (B) in the case of a breach of a covenant
or agreement, if such breach is reasonably capable of being
cured, such breach shall not have been cured prior to the
earlier of (I) 20 days following notice of such breach
and (II) the Termination Date; provided that the Company
shall not have the right to terminate this Agreement pursuant to
this Section 9.1(g) if the Company is then in material
breach of any of its representations, warranties, covenants or
agreements contained in this Agreement; or
(h) By Parent if there shall have been a breach of any
representation, warranty, covenant or agreement on the part of
the Company contained in this Agreement such that the conditions
set forth in Sections 8.2(a) or 8.2(b) would not be
satisfied and (A) such breach is not reasonably capable of
being cured or (B) in the case of a breach of a covenant or
agreement, if such breach is reasonably capable of being cured,
such breach shall not have been cured prior to the earlier of
(I) 20 days following notice of such breach and
(II) the Termination Date; provided that Parent shall not
have the right to terminate this Agreement pursuant to this
Section 9.1(h) if Parent or Merger Sub is then in material
breach of any of its representations, warranties, covenants or
agreements contained in this Agreement.
(i) By the Company if the Credit Agreement Amendment has
not been executed on or prior to September 7, 2007 or such
later date as is mutually agreed to by Parent and the Company;
provided that the Company shall not have the right to terminate
this Agreement pursuant to this Section 9.1(i) if Parent
agrees to waive satisfaction of the condition in
Section 8.2(f).
Section 9.2. Effect
of Termination.
(a) In the event of termination of this Agreement by either
the Company or Parent as provided in Section 9.1, this
Agreement shall forthwith become void and there shall be no
liability or obligation on the part of Parent or the Company or
their respective officers or directors except with respect to
this Section 9.2, Article X and the last sentence of
Section 7.2, provided that the termination of this
Agreement shall not relieve any party from any liability for any
willful breach of any covenant, agreement, representation or
warranty in this Agreement occurring prior to termination.
(b) If the Company or Parent shall terminate this Agreement
pursuant to Section 9.1(d), the Company shall reimburse
Parent for all the Parent Expenses up to a maximum of
$1,500,000, within two Business Days after delivery to the
Company of written notice of the amount of such Parent Expenses
and a documented itemization setting forth such expenses in
reasonable detail.
(c) If (i) the Company or Parent shall terminate this
Agreement pursuant to Section 9.1(b) and (ii) at the
time of termination there shall have been made known to or
proposed to the Company or otherwise publicly
disclosed or announced an Acquisition Proposal, the Company
shall reimburse Parent for all the Parent Expenses up to a
maximum of $1,500,000, within two Business Days after delivery
to the Company of written notice of the amount of such Parent
Expenses and a documented itemization setting forth such
expenses in reasonable detail.
(d) If Parent shall terminate this Agreement pursuant to
Section 9.1(e), then the Company shall pay to Parent, not
later than two Business Days following such termination, an
amount equal to $2,250,000 (the “Termination
Fee”).
(e) If the Company shall terminate this Agreement pursuant
to Section 9.1(f), then the Company shall pay to Parent,
prior to or concurrently with such termination, the Termination
Fee.
(f) If (i) the Company or Parent shall terminate this
Agreement pursuant to Section 9.1(b) or 9.1(d),
(ii) at or prior to the time of the event giving rise to
such termination, an Acquisition Proposal shall have been made
known or proposed to the Company or otherwise publicly disclosed
or announced and (iii) within 12 months of the
termination of this Agreement, the Company enters into a
definitive agreement with respect to, or consummates, an
Acquisition Proposal, then the Company shall pay to Parent, not
later than two Business Days after the execution of the
definitive agreement or consummation of the transaction, as
applicable, the Termination Fee (less any amounts previously
reimbursed to Parent as Parent Expenses).
(g) For purposes of this Section 9.2, the term
“Acquisition Proposal” shall have the meaning assigned
to such term in Section 7.4(a), except that the reference
to “more than 20%” in the definition of
“Acquisition Proposal” shall be deemed to be a
reference to “more than 50%”.
(h) All payments under this Section 9.2 shall be made
by wire transfer of immediately available funds to an account
designated by Parent.
(i) The Company acknowledges that the agreements contained
in this Section 9.2 are an integral part of the
transactions contemplated by this Agreement and are not a
penalty, and that, without these agreements, Parent would not
enter into this Agreement. If the Company fails to pay promptly
the fee due pursuant to this Section 9.2, the Company will
also pay to Parent Parent’s reasonable costs and expenses
(including legal fees and expenses) in connection with any
action, including the filing of any lawsuit or other legal
action, taken to collect payment, together with interest on the
amount of the unpaid fee under this Section 9.2, accruing
from its due date, at an interest rate per annum equal to two
percentage points in excess of the prime commercial lending rate
quoted by Bank of America. Any change in the interest rate
hereunder resulting from a change in such prime rate will be
effective at the beginning of the date of such change in such
prime rate. If applicable, the Termination Fee shall not be
payable by the Company more than once pursuant to this
Section 9.2.
Section 9.3. Amendment. This
Agreement may be amended by the parties hereto, by action taken
or authorized by their respective Boards of Directors, at any
time before or after approval of the matters presented in
connection with the Merger by the stockholders of the Company,
but, after any such approval, no amendment shall be made which
by law requires further approval by such stockholders without
such further approval. This Agreement may not be amended except
by an instrument in writing signed on behalf of each of the
parties hereto.
Section 9.4. Extension;
Waive. At any time prior to the Effective
Time, the parties hereto, by action taken or authorized by their
respective Boards of Directors, may, to the extent legally
allowed, (i) extend the time for the performance of any of
the obligations or other acts of the other parties hereto,
(ii) waive any inaccuracies in the representations and
warranties contained herein or in any document delivered
pursuant hereto and (iii) waive compliance with any of the
agreements or conditions contained herein. Any agreement on the
part of a party hereto to any such extension or waiver shall be
valid only if set forth in a written instrument signed on behalf
of such party. The failure of any party to this Agreement to
assert any of its rights under this Agreement or otherwise shall
not constitute a waiver of those rights.
Section 10.1. Non-Survival
of Representations, Warranties and
Agreements. None of the representations,
warranties, covenants and other agreements in this Agreement or
in any instrument delivered pursuant to this Agreement,
including any rights arising out of any breach of such
representations, warranties, covenants and other agreements,
shall survive the Effective Time, except for those covenants and
agreements contained herein and therein that by their terms
apply or are to be performed in whole or in part after the
Effective Time and this Article X.
Section 10.2. Disclosure
Schedules. The inclusion of any information
in the disclosure schedules accompanying this Agreement will not
be deemed an admission or acknowledgment, in and of itself,
solely by virtue of the inclusion of such information in such
schedules, that such information is required to be listed in
such schedules or that such information is material to any Party
or the conduct of the business of any Party.
Section 10.3. Successors
and Assigns. No party hereto shall assign
this Agreement or any rights or obligations hereunder without
the prior written consent of the other parties hereto and any
such attempted assignment without such prior written consent
shall be void and of no force and effect; provided, that,
without the prior consent of the Company, Merger Sub may assign
any of its rights hereunder to its Affiliates. This Agreement
shall inure to the benefit of and shall be binding upon the
successors and permitted assigns of the parties hereto.
Section 10.4. Governing
Law; Jurisdiction.
(a) This Agreement shall be construed, performed and
enforced in accordance with, and governed by, the laws of the
State of Delaware. The parties hereto irrevocably elect as the
sole judicial forum for the adjudication of any matters arising
under or in connection with this Agreement, and consent to the
jurisdiction of, the courts of the State of Delaware.
(b) Each party hereto irrevocably submits to the
jurisdiction of (i) the Chancery Court of the State of
Delaware (or other appropriate state court in the State of
Delaware), and (ii) the United States District Court for
the District of Delaware, for the purposes of any suit, action
or other proceeding arising out of this Agreement or any
transaction contemplated hereby. Each party hereto agrees to
commence any action, suit or proceeding relating hereto in the
Chancery Court of the State of Delaware or, if such suit, action
or other proceeding may not be brought in such court for reasons
of subject matter jurisdiction in the United States District
Court for the District of Delaware. Each party hereto
irrevocably and unconditionally waives any objection to the
laying of venue of any action, suit or proceeding arising out of
this Agreement or the transactions contemplated hereby in
(A) the Chancery Court of the State of Delaware, or
(B) the United States District Court for the District of
Delaware, and hereby further irrevocably and unconditionally
waives and agrees not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court
has been brought in an inconvenient forum. Each party hereto
further irrevocably consents to the service of process out of
any of the aforementioned courts in any such suit, action or
other proceeding by the mailing of copies thereof by mail to
such party at its address set forth in this Agreement, such
service of process to be effective upon acknowledgment of
receipt of such registered mail; provided that nothing in this
Section 10.4 shall affect the right of any party to serve
legal process in any other manner permitted by law. The consent
to jurisdiction set forth in this Section 10.4 shall not
constitute a general consent to service of process in the State
of Delaware and shall have no effect for any purpose except as
provided in this Section 10.4. The parties hereto agree
that a final judgment in any such suit, action or proceeding
shall be conclusive and may be enforced in other jurisdictions
by suit on the judgment or in any other manner provided by law.
(c) The parties hereto agree that irreparable damage would
occur in the event that any of the provisions of this Agreement
were not performed in accordance with their specific terms on a
timely basis or were otherwise breached. It is accordingly
agreed that the parties shall be entitled to seek an injunction
or other equitable relief to prevent breaches of this Agreement
and to seek to enforce specifically the terms and provisions of
this Agreement in any court identified in Section 10.4(b),
this being in addition to any other remedy to which they are
entitled at law or in equity.
(d) WAIVER OF JURY TRIAL. EACH OF THE PARTIES HEREBY WAIVES
TRIAL BY JURY IN ANY JUDICIAL PROCEEDING INVOLVING, DIRECTLY, IN
ANY MATTERS (WHETHER SOUNDING IN TORT, CONTRACT OR OTHERWISE) IN
ANY WAY ARISING OUT OF, RELATED TO, OR CONNECTED WITH, THIS
AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
Section 10.5. Expenses. All
fees and expenses incurred in connection with the Merger
including, without limitation, all legal, accounting, financial
advisory, consulting and all other fees and expenses of third
parties incurred by a party in connection with the negotiation
and effectuation of the terms and conditions of this Agreement
and the transactions contemplated hereby, shall be the
obligation of the respective party incurring such fees and
expenses, except (a) Parent and the Company shall each bear
and pay one-half of the expenses incurred in connection with the
filing, printing and mailing of the Registration Statement and
Proxy Statement and (b) as provided in Section 9.2.
Section 10.6. Severability;
Construction.
(a) In the event that any part of this Agreement is
declared by any court or other judicial or administrative body
to be null, void or unenforceable, said provision shall survive
to the extent it is not so declared, and all of the other
provisions of this Agreement shall remain in full force and
effect.
(b) The Parties have participated jointly in the
negotiation and drafting of this Agreement. If any ambiguity or
question of intent arises, this Agreement will be construed as
if drafted jointly by the Parties and no presumption or burden
of proof will arise favoring or disfavoring any Party because of
the authorship of any provision of this Agreement.
Section 10.7. Notices. All
notices, requests, demands and other communications under this
Agreement shall be in writing and shall be deemed to have been
duly given (i) on the date of service if served personally
on the party to whom notice is to be given; (ii) on the day
after delivery to Federal Express or similar overnight courier
or the Express Mail service maintained by the United States
Postal Service; or (iii) on the fifth day after mailing, if
mailed to the party to whom notice is to be given, by first
class mail, registered or certified, postage prepaid and
properly addressed, to the party as follows:
Latham & Watkins LLP
650 Town Center Drive
20th Floor Costa Mesa, CA92626
Tel:
(714) 540-1235
Fax:
(714) 755-8290
Attn:
Kevin B. Espinola
B. Shayne Kennedy
If to Parent or Merger Sub:
Integra LifeSciences Holdings Corporation
311 Enterprise Drive Plainsboro, New Jersey08536
Attn: General Counsel
Tel:
(609) 936-2238
Fax:
(609) 275-9006
Willkie Farr & Gallagher LLP
787 Seventh Avenue New York, NY10019
Attn: David K. Boston
Tel:
(212) 728-8000
Fax:
(212) 728-8111
Any party may change its address for the purpose of this Section
by giving the other party written notice of its new address in
the manner set forth above.
Section 10.8. Entire
Agreement. This Agreement and the
Confidentiality Agreement contain the entire understanding among
the parties hereto with respect to the transactions contemplated
hereby and supersede and replace all prior and contemporaneous
agreements and understandings, oral or written, with regard to
such transactions. All Exhibits and Schedules hereto and any
documents and instruments delivered pursuant to any provision
hereof are expressly made a part of this Agreement as fully as
though completely set forth herein.
Section 10.9. Parties
in Interest. Except for (i) the rights
of the Company stockholders to receive the Merger Consideration
following the Effective Time in accordance with the terms of
this Agreement (of which the stockholders are the intended
beneficiaries following the Effective Time) and (ii) the
rights to continued indemnification and insurance pursuant to
Section 6.2 hereof (of which the Persons entitled to
indemnification or insurance, as the case may be, are the
intended beneficiaries following the Effective Time), nothing in
this Agreement is intended to confer any rights or remedies
under or by reason of this Agreement on any Persons other than
the parties hereto and their respective successors and permitted
assigns. Nothing in this Agreement is intended to relieve or
discharge the obligations or liability of any third Persons to
the Company or Parent. No provision of this Agreement shall give
any third parties any right of subrogation or action over or
against the Company or Parent.
Section 10.10. Section
and Paragraph Headings. The section and
paragraph headings in this Agreement are for reference purposes
only and shall not affect the meaning or interpretation of this
Agreement.
Section 10.11. Counterparts. This
Agreement may be executed in counterparts, each of which shall
be deemed an original, but all of which shall constitute the
same instrument.
Section 10.12. Definitions. As
used in this Agreement:
“510(k)” shall have the meaning set
forth in Section 3.17(j).
“Accell Products” shall mean the
Company’s line of demineralized bone matrix products
included in the 510(k), K061880, submitted to the FDA on
June 28, 2006 and currently under review by the FDA,
including, Accell Putty (A2i), Accell DBM 100, Accell TBM, and
Accell Connexus.
“Acquisition Proposal” shall have the
meaning set forth in Section 7.4(a).
“Action” shall have the meaning set
forth in Section 3.20.
“Affiliate” shall mean, with respect to
any Person, any other Person that directly, or through one or
more intermediaries, controls or is controlled by or is under
common control with such Person.
“Agreement” shall have the meaning set
forth in the Preamble hereto.
“Applicable Securities Laws” shall have
the meaning set forth in Section 3.35(a).
“Appraisal Shares” shall have the
meaning set forth in Section 1.8(e).
“Board of Directors” shall mean the
Board of Directors of any specified Person and any committees
thereof.
“Business Day” shall mean any day on
which banks are not required or authorized to close in the City
of New York.
“Certificate” shall have the meaning set
forth in Section 1.8(b).
“Certificate of Merger” shall have the
meaning set forth in Section 1.3.
“Closing” shall have the meaning set
forth in Section 1.2.
“Closing Date” shall have the meaning
set forth in Section 1.2.
“Code” shall have the meaning set forth
in Section 2.7.
“Company” shall have the meaning set
forth in the Preamble hereto.
“Company Common Stock” shall have the
meaning set forth in the Recitals hereto.
“Company Disclosure Letter” shall have
the meaning set forth in Article III.
“Company Material Adverse Effect” shall
mean any event, change, circumstance, effect, development or
state of facts that, individually or in the aggregate,
(a) is or is reasonably likely to become, materially
adverse to the business, assets, condition (financial or
otherwise) or results of operations of the Company and its
Subsidiaries, taken as a whole; provided, however, that Company
Material Adverse Effect shall not include the effect of any
event, change, circumstance, effect, development or state of
facts arising out of or attributable to (i) general
economic conditions in the U.S., any U.S. state or any
foreign country in which the Company and any of its Subsidiaries
operate, (ii) the industry in which the Company and its
Subsidiaries operate, and (iii) the execution and public
announcement of this Agreement and the pendency of the
transactions contemplated hereby, except, in the case of the
foregoing clauses (i) and (ii), to the extent that such
event, change, circumstance, effect, development or state of
facts affects the Company and its Subsidiaries in a materially
disproportionate manner when compared to the effect of such
event, change, circumstance, effect, development or state of
facts on other Persons in the industry in which the Company and
its Subsidiaries operate, or (b) would prevent or
materially delay the ability of the Company to perform its
obligations under this Agreement or to consummate the
transactions contemplated hereby.
“Company Options” shall have the meaning
set forth in Section 1.9(a).
“Company Organizational Documents” shall
mean the Certificate of Incorporation and the Bylaws of the
Company, together with all amendments thereto.
“Company Preferred Stock” shall mean the
preferred stock, par value $.01 per share, of the Company.
“Company Property” shall have the
meaning set forth in Section 3.12(b).
“Company SEC Reports” shall have the
meaning set forth in Section 3.8(a).
