AGREEMENT AND PLAN OF MERGER

Exhibit 2.1

AGREEMENT AND PLAN OF MERGER

by and among

ev 3 INC.,

STARSKY MERGER SUB, INC.,

STARSKY ACQUISITION SUB, INC.,

CHESTNUT MEDICAL TECHNOLOGIES, INC.

and

CMT SR, INC.

Dated as of June 2, 2009

TABLE OF CONTENTS

INDEX OF DEFINED TERMS

AGREEMENT AND PLAN OF MERGER

     This AGREEMENT AND PLAN OF MERGER, dated as of June 2, 2009 (this “ Agreement ”), is by and among ev3 Inc., a Delaware corporation (“ Parent ”), Starsky Merger Sub, Inc., a California corporation and a direct wholly owned subsidiary of Parent (“ Merger Co. ”), Starsky Acquisition Sub, Inc., a California corporation and a direct wholly owned subsidiary of Parent (“ Acquisition Co. ”), Chestnut Medical Technologies, Inc., a California corporation (“ Company ”), and CMT SR, Inc., a California corporation (“ Shareholder Representative ”).

     A. Each of the respective Boards of Directors of Parent, Merger Co., Acquisition Co. and Company has approved, and declared it advisable and in the best interests of its stockholders or shareholders, as the case may be, to consummate the business combination transaction and other transactions provided for herein, including the merger (the “ Reverse Merger ”) of Merger Co. with and into the Company and the immediately subsequent merger of Company with and into Acquisition Co. (the “ Forward Merger ”; together with the Reverse Merger, the “ Merger ”), in accordance with the laws of their respective states of incorporation, including the California Corporations Code (the “ CCC ”), and upon the terms and subject to the conditions set forth herein.

     B. Parent and Company intend the Merger to qualify as a reorganization within the meaning of Section 368 of the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder (the “ Code ”).

     C. Parent and Company desire to make certain representations, warranties, covenants and agreements in connection with the Merger and also to prescribe certain conditions to the Merger.

     D. Contemporaneously with the execution of this Agreement, as an inducement to Parent’s willingness to enter into this Agreement and incur the obligations set forth herein, certain of Company’s shareholders, which beneficially or of record hold an aggregate of approximately 66% of the outstanding shares of the capital stock of Company (on an as-converted to Company Common Stock basis), have entered into a voting agreement, dated as of the date hereof, with Parent (each, a “ Voting Agreement ”), pursuant to which, upon the terms set forth therein, such shareholders have agreed to vote their shares of Company Common Stock and Company Preferred Stock, as applicable, in favor of this Agreement and the transactions contemplated hereby.

     Accordingly, and in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth herein and intending to be legally bound, the parties hereto agree as follows:

ARTICLE I.
The Merger

     1.1 Effective Time of Merger . Subject to the provisions of this Agreement, an agreement of merger (the “ First Agreement of Merger ”) for the Reverse Merger shall be duly

prepared, executed by Company and Merger Co. and thereafter delivered to the Secretary of State of the State of California for filing, as provided in the CCC, on the Closing Date (as defined in Section 1.2). The Reverse Merger shall become effective upon the filing of the First Agreement of Merger with the Secretary of State of the State of California or at such time thereafter as is agreed upon in writing by Parent and Company and provided in the First Agreement of Merger (the “ Effective Time ”). Subject to the provisions of this Agreement, an agreement of merger (the “ Second Agreement of Merger ”) for the Forward Merger shall be duly prepared, executed by Company and Acquisition Co. and thereafter delivered to the Secretary of State of the State of California for filing, as provided in the CCC, on the Closing Date (as defined in Section 1.2) immediately after the Effective Time. The Forward Merger shall become effective upon the filing of the Second Agreement of Merger with the Secretary of State of the State of California or at such time thereafter as is agreed upon in writing by Parent and Company and provided in the Second Agreement of Merger (the “ Second Effective Time ”)

     1.2 Closing . The closing of the Merger (the “ Closing ”) will take place at 10:00 a.m., California time, on the date (the “ Closing Date ”) that is the second Business Day after the satisfaction or waiver (subject to Applicable Law) of the conditions set forth in Article V (excluding conditions that, by their terms, are to be satisfied on the Closing Date but subject to the satisfaction or waiver of such conditions), unless another time or date is agreed to in writing by the parties hereto. The Closing shall be held at the offices of Oppenheimer Wolff & Donnelly LLP, 3300 Plaza VII, 45 South Seventh Street, Minneapolis, Minnesota 55402, unless another place is agreed to in writing by the parties hereto. For the purposes of this Agreement, “ Business Day ” shall mean each day other than a Saturday, Sunday or any other day when commercial banks in Minneapolis, Minnesota are authorized or required by law to close.

     1.3 Effects of the Merger . At the Effective Time, Merger Co. shall be merged with and into Company and the separate existence of Merger Co. shall cease. At the Second Effective Time, Company as the surviving corporation in the Reverse Merger (the “ First Surviving Corporation ”) shall be merged with and into Acquisition Co. and the separate existence of the First Surviving Corporation shall cease and Acquisition Co. shall continue as the surviving corporation in the Merger. The Merger will have the effects set forth in the CCC. As used in this Agreement, “ Constituent Corporations ” shall mean each of Merger Co., Acquisition Co. and Company, and “ Surviving Corporation ” shall mean Acquisition Co., at and after the Second Effective Time, as the surviving corporation in the Merger and a direct wholly owned subsidiary of Parent. The parties intend the Merger (i.e., the Reverse Merger and the Forward Merger taken together as a single integrated transaction) to be treated as a tax-free reorganization pursuant to Section 368(a)(2)(D) of the Code and Revenue Ruling 2001-46, 2001-2 C.B. 321 (and any comparable provisions of any applicable state or local law); provided, however, that if the Merger is determined (within the meaning of Section 1313(a) of the Code) not to qualify as a tax-free reorganization, the parties intend the Reverse Merger and the Forward Merger each to be treated as separate transactions for income tax purposes pursuant to Revenue Ruling 90-95, 1990-2 C.B. 67 (and any comparable provisions of any applicable state or local law).

     1.4 Articles of Incorporation . At the Second Effective Time, the articles of incorporation of Acquisition Co. as in effect immediately prior to the Second Effective Time shall be the articles of incorporation of the Surviving Corporation until thereafter changed or amended as provided therein or by Applicable Law except that the articles of incorporation shall

be amended so that the name of the Surviving Corporation shall be “Chestnut Medical Technologies, Inc.”.

     1.5 By-Laws . At the Second Effective Time, the By-laws of Acquisition Co. as in effect immediately prior to the Second Effective Time shall be the By-laws of the Surviving Corporation until thereafter changed or amended as provided therein or by Applicable Law.

     1.6 Officers and Directors of Surviving Corporation . The officers of Acquisition Co. as of the Second Effective Time shall be the officers of the Surviving Corporation, until the earlier of their resignation or removal or otherwise ceasing to be an officer or until their respective successors are duly appointed and qualified, as the case may be. The directors of Acquisition Co. as of the Second Effective Time shall be the directors of the Surviving Corporation until the earlier of their resignation or removal or otherwise ceasing to be a director or until their respective successors are duly elected and qualified.

ARTICLE II.
Effects of the Merger; Merger Consideration

     2.1 Effect on Capital Stock .

          (a)  Cancellation of Certain Stock . At the Effective Time, by virtue of the Reverse Merger and without any action on the part of the holder of any shares of Company Common Stock or Company Preferred Stock, all shares of common stock, without par value, of Company (the “ Company Common Stock ”), series A preferred stock, without par value, of Company (the “ Series A Preferred Stock ”), series B preferred stock, without par value, of Company (the “ Series B Preferred Stock ”) and series C preferred stock, without par value, of Company (the “ Series C Preferred Stock ” and, collectively with the Series A Preferred Stock and Series B Preferred Stock, the “ Company Preferred Stock ” and, collectively with the Company Common Stock, the “ Company Capital Stock ”) that are owned by Company, or any direct or indirect wholly owned Subsidiary of Company, shall be canceled and shall cease to exist, and no cash or shares of common stock, par value $0.01 per share, of Parent (the “ Parent Common Stock ”) or other consideration shall be delivered in exchange therefor.

