-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OR3jRJ/3SoJnHkvB+XncW5h6ckFfWvYVneH0wG6L3HvI9AAWGHoL7tWRigspVpVX LL6Oex4/fpwu/BGzoXZ2pw== 0000950124-04-005470.txt : 20041109 0000950124-04-005470.hdr.sgml : 20041109 20041109154222 ACCESSION NUMBER: 0000950124-04-005470 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20040930 FILED AS OF DATE: 20041109 DATE AS OF CHANGE: 20041109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ORTHOLOGIC CORP CENTRAL INDEX KEY: 0000887151 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 860585310 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-21214 FILM NUMBER: 041129443 BUSINESS ADDRESS: STREET 1: 1275 WEST WASHINGTON STREET CITY: TEMPE STATE: AZ ZIP: 85281 BUSINESS PHONE: 6024375520 MAIL ADDRESS: STREET 1: 1275 WEST WASHINGTON STREET CITY: TEMPE STATE: AZ ZIP: 85281 10-Q 1 p69834e10vq.htm 10-Q e10vq
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

     
(Mark One)
 
[X]
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2004

or

     
[  ]
  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the transition period from ______ to _______

Commission File Number: 0-21214

ORTHOLOGIC CORP.


(Exact name of registrant as specified in its charter)
     
Delaware   86-0585310

 
 
 
(State of other jurisdiction of incorporation or organization)   (IRS Employer Identification No.)
     
1275 W. Washington Street, Tempe, Arizona   85281

 
 
 
(Address of principal executive offices)   (Zip Code)

(602) 286-5520


(Registrant’s telephone number, including area code)


(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes o No

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 126-2 of the Exchange Act): x Yes o No

APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

37,998,542 shares of common stock outstanding as of November 8, 2004

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ORTHOLOGIC CORP.
(A Development Stage Company)
INDEX

         
    Page No.
       
       
    3  
    4  
    5  
    6  
    14  
    23  
    23  
       
    33  
    34  
 EX-10.2
 EX-10.3
 EX-31.1
 EX-31.2
 EX-32

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PART I – Financial Information

Item 1. Financial Statements

ORTHOLOGIC CORP.
(A Development Stage Company)

CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share data)
(Unaudited)
                 
    September 30,   December 31,
    2004
  2003
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 43,011     $ 84,357  
Short-term investments
    60,406       32,499  
Accounts receivable less allowance for doubtful accounts, $405 and $556
    343       792  
Prepaids and other current assets
    302       882  
 
   
 
     
 
 
Total current assets
    104,062       118,530  
Furniture and equipment, net
    495       560  
Escrow account
    6,809       5,144  
Long-term investments
    5,937       4,156  
Deferred income taxes – non-current
    801       770  
Trademarks
    2,142       0  
Deposits and other assets
    309       196  
Investment in Chrysalis BioTechnology
    0       750  
 
   
 
     
 
 
Total assets
  $ 120,555     $ 130,106  
 
   
 
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
  $ 707     $ 201  
Accrued compensation
    597       609  
Accrued taxes
    57       2,924  
Excess space reserve
    570       314  
Other accrued liabilities
    2,625       1,596  
Accrued severance and other divestiture costs
    0       279  
 
   
 
     
 
 
Total current liabilities
    4,556       5,923  
Deferred rent and capital lease obligation
    155       208  
 
   
 
     
 
 
Total liabilities
    4,711       6,131  
 
   
 
     
 
 
Stockholders’ Equity
               
Common stock, $.0005 par value;
               
50,000,000 shares authorized; and 37,998,542
               
and 33,533,443 shares issued and outstanding
    19       16  
Additional paid-in capital
    170,846       142,329  
Accumulated deficit
    (55,021 )     (18,233 )
Treasury stock at cost, 41,800 shares
    0       (137 )
 
   
 
     
 
 
Total stockholders’ equity
    115,844       123,975  
 
   
 
     
 
 
Total liabilities and stockholders’ equity
  $ 120,555     $ 130,106  
 
   
 
     
 
 

See Notes to Unaudited Condensed Consolidated Financial Statements

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ORTHOLOGIC CORP.
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
                                         
    Three months ended September 30,
  Nine months ended September 30,
  As a Development
                                    Stage Company
    2004
  2003
  2004
  2003
  8/5/04 - 9/30/04
                                    (Note 1)
OPERATING EXPENSES
                                       
General and administrative
  $ 1,226     $ 1,116     $ 2,397     $ 3,683     $ 970  
Research and development
    4,803       2,437       12,163       6,063       3,127  
CPM divestiture and related gains
    (79 )     (132 )     (272 )     (477 )     (50 )
CBI in process research and development
    25,840       0       25,840       0       25,840  
 
   
 
     
 
     
 
     
 
     
 
 
Total operating expense
    (31,790 )     (3,421 )     (40,128 )     (9,269 )     (29,887 )
Interest income, net
    344       124       950       387       237  
 
   
 
     
 
     
 
     
 
     
 
 
Loss from continuing operations before taxes
    (31,446 )     (3,297 )     (39,178 )     (8,882 )     (29,650 )
Income tax benefit
    (411 )     (1,596 )     (705 )     (3,747 )     (411 )
 
   
 
     
 
     
 
     
 
     
 
 
Net loss from continuing operations
    (31,035 )     (1,701 )     (38,473 )     (5,135 )     (29,239 )
Discontinued operations (Note 3)
                                       
Net gain on the sale of the Bone Device Business
    1,685               1,685               1,685  
Income from operations of Bone Device Business, net of taxes of $0, $1,596, $0 and $3,747
            2,207               6,341          
 
   
 
     
 
     
 
     
 
     
 
 
Net income from discontinued operations
    1,685       2,207       1,685       6,341       1,685  
 
   
 
     
 
     
 
     
 
     
 
 
NET INCOME (LOSS)
  $ (29,350 )   $ 506     $ (36,788 )   $ 1,206     $ (27,554 )
 
   
 
     
 
     
 
     
 
     
 
 
Per Share Information:
                                       
Net loss from continuing operations
                                       
Basic
  $ (0.85 )   $ (0.05 )   $ (1.09 )   $ (0.15 )        
 
   
 
     
 
     
 
     
 
         
Diluted
  $ (0.85 )   $ (0.05 )   $ (1.09 )   $ (0.15 )        
 
   
 
     
 
     
 
     
 
         
Net income from discontinued operations
                                       
Basic
  $ 0.05     $ 0.07     $ 0.05     $ 0.19          
 
   
 
     
 
     
 
     
 
         
Diluted
  $ 0.05     $ 0.07     $ 0.05     $ 0.19          
 
   
 
     
 
     
 
     
 
         
Net income (loss)
                                       
Basic
  $ (0.80 )   $ 0.02     $ (1.04 )   $ 0.04          
 
   
 
     
 
     
 
     
 
         
Diluted
  $ (0.80 )   $ 0.02     $ (1.04 )   $ 0.04          
 
   
 
     
 
     
 
     
 
         
Basic shares outstanding
    36,726       32,975       35,281       32,892          
Equivalent shares
    0       684       0       385          
 
   
 
     
 
     
 
     
 
         
Diluted shares outstanding
    36,726       33,659       35,281       33,277          
 
   
 
     
 
     
 
     
 
         

See Notes to Unaudited Condensed Consolidated Financial Statements

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ORTHOLOGIC CORP.
(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(in thousands)
(Unaudited)
                         
    Nine months ended
   
                    As a Development
    September 30,   September 30,   Stage Company
    2004
  2003
  8/5/04 - 9/30/04
OPERATING ACTIVITIES
                       
Net income (loss)
  $ (36,788 )   $ 1,206     $ (27,554 )
Non-cash items:
                       
Depreciation and amortization
    152       487       24  
Escrow account amortization
    20              
Deferred tax asset
    (31 )           (31 )
Gain on sale of the Bone Device Business
    (1,685 )           (1,685 )
CBI in process R&D
    25,840             25,840  
Net change in other operating items:
                       
Accounts receivable
    449       162       (257 )
Inventories
          284          
Prepaids and other current assets
    590       3       788  
Deposits and other assets
    (113 )     (81 )     (3 )
Accounts payable
    506       511       (13 )
Accrued liabilities and deferred rent
    (2,066 )     865       1,298  
 
   
 
     
 
     
 
 
Cash flows used (provided by) in operating activities
    (13,126 )     3,437       (1,593 )
 
   
 
     
 
     
 
 
INVESTING ACTIVITIES
                       
Expenditures for furniture and equipment
    (68 )     (234 )     (33 )
Cash paid for CBI acquisition
    (3,668 )           (3,668
Purchase of investments
    (67,316 )     (19,945 )     (22,791 )
Maturities of investments
    37,628       17,066       12,386  
 
   
 
     
 
     
 
 
Cash flows used in investing activities
    (33,424 )     (3,113 )     (14,106 )
 
   
 
     
 
     
 
 
FINANCING ACTIVITIES
                       
Net proceeds from stock option exercises
    5,204       677       1,303  
 
   
 
     
 
     
 
 
Cash flows provided by financing activities
    5,204       677       1,303  
 
   
 
     
 
     
 
 
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
    (41,346 )     1,001       (14,396 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
    84,357       11,286       57,407  
 
   
 
     
 
     
 
 
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $ 43,011     $ 12,287     $ 43,011  
 
   
 
     
 
     
 
 
SUPPLEMENTAL SCHEDULE OF NON-CASH, INVESTING AND FINANCING ACTIVITIES:
                       
Cash paid during the period for interest
  $ 4     $ 9     $ 1  
Cash paid during the period for income taxes
    2,679       21     $ 6  
Common stock issued for legal settlement
        $ 2,078          
CBI Acquisition:
                       
Current assets acquired
    29               29  
Trademarks acquired
    2,142               2,142  
Liabilities acquired
    (140 )             (140 )
Original investment reversal
    (750 )             (750 )
In process R&D acquired
    25,840               25,840  
Common stock issued for acquisition
    (23,453 )             (23,453 )
 
   
 
     
 
     
 
 
Cash paid for CBI acquisition
  $ 3,668             $ 3,668  

See Notes to Unaudited Condensed Consolidated Financial Statements

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ORTHOLOGIC CORP.
(A Development Stage Company)

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

     Description of the organization.

     OrthoLogic is a drug development company focused on the healing of musculoskeletal, dermal and cardiovascular tissue through biopharmaceutical approaches. Our research is focused exclusively on the potential commercialization of our Chrysalin® Product Platform. Chrysalin, or TP508, is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human thrombin molecule, a naturally occurring molecule in the body responsible for both blood clotting and initiating many of the cellular events responsible for tissue repair. We are currently enrolling patients in a Chrysalin Phase 3 human clinical trial for acceleration of fracture repair and have recently submitted a new protocol for an Investigational New Drug (“IND”) application to begin an additional human clinical trial for this indication. In the spring of 2004 we completed enrollment of patients in a Chrysalin Phase 1/2 human clinical trial for spine fusion. Data from this trial is expected to be available during the summer of 2005. We are also planning to conduct a Chrysalin human clinical trial for cartilage defect repair, a second Chrysalin human clinical trial in dermal wound healing (diabetic ulcer), and additional preclinical research in cardiovascular repair and tendon repair.

     On August 5, 2004, we purchased substantially all of the assets and intellectual property of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide license for Chrysalin for all medical indications for $2.5 million in cash and $25.0 million in OrthoLogic common stock. We issued 3,462,124 shares of OrthoLogic common stock to CBI for this transaction, based on the 10-day average closing price of $7.221. Pursuant to the terms of the definitive agreement, we must issue an additional number of shares of OrthoLogic common stock valued at $7.0 million upon the occurrence of certain trigger events, which include the sale or other transactions that result in a change of control of OrthoLogic or the acceptance by the U.S. Food and Drug Administration of a new drug application for a product based on Chrysalin, if either such trigger occurs within five years of closing. The largest portion of the purchase price was expensed as In-process Research and Development of $25.8 million. The remainder of the purchase price was allocated to trademarks totaling $2.1 million, liabilities of $140,000 and other assets of $29,000. If a triggering event occurs, the additional $7.0 million will be allocated in the same manner as the initial purchase price.

     On November 26, 2003, we sold our bone growth stimulation and fracture fixation device business (“Bone Device Business”) to dj Orthopedics, LLC for a purchase price of approximately $93.0 million in cash and the assumption of substantially all of the Bone Device Business trade payables and other current liabilities. Through this divestiture, we sold all of our revenue producing operations. The Bone Device Business assets included the rights to produce and market the OL1000, OL1000 SC, SpinaLogic and OrthoFrame/Mayo.

     As of September 30, 2004, we had cash and cash equivalents of $43.0 million, short-term investments of $60.4 million and long-term investments of $5.9 million. We currently intend to utilize these resources to fund the development, testing and commercialization of our Chrysalin product platform.

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     We began operating as a development stage company upon the acquisition of CBI and following the prior divestitures of our revenue producing operations, effective August 5, 2004. Subsequently, all of our collective efforts are focused on research and development of the Chrysalin Product Platform, with the goal of commercializing our products. Excluding the initial 1998 equity investment of $750,000 and the 2004 purchase price for the assets of CBI, we have spent approximately $34.4 million in total research and development efforts on the Chrysalin product platform to date. We have incurred $4.8 million and $12.2 million on the Chrysalin research efforts during the last three-month and nine-month periods, respectively.

     In these notes, references to “we”, “our” and the “Company” refer to OrthoLogic Corp. and its subsidiaries. References to our Bone Device Business refer to our former business line of bone growth stimulation and fracture fixation devices, including the OL1000 product line, SpinaLogic®, OrthoFrame® and OrthoFrame/Mayo.

Financial Statement Presentation

     In the opinion of management, the unaudited interim financial statements include all adjustments necessary for the fair presentation of our financial position, results of operations, and cash flows. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the complete fiscal year. The balance sheet as of December 31, 2003 is derived from our audited financial statements included in the 2003 Annual Report on Form 10-K. These financial statements should be read in conjunction with the financial statements and notes thereto included in the 2003 Annual Report on Form 10-K.

     Use of estimates. The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. These estimates and assumptions form the basis for the carrying values of assets and liabilities. On an on-going basis we evaluate these estimates, including those related to purchase price allocations, allowance for doubtful accounts, guarantees, income taxes, contingencies and litigation. Management bases its estimates on historical experience and various other assumptions and believes its estimates are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities not readily apparent from other sources. Under different assumptions and conditions, actual results may differ from these estimates.

     The significant estimates include the CBI purchase price allocation, allowance for doubtful accounts (approximately $405,000 and $556,000 at September 30, 2004 and December 31, 2003, respectively), the fair value of certain representations and warranties issued in conjunction with the sale of the Bone Device Business, the excess space reserve and the valuation allowance for deferred tax assets.

     Principles of consolidation. The consolidated financial statements include the accounts of OrthoLogic and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. We prepare our condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America for interim financial statements. Accordingly, the accompanying condensed consolidated financial statements do not include all information and notes required for complete financial statements.

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The following briefly describes the significant accounting policies used in the preparation of our financial statements.

     A. Cash and cash equivalents. Cash and cash equivalents consist of cash on hand and cash deposited with financial institutions, including money market accounts, and commercial paper purchased with an original maturity of three months or less.

     B. Furniture and equipment. Furniture and equipment are stated at cost or, in the case of leased assets under capital leases, at the present value of future lease payments at the inception of the lease. Depreciation is calculated on a straight-line basis over the estimated useful lives of the various assets, which range from three to seven years. Leasehold improvements and leased assets under capital leases are amortized over the life of the asset or the period of the respective lease using the straight-line method, whichever is the shortest.

     We adopted Statement of Financial Accounting Standards (“SFAS”) No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets” effective January 1, 2002. SFAS No. 144 requires that we evaluate long-lived assets based on the net future cash flow expected to be generated from the asset on an undiscounted basis whenever significant events or changes in circumstances occur that indicate that the carrying amount of an asset may not be recoverable.

     C. Escrow receivable. A portion of the purchase price payable to us from dj Orthopedics, LLP, related to the sale of the Bone Device Business was required to be placed in escrow (Note 3). Under Financial Accounting Standards Board (“FASB”) Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of the Indebtedness of Others,” indemnifications, representations and warranties issued in conjunction with the sale of a business are required to be valued and recorded in the financial statements. We made certain representations and warranties in conjunction with the sale of the Bone Device Business and currently determine the discounted fair value to be approximately $228,000 which is reflected as a reduction of the escrow receivable. The discount of $22,000 is being accreted to interest expense through November 26, 2005, which is when the portion of the purchase price allocated to the representations and warranties is required to be released from escrow.

     D. Investment in Chrysalis. Prior to the asset acquisition of CBI on August 5, 2004, we owned a minority ownership interest in CBI, which is recorded at cost (see Note 2) through December 31, 2003. We purchased substantially all of the assets and intellectual property of CBI, replacing our initial investment.