“Company Stock Plans” shall have the
meaning set forth in Section 3.6(a).
“Company Stockholders Meeting” shall
have the meaning set forth in Section 3.31.
“Company Welfare Plans” shall have the
meaning set forth in Section 6.1(b).
“Competing Confidentiality Agreement”
shall have the meaning set forth in Section 7.4(b).
“Confidentiality Agreement” shall have
the meaning set forth in Section 7.2.
“Continuing Employees” shall have the
meaning set forth in Section 6.1(a).
“Contract” shall have the meaning set
forth in Section 3.21(c).
“Credit Agreement Amendment” shall have
the meaning set forth in Section 8.2(f).
“Customer Contracts” shall have the
meaning set forth in Section 3.21(c).
“DGCL” shall mean the Delaware General
Corporation Law.
“Effective Time” shall have the meaning
set forth in Section 1.3.
“Employee Benefit Plans” shall have the
meaning set forth in Section 3.22(a).
“Encumbrances” shall mean any claim,
lien, pledge, option, right of first refusal or offer,
preemptive right, charge, easement, security interest, deed of
trust, mortgage,
right-of-way,
covenant, condition, restriction, encumbrance or other rights of
third parties.
“Environmental Laws” shall mean any
federal, state, local or foreign, statute, regulation,
ordinance, order, decree, directive or other requirement of law
(including, without limitation, common law) relating to human
health, safety or welfare, wildlife, natural resources, flora,
fauna or the environment (including, without limitation, indoor
or outdoor air, water, water vapor, groundwater, drinking water,
surface or subsurface land, noise and odor), or to the
identification, generation, use, labeling, processing, control,
transportation, handling, discharge, emission, treatment,
storage, disposal, investigation, removal, remediation,
import/export, or monitoring of, or exposure to, any pollutant,
contaminant, hazardous or solid waste, or any hazardous or toxic
substance, or material.
“ERISA” shall mean the Employee
Retirement Income Security Act of 1974.
“ERISA Affiliate” shall have the meaning
set forth in Section 3.22(a).
“Exchange Act” shall have the meaning
set forth in Section 3.4.
“Exchange Agent” shall have the meaning
set forth in Section 2.1.
“Exchange Fund” shall have the meaning
set forth in Section 2.1.
“Exchange Offer” shall have the meaning
set forth in Section 3.35.
“Existing Policy” shall have the meaning
set forth in Section 6.2(c).
“FDA” shall have the meaning set forth
in Section 3.4.
“FDCA” shall have the meaning set forth
in Section 3.17(a).
“GAAP” shall mean United States
generally accepted accounting principles as in effect from time
to time, consistently applied.
“Goodyear Landlord” shall have the
meaning set forth in Section 3.12(c).
“Governmental Entity” shall mean any
federal, state, local or foreign governmental, regulatory or
administrative authority, branch, agency or commission or any
court, tribunal or judicial body.
“Hazardous Material” shall mean any
product, substance, gas, chemical, microbial matter, material or
waste, whose presence, nature, quantity or concentration, either
by itself or in combination with other materials is
(a) potentially injurious to human health or safety, the
environment or natural resources; or (b) regulated,
monitored or subject to reporting by any Governmental Entity
relating to Environmental Laws.
“IDE” shall have the meaning set forth
in Section 3.17(k).
“Indemnified Person” shall have the
meaning set forth in Section 6.2(a).
“Intellectual Property” shall mean all
of the following, owned or used by the Company and its
Subsidiaries: material (i) trademarks and service marks,
trade dress, product configurations, trade names and other
indications of origin, applications or registrations in any
jurisdiction pertaining to the foregoing and all goodwill
associated therewith; (ii) inventions (whether or not
patentable), discoveries, improvements, ideas, know-how, formula
methodology, processes, technology, software (including password
unprotected interpretive code or source code, object code,
development documentation, programming tools, drawings,
specifications and data) and applications and patents in any
jurisdiction pertaining to the foregoing, including re-issues,
continuations, divisions,
continuations-in-part,
renewals or extensions; (iii) trade secrets, including
confidential information and the right in any jurisdiction to
limit the use or disclosure thereof; (iv) copyrighted and
copyrightable writings, designs, software, mask works or other
works, applications or registrations in any jurisdiction for the
foregoing and all moral rights related
thereto; (v) database rights; (vi) Internet Web sites,
domain names and applications and registrations pertaining
thereto and all intellectual property used in connection with or
contained in all versions of the Web sites of the Company and
its Subsidiaries; (vii) rights under all agreements
relating to the foregoing; (viii) books and records
pertaining to the foregoing; and (ix) claims or causes of
action arising out of or related to past, present or future
infringement or misappropriation of the foregoing.
“Intervening Event” shall mean a
material event with respect to the Company’s business,
neither known by the Board of Directors of the Company nor
reasonably foreseeable as of the date hereof, which event (or
any material consequence of which) becomes known to or by (or
understood by) the Board of Directors of the Company prior to
the Company Stockholders Meeting; provided, however, that in no
event shall (i) any event resulting from a breach of this
Agreement by the Company or any of its Subsidiaries or
(ii) the receipt, existence or terms of a Acquisition
Proposal or any matter relating thereto or consequence thereof,
constitute an Intervening Event.
“IRS” shall mean the United States
Internal Revenue Service.
“Knowledge” shall mean, with respect to
the Company, the actual knowledge of the executives of the
Company listed on Section 10.12(a) of the Company
Disclosure Letter after due inquiry of the senior employees of
the Company and its Subsidiaries who have administrative or
operational responsibility for the particular subject matter in
question.
“Leases” shall have the meaning set
forth in Section 3.12(b).
“Leased Real Property” shall have the
meaning set forth in Section 3.12(b).
“Licenses and Permits” shall have the
meaning set forth in Section 3.16(a).
“Lien” shall mean any mortgage, pledge,
security interest, encumbrance or title defect, lease, lien
(statutory or other), conditional sale agreement, claim, charge,
limitation or restriction.
“Listing Terminations” shall have the
meaning set forth in Section 3.35(c).
“Merger” shall have the meaning set
forth in the Recitals hereto.
“Merger Consideration” shall have the
meaning set forth in Section 1.8(a).
“Merger Sub” shall have the meaning set
forth in the Preamble hereto.
“Multiemployer Plan” shall have the
meaning set forth in Section 3.22(c).
“Nasdaq” shall mean The Nasdaq Stock
Market, Inc.
“Other Acquisition Documentation” shall
have the meaning set forth in Section 7.4(d).
“Offer Memoranda” shall have the meaning
set forth in Section 3.35(a).
“Owned Real Property” shall have the
meaning set forth in Section 3.12(a).
“Parent” shall have the meaning set
forth in the Preamble hereto.
“Parent Expenses” shall mean all of
Parent’s actual and reasonably documented
out-of-pocket
fees and expenses (including fees and expenses of counsel,
accountants, financial advisors or consultants and commitment
and funding fees) actually incurred by Parent and its respective
affiliates on or prior to the termination of this Agreement in
connection with the transactions contemplated by this Agreement,
including the financing thereof.
“Parent Organizational Documents” shall
mean the Amended and Restated Certificate of Incorporation and
the Amended and Restated Bylaws of Parent, together with all
amendments thereto.
“Pension Plans” shall have the meaning
set forth in Section 3.22(a).
“Permitted Liens” shall mean
(a) liens for utilities and current Taxes and assessments
not yet due and payable, (b) mechanics’,
carriers’, workers’, repairers’,
materialmen’s, warehousemen’s, lessor’s,
landlord’s and other similar liens arising or incurred in
the ordinary course of business not yet due and payable, if the
same shall not at the time be delinquent or thereafter can be
paid without penalty or are being contested in good faith by
appropriate proceedings and for which appropriate reserves have
been included on the balance sheet of the applicable Person,
(c) easements, restrictive covenants and similar
Encumbrances (which Parent has determined are acceptable and
shall be deemed Permitted Liens), (d) minor encroachments
or any state of facts an accurate survey of the Company would
disclose which individually or in the aggregate do not
materially interfere with an entity’s business or the
operation of the property as currently conducted to which they
apply, (e) Liens disclosed to Parent (which Parent has
determined are acceptable and shall be deemed Permitted Liens),
(f) Liens granted in respect of any Debt or securing any
obligations with respect thereto and other Liens as set forth on
Section 10.12(b) of the Company Disclosure Letter,
(g) customary Liens arising out of pledges or deposits
under worker’s compensation laws, unemployment insurance,
old age pensions or other social security or retirement benefits
or similar legislation, (h) customary deposits securing
liability to insurance carriers under insurance or
self-insurance arrangements, (i) customary deposits to
secure the performance of bids, tenders, trade contracts,
leases, statutory obligations, surety and appeal bonds,
performance bonds and other obligations of a like nature
incurred in the ordinary course of business, (j) Liens
arising from protective filings, and (k) Liens in favor of
a banking institution arising as a matter of applicable law
encumbering deposits (including the right of set-off) held by
such banking institution incurred in the ordinary course of
business and which are within the general parameters customary
in the banking industry.
“Person” shall mean an individual,
corporation, limited liability company, partnership,
association, trust, unincorporated organization, other entity or
group (as defined in the Exchange Act).
“Proceeding” shall have the meaning set
forth in Section 6.2(a).
“Proxy Statement” shall have the meaning
set forth in Section 3.31.
“PMA” shall have the meaning set forth
in Section 3.17(j).
“Registered Intellectual Property” shall
have the meaning set forth in Section 3.14(b).
“Regulatory Law” shall have the meaning
set forth in Section 7.3(b).
“Required Company Vote” shall have the
meaning set forth in Section 3.33.
“Sarbanes-Oxley Act” shall have the
meaning set forth in Section 3.19(b).
“SEC” shall mean the United States
Securities and Exchange Commission.
“Securities Act” shall have the meaning
set forth in Section 3.4.
“Section 262” shall have the
meaning set forth in Section 1.8(e).
“Software” shall have the meaning set
forth in Section 3.15(a).
“Subsidiary” when used with respect to
any party shall mean any corporation, partnership or other
organization, whether incorporated or unincorporated,
(i) of which such party or any other Subsidiary of such
party is a general partner (excluding partnerships, the general
partnership interests of which held by such party or any
Subsidiary of such party do not have a majority of the voting
interests in such partnership) or (ii) at least a majority
of the securities or other interests of which having by their
terms ordinary voting power to elect a majority of the Board of
Directors or others performing similar functions with respect to
such corporation or other organization is directly or indirectly
owned or controlled by such party or by any one or more of its
Subsidiaries, or by such party and one or more of its
Subsidiaries.
“Superior Proposal” shall have the
meaning set forth in Section 7.4(b).
“Surviving Corporation” shall have the
meaning set forth in Section 1.1.
“Swiss Merger” shall have the meaning
set forth in Section 3.35(c).
“Swiss SPV” shall have the meaning set
forth in Section 3.35(a).
“Tail Period” shall have the meaning set
forth in Section 6.2(c).
“Tax Return” shall mean any report,
return, information return, filing, claim for refund or other
information, including any schedules or attachments thereto, and
any amendments to any of the foregoing required to be supplied
to a taxing authority in connection with Taxes.
“Taxes” shall mean all federal, state,
local or foreign taxes, including, without limitation, income,
gross income, gross receipts, production, excise, employment,
sales, use, transfer, ad valorem, value added, profits, license,
capital stock, franchise, severance, stamp, withholding, Social
Security, employment, unemployment, disability, worker’s
compensation, payroll, utility, windfall profit, custom duties,
personal property, real property, taxes required to be collected
from customers on the sale of services, registration,
alternative or add-on minimum, estimated and other taxes,
governmental fees or like charges of any kind whatsoever,
whether disputed or not, including any interest, penalties or
additions thereto; and “Tax” shall mean any one of
them.
“Termination Date” shall have the
meaning set forth in Section 9.1(b).
“Termination Fee” shall have the meaning
set forth in Section 9.2(d).
“the other party” shall mean, with
respect to the Company, Parent and shall mean, with respect to
Parent, the Company.
“Trade Laws” shall have the meaning set
forth in Section 3.37(a).
“Treasury Regulations” shall have the
meaning set forth in Section 2.7. “Unit B
Premises” shall have the meaning set forth in
Section 3.12(c).
“Vendor Contracts” shall have the
meaning set forth in Section 3.21(c).
“WARN” shall have the meaning set forth
in Section 3.26(c).
The Board of Directors (the “Board”) of IsoTis, Inc.,
a Delaware corporation (the “Company”), has requested
our opinion as investment bankers as to the fairness, from a
financial point of view, to the holders of the issued and
outstanding common shares, par value $0.0001 per share, of the
Company (the “Company Common Stock”), of the Merger
Consideration pursuant to the Agreement and Plan of Merger (the
“Merger Agreement”) to be entered into by and among
the Company, Integra LifeSciences Holdings Corporation, a
Delaware corporation (“Parent”) and IsoTis Acquisition
Company, a Delaware corporation and wholly-owned subsidiary of
Parent (“Merger Sub”). All capitalized terms used and
not otherwise defined herein have the respective meanings
assigned to such terms in the Merger Agreement.
The Merger Agreement contemplates that at the closing of the
transaction contemplated thereby, among other things, Merger Sub
will be merged with and into the Company (the
“Merger”) and each share of Company Common Stock
issued and outstanding immediately prior to the Effective Time
of the Merger (other than treasury shares and any shares held
directly or indirectly by Parent and shares for which appraisal
rights have been perfected under applicable law) will be
converted into the right to receive the Merger Consideration,
comprised of $7.25 in cash, without interest, subject to
adjustment pursuant to Section 1.8(d) of the Merger
Agreement. The terms and conditions of the Merger are set forth
in more detail in the Merger Agreement.
In connection with rendering this opinion, we have, among other
things:
(i) reviewed a copy of the Merger Agreement, dated as of
August 6, 2007 (the “Draft Agreement”), and the
financial terms and conditions set forth therein, as well as the
schedules thereto;
(ii) reviewed certain publicly available information
concerning the Company, including the Company’s Quarterly
Report on
Form 10-Q
for the period ended March 31, 2007;
(iii) reviewed certain unaudited internal information,
primarily financial in nature and including financial forecasts
for the fiscal years ending December 31, 2007 through
December 31, 2012, as well as unaudited financial
information for the period ending June 30, 2007, prepared
and furnished to us by the Company’s management for
purposes of our analysis;
(iv) reviewed certain publicly available information
concerning the trading of, and the trading market for, the
Company Common Stock;
(v) reviewed certain publicly available information with
respect to certain other companies that we believe to be
comparable to the Company and the trading markets for certain of
such other companies’ securities;
(vi) compared the proposed financial terms of the Merger
with certain publicly available information concerning the
nature and terms of certain other transactions that we
considered to be relevant;
(vii) discussed past and current operations and financial
condition and the prospects of the Company, as well as other
matters we believe relevant to our inquiry, with certain
officers and employees of the Company; and
(viii) conducted such other financial studies, analyses and
investigations, and considered such other information, as we
deemed necessary or appropriate, including our assessment of
general financial, economic, market and other conditions.
In our review and analysis and in arriving at our opinion, we
have relied upon, without any responsibility for independent
verification or liability therefor, the accuracy and
completeness of all of the financial and other information that
was publicly available or supplied or otherwise made available
to us by the Company, and upon the assurances of the management
of the Company that no relevant information has been omitted or
remains undisclosed to us. We have not been engaged to, and have
not independently attempted to, verify any of such information.
We have also assumed that there have been no material changes in
the Company’s assets, financial condition, results of
operations, business or prospects since the respective dates of
its last financial statements made available to us.
We have also relied upon the management of the Company as to the
reasonableness and achievability of the financial and operating
forecasts (and the assumptions and bases therefor) of the
Company provided to us and, with your consent, we have assumed
that such forecasts reflect management’s best currently
available estimates and judgments, and we express no opinion
with respect to such forecasts or any of the analyses or the
assumptions upon which they are based. We have not been engaged
to assess the reasonableness or achievability of such forecasts
or the assumptions on which they were based and express no view
as to such forecasts or assumptions. We further understand from
the Company that the ability of the Company to continue as a
going concern and achieve the results reflected in its financial
and operating forecasts is dependent on the Company raising a
significant amount of new capital in the near future, and that
the ability of the Company to raise such capital within the
necessary time frame is unlikely. In addition, we have not
evaluated or appraised any of the assets, properties or
facilities of the Company nor have we been furnished with any
such evaluation or appraisal. We have also not been requested to
assume, and have not assumed, any obligation to conduct any
inspection of the properties or facilities of the Company.