          (b)  Conversion of Company Preferred Stock . If the condition to the obligation of Parent, Merger Co. and Acquisition Co. to effect the Merger set forth in Section 5.2(d) is not satisfied prior to the Closing and Parent has waived the satisfaction of such condition, each share of Company Preferred Stock issued and outstanding immediately prior to the Effective Time (other than (i) shares to be canceled in accordance with Section 2.1(a) and (ii) Dissenting Shares) shall be, at the Effective Time by virtue of the Reverse Merger, canceled and extinguished and automatically converted into the right to receive the Liquidation Preference Payment applicable to such share, without interest, payable (A) such percentage that is equal to 100% minus the Closing Stock Percentage (the “ Closing Cash Percentage ”) in cash and (B) such percentage that is between 60% and 70% (inclusive) as is selected by Parent in its sole discretion and set forth in a written notice to Company delivered by Parent at least 3 days prior to the anticipated Closing Date (the “ Closing Stock Percentage ”) in shares of Parent Common Stock (assuming each share of Parent Common Stock has a value equal to the Applicable Denominator). Upon conversion of the shares of Company Preferred Stock pursuant to this Section 2.1(b) into the right to receive

the Liquidation Preference Payment in cash and shares of Parent Common Stock, all such shares of the Company Preferred Stock shall no longer be outstanding and shall automatically be canceled and extinguished and shall cease to exist, and each certificate previously representing any such shares shall thereafter represent only the right to receive the Liquidation Preference Payment in respect of such shares as provided in this Section 2.1(b) upon the surrender of the certificate representing such shares in accordance with Section 2.4(c) (or in the case of a lost, stolen or destroyed certificate, upon delivery of an affidavit (and bond, if required) in the manner provided in Section 2.4(k)). If the condition to the obligation of Parent, Merger Co. and Acquisition Co. to effect the Merger set forth in Section 5.2(d) is not satisfied prior to Closing and Parent has waived the satisfaction of such condition because shares of Company Preferred Stock have not converted and holders thereof will receive the Liquidation Preference Payment, the calculation of the Per Share Merger Consideration payable to the holders of Company Common Stock and Company Options immediately prior to the Effective Time will be adjusted such that the holders of Company Common Stock and Company Options immediately prior to the Effective Time will receive the benefit of the holders of Company Preferred Stock that are paid the Liquidation Preference Payment receiving less than the Per Share Merger Consideration that would have been payable if such holders of Company Preferred Stock had converted prior to the Effective Time.

          (c)  Conversion of Company Common Stock . Each share of Company Common Stock issued and outstanding immediately prior to the Effective Time (other than (i) shares to be canceled in accordance with Section 2.1(a) or (ii) Dissenting Shares) shall be, at the Effective Time by virtue of the Reverse Merger, canceled and extinguished and automatically converted into the right to receive (i) the Closing Date Per Share Consideration and (ii) the FDA Milestone Per Share Consideration (collectively, the “ Per Share Merger Consideration ”) that may be payable in respect of such share pursuant to this Agreement, if any, at the respective times and subject to the conditions and contingencies herein. Upon conversion of the shares of Company Common Stock pursuant to this Section 2.1(c), all such shares of the Company Common Stock shall no longer be outstanding and shall automatically be canceled and extinguished and shall cease to exist, and each certificate previously representing any such shares shall thereafter represent only the right to receive the Per Share Merger Consideration in respect of such shares upon the surrender of the certificate representing such shares in accordance with Section 2.4(c) (or in the case of a lost, stolen or destroyed certificate, upon delivery of an affidavit in the manner provided in Section 2.4(k)).

          (d)  Definitions .

               (i) “ Closing Date Cash Consideration ” means an amount payable in cash equal to (A) the Closing Cash Percentage multiplied by the Closing Date Merger Consideration, less (B) the Representative Funds, less (C) any Closing Date Cash Adjustment Amount.

               (ii) “ Closing Date Merger Consideration ” means (A) Seventy-Five Million Dollars ($75,000,000), plus (B) the amount of cash and cash equivalents held by the Company as of the Closing Date, plus (C) an amount equal to the aggregate of with respect to each Company Option (as defined below) which is outstanding immediately prior to the Effective Time (I) such Company Option’s exercise price per share multiplied by (II) the total

number of shares of Company Capital Stock issuable upon full exercise of such Company Options, less (D) the amount of Indebtedness of Company as of the Closing Date.

               (iii) “ Closing Date Stock Consideration ” means that number of whole shares of Parent Common Stock equal to the quotient of (A) an amount equal to the Closing Stock Percentage multiplied by the Closing Date Merger Consideration, divided by (B) the Applicable Denominator, payable in validly issued, fully paid and non-assessable shares of Parent Common Stock. For purposes of this definition, the “ Applicable Denominator ” shall be determined as follows:

     (A) If the Upfront Closing Price is at least 80% but not more than 120% of the Upfront Signing Price, then the Applicable Denominator shall equal the Upfront Closing Price;

     (B) If the Upfront Closing Price is greater than 120% of the Upfront Signing Price, then the Applicable Denominator shall equal 120% of the Upfront Signing Price; and

     (C) If the Upfront Closing Price is less than 80% of the Upfront Signing Price, then the Applicable Denominator shall equal 80% of the Upfront Signing Price.

The “ Upfront Closing Price ” shall equal the average of the closing prices of Parent Common Stock as reported on the NASDAQ Global Select Market for the ten (10) trading days ending on the date that is two (2) Business Days prior to the Closing Date.

The “ Upfront Signing Price ” is $8.68, which the parties hereto agree is equal to the average of the closing prices of Parent Common Stock as reported on the NASDAQ Global Select Market for the ten (10) trading days ending on the date that is two (2) Business Days prior to the date of execution of this Agreement.

In determining the Applicable Denominator, the amounts of the Upfront Closing Price and Upfront Signing Price will be adjusted, as necessary, to take into account stock splits or reverse stock splits or any dividends of stock or rights with respect to stock that are declared or made to holders of Parent Common Stock in the period between the first measurement date for the Upfront Signing Price and the last measurement date for the Upfront Closing Price.

               (iv) “ Closing Date Per Share Consideration ” means the aggregate of (A) the Closing Date Stock Consideration (consisting of the number of whole shares of Parent Common Stock described in Section 2.1(d)(iii)) divided by the number of Fully Diluted Shares (the “ Closing Date Stock Per Share Consideration ”) and (B) the Closing Date Cash Consideration divided by the number of Fully Diluted Shares (the “ Closing Date Cash Per Share Consideration ”).

               (v) “ Fully Diluted Shares ” means (i) the aggregate number of shares of Company Common Stock (other than shares to be canceled in accordance with Section 2.1(a)),

outstanding immediately prior to the Effective Time plus (ii) the number of shares of Company Common Stock issuable upon conversion of all shares of Company Preferred Stock outstanding immediately prior to the Effective Time plus (iii) the number of shares of Company Common Stock issuable upon any exercise of any options or warrants or other rights that gives the holder thereof the right to purchase shares of Company Common Stock that are outstanding immediately prior to the Effective Time plus (iv) the number of shares of Company Common Stock that are issuable upon conversion of all shares of Company Preferred Stock that are issuable upon any exercise of any options or warrants or other rights that give the holder thereof the right to purchase shares of Company Preferred Stock that are outstanding immediately prior to the Effective Time.

               (vi) “ Indebtedness ” means any and all amounts that would be required to be set forth as a liability on a balance sheet prepared in accordance with GAAP (as defined in Section 3.1(d)) as of the Closing Date, including (a) all obligations for borrowed money, (b) any reimbursement obligations in respect of letters of credit, surety bonds or obligations in respect of bankers acceptances, whether or not matured, (c) all obligations to pay the deferred purchase price of property or services, including trade accounts payable and accrued commercial or trade liabilities, (d) all indebtedness created or arising under any conditional sale or other title retention agreement with respect to property acquired (even though the rights and remedies of the seller or lender under such agreement in the event of default are limited to repossession or sale of such property), (e) all capital lease obligations; (f) all unpaid fees and expenses of financial advisors, brokers, attorneys, accountants, consultants and other advisors, including all such fees incurred by Company or for which Company is responsible, relating to this Agreement and the transaction contemplated hereby, regardless of when incurred including any legal expenses incurred after the Closing to assist Company Shareholders in remitting Certificates to the Exchange Agent, completing lost certificate affidavits, etc.; (g) all employment-related taxes that are payable by the Company with respect to the payment of any Merger Consideration to the holders of Company Options; (h) all Taxes that are or may become owing by the Company (exclusive of any reserve for deferred Taxes established to reflect timing differences between book and Tax income) as a result of the operations of the Company prior to the Effective Time regardless of whether or not accrued and (i) in the event that Parent prepares and files a Form S-4 pursuant to Section 4.20, 50% of all of the reasonable costs and expenses, including attorneys’ fees and expenses, of Parent incurred after delivery of the S-4 Notice in preparing, filing and causing the Form S-4 to be declared effective but in any event no more than $50,000; but excluding from the definition of “Indebtedness” total current liabilities of the Company incurred in the ordinary course of business so long as such current liabilities are less than $425,000, but including in the definition of “Indebtedness” any such current liabilities to the extent in excess of $425,000.

               (vii) “ Liquidation Preference Payment ” of a share of Company Preferred Stock shall mean the stated face or redemption amount plus any accrued dividend amounts that, under the terms set forth in Company’s articles of incorporation, are payable in respect of such series of such share of Company Preferred Stock.

               (viii) “ Closing Date Merger Stock Consideration Value ” means the aggregate value of all of the shares of Parent Common Stock issued to the Company Shareholders and Company Option Holders as part of the Closing Date Merger Consideration as

determined by the opening price for such shares as reported on the NASDAQ Global Select Market (or such other exchange on which shares of Parent Common Stock may be traded on the date of issuance) on the date of issuance. The “ Closing Date Merger Consideration Value ” means the sum of the Closing Date Merger Stock Consideration Value and the aggregate amount of cash issued to the Company Shareholders and Company Option Holders as part of the Closing Date Merger Consideration, which shall include for purposes of the definition of Closing Date Merger Consideration Value all amounts paid with respect to shareholders who assert dissenters rights, payments to holders of Company Preferred Stock and any and all other consideration paid to any Person in connection with the Merger by virtue of such Person’s holdings of shares of Company Capital Stock or options or warrants to acquire shares of Company Capital Stock, exclusive of any amounts considered to be imputed interest with respect to the payment of any Closing Date Merger Consideration.