     E. Excess Space Reserve. We lease a facility in Tempe, Arizona and sublease portions to other tenants. We have established a reserve for the period the sublease space is anticipated to be vacant. In the opinion of management, the reserve balance of $570,000 at September 30, 2004 is appropriate to allow for time necessary to acquire an additional tenant for the building.

     F. Income taxes. Under SFAS No. 109, “Accounting for Income Taxes,” income taxes are recorded based on current year amounts payable or refundable, as well as the consequences of events that give rise to deferred tax assets and liabilities. We base our estimate of current and deferred taxes on the tax laws and rates that are currently in effect in the appropriate jurisdictions. Pursuant to SFAS No. 109, we have determined that the majority of the deferred tax assets at September 30, 2004 require a valuation allowance. We believe the remaining

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deferred tax asset of $801,000 will be realized as it relates to alternative minimum tax credits that do not expire.

     G. Research and development. Research and development represents costs incurred internally for research and development activities, costs incurred to fund the research activities we have contracted externally and certain milestone payments regarding the continued clinical testing of Chrysalin. All research and development costs are expensed when incurred.

     H. Stock-based compensation. At September 30, 2004, we had two stock-based employee compensation plans. We account for those plans under the recognition and measurement principles of Accounting Priniciples Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations. In the quarter ended September 30, 2004, we recorded approximately $23,000 in net compensation expense related to the vesting of performance-based options.

     In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation — Transition and Disclosure” which is effective for fiscal years ended after December 15, 2002. SFAS No. 148 amends SFAS No. 123 to provide alternative methods of transition to SFAS No. 123’s fair value method of accounting for stock-based employee compensation if a company elects to account for its equity awards under this method. SFAS No. 148 also amends the disclosure provisions of SFAS No. 123 and APB Opinion No. 28, “Interim Financial Reporting” to require disclosure of the effects of an entity’s accounting policy with respect to stock-based employee compensation on reported net income and earnings per share in both annual and interim financial statements. We have provided the required additional annual disclosures below which illustrate the effect on net income and earnings per share if we had applied the fair value recognition provisions of SFAS No. 123, “Accounting for Stock-Based Compensation” to stock-based employee compensation (in thousands except per share data).

                                 
    Three months ended September 30,
  Nine months ended September 30,
    2004
  2003
  2004
  2003
Estimated weighted-average fair value of options granted during the period
  $ 2.74     $ none   $ 2.32     $ 1.74  
 
   
 
     
 
     
 
     
 
 
Net income (loss) attributable to common stockholders:
                               
As reported
  $ (29,350 )   $ 506     $ (36,788 )   $ 1,206  
Stock based compensation expense
    (45 )     (115 )     (597 )     (355 )
 
   
 
     
 
     
 
     
 
 
Pro forma
  $ (29,395 )   $ 391     $ (37,385 )   $ 851  
 
   
 
     
 
     
 
     
 
 
Basic net income per share:
                               
As reported
  $ (0.80 )   $ 0.02     $ (1.04 )   $ 0.04  
Pro forma
  $ (0.80 )   $ 0.01     $ (1.06 )   $ 0.03  
Diluted net income per share:
                               
As reported
  $ (0.80 )   $ 0.02     $ (1.04 )   $ 0.04  
Pro forma
  $ (0.80 )   $ 0.01     $ (1.06 )   $ 0.03  
Black Scholes model assumptions:
                               
Risk free interest rate
    3.1 %     1.6 %     3.1 %     1.6 %
Expected volatility
    41 %     44 %     44 %     41 %
Expected term
  2.7 Years     2.7 Years     2.7 Years     2.7 Years  
Dividend yield
    0 %     0 %     0 %     0 %

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     I. Income (loss) per common share. Income (loss) per common share is computed on the weighted average number of common or common and equivalent shares outstanding during each year. Basic earnings per share is computed as net income (loss) divided by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants, and other convertible securities when the effect would be dilutive.

     J. Discontinued operations. Under SFAS No. 144, “Accounting for the Impairment and Disposal of Long-Lived Assets,” discontinued operations are reported if a component of the entity is held for sale or sold during the period. The Bone Device Business qualified as a component of the entity under the standard as of the November 26, 2003 sale date. Therefore, the gain on the sale of the Bone Device Business and related results of operations for 2003, prior to the sale, have been presented as discontinued operations in the financial statements.

     K. New Accounting Pronouncements. In January 2003, the FASB issued Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities,” (revised in December 2003) which clarifies the application of Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” relating to consolidation of certain entities. We do not participate in any variable interest entities. The adoption of FIN 46 did not have a material impact on our financial statements.

     L. Certain reclassifications. Certain reclassifications have been made to the prior year financial statements to conform to the 2004 presentation.

2. ASSET ACQUISITION OF CHRYSALIS BIOTECHNOLOGY, INC.

     In January 1998, we acquired a minority equity investment (less than 10%) in Chrysalis BioTechnology, Inc. (“CBI”) for $750,000. As part of the transaction, we were awarded a worldwide exclusive option to license the orthopedic applications of Chrysalin, a patented 23-amino acid synthetic peptide that had shown promise in accelerating the healing process.

     On August 5, 2004, we purchased substantially all of the assets and intellectual property of CBI, including its exclusive worldwide license for Chrysalin for all medical indications for $2.5 million in cash and $25.0 million in OrthoLogic common stock issued. We issued 3,462,124 shares of OrthoLogic common stock to CBI for this transaction based on the 10-day average closing price of $7.221. Pursuant to the terms of the definitive agreement, we must issue an additional number of shares of OrthoLogic common stock valued at $7.0 million upon the occurrence of certain trigger events, which include the sale or other transactions that result in a change of control of OrthoLogic or the acceptance by the U.S. Food and Drug Administration of a new drug application for a product based on Chrysalin, if either such trigger occurs within five years of closing. The largest portion of the purchase price and acquisition costs was expensed as In-process Research and Development of $25.8 million. The remainder of the purchase price was allocated to trademarks totaling $2.1 million, liabilities of $140,000 and other assets of $29,000. If a triggering event occurs, the additional $7.0 million will be allocated in the same manner as the initial purchase price.

     The initial $750,000 investment was recognized as part of the purchase price of the transaction. In return for the initial investment in CBI, we received 214,234 shares of OrthoLogic common stock as the prorated share of the purchase price, in accordance with the

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liquidation plan adopted by CBI at the time of the asset acquisition. The shares of OrthoLogic common stock, valued at $1.5 million, were accumulated with the other 41,800 shares of Treasury Stock previously outstanding and reverted back into the authorized but unissued common stock during the third quarter of 2004.

     Pursuant to the Asset Purchase Agreement, fifteen percent of the shares of OrthoLogic common stock issued for the acquisition of CBI were placed in escrow for eighteen months from the closing date to cover indemnifications for the representations and warranties made by CBI in the Asset Purchase Agreement. We assumed the CBI lease for the location in Galveston, Texas, with approximately 6,000 sq. ft. of office space and laboratory space. We hired eight of the eleven full time CBI employees, and retained the President and founder of the company through a two-year consulting agreement.

     At this stage of research, we are not yet able to apply for FDA approval to market Chrysalin. The process of obtaining necessary government approvals is time consuming and expensive. There can be no assurance that the necessary approvals for new products or applications will be obtained by us or, if they are obtained, that they will be obtained on a timely basis. Significant additional costs will be necessary to complete development of these products.

     The CBI acquisition has been accounted for using the purchase method of accounting whereby the total purchase price has been allocated to tangible and intangible assets acquired and liabilities assumed based on their estimated fair market values as of the acquisition date. The purchase price was comprised of the following (in thousands):

         
Cash paid including acquisition costs
  $ 3,668  
Common stock issued (less treasury stock received)
    23,453  
Original investment in CBI
    750  
 
   
 
 
Total purchase price
  $ 27,871  

     The fair value of CBI net assets acquired:

         
Trademarks
  $ 2,142  
In-process research and development
    25,840  
Furniture, equipment and other
    29  
Liabilities acquired
    (140 )
 
   
 
 
Fair value of the assets purchased
  $ 27,871  

     The following unaudited pro forma condensed consolidated statements of operations are based on the historical consolidated financial statements of OrthoLogic, adjusted to give effect to the acquisition of substantially all the assets of CBI for the three and nine months ended September 30, 2004, as if the transaction had occurred on January 1, 2004.

     The pro forma consolidated financial information is presented for illustrative purposes only, and is not necessarily indicative of the operating results or financial position that would have occurred if all the events described had occurred on the first day of the respective periods presented, nor is it necessarily indicative of future operating results or financial position.

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Selected Historical Financial Data
(in thousands, expect per share data)

                                 
    Three months ended September 30,
  Nine months ended September 30,
    2004
  2003
  2004
  2003
Total operating expenses
  $ 31,853     $ 3,401     $ 41,876     $ 9,665  
Loss from continuing operations
    (31,104 )     (1,680 )     (40,266 )     (5,527 )
Gain from discontinued operations
    1,685       2,207       1,685       6,341  
 
   
 
     
 
     
 
     
 
 
Net loss (income)
  $ (29,420 )   $ 527     $ (38,582 )   $ 814  
Basic loss per share for continuing operations
  $ (0.85 )   $ (0.05 )   $ (1.14 )   $ (0.17 )
Basic income per share for
                               
discontinued operations
  $ 0.05     $ 0.07     $ 0.05     $ 0.19  
Basic loss per share
  $ (0.80 )   $ 0.02     $ (1.09 )   $ 0.02  

3. ASSET SALE OF THE BONE DEVICE BUSINESS

     On November 26, 2003, we completed the sale of the Bone Device Business assets and related liabilities (including the rights to produce and market the OL1000, OL1000 SC, SpinaLogic and OrthoFrame/Mayo) to dj Orthopedics, LLC. Pursuant to the asset purchase agreement, we sold substantially all of the assets of the Bone Device Business (other than our Medicare accounts receivable, which were $1.2 million in the aggregate), including substantially all of the related machinery, equipment, inventory, work in process, licenses, customer lists, intellectual property, certain agreements and contracts. dj Orthopedics paid $93.0 million in cash at closing and assumed substantially all of the Bone Device Business trade payables and other current liabilities less payables in an amount approximately equal to the amount of retained Medicare receivables. Upon the closing of the sale we assigned and dj Orthopedics agreed to assume and perform the obligations outstanding on November 26, 2003, related to the operation of the Bone Device Business (including various liabilities related to the Company’s employees).

     Of the $93.0 million we received in the sale, $7.5 million was placed in an escrow account. The funds were divided into two accounts: $7.0 million from which dj Orthopedics, LLP is eligible for indemnity and breach of contract claims, if any, and $0.5 million from which a portion of the agreed upon incentive stay bonuses will be paid by dj Orthopedics to former OrthoLogic executives on the first anniversary of the closing. The funds in the $7.0 million escrow account, in excess of the amount of any pending claims, will be released to us on the second anniversary of the closing. The amount reserved for the potential liability at closing was $1.9 million related to the fair value of the representation and warranties in the Asset Purchase Agreement. We received updated information during the third quarter of 2004 that eliminated most of the potential exposure of the representations and warranties in the Asset Purchase Agreement, substantiating a decrease in the reserve of approximately $1.7 million, leaving a net reserve of approximately $228,000. This decrease in the reserve resulted in an additional $1.7 million gain to be recognized on the sale of the Bone Device Business in discontinued operations during the current quarter.

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     The sale of the Bone Device Business was considered an accelerating event for our stock-based compensation plans. Terminated employees’ unvested options vested immediately upon the sale. Our directors and employees who were retained had 75% of their unvested options vest upon the sale, with the remainder vesting over a 12 month period or on their regular vesting period, whichever is shorter.

     The sale of the Bone Device Business is accounted for as discontinued operations. The income from the divested business and related tax effects is summarized as discontinued operations in the consolidated statement of operations. Included in the discontinued operations for the 2003 period is the net income from the Bone Device Business of $2.2 million and $6.3 million resulting from the three months and nine months of operations through September 30, 2003, respectively.

     The presentation of discontinued operations for the Bone Device Business reflects the elimination of the historical revenues as well as historical expenses related to the operations of such business. The revenue, cost of revenue, gross profit and pretax income attributable to the Bone Device Business for the three months and nine months ending September 30, 2003 were as follows (in thousands):

                 
    Three months ended   Nine months ended
    September 30, 2003
  September 30, 2003
Net revenue
  $ 12,523     $ 34,263  
Cost of sales
    1,926       5,088  
 
   
 
     
 
 
Gross profit
    10,597       29,175  
 
   
 
     
 
 
Pretax income
  $ 3,803     $ 10,088  
 
   
 
     
 
 

     The historical expenses of the Bone Device Business were derived using a variety of factors including percentage of revenues, headcount, and specific identification. Subsequent to the sale, we no longer have any revenue producing products.

     The sale of our Bone Device Business was a transaction taxable to us for United States federal income tax purposes. We recognized taxable income for fiscal year ended 2003 equal to the amount realized on the sale in excess of our tax basis in the assets sold. A portion of the taxable gain was offset by available net operating loss carry forwards.

4. CPM DIVESTITURE AND RELATED GAINS

     In July 2001, we announced the sale of our continuous passive motion (“CPM”) business to OrthoRehab, Inc. Under the CPM Asset Purchase Agreement, we were eligible to receive up to an additional $2.5 million of cash if certain objectives were achieved by OrthoRehab, Inc.

     We settled litigation over the $2.5 million payment and other matters in April 2003. OrthoRehab, Inc. agreed to pay $1.2 million to settle the contingent payment due to us, and all outstanding claims between the two companies. Payments of $79,000 and $272,000, and $132,000 and $477,000 were collected during the three months and nine months ended September 30, 2004 and 2003, respectively, and recognized on the “CPM divestiture and related

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gains” line item on the Consolidated Statement of Operations. The remaining balance plus interest is scheduled to be paid over the next 18 months. Due to the uncertainty of the future payments, income on the settlement will continue to be recorded as cash is received.

5. LITIGATION

     OrthoLogic Corp. v. Maricopa County, Superior Court of the State of Arizona, Arizona Tax Court, No. TX2004-000657. On October 28, 2004, the Company filed a complaint and notice of tax appeal against Maricopa County. The Maricopa County Assessor valuated the Corporation’s leased property located at 1275 W. Washington St., Tempe, AZ 85281 and billed the Company in the amount of $228,574.40 for the 2004 personal property tax. The Company paid $114,288 of the property tax bill, and accrued $57,114 for the amount due through September 30, 2004. The leased property is owned by the City of Tempe and the underlying real property is owned by Salt River Project, an agricultural improvement district. The leased property was previously exempt from personal property taxes. Upon information and belief, the Company has been taxed pursuant to a recent change in the state taxation law that allows taxation in the name of the lessee or sublessee of otherwise tax exempt improvements located on land owned by an agricultural improvement district. The Company believes that this taxation is illegal and if legal, was applied incorrectly. The Company intends to pursue this matter vigorously.

     The Company is involved in various legal proceedings that arise in the ordinary course of business. In management’s opinion, the ultimate resolution of these other legal proceedings are not likely to have a material adverse effect on the financial position, results of operations or cash flows of the Company.

     The health care industry is subject to numerous laws and regulations of federal, state, and local governments. Compliance with these laws and regulations, specifically those relating to the Medicare and Medicaid programs, can be subject to government review and interpretations, as well as regulatory actions unknown and unasserted at this time. Recently, federal government activity has increased with respect to investigations and allegations concerning possible violations by health care providers of regulations, which could result in the imposition of significant fines and penalties, as well as significant repayments of previously billed and collected revenues from patient services. Management believes that the Company is in substantial compliance with current laws and regulations.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

     When used in this report, the terms “OrthoLogic,” “we,” “our,” or “us” refer to OrthoLogic Corp. or OrthoLogic Corp. and its subsidiaries, as appropriate in the context, and the term “Bone Device Business” refers to our former business line of bone growth stimulation and fracture fixation devices, including the OL1000 product line, SpinaLogic®, OrthoFrame® and OrthoFrame/Mayo.

     The following is management’s discussion of significant factors that affected OrthoLogic’s interim financial condition and results of operations. This should be read in conjunction with our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended

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December 31, 2003 and the “Special Note Regarding Forward Looking Statements” below, following Item 4.

Overview

     On August 5, 2004, we purchased substantially all of the assets and intellectual property of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide license for Chrysalin for all medical indications, for $2.5 million in cash and $25.0 million in OrthoLogic common stock. We issued 3,462,124 shares of OrthoLogic common stock to CBI for this transaction, based on the 10-day average closing price of $7.221. Pursuant to the terms of the definitive agreement, we must issue an additional number of shares of OrthoLogic common stock valued at $7.0 million upon the occurrence of certain trigger events, which include the sale or other transactions that result in a change of control of OrthoLogic or the acceptance by the U.S. Food and Drug Administration of a new drug application for a product based on Chrysalin, if either such trigger occurs within five years of closing. The largest portion of the purchase price was expensed as In-process Research and Development of $25.8 million. The remainder of the purchase price was allocated to trademarks totaling $2.1 million, liabilities of $140,000 and other assets of $29,000. If a triggering event occurs, the additional $7.0 million will be allocated in the same manner as the initial purchase price.