At your direction, we have not been asked to, nor do we offer
any opinion as to the material terms of the Merger Agreement or
the form of the transaction as a merger. We have also assumed,
with your consent, that the final executed form of the Merger
Agreement will not differ in any material respect from the Draft
Agreement furnished to and reviewed by us. For purposes of
rendering our opinion, we have assumed, in all respects material
to our analysis, with your consent, (a) that the proposed
Merger will be consummated as described in the Merger Agreement
and in compliance with all applicable laws, (b) that all
the representations and warranties of each party contained in
the Merger Agreement are true and correct, (c) that each
party to the Merger Agreement will perform all of the covenants
and agreements required to be performed by it thereunder without
any consents or waivers of the other parties thereto,
(d) that the Merger will be consummated in a manner that
complies in all respects with the applicable provisions of the
Securities Exchange Act of 1934, as amended, and all other
applicable federal and state statutes, rules and regulations,
and (e) that all conditions to the consummation of the
proposed Merger will be satisfied without waiver thereof. We
note that we are not legal, tax or regulatory experts, and have
made no independent investigation of any legal matters involving
the Company or the Merger, and we have assumed the correctness
of all statements with respect to legal matters made or
otherwise provided to you and us by counsel.
It should be noted that this opinion is necessarily based on the
economic, monetary, market and other conditions as in effect on,
and the information made available to us, as of the date hereof
and does not address any matters subsequent to such date. It
should be further noted that although subsequent developments
may affect this opinion, we do not have any obligation to
update, revise or reaffirm our opinion after the date hereof. We
disclaim any undertaking or obligation to advise any person of
any change in any fact or matter affecting the opinion which may
come or be brought to our attention after the date hereof.
Without limiting the foregoing, in the event that in our
judgment there is any material change in any fact, assumption
upon which our opinion is based or matter affecting the opinion
after the date hereof, we reserve the right to withdraw, revise
or modify our opinion.
Our opinion is limited to the fairness, as of the date hereof,
from a financial point of view, of the Merger Consideration to
the holders of Company Common Stock. Our opinion does not
address the underlying or relative merits of the proposed Merger
or any related transaction and any other transactions or
business strategies discussed by the Board of Directors of the
Company or that might be available as alternatives to the
proposed Merger or the decision of the Company to proceed with
the proposed Merger or any related transaction. Our opinion is
not, and should not be construed as, a valuation of the Company
or its respective
assets or any of the Company Common Stock. We express no opinion
herein as to the price at which the Company Common Stock will
trade at any future time.
We provide a full range of financial, advisory and securities
services and, as part of our investment banking activities, are
regularly engaged in the valuation of businesses and their
respective securities in connection with mergers and
acquisitions, underwritings, private placements and valuations
for corporate and other purposes. In the ordinary course of our
business, we may actively trade the Company Common Stock and
other securities of the Company, as well as the common stock of
Parent and other securities of Parent, for our own account and
for the accounts of customers and, accordingly, may at any time
hold a long or short position in such securities.
We are acting as financial advisor to the Company in connection
with the Merger and will receive a fee from the Company for our
services, including rendering this opinion, a substantial
portion of which is contingent on the consummation of the
Merger. In addition, the Company has agreed to indemnify us for,
and exculpate us from, certain liabilities arising out of our
engagement. In furnishing this opinion, we do not admit that we
are experts within the meaning of the term “experts”
as used in the Securities Act of 1933, as amended (the
“Securities Act”) and the rules and regulations
promulgated thereunder, nor do we admit that this opinion
constitutes a report or valuation within the meaning of
Section 11 of the Securities Act.
This opinion has been prepared solely for the information of the
Board of Directors of the Company for its confidential use in
connection with its consideration of the proposed Merger and may
not, in whole or in part, be reproduced, disseminated, quoted,
summarized, described or referred to at any time, communicated
or provided to or relied upon by any person or otherwise made
public or used for any purpose without our prior written
consent; provided, however, that this opinion may be
reproduced in full in the proxy statement related to the
proposed Merger filed by the Company with the Securities and
Exchange Commission. Our opinion is directed to the Board of
Directors of the Company and does not constitute a
recommendation to any stockholder of the Company as to how such
stockholder should vote with respect to the Merger or any other
matter. In addition, you have not asked us to address, and this
opinion does not address, the fairness to, or any other
consideration of, the holders of any class of securities,
creditors or other constituencies of the Company, and this
letter does not address the fairness of any specific portion of
the Merger.
Based upon and subject to the foregoing, it is our opinion as
investment bankers that, as of the date hereof, the Merger
Consideration is fair, from a financial point of view, to the
holders of the Company Common Stock.
(a) Any stockholder of a corporation of this State who
holds shares of stock on the date of the making of a demand
pursuant to subsection (d) of this section with respect to
such shares, who continuously holds such shares through the
effective date of the merger or consolidation, who has otherwise
complied with subsection (d) of this section and who has
neither voted in favor of the merger or consolidation nor
consented thereto in writing pursuant to § 228 of this
title shall be entitled to an appraisal by the Court of Chancery
of the fair value of the stockholder’s shares of stock
under the circumstances described in subsections (b) and
(c) of this section. As used in this section, the word
“stockholder” means a holder of record of stock in a
stock corporation and also a member of record of a nonstock
corporation; the words “stock” and “share”
mean and include what is ordinarily meant by those words and
also membership or membership interest of a member of a nonstock
corporation; and the words “depository receipt” mean a
receipt or other instrument issued by a depository representing
an interest in one or more shares, or fractions thereof, solely
of stock of a corporation, which stock is deposited with the
depository.
(b) Appraisal rights shall be available for the shares of
any class or series of stock of a constituent corporation in a
merger or consolidation to be effected pursuant to
§ 251 (other than a merger effected pursuant to
§ 251(g) of this title), § 252,
§ 254, § 257, § 258,
§ 263 or § 264 of this title:
(1) Provided, however, that no appraisal rights under this
section shall be available for the shares of any class or series
of stock, which stock, or depository receipts in respect
thereof, at the record date fixed to determine the stockholders
entitled to receive notice of and to vote at the meeting of
stockholders to act upon the agreement of merger or
consolidation, were either (i) listed on a national
securities exchange or (ii) held of record by more than
2,000 holders; and further provided that no appraisal rights
shall be available for any shares of stock of the constituent
corporation surviving a merger if the merger did not require for
its approval the vote of the stockholders of the surviving
corporation as provided in subsection (f) of
§ 251 of this title.
(2) Notwithstanding paragraph (1) of this subsection,
appraisal rights under this section shall be available for the
shares of any class or series of stock of a constituent
corporation if the holders thereof are required by the terms of
an agreement of merger or consolidation pursuant to
§§ 251, 252, 254, 257, 258, 263 and 264 of this
title to accept for such stock anything except:
a. Shares of stock of the corporation surviving or
resulting from such merger or consolidation, or depository
receipts in respect thereof;
b. Shares of stock of any other corporation, or depository
receipts in respect thereof, which shares of stock (or
depository receipts in respect thereof) or depository receipts
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 holders;
c. Cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.
and b. of this paragraph; or
d. Any combination of the shares of stock, depository
receipts and cash in lieu of fractional shares or fractional
depository receipts described in the foregoing subparagraphs a.,
b. and c. of this paragraph.
(3) In the event all of the stock of a subsidiary Delaware
corporation party to a merger effected under § 253 of
this title is not owned by the parent corporation immediately
prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation.
(c) Any corporation may provide in its certificate of
incorporation that appraisal rights under this section shall be
available for the shares of any class or series of its stock as
a result of an amendment to its certificate of incorporation,
any merger or consolidation in which the corporation is a
constituent corporation or the sale
of all or substantially all of the assets of the corporation. If
the certificate of incorporation contains such a provision, the
procedures of this section, including those set forth in
subsections (d) and (e) of this section, shall apply
as nearly as is practicable.
(d) Appraisal rights shall be perfected as follows:
(1) If a proposed merger or consolidation for which
appraisal rights are provided under this section is to be
submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting,
shall notify each of its stockholders who was such on the record
date for such meeting with respect to shares for which appraisal
rights are available pursuant to subsection (b) or
(c) hereof that appraisal rights are available for any or
all of the shares of the constituent corporations, and shall
include in such notice a copy of this section. Each stockholder
electing to demand the appraisal of such stockholder’s
shares shall deliver to the corporation, before the taking of
the vote on the merger or consolidation, a written demand for
appraisal of such stockholder’s shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such stockholder’s
shares. A proxy or vote against the merger or consolidation
shall not constitute such a demand. A stockholder electing to
take such action must do so by a separate written demand as
herein provided. Within 10 days after the effective date of
such merger or consolidation, the surviving or resulting
corporation shall notify each stockholder of each constituent
corporation who has complied with this subsection and has not
voted in favor of or consented to the merger or consolidation of
the date that the merger or consolidation has become
effective; or
(2) If the merger or consolidation was approved pursuant to
§ 228 or § 253 of this title, then either a
constituent corporation before the effective date of the merger
or consolidation or the surviving or resulting corporation
within 10 days thereafter shall notify each of the holders
of any class or series of stock of such constituent corporation
who are entitled to appraisal rights of the approval of the
merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such
constituent corporation, and shall include in such notice a copy
of this section. Such notice may, and, if given on or after the
effective date of the merger or consolidation, shall, also
notify such stockholders of the effective date of the merger or
consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice,
demand in writing from the surviving or resulting corporation
the appraisal of such holder’s shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such holder’s shares. If
such notice did not notify stockholders of the effective date of
the merger or consolidation, either (i) each such
constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of
the holders of any class or series of stock of such constituent
corporation that are entitled to appraisal rights of the
effective date of the merger or consolidation or (ii) the
surviving or resulting corporation shall send such a second
notice to all such holders on or within 10 days after such
effective date; provided, however, that if such second notice is
sent more than 20 days following the sending of the first
notice, such second notice need only be sent to each stockholder
who is entitled to appraisal rights and who has demanded
appraisal of such holder’s shares in accordance with this
subsection. An affidavit of the secretary or assistant secretary
or of the transfer agent of the corporation that is required to
give either notice that such notice has been given shall, in the
absence of fraud, be prima facie evidence of the facts stated
therein. For purposes of determining the stockholders entitled
to receive either notice, each constituent corporation may fix,
in advance, a record date that shall be not more than
10 days prior to the date the notice is given, provided,
that if the notice is given on or after the effective date of
the merger or consolidation, the record date shall be such
effective date. If no record date is fixed and the notice is
given prior to the effective date, the record date shall be the
close of business on the day next preceding the day on which the
notice is given.
(e) Within 120 days after the effective date of the
merger or consolidation, the surviving or resulting corporation
or any stockholder who has complied with subsections (a)
and (d) of this section hereof and who is otherwise
entitled to appraisal rights, may commence an appraisal
proceeding by filing a petition in the Court of Chancery
demanding a determination of the value of the stock of all such
stockholders.
Notwithstanding the foregoing, at any time within 60 days
after the effective date of the merger or consolidation, any
stockholder who has not commenced an appraisal proceeding or
joined that proceeding as a named party shall have the right to
withdraw such stockholder’s demand for appraisal and to
accept the terms offered upon the merger or consolidation.
Within 120 days after the effective date of the merger or
consolidation, any stockholder who has complied with the
requirements of subsections (a) and (d) of this
section hereof, upon written request, shall be entitled to
receive from the corporation surviving the merger or resulting
from the consolidation a statement setting forth the aggregate
number of shares not voted in favor of the merger or
consolidation and with respect to which demands for appraisal
have been received and the aggregate number of holders of such
shares. Such written statement shall be mailed to the
stockholder within 10 days after such stockholder’s
written request for such a statement is received by the
surviving or resulting corporation or within 10 days after
expiration of the period for delivery of demands for appraisal
under subsection (d) of this section hereof, whichever is
later. Notwithstanding subsection (a) of this section, a
person who is the beneficial owner of shares of such stock held
either in a voting trust or by a nominee on behalf of such
person may, in such person’s own name, file a petition or
request from the corporation the statement described in this
subsection.
(f) Upon the filing of any such petition by a stockholder,
service of a copy thereof shall be made upon the surviving or
resulting corporation, which shall within 20 days after
such service file in the office of the Register in Chancery in
which the petition was filed a duly verified list containing the
names and addresses of all stockholders who have demanded
payment for their shares and with whom agreements as to the
value of their shares have not been reached by the surviving or
resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be
accompanied by such a duly verified list. The Register in
Chancery, if so ordered by the Court, shall give notice of the
time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting
corporation and to the stockholders shown on the list at the
addresses therein stated. Such notice shall also be given by 1
or more publications at least 1 week before the day of the
hearing, in a newspaper of general circulation published in the
City of Wilmington, Delaware or such publication as the Court
deems advisable. The forms of the notices by mail and by
publication shall be approved by the Court, and the costs
thereof shall be borne by the surviving or resulting corporation.
(g) At the hearing on such petition, the Court shall
determine the stockholders who have complied with this section
and who have become entitled to appraisal rights. The Court may
require the stockholders who have demanded an appraisal for
their shares and who hold stock represented by certificates to
submit their certificates of stock to the Register in Chancery
for notation thereon of the pendency of the appraisal
proceedings; and if any stockholder fails to comply with such
direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After the Court determines the stockholders entitled to
an appraisal, the appraisal proceeding shall be conducted in
accordance with the rules of the Court of Chancery, including
any rules specifically governing appraisal proceedings. Through
such proceeding the Court shall determine the fair value of the
shares exclusive of any element of value arising from the
accomplishment or expectation of the merger or consolidation,
together with interest, if any, to be paid upon the amount
determined to be the fair value. In determining such fair value,
the Court shall take into account all relevant factors. Unless
the Court in its discretion determines otherwise for good cause
shown, interest from the effective date of the merger through
the date of payment of the judgment shall be compounded
quarterly and shall accrue at 5% over the Federal Reserve
discount rate (including any surcharge) as established from time
to time during the period between the effective date of the
merger and the date of payment of the judgment. Upon application
by the surviving or resulting corporation or by any stockholder
entitled to participate in the appraisal proceeding, the Court
may, in its discretion, proceed to trial upon the appraisal
prior to the final determination of the stockholders entitled to
an appraisal. Any stockholder whose name appears on the list
filed by the surviving or resulting corporation pursuant to
subsection (f) of this section and who has submitted such
stockholder’s certificates of
stock to the Register in Chancery, if such is required, may
participate fully in all proceedings until it is finally
determined that such stockholder is not entitled to appraisal
rights under this section.
(i) The Court shall direct the payment of the fair value of
the shares, together with interest, if any, by the surviving or
resulting corporation to the stockholders entitled thereto.
Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of
holders of shares represented by certificates upon the surrender
to the corporation of the certificates representing such stock.
The Court’s decree may be enforced as other decrees in the
Court of Chancery may be enforced, whether such surviving or
resulting corporation be a corporation of this State or of any
state.
(j) The costs of the proceeding may be determined by the
Court and taxed upon the parties as the Court deems equitable in
the circumstances. Upon application of a stockholder, the Court
may order all or a portion of the expenses incurred by any
stockholder in connection with the appraisal proceeding,
including, without limitation, reasonable attorney’s fees
and the fees and expenses of experts, to be charged pro rata
against the value of all the shares entitled to an appraisal.
(k) From and after the effective date of the merger or
consolidation, no stockholder who has demanded appraisal rights
as provided in subsection (d) of this section shall be
entitled to vote such stock for any purpose or to receive
payment of dividends or other distributions on the stock (except
dividends or other distributions payable to stockholders of
record at a date which is prior to the effective date of the
merger or consolidation); provided, however, that if no petition
for an appraisal shall be filed within the time provided in
subsection (e) of this section, or if such stockholder
shall deliver to the surviving or resulting corporation a
written withdrawal of such stockholder’s demand for an
appraisal and an acceptance of the merger or consolidation,
either within 60 days after the effective date of the
merger or consolidation as provided in subsection (e) of
this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal
shall cease. Notwithstanding the foregoing, no appraisal
proceeding in the Court of Chancery shall be dismissed as to any
stockholder without the approval of the Court, and such approval
may be conditioned upon such terms as the Court deems just;
provided, however that this provision shall not affect the right
of any stockholder who has not commenced an appraisal proceeding
or joined that proceeding as a named party to withdraw such
stockholder’s demand for appraisal and to accept the terms
offered upon the merger or consolidation within 60 days
after the effective date of the merger or consolidation, as set
forth in subsection (e) of this section.
(l) The shares of the surviving or resulting corporation to
which the shares of such objecting stockholders would have been
converted had they assented to the merger or consolidation shall
have the status of authorized and unissued shares of the
surviving or resulting corporation.
PRIVATE LABEL DISTRIBUTION AGREEMENT (the “Agreement”), dated as of August 6, 2007
(the “Effective Date”), by and between IsoTis OrthoBiologics, Inc., a Washington
corporation (“Manufacturer”), and Integra LifeSciences Corporation, a Delaware corporation
(“Purchaser”).
W I T N E S S E T H:
WHEREAS, Manufacturer is engaged in the business of bone regeneration technologies including
the development, production, distribution and selling of proprietary natural and synthetic bone
graft substitutes, including, without limitation, the products defined in, and meeting the
specifications attached to, Exhibit A hereto (each a “Product” and collectively the
“Products”);
WHEREAS, Purchaser is in the business of developing, manufacturing, and distributing medical
products;
WHEREAS, Manufacturer has obtained the 510K (as hereinafter defined) to market the Products in
the United States and, based on the 510K and such other regulatory clearances and approvals for the
Products obtained by the Manufacturer or to be obtained by the Purchaser, Purchaser desires to
distribute the Products; and
WHEREAS, Manufacturer and Purchaser are agreeing that Manufacturer will produce and sell to
Purchaser the Products for distribution throughout the Territory under the Purchaser’s own
respective brand names, in accordance with the terms and conditions set forth in this Agreement.
