UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
Form 10-Q

(Mark One)
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended:    September 30, 2011
 
Or
 
o
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: 0-11634

STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)

Delaware
95-3797439
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)

1911 Walker Avenue
Monrovia, California 91016
(Address of principal executive offices)
(626) 303-7902
(Registrant’s telephone number, including area code))

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. Yes  þ      No  ¨

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files).    Yes  þ      No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

¨  Large accelerated filer
þ  Accelerated filer
¨  Non-accelerated filer
¨  Smaller reporting company
   
  (Do not check if a smaller
 
           reporting company)  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  o      No  þ

The registrant has 36,096,107 shares of common stock, par value $0.01 per share, issued and outstanding as of October 25, 2011.

 
 

 

STAAR SURGICAL COMPANY

INDEX

   
PAGE
   
NUMBER
     
PART I – FINANCIAL INFORMATION
 
     
 
Item 1.
Financial Statements (Unaudited).
1
       
 
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations.
13
       
 
Item 3.
Quantitative and Qualitative Disclosures About Market Risk.
23
       
 
Item 4.
Controls and Procedures.
23
       
PART II – OTHER INFORMATION
 
       
 
Item 1.
Legal Proceedings.
24
       
 
Item 1A.
Risk Factors.
24
       
 
Item 5.
Other Information.
25
       
 
Item 6.
Exhibits.
25
 
 
 

 

STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
(Unaudited)
   
September 30, 
2011
   
December 31,
2010
 
ASSETS
           
             
Current assets:
           
Cash and cash equivalents
  $ 16,755     $ 9,376  
Restricted cash
    136       133  
Accounts receivable trade, net
    6,786       8,219  
Inventories, net
    10,612       10,543  
Prepaids, deposits and other current assets
    1,498       1,715  
Total current assets
    35,787       29,986  
Property, plant and equipment, net
    3,710       3,732  
Intangible assets, net
    3,210       3,672  
Goodwill
    1,786       1,786  
Deferred income taxes
    202       202  
Other assets
    1,202       1,207  
Total assets
  $ 45,897     $ 40,585  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
                 
Current liabilities:
               
Accounts payable
  $ 3,586     $ 3,717  
Line of credit
    2,600       2,460  
Deferred income taxes
    326       326  
Obligations under capital leases
    590       431  
Other current liabilities
    5,722       6,513  
Total current liabilities
    12,824       13,447  
Obligations under capital leases
    990       1,403  
Deferred income taxes
    638       488  
Other long-term liabilities
    3,068       2,820  
Total liabilities
    17,520       18,158  
                 
Commitments and contingencies (Note 13)
               
                 
Stockholders’ equity:
               
Common stock, $0.01 par value; 60,000 shares authorized; 35,932  and 35,084 shares issued and outstanding at September 30, 2011 and December 31, 2010
    359       351  
Additional paid-in capital
    156,429       152,014  
Accumulated other comprehensive income
    2,388       2,100  
Accumulated deficit
    (130,799 )     (132,038 )
Total stockholders’ equity
    28,377       22,427  
Total liabilities and stockholders’ equity
  $ 45,897     $ 40,585  

See accompanying notes to the condensed consolidated financial statements.

 
1

 

STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share amounts)
(Unaudited)
   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
 
                         
Net sales
  $ 15,266     $ 13,152     $ 46,385     $ 40,569  
Cost of sales
    4,816       4,892       15,445       14,801  
                                 
Gross profit
    10,450       8,260       30,940       25,768  
                                 
General and administrative
    3,820       3,591       11,448       10,247  
Marketing and selling
    4,439       4,552       13,098       12,517  
Research and development
    1,454       1,309       4,279       4,218  
Other general and administrative expenses
                      700  
                                 
Operating income (loss)
    737       (1,192 )     2,115       (1,914 )
                                 
Other income (expense):
                               
Interest income
    7       7       24       22  
Interest expense
    (134 )     (152 )     (440 )     (783 )
Gain (loss) on foreign currency transactions
    (277 )     446       167       6  
Loss on early extinguishment of note payable
                      (267 )
Other (expense) income, net
    (42 )     89       358       77  
Other (expense) income, net
    (446 )     390       109       (945 )
                                 
Income (loss) before provision for income taxes
    291       (802 )     2,224       (2,859 )
Provision for income taxes
    214       356       985       563  
Income (loss) from continuing operations
    77       (1,158 )     1,239       (3,422 )
                                 
Income from discontinued operations, net of income taxes
                      4,166  
Net income (loss)
  $ 77     $ (1,158 )   $ 1,239     $ 744  
                                 
Net income (loss) per share from continuing operations – basic
  $ 0.00     $ (0.03 )   $ 0.04     $ (0.10 )
Net income (loss)  per share from continuing operations –diluted
  $ 0.00     $ (0.03 )   $ 0.03     $ (0.10 )
                                 
Income per share from discontinued operations – basic and diluted
  $     $     $     $ 0.12  
                                 
Net income (loss) per share - basic
  $ 0.00     $ (0.03 )   $ 0.04     $ 0.02  
                                 
Net income (loss) per share - diluted
  $ 0.00     $ (0.03 )   $ 0.03     $ 0.02  
                                 
Weighted average shares outstanding - basic
    35,539       34,831       35,304       34,790  
Weighted average shares outstanding - diluted
    36,953       34,831       36,507       34,790  

See accompanying notes to the condensed consolidated financial statements.

 
2

 

STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
 
Cash flows from operating activities:
           
                 
Net income
  $ 1,239     $ 744  
Adjustments to reconcile net income to net cash provided byoperating activities:
               
Income from discontinued operations
          (4,166 )
Depreciation of property and equipment
    890       1,191  
Amortization of intangibles
    595       607  
Amortization of discount
          236  
Loss on early extinguishment of note payable
          267  
Deferred income taxes
    150        
Fair value adjustment of warrant
    (29 )     117  
Gain (loss) on disposal of property and equipment
    (14 )     4  
Change in net pension liability
    147       256  
Stock-based compensation expense
    1,330       945  
Other
    (70 )     40  
Changes in working capital:
               
Accounts receivable
    1,630       862  
Inventories
    241       1,042  
Prepaids, deposits and other current assets
    331       717  
Accounts payable
    (201 )     (1,395 )
Other current liabilities
    (829 )     (5,462 )
Net cash used in operating activities of discontinued operations
          (635 )
Net cash provided by (used in) operating activities
    5,410       (4,630 )
                 
Cash flows from investing activities:
               
Proceeds from sale of subsidiary, net of transaction costs
          11,824  
Release of restricted cash
          7,396  
Deposit to restricted escrow account
          (136 )
Acquisition of property and equipment
    (722 )     (247 )
Proceeds from sale of property and equipment
    26        
Net change in other assets
    48       10  
Net cash used in investing activities of discontinued operations
          (50 )
Net cash (used in) provided by investing activities
    (648 )     18,797  
                 
Cash flows from financing activities:
               
Repayment of notes payable
          (5,000 )
Redemption of Series A preferred stock
          (6,800 )
Repayment of capital lease obligations
    (412 )     (609 )
Proceeds from exercise of stock options
    2,983       292  
Net cash used in financing activities of discontinued operations
          (50 )
Net cash provided by (used in) financing activities
    2,571       (12,167 )
                 
Effect of exchange rate changes on cash and cash equivalents
    46       158  
 
 
3

 
 
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
 
Increase in cash and cash equivalents
    7,379       2,158  
Cash and cash equivalents, at beginning of the period
    9,376       6,330  
Cash and cash equivalents, at end of the period
  $ 16,755     $ 8,488  
 
See accompanying notes to the condensed consolidated financial statements.

 
4

 

STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)

Note 1 — Basis of Presentation and Significant Accounting Policies

The consolidated financial statements of the Company present the financial position, results of operations, and cash flows of STAAR Surgical Company and its wholly owned subsidiaries.  All significant intercompany accounts and transactions have been eliminated.  The accompanying unaudited condensed consolidated financial statements, have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission.  In accordance with those rules and regulations certain information and footnote disclosures normally included in comprehensive financial statements have been condensed or omitted pursuant to such rules and regulations.  The consolidated balance sheet as of December 31, 2010 derives from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP.  These financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010.

The condensed consolidated financial statements for the three and nine months ended September 30, 2011 and October 1, 2010, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition and results of operations.  The results of operations for the three and nine months ended September 30, 2011 and October 1, 2010 are not necessarily indicative of the results to be expected for any other interim period or for the entire year.  As discussed in Note 2, on March 2, 2010, the Company disposed of all of its interests in a subsidiary, Domilens GmbH (“Domilens”), and in accordance with GAAP reported the income received from Domilens prior to the disposition as “income from discontinued operations.”  Income from continuing operations does not include the results of operations of  Domilens.

Each of the Company's reporting periods ends on the Friday nearest to the quarter ending date and generally consists of 13 weeks.  Unless the context indicates otherwise “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.

Note 2 — Disposal of Domilens Subsidiary

On March 2, 2010 (the “Closing Date”), STAAR Surgical Company completed the divestiture (the “Transaction”) of all of its interest in its German distribution subsidiary, Domilens GmbH (“Domilens”), through a management buyout led by funds managed by Hamburg-based Small Cap Buyout Specialist BPE Unternehmensbeteiligungen GmbH (“BPE”).  

See Note 3, Disposal of Domilens Subsidiary ,   to the consolidated financial statements accompanying the 2010 Annual Report on Form 10-K for additional information regarding the sale of Domilens.

Note 3 — Restricted Cash

On March 2, 2010, as part of the disposition of Domilens, the Company deposited $136,000 into a restricted escrow account to provide for the potential payment of unaccrued taxes assessed for periods prior to December 31, 2009.  The balance of funds remaining, if any, after the payment of such taxes, will be distributed to STAAR from the escrow account, no later than December 31, 2011.  As of September 30, 2011, restricted cash was $136,000, an increase of $3,000 from December 31, 2010, due to the effect of foreign currency translation.

Note 4 — Inventories
 
Inventories, net are stated at the lower of cost, determined on a first-in, first-out basis, or market and consisted of the following (in thousands):

   
September 30,
   
December 31,
 
   
2011
   
2010
 
Raw materials and purchased parts
  $ 1,986     $ 1,920  
Work-in-process
    2,108       2,255  
Finished goods
    7,295       7,349  
      11,389       11,524  
Inventory reserves
    (777 )     (981 )
    $ 10,612     $ 10,543  
 
 
5

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
 
Note 5 — Prepaids, Deposits, and Other Current Assets
 
Prepaids, deposits, and other current assets consisted of the following (in thousands):

  
 
September 30, 
2011
   
December 31, 
2010
 
Prepaids and deposits
  $ 816     $ 1,219  
Other current assets
    682       496  
  
  $ 1,498     $ 1,715  

 
Note 6 – Amortizable Intangible Assets

Amortizable intangible assets consisted of the following (in thousands):

   
September 30, 2011
   
December 31, 2010
   
   
Gross Carrying
Amount
   
Accumulated
Amortization
   
Net
   
Gross
Carrying
Amount
   
Accumulated
Amortization
   
Net
Amortized intangible assets:
                                 
Patents and licenses
  $ 10,875     $ ( 9, 400 )   $ 1,475     $ 10,827     $ (9,064 )   $ 1,763  
Customer relationships
    2,039       ( 765 )     1,274       1,929       (579 )     1,350  
Developed technology
    1,296       ( 835 )     461       1,226       (667 )     559  
Total
  $ 14,210     $ (11,000 )   $ 3,210     $ 13,982     $ (10,310 )   $ 3,672  

As of September 30, 2011 the gross carrying amount of amortizable intangible assets increased by $228,000 due to changes in the foreign exchange rate.

Note 7 – Other Current Liabilities

Other current liabilities consisted of the following (in thousands):

   
September 30, 
2011
   
December 31,
2010
 
Accrued salaries and wages
  $ 1,853     $ 2,121  
Accrued audit fees
    408       417  
Customer credit balances
    572       566  
Accrued bonuses
    1,070       751  
Accrued income taxes
    165       147  
Accrued insurance
    120       422  
Accrued severance
    104       570  
Other
    1,430       1,519  
    $ 5,722     $ 6,513  
 
 
6

 

STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
      
Note 8 – Pension Plans

The following table summarizes the components of net periodic pension cost recorded for the Company’s defined benefit pension plans (in thousands):

   
Three Months
Ended 
September 30, 
2011
   
Three Months
Ended 
October 1, 
2010
   
Nine Months
Ended
September 30, 
2011
   
Nine Months
Ended
October 1, 
2010
 
Service cost
  $ 161     $ 144     $ 423     $ 421  
Interest cost
    42       35       104       103  
Expected return on plan assets
    (34 )     (25 )     (83 )     (73 )
Amortization of unrecognized transition  obligation
    4             12        
Amortization of prior service cost
    (1 )           (1 )      
Recognized actuarial (gain) loss
    (2 )     13       (18 )     41  
 
  $ 170     $ 167     $ 437     $ 492  

During the nine months ended September 30, 2011 and October 1, 2010, the Company made cash contributions totaling approximately $203,000 and $183,000 to its Swiss defined benefit pension plan.  The Company expects to make additional cash contributions totaling approximately $68,000 during the remainder of 2011.  The Company is not required to and does not make contributions to its Japan pension plan.  Benefits are paid from operating cash flows and were not material during the quarter ended September 30, 2011.
 
Note 9 — Lines of Credit and Capital Lease Obligations

Lines of Credit
  
The Company’s Japanese subsidiary, STAAR Japan, has an agreement, as amended on June 30, 2009, with Mizuho Bank, which provides for borrowings of up to 300,000,000 Yen (approximately $3.9 million based on the rate of exchange on September 30, 2011), at an interest rate equal to the Tokyo short-term prime interest rate (approximately 1.475% as of September 30, 2011) plus 1.125%.  The agreement may be renewed annually (the current line expires on April 2, 2012).  The credit facility is not collateralized.  The Company had 200,000,000 Yen outstanding on the line of credit as of September 30, 2011 and December 31, 2010, (approximately $2.6 million and $2.5 million based on the foreign exchange rates on September 30, 2011 and December 31, 2010) which approximates fair value due to the short-term maturity and market interest rates of the line of credit.  In case of default, the interest rate will increase to 14% per annum. As of September 30, 2011, 100,000,000 Yen (approximately $1.3 million based on the rate of exchange on September 30, 2011) of the line was available for borrowing.

In August 2010, the Company’s wholly-owned Swiss subsidiary, STAAR Surgical AG, entered into a credit agreement with Credit Suisse (the “Bank”). The credit agreement provides for borrowings of up to 1,000,000 Swiss Francs ($1,114,000 at the rate of exchange on September 30, 2011), to be used for working capital purposes.  Accrued interest and 0.25% commissions on average outstanding borrowings is payable quarterly and the interest rate will be determined by the Bank based on the then prevailing market conditions at the time of borrowing.  The credit agreement renews automatically on an annual basis based on the same terms, assuming there is no default.  The credit agreement may be terminated by either party at any time in accordance with its general terms and conditions.  The credit facility is not collateralized and contains customary conditions such as providing the Bank with audited financial statements annually and notice of significant events or conditions as defined in the credit agreement.  The Bank may also declare all amounts outstanding to be immediately due and payable upon a change of control or a “material qualification” in STAAR Surgical AG’s independent auditors’ report.  There were no borrowings outstanding as of September 30, 2011 and the full amount of the line was available for borrowing.

Capital Lease Obligations
The Company leases certain property, plant, and equipment under non-cancelable capital lease agreements.  These leases vary in amount, duration, and rates.

Estimated future minimum payments under capital lease obligations are as follows (in thousands):

 
7

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
 
 
Fiscal Year
 
September 30,
2011
   
December 31,
2010
 
2011
  $ 187     $ 938  
2012
    844       763  
2013
    595       627  
2014
    75       68  
2015
          36  
Thereafter
           
Total minimum lease payments
  $ 1,701     $ 2,432  
Less: interest
    (121 )     (598 )
Total lease obligation
  $ 1,580     $ 1,834  
                 
Current
  $ 590     $ 431  
Long-term
  $ 990     $ 1,403  

Borrowings available under the Company’s lease lines of credit with Farnam Street Financial are approximately $238,350.   See Note 10, Notes Payable ,   to the consolidated financial statements accompanying the 2010 Annual Report Form 10-K for additional information regarding the Company’s capital lease agreements.

Covenant Compliance

The Company is in compliance with the covenants of its credit facilities as of the date of this report. 
 
Note 10 — Basic and Diluted Income Per Share
 
The following table sets forth the computation of basic and diluted net income per share (in thousands except per share amounts):

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
(Note A)
 
Numerator:
                       
                         
Net Income (loss)
  $ 77     $ (1,158 )   $ 1,239     $ 744  
                                 
Denominator:
                               
Weighted average common shares and denominator for basic calculation:
                               
Weighted average common shares outstanding
    35,695       34,945       35,442       34,879  
Less: Unvested restricted stock
    (156 )     (114 )     (138 )     (89 )
Denominator for basic calculation
    35,539       34,831       35,304       34,790  
Weighted average effects of dilutive equity-based compensation awards:
                               
Employee stock options
    846             751        
Warrants
    568             452        
Denominator for diluted calculation
    36,953       34,831       36,507       34,790  
                                 
Net income (loss) per share – basic
  $ 0.00     $ (0.03 )   $ 0.04     $ 0.02  
                                 
Net income (loss) per share - diluted
  $ 0.00     $ (0.03 )   $ 0.03     $ 0.02  
 
 
8

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
 
Note A:  For 2010, although the Company reported net income as a result of the gain on sale of Domilens, it used the net loss from continuing operations as the control number in determining whether including potential common shares in the diluted income per share calculation would be dilutive or anti-dilutive.

The following table sets forth (in thousands) the weighted average number of options and warrants to purchase shares of common stock, restricted stock and preferred stock which were not included in the calculation of diluted per share amounts because the effects would be anti-dilutive.