     On November 26, 2003, we sold our Bone Device Business to djOrthopedics, LLC for a purchase price of approximately $93.0 million in cash and the assumption of substantially all of the Bone Device Business trade payables and other current liabilities. Through this divestiture, we sold all of our revenue producing operations and became a pure drug development company. Our principal business remains focused on the healing of musculoskeletal tissue, although through biopharmaceutical approaches rather than through the use of medical devices.

     As of September 30, 2004, we had cash and cash equivalents of $43.0 million, short-term investments of $60.4 million and long-term investments of $5.9 million. We currently intend to utilize these resources to fund the development, testing and commercialization of our Chrysalin product platform.

     Research and Development of the Chrysalin Product Platform

     Chrysalin, or TP508, is a 23-amino acid synthetic peptide representing a receptor-binding domain of the human thrombin molecule, a naturally occurring molecule in the body responsible for both blood clotting and initiating many of the cellular events responsible for tissue repair. The Chrysalin molecule serves as the basis for a family of potential therapeutic products we refer to collectively as the “Chrysalin product platform.” To date, we have identified six potential medical applications for Chrysalin:

  fracture repair;
 
  spine fusion;
 
  dermal wound healing (diabetic ulcers);
 
  cartilage defect repair;

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  cardiovascular repair, and
 
  tendon repair.

    Fracture Repair

     We are currently enrolling patients in a Chrysalin Phase 3 human clinical trial for acceleration of fracture repair. We have recently submitted a new protocol for an Investigational New Drug (“IND”) application to begin an additional human clinical trial to provide dosing information to support a potential future New Drug Application (“NDA”). The focus of the Phase 3 trial is to identify if a single injection of Chrysalin into the fracture can accelerate healing. Our preclinical fracture repair studies currently underway focus on isolating and identifying functions of Chrysalin in acceleration of fracture repair, and what genes are stimulated by the injection of the Chrysalin peptide. Our analysis of the effect of Chrysalin at the genetic level is performed using gene array and quantitative PCR technology, with this work performed both in house at OrthoLogic and in collaboration with academic institutions. Preclinical studies using segmental defect, distraction osteogenesis and non-union models are performed by collaborators at academic institutions. Preclinical segmental defect studies are meant to mimic reconstructive surgical procedures. These studies provide information on advanced formulations of Chrysalin and potential new clinical indications to investigate. Distraction osteogenesis is a technique that is used to replace lost segments of bone due to severe injury, or to correct congenital deformity. Preclinical studies on non-union fractures address the effects of Chrysalin to heal fractures that do not heal in the normal expected time. Positive results in these studies may provide additional clinical indications for Chrysalin.

     Spine Fusion

     Our preclinical studies on spine fusion address questions of safety and efficacy when the Chrysalin peptide is used for spine fusion surgeries. These studies are performed by collaborators at academic institutions, with the experimental study design provided by OrthoLogic scientists. We completed enrollment in a Chrysalin Phase 1/2 human clinical trial for spine fusion during the second quarter of 2004. We may conduct preclinical studies evaluating Chrysalin for interbody spinal fusion. Should these studies be performed, and based on this preclinical data, we plan to seek FDA authorization to begin a human clinical trial evaluating Chrysalin for interbody spinal fusion.

     Dermal Wound Healing

     Our preclinical studies and initial Phase 1/2 human clinical trial evaluate Chrysalin as a potential product for diabetic ulcer healing in a saline formulation. We are currently evaluating various gel formulations to develop the protocol for a future Chrysalin human clinical trial for this indication. We plan to determine a final gel formulation for this indication before the end of 2005 with the potential to initiate a new human clinical trial in 2006.

     Cartilage Defect Repair

     Our preclinical cartilage repair studies are performed at academic institutions with the protocol designed by OrthoLogic scientists. The goal of these studies is to understand the way Chrysalin works to stimulate cartilage defect repair as well as to address formulation questions.

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Data permitting, we intend to submit an IND to the FDA and begin a human clinical trial for this indication in 2005.

     Cardiovascular Repair

     The focus of our research is to evaluate delivery mechanisms for a Chrysalin-based potential product for myocardial revascularization. We plan to conduct preclinical studies for this indication during 2005.

     Tendon Repair

     Our first Chrysalin preclinical tendon repair study has begun in collaboration with an academic institution. The results from this study should be available in the first half of 2005.

     The development of each of our potential product candidates in the Chrysalin product platform is based on our collective knowledge and understanding of how the human thrombin molecule contributes to the repair of soft tissue and bone. While there are important differences in each of the product candidates in terms of their purpose, (fracture repair, spine fusion, cartilage repair, etc.) each product candidate is focused on accelerating and enhancing tissue repair and is based on the ability of Chrysalin to mimic specific attributes of the human thrombin molecule to stimulate the body’s natural healing process.

     We are developing the Chrysalin-based product candidates in parallel. We expect to learn from the results of each trial and apply the findings to the development of the other product candidates. We believe there are distinct research activities within the product candidates whose outcomes and results will apply across the product platform in terms of safety and efficacy.

     The fracture repair studies are furthest in the development process. We are currently enrolling patients in the Phase 3 human clinical trial for this indication and after the appropriate follow-up period, expect to have data from this trial before the end of 2005. We are in the process of beginning an additional human clinical trial for this indication to generate additional dosing information. Should these studies be performed, and based on the results of this data, we intend to submit a NDA for the acceleration of fresh fracture repair to the FDA before the end of 2006. Our current timeline for potential product development anticipates the commercialization of this product candidate in the 2007-2008 timeframe. This would be the first period in which we expect to begin to receive cash flows resulting from our research and development efforts.

     Excluding the initial 1998 equity investment of $750,000 and the 2004 purchase price for the assets of CBI, we have spent approximately $34.4 million in total research and development efforts on the Chrysalin product platform. We have incurred $4.8 million and $12.2 million on the Chrysalin research efforts during the last three-month and nine-month periods, respectively.

     All of our collective efforts are focused on the research and development of the Chrysalis product platform. We estimate our 2004 net cash expenditures, including the cash associated with the CBI acquisition, will be approximately $20.0 million. We continue to evaluate our research projects to determine future cash flow requirements for the product development for the expanded indications, beyond orthopedics. Based on current research and development plans, we expect our 2005 cash expenditures to be approximately $35.0 million. Assuming cash expenditures continue at approximately the same level, we expect our cash reserves to support our research and development for approximately the next three years.

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     OrthoLogic cautions that its future cash expenditure levels are difficult to estimate because the estimates include a number of assumptions about the number of research projects OrthoLogic pursues, the pace at which it pursues them, the quality of the data collected and the requests of the FDA to expand, narrow or conduct additional clinical trials and data analysis. Changes in any of these assumptions can change OrthoLogic’s estimated cash expenditure levels significantly. However, absent any unforeseen changes to OrthoLogic’s current business plans, OrthoLogic intends to maintain annual expenditure levels within the $35.0 million range.

Critical Accounting Policies and Estimates

     Income Taxes: SFAS No. 109 “Accounting for Income Taxes” requires that a valuation allowance be established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. Changes in valuation allowances from period to period are included in the tax provision in the period of change. In determining whether a valuation allowance is required, we take into account all evidence with regard to the utilization of a deferred tax asset included in past earnings history, expected future earnings, the character and jurisdiction of such earnings, unsettled circumstances that, if unfavorably resolved, would adversely affect utilization of a deferred tax asset, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization of a deferred tax asset. The valuation allowance reduces deferred tax assets to an amount that management believes will more likely than not to be realized. We believe that the net deferred tax asset of $801,000 at September 30, 2004 will be realized as it relates to alternative minimum tax credits that do not expire. However, the amount of the deferred tax assets actually realized could differ if we have little or no future earnings.

     Discontinued Operations: Under SFAS No. 144, “Accounting for the Impairment and Disposal of Long-Lived Assets,” discontinued operations are reported if a component of the entity is held for sale or sold during the period. The Bone Device Business qualifies as a component of the entity under the standard. Therefore, the gain from the sale of the Bone Device Business and the related operational results, have been presented as discontinued operations in the financial statements.

     Liability for Representations and Warranties Made in Conjunction with the Sale of the Bone Device Business: Under FASB Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of the Indebtedness of Others,” indemnifications, representations and warranties issued in conjunction with the sale of a business are required to be valued and recorded in the financial statements. We made certain representations and warranties in conjunction with the sale of the Bone Device Business and determined the discounted fair value to be approximately $1.9 million at the time of closing the sale. We received updated information during the third quarter of 2004 that eliminated most of the potential exposure of the representations and warranties in the Asset Purchase Agreement, substantiating a decrease in the reserve of approximately $1.7 million, leaving a net reserve of approximately $228,000. This decrease in the reserve resulted in additional $1.7 million gain to be recognized on the sale of the Bone Device Business during the current quarter. The discount is being accreted to interest expense through November 26, 2005, which is when the portion of the purchase price allocated to the representations and warranties is required to be released from escrow.

     Excess Space Reserve: We lease a facility in Tempe, Arizona. This approximately 100,000 square foot facility is designed and constructed for industrial purposes and is located in an industrial district. We have subleased approximately 13,500 square feet of the building

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through June 2005 and another 18,900 through March 2005. We believe the facility is well-maintained and adequate for use in the forseeable future. We believe the remainder of the facility that we are using is suitable for our purposes and is effectively utilized. While we believe the facility is well maintained and adequate for use in the forseeable future, there can be no guarantee that a different lessee will assume the remaining lease obligation. We established a reserve for the period the available sublease space is anticipated to be vacant during the third quarter of 2004 for $570,000. In the opinion of management, the reserve balance is adequate to allow for time necessary to acquire an additional tenant for the building.

     Allowance for Doubtful Accounts: The Company retained certain receivables related to the Bone Device Business after the divestiture. The allowance for doubtful accounts (approximately $405,000 and $556,000 at September 30, 2004 and December 31, 2003, respectively) is based primarily on trends in historical collection rates, consideration of current events, payor mix and other considerations. In the opinion of management, adequate allowances have been provided for doubtful accounts. If the financial condition of the third-party payors were to deteriorate, resulting in an inability to make payments, or the other considerations underlying the estimates was to change, additional allowances might be necessary.

Results of Operations Comparing Three-Month Period Ended September 30, 2004 to the Corresponding Period in 2003.

     Revenues, Cost of Revenues and Gross profits: We are a research and development company. We had no revenues, costs of revenues, or gross profit from continuing operations in 2004 or 2003. The Bone Device Business revenue is included as discontinued operations and is presented reflecting only the net income after tax under the line item “Income from operations of Bone Device Business, net of taxes.”

     General and Administrative (“G&A”) Expenses: G&A expenses related to our ongoing development operations increased by approximately 9.9% from $1.1 million to $1.2 million from the third quarter of 2003 to 2004. The increase is substantially related to the additional excess space reserve established in the third quarter of 2004, which represents the cost of the anticipated excess space in our current building. Without the recognition of the excess space reserve, the administrative expenses would have decreased from the prior year period. Our administrative functions previously serviced a large organization that had manufacturing, sales, healthcare reimbursement and research and development functions, compared to the pure research and development company that exists currently.

     Research and Development Expenses: Research and development expenses were $4.8 million in the third quarter of 2004 compared to $2.4 million in the third quarter of 2003. The increase in our research and development expenses is attributed to the significant expansion of our research and preclinical programs since the third quarter of 2003. The majority of the initial start up activity to begin the additional human clinical trial for acceleration of fracture repair was initiated during the third quarter of 2004. In addition, the asset acquisition of CBI on August 5, 2004, expanded the research costs for the Chrysalin platform to other indications during the third quarter. During 2004, we incurred additional research costs for the development of specific programs that we believe will enhance our ability to successfully receive authorization for a new drug application filing for our fracture repair indication. Research and development expenses consisted primarily of Chrysalin related expenses, which include preclinical studies in cartilage defect repair, final patient enrollment and the early completion of the Phase 1/2 spinal fusion

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clinical trial, start up costs for the additional human clinical trial for fracture repair, and continuation of the Phase 3 human clinical trial for fracture repair. During 2004, we expect to double our research and development expenses over 2003 levels of $9.0 million.

     CPM Divestiture and Change in Estimated Collectability of CPM Receivables: In July 2001, we announced the sale of our continuous passive motion (“CPM”) business to OrthoRehab, Inc. We settled litigation over certain contingent purchase price payment matters in April 2003. OrthoRehab, Inc. agreed to pay $1.2 million to settle the dispute arising out of a contingent payment due to us and all outstanding claims between the two companies. We received payments totaling $79,000 during the third quarter of 2004. The payments appear on the “CPM divestiture and related gains” line on the Statement of Operations. The remaining balance plus interest is scheduled to be paid over the next 18 months. Due to the uncertainty of the future payments, income on the settlement will be recorded as cash is received.

     Interest Income, net: Interest income in the third quarter increased from $124,000 in 2003 to $344,000 in 2004, primarily as a result of the additional interest earned on the cash and investments from the proceeds of the sale of the Bone Device Business.

     Discontinued operations of the Bone Device Business: The sale of the Bone Device Business in 2003 is accounted for as discontinued operations. The net gain on the sale of the Bone Device Business during 2004 is due to the decrease in the reserve for the potential exposure under the representations and warranties in the sale agreement by approximately $1.7 million from the initial discounted fair value of $1.9 million at the time of closing. The decrease in the reserve resulted in an additional $1.7 million gain to be recognized in the third quarter of 2004. The operating income from the divested business and related tax effects are summarized as discontinued operations in the consolidated statement of operations during 2003. Included in the discontinued operations is the net income from the Bone Device Business of $2.2 million for the third quarter of 2003, which is net of taxes.

     Net Income (Loss): We had a net loss in the third quarter of 2004 of $29.4 million compared to net income of $506,000 for the third quarter of 2003. The net loss in 2004 is substantially a result of the expanded research and development programs, expense of in-process research and development of $25.8 million for the CBI acquisition, offset by the gain on the sale of discontinued operations of $1.7 million. The net income in 2003 is composed primarily of the income of $2.2 million from the discontinued operations of the Bone Device Business and a $1.7 million loss resulting from continuing operations.

Results of Operations Comparing Nine-Month Period Ended September 30, 2004 to the Corresponding Period in 2003.

     Revenues, Cost of Revenues and Gross profits: We are a research and development company. We had no revenues, costs of revenues, or gross profit from continuing operations in 2004 or 2003. The Bone Device Business revenue is included as discontinued operations and is presented reflecting only the net income after tax under the line item “Income from operations of Bone Device Business, net of taxes.”

     General and Administrative (“G&A”) Expenses: G&A expenses related to our ongoing development operations decreased by approximately 34.9% from $3.7 million to $2.4 million from the nine-month period ending 2003 to 2004. Our administrative functions previously serviced a larger organization that had manufacturing, sales, healthcare reimbursement and

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research and development functions, compared to the pure research and development company that exists currently.

     Research and Development Expenses: Research and development expenses were $12.2 million in the first nine months of 2004 compared to $6.1 million in the first nine months of 2003. The increase in our research and development expenses is attributed to the significant expansion of our research and preclinical programs since the equivalent period in 2003. We have more patients enrolled in the clinical trials than in 2003, when we were starting our Phase 3 human clinical trial for fracture repair indications. The start up costs for an additional clinical trial for the acceleration of fracture repair has been initiated during the second and third quarters of 2004. In addition, the asset acquisition of CBI on August 5, 2004 expanded the research costs for the Chrysalin platform to other indications during the third quarter. During 2004, we incurred additional research costs for the development of specific programs that we believe will enhance our ability to successfully receive authorization for a new drug application filing for our fracture repair indication. Research and development expenses consisted primarily of Chrysalin related expenses, which include preclinical studies in cartilage defect repair, final patient enrollment and the early completion of the Phase 1/2 spinal fusion clinical trial, start up costs for the additional human clinical trial for acceleration of fracture repair and continuation of the Phase 3 human clinical trial for fracture repair. During 2004, we expect to double our research and development expenses over 2003 levels of $9.0 million.

     CPM Divestiture and Change in Estimated Collectability of CPM Receivables: In July 2001, we announced the sale of our continuous passive motion (“CPM”) business to OrthoRehab, Inc. We settled litigation over certain contingent purchase price payment matters in April 2003. OrthoRehab, Inc. agreed to pay $1.2 million to settle the dispute arising out of a contingent payment due to us and all outstanding claims between the two companies. Payments totaling $272,000 were received during the nine-month period ended September 30, 2004, and appear on the “CPM divestiture and related gains” line on the Statement of Operations. The remaining balance plus interest is scheduled to be paid over the next 18 months. Due to the uncertainty of the future payments, income on the settlement will be recorded as cash is received.