NOW, THEREFORE, for and in consideration of these premises and the mutual covenants and
agreements set forth herein and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged by the parties hereto, Manufacturer and Purchaser agree as
follows:
DEFINITIONS:
For purposes of this Agreement, the following capitalized terms shall have the meanings set
forth below and any of such terms which are defined below in the singular shall have the same
meanings when used in the plural and vice versa:
“AAA” shall have the meaning set forth in Section 17(k) hereof.
“Calendar Quarter” shall mean the initial three (3) month period commencing on January1, 2008 and ending on the last day of the third calendar month subsequent thereto and each
successive three (3) month period thereafter during the Term (as hereinafter defined).
“Claim” shall have the meaning set forth in Section 15(a) hereof.
“COA” shall have the meaning set forth in Section 6(b) hereof.
“Confidential Information” shall have the meaning set forth in Section 13 hereof.
“Consumer Price Index” shall mean the Consumer Price Index for All Urban Consumers
(CPI-U) — U.S. All Items as published by the U.S. Bureau of Labor Statistics.
“Contract Year” shall mean the five (5) month period commencing on the Effective Date,
and ending on December 31, 2007, and each successive twelve (12) month period thereafter during the
Term.
“Damages” shall have the meaning set forth in Section 15(a) hereof.
“Dental Field” shall mean reconstructive and implant dental surgery, periodontics,
endodontics, orthodontics, oral surgery, and other dental applications.
“Designated Territories” shall mean, with respect to a Product, the countries in which
IsoTis is selling such Product as of the Effective Date, as set forth on Appendix 1 hereto.
“Effective Date” shall mean the date first written in the introduction to this
Agreement.
“FDA” shall mean the United States Food and Drug Administration.
“First Renewal Option” shall have the meaning set forth in Section 11(a) hereof.
“First Renewal Term” shall have the meaning set forth in Section 11(a) hereof.
“Force Majeure Event” shall have the meaning set forth in Section 12 hereof.
“510K” shall mean a clearance by the FDA of the Manufacturer’s submissions under
Section 510(k) of the Food, Drug and Cosmetics Act, which as to the DynaGraft II Products shall be
# K040419 and as to the Orthoblast II Products shall be # K060332 (OrthoBlast II DBM) # K050642
(OrthoBlast II Putty and Paste) and #K070751 (OrthoBlast II).
“Forecast” shall have the meaning set forth in Section 3 hereof.
“Lot” shall mean a unit of Products, all of which are derived from a single donor.
“Manufacturer’s Facility” shall mean Manufacturer’s designated shipping facility, as
of the Effective Date located at Irvine, California.
“Nonconforming Product” shall mean any Product which, as delivered to Purchaser
hereunder, fails to conform to the Specifications.
“Products” shall have the meaning set forth in Exhibit A hereto.
“Product Complaint” shall mean any oral, written or electronic communication that
alleges deficiencies related to the identity, quality, durability, reliability, safety,
effectiveness or performance of a Product after it is released for sale.
“Product Improvement” shall mean (a) the use, without substantial modification, of
Products to perform a function not initially intended for it or (b) any improvement, redesign, or
modification of any Product.
“Purchase Order” shall have the meaning set forth in Section 4(a) hereof.
“Purchase Price” shall have the meaning set forth in Section 5(a) hereof.
“Samples” shall have the meaning set forth in Section 2(b) hereof.
“Sample Price” shall have the meaning set forth in Section 5(d) hereof.
“Specifications” shall mean the specifications set forth in the 510K, the shelf life
requirements set forth in Section 6(c) hereof, the labeling requirements provided by Purchaser
pursuant to Section 7(c) hereof and the supplemental finished product specifications detailed in
the Schedules attached to Exhibit A hereto.
“Term” shall mean the Initial Term, together with (i) the First Renewal Term, if the
First Renewal Option is exercised, and (ii) the Second Renewal Term, if the parties agree to extend
the term of this Agreement pursuant to Section 11(a)(iii), unless this Agreement is terminated
earlier.
“Territory” shall mean the world.
“Threshold Dollar Amount” shall have the meaning set forth in Section 5(a) hereof.
“Threshold Purchase Price” shall have the meaning set forth in Section 5(a) hereof.
1. Appointment of Distributor. Manufacturer hereby appoints Purchaser, and Purchaser
hereby accepts appointment, as a non-exclusive distributor of the Products in the Territory for all
fields of use other than the Dental Field (collectively, the “General Orthopedic Field”).
Manufacturer will produce, sell and deliver Products which comply with the Specifications to
Purchaser, and Purchaser will purchase and take delivery of Products from Manufacturer and
distribute the Products, subject to the terms and conditions set forth in this Agreement. This
Agreement does not grant Purchaser any exclusive rights. Purchaser shall not sell any Products to
any customer that it knows or has reason to believe will use the Products in any field of use other
than the General Orthopedic Field.
(a) During the Term, Manufacturer will sell to Purchaser, and Purchaser will purchase from
Manufacturer, Products for resale in the Territory.
(b) Upon commercial launch of the Products by Purchaser, Manufacturer will sell to Purchaser
and Purchaser shall purchase from Manufacturer 1,000 Samples (as defined below) in accordance with
Section 5(e) hereof. During the remainder of the Term, Manufacturer will sell to Purchaser a
reasonable number of samples of non-implantable Products, produced from bovine or human bone (at
Manufacturer’s sole discretion) for use only for demonstration and training purposes
(“Samples”).
(c) In the event Manufacturer becomes unwilling, unable or otherwise fails to manufacture or
deliver, whether as a result of a Force Majeure Event or otherwise, at least seventy five percent
(75%) of the Products subject to Purchase Orders properly delivered by Purchaser pursuant to
Section 4(a) hereof and due for delivery during any consecutive ninety (90) day period, and fails
to satisfactorily remediate the deficiency within sixty (60) days following receipt of written
notice thereof, Manufacturer shall fulfill its supply obligations under this Agreement and any
other agreements with third parties with respect to the manufacture and delivery of the Products on
a pro rata basis, and Purchaser shall be entitled to receive its ratable portion of any
manufactured Products.
3. Forecasts. No later than fifteen (15) days prior to the first day of each Calendar
Quarter, Purchaser shall provide Manufacturer with a non-binding (other than as provided in the
sentence immediately following this sentence) written rolling forecast made in good faith (each, a
“Forecast”) of its requirements of Products for the following twelve (12) months. Purchaser
shall be obligated to purchase one hundred percent (100%) of the requirements stated in each such
Forecast for the first three (3) months covered thereby and the balance of such Forecast shall be
non-binding. Manufacturer shall maintain or place in service sufficient production capacity to meet
the Forecasts and, upon Purchaser’s request, Manufacturer shall use reasonable efforts to deliver
any Product for any month during the Term in excess of the most recent Forecast given for such
month.
4. Orders.
(a) Purchase of Products hereunder shall be made pursuant to individual purchase orders issued
in writing by Purchaser to Manufacturer (each, a “Purchase Order”). Purchaser shall provide
Manufacturer with Purchase Orders no later than sixty (60) days prior to the desired date of
delivery. Each Purchase Order submitted by Purchaser shall identify the quantity of Products
ordered and the desired shipping schedule and instructions therefore, including the desired carrier
and class of service. Manufacturer shall ship the Products in accordance with Purchaser’s
instructions and shall use reasonable efforts to ship the Products in accordance with Purchaser’s
shipping schedule, but in no event later than sixty (60) days after receipt of the Purchase Order
therefor, unless otherwise agreed in writing by Purchaser.
(b) Product shall be ordered and supplied in whole Lot increments.
(c) The parties hereto agree that in the event that any of the terms or conditions contained
in any Purchase Order or invoice shall be in addition to, or conflict in any way with any of the
terms or conditions contained in this Agreement, the terms of this Agreement shall govern and shall
supersede those contained in any such Purchase Order or invoice.
5. Price; Payment; Consideration.
(a) Purchaser shall purchase the Products at the unit prices set forth under the heading
“Purchase Price” on Exhibit B hereto (the “Purchase Price”). In the event
Purchaser shall purchase at least the aggregate dollar amount of Products set forth on Exhibit
B hereto (the “Threshold Dollar Amount”), in any mix, for the applicable Contract Year,
Purchaser shall purchase the Products at the unit prices set forth under the heading “Threshold
Purchase Price” on Exhibit B hereto (the “Threshold Purchase Price”), for the
remainder of the applicable Contract Year. All prices for Products delivered hereunder are F.O.B.
Manufacturer’s Facility, with freight for the account of Purchaser. Title and risk of loss or
damage to any Product shall pass to Purchaser upon delivery to Purchaser (or the designated
carrier) at the facilities designated by Manufacturer for loading and unloading at Manufacturer’s
Facility.
(b) The Purchase Price and Threshold Purchase Price set forth on Exhibit B shall be
fixed through December 31, 2008. Beginning on January 1, 2009, the Purchase Price and Threshold
Purchase Price may be increased annually by Manufacturer with sixty (60) days advance notice in
writing provided that such change to the Purchase Price is the result of Manufacturer increasing
its list price for the respective Products and provided that such change shall be limited to the
percentage changes in the Consumer Price Index during the applicable period. The prices
subsequently agreed to by the parties pursuant to this Section 5(b), shall be fixed for at least
twelve (12) months after the effective date thereof and shall not be subject to change until after
the end of such period.
(c) In the event that Manufacturer’s list price for the Products shall decrease, the parties
agree to negotiate in good faith regarding an adjustment to the Purchase Price, Threshold Dollar
Amount and Threshold Purchase Price provided pursuant to Section 5(a) hereof. Exhibit B
hereto sets forth Manufacturer’s current list price for the Products which shall serve as a
benchmark against which future price adjustments, if any, shall be made.
(d) Subject to this Section 5(d), below, after the Effective Date, Manufacturer shall treat
the Purchaser as a most favored distributor. Manufacturer represents that the prices being
provided hereunder are equivalent to or better than the terms being offered by Manufacturer to any
of its current distributors of the Products, excluding prices offered under any agreement between
Manufacturer and Keystone Dental, Inc. If, after the Effective Date, Manufacturer enters into an
agreement with any third party (other than any amendment of any agreement between Manufacturer and
Keystone Dental, Inc.) providing such distributor with more favorable pricing terms, then this
Agreement will be deemed appropriately amended to provide such terms to the Purchaser.
Manufacturer shall promptly provide the Purchaser with notice of any such required amendment and
any refund or credits thereby created.
(e) Purchaser shall purchase Samples at the amounts for such Samples set forth on Exhibit
B hereto, as may be amended from time to time (the “Sample Price”). The Sample Price
may be increased by not more than ten percent (10%) annually by Manufacturer with sixty (60) days
advance notice in writing.
6. Invoicing and Payment; Delivery; Quality.
(a) Manufacturer shall submit an invoice to Purchaser covering each shipment of Products made
to Purchaser pursuant to this Agreement, specifying the batch number for each shipment. Terms of
payment shall be net thirty (30) days (in U.S. dollars) after the date of Manufacturer’s invoice.
In no event shall such invoices be dated earlier than the date of shipment of the invoiced Product.
An additional three percent (3%) Purchase Price discount shall be credited to a shipment of
Products if Manufacturer receives payment within fifteen (15) days of Purchaser’s receipt of the
applicable invoice; provided that such discount shall be two percent (2%) for the remainder of the
applicable Contract Year in the event Purchaser shall purchase Products in excess of the Threshold
Dollar Amount, in any mix, for the applicable Contract Year.
(b) Manufacturer will provide a Certificate of Analysis (each, a “COA”) in the form
set forth in Exhibit C hereto with each lot of Products shipped to Purchaser. The parties
agree to modify the criteria set forth in the Specifications as necessary to reflect any changes in
such Specifications agreed on by the parties during the Term. Each COA must state that the raw
materials and components used in each lot of Product delivered to Purchaser are equal to or better
than the criteria set forth in the Specifications. Additionally, each COA must also include a date
of manufacture and expiration date for the shipped Product as well as results of the tests
described in Exhibit A hereto. Delivery of a COA shall in no way limit or enlarge
Manufacturer’s obligations under this Agreement.
(c) At the time of delivery to Purchaser, all Products shall have a remaining shelf life equal
to no less than the greater of 80% of the shelf life specified in the 510K or twenty months.
(d) Manufacturer shall have the right to modify the Products as necessary to comply with
changes in applicable law or regulatory approvals. If Manufacturer is required to materially
modify any Product or its Specifications, Manufacturer shall provide Purchaser written notice at
least thirty (30) days in advance of the effect of such change (unless impractical for regulatory
reasons, in which case such notice shall be provided immediately after the need to materially
modify the Products or its Specifications is determined by Manufacturer). In the event that
Manufacturer makes a change to the Products in accordance with this Section 6(d), Manufacturer
shall provide Purchaser with information on the changes, and corresponding updated guidelines and
instructions for use. In addition, in the event of a recall, Manufacturer shall provide
replacement Products and Samples for Purchaser’s current stock, and Purchaser shall return all old
stock to Manufacturer at Manufacturer’s expense.
(e) If Purchaser desires changes to be made to the Products or its Specifications, Purchaser
shall provide Supplier with written notice at least sixty (60) days in advance of the desired
effect of such change. Within thirty (30) days after such notice,
Manufacturer will approve or disapprove such change (such approval not to be unreasonably
withheld or delayed) and estimate the cost and lead times required to make such change.
Manufacturer shall provide Purchaser with written notice of its approval or disapproval, the cost
to implement such change, any resulting change in the Purchase Price for such Products and the time
reasonably necessary to implement such change. If such change is approved by Manufacturer,
Purchaser shall have ten (10) days to determine whether or not it desires to proceed with such
change at Purchaser’s sole cost and expense. If Purchaser elects to proceed with such approved
change, Manufacturer shall promptly implement such approved change and the Purchase Price shall be
modified accordingly.
(f) Purchaser shall be permitted to return, and Manufacturer shall accept for full invoice
credit, all Nonconforming Products, provided that, in the case of Products returned because of
defects or damage that could have been detected by visual inspection of the labeling or packaging
of the Product, such returns are reported to Manufacturer within 15 days following delivery of the
Products by Manufacturer, and when possible returned Products shall be still in original factory
packaging. Manufacturer’s obligations under this Section 6(f) shall not extend to any Products
that are abused, misused, or tampered with outside its facilities or control. Except in accordance
with the terms of this Agreement, no returns shall be permitted without Manufacturer’s prior
consent in its sole discretion.
7. Certain Agreements and Responsibilities of Purchaser.
(a) Purchaser shall be solely responsible for all marketing decisions with respect to Product
purchased by it hereunder, including, without limitation, those related to the labeling, graphic
design of packaging, advertising, promotion, resale, and distribution of Product purchased
hereunder and Purchaser shall have the right to sell any Product purchased hereunder under any of
Purchaser’s trademarks or tradenames.
(b) Purchaser shall promote and sell Product purchased by it hereunder under trademarks
selected by Purchaser, which trademarks shall be and shall remain the property of Purchaser.
Nothing herein shall be deemed to give Manufacturer any right to or in any trademark or copyright
of Purchaser or any right to use the same without the written consent of Purchaser.
(c) Purchaser shall, at its sole cost and expense, provide Manufacturer with artwork and text
required for the labeling of all Products to be supplied by Manufacturer to Purchaser hereunder and
for the compliance of the same with all applicable laws, statutes, rules, regulations, and
ordinances. The parties agree that Manufacturer shall have the right to review and comment on any
and all such labeling materials, provided that such labeling requirements shall be deemed approved
by Manufacturer if Manufacturer does not respond within fifteen (15) days of receipt of such
labeling information.
(d) Purchaser shall comply, in all material respects, with all applicable laws, rules,
regulations, and ordinances relating to the labeling, advertising, promotion, sale, or distribution
of Products and the performance of its obligations under this Agreement, including, but not limited
to, all applicable laws and regulations in the Territory pertaining to resale and promotion of the
Products, and any and all regulations relating to health, safety, and
environmental matters. Purchaser agrees to notify Manufacturer as soon as practicable after
receiving any notice with respect to a violation or alleged violation of any of the aforementioned
laws, rules, regulations, or ordinances.
(e) Purchaser shall, upon reasonable request, provide Manufacturer with all information in its
possession which is reasonably necessary to enable Manufacturer to comply with its obligations
under this Agreement and to use reasonable efforts to consult with Manufacturer, upon request, with
respect to the performance by Manufacturer of its obligations hereunder.