          (e) Potential Adjustment to Closing Date Cash Consideration . In the event that the Closing Date Merger Stock Consideration Value would constitute less than 40% of the Closing Date Merger Consideration Value to be paid and issued to the Company Shareholders and Company Option Holders hereunder before giving effect to this Section 2.1(e), then there shall be a reduction in the amount of cash that comprises the Closing Date Cash Consideration such that, after giving effect to such reduction, the Closing Date Merger Stock Consideration Value equals 40% of the aggregate Closing Date Merger Consideration paid and issued to the Company Shareholders and Company Option Holders hereunder. The amount of any such reduction is referred to herein as the “ Closing Date Cash Adjustment Amount ”.

          (f) Merger Co., First Surviving Corporation and Acquisition Co. Capital Stock . At the Effective Time by virtue of the Reverse Merger, each share of common stock, par value $0.01 per share, of Merger Co. outstanding immediately prior to the Effective Time shall be automatically converted into and become one fully paid and non-assessable share of common stock, par value $0.01 per share, of the First Surviving Corporation. Each certificate evidencing ownership of shares of common stock of Merger Co. shall thereafter evidence ownership of shares of common stock of First Surviving Corporation. At the Second Effective Time by virtue of the Forward Merger, each share of common stock, par value $0.01 per share, of First Surviving Corporation outstanding immediately prior to the Second Effective Time shall be automatically canceled without any consideration or other payment therefore. At the Second Effective Time by virtue of the Forward Merger, each share of common stock, par value $0.01 per share, of Acquisition Co. outstanding immediately prior to the Second Effective Time shall be automatically converted into and become one fully paid and non-assessable share of common stock, par value $0.01 per share, of the Surviving Corporation. Each certificate evidencing ownership of shares of common stock of Acquisition Co. shall thereafter evidence ownership of shares of common stock of Surviving Corporation.

     2.2 Options and Warrants . All options, warrants, or other rights to purchase shares of Company Capital Stock (each, a “ Company Option ”) which are outstanding immediately prior to the Effective Time shall not be assumed by Parent, First Surviving Corporation or Surviving Corporation and shall therefore become, pursuant to their respective terms, fully vested and exercisable prior to the Effective Time. Holders of Company Options shall be given the opportunity to exercise their Company Options effective prior to the Effective Time. All Company Options that remain unexercised and outstanding as of the Effective Time shall be

terminated and canceled as of the Effective Time and converted into, and represent only, the right to receive from Parent, for each share of Company Common Stock that is issuable upon full exercise of the Company Option (including, for this purpose, the number of shares of Company Common Stock that are issuable upon conversion of all shares of Company Preferred Stock that are issuable upon any exercise of a Company Option) the Closing Date Per Share Consideration and the FDA Milestone Per Share Consideration all on the terms set forth in this Article II; provided , however , that (i) there shall be deducted from the aggregate Closing Date Cash Per Share Consideration payable with respect to each Company Option, an amount equal to (A) the Closing Cash Percentage multiplied by the exercise per share price of the applicable Company Option multiplied by (B) the total number of shares of Company Common Stock issuable upon full exercise of the Company Option and (ii) there shall be deducted from the aggregate Closing Date Stock Per Share Consideration payable with respect to each Company Option a number of shares of Parent Common Stock that have a value (based on the Applicable Denominator) equal to (C) the Closing Stock Percentage multiplied by the exercise per share price of the applicable Company Option multiplied by (D) the total number of shares of Company Common Stock issuable upon full exercise of the Company Option, provided further , however , that if the product of clause (A) and (B) in clause (i) is greater than the aggregate Closing Date Cash Per Share Consideration payable with respect to a Company Option, then a number of shares of Parent Common Stock that have a value (based on the Applicable Denominator) equal to the amount of the excess of the product of (A) and (B) over the aggregate Closing Date Cash Per Share Consideration payable with respect to such Company Option shall also be deducted from the aggregate Closing Date Stock Per Share Consideration payable with respect to such Company Option. Following the Effective Time, no holder of Company Options, or any participant in or beneficiary of any of the Company Benefit Plans, shall have any right to acquire or receive any equity securities or other interests in the First Surviving Corporation, Parent, Surviving Corporation or their respective Subsidiaries, or any other consideration.

     2.3 FDA Milestone Payments .

          (a) FDA Milestone Consideration Generally .

               (i)  FDA Milestone Consideration . Parent shall pay, or cause the Exchange Agent to pay, the FDA Milestone Consideration (as defined in Section 2.3(b)(ii)) to the holders of Company Common Stock entitled to such payment pursuant to Section 2.1(c) and holders of Company Options entitled to such payment pursuant to Section 2.2 (the “ Milestone Payees ”) if, and only if, the Surviving Corporation receives the PMA Letter (as defined in Section 2.3(b)(vii)) on or before December 31, 2012, in which case the FDA Milestone Consideration will become payable as set forth in this Section 2.3.

               (ii)  Payout of FDA Milestone Consideration . The amount of FDA Milestone Consideration that each Milestone Payee shall be entitled to receive hereunder, if any, shall be an amount equal to the FDA Milestone Per Share Consideration (as defined in Section 2.3(b)(iii)) for each share of Company Common Stock held, or subject to a Company Option held, by each Milestone Payee at the Effective Time.

               (iii)  FDA Milestone Consideration as Merger Consideration . The parties acknowledge and agree that the achievement by the Surviving Corporation of certain

regulatory approvals is a material factor in determining the valuation of Company by Parent. The FDA Milestone Consideration payable pursuant to this Section 2.3 does not constitute payment for services, but rather constitutes part of the merger consideration payable by Parent in connection with the Merger (the “ Merger Consideration ”) and shall be treated as such for all purposes, including for tax purposes.

               (iv)  FDA Milestone Consideration Not Transferable . No Milestone Payee may sell, exchange, transfer or otherwise dispose of his, her or its right to receive any portion of the FDA Milestone Consideration, other than with the consent of the Parent or by the laws of descent and distribution or succession. Any transfer in violation of this Section 2.3(a)(iv) shall be null and void and shall not be recognized by Parent or the Surviving Corporation.

          (b) Definitions . For purposes of this Agreement:

               (i) “ Milestone Cash Consideration ” means an amount payable in cash equal to (A) the FDA Milestone Consideration less (B) the product of (x) the number of shares that comprise the Milestone Stock Consideration multiplied by (y) the Deemed FDA Milestone Price less (C) any amount payable to Asante Partners with respect to the FDA Milestone Consideration as set forth in the waiver and release referred to in Section 5.2(i) less (D) any Milestone Cash Adjustment Amount.

               (ii) “ FDA Milestone Consideration ” means $75,000,000, subject to reduction as provided in Section 2.3(d), less any reduction as provided in Section 7.3.

               (iii) “ FDA Milestone Per Share Consideration ” means the aggregate of (A) the Milestone Stock Consideration (consisting of the number of whole shares of Parent Common Stock described in Section 2.3(b)(iv)) divided by the number of Fully Diluted Shares and (B) the Milestone Cash Consideration divided by the number of Fully Diluted Shares.

               (iv) “ Milestone Stock Consideration ” means that number of whole shares of Parent Common Stock equal to the quotient of (A) an amount equal to the Milestone Stock Percentage multiplied by the FDA Milestone Consideration, divided by (B) the greater of (i) the average of the closing prices of Company Common Stock as reported on the NASDAQ Global Select Market for the ten (10) trading days ending on the date that is two (2) Business Days prior to the Milestone Achievement Date (the “ Actual FDA Milestone Price ”) or (ii) two dollars ($2.00) (the greater of such prices, the “ Deemed FDA Milestone Price ”), payable in validly issued, fully paid and non-assessable shares of Parent Common Stock. In determining the Deemed FDA Milestone Payment, the amount of two dollars ($2.00) will be adjusted, as necessary, to take into account stock splits or reverse stock splits or any dividends of stock or rights with respect to stock that are declared or made to holders of Parent Common Stock in the period between the last measurement date for the Upfront Signing Price and the last measurement date for the Actual FDA Milestone Price.

               (v) “ Milestone Stock Percentage ” means such percentage as is selected by Parent in its sole discretion subject to the following parameters: (A) such percentage must be between (1) a percentage equal to 80% minus the Closing Stock Percentage and (2) 70%

(inclusive) and (B) if the Actual FDA Milestone Price is equal to or greater than 80% of the Upfront Signing Price, then such percentage must be at least equal to 100% minus the Closing Stock Percentage; provided, however, that in no event can the Milestone Stock Percentage be a percentage that would result in the aggregate number of shares of Parent Common Stock issued to Company Shareholders and Company Option Holders as part of the Merger Consideration to exceed a number that would require the approval of Parent’s stockholders under NASDAQ Market Place Rule 5635 (or any successor rule). In comparing the Actual FDA Milestone Price with the Upfront Signing Price, the amounts will be adjusted, as necessary, to take into account any stock splits or reverse stock splits or any dividend of stock or rights with respect to stock that are declared or made to holders of Parent Common Stock in the period between the first measurement date for the Upfront Signing Price and the last measurement date for the Actual FDA Milestone Price.