     Interest Income, net: Interest income in the nine-month period increased from $387,000 in 2003 to $950,000 in 2004 primarily as a result of the additional interest earned on the cash and investments from the sale of the Bone Device Business.

     Discontinued operations of the Bone Device Business: The sale of the Bone Device Business in 2003 is accounted for as discontinued operations. The net gain on the sale of the Bone Device Business during 2004 is due to the decrease in the reserve for the potential exposure of the representations and warranties in the sale agreement by approximately $1.7 million from the initial discounted fair value of $1.9 million at the time of closing. The decrease in the reserve resulted in an additional $1.7 million gain to be recognized in the third quarter of 2004. The operating income from the divested business and related tax effects are summarized as discontinued operations on the consolidated statement of operations. Included in the discontinued operations is the net income from the Bone Device Business of $6.3 million for the nine-month period ended September 30, 2003, which is net of taxes.

     Net Income (Loss): We had a net loss during the nine-month period ended September 30, 2004 of $36.8 million compared to net income of $1.2 million for the same period of 2003. The net loss in 2004 is primarily a result of the expanded research and development programs, expense of in-process research and development of $25.8 million for the CBI acquisition, offset by the gain on the sale of discontinued operations of $1.7 million. The net income for the first

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nine months of 2003 is composed primarily of the income of $6.3 million from the discontinued operations of the Bone Device Business and a $5.1 million loss resulting from continuing operations.

Liquidity and Capital Resources

     We have historically financed our operations through operating cash flows and the public and private sales of equity securities. With the sale of our Bone Device Business, we sold all of our revenue producing operations. We received approximately $86.0 million in cash from the sale of our Bone Device Business. The remaining $7.0 million escrow held from the sale of the Bone Device Business is due to be released in November of 2005. At September 30, 2004, we had cash and cash equivalents of $43.0 million, short-term investments of $60.4 million and long-term investments of $5.9 million.

     With the exception of the purchase of substantially all of the assets of CBI, we do not expect to make significant capital investments during the remainder of 2004, but anticipate growing our research and development expenditures related to the human clinical trials for Chrysalin in fresh fracture repair and spinal fusion and for further studies in articular cartilage repair, dermal wound healing, and cardiovascular indications.

     As of the end of the 2003 fiscal year, our cash reserves were approximately $121.0 million and were approximately $109.4 million at the end of the third quarter of 2004. We estimate that our 2004 net cash expenditures, including the cash associated with the CBI acquisition, will be approximately $19.0 million. We continue to evaluate our research projects to determine future cash flow requirements. However, based on current research and development plans, OrthoLogic expects its 2005 cash expenditures to be approximately $35.0 million. Assuming cash expenditures continue at approximately the same level, OrthoLogic expects its cash reserves to support its research and development for the next three years.

     We caution that our future cash expenditure levels are difficult to estimate because the estimates include a number of assumptions about the number of research projects OrthoLogic pursues, the pace at which it pursues them, the quality of the data collected and the requests of the FDA to expand, narrow or conduct again clinical trials and analyze data. Changes in any of these assumptions can change significantly OrthoLogic’s estimated cash expenditure levels. However, absent any unforeseen changes to OrthoLogic’s current business plans, OrthoLogic intends to maintain annual expenditure levels within the $35.0 million range.

     Our forecasts of the period of time through which our financial resources will be adequate to support our research and development depends on many factors, most notably the progress of our research and development relative to our projections and to the pace of our competitors. If we decide to expand our clinical trials, in particular, or if we consider other opportunities in the market, our projected expense levels may change, which could require us to seek other sources of financial resources. There is no assurance that we will be successful in obtaining such other resources. If such a situation were to arise, we may be required to scale back or delay our research and development programs.

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     The following table sets forth all known commitments as of September 30, 2004 and the year in which these commitments become due or are expected to be settled (in thousands):

                         
            Accounts Payable    
Year
  Operating Leases
  and Other Liabilities
  Total
2004
  $ 304     $ 4,556     $ 4,860  
2005
  $ 1,084       55     $ 1,239  
2006
  $ 1,078           $ 1,078  
2007
  $ 989           $ 989  
 
   
 
     
 
     
 
 
Total
  $ 3,455     $ 4,711     $ 8,166  
 
   
 
     
 
     
 
 

     Approximately 17% of the leased facility is subleased through June 2005 and another approximately 20% is subleased through March of 2005, payments from which will offset a portion of the lease commitments listed above.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

     We had no debt outstanding and no derivative instruments at September 30, 2004.

     Our investment portfolio is used to preserve our capital until it is required to fund our operations. All of these investment instruments are classified as held-to-maturity. We do not own derivative financial instruments in our investment portfolio. Our investment portfolio contains instruments that are subject to the risk of a decline in interest rates. We maintain a non-trading investment portfolio of investment grade, liquid debt securities that limits the amount of credit exposure of any one issue, issuer or type of instrument. Due to the short duration and conservative nature of these instruments, we do not believe that we have a material exposure to interest rate risk.

     We have deposited our cash with national banking institutions which we believe are stable. Even though our accounts in each of these banks have balances in excess of the $100,000 limit that is insured by the Federal Deposit Insurance Corporation, we believe these accounts are not subject to significant market risk due to bank failure.

Item 4. Controls and Procedures

     Our Chief Executive Officer and Chief Financial Officer have reviewed and evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Form 10-Q, which included inquiries made of certain other employees. Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have each concluded that, as of the end of such period, our disclosure controls and procedures are effective and provide reasonable assurance that we record, process, summarize, and report information required to be disclosed in the reports we file under the Securities Exchange Act of 1934 within the time periods specified by the Securities and Exchange Commission’s rules and forms. We have performed extensive financial reporting and data system reviews of internal controls to formalize and standardize the documentation of these operating procedures. As part of this process,

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additional procedures and operational functions have been adopted to provide further verification of effective operating internal controls.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

     We may from time to time make written or oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and its reports to stockholders. This report contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In connection with these “safe harbor” provisions, we identify important factors that could cause actual results to differ materially from those contained in any forward-looking statements made by or on our behalf. Any such forward-looking statement is qualified by reference to the following cautionary statements.

Risks of OrthoLogic’s Business

     OrthoLogic is a development stage biopharmaceutical company with no revenue generating operations and high investment costs. OrthoLogic expects to incur losses for a number of years as it expands its research and development projects. There is no assurance that OrthoLogic’s current level of funds will be sufficient to support all research expenses to achieve commercialization.

     With the November 2003 sale of its bone growth stimulation business, OrthoLogic currently has no revenue generating operations. With the acquisition of CBI, OrthoLogic is now a pure research and development company. As of the end of the 2003 fiscal year, OrthoLogic’s cash and investments were approximately $121.0 million and were approximately $109.4 million at the end of the third quarter of 2004. OrthoLogic estimates that its 2004 net cash expenditures, including the cash associated with the CBI acquisition, will be approximately $20.0 million. OrthoLogic is currently evaluating other research projects from the CBI acquisition to determine future cash flow requirements. Based on current research and development plans, OrthoLogic expects its 2005 cash expenditures to be approximately $35.0 million. Assuming cash expenditures continue at approximately the same level, OrthoLogic expects its cash reserves to support its research and development for the next three years.

     OrthoLogic cautions that its future cash expenditure levels are difficult to forecast because the forecast is based on assumptions about the number of research projects OrthoLogic pursues, the pace at which it pursues them, the quality of the data collected and the requests of the FDA to expand, narrow or conduct again clinical trials and analyze data. Changes in any of these assumptions can change significantly OrthoLogic’s estimated cash expenditure levels. However, absent any unforeseen changes to OrthoLogic’s current business plans, OrthoLogic intends to maintain annual expenditure levels within the $35.0 million range.

     OrthoLogic’s product candidates are in various stages of development and may not be successfully developed or commercialized. If it fails to commercialize its product candidates, it will not be able to generate revenue:

     OrthoLogic currently does not sell any products. OrthoLogic’s product candidates are at the following stages of development:

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  Acceleration of Fracture Repair — Phase 3 human clinical trials
 
  Spine Fusion — Phase 1/2 human clinical trials
 
  Dermal Wound Healing (Diabetic Ulcers) — Phase 1/2 human clinical trials
 
  Cartilage Defect Repair — Late stage preclinical trials
 
  Cardiovascular Repair – Early stage preclinical trials
 
  Tendon Repair — Early stage preclinical trials

Consequently, OrthoLogic is subject to the risk that:

  the FDA finds some or all of OrthoLogic’s product candidates ineffective or unsafe;
 
  OrthoLogic does not receive necessary regulatory approvals;
 
  OrthoLogic is unable to get some or all of its product candidates to market in a timely manner;
 
  OrthoLogic is not able to produce its product candidates in commercial quantities at reasonable costs;
 
  OrthoLogic’s products undergo post-market evaluations resulting in marketing restrictions or withdrawal; or
 
  the patient and physician community does not accept OrthoLogic’s products.

     In addition, OrthoLogic’s product development programs may be curtailed, redirected or eliminated at any time for many reasons, including:

  adverse or ambiguous results;
 
  undesirable side effects which delay or extend the clinical trials;
 
  inability to locate, recruit, qualify and retain a sufficient number of patients for clinical trials;
 
  regulatory delays or other regulatory actions;
 
  difficulties in obtaining sufficient quantities of the particular product candidate or any other components needed for OrthoLogic’s preclinical testing or clinical trials;
 
  change in the focus of OrthoLogic’s development efforts; and
 
  re-evaluation of OrthoLogic’s clinical development strategy.

     OrthoLogic cannot predict whether it will successfully develop and commercialize any of its product candidates. If it fails in such development or commercialization, it will not be able to generate revenue.

     OrthoLogic’s product candidates are all based on the same synthetic peptide, Chrysalin. If one of OrthoLogic’s product candidates reveals safety or fundamental inefficacy issues in clinical trials, it could impact the development path for all OrthoLogic’s other current product candidates.

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     The development of each of OrthoLogic’s product candidates in the Chrysalin product platform is based on OrthoLogic’s knowledge and understanding of how the human thrombin molecule contributes to the repair of soft tissue and bone. While there are important differences in each of the product candidates in terms of their purpose (fracture repair, spine fusion, cartilage repair, etc.), each product candidate is focused on accelerating the repair of soft tissue and bone and is based on the ability of Chrysalin to mimic specific attributes of the human thrombin molecule to stimulate the body’s natural healing processes.

     Since OrthoLogic is developing the product candidates in the Chrysalin product platform in parallel, OrthoLogic expects to learn from the results of each trial and apply some of OrthoLogic’s findings to the development of the other product candidates in the platform. If one of the product candidates has negative clinical trial results or is shown to be ineffective, it could impact the development path or future development of the other product candidates in the platform. If OrthoLogic finds that one of the biopharmaceutical product candidates is unsafe, it could impact the development of OrthoLogic’s other product candidates in clinical trials.

     OrthoLogic’s rights to Chrysalin are licensed from the University of Texas and if the license is invalid or unenforceable, OrthoLogic may lose its rights to use the Chrysalin technology, which would ultimately prevent OrthoLogic from commercializing and selling any Chrysalin-based products.

     At the closing of the CBI asset acquisition on August 5, 2004, the license agreements between CBI and OrthoLogic for the development, use, and marketing of the therapeutic products within the Chrysalin product platform were replaced by a direct license agreement with the University of Texas, which OrthoLogic and Chrysalis negotiated in conjunction with the asset acquisition. Under this direct license, OrthoLogic expanded its current license for Chrysalin from a license for only orthopedic “soft tissue” indications to a license for any and all indications. In return, OrthoLogic must pay the University of Texas continuing royalties, sublicense fees and various other fees in connection with filing and maintaining Chrysalin-related patents. The license agreement will expire upon the expiration of all licensed patents, and is not subject to termination by the University of Texas, except for fraud by OrthoLogic or a payment default following assignment of the license by OrthoLogic. If OrthoLogic loses its rights to Chrysalin under the license agreement, OrthoLogic would be unable to continue its product development programs and its business and prospects would be materially harmed.

     If OrthoLogic cannot protect the Chrysalin patent or its intellectual property generally, OrthoLogic’s ability to develop and commercialize its products will be severely limited.

     OrthoLogic’s success will depend in part on the University of Texas’ and OrthoLogic’s ability to maintain and enforce patent protection for Chrysalin and each product resulting from Chrysalin. Without patent protection, other companies could offer substantially identical products for sale without incurring the sizable discovery, development and licensing costs that OrthoLogic has incurred. OrthoLogic’s ability to recover these expenditures and realize profits upon the sale of products would then be diminished.

     Chrysalin is patented and there have been no successful challenges to the Chrysalin patent. However, if there were to be a challenge to the patent or any of the patents for product candidates, a court may determine that the patents are invalid or unenforceable. Even if the validity or enforceability of a patent is upheld by a court, a court may not prevent alleged infringement on the grounds that such activity is not covered by the patent claims. Any litigation, whether to enforce OrthoLogic’s rights to use its or its licensors’ patents or to defend against

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allegations that OrthoLogic infringes third party rights, will be costly, time consuming, and may distract management from other important tasks.

     As is commonplace in the biotechnology and pharmaceutical industry, OrthoLogic employs individuals who were previously employed at other biotechnology or pharmaceutical companies, including OrthoLogic’s competitors or potential competitors. To the extent OrthoLogic’s employees are involved in research areas which are similar to those areas in which they were involved at their former employers, OrthoLogic may be subject to claims that such employees and/or OrthoLogic have inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary information of the former employers. Litigation may be necessary to defend against such claims, which could result in substantial costs and be a distraction to management and which may have a material adverse effect on OrthoLogic, even if it is successful in defending such claims.

     OrthoLogic also relies on its business on trade secrets, know-how and other proprietary information. OrthoLogic seeks to protect this information, in part, through the use of confidentiality agreements with employees, consultants, advisors and others. Nonetheless, OrthoLogic cannot assure you that those agreements will provide adequate protection for its trade secrets, know-how or other proprietary information and prevent their unauthorized use or disclosure. To the extent that consultants, key employees or other third parties apply technical information independently developed by them or by others to OrthoLogic’s proposed products, disputes may arise as to the proprietary rights to such information, which may not be resolved in OrthoLogic’s favor. The breach by other parties of confidentiality agreements with OrthoLogic, or OrthoLogic’s trade secrets becoming known or independently discovered by competitors, could adversely affect OrthoLogic by enabling its competitors, who may have greater experience and financial resources, to copy or use its trade secrets and other proprietary information in the advancement of their products, methods or technologies.

     Some of OrthoLogic’s product candidates are in early stages of development and may never be commercialized.

     Research, development and preclinical testing are long, expensive and uncertain processes. Other than indications for fracture repair, spine fusions and wound healing, none of OrthoLogic’s other Chrysalin product candidates have reached clinical trial testing. OrthoLogic’s development of Chrysalin for cartilage defect repair, cardiovascular repair, and tendon repair is currently in preclinical testing or the research stage. OrthoLogic’s future success depends, in part, on its ability to complete preclinical development of these and other product candidates and advance them through the clinical trial process.

     If OrthoLogic is unsuccessful in advancing its early stage product candidates into and through clinical testing for any reason, its business prospects may be harmed.

     The loss of OrthoLogic’s key scientific personnel may hinder its ability to execute its business plan.

     As a small company with approximately 40 employees, OrthoLogic’s success depends on the continuing contributions of OrthoLogic’s scientific personnel and maintaining relationships with the network of medical and academic centers in the United States that conduct its clinical trials. OrthoLogic is most highly dependent on the services of Dr. James Ryaby, its Senior Vice-President and Chief Technology Officer, whom OrthoLogic considers its key scientific employee. A long time employee of OrthoLogic, Dr. Ryaby oversees all of OrthoLogic’s clinical

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trials, is a well respected orthopedic scientist and is OrthoLogic’s primary contact with the medical community. Like all companies in its field, OrthoLogic faces intense competition in its hiring efforts with other pharmaceutical and biotechnology companies, as well as universities and nonprofit research organizations, and it may have to pay higher salaries to attract and retain qualified personnel. The loss of one or more members of OrthoLogic’s current management team or any of its scientific personnel, could delay OrthoLogic’s business plan. The loss of Dr. Ryaby, depending on what stage of development OrthoLogic’s research is at upon Dr. Ryaby’s departure, could cause a substantial delay in implementing OrthoLogic’s business plan. Not only could the nationwide search for a similarly qualified candidate be lengthy, but Dr. Ryaby’s replacement would need time to become familiar with OrthoLogic’s Chrysalin product platform. OrthoLogic does not maintain key man insurance on Dr. Ryaby. However, OrthoLogic currently has in place employment contracts with several members of its senior management team, including Dr. Ryaby.