(f) Purchaser shall handle all customer inquiries, orders, and shipments involving Products
sold by it in the Territory, and Purchaser shall advise Manufacturer, by telephone or facsimile,
within forty-eight (48) hours after it becomes aware of any (i) third party Product Complaint,
whether written or oral, (ii) serious injury from the use or malfunction of Products and (iii) any
defect in, or condition of, the Products or any other fact or circumstance which may result in a
violation or alleged violation of any applicable statutes, laws, rules, regulations, ordinances or
decrees of any governmental authority, which Purchaser subsequently shall confirm in writing,
within five (5) business days. Manufacturer shall investigate each such Product Complaint with
respect to which Purchaser advised Manufacturer and shall maintain a written record of each such
investigation. Manufacturer shall send Purchaser copies of each such Product Complaint and a full
report on each such investigation promptly after completing such investigation. If the
investigation is incomplete after ten (10) business days, Manufacturer shall issue to Purchaser a
preliminary report of the Product Complaint status at that time. Such report shall include, to the
extent permissible under applicable law, (A) a summary of similar and relevant Product Complaints
respecting the applicable Products, including Product Complaints or information regarding
performance or allegations or reports of any adverse effects on a patient from use of such
Products, and (B) the pertinent material facts known to Manufacturer or Purchaser relating to such
Product Complaints, including but not limited to patient information, name and address of the
health care professional and institution where the Product Complaint occurred, and lot or serial
number, as appropriate, of the Product in question. Manufacturer and Purchaser shall cooperate
with each other to the extent reasonably necessary to resolve outstanding Product Complaints and
Manufacturer shall have primary responsibility for filing all Medical Device Reports required to be
filed with the FDA. In addition, Manufacturer shall notify Purchaser within twenty-four (24) hours
after receipt of contact from the FDA or other governmental authority with authority over any
Products if such entity contacts Manufacturer to investigate or inspect Manufacturer or any of its
facilities with respect to alleged non-compliances or non-conformances of such Products produced or
manufactured by Manufacturer.
8. Certain Agreements and Responsibilities of Manufacturer.
(a) Upon ten (10) days’ prior written notice to Manufacturer, Purchaser shall have the right
to audit Manufacturer’s facilities, and Manufacturer shall use reasonable efforts to secure the
right for Purchaser to audit the facilities of any vendor of Manufacturer that supplies
Manufacturer with raw materials for use with respect to the Products, including but not limited to
Manufacturer’s Quality System and such vendors’ Quality Systems, and any and all records pertaining
thereto and Manufacturer’s and such vendors’ compliance with any and all laws,
regulations and rules pertaining to the manufacture, storage, handling, shipping and labeling
of the Product. Any such audits shall be at the expense of Purchaser. Purchaser agrees to notify
Manufacturer in writing of any non-conformances or non-compliances discovered during any such
audits or otherwise. Manufacturer shall investigate and implement, or cause the appropriate vendor
to implement, appropriate corrective actions when required. If Manufacturer determines that an
alleged non-conformance or non-compliance is unwarranted, it shall notify Purchaser in writing of
its findings and the reasons for its disagreement. The parties shall attempt to resolve any such
dispute, but if they cannot do so within fifteen (15) days after the date that Purchaser receives
Manufacturer’s findings, then the parties shall jointly select a mutually agreeable independent
third party qualified to resolve the dispute. The determination made by such independent third
party shall be final and binding on the parties, and Purchaser and Manufacturer shall share equally
the cost of retaining such independent third party. Manufacturer shall be responsible for any
changes required (i) to maintain or achieve substantial compliance with existing quality systems or
product regulations and standards, or (ii) to correct non-conformances from any FDA inspection
report. Manufacturer agrees to allow Purchaser to review all submissions by Manufacturer to the
FDA and other relevant data related to the safety and efficacy of the Product. Upon reasonable
request, Manufacturer shall supply Purchaser, at no cost to Purchaser, with any information in
Manufacturer’s possession necessary to enable Purchaser to obtain any required approvals pertaining
to the labeling, advertising, promotion, sale or distribution of the Products, which information
Manufacturer is not restricted by law or agreement from providing to Purchaser. Subject to
applicable law, Manufacturer shall label Products delivered to Purchaser and the shipping
containers therefor in accordance with Purchaser’s instructions.
(b) Upon reasonable request, Manufacturer shall reasonably provide Purchaser with information
in its possession that is necessary to enable Purchaser to comply with its obligations under this
Agreement and shall use reasonable efforts to consult with Purchaser, upon request, with respect to
the performance by Purchaser of its obligations hereunder.
(c) Manufacturer agrees to provide Products manufactured in accordance with ISO 13485:2003
Standards and FDA Quality System Regulations, any other applicable regulatory requirements, and all
regulatory submissions and the then-current product Specifications. Purchaser and Manufacturer
shall jointly develop an incoming inspection and release process designed to determine if the
Products are in compliance with this Section 8(c). In addition to any other rights of termination
Purchaser may have under Section 11 hereof, Purchaser shall have the right, upon thirty (30) days
prior written notice to Manufacturer, to terminate this Agreement in the event Manufacturer fails
to comply with ISO 13485:2003 Standards or FDA Quality System Regulations.
(d) Manufacturer shall comply, in all material respects, with all applicable laws, rules,
regulations, and ordinances relating to the manufacture of the Products and the performance of its
obligations hereunder. Manufacturer represents, warrants, and covenants that it has, and that it
will throughout the Term, maintain effective 510K clearance to market the Products in the United
States and that the submissions made by Manufacturer to obtain any such 510K were made in good
faith and contained accurate and complete data and information regarding the Product as required by
applicable laws, rules, and regulations. Manufacturer agrees
to notify Purchaser as soon as practicable after receiving notice of any claim or action by
the FDA or any other regulatory agency relating to non-compliance with this Section 8(d) or any
notice with respect to a violation or alleged violation of any of the aforementioned laws, rules,
regulations, or ordinances. Manufacturer shall also be responsible for maintaining the 510K’s and
for making any necessary changes or amendments thereto. In addition, Manufacturer shall notify the
Purchaser of any adverse reaction to, or other similar claims with respect to, the Products
(whether or not sold by Purchaser) of which it becomes aware.
(e) Manufacturer shall give Purchaser reasonable access to all technical data which is
reasonably necessary to support Purchaser’s label and promotional claims with respect to the
Products which data Manufacturer is not restricted by law or agreement from providing to Purchaser.
(f) Manufacturer represents that, to the best of its knowledge and belief, the manufacture and
sale of each Product supplied under this Agreement do not infringe, in the applicable Designated
Territories for such Product, the patent rights of any third party. Notwithstanding any other
provision of this Agreement to the contrary, Manufacturer shall be under no obligation to supply,
and Purchaser shall be under no obligation to purchase or accept delivery of any Product in a
country if it has been determined by a court of competent jurisdiction that such Product infringes,
in such country, an adversely held patent or constitutes a misappropriation, in such country, of a
third party’s trade secret, know-how, or other proprietary right. Manufacturer shall repurchase
from Purchaser, at Purchaser’s cost, any inventory of Product purchased by Purchaser from
Manufacturer hereunder for sale in a country in the applicable Designated Territories for such
Product and held by Purchaser if such Product is determined by a court of competent jurisdiction to
infringe, in such country, any patent or to constitute a misappropriation, in such country, of a
third party’s trade secret, know-how, or other proprietary right, unless Manufacturer shall have
entered into a license agreement with the holder of such patent, which agreement shall be
satisfactory to Purchaser in its reasonable discretion, provided that such license shall not
increase the cost of Product purchased by Purchaser hereunder beyond the limitations of Section
5(b).
(g) Manufacturer represents and warrants that it is currently insured and covenants that at
all times during the term of this Agreement it will maintain a comprehensive general liability
insurance policy (including products liability coverage and payment of attorneys fees coverage)
with a financially sound and reputable insurer which is sufficient to adequately protect against
the risks associated with its ongoing business, including the risks which might possibly arise in
connection with the transactions contemplated by this Agreement, and including without limitation,
products liability insurance, with minimum coverage amounts of $5,000,000 per occurrence and per
year in the aggregate. Manufacturer shall provide Purchaser a copy of its insurance policy upon
request. Manufacturer shall have Purchaser named as an additional insured beneficiary and shall
cause such policies to provide that they shall not be canceled by the insurer without thirty (30)
days’ prior notice thereof to Purchaser, and, upon Purchaser’s request, Manufacturer shall furnish
Purchaser with a certificate of insurance evidencing such coverage.
(h) If Manufacturer becomes unable, unwilling or otherwise fails to manufacture or deliver at
least ninety percent (90%) of the Products subject to purchase orders
properly delivered by
Purchaser pursuant to Section 4(a) hereof and due for delivery during any consecutive one hundred
twenty (120) day period, and fails to satisfactorily remediate the deficiency within sixty (60)
days following receipt of written notice thereof, Purchaser may terminate this Agreement on thirty
(30) days written notice.
(i) Manufacturer represents and warrants that it has not granted exclusive distribution rights
to the Products to any party (other than with respect to the exclusive rights to the Dental Field
granted to a third party) and that it is not a party to any agreement that is inconsistent with
the grant of rights to Purchaser contemplated by this Agreement. During the Term, Manufacturer
shall take no action inconsistent with the grant of rights to Purchaser hereunder and would
otherwise limit the exercise by Purchaser of its rights under the Agreement.
(j) Manufacturer shall be solely responsible for the costs, decision and execution for a
Product recall; provided, however, that Purchaser shall be responsible for the cost to the extent
the recall is caused by Purchaser. Purchaser shall fully cooperate and reasonably assist
Manufacturer in the event of a recall. All information obtained by Purchaser will be provided as
soon as reasonably possible to Manufacturer.
9. Warranties.
(a) Manufacturer warrants that: (i) Products delivered to Purchaser hereunder shall conform to
the Specifications and the 510K; (ii) it will convey good title to all Products delivered to
Purchaser hereunder free from any security interest, lien, or other encumbrance; (iii) Products
delivered to Purchaser hereunder shall be free from defects in materials, workmanship and design;
and (iv) Products delivered to Purchaser hereunder will be manufactured, in all material respects,
in accordance with all applicable laws, rules, regulations, statutes, and ordinances, including,
without limitation, those promulgated or enforced by the FDA and the United States Department of
Health and Human Services. THE WARRANTIES SET FORTH IN SECTIONS 8(d), 8(f), 8(g), THIS SECTION
9(a) AND SECTION 9(b) BELOW ARE IN LIEU OF ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS
OR IMPLIED, WRITTEN OR ORAL, REGARDING ANY PRODUCT DELIVERED BY MANUFACTURER TO PURCHASER
HEREUNDER, AND, WITHOUT LIMITING THE FOREGOING, MANUFACTURER EXPRESSLY DISCLAIMS ANY EXPRESS OR
IMPLIED WARRANTY OF MERCHANTABILITY, SUITABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
REPRESENTATION OR WARRANTY REGARDING THE QUALITY OF ANY PRODUCT SUPPLIED HEREUNDER OR AS TO THE
CONDITION OR WORKMANSHIP THEREOF.
(b) Manufacturer represents that the Products are suitable for use under all claims made in
the 510K. Purchaser assumes all risk and liability for its use of any Product delivered by
Manufacturer hereunder in any manufacturing process or in combination with any other substance.
10. Claims.
(a) All claims by a party against the other party hereto with respect to this Agreement,
including, but not limited to, Purchaser’s right to reject any Nonconforming Product,
shall be
deemed waived unless made in writing, with a detailed description of the nature of the claim,
within ninety (90) days after the party making the claim becomes aware of the basis for such claim.
(b) WITH THE EXCEPTION OF THIRD PARTY INDEMNIFICATION CLAIMS, IN NO EVENT SHALL EITHER PARTY
HERETO BE LIABLE FOR INCIDENTAL, SPECIAL, CONSEQUENTIAL DAMAGES, OR LOST PROFITS, WHETHER OR NOT
CAUSED BY OR RESULTING FROM THE NEGLIGENCE OF THEIR RESPECTIVE EMPLOYEES, AGENTS, SUBCONTRACTORS,
OR REPRESENTATIVES.
11. Term; Termination.
(a)
Term.
(i) The initial term of this Agreement shall commence on the Effective Date and terminate on
December 31, 2012 unless terminated earlier pursuant to this Section 11 (the “Initial
Term”).
(ii) Purchaser shall have the right, upon written notice at least sixty (60) days prior to the
end of the Initial Term, to extend the term of this Agreement (the “First Renewal Option”)
for an additional successive three (3) year period (the “First Renewal Term”).
(iii) Provided Purchaser has exercised the First Renewal Option and the Distribution Agreement
remains in full force and effect, the parties, upon prior written agreement at least sixty (60)
days prior to the end of the First Renewal Term, may extend the term of this Agreement for an
additional successive three (3) year period (the “Second Renewal Term”).
(b) At any time during the Term, Purchaser shall have the right to terminate this Agreement
upon three (3) months prior written notice to Manufacturer.
(c) Either party shall have the right to terminate this Agreement, with respect to all
Products or certain Products, upon the occurrence and at any time during the continuance of any of
the following events:
(i) the failure by a party hereto to perform or fulfill, at the time and in the manner herein
provided, any obligation or condition required to be performed or fulfilled by such party hereunder
which failure remains uncured thirty (30) days after the date of the written notice thereof given
by the non-defaulting party to the defaulting party;
(ii) the filing of bankruptcy for, on the part of, or with respect to, a party hereto (whether
voluntary or involuntary);
(iii) the appointment of a receiver, liquidator, custodian, trustee, assignee, or similar
official for a party hereto, or for all or a substantial portion of the assets of a party hereto;
or
(iv) the assignment by a party hereto for the benefit of creditors, or the failure by a party
hereto, or the admission in writing by a party hereto of its inability, to pay its debts generally
as they become due.
Any termination of this Agreement pursuant to Section 11(c) hereof shall be in addition to, and
shall not be exclusive of or prejudicial to, any other rights or remedies at law or in equity which
a non-defaulting party may have on account of the default.
(d) It is understood by the parties that, from and after the effective date of the expiration
or any termination of this Agreement, the parties shall incur no further obligations to each other
hereunder; provided, however, that no such expiration or termination shall relieve either party of
any rights or obligations incurred or accrued by it or to its benefit prior to the effective date
thereof and, specifically, and without limiting the foregoing, the parties’ rights under Section 15
hereof shall survive such expiration or termination with respect to Claims or Damages arising prior
to such expiration or termination and, furthermore, the rights and obligations of the parties under
Section 13 hereof shall survive such expiration or termination in accordance with the terms of such
Section 13.
12. Force Majeure. Neither party shall be liable for its failure to perform hereunder
due to any occurrence beyond its reasonable control, including, without limitation, acts of God;
fires; floods; explosions; mechanical breakdowns; military operations; civil commotions; wars;
sabotage; accidents; labor disputes or shortages; governmental laws, ordinances, rules, and
regulations, whether valid or invalid (including, but not limited to, priorities, requisitions,
allocations, and price adjustment restrictions); inability to obtain material, equipment or
transportation; and any other similar or different occurrence (each a “Force Majeure
Event”). The parties hereto acknowledge that the occurrences listed above are intended to refer
to general categories of occurrences and that, under certain circumstances, specific occurrences of
such nature may be within a party’s reasonable control. The failing party shall notify the other
party thereof in writing as soon as is reasonably practicable after the commencement of any such
occurrence, setting forth the particulars in connection therewith and shall promptly give written
notice to the other party of the cessation of such occurrence. To the extent affected by any such
occurrence, performance by the process hereof of their obligations hereunder shall be omitted
without liability, during the continuance of any such occurrence, but for no longer period. It is
understood and agreed that nothing contained herein shall relieve Purchaser of its obligation to
make payments of any and all amounts due hereunder for quantities of Products previously delivered.
13. Confidentiality. During the Term, and for a period of three (3) years after the
expiration or termination of this Agreement, each party agrees that it will not, and shall cause
its employees, agents, and other representatives not to, without the other’s prior written consent,
disclose or use, other than for purposes of this Agreement, any Confidential Information (as
hereinafter defined) which is disclosed in writing or, if disclosed orally, is confirmed in writing
as Confidential Information for purposes of this Section 13 within thirty (30) days of such
oral disclosure or is obvious from the circumstances of the disclosure or nature of the information
disclosed that such information should be treated as confidential. The term “Confidential
Information” shall include, without limitation, trade secrets, know-how, formulae, compositions
of
matter, inventions, techniques, processes, programs, diagrams, schematics, pricing, customer and
financial information, and sales and marketing plans but information shall not include information
which (a) is generally available to the public; (b) was already known to it on a non-confidential
basis on the date of its receipt thereof; or (c) is subsequently disclosed to it on a
non-confidential basis by a third party which, in its reasonable judgment, was not obligated to
keep such information confidential. Notwithstanding the foregoing, each of the parties shall be
free to disclose any such information or data to the extent, but only to the extent, required by
law or by legal process. Prior to any disclosure pursuant to the preceding sentence, the disclosing
party shall give reasonable prior notice to the other party of such intended disclosure in order
that the other party may seek a protective order or similar protection with respect to such
information. Upon termination of this Agreement, each party shall return to the other party all of
the other party’s Confidential Information, including all copies in tangible or (to the extent
reasonably practicable) electronic form, promptly after a written request to do so.