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
 
Options and restricted stock
    1,405       3,929       1,279       3,900  
Warrants
    70       1,470       70       1,470  
Preferred Stock
    0       0       0       897  
Total
    1,475       5,399       1,349       6,267  
 
Note 11 — Comprehensive Income

The components of comprehensive income (loss) are as follows (in thousands):

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
 
Net income (loss)
  $ 77     $ (1,158 )   $ 1,239     $ 744  
Other comprehensive income (loss):
                               
Minimum pension liability adjustment
    19       3       (22 )     9  
Foreign currency translation adjustment
    407       519       310       (1,414 )(1)
Comprehensive income (loss)
    426       522       288       (1,405 )
Total comprehensive income (loss)
  $ 503     $ (636 )   $ 1,527     $ (661 )

 
(1)
Includes $2,256 related to the sale of Domilens.

Note 12 — Geographic and Product Data

The Company markets and sells its products in more than 50 countries and has manufacturing sites in the United States, Switzerland and Japan. Other than the United States, Japan, Korea, and China, the Company does not conduct business in any country in which its sales exceed 5% of consolidated sales. Sales are attributed to countries based on location of customers. The composition of the Company’s net sales to unaffiliated customers is set forth below (in thousands):

   
Three Months Ended
   
Nine Months Ended
   
September  30,
   
October 1,
   
September  30,
   
October 1,
   
2011
   
2010
   
2011
   
2010
United States
  $ 3,211     $ 3,727     $ 10,448     $ 11,560  
Japan
    4,037       3,283       11,772       10,170  
Korea
    2,069       1,710       5,463       4,356  
China
    1,825       785       4,832       2,641  
Other
    4,124       3,647       13,870       11,842  
Total
  $ 15,266     $ 13,152     $ 46,385     $ 40,569  
 
 
9

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
 
100% of the Company’s sales are generated from the ophthalmic surgical product segment and therefore the Company operates as one operating segment for financial reporting purposes. The Company’s principal products are implantable Collamer lenses (“ICLs”) used in refractive surgery and intraocular lenses (“IOLs”) used in cataract surgery.  The composition of the Company’s net sales by product line is as follows (in thousands):

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
October 1,
   
September 30,
   
October 1,
 
   
2011
   
2010
   
2011
   
2010
 
ICLs
  $ 7,902     $ 6,034     $ 23,093     $ 17,757  
IOLs
    6,571       6,559       20,767       20,442  
Core products
    14,473       12,593       43,860       38,199  
Other Surgical Products
    793       559       2,525       2,370  
Total
  $ 15,266     $ 13,152     $ 46,385     $ 40,569  
 
The Company sells its products internationally, which subjects the Company to several potential risks, including fluctuating foreign currency exchange rates (to the extent the Company’s transactions are not in U.S. dollar), regulation of fund transfers by foreign governments, United States and foreign export and import duties and tariffs, and political instability.

Note 13— Commitments and Contingencies

On May 24, 2010, the Company accrued $700,000 in executive termination benefit costs in connection with the notice of non-renewal given under an executive employment agreement. This accrual represented the Company’s best estimate of the contractual termination benefits due to the former executive. The actual amount ultimately paid to the former executive may be different than the amount estimated.   As of September 30, 2011, accrued unpaid severance was approximately $104,000.

Note 14 — Stock-Based Compensation

The cost that has been charged against income for stock-based compensation is set forth below (in thousands):
   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
 
SFAS 123R expense
  $ 363     $ 200     $ 978     $ 642  
Restricted stock expense
    115       77       320       214  
Consultant compensation
    45       19       32       89  
Total
  $  523     $  296     $  1,330     $  945  

The Company recognized no net income tax benefit in its income statement for share-based compensation arrangements because the Company fully offsets net deferred tax assets with a valuation allowance.  In addition, the Company capitalized $33,000 and $109,000 of stock compensation to inventory for the three and nine months ended September 30, 2011, and $22,000 and $65,000, respectively, for the three and nine months ended October 1, 2010. It recognizes those amounts as expense in Cost of Sales as the inventory is sold.

Stock Option Plans
 
In fiscal year 2003, the Board of Directors approved the 2003 Omnibus Equity Incentive Plan (the “2003 Plan”) authorizing awards of equity compensation, including options to purchase common stock and restricted shares of common stock. The 2003 Plan amends, restates and replaces the 1991 Stock Option Plan, the 1995 Consultant Stock Plan, the 1996 Non-Qualified Stock Plan, and the 1998 Stock Option Plan (the “Restated Plans”).  On May 19, 2010, the stockholders of STAAR approved the Restated 2003 Omnibus Plan, which increased the number of shares available for grants under the plan by 2,000,000 shares and extended the term of the plan to May 18, 2020.  As of September 30, 2011, there were 1,755,697 shares authorized and available for grants under the Restated 2003 Omnibus Plan.  The 2003 Plan provides for various forms of stock-based incentives.  To date, of the available forms of awards under the 2003 Plan, the Company has granted only stock options, restricted stock and unrestricted share grants. Options under the plan are granted at fair market value on the date of grant, become exercisable over a three or four-year period, or as determined by the Board of Directors, and expire over periods not exceeding 10 years from the date of grant. Certain option and share awards provide for accelerated vesting if there is a change in control (as defined in the 2003 Plan). Pursuant to the plan, options for 3,121,972 shares were outstanding at September 30, 2011 with exercise prices ranging between $0.95 and $8.12 per share.  Restricted stock grants under the 2003 Plan generally vest over a period of one, three or four years.  There were 155,500 shares of restricted stock outstanding at September 30, 2011.

 
10

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)
 
In fiscal year 1998, the Board of Directors approved the 1998 Stock Option Plan, authorizing the granting of options to purchase common stock or awards of common stock. Pursuant to the plan, options for 7,000 shares were outstanding at September 30, 2011 with an exercise price of $3.60 per share. No further awards may be made under this plan.

Assumptions
 
The fair value of each option award is estimated on the date of grant using a Black-Scholes option valuation model applying the assumptions noted in the following table.  Expected volatilities are based on historical volatility of the Company’s stock. The Company uses historical data to estimate option exercise and employee termination behavior. The expected term of options granted is derived from the historical exercise activity over the past 15 years, and represents the period of time that options granted are expected to be outstanding.  Options granted with a three-year vesting life during the nine months ended September 30, 2011 and October 1, 2010 had an expected term of 5.49 and 5.60 years, respectively, and were derived from historical exercise and termination activity.   The Company has calculated a 10.05% estimated forfeiture rate used in the model for fiscal year 2011 option grants based on historical forfeiture experience.  The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
2011
   
October 1,
2010
   
September 30,
2011
   
October 1,
2010
 
Expected dividend yield
    0 %     0 %     0 %     0 %
Expected volatility
    76.99 %     80.17 %     76.93 %     80.53 %
Risk-free interest rate
    1.12 %     1.40 %     1.94 %     2.15 %
Expected term (in years)
    5.49       5.6       5.49       5.6  

A summary of option activity under the Plans as of September 30, 2011 is presented below:

 
 
Options
 
 
 
Shares
(000’s)
   
Weighted-
Average
Exercise
Price
   
Weighted-
Average
Remaining
Contractual
Term
   
Aggregate
Intrinsic
Value
(000’s)
 
Outstanding at December 31, 2010
    3,331     $ 4.35           $  
Granted
    629       5.59              
Exercised
    (742 )     4.02              
Forfeited or expired
    (88 )     5.41              
Outstanding at September 30, 2011
    3,130     $ 4.65       6.69       3,245  
Exercisable at September 30, 2011
    1,996     $ 4.37       5.30     $ 2,784  

The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2011 and October 1, 2010 was $3.63 and $2.84 per option.  The total fair value of options vested during the nine months ended September 30, 2011 and October 1, 2010 was $806,000 and $995,000, respectively.  There were 742,264 and 84,732 options exercised with an intrinsic value of $1,823,000 and $152,000 during the nine months ended September 30, 2011 and October 1, 2010.

A summary of the status of the Company’s non-vested shares as of September 30, 2011 and changes during the period is presented below:

 
 
 
Nonvested Shares
 
 
Shares
(000’s)
   
Weighted-
Average
Grant Date
Fair Value
 
Nonvested at December 31, 2010
    885     $ 2.89  
Granted
    629       3.63  
Vested
    (330 )     2.45  
Forfeited
    (65 )     3.73  
Nonvested at September 30, 2011
    1,119     $ 3.67  
 
 
11

 
 
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011
(Unaudited)

As of September 30, 2011, the Company had $2.9 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plans. That cost is expected to be recognized over a weighted-average period of 1.80 years.

Note 15 — Supplemental Disclosure of Cash Flow Information
 

Interest paid was $374,000 and $930,000 for the nine months ended September 30, 2011 and October 1, 2010, respectively. Income taxes paid amounted to approximately $648,000 and $1,081,000 for the nine months ended September 30, 2011 and October 1, 2010, respectively.

The Company’s non-cash investing and financing activities were as follows (in thousands):
 
   
September 30,
2011
   
October 1,
2010
 
Non-cash investing and financing activities:
           
                 
Assets obtained by capital lease
  $ 79     $ 776  

Note 16 — New Accounting Pronouncements

In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU No. 2011-05) “Comprehensive Income (Topic 220) — Presentation of Comprehensive Income.” ASU 2011-05 requires that all nonowner changes in stockholders’ equity be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements.  In both choices, an entity is required to present each component of net income along with total net income, each component of other comprehensive income along with a total for other comprehensive income, and a total amount for comprehensive income.  ASU 2011-05 is effective retrospectively for fiscal years, and interim periods within those years, beginning after December 15, 2011.  We are assessing the impact of ASU 2011-05 on our comprehensive income presentation.

In May 2011, the FASB issued ASU No. 2011-04 “Fair Value Measurement (Topic 820) - Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs.”   ASU 2011-04 changes the wording used to describe many of the requirements in U.S. GAAP for measuring fair value and for disclosing information about fair value measurements.  Consequently, the amendments in this update result in common fair value measurement and disclosure requirements in U.S. GAAP and IFRSs (International Financial Reporting Standards).  ASU 2011-04 is effective prospectively during interim and annual periods beginning on or after December 15, 2011.  We are assessing the impact of ASU 2011-04 on our fair value disclosures.
 
 
12

 
 
ITEM 2. 
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The matters addressed in this Item 2 that are not historical information constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Although we believe that the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risks and STAAR can give no assurances that its expectations will prove to be correct.  Actual results could differ materially from those described in this report because of numerous factors, many of which are beyond the control of STAAR.  These factors include, without limitation, those described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in this Quarterly Report under the heading “ Risk Factors .”  STAAR undertakes no obligation to update these forward-looking statements that may be made to reflect events or circumstances after the date of this report or to reflect actual outcomes.
 
The following discussion should be read in conjunction with STAAR’s interim condensed financial statements and the related notes provided under “ Item 1— Financial Statements ” above.
 
Overview
 
STAAR Surgical Company designs, develops, manufactures and sells implantable lenses for the eye.  We are the world’s leading manufacturer of intraocular lenses used in corrective or “refractive” surgery, and we also make lenses for use in surgery that treats cataracts.  All of the lenses we make are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Cataract surgery is a relatively common outpatient procedure where the eye’s natural lens that has become cloudy with age is removed and replaced with an artificial lens called an intraocular lens (IOL) to restore the patient’s vision.  Refractive surgery is performed to treat the type of visual disorders that have traditionally been corrected using eyeglasses or contact lenses.  We refer to our lenses used in refractive surgery as “implantable Collamer® lenses” or “ICLs” and market them under the Visian® brand name. The field of refractive surgery includes both lens-based procedures, using products like the Visian ICL, and laser-based procedures like LASIK.  Successful refractive surgery can correct common vision disorders such as myopia, hyperopia and astigmatism.
 
Originally incorporated in California in 1982, STAAR Surgical Company reincorporated in Delaware in 1986.  Unless the context indicates otherwise, “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.
 
STAAR Surgical Company, Visian®, Collamer®, STAARVISC®, Elastimide®, nanoFLEX™, nanoPOINT™, CentraFLOW™, AquaPORT™,  Epiphany™ and AquaFlow™ are trademarks or registered trademarks of STAAR in the U.S. and other countries.
 
Collamer® is the brand name for STAAR’s proprietary collagen copolymer lens material.
 
Background Regarding Our Business
 
A detailed description of STAAR’s business appears in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010, along with a glossary explaining many of the specialized terms used in describing our products and our business.  We recommend that readers unfamiliar with STAAR refer to that description.
 
Visian Implantable Collamer Lenses.    Sales of refractive lenses make up approximately half of our total sales.  Made from our proprietary biocompatible Collamer material, STAAR’s VISIAN ICL and VISIAN Toric ICL, or TICL™, treat refractive disorders such as myopia (near-sightedness), hyperopia (far-sightedness) and astigmatism.  The surgeon implants the foldable Visian lens through a tiny incision, generally under topical anesthesia.  STAAR began selling the Visian ICL outside the U.S. in 1996 and inside the U.S. in 2006.  STAAR began selling the Visian TICL outside the U.S. in 2002.  STAAR’s goal is to position the ICL and TICL throughout the world as primary choices for refractive surgery.
 
Sales of ICLs during the three months and nine months ended September 30, 2011 were $7.9 million and $23.1 million, compared to $6.0 million and $17.8 million for the same periods in the prior year.  Having surpassed our sales of IOLs for the first time in the second quarter of 2011, ICL sales represented approximately 52% of total net sales in the three-month period and 50% in the nine-month period.
 
IOLs - Intraocular Lenses for Cataract Surgery .   Sales of foldable IOLs used in minimally invasive cataract surgery made up approximately 43% of our total sales in the third quarter.  Our range of IOLs includes the following:

 
13

 
 
·
Aspheric IOLs, available in silicone and in Collamer®, STAAR’s proprietary biocompatible collagen copolymer lens material. Aspheric IOLs are designed to improve the patient’s quality of vision when compared to earlier spherical IOL designs.
 
 
·
The nanoFLEX IOL, a single-piece Collamer aspheric IOL that can be implanted through a 2.2 mm incision with the nanoPOINT injector system is available in the U.S and other territories that accept the CE Mark .
 
 
·
The Preloaded Injector, a three-piece silicone or acrylic IOL preloaded into a single-use disposable injector and currently available outside the U.S.  The acrylic Preloaded Injector uses an acrylic lens sourced from another manufacturer.
 
 
·
The silicone Toric IOL, used in cataract surgery to treat preexisting astigmatism which is currently available in the U.S.  Astigmatism is a condition that causes blurred vision when an irregular shape of the cornea prevents light from focusing properly on the retina.
 
Because most cataract patients are elderly, government agencies or government sponsored entities generally pay the cost of IOLs in our major markets, including the U.S.  As a result, IOL revenues will likely remain relatively stable even under adverse conditions in the general economy.  However, changes in reimbursement policy under these agencies and entities can reduce our selling prices or reduce the volume of cataract procedures.
 
Sales of IOLs during the three months and nine months ended September 30, 2011 were $6.6 million and $20.8 million, compared to $6.6 million and $20.4 million for the same periods in the prior year.  IOL sales represented approximately 43% of total net sales in the three-month period and 45% in the nine-month period.
 
Other Surgical Products.   We also sell other instruments, devices, and equipment used in cataract or refractive surgery, which we either manufacture or have manufactured for us.  However, we have been deemphasizing these products since 2009 because of their lower overall gross profit margins.  We also make the AquaFlow Collagen Glaucoma Drainage Device, an implantable device used for surgical treatment of glaucoma.
 
Sales of other surgical products during the three months and nine months ended September 30, 2011 were $0.8 million and $2.5 million, compared to $0.6 million and $2.4 million for the same periods in the prior year, representing approximately 5% of total net sales in both the three-month and nine-month periods.
 
Operations
 
STAAR has significant operations both within and outside the U.S.  Sales from activities outside the U.S. accounted for approximately 79% of our total sales for the quarter ended September 30, 2011.  STAAR operates its global administrative headquarters and a manufacturing facility in Monrovia, California.  STAAR operates an administrative, manufacturing and distribution facility in Nidau, Switzerland under its wholly owned subsidiary, STAAR Surgical AG.  STAAR operates administrative, manufacturing and distribution facilities in Chiba Prefecture, Japan under its wholly owned subsidiary, STAAR Japan Inc. We also have a manufacturing facility in Aliso Viejo, California.
 
The global nature of STAAR’s business operations subjects it to risks, including the effect of changes in currency exchange rates, differences in laws, including laws protecting intellectual property and regulating medical devices, political risks and the challenge of managing foreign subsidiaries.
 
STAAR has developed a plan to methodically consolidate its manufacturing in a single site at its Monrovia, California location by the end of 2013, which is expected subsequently to yield significant savings in cost of goods and to lower our global administrative and regulatory costs.  This plan, which is subject to significant risks, is described in greater detail in Management’s Discussion and Analysis of Financial Condition under the caption “ Manufacturing Consolidation Project and Tax Strategy .”
 
Strategy and Key Operational Metrics
 
STAAR’s strategy is to be valued as a leading global provider of innovative intraocular lens system technologies.  STAAR will employ a focused commercialization strategy that enables sustainable profitable growth.
 
STAAR’s key operational metrics in 2011 are guided by two principal strategic goals:  to achieve and maintain profitability and to lay the groundwork for further growth.  In pursuit of these goals, STAAR has aligned its business initiatives during 2011 along four key operational metrics it uses to gauge its success during the year.  Based on performance in excess of targets during the second quarter, STAAR increased the targets for three of the four metrics, and they are currently established as follows:
 
 
·
Increase total revenue by double digits.
 
 
·
Grow Visian ICL and TICL sales by 30%.

 
14

 
 
·
Continuously increase gross profit margin each quarter to achieve a level of 66.5% for the full year.
 
 
·
Achieve profitability in all four quarters of 2011.
 
STAAR satisfied all four of the metrics, including the three increased metrics, during the third quarter of 2011.
 
Increase total revenue by double digits .  As STAAR continues to place less emphasis on its less profitable non-core products and experiences increasing revenue in its higher value core products, it has set a target of double digit growth in total revenue during 2011.  In the third quarter of 2011, STAAR achieved year-over-year total revenue growth of 16%, and for the nine-month period it achieved growth of 14% in total revenue.
 