     OrthoLogic faces an inherent risk of liability in the event that the use or misuse of its products results in personal injury or death.

     The use of OrthoLogic’s product candidates in clinical trials, and the sale of any approved products, may expose OrthoLogic to product liability claims, which could result in financial losses. OrthoLogic’s clinical liability insurance coverage may not be sufficient to cover claims that may be made against the possible risk related to its clinical trials. In addition, OrthoLogic may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts or scope to protect it against losses. Any claims against OrthoLogic, regardless of their merit, could severely harm OrthoLogic’s financial condition, strain its management and other resources and adversely impact or eliminate the prospects for commercialization of the product which is the subject of any such claim.

     OrthoLogic’s stock price is volatile and fluctuates due to a variety of factors.

     OrthoLogic’s stock price has varied significantly in the past (from a low of $3.22 to a high of $8.96 since January 1, 2002) and may vary in the future due to a number of factors, including:

  fluctuations in OrthoLogic’s research and development efforts;
 
  developments in litigation to which OrthoLogic or a competitor is subject;
 
  announcements and timing of potential acquisitions, divestitures, and conversions of preferred stock;
 
  announcements of technological innovations or new products by OrthoLogic or its competitors;
 
  FDA and international regulatory actions;
 
  actions with respect to reimbursement matters;
 
  developments with respect to OrthoLogic or its competitors’ patents or proprietary rights;
 
  public concern as to the safety of products developed by OrthoLogic or others;
 
  changes in health care policy in the United States;
 
  changes in stock market analyst recommendations regarding OrthoLogic, other drug development companies or the pharmaceutical industry generally; and

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  general market conditions.

     In addition, the stock market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These broad market fluctuations may adversely affect the market price of OrthoLogic’s stock.

Risks of OrthoLogic’s Industry

     OrthoLogic is in a highly regulated field with high investment costs and high risks.

     OrthoLogic’s Chrysalin product platform is currently in the human testing phase for three potential products and earlier preclinical testing phases for three other potential products. The U.S. Food and Drug Administration (“FDA”) and comparable agencies in many foreign countries impose substantial limitations on the introduction of new pharmaceuticals through costly and time-consuming laboratory and clinical testing and other procedures. The process of obtaining FDA and other required regulatory approvals is lengthy, expensive and uncertain. Chrysalin, as a new drug, is subject to the most stringent level of FDA review.

     There can be no guarantee that the FDA will grant approval of Chrysalin for the indicated uses or that it will do so in a timely manner.

     If OrthoLogic successfully brings one or more products to market, there is no assurance that it will be able to successfully manufacture or market the products or that potential customers will buy them if, for example, a competitive product has greater efficacy or is deemed more cost effective. In addition, the market in which OrthoLogic will sell any such products is dominated by a number of large corporations that have vastly greater resources than OrthoLogic has, which may impact OrthoLogic’s ability to successfully market its products or maintain any technological advantage OrthoLogic has or might develop. OrthoLogic also would be subject to changes in regulations governing the manufacture and marketing of its products, which could increase its costs, reduce any competitive advantage it may have and/or adversely affect its marketing effectiveness.

     The results of OrthoLogic’s late stage clinical trials may be insufficient to obtain FDA approval which could result in a substantial delay in OrthoLogic’s ability to generate revenue.

     Positive results from preclinical studies and early clinical trials do not ensure positive results in more advanced clinical trials. If OrthoLogic is unable to demonstrate that a product candidate will be safe and effective in advanced clinical trials involving larger numbers of patients, OrthoLogic will be unable to submit the new drug application necessary to receive approval from the FDA to commercialize that product.

     OrthoLogic is currently conducting a Chrysalin Phase 3 human clinical trial for the acceleration of fracture repair and is in the process of beginning an additional human clinical trial for this indication. OrthoLogic expects to complete enrollment and have results for the Phase 3 trial before the end of 2005. If this Phase 3 trial fails to achieve the clinical benefits sought or the results are ambiguous, OrthoLogic will have to determine whether to redesign its Chrysalin fracture repair product candidate and its corresponding protocols and continue with additional testing, or cease activities in this area. Redesigning the product could be extremely costly and time-consuming. A substantial delay in obtaining FDA approval or termination of the Chrysalin fracture repair product candidate could result in a delay in OrthoLogic’s ability to generate revenue.

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     Patients may discontinue their participation in OrthoLogic’s clinical studies, which may negatively impact the results of these studies and extend the timeline for completion of OrthoLogic’s development programs.

     As with all clinical trials, OrthoLogic is subject to the risk that patients enrolled in its clinical studies may discontinue their participation at any time during the study as a result of a number of factors, including, withdrawing their consent or experiencing adverse clinical events, which may or may not be judged related to its product candidates under evaluation. OrthoLogic is subject to the risk that if a large number of patients in any one of its studies discontinue their participation in the study, the results from that study may not be positive or may not support an NDA for regulatory approval of OrthoLogic’s product candidates.

     In addition, the time required to complete clinical trials is dependent upon, among other factors, the rate of patient enrollment. Patient enrollment is a function of many factors, including

  the size of the patient population;
 
  the nature of the clinical protocol requirements;
 
  the diversion of patients to other trials or marketed therapies;
 
  OrthoLogic’s ability to recruit and manage clinical centers and associated trials;
 
  the proximity of patients to clinical sites; and
 
  the patient eligibility criteria for the study.

     Even if OrthoLogic obtains marketing approval, its products will be subject to ongoing regulatory oversight, which may affect OrthoLogic’s ability to successfully commercialize any products it may develop.

     Even if OrthoLogic receives regulatory approval of a product candidate, the approval may be subject to limitations on the indicated uses for which the product is marketed or require costly post-marketing follow-up studies. After OrthoLogic obtains marketing approval for any product, the manufacturer and the manufacturing facilities for that product will be subject to continual review and periodic inspections by the FDA and other regulatory agencies. The subsequent discovery of previously unknown problems with the product, or with the manufacturer or facility, may result in restrictions on the product or manufacturer, including withdrawal of the product from the market.

     If OrthoLogic fails to comply with applicable regulatory requirements, it may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

     OrthoLogic’s product candidates may not gain market acceptance among physicians, patients and the medical community. If OrthoLogic’s product candidates fail to achieve market acceptance, its ability to generate revenue will be limited.

     Even if OrthoLogic obtains regulatory approval for its products, market acceptance will depend on its ability to demonstrate to physicians and patients the benefits of its products in terms of safety, efficacy, convenience, ease of administration and cost effectiveness. In addition, OrthoLogic believes market acceptance depends on the effectiveness of its marketing strategy, the pricing of its products and the reimbursement policies of government and third-party payors.

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Physicians may not prescribe OrthoLogic’s products, and patients may determine, for any reason, that OrthoLogic’s product is not useful to them. If OrthoLogic’s product candidates fail to achieve market acceptance, its ability to generate revenue will be limited.

     OrthoLogic’s success also depends on its ability to operate and commercialize products without infringing on the patents or proprietary rights of others.

     Third parties may claim that OrthoLogic or its licensors or suppliers are infringing their patents or are misappropriating their proprietary information. In the event of a successful claim against OrthoLogic or its licensors or suppliers for infringement of the patents or proprietary rights of others, OrthoLogic may be required to, among other things:

  pay substantial damages;
 
  stop using certain OrthoLogic technologies;
 
  stop certain research and development efforts;
 
  develop non-infringing products or methods; and
 
  obtain one or more licenses from third parties.

     A license required under any such patents or proprietary rights may not be available to us, or may not be available on acceptable terms. If OrthoLogic or its licensors or suppliers are sued for infringement, OrthoLogic could encounter substantial delays in, or be prohibited from, developing, manufacturing and commercializing OrthoLogic’s product candidates.

     The pharmaceutical industry is subject to stringent regulation, and failure to obtain regulatory approval from the United States Food and Drug Administration will prevent commercialization of OrthoLogic’s products.

     OrthoLogic’s research, development, preclinical and clinical trial activities and the manufacture and marketing of any products that it may successfully develop are subject to an extensive regulatory approval process by the FDA. The process of obtaining required regulatory approvals for drugs is lengthy, expensive and uncertain, and any such regulatory approvals may entail limitations on the indicated usage of a drug, which may reduce the drug’s market potential.

     In order to obtain FDA approval to commercialize any product candidate, an NDA must be submitted to the FDA demonstrating, among other things, that the product candidate is safe and effective for use in humans for each target indication. OrthoLogic’s regulatory submissions may be delayed, or OrthoLogic may cancel plans to make submissions for product candidates for a number of reasons, including:

  negative or ambiguous preclinical or clinical trial results;
 
  changes in regulations or the adoption of new regulations;
 
  unexpected technological developments; and
 
  developments by OrthoLogic’s competitors that are more effective than OrthoLogic’s product candidates.

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     Consequently, OrthoLogic cannot assure you that it will make its submissions to the FDA in the timeframe that OrthoLogic has planned, or at all, or that its submissions will be approved by the FDA. Even if regulatory clearance is obtained, post-market evaluation of OrthoLogic’s products, if required, could result in restrictions on a product’s marketing or withdrawal of a product from the market as well as possible civil and criminal sanctions.

     Clinical trials are subject to oversight by institutional review boards and the FDA to ensure compliance with the FDA’s good clinical practice regulations, as well as other requirements for good clinical practices. OrthoLogic depends, in part, on third-party laboratories and medical institutions to conduct preclinical studies and clinical trials for its products and other third-party organizations, usually universities, to perform data collection and analysis, all of which must maintain both good laboratory and good clinical practices. If any such standards are not complied with in OrthoLogic’s clinical trials, the FDA may suspend or terminate such trials, which would severely delay OrthoLogic’s development of, and possibly end the development of, a product candidate.

     OrthoLogic also currently depends and in the future will depend upon third party manufacturers of its products, which are and will be required to comply with the applicable FDA Good Manufacturing Practices regulations. OrthoLogic cannot be certain that its present or future manufacturers and suppliers will comply with these regulations. The failure to comply with these regulations may result in restrictions on the sale of, or withdrawal of the products from the market. Compliance by third parties with these standards and practices are outside of OrthoLogic’s direct control.

     If OrthoLogic’s competitors develop and market products that are more effective than OrthoLogic’s, or obtain marketing approval before OrthoLogic does, OrthoLogic’s commercial opportunities will be reduced or eliminated.

     Competition in the pharmaceutical and biotechnology industries is intense and is expected to increase. Several biotechnology and pharmaceutical companies, as well as academic laboratories, universities and other research institutions, are involved in research and/or product development for various treatments for or involving fracture repair, spine fusion, diabetic ulcer healing, cartilage defect repair, tendon repair and cardiovascular repair. Many of OrthoLogic’s competitors have significantly greater research and development capabilities, experience in obtaining regulatory approvals and manufacturing, marketing, financial and managerial resources than OrthoLogic has. OrthoLogic is currently aware of the following development efforts by its competitors:

  Acceleration of Fracture Repair: While there is currently no product approved by the FDA for acceleration of fracture repair, at least one large pharmaceutical company, Pfizer, Inc., has received FDA clearance to begin human clinical trials in the United States for this indication.
 
  Spine Fusion: Although there are already many products approved by the FDA for use in spinal fusion, only two products, InFuse from Medtronic and OP-1 from Stryker, both bone morphogenic protein (“BMP”), includes a bioactive component. OrthoLogic knows other candidates are in the development stage, but none are yet in human clinical trials in the United States.
 
  Dermal Wound Healing (Diabetic Ulcers): Only one product, Regranix from Johnson and Johnson has been FDA approved for a diabetic ulcer indication.

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Table of Contents

  Cartilage Defect Repair: Several products with bioactive components are in the development stage for this indication, including BMPs. However, OrthoLogic believes no company has yet received FDA authorization for a drug product to begin human clinical trials in the United States for this indication.
 
  Cardiovascular Repair: This is a very large and complicated market with numerous products FDA approved or under development for a variety of indications. There are significant product opportunities that still exist, particularly in the area of myocardial revascularization.
 
  Tendon Repair: There are currently no drug products specifically approved for a tendon repair indication. Physicians currently employ a variety of surgical techniques to address this medical problem.

     OrthoLogic’s competitors may succeed in developing products that are more effective than the ones OrthoLogic has under development or that render OrthoLogic’s proposed products or technologies noncompetitive or obsolete. In addition, certain of such competitors may achieve product commercialization before OrthoLogic does. If any of OrthoLogic’s competitors develops a product that is more effective than one OrthoLogic is developing or plans to develop, or is able to obtain FDA approval for commercialization before OrthoLogic does, OrthoLogic may not be able to achieve significant market acceptance for certain of its products, which would have a material adverse effect on OrthoLogic’s business.

     Healthcare reform and restrictions on reimbursements may limit OrthoLogic’s financial returns.

     OrthoLogic’s ability to successfully commercialize its products will depend in part on the extent to which government health administration authorities, private health insurers and other third party payors will reimburse consumers for the cost of these products. Third party payors are increasingly challenging both the need for, and the price of, novel therapeutic drugs and uncertainty exists as to the reimbursement status of newly approved therapeutics. Adequate third party reimbursement may not be available for OrthoLogic’s drug products to enable OrthoLogic to maintain price levels sufficient to realize an appropriate return on OrthoLogic’s investments in research and product development, which could restrict OrthoLogic’s ability to commercialize a particular drug candidate.

Part II – Other Information

Item 5. Other Information

     On November 8, 2004, we entered into a Third Amended and Restated Employment Agreement with Sherry A. Sturman (the “Sturman Agreement”) under which Ms. Sturman will continue to serve as our Senior Vice President / Chief Financial Officer. The Sturman Agreement provides for a minimum base salary of $200,000 per year. Ms. Sturman will also be eligible for annual and long-term incentives, including performance-based bonuses and stock option grants. Under the terms of the Sturman Agreement, OrthoLogic or Ms. Sturman may elect to begin a two-year transition leading to the termination of Ms. Sturman’s employment with OrthoLogic. Ms. Sturman may make such an election at any time after June 30, 2005 and we may make such an election at any time. In the event an election is made by either Ms. Sturman

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or OrthoLogic, Ms. Sturman would be entitled to continue receiving salary, at declining base salary rates, and benefits for a period of two years.

       
Item 6.
    Exhibits
 
 
    See Exhibit List following this report

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

ORTHOLOGIC CORP.


(Registrant)
         
Signature
  Title
  Date
/s/ Thomas R. Trotter
Thomas R. Trotter
  President and Chief Executive Officer
(Principal Executive Officer)
  November 9, 2004
 
       
/s/ Sherry A. Sturman
Sherry A. Sturman
  Senior Vice-President and Chief Financial Officer
(Principal Financial and Accounting Officer)
  November 9, 2004

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Table of Contents

OrthoLogic Corp.
Exhibit Index to Quarterly Report on Form 10-Q
For the Quarterly Period Ended September 30, 2004

             
Exhibit            
No.
  Description
  Incorporated by Reference To:
  Filed Herewith
3.1
  Amended and Restated Certificate of Incorporation, executed May 9, 2000   Exhibit 3.1 to the Company’s Form 10-Q for the quarter ended September 30, 2003 (“September 2003 10-Q”)    
 
           
3.2
  Certificate of Designation of Series A Preferred Stock   Exhibit 3.2 to the Company’s September 2003 10-Q    
 
           
3.3
  Bylaws of the Company   Exhibit 3.4 to Company’s Amendment No. 2 to Registration Statement on Form S-1 (No. 33-47569) filed with the SEC on January 25, 1993    
 
           
4.1
  Rights Agreement dated as of March 4, 1997, between the Company and Bank of New York, and Exhibits A, B and C thereto   Exhibit 4.1 to the Company’s Registration Statement on Form 8-A filed with the SEC on March 6, 1997    
 
           
4.2
  1987 Stock Option Plan of the Company, as amended and approved by stockholders (1)   Exhibit 4.4 to the Company’s Form 10-Q for the quarter ended June 30, 1997 (“June 1997 10-Q”)    
 
           
4.3
  1997 Stock Option Plan of the Company, as amended and approved by the stockholders(1)   Exhibit 4.5 to the Company’s June 1997 10-Q    
 
           
10.1
  Amendment No. 2 to the Asset Purchase Agreement and Plan of Reorganization between OrthoLogic Corp. and Chrysalis Biotechnology, Inc., dated August 5, 2004 *   Exhibit 2.1 to Current Report on Form 8-K, filed August 6, 2004    
 
           
10.2
  Consulting Agreement with Darrell H. Carney, Ph.D., dated August 5, 2004       X
 
           
10.3
  Third Amended and Restated Employment Agreement effective November 8, 2004, between the Company and Sherry A. Sturman       X
 
           
31.1
  Certification of CEO pursuant to Securities Exchange Act Rule 13a-14 (a).       X
 
           
31.2
  Certification of CFO pursuant to Securities Exchange Act Rule 13a-14 (a).       X
 
           
32
  Certification pursuant to the Securities Exchange Act Rule 13a-14(b) and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
— Thomas R. Trotter
— Sherry A. Sturman
       

     (1)Management contract or compensatory plan or arrangement
     *OrthoLogic Corp. agrees to furnish supplementally a copy of any schedule to the Asset Purchase Agreement and Plan of Reorganization dated as of April 28, 2004 and to Amendment Nos. 1 and 2 omitted from this filing to the Securities and Exchange Commission upon its request.
     **Furnished herewith

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EX-10.2 2 p69834exv10w2.htm EX-10.2 exv10w2
 

Exhibit 10.2

CONSULTING AGREEMENT

     This Consulting Agreement (the “Agreement”) dated as of August 5, 2004, is by and between OrthoLogic Corp., a Delaware corporation (the “Company”), and Darrell Carney, Ph.D. (“Consultant”).