14. Independent Contractor. In the performance of this Agreement, Purchaser’s
relationship to Manufacturer will be that of an independent contractor only. This Agreement does
not create any employer-employee, agency, joint venture, or partnership relationship between
Manufacturer and Purchaser. Purchaser shall not represent itself as an agent of Manufacturer.
Purchaser is not authorized or empowered to act as agent for Manufacturer, to enter into any
contract, undertaking, commitment, or agreement of any kind on behalf of Manufacturer.
15. Indemnification.
(a) Manufacturer shall (i) indemnify and hold harmless Purchaser from and against any damages,
assessments, losses, liabilities, fines, demands, recoveries, costs, and expenses (including,
without limitation, the costs associated with a Product recall and reasonable attorneys’ fees and
disbursements of counsel) (collectively, “Damages”) incurred by Purchaser in connection
with any Product sold to Purchaser hereunder, which Damages arise out of, or are based on (A)
defects in materials, workmanship, or design of any such Product, which defects are caused by
Manufacturer, (B) a breach by Manufacturer of any representation or warranty made by Manufacturer
in this Agreement, (C) any product liability arising out of, in connection with or resulting from
the manufacture or supply of the Products, or (D) any claim that a Product, when used or
distributed as provided for by this Agreement, infringes in a country in the applicable Designated
Territories for such Product any intellectual property rights of a third party in such country,
including but not limited to trade secret, copyright and/or patent rights and (ii) defend Purchaser
from and against any claims, suits, and proceedings (each, a “Claim” and, collectively,
“Claims”) related to the Damages referred to in subsection (i) of this Section 15(a).
(b) Purchaser shall (i) indemnify and hold harmless Manufacturer from and against any Damages
incurred by Manufacturer in connection with (A) any Product sold to Purchaser hereunder, which
Damages arise out of, or are based on, the sale or distribution of such Product (other than those
based on defects in materials, workmanship, or design thereof) or
claims with respect to any such Product, whether oral or written, made by Purchaser where such
claims are not based on information supplied by Manufacturer and are caused by Purchaser or (B) a
breach by Purchaser of any representation or warranty made by Purchaser in this
Agreement and (ii)
to defend Manufacturer from and against any Claims related subsection (i) of this Section 15(b).
(c) If either party believes that it has suffered or will suffer any Claim or Damages for
which the other party is obligated to indemnify it hereunder, that party shall promptly notify the
indemnifying party in writing of the Claim or Damages, specifying therein the reason why the party
believes that the indemnifying party is or will be obligated to indemnify that party for such Claim
or Damages and shall cooperate fully with the indemnifying party in the defense of such Claim or
Damages. No settlement or compromise entered into without the prior written consent of the
indemnifying party shall be binding upon the indemnifying party or used in any way as evidence
against the indemnifying party.
16. Trademarks and Labeling. Purchaser hereby grants to Manufacturer a limited,
non-exclusive, world-wide, non-transferable, royalty-free license, with the right to sublicense,
solely to use the brands, trademarks, service marks, trade names, and logos owned by or licensed to
Purchaser (the “Purchaser Trademarks”) in labeling and packaging the Products for
distribution exclusively to Purchaser, as directed from time to time by Purchaser throughout the
term of this Agreement, subject to the terms and conditions of this Agreement. Manufacturer hereby
agrees that the Purchaser Trademarks shall only be affixed to the Products or other promotional
materials as directed by the Purchaser. Supplier shall have no rights to use the Purchaser
Trademarks other than for purposes of labeling and packaging Products for distribution exclusively
to Purchaser pursuant to this Agreement or in connection with other promotional materials, which
labeling and packaging or other promotional materials shall be in form and substance satisfactory
to Purchaser. Manufacturer shall not use the Purchaser Trademarks in any manner that, in
Purchaser’s sole and absolute discretion, may be inconsistent with Purchaser’s public image or be
misleading or harmful to Purchaser. Upon the termination or expiration of this Agreement,
Manufacturer shall not have any right to supply or distribute any Products remaining that are
labeled with any of Purchaser Trademarks in any of Manufacturer’s inventory.
17. Miscellaneous.
(a) Any notice, request, report, statement, or other communication to be given hereunder shall
be in writing and shall be deemed to have been duly given if addressed as follows and either (i)
hand delivered, in which case such notice shall been deemed to have been given upon receipt; (ii)
sent by registered or certified mail (postage prepaid, return receipt requested), in such case such
notice shall be deemed to have been given on the date of the mailing thereof as shown on the Post
Office receipt therefor; or (iii) sent by overnight courier, in which case such notice shall be
deemed to have been given on the date of the mailing thereof as evidenced by the courier’s receipt
therefor:
Latham & Watkins
650 Town Center Drive, 20th Floor Costa Mesa, California92626
Facsimile: 714 755 8290
Attention: Charles K. Ruck
If to Purchaser:
Integra LifeSciences Corporation
311 Enterprise Drive Plainsboro, New Jersey08536
Telephone: 609 936 2238
Facsimile: 609 275 1082
Attention: General Counsel
With a copy to:
Willkie Farr & Gallagher LLP
787 Seventh Avenue New York, New York10019
Facsimile: 212-728-8625
Attention: David Boston
Or to the attention of such other individual or to such other address as either party may give to
the other in writing.
(b) It is the desire and intent of the parties hereto to provide certainty as to their future
rights and undertakings with respect to the sale of the Products by Manufacturer to Purchaser. The
parties have incorporated all representations, warranties, covenants, commitments, and
understandings in this Agreement on which they have relied in entering into this Agreement and,
except as the parties are otherwise obligated pursuant hereto, neither party makes any covenants or
other commitment to the other party concerning its future action.
Accordingly, this Agreement constitutes the entire agreement between the parties hereto with
respect to the sale of the Products by Manufacturer to Purchaser and supersedes any and all other
agreements or understandings of whatever nature, whether written or oral, between the parties
hereto with respect to the sale of the Products by Manufacturer to Purchaser and there are no
promises, representations, conditions, provisions, or terms related to the sale of the Products by
Manufacturer to Purchaser other than as set forth in this Agreement.
(c) The failure of either party to enforce at any time any provision hereof shall not be
construed to be a waiver of such provision or of the right of such party thereafter to enforce such
provision. No waiver by either party hereto of any provision of this Agreement shall constitute a
waiver of any other provision hereof, whether such provision shall be the same or different term
hereof.
(d) Except as required by law or in connection with the sale of all or substantially all of
the stock or assets of a party hereto, or the sale by Manufacturer of its rights in and to a
Product line, in each case subject to obligations of confidentiality consistent with those set
forth in this Agreement, neither party shall disclose the contents of this Agreement to any third
party without the written consent of the other party.
(e) This Agreement shall be binding upon and inure to the benefit of, the parties hereto and
their respective successors and assigns. Any assignment of this Agreement by either party hereto,
whether by operation of law or otherwise, without the prior written consent of the other party
shall be void and of no force or effect. Notwithstanding anything herein to the contrary, this
Agreement may be assigned without the consent of the other party to any subsidiary or affiliate of
a party hereto, a successor in interest to a party hereto (whether as a result of the acquisition
of all or substantially all of its assets or stock by reorganization, merger, share exchange, or
otherwise), or in the event of a sale or other disposition of that portion of the business of a
party hereto to which this Agreement relates if the assignee hereof shall expressly assume in
writing all of the obligations and liabilities of the assigning party hereunder effective as of the
date of such assignment; provided, however, that the assigning party shall give at least thirty
(30) days prior written notice of any such assignment to the other party hereto, and provided,
further, that in the event that a party shall assign this agreement to a successor in interest or
acquiror of that portion of the business of a party hereto to which the Agreement relates, the
other party hereto shall have the right to terminate this Agreement upon prior written notice to
the assigning party, it being acknowledged by the parties that a decision by a party to so
terminate or not so terminate this Agreement shall in no way affect or limit any of its rights or
remedies hereunder. In the event that the assignee shall agree to be liable for the aforementioned
obligations and liabilities, the parties agree that the assignment hereof shall be deemed to be a
novation and that the assigning party shall have no obligations or liabilities hereunder from and
after the effective date of such assignment. No assignment pursuant to the preceding sentence shall
relieve the assigning party of any of its rights or obligations which arose prior to the date of
such assignment.
(f) No modification of, addition to, or waiver of any of the provisions of this Agreement (i)
shall be binding upon either party hereto unless the same shall be made in writing and duly
executed by a duly authorized representative of both parties or (ii) shall be affected by
the acknowledgment or acceptance of any purchase order (including any Purchase Order) or
other
form containing additional or different terms or conditions to those contained herein, whether or
not signed by an authorized representative of a party.
(g) Neither course of performance, nor course of dealing, nor usage of trade, shall be used to
qualify, explain, supplement, or otherwise modify any of the provisions of this Agreement.
(h) The Exhibits to this Agreement and any attachments thereto, including, without limitation,
the Specifications, are incorporated herein by this reference and expressly made a part hereof as
fully as though completely set forth herein.
(i) If any provision of this Agreement shall hereafter be held to be invalid or unenforceable
for any reason, such provision shall be reformed to the maximum extent permitted to preserve the
parties’ original intent, failing which, such provision shall be severed from this Agreement and
the remainder of this Agreement shall continue in full force and effect. Such occurrence shall not
have the effect of rendering the provision in question invalid in any other jurisdiction or in any
other case or circumstance, or of rendering invalid any other provision contained herein, to the
extent that such other provision is not actually in conflict with any applicable law.
(j) THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE
OF NEW YORK, WITHOUT GIVING EFFECT TO THE PRINCIPLES OF CONFLICT OF LAWS THEREOF.
(k) Any and all disputes between the parties relating in any way to the entering into of this
Agreement and/or the validity, construction, meaning, enforceability, or performance of this
Agreement or any of its provisions, or the intent of the parties in entering into this Agreement,
or any of its provisions, or any dispute relating to patent validity or infringement arising under
this Agreement shall be settled by arbitration. Such arbitration shall be conducted in accordance
with the rules then pertaining to the American Arbitration Association (“AAA”) with a panel
of a sole (1) arbitrator. The arbitrator shall be selected from the National Panel of Arbitrators
of the AAA. Reasonable discovery as determined by the arbitrator shall apply to the arbitration
proceeding. The law of the State of New York shall apply to the arbitration proceedings, except
that the interpretation and enforcement of this Section 16(k) shall be governed by the Federal
Arbitration Act. Judgment upon the award rendered by the arbitrator may be entered in any court
having jurisdiction thereof. The successful party in such arbitration, in addition to all other
relief provided, shall be entitled to an award of all its reasonable costs and expenses including
attorney costs.
(l) Each of the parties hereto represents that (i) it has full authority to execute this
Agreement and to perform its obligations hereunder and (ii) the execution, delivery, and
performance of this Agreement by it will not conflict with, or constitute or result in a breach,
default, or violation of any contract or agreement to which it is a party, which conflict or
breach, default or violation would have a material adverse effect on the transactions contemplated
by this Agreement.
(m) The Section headings included in this Agreement are for convenience of reference only and
shall not affect the meaning or interpretation of this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by their duly
authorized representatives on the date first above written.
For purposes of this Agreement, the terms “Products” and “the Product” shall
mean the following products and all Product Improvements:
DynaGraft® II Demineralized Bone Matrix Putty
DynaGraft® II Demineralized Bone Matrix Gel
OrthoBlast® II DBM and Cancellous Bone in Reverse Phase Medium Putty
OrthoBlast® II DBM and Cancellous Bone in Reverse Phase Medium Paste
Specifications: The supplemental finished product specifications are set forth in the
Schedules attached to this Exhibit A. These Schedules shall comprise part of the Specifications.
FINISHED PRODUCT SPECIFICATION
DynaGraft II Gel and DynaGraft II Putty
1.0 PURPOSE
The purpose of this document is to detail the minimum manufacturing requirements and acceptance
criteria for the finished products referenced above manufactured by IsoTis OrthoBiologics. This
specification is intended for use following final packaging, but prior to release of product
into finished goods (i.e., distribution).
2.0 RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.1
ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes
2.2
Form-118, IsoTis OrthoBiologics Product Accountability Form
M-016, Sterile Processing of IsoTis OrthoBiologics Products by E-Beam Radiation
2.5
TM-014, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Associates of Cape Cod Reagents
2.6
TM-022, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Charles River Reagents
2.7
QA-012, Handling of QA Archive Samples
2.8
QA-051, Device History Record Review
2.9
QA-052, Control and Disposition of Non-Conforming Materials
3.0 PRODUCT SAMPLING
3.1
Visual Inspection
Each Finished Product lot shall be randomly sampled in accordance with ANSI/ASQ
Z1.4, current revision. General Inspection Level II, Single Normal Sample (minimum
sample size 20 units or the entire lot, whichever is smaller).
Visual inspection shall be performed in accordance with section 4.0.
LAL test samples, representative of final product, shall be submitted to an approved
test laboratory in accordance with section 5.2.
4.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of 18” — 24” in a well-lighted area with the
unaided eye. All defects within each category are cumulative. Record results on Form-125.
4.1 Critical Defects (AQL — 0.0% — One defect in the sample rejects the entire lot)
4.1.1
Incorrect lot number, expiration date, label, labeling, DFU,
chart label, GTR, catalog number or product description
4.1.2
Incorrect product configuration
4.1.3
Incorrect, missing or mixed product
4.1.4
Missing labels, DFU, chart labels or GTR
4.1.5
Failure of components or packaging materials to meet
traceability requirements
4.1.6
Empty package
4.2 Major A Defects (AQL — 0.4%)
4.2.1
Cracks, splits, pin holes, tears or other defects in packaging
which have the potential to violate the product sterility barrier (if
applicable)
4.2.2
Missing or illegible lot number or expiration date
4.2.3
Dirt, debris or foreign contamination readily visible on
package or within the outer package
4.3 Major B Defects (AQL — 1.5%)
4.3.1
Smeared, but legible, printing on labels or labeling
4.3.2
Smudges on exterior of packaging
4.3.3
Minor damage which may have the potential to violate the
product sterility barrier (if applicable)
4.4 Minor Defects (AQL — 2.5%)
4.4.1
Scratches or imperfections on external portions of packaging
Sterile products are dosimetrically released in accordance with SOP M-016, prior to
final packaging. No routine sterility testing is performed on a lot-to-lot basis.
5.2
Endotoxin Testing (LAL)
One (1) sample = 0.5cc, representative of final product, shall be removed from each
lot after sterilization and submitted to a qualified test laboratory for bacterial
Endotoxin testing via Limulus Amebocyte Lysate, gel clot method with
ß-Glucan Blocker in accordance with either TM-014 or nTM-022, as
appropriate (reference USP <85>). Document sample removal on Form-118.
Note: If more than one size, remove sample from smallest size.
Specification: < 0.5 EU/mL
In the event of failure, additional testing shall be performed. Test shall be
performed on one sample in quadruplicate. Each must pass.
6.0 SHELF LIFE
Shelf Life shall be in accordance with the appropriate approved IsoTis Production Record (IPR).
7.0 PRODUCT ARCHIVE SAMPLES
Following inspection, one (1) sample, representative of the largest volume, shall be removed
from each finished product lot in the original, unopened, labeled package. Sample shall be
identified and maintained as an archive sample in accordance with QA-012. Document sample
removal on Form-118.
Record inspection results on appropriate check sheets. Disposition, sign and date the
documents. Document any discrepant inspection findings in accordance with QA-052. Forward
Device History Record and all attachments, along with any discrepant samples, to the Manager of
Quality Assurance or designee for final document review and disposition approval in accordance
with QA-051.
FINISHED PRODUCT SPECIFICATION
OrthoBlast II Paste and Putty
1.0 PURPOSE
The purpose of this document is to detail the minimum manufacturing requirements and acceptance
criteria for the finished products referenced above manufactured by IsoTis OrthoBiologics. This
specification is intended for use following final packaging, but prior to release of product
into finished goods (i.e., distribution).
2.0 RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.1
ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes
2.2
Form-118, IsoTis OrthoBiologics Product Accountability Form
M-016, Sterile Processing of IsoTis OrthoBiologics Products by E-Beam Radiation
2.5
QA-012, Handling of QA Archive Samples
2.6
QA-051, Device History Record Review
2.7
QA-052, Control and Disposition of Non-Conforming Materials
2.8
TM-014, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Associates of Cape Cod Reagents
2.9
TM-022, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Charles River Reagents
3.0 PRODUCT SAMPLING
3.1
Visual Inspection
Each Finished Product lot shall be randomly sampled in accordance with ANSI/ASQ
Z1.4, current revision. General Inspection Level II, Single Normal Sample (minimum
sample size 20 units or the entire lot, whichever is smaller).
Visual inspection shall be performed in accordance with section 4.0.
LAL test samples, representative of final product, shall be submitted to an approved
test laboratory in accordance with section 5.2.
4.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of 18” — 24” in a well-lighted area with the
unaided eye. All defects within each category are cumulative. Record results on Form-125.
