1120438--3/7/2008--THIRD_WAVE_TECHNOLOGIES_INC

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{customer, product, revenue}

{provision, law, control}

{product, market, service}

{operation, international, foreign}

{personnel, key, retain}

{acquisition, growth, future}

{cost, regulation, environmental}

{stock, price, operating}

OUR TECHNOLOGIES AND COMMERCIAL PRODUCTS MAY NOT BE COMMERCIALLY VIABLE OR SUCCESSFUL, WHICH COULD ADVERSELY AFFECT OUR BUSINESS. WE ARE RELIANT ON OUR ABILITY TO MANUFACTURE AND DEVELOP PRODUCTS. IF THERE IS A DISRUPTION TO THE MANUFACTURING OF OUR PRODUCTS, IT MAY HAVE AN ADVERSE AFFECT TO OUR BUSINESS. WE MAY NOT BE ABLE TO CONTINUE TO OUTSOURCE THE MANUFACTURE OF COMPONENTS FOR OUR PRODUCTS ON FAVORABLE TERMS, IF AT ALL, AND EVEN SUCCESSFUL OUTSOURCING CREATES RISK DUE TO OUR RESULTING RELIANCE ON VENDORS. OUR LIMITED SALES AND MARKETING EXPERIENCE AND CAPACITY MAY ADVERSELY AFFECT OUR ABILITY TO GROW AND TO COMPETE SUCCESSFULLY IN COMMERCIALIZING OUR POTENTIAL PRODUCTS. OUR CUSTOMER BASE IS DOMINATED BY A SMALL NUMBER OF LARGE CLINICAL TESTING LABORATORIES AND MANY OF OUR CONTRACTS WITH KEY CUSTOMERS ARE SHORT-TERM CONTRACTS AND/OR SUBJECT TO EARLY TERMINATION. WE MAY REQUIRE ADDITIONAL FINANCING FOR OUR FUTURE OPERATING PLANS. FINANCING MAY NOT BE AVAILABLE ON ACCEPTABLE TERMS, IF AT ALL. COMMERCIALIZATION OF OUR TECHNOLOGIES MAY DEPEND ON STRATEGIC PARTNERSHIPS AND COLLABORATIONS WITH OTHER COMPANIES, AND IF OUR CURRENT OR FUTURE PARTNERSHIPS AND COLLABORATIONS ARE NOT SUCCESSFUL, WE MAY EXPERIENCE DIFFICULTY COMMERCIALIZING OUR TECHNOLOGIES AND PRODUCTS. WE ARE IN A HIGHLY COMPETITIVE INDUSTRY AND MARKETPLACE. COMPETITIVE DEVELOPMENTS, INCLUDING NEW TECHNOLOGIES THAT RENDER OURS LESS COMPETITIVE OR OBSOLETE, COULD SERIOUSLY HARM OUR BUSINESS. WE MAY BE UNABLE TO PROTECT OUR PROPRIETARY METHODS AND TECHNOLOGIES AND MAY BE SUBJECT TO CLAIMS OF INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. OTHER RIGHTS AND MEASURES THAT WE RELY UPON TO PROTECT OUR INTELLECTUAL PROPERTY MAY NOT BE ADEQUATE TO PROTECT OUR PRODUCTS AND COULD REDUCE OUR ABILITY TO COMPETE IN THE MARKET. IF WE FAIL TO RETAIN OUR KEY PERSONNEL AND HIRE, TRAIN AND RETAIN QUALIFIED EMPLOYEES, WE MAY NOT BE ABLE TO COMPETE EFFECTIVELY, WHICH COULD RESULT IN REDUCED REVENUES. IF WE FAIL TO MAINTAIN REGULATORY APPROVALS AND CLEARANCES, OR ARE UNABLE TO OBTAIN, OR EXPERIENCE SIGNIFICANT DELAYS IN OBTAINING, FDA CLEARANCES OR APPROVALS FOR OUR FUTURE PRODUCTS OR PRODUCT ENHANCEMENTS, OUR ABILITY TO COMMERCIALLY DISTRIBUTE AND MARKET THESE PRODUCTS COULD SUFFER. THERE IS NO GUARANTEE THAT THE FDA WILL GRANT 510(K) CLEARANCE OR PMA APPROVAL OF OUR FUTURE PRODUCTS AND FAILURE TO OBTAIN NECESSARY CLEARANCES OR APPROVALS FOR OUR FUTURE PRODUCTS WOULD ADVERSELY AFFECT OUR ABILITY TO GROW OUR BUSINESS. EVEN IF OUR PRODUCTS ARE APPROVED OR CLEARED BY REGULATORY AUTHORITIES, IF WE FAIL TO COMPLY WITH ONGOING FDA OR OTHER FOREIGN REGULATORY AUTHORITY REQUIREMENTS, OR IF WE EXPERIENCE UNANTICIPATED PROBLEMS WITH OUR PRODUCTS, THESE PRODUCTS COULD BE SUBJECT TO RESTRICTIONS OR WITHDRAWAL FROM THE MARKET. MODIFICATIONS TO OUR PRODUCTS MAY REQUIRE NEW REGULATORY CLEARANCES OR APPROVALS OR MAY REQUIRE US TO RECALL OR CEASE MARKETING OUR PRODUCTS UNTIL CLEARANCES OR APPROVALS ARE OBTAINED. FEDERAL REGULATORY REFORMS MAY ADVERSELY AFFECT OUR ABILITY TO SELL OUR PRODUCTS PROFITABLY. OUR INTERNATIONAL SALES ARE SUBJECT TO CURRENCY, MARKET AND REGULATORY RISKS THAT ARE BEYOND OUR CONTROL. OUR FAILURE TO COMPLY WITH ANY APPLICABLE ENVIRONMENTAL, HEALTH, SAFETY AND RELATED GOVERNMENT REGULATIONS MAY AFFECT OUR ABILITY TO DEVELOP, PRODUCE OR MARKET OUR POTENTIAL PRODUCTS AND MAY ADVERSELY AFFECT OUR RESULTS OF OPERATIONS. WE MAY BE HELD LIABLE FOR ANY INACCURACIES ASSOCIATED WITH NUCLEIC ACID TESTS PERFORMED USING OUR PRODUCTS, WHICH MAY REQUIRE US TO DEFEND OURSELVES IN COSTLY LITIGATION. WE HAVE VARIOUS MECHANISMS IN PLACE THAT A STOCKHOLDER MAY NOT CONSIDER FAVORABLE AND WHICH MAY DISCOURAGE POTENTIAL ACQUISITIONS. OUR PRINCIPAL STOCKHOLDERS WILL HAVE SUBSTANTIAL CONTROL OVER OUR AFFAIRS.

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1120438--3/7/2008--THIRD_WAVE_TECHNOLOGIES_INC_/WI