RECITAL:

     The Company desires to engage Consultant, and Consultant desires to accept such engagement, on the terms and conditions set forth in this Agreement.

AGREEMENT:

     In consideration of the conditions and covenants contained herein, the parties agree as follows:

     1. Engagement. The Company hereby engages Consultant and Consultant hereby accepts such engagement with the Company, under the terms and conditions set forth in this Agreement (the “Engagement”).

     2. Duties.

          (a) During the Engagement, Consultant shall perform such consulting services for the Company as the Company may reasonably request Consultant to perform. Consultant shall initially serve as General Manager of the CBI Division of the Company (“GM”). Consultant shall operate and manage the business operations of the CBI Division subject to the general policies of the Company and the supervision of the Vice President and Chief Technology Officer. Consultant shall devote time as required for the performance of services for the Company hereunder. A more specific list of Consultant’s duties is set forth in Exhibit A.

          (b) The Company recognizes that Consultant currently serves as professor in the Department of Human Biological Chemistry and Genetics at the University of Texas Medical Branch in Galveston (“UTMB”), and that unless and until Consultant shall no longer serve in such position, Consultant will determine the portion of his business time to be devoted to UTMB and the portion of his business time to be devoted to the Company, provided, that Consultant shall devote to the affairs of the Company such time as is necessary to carry out his duties hereunder. Subject to his duties to UTMB, Consultant shall devote substantially all of his business time, attention, and energies to the business and affairs of the Company and use his best efforts to advance the interests of the Company.

          (c) During the Initial Term, the Consultant shall serve as the Chairman of the Company’s Scientific Advisory Board.

     3. Term. Unless terminated for cause as provided herein, the Engagement shall commence on August 5, 2004 and continue through the second anniversary of the

1


 

commencement date (the “Initial Term”). Thereafter the Engagement will be terminable by either party with or without cause pursuant to Section 5 of this Agreement.

     4. Fees and Expenses.

          (a) The Company shall pay to Consultant a fee of $200,000 per year, payable in equal monthly installments or, at the discretion of the Company, on the Company’s regular employee payroll schedule.

          (b) The Company shall pay or reimburse Consultant for all reasonable travel and other expenses incurred or paid by Consultant, with the prior approval of the Company, in connection with the performance of services under this Agreement. Payment shall be made within 30 days following the presentation of expense statements or vouchers and supporting information consistent with the Company’s reimbursement policies.

          (c) The Consultant shall be eligible for performance bonuses and stock option programs created for the Consultant by the Company’s Board of Directors on an annual basis in its sole discretion.

     5. Termination. Consultant’s Engagement by the Company shall terminate as set forth below. No termination shall affect any rights or obligations accruing prior thereto or any continuing obligations of the parties hereunder.

          (a) The Engagement shall be terminable by the Company for cause during the Initial Term of the Engagement. After the Initial Term, the Engagement will be terminable by either party with or without cause 45 days after notice of termination is given by either party. If the Company terminates the Engagement during the Initial Term for cause, or after the Initial Term with or without cause, the Company shall have no further obligation to pay the Consultant his consulting fee. If the Company terminates the Engagement during the Initial Term without cause and provided the Consultant first executes a Severance Agreement in the form then used by the Company, the Company shall continue to pay the Consultant his consulting fee for the time period that is the greater of (i) the remaining period on the Initial Term, or (ii) 12 months, in either case payable monthly, or, at the discretion of the Company, on the Company’s regular employee payroll schedule.

          (b) Either party may terminate the Engagement for cause by giving the other party 10 days notice, which shall specify the cause for the termination. Cause shall include material neglect of duties, violations of ethical policies (including insider trading policies) established by the Company, and commission of acts of dishonesty that negatively affect the Consultant’s standing in the academic community or challenge Consultant’s research integrity. However, during such 10-day period, if the reason for termination is curable and the party receiving notice cures the specified cause, the Engagement shall not terminate.

          (c) Additionally, the Engagement shall terminate immediately upon the death or disability of the Consultant. For this purpose, the Consultant shall be deemed to be disabled if

2


 

he is unable substantially to perform the duties required by the Engagement for a continuous period of 30 days or for any 30 days within any 90-day period.

          (d) If, upon a merger in which the Company is not the surviving entity or upon the sale of substantially all the Company’s assets, the entity who steps into the shoes of the Company under this Agreement requires the Consultant to relocate over 30 miles outside of Galveston, Texas, such requirement will be deemed under this Agreement as a termination without cause.

     6. Loyalty During Engagement Term. Except as it relates to his employment as a professor at the University of Texas, the Consultant will not engage in any way whatsoever, directly or indirectly, in any business that is in the business of developing growth factors, proteins, peptides and small molecules intended for tissue repair or regeneration, nor solicit, or in any other manner work for or assist any such business. During the term of Consultant’s engagement by the Company, Consultant will undertake no planning for or organization of any such business activity, and Consultant will not combine or conspire with any employee of the Company or any other person or entity for the purpose of organizing any such competitive business activity.

     7. Injunctive Relief. It is agreed that the restrictions contained in Section 6 of this Agreement are reasonable, but it is recognized that damages in the event of the breach of any of those restrictions will be difficult or impossible to ascertain; and, therefore, Consultant agrees that, in addition to and without limiting any other right or remedy the Company may have, the Company shall have the right to an injunction against Consultant issued by a court of competent jurisdiction enjoining any such breach without showing or proving any actual damage to the Company.

     8. Part of Consideration. Consultant also agrees, acknowledges, covenants, represents and warrants that he is fully and completely aware that, and further understands that, the restrictive covenants contained in Section 6 of this Agreement and in the Intellectual Property, Confidentiality and Non-Competition Agreement dated August 5, 2004 between the Company and the Consultant (the “IP Agreement”) which is incorporated herein are an essential part of the consideration for the Company entering into this Agreement and that the Company is entering into this Agreement in full reliance on such acknowledgments, covenants, representations and warranties.

     9. Nondelegability of Consultant’s Rights and Company Assignment Rights. The obligations, rights and benefits of Consultant hereunder are personal and may not be delegated, assigned or transferred in any manner whatsoever, nor are such obligations, rights or benefits subject to involuntary alienation, assignment or transfer. Upon mutual agreement of the parties, the Company upon reasonable notice to Consultant may transfer Consultant to an affiliate of the Company, which affiliate shall assume the obligations of the Company under this Agreement. This Agreement shall be assigned automatically to any entity merging with or acquiring the Company.

3


 

     10. Amendment. Except for any documents regarding the grant of stock options, this Agreement and the IP Agreement contain, and their terms constitute, the entire agreement of the parties and supersede any prior agreements, and they may be amended only by a written document signed by both parties to the respective agreements.

     11. Governing Law. This Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Arizona, exclusive of the conflict of law provisions thereof, and the parties agree that any litigation pertaining to this Agreement shall be in courts located in Maricopa County, Arizona.

     12. Attorneys’ Fees. If any party finds it necessary to employ legal counsel or to bring an action at law or other proceeding against the other party to enforce any of the terms hereof, the party prevailing in any such action or other proceeding shall be paid by the other party its reasonable attorneys’ fees as well as court costs all as determined by the court and not a jury.

     13. Notices. All notices and other communications required or permitted to be given under this Agreement shall be in writing and shall be considered given and delivered when personally delivered to the party to whom such notice or communication is addressed, or one business day after posting with an overnight courier, or when confirmation is received if sent by facsimile, or five business days after deposit in the United States mail, postage prepaid, with return receipt requested, properly addressed to a party at the address set forth below, or at such other address as such party shall have specified by notice given in accordance with this Section:

      If to the Company, to:                       OrthoLogic Corp.
                    1275 W. Washington St.
                    Tempe, AZ 85281
                    James T. Ryaby, Ph.D.
                    Attn: Senior Vice President of Research
                    And Clinical Affairs
                    (602) 286-5326

      If to Consultant, to:                          Darrell Carney, Ph.D.
                       2200 Market, Suite 600
                       Galveston, TX 77550
                       (409) 750-9251 phone
                       (409) 750-9253 fax

     14. Entire Agreement. This Agreement and the IP Agreement constitute the final written expressions of the agreement between the parties with regard to Consultant’s engagement and are complete and exclusive statements of those terms. They supersede all understandings and negotiations concerning the matters specified herein and therein. Any representations, promises, warranties or statements made by either party that differ in any way from the terms of this written Agreement or the IP Agreement shall be given no force or effect. The parties

4


 

specifically represent, each to the other, that there are no additional or supplemental agreements between them related in any way to the matters herein contained unless specifically included or referred to herein. No addition to or modification of any provision of this Agreement and the IP Agreement shall be binding upon any party unless made in writing and signed by all parties.

     15. Waiver. The waiver by either party of the breach of any covenant or provision in this Agreement shall not operate or be construed as a waiver of any subsequent breach by either party.

     16. Invalidity of any Provision. The provisions of this Agreement are severable, it being the intention of the parties hereto that should any provisions hereof be invalid or unenforceable, such invalidity or unenforceability of any provision shall not affect the remaining provisions hereof, but the same shall remain in full force and effect as if such invalid or unenforceable provisions were omitted.

     17. Attachments. The IP Agreement and all attachments or exhibits to this Agreement are incorporated herein by this reference as though fully set forth herein. In the event of any conflict, contradiction or ambiguity between the terms and conditions in this Agreement and any of its attachments, the terms of this Agreement shall prevail.

     18. Interpretation of Agreement. When a reference is made in this Agreement to an article or section, such reference shall be to an article or section of this Agreement unless otherwise indicated. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the words “include,” “includes,” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”

     19. Headings. Headings in this Agreement are for informational purposes only and shall not be used to construe the intent of this Agreement.

     20. Counterparts. This Agreement may be executed simultaneously in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same agreement.

     21. Binding Effect; Benefits. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective heirs, successors, executors, administrators and assigns. Notwithstanding anything contained in this Agreement to the contrary, nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties hereto or their respective heirs, successors, executors, administrators and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement.

     22. Indemnification. The Company will indemnify Consultant for all costs, expenses, losses and damages arising out of the Company’s promotion, manufacture or use of its products (including, but not limited to Chrysalin) provided that Consultant agrees to promptly notify the Company of any such indemnifiable claims, and to give sole control of litigation and settlement of such claims to the Company, and to participate in the defense thereof. Consultant will

5


 

indemnify the Company, its directors, officers and employees, for all costs, expenses, losses and damages arising from its breach or its affiliates’ breach of this Agreement.

     This Agreement has been executed by the parties as the date first written above.

     IN WITNESS WHEREOF, Consultant and the Company have executed this Agreement as of the day and year first written above.

             
COMPANY   CONSULTANT    

           
OrthoLogic Corp.   Darrell Carney, Ph.D.    




           
By:
  /s/ Thomas R. Trotter   /s/ Darrell Carney    
 
 
   
  Thomas R. Trotter        
  Chief Executive Officer        

6


 

Exhibit A — Consultant’s Duties

     1. General management of the CBI Division of OrthoLogic Corp.

7


 

INTELLECTUAL PROPERTY
AND CONFIDENTIALITY AGREEMENT

     This Agreement made as of the 5th day of August, 2004, between OrthoLogic Corp., a Delaware corporation with its principal place of business in Arizona (the “Company”), and Darrell Carney, a consultant of the Company (the “Contractor”).

RECITALS

     A. The Contractor is engaged by the Company, or is about to be engaged by the Company, as a consultant (the “Engagement”) pursuant to the terms of the Consultant Agreement dated as of August 5, 2004 between the Consultant and the Company and which is incorporated by reference into this Agreement.

     B. The Contractor has been, or will be, given access by the Company to confidential and proprietary information of the Company.

     C. The Company has retained the Contractor pursuant to the terms of the Engagement.

     D. During the term of the Engagement, Contractor may, in the course of providing services under the Engagement, create or develop Inventions and/or Creations for the Company, as defined herein, that are intended to be owned exclusively by the Company, and the parties understand that Company shall exclusively own all such Inventions and Creations.

AGREEMENTS

     IN CONSIDERATION of the foregoing and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Contractor and the Company agree as follows:

     1. Nondisclosure of Proprietary Information. The Company invents, develops, manufactures and markets processes and products that involve experimental or inventive work. The Company’s success depends upon the protection of these processes and products by patent, by copyright, or by secrecy. The Contractor has had, or may have, access to the Company’s Proprietary Information, as defined in this Section 1. Access to this Proprietary Information is given to the Contractor only if the Contractor agrees to keep that information secret as follows:

          (a) “Proprietary Information” is all information, in whatever form, tangible or intangible, pertaining in any manner to the business of the Company, or any of its agents or employees, which was produced by any employee, consultant, or independent contractor of the Company including: (i) any and all methods, inventions, improvements, information, data or discoveries, whether or not patentable, that are secret, proprietary, confidential or generally undisclosed, (including information originated or provided by the Contractor) in any area of knowledge, including information concerning trade secrets, processes, software, products, patents, patent applications, inventions, formulae, apparatus, techniques, technical data, clinical data, clinical trials, improvements, specifications, servicing, attributes and relative attributes relating to any of the Company’s equipment, devices, processes, or products, or research and

1


 

development thereof, including all information relating to the Chrysalin peptide and Chrysalin preclinical and human clinical study data, products, engineering reports, drawings, diagrams, computer programs and data, peptide formulation information, specifications, prototypes, models, apparatus, techniques, know-how, marketing plans, other data, improvements, strategies, forecasts, customer lists, technical requirements of customers, and participating investigator lists, unless such information is in the public domain to such an extent as to be readily available to competitors; and (ii) the identities of the Company’s customers and potential customers (“Customers”) including Customers the Contractor successfully cultivates or maintains during his Engagement using the Company’s products, name or infrastructure; the identities of contact persons at Customers; the preferences, likes, dislikes and technical and other requirements of Customers and contact persons with respect to product types, pricing, sales calls, timing, sales terms, rental terms, lease terms, service plans, and other marketing terms and techniques; the Company’s business methods, practices, strategies, forecasts, know-how, pricing, and marketing plans and techniques; the identity of key accounts; the identity of potential key accounts; and the identities of the Company’s key employees and key business partners. Proprietary Information shall not include information which (i) is known to Contractor on a non-confidential basis prior to disclosure by the Company; (ii) is or hereafter becomes known to the general public without breach or fault on the part of Contractor; (iii) is disclosed to Contractor by a third party without restriction on disclosure and without breach of any nondisclosure obligation; or (iv) is independently developed by Contractor from information not protected under this Agreement by Contractor while Contractor has no access to related information disclosed by the Company.

          (b) The Contractor acknowledges that the Company has exclusive property rights to all Proprietary Information and the Contractor hereby assigns any and all rights Contractor might otherwise possess in any Proprietary Information to the Company. Except as required in the performance of the duties of his Engagement with the Company, the Contractor will not at any time during or after the term of his Engagement, without the prior written consent of the Company, directly or indirectly use, communicate, disclose, disseminate, lecture upon, publish articles or otherwise put in the public domain, any Proprietary Information or any other information of a secret, proprietary, confidential or general undisclosed nature relating to the Company, its products, Customers, processes or services, including information relating to testing, research, development, manufacturing, marketing or selling.

          (c) All documents, records, notebooks, notes, memoranda, data bases, and similar repositories containing Proprietary Information made or compiled by the Contractor at any time, including any and all copies thereof, are and shall be the property of the Company, shall be held by him in trust solely for the benefit of the Company, and shall be delivered to the Company by him on the termination of his Engagement or at any other time upon the request of the Company.

          (d) The Contractor agrees to certify in writing at or before final termination of the Engagement that the Contractor no longer has in the Contractor’s possession, custody or control of any copies of any business documents generated at or relating to the Company nor any Proprietary Information, whether in hard copy, on a computer’s hard drive, on disks or in any other form or media.