4.1
Critical Defects (AQL — 0.0% — One defect in the sample rejects the entire lot)
4.1.1
Incorrect lot number, expiration date, label, labeling, DFU,
chart label, GTR, catalog number or product description
4.1.2
Incorrect product configuration
4.1.3
Incorrect, missing or mixed product
4.1.4
Missing labels, DFU, chart labels or GTR
4.1.5
Failure of component or packaging materials to meet
traceability requirements
4.1.6
Empty package
4.2
Major A Defects (AQL — 0.4%)
4.2.1
Cracks, splits, pin holes, tears or other defects in packaging
which have the potential to violate the product sterility barrier (if
applicable)
4.2.2
Missing or illegible lot number or expiration date
4.2.3
Dirt, debris or foreign contamination readily visible on
package or within the outer package
4.3
Major B Defects (AQL — 1.5%)
4.3.1
Smeared, but legible, printing on labels or labeling
4.3.2
Smudges on exterior of packaging
4.3.3
Minor damage which may have the potential to violate the
product sterility barrier (if applicable)
4.4
Minor Defects (AQL — 2.5%)
4.4.1
Scratches or imperfections on external portions of packaging
Sterile products are dosimetrically released in accordance with SOP M-016, prior to
final packaging. No routine sterility testing is performed on a lot-to-lot basis.
5.2
Endotoxin Testing (LAL)
One (1) sample = 0.5cc, representative of final product, shall be removed from each
lot after sterilization and tested for bacterial endotoxins in accordance with
either TM-014 or TM-022, as appropriate. Document sample removal on Form-118.
Note: If more than one size, remove sample from smallest size.
Specification: < 0.5 EU/mL
In the event of failure, additional testing shall be performed. Test shall be
performed on one sample in quadruplicate. Each must pass.
6.0 SHELF LIFE
Shelf Life shall be in accordance with the appropriate approved IsoTis Production Record (IPR).
7.0 PRODUCT ARCHIVE SAMPLES
Following inspection, one (1) sample, representative of the largest volume, shall be removed
from each finished product lot in the original, unopened, labeled package. Sample shall be
identified and maintained as an archive sample in accordance with QA-012. Document sample
removal on Form-118.
8.0 LOT DISPOSITION
Record inspection results on appropriate check sheets. Disposition, sign and date the documents.
Document any discrepant inspection findings in accordance with QA-052. Forward Device History
Record and all attachments, along with any discrepant samples, to the Manager
of Quality Assurance or designee for final document review and disposition approval in accordance
with QA-051.
This is to certify that the sterile product listed below has been manufactured in accordance with
ISO 13485:2003 Standards and FDA Quality System Regulations, and any other applicable regulatory
requirements and complies with the 510K. The product units have been inspected and meet the
Specifications and is hereby released by Isotis OrthoBiologics, Inc.
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa
Rica, Cyprus, Denmark, Dominican Republic, England, France,
Germany, Honduras, Hungary, India, Iran, Ireland, Israel,
Italy, South Korea, Kuwait, Lebanon, Luxembourg, Mexico,
Netherlands, New Zealand, Panama, Peru, Portugal, Saudi
Arabia, South Africa, Spain, Switzerland, Thailand, Turkey,
UAE, USA
OrthoBlast II
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa
Rica, Cyprus, Denmark, Dominican Republic, England,
Honduras, Hungary, India, Iran, Ireland, Israel, Italy,
South Korea, Kuwait, Lebanon, Luxembourg, Mexico,
Netherlands, New Zealand, Panama, Peru, Portugal, Saudi
Arabia, South Africa, Spain, Switzerland, Thailand, Turkey,
UAE, USA
IsoTis OrthoBiologics, Inc.
2 Goodyear Irvine, CA92618
Re: Option to Extend Scope of Distribution Agreement
Ladies and Gentlemen:
Integra LifeSciences Corporation (the “Integra”), Isotis Acquisition Company, a wholly
owned subsidiary of Integra (“Merger Sub”) and IsoTis OrthoBiologics, Inc. (
“IsoTis”) are, today, entering into an Agreement and Plan of Merger (the “Merger
Agreement”) by which Merger Sub will be merged with and into Isotis upon the satisfaction of
the closing conditions set forth in the Merger Agreement. Integra and IsoTis are, today, also
entering into a Distribution Agreement relating to the manufacture and distribution of DynaGraft II
Gel, DynaGraft II Putty, Orthoblast II Paste and Orthoblast II Putty (the “Distribution
Agreement”). As a further inducement to Integra to enter into the Distribution Agreement,
IsoTis is willing to grant certain option rights to Integra to expand the scope of the Distribution
Agreement, as follows:
1. The Option. For a term commencing on January 1, 2008 and ending on December 31,2008 (the “Option Term”), IsoTis hereby grants Integra an option (the “Option”),
to expand the scope of the Distribution Agreement to include the exclusive right to distribute
the Accell® line of proprietary natural and synthetic bone graft substitutes, including, without
limitation, Accell DBM100, Accell Connexus, Accell TBM and A2i (collectively the “Option
Items”), solely for use in all surgical applications in the foot and ankle (collectively the
“Lower Extremities Field”), in consideration for the payment by Integra at such time, if
any, as it elects to exercise the Option of a payment to IsoTis of one million U.S. dollars
($1,000,000) in cash (the “Option Exercise Price”).
2. Exercise of Option. Integra may exercise the Option in its sole discretion at
any time during the Option Term by delivering a written notice of such exercise to IsoTis (the
“Option Notice”), together with a wire transfer to IsoTis of the Option Exercise Price;
provided, however, that the Option shall not be exerciseable, and the Option and this letter
agreement shall immediately terminate without any further action of the parties, upon the
occurrence of any of the option termination events set forth on Schedule 1 hereto (each, an
“Option Termination Event”); provided, further, that in the event Integra shall have
exercised the Option prior to the occurrence of an Option Termination Event, Isotis shall be
obligated to return the payment of the Option Exercise Price to effect the termination of the
Option and this letter agreement.
3. Effect of Option Exercise. If Integra exercises the Option, then simultaneously
with the delivery of the Option Notice, the Distribution Agreement shall be deemed, without the
need for additional documentation, to be amended as follows:
(a) Exhibit A to the Distribution Agreement shall be amended in its entirety to
be and read as the Exhibit A attached to this agreement, with the effect that the
definition of “Product” and “Products” in the Distribution Agreement will be extended to
include the Option Items. The then-current Final Product Specifications attached as
Schedule 1 and Schedule 2 to the existing Exhibit A shall be retained and become
part of the new Exhibit A. A new Schedule 3 to Exhibit A, as attached to
this agreement, shall become part of Exhibit A; however, if the Final Product
Specifications for the Option Items have changed in any respect between the date hereof and
the date Integra exercises the Option, IsoTis shall substitute the then-current Final
Product Specifications for the Option Items as the new Schedule 3 to Exhibit A.
(b) The definition of 510K in the Distribution Agreement shall be amended in its
entirety to read as follows:
‘“510K” shall mean a clearance by the FDA of the
Manufacturer’s submissions under Section 510(k) of the Food, Drug
and Cosmetics Act, which as to the DynaGraft II Products shall be #
K040419 and as to the Orthoblast II Products shall be # K060332
(OrthoBlast II DBM) # K050642 (OrthoBlast II Putty and Paste) and
#K070751 (OrthoBlast II) and as to the Accell Products shall be #
K061880.’
which such numbers to be appropriately cross referenced to the actual 510(k)
clearances issued by the FDA.
(c) Section 1 of the Distribution Agreement shall be amended in its entirety to read as
follows:
“Manufacturer hereby appoints Distributor, and Distributor hereby
accepts appointment, as (i) a non-exclusive distributor of the
DynaGraft II Products and Orthoblast II Products in the Territory,
for all fields of use other than the Dental Field collectively, the
(“General Orthopedic Field”) and (ii) the exclusive
distributor of Accell Products solely for use in all surgical
applications in the foot and ankle (collectively the “Lower
Extremities Field”) in the Territory. This Agreement does not
grant Distributor any exclusive rights to the DynaGraft II Products
and Orthoblast II Products. Manufacturer will produce, sell and
deliver Products which comply with the Specifications to
Distributor, and Distributor will purchase and take delivery of
Products from Manufacturer and distribute the Products, subject to
the terms and conditions set forth in this Agreement. Distributor
shall not sell any Products to any customer that it knows or has
reason to believe
will use the Products in any field of use other than as provided in
this Section 1.”
(d) Section 6(c) of the Distribution Agreement shall be amended in its entirety to read
as follows:
“At the time of delivery to Purchaser, all Products shall have a
remaining shelf life equal to no less than the greater of (i) 80% of
the shelf life specified in the 510K, or (ii) twenty months (in the
case of the Products other than Accell 100) and five months (in the
case of Accell 100).
(e) Section 11(a)(ii) of the Distribution Agreement shall be amended in its entirety to
read as follows:
“Purchaser shall have the right, upon written notice at least sixty
(60) days prior to the end of the Initial Term, to extend the term
of this Agreement (the “First Renewal Option”) for an
additional successive three (3) year period (the “First Renewal
Term”); provided that the foregoing right shall not apply to any
Accell Products unless Purchaser has used commercially reasonable
efforts during the Initial Term to sell such Products and, during
the one (1) year period preceding exercise of the First Renewal
Option, Purchaser has purchased from Manufacturer an amount of such
Products for an aggregate dollar amount of at least two million U.S.
dollars ($2,000,000).”
(f) Section 11(a)(iii) of the Distribution Agreement shall be amended in its entirety
to read as follows:
“Provided Purchaser has exercised the First Renewal Option and the
Distribution Agreement remains in full force and effect, the
parties, upon prior written agreement at least sixty (60) days prior
to the end of the First Renewal Term, may extend the term of this
Agreement for an additional successive three (3) year period (the
“Second Renewal Term”). For purposes of clarification,
during the Second Renewal Term, Purchaser shall have no rights under
this Agreement with respect to any Accell Products if Purchaser did
not have the right pursuant to Section 11(a)(ii) to exercise the
First Renewal Option with respect to such Products.”
(g) Exhibit B to the Distribution Agreement shall be amended in its entirety to
be and read as the Exhibit B attached to this agreement.
(h) Appendix 1 to the Distribution Agreement shall be amended in its entirety
to be and read as the Appendix 1 attached to this agreement.
(i) Within fifteen (15) days following delivery by Option Notice, Integra shall deliver
to IsoTis a revised forecast under Section 3 of the Distribution Agreement to take into
account the addition of the Option Items.
4. Representations and Warranties. IsoTis represents and warrants that:
(a) IsoTis has not granted exclusive distribution rights to the Option Items in the
Lower Extremities Field to any party and is not a party to any agreement that is
inconsistent with the grant of rights to Integra contemplated by this agreement. During
the Option Term, IsoTis shall take no action inconsistent with the grant of rights to
Integra hereunder and that would otherwise limit the exercise by Integra of its rights under
the Distribution Agreement following exercise of the Option.
(b) The execution, delivery and performance of this letter and the Distribution
Agreement by IsoTis does not and will not (a) violate, conflict with or result in the breach
of any provision of its Certificate of Incorporation or Bylaws, (b) conflict with or violate
any law or order applicable to IsoTis or (c) conflict with, result in any breach of,
constitute a default (or event which with the giving of notice or lapse of time, or both,
would become a default) under, require any consent under, or give to others any rights of
termination, amendment, acceleration, suspension, revocation or cancellation of any note,
bond, mortgage or indenture, contract, agreement, license, permit, franchise or other
instrument or arrangement to which IsoTis is a party.
5. Disclosure. Integra and IsoTis agree that no disclosure of the Option shall be
made to any third party without the consent of the other party hereto, except as may be required
by law (in which event the non-disclosing party shall be given an opportunity to review in
advance the proposed disclosure) and except that IsoTis may, without notice to or consent from
Integra, (i) disclose to prospective third party distributors of the Option Items that the Lower
Extremities Field is not available and (ii) disclose the Option and the terms of this option
agreement to any third party seeking to merge with or acquire IstoTis or all or substantially all
of its assets or IsoTis’ rights in and to the Option Items.
6. Expenses. Except as otherwise expressly provided herein, each party will be
responsible for its own costs and expenses, including attorneys’ fees, incurred in connection
with the transactions contemplated by this letter.
7. Binding Effect. This letter is intended to constitute the binding agreement of
each party hereto; provided, that Integra’s obligation to purchase the Option Items and IsoTis’
obligation to provide the Option Items shall be subject to the exercise of the Option by Integra
and the terms and conditions set forth in the Distribution Agreement.
8. Notices. Any notice or other communication in connection with this letter shall
be in writing and (i) deposited in the United States mail, postage prepaid, by registered or
certified mail, or (ii) hand delivered by any commercially recognized courier service or
overnight delivery service, such as Federal Express, addressed as follows:
IsoTis OrthoBiologics, Inc.
2 Goodyear Irvine, CA92618
Attn: Chief Executive Officer
Cc: General Counsel
If to Integra:
Integra LifeSciences Corporation
311 Enterprise Drive Plainsboro, New Jersey08536
Attn: General Counsel
Any such addressee may change its address for such notices to any other address in the United
States as such addressee shall have specified by written notice given as set forth above.
All periods of notice shall be measured from the deemed date of delivery. A notice shall be
deemed to have been given, delivered and received upon the earliest of: (i) if sent by such
certified or registered mail, on the third business day following the date of postmark; or (ii)
if hand delivered by such courier or overnight delivery service, when so delivered or tendered
for delivery during customary business hours on a business day at the specified address; or (iii)
if so mailed, on the date of actual receipt (or tender of delivery) as evidenced by the return
receipt; or (iv) if so delivered, upon actual receipt.
9. Entire Agreement. This letter (including all exhibits attached hereto)
represents the entire understanding between the parties with respect to the Option, and all prior
agreements and understandings between the parties with respect to the subject matter of this
letter shall be deemed merged in this letter.
10. No Oral Amendment or Modification. No amendments, waivers or modifications of
this letter shall be made or deemed to have been made unless in writing executed by both IsoTis
and Integra.
11. No Waivers. Any waiver of a breach of any provision contained in this letter
must be in writing to be valid and enforceable. No waiver of breach shall be deemed a waiver of
any preceding or succeeding breach, nor of any other breach of a provision contained in this
letter.
12. Choice of Law; Construction. This agreement shall be governed by and construed
in accordance with the laws of the State of New York. IsoTis and Integra hereby acknowledge that
both parties participated equally in the negotiation of this letter and that, accordingly, no
court construing this letter shall construe it more stringently against one party than against
the other, regardless of which party’s counsel drafted this letter or any particular provision
within this letter.
13. Counterparts. This agreement may be executed in several counterparts, each of
which shall constitute an original, but all of which, when taken together, shall constitute but
one agreement.
The Option and this letter agreement shall immediately terminate without any further action of
the parties (except in the event that Integra shall have exercised the Option prior to the
occurrence of an Option Termination Event, in which case Isotis shall be obligated to return the
payment of the Option Exercise Price to effect the termination of the Option and this letter
agreement), if the Merger Agreement has been previously terminated pursuant to any of the following
provisions of the Merger Agreement:
(i) Section 9.1(b) (only to the extent such termination derives from the failure of the
condition set forth in Section 8.2(c) of the Merger Agreement being satisfied on the date of such
termination),
(ii) Section 9.1(g),
(iii) Section 9.1(h) (excluding any intentional breach of the Merger Agreement by Isotis which
breach was the event that gave rise to the termination of the Merger Agreement pursuant to such
Section 9.1(h)), or
For purposes of this Agreement, the terms “Products” and “the Product” shall
mean the following products and all Product Improvements:
DynaGraft® II Demineralized Bone Matrix Putty
DynaGraft® II Demineralized Bone Matrix Gel
OrthoBlast® II DBM and Cancellous Bone in Reverse Phase Medium Putty
OrthoBlast® II DBM and Cancellous Bone in Reverse Phase Medium Paste
Accell® DBM100
Accell® Connexus
Accell® Total Bone Matrix
A2i [Accell product pending regulatory clearance]
Specifications: The supplemental finished product specifications are set forth in the
Schedules attached to this Exhibit A. These Schedules shall comprise part of the Specifications.
The purpose of this document is to detail the minimum manufacturing requirements and acceptance
criteria for finished Accell DBM100 manufactured by IsoTis OrthoBiologics. This procedure is
intended for use following final packaging, but prior to release of product into finished goods
(i.e., distribution).
2.0RELATED DOCUMENTATION
Note: All documents current revision unless otherwise specified.
2.1
ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes
2.2
Form-118, IsoTis OrthoBiologics Product Accountability Form
M-016, Sterile Processing of IsoTis OrthoBiologics Products by E-Beam Radiation
2.6
QA-051, Device History Record Review
2.7
QA-052, Control and Disposition of Non-Conforming Materials
2.8
TM-010, Handling Test for Accell Products
2.9
TM-014, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Associates of Cape Cod Reagents
2.10
TM-022, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Charles River Reagents
3.0 PRODUCT SAMPLING
3.1 Visual Inspection
Each Finished Product lot shall be randomly sampled in accordance with ANSI/ASQ
Z1.4, current revision. General Inspection Level II, Single Normal Sample (minimum
sample size 20 units or the entire lot, whichever is smaller).