Grow Visian ICL and TICL sales by 30%.   STAAR achieved a growth rate of 31% in the third quarter, and 30% growth for the first nine months of the year.  We have been pursuing the goal of increased ICL and TICL sales by identifying the top ten markets and concentrating our sales and marketing efforts on increasing our market share in those regions. Growth rates in the top ten markets on which we currently focus were 33% during the third quarter, and 32% for the first nine months of the year.  STAAR launched its new Visian V4c with CentraFLOW™ technology in the countries covered by the CE Mark in the third week of September 2011, which is expected to positively affect sales growth in Europe in the fourth quarter. U.S. ICL sales have continued a trend of relatively slow growth seen over the last two years, and experienced a decline of 7% for the third quarter and declined 2% for the first nine months of 2011.  Our goal had originally been to increase Visian ICL and TICL sales by 25%; we increased the goal after exceeding the target level in the second quarter.  Because Visian products are used in elective surgery, the rate of sales growth depends on continued improvement in global economic conditions.  We discuss recent trends in Visian sales in greater detail below under the heading Visian ICL and TICL sales .
 
Continuously expand gross profit margin each quarter to achieve a level of 66.5% for the full year.   STAAR’s gross profit margin was 68.5% for the third quarter and 66.7% for the first nine months of 2011. While cost savings have contributed to improving margins, the biggest factor has been the change in our product mix. Visian products yield a significantly higher profit margin than IOLs.  Among IOLs, STAAR has increased average selling prices by emphasizing sales of its higher value IOLs, such as nanoFLEX and our Toric IOL.  Preloaded IOL sales in some territories, especially Japan, have historically yielded good profit margins and their sales increased during the first half of 2011.  Since 2009 STAAR has de-emphasized lower margin sales of non-IOL, non-ICL products.  Based on performance in the first half of 2011, STAAR raised this target to 66.5% for the full year from an initial target of 66%.
 
Achieve profitability in all four quarters of 2011. In the third quarter STAAR achieved net earnings of $0.08 million, or $0.00 per share.  STAAR’s achievement of net earnings of $0.3 million in the first quarter of 2011 was the first quarter since 1999 during which the company reported net income from continuing operations.  Based on this performance STAAR increased this metric from an original target of profitability in three of four quarters.  We caution that STAAR has just crossed the threshold of profitability, and sustained profitability remains vulnerable to the competitive nature of our industry and to the risk factors described in our Annual Report on Form 10-K.
 
Other Highlights
 
Global Visian ICL and TICL Sales

STAAR continues to focus its Visian marketing and sales efforts in the key territories where it has established significant market share, based on the success of this strategy in 2009 and 2010.  The key territories in which STAAR is currently seeking to enhance Visian sales are the U.S., Japan, Korea, China, India, Spain, Middle East, Germany, U.K., and Latin America.
 
Since 2009, STAAR has experienced a breakthrough in market penetration in Korea, where it believes implants of Visian products have reached approximately 15% of the total volume of refractive surgery procedures.  Revenues from sales of Visian ICL products in Korea increased 22% in the third quarter and 26% in the first nine months of 2011.  Because of the rapid growth of Visian ICL sales and market share in Korea, STAAR is using Korea as a model of best practices for marketing that may serve to significantly increase market share in other key territories.  Other territories where Visian products have experienced significant growth in the first nine months of 2011 over prior year were China, Japan, Germany, the Middle East and India.
 
In September 2011, STAAR launched the V4c model of the Visian ICL with CentraFLOW technology in countries that recognize the CE Mark.  The CentraFLOW technology uses a proprietary port in the center of the ICL optic of a size determined to optimize the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant or a surgical iridotomy at time of implant.   By simplifying the procedure and increasing patient comfort, the V4c makes the superior visual outcomes of the Visian ICL available through a surgical  implantation experience closer to LASIK, which should attract new surgeons and patients to the product. STAAR believes that a number of presentations by surgeons at the September 2011 Congress of the European Society of Cataract and Refractive Surgery demonstrated keen interest in V4c among surgeons.  Based on these clinical presentations and early ordering activity for the V4c, STAAR believes the product has the potential to further increase the rate of global Visian sales growth.  Availability of the V4c will begin to affect sales in the fourth quarter of 2011, so it is too early to determine whether and to what degree the product will actually affect sales.

 
15

 

The launch of V4c follows the September 2010 introduction of the V4b model, which offers an expanded range of correction, in territories that recognize the CE Mark.  The expanded range includes ICLs with lower levels of myopia correction in quarter-diopter increments, Toric hyperopic ICLs to treat astigmatism and far-sightedness, and Toric ICLs in the low to zero range of myopia to treat patients primarily affected by astigmatism.  These product line extensions more than double the number of patients who could benefit from Visian products in Europe and other territories that accept the CE Mark. In the first nine months of 2011, approximately 7 % of the V4b sales in the markets in which it is available were in the new expanded treatment range.
 
STAAR believes that, where available, the V4c and V4b models have significantly improved the competitiveness of the Visian product line and have moved STAAR closer to its goal of positioning the ICL and TICL throughout the world as primary choices for refractive surgery.  Visian products now address all degrees of refractive error that can be treated with laser eye surgery, as well as moderate and severe errors beyond the effective range of laser eye surgery.
 
In some key markets of the Asia Pacific region where STAAR has not yet introduced the V4b, STAAR plans to seek approval of the V4c and to move directly to that model.
 
STAAR is currently seeking approval of the TICL in the U.S. and Japan.
 
STAAR’s ability to maintain or accelerate the rate of growth in Visian ICL sales will partly depend on continued improvement in worldwide economic conditions and progress with regulatory agencies.  ICL surgery is a relatively expensive elective procedure and is seldom reimbursed by insurers or government agencies.  STAAR believes that the global recession reduced overall demand for refractive surgery particularly in the U.S., and it has been reported that consumer spending and consumer confidence has not returned to pre-recession levels.
 
In May 2011 STAAR received approval to market the Visian model V4 ICL in Brazil.  This approval helped to drive STAAR’s decision to target the Latin American market for Visian ICL growth, and it intends to add sales and marketing resources in the region to capitalize on the new opportunity.  In addition, STAAR is working to expand regulatory approvals in the market.

U.S. Visian ICL Sales

We consider Visian ICL sales growth in the U.S. market important because of the size of the U.S. refractive surgery market and the perceived worldwide leadership of the U.S. in adopting innovative medical technologies.  The Visian ICL was approved by the FDA for treatment of myopia on December 22, 2005.
 
U.S. sales of ICLs decreased by 7% in the third quarter and 2% for the first nine months of 2011, compared to prior year.  Sales in the private sector continued to increase by 1% in the quarter and were up 13% for the nine months. Sales to the military declined 15% in the quarter bringing the year to date decline to 37%. This percentage decline has decreased on a sequential quarterly basis, the first quarter and second quarter declines were 57% and 34% respectively, and we anticipate this trend will continue and that military sales will return to growth in 2012.  Military sales accounted for 16% of total US ICL sales in the first nine months, compared to 25% in the same period last year. The increase in private sector sales, which STAAR believes resulted from its efforts to drive greater adoption and increased usage of the lower diopter range among its existing customer base.  If the economy continues to improve, and overall refractive procedures volume increases, STAAR could see further growth in private sector ICL sales in the U.S.
 
STAAR believes that the FDA’s scrutiny of patient satisfaction levels following laser refractive surgery, which began in 2008, has affected the overall U.S. market for refractive surgery.  The negative publicity generated by that regulatory activity continued in 2010 after a former FDA official publicly petitioned FDA to revoke its approval of LASIK.  Patient concerns about LASIK could increase interest in the Visian ICL as an alternative for patients who have a greater risk of complications from LASIK.  The fact that the Visian ICL is removable may also be appealing to some patients with new concerns about risks of refractive surgery.  However, STAAR believes in the short term the negative publicity concerning LASIK has decreased patient interest in all refractive surgery, including Visian ICL.  Because nearly all candidates for refractive surgery can achieve acceptable vision through the use of spectacles or contact lenses, for most patients the decision to have refractive surgery is a lifestyle choice that depends on high confidence in achieving a satisfactory outcome.
 
In addition to poor conditions in the general economy, in particular the refractive surgery market, and negative publicity concerning LASIK, other challenges to resumed growth in U.S. Visian ICL sales include the following:

 
·
the U.S. refractive surgery market has been dominated by corneal laser-based techniques, which continue to be better known than the Visian ICL among potential refractive patients;

 
16

 

 
·
other newly introduced surgical products will continue to compete with the Visian ICL for the attention of surgeons seeking to add new, high value surgical products, in particular multifocal and accommodating IOLs;
 
 
·
the fact that the FDA has not granted approval to sell the TICL, which STAAR sells in over 50 international markets for treating patients affected by both myopia and astigmatism; and.
 
 
·
FDA approval of the V4c is expected to be significantly more time consuming than regulatory approval in most international markets.
 
Beginning the fourth quarter of 2010 STAAR has been testing direct-to-consumer advertising initiatives online and has used conventional DTC media to test a campaign in selected markets. This activity seeks to increase potential refractive patient visits and to encourage patients to inquire specifically about the Visian ICL by distinguishing it from other refractive treatments.  The current materials for the campaign are a series of humorous videos contrasting the Visian ICL with LASIK, eyeglasses and contact lenses.  The videos highlight certain benefits of the ICL over other treatments, including clarity of vision, absence of surgically induced dry eye, removability and ultraviolet protection.  STAAR is assessing the data obtained to date to determine whether, and in what form, to launch a broader direct-to-consumer campaign

Additionally, STAAR has begun efforts to increase the visibility of the Visian ICL technology on social network sites.  The Facebook Visian ICL Contest was just completed which saw the fan base for the Visian ICL more than double in size.  Contestants developed videos in which they were trying to convince voters why they needed a free Visian ICL procedure.  STAAR worked with nine ophthalmic practices across the U.S. and five winners were determined based upon consumer voting on the network.  The Visian ICL procedures are now being arranged along with a focus to drive local media around the event.  During the recent American Academy of Ophthalmology meeting STAAR offered online marketing consulting for key practices to support their viral efforts around the Visian ICL technology.  STAAR has decided to expand its social networking department in 2012 in order to more effectively drive consumer testimonials and respond to consumer questions. 
 
Global IOL Sales.
 
STAAR pioneered the development of folding lenses for use in cataract surgery, and IOLs continue to represent approximately 45% of STAAR’s business.  Sales of IOLs during the three months and nine months ended September 30, 2011 were $6.6 million and $20.8 million, compared to $6.6 million and $20.4 million for the same periods in the prior year.
 
In September 2011, STAAR launched its nanoFLEX Collamer Single Piece IOL which can be injected through a 2.2 mm incision with the nanoPOINT™ Injector System, in the territories that the recognize the CE Mark.  This follows the April 2011 CE Mark approval of the product.  nanoFLEX has been STAAR’s fastest growing IOL product in U.S. markets and STAAR believes the lens can receive broad commercial acceptance outside the U.S.  STAAR hopes that the biocompatibility and outstanding optical properties of Collamer, with which surgeons have become acquainted through the ICL, will build interest in the nanoFLEX IOL worldwide.  STAAR’s Collamer Accommodating Study Team (CAST) used the nanoFLEX lens in its 2009 clinical observations and reported promising assessments regarding initial intermediate and near vision results.  These properties of nanoFLEX may also spur interest in the lens in new markets, especially among surgeons seeking an IOL for monovision treatment.
 
Among STAAR’s initiatives to grow its IOL business are the following:

 
·
we plan to seek further approvals for the nanoFLEX in an effort to build a global product franchise for Collamer IOLs;
 
 
·
we are seeking approval to introduce the silicone Preloaded Injector in the U.S. market to enhance our U.S. IOL offering and help STAAR maintain or increase its market share in the hospital based segment;
 
 
·
a new version of the hydrophobic acrylic Preloaded Injector, featuring the popular single-piece IOL format, received CE Mark approval in May 2011, and STAAR plans to introduce it into international markets in the2012;
 
 
·
we plan to introduce a preloaded injector for the nanoFLEX;
 
 
·
we are developing a Collamer Toric IOL on the nanoFLEX platform to complement our pioneering silicone Toric IOL and better compete with other Toric IOL;
 
 
·
we have recently seen renewed interest in our silicone Toric IOL among U.S. surgeons and are ramping up marketing efforts for the lens; and
 
 
·
we are researching accommodating and/or multifocal designs that exploit the unique optical properties of the Collamer material.

 
17

 

STAAR cautions that the successful development and introduction of new products is subject to risks and uncertainties, including the risk of unexpected delays and, in some cases, approval of regulatory authorities.
 
STAAR’s efforts to increase U.S. IOL sales face a number of short and long-term challenges, including successfully meeting its objectives to develop new and enhanced products and marketing them with limited resources.  The U.S. IOL market has recently become more fragmented with the entry of new competitors, resulting in greater competition for market share.  We cannot assure that our efforts will ultimately be successful.
 
Manufacturing Consolidation Project and Tax Strategy.   During 2011 STAAR has devoted significant resources to two initiatives:  a project to consolidate global manufacturing, and development of a strategy to optimize our global organization for tax purposes.  The goal of both of these strategies is to continue our improvement in gross profit margin by reducing costs and to position the company for future growth.
 
STAAR currently manufactures its products in four facilities worldwide.  It has developed a plan to methodically consolidate its manufacturing in a single site at its Monrovia, California location by the end of 2013, which is expected subsequently to yield significant savings in cost of goods and to lower our global administrative and regulatory costs.
 
In addition, as STAAR’s profitability grows, its liability for income taxes in various jurisdictions has also increased.  STAAR has developed a strategy to minimize its future tax liabilities as its business grows.  Among other things, STAAR seeks to utilize the approximately $125 million in net operating losses that it has accumulated in the U.S.
 
In connection with its Centers of Excellence project in 2009 and 2010, STAAR successfully transferred manufacturing of some of its products; STAAR believes this experience will be helpful in undertaking the more ambitious transfers involved in the manufacturing consolidation project.
 
STAAR expects these initiatives to cost approximately $6 million over a three-year period, of which it has spent approximately $0.5 million for the nine months ended September 30, 2011 and expects to spend approximately $150,000 in the fourth quarter of 2011. Expenditures to date have largely consisted of professional fees to advisors and consultants. We expect approximately $1 million in additional capital expenditures to consolidate our manufacturing.  STAAR anticipates that the two initiatives could yield savings of $100 million over the period 2014 to 2020, and could result in profit margin in the 75% range.
 
We cannot assure that we will achieve the expected benefits of these initiatives. Among other things, costs could exceed current estimates, product manufacturing transfers can result in delays or supply interruptions, changes in tax laws could reduce or eliminate expected benefits of some or our tax strategies, and future profit margins can be affected by a variety of factors unrelated to our level of manufacturing efficiency.
 
Effect of Earthquake on Japan Operations .  On March 11, 2011, a 9.0 magnitude earthquake struck northeastern Japan, followed by a tsunami that devastated the region’s coastal communities.    STAAR Japan’s staff and their immediate families suffered no serious injuries.  STAAR’s manufacturing facilities in Ichikawa City, Chiba Prefecture, suffered only minor damage and resumed operations on Wednesday, March 16, 2011.  Despite the disaster, STAAR Japan’s revenues and its domestic IOL and ICL business have continued to grow; revenues in the third quarter were 32% higher than prior year and revenues in the first nine months of 2011 were 21% higher than prior year.  Nevertheless, widespread disruptions in the Japanese economy and infrastructure may have slowed the rate of growth in STAAR Japan’s recently launched ICL business, and that effect may continue until recovery is complete.
 
Backlog.   The ICL is manufactured to precisely address refractive prescriptions across a broad range of correction, resulting in a large number of Stock Keeping Units (SKUs) .  The challenge of maintaining inventory in all models, combined with rapidly increasing global demand for the ICL, can result in a backlog in customer orders.  While the dollar amount of backlog orders is not currently significant in relation to our total annual sales, unexpectedly large orders for ICLs could increase our backlog.   STAAR believes it has sufficient capacity to ramp up production levels to meet demand and that any backlogs will be temporary.  However, delays in filling orders can result in lost sales if alternative refractive treatments are available to the patient. Because Toric ICLs treat an even greater variety of refractive errors and at times must be custom made for the patient, customers are accustomed to a special order procedure and do not expect immediate delivery of Toric ICLs from inventory.
 
Status of U.S. TICL Submission . STAAR submitted a Pre-Market Approval Application (PMA) supplement for the TICL to the FDA on April 28, 2006, which the agency has designated as a panel-track supplement.  In August 2007, following negative inspectional observations and a Warning Letter from FDA’s Division of Bioresearch Monitoring (“BIMO”), the FDA Office of Device Evaluation placed an integrity hold on STAAR’s TICL application.  Over a two-year period STAAR took a number of corrective actions to address BIMO’s concerns and to remove the integrity hold, including engaging an independent third party to conduct a 100% audit of patient records in the TICL clinical study, along with an audit of clinical systems to ensure accuracy and completeness of data before resubmitting the application.  On July 21, 2009, the FDA notified STAAR that as a result of STAAR’s corrective actions the FDA had removed the integrity hold on our application for approval of the TICL, and would resume its consideration of the application.  During August and September 2009, the agency and STAAR resolved a number of questions related to the TICL supplement in an interactive process.  On February 3, 2010, STAAR received a letter of deficiency from the FDA outlining additional questions.  On August 2, 2010 we responded to the FDA’s deficiency letter.  Since that response, STAAR has been in dialogue with the agency, working interactively to resolve a series of follow-up questions.  On April 22, 2011, STAAR responded to the most recent questions from the agency, which concerned the basis for an increase in the number of reported patient follow-up visits following the independent third party audit of the clinical data, and has responded to additional follow-up questions after that date.  STAAR cannot predict when, or if, the FDA may grant approval of the Visian Toric ICL.