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          (e) All information regarding the Company’s business disclosed to, learned by or developed by the Contractor during the course of the Engagement shall be presumed to be Proprietary Information.

          (f) For five years after the termination of his consulting engagement for the Company, the Consultant agrees to provide notification, at the start of any new engagement or employment, to all subsequent employers or contracting parties who are involved in any way in the pharmaceuticals industry or are otherwise competitors of the Company, of the terms and conditions of this Agreement, along with a copy of this Agreement.

     2. Inventions.

          (a) “Inventions” shall mean discoveries, concepts and ideas, whether patentable or not, including improvements, know-how, data, processes, methods, formulae and techniques, as well as improvements thereof or know-how related thereto, but only those which Consultant makes, discovers or conceives, either solely or jointly with others, in the course of performing his consulting services for the Company pursuant to this Agreement, or with the use of the Company’s facilities, materials or personnel, or arising from the Company’s Confidential Information, including, but not limited to, Chrysalin, its derivatives and variations, and any ancillary products to Chrysalin’s distribution, disbursement, storage or distribution, and thrombin peptide or TP508 Technology, as defined in the Patent License Agreement dated April 27, 2004. All Inventions shall be solely the property of the Company and the Contractor agrees to perform the requirements of this Section with respect thereto without the payment by the Company of any royalty or any consideration other than as provided in this Agreement.

          (b) The Contractor shall maintain written notebooks in which he shall set forth on a current basis information as to all Inventions describing in detail the procedures employed and the results achieved as well as information as to any studies or research projects undertaken on the Company’s behalf, whether or not in the Contractor’s opinion a given project has resulted in an Invention. The written notebooks shall at all times be the property of the Company and shall be surrendered to the Company upon termination of his Engagement or upon request of the Company.

          (c) The Contractor shall apply, at the Company’s request and expense, for United States and foreign letters patent either in the Contractor’s name or otherwise as the Company shall desire.

          (d) The Contractor hereby assigns to the Company all of his rights to Inventions, applications for United States Patent and/or foreign letters patent and to United States and/or foreign letters patent granted upon Inventions, including without limitation, all renewals, reissues, extensions, continuations, divisions or continuations-in-part thereof.

          (e) The Contractor shall acknowledge and deliver promptly to the Company without charge to the Company but at its expense such written instruments (including applications and assignments) and do such other acts, such as giving testimony in support of the Contractor’s inventorship, as may be necessary in the opinion of the Company to obtain,

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maintain, extend, reissue and enforce United States and/or foreign letters patent relating to the Inventions and to vest the entire right and title thereto in the Company or its nominee.

          (f) The Contractor’s obligation to assist the Company in obtaining and enforcing patents for Inventions in any and all countries shall continue beyond the Engagement, but the Company shall compensate the Contractor at a reasonable rate for time actually spent by him at the Company’s request on such assistance. If the Company is unable for any reason whatsoever to secure the Contractor’s signature to any lawful and necessary document required to apply for or execute any patent application with respect to any Inventions, including renewals, reissues, extensions, continuations, divisions or continuations-in-part thereof, the Contractor hereby irrevocably designates and appoints the Company and its duly authorized officers and agents, as his agents and attorneys-in-fact to act for and in his behalf and instead of the Contractor, to execute and file any application and to do all other lawful permitted acts to further the prosecution and issuance of patents with the same legal force and effect as if executed by the Contractor.

          (g) As a matter of record the Contractor has identified on Exhibit A, attached hereto, all inventions or improvements relevant to the activity of the Company which have been made or conceived or first reduced to practice by the Contractor alone or jointly with others prior to his Engagement by the Company, that he desires to remove from the operation of this Section 2; and the Contractor covenants that such list is complete as of the date of this Agreement. The Consultant may update the list on a periodic basis. If there is no such list or if no Exhibit A is attached, the Contractor represents that he has made no such inventions and improvements at the time of signing this Agreement.

          (h) The Contractor will not assert any rights under any inventions, discoveries, concepts or ideas, or improvements thereof, or know-how related thereto, as having been made or acquired by him prior to his being engaged by the Company or during the term of his Engagement if based on or otherwise related to Proprietary Information.

          (i) No provisions of this Section shall be deemed to limit the restrictions applicable to the Contractor under Section 1.

     3. Creations.

          (a) “Creations” shall include, without limitation, all designs, logos, slogans, improvements, plans, developments, marks, names, symbols, phrases, graphics, advertising, images, art work, processes, business methods, trade secrets, any and all copyrightable expression, all copyrightable works, and all patentable subject matter, in all media (whether existing now or to be invented), that are conceived, created, made, developed, or acquired by or for Contractor as a result of the services performed by him during the Engagement and for the Company, whether or not protected by statute and including all derivative works.

          (b) Creations shall be deemed “work made for hire” under the United States Copyright laws, Title 17 of the United States Code, and the Company will be deemed the author of the work product.

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          (c) Contractor hereby assigns to Company its entire right, title, and interest, if any, in and to any and all Creations, including without limitation all copyright rights, patent rights, trade secrets, trademark rights and associated goodwill, along with all rights to derivative works and the right to apply for and obtain any applicable registrations and all other available legal protections for the Creations.

          (d) The Contractor shall acknowledge and deliver promptly to the Company without charge to the Company but at its expense such written instruments (including applications and assignments) and do such other acts, such as giving testimony in support of the Creations, as may be necessary in the opinion of the Company to obtain, maintain, extend, reissue and enforce any applicable registrations relating to the Creations and to vest the entire right and title thereto in the Company or its nominee.

     4. Shop Rights. The Company shall also have the royalty-free right to use in its business, and to make, use and sell products, processes and/or services derived from any inventions, discoveries, concepts and ideas, whether or not patentable, including processes, methods, formulas and techniques, as well as improvements thereof or know-how related thereto, which are not within the scope of Inventions as defined in Section 2 but which are conceived or made by the Consultant during the period Consultant is engaged by the Company or with the use or assistance of the Company’s facilities, materials or personnel.

     5. Non-solicitation of Customers or Employees of Company.

          (a) For a period of one year after termination of his Engagement, the Contractor agrees that he will not solicit the business of any company that was a Customer or strategic partner of the Company at any time during the Consultant’s Engagement by the Company, provided, however, if the Consultant becomes employed by or represents a business that exclusively sells products that do not compete with products then marketed or intended to be marketed by the Company, such contact shall be permissible.

          (b) During the term of his Engagement and for a period of one year after termination of his Engagement, the Contractor will not solicit any of the Company’s employees for a competing business or otherwise induce or attempt to induce such employees to terminate their employment with the Company.

     6. Exclusive Engagement. During the period of this Engagement by the Company, the Consultant shall not, without the Company’s express written consent, engage in any employment, consulting activity or business other than for the Company or for the University of Texas. Activity as a passive investor in or outside director for another business enterprise shall not be considered a violation of this section for so long as such business enterprise is not competing or conducting business with the Company and so long as such activities do not adversely impact Consultant’s performance of job duties.

     7. Non-Compete. The parties acknowledge that the Consultant has acquired or will acquire much knowledge and information concerning the Company’s business and Customers as the result of the Consultant’s Engagement. The parties further acknowledge that the scope of business in which the Company is engaged is nationwide and very competitive, that such

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business is one in which few companies can compete successfully, and that competition by the Consultant in that business would injure the Company severely. Accordingly, Consultant agrees that during this Engagement and for a period of one year following the end of the Engagement (i) if he is paid a severance under section 5 of his Consulting Agreement; or (ii) if he is paid his Non-Compete Fee (as defined below); Consultant will not take any of the following actions:

          (a) Engage in work activity or in conjunction with a company that is in the business of developing growth factors, proteins, peptides or small molecules intended for tissue repair or regeneration;

          (b) With respect to any Customer that Consultant worked with during the Engagement, directly or indirectly, sell or attempt to sell products for or on behalf of any business that manufactures, assembles, distributes, offers or sells any products that compete with products in human clinical trials, manufactured, assembled, distributed, offered or sold by the Company;

          (c) With respect to any Customer or client with which Consultant worked during the Engagement and to which the Company has made a proposal or sale, or with which the Company has been having discussions, persuade or attempt to persuade such Customer not to transact business with the Company, or instead to transact business with another person or organization; or

          (d) Work directly or indirectly in any position that requires the Consultant to disclose Proprietary Information.

If the Consultant’s Engagement ends without a severance payment under section 5 of the Consulting Agreement, the Company will have 60 days following the end of the Consultant’s Engagement to notify the Consultant of its decision to avail itself of the option pay him a Non-Compete Fee, which is the sum equal to 50 percent of his last 12 month’s regular consulting fees, payable in accordance with the Company’s regular payroll schedule, in exchange for Consultant’s adherence to the non-compete restrictions in this section 7.

     8. Compliance with Law and Amendment by Court: If there is any conflict between any provision of this Agreement and any statue, law, regulation or judicial precedent, the latter shall prevail, but the provisions of this Agreement thus affected shall be curtailed and limited only to the extent necessary to bring them within the requirements of the law. If any part of this Agreement shall be held by a court of proper jurisdiction to be indefinite, invalid or otherwise unenforceable, the entire Agreement shall not fail on account thereof, but: (i) the balance of the Agreement shall continue in full force and effect unless such construction would clearly be contrary to the intention of the parties or would result in an unconscionable injustice; and (ii) the court shall amend the Agreement to the extent necessary to make the Agreement valid and enforceable.

     9. Freedom From Engagement Restrictions. The Contractor represents and warrants that the Contractor has not entered into any agreement, whether express, implied, oral, or written, that poses an impediment to the Contractor’s Engagement by the Company including the Contractor’s compliance with the terms of this Agreement. In particular, the Contractor is not subject to a preexisting non-competition agreement, and no restrictions or limitations exist

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respecting the Contractor’s ability to perform fully the Contractor’s obligations with the Company including the Contractor’s compliance with the terms of this Agreement.

     10. Third Party Trade Secrets. During the Contractor’s Engagement by the Company, the Contractor agrees not to copy, refer to, or in any way use information which is proprietary to any third party (including any previous employer). The Contractor represents and warrants that the Contractor has not improperly taken any documents, listings, hardware, software, discs, or any other tangible medium that embodies proprietary information from any third party, and that the Contractor does not intend to copy, refer to, or in any way use information which is proprietary to any third party in performing the Contractor’s duties for the Company.

     11. Legitimate Business Purpose. Contractor hereby acknowledges and agrees that each and every provision of this Agreement serves a legitimate business purpose and exists to protect the legitimate business interests of the Company.

     12. Injunctive Relief; Legal Fees. The Contractor acknowledges that a breach of this Agreement is likely to result in irreparable and unreasonable harm to the Company, that damages caused by a breach would be extremely difficult to calculate, and that injunctive relief, as well as damages, would be appropriate. If any party finds it necessary to employ legal counsel or to bring an action at law or other proceeding against the other party to enforce any of the terms hereof, the party prevailing in any such action or other proceeding shall be paid by the other party its reasonable attorneys’ fees as well as court costs all as determined by the court and not a jury.

     13. Survival. The obligations described in Sections 1, 2, 3, 4, 5, 7 and 12 of this Agreement shall survive any termination of this Agreement.

     14. Successors and Assigns. This Agreement is personal to the Contractor and any may not be assigned by Contractor. Any and all rights acknowledged or granted to the Company under this Agreement may be freely assigned by the Company.

     15. Prior Agreements; Waiver. If Contractor currently has a written confidentiality or non-compete agreement with the Company, this Agreement will supersede all provisions of that agreement that cover the same subject matter as this Agreement. This Agreement constitutes the entire Agreement between the parties pertaining to the subject matter contained in it and supersedes those provisions of all prior and contemporaneous agreements, representations and understandings of the parties pertaining to the same subject matter. No waiver of any of the provisions of this Agreement shall be deemed to, or shall constitute a waiver of, any other provisions, whether or not similar, nor shall any waiver constitute a continuing waiver. No waiver shall be binding unless executed in writing by the party making the waiver.

     16. Governing Law. This Agreement is entered into in Arizona and shall be governed by the laws of the State of Arizona for all purposes. The parties hereby submit themselves to the courts of the State of Arizona, located in the County of Maricopa, for the purpose of personal jurisdiction in any action to enforce this Agreement.

     17. Construction. The language in all parts of this Agreement shall in all cases be construed as a whole according to its fair meaning and not strictly for or against either party.

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The headings contained in this Agreement are for reference purposes only and will not affect the meaning or interpretation of this Agreement in any way. All terms used in one number or gender shall be construed to include any other number or gender as the context may require. The parties agree that each party has reviewed this Agreement and has had the opportunity to have counsel review the same and that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not apply in the interpretation of this Agreement. Whenever the words “include,” “includes,” or “including” are used in the Agreement, they shall be deemed to be followed by the words “without limitation.”

     18. Consultation. The Consultant is advised to obtain the advice of legal counsel before signing this Agreement. By their signatures below, the Consultant and the Company’s representative acknowledge that they have each read the entire contents of this Agreement, that they fully understand the terms and conditions hereof, and that each has independently had an opportunity to review and discuss the Agreement with the advisor(s) or counsel of their respective choosing.

 
OrthoLogic Corp.
 
/s/ Thomas R. Trotter

Thomas R. Trotter
For the Company

8/5/04

Date




/s/ Darrell Carney

Darrell Carney
General Manager of the CBI Division of OrthoLogic Corp.

8/5/04

Date

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EXHIBIT A

     Ladies and Gentlemen:

     The following is a complete list of all inventions or improvements relevant to the subject matter of my engagement by OrthoLogic (the “Company”) which have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:

     X No inventions or improvements

         See below









         Additional sheets attached

     
  /s/ Darrell Carney
 

  Name

Date: 8/5/04
 

 

EX-10.3 3 p69834exv10w3.htm EX-10.3 exv10w3
 

Exhibit 10.3

THIRD AMENDED AND RESTATED EMPLOYMENT AGREEMENT

     This Agreement is to be effective as of November 8, 2004, by and between OrthoLogic Corp., a Delaware corporation (the “Company”), and Sherry A. Sturman (“Employee”), and supersedes in its entirety the Second Amended and Restated Employment Agreement, dated March 2, 2004, between the Company and Employee.

RECITALS:

     A. The parties wish to set forth in this Agreement the terms and conditions of employment.

AGREEMENT:

     In consideration of the mutual covenants and agreements set forth herein, the parties agree as follows:

     1. EMPLOYMENT AND DUTIES.

          (a) DEFINITION OF “ELECTION.” Within the limitations described in Sections 7 and 8 of this Agreement, either party may give the other notice that she or it has elected to begin a two-year transition leading to the termination of Employee’s employment by the Company. Such a notice is referred to in this Agreement as an “Election.” The “Election Effective Date” shall be the date of the Election, in the case of an Election by the Company pursuant to Section 7 hereof, or 30 days after the date of the Election, in the case of an Election by Employee pursuant to Section 8 hereof.

          (b) DUTIES BEFORE AN ELECTION. Subject to the terms and conditions of this Agreement, prior to the Election Effective Date, the Company employs Employee to serve in the capacity of Senior Vice President / Chief Financial Officer and Employee accepts such employment and agrees to perform such reasonable responsibilities and duties as may be assigned to her from time to time by the Company’s Chief Executive Officer (“CEO”). Employee’s title shall be Senior Vice President / Chief Financial Officer with general responsibility for all administrative functions. Such title and duties may be changed from time to time by the CEO. Employee will report directly to the CEO.

          (c) DUTIES AFTER AN ELECTION. Effective upon the Election Effective Date, Employee will report to the CEO. Employee shall not have an official title or any set work hours. While various projects assigned to Employee may require more or less time within any given month, it is contemplated that, without her consent, Employee will not be asked to work on Company matters: (i) for more than 4 days (or the equivalent thereof) per quarter during the period commencing on the Election Effective Date and ending on the first anniversary of the Election Effective Date; and (ii) for more than 2 days (or the equivalent thereof) per quarter during the 12 months following the period described in the foregoing clause (i). It is understood that Employee may have limited availability during normal business hours. Employee agrees to use her reasonable best efforts to be available during normal business hours when necessary to accomplish a specific assigned project. Employee understands that from and after the Election

 


 

Effective Date, and until the end of the term of this Agreement, the Company will not provide her with an office, but will provide reasonable secretarial and other staff support and will provide ancillary office equipment such as dictating equipment and a desk-top computer that Employee may continue to use until the end of the term at another location selected by her. After the Election Effective Date, Employee shall not be entitled to use any Company owned or supported laptop computers or cell phones except to the extent required by specific projects assigned to Employee.

     2. TERM. Before an Election, Employee’s employment shall have an indefinite term and shall continue until terminated as provided in this Agreement. Upon an Election, the term of Employee’s employment by the Company shall convert automatically to a term beginning on the Election Effective Date and ending on the two year anniversary of the Election Effective Date (the “Election Term”). After the Election, any extension or renewal of such term shall require the written consent of both parties.