Visual inspection shall be performed in accordance with section 4.0.
A random sample, representative of the smallest volume final product lot from a
single donor, shall be removed for functional testing. Document sample removal on
Form-118.
Testing shall be performed in accordance with section 5.0.
3.3 Endotoxin Testing (LAL)
LAL test samples, representative of final product, shall be submitted to an approved
test laboratory in accordance with section 6.2.
4.0VISUAL CLASSIFICATION OF DEFECTS
Note: Visual inspection shall be performed at a distance of 18” — 24” in a well-lighted area
with the unaided eye. All defects within each category are cumulative. Document results on
Form-125.
4.1 Critical Defects (AQL — 0.0% — One defect in the sample rejects the entire lot)
4.1.1
Incorrect lot number, expiration date, label, labeling, DFU,
chart label, GTR, catalog number or product description
4.1.2
Incorrect product configuration
4.1.3
Incorrect, missing or mixed product
4.1.4
Missing labels, DFU, chart labels or GTR
4.1.5
Failure of component or packaging materials to meet
traceability requirements
4.1.6
Empty package
4.2 Major A Defects (AQL — 0.4%)
4.2.1
Cracks, splits, pin holes, tears or other defects in packaging
which have the potential to violate the product sterility barrier (if
applicable)
4.2.2
Missing or illegible lot number or expiration date
4.2.3
Dirt, debris or foreign contamination readily visible on
package or within the outer package
4.3 Major B Defects (AQL — 1.5%)
4.3.1
Smeared, but legible, printing on labels or labeling
4.3.2
Smudges on exterior of packaging
4.3.3
Minor damage which may have the potential to violate the
product sterility barrier (if applicable)
Scratches or imperfections on external portions of packaging
4.4.2
Inclusions or foreign materials in packaging
4.4.3
Variations in color of printing on package
4.4.4
Minor package discoloration
SAVE AND IDENTIFY ALL DEFECTS
5.0 FUNCTIONAL TESTING
5.1 Handling Testing
Test one random sample from each lot in accordance with TM-010.
Acceptance Criteria: Putty must maintain diamond shaped for approximately 30
seconds.
NOTE: If test results show dry consistency, continue testing weekly with additional
unit until putty is formed. Failure occurs if results show product is too moist or
sticky.
5.2 Water Testing
Using the sample from 5.1, test in accordance with TM-010.
Acceptance Criteria: Putty must hold its shape for approximately 30 seconds.
NOTE: A slight dispersion around the edge of putty is acceptable.
6.0 BIOLOGICAL TESTING
6.1 Sterility Testing
Sterile products are dosimetrically released in accordance with SOP M-016, prior to
final packaging. No routine sterility testing is performed on a lot-to-lot basis.
One
(1) sample > 0.5cc, representative of final product, shall be removed from each
lot after sterilization and submitted to a qualified test laboratory for Endotoxin
testing via Limulus Amebocyte Lysate, gel clot method with ß -Glucan
Blocker in accordance with either TM-014 or TM-022, as appropriate (reference USP
<85>).
Note: If more than one size, remove sample from smallest size.
Specification: < 0.5 EU/mL
In the event of failure, additional testing shall be performed. Test shall be
performed on one sample in quadruplicate. Each must pass.
7.0 SHELF LIFE
Shelf Life of all double aseptically packaged products shall be in accordance with the
appropriate approved IsoTis Production Record (IPR).
8.0 PRODUCT ARCHIVE SAMPLES
One sample, representative of the largest volume, shall be removed from each finished product
lot in the original, unopened, labeled package identified as an archive sample. This sample
shall be forwarded to QA for cataloging and storage. Document sample removal on Form-118.
9.0 LOT DISPOSITION
Record inspection results on appropriate check sheets. Disposition, sign and date the
documents. Document any discrepant inspection findings in accordance with QA-052. Forward
Device History Record and all attachments, along with any discrepant samples, to the Manager of
Quality Assurance or designee for final document review and disposition approval in accordance
with QA-051.
The purpose of this document is to detail the minimum manufacturing requirements and acceptance
criteria for finished Accell Connexus Putty manufactured by IsoTis OrthoBiologics. This
specification is intended for use following final packaging, but prior to release of product
into finished goods (i.e., distribution).
2.0 RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.11
ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes
2.12
Form-118, IsoTis OrthoBiologics Product Accountability Form
M-016, Sterile Processing of IsoTis OrthoBiologics Products by E-Beam Radiation
2.16
QA-012, Handling of QA Archive Samples
2.17
QA-051, Device History Record Review
2.18
QA-052, Control and Disposition of Non-Conforming Materials
2.19
TM-010, Handling Test for Accell Products
2.20
TM-014, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product Associates of Cape Cod Reagents
2.21
TM-022, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product Charles River Reagents
3.0 PRODUCT SAMPLING
3.1 Visual Inspection
Each Finished Product lot shall be randomly sampled in accordance with ANSI/ASQ
Z1.4, current revision. General Inspection Level II, Single Normal Sample (minimum
sample size 20 units or the entire lot, whichever is smaller).
Visual inspection shall be performed in accordance with section 4.0.
A random sample, representative of the smallest volume final product lot from a
single donor, shall be removed for functional testing. Document sample removal on
Form-118.
Testing shall be performed in accordance with section 5.0.
3.3 Endotoxin Testing (LAL)
LAL test samples, representative of final product, shall be submitted to an approved
test laboratory in accordance with section 6.2. Document sample removal on
Form-118.
4.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of 18” — 24” in a well-lighted area with the
unaided eye. All defects within each category are cumulative. Document results on Form-125.
4.1 Critical Defects (AQL — 0.0% — One defect in the sample rejects the entire lot)
4.1.1
Incorrect lot number, expiration date, label, labeling, DFU, chart label, GTR,
catalog number or product description
4.1.2
Incorrect product configuration
4.1.3
Incorrect, missing or mixed product
4.1.4
Missing labels, DFU, chart labels or GTR
4.1.5
Failure of component or packaging materials to meet traceability requirements
4.1.6
Empty package
4.2 Major A Defects (AQL — 0.4%)
4.2.1
Cracks, splits, pin holes, tears or other defects in packaging which have the
potential to violate the product sterility barrier (if applicable)
4.2.2
Missing or illegible lot number or expiration date
4.2.3
Dirt, debris or foreign contamination readily visible on package or within the
outer package
4.3 Major B Defects (AQL — 1.5%)
4.3.1
Smeared, but legible, printing on labels or labeling
4.3.2
Smudges on exterior of packaging
4.3.3
Minor damage which may have the potential to violate the
product sterility barrier (if applicable)
Scratches or imperfections on external portions of packaging
4.4.2
Inclusions or foreign materials in packaging
4.4.3
Variations in color of printing on package
4.4.4
Minor package discoloration
SAVE AND IDENTIFY ALL DEFECTS
5.1FUNCTIONAL TESTING
5.1 Handling Testing
Test one (1) random sample from each lot in accordance with TM-010.
Acceptance Criteria: Putty must maintain diamond shaped for approximately 30
seconds.
NOTE: If test results show dry consistency, continue testing weekly with additional
unit until putty is formed. Failure occurs if results show product is too moist or
sticky.
5.2 Water Testing
Using the sample from 5.1, test in accordance with TM-010.
Acceptance Criteria: Putty must hold its shape for approximately 30 seconds.
NOTE: A slight dispersion around the edge of putty is acceptable.
6.0 BIOLOGICAL TESTING
6.1Sterility Testing
Sterile products are dosimetrically released in accordance with SOP M-016, prior to
final packaging. No routine sterility testing is performed on a lot-to-lot basis.
One
(1) sample > 0.5cc, representative of final product, shall be removed from each
lot after sterilization and submitted to a qualified test laboratory for Endotoxin
testing via Limulus Amebocyte Lysate, gel clot method with ß -Glucan
Blocker in accordance with either TM-014 or TM-022, as appropriate (reference USP
<85>). Document sample removal on Form-118.
Note: If more than one size, remove sample from smallest size.
Specification: < 0.5 EU/mL
In the event of failure, additional testing shall be performed. Test shall be
performed on one sample in quadruplicate. Each must pass.
7.0 SHELF LIFE
Shelf Life shall be in accordance with the appropriate approved IsoTis Production Record (IPR).
8.0 PRODUCT ARCHIVE SAMPLES
Following inspection, one (1) sample, representative of the largest volume, shall be removed
from each finished product lot in the original, unopened, labeled package. Sample shall be
identified and maintained as an archive sample in accordance with QA-012. Document sample
removal on Form-118.
9.0 LOT DISPOSITION
Record inspection results on appropriate check sheets. Disposition, sign and date the
documents. Document any discrepant inspection findings in accordance with QA-052. Forward
Device History Record and all attachments, along with any discrepant samples, to the Manager of
Quality Assurance or designee for final document review and disposition approval in accordance
with QA-051.
FINISHED PRODUCT SPECIFICATION
Accell® Total Bone Matrix
1.0 PURPOSE
The purpose of this document is to detail the minimum manufacturing requirements and acceptance
criteria for finished Total Bone Matrix (TBM) manufactured by IsoTis OrthoBiologics. This
specification is intended for use following final packaging, but prior to release of product
into finished goods (i.e., distribution).
2.0RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.1
ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes
2.2
Form-118, IsoTis OrthoBiologics Product Accountability Form
M-016, Sterile Processing of IsoTis OrthoBiologics Products by E-Beam Radiation
2.5
QA-012, Handling of QA Archive Samples
2.6
QA-051, Device History Record Review
2.7
QA-052, Control and Disposition of Non-Conforming Materials
2.8
TM-014, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Associates of Cape Cod Reagents
2.9
TM-022, Limulus Amebocyte Lysate (LAL) Gel Clot Testing Finished Product
Charles River Reagents
3.0PRODUCT SAMPLING
3.1Visual Inspection
Each Finished Product lot shall be randomly sampled in accordance with ANSI/ASQ
Z1.4, current revision. General Inspection Level II, Single Normal Sample (minimum
sample size 20 units or the entire lot, whichever is smaller).
Visual inspection shall be performed in accordance with section 4.0.
LAL test samples shall be representative of the final product in quantities specified in 6.2
of this specification.
5.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of 18” — 24” in a well-lighted area with the
unaided eye. All defects within each category are cumulative. Record results on Form-125.
5.1 Critical Defects (AQL — 0.0% — One defect in the sample rejects the entire lot.)
5.1.1
Incorrect lot number, expiration date, label, labeling, DFU,
chart label, GTR, catalog number or product description
5.1.2
Incorrect product configuration
5.1.3
Incorrect, missing or mixed product
5.1.4
Missing labels, DFU, chart labels or GTR
5.1.5
Failure of components or packaging materials to meet
traceability requirements
5.1.6
Empty package
5.2 Major A Defects (AQL — 0.4%)
5.2.1
Cracks, splits, pin holes, tears or other defects in packaging
which have the potential to violate the product sterility barrier (if
applicable)
5.2.2
Missing or illegible lot number or expiration date
5.2.3
Dirt, debris or foreign contamination readily visible on
package or within the outer package
5.3 Major B Defects (AQL — 1.5%)
5.3.1
Smeared, but legible, printing on labels or labeling
5.3.2
Smudges on exterior of packaging
5.3.3
Minor damage which may have the potential to violate the
product sterility barrier (if applicable)
5.4 Minor Defects (AQL — 2.5%)
5.4.1
Scratches or imperfections on external portions of packaging
Sterile products are dosimetrically released in accordance with SOP M-016, prior to
final packaging. No routine sterility testing is performed on a lot-to-lot basis.
6.2Endotoxin Testing
One sample shall be collected from each lot tested after sterilization and submitted
to a qualified test laboratory for Pyrogen testing via Limulus Amebocyte Lysate, gel
clot method with ß-Glucan Blocker in accordance with either TM-014 or
TM-022, or a similar method, as appropriate (reference USP <85>).
Specification: < 0.5 EU/mL and < 20 EU/device.
In the event of failure, additional testing shall be performed. Test shall be
performed on one sample in quadruplicate. Each must pass.
7.0 SHELF LIFE
Shelf Life shall be in accordance with the appropriate approved IsoTis Production Record (IPR).
8.0 PRODUCT ARCHIVE SAMPLES
Following inspection, one (1) sample, representative of the largest volume, shall be removed
from each finished product lot in the original, unopened, labeled package. Sample shall be
identified and maintained as an archive sample in accordance with QA-012. Document sample
removal on Form-118.
Record inspection results on appropriate check sheets. Disposition, sign and date the documents.
Document any discrepant inspection findings in accordance with QA-052. Forward Device History
Record and all attachments, along with any discrepant samples, to the Manager of Quality Assurance
or designee for final document review and disposition approval in accordance with QA-051.
Pricing to be determined after clearance for A2i is obtained and
upon launch if such Product and shall be on similar terms as those
set forth above in this Exhibit B (i.e. 55% off of list price, 58% off
of list price after reaching the Threshold Dollar Amount)
Sample Purchase Price
Manufacturer shall offer 1,000 Samples
to Purchaser for initial launch at the cost to Purchaser of
$25 per unit, or $25,000 in the aggregate.
All additional Samples are available at $50 per unit.
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa Rica,
Cyprus, Denmark, Dominican Republic, England, France, Germany, Honduras, Hungary, India, Iran, Ireland,
Israel, Italy, South Korea, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Panama, Peru,
Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, UAE, USA
OrthoBlast II
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa Rica,
Cyprus, Denmark, Dominican Republic, England, Honduras, Hungary, India, Iran, Ireland, Israel, Italy,
South Korea, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal,
Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, UAE, USA
Accell 100
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa Rica, Cyprus,
Denmark, Dominican Republic, England, Honduras, Hungary, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon,
Luxembourg, Mexico, Netherlands, New Zealand, Panama, Portugal, South Africa, Spain, Switzerland, Thailand,
Turkey, UAE, USA
Accell Connexus
Austria, Australia, Belgium, Canada, Caribbean, Chile, Costa Rica,
Cyprus, Denmark, Dominican Republic, England, Honduras, Hungary, India, Iran, Ireland, Israel, Italy,
Kuwait, Luxembourg, Mexico, Netherlands, New Zealand, Panama, Portugal, Saudi Arabia, South Africa,
South Korea, Spain, Switzerland, Thailand, Turkey, UAE, USA
Accell TBM
Austria, Australia, Belgium, Caribbean, Chile, Costa Rica, Cyprus,
Denmark, Dominican Republic, England, Honduras, Hungary, India, Iran, Ireland, Kuwait, Luxembourg,
Mexico, Netherlands, New Zealand, Panama, Portugal, South Africa, Spain, Thailand, Turkey, UAE, USA
This proxy is solicited by the Board of Directors of IsoTis, Inc. for use at the Special Meeting of
Stockholders of IsoTis, Inc. on .
This proxy when properly executed will be voted as you specify on the reverse side.
If no choice is specified, the proxy will be voted “FOR” Proposals 1 and 2.
By signing this proxy, you revoke all prior proxies and appoint Pieter Wolters and Robert Morocco,
and each of them with full power of substitution, to vote your shares on the matters shown on the
reverse side and on any other matters which may come before the Special Meeting and all
adjournments.
See Reverse Side for Voting Instruction
Address Change (Mark the corresponding box on the reverse side)
If you vote over the Internet or by telephone, please do not mail your card.
DETACH HERE IF YOU ARE RETURNING YOUR PROXY CARD BY MAIL
The Board of Directors Recommends a Vote “FOR” Proposals 1 and 2.
1. Proposal to adopt the Agreement and Plan of Merger, dated as of August 6,2007, by and among IsoTis, Inc., Integra LifeSciences Holdings Corporation and Ice MergerCorp, Inc.
FOR o
AGAINST o
ABSTAIN o
2. Proposal to approve the adjournment of the special meeting, if necessary, to solicit
additional proxies if there are insufficient votes at the time of the special meeting to adopt the
merger agreement.
FOR o
AGAINST o
ABSTAIN o
THIS PROXY WHEN PROPERLY EXECUTED WILL BE VOTED AS DIRECTED OR, IF NO DIRECTION IS GIVEN,
WILL BE VOTED “FOR” PROPOSALS 1 AND 2.
Both of the attorneys-in-fact or their substitutes or, if only one shall be present and acting at
the special meeting or any adjournment(s) or postponement(s) thereof, the attorney-in-fact so
present, shall have and may exercise all of the powers of said attorney-in-fact hereunder.
MARK HERE FOR ADDRESS CHANGE (SEE REVERSE SIDE) o
Please date this Proxy and sign it exactly as your name or names appear. When shares are held
by joint tenants, both should sign. When signing as an attorney, executor, administrator,
trustee or guardian, please give full title as such. If shares are held by a corporation,
please sign in full corporate name by the president or other authorized officer. If shares are
held by a partnership, please sign in full partnership name by an authorized person.
Signature:
Date:
Signature:
Date:
Dates Referenced Herein and Documents Incorporated by Reference