               (vi) “ Merger Stock Consideration Value ” means the aggregate value of all of the shares of Parent Common Stock issued to Company Shareholders and Company Option Holders as part of the Merger Consideration as determined by the opening price for such shares as reported on the NASDAQ Global Select Market (or such other exchange on which shares of Parent Common Stock may be traded at the time of issuance) on the date of issuance. “ Merger Consideration Value ” means the sum of Merger Stock Consideration Value and the amount of cash issued to Company Shareholders and Company Option Holders as part of the Merger Consideration, which shall include for purposes of the definition of Merger Consideration Value all amounts paid with respect to shareholders who assert dissenters rights, payments to holders of Company Preferred Stock and any and all other consideration paid to any Person in connection with the Merger by virtue of such Person’s holdings of shares of Company Capital Stock or options or warrants to acquire shares of Company Capital Stock, exclusive of any amounts considered to be imputed interest with respect to the payment of any FDA Milestone Consideration.

               (vii) “ PMA Letter ” shall mean a letter issued by the United States Food and Drug Administration (“ FDA ”) which grants clearance or premarket approval for the sale of the Pipeline device in the United States with an indication to treat any subset of intracranial aneurysms, provided that such letter does not impose material restrictions that severely diminish the long term commercial viability of the Pipeline device in the United States, it being understood that none of the following conditions contained in the letter will be deemed to severely diminish the long term commercial viability of the Pipeline device in the United States: (a) the standard conditions (Conditions of Approval) found in all medical device premarket approval and 510(k) clearance letters, as the case may be, issued by the FDA, (b) warnings, cautions, precautions and contraindications that are customary or reasonable given the nature and purpose of the Pipeline device that don’t otherwise, individually or in the aggregate, severely diminish the long term commercial viability of the Pipeline device in the United States, (c) a requirement that a post approval study be conducted on the Pipeline device, (d) a requirement that physicians who will be working with the Pipeline device receive reasonable training with respect to the device, or (e) a requirement that only physicians with expertise in neurovascular procedures use the device. In the event that the FDA issues a letter which does not satisfy the definition of PMA Letter above, then the obligations of the parties under this Agreement to continue to attempt to obtain the PMA Letter shall continue in accordance with the terms of this Agreement.

          (c) Potential Adjustment to Milestone Cash Consideration . In the event that the Merger Stock Consideration Value would constitute less than 40% of the aggregate Merger Consideration Value to be paid and issued to the Company Shareholders and Company Option Holders hereunder before giving effect to this Section 2.3(c), then there shall be a reduction in the amount of cash that comprises the Milestone Cash Consideration such that, after giving effect to such reduction, the Merger Stock Consideration Value equals 40% of the aggregate Merger Consideration paid and issued to the Company Shareholders and Company Option Holders hereunder. The amount of any such reduction is referred to herein as the “ Milestone Cash Adjustment Amount ”.

          (d) Adjustments to FDA Milestone Consideration .

               (i) If the PMA Letter is issued by the FDA prior to October 1, 2011, the Milestone Payees shall be entitled to the entire FDA Milestone Consideration, which payment shall be distributed as provided in Section 2.3(e) hereof.

               (ii) If the PMA Letter is issued by the FDA on or after October 1, 2011 but on or before December 31, 2012, the FDA Milestone Consideration shall be reduced by $3,750,000 per month commencing on October 1, 2011 and calculated pro-rata on a daily basis, which net amount shall be distributed as provided in Section 2.3(e) hereof.

               (iii) If the PMA Letter is not issued by the FDA on or before December 31, 2012, no FDA Milestone Consideration shall be payable and will be deemed forfeited and retained permanently by Parent.

          (e) FDA Milestone Consideration Distributions .

               (i) If the FDA issues the PMA Letter to the Surviving Corporation on or before December 31, 2012, Parent shall, within 15 days following the date on which the FDA issues the PMA Letter (i.e., the date of the PMA Letter) (the “ Milestone Achievement Date ”), either (A) pay, or cause the Exchange Agent to pay, and distribute to each Milestone Payee in respect of each share of Company Common Stock held or subject to a Company Option held, by such Milestone Payee at the Effective Time, the FDA Milestone Per Share Consideration, or (B) if there is a setoff pursuant to Section 7.3 or a deferment pursuant to Section 2.3(e)(ii), (I) deliver a notice to the Shareholder Representative specifying (1) the amount of FDA Milestone Consideration due and payable, (2) the amount of the offset pursuant to Section 7.3 or the amount of the deferment pursuant to Section 2.3(e)(ii) and a reasonably detailed explanation of any such offset or deferment, and (3) the net aggregate amount of FDA Milestone Consideration, if any, to be distributed to the Milestone Payees with respect to such notice (such notice an “ FDA Milestone Notice ”), and (II) pay, or cause the Exchange Agent to pay, and distribute to each Milestone Payee in respect of each share of Company Common Stock held, or subject to a Company Option held, by such Milestone Payee at the Effective Time, the FDA Milestone Per Share Consideration payable as set forth in such FDA Milestone Notice, if any.

               (ii) Parent’s obligation to pay the Milestone Cash Consideration as described herein is subject to the following conditions: (A) as of the Milestone Achievement Date, Parent has a cash and cash equivalents balance of at least $75,000,000 (the “ Deferral Cash

Threshold ”); (B) such payment would not cause an “event of default” or otherwise cause Parent to become in material default under any of its credit facilities with a balance owing in excess of $3,000,000; and (C) the Board of Directors of Parent reasonably determines, based on a written analyses provided by a nationally recognized investment banking firm after giving the Shareholder Representative the opportunity to consult with the investment banking firm performing such analyses, that such payment would not be viewed as materially adverse to its business. The Deferral Cash Threshold shall be reduced in an amount equal to the aggregate of (a) the purchase price of any acquisition of another entity (including any acquisition of another entity via a purchase of assets) undertaken by Parent, or any of its affiliates (including without limitation the Surviving Corporation), including without limitation by means of a merger, reorganization, share exchange, consolidation, business combination, recapitalization, liquidation, dissolution or similar transaction or any purchase or sale of, or tender or exchange offer for, voting securities that, if consummated, would result in Parent, and/or any of its affiliates (including without limitation the Surviving Corporation), beneficially owning securities representing 15% or more of the total voting power of another entity, or the sale, license or disposition of any material portion of the assets of another entity to Parent, or any of its affiliates (including without limitation the Surviving Corporation); (b) any distributions by Parent, or any of its affiliates (including without limitation the Surviving Corporation), to holders of its securities (including debt securities) or prepayment by Parent, or any of its affiliates (including without limitation the Surviving Corporation), of any note, bond, debt security, indebtedness for borrowed money or any capitalized lease obligation; and (c) any extraordinary capital expenditures by Parent that are not made to accommodate planned growth, replace existing equipment or fixtures or in relation to the business of the Surviving Corporation; in any of the cases described in (a), (b) and (c) only to the extent that such amounts individually exceed $3,000,000 or in the aggregate exceed $5,000,000 and are undertaken during the period from the Closing Date until the earlier of (A) the Milestone Achievement Date and (B) December 31, 2012. In the event all of the foregoing conditions are not satisfied at the time the FDA Milestone Consideration is payable, Parent may at its option defer up to $30,000,000 of the Milestone Cash Consideration until the earlier of (1) the first date that any of the conditions set forth above is satisfied or (2) twelve (12) months following the Milestone Achievement Date. Any amounts so deferred shall accrue interest at a rate of 8.0% per annum.

     2.4 Exchange Agent; Exchange of Certificates .

          (a) Prior to the Effective Time, Parent shall designate a bank or trust company reasonably acceptable to Company (the “ Exchange Agent ”) for the purpose of exchanging certificates which, immediately prior to the Effective Time, represented shares of Company Capital Stock (the “ Company Certificates ”), and Company Options for the Liquidation Preference Payment or Per Share Merger Consideration, as the same may become payable from time to time pursuant to the provisions of this Article II, pursuant to an agreement between Parent and the Exchange Agent. The fees and expenses of the Exchange Agent shall be paid by Parent.

          (b)  Deposit of Merger Consideration; Adjustment to Closing Date Cash Consideration . On or before the Closing Date, Parent shall deposit, or shall cause to be deposited, with the Exchange Agent, for the benefit of the shareholders of Company as of the Effective Time (the “ Company Shareholders ”) and holders of Company Options as of the

Effective Time (the “ Company Option Holders ”) (A) cash in an amount sufficient to pay to all Company Shareholders and Company Option Holders the aggregate Closing Date Cash Consideration (or any Liquidation Preference Payment payable in cash) together with any cash to be paid in lieu of fractional shares with respect to the Closing Date Stock Consideration pursuant to Section 2.8 and (B) certificates or, at Parent’s option, evidence of shares in book entry form, representing shares of Parent Common Stock that comprise the Closing Date Stock Consideration (or any Liquidation Preference Payment payable in stock) (the “ Parent Certificates ”). Notwithstanding the foregoing, however, the Closing Date Cash Consideration and the Closing Date Stock Consideration to be deposited with the Exchange Agent under and paid to the Company Shareholders and Company Option Holders following the Effective Time as provided herein will be calculated based on the Estimated Closing Cash and the Estimated Indebtedness, and the Closing Date Cash Consideration to be deposited with the Exchange Agent following the Effective Time will be subject to true up as provided in Section 2.5. Such Parent Certificates and such cash so deposited, together with any dividends or distributions with respect thereto, are hereinafter referred to as the “ Exchange Fund ”.