 
18

 

Status of Japan TICL Submission . On February, 2, 2010, Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the sale of the Visian ICL.  STAAR submitted a partial change application for approval of the Visian Toric ICL to the Pharmaceuticals and Medical Device Agency (PMDA) on April 9, 2010.   PMDA conducted an audit of clinical practices related to the application during August 2011, and subsequent to quarter end the Company received notice from the PMDA that the TICL application will not need to go before the Approval Committee. In addition the PMDA and MHLW have permitted STAAR to add the clinical data collection on the Toric ICL Post Market Studies (PMS) to the current PMS protocols underway for the Visian ICL.  Final regulatory approval in Japan will require that the DFU (Directions for Use) be finalized, the Post Market Study protocol for the Toric ICL be completed, and the GCP (Good Clinical Practices) audit of the U.S. clinical trial data be finalized.  We believe that these items can be completed within the fourth quarter and final approval should be announced shortly after their completion.
 
Critical Accounting Policies

This Management's Discussion and Analysis of Financial Condition and Results of Operations discusses and analyzes data in our unaudited Condensed Consolidated Financial Statements, which we have prepared in accordance with U.S. generally accepted accounting principles.  Preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.

An accounting policy is deemed critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably likely to occur could materially impact the financial statements. Management believes that there have been no significant changes during the nine months ended September 30, 2011 to the items that we disclosed as our critical accounting policies and estimates in Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

 
19

 

Results of Operations

The following table shows the percentage of our total sales represented by the specific items listed in our statements of operations for the periods indicated, and the percentage by which these items increased or decreased over the prior period.

   
Percentage of Net Sales for
Three Months
   
Percentage
Change for
Three
Months
   
Percentage of Net Sales for
Nine Months
   
Percentage
Change
for Nine
Months
 
    
September 30,
2011
   
October 1,
2010
   
2011
vs. 2010
   
September
30, 2011
   
October 1,
2010
   
2011
vs. 2010
 
Net sales
    100.0 %     100.0 %     16.1 %     100.0 %     100.0 %     14.3 %
Cost of sales
    31.5       37.2       (1.6 )     33.3       36.5       4.4  
Gross profit
    68.5       62.8       26.5       66.7       63.5       20.1  
                                                 
General and administrative
    25.0       27.3       6.4       24.7       25.3       11.7  
Marketing and selling
    29.1       34.6       (2.5 )     28.2       30.9       4.6  
Research and development
    9.5       10.0       11.1       9.2       10.4       1.4  
Other general and administrative expenses
                *           1.7       (100.0 )
      63.6       71.9       2.8       62.1       68.2       4.1  
Operating income (loss)
    4.8       (9.1 )     *     4.6       (4.7 )     *
Other expense, net
    (2.9 )     3.0       *     0.2       (2.3 )     *
                                                 
Income (loss) before provision for income taxes
    1.9       (6.1 )     *     4.8       (7.0 )     *
Provision for income taxes
    1.4       2.7       (39.9 )     2.1       1.4       75.0  
Income (loss) from continuing operations
    0.5       (8.8 )     *     2.7       (8.4 )     *
Income from discontinued operations, net of taxes
                            10.3       (100.0 )
Net income (loss)
    0.5 %     (8.8 ) %     *     2.7 %     1.8 %     66.5 %

*        Denotes change is greater than + 100%.
Net Sales

Net sales for the three and nine months ended September 30, 2011 were $15.3 million and $46.4 million, an increase of approximately 16.1% and 14.3%, respectively, compared with $13.2 million and $40.6 million for the three and nine months ended October 1, 2010.  The increase in net sales was due primarily to increased sales of ICLs.  Changes in currency had a $0.4 million and $1.4 million favorable impact on net sales, respectively for the three and nine months ended September 30, 2011.

Total ICL sales for the three and nine months ended September 30, 2011 were $7.9 million and $23.1 million, an increase of 31% and 30% respectively, compared with $6.0 million and $17.8 million for the comparable periods in 2010.  The increase in ICL sales primarily resulted from a 33% increase in our top ten refractive markets during the third quarter.  ICL sales represented 52% and 50%, respectively, of our total sales for the three and nine months ended September 30, 2011.

Total IOL sales for the three and nine months ended September 30, 2011 were $6.6 million and $20.8 million, an increase of 0.2% and 1.6% respectively,  compared with $6.6 million and $20.4 million for the three and nine months ended October 1, 2010.  The increase in IOL sales is due to the favorable effect of currency. IOL sales represent 43.0% and 44.8% of the sales for the three and nine months ended September 30, 2011.

Gross Profit

Gross profit for the third quarter was $10.5 million, or 68.5% of revenue, compared with $8.3 million, or 62.8% of revenue, in the prior year period.  During the nine months of 2011, gross profit was $30.9 million, or 66.7% of revenue, compared with $25.8 million, or 63.5% of revenue, in the prior year period.  The increase in gross profit and gross profit margin was largely attributable to a higher mix of ICL sales and improved margins on IOL sales.

 
20

 

General and Administrative

General and administrative expenses increased by 6.4% to $3.8 million in the third quarter of 2011 from the $3.6 million reported in the third quarter of 2010.  General and administrative expenses for the nine months ended September 30, 2011 were $11.4 million, an increase of 11.7% when compared with $10.2 million reported last year.  The increase in both periods was primarily due to increased bonus accruals and professional fees incurred in evaluating future manufacturing and tax strategies.

Marketing and Selling

Marketing and selling expenses decreased by 2.5% to $4.4 million in the third quarter of 2011, compared with $4.6 million in the third quarter of 2010.  Marketing and selling expenses for the nine months ended September 30, 2011 were $13.1 million, an increase of 4.6% when compared with $12.5 million reported last year.  The decrease for the third quarter resulted from transition of the Company’s Australia business to a distribution model.  For the nine month period the increase in expense was primarily due to increased salaries and promotional activities.

Research and Development

Research and development expenses increased by 11.1% to $1.5 million in the third quarter of 2011, compared with $1.3 million in the third quarter of 2010.  Research and development expenses for the nine months ended September 30, 2011 were $4.3 million, an increase of 1.4% when compared with $4.2 million reported last year.  The increases for both periods resulted from increased payroll and patent related cost.

Other General and Administrative Expenses

Other general and administrative expenses in 2010 reflected a $700,000 charge for executive termination benefits cost recorded in connection with the non-renewal of an executive employment agreement.  There was no corresponding expense in 2011.

Other Income (Expense), net
Other expenses total $0.4 million, compared with other income in the third quarter of 2010 of $0.4 million. This $0.8 million swing is due primarily to foreign exchange losses of $0.3 million recorded during the quarter compared with $0.4 in exchange gain which was recorded in the third quarter of 2010.  In addition, other expense increased approximately $0.2 million as a result of the fair value adjustment of outstanding warrants. For the nine months of 2011, other income was $0.1 million, compared with other expense of $0.9 million for the nine months of 2010. This swing is due to reduced interest and other expense resulting from the repayment of the Broadwood note in 2010, foreign exchange gains, increased royalty income, and income from the fair value adjustment of outstanding warrants.

Liquidity and Capital Resources

STAAR’s liquidity requirements arise from the funding of our working capital needs, primarily inventory and accounts receivable.  Our primary sources for working capital and capital expenditures are cash flows from operating activities, proceeds from the exercise of stock options, and borrowings under our credit facilities.  Our liquidity also depends, in part, on customers paying within credit terms, and any extended delays in payments or changes in credit terms given to major customers may have an impact on STAAR’s cash flow.  In addition, any abnormal product returns or pricing adjustments may also affect our short-term funding.
 
STAAR believes its current cash balances, coupled with cash flow from operating activities will be sufficient to meet its working capital requirements for the foreseeable future, including the estimated $6 million cost associated with the manufacturing consolidation plan.  STAAR’s need for working capital, and the terms on which financing may be available, will depend in part on its degree of success in maintaining positive cash flow and earnings through the strategies described above under the caption “Strategy.” If the need for financing arises, STAAR cannot assure that it  will be available on acceptable terms, if at all.
 
STAAR’s cash balances have steadily increased over the last two years.  To the extent STAAR’s cash balances exceed levels needed for working capital and as a cushion for unforeseen demands, STAAR intends to invest its cash in expanding and improving its business.  It does not anticipate paying dividends from its earnings for the foreseeable future.

 
21

 

Overview of Changes in Cash and Cash Equivalents and Other Working Capital Accounts.

As of September 30, 2011 and December 31, 2010, STAAR had $16.9 million and $9.5 million, respectively, of cash and cash equivalents and restricted cash.
 
Net cash provided by operating activities was $5.4 million for the nine months ended September 30, 2011, compared to $4.6 million in net cash used by operating activities for the nine months ended October 1, 2010.  For the nine months ended September 30, 2011, net cash provided by operating activities consisted of net income of $1.2 million, $3.0 million in non-cash activities and $1.2 million generated from working capital. For the nine months ended October 1, 2010, net cash provided by investing activities was due to the $11.8 million net cash proceeds from the sale of our German subsidiary in March 2010 and the release of the $7.4 million restricted deposit, including interest, by the Court, offset by $0.2 million of acquisitions of property, plant and equipment.
 
 Net cash used in investing activities was $0.6 million for the nine months ended September 30, 2011, compared with cash provided by investing activities of $18.8 million for the nine months ended October 1, 2010.  Net cash used in investing activities was mainly due to $0.7 million in acquisitions of property, plant and equipment. For the nine months ended October 1, 2010, net cash provided by investing activities was mainly due to $11.8 million of net cash proceeds from sale of our German subsidiary in March 2010 and the release of the $7.3 million restricted deposit by the Court in June 2010, offset by $0.3 million of acquisitions of property, plant and equipment.
 
Net cash provided by financing activities was $2.6 million for the nine months ended September 30, 2011, compared to net cash used in financing activities of $12.2 million for the nine months ended October 1, 2010.  Net cash provided by financing activities consisted of $3.0 million in proceeds from the exercise of stock options, partially offset by $0.4 million in capital lease repayments.  For the nine months ended October 1, 2010, net cash used in financing activities was due to the $5 million payment of the Broadwood note, the $6.8 million cash redemption of the Series A preferred shares and repayment of our capital lease obligations of $0.6 million, partially offset by $0.2 million in proceeds from stock option exercises.

Credit Facilities, Contractual Obligations and Commitments

Accrued Termination Benefits for Executive

On May 24, 2010, STAAR accrued $700,000 in executive termination benefit costs in connection with the notice of non-renewal given under an executive employment agreement.  This accrual represented STAAR’s estimate of the contractual termination benefits due to the former executive.  The actual amount ultimately paid to the former executive may be different than the amount estimated.  The balance of accrued unpaid severance at September 30, 2011 was approximately $104,000.
 
Lines of Credit
 
The Company’s Japanese subsidiary, STAAR Japan, has an agreement, as amended on June 30, 2009, with Mizuho Bank, which provides for borrowings of up to 300,000,000 Yen (approximately $3.9 million based on the rate of exchange on September 30, 2011), at an interest rate equal to the Tokyo short-term prime interest rate (approximately 1.475% as of September 30, 2011) plus 1.125%.  The agreement may be renewed annually (the current line expires on April 2, 2012).  The credit facility is not collateralized.  The Company had 200,000,000 Yen outstanding on the line of credit as of September 30, 2011 and December 31, 2010, (approximately $2.6 million and $2.5 million based on the foreign exchange rates on September 30, 2011 and December 31, 2010) which approximates fair value due to the short-term maturity and market interest rates of the line of credit.  In case of default, the interest rate will increase to 14% per annum. As of September 30, 2011, 100,000,000 Yen (approximately $1.3 million based on the rate of exchange on September 30, 2011) of the line was available for borrowing.

In August 2010, our wholly owned Swiss subsidiary, STAAR Surgical AG, entered into a credit agreement with Credit Suisse (the “Bank”). The credit agreement provides for borrowings of up to 1,000,000 Swiss Francs ($1,114,000 at the rate of exchange on September 30, 2011), to be used for working capital purposes.  Accrued interest and 0.25% commissions on average outstanding borrowings is payable quarterly and the interest rate will be determined by the Bank based on the then prevailing market conditions at the time of borrowing.  The credit agreement is automatically renewed on an annual basis based on the same terms assuming there is no default.  The credit agreement may be terminated by either party at any time in accordance with its general terms and conditions.  The credit facility is not collateralized and contains certain conditions such as providing the Bank with audited financial statements annually and notice of significant events or conditions as defined in the credit agreement.  The Bank may also declare all amounts outstanding to be immediately due and payable upon a change of control or a “material qualification” in STAAR Surgical AG’s independent auditors’ report.  There were no borrowings outstanding as of September 30, 2011 and the full amount of the line was available for borrowing.

 
22

 

Capital Lease Obligations

STAAR leases certain property, plant, and equipment under non-cancelable capital lease agreements.  These leases vary in amount, duration, and rates.

Estimated future minimum payments under capital lease obligations were as follows (in thousands):

Fiscal Year
 
September 30,
2011
   
December 31,
2010
 
2011
  $ 187     $ 938  
2012
    844       763  
2013
    595       627  
2014
    75       68  
2015
          36  
Thereafter
           
Total minimum lease payments
  $ 1,701     $ 2,432  
Less: interest
    (121 )     (598 )
Total lease obligation
  $ 1,580     $ 1,834  
                 
Current
  $ 590     $ 431  
Long-term
  $ 990     $ 1,403  

Borrowings available under our lease lines of credit with Farnam Street Financial are approximately $238,350.   See Note 10, Notes Payable ,   to the consolidated financial statements accompanying the 2010 Form 10-K for additional information regarding STAAR’s Company’s capital lease agreements.

Covenant Compliance

The Company is in compliance with the covenants of its credit facilities as of the date of this report. 

Off-Balance Sheet Arrangements
 
 We do not have any off-balance sheet arrangements, as that term is defined in the rules of the SEC, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
 
ITEM 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company’s qualitative and quantitative market risk since the disclosure in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010.

ITEM 4.   CONTROLS AND PROCEDURES

Disclosure Controls and Procedures
 
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of the disclosure controls and procedures of STAAR Surgical Company and its subsidiaries (the “Company”).  Based on that evaluation, our CEO and CFO concluded, as of the end of the period covered by this quarterly report on Form 10-Q, that our disclosure controls and procedures were effective.  For purposes of this statement, the term “disclosure controls and procedures” means controls and other procedures of the Company that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized and reported, within the time periods specified in the Commission's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Act is accumulated and communicated to the issuer's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 
23

 

Our management, including the CEO and the CFO, do not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud or material errors. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations on all internal control systems, our internal control system can provide only reasonable assurance of achieving its objectives and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of internal control is also based in part upon certain assumptions about the likelihood of future events, and can provide only reasonable, not absolute, assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in circumstances, or the degree of compliance with the policies and procedures may deteriorate.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1.
LEGAL PROCEEDINGS

From time to time the Company may be subject to various claims and legal proceedings arising out of the normal course of our business.  These claims and legal proceedings may relate to contractual rights and obligations, employment matters, or claims of product liability.  STAAR maintains insurance coverage for product liability claims.  While the Company does not believe that any of the claims known is likely to have a material adverse effect on its financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.

ITEM 1A.
RISK FACTORS
 
Our short and long-term success is subject to many factors that are beyond our control. Investors and prospective investors should consider carefully the following risk factors, in addition to other information contained in this report and the risks and uncertainties described in “Part I—Item 1A—Risk Factors” of the Company’s Form 10-K for the fiscal year ended December 31, 2010.. Such risks and uncertainties could materially adversely affect our business, financial condition or operating results.
 
We may not realize the expected benefits of our manufacturing consolidation project and tax strategies.   Beginning in 2011 STAAR  has invested significant resources in a manufacturing consolidation project and a tax strategy initiative, and it expects to invest several million dollars to complete the projects.  The goal of these projects is to increase profit margins by improving manufacturing efficiency, simplifying administrative and regulatory functions, and reducing tax liabilities.  We cannot assure that we will achieve the expected benefits of these initiatives.  Among other things, costs could exceed current estimates, product manufacturing transfers can be affected by delays or cause supply interruptions, changes in tax laws could reduce or eliminate expected benefits of some of our tax strategies, and future profit margins can be affected by a variety of factors unrelated to our level of manufacturing efficiency.
 
We may experience backlog in ICL orders due to rapid increases in demand .   The challenge of maintaining inventory across the large number of ICL models, combined with rapidly increasing global demand for the ICL, has from time to time resulted in a backlog in customer orders.  While the dollar amount of backlog orders is not currently significant in relation to our total annual sales, unexpectedly large orders for ICLs could increase our backlog to levels that are financially significant.  In addition, delays in filling orders can result in lost sales if alternative refractive treatments are available to the patient. If we are unable to ramp up production to meet growing demand we may not achieve our growth targets.

 
24

 

ITEM 5.
OTHER INFORMATION
 
a.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

The following information is provided pursuant to Item 5.02(e) of Form 8-K:

Compensatory Arrangements of Certain Officers

On November 2, 2011, STAAR entered into an Executive Severance Agreement and Executive Change in Control Agreement with each of the following Named Executive Officers:  Deborah Andrews (Chief Financial Officer) and Robin Hughes (Vice President, Global Marketing).
 
In each case the Executive Severance Agreement and Executive Change in Control Agreement replaces and supersedes any other prior agreements, arrangements and understandings between the officer and STAAR with respect to rights upon severance or a change in control, except rights expressly provided under option agreements and other equity compensation agreements.  Stock options and other equity compensation awards will continue to be governed by the original agreements in place with respect to the awards.

A summary of the terms and conditions of the agreements is provided below.

Severance Agreement.   If the officer is terminated without cause or resigns for good reason (except in connection with a change in control of STAAR), the officer will receive the following, subject to the officer entering into a release of claims with STAAR:
 
·
Six months’ base salary at the rate applicable at the time of termination; and
 
 
·
Six months’ continuation of group health and dental benefits.
 