     3. COMPENSATION.

          (a) SALARY. (i) Before the Election Effective Date, the Company shall pay Employee a minimum base annual salary, before deducting all applicable withholdings, of $200,000 per year, payable at the times and in the manner dictated by the Company’s standard payroll policies; (ii) during the period commencing on the Election Effective Date and ending on the first anniversary of the Election Effective Date, Employee’s base annual salary shall remain at the same level as it was on the Election Effective Date; and (iii) during the 12 months following the period described in the foregoing clause (ii), Employee’s base annual salary shall be $50,000, regardless of the level of base annual salary being paid to Employee prior to the Election Effective Date.

          (b) BONUS. (i) Before the Election Effective Date, Employee shall be eligible to participate in such bonus and incentive programs as determined from time to time by the Board. Any bonuses shall be based upon the achievement of individual goals and Company performance. Employee’s bonus, if any, will be calculated using $200,000 as Employee’s annual base salary, pro rated as necessary to reflect the number of months worked by Employee prior to the Election Effective Date; (ii) Employee shall not be entitled to accrue any additional bonus amount after the Election Effective Date, but any bonuses fully earned prior to the Election Effective Date shall remain due in accordance with their terms.

          (c) STOCK OPTIONS. From time to time, as determined by the Compensation Committee of the Company’s Board of Directors in its discretion, the Company shall grant to Employee options to purchase shares of the Company’s common stock, with an exercise price equal to the fair market value of the stock on the effective date of the grant.

     4. FRINGE BENEFITS. Both before and after the Election Effective Date, in addition to the compensation, bonus and options described in Section 3, and any other employee benefit plans (including without limitation pension, savings and disability plans) generally available to employees, the Company shall include Employee in any group health insurance plan and, if eligible, any group retirement plan instituted by the Company. The manner of implementation of such benefits with respect to such items as procedures and amounts are

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discretionary with the Company. Upon Employee’s acceptance of employment with another employer in connection with which Employee works, or is expected to work, 1,000 hours or more per year, Employee shall no longer be entitled to participate in any health, dental, retirement or other employee benefit plans of the Company. During the term of Employee’s employment under this Agreement, Employee shall be considered as an employee for the purposes of any Company stock option plans.

     5. VACATION. Employee shall be entitled to vacation with pay in accordance with the Company’s vacation policy as in effect from time to time. In addition, Employee shall be entitled to such holidays as the Company may approve from time to time.

     6. TERMINATION.

          (a) FOR CAUSE. The Company may terminate this Agreement for cause upon written notice to Employee stating the facts constituting such cause, provided that Employee shall have 30 days following such notice to cure any conduct or act, if curable, alleged to provide grounds for termination for cause hereunder. In the event of termination for cause, the Company shall be obligated to pay Employee only the minimum base salary due her through the date of termination. The written notice shall state the cause for termination. Cause shall include neglect of duties, willful failure to abide by instructions or policies from or set by the Board of Directors, commission of a felony or serious misdemeanor offense or pleading guilty or nolo contendere to same, Employee’s breach of this Agreement or Employee’s breach of any other material obligation to the Company.

          (b) DISABILITY. If during the term of this Agreement, Employee fails to perform her duties hereunder on account of illness or other incapacity for a period of 45 consecutive days, or for 60 days during any six-month period, the Company shall have the right to terminate this Agreement without further obligation hereunder except as otherwise provided in disability plans generally applicable to employees.

          (c) DEATH. If Employee dies during the term of this Agreement, this Agreement shall terminate immediately, and Employee’s legal representatives shall be entitled to receive the base salary due Employee through the last day of the calendar month in which her death shall have occurred and any other death benefits generally applicable to executive employees.

          (d) RESIGNATION. Employee may resign her employment by giving the Company written notice. In the event of such a resignation, the Company shall be obligated to pay Employee only the minimum base salary due her through the effective date of the resignation.

     7. ELECTION BY THE COMPANY. The Company may make an Election at any time with or without cause.

     8. ELECTION BY EMPLOYEE. Employee may make an Election on or at any time after June 30, 2005, with or without cause.

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     9. CONFIDENTIAL INFORMATION. Employee acknowledges that Employee may receive, or contribute to the production of, Confidential Information. For purposes of this Agreement, Employee agrees that “Confidential Information” shall mean any and all information or material proprietary to the Company or designated as Confidential Information by the Company and not generally known by non-Company personnel, which Employee develops or of or to which Employee may obtain knowledge or access through or as a result of Employee’s relationship with the Company (including information conceived, originated, discovered or developed in whole or in part by Employee). Confidential Information includes, but is not limited to, the following types of information and other information of a similar nature (whether or not reduced to writing) related to the Company’s business: discoveries, inventions, ideas, concepts, research, development, processes, procedures, “know-how”, formulae, marketing or manufacturing techniques and materials, marketing and development plans, business plans, customer names and other information related to customers, price lists, pricing policies, methods of operation, financial information, employee compensation, and computer programs and systems. Confidential Information also includes any information described above which the Company obtains from another party and which the Company treats as proprietary or designates as Confidential Information, whether or not owned by or developed by the Company, including Confidential Information acquired by the Company from any of its affiliates. Employee acknowledges that the Confidential Information derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use. Information publicly known without breach of this Agreement that is generally employed by the trade at or after the time Employee first learns of such information, or generic information or knowledge which Employee would have learned in the course of similar employment or work elsewhere in the trade, shall not be deemed part of the Confidential Information. Employee further agrees:

          (a) To furnish the Company on demand, at any time during or after employment, a complete list of the names and addresses of all present, former and potential suppliers, financing sources, clients, customers and other contacts gained while an employee of the Company in Employee’s possession, whether or not in the possession or within the knowledge of the Company.

          (b) That all notes, memoranda, electronic storage, documentation and records in any way incorporating or reflecting any Confidential Information shall belong exclusively to the Company, and Employee agrees to turn over all copies of such materials in Employee’s control to the Company upon request or upon termination of Employee’s employment with the Company.

          (c) That while employed by the Company and thereafter, Employee will hold in confidence and not directly or indirectly reveal, report, publish, disclose or transfer any of the Confidential Information to any person or entity, or utilize any of the Confidential Information for any purpose, except in the course of Employee’s work for the Company.

          (d) That any idea in whole or in part conceived of or made by Employee during the term of her employment, consulting, or similar relationship with the Company which relates directly or indirectly to the Company’s current or planned lines of business and is made through the use of any of the Confidential Information of the Company or any of the Company’s

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equipment, facilities, trade secrets or time, or which results from any work performed by Employee for the Company, shall belong exclusively to the Company and shall be deemed a part of the Confidential Information for purposes of this Agreement. Employee hereby assigns and agrees to assign to the Company all rights in and to such Confidential Information whether for purposes of obtaining patent or copyright protection or otherwise. Employee shall acknowledge and deliver to the Company, without charge to the Company (but at its expense) such written instruments and do such other acts, including giving testimony in support of Employee’s authorship or inventorship, as the case may be, necessary in the opinion of the Company to obtain patents or copyrights or to otherwise protect or vest in the Company the entire right and title in and to the Confidential Information.

     10. LOYALTY DURING EMPLOYMENT TERM. Employee agrees that during the term of Employee’s employment by the Company, Employee will devote substantially all of Employee’s business time and effort to and give undivided loyalty to the Company, and will not engage in any way whatsoever, directly or indirectly, in any business that is competitive with the Company or its affiliates, nor solicit, or in any other manner work for or assist any business which is competitive with the Company or its affiliates. During the term of Employee’s employment by the Company, Employee will undertake no planning for or organization of any business activity competitive with the Company or its affiliates, and Employee will not combine or conspire with any other employee of the Company or any other person for the purpose of organizing any such competitive business activity.

     11. NON-COMPETITION; NON-SOLICITATION. The parties acknowledge that Employee will acquire much knowledge and information concerning the business of the Company and its affiliates as the result of Employee’s employment. The parties further acknowledge that the scope of business in which the Company is engaged as of the date of execution of this Agreement is world-wide and very competitive and one in which few companies can successfully compete. Certain activities by Employee after this Agreement is terminated would severely injure the Company. Accordingly, until one year after this Agreement is terminated or Employee leaves the employment of the Company for any reason, Employee will not:

          (a) Engage in any work activity for or in conjunction with any business or entity that is in competition with or is preparing to compete with the Company;

          (b) Persuade or attempt to persuade any potential customer or client to which the Company or any of its affiliates has made a proposal or sale, or with which the Company or any of its affiliates has been having discussions, not to transact business with the Company or such affiliate, or instead to transact business with another person or organization;

          (c) Solicit the business of any customers, financing sources, clients, suppliers, or business patrons of the Company or any of its predecessors or affiliates which were customers, financing sources, clients, suppliers, or business patrons of the Company at any time during Employee’s employment by the Company, or within three years prior to the effective date of Employee’s employment, provided, however, that if Employee becomes employed by or represents a business that exclusively sells products that do not compete with products then marketed or intended to be marketed by the Company, such contact shall be permissible; or

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          (d) Solicit, endeavor to entice away from the Company or any of its affiliates, or otherwise interfere with the relationship of the Company or any of its affiliates with, any person who is employed by or otherwise engaged to perform services for the Company or any of its affiliates, whether for Employee’s account or for the account of any other person or organization.

     12. INJUNCTIVE RELIEF. It is agreed that the restrictions contained in Sections 9, 10 and 11 of this Agreement are reasonable, but it is recognized that damages in the event of the breach of any of those restrictions will be difficult or impossible to ascertain; and, therefore, Employee agrees that, in addition to and without limiting any other right or remedy the Company may have, the Company shall have the right to an injunction against Employee issued by a court of competent jurisdiction enjoining any such breach without showing or proving any actual damage to the Company. This paragraph shall survive the termination of Employee’s employment.

     13. PART OF CONSIDERATION. Employee also agrees, acknowledges, covenants, represents and warrants that she is fully and completely aware that, and further understands that, the restrictive covenants contained in Sections 9, 10, and 11 of this Agreement are an essential part of the consideration for the Company entering into this Agreement and that the Company is entering into this Agreement in full reliance on these acknowledgments, covenants, representations and warranties.

     14. TIME AND TERRITORY REDUCTION. If any of the periods of time and/or territories described in Sections 9, 10 and 11 of this Agreement are held to be in any respect an unreasonable restriction, it is agreed that the court so holding may reduce the territory to which the restriction pertains or the period of time in which it operates or may reduce both such territory and such period, to the minimum extent necessary to render such provision enforceable.

     15. SURVIVAL. The obligations described in Sections 9 and 11 of this Agreement shall survive any termination of this Agreement or any termination of the employment relationship created hereunder.

     16. NONDELEGABILITY OF EMPLOYEE’S RIGHTS AND COMPANY ASSIGNMENT RIGHTS. The obligations, rights and benefits of Employee hereunder are personal and may not be delegated, assigned or transferred in any manner whatsoever, nor are such obligations, rights or benefits subject to involuntary alienation, assignment or transfer. Upon mutual agreement of the parties, the Company, upon reasonable notice to Employee, may transfer Employee to an affiliate of the Company, which affiliate shall assume the obligations of the Company under this Agreement. This Agreement shall be assigned automatically to any entity merging with or acquiring the Company.

     17. GOVERNING LAW. This Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Arizona, exclusive of the conflict of law provisions thereof, and the parties agree that any litigation pertaining to this Agreement shall be in courts located in Maricopa County, Arizona.

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     18. ATTORNEYS’ FEES. If any party finds it necessary to employ legal counsel or to bring an action at law or other proceeding against the other party to enforce any of the terms hereof, the party prevailing in any such action or other proceeding shall be paid by the other party its reasonable attorneys’ fees as well as court costs all as determined by the court and not a jury.

     19. NOTICES. All notices, demands, instructions, or requests relating to this Agreement shall be in writing and, except as otherwise provided herein, shall be deemed to have been given for all purposes (i) upon personal delivery, (ii) one day after being sent, when sent by professional overnight courier service from and to locations within the Continental United States, (iii) five days after posting when sent by United States registered or certified mail, with return receipt requested and postage paid, or (iv) on the date of transmission when sent by facsimile with a hard-copy confirmation; if directed to the person or entity to which notice is to be given at her or its address set forth in this Agreement or at any other address such person or entity has designated by notice.

         
  To the Company:   ORTHOLOGIC CORP.
      1275 West Washington Street
      Tempe, AZ 85281
      Attention: Chief Executive Officer
 
       
  To Employee:   Sherry A. Sturman
      1275 W. Washington St.
      Tempe, AZ 85281

     20. ENTIRE AGREEMENT. This Agreement, the Invention, Confidential Information and Non-Competition Agreement dated February 3, 1999, and documents regarding the grant of stock options constitute the final written expression of all of the agreements between the parties and are a complete and exclusive statement of those terms. They supersede all understandings and negotiations concerning the matters specified herein. Any representations, promises, warranties or statements made by either party that differ in any way from the terms of this written Agreement shall be given no force or effect. The parties specifically represent, each to the other, that there are no additional or supplemental agreements between them related in any way to the matters herein contained unless specifically included or referred to herein. No addition to or modification of any provision of this Agreement shall be binding upon any party unless made in writing and signed by all parties. To the extent that there is any conflict between this Agreement and the Invention, Confidential Information and Non-Competition Agreement, the provisions of this Agreement shall govern.

     21. WAIVER. The waiver by either party of the breach of any covenant or provision in this Agreement shall not operate or be construed as a waiver of any subsequent breach by either party.

     22. INVALIDITY OF ANY PROVISION. The provisions of this Agreement are severable, it being the intention of the parties hereto that should any provisions hereof be invalid or unenforceable, such invalidity or unenforceability of any provision shall not affect the

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remaining provisions hereof, but the same shall remain in full force and effect as if such invalid or unenforceable provisions were omitted.

     23. ATTACHMENTS. All attachments or exhibits to this Agreement are incorporated herein by this reference as though fully set forth herein. In the event of any conflict, contradiction or ambiguity between the terms and conditions in this Agreement and any of its attachments, the terms of this Agreement shall prevail.

     24. INTERPRETATION OF AGREEMENT. When a reference is made in this Agreement to an article or section, such reference shall be to an article or section of this Agreement unless otherwise indicated. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the words “include,” “includes,” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”

     25. COUNTERPARTS. This Agreement may be executed simultaneously in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same agreement.

     26. BINDING EFFECT; BENEFITS. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective heirs, successors, executors, administrators and assigns. Notwithstanding anything contained in this Agreement to the contrary, nothing in this Agreement, expressed or implied, is intended to confer on any person other than the parties hereto or their respective heirs, successors, executors, administrators and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement.

8


 

     This Agreement has been executed by the parties as the date first written above.

             
    ORTHOLOGIC CORP.
    (“Company”)
 
           
    By:   /s/ Thomas R. Trotter
     
 
   
        Name: Thomas R. Trotter
        Title: President/Chief Executive Officer
 
           
    /s/ Sherry A. Sturman
 
 
   
    Sherry A. Sturman

9

EX-31.1 4 p69834exv31w1.htm EX-31.1 exv31w1
 

Exhibit 31.1

Certification of CEO Pursuant to Securities Exchange Act Rules 13a – 14 and 15d – 14
as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Thomas R. Trotter, the Chief Executive Officer of OrthoLogic Corp., certify that:

1. I have reviewed this quarterly report on Form 10-Q of OrthoLogic Corp.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

c) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2004

/s/ Thomas R. Trotter

President and Chief Executive Officer

 

EX-31.2 5 p69834exv31w2.htm EX-31.2 exv31w2
 

Exhibit 31.2

Certification of CFO Pursuant to Securities Exchange Act Rules 13a – 14 and 15d – 14 as
Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Sherry A. Sturman, the Chief Financial Officer of OrthoLogic Corp., certify that:

1. I have reviewed this quarterly report on Form 10-Q of OrthoLogic Corp.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

c) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 9, 2004

/s/ Sherry A. Sturman

Chief Financial Officer

 

EX-32 6 p69834exv32.htm EX-32 exv32
 

Exhibit 32

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

     In connection with the Quarterly Report of OrthoLogic Corp. (the “Company ”) on Form 10-Q for the period ended September 30, 2004 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of, Thomas R. Trotter, Chief Executive Officer of the Company, and Sherry A. Sturman, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to the best of his or her respective knowledge:

     (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

     (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 9, 2004

/s/ Thomas R. Trotter


Thomas R. Trotter
President and Chief Executive Officer

/s/ Sherry A. Sturman


Sherry A. Sturman
Chief Financial Officer

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to OrthoLogic Corp. and will be retained by OrthoLogic Corp. and furnished to the Securities and Exchange Commission or its staff upon request.

 

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