          (c)  Exchange Procedures . Parent will cause the Exchange Agent to send to each Company Shareholder or Company Option Holder within five Business Days after the Effective Time (i) a letter of transmittal (which shall specify that delivery shall be effected, and risk of loss and title to the Company Certificates shall pass, only upon delivery of the Company Certificates to the Exchange Agent and shall be in such form and have such other provisions as Parent and Company may reasonably specify), and (ii) instructions to effect the surrender of the Company Certificates in exchange for, or for the Company Option Holders to receive payment of, the Liquidation Preference Payment or Per Share Merger Consideration, as applicable. Until surrendered as contemplated by this Section 2.4(c), each Company Certificate, or until the Exchange Agent receives a duly completed and signed letter of transmittal, each Company Option, shall be deemed at any time after the Effective Time to represent only the right to receive upon such surrender the Liquidation Preference Payment or the Per Share Merger Consideration, as the same may become payable from time to time pursuant to the provisions of this Article II. Except pursuant to Section 2.3(e)(ii), no interest will be paid or will accrue on any cash payable to holders of Company Certificates or Company Options under the provisions of this Article II.

          (d)  Transfers . In the event that a transfer of ownership of shares of Company Capital Stock is not registered in the stock transfer books or ledger of Company, or if any Parent Certificate for the portion of the Liquidation Preference Payment or the Per Share Merger Consideration payable in stock is to be issued in a name other than that in which the Company Certificate surrendered in exchange therefor is registered, it shall be a condition to the issuance thereof that the Company Certificates so surrendered shall be properly endorsed or otherwise be in proper form for transfer and that the Person requesting such exchange shall have paid to the Exchange Agent any transfer or other taxes required as a result of the issuance of a Parent Certificate in any name other than that of the registered holder of such shares of Company Capital Stock or Company Option, or establish to the satisfaction of the Exchange Agent that such tax has been paid or is not payable. For purposes of this Agreement, “ Person ” means an individual, a corporation, a limited liability company, a partnership, an association, a trust or any other entity or organization, including a government or political subdivision or any agency or instrumentality thereof.

          (e)  Tax Withholding . Each of the Exchange Agent, the Surviving Corporation and Parent shall be entitled to deduct and withhold from the Liquidation Preference Payment or Per Share Merger Consideration otherwise payable to any Company Shareholder or Company Option Holder, such amounts as the Exchange Agent, the Surviving Corporation or Parent is required to deduct and withhold with respect to the making of such payment under the Code, or any provision of United States federal, state or local tax law or any other non-U.S. tax law or any other applicable legal requirement. To the extent that amounts are so withheld by the Exchange Agent, the Surviving Corporation or Parent, such amounts withheld from the Liquidation Preference Payment or Per Share Merger Consideration and other such amounts payable under Section 2.4(e) shall be treated for all purposes of this Agreement as having been received by the Company Shareholder or Company Option Holder in respect of which such deduction and withholding was made by the Exchange Agent, the Surviving Corporation or Parent. Any amounts withheld pursuant to this provision will be promptly paid to the relevant federal, state or local or other non-U.S. tax authority, and the withholding party shall provide evidence of such payment to the Shareholder Representative upon request.

          (f)  Distributions with Respect to Unexchanged Shares . No dividends or other distributions with respect to Parent Common Stock with a record date on or after the Effective Time, or that are payable to the holders of record thereof who become such on or after the Effective Time, shall be paid to the holder of any unsurrendered Company Certificate or to the holder of any Company Option that has not submitted a duly completed and signed letter of transmittal for payment therefor until those certificates are surrendered or until duly completed and signed letters of transmittal are submitted as provided in this Article II. All such dividends, other distributions and cash in lieu of fractional shares of Parent Common Stock which are to be paid in respect of the shares of Parent Common Stock to be received upon surrender of the Company Certificate or upon receipt of such letter of transmittal shall be paid by Parent to the Exchange Agent and shall be included in the Exchange Fund, in each case until the surrender of such Company Certificate or receipt of such letter of transmittal in accordance with this Article II. Subject to the effect of applicable escheat or similar Applicable Laws and Applicable Laws with respect to the withholding of taxes, following surrender of any such certificate there shall be paid to the holder of the Parent Certificate representing whole shares of Parent Common Stock issued in exchange therefor, without interest (i) at the time of such surrender, the amount of dividends or other distributions with a record date after the Effective Time previously paid with respect to such whole shares of Parent Common Stock and the amount of any cash payable in lieu of a fractional share of Parent Common Stock to which such holder is entitled pursuant to Section 2.8 and (ii) at the appropriate payment date, the amount of dividends or other distributions with a record date after the Effective Time but prior to such surrender and with a payment date subsequent to such surrender payable with respect to such whole shares of Parent Common Stock.

          (g)  No Further Rights in Company Capital Stock . All Parent Common Stock issued and cash paid upon surrender of a Company Certificate or upon delivery of a duly completed and signed letter of transmittal with respect to a Company Option in accordance with the terms of this Article II and any cash paid pursuant to Section 2.4(f) or Section 2.8 shall be deemed to have been issued in full satisfaction of all rights pertaining to the Company Capital Stock or Company Options formerly represented by such certificate or option.

          (h)  Termination of Exchange Fund . Any portion of the Exchange Fund which remains undistributed to the holders of the Company Certificates or Company Options for one year after the Effective Time shall be delivered to Parent upon demand, and any holders of Company Capital Stock or Company Options who have not theretofore complied with this Article II shall thereafter look only to Parent for payment of Liquidation Preference Payment or Per Share Merger Consideration payable with respect to their shares of Company Capital Stock or Company Options pursuant to this Article II and any dividends or distributions with respect to shares of Parent Common Stock to which they are entitled pursuant to Section 2.4(f).

          (i)  Closing of Transfer Books . At the Effective Time, the stock transfer books of Company shall be closed, and there shall be no further registration of transfers of shares of Company Capital Stock that were outstanding immediately prior to the Effective Time thereafter on the transfer books of the Surviving Corporation. From and after the Effective Time, the holders of Company Certificates representing shares of Company Capital Stock outstanding immediately prior to the Effective Time shall cease to have any rights with respect to such shares, except as otherwise provided in this Agreement or by Applicable Law. On or after the Effective Time, any Company Certificates presented to the Exchange Agent or Parent for any reason shall be canceled and converted in accordance with the terms of this Article II.

          (j)  Investment of Exchange Fund . The Exchange Agent shall invest all cash included in the Exchange Fund as directed by Parent. Any interest and other income resulting from such investments shall be paid to Parent.

          (k)  Lost, Stolen or Destroyed Certificates . If any Company Certificates has been lost, stolen or destroyed, the Exchange Agent will be authorized to pay the Liquidation Preference Payment or Per Share Merger Consideration, as applicable and as the same may become payable from time to time pursuant to this Article II, attributable to any such Company Certificate upon receipt of satisfactory evidence of ownership of the shares of Company Capital Stock represented thereby and of appropriate indemnification. Neither Parent nor the Surviving Corporation will be liable to any Company Shareholder or Company Option Holder for any portion of the Merger Consideration delivered to a public official pursuant to any applicable abandoned property, escheat or similar Applicable Laws.

     2.5 Adjustments to Closing Date Merger Consideration .

          (a)  Estimated Closing Amounts . Company will prepare and deliver to Parent not less than three (3) or more than ten (10) Business Days prior to the anticipated Closing Date, a statement which will set forth a good faith estimate of (i) the amount of cash and cash equivalents held by the Company, as of the anticipated Closing Date (the “ Estimated Closing Cash ”), and (ii) the Indebtedness of Company as of the anticipated Closing Date (the “ Estimated Indebtedness ”).

          (b)  Final Closing Amounts . The Surviving Corporation will prepare and deliver to the Shareholder Representative within 30 days after the Closing Date, a statement (the “ Closing Statement ”) (i) setting forth (A) the amount of cash and cash equivalents held by Company as of the Closing Date (the “ Closing Cash ”), and (B) the Indebtedness of Company as

of the Closing Date (the “ Closing Indebtedness ”), and (ii) setting forth the amount of any required adjustments pursuant to this Section 2.5.

          (c)  Post-Closing Cash Adjustment .

               (i) If the Closing Cash is less than the Estimated Closing Cash, there shall be a negative true-up adjustment in an amount equal to the difference between the Closing Cash and the Estimated Closing Cash.

               (ii) If the Closing Cash is greater than the Estimated Closing Cash, there shall be a positive true-up adjustment in an amount equal to the difference between the Closing Cash and the Estimated Closing Cash.

          (d) Post-Closing Indebtedness Adjustment .

               (i) If the Closing Indebtedness is less than the Estimated Indebtedness, there shall be a positive true-up adjustment in an amount equal to the difference between the Closing Indebtedness and the Estimated Indebtedness.

               (ii) If the Closing Indebtedness is greater than the Estimated Indebtedness, there shall be a negative true-up adjustment in an amount equal to the difference between the Closing Indebtedness and the Estimated Indebtedness.