Change in Control Agreement .  If the officer is terminated within 12 months after a change in control of STAAR, or resigns for good reason within 15 months after a change in control of STAAR, the officer will receive the following, subject to the officer entering into a release of claims with the employer:
 
·
One year’s base salary at the greater of the rate applicable at the time of termination or the rate applicable immediately prior to the announcement of the change in control;
 
 
·
One year’s target cash bonus amount, plus the greater of the amount of any bonus earned in the year of termination and the provided amount of the previous year s bonus;
 
 
·
One year’s continuation of group health and dental benefits; and
 
 
·
Limited roll-backs or deferrals in compensation if necessary to reduce liability for excise taxes under Section 280G of the Internal Revenue Code, but no provision of any kind for the gross-up of payments for taxes or for any other purpose
 
Under both forms of agreement, resignation “for good reason” generally means that an employer has adversely changed the officer’s salary, location or other terms and conditions of employment to such a degree that the executive is entitled to voluntarily resign and to receive severance benefits.
 
The foregoing summary of the terms of the Executive Severance Agreements and Executive Change in Control Agreement is qualified in its entirety by reference to the full text of the forms of the agreements, copies of which are attached to this Report as Exhibit 10.88 and Exhibit 10.89, and which are incorporated into this Report by this reference.
 
ITEM 6.
EXHIBITS
 
3.1
Certificate of Incorporation, as amended to date.(1)
3.2
By-laws, as amended to date.(2)
†4.2
1991 Stock Option Plan of STAAR Surgical Company.(4)
†4.3
1998 STAAR Surgical Company Stock Plan, adopted April 17, 1998.(5)
4.4
Form of Certificate for Common Stock, par value $0.01 per share.(6)
†4.5
Amended and Restated 2003 Omnibus Equity Incentive Plan, and form of Option Grant and Stock Option Agreement.(3)
†10.88
Form of Executive Severance Agreement. *
†10.89
Form of Executive Change in Control Agreement. *

 
25

 

 
31.1
Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
31.2
Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *
32.1
Certification Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
101
Financial statements from the quarterly report on Form 10-Q of  STAAR Surgical Company for the quarter ended July 1, 2011, formatted in XBRL, are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Income, (iii) the Condensed Consolidated Statements of Cash Flows, and (iv) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text.
  
(1)
Incorporated by reference to the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2007, as filed with the Commission on March 12, 2008.
 
(2)
Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission on May 23, 2006.
 
(3)
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for quarter ended July 2, 2010, filed with the Commission on August 11, 2010.
 
(4)
Incorporated by reference to the Company’s Registration Statement on Form S-8, File No. 033-76404, as filed with the Commission on March 11, 1994.
 
(5)
Incorporated by reference to the Company’s Proxy Statement for its Annual Meeting of Stockholders held on May 29, 1998, filed with the Commission on May 1, 1998.
 
(6)
Incorporated by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Registration Statement on Form 8-A/A, as filed with the Commission on April 18, 2003.
 
*
Filed herewith.
Management contract or compensatory plan or arrangement

 
26

 

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.

 
STAAR SURGICAL COMPANY
   
Date:  November 2, 2011
By:
/s/ DEBORAH ANDREWS
 
Deborah Andrews
   
 
Chief Financial Officer
 
(on behalf of the Registrant and as its
 
principal financial officer)
 
 
27

 

Exhibit 10.88

STAAR SURGICAL COMPANY
FORM OF EXECUTIVE SEVERANCE AGREEMENT
 
THIS SEVERANCE AGREEMENT (this "Agreement"), dated as of ________________, is made by and between STAAR Surgical Company, a Delaware corporation (the "Company"), and ____________________ ("Executive").
 
WITNESSETH :
 
WHEREAS, Executive is an executive of the Company and has made and is expected to continue to make significant contributions to the short- and long-term profitability, growth and financial strength of the Company;
 
WHEREAS, the Company desires to assure itself of both present and future continuity of management and desires to establish certain severance benefits for valued executives such as Executive;
 
WHEREAS, the Company desires to provide additional inducement for Executive to continue to remain in the employ of the Company; and
 
WHEREAS, the Company and Executive acknowledge and agree that this Agreement replaces and supersedes any other prior agreements, arrangements and understandings, written or oral, between them concerning Executive's rights to receive severance compensation and/or benefits from the Company.
 
NOW, THEREFORE, the Company and Executive agree as follows:
 
1.            Certain Defined Terms.   In addition to terms defined elsewhere herein, the following terms have the following meanings when used in this Agreement with initial capital letters:
 
1.1          "Base Pay" means Executive's annual base salary rate as in effect from time to time.
 
1.2          "Board" means the Company's Board of Directors.
 
1.3          "Cause" means any of the following, each as determined in the discretion of the Board:
 
(a)           any willful breach or habitual neglect of the duties which Executive is required to perform;
 
(b)           any act of dishonesty, fraud, insubordination, misrepresentation, gross negligence or willful misconduct;
 
(c)           conviction of a felony; or
 
(d)           intentional violation of any Company policy.

 
 

 

Notwithstanding the foregoing, no act or failure to act on Executive's part will be deemed "willful" unless done, or omitted to be done, by Executive not in good faith and without reasonable belief that the action or omission was in the best interest of the Company.
 
1.4          "Change in Control" means the occurrence of any one (or more) of the following events:
 
(a)           any person, including a group as defined in Section 13(d)(3) of the Exchange Act, but excluding Broadwood Partners, L.P. or a group of which it is a member, becomes the beneficial owner of stock of the Company with respect to which twenty-five percent (25%) or more of the total number of votes for the election of the Board may be cast;
 
(b)           as a result of, or in connection with, any cash tender offer, exchange offer, merger or other business combination, sale of assets or contested election, or combination of the foregoing, persons who were directors of the Company just prior to such event shall cease to constitute a majority of the Board;
 
(c)           the stockholders of the Company shall approve an agreement providing either for a transaction in which the Company will cease to be an independent publicly owned corporation or for a sale or other disposition of all or substantially all the assets of the Company; or
 
(d)          acquisition in a single or series of related transactions, including without limitation a tender offer or exchange offer, by any person or related group of persons (other than the Company or by a Company-sponsored employee benefit plan), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than fifty percent (50%) of the total combined voting power of the Company’s outstanding securities.
 
Notwithstanding the foregoing, the formation of a holding company for the Company in which the stockholdings of the holding company after its formation are substantially the same as for the Company prior to the holding company formation does not constitute a Change in Control for purposes of this Agreement.
 
1.5          "Code" means the Internal Revenue Code of 1986, as amended.
 
1.6          "Disability" means that Executive is (a) unable to perform the essential functions of his or her position, with or without reasonable accommodation, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, or (b) by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, and is receiving income replacement benefits for a period of not less than three months under an accident and health plan covering the Company's employees, or (c) determined to be totally disabled by the Social Security Administration, as interpreted by the Company in its discretion, or (d) deemed to be disabled in accordance with the applicable disability insurance program of the Company, provided that the definition of "disability" applied under such disability insurance program complies with the requirements of this Section, as determined by the Company in its discretion.  A determination that Executive has a Disability shall not be arbitrary or unreasonable and the Company, in making such determination, shall take into consideration the opinion of Executive's personal physician, if reasonably available, and any other physician deemed appropriate by the Company, but such determination by the Company shall be final and binding on the parties hereto.  The Company will provide all applicable legally-required leaves to Executive, which shall be provided on an unpaid basis unless pay is otherwise required under applicable law.  This provision shall be interpreted and applied in a manner consistent with all applicable laws, including laws regarding workers' compensation, disability, and family and medical leave laws.

 
-2-

 

1.7          "Employee Benefits" means any Company-sponsored group health and dental insurance plans that are provided to Executive as of the Termination Date.  For the avoidance of doubt, Employee Benefits shall not include contributions made by the Company to any retirement plan, pension plan or profit sharing plan for the benefit of Executive in connection with amounts earned by Executive.
 
1.8          "Exchange Act" means the Securities Exchange Act of 1934, as amended.
 
1.9          "Good Reason" means that one or more of the following have occurred without Executive's written consent, and not in connection with, or in anticipation of, a Change in Control:
 
(a)           Executive has experienced a material diminution in Base Pay;
 
(b)           Executive has experienced a material diminution in his/her authority, duties, responsibilities, or reporting structure;
 
(c)           Executive has been notified that he/she will experience a material change in the geographic location at which he/she must perform his/her services to the Company; or
 
(d)           The Company has materially breached this Agreement.
 
For purposes of this Agreement, Executive must tender any resignation from the Company for "Good Reason" within ninety (90) days after the date that any one of the events shown above in (a) through (d) has first occurred without Executive's written consent and which is not in connection with, or in anticipation of, a Change in Control.  Failure to terminate his/her employment within such ninety (90) day period shall mean that Executive has forever waived his/her ability to resign for Good Reason with respect to the event in question.  Executive's resignation for Good Reason will only be effective if the Company has not cured or remedied the Good Reason event within thirty (30) days after its receipt of the written notice.  Such written notice must be provided to the Company within thirty (30) days of the initial existence of the purported Good Reason event and shall describe in detail the basis and underlying facts supporting Executive's belief that a Good Reason event has occurred.  Failure to timely provide such written notice to the Company means that Executive will be deemed to have consented to and irrevocably waived the potential Good Reason event.  If the Company does timely cure or remedy the Good Reason event, then Executive may either resign his/her employment without Good Reason or Executive may continue to remain employed under the then-current terms of his/her employment relationship with the Company.

 
-3-

 

1.10        "Qualifying Termination" means the termination of Executive's employment (a) by the Company without Cause, or (b) by Executive for Good Reason, and in each case, not in connection with, or in anticipation of, a Change in Control.  For the avoidance of doubt, termination of Executive's employment by the Company for Cause, or due to Executive's death, Disability or voluntary resignation, shall not constitute a Qualifying Termination.
 
1.11        "Termination Date" means Executive's last day of employment with the Company (and any Company subsidiary or affiliate) upon experiencing a Qualifying Termination and where such termination of employment constitutes a "separation from service" within the meaning of Code Section 409A.
 
2.            Termination.   If Executive experiences a Qualifying Termination, then the following subsections in this Section 2 shall apply (with Sections 2.1 and 2.2 being subject to the effectiveness of the general release of claims referenced in Section 2.4 below):
 
2.1          Executive shall receive from the Company severance pay in the aggregate that equals six months of Base Pay (determined as of the Termination Date, or, in the event of a resignation for Good Reason pursuant to Section 1.9(a), determined at the rate prior to the relevant diminution in Base Pay).  The severance pay provided by this Section 2.1 shall be paid to Executive in a single lump sum payment on the thirtieth day (30 th ) day following Executive's Termination Date (or if such 30 th day falls on a weekend or holiday, on the next following business day).  Notwithstanding the foregoing, if Executive's Qualifying Termination is determined by the Company to be part of a group termination, then the severance pay provided by this Section 2.1 shall instead be paid to Executive in a single lump sum payment on the sixtieth day (60 th ) day following Executive's Termination Date (or if such 60 th day falls on a weekend or holiday, on the next following business day).
 
2.2          For the six-month period commencing with the month following the month in which Executive's Termination Date occurs, the Company shall continue to provide to Executive all Employee Benefits which were received by, or with respect to, Executive as of the Termination Date, at the same expense to Executive as before the Termination Date subject to immediate cessation in a manner consistent with applicable law if Executive is offered comparable employee benefits coverage in connection with new employment.  For purposes of the foregoing, the Company shall provide Executive with the appropriate notice(s) informing Executive of the right to elect continuation coverage under the Company's group health plan pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985 ("COBRA"), and, in turn, Executive shall be responsible for timely electing COBRA continuation coverage following Executive's Termination Date.  Executive shall provide advance written notice to the Company informing the Company when and if Executive is offered or becomes eligible for other employee benefits in connection with new employment.  In addition, if periodically requested by the Company, Executive will provide the Company with written confirmation that he/she has not been offered other employee benefits.  The availability of Executive's continued participation in the Employee Benefits and the Company's obligation to maintain the level of Executive's share of the cost of such benefits, shall be subject to the terms and conditions of the plan documents governing the Employee Benefits.  Notwithstanding any provision in this Section 2.2, the availability of Executive's continued participation in the Employee Benefits and the Company's obligation to maintain the level of Executive's share of the cost of such benefits, shall be subject to the terms and conditions of the plan documents governing the Employee Benefits and is conditioned on the Company's ability to provide such benefits without creating a discriminatory arrangement that would subject the Company to any excise tax imposed under the Code.  To the extent that the Company's payment of COBRA premiums on behalf of Executive in accordance with this Section 2.2 would create a discriminatory arrangement that subjects the Company to any excise tax imposed under the Code, or the Company otherwise determines in its reasonable discretion that payment of COBRA premiums is impermissible or impractical, the Company shall instead provide Executive with a cash lump sum payment in an amount equal to the monthly COBRA premium that would otherwise be payable by Executive to continue the Employee Benefits multiplied by six, which shall be paid to Executive at the same time as the severance pay provided under Section 2.1 above.

 
-4-

 

2.3          As of his/her Termination Date, Executive shall also be paid for his/her accrued but unpaid salary and vacation and unreimbursed valid business expenses that were submitted in accordance with Company policies and procedures, and shall be eligible for other vested benefits pursuant to the express terms of any employee benefit plan.
 
2.4          All payments and benefits provided under Sections 2.1 and 2.2 are conditioned on and subject to Executive's continuing compliance with this Agreement and Executive's timely execution (and non-revocation and effectiveness) of a general release of claims in the form attached hereto as Exhibit A (or as may be reasonably modified by the Company in its reasonable discretion).  There is no entitlement to any payments or benefits unless and until such release of claims is effective.  Such release of claims must become effective within thirty (30) days after the Termination Date (or, in the case Executive's Qualifying Termination is determined by the Company to be part of a group termination, within sixty (60) days after the Termination Date), or else Executive will be deemed to have waived all rights to any payments or benefits under this Agreement.  In addition, if during the six-month period after the Termination Date (the "Severance Period"), Executive receives or is entitled to receive payments or benefits under the WARN Act or similar state law, the severance pay for which Executive is potentially eligible under this Agreement will be correspondingly reduced on a dollar-for-dollar basis by the amount of any such payments or benefits Executive receives or is entitled to receive during the Severance Period in a manner that complies with Code Section 409A.  If Executive has any rights to severance compensation and/or benefits upon termination of employment under any employment agreement or other Company plan, program, agreement, policy or practice, this Agreement is intended to completely supersede any such rights, and Executive shall be entitled to severance compensation and benefits only as set forth under this Agreement and not under any other arrangement with the Company.

 
-5-

 

3.            Successors and Binding Agreement .
 
3.1           The Company will require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise) to all or substantially all of the business or assets of the Company expressly to assume and agree to perform this Agreement in the same manner and to the same extent the Company would be required to perform if no such succession had taken place.  This Agreement will be binding upon and inure to the benefit of the Company and any successor to the Company, including without limitation any persons acquiring directly or indirectly all or substantially all of the business or assets of the Company whether by purchase, merger, consolidation, reorganization or otherwise (and such successor shall thereafter be deemed the "Company" for the purposes of this Agreement), but will not otherwise be assignable, transferable or delegable by the Company.
 
3.2           This Agreement will inure to the benefit of and be enforceable by Executive's personal or legal representatives, executors, administrators, successors, heirs, distributees and legatees.
 
3.3           This Agreement is personal in nature and neither of the parties hereto shall, without the consent of the other, assign, transfer or delegate this Agreement or any rights or obligations hereunder except as expressly provided in Sections 3.1 and 3.2.  Without limiting the generality or effect of the foregoing, Executive's right to receive payments hereunder will not be assignable, transferable or delegable, whether by pledge, creation of a security interest, or otherwise, other than by a transfer by Executive's will or by the laws of descent and distribution and, in the event of any attempted assignment or transfer contrary to this Section 3.3, the Company shall have no liability to pay any amount so attempted to be assigned, transferred or delegated.
 
4.            No Retention Rights.   This Agreement is not an employment agreement and does not give Executive the right to be retained by the Company (or its subsidiaries or affiliates) and Executive agrees that he/she is an employee-at-will.  The Company (or its subsidiaries or affiliates) reserves the right to terminate Executive's service as an employee at any time and for any reason.
 
5.            Notices.   For all purposes of this Agreement, all communications, including without limitation notices, consents, requests or approvals, required or permitted to be given hereunder will be in writing and will be deemed to have been duly given when hand delivered or dispatched by electronic facsimile transmission (with receipt thereof orally confirmed), or five business days after having been mailed by United States registered or certified mail, return receipt requested, postage prepaid, or three business days after having been sent by a nationally recognized overnight courier service such as FedEx or UPS addressed to the Company (to the attention of the Company's General Counsel) at its principal executive office and to Executive at his/her principal residence, or to such other address as any party may have furnished to the other in writing and in accordance herewith, except that notices of changes of address shall be effective only upon receipt.
 
6.            Validity.   If any provision of this Agreement or the application of any provision hereof to any person or circumstances is held invalid, unenforceable or otherwise illegal, the remainder of this Agreement and the application of such provision to any other person or circumstances will not be affected, and the provision so held to be invalid, unenforceable or otherwise illegal will be reformed to the extent (and only to the extent) necessary to make it enforceable, valid or legal.

 
-6-

 

7.            Governing Law.   This Agreement is governed by the laws of the State of California, without reference to the conflict of law provisions thereof.
 
8.            Miscellaneous.
 
8.1          No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing signed by Executive and the Company.  Notwithstanding the preceding sentence, the Company may terminate or amend this Agreement at any time, in whole or in part, and in any manner, and for any reason provided that the termination or amendment of this Agreement will be effective only after one (1) year advance written notice to Executive if such amendment or termination would result in a reduction of benefits that Executive would have otherwise been able to receive under the pre-amended Agreement.
 
8.2          No waiver by either party hereto at any time of any breach by the other party hereto or compliance with any condition or provision of this Agreement to be performed by such other party will be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time.
 
8.3          This Agreement constitutes the entire agreement of the parties with respect to the subject matter hereof and supersedes any and all prior agreements of the parties with respect to such subject matter.  No agreements or representations, oral or otherwise, expressed or implied with respect to the subject matter hereof have been made by either party which are not set forth expressly in this Agreement.
 
8.4          Notwithstanding any provision in this Agreement to the contrary, this Agreement shall automatically terminate without consideration upon the earlier of (a) the termination of Executive's employment with the Company for any reason other than a Qualifying Termination, or (b) a Change in Control that first occurs following the date that the parties execute this Agreement.
 
9.            Counterparts.   This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together will constitute one and the same agreement.
 
10.          Code Section 409A.   This Agreement is intended to comply with, or be exempt from, the requirements of Code Section 409A.  In the event this Agreement or any benefit paid to Executive hereunder is deemed to be subject to Code Section 409A, Executive consents to the Company adopting such conforming amendments as the Company deems necessary, in its reasonable discretion, to comply with Code Section 409A.  Each payment made pursuant to any provision of this Agreement shall be considered a separate payment and not one of a series of payments for purposes of Code Section 409A.  In addition, if upon Executive's "separation from service" within the meaning of Code Section 409A, he or she is then a "specified employee" (as defined in Code Section 409A), then only to the extent necessary to comply with Code Section 409A and avoid the imposition of taxes under Code Section 409A, the Company shall defer payment of "nonqualified deferred compensation" subject to Code Section 409A payable as a result of and within six (6) months following such "separation from service" under this Agreement until the earlier of (i) the first business day of the seventh month following Executive's "separation from service," or (ii) ten (10) days after the Company receives written notification of Executive's death.  Any such delayed payments shall be made without interest.

 
-7-

 

11.          Withholding.   All payments and benefits made under this Agreement shall be subject to reduction to reflect any withholding taxes or other amounts required by applicable law or regulation.
 
12.          Restrictive Covenants.   Executive must fully comply with the provisions specified in this Section 12 and also with all of the Company's written policies and procedures.  In addition, Executive may be required to repay to the Company certain previously paid compensation (including, without limitation, payments and benefits provided under this Agreement) in accordance with Company policies and/or applicable law in the event that Executive breaches any provision of this Agreement.
 
12.1         Nondisparagement .  Executive will not disparage the Company, its directors, officers, employees, affiliates, subsidiaries, predecessors, successors or assigns in any written or oral communications to any third party.  Executive further agrees that he/she will not direct anyone to make any disparaging oral or written remarks to any third parties.
 
12.2         Nonsolicit .  During Executive's employment with the Company and for twelve (12) months after Executive's Termination Date, Executive shall not, directly or indirectly, either as an individual or as an employee, agent, consultant, advisor, independent contractor, general partner, officer, director, stockholder, investor, lender, or in any other capacity whatsoever, of any person, firm, corporation or partnership: (i) solicit, induce, recruit or encourage any of the Company's employees or consultants to terminate their relationship with the Company, or attempt to solicit, induce, recruit, or encourage any of the Company's employees or consultants to terminate their relationship with the Company, or attempt to solicit, induce, recruit, encourage or take away employees or consultants of the Company or (ii) use the Company's trade secret information to solicit and/or negotiate with any of the Company's customers, or use such trade secret information to disrupt, damage, impair, or interfere with the Company's business.  Subject to the limitations noted herein, the Executive is not, however, restricted from being employed by or engaged in any type of business following the termination of the Executive's employment relationship with the Company.
 
12.3         Nondisclosure .  Notwithstanding any requirement that the Company may have to publicly disclose the terms of this Agreement pursuant to applicable law or regulations, Executive agrees to use reasonable efforts to maintain in confidence the existence of this Agreement, the contents and terms of this Agreement, and the consideration for this Agreement (hereinafter collectively referred to as "Agreement Information").  Executive also agrees to take every reasonable precaution to prevent disclosure of any Agreement Information to third parties, except for disclosures required by law or absolutely necessary with respect to Executive's immediate family members or personal advisors who shall also agree to maintain the confidentiality of the Agreement Information.

 
-8-

 

12.4         Confidentiality .  Executive shall not, except as required by any court or administrative agency, without the written consent of the Board or a person authorized thereby, disclose to any person, other than an employee of the Company or a person to whom disclosure is reasonably necessary or appropriate in connection with the performance by Executive or his duties to the Company, any confidential information obtained by him while in the employ of the Company with respect to any of the Company's inventions, processes, customers, methods of distribution, methods of manufacturing, attorney-client communications, pending or contemplated acquisitions, other trade secrets, or any other material which the Company is obliged to keep confidential pursuant to any confidentiality agreement or protective order; provided, however, that confidential information shall not include any information now known or which becomes known generally to the public (other than as a result of an unauthorized disclosure by Executive) or any information of a type not otherwise considered confidential by a person engaged in the same business or a business similar to that conducted by the Company.
 
12.5         Remedy for Breach .  The parties hereto agree that, in the event of breach or threatened breach of any covenants herein, the damage or imminent damage shall be inestimable, and that therefore any remedy at law or in damages shall be inadequate. Accordingly, the parties hereto agree that the Company and Executive shall be entitled to apply for injunctive relief in the event of any breach or threatened breach of any of such provisions by Executive or the Company, in addition to any other relief (including damages) available to the Company or Executive under this Agreement or under law.
 
13.          Arbitration .  The Company and Executive hereby agree that any and all disputes, claims or controversies arising out of or relating to this Agreement, the employment relationship between the parties, the termination of this Agreement or the termination of the employment relationship, that are not resolved by their mutual agreement shall be resolved by final and binding arbitration by a neutral arbitrator.  The Company and Executive further agree that this Agreement is subject to and enforceable under the provisions of the Federal Arbitration Act (the "FAA"), 9 U.S.C. § § 1 et seq .  Notwithstanding the foregoing, nothing in this provision shall prohibit or limit the parties from seeking provisional relief pursuant to California Code of Civil Procedure Section 1281.8, in each case without the necessity to post a bond or other collateral.  The selection of the arbitrator and the arbitration proceedings will be conducted in accordance with the applicable rules of the American Arbitration Association ("AAA") in effect at the time of filing of the demand for arbitration, and will take place in Los Angeles, California.   BY SIGNING THIS AGREEMENT, EXECUTIVE AND THE COMPANY HEREBY WAIVE THEIR RIGHT TO HAVE ANY DISPUTE, CLAIM OR CONTROVERSY DECIDED BY A JUDGE OR JURY IN A COURT.
 
* * * * *
 
[SIGNATURE PAGE TO SEVERANCE AGREEMENT FOLLOWS]

 
-9-

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered as of the date first above written.  By signing below, Executive acknowledges that he/she (i) has received a copy of this Agreement, (ii) is voluntarily entering into this Agreement and (iii) is agreeing to be bound by the terms of this Agreement.
 
 
"COMPANY"
   
 
STAAR SURGICAL COMPANY
   
 
By:
 
   
 
Its:
 
   
 
"EXECUTIVE"
   
 
  
 
[Print Name]
 
E

 
-10-

 

EXHIBIT A
 
GENERAL RELEASE OF CLAIMS

 
Exhibit A

 

GENERAL RELEASE OF CLAIMS
 
I, _________________________ (hereinafter referred to as the "Releasing Party"), do as follows in consideration for STAAR Surgical Company's agreement to provide me with the payments and benefits referenced in the "STAAR Surgical Company Severance Agreement" to which this Release is attached, less applicable payroll deductions, which I acknowledge is consideration beyond that to which I am otherwise entitled:
 
1.           Fully release and discharge forever STAAR Surgical Company and its agents, employees, officers, directors, trustees, representatives, owners, attorneys, subsidiaries, related corporations, assigns, successors, and affiliated organizations (hereafter referred to collectively as the "Released Parties"), and each and all of them, from any and all liabilities, claims, causes of action, charges, complaints, obligations, costs, losses, damages, injuries, attorneys' fees, and other legal responsibilities, of any form whatsoever, whether known or unknown, unforeseen, unanticipated, unsuspected or latent, which Releasing Party or Releasing Party's heirs, administrators, executors, successors in interest, and/or assigns have incurred or expect to incur, or now own or hold, or have at any time heretofore owned or held, or may at any time own, hold, or claim to hold by reason of any matter or thing arising from any cause whatsoever prior to the date of the Releasing Party's execution of this Release.
 
2.           Without limiting the generality of the foregoing, and by way of example only, I fully release and discharge each and all of the Released Parties from any and all claims, demands, rights, and causes of action that have been or could be alleged against any of said Released Parties (a) in connection with my employment, prior employment agreements, or the termination of such employment; (b) in connection with any and all matters pertaining to my employment by any of the Released Parties, including, but not limited to, any and all compensation, salaries, wages, bonuses, commissions, overtime, monies, pay, allowances, benefits, sick pay, severance pay, retention pay or benefits, paid leave benefits, vacation pay, penalties, interest, damages, and promises on any and all of the above; and (c) under or in connection with the state and federal age discrimination laws, as explained further in Section 3 below.  Notwithstanding the foregoing, this Release does not apply to any claims that cannot be released as a matter of law.
 
3.           Without limiting the scope of this Release in any way, I also certify that this Release constitutes a knowing and voluntary waiver of any and all rights or claims that exist or that I have or may claim to have under the Federal Age Discrimination in Employment Act ("ADEA"), as amended by the Older Workers Benefit Protection Act of 1990 ("OWBPA"), which is set forth at 29 U.S.C. § § 621, et seq .  This Release does not govern any rights or claims that may arise under the ADEA after the date this Release is signed by the Releasing Party.

 
-1-

 

4.           This Release extends to any and all claims including, but not limited to, any alleged (a) violation of the National Labor Relations Act, Title VII of the Civil Rights Act, the California Fair Employment and Housing Act, the Americans With Disabilities Act of 1990, the ADEA, as amended by the OWBPA, the Fair Labor Standards Act, the California Labor Code, the applicable California Wage Order, the California Private Attorneys General Act, the Occupational Safety and Health Act, the Consolidated Omnibus Budget Reconciliation Act of 1985; (b) discrimination on the basis of national origin, sex, race, religion, age, disability, marital status, or any other characteristic protected by law, breach of any express or implied employment contract or agreement, wrongful discharge, breach of the implied covenant of good faith and fair dealing, intentional or negligent infliction of emotional distress, fraud, retaliation, misrepresentation, defamation, interference with prospective economic advantage, failure to pay wages due or other monies owed; and (c) any other violation of any local, state or federal law, regulation or ordinance and/or public policy, contract, or tort or common law claim having any bearing whatsoever on the terms and conditions of employment with any of the Released Parties, including, but not limited to, any allegations for costs, fees, including attorneys' fees, incurred in any of these matters, which the Releasing Party ever had, now has, or may have as of the date of this Release.  Notwithstanding the foregoing, this Release does not apply to any claims that cannot be released as a matter of law.
 
5.           Acknowledge that I have been fully compensated for all labor and services performed for the Released Parties and have been reimbursed for all business expenses incurred on behalf of the Released Parties through the date I signed this Release, and that the Released Parties do not owe me any expense reimbursement amounts or any wages, including any vacation, paid time off benefits, or sick pay.
 
6.           Acknowledge that this Release constitutes written notice that the Releasing Party has been advised to consult with an attorney prior to executing this Release and that the Releasing Party has carefully considered other alternatives to executing this Release.
 
7.           Waive any right that I may have to re-employment by the Released Parties and agree that I have no expectation or intent for re-employment with the Released Parties.
 
8.           Agree not to damage, disparage, disrupt or interfere with the Released Parties' business or to undermine, in any way, the Released Parties' relationships or potential relationships with any actual or prospective employee, vendor or customer.  The Releasing Party further agrees not to make critical, negative or disparaging remarks about the Released Parties or their services or products.  The Releasing Party understands and agrees that any violation of this provision shall be a material breach of this Release.
 
9.           Understand that the aforementioned consideration is not to be construed as an admission on the part of said Released Parties of any liability whatsoever and that the Released Parties deny that they have engaged in any wrongdoing or have any liability whatsoever.
 
10.         Understand that the Released Parties dispute that any amounts whatsoever are owed to the Releasing Party, but wish to avoid the disruption, inconvenience, and the administrative, legal, and other costs associated with any litigation or other claims by the Releasing Party.  Accordingly, the RELEASING  PARTY AGREES  NOT TO DISCLOSE, PUBLICIZE OR ALLOW OR CAUSE TO BE PUBLICIZED OR DISCLOSED ANY OF THE TERMS AND CONDITIONS OF THIS RELEASE, THE SETTLEMENT, OR THAT THIS OR ANY SETTLEMENT OR RELEASE HAS BEEN ENTERED INTO, EXCEPT FOR DISCLOSURES TO THE RELEASING PARTY'S SPOUSE AND TAX CONSULTANT, UNLESS SUCH PUBLICATION OR DISCLOSURE IS REQUIRED OR COMPELLED BY LAW OR IS NECESSARY TO ENFORCE THIS RELEASE.

 
-2-

 

11.         Acknowledge that in the event of a lawsuit in which any party claims a breach of this Release, the prevailing party shall be entitled to reasonable attorneys' fees and costs.
 
12.         Agree to return all amounts paid pursuant to this Release and to indemnify and hold harmless each of the Released Parties for and against any and all costs, losses or liability, whatsoever, including reasonable attorneys' fees, caused by my breach of the non-disclosure or non-publicity provisions contained herein.  Furthermore, the Releasing Party agrees that the return or obligation to return any amounts paid pursuant to this Release due to the Releasing Party's breach of the non-disclosure or non-publicity provisions of this Release will not abrogate or affect in any way the Releasing Party's full release of any and all claims against the Released Parties.
 
13.         Except as otherwise provided for herein, the Releasing Party expressly releases any and all claims, damages, and causes of action whatsoever, of whatever kind or nature, whether known or unknown, or suspected or unsuspected, against the Released Parties.  The Releasing Party understands that this Release SHALL APPLY TO ALL UNKNOWN OR UNANTICIPATED CLAIMS, DAMAGES AND CAUSES OF ACTION, AS WELL AS THOSE KNOWN AND ANTICIPATED, and does hereby waive any and all rights under Section 1542 of the California Civil Code , which reads as follows:
 
Section 1542. A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known to him or her must have materially affected his or her settlement with the debtor.
 
14.         Understand and agree that the Releasing Party will not, for any reason, disclose to others or use for the benefit of anyone other than the Released Parties any trade secret, confidential or proprietary information of the Released Parties, including, but not limited to, information relating to the Released Parties' customers, clients, employees, consultants, affiliates, products, know-how, techniques, computer systems, programs, policies and procedures, research projects, future developments, costs, profits, pricing, customer and client business information.  The Releasing Party further understands and agrees that the use of any trade secret, confidential or proprietary information belonging to the Released Parties shall be a material breach of this Release.  The Releasing Party further certifies that he or she will not keep in his or her possession or under his or her control any specifications, formulae, notes, reports, proposals, correspondence, customer lists, sales bulletins, pricing information, planning documents, or copies of them, or any other property of the Released Parties.  The Releasing Party will return all such documents and property to the company after his or her separation from the company, and not later than 72 hours after this Release is executed.
 
15.         Acknowledge that I am aware of my right to revoke this Release at any time within the seven-day period following the date I sign it and that the Release shall not become effective or enforceable until the seven-day revocation period expires.  Revocation may be accomplished by providing written notice to:
 
STAAR Surgical Company
Attn:  Charles Kaufman

 
-3-

 

1911 Walker Avenue
Monrovia, CA 91016

I understand that I will relinquish any right I have to the consideration specified in this Release if I exercise my right to revoke it.
 
16.         Acknowledge that I am relying solely upon the contents of this Release and am not relying on any other representations whatsoever of the Released Parties as an inducement to enter into this agreement and Release.
 
17.         The Releasing Party further acknowledges that the Releasing Party (a) has read this Release, including Attachment "1", (b) has been provided a full and ample opportunity to study it, including a period of at least 45 days within which to consider it (although the Releasing Party may voluntarily choose to execute the Release earlier), (c) has been advised in writing to consult with an attorney prior to signing it, and (d) is signing it voluntarily with full knowledge that it is intended, to the maximum extent permitted by law, as a complete release and waiver of any and all claims.
 
Dated:   
  
 
  
     
(Executive)
       
Dated:
  
 
  
   
Charles Kaufman
   
for STAAR Surgical Company
 
 
-4-

 

ATTACHMENT 1
 
[OWBPA Informational Disclosure]

 
-5-

 
 

Exhibit 10.89
 
STAAR SURGICAL COMPANY
FORM OF EXECUTIVE CHANGE IN CONTROL AGREEMENT
 
THIS CHANGE IN CONTROL AGREEMENT (this "Agreement"), dated as of ________________, is made by and between STAAR Surgical Company, a Delaware corporation (the "Company"), and ____________________ ("Executive").
 
WITNESSETH :
 
WHEREAS, Executive is an executive of the Company and has made and is expected to continue to make significant contributions to the short- and long-term profitability, growth and financial strength of the Company;
 
WHEREAS, the Company recognizes that, as is the case for most publicly-held companies, the possibility of a Change in Control exists;
 
WHEREAS, the Company desires to assure itself of both present and future continuity of management and desires to establish certain severance benefits for valued executives such as Executive, applicable in the event of a Change in Control;
 
WHEREAS, the Company wishes to ensure that Executive is not practically disabled from discharging his or her duties in respect of a proposed or actual transaction involving a Change in Control;
 
WHEREAS, the Company desires to provide additional inducement for Executive to continue to remain in the employ of the Company; and
 
WHEREAS, the Company and Executive acknowledge and agree that this Agreement replaces and supersedes any other prior agreements, arrangements and understandings, written or oral, between them concerning Executive's rights to receive severance compensation and/or benefits from the Company in the context of a Change in Control.
 
NOW, THEREFORE, the Company and Executive agree as follows:
 
1.            Certain Defined Terms.   In addition to terms defined elsewhere herein, the following terms have the following meanings when used in this Agreement with initial capital letters:
 
1.1         "Base Pay" means Executive's annual base salary rate as in effect from time to time.
 
1.2         "Board" means the Company's Board of Directors.
 
1.3         "Cause" means any of the following, each as determined in the discretion of the Company's (or its successor's) Board:
 
(a)           any willful breach or habitual neglect of the duties which Executive is required to perform;
 
 
 

 

(b)           any act of dishonesty, fraud, insubordination, misrepresentation, gross negligence or willful misconduct;
 
(c)           conviction of a felony; or
 
(d)           intentional violation of any Company policy.
 