          (e)  Review by Shareholder Representative . The Shareholder Representative shall have 30 days after the receipt of the Closing Statement to review the Closing Statement and all work papers and other documents generated or reviewed by the Surviving Corporation in connection with the preparation of the Closing Statement, and all books and records of the Surviving Corporation related to the Closing Statement (the “ Statement Review Period ”). If, within the Statement Review Period, the Shareholder Representative disputes any item(s) on the Closing Statement, the Shareholder Representative shall give Parent written notice of such disagreement specifically identifying the item(s) and amount(s) in dispute and the basis for such dispute (the “ Dispute Notice ”). The parties shall use reasonable efforts to reach agreement with respect to such disputed items within 10 days following the delivery of the Dispute Notice, or such longer period as may be agreed upon in writing by the parties (the “ Resolution Period ”). Any item(s) on or omitted from the Closing Statement not specifically identified in writing as a disputed item before the end of the Statement Review Period shall be deemed to have been accepted by the Shareholder Representative and shall not be subject to any further dispute, review or change. If the parties fail to resolve any such disputes with respect to the Closing Statement within the Resolution Period, the disputed item(s) shall be resolved and, as a result thereof, the amount of the Closing Cash or Closing Indebtedness, as the case may be, shall be definitely and finally determined using the Financial Issue Resolution Process set forth in Section 2.5(f).

          (f)  Financial Issue Resolution Process . Disputes between Parent and the Shareholder Representative relating to accounting matters under Section 2.5 of this Agreement that cannot be resolved by negotiation in accordance with Section 2.5(e) shall be definitely and finally determined by a nationally or regionally recognized firm of independent public accountants agreed upon by both Parent and the Shareholder Representative (the “ Accounting

Firm ”), who shall act as experts as to accounting matters and not as arbitrators and whose determination shall be final and binding strictly with respect to matters dependent only on accounting issues. Parent and the Shareholder Representative shall select, by mutual agreement, the Accounting Firm if the stated accounting firm is unwilling to serve, and the Accounting Firm shall have agreed in writing to serve in such capacity pursuant to the terms herein described, within 10 days following the end of the applicable resolution period described in Section 2.5(e). The resolution of any disputed item(s) as to accounting matters and the determination of the Closing Cash or the Closing Indebtedness, as the case may be, shall be completed by the Accounting Firm within 30 days following the time the dispute is submitted to it. The Accounting Firm’s determination of the Closing Cash and Closing Indebtedness shall be completed in a manner consistent with GAAP as applied by Company in accordance with past practices. The fees and expenses associated with the Accounting Firm’s determination shall be allocated between Parent and Surviving Corporation, on the one hand, and the Company Shareholders, on the other hand, based on the percentage which the portion of the contested amount not awarded of such party bears to the amount actually contested by such party.

          (g)  Payment of True Up Amount . After the amount of the Closing Cash and Closing Indebtedness has been finally determined in accordance with Section 2.5(e) or Section 2.5(f), there shall be one true-up adjustment made based on the net of all of the adjustments contemplated by subsections (c) and (d) under Section 2.5. If such net adjustment is a positive amount (the “ Additional Consideration ”), Parent shall pay such Additional Consideration, which amount shall be made in all cash, into the account in which the Exchange Fund is maintained and thereafter such amount shall be considered part of the Exchange Fund. If such net adjustment is a negative amount (the “ Negative Adjustment ”), Parent shall be entitled to indemnification pursuant to Section 7.2 in the amount of the Negative Adjustment, less the amount of any payments received by Parent for the Negative Adjustment, in whole or in part, pursuant to any other contractual arrangement for payment of the Negative Adjustment, in whole or in part, to Parent (the “ Negative Adjustment Shortfall ”). Any payment by Parent into the account in which the Exchange Fund is maintained shall be made within five Business Days following agreement on or final determination of such amount. After such payment is made, the Shareholder Representative and Parent shall cause the Exchange Agent to pay any amount in the Exchange Fund to the Company Shareholders and Company Option Holders entitled to such amounts pursuant to this Article II. Any expenses of the Accounting Firm that are to be borne by the Company Shareholders shall be satisfied by indemnification pursuant to Section 7.2.

     2.6 Intentionally Omitted.

     2.7 Intentionally Omitted.

     2.8 No Fractional Shares . Notwithstanding any provision herein to the contrary, no certificates representing less than one share of Parent Common Stock shall be issued in exchange for shares of Company Capital Stock or Company Options upon the surrender for exchange of a Company Certificate or upon the delivery of a letter of transmittal with respect to a Company Option. In lieu of any such fractional share, each holder of shares of Company Capital Stock or Company Options who would otherwise have been entitled to a fraction of a share of Parent Common Stock upon surrender of a Company Certificate for exchange (or in the case of a lost, stolen or destroyed certificate, upon delivery of an affidavit in the manner provided in Section

2.4(k)) or upon delivery of a letter of transmittal with respect to a Company Option shall be paid upon such surrender or delivery (and after taking into account and aggregating shares of Company Capital Stock or Company Options represented by all Company Certificates surrendered by or Company Options held by such holder) cash (without interest) in an amount equal to the product obtained by multiplying (a) the fractional share interest to which such holder (after taking into account and aggregating all shares of Company Capital Stock or Company Options represented by all Company Certificates surrendered by or Company Options held by such holder) would otherwise be entitled by (b) the Applicable Denominator (in the case of the Closing Date Per Share Consideration) or the Deemed FDA Milestone Price in the case of the FDA Milestone Per Share Consideration.

     2.9 Dissenting Shares . Notwithstanding any provision of this Agreement to the contrary, shares of Company Capital Stock that are issued and outstanding immediately prior to the Effective Time and that are held by a holder of such shares of Company Capital Stock who properly exercises appraisal rights with respect thereto in accordance with CCC (such shares, the “ Dissenting Shares ”) shall not be converted into or represent the right to receive the consideration provided for above, and the holder of such Dissenting Shares will be entitled only to such rights as are granted by the CCC unless and until such holder fails to perfect or effectively withdraws or loses such holder’s right to appraisal and payment under the CCC. Company shall give prompt notice to Parent of any demands received by Company for appraisals of shares of Company Capital Stock. Parent shall have the right to control all negotiations and proceedings with respect to demands for appraisal under the CCC. Company shall not, except with the prior written consent of Parent which shall not be unreasonably withheld, conditioned or delayed, make any payment with respect to any demands for appraisal or offer to settle or settle any such demands.

     2.10 Adjustments . If at any time during the period between the date of this Agreement and the Effective Time, any change in the outstanding shares of capital stock of Parent or Company shall occur as a result of any reclassification, recapitalization, stock split (including a reverse stock split) or combination, exchange or readjustment of shares, or any stock dividend or stock distribution with a record date during such period, the Merger Consideration, and any other items similarly dependent on the outstanding shares of capital stock of Parent or Company, as the case may be, shall be equitably adjusted; provided , however , that nothing contained herein shall be deemed to permit any action that Parent is otherwise prohibited from taking pursuant to this Agreement.

     2.11 Shareholder Representative .

          (a) Immediately prior to the Effective Time, each Company Shareholder and Company Option Holder hereby irrevocably constitutes and appoints CMT SR, Inc. as her, his or its Shareholder Representative as the true and lawful agent and attorney-in-fact of such Company Shareholder and/or Company Option Holder with full powers of substitution to act in the name, place and stead of such Company Shareholder and/or Company Option Holder with respect to the performance, and exercise of any rights and obligations, on behalf of such Company Shareholder and/or Company Option Holder under the terms and provisions of this Agreement, as the same may be from time to time amended, and to do or refrain from doing all such further acts and things, and to execute all such documents on such Company Shareholder’s and/or

Company Option Holder’s behalf, as the Shareholder Representative shall deem necessary or appropriate in connection with any of the transactions contemplated under this Agreement, including:

               (i) execute and deliver this Agreement (and any amendments hereto),

               (ii) take all actions required, or agree upon or compromise any matter related to the calculation of any true-up adjustments described in Section 2.5, or pursuant to the terms hereof or other payments to be made in respect of the transactions contemplated by this Agreement, including the Merger,

               (iii) to do or refrain from doing any act or deed in respect of the exchange procedures contemplated by Section 2.4 or related thereto,

               (iv) give and receive notices and communications and receive service of process on behalf of each of the Company Shareholders and Company Option Holders,

               (v) act on behalf of the Company Shareholders and Company Option Holders with respect to all indemnification matters referred to in this Agreement, including the right to compromise on behalf of such Company Shareholder and/or Company Option Holder any indemnification claim made by or against such Company Shareholder and/or Company Option Holder involving this Agreement,

               (vi) act for the Company Shareholders and Company Option Holders with respect to all post-Closing matters, including without limitation pursuing any claim for any alleged breach of this Agreement by Parent,

               (vii) terminate, amend, or waive any provision of this Agreement; provided that any such action, if material to the rights and obligations of such Company Shareholders and Company Option Holders in the reasonable judgment of the Shareholder Representative, shall be taken in the same manner with respect to all such Company Shareholders and Company Option Holders, unless otherwise agreed by each such Company Shareholder or Company Option Holder who is subject to any disparate treatment of a potentially adverse nature,

               (viii) employ and obtain the advice of legal counsel, accountants and other professional advisors as the Shareholder Representative, in its sole discretion deems necessary or advisable in the performance of its duties as the Shareholder Representative and to rely on their advice and counsel,

               (ix) incur expenses, including fees of brokers, attorneys and accountants incurred pursuant to the transactions contemplated by this Agreement, including the Merger, and any other fees and expenses allocable or in any way relating to the transactions contemplated by this Agreement, including the Merger, or any indemnification claim, whether incurred prior or subsequent to Closing, and

               (x) to do or refrain from doing any further act or deed on behalf of the Company Shareholders and Company Option Holders that the Shareholder Representative deems

necessary or appropriate in his or her discretion relating to or arising out of the subject matter of this Agreement as fully and completely as any of such Company Shareholders and Company Option Holders could do if personally present and acting.