Notwithstanding the foregoing, no act or failure to act on Executive's part will be deemed "willful" unless done, or omitted to be done, by Executive not in good faith and without reasonable belief that the action or omission was in the best interest of the Company.
 
1.4         "Change in Control" means the occurrence of any one (or more) of the following events:
 
(a)           any person, including a group as defined in Section 13(d)(3) of the Exchange Act, but excluding Broadwood Partners, L.P. or a group of which it is a member, becomes the beneficial owner of stock of the Company with respect to which twenty-five percent (25%) or more of the total number of votes for the election of the Board may be cast;
 
(b)           as a result of, or in connection with, any cash tender offer, exchange offer, merger or other business combination, sale of assets or contested election, or combination of the foregoing, persons who were directors of the Company just prior to such event shall cease to constitute a majority of the Board;
 
(c)           the stockholders of the Company shall approve an agreement providing either for a transaction in which the Company will cease to be an independent publicly owned corporation or for a sale or other disposition of all or substantially all the assets of the Company;
 
(d)           acquisition in a single or series of related transactions, including without limitation a tender offer or exchange offer, by any person or related group of persons (other than the Company or by a Company-sponsored employee benefit plan), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than fifty percent (50%) of the total combined voting power of the Company's outstanding securities; or
 
(e)           any other event that a majority of the incumbent Board in its sole discretion determines to be a Change in Control.
 
Notwithstanding the foregoing, the formation of a holding company for the Company in which the stockholdings of the holding company after its formation are substantially the same as for the Company prior to the holding company formation does not constitute a Change in Control for purposes of this Agreement.
 
1.5         "Code" means the Internal Revenue Code of 1986, as amended.

 
-2-

 
 
1.6         "Disability" means that Executive is (a) unable to perform the essential functions of his or her position, with or without reasonable accommodation, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, or (b) by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, and is receiving income replacement benefits for a period of not less than three months under an accident and health plan covering the Company's employees, or (c) determined to be totally disabled by the Social Security Administration, as interpreted by the Company in its discretion, or (d) deemed to be disabled in accordance with the applicable disability insurance program of the Company, provided that the definition of "disability" applied under such disability insurance program complies with the requirements of this Section, as determined by the Company in its discretion.  A determination that Executive has a Disability shall not be arbitrary or unreasonable and the Company, in making such determination, shall take into consideration the opinion of Executive's personal physician, if reasonably available, and any other physician deemed appropriate by the Company, but such determination by the Company shall be final and binding on the parties hereto.  The Company will provide all applicable legally-required leaves to Executive, which shall be provided on an unpaid basis unless pay is otherwise required under applicable law.  This provision shall be interpreted and applied in a manner consistent with all applicable laws, including laws regarding workers' compensation, disability, and family and medical leave laws.
 
1.7         "Earned Bonus Amount" means an amount equal to the greater of (A) the annual bonus earned by Executive for the Company's fiscal year immediately preceding the Termination Year, prorated for the portion of the Termination Year that elapsed prior to the Termination Date (unless the Termination Date occurs prior to the Company’s payment of earned bonuses for the year immediately preceding the Termination Year, in which case no proration will be necessary) and (B) the amount of bonus accrued for the Executive for accounting purposes in the Termination Year.  Notwithstanding the foregoing, if the Executive was not employed by the Company in the fiscal year preceding the Termination Year, the Earned Bonus Amount shall be the Executive's target bonus in the Termination Year, reduced or increased by any Company performance factor generally applied to executive bonuses in the preceding fiscal year and prorated for the portion of the Termination Year that elapsed prior to the Termination Date; provided, that, if the Executive was employed for part of the fiscal year preceding the Termination Year the Earned Bonus Amount shall be the annualized amount of any bonus earned for such preceding fiscal year, prorated for the portion of the Termination Year that elapsed prior to the Termination Date (unless the Termination Date occurs prior to the Company’s payment of earned bonuses for the year immediately preceding the Termination Year, in which case no proration will be necessary).
 
1.8         "Employee Benefits" means any Company-sponsored group health and dental insurance plans that are provided to Executive as of the Termination Date.  For the avoidance of doubt, Employee Benefits shall not include contributions made by the Company to any retirement plan, pension plan or profit sharing plan for the benefit of Executive in connection with amounts earned by Executive.
 
1.9         "Exchange Act" means the Securities Exchange Act of 1934, as amended.
 
 
-3-

 
 
1.10       "Good Reason" means that one or more of the following have occurred without Executive's written consent:
 
(a)           Executive has experienced a material diminution in Base Pay after the Company's public announcement of a Change in Control;
 
(b)           Executive has experienced a material diminution in his/her authority, duties, responsibilities, or reporting structure as in effect immediately prior to the Company's public announcement of a Change in Control;
 
(c)           Executive has been notified that he/she will experience a material change in the geographic location at which he/she must perform his/her services to the Company after a Change in Control; or
 
(d)           The Company has materially breached this Agreement, provided that the effective date of any such material breach cannot occur until on or after a Change in Control.
 
For purposes of this Agreement, Executive must tender any resignation from the Company for "Good Reason" within ninety (90) days after the date that any one of the events shown above in (a) through (d) has first occurred without Executive's written consent within twelve (12) months following the Change in Control.  Failure to terminate his/her employment within such ninety (90) day period shall mean that Executive has forever waived his/her ability to resign for Good Reason with respect to the event in question.  Executive's resignation for Good Reason will only be effective if the Company has not cured or remedied the Good Reason event within thirty (30) days after its receipt of the written notice.  Such written notice must be provided to the Company within thirty (30) days of the initial existence of the purported Good Reason event and shall describe in detail the basis and underlying facts supporting Executive's belief that a Good Reason event has occurred.  Failure to timely provide such written notice to the Company means that Executive will be deemed to have consented to and irrevocably waived the potential Good Reason event.  If the Company does timely cure or remedy the Good Reason event, then Executive may either resign his/her employment without Good Reason or Executive may continue to remain employed subject to the terms of this Agreement.
 
1.11       "Qualifying Termination" means that Executive's employment with the Company is either (i) terminated by the Company without Cause within twelve (12) months following a Change in Control, or (ii) terminated by Executive for Good Reason within fifteen (15) months following a Change in Control.  Notwithstanding anything contained in this Agreement to the contrary, if Executive's employment is terminated without Cause or for Good Reason prior to a Change in Control, and the Board determines that such termination or Good Reason event (i) was at the request of a third party who has indicated an intention or taken steps reasonably calculated to effect a Change in Control and who subsequently effectuates a Change in Control or (ii) otherwise occurred in connection with, or in anticipation of, a Change in Control which actually occurs, then, for all purposes of this Agreement, the date of a Change in Control with respect to Executive shall mean the date immediately prior to the date of such termination of Executive's employment or Good Reason event, as applicable.  For the avoidance of doubt, termination of Executive's employment by the Company for Cause, or due to Executive's death, Disability or voluntary resignation, shall not constitute a Qualifying Termination.
 
 
-4-

 
 
1.12       "Target Bonus Amount" means Executive's potential bonus under any bonus plan of the Company, assuming 100% achievement of Company and individual performance criteria.
 
1.13       "Termination Date" means Executive's last day of employment with the Company (and any Company subsidiary or affiliate) upon experiencing a Qualifying Termination and where such termination of employment constitutes a "separation from service" within the meaning of Code Section 409A.
 
2.            Termination.   If Executive experiences a Qualifying Termination, then the following subsections in this Section 2 shall apply (with Sections 2.1 and 2.2 being subject to the effectiveness of the general release of claims referenced in Section 2.5 below):
 
2.1         Executive shall receive from the Company severance pay in the aggregate that equals (i) twelve months of Base Pay (at the greater of the rate on the Termination Date, or the rate on the date immediately prior to the Company's public announcement of the Change in Control), plus (ii) the Earned Bonus Amount, plus (iii) the Target Bonus Amount.  The severance pay provided by this Section 2.1 shall be paid to Executive in a single lump sum payment on the thirtieth day (30 th ) day following Executive's Termination Date (or if such 30 th day falls on a weekend or holiday, on the next following business day).  Notwithstanding the foregoing, if Executive's Qualifying Termination is determined by the Company to be part of a group termination, then the severance pay provided by this Section 2.1 shall instead be paid to Executive in a single lump sum payment on the sixtieth day (60 th ) day following Executive's Termination Date (or if such 60 th day falls on a weekend or holiday, on the next following business day).
 
2.2         For the twelve-month period commencing with the month following the month in which Executive's Termination Date occurs, the Company shall continue to provide to Executive all Employee Benefits which were received by, or with respect to, Executive as of the Termination Date, at the same expense to Executive as before the Termination Date subject to immediate cessation in a manner consistent with applicable law if Executive is offered comparable employee benefits coverage in connection with new employment.  For purposes of the foregoing, the Company shall provide Executive with the appropriate notice(s) informing Executive of the right to elect continuation coverage under the Company's group health plan pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985 ("COBRA"), and, in turn, Executive shall be responsible for timely electing COBRA continuation coverage following Executive's Termination Date.  Executive shall provide advance written notice to the Company informing the Company when and if Executive is offered or becomes eligible for other employee benefits in connection with new employment.  In addition, if periodically requested by the Company, Executive will provide the Company with written confirmation that he/she has not been offered other employee benefits.  The availability of Executive's continued participation in the Employee Benefits and the Company's obligation to maintain the level of Executive's share of the cost of such benefits, shall be subject to the terms and conditions of the plan documents governing the Employee Benefits.  Notwithstanding any provision in this Section 2.2, the availability of Executive's continued participation in the Employee Benefits and the Company's obligation to maintain the level of Executive's share of the cost of such benefits, shall be subject to the terms and conditions of the plan documents governing the Employee Benefits and is conditioned on the Company's ability to provide such benefits without creating a discriminatory arrangement that would subject the Company to any excise tax imposed under the Code.  To the extent that the Company's payment of COBRA premiums on behalf of Executive in accordance with this Section 2.2 would create a discriminatory arrangement that subjects the Company to any excise tax imposed under the Code, or the Company otherwise determines in its reasonable discretion that payment of COBRA premiums is impermissible or impractical, the Company shall instead provide Executive with a cash lump sum payment in an amount equal to the monthly COBRA premium that would otherwise be payable by Executive to continue the Employee Benefits multiplied by twelve, which shall be paid to Executive at the same time as the severance pay provided under Section 2.1 above.
 
 
-5-

 
 
2.3         As of his/her Termination Date, Executive shall also be paid for his/her accrued but unpaid salary and vacation and unreimbursed valid business expenses that were submitted in accordance with Company policies and procedures, and shall be eligible for other vested benefits pursuant to the express terms of any employee benefit plan.
 
2.4         In the event that it is determined that any payment or distribution of any type to or for the benefit of Executive made by the Company, by any of its affiliates, by any person who acquires ownership or effective control of the Company or ownership of a substantial portion of the Company's assets (within the meaning of Code Section 280G, and the regulations thereunder) or by any affiliate of such person, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (the "Total Payments"), would be subject to the excise tax imposed by Code Section 4999 or any interest or penalties with respect to such excise tax (such excise tax, together with any such interest or penalties, are collectively referred to as the "Excise Tax"), then such payments or distributions shall be payable either in (x) full or (y) as to such lesser amount which would result in no portion of such payments or distributions being subject to the Excise Tax and Executive shall receive the greater, on an after-tax basis, of (x) or (y) above.  In order to produce the best possible after-tax result, for Executive, Executive hereby agrees to the reduction of any payments or benefits under this Agreement, as well as any other payments or benefits provided for under agreements entered into between Executive and the Company that are included in the calculation of the Total Payments, such as, for example, the accelerated vesting of equity awards.  If a reduction in the Total Payments constituting "parachute payments" is necessary so that no portion of such Total Payments is subject to the excise tax under Section 4999 of the Code, the reduction shall occur in the following order: (1) reduction of cash payments for which the full amount is treated as a parachute payment; (2) cancellation of any accelerated vesting of equity awards; and (3) reduction of any continued employee benefits.  In selecting the equity awards (if any) for which vesting will be reduced under clause (2) of the preceding sentence, awards shall be selected in a manner that maximizes the after-tax aggregate amount of Total Payments provided to Executive, provided that if (and only if) necessary in order to avoid the imposition of an additional tax under Section 409A of the Code, awards instead shall be selected in the reverse order of the date of grant.  For the avoidance of doubt, for purposes of measuring an equity compensation award's value to Executive when performing the foregoing comparison between (x) and (y) above, such award's value shall equal the then aggregate fair market value of the vested shares underlying the award less any aggregate exercise price less applicable taxes.  Also, if two or more equity awards are granted on the same date, each award will be reduced on a pro-rata basis.  In no event shall the Executive have any discretion with respect to the ordering of payment reductions.  All mathematical determinations and all determinations of whether any of the Total Payments are "parachute payments" (within the meaning of Code Section 280G) that are required to be made under this Section 2.4, shall be made by a nationally recognized independent audit firm not currently retained by the Company most recently prior to the Change in Control (the "Accountants"), who shall provide their determination, together with detailed supporting calculations regarding the amount of any relevant matters, both to the Company and to Executive within seven (7) business days of Executive's Termination Date, if applicable, or such earlier time as is requested by the Company.  Such determination shall be made by the Accountants using reasonable good faith interpretations of the Code.  Any determination by the Accountants shall be binding upon the Company and Executive, absent manifest error.  The Company shall pay the fees and costs of the Accountants which are incurred in connection with this Section 2.4.

 
-6-

 
 
2.5         All payments and benefits provided under Sections 2.1 and 2.2 are conditioned on and subject to Executive's continuing compliance with this Agreement and Executive's timely execution (and non-revocation and effectiveness) of a general release of claims in the form attached hereto as Exhibit A (or as may be reasonably modified by the Company in its reasonable discretion).  There is no entitlement to any payments or benefits unless and until such release of claims is effective.  Such release of claims must become effective within thirty (30) days after the Termination Date (or, in the case Executive's Qualifying Termination is determined by the Company to be part of a group termination, within sixty (60) days after the Termination Date), or else Executive will be deemed to have waived all rights to any payments or benefits under this Agreement.  In addition, if during the twelve-month period after the Termination Date (the "Severance Period"), Executive receives or is entitled to receive payments or benefits under the WARN Act or similar state law, the severance pay for which Executive is potentially eligible under this Agreement will be correspondingly reduced on a dollar-for-dollar basis by the amount of any such payments or benefits Executive receives or is entitled to receive during the Severance Period in a manner that complies with Code Section 409A.  If Executive has any rights to severance compensation and/or benefits upon termination of employment under any employment agreement or other Company plan, program, agreement, policy or practice, this Agreement is intended to completely supersede any such rights, and Executive shall be entitled to severance compensation and benefits only as set forth under this Agreement and not under any other arrangement with the Company.
 
3.            Successors and Binding Agreement .
 
3.1           The Company will require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise) to all or substantially all of the business or assets of the Company expressly to assume and agree to perform this Agreement in the same manner and to the same extent the Company would be required to perform if no such succession had taken place.  This Agreement will be binding upon and inure to the benefit of the Company and any successor to the Company, including without limitation any persons acquiring directly or indirectly all or substantially all of the business or assets of the Company whether by purchase, merger, consolidation, reorganization or otherwise (and such successor shall thereafter be deemed the "Company" for the purposes of this Agreement), but will not otherwise be assignable, transferable or delegable by the Company.
 
 
-7-

 
 
3.2         This Agreement will inure to the benefit of and be enforceable by Executive's personal or legal representatives, executors, administrators, successors, heirs, distributees and legatees.
 
3.3         This Agreement is personal in nature and neither of the parties hereto shall, without the consent of the other, assign, transfer or delegate this Agreement or any rights or obligations hereunder except as expressly provided in Sections 3.1 and 3.2.  Without limiting the generality or effect of the foregoing, Executive's right to receive payments hereunder will not be assignable, transferable or delegable, whether by pledge, creation of a security interest, or otherwise, other than by a transfer by Executive's will or by the laws of descent and distribution and, in the event of any attempted assignment or transfer contrary to this Section 3.3, the Company shall have no liability to pay any amount so attempted to be assigned, transferred or delegated.
 
4.            No Retention Rights.   This Agreement is not an employment agreement and does not give Executive the right to be retained by the Company (or its subsidiaries or affiliates) and Executive agrees that he/she is an employee-at-will.  The Company (or its subsidiaries or affiliates) reserves the right to terminate Executive's service as an employee at any time and for any reason.
 
5.            Notices.   For all purposes of this Agreement, all communications, including without limitation notices, consents, requests or approvals, required or permitted to be given hereunder will be in writing and will be deemed to have been duly given when hand delivered or dispatched by electronic facsimile transmission (with receipt thereof orally confirmed), or five business days after having been mailed by United States registered or certified mail, return receipt requested, postage prepaid, or three business days after having been sent by a nationally recognized overnight courier service such as FedEx or UPS addressed to the Company (to the attention of the Company's General Counsel) at its principal executive office and to Executive at his/her principal residence, or to such other address as any party may have furnished to the other in writing and in accordance herewith, except that notices of changes of address shall be effective only upon receipt.
 
6.            Validity.   If any provision of this Agreement or the application of any provision hereof to any person or circumstances is held invalid, unenforceable or otherwise illegal, the remainder of this Agreement and the application of such provision to any other person or circumstances will not be affected, and the provision so held to be invalid, unenforceable or otherwise illegal will be reformed to the extent (and only to the extent) necessary to make it enforceable, valid or legal.
 
7.            Governing Law.   This Agreement is governed by the laws of the State of California, without reference to the conflict of law provisions thereof.
 
 
-8-

 

8.           Miscellaneous.
 
8.1         No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing signed by Executive and the Company.  Notwithstanding the preceding sentence, the Company may terminate or amend this Agreement at any time, in whole or in part, and in any manner, and for any reason provided that the termination or amendment of this Agreement will be effective only after one (1) year advance written notice to Executive if such amendment or termination would result in a reduction of benefits that Executive would have otherwise been able to receive under the pre-amended Agreement.
 