          (b) The appointment of the Shareholder Representative shall be deemed coupled with an interest and shall be irrevocable, and any other Person may conclusively and absolutely rely, without inquiry, upon any actions of the Shareholder Representative as the acts of the Company Shareholders and Company Option Holders hereunder appointing the Shareholder Representative and Company Option Holders in all matters referred to in this Agreement. Each of the Company Shareholders and Company Option Holders appointing the Shareholder Representative hereby ratifies and confirms all that the Shareholder Representative shall do or cause to be done by virtue of such Shareholder Representative’s appointment as Shareholder Representative of such Company Shareholder and/or Company Option Holder. The Shareholder Representative shall act for the Company Shareholders and Company Option Holders appointing the Shareholder Representative as well as all Company Option Holders on all of the matters set forth in this Agreement in the manner the Shareholder Representative believes to be in the best interest of such Company Shareholders and Company Option Holders, but the Shareholder Representative shall not be responsible to any Company Shareholders or Company Option Holders for any loss or damage any Company Shareholders or Company Option Holders may suffer by reason of the performance by the Shareholder Representative of such Shareholder Representative’s duties under this Agreement, other than loss or damage arising from willful misconduct in the performance of such Shareholder Representative’s duties under this Agreement.

          (c) From and after the Effective Time, the Shareholder Representative, and only the Shareholder Representative, is authorized to act on behalf of all Company Shareholders and Company Option Holders notwithstanding any dispute or disagreement among Company Shareholders or Company Option Holders. Any Company Shareholder or Company Option Holder shall be entitled to rely on any and all actions taken by the Shareholder Representative under this Agreement without liability to, or obligation to inquire of, any Company Shareholders or Company Option Holders. If the Shareholder Representative resigns or ceases to function in such capacity for any reason whatsoever, then the successor Shareholder Representative shall be the Person appointed by the Company Shareholders and Company Option Holders holding a majority of the Company Common Stock at the Closing (assuming that all Company Options had been then exercised); provided that if for any reason no successors have been appointed within 30 days, then any Company Shareholder or Company Option Holder shall have the right to petition a court of competent jurisdiction for appointment of a successor Shareholder Representative.

          (d) From and after the Effective Time, only the Shareholder Representative may (i) bring any action against Parent or the Surviving Corporation based on any claim that relates to or arises out of the Agreement or (ii) otherwise assert any rights of any of the Company Shareholders or Company Option Holders under this Agreement.

          (e) The Shareholder Representative shall retain $100,000 of the Closing Date Cash Consideration in order to pay for expenses incurred in connection with the Shareholder Representative’s duties (the “ Representative Funds ”). The Exchange Agent Agreement shall

provide that the Shareholder Representative may remit any unused funds to the Exchange Agent for distribution among the Company Shareholders and Company Option Holders.

ARTICLE III.
Representations and Warranties

     3.1 Representations and Warranties of Company . Except with respect to any subsection of this Section 3.1, as set forth in the correspondingly identified subsection of the disclosure schedule delivered by Company to Parent concurrently herewith (the “ Company Disclosure Schedule ”) (it being understood by the parties that the information disclosed in one subsection of the Company Disclosure Schedule shall be deemed to be included in each other subsection of the Company Disclosure Schedule in which the relevance of such information thereto would be readily apparent on the face thereof), Company represents and warrants to Parent as follows:

          (a) Organization, Standing and Power . Company is a corporation duly organized, validly existing and in good standing under the laws of the State of California, has all requisite power and authority to own, lease and operate its properties and to carry on its business as now being conducted, and is duly qualified and in good standing to do business in each jurisdiction in which the nature of its business or the ownership or leasing of its properties makes such qualification necessary, other than in such other jurisdictions where the failure so to qualify and be in such standing would not, either individually or in the aggregate, reasonably be expected to have a material adverse effect on Company. The Articles of Incorporation and By-laws of Company, copies of which were previously made available to Parent, are true, complete and correct copies of such documents as in effect on the date of this Agreement. Company does not have any Subsidiary. For purposes of this Agreement,

               (i) the word “ Subsidiary ” when used with respect to any party, means any corporation or other organization, whether incorporated or unincorporated, (x) 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 (y) at least a majority of the securities or other interests of which, that have 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;

               (ii) any reference to any event, change or effect being “ material ” with respect to any entity means an event, change or effect which is material in relation to the financial condition, properties, assets, liabilities, businesses or results of operations of such entity taken as a whole; and

               (iii) the term “ material adverse effect ” means, with respect to any entity, any occurrence, condition, change, event or development, or series of any of the foregoing that, individually or in the aggregate, is or is reasonably likely to be materially adverse to the business, assets (including intangible assets), capitalization, financial condition or results of operations of such entity; provided that, for purposes of paragraph (ii) above and this paragraph

(iii), the following shall not be deemed “material” or to have a “material adverse effect”: any change or event caused by or resulting from (1) changes in prevailing economic or market conditions in the United States or any other jurisdiction in which such entity has substantial business operations (except to the extent those changes have a materially disproportionate effect on such entity), (2) changes or events, after the date hereof, affecting the industries in which such entity operates generally (except to the extent those changes or events have a materially disproportionate effect on such entity), (3) changes, after the date hereof, in GAAP or requirements applicable to such entity (except to the extent those changes have a materially disproportionate effect on such entity), (4) changes, after the date hereof, in laws, rules or regulations of general applicability or interpretations thereof by any Governmental Entity (except to the extent those changes have a materially disproportionate effect on such entity), (5) the execution, delivery and performance of this Agreement or the consummation of the transactions contemplated hereby or thereby or the announcement thereof, or (6) any outbreak of major hostilities in which the United States is involved or any act of terrorism within the United States or directed against its facilities or citizens wherever located except to the extent such activities have directly impacted the facilities of the Company or Parent; provided , further , that in no event shall a change in the trading prices of a party’s capital stock, by itself, be considered material or constitute a material adverse effect; and provided , further , that in no event shall the following be considered material or constitute a material adverse effect with respect to the Company: any actions, suits or claims brought after the date of this Agreement which the Parent and Company reasonably and mutually agree, with advice of counsel, to have little or no merit.

          (b) Capital Structure .

               (i) The authorized capital stock of Company consists, or will consist immediately prior to Closing, of 10,000,000 shares of Company Common Stock, 2,272,622 shares of Series A Preferred Stock, 1,250,000 shares of Series B Preferred Stock, 1,600,000 shares of Series C Preferred Stock and no shares of undesignated Company Preferred Stock. As of the date of this Agreement and immediately prior to the Closing, (A) 3,138,198 shares of Company Common Stock were issued and outstanding, (B) 2,261,622 shares of Series A Preferred Stock were issued and outstanding, (C) 1,250,000 shares of Series B Preferred Stock were issued and outstanding, (D) 1,240,694 shares of Series C Preferred Stock were issued and outstanding, and (E) no shares of Company Capital Stock were held by Company in its treasury. All outstanding shares of Company Common Stock and Company Preferred Stock have been duly authorized and validly issued, are fully paid and, except as set forth in the CCC, non-assessable and are not subject to preemptive rights, and were issued in compliance with all Applicable Laws. The Company Capital Stock are held of record by the Persons and in the class, series and amounts with the corresponding certificate numbers set forth in Section 3.1(b)(i) of the Company Disclosure Schedule.

               (ii) The Company has reserved for issuance 1,449,112 shares of Company Common Stock for issuance to officers, directors, employees and consultants to the Company pursuant to the 2004 Stock Option/Stock Issuance Plan duly adopted by the Board of Directors. Of such reserved shares of Company Common Stock and as of the date hereof, options to purchase 872,017 shares have been granted and are currently outstanding. Section 3.1(b)(ii) of the Company Disclosure Schedule contains a complete and accurate list of

each outstanding option, including the holder, number of shares of Company Common Stock subject thereto, exercise price and vesting schedule (the “ Outstanding Company Options ”).

               (iii) The Company has reserved for issuance 51,250 shares of Company Common Stock pursuant to outstanding warrants exercisable for shares of Company Common Stock with an exercise price of $0.15 per share, and has reserved for issuance 102,547 shares of Series C Preferred Stock pursuant to outstanding warrants exercisable for shares of Series C Preferred Stock with an exercise price of $6.8733 per share. Section 3.1(b)(iii) of the Company Disclosure Schedule contains a complete and accurate list of each outstanding warrant, including the holder, number of shares of Company Capital Stock subject thereto, exercise price, and vesting schedule (the “ Company Warrants ”). There are no Company Options granted and outstanding other than the Outstanding Company Options and the Company Warrants.

               (iv) No bonds, debentures, notes or other indebtedness having the right to vote (or convertible into, or exchangeable for, securities having the right to vote) on any matters on which shareholders may vote (“ Voting Debt ”) of Company are issued or outstanding.

               (v) Except for (A) this Agreement and (B) the Outstanding Company Options and Company Warrants specified in paragraphs (ii) and (iii) above, there are no options, warrants, calls, rights, commitments or agreements of any character to which Company is a party or by which it is bound obligating Company to issue, deliver or sell, or cause to be issued, delivered or sold, additional shares of capital stock, Voting Debt or stock appreciation rights of Company or obligating Company to grant, extend or enter into any such option, warrant, call, right, commitment or agreement. Except in accordance with the terms of Outstanding Company Options and Company Warrants, there are no outstanding contractual obligations of Company (x) to repurchase, redeem or otherwise acquire any shares of capital stock of Company, or (y) pursuant to which Company is or could be required to register shares of Company Common Stock or other securities under the Securities Act of 1933, as amended (the “ Securities Act ”).

               (vi) since the date of this Agreement, Company has not except as disclosed on Section 3.1(b)(vi) of the Company Disclosure Schedule, (A) issued or permitted to be issued any shares of capital stock, stock appreciation rights or securities exercisable or exchangeable for or convertible into shares of capital stock of Company; (B) repurchased, redeemed or otherwise acquired, any shares of capital stock of Company; or (C) declared, set aside, made or paid to the Company Shareholders dividends or other distributions on the outstanding shares of capital stock of Company.

               (vii) There are no shareholder agreements, voting trusts or other agreements or understandings to which the Company is a party or by which it is bound relating to the voting or registration of any shares of capital stock of Company.

          (c) Authority .

               (i) Company has all requisite corporate power and authority to enter into this Agreement and, subject in the case of the consummation of the Merger to the adoption of this Agreement by the Required Company Shareholder Vote, to consummate the transactions contemplated hereby. The execution and delivery of this Agreement and the consummation of

the transactions contemplated hereby have been duly authorized by all necessary corporate action on the part of Company, subject in the case of the consummation of the Merger to the Required Company Shareholder Vote. This Agreement has been duly executed and delivered by Company and, assuming due authorization, execution and delivery by Parent, Merger Co. and Acquisition Co., constitutes a valid and binding obligation of Company, enforceable against Company in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equitable principles. Each Voting Agreement has been duly executed and delivered by the Company Shareholder who is a party thereto and each, assuming due authorization, execution and delivery by Parent, constitutes a valid and binding obligation of such shareholder, enforceable against he, she or it in accordance with its terms.

               (ii) The execution and delivery of this Agreement does not, and the consummation of the transactions contemplated hereby will not, (A) conflict with or violate the Articles of Incorporation or Bylaws of the Company; (B) conflict with or violate any Applicable Law applicable to the Company or by which any property or asset of the Company is bound or affected, (C) result in any violation of, or constitute a default (or an event that, with or without notice or lapse of time, or both, would become a default) under, require any consent of any Person pursuant to, give to others any right of termination, cancellation, modification or acceleration of any obligation or the loss of a material benefit under, or the creation of a lien, pledge, security interest, charge or other encumbrance on any assets pursuant to, allow the imposition of any fees or penalties under, require the offering or making of any payment or redemption pursuant to, give rise to any increased, guaranteed, accelerated or additional (any such conflict, violation, default, right of termination, cancellation, modification or acceleration, loss or creation, a “ Violation ”), rights or entitlements of any Person or (D) adversely affect any rights of the Company under, or result in the creation of any Lien on any property, asset or right of the Company pursuant to any note, bond, mortgage, indenture, agreement, lease, Company Benefit Plan, license, permit, franchise, instrument, obligation or other contract to which the Company is a party or by which the Company or any of its properties, assets or rights are bound or affected.

               (iii) No consent, approval, order or authorization of, or registration, declaration or filing with, any court, administrative agency or commission or other governmental authority or instrumentality, domestic or foreign (a “ Governmental Entity ”) is required by or with respect to Company in connection with the execution and delivery of this Agreement by Company or the consummation by Company of the transactions contemplated hereby, except for the filing of the First Agreement of Merger and Second Agreement of Merger with the Secretary of State of the State of California.

          (d) Financial Statements; Undisclosed Liabilities; Internal Controls .

               (i) Company has made available to Parent copies of (i) the audited balance sheet of Company as at December 31, 2007 and the audited balance sheet of the Company as of December 31, 2008 and the related audited statements of income, statements of shareholders’ equity and cash flows of Company for the years then ended and (ii) the unaudited balance sheet of Company and the Subsidiaries as at April 30, 2009 and the related statements of income, statements of shareholders’ equity and cash flows of Company for the 4-month period

then ended (such statements, including the related notes and schedules thereto, are referred to herein as the “ Financial Statements ”). Except as set forth in the notes thereto, each of the Financial Statements (a) has been based upon information contained in Company’s books and records, (b) present fairly in all respects the financial condition, cash flows, shareholders’ equity and results of operations of Company as of the times and for the periods referred to therein in accordance with United States generally accepted accounting principles (“ GAAP ”) (subject in the case of the April 30, 2009 financial statements, changes resulting from normal year-end adjustments, none of which are material), (c) reflect and provide in accordance with GAAP adequate reserves in respect of all known liabilities of Company, including all known contingent liabilities, and (d) do not contain any items of special or nonrecurring income or any other income not earned in the ordinary course of business except as expressly specified therein.

          For the purposes hereof, April 30, 2009 is referred to as the “ Balance Sheet Date ”.

               (ii) Company keeps books, records and accounts that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets of Company.

               (iii) Except for (A) those liabilities that are fully reflected or reserved for in the Financial Statements, (B) liabilities incurred since the Balance Sheet Date in the ordinary course of business consistent with past practice (none of which is a liability for breach of contract, breach of warranty, tort, infringement, litigation, or violation or other breach of Applicable Law), (C) liabilities that would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on Company, (D) liabilities incurred pursuant to the transactions contemplated by this Agreement, and (E) liabilities or obligations discharged or paid in full prior to the date of this Agreement in the ordinary course of business consistent with past practice, Company does not have, and since the Balance Sheet Date, Company has not incurred (except as permitted by Section 4.1), any material liabilities or obligations of any nature whatsoever (whether accrued, absolute, matured, determined, contingent or otherwise and whether or not would be required to be reflected in Company’s financial statements in accordance with GAAP).

               (iv) Company has designed and maintain a system of internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Securities and Exchange Act of 1934, as amended (the “ Exchange Act ”)) sufficient to provide reasonable assurances regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.

          (e) Compliance with Applicable Laws .

               (i) Company holds all permits, licenses, variances, exemptions, orders and approvals of all Governmental Entities which are material to the operation of the businesses of Company, taken as a whole (the “ Company Permits ”), and Company is and has been in compliance with the terms of the Company Permits and all Applicable Laws and its own privacy policies, except where the failure so to hold or comply, individually or in the aggregate, would not reasonably be expected to have a material adverse effect on Company. For purposes of this Agreement, “ Applicable Law ” means, with respect to any Person, any U.S. federal, state or local or any foreign law (in each case, statutory, common or otherwise), constitution, treaty,

convention, ordinance, code, rule, regulation, order, injunction, judgment, decree, ruling or other similar requirement enacted, adopted, promulgated or applied by a Governmental Entity that is binding upon or applicable to that Person. The business of Company is not being and has not been conducted in violation of any law, ordinance or regulation of any Governmental Entity, except for possible violations which, individually or in the aggregate, do not have, and would not reasonably be expected to have, a material adverse effect on Company.

               (ii) To the extent any product produced, manufactured, marketed or distributed at any time by Company (“ Company Product ”) is being marketed in the United States or internationally, Company has obtained all necessary approvals, certifications, authorizations, clearances, and permits of the FDA and any other Governmental Entity (“ Company Licenses ”), and is in compliance with the United States Food, Drug and Cosmetic Act, as amended (the “ FDCA ”) and comparable state laws, and with other Applicable Laws relating to the clinical study, approval/clearance, manufacturing, export, labeling, marketing and selling of medical devices except where the failure so to comply, individually or in the aggregate, would not reasonably be expected to have a material adverse effect on Company. Any modifications to any Company Product marketed by Company have been made in accordance with Applicable Laws. All manufacturing facilities producing Company Products are in compliance in all material respects with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820 as applicable, and/or European Union Quality System requirements per ISO 13485, as applicable. There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or threatened by the FDA or any other Governmental Entity with respect to any of the Company Products, including any facilities where any Company Products are produced, processed, packaged or stored. Neither the FDA nor any other Governmental Entity has served any notice, warning letter, regulatory letter, or any other similar communication stating that Company was or is or may be in violation of any law, regulation, rule, ordinance, clearance, approval, exemption, or guidance. Company has no knowledge of any pending regulatory action (other than non-material routine or periodic inspections or reviews) against Company by the FDA or any other Governmental Entity. All filings with and submissions to the FDA and any other Governmental Entity made by Company with regard to the Company Products were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. All Medical Device Reports for adverse events with respect to any Company Products required to be filed under the FDCA and FDA regulations have been filed. Company has been and is in compliance with all applicable advertising and promotional regulations promulgated in accordance with the FDCA, including but not limited to regulations relating to the unlawful promotion of medical devices for off-label uses.

               (iii) All non-clinical laboratory studies of products sponsored by Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 C.F.R. Part 58) in the U.S. and, to the extent applicable to Company, counterpart regulations in the European Union and all other countries. All clinical studies of products sponsored by Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA’s Good Clinical Practice regulations, (collectively 21 C.F.R. Parts 11, 50, 54, 56,

812 and 814) in the U.S. and, to the extent applicable to Company, counterpart regulations in the European Union and all other countries. Company has conducted all of its clinical trials with reasonable