8.2         No waiver by either party hereto at any time of any breach by the other party hereto or compliance with any condition or provision of this Agreement to be performed by such other party will be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time.
 
8.3         This Agreement constitutes the entire agreement of the parties with respect to the subject matter hereof and supersedes any and all prior agreements of the parties with respect to such subject matter.  No agreements or representations, oral or otherwise, expressed or implied with respect to the subject matter hereof have been made by either party which are not set forth expressly in this Agreement.
 
8.4         Notwithstanding any provision in this Agreement to the contrary, this Agreement shall automatically terminate without consideration upon the termination of Executive's employment with the Company for any reason other than a Qualifying Termination.
 
9.           Counterparts.   This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together will constitute one and the same agreement.
 
10.         Code Section 409A.   This Agreement is intended to comply with, or be exempt from, the requirements of Code Section 409A.  In the event this Agreement or any benefit paid to Executive hereunder is deemed to be subject to Code Section 409A, Executive consents to the Company adopting such conforming amendments as the Company deems necessary, in its reasonable discretion, to comply with Code Section 409A.  Each payment made pursuant to any provision of this Agreement shall be considered a separate payment and not one of a series of payments for purposes of Code Section 409A.  In addition, if upon Executive's "separation from service" within the meaning of Code Section 409A, he or she is then a "specified employee" (as defined in Code Section 409A), then only to the extent necessary to comply with Code Section 409A and avoid the imposition of taxes under Code Section 409A, the Company shall defer payment of "nonqualified deferred compensation" subject to Code Section 409A payable as a result of and within six (6) months following such "separation from service" under this Agreement until the earlier of (i) the first business day of the seventh month following Executive's "separation from service," or (ii) ten (10) days after the Company receives written notification of Executive's death.  Any such delayed payments shall be made without interest.
 
11.         Withholding.   All payments and benefits made under this Agreement shall be subject to reduction to reflect any withholding taxes or other amounts required by applicable law or regulation.
 
 
-9-

 
 
12.          Restrictive Covenants.   Executive must fully comply with the provisions specified in this Section 12 and also with all of the Company's written policies and procedures.  In addition, Executive may be required to repay to the Company certain previously paid compensation (including, without limitation, payments and benefits provided under this Agreement) in accordance with Company policies and/or applicable law in the event that Executive breaches any provision of this Agreement.
 
12.1        Nondisparagement .  Executive will not disparage the Company, its directors, officers, employees, affiliates, subsidiaries, predecessors, successors or assigns in any written or oral communications to any third party.  Executive further agrees that he/she will not direct anyone to make any disparaging oral or written remarks to any third parties.
 
12.2        Nonsolicit .  During Executive's employment with the Company and for twelve (12) months after Executive's Termination Date, Executive shall not, directly or indirectly, either as an individual or as an employee, agent, consultant, advisor, independent contractor, general partner, officer, director, stockholder, investor, lender, or in any other capacity whatsoever, of any person, firm, corporation or partnership: (i) solicit, induce, recruit or encourage any of the Company's employees or consultants to terminate their relationship with the Company, or attempt to solicit, induce, recruit, or encourage any of the Company's employees or consultants to terminate their relationship with the Company, or attempt to solicit, induce, recruit, encourage or take away employees or consultants of the Company or (ii) use the Company's trade secret information to solicit and/or negotiate with any of the Company's customers, or use such trade secret information to disrupt, damage, impair, or interfere with the Company's business.  Subject to the limitations noted herein, the Executive is not, however, restricted from being employed by or engaged in any type of business following the termination of the Executive's employment relationship with the Company.
 
12.3        Nondisclosure .  Notwithstanding any requirement that the Company may have to publicly disclose the terms of this Agreement pursuant to applicable law or regulations, Executive agrees to use reasonable efforts to maintain in confidence the existence of this Agreement, the contents and terms of this Agreement, and the consideration for this Agreement (hereinafter collectively referred to as "Agreement Information").  Executive also agrees to take every reasonable precaution to prevent disclosure of any Agreement Information to third parties, except for disclosures required by law or absolutely necessary with respect to Executive's immediate family members or personal advisors who shall also agree to maintain the confidentiality of the Agreement Information.
 
12.4        Confidentiality .  Executive shall not, except as required by any court or administrative agency, without the written consent of the Board or a person authorized thereby, disclose to any person, other than an employee of the Company or a person to whom disclosure is reasonably necessary or appropriate in connection with the performance by Executive or his duties to the Company, any confidential information obtained by him while in the employ of the Company with respect to any of the Company's inventions, processes, customers, methods of distribution, methods of manufacturing, attorney-client communications, pending or contemplated acquisitions, other trade secrets, or any other material which the Company is obliged to keep confidential pursuant to any confidentiality agreement or protective order; provided, however, that confidential information shall not include any information now known or which becomes known generally to the public (other than as a result of an unauthorized disclosure by Executive) or any information of a type not otherwise considered confidential by a person engaged in the same business or a business similar to that conducted by the Company.
 
 
-10-

 
 
12.5        Remedy for Breach .  The parties hereto agree that, in the event of breach or threatened breach of any covenants herein, the damage or imminent damage shall be inestimable, and that therefore any remedy at law or in damages shall be inadequate. Accordingly, the parties hereto agree that the Company and Executive shall be entitled to apply for injunctive relief in the event of any breach or threatened breach of any of such provisions by Executive or the Company, in addition to any other relief (including damages) available to the Company or Executive under this Agreement or under law.
 
13.          Arbitration .  The Company and Executive hereby agree that any and all disputes, claims or controversies arising out of or relating to this Agreement, the employment relationship between the parties, the termination of this Agreement or the termination of the employment relationship, that are not resolved by their mutual agreement shall be resolved by final and binding arbitration by a neutral arbitrator.  The Company and Executive further agree that this Agreement is subject to and enforceable under the provisions of the Federal Arbitration Act (the "FAA"), 9 U.S.C. § § 1 et seq .  Notwithstanding the foregoing, nothing in this provision shall prohibit or limit the parties from seeking provisional relief pursuant to California Code of Civil Procedure Section 1281.8, in each case without the necessity to post a bond or other collateral.  The selection of the arbitrator and the arbitration proceedings will be conducted in accordance with the applicable rules of the American Arbitration Association ("AAA") in effect at the time of filing of the demand for arbitration, and will take place in Los Angeles, California.   BY SIGNING THIS AGREEMENT, EXECUTIVE AND THE COMPANY HEREBY WAIVE THEIR RIGHT TO HAVE ANY DISPUTE, CLAIM OR CONTROVERSY DECIDED BY A JUDGE OR JURY IN A COURT.
 
* * * * *
 
[SIGNATURE PAGE TO CHANGE IN CONTROL AGREEMENT FOLLOWS]
 
 
-11-

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed and delivered as of the date first above written.  By signing below, Executive acknowledges that he/she (i) has received a copy of this Agreement, (ii) is voluntarily entering into this Agreement and (iii) is agreeing to be bound by the terms of this Agreement.
 
 
"COMPANY"
   
 
STAAR SURGICAL COMPANY
   
 
By:
   
     
 
Its:
   
   
 
"EXECUTIVE"
   
      
 
[Print Name]
 
 
-12-

 

EXHIBIT A
 
GENERAL RELEASE OF CLAIMS
 
 
Exhibit A

 

GENERAL RELEASE OF CLAIMS
 
I, _________________________ (hereinafter referred to as the "Releasing Party"), do as follows in consideration for STAAR Surgical Company's agreement to provide me with the payments and benefits referenced in the "STAAR Surgical Company Change in Control Agreement" to which this Release is attached, less applicable payroll deductions, which I acknowledge is consideration beyond that to which I am otherwise entitled:
 
1.           Fully release and discharge forever STAAR Surgical Company and its agents, employees, officers, directors, trustees, representatives, owners, attorneys, subsidiaries, related corporations, assigns, successors, and affiliated organizations (hereafter referred to collectively as the "Released Parties"), and each and all of them, from any and all liabilities, claims, causes of action, charges, complaints, obligations, costs, losses, damages, injuries, attorneys' fees, and other legal responsibilities, of any form whatsoever, whether known or unknown, unforeseen, unanticipated, unsuspected or latent, which Releasing Party or Releasing Party's heirs, administrators, executors, successors in interest, and/or assigns have incurred or expect to incur, or now own or hold, or have at any time heretofore owned or held, or may at any time own, hold, or claim to hold by reason of any matter or thing arising from any cause whatsoever prior to the date of the Releasing Party's execution of this Release.
 
2.           Without limiting the generality of the foregoing, and by way of example only, I fully release and discharge each and all of the Released Parties from any and all claims, demands, rights, and causes of action that have been or could be alleged against any of said Released Parties (a) in connection with my employment, prior employment agreements, or the termination of such employment; (b) in connection with any and all matters pertaining to my employment by any of the Released Parties, including, but not limited to, any and all compensation, salaries, wages, bonuses, commissions, overtime, monies, pay, allowances, benefits, sick pay, severance pay, retention pay or benefits, paid leave benefits, vacation pay, penalties, interest, damages, and promises on any and all of the above; and (c) under or in connection with the state and federal age discrimination laws, as explained further in Section 3 below.  Notwithstanding the foregoing, this Release does not apply to any claims that cannot be released as a matter of law.
 
3.           Without limiting the scope of this Release in any way, I also certify that this Release constitutes a knowing and voluntary waiver of any and all rights or claims that exist or that I have or may claim to have under the Federal Age Discrimination in Employment Act ("ADEA"), as amended by the Older Workers Benefit Protection Act of 1990 ("OWBPA"), which is set forth at 29 U.S.C. § § 621, et seq .  This Release does not govern any rights or claims that may arise under the ADEA after the date this Release is signed by the Releasing Party.
 
 
-1-

 

4.           This Release extends to any and all claims including, but not limited to, any alleged (a) violation of the National Labor Relations Act, Title VII of the Civil Rights Act, the California Fair Employment and Housing Act, the Americans With Disabilities Act of 1990, the ADEA, as amended by the OWBPA, the Fair Labor Standards Act, the California Labor Code, the applicable California Wage Order, the California Private Attorneys General Act, the Occupational Safety and Health Act, the Consolidated Omnibus Budget Reconciliation Act of 1985; (b) discrimination on the basis of national origin, sex, race, religion, age, disability, marital status, or any other characteristic protected by law, breach of any express or implied employment contract or agreement, wrongful discharge, breach of the implied covenant of good faith and fair dealing, intentional or negligent infliction of emotional distress, fraud, retaliation, misrepresentation, defamation, interference with prospective economic advantage, failure to pay wages due or other monies owed; and (c) any other violation of any local, state or federal law, regulation or ordinance and/or public policy, contract, or tort or common law claim having any bearing whatsoever on the terms and conditions of employment with any of the Released Parties, including, but not limited to, any allegations for costs, fees, including attorneys' fees, incurred in any of these matters, which the Releasing Party ever had, now has, or may have as of the date of this Release.  Notwithstanding the foregoing, this Release does not apply to any claims that cannot be released as a matter of law.
 
5.           Acknowledge that I have been fully compensated for all labor and services performed for the Released Parties and have been reimbursed for all business expenses incurred on behalf of the Released Parties through the date I signed this Release, and that the Released Parties do not owe me any expense reimbursement amounts or any wages, including any vacation, paid time off benefits, or sick pay.
 
6.           Acknowledge that this Release constitutes written notice that the Releasing Party has been advised to consult with an attorney prior to executing this Release and that the Releasing Party has carefully considered other alternatives to executing this Release.
 
7.           Waive any right that I may have to re-employment by the Released Parties and agree that I have no expectation or intent for re-employment with the Released Parties.
 
8.           Agree not to damage, disparage, disrupt or interfere with the Released Parties' business or to undermine, in any way, the Released Parties' relationships or potential relationships with any actual or prospective employee, vendor or customer.  The Releasing Party further agrees not to make critical, negative or disparaging remarks about the Released Parties or their services or products.  The Releasing Party understands and agrees that any violation of this provision shall be a material breach of this Release.
 
9.           Understand that the aforementioned consideration is not to be construed as an admission on the part of said Released Parties of any liability whatsoever and that the Released Parties deny that they have engaged in any wrongdoing or have any liability whatsoever.
 
10.         Understand that the Released Parties dispute that any amounts whatsoever are owed to the Releasing Party, but wish to avoid the disruption, inconvenience, and the administrative, legal, and other costs associated with any litigation or other claims by the Releasing Party.  Accordingly, the RELEASING  PARTY AGREES  NOT TO DISCLOSE, PUBLICIZE OR ALLOW OR CAUSE TO BE PUBLICIZED OR DISCLOSED ANY OF THE TERMS AND CONDITIONS OF THIS RELEASE, THE SETTLEMENT, OR THAT THIS OR ANY SETTLEMENT OR RELEASE HAS BEEN ENTERED INTO, EXCEPT FOR DISCLOSURES TO THE RELEASING PARTY'S SPOUSE AND TAX CONSULTANT, UNLESS SUCH PUBLICATION OR DISCLOSURE IS REQUIRED OR COMPELLED BY LAW OR IS NECESSARY TO ENFORCE THIS RELEASE.
 
 
-2-

 
 
11.         Acknowledge that in the event of a lawsuit in which any party claims a breach of this Release, the prevailing party shall be entitled to reasonable attorneys' fees and costs.
 
12.         Agree to return all amounts paid pursuant to this Release and to indemnify and hold harmless each of the Released Parties for and against any and all costs, losses or liability, whatsoever, including reasonable attorneys' fees, caused by my breach of the non-disclosure or non-publicity provisions contained herein.  Furthermore, the Releasing Party agrees that the return or obligation to return any amounts paid pursuant to this Release due to the Releasing Party's breach of the non-disclosure or non-publicity provisions of this Release will not abrogate or affect in any way the Releasing Party's full release of any and all claims against the Released Parties.
 
13.         Except as otherwise provided for herein, the Releasing Party expressly releases any and all claims, damages, and causes of action whatsoever, of whatever kind or nature, whether known or unknown, or suspected or unsuspected, against the Released Parties.  The Releasing Party understands that this Release SHALL APPLY TO ALL UNKNOWN OR UNANTICIPATED CLAIMS, DAMAGES AND CAUSES OF ACTION, AS WELL AS THOSE KNOWN AND ANTICIPATED, and does hereby waive any and all rights under Section 1542 of the California Civil Code , which reads as follows:
 
Section 1542. A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known to him or her must have materially affected his or her settlement with the debtor.
 
14.         Understand and agree that the Releasing Party will not, for any reason, disclose to others or use for the benefit of anyone other than the Released Parties any trade secret, confidential or proprietary information of the Released Parties, including, but not limited to, information relating to the Released Parties' customers, clients, employees, consultants, affiliates, products, know-how, techniques, computer systems, programs, policies and procedures, research projects, future developments, costs, profits, pricing, customer and client business information.  The Releasing Party further understands and agrees that the use of any trade secret, confidential or proprietary information belonging to the Released Parties shall be a material breach of this Release.  The Releasing Party further certifies that he or she will not keep in his or her possession or under his or her control any specifications, formulae, notes, reports, proposals, correspondence, customer lists, sales bulletins, pricing information, planning documents, or copies of them, or any other property of the Released Parties.  The Releasing Party will return all such documents and property to the company after his or her separation from the company, and not later than 72 hours after this Release is executed.
 
15.         Acknowledge that I am aware of my right to revoke this Release at any time within the seven-day period following the date I sign it and that the Release shall not become effective or enforceable until the seven-day revocation period expires.  Revocation may be accomplished by providing written notice to:
 
STAAR Surgical Company
Attn:  Charles Kaufman

 
-3-

 

1911 Walker Avenue
Monrovia, CA 91016

I understand that I will relinquish any right I have to the consideration specified in this Release if I exercise my right to revoke it.
 
16.         Acknowledge that I am relying solely upon the contents of this Release and am not relying on any other representations whatsoever of the Released Parties as an inducement to enter into this agreement and Release.
 
17.         The Releasing Party further acknowledges that the Releasing Party (a) has read this Release, including Attachment "1", (b) has been provided a full and ample opportunity to study it, including a period of at least 45 days within which to consider it (although the Releasing Party may voluntarily choose to execute the Release earlier), (c) has been advised in writing to consult with an attorney prior to signing it, and (d) is signing it voluntarily with full knowledge that it is intended, to the maximum extent permitted by law, as a complete release and waiver of any and all claims.
 
Dated:
 
 
  
     
(Executive)
       
Dated:
  
 
 
     
Charles Kaufman
     
for STAAR Surgical Company

 
-4-

 

ATTACHMENT 1
 
[OWBPA Informational Disclosure]

 
-5-

 

Exhibit 31.1

Certifications

I, Barry Caldwell, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q of STAAR Surgical Company;
 
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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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)  Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c) 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
 
d) 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 officers 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 2, 2011
/s/ BARRY CALDWELL
 
Barry Caldwell
   
 
President, Chief Executive Officer, and
Director (principal executive officer)
 
 
 

 
 

Exhibit 31.2

Certifications

I, Deborah Andrews, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q of STAAR Surgical Company;
 
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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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)  Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c) 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
 
d) 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 officers 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 2, 2011
/s/ DEBORAH ANDREWS
   
 
Deborah Andrews
 
Chief Financial Officer
(principal financial officer)
 
 
 

 
 

Exhibit 32.1

 
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 filing of the Quarterly Report on Form 10-Q for the period ended September 30, 2011 (the “Report”) by STAAR Surgical Company (“Registrant”), each of the undersigned hereby certifies that:
 
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and
 
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Registrant as of and for the periods presented in the Report.
 
Dated:    November 2, 2011
/s/ BARRY CALDWELL
 
Barry Caldwell
   
 
President, Chief Executive Officer,
and Director (principal executive officer)
   
Dated:    November 2, 2011
/s/ DEBORAH ANDREWS
 
Deborah Andrews
   
 
Chief Financial Officer
(principal financial officer)
 
A signed original of this written statement required by 18   U.S.C. Section 1350   has been provided to STAAR Surgical Company and will be furnished to the Securities and Exchange Commission or its staff